e424b5
|
|
|
PROSPECTUS SUPPLEMENT
|
|
Filed Pursuant to Rule 424(b)(5) |
(To prospectus dated February 12, 2007)
|
|
Registration File No. 333-140034 |
CYCLACEL PHARMACEUTICALS, INC.
2,350,000 Shares of Common Stock
Warrants to Purchase 705,000 Shares of Common Stock
We are offering up to 2,350,000 shares of our common stock and warrants to purchase up to
705,000 shares of our common stock. Of the 3,055,000 shares of our common stock, 2,350,000 shares
are to be issued directly to the purchasers at the closing of the offering and the remaining
705,000 shares are issuable upon exercise of the warrants. The 2,350,000 shares of common stock and
the warrants to purchase 705,000 shares of our common stock will be sold in units, with each unit
consisting of one share of common stock and a five-year warrant to purchase 0.30 of one share of
common stock at an exercise price of $2.85 per share of common stock. Each unit will be sold at a
negotiated price of $2.50 per unit. Units will not be issued or certificated. The shares of common
stock and warrants are immediately separable and will be issued separately. We refer to the shares
of common stock issued or issuable hereunder upon exercise of the warrants, and the warrants to
purchase common stock issued hereunder, collectively, as the securities. For a more detailed
description of our common stock and warrants, see the section entitled Description of the
Securities We are Offering beginning on page S-15 of this prospectus supplement.
Our common stock is listed on The NASDAQ Global Market under the symbol CYCC. On January 20,
2010, the last reported sale price of our common stock on the NASDAQ Global Market was $2.61.
We are offering these shares of common stock and warrants to purchase common stock on a best
efforts basis primarily to institutional investors. We have retained Roth Capital Partners, LLC to
act as placement agent in connection with this offering.
Investing in our securities involves significant risks. See Risk Factors beginning on page
S-11 of this prospectus supplement and each of the Risk Factors beginning on page 12 of the
accompanying prospectus.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of this
prospectus supplement or the accompanying prospectus. Any representation to the contrary is a
criminal offense.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Maximum |
|
|
Per Unit |
|
Offering Amount |
Public offering price |
|
$ |
2.50 |
|
|
$ |
5,875,000 |
|
Placement agents fees |
|
$ |
0.125 |
|
|
$ |
293,750 |
|
Proceeds, before expenses, to us |
|
$ |
2.375 |
|
|
$ |
5,581,250 |
|
We estimate the total expenses of this offering, excluding the placement agents fees, will be
approximately $136,750. Because there is no minimum offering amount required as a condition to
closing in this offering, the actual offering amount, the placement agents fees and net proceeds
to us, if any, in this offering may be substantially less than the total maximum offering amounts
set forth above. We are
not required to sell any specific number or dollar amount of the units offered in this offering,
but the placement agent will use its best efforts to arrange for the sale of all of the units
offered.
Roth Capital Partners
The date of this prospectus supplement is January 21, 2010.
TABLE OF CONTENTS
Prospectus Supplement
|
|
|
|
|
|
|
|
S-2 |
|
|
|
|
S-11 |
|
|
|
|
S-12 |
|
|
|
|
S-13 |
|
|
|
|
S-14 |
|
|
|
|
S-15 |
|
|
|
|
S-17 |
|
|
|
|
S-19 |
|
|
|
|
S-19 |
|
|
|
|
S-19 |
|
|
|
|
S-20 |
|
|
Prospectus |
|
|
|
|
|
|
|
2 |
|
|
|
|
3 |
|
|
|
|
7 |
|
|
|
|
24 |
|
|
|
|
24 |
|
|
|
|
25 |
|
|
|
|
25 |
|
|
|
|
27 |
|
|
|
|
36 |
|
|
|
|
37 |
|
|
|
|
42 |
|
|
|
|
45 |
|
|
|
|
46 |
|
|
|
|
46 |
|
|
|
|
46 |
|
|
|
|
47 |
|
|
|
|
47 |
|
i
You should rely only on the information contained in this prospectus supplement, the
accompanying prospectus or information incorporated by reference herein. We have not authorized
anyone else to provide you with different information. You should not assume that the information
in this prospectus supplement or the accompanying prospectus is accurate as of any date other than
the date on the front of those documents or that any document incorporated by reference is accurate
as of any date other than its filing date. You should not consider this prospectus supplement or
the accompanying prospectus to be an offer or solicitation relating to the securities in any
jurisdiction in which such an offer or solicitation relating to the securities is not authorized.
Furthermore, you should not consider this prospectus supplement or the accompanying prospectus to
be an offer or solicitation relating to the securities if the person making the offer or
solicitation is not qualified to do so, or if it is unlawful for you to receive such an offer or
solicitation.
This prospectus supplement is part of a registration statement that we have filed with the
Securities and Exchange Commission utilizing a shelf registration process. Under this shelf
registration process, we are offering to sell our common stock and warrants to purchase our common
stock, which we refer herein collectively as the securities, using this prospectus supplement and
the accompanying prospectus. In this prospectus supplement, we provide you with specific
information about the securities that we are selling in this offering. Both this prospectus
supplement and the accompanying prospectus include important information about us, our securities
being offered and other information you should know before investing. This prospectus supplement
also adds, updates and changes information contained in the accompanying prospectus. You should
read this prospectus supplement and the accompanying prospectus as well as additional information
described under Incorporation of Certain Documents by Reference on page 47 of the accompanying
prospectus before investing in our securities.
S-1
PROSPECTUS SUPPLEMENT SUMMARY
This summary highlights certain information appearing elsewhere in this prospectus
supplement and in the accompanying prospectus and in the documents we incorporate by reference.
After you read this summary, you should read and consider carefully the more detailed information
and financial statements and related notes that we include in and/or incorporate by reference into
this prospectus supplement and the accompanying prospectus, especially the section entitled Risk
Factors. If you invest in our securities, you are assuming a high degree of risk.
Our Company
We are a diversified biopharmaceutical company dedicated to the discovery, development and
commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious
disorders. Our strategy is focused on leading edge therapeutic management of cancer patients based
on our clinical development pipeline, led by sapacitabine, and the medicines marketed by our
subsidiary, ALIGN Pharmaceuticals, LLC, or ALIGN. Our core area of expertise is in cell cycle
biology, or the processes by which cells divide and multiply. We have concentrated since our
inception on the discovery and development of orally available anticancer agents that target the
cell cycle with the aim of eradicating cancer cells to slow the progression or shrink the size of
tumors, enhancing quality of life and improving survival rates of cancer patients. We market
directly in the United States Xclair® Cream for dermatoses, such as radiation
dermatitis, and Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia or dry
mouth.
We are focusing our clinical development priorities on:
|
|
|
Sapacitabine in acute myeloid leukemia, or AML, in elderly patients; |
|
|
|
|
Sapacitabine in myelodysplastic syndromes, or MDS, in older patients; and |
|
|
|
|
Sapacitabine in non-small cell lung cancer, or NSCLC. |
The Company has additional ongoing programs in clinical development which are currently
pending the availability of clinical data. Once these data become available and are reviewed, we
will determine the feasibility of pursuing further development and/or partnering of these assets
including sapacitabine in combination with seliciclib, seliciclib in nasopharyngeal cancer, or NPC,
and NSCLC and CYC116.
We were founded by Professor Sir David Lane, a recognized leader in the field of tumor
suppressor biology who discovered the p53 protein, which operates as one of the bodys own
anticancer drugs by regulating the function of cell cycle targets. Our Chief Scientist, Professor
David Glover, is a recognized leader in the biology of mitosis, or cell division. Professor Glover
discovered, among other cell cycle targets, the mitotic kinases, Polo and Aurora, enzymes that act
in the cell division, or mitosis phase, of the cell cycle. Our expertise in cell cycle biology is
at the center of our business strategy to build a diversified biopharmaceutical business focused in
oncology, hematology and other therapeutic areas based on a portfolio of commercial products and a
development pipeline of novel drug candidates.
We are advancing three of our anticancer drug candidates, seliciclib, sapacitabine and CYC116,
through in-house development activities. We are also progressing further novel drug series which
are at
S-2
earlier stages. Taken together, our pipeline covers all four phases of the cell cycle, which we
believe will improve the chances of successfully developing and commercializing novel drugs that
work on their own or in combination with approved conventional chemotherapies or with other
targeted drugs to treat human cancers.
Sapacitabine
Our lead candidate, sapacitabine, is an orally available prodrug of CNDAC, which is a novel
nucleoside analog, or a compound with a structure similar to a nucleoside. A prodrug is a compound
that has a therapeutic effect after it is metabolized within the body. CNDAC has a significantly
longer residence time in the blood when it is produced in the body through metabolism of
sapacitabine than when it is given directly. Sapacitabine acts through a dual mechanism whereby the
compound interferes with DNA synthesis by causing single-strand DNA breaks and induces arrest of
the cell division cycle at G2/M checkpoint. A number of nucleoside drugs, such as gemcitabine, or
Gemzar®, from Eli Lilly, and cytarabine, also known as Ara-C, a generic drug, are in
wide use as conventional chemotherapies. Both sapacitabine and its major metabolite, CNDAC, have
demonstrated potent anti-tumor activity in both blood and solid tumors in preclinical studies. In a
liver metastatic mouse model, sapacitabine was shown to be superior to gemcitabine and 5-FU, two
widely used nucleoside analogs, in delaying the onset and growth of liver metastasis. We have
retained worldwide rights to commercialize sapacitabine, except for Japan, for which Daiichi-Sankyo
Co., Ltd., or Daiichi-Sankyo, has a right of first negotiation.
We are currently exploring sapacitabine in both hematalogic cancers and solid tumors. To date,
sapacitabine has been evaluated in approximately 400 patients in several Phase 1 and 2 studies and
has shown signs of anti-cancer activity.
Hematological Cancers
Phase 1 clinical trial in patients with advanced leukemias and myelodysplastic syndromes
In December 2007, at the American Society of Hematology, or ASH, annual meeting, we reported
interim results from a Phase 1 clinical trial of oral sapacitabine in patients with advanced
leukemias and MDS. The data demonstrated that sapacitabine had a favorable safety profile and
promising anti-leukemic activity in patients with relapsed and refractory AML and MDS when
administered by two different dosing schedules. The primary objective of the study is to determine
the maximum tolerated dose, or MTD, of sapacitabine administered twice daily for seven consecutive
days every 21 days or three consecutive days per week for two weeks every 21 days. The MTD was
reached at 375 mg on the seven-day schedule and 475 mg on the three-day schedule. Dose-limiting
toxicity was gastrointestinal which included abdominal pain, diarrhea, small bowel obstruction and
neutropenic colitis. One patient treated at the MTD of 375 mg on the seven-day schedule died of
complications from neutropenic colitis. Among 46 patients, 42 with AML and 4 with MDS, in this dose
escalating study, the best responses were complete remission, or CR, or complete remission without
platelet recovery, or CRp, in six patients for an Overall Response Rate of 13%. In addition, 15
patients had a significant decrease in bone marrow blasts including seven with blast reduction to
5% or less. The study was conducted at The University of Texas M. D. Anderson Cancer Center and is
led by Hagop Kantarjian, M.D., Professor of Medicine and Chairman of the Leukemia Department and
Dr. William Plunkett, Professor and Chief, Section of Molecular and Cellular Oncology, Department
of Experimental Therapeutics.
S-3
Phase 2 randomized clinical trial in elderly patients with AML previously untreated or in
first relapse
In December 2007, we initiated an open-label, multicenter, randomized Phase 2 clinical trial
of oral sapacitabine in 60 elderly patients with AML aged 70 or older who are previously untreated
or in first relapse. The Phase 2 study, led by Dr. Kantarjian, has a primary endpoint of one year
survival rate of three dosing schedules of sapacitabine in elderly patients with previously
untreated or first relapsed AML. Secondary objectives are to assess CR or CRp, partial remission,
or PR, duration of CR or CRp, or major hematological improvement and their corresponding durations,
transfusion requirements, number of hospitalized days and safety. The study uses a selection design
with the objective of identifying a dosing schedule among three different arms, A. 200 mg twice
daily for seven days every 21 days, B. 300 mg twice daily for seven days every 21 days and C. 400
mg twice daily for three days per week for two weeks every 21 days, which produces a better one
year survival rate in the event that all three dosing schedules are active. Each arm enrolled and
treated 20 patients. Approximately 55% of patients had AML de novo and the rest had AML preceded by
antecedent hematological disorder, or AHD, such as MDS, or myeloproliferative disease. Eighty
percent of the patients were untreated and twenty percent in first relapse. We completed enrollment
of 60 AML patients in this study in October 2008. In December 2009, at the 51st Annual Meeting of
the American Society of Hematology, or ASH, we reported one-year survival data.
The primary endpoint of one-year survival was 35% on Arm A, 30% on Arm C and 10% on Arm B.
The median overall survival was 212 days on Arm C (range of 13 to over 654 days), 197 days on Arm A
(range of 26 to over 610 days) and 100 days on Arm B (range of 6 to over 646 days). Overall
response rate, a secondary endpoint, was 45% on Arm A, 35% on Arm C and 25% on Arm B with CR rate
of 25% on Arm C and 10% on Arms A and B. Thirty-day mortality was 10.0% on Arm C and Arm A and
20.0% on Arm B. Approximately 30% of all patients received sapacitabine for at least 6 cycles.
Fifteen patients who survived one year or more received an average of 12 treatment cycles.
Exploratory subgroup analysis suggests that (i) Arm C may be more effective for de novo AML
and (ii) Arm A may be more effective for AML preceded by AHD, such as MDS.
The 3-day dosing schedule in Arm C was selected for further clinical development in elderly
patients with de novo AML based on a one-year survival rate of 30%, ORR of 35% with durable CRs.
The 7-day dosing schedule in Arm A was selected for further clinical development in elderly
patients with AML preceded by AHD based on a one-year survival rate of 35%, ORR of 45% with durable
hematological improvement.
Randomized Phase 2 clinical trial in older patients with MDS as a second-line treatment
In September 2008, we advanced sapacitabine into Phase 2 development as a second-line
treatment in patients aged 60 or older with MDS who are previously treated with hypomethylating
agents. The MDS stratum of the study is designed as a protocol amendment expanding the ongoing
Phase 2 trial of sapacitabine in AML described above, to include a cohort of patients with MDS.
Patients with MDS often progress to AML. The primary objective of the MDS stratum is to evaluate
the one-year survival rate of three dosing schedules of sapacitabine. Secondary objectives are to
assess the number of patients who have achieved CR or CRp, PR, hematological improvement and their
corresponding durations, transfusion requirements, number of hospitalization days and safety. The
study uses a selection design with the objective of identifying a dosing schedule which produces a
better one year survival rate for each stratum in the event that all three dosing schedules are
active.
S-4
In December 2009, at the ASH Annual Meeting we reported interim response data for the ongoing
Phase 2 clinical trial of sapacitabine in older patients with MDS. The study has recently completed
enrollment of 60 patients aged 60 or older with MDS who were previously treated with azacitidine
and/or decitabine. Each arm enrolled 20 patients randomized across the same three dosing schedules
of sapacitabine (Arms A, B and C) tested in the AML stratum of the study. Forty-nine of the
patients enrolled have been followed-up for more than 30 days. Approximately 46% of the 49 patients
had baseline bone marrow blast counts above 10%.Based on interim data, the highest number of
responses was observed on Arm B, the 7-day high dose schedule. Thirty-day mortality from
all-causes is 8.2%. Approximately 30% of the patients received 4 or more cycles of sapacitabine.
Pivotal trial plan for sapacitabine for the treatment of hematological malignancies.
In December 2009, we announced that we held a Type A meeting with the U.S. Food and Drug
Administration (FDA) to discuss a randomized Phase 3 study design for our oral sapacitabine
capsules in AML and separately in MDS. Based on the FDAs confirmation that the proposed study
design would be acceptable for a Special Protocol Assessment (SPA), we plan to submit a SPA request
during the first quarter of 2010. We expect to start enrolling patients in such a pivotal study
within 2010. The SPA process allows for official FDA evaluation of clinical protocols of a Phase 3
clinical trial intended to form the primary basis for an efficacy claim. A SPA provides trial
sponsors with a binding FDA agreement that the design and analysis of the trial adequately address
objectives in support of a submission for a marketing application if the trial is performed
according to the SPA. The SPA agreement may only be changed through a written agreement between the
sponsor and the FDA or if the FDA becomes aware of a substantial scientific issue essential to
product efficacy or safety.
Solid Tumors
Phase 1 clinical trials in patients with refractory solid tumors or lymphomas
Two Phase 1 studies of sapacitabine were completed by Daiichi-Sankyo, from which we
in-licensed sapacitabine, evaluating 87 patients in refractory solid tumors. In addition we
conducted a Phase 1b dose escalation clinical trial in patients with refractory solid tumors or
lymphomas. Preliminary results of the Phase 1b study were reported at the EORTC-NCI-AACR Molecular
Targets and Cancer Therapeutics meeting in November 2006. The primary objective of the study was to
evaluate the safety profile of sapacitabine administered twice daily for 14 consecutive days or 7
consecutive days every 21 days. Of the 37 treated patients, 28 received the drug twice daily for 14
days and 9 received the drug twice daily for 7 days. The dose-limiting toxicity was reversible
myelosuppression. One patient treated at the maximum tolerated dose died of candida sepsis in the
setting of grade 4 neutropenia and thrombocytopenia. Non-hematological toxicities were mostly mild
to moderate. The best response by investigator assessment was stable disease in 13 patients, five
with non-small cell lung cancer, two with breast cancer, two with ovarian cancer and one each with
colorectal cancer, adenocarcinoma of unknown primary, gastrointestinal stromal tumor, and parotid
acinar carcinoma.
Phase 2 clinical trial in patients with cutaneous T-cell lymphoma, or CTCL
In April 2007, we initiated a Phase 2 clinical trial in patients with advanced CTCL, a cancer
of T-lymphocytes, or white blood cells, which causes disfiguring skin lesions and severe itching.
The primary objective of the study is to evaluate tolerability and response rate of 50 mg and 100
mg regimens of sapacitabine both twice a day for three days per week for two weeks in a three week
cycle in patients with progressive, recurrent, or persistent CTCL on or following two systemic
therapies. The study uses a selection design to choose an optimal dose if both are active.
Secondary objectives are to assess response duration, time to response, time to progression and
relief of pruritus or itching. Non-hematological
S-5
toxicities were mostly mild to moderate. The best response by investigator assessment was partial
response in 3 patients out of 16 enrolled.
Phase 2 clinical trial in patients with non-small cell lung cancer
In January 2009, we began treating patients in a Phase 2, open label, single arm, multicenter
clinical trial in patients with NSCLC who have had one prior chemotherapy. This study builds on the
observation of prolonged stable disease of four months or longer experienced by heavily pretreated
NSCLC patients involved in two Phase 1 studies of sapacitabine. The multicenter Phase 2 trial is
led by Philip D. Bonomi, M.D., at Rush University Medical Center, Chicago. The primary objective of
the study is to evaluate the rate of response and stable disease in patients with previously
treated NSCLC. Secondary objectives are to assess progression-free survival, duration of response,
duration of stable disease, one year survival, overall survival and safety. The study will enroll
approximately 40 patients and has a lead-in phase for dose escalation with the objective of
defining a recommended dose followed by a second stage in which patients will be treated at the
recommended dose.
EU Orphan Designation
During May 2008, we received designation from the European Medicines Evaluation Agency, or
EMEA, for sapacitabine as an orphan medicine in two separate indications: AML and MDS. The EMEAs
Committee for Orphan Medicinal Products, or COMP, adopted a positive opinion on the Companys
application to designate sapacitabine as an orphan medicinal product for the indications of AML and
MDS. The objective of European orphan medicines legislation is to stimulate research and
development of medicinal products for rare diseases by providing incentives to industry. An orphan
designation in the European Union confers a range of benefits to sponsor companies including market
exclusivity for a period of 10 years, EMEA scientific advice on protocol development, direct access
to the centralized procedure for review of marketing authorizations, EMEA fee reductions and
eligibility for grant support from European agencies.
Seliciclib
Our second drug candidate, seliciclib, is a novel, first-in-class, orally available, CDK
inhibitor. The compound selectively inhibits a spectrum of enzyme targets -CDK2/E, CDK2/A, CDK7 and
CDK9- that are central to the process of cell division and cell cycle control. Preclinical studies
have shown that the drug works by inducing cell apoptosis, or cell suicide, in multiple phases of
the cell cycle. To date, seliciclib has been evaluated in approximately 400 patients in several
Phase 1 and 2 studies and has shown signs of anti-cancer activity. We have retained worldwide
rights to commercialize seliciclib.
Phase 1 clinical trials in patients with refractory solid tumors
We have completed two Phase 1 trials that enrolled 24 healthy volunteers and three Phase 1
trials that enrolled a total of 84 cancer patients testing different doses and schedules. The
primary toxicities observed were of a non-hematological nature, including asthenia or weakness,
elevation of liver enzymes, hypokalemia or decreased potassium levels, nausea and vomiting and
elevation in creatinine. Although these trials were designed to test safety rather than efficacy of
seliciclib given alone as monotherapy in patients with solid tumors who failed multiple previous
treatments, several of these patients appeared to have benefited from seliciclib treatment.
Seliciclib was shown in a further Phase 1 study sponsored and conducted by independent
investigators to have clinical antitumor activity in patients with nasopharyngeal cancer, measured
as a
S-6
decrease in the size of primary tumor and involved lymph nodes, as well as an increase in tumor
cell deaths by biomarker analyses.
Phase 2 clinical trials in patients with NSCLC or breast cancer
Four Phase 2 trials have been conducted in cancer patients to evaluate the tolerability and
antitumor activities of seliciclib alone or in combination with standard chemotherapies used in the
treatment of advanced NSCLC or breast cancer. Interim data from two Phase 2 open-label studies of a
total of 52 patients with NSCLC, suggest that seliciclib treatment did not aggravate the known
toxicities of standard first and second-line chemotherapies nor appear to cause unexpected
toxicities, although these trials were not designed to provide statistically significant
comparisons. The combination of seliciclib with a standard dose of capecitabine was not well
tolerated in patients with advanced breast cancer.
Seliciclib is currently being investigated in the Phase 2b APPRAISE study as a treatment for
patients with advanced NSCLC. APPRAISE is a double-blinded, randomized study of single agent
seliciclib versus best supportive care in patients with NSCLC treated with at least two prior
systemic therapies. APPRAISE is led by Chandra P. Belani, M.D. at Milton S. Hershey Medical Center,
Penn State University and Alan B. Sandler, M.D. at Vanderbilt-Ingram Cancer Center. The studys
main objective is to learn the anti-tumor activity of seliciclib as a single agent in refractory
NSCLC and help determine further development strategies. The study design is randomized
discontinuation. All patients receive seliciclib at a dose of 1200 mg twice a day for three days
for at least three cycles of two weeks each. Patients who achieve stable disease after three cycles
will be randomized to continue on seliciclib or receive placebo with best supportive care. Patients
in the placebo arm who progress will be given the option to cross-over and again receive
seliciclib. The primary efficacy endpoint of APPRAISE is doubling progression free survival or PFS
measured in the randomized portion of the study.
In August 2008, we announced that an independent data review committee, or IDRC, completed a
review of the first interim analysis data from the study. The IDRC assessed the safety profile of
seliciclib and recommended that the study continue after reviewing data from 173 patients with
previously-treated NSCLC, of whom 45 proceeded into the blinded portion of the study and were
randomized to receive either seliciclib or best supportive care. Based on the interim data, the
IDRC reached the following main conclusions: there were no safety concerns that would warrant
stopping the study; there was no trend favoring the seliciclib treatment arm; and as a definitive
conclusion could not be reached because of the low number of events, it was recommended that the
study be continued. Based on our cost versus benefit analysis we decided not to enroll additional
patients. The APPRAISE trial continues with the 191 patients already enrolled until the last
enrolled patient has completed follow-up. In accordance with the protocol, we remain blinded to the
study data.
Phase 2 clinical trials in patients with NPC
In November 2007, we commenced a Phase 2 multicenter, international, blinded randomized study
of oral seliciclib as a single agent in patients with NPC. The primary objective is to evaluate
6-month progression free survival, or PFS, of two dosing schedules of seliciclib in approximately
75 patients with previously treated NPC. Secondary objectives are overall survival, response rate,
response duration, safety and tolerability. The first part of the study is designed to confirm
safety and tolerability of 400 mg twice a day for four days per week or 800 mg once a day for four
days per week of seliciclib. It is open to approximately 12 to 24 patients with advanced solid
tumors as well as patients with NPC. The second part of the study is designed to detect major
differences between the two dosing schedules of seliciclib and a placebo group in terms of 6-month
PFS in approximately 51 patients. The start of the second part of the study is dependent on
clinical data from the lead-in phase and available resources.
S-7
In May 2009, at the American Society of Clinical Oncology, or ASCO, annual meeting, we
reported interim data from the lead-in portion of the Phase 2 study which demonstrated that oral
seliciclib could be safely administered in two dosing schedules which were well tolerated and met
the criteria for proceeding to the randomized stage of the study. Seliciclib treatment resulted in
prolonged stable disease in 70% of previously-treated NPC patients, including 3 with stable disease
lasting longer than 8 months, suggesting seliciclib inhibits tumor growth in NPC. The data supports
further clinical development of oral seliciclib in NPC.
CYC116
In June 2007, we initiated a multicenter Phase 1 pharmacologic clinical trial of CYC116, an
orally-available inhibitor of Aurora kinase A and B and VEGFR2, in patients with advanced solid
tumors. The multicenter Phase 1 trial, currently on-going, is designed to examine the safety and
tolerability of CYC116 in patients with advanced solid tumors. The primary objective of the study
is to determine the maximum tolerated dose. Secondary objectives are to evaluate pharmacokinetic
and pharmacodynamic effects of the drug and document anti-tumor activity. Aurora kinases, or AK,
are a family of serine/threonine protein kinases discovered by Professor David Glover, our Chief
Scientist, that are only expressed in actively dividing cells and are crucial for the process of
cell division or mitosis. These proteins, which have been found to be over-expressed in many types
of cancer, have generated significant scientific and commercial interest as cancer drug targets.
VEGFR2 is a receptor protein that plays a key regulatory role in the angiogenesis pathway, or blood
vessel formation. VEGFR is targeted by recently approved drugs such as bevacizumab and sorafenib
indicated for the treatment of several solid cancers, such as breast, colorectal, kidney, liver and
lung. We have retained worldwide rights to commercialize CYC116.
Other programs
We have allocated limited resources to other programs allowing us to maintain and build on our
core competency in cell cycle biology and related drug discovery. In our second generation CDK
inhibitor program, we have discovered over 600 novel CDK inhibitors that we believe may prove to be
more potent anticancer agents than seliciclib based on preclinical observations. Our polo-like
kinase, or Plk, inhibitor program targets the mitotic phase of the cell cycle with the objective of
identifying potent and selective compounds which inhibit Plk1, a kinase active during mitosis. Plk
was discovered by Professor David Glover, our Chief Scientist. The Company has a number of earlier
stage programs for which no resources will be allocated in accordance with our revised operating
plan announced in September 2008.
For example, extensive preclinical data published by independent investigators evidence
activity by our CDK inhibitors, including seliciclib, in various autoimmune and inflammatory
diseases including lupus nephritis, pulmonary kidney disease, idiopathic pulmonary fibrosis and
rheumatoid arthritis. In our GSK-3 inhibitor program we have demonstrated evidence of activity in
preclinical models of Type 2 Diabetes. Where appropriate we intend to progress such programs
through collaboration with groups that specialize in the particular mechanism of action or disease
area.
Commercial products
In October 2007, we acquired exclusive rights to sell and distribute three products in the
United States, through our ALIGN Pharmaceuticals subsidiary, used primarily to manage the effects
of radiation or chemotherapy in cancer patients. All three products, Xclair® Cream,
Numoisyn® Liquid and Numoisyn® Lozenges, are approved in the United States
under FDA 510(k) or medical device registrations and were launched in the United States in January
2006.
S-8
Xclair® Cream
Xclair is an aqueous cream containing sodium hyaluronate, or hyaluronic acid, glycyrrhetinic
acid and telmesteine. Xclair is approved by FDA for the relief of symptoms associated with
dermatoses or inflammation of the skin. Cancer patients suffer dermatoses as a result of radiation
treatment, a condition called radiation dermatitis, and pharmacological treatment, such as the
acneiform dermatoses caused by epidermal growth factor receptor, or EGFR, inhibitor drugs such as
cetuximab and erlotinib, and the hand-and-foot syndrome caused by drugs such as capecitabine and
sorafenib.
Numoisyn® Lozenges & Numoisyn® Liquid
Numoisyn Lozenges are taken by mouth and contain malic acid and sorbitol to stimulate normal
salivation. Numoisyn Lozenges are approved by FDA for the treatment of xerostomia, or dry mouth,
and
for temporary relief of dry mouth due to damaged salivary function in patients with some residual
secretory function and taste perception. Numoisyn Lozenges have been demonstrated to be safe and
effective for long-term use and are well tolerated by patients. Numoisyn Liquid is an oral solution
that contains linseed extract which in turn contains mucins that provide superior viscosity,
similar to that of natural saliva, and reduced friction compared to water or
carboxymethylcellulose-based solutions. Numoisyn Liquid is approved by FDA for the relief of
symptoms of xerostomia, or dry mouth, by enhancing swallowing, improving speech mechanics, and
lubricating the oral cavity like natural saliva. Numoisyn Liquid may be used to replace natural
saliva when salivary glands are damaged or not functioning. Xerostomia is caused by chemotherapy,
radiotherapy, Sjogrens syndrome, an autoimmune disease, or oral inflammation.
Corporate Information
Our corporate headquarters are located at 200 Connell Drive, Suite 1500, Berkeley
Heights, New Jersey, 07922, and our telephone number is (908) 517-7330. This is also where our
marketing, medical and regulatory functions are located. Our research facility is located in
Dundee, Scotland, which is also the center of our translational work and development programs.
S-9
The Offering
|
|
|
Common stock offered by us
|
|
2,350,000 shares directly |
|
|
|
|
|
705,000 shares issuable upon exercise of warrants |
|
|
|
Warrants
|
|
Warrants to purchase 705,000 shares of common stock
will be offered in this offering. The warrants will
be exercisable beginning on the date that is six
months after the date of original issuance and at
any time up to the date that is five years after
such date of issuance at an exercise price of $2.85
per share of common stock. |
|
|
|
Common stock outstanding before
this offering
|
|
29,043,080 shares |
|
|
|
Common stock to be outstanding
after this offering
|
|
31,393,080 shares |
|
|
|
Use of proceeds
|
|
We intend to use the net proceeds this offering for
general corporate purposes, including our internal
discovery and development programs and the
development of new technologies and general working
capital. See Use of Proceeds on page S-13. |
|
|
|
NASDAQ Global Market symbol
|
|
CYCC |
Our common stock to be outstanding after this offering is based on 29,043,080 shares
outstanding as of January 20, 2010, and excludes the following as of that date:
|
|
|
3,274,307 shares of common stock issuable upon the exercise of outstanding
options, restricted stock and restricted common stock units at a weighted-average
exercise price of $4.12 per share; |
|
|
|
|
715,951 shares of common stock available for issuance under our 2006
Equity Incentive Plan; |
|
|
|
|
8,386,863 shares of common stock issuable upon the exercise of outstanding
warrants at a weighted-average exercise price of $4.13 per share, including the
warrants to purchase 705,000 shares of common stock offered hereby; and |
|
|
|
|
870,980 shares of common stock, subject to adjustment, that are issuable
upon the conversion of 2,046,813 shares of convertible preferred stock that are issued
and outstanding. |
S-10
RISK FACTORS
Investing in our common stock involves a high degree of risk. You should carefully consider
the risk factors beginning on page 12 of the accompanying prospectus, as well as the risks
discussed under the caption Risk Factors in our Annual Report on Form 10-K for the year ended
December 31, 2008, and in our Quarterly Report on Form 10-Q for the three-month period ended
September 30, 2009, each of which is incorporated by reference into this prospectus supplement. If
any of these risks actually occur, our business, financial condition and results of operations
would suffer. In that case, the trading price of our common stock would likely decline and you
might lose all or part of your investment in our common stock.
Investors in this offering will pay a much higher price than the book value of our stock.
If you purchase common stock and warrants to purchase common stock in this offering, you will
incur immediate and substantial dilution in net tangible book value of $2.00 per share, after
giving effect to the sale by us of 2,350,000 shares included in the units in this offering at the
public offering price of $2.50 per share. Net tangible book value per share represents our total
tangible assets less our total liabilities, divided by the aggregate number of shares of our common
stock outstanding.
Our management will have broad discretion over the use of the net proceeds from this offering. You
may not agree with how we use the proceeds and the proceeds may not be invested successfully.
Our management will have broad discretion as to the use of the net proceeds from any offering
by us and could use them for purposes other than those contemplated at the time of this offering.
Accordingly, you will be relying on the judgment of our management with regard to the use of these
net proceeds, and you will not have the opportunity as part of your investment decision to assess
whether the proceeds are being used appropriately. It is possible that the proceeds will be
invested in a way that does not yield a favorable, or any, return for our company.
S-11
CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION
This prospectus supplement and the accompanying prospectus and the documents we have filed
with the SEC that are incorporated by reference into this prospectus supplement and the
accompanying prospectus contain forward-looking statements, within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that involve
risk and uncertainties. Any statements contained, or incorporated by reference, in this prospectus
supplement and the accompanying prospectus that are not statements of historical fact may be
forward-looking statements. When we use the words anticipates, plans, expects and similar
expressions, we are identifying forward-looking statements. Forward-looking statements involve
risks and uncertainties which may cause our actual results, performance or achievements to be
materially different from those expressed or implied by forward-looking statements. These factors
include, among others, the uncertainties associated with product research and development, the risk
that clinical trials by us or our collaborators will not commence or proceed as planned, the risks
and uncertainties associated with dependence upon the actions of our collaborators and of
government regulatory agencies, the risk that our intellectual property rights may be infringed or
challenged by third parties, the uncertainty of future profitability and other factors set forth
more fully in this prospectus supplement and the accompanying prospectus, including those described
under the caption Risk Factors beginning of page 7 of the accompanying prospectus.
Although we believe that the expectations reflected in the forward-looking statements are
reasonable, we cannot guarantee future results, levels of activity, performance or achievements.
Except as may be required by law, we do not intend to update any of the forward-looking statements
for any reason after the date of this prospectus supplement to conform such statements to actual
results or if new information becomes available.
All forward-looking statements attributable to us, or to persons acting on our behalf, are
expressly qualified in their entirety by these cautionary statements.
S-12
USE OF PROCEEDS
We estimate that the net proceeds from this offering will be approximately $5.4 million after
deducting the placement agents fees and estimated offering expenses. This amount does not include
the proceeds which we may receive in connection with the exercise of the warrants. We intend to use
the net proceeds of this offering for general corporate purposes, including our internal discovery
and development programs and general working capital. Pending use of the net proceeds, we intend to
invest these net proceeds in interest bearing investment grade securities.
S-13
DILUTION
Our net tangible book value as of September 30, 2009, was approximately $7.9 million, or $0.32
per share of common stock. Net tangible book value per share is calculated by subtracting our total
liabilities from our total tangible assets, which is total assets less intangible assets, and
dividing this amount by the number of shares of common stock outstanding. After giving effect to
the sale by us of the 2,350,000 shares of common stock included in the units offered in this
offering, at a public offering price of $2.50 per share and after deducting the placement agents
fees and estimated offering expenses payable by us, our net tangible book value as of September 30,
2009, would have been approximately $13.4 million, or $0.50 per share of common stock. This
represents an immediate increase in net tangible book value of $0.18 per share to our existing
stockholders and an immediate and substantial dilution of $2.00 per share to new investors. The
following table illustrates this per share dilution:
|
|
|
|
|
|
|
|
|
Offering price per share |
|
|
|
|
|
$ |
2.50 |
|
Net tangible book value per share as of September 30, 2009 |
|
$ |
0.32 |
|
|
|
|
|
Increase per share after the offering |
|
$ |
0.18 |
|
|
|
|
|
Net tangible book value per share after this offering |
|
|
|
|
|
$ |
0.50 |
|
Dilution per share to new investors |
|
|
|
|
|
$ |
2.00 |
|
The foregoing table does not take into account further dilution to new investors that could
occur upon the exercise of outstanding options and warrants having a per share exercise price less
than the per share offering price to the public in this offering, including the warrants to
purchase 705,000 shares of common stock offered hereby. As of September 30, 2009, there were
24,483,129 shares of common stock outstanding, which does not include:
|
|
|
3,538,933 shares of common stock issuable upon exercise of options
outstanding as of September 30, 2009, at a weighted average exercise price of $4.14 per
share. |
|
|
|
|
7,044,363 shares of common stock issuable upon exercise of warrants
outstanding as of September 30, 2009, at a weighted average exercise price of $4.47 per
share. |
|
|
|
|
141,700 shares of common stock issuable upon the vesting of restricted
stock units outstanding as of September 30, 2009. |
|
|
|
|
870,980 shares of common stock issuable upon conversion of the Convertible
Preferred Stock outstanding as of September 30, 2009. |
S-14
DESCRIPTION OF THE SECURITIES WE ARE OFFERING
In this offering, we are offering a maximum of 2,350,000 units, consisting of 2,350,000 shares
of common stock and warrants to purchase an aggregate of 705,000 shares of common stock. Each unit
consists of one (i) share of common stock and (ii) one warrant to purchase 0.30 of one share of
common stock, such warrant being exercisable at an exercise price of $2.85 per share. This
prospectus supplement also relates to the offering of 705,000 shares of our common stock issuable
upon exercise, if any, of the warrants.
Common Stock
A description of the common stock we are offering pursuant to this prospectus supplement is
set forth under the heading Description of Common Stock, starting on page 25 of the prospectus.
As of January 20, 2010, we had 29,043,080 shares of common stock outstanding.
Warrants
The warrants offered in this offering will be issued in registered form pursuant to a
subscription agreement between each of the purchasers and us. You should review the forms of
subscription agreement and warrant, which are attached thereto and which will be filed as exhibits
to a Current Report on Form 8-K filed with the Securities and Exchange Commission in connection
with this offering, for a complete description of the terms and conditions applicable to the
warrants. The following is a brief summary of the warrants and is subject in all respects to the
provisions contained in such warrants.
Terms Applicable to the Warrants
Exercisability. Holders may exercise the warrants beginning on the date that is six months
after the date of original issuance and at any time up to the date that is five years after such
date of issuance. The warrants will be exercisable, at the option of each holder, in whole or in
part, by delivering to us a duly executed exercise notice accompanied by payment in full for the
number of shares of our common stock purchased upon such exercise, except in the case of a cashless
exercise, as discussed below.
Exercise Price. Each warrant is exercisable for 0.30 of one share of common stock at an
exercise price of $2.85 per share of common stock being purchased. The exercise price is subject to
appropriate adjustment in the event of stock dividends and distributions, stock splits, stock
combinations, reclassifications or similar events affecting our common stock.
Cashless Exercise. If, at any time during the warrant exercisability period, the holder is not
permitted to sell shares of common stock issuable upon exercise of the relevant warrant pursuant to
the registration statement or an exemption from registration is not available, and the fair market
value of our common stock exceeds the exercise price of the warrants, the holder may elect to
effect a cashless exercise of the warrants, in whole or in part, by surrendering the warrants to
us, together with delivery to us of a duly executed exercise notice, and canceling a portion of the
relevant warrant in payment of the purchase price payable in respect of the number of shares of our
common stock purchased upon such exercise.
Transferability. Subject to applicable laws and the restriction on transfer set forth in the
subscription agreement, the warrants may not be transferred at the option of the holders without
our consent, such consent not to be unreasonably withheld or delayed, upon surrender of the
warrants to us together with the appropriate instruments of transfer.
S-15
Exchange Listing. We do not plan on making an application to list the warrants on The NASDAQ
Global Market, any national securities exchange or other nationally recognized trading system. The
common stock underlying the warrants is listed on the NASDAQ Global Market.
Fundamental Transactions. In the event of any fundamental transaction, as described in the
warrants, and generally including any merger with or into another entity (whether or not we are the
surviving entity but excluding a migratory merger effected solely for the purpose of changing our
jurisdiction of incorporation), sale of all or substantially all of our assets, tender offer or
exchange offer, our consummation of a stock purchase agreement or other business combination
(including, without limitation, a reorganization, recapitalization, spin-off or scheme of
arrangement) or reclassification of our common stock, then upon any subsequent exercise of a
warrant, the holder shall have the right to receive, as alternative consideration, for each share
of our common stock that would have been issuable upon such exercise immediately prior to the
occurrence of such fundamental transaction, the number of shares of common stock of the successor
or acquiring corporation or of Cyclacel, if it is the surviving corporation, and any additional
consideration receivable upon or as a result of such transaction by a holder of the number of
shares of our common stock for which the warrant is exercisable immediately prior to such event.
Rights as a Stockholder. Except as otherwise provided in the warrants or by virtue of such
holders ownership of shares of our common stock, the holders of the warrants do not have the
rights or privileges of holders of our common stock, including any voting rights, until they
exercise their warrants.
Waivers and Amendments. The provisions of each warrant may be amended and we may take any
action prohibited by the warrant, or omit to perform any act required to be performed pursuant to
the warrant, only with the written consent of the holder of that warrant.
Other Provisions. Unless otherwise specified in the applicable warrant, except upon at least
61 days prior notice from the holder to us, the holder will not have the right to exercise any
portion of the warrant if the holder, together with its affiliates, would beneficially own in
excess of 4.99% of the number of shares of our common stock outstanding immediately after giving
effect to the exercise, as such percentage ownership is determined in accordance with the terms of
the warrants.
No fractional shares will be issued upon exercise of the warrants, but rather the number of
shares of common stock to be issued shall be rounded up to the nearest whole number.
S-16
PLAN OF DISTRIBUTION
We are offering the units through a placement agent. Subject to the terms and conditions
contained in the placement agent agreement, dated January 21, 2010, Roth Capital Partners, LLC has
agreed to act as the placement agent for the sale of up to 2,350,000 units. The placement agent is
not purchasing or selling any shares or warrants by this prospectus supplement or the accompanying
prospectus, nor is it required to arrange for the purchase or sale of any specific number or dollar
amount of units, but has agreed to use its best efforts to arrange for the sale of all units.
The placement agent agreement provides that the obligations of the placement agent and the
investors are subject to certain conditions precedent, including the absence of any material
adverse change in our business and the receipt of customary legal opinions, letters and
certificates.
Confirmations and definitive prospectuses will be distributed to all investors who agree to
purchase the units, informing investors of the closing date as to such units. We currently
anticipate that closing of the sale of units will take place on or about January 25, 2010.
Investors will also be informed of the date and manner in which they must transmit the purchase
price for their units.
On the scheduled closing date, the following will occur:
|
|
|
we will receive funds in the amount of the aggregate purchase price for the units we
sell; and |
|
|
|
|
Roth Capital Partners, LLC will receive the placement agents fee in accordance with the
terms of the placement agent agreement. |
We will pay the placement agent an aggregate cash commission equal to 5.0% of the gross
proceeds from the sale of units. We will also reimburse the placement agent for legal expenses
incurred by it in connection with this offering, subject to a cap of $40,000. In no event will the
total amount of compensation paid to the placement agent and other securities brokers and dealers
upon completion of this offering exceed 8.0% of the gross proceeds of this offering. The estimated
offering expenses payable by us, in addition to the placement agents fee of approximately
$293,750, are approximately $136,750, which includes legal, accounting and printing costs, a
financial advisory fee and various other fees associated with registering and listing the common
stock. After deducting the payments to the placement agent described above and our estimated
offering expenses, we expect the net proceeds from this offering to be approximately $5.4 million.
We will pay Merriman Curhan Ford & Co. an advisory fee equal to 1% of the gross proceeds from the
sale of the units.
We have agreed to indemnify the placement agent against certain liabilities, including
liabilities under the Securities Act of 1933, as amended, and liabilities arising from breaches of
representations and warranties contained in the placement agent agreement. We have also agreed to
contribute to payments the placement agent may be required to make in respect of such liabilities.
We, along with our executive officers and directors, have agreed to certain lock-up provisions
with regard to future sales of our common stock and other securities convertible into or
exercisable or exchangeable for common stock for a period of thirty (30) days after the offering as
set forth in the placement agent agreement. In the subscription agreements to be entered into with
the investors in the offering, we have agreed to similar lock-up provisions for a period of ten
(10) business days after the offering. In addition, pursuant to those subscription agreements, we
have granted to the investors in the offering certain participation rights with respect to sales of
common stock and other securities convertible
S-17
into or exercisable or exchangeable for common stock, made during the period ending 120 days after
the offering.
The placement agent agreement and the form of subscription agreement are included as exhibits
to our Current Report on Form 8-K that we will file with the SEC in connection with the
consummation of this offering.
The transfer agent for our common stock to be issued in this offering is American Stock
Transfer & Trust Company located at 59 Maiden Lane, Plaza Level, New York, New York 10038.
Our common stock is traded on the Nasdaq Global Market under the symbol CYCC.
S-18
LEGAL MATTERS
The validity of the issuance of the securities offered by this prospectus supplement and the
accompanying prospectus will be passed upon for us by Mintz, Levin, Cohn, Ferris, Glovsky and
Popeo, P.C., New York, New York. Lowenstein Sandler, P.C., Roseland, New Jersey, is acting as
counsel for the placement agent in connection with various matters related to the securities
offered hereby.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has audited our consolidated
financial statements included in our Annual Report on Form 10-K for the year ended December 31,
2008, which is incorporated by reference in this prospectus and elsewhere in the registration
statement. Our financial statements as of December 31, 2008 are incorporated by reference in
reliance on Ernst & Young LLPs reports, given on their authority as experts in accounting and
auditing.
WHERE YOU CAN FIND MORE INFORMATION
This prospectus supplement and accompanying prospectus constitute a part of a registration
statement on Form S-3 that we filed on February 12, 2007 with the SEC under the Securities Act of
1933, as amended. We refer you to this registration statement for further information about us and
the common stock and warrants to purchase our common stock offered hereby.
We file annual, quarterly and special reports and other information with the SEC (Commission
File Number 0-50626). These filings contain important information that does not appear in this
prospectus supplement or the accompanying prospectus. For further information about us, you may
read and copy any reports, statements and other information filed by us at the SECs Public
Reference Room at 100 F Street, N.E., Room 1580, Washington, D.C. 20549-0102. You may obtain
further information on the operation of the Public Reference Room by calling the SEC at
1-800-SEC-0330. Our SEC filings are also available on the SEC Internet site at
http://www.sec.gov, which contains periodic reports and other information regarding issuers
that file electronically.
S-19
INCORPORATION OF CERTAIN DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference the information we file with it, which means
that we can disclose important information to you by referring you to those documents. The
information incorporated by reference is considered to be part of this prospectus and information
we file later with the SEC will automatically update and supersede this information. We incorporate
by reference the documents listed below and any future filings made by us with the SEC under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934, as amended. The
documents we are incorporating by reference as of their respective dates of filing are:
|
|
|
our Annual Report on Form 10-K for the year ended December 31, 2008
(including information specifically incorporated by reference into our Form 10-K from
our Proxy Statement for our 2009 Annual Meeting of Stockholders); |
|
|
|
|
our Quarterly Reports on Form 10-Q filed on May 15, 2009, August 13, 2009
and November 12, 2009; |
|
|
|
|
our Current Reports on Form 8-K filed on January 13, 2009, February 6,
2009, February 12, 2009, March 17, 2009, April 8, 2009, April 20, 2009, May 7, 2009,
June 26, 2009, July 24, 2009, August 28, 2009, October 20, 2009, October 30, 2009,
November 25, 2009, December 15, 2009, December 31, 2009, January 8, 2010, January 11,
2010 and January 13, 2010; |
|
|
|
|
our Proxy Statement for our 2009 Annual Meeting of Stockholders; and |
|
|
|
|
the description of our common stock contained in our registration
statement on Form 8-A and any amendments or reports filed for the purpose of updating
such description. |
This prospectus supplement may contain information that updates, modifies or is contrary to
information in one or more of the documents incorporated by reference in this prospectus
supplement. To the extent that any statements contained in a document incorporated by reference are
modified or superseded by any statements contained in this prospectus, such statements shall not be
deemed incorporated in this prospectus except as so modified or superseded. Reports we file with
the SEC after the date of this prospectus supplement may also contain information that updates,
modifies or is contrary to information in this prospectus supplement or in documents incorporated
by reference in this prospectus supplement. Investors should review these reports as they may
disclose a change in our business, prospectus, financial condition or other affairs after the date
of this prospectus supplement.
You may request, orally or in writing, a copy of these filings, which will be provided to
you at no cost, by contacting our investor relations department our principal executive offices,
which are located at 200 Connell Drive, Suite 1500, Berkeley Heights, NJ 07922, Attention: Investor
Relations, Telephone: (908) 517-7330.
S-20
PROSPECTUS
CYCLACEL PHARMACEUTICALS, INC.
$75,000,000
COMMON STOCK
PREFERRED STOCK
WARRANTS
DEBT SECURITIES
We may, from time to time, issue up to $75,000,000 aggregate principal amount of common stock,
preferred stock, warrants and/or debt securities. We will specify in an accompanying prospectus
supplement the terms of the securities. We may sell these securities to or through underwriters and
also to other purchasers or through agents. We will set forth the names of any underwriters or
agents in the accompanying prospectus supplement.
Our common stock is quoted on the Nasdaq Global Market under the symbol CYCC. On February
9, 2007, the last reported sale price of our common stock was $8.12 per share. Our preferred stock
is quoted on the Nasdaq Capital Market under the symbol CYCCP. On February 9, 2007, the last
reported sale price of our preferred stock was $5.30 per share.
Investing
in our securities involves risks.
See Risk Factors on page 7.
Neither the Securities and Exchange Commission nor any state securities commission has
approved or disapproved of these securities or passed upon the accuracy or adequacy of this
prospectus. Any representation to the contrary is a criminal offense.
This prospectus may not be used to consummate sales of securities unless it is accompanied by
a prospectus supplement.
The date of this prospectus is February 12, 2007.
TABLE OF CONTENTS
|
|
|
|
|
|
|
Page |
|
|
|
2 |
|
|
|
|
3 |
|
|
|
|
7 |
|
|
|
|
24 |
|
|
|
|
24 |
|
|
|
|
25 |
|
|
|
|
25 |
|
|
|
|
27 |
|
|
|
|
36 |
|
|
|
|
37 |
|
|
|
|
42 |
|
|
|
|
45 |
|
|
|
|
46 |
|
|
|
|
46 |
|
|
|
|
46 |
|
|
|
|
47 |
|
|
|
|
47 |
|
ABOUT THIS PROSPECTUS
This prospectus is part of a registration statement that we filed with the Securities and
Exchange Commission, or SEC, utilizing a shelf registration process. Under this shelf process,
we may sell any combination of the securities described in this prospectus in one or more offerings
up to a total dollar amount of $75,000,000. We have provided to you in this prospectus a general
description of the securities we may offer. Each time we sell securities, we will provide a
prospectus supplement that will contain specific information about the terms of that offering. In any applicable prospectus supplements, we may add to, update or
change any of the information contained in this prospectus.
2
PROSPECTUS SUMMARY
The following is only a summary. We urge you to read the entire prospectus, including the more
detailed consolidated financial statements, notes to the consolidated financial statements and
other information included herein or incorporated by reference from our other filings with the SEC.
Investing in our securities involves risks. Therefore, please carefully consider the information
provided under the heading Risk Factors starting on page 7.
Our Business
We are a development-stage biopharmaceutical company dedicated to the discovery, development
and eventual commercialization of novel, mechanism-targeted drugs to treat human cancers and other
serious disorders. Our core area of expertise is in cell cycle biology, or the processes by which
cells divide and multiply. We focus primarily on the discovery and development of orally available
anticancer agents that target the cell cycle with the aim of slowing the progression or shrinking
the size of tumors, and enhancing quality of life and improving survival rates of cancer patients.
We have been focused on the cell cycle since our inception. We were founded in 1996 by Professor
Sir David Lane, a recognized leader in the field of tumor suppressor biology who discovered the p53
protein, which operates as one of the bodys own anticancer drugs by inhibiting cell cycle
targets. In 1999, we were joined by Professor David Glover, a recognized leader in the mechanism of
mitosis or cell division who discovered, among other cell cycle targets, the mitotic kinases, Polo
and Aurora, enzymes that act in the mitosis phase of the cell cycle. Our expertise in cell cycle
biology is at the center of our business strategy.
We are generating several families of anticancer drugs that act on the cell cycle including
cyclin dependent kinase (CDK) and Aurora kinase inhibitors. Although a number of pharmaceutical and
biotechnology companies are currently attempting to develop CDK inhibitor drugs, we believe that
our lead drug candidate, seliciclib, is the only orally available CDK inhibitor drug candidate
currently in Phase II trials.
We are advancing three of our anticancer drug candidates, seliciclib, sapacitabine and CYC116
through in-house research and development activities. In addition we are progressing further novel
drug series, principally for cancer, which are at earlier stages. Taken together, our pipeline
covers all four phases of the cell cycle, which we believe will improve the chances of successfully
developing and commercializing novel drugs that work on their own or in combination with approved
conventional chemotherapies or with other targeted drugs to treat human cancers.
Our lead drug candidate, seliciclib, is a novel, first-in-class, orally available, CDK
inhibitor. The compound selectively inhibits a spectrum of enzyme targets CDK2/E, CDK2/A, CDK7
and CDK9 that are central to the process of cell division and cell cycle control. Preclinical
studies have shown that the drug works by inducing cell
apoptosis, or cell suicide, in multiple phases of the cell cycle. To date, seliciclib has been
evaluated in approximately 240 patients in several Phase I and II uncontrolled studies and has
shown early signs of anti-cancer activity.
We have completed two Phase I trials that enrolled 24 healthy volunteers and three Phase I
trials that enrolled a total of 84 cancer patients testing different doses and schedules. The
primary toxicities observed were of a non-hematological nature including asthenia or weakness,
elevation of liver enzymes, hypokalemia or decreased potassium levels, nausea and vomiting and
elevation in creatinine. Although these trials were designed to test safety rather than efficacy of
seliciclib given alone as monotherapy in patients with solid tumors who failed multiple previous
treatments, several of these patients appeared to have benefited from seliciclib treatment.
3
Seliciclib was shown in a further Phase I study sponsored and conducted by independent
investigators to have clinical antitumor activity in patients with nasopharyngeal cancer, measured
as a decrease in the size of primary tumor and involved lymph nodes, as well as an increase in
tumor cell deaths by biomarker analyses. Four Phase II trials have been conducted in cancer
patients to evaluate the tolerability and antitumor activities of seliciclib alone or in
combination with standard chemotherapies used in the treatment of advanced non-small cell lung
cancer, or NSCLC, or breast cancer. Interim data from two Phase II open-label studies of a total of
54 patients with NSCLC, suggest that seliciclib treatment did not aggravate the known toxicities of
standard first and second-line chemotherapies nor appear to cause unexpected toxicities, although
these trials were not designed to provide statistically significant comparisons. The combination of
seliciclib with standard dose of capecitabine was not well tolerated in patients with advanced
breast cancer. The Phase II open-label trials of seliciclib have been closed and we expect to
report final data within the first quarter of 2007.
Based on our observations of tolerability and antitumor activity of seliciclib in the clinical
trials conducted to date, the oral availability of seliciclib, the recommendation of a NSCLC expert
panel, and regulatory and marketing considerations, seliciclib is currently being evaluated in the
APPRAISE trial, a Phase IIb randomized double-blinded study to evaluate the safety and efficacy of
the drug as a third line treatment in patients with NSCLC. The trial, which is expected to enroll
approximately 200 patients, is using a randomized discontinuation trial design. We have retained
worldwide rights to commercialize seliciclib.
Our second drug candidate, sapacitabine, is an orally available prodrug of CNDAC, which is a
novel nucleoside analog, or a compound with a structure similar to a nucleoside. A prodrug is a
compound that has a therapeutic effect after it is metabolized within the body. CNDAC has a
significantly longer residence time in the blood when it is produced in the body through metabolism
of sapacitabine than when it is given directly. Sapacitabine acts through a dual mechanism whereby
the compound interferes with DNA synthesis by causing single-strand DNA breaks and induces arrest
of the cell division cycle at G2 phase. A number of nucleoside drugs, such as gemcitabine, or
Gemzar ® ; Eli Lilly, are in wide use as conventional chemotherapies. Both sapacitabine and its
major metabolite, CNDAC, have demonstrated potent anti-tumor activity in both blood and solid
tumors in preclinical studies. In a liver metastatic mouse model, sapacitabine was shown to be
superior to gemcitabine or 5-FU, two widely used nucleoside analogs, in delaying the onset and
growth of liver metastasis.
Two Phase I studies of sapacitabine have been completed in the United States by Sankyo, from
which we in-licensed sapacitabine, evaluating 87 patients in refractory solid tumors. A Phase Ib
dose escalation clinical trial is currently in progress in the United States for the treatment of
patients with refractory solid tumors or lymphomas. Preliminary results from this study were
reported at the 18 th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics meeting in November
2006. The primary objective of the study was to evaluate the safety profile of sapacitabine
administered twice daily for 14 consecutive days or 7 consecutive days every 21 days. Of the 37
treated patients, 28 received the drug twice daily for 14 days and 9 received the drug twice daily
for 7 days. The dose-limiting toxicity was reversible myelosuppression. One patient treated at the
maximum tolerated dose died of candida sepsis in the setting of grade 4 neutropenia and
thrombocytopenia. Non-hematological toxicities were mostly mild to moderate. The best response by
investigator assessment was stable disease in 13 patients with five with NSCLC, two with breast
cancer, two with ovarian cancer and one each with colorectal cancer, adenocarcinoma of unknown
primary, gastrointestinal stroma tumor and parotid acinar carcinoma. The primary toxicity was
reversible myelosuppression.
Sapacitabine is also currently being evaluated in a Phase I clinical trial in advanced
leukemias and myelodysplastic syndromes, or MDS. The Phase I study is being conducted by Dr. Hagop
Kantarjian, Professor of Medicine and Chairman of the Leukemia Department at M.D. Anderson Cancer
Center in Houston, Texas. The
studys primary objective is to determine the maximum tolerated dose, or MTD, of sapacitabine
administered twice daily, or b.i.d., by mouth for
4
seven consecutive days every 21 days. As of November 2006, 26 patients were enrolled and 25
patients have received at least one dose of sapacitabine. Preliminary interim data are available on
22 patients, of which nine had de novo acute myelogenous leukemia, or AML; seven had AML preceded
by MDS; three had MDS-refractory anemia with excess blasts, or MDS-RAEB; and one each had
treatment-related AML, acute lymphocytic leukemia, or ALL and chronic lymphocytic leukemia or CLL.
The median age is 62 ranging from 39 to 91. Twenty-one patients received prior chemotherapy and one
elderly patient (aged 91) did not receive any prior chemotherapy. The median number of prior
chemotherapy regimens is two, ranging from one to four. Fifteen patients were previously treated
with Ara-C-containing regimens of which nine had de novo AML and six had AML preceded by MDS. Six
patients were previously treated with decitabine of which three had MDS-RAEB, and one each had de
novo AML, AML preceded by MDS, and treatment-related AML. One patient treated at the dose level of
275 mg b.i.d. experienced a dose limiting toxicity, or DLT consisting of Grade 3 diarrhea and Grade
3 neutropenic colitis, which resolved after cessation of dosing and medical treatment. No DLTs were
reported in the remaining five patients treated at 275 mg b.i.d. Dose escalation continues and the
MTD has not been reached at the dose level of 325 mg b.i.d., which is approximately four times the
recommended Phase II dose for solid tumor patients. To date, the best response to sapacitabine was
reduction in bone marrow blast counts to 5% or less, which was observed in seven patients of which
three had de novo AML, two had AML preceded by MDS, and two had MDS-RAEB. We expect to start Phase
II evaluation of sapacitabine in 2007. We have retained worldwide rights to commercialize
sapacitabine with the exception of Japan where Sankyo has a right of first refusal to market the
drug under terms to be negotiated.
We have selected CYC116 as a lead development candidate from our Aurora kinase inhibitor
program. In this program, several compounds have demonstrated efficacy by oral administration in
hematological and solid tumor models with a mechanism consistent with inhibition of the target. We
submitted in December 2006 an Investigational New Drug, or IND application, with the Food and Drug
Administration, or FDA, to begin clinical trials of CYC116, an orally-active inhibitor of Aurora
kinases A & B and VEGFR2, for the treatment of cancer. Aurora kinases are a family of
serine/threonine protein kinases that are only expressed in actively dividing cells and are crucial
for the process of cell division, or mitosis. These proteins, which have been found to be
over-expressed in many types of cancer, have generated significant scientific and commercial
interest as cancer drug targets. Aurora kinases were discovered by Professor David Glover, Chief
Scientist of Cyclacels Polgen Division. VEGFR2 is a receptor protein that is part of an important
and validated pathway in angiogenesis, or blood vessel formation. We have retained worldwide rights
to commercialize CYC116.
In our development programs, we have been an early adopter in the use of biomarker analysis to
help evaluate whether our drug candidates are having their intended effect through their assumed
mechanisms. Biomarkers are proteins or other substances whose presence in the blood can serve as an
indicator or marker of diseases. Biomarker data from early clinical trials may also enable us to
design subsequent trials more efficiently and to monitor patient compliance with trial protocols.
We believe that in the longer term biomarkers may allow the selection of patients more likely to
respond to its drugs for clinical trial and marketing purposes and increase the benefit to
patients.
Our approach to drug discovery and development relies on proprietary genomic technology to
identify gene targets, which are then progressed by means of structure-based design techniques
through to the development stage. This approach is exemplified by our Aurora kinase and Plk, or
Polo-like kinase, inhibitor programs. Fundamentally, this approach to drug discovery and design
aims to improve our ability to select promising drug targets in the early stages of the process so
as to decrease compound attrition rates during the later, more expensive stages of drug
development. We devote more resources initially to enrich the target selection process, so that we
focus our efforts on targets that have a higher probability of yielding successful drug candidates.
To this end, we have assembled an integrated suite of sophisticated discovery and design
technologies, together with highly skilled personnel.
5
Our corporate headquarters are located at 200 Connell Drive, Suite 1500, Berkeley Heights, NJ
07922; telephone number (908) 517-7330, where our medical and regulatory functions are also
located. Our primary research facility is located in Dundee, Scotland which is the center of our
structure-based drug design and development programs. A second research facility is located in
Cambridge, England and is home to our Polgen division, which is focused on discovering the function
of new cancer genes and validating their use as potential druggable targets.
6
RISK FACTORS
The following factors should be considered carefully in evaluating whether to purchase shares
of Cyclacel common stock. These factors should be considered in conjunction with any other
information included or incorporated by reference herein, including in conjunction with
forward-looking statements made herein. See Where You Can Find More Information on page 47.
RISKS RELATED TO OUR BUSINESS
We are at an early stage of development as a company and we do not have, and may never have, any
products that generate revenues.
We are at an early stage of development as a company and have a limited operating history on
which to evaluate our business and prospects. Since beginning operations in 1997, we have not
generated any product revenues. We currently have no products for sale and we cannot guarantee that
we will ever have any marketable products. We must demonstrate that our drug candidates satisfy
rigorous standards of safety and efficacy for their intended uses before the Food and Drug
Administration, or FDA, and other regulatory authorities in the United States, the European Union
and elsewhere. Significant additional research, preclinical testing and clinical testing is
required before we can file applications with the FDA or other regulatory authorities for premarket
approval of our drug candidates. In addition, to compete effectively, our drugs must be easy to
administer, cost-effective and economical to manufacture on a commercial scale. We may not achieve
any of these objectives. Seliciclib and sapacitabine, our most advanced drug candidates for the
treatment of cancer, are currently our only drug candidates in clinical trials and we cannot be
certain that the clinical development of these or any other drug candidates in preclinical testing
or clinical development will be successful, that they will receive the regulatory approvals
required to commercialize them or that any of our other research and drug discovery programs will
yield a drug candidate suitable for investigation through clinical trials. Our commercial revenues,
if any, will be derived from sales of drugs that we do not expect to become marketable for several
years, if at all.
We have a history of operating losses and we may never become profitable. Our stock is a highly
speculative investment.
We have incurred operating losses in each year since beginning operations in 1997 due to costs
incurred in connection with our research and development activities and general and administrative
costs associated with our operations, and we may never achieve profitability. As of September 30,
2006, our accumulated deficit was $132.7 million. Our net loss from inception through September 30,
2006 was $170.9 million. Our initial drug candidates are in the early stages of clinical testing
and we must conduct significant additional clinical trials before we can seek the regulatory
approvals necessary to begin commercial sales of our drugs. We expect to incur continued losses for
several years, as we continue our research and development of our initial drug candidates, seek
regulatory approvals and commercialize any approved drugs. If our initial drug candidates are
unsuccessful in clinical trials or we are unable to obtain regulatory approvals, or if our drugs
are unsuccessful in the market, we will not be profitable. If we fail to become and remain
profitable, or if we are unable to fund our continuing losses, you could lose all or part of your
investment.
We will need to raise substantial additional capital to fund our operations and if we fail to
obtain additional funding, we may be unable to complete the development and commercialization of
our drug candidates or continue our research and development programs.
We have funded all of our operations and capital expenditures with proceeds from the issuance
of public equity securities, private placements of our securities, interest on investments,
government grants and research
and development tax credits. In order to conduct the lengthy and expensive research,
preclinical testing and clinical trials necessary to complete the development and marketing of our
drug candidates, we will require substantial additional funds. Based on our current operating
plans, we expect our existing resources to be sufficient to fund our planned operations for at
least the next 12 months. To meet these financing requirements, we may raise funds through public
or private
7
equity offerings, debt financings or strategic alliances. Raising additional funds by issuing
equity or convertible debt securities will cause our shareholders to experience substantial
dilution in their ownership interests and new investors may have rights superior to the rights of
our other stockholders. Raising additional funds through debt financing, if available, may involve
covenants that restrict our business activities and options. To the extent that we raise additional
funds through collaborations and licensing arrangements, we may have to relinquish valuable rights
to our drug discovery and other technologies, research programs or drug candidates, or grant
licenses on terms that may not be favorable to us. Additional funding may not be available to us on
favorable terms, or at all. If we are unable to obtain additional funds, we may be forced to delay
or terminate our clinical trials and the development and marketing of our drug candidates.
Clinical trials are expensive, time consuming and subject to delay.
Clinical trials are expensive and complex, can take many years and have uncertain outcomes. We
estimate that clinical trials of our most advanced drug candidates will continue for several years,
but may take significantly longer to complete. The designs used in some of our trials have not been
used widely by other pharmaceutical companies. Failure can occur at any stage of the testing and we
may experience numerous unforeseen events during, or as a result of, the clinical trial process
that could delay or prevent commercialization of our current or future drug candidates, including
but not limited to:
|
|
|
delays in securing clinical investigators or trial sites for our clinical trials; |
|
|
|
|
delays in obtaining institutional review board, or IRB, and other regulatory
approvals to commence a clinical trial; |
|
|
|
|
slower than anticipated rates of patient recruitment and enrollment, or reaching the
targeted number of patients; |
|
|
|
|
negative or inconclusive results from clinical trials; |
|
|
|
|
unforeseen safety issues; |
|
|
|
|
uncertain dosing issues; |
|
|
|
|
introduction of new therapies or changes in standards of practice or regulatory
guidance that render our clinical trial endpoints or the targeting of our proposed
indications obsolete; |
|
|
|
|
inability to monitor patients adequately during or after treatment or problems with
investigator or patient compliance with the trial protocols; |
|
|
|
|
inability to replicate in large controlled studies safety and efficacy data obtained
from a limited number of patients in uncontrolled trials; and |
|
|
|
|
inability or unwillingness of medical investigators to follow our clinical protocols. |
If we suffer any significant delays, setbacks or negative results in, or termination of, our
clinical trials, we may be unable to continue development of our drug candidates or generate
revenue and our development costs could increase significantly.
Adverse events have been observed in our clinical trials and may force us to stop development of
our product candidates or prevent regulatory approval of our product candidates.
Adverse or inconclusive results from our clinical trials may substantially delay, or halt
entirely, any further development of our drug candidates. Many companies have failed to demonstrate
the safety or effectiveness of drug candidates in later stage clinical trials notwithstanding
favorable results in early stage clinical trials. Previously unforeseen and unacceptable side
effects could interrupt, delay or halt clinical trials of our drug candidates and could result in
the FDA or other regulatory authorities denying approval of our drug candidates. We will need to
demonstrate safety and efficacy for specific indications of use, and monitor safety and compliance
with clinical trial protocols throughout the development process. To date, long-term safety and
efficacy has not been
8
demonstrated in clinical trials for any of our drug candidates. Toxicity and severe adverse
effects as defined in trial protocols have been noted in preclinical and clinical trials
involving certain of our drug candidates. For example, elevations of liver enzymes and decrease in
potassium levels have been observed in some patients receiving our lead drug candidate, seliciclib
and neutropenia was observed in patients receiving sapacitabine. In addition, we may pursue
clinical trials for seliciclib in more than one indication. There is a risk that severe toxicity
observed in a trial for one indication could result in the delay or suspension of all trials
involving the same drug candidate. We are currently conducting Phase IIb clinical trials to test
the safety and efficacy of seliciclib in the treatment of non small cell lung cancer. Independent
investigators are conducting Phase I clinical trials to test the safety of sapacitabine in patients
with advanced cancers. If these trials or any future trials are unsuccessful, our business and
reputation could be harmed and our share price could be negatively affected.
Even if we believe the data collected from clinical trials of our drug candidates are
promising with respect to safety and efficacy, such data may not be deemed sufficient by regulatory
authorities to warrant product approval. Clinical data can be interpreted in different ways.
Regulatory officials could interpret such data in different ways than we do which could delay,
limit or prevent regulatory approval. The FDA, other regulatory authorities or we may suspend or
terminate clinical trials at any time. Any failure or significant delay in completing clinical
trials for our drug candidates, or in receiving regulatory approval for the commercialization of
our drug candidates, may severely harm our business and reputation.
If our understanding of the role played by CDKs or Aurora kinases in regulating the cell cycle is
incorrect, this may hinder pursuit of our clinical and regulatory strategy.
We have programs to develop small molecule inhibitors of cyclin dependent kinases (CDK) and
Aurora kinases. Our lead drug candidate, seliciclib, is a CDK inhibitor, and CYC116 is an Aurora
kinase inhibitor, based on our understanding of CDK and Aurora kinase inhibitors. Although a number
of pharmaceutical and biotechnology companies are attempting to develop CDK or Aurora inhibitor
drugs for the treatment of cancer, no CDK or Aurora kinase inhibitor has yet reached the market.
Our seliciclib program relies on our understanding of the interaction of CDKs with other cellular
mechanisms that regulate key stages of cell growth. If our understanding of the role played by CDKs
or Aurora kinase inhibitors in regulating the cell cycle is incorrect, our lead drug and CYC116 may
fail to produce therapeutically relevant results, hindering our ability to pursue our clinical and
regulatory strategy.
If we fail to enter into and maintain successful strategic alliances for our drug candidates, we
may have to reduce or delay our drug candidate development or increase our expenditures.
An important element of our strategy for developing, manufacturing and commercializing our
drug candidates is entering into strategic alliances with pharmaceutical companies or other
industry participants to advance our programs and enable us to maintain our financial and
operational capacity.
We face significant competition in seeking appropriate alliances. We may not be able to
negotiate alliances on acceptable terms, if at all. In addition, these alliances may be
unsuccessful. If we fail to create and maintain suitable alliances, we may have to limit the size
or scope of, or delay, one or more of our drug development or research programs. If we elect to
fund drug development or research programs on our own, we will have to increase our expenditures
and will need to obtain additional funding, which may be unavailable or available only on
unfavorable terms.
We are making extensive use of biomarkers, which are not scientifically validated, and our reliance
on biomarker data may thus lead us to direct our resources inefficiently.
We are making extensive use of biomarkers in an effort to facilitate our drug development and
to optimize our clinical trials. Biomarkers are proteins or other substances whose presence in the
blood can serve as an indicator of specific cell processes. We believe that these biological
markers serve a useful purpose in helping us to evaluate whether our drug candidates are having
their intended effects through their assumed mechanisms, and thus enable us to identify more
promising drug candidates at
9
an early stage and to direct our resources efficiently. We also believe that biomarkers may
eventually allow us to improve patient selection in connection with clinical trials and monitor
patient compliance with trial protocols.
For most purposes, however, biomarkers have not been scientifically validated. If our
understanding and use of biomarkers is inaccurate or flawed, or if our reliance on them is
otherwise misplaced, then we will not only fail to realize any benefits from using biomarkers, but
may also be led to invest time and financial resources inefficiently in attempting to develop
inappropriate drug candidates. Moreover, although the FDA has issued for comment a draft guidance
document on the potential use of biomarker data in clinical development, such data are not
currently accepted by the FDA or other regulatory agencies in the United States, the European Union
or elsewhere in applications for regulatory approval of drug candidates and there is no guarantee
that such data will ever be accepted by the relevant authorities in this connection. Our biomarker
data should not be interpreted as evidence of efficacy.
To the extent we elect to fund the development of a drug candidate or the commercialization of a
drug at our expense, we will need substantial additional funding.
We plan to market drugs on our own, with or without a partner, that can be effectively
commercialized and sold in concentrated markets that do not require a large sales force to be
competitive. To achieve this goal, we will need to establish our own specialized sales force,
marketing organization and supporting distribution capabilities. The development and
commercialization of our drug candidates is very expensive. To the extent we elect to fund the full
development of a drug candidate or the commercialization of a drug at our expense, we will need to
raise substantial additional funding to:
|
|
|
fund research and development and clinical trials connected with our research; |
|
|
|
|
fund clinical trials and seek regulatory approvals; |
|
|
|
|
build or access manufacturing and commercialization capabilities; |
|
|
|
|
implement additional internal control systems and infrastructure; |
|
|
|
|
commercialize and secure coverage, payment and reimbursement of our drug
candidates, if any such candidates receive regulatory approval; |
|
|
|
|
maintain, defend and expand the scope of our intellectual property; and |
|
|
|
|
hire additional management and scientific personnel. |
Our future funding requirements will depend on many factors, including:
|
|
|
the scope, rate of progress and cost of our clinical trials and other
research and development activities; |
|
|
|
|
the costs and timing of seeking and obtaining regulatory approvals; |
|
|
|
|
the costs of filing, prosecuting, defending and enforcing any patent claims
and other intellectual property rights; |
|
|
|
|
the costs associated with establishing sales and marketing capabilities; |
|
|
|
|
the costs of acquiring or investing in businesses, products and technologies; |
|
|
|
|
the effect of competing technological and market developments; and |
|
|
|
|
the payment, other terms and timing of any strategic alliance, licensing or
other arrangements that we may establish. |
If we are not able to secure additional funding when needed, we may have to delay, reduce the
scope of or eliminate one or more of our clinical trials or research and development programs or
future commercialization efforts.
10
Due to our reliance on contract research organizations or other third parties to conduct clinical
trials, we are unable to directly control the timing, conduct and expense of our clinical trials.
We do not have the ability to independently conduct clinical trials required to obtain
regulatory approvals for our drug candidates. We must rely on third parties, such as contract
research organizations, medical institutions, clinical investigators and contract laboratories to
conduct our clinical trials. In addition, we rely on third parties to assist with our preclinical
development of drug candidates. If these third parties do not successfully carry out their
contractual duties or regulatory obligations or meet expected deadlines, if the third parties need
to be replaced or if the quality or accuracy of the data they obtain is compromised due to the
failure to adhere to our clinical protocols or regulatory requirements or for other reasons, our
preclinical development activities or clinical trials may be extended, delayed, suspended or
terminated, and we may not be able to obtain regulatory approval for or successfully commercialize
our drug candidates.
To the extent we are able to enter into collaborative arrangements or strategic alliances, we will
be exposed to risks related to those collaborations and alliances.
Although we are not currently party to any collaboration arrangement or strategic alliance
that is material to our business, in the future we expect to be dependent upon collaborative
arrangements or strategic alliances to complete the development and commercialization of some of
our drug candidates particularly after the Phase II stage of clinical testing. These arrangements
may place the development of our drug candidates outside our control, may require us to relinquish
important rights or may otherwise be on terms unfavorable to us.
We may be unable to locate and enter into favorable agreements with third parties, which could
delay or impair our ability to develop and commercialize our drug candidates and could increase our
costs of development and commercialization. Dependence on collaborative arrangements or strategic
alliances will subject us to a number of risks, including the risk that:
|
|
|
we may not be able to control the amount and timing of resources that our collaborators may
devote to the drug candidates; |
|
|
|
|
our collaborators may experience financial difficulties; |
|
|
|
|
we may be required to relinquish important rights such as marketing and distribution rights; |
|
|
|
|
business combinations or significant changes in a collaborators business strategy may also
adversely affect a collaborators willingness or ability to complete our obligations under
any arrangement; |
|
|
|
|
a collaborator could independently move forward with a competing drug candidate developed
either independently or in collaboration with others, including our competitors; and |
|
|
|
|
collaborative arrangements are often terminated or allowed to expire, which would delay the
development and may increase the cost of developing our drug candidates. |
We have no manufacturing capacity and will rely on third party manufacturers for the late stage
development and commercialization of any drugs we may develop.
We do not currently operate manufacturing facilities for clinical or commercial production of
our drug candidates under development. We currently lack the resources or the capacity to
manufacture any of our products on a clinical or commercial scale. We anticipate future reliance on
a limited number of third party manufacturers until we are able to expand our operations to include
manufacturing capacities. Any performance failure on the part of future manufacturers could delay
late stage clinical development or regulatory approval of our drug candidates or commercialization
of our drugs, producing additional losses and depriving us of potential product revenues.
If the FDA or other regulatory agencies approve any of our drug candidates for commercial
sale, or if we significantly expand our clinical trials, we will need to manufacture them in larger
quantities. To date, our drug candidates have been manufactured in small quantities for preclinical
testing and
11
clinical trials and we may not be able to successfully increase the manufacturing capacity, whether
in collaboration with third party manufacturers or on our own, for any of our drug candidates in a
timely or economic manner, or at all. For example, the manufacture of our drug candidate
sapacitabine and CYC116 require several steps and it is not known if scale up to commercial
production is feasible. Significant scale-up of manufacturing may require additional validation
studies, which the FDA and other regulatory bodies must review and approve. If we are unable to
successfully increase the manufacturing capacity for a drug candidate whether for late stage
clinical trials or for commercial sale, the drug development, regulatory approval or commercial
launch of any related drugs may be delayed or there may be a shortage in supply. Even if any third
party manufacturer makes improvements in the manufacturing process for our drug candidates, we may
not own, or may have to share, the intellectual property rights to such innovation.
We currently have no marketing or sales staff. If we are unable to conclude strategic alliances
with marketing partners or if we are unable to develop our own sales and marketing capabilities, we
may not be successful in commercializing any drugs we may develop.
Our strategy is to develop compounds through the Phase II stage of clinical testing and market
or co-promote certain of our drugs on our own. We have no sales, marketing or distribution
capabilities. We will depend primarily on strategic alliances with third parties, which have
established distribution systems and sales forces, to commercialize our drugs. To the extent that
we are unsuccessful in commercializing any drugs ourselves or through a strategic alliance, product
revenues will suffer, we will incur significant additional losses and our share price will be
negatively affected.
If we evolve from a company primarily involved in discovery and development to one also involved in
the commercialization of drugs, we may encounter difficulties in managing our growth and expanding
our operations successfully.
If we advance our drug candidates through clinical trials, we will need to expand our
development and regulatory capabilities and develop manufacturing, marketing and sales capabilities
or contract with third parties to provide these capabilities for us. If our operations expand, we
expect that we will need to manage additional relationships with various collaborative partners,
suppliers and other third parties. Our ability to manage our operations and any growth will require
us to make appropriate changes and upgrades (as necessary) to our operational, financial and
management controls, reporting systems and procedures where we may operate. Any inability to manage
growth could delay the execution of our business plan or disrupt our operations.
The failure to attract and retain skilled personnel could impair our drug development and
commercialization efforts.
We are highly dependent on our senior management and key scientific and technical personnel.
The loss of the services of any member of our senior management, scientific or technical staff may
significantly delay or prevent the achievement of drug development and other business objectives
and could have a material adverse effect on our business, operating results and financial
condition. We also rely on consultants and advisors to assist us in formulating our research and
development strategy. All of our consultants and advisors are either self-employed or employed by
other organizations, and they may have conflicts of interest or other commitments, such as
consulting or advisory contracts with other organizations, that may affect their ability to
contribute to us.
We intend to expand and develop new drug candidates. We will need to hire additional employees
in order to continue our clinical trials and market our drug candidates. This strategy will require
us to recruit additional executive management and scientific and technical personnel. There is currently intense
competition for skilled executives and employees with relevant scientific and technical expertise,
and this competition is likely to continue. The inability to attract and retain sufficient
scientific, technical and managerial personnel could limit or delay our product development
efforts, which would adversely affect the development of our drug candidates and commercialization
of our potential drugs and growth of our business.
12
Our drug candidates are subject to extensive regulation, which can be costly and time-consuming,
and we may not obtain approvals for the commercialization of any of our drug candidates.
The clinical development, manufacturing, selling and marketing of our drug candidates are
subject to extensive regulation by the FDA and other regulatory authorities in the United States,
the European Union and elsewhere. These regulations also vary in important, meaningful ways from
country to country. We are not permitted to market a potential drug in the United States until we
receive approval of a New Drug Application, or NDA, from the FDA. We have not received an NDA
approval from the FDA for any of our drug candidates.
Obtaining an NDA approval is expensive and is a complex, lengthy and uncertain process. The
FDA approval process for a new drug involves completion of preclinical studies and the submission
of the results of these studies to the FDA, together with proposed clinical protocols,
manufacturing information, analytical data and other information in an Investigational New Drug
application, or IND, which must become effective before human clinical trials may begin. Clinical
development typically involves three phases of study: Phase I, II and III. The most significant
costs associated with clinical development are the Phase III clinical trials as they tend to be the
longest and largest studies conducted during the drug development process. After completion of
clinical trials, an NDA may be submitted to the FDA. In responding to an NDA, the FDA may refuse to
file the application, or if accepted for filing, the FDA may grant marketing approval, request
additional information or deny the application if it determines that the application does not
provide an adequate basis for approval. In addition, failure to comply with FDA and other
applicable foreign and U.S. regulatory requirements may subject it to administrative or judicially
imposed sanctions. These include warning letters, civil and criminal penalties, injunctions,
product seizure or detention, product recalls, total or partial suspension of production and
refusal to approve either pending NDAs, or supplements to approved NDAs.
Despite the substantial time and expense invested in preparation and submission of an NDA or
equivalents in other jurisdictions, regulatory approval is never guaranteed. The FDA and other
regulatory authorities in the United States, the European Union and elsewhere exercise substantial
discretion in the drug approval process. The number, size and design of preclinical studies and
clinical trials that will be required for FDA or other regulatory approval will vary depending on
the drug candidate, the disease or condition for which the drug candidate is intended to be used
and the regulations and guidance documents applicable to any particular drug candidate. The FDA or
other regulators can delay, limit or deny approval of a drug candidate for many reasons, including,
but not limited to:
|
|
|
those discussed in the risk factor which immediately follows; |
|
|
|
|
the fact that FDA or other regulatory officials may not approve our or
our third party manufacturers processes or facilities; or |
|
|
|
|
the fact that new regulations may be enacted by the FDA or other
regulators may change their approval policies or adopt new regulations
requiring new or different evidence of safety and efficacy for the
intended use of a drug candidate. |
Following regulatory approval of any drug candidate, we would be subject to ongoing regulatory
obligations and restrictions, which may result in significant expense and limit our ability to
commercialize our potential drugs.
If one of our drug candidates is approved by the FDA or by another regulatory authority, we
would be held to extensive regulatory requirements over product manufacturing, labeling, packaging,
adverse event reporting, storage, advertising, promotion and record keeping. Regulatory approvals
may also be subject to significant limitations on the indicated uses or marketing of the drug
candidates. Potentially costly follow-up or post-marketing clinical studies may be required as a
condition of approval to further substantiate safety or efficacy, or to investigate specific issues
of interest to the regulatory authority. Previously unknown problems with the drug candidate,
including adverse events of unanticipated severity or frequency, may result in restrictions on the
marketing of the drug, and could include withdrawal of the drug from the market.
13
In addition, the law or regulatory policies governing pharmaceuticals may change. New
statutory requirements may be enacted or additional regulations may be enacted that could prevent
or delay regulatory approval of our drug candidates. We cannot predict the likelihood, nature or
extent of adverse government regulation that may arise from future legislation or administrative
action, either in the United States or elsewhere. If we are not able to maintain regulatory
compliance, it might not be permitted to market our drugs and our business could suffer.
Our applications for regulatory approval could be delayed or denied due to problems with studies
conducted before we in-licensed some of our product candidates.
We currently license some of the compounds and drug candidates used in our research programs
from third parties. These include sapacitabine, licensed from Sankyo Co., Ltd and CYC381 and
related intellectual property, licensed from Lorus Therapeutics, Inc. Our present research
involving these compounds relies upon previous research conducted by third parties over whom we had
no control and before we in-licensed the drug candidates. In order to receive regulatory approval
of a drug candidate, we must present all relevant data and information obtained during our research
and development, including research conducted prior to our licensure of the drug candidate.
Although we are not currently aware of any such problems, any problems that emerge with preclinical
research and testing conducted prior to our in-licensing may affect future results or our ability
to document prior research and to conduct clinical trials, which could delay, limit or prevent
regulatory approval for our drug candidates.
We face intense competition and our competitors may develop drugs that are less expensive, safer,
or more effective than our drug candidates.
We are engaged in a rapidly changing and highly competitive field. We are seeking to develop
and market products that will compete with other products and drugs that currently exist or are
being developed. We compete with companies that are developing small molecule drugs, as well as
companies that have developed drugs or are developing alternative drug candidates for cancer or
other serious disorders where there is abnormal cell proliferation. We believe that other companies
are currently developing drugs targeting cancer that may compete with our drug candidates,
including Astex, AstraZeneca, Eisai, Kyowa Hakko, Onconova, Pfizer, Roche, Schering AG, and
Sunesis. Although Aventis, a predecessor of Sanofi-Aventis, had previously announced that it has
ceased Phase II development of alvocidib or flavopiridol, a CDK inhibitor, we believe that the
National Cancer Institutes Cancer Therapy Evaluation Program is continuing to enroll patients in a
Phase II trial and that Sanofi-Aventis has reinitiated development of alvocidib in Phase III
clinical trials in patients with chronic leukemia. Several pharmaceutical and biotechnology
companies have nucleoside analogs on the market or in clinical trials for oncology indications,
including Clavis Pharmaceuticals, Eli Lilly, Genzyme, GlaxoSmithKline and Supergen. A number of
companies are pursuing discovery and research activities in each of the other areas that are the
subject of our research and drug development programs. We believe that Astex, AstraZeneca, Merck,
jointly with Vertex, Millennium Nerviano Medical Sciences and Serono have commenced Phase II or
Phase I clinical trials of Aurora kinase inhibitors in patients with advanced cancers. Several
companies have reported selection of Aurora kinase inhibitor candidates for development, including
Entremed and Sunesis, and may have started or are expected to start clinical trials within the next
twelve months. We believe that Boehringer Ingelheim and Onconova have entered clinical development
with Plk inhibitor candidates for oncology indications.
Our competitors, either alone or together with collaborators, may have substantially greater
financial resources and research and development staff. Our competitors may also have more
experience:
|
|
|
developing drug candidates; |
|
|
|
|
conducting preclinical and clinical trials; |
|
|
|
|
obtaining regulatory approvals; and |
|
|
|
|
commercializing drug candidates. |
14
Our competitors may succeed in obtaining patent protection and regulatory approval and may
market drugs before we do. If our competitors market drugs that are less expensive, safer, more
effective or more convenient to administer than our potential drugs, or that reach the market
sooner than our potential drugs, we may not achieve commercial success. Scientific, clinical or
technical developments by our competitors may render our drug candidates obsolete or
noncompetitive. We anticipate that we will face increased competition in the future as new
companies enter the markets and as scientific developments progress. If our drug candidates obtain
regulatory approvals, but do not compete effectively in the marketplace, our business will suffer.
The commercial success of our drug candidates depends upon their market acceptance among
physicians, patients, healthcare providers and payors and the medical community.
If our drug candidates are approved by the FDA or by another regulatory authority, the
resulting drugs, if any, may not gain market acceptance among physicians, healthcare providers and
payors, patients and the medical community. The degree of market acceptance of any of our approved
drugs will depend on a variety of factors, including:
|
|
|
timing of market introduction, number and clinical profile of competitive drugs; |
|
|
|
|
our ability to provide acceptable evidence of safety and efficacy; |
|
|
|
|
relative convenience and ease of administration; |
|
|
|
|
cost-effectiveness; |
|
|
|
|
availability of coverage, reimbursement and adequate payment from health
maintenance organizations and other third party payors; |
|
|
|
|
prevalence and severity of adverse side effects; and |
|
|
|
|
other potential advantages over alternative treatment methods. |
If our drugs fail to achieve market acceptance, we may not be able to generate significant
revenue and our business would suffer.
There is uncertainty related to coverage, reimbursement and payment by healthcare providers and
payors for newly approved drugs. The inability or failure to obtain coverage could affect our
ability to market our future drugs and decrease our ability to generate revenue.
The availability and levels of coverage and reimbursement of newly approved drugs by
healthcare providers and payors is subject to significant uncertainty. The commercial success of
our drug candidates in both the U.S. and international markets is substantially dependent on
whether third party coverage and reimbursement is available. The U.S. Centers for Medicare and
Medicaid Services, health maintenance organizations and other third party payors in the United
States, the European Union and other jurisdictions are increasingly attempting to contain
healthcare costs by limiting both coverage and the level of reimbursement of new drugs and, as a
result, they may not cover or provide adequate payment for our potential drugs. Our drug candidates
may not be considered cost-effective and reimbursement may not be available to consumers or may not
be sufficient to allow our drug candidates to be marketed on a competitive basis.
In some countries, pricing of prescription drugs is subject to government control. In such
countries, pricing negotiations with governmental authorities can take three to 12 months or longer
following application to the competent authorities. To obtain reimbursement or pricing approval in
such countries may require conducting an additional clinical trial comparing the cost-effectiveness
of the drug to other alternatives. In the United States, the Medicare Part D drug benefit to be
implemented in 2006 will limit drug coverage through formularies and other cost and utilization
management programs, while Medicare Part B limits drug payments to a certain percentage of average
price or through restrictive payment policies of least costly alternatives and inherent
reasonableness. Our business could be materially harmed if coverage, reimbursement or pricing is
unavailable or set at unsatisfactory levels.
15
We may be exposed to product liability claims that may damage our reputation and may not be able to
obtain adequate insurance.
Because we conduct clinical trials in humans, we face the risk that the use of our drug
candidates will result in adverse effects. We believe that we have obtained reasonably adequate
product liability insurance coverage for our trials. We cannot predict, however, the possible harm
or side effects that may result from our clinical trials. Such claims may damage our reputation and
we may not have sufficient resources to pay for any liabilities resulting from a claim excluded
from, or beyond the limit of, our insurance coverage.
Once we have commercially available drugs based on our drug candidates, we will be exposed to
the risk of product liability claims. This risk exists even with respect to those drugs that are
approved for commercial sale by the FDA or other regulatory authorities in the United States, the
European Union or elsewhere and manufactured in facilities licensed and regulated by the FDA or
other such regulatory authorities. We intend to secure limited product liability insurance
coverage, but may not be able to obtain such insurance on acceptable terms with adequate coverage,
or at reasonable cost. There is also a risk that third parties that we have agreed to indemnify
could incur liability. Even if we were ultimately successful in product liability litigation, the
litigation would consume substantial amounts of our financial and managerial resources and may
create adverse publicity, all of which would impair our ability to generate sales of the litigated
product as well as our other potential drugs.
We may be subject to damages resulting from claims that our employees or we have wrongfully used or
disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at universities or other biotechnology or
pharmaceutical companies, including our competitors or potential competitors. Although no claims
against us are currently pending, we may be subject to claims that these employees or we have
inadvertently or otherwise used or disclosed trade secrets or other proprietary information of
their former employers. Litigation may be necessary to defend against these claims. If we fail in
defending such claims, in addition to paying monetary damages, we may lose valuable intellectual
property rights or personnel. A loss of key research personnel or their work product could hamper
or prevent our ability to commercialize certain potential drugs, which could severely harm our
business. Even if we are successful in defending against these claims, litigation could result in
substantial costs and be a distraction to management.
Defending against claims relating to improper handling, storage or disposal of hazardous chemical,
radioactive or biological materials could be time consuming and expensive.
Our research and development involves the controlled use of hazardous materials, including
chemicals, radioactive and biological materials such as chemical solvents, phosphorus and bacteria.
Our operations produce hazardous waste products. We cannot eliminate the risk of accidental
contamination or discharge and any resultant injury from those materials. Various laws and
regulations govern the use, manufacture, storage, handling and disposal of hazardous materials. We
may be sued for any injury or contamination that results from our use or the use by third parties
of these materials. Compliance with environmental laws and regulations may be expensive, and
current or future environmental regulations may impair our research, development and production
efforts.
If we fail to enforce adequately or defend our intellectual property rights our business may be
harmed.
Our commercial success depends in large part on obtaining and maintaining patent and trade
secret protection for our drug candidates, the methods used to manufacture those drug candidates
and the methods for treating patients using those drug candidates. Specifically our two lead drug
candidates have composition of matter patents that expire at the earliest case at 2016 and 2014
respectively. Failure to obtain, maintain or extend the patents could adversely affect our
business. We will only be able to protect our drug candidates and our technologies from
unauthorized use by third parties to the extent that valid and enforceable patents or trade secrets
cover them.
Our ability to obtain patents is uncertain because legal means afford only limited protections
and may not adequately protect our rights or permit it to gain or keep any competitive advantage.
Some
16
legal principles remain unresolved and the breadth or interpretation of claims allowed in patents
in the United States, the European Union or elsewhere can still be difficult to ascertain or
predict. In addition, the specific content of patents and patent applications that are necessary to
support and interpret patent claims is highly uncertain due to the complex nature of the relevant
legal, scientific and factual issues. Changes in either patent laws or in interpretations of patent
laws in the United States, the European Union or elsewhere may diminish the value of our
intellectual property or narrow the scope of our patent protection. Our existing patents and any
future patents we obtain may not be sufficiently broad to prevent others from practicing our
technologies or from developing competing products and technologies. In addition, we generally do
not control the patent prosecution of subject matter that we license from others and have not
controlled the earlier stages of the patent prosecution. Accordingly, we are unable to exercise the
same degree of control over this intellectual property as we would over our own.
Even if patents are issued regarding our drug candidates or methods of using them, those
patents can be challenged by our competitors who may argue such patents are invalid and/or
unenforceable. Patents also will not protect our drug candidates if competitors devise ways of
making or using these product candidates without legally infringing our patents. The U.S. Federal
Food, Drug and Cosmetic, or FD&C, Act and FDA regulations and policies and equivalents in other
jurisdictions provide incentives to manufacturers to challenge patent validity or create modified,
noninfringing versions of a drug in order to facilitate the approval of abbreviated new drug
applications for generic substitutes. These same types of incentives encourage manufacturers to
submit new drug applications that rely on literature and clinical data not prepared for or by the
drug sponsor.
Proprietary trade secrets and unpatented know-how are also very important to our business. We
rely on trade secrets to protect our technology, especially where we do not believe that patent
protection is appropriate or obtainable. However, trade secrets are difficult to protect. Our
employees, consultants, contractors, outside scientific collaborators and other advisors may
unintentionally or willfully disclose our confidential information to competitors, and
confidentiality agreements may not provide an adequate remedy in the event of unauthorized
disclosure of confidential information. Enforcing a claim that a third party obtained illegally and
is using trade secrets is expensive and time consuming, and the outcome is unpredictable. Moreover,
our competitors may independently develop equivalent knowledge, methods and know-how. Failure to
obtain or maintain trade secret protection could adversely affect our competitive business
position.
If we infringe intellectual property rights of third parties, we may increase our costs or be
prevented from being able to commercialize our drug candidates.
There is a risk that we are infringing or will infringe the proprietary rights of third
parties because patents and pending applications belonging to third parties exist in the United
States, the European Union and elsewhere in the world in the areas our research explores. Others
might have been the first to make the inventions covered by each of our or our licensors pending
patent applications and issued patents and might have been the first to file patent applications
for these inventions. In addition, because the patent application process can take several years to
complete, there may be currently pending applications, unknown to us, which may later result in
issued patents that cover the production, manufacture, commercialization or use of our drug
candidates. In addition, the production, manufacture, commercialization or use of our product
candidates may infringe existing patents of which we are not aware. Numerous third-party United
States and foreign issued patents and pending applications exist in the area of kinases, including
CDK, Aurora and Plk for which we have research programs. Because patent applications can take
several years to issue, there may be pending applications that may result in issued patents that
cover our technologies or product candidates. For example, some pending patent applications contain
broad claims that could represent freedom to operate limitations for some of our kinase programs
should they be issued unchanged. If we wish to use the technology or compound claimed in issued and
unexpired patents owned by others, we will need to obtain a license from the owner, enter into
litigation to challenge the validity of the patents or incur the risk of litigation in the event
that the owner asserts that we infringe its patents. In one case we have opposed a European patent
relating to human aurora kinase. We are also aware of
17
a corresponding U.S. patent containing method of treatment claims for specific cancers using aurora
kinase modulators which, if held valid, could potentially restrict the use of certain of our aurora
kinase inhibitors once clinical trials are completed.
There has been substantial litigation and other proceedings regarding patent and other
intellectual property rights in the pharmaceutical and biotechnology industries. Defending against
third party claims, including litigation in particular, would be costly and time consuming and
would divert managements attention from our business, which could lead to delays in our
development or commercialization efforts. If third parties are successful in their claims, we might
have to pay substantial damages or take other actions that are adverse to our business. As a result
of intellectual property infringement claims, or to avoid potential claims, we might:
|
|
|
be prohibited from selling or licensing any product that we may
develop unless the patent holder licenses the patent to us, which it
is not required to do; |
|
|
|
|
be required to pay substantial royalties or grant a cross license to
our patents to another patent holder; |
|
|
|
|
be required to pay substantial damages for past infringement, which we
may have to pay if a court determines that our product candidates or
technologies infringe a competitors patent or other proprietary
rights; or |
|
|
|
|
be required to redesign the formulation of a drug candidate so it does
not infringe, which may not be possible or could require substantial
funds and time. |
The development programs for our two lead drug candidates are based in part on intellectual
property rights we license from others, and any termination of those licenses could seriously harm
our business.
We have in-licensed certain patent rights in connection with the development programs for each
of our two lead drug candidates. With respect to seliciclib, we hold a license from Centre National
de Recherche Scientifique, or CNRS, and Institut Curie. With respect to sapacitabine, we hold a
license from Sankyo Co., Ltd. of Japan. Both of these license agreements impose payment and other
material obligations on us. Under the CNRS/Institut Curie license, we are obligated to pay license
fees, milestone payments and royalties. We are also obligated to use reasonable efforts to develop
and commercialize products based on the licensed patents. Under the Sankyo license, we are
obligated to pay license fees, milestone payments and royalties. We are also obligated to use
commercially reasonable efforts to commercialize products based on the licensed rights and to use
reasonable efforts to obtain regulatory approval to sell the products in at least one country by
September 2011. Although we are currently in compliance with all of our material obligations under
these licenses, if we were to breach any such obligations our counterparties would be permitted to
terminate the licenses. This would restrict or delay or eliminate our ability to develop and
commercialize these drug candidates, which could seriously harm our business.
Intellectual property rights of third parties could adversely affect our ability to commercialize
our drug candidates.
If patents issued to third parties contain valid claims that cover our compounds or their
manufacture or uses relevant to our development plans, we may be required to obtain licenses to
these patents or to develop or obtain
alternative technology. We are aware of several published patent applications, and understand
that others may exist, that could support claims that, if granted, could cover various aspects of
our developmental programs, including in some cases our lead drug candidate, seliciclib, particular
uses of that compound, sapacitabine or other therapeutic candidates, or gene sequences and
techniques that we use in the course of our research and development. Based on our review of the
published applications, we believe that it is unlikely that a valid claim would be issued that
covered seliciclib. In addition, we understand that other applications exist relating to potential
uses of seliciclib and sapacitabine that are not part of our current clinical programs for these
compounds. Although we intend to continue to monitor these applications, we cannot predict what
claims will ultimately be allowed and if allowed what their scope would be. If a patent is issued
that covers our compounds or their manufacture or uses related to our development plans then we may
18
not be in a position to commercialize the related drug candidate unless we successfully pursue
litigation to have that patent invalidated or enter into a licensing arrangement with the patent
holder. Any such litigation would be time consuming and costly, and our outcome would not be
guaranteed, and we cannot be certain that we would be able to enter into a licensing arrangement
with the patent holder on commercially reasonable terms. In either case, our business prospects
could be materially adversely affected.
The number of shares of common stock which are being registered, including the shares to be issued
upon exercise of our outstanding warrants, is significant in relation to our currently outstanding
common stock and could cause downward pressure on the market price for our common stock.
The number of shares of common stock registered for resale, including those shares which are
to be issued upon exercise of our outstanding warrants, is significant in relation to the number of
shares of common stock currently outstanding. If those security holders determine to sell a
substantial number of shares into the market at any given time, there may not be sufficient demand
in the market to purchase the shares without a decline in the market price for our common stock.
Moreover, continuous sales into the market of a number of shares in excess of the typical trading
volume for our common stock, or even the availability of such a large number of shares, could
depress the trading market for our common stock over an extended period of time.
If persons engage in short sales of our common stock, including sales of shares to be issued upon
exercise of our outstanding warrants, the price of our common stock may decline.
Selling short is a technique used by a stockholder to take advantage of an anticipated decline
in the price of a security. In addition, holders of options and warrants will sometimes sell short
knowing they can, in effect, cover through the exercise of an option or warrant, thus locking in a
profit. A significant number of short sales or a large volume of other sales within a relatively
short period of time can create downward pressure on the market price of a security. Further sales
of common stock issued upon exercise of our outstanding warrants could cause even greater declines
in the price of our common stock due to the number of additional shares available in the market
upon such exercise, which could encourage short sales that could further undermine the value of our
common stock. You could, therefore, experience a decline in the value of your investment as a
result of short sales of our common stock.
We have limited experience attempting to comply with public company obligations. Attempting to
comply with these requirements will increase our costs and require additional management resources,
and we still may fail to comply.
As a newly public company, we face and will continue to face increased legal, accounting,
administrative and other costs and expenses as a public company that we did not incur as a private
company. Compliance with the Sarbanes Oxley Act of 2002, as well as other rules of the SEC, the
Public Company Accounting Oversight Board and The Nasdaq Global Market has resulted in a
significant initial cost to us as well as an ongoing increase in our legal, audit and financial
compliance costs. As a public company, we are subject to Section 404 of the Sarbanes Oxley Act
relating to internal control over financial reporting. We have commenced a formal process to
evaluate our internal controls for purposes of Section 404, and we cannot assure that our internal
control over financial reporting will prove to be effective.
Effective internal controls over financial reporting are necessary for us to provide reliable
financial reports and, together with adequate disclosure controls and procedures, are designed to
prevent fraud. If we cannot provide reliable financial reports or prevent fraud, our operating
results could be harmed. We have commenced a
formal process to evaluate our internal control over financial reporting. Given the status of
our efforts, coupled with the fact that guidance from regulatory authorities in the area of
internal controls continues to evolve, substantial uncertainty exists regarding our ability to
comply by applicable deadlines. Any failure to implement required new or improved controls, or
difficulties encountered in their implementation, could harm our operating results or cause us to
fail to meet our reporting obligations. Ineffective internal controls could also cause investors to
lose confidence in our reported financial information, which could have a negative effect on the
trading price of our common stock.
19
Our common stock may have a volatile public trading price.
An active public market for our common stock has not developed. Our stock can trade in small
volumes which may make the price of our stock highly volatile. The last reported price of our stock
may not represent the price at which you would be able to buy or sell the stock. The market prices
for securities of companies comparable to us have been highly volatile. Often, these stocks have
experienced significant price and volume fluctuations for reasons unrelated to the operating
performance of the individual companies. Factors giving rise to this volatility may include:
|
|
|
disclosure of actual or potential clinical results with respect to product
candidates we are developing; |
|
|
|
|
regulatory developments in both the United States and abroad; |
|
|
|
|
developments concerning proprietary rights, including patents and litigation matters; |
|
|
|
|
public concern about the safety or efficacy of our product candidates or technology,
or related technology, or new technologies generally; |
|
|
|
|
concern about the safety or efficacy of our product candidates or technology, or
related technology, or new technologies generally; |
|
|
|
|
public announcements by our competitors or others; and |
|
|
|
|
general market conditions and comments by securities analysts and investors. |
Fluctuations in our operating losses could adversely affect the price of our common stock.
Our operating losses may fluctuate significantly on a quarterly basis. Some of the factors
that may cause our operating losses to fluctuate on a period-to-period basis include the status of
our preclinical and clinical development programs, level of expenses incurred in connection with
our preclinical and clinical development programs, implementation or termination of collaboration,
licensing, manufacturing or other material agreements with third parties, non-recurring revenue or
expenses under any such agreement, and compliance with regulatory requirements. Period-to-period
comparisons of our historical and future financial results may not be meaningful, and investors
should not rely on them as an indication of future performance. Our fluctuating losses may fail to
meet the expectations of securities analysts or investors. Our failure to meet these expectations
may cause the price of our common stock to decline.
Anti-takeover provisions in our charter documents and provisions of Delaware law may make an
acquisition more difficult and could result in the entrenchment of management.
We are incorporated in Delaware. Anti-takeover provisions of Delaware law and our amended and
restated certificate of incorporation and amended and restated bylaws may make a change in control
or efforts to remove management more difficult. Also, under Delaware law, our board of directors
may adopt additional anti-takeover measures.
We have the authority to issue up to 5,000,000 shares of preferred stock and to determine the
terms of those shares of stock without any further action by our stockholders. If the board of
directors exercises this power to issue preferred stock, it could be more difficult for a third
party to acquire a majority of our outstanding voting stock and vote the stock they acquire to
remove management or directors.
Our amended and restated certificate of incorporation and amended and restated bylaws also
provides staggered terms for the members of our board of directors. Under Section 141 of the
Delaware General Corporation Law, our directors may be removed by stockholders only for cause and
only by vote of the holders of a majority of voting shares then outstanding. These provisions may
prevent stockholders from replacing the entire board in a single proxy contest, making it more
difficult for a third party to acquire control of us without the consent of our board of directors.
These provisions could also delay the removal of management by the board of directors with or
without cause. In addition, our directors may only be removed for cause and amended and restated
bylaws limit the ability our stockholders to call special meetings of stockholders.
20
Under Section 203 of the Delaware General Corporation Law, a corporation may not engage in a
business combination with any holder of 15% or more of its capital stock until the holder has held
the stock for three years unless, among other possibilities, the board of directors approves the
transaction. Our board of directors could use this provision to prevent changes in management. The
existence of the foregoing provisions could limit the price that investors might be willing to pay
in the future for shares of our common stock.
Our certificate of incorporation and bylaws and certain provisions of Delaware law may delay or
prevent a change in our management and make it more difficult for a third party to acquire us.
Our certificate of incorporation and bylaws contain provisions that could delay or prevent a
change in our board of directors and management teams. Some of these provisions:
|
|
|
authorize the issuance of preferred stock that can be created and
issued by the board of directors without prior stockholder approval,
commonly referred to as blank check preferred stock, with rights
senior to those of our common stock; |
|
|
|
|
provide for the board of directors to be divided into three classes; and |
|
|
|
|
require that stockholder actions must be effected at a duly called
stockholder meeting and prohibit stockholder action by written consent. |
In addition, because we are incorporated in Delaware, we are governed by the provisions of
Section 203 of the Delaware General Corporation Law, which limits the ability of large stockholders
to complete a business combination with, or acquisition of, us. These provisions may prevent a
business combination or acquisition that would be attractive to stockholders and could limit the
price that investors would be willing to pay in the future for our stock.
These provisions also make it more difficult for our stockholders to replace members of our
board of directors. Because our board of directors is responsible for appointing the members of our
management team, these provisions could in turn affect any attempt to replace our current
management team. Additionally, these provisions may prevent an acquisition that would be attractive
to stockholders and could limit the price that investors would be willing to pay in the future for
our common stock.
We may have limited ability to pay cash dividends on the convertible preferred stock.
Delaware law may limit our ability to pay cash dividends on the convertible preferred stock.
Under Delaware law, cash dividends on our capital stock may only be paid from surplus or, if
there is no surplus, from the corporations net profits for the current or preceding fiscal
year. Delaware law defines surplus as the amount by which the total assets of a corporation,
after subtracting its total liabilities, exceed the corporations capital, as determined by its
board of directors. Since we are not profitable, our ability to pay cash dividends will require the
availability of adequate surplus. Even if adequate surplus is available to pay cash dividends on
the convertible preferred stock, we may not have sufficient cash to pay dividends on the
convertible preferred stock. If that was to happen, holders of preferred stock would be granted
certain additional rights until such dividends were repaid.
Our common and convertible preferred stock may experience extreme price and volume fluctuations,
which could lead to costly litigation for the Company and make an investment in the Company less
appealing.
The market price of our common and convertible preferred stock may fluctuate substantially due
to a variety of factors, including:
|
|
|
additions to or departures of our key personnel; |
|
|
|
|
announcements of technological innovations or new products or services by us or our competitors; |
|
|
|
|
announcements concerning our competitors or the biotechnology industry in general; |
21
|
|
|
new regulatory pronouncements and changes in regulatory guidelines; |
|
|
|
|
general and industry-specific economic conditions; |
|
|
|
|
changes in financial estimates or recommendations by securities analysts; |
|
|
|
|
variations in our quarterly results; |
|
|
|
|
announcements about our collaborators or licensors; and |
|
|
|
|
changes in accounting principles. |
The market prices of the securities of biotechnology companies, particularly companies like us
without product revenues and earnings, have been highly volatile and are likely to remain highly
volatile in the future. This volatility has often been unrelated to the performance of particular
companies. In the past, companies that experience volatility in the market price of their
securities have often faced securities class action litigation.
Moreover, market prices for stocks of biotechnology-related and technology companies
frequently reach levels that bear no relationship to the performance of these companies. These
market prices generally are not sustainable and are highly volatile. Whether or not meritorious,
litigation brought against us could result in substantial costs, divert our managements attention
and resources and harm our financial condition and results of operations.
The future sale of our common and convertible preferred stock, and future issuances of our common
stock upon conversion of our convertible preferred stock and upon the payment of make-whole
dividends, if any, could negatively affect our stock price.
If our common or convertible preferred stockholders sell substantial amounts of its stock in
the public market, or the market perceives that such sales may occur, the market price of our
common and convertible preferred stock could fall.
In addition, if we exercise our rights to pay make-whole dividends in common stock rather than
in cash upon conversion of our convertible preferred stock to common stock, then the sale of such
shares of common stock or the perception that such sales may occur could cause the market price of
our stock to fall. Additionally, after our convertible preferred stock offering, the holders of our
convertible preferred stock had the right to convert each share of convertible preferred stock into
approximately 0.42553 shares of our common stock. Such conversion rate is subject to certain
antidilution adjustments that, upon the occurrence of certain events, will increase the number of
shares of common stock that each holder of convertible preferred stock will receive upon conversion
into common stock. Such antidilution price adjustments may apply in the case of any strategic
alternative that we pursue which may result in further dilution to the holders of outstanding
common stock. The conversion of our convertible preferred stock into common stock and the payment
of any make-whole dividends in shares of common stock in lieu of cash, may result in substantial
dilution to the interests of our holders of common stock.
If we exchange the convertible preferred stock for debentures, the exchange will be taxable but we
will not provide any cash to pay any tax liability that any convertible preferred stockholder may
incur.
An exchange of convertible preferred stock for debentures, as well as any dividend make-whole
or interest make-whole payments paid in our common stock, will be taxable events for U.S. federal
income tax purposes, which may result in tax liability for the holder of convertible preferred
stock without any corresponding receipt of cash by the holder. In addition, the debentures may be
treated as having original issue discount, a portion of which would generally be required to be
included in the holders gross income even though the cash to which such income is attributable
would not be received until maturity or redemption of the debenture. We will not distribute any
cash to you to pay these potential tax liabilities.
If we automatically convert the convertible preferred stock, there is a substantial risk of
fluctuation in the price of our common stock from the date we elect to automatically convert to the
conversion date.
We may elect to automatically convert the convertible preferred stock on or prior to maturity
if our common stock price has exceeded 150% of the conversion price for at least 20 trading days
during
22
a 30-day trading period ending within five trading days prior to the notice of automatic
conversion. You should be aware that there is a risk of fluctuation in the price of our common
stock between the time when we may first elect to automatically convert the preferred and the
automatic conversion date.
We do not intend to pay cash dividends on its common stock in the foreseeable future.
We do not anticipate paying cash dividends on our common stock in the foreseeable future. Any
payment of cash dividends will depend on our financial condition, results of operations, capital
requirements, the outcome of the review of our strategic alternatives and other factors and will be
at the discretion of our board of directors. Accordingly, investors will have to rely on capital
appreciation, if any, to earn a return on their investment in our common stock. Furthermore, we may
in the future become subject to contractual restrictions on, or prohibitions against, the payment
of dividends.
23
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
The Securities and Exchange Commission encourages companies to disclose forward-looking
information so that investors can better understand a companys future prospects and make informed
investment decisions. This prospectus contains such forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. These statements may be made
directly in this prospectus, and they may also be made a part of this prospectus by reference to
other documents filed with the Securities and Exchange Commission, which is known as
incorporation by reference.
Words such as may, anticipate, estimate, expects, projects, intends,
plans, believes and words and terms of similar substance used in connection with any
discussion of future operating or financial performance identify forward-looking statements. All
forward-looking statements are managements present expectations of future events and are subject
to a number of risks and uncertainties that could cause actual results to differ materially from
those described in the forward-looking statements. Forward-looking statements might include one or
more of the following:
|
|
|
anticipated results of financing activities; |
|
|
|
|
anticipated agreements with marketing partners; |
|
|
|
|
anticipated clinical trial timelines or results; |
|
|
|
|
anticipated research and product development results; |
|
|
|
|
projected regulatory timelines; |
|
|
|
|
descriptions of plans or objectives of management for future operations, products or services; |
|
|
|
|
forecasts of future economic performance; and |
|
|
|
|
descriptions or assumptions underlying or relating to any of the above items. |
Please also see the discussion of risks and uncertainties under the heading Risk Factors
starting on page 7.
In light of these assumptions, risks and uncertainties, the results and events discussed in
the forward-looking statements contained in this prospectus or in any document incorporated by
reference might not occur. Investors are cautioned not to place undue reliance on the
forward-looking statements, which speak only as of the date of
this prospectus or the date of the document incorporated by reference in this prospectus. We
are not under any obligation, and we expressly disclaim any obligation, to update or alter any
forward-looking statements, whether as a result of new information, future events or otherwise. All
subsequent forward-looking statements attributable to Coley or to any person acting on its behalf
are expressly qualified in their entirety by the cautionary statements contained or referred to in
this section.
USE OF PROCEEDS
Unless we indicate otherwise in the applicable prospectus supplement, we currently intend to
use the net proceeds from this offering for general corporate purposes, including our internal
discovery and development programs and the development of new technologies, general working capital
and possible future acquisitions.
We have not determined the amounts we plan to spend on any of the areas listed above or the
timing of these expenditures. As a result, our management will have broad discretion to allocate
the net proceeds from this offering. Pending application of the net proceeds as described above, we
intend to invest the net proceeds of the offering in short-term, investment-grade, interest-bearing
securities.
We may set forth additional information on the use of net proceeds from the sale of securities
we offer under this prospectus in a prospectus supplement relating to the specific offering.
24
THE SECURITIES WE MAY OFFER
The descriptions of the securities contained in this prospectus, together with the applicable
prospectus supplements, summarize all the material terms and provisions of the various types of
securities that we may offer. We will describe in the applicable prospectus supplement relating to
any securities the particular terms of the securities offered by that prospectus supplement. If we
indicate in the applicable prospectus supplement, the terms of the securities may differ from the
terms we have summarized below. We will also include information in the prospectus supplement,
where applicable, about material United States federal income tax considerations relating to the
securities, and the securities exchange, if any, on which the securities will be listed.
We may sell from time to time, in one or more offerings:
|
|
|
common stock; |
|
|
|
|
preferred stock; |
|
|
|
|
warrants to purchase common stock; and/or |
|
|
|
|
debt securities. |
This prospectus may not be used to consummate a sale of securities unless it is accompanied by
a prospectus supplement.
DESCRIPTION OF COMMON STOCK
We are authorized to issue 100,000,000 shares of common stock, $0.001 par value per share. As
of February 9, 2007, approximately 16,157,991 shares of common stock were issued and outstanding.
The following descriptions of our common stock and provisions of our amended and restated
certificate of incorporation and amended and restated by-laws are only summaries, and we encourage
you to review complete copies of these documents, which have been filed as exhibits to our periodic
reports with the Securities and Exchange Commission.
Dividends, Voting Rights and Liquidation
Holders of common stock are entitled to one vote for each share held of record on all matters
submitted to a vote of the stockholders, and do not have cumulative voting rights. Subject to
preferences that may be applicable to any outstanding shares of preferred stock, holders of common
stock are entitled to receive ratably such dividends, if any, as may be declared from time to time
by our board of directors out of funds legally available for dividend payments. All outstanding
shares of common stock are fully paid and non-assessable, and the shares of common stock to be
issued upon completion of this offering will be fully paid and non-assessable. The holders of
common stock have no preferences or rights of conversion, exchange, pre-emption or other
subscription rights. There are no redemption or sinking fund provisions applicable to the common
stock. In the event of any liquidation, dissolution or winding-up of our affairs, holders of common
stock will be entitled to share ratably in our assets that are remaining after payment or provision
for payment of all of our debts and obligations and after liquidation payments to holders of
outstanding shares of preferred stock, if any.
Listing
Our common stock is listed on the Nasdaq Global Market under the symbol CYCC. Our
preferred stock is listed on the Nasdaq Capital Market under the symbol CYCCP.
Transfer Agent and Registrar
American Stock Transfer & Trust Company is the transfer agent and registrar for our common
stock. Their address is 59 Maiden Lane, Plaza Level, New York, NY 10038, and their telephone number
is (800) 937-5449.
Delaware Law and Certain Charter and By-law Provisions
The provisions of (1) Delaware law, (2) our amended and restated certificate of incorporation,
and (3) our amended and restated bylaws discussed below could discourage or make it more difficult
25
to accomplish a proxy contest or other change in our management or the
acquisition of control by a holder of a substantial amount of our voting
stock. It is possible that these provisions could make it more difficult to
accomplish, or could deter, transactions that stockholders may otherwise
consider to be in their best interests or in our best interests. These
provisions are intended to enhance the likelihood of continuity and stability
in the composition of our board of directors and in the policies formulated by
the board of directors and to discourage certain types of transactions that
may involve an actual or threatened change of control of us. These provisions
are designed to reduce our vulnerability to an unsolicited acquisition
proposal. The provisions also are intended to discourage certain tactics that
may be used in proxy fights. Such provisions also may have the effect of
preventing changes in our management.
Delaware Statutory Business Combinations Provision. We are subject to
the anti-takeover provisions of Section 203 of the Delaware General
Corporation Law. In general, Section 203 prohibits a publicly-held Delaware
corporation from engaging in a business combination with an interested
stockholder for a period of three years after the date of the transaction in
which the person became an interested stockholder, unless the business
combination is, or the transaction in which the person became an interested
stockholder was, approved in a prescribed manner or another prescribed
exception applies. For purposes of Section 203, a business combination is
defined broadly to include a merger, asset sale or other transaction resulting
in a financial benefit to the interested stockholder, and, subject to certain
exceptions, an interested stockholder is a person who, together with his
or her affiliates and associates, owns (or within three years prior, did own)
15% or more of the corporations voting stock.
Classified Board of Directors; Removal of Directors for Cause. Our
amended and restated certificate of incorporation and amended and restated
bylaws provide that our board of directors is divided into three classes, each
serving staggered three-year terms ending at the annual meeting of our
stockholders. All directors elected to our classified board of directors will
serve until the election and qualification of their respective successors or
their earlier resignation or removal. The board of directors is authorized to
create new directorships and to fill such positions so created and is
permitted to specify the class to which any such new position is assigned. The
person filling such position would serve for the term applicable to that
class. The board of directors (or its remaining members, even if less than a
quorum) is also empowered to fill vacancies on the board of directors
occurring for any reason for the remainder of the term of the class of
directors in which the vacancy occurred. Members of the board of directors may
only be removed for cause and only by the affirmative vote of 80% of our
outstanding voting stock. These provisions are likely to increase the time
required for stockholders to change the composition of the board of directors.
For example, in general, at least two annual meetings will be necessary for
stockholders to effect a change in a majority of the members of the board of
directors.
Advance Notice Provisions for Stockholder Proposals and Stockholder
Nominations of Directors. Our amended and restated bylaws provide that,
for nominations to the board of directors or for other business to be properly
brought by a stockholder before a meeting of stockholders, the stockholder
must first have given timely notice of the proposal in writing to our
Secretary. For an annual meeting, a stockholders notice generally must be
delivered not less than 45 days nor more than 75 days prior to the anniversary
of the mailing date of the proxy statement for the previous years annual
meeting. For a special meeting, the notice must generally be delivered by the
later of 90 days prior to the special meeting or ten days following the day on
which public announcement of the meeting is first made. Detailed requirements
as to the form of the notice and information required in the notice are
specified in the amended and restated bylaws. If it is determined that
business was not properly brought before a meeting in accordance with our
bylaw provisions, such business will not be conducted at the meeting.
Special Meetings of Stockholders. Special meetings of the
stockholders may be called only by our board of directors pursuant to a
resolution adopted by a majority of the total number of directors.
No Stockholder Action by Written Consent. Our amended and restated
certificate of incorporation and amended and restated bylaws do not permit our
stockholders to act by written
26
consent. As a result, any action to be effected by our stockholders must be
effected at a duly called annual or special meeting of the stockholders.
Super-Majority Stockholder Vote Required for Certain Actions. The
Delaware General Corporation Law provides generally that the affirmative vote
of a majority of the shares entitled to vote on any matter is required to
amend a corporations certificate of incorporation or bylaws, unless the
corporations certificate of incorporation or bylaws, as the case may be,
requires a greater percentage. Our amended and restated certificate of
incorporation requires the affirmative vote of the holders of at least 80% of
our outstanding voting stock to amend or repeal any of the provisions
discussed in this section of this prospectus entitled Anti-Takeover
Provisions or to reduce the number of authorized shares of common stock or
preferred stock. This 80% stockholder vote would be in addition to any
separate class vote that might in the future be required pursuant to the terms
of any preferred stock that might then be outstanding. In addition, an 80%
vote is also required for any amendment to, or repeal of, our amended and
restated bylaws by the stockholders. Our amended and restated bylaws may be
amended or repealed by a simple majority vote of the board of directors.
DESCRIPTION OF PREFERRED STOCK
Preferred Stock
We have the authority to issue up to 5,000,000 shares of preferred stock.
As of February 9, 2007, 2,046,813 shares of our preferred stock were
outstanding (see 6% Convertible Exchangeable Preferred Stock below). The
description of preferred stock provisions set forth below is not complete and
is subject to and qualified in its entirety by reference to our certificate of
incorporation and the certificate of designations relating to each series of
preferred stock.
The board of directors has the right, without the consent of holders of
common stock, to designate and issue one or more series of preferred stock,
which may be convertible into common stock at a ratio determined by the board.
A series of preferred stock may bear rights superior to common stock as to
voting, dividends, redemption, distributions in liquidation, dissolution, or
winding up, and other relative rights and preferences. The board may set the
following terms of any series preferred stock, and a prospectus supplement
will specify these terms for each series offered:
|
|
|
the number of shares constituting the series and the distinctive designation of the series; |
|
|
|
|
dividend rates, whether dividends are cumulative, and, if so, from what date; and the
relative rights of priority of payment of dividends; |
|
|
|
|
voting rights and the terms of the voting rights; |
|
|
|
|
conversion privileges and the terms and conditions of conversion, including provision for
adjustment of the conversion rate; |
|
|
|
|
redemption rights and the terms and conditions of redemption, including the date or dates
upon or after which shares may be redeemable, and the amount per share payable in case of
redemption, which may vary under different conditions and at different redemption dates; |
|
|
|
|
sinking fund provisions for the redemption or purchase of shares; |
|
|
|
|
rights in the event of voluntary or involuntary liquidation, dissolution or winding up of
the corporation, and the relative rights of priority of payment; and |
|
|
|
|
any other relative powers, preferences, rights, privileges, qualifications, limitations
and restrictions of the series. |
Dividends on outstanding shares of preferred stock will be paid or
declared and set apart for payment before any dividends may be paid or
declared and set apart for payment on the common stock with respect to the
same dividend period.
If, upon any voluntary or involuntary liquidation, dissolution or winding
up of the company, the assets available for distribution to holders of
preferred stock are insufficient to pay the full
27
preferential amount to which the holders are entitled, then the available
assets will be distributed ratably among the shares of all series of preferred
stock in accordance with the respective preferential amounts (including unpaid
cumulative dividends, if any) payable with respect to each series.
Holders of preferred stock will not be entitled to preemptive rights to
purchase or subscribe for any shares of any class of capital stock of the
corporation. The preferred stock will, when issued, be fully paid and
nonassessable. The rights of the holders of preferred stock will be
subordinate to those of our general creditors.
We have previously issued 2,990,000 shares of preferred stock in one
series, designated as 6% Convertible Exchangeable Preferred Stock, of which
2,046,813 are currently outstanding and is quoted on the Nasdaq Global Market
under the symbol CYCCP.
6% Convertible Exchangeable Preferred Stock
General
Our board of directors has designated 2,990,000 shares of the preferred
stock that were issued as convertible preferred stock on November 3, 2004. The
shares of convertible preferred stock are duly and validly issued, fully paid
and nonassessable. These shares will not have any preemptive rights if we
issue other series of preferred stock. The convertible preferred stock is not
subject to any sinking fund. We have no obligation to retire the convertible
preferred stock. The convertible preferred stock has a perpetual maturity and
may remain outstanding indefinitely, subject to the holders right to convert
the convertible preferred stock and our right to cause the conversion of the
convertible preferred stock and exchange or redeem the convertible preferred
stock at our option. Any convertible preferred stock converted, exchanged or
redeemed or acquired by us will, upon cancellation, have the status of
authorized but unissued shares of convertible preferred stock. We will be able
to reissue these cancelled shares of convertible preferred stock.
Dividends
When and if declared by our board of directors out of the legally
available funds, holders of the convertible preferred stock are entitled to
receive cash dividends at an annual rate of 6% of the liquidation preference
of the convertible preferred stock. Dividends are payable, and have been paid
since February 1, 2005, quarterly on the first day of February, May, August
and November. If any dividends are not declared, they will accrue and be paid
at such later date, if any, as determined by our board of directors. Dividends
on the convertible preferred stock will be cumulative from the issue date.
Dividends will be payable to holders of record as they appear on our stock
books not more than 60 days nor less than 10 days preceding the payment dates,
as fixed by our board of directors. If the convertible preferred stock is
called for redemption on a redemption date between the dividend record date
and the dividend payment date and the holder does not convert the convertible
preferred stock (as described below), the holder shall receive the dividend
payment together with all other accrued and unpaid dividends on the redemption
date instead of receiving the dividend on the dividend date. Dividends payable
on the convertible preferred stock for any period greater or less than a full
dividend period will be computed on the basis of a 360-day year consisting of
twelve 30-day months. Accrued but unpaid dividends will not bear interest.
If we do not pay or set aside cumulative dividends in full on the
convertible preferred stock and any other preferred stock ranking on the same
basis as to dividends, all dividends declared upon shares of the convertible
preferred stock and any other preferred stock ranking on the same basis as to
dividends will be declared on a pro rata basis until all accrued dividends are
paid in full. For these purposes, pro rata means that the amount of
dividends declared per share on the convertible preferred stock and any other
preferred stock ranking on the same basis as to dividends bear to each other
will be the same ratio that accrued and unpaid dividends per share on the
shares of the convertible preferred stock and such other preferred stock bear
to each other. We will not be able to redeem, purchase or otherwise acquire
any of our stock ranking on the same basis as the convertible preferred stock
as to dividends or liquidation preferences unless we have paid or set aside
full cumulative dividends, if any, accrued on all outstanding shares of
convertible preferred stock.
28
Unless we have paid or set aside cumulative dividends in full on the
convertible preferred stock and any other of the convertible preferred stock
ranking on the same basis as to dividends:
|
|
|
we may not declare or pay or set aside dividends on common stock or
any other stock ranking junior to the convertible preferred stock as
to dividends or liquidation preferences, excluding dividends or
distributions of shares, options, warrants or rights to purchase
common stock or other stock ranking junior to the convertible
preferred stock as to dividends; or |
|
|
|
|
we will not be able to redeem, purchase or otherwise acquire any of
our other stock ranking junior to the convertible preferred stock as
to dividends or liquidation preferences, except in very limited
circumstances. |
Under Delaware law, we may only make dividends or distributions to our
stockholders from:
|
|
|
our surplus; or |
|
|
|
|
the net profits for the current fiscal year or the fiscal year before
which the dividend or distribution is declared under certain
circumstances. |
Our ability to pay dividends and make any other distributions in the
future will depend upon our financial results, liquidity and financial
condition.
Conversion
Conversion Rights
Holders of our convertible preferred stock may convert the convertible
preferred stock at any time into a number of shares of common stock determined
by dividing the $10 liquidation preference by the conversion price of $23.50,
being the original conversion price of $2.35 as adjusted following a reverse
stock split, subject to adjustment as described below. This conversion price
is equivalent to a conversion rate of approximately 0.42553 shares of common
stock for each share of convertible preferred stock. We will not make any
adjustment to the conversion price for accrued or unpaid dividends upon
conversion. We will not issue fractional shares of common stock upon
conversion. However, we will instead pay cash for each fractional share based
upon the market price of the common stock on the last business day prior to
the conversion date. If we call the convertible preferred stock for
redemption, the holders right to convert the convertible preferred stock will
expire at the close of business on the business day immediately preceding the
date fixed for redemption, unless we fail to pay the redemption price.
Automatic Conversion
Unless we redeem or exchange the convertible preferred stock, we may
elect to convert some or all of the convertible preferred stock into shares of
our common stock if the closing price of our common stock has exceeded 150% of
the conversion price for at least 20 out of 30 consecutive trading days ending
within five trading days prior to the notice of automatic conversion. If we
elect to convert less than all of the shares of convertible preferred stock,
we shall select the shares to be converted by lot or pro rata or in some other
equitable manner in our discretion. If we elect to automatically convert
shares of our convertible preferred stock prior to November 3, 2007, we are
required to make the payment discussed under the heading, Dividend
Make-Whole Payment below. On or after November 3, 2007, we may not elect to
automatically convert the convertible preferred stock if full cumulative
dividends on the convertible preferred stock for all past dividend periods
have not been paid or set aside for payment.
Conversion Price Adjustment General
The conversion price of $23.50 will be adjusted if:
|
(1) |
|
we dividend or distribute common stock on shares of our common stock; |
|
|
(2) |
|
we subdivide or combine our common stock; |
29
|
(3) |
|
we issue to all holders of common stock certain rights or warrants to purchase our common stock at less than the current market
price; |
|
|
(4) |
|
we dividend or distribute to all holders of our common stock shares of our capital stock or evidences of indebtedness or assets,
excluding: |
|
|
|
those rights, warrants, dividends or distributions referred to in (1) or (3), or |
|
|
|
|
dividends and distributions paid in cash; |
|
(5) |
|
we make a dividend or distribution consisting of cash to all holders of common stock; |
|
|
(6) |
|
we purchase common stock pursuant to a tender offer made by us or any of our subsidiaries; and |
|
|
(7) |
|
a person other than us or any of our subsidiaries makes any payment on a tender offer or exchange offer and, as of the closing of
the offer, the board of directors is not recommending rejection of the offer. We will only make this adjustment if the tender or
exchange offer increases a persons ownership to more than 25% of our outstanding common stock, and only if the payment per share of
common stock exceeds the current market price of our common stock. We will not make this adjustment if the offering documents
disclose our plan to engage in any consolidation, merger, or transfer of all or substantially all of our properties and if specified
conditions are met. |
If we implement a stockholder rights plan, this new rights plan must
provide that, upon conversion of the existing convertible preferred stock the
holders will receive, in addition to the common stock issuable upon such
conversion, the rights under such rights plan regardless of whether the rights
have separated from the common stock before the time of conversion. The
distribution of rights or warrants pursuant to a stockholder rights plan will
not result in an adjustment to the conversion price of the convertible
preferred stock until a specified triggering event occurs.
The occurrence and magnitude of certain of the adjustments described
above is dependent upon the current market price of our common stock. For
these purposes, current market price generally means the lesser of:
|
|
|
the closing sale price on certain specified dates, or |
|
|
|
|
the average of the closing prices of the common stock for the ten
trading day period immediately prior to certain specified dates. |
We may make a temporary reduction in the conversion price of the
convertible preferred stock if our board of directors determines that this
decrease would be in our best interest. We may, at our option, reduce the
conversion price if our board of directors deems it advisable to avoid or
diminish any income tax to holders of common stock resulting from any dividend
or distribution of stock or rights to acquire stock or from any event treated
as such for income tax purposes.
Conversion Price Adjustment Merger, Consolidation or Sale of Assets
If we are involved in a transaction in which shares of our common stock
are converted into the right to receive other securities, cash or other
property, or a sale or transfer of all or substantially all of our assets
under which the holders of our common stock shall be entitled to receive other
securities, cash or other property, then appropriate provision shall be made
so that the shares of convertible preferred stock will convert into:
|
(1) |
|
if the transaction is a common stock fundamental change, as defined
below, common stock of the kind received by holders of common stock as
a result of common stock fundamental change in accordance with
paragraph (1) below under the subsection entitled Fundamental
Change Conversion Price Adjustments, and |
|
|
(2) |
|
if the transaction is not a common stock fundamental change, and
subject to funds being legally available at conversion, the kind and
amount of the securities, cash or other property that would have been
receivable upon the recapitalization, reclassification, consolidation, |
30
|
|
|
merger, sale, transfer or share exchange by a holder of the number of shares of
common stock issuable upon conversion of the convertible preferred stock
immediately prior to the recapitalization, reclassification, consolidation,
merger, sale, transfer or share exchange, after giving effect to any adjustment
in the conversion price in accordance with paragraph (2) below under the
subsection entitled Fundamental Change Conversion Price Adjustments. |
The company formed by the consolidation, merger, asset acquisition or
share acquisition shall provide for this right in its organizational document.
This organizational document shall also provide for adjustments so that the
organizational document shall be as nearly practicably equivalent to
adjustments in this section for events occurring after the effective date of
the organizational document.
The following types of transactions, among others, would be covered by
this adjustment:
|
(1) |
|
we recapitalize or reclassify our common stock, except for: |
|
|
|
a change in par value, |
|
|
|
|
a change from par value to no par value, |
|
|
|
|
a change from no par value to par value, or |
|
|
|
|
a subdivision or combination of our common stock, |
|
(2) |
|
we consolidate or merge into any other person, or any merger of another person into
us, except for a merger that does not result in a reclassification, conversion,
exchange or cancellation of common stock, |
|
|
(3) |
|
we sell, transfer or lease all or substantially all of our assets and holders of our
common stock become entitled to receive other securities, cash or other property, or |
|
|
(4) |
|
we undertake any compulsory share exchange. |
Fundamental Change Conversion Price Adjustments
If a fundamental change occurs, the conversion price will be adjusted as
follows:
|
(1) |
|
in the case of a common stock fundamental change, the
conversion price shall be the conversion price after giving
effect to any other prior adjustments effected pursuant to
the preceding paragraphs, multiplied by a fraction, the
numerator of which is the purchaser stock price, as defined
below, and the denominator of which is the applicable price,
as defined below. However, in the event of a common stock
fundamental change in which: |
|
|
|
100% of the value of the consideration
received by a holder of our common stock is
common stock of the successor, acquiror or
other third party, and cash, if any, paid
with respect to any fractional interests in
such common stock resulting from such common
stock fundamental change, and |
|
|
|
|
all of our common stock shall have been
exchanged for, converted into or acquired
for, common stock of the successor, acquiror
or other third party, and any cash with
respect to fractional interests, |
the conversion price shall be the conversion price in effect immediately prior
to such common stock fundamental change multiplied by a fraction, the
numerator of which is one (1) and the denominator of which is the number of
shares of common stock of the successor, acquiror or other third party
received by a holder of one share of our common stock as a result of the
common stock fundamental change; and
|
(2) |
|
in the case of a non-stock fundamental change, the conversion price shall be the lower of: |
|
|
|
the conversion price after giving effect to
any other prior adjustments effected
pursuant to the preceding paragraphs, and |
31
|
(A) |
|
the applicable price, and |
|
|
(B) |
|
a fraction, the numerator of which is $10 and
the denominator of which is (x) the amount of
the redemption price for one share of
convertible preferred stock if the redemption
date were the date of the non-stock fundamental
change (or if the date of such non-stock
fundamental change falls within the period
beginning on the first issue date of the
convertible preferred stock through October 31,
2005, the twelve-month period commencing
November 1, 2005 and the twelve-month period
commencing November 1, 2006, the product of
106.0%, 105.4% or 104.8%, respectively, and
$10) plus (y) any then-accrued and unpaid
distributions on one share of convertible
preferred stock. |
Holders of convertible preferred stock may receive significantly
different consideration upon conversion depending upon whether a fundamental
change is a non-stock fundamental change or a common stock fundamental change.
In the event of a non-stock fundamental change, the shares of convertible
preferred stock will convert into stock and other securities or property or
assets, including cash, determined by the number of shares of common stock
receivable upon conversion at the conversion price as adjusted in accordance
with (2) above. In the event of a common stock fundamental change, under
certain circumstances, the holder of convertible preferred stock will receive
different consideration depending on whether the holder converts his or her
shares of convertible preferred stock on or after the common stock fundamental
change.
Definitions for the Fundamental Change Adjustment Provision
applicable price means:
|
|
|
in a non-stock fundamental change in which the holders of common stock
receive only cash, the amount of cash received by a holder of one
share of common stock, and |
|
|
|
|
in the event of any other fundamental change, the average of the daily
closing price for one share of common stock during the 10 trading days
immediately prior to the record date for the determination of the
holders of common stock entitled to receive cash, securities, property
or other assets in connection with the fundamental change or, if there
is no such record date, prior to the date upon which the holders of
common stock shall have the right to receive such cash, securities,
property or other assets. |
common stock fundamental change means any fundamental change in which
more than 50% of the value, as determined in good faith by our board of
directors, of the consideration received by holders of our common stock
consists of common stock that, for the 10 trading days immediately prior to
such fundamental change, has been admitted for listing or admitted for listing
subject to notice of issuance on a national securities
exchange or quoted on the Nasdaq National Market, except that a
fundamental change shall not be a common stock fundamental change unless
either:
|
|
|
we continue to exist after the occurrence of the fundamental change
and the outstanding convertible preferred stock continues to exist as
outstanding convertible preferred stock, or |
|
|
|
|
not later than the occurrence of the fundamental change, the
outstanding convertible preferred stock is converted into or exchanged
for shares of preferred stock, which preferred stock has rights,
preferences and limitations substantially similar, but no less
favorable, to those of the convertible preferred stock. |
fundamental change means the occurrence of any transaction or event
or series of transactions or events pursuant to which all or substantially all
of our common stock shall be exchanged for, converted into, acquired for or
shall constitute solely the right to receive cash, securities, property or
other assets, whether by means of an exchange offer, liquidation, tender
offer, consolidation, merger, combination, reclassification, recapitalization
or otherwise. However, for purposes of adjustment of the conversion price, in
the case of any series of transactions or events, the fundamental change shall
be deemed to have occurred when substantially all of the common stock shall
have been exchanged for,
32
converted into or acquired for, or shall constitute solely the right to
receive, such cash, securities, property or other assets, but the adjustment
shall be based upon the consideration that the holders of our common stock
received in the transaction or event as a result of which more than 50% of our
common stock shall have been
exchanged for, converted into or acquired for, or shall constitute solely the
right to receive, such cash, securities, property or other assets.
non-stock fundamental change means any fundamental change other than
a common stock fundamental change.
purchaser stock price means the average of the daily closing price
for one share of the common stock received by holders of the common stock in
the common stock fundamental change during the 10 trading days immediately
prior to the date fixed for the determination of the holders of the common
stock entitled to receive such common stock or, if there is no such date,
prior to the date upon which the holders of the common stock shall have the
right to receive such common stock.
Dividend Make-Whole Payment
If we elect to automatically convert, or the holder voluntarily converts,
some or all of the convertible preferred stock into shares of our common stock
prior to November 3, 2007, we will make an additional payment equal to the
total value of the aggregate amount of cumulative dividends that would have
accrued and become payable on the convertible preferred stock from the date of
original issue through and including November 3, 2007, less any dividends
already paid on the convertible preferred stock. This additional payment is
payable by us, in cash, or, at our option, in shares of our common stock or a
combination of cash and shares of our common stock. In the event of an
automatic conversion or any voluntary conversion undertaken after we provide
notice of an automatic conversion, the shares of common stock issued in
payment of the dividend make-whole payment will be valued at 150% of the
conversion price on the effective date of the conversion. In all other
circumstances, any shares of our common stock issued in payment of the
dividend make-whole payment will be valued at the greater of (i) 95% of the
average closing price of our common stock for the two trading days prior to
the effective date of conversion or (ii) $2.00, which was the last reported
sale price of our common stock on October 28, 2004. In the event of an
automatic conversion, the notice of automatic conversion will specify whether
we will make the dividend make-whole payment in cash, shares of our common
stock or a combination of cash and shares of our common stock. We will not
issue fractional shares for any additional payment upon conversion but will
instead make a cash adjustment for any fractional share payment.
Liquidation Rights
In the event of our voluntary or involuntary dissolution, liquidation, or
winding up, the holders of the convertible preferred stock shall receive a
liquidation preference of $10 per share and all accrued and unpaid dividends
through the distribution date. Holders of any class or series of preferred
stock ranking on the same basis as your convertible preferred stock as to
liquidation shall also be entitled to receive the full respective liquidation
preferences and any accrued and unpaid dividends through the distribution
date. Only after the preferred stock holders have received their liquidation
preference and any accrued and unpaid dividends will we distribute assets to
common stock holders or any of our other stock ranking junior to the shares of
convertible preferred stock upon liquidation. If upon such dissolution,
liquidation or winding up, we do not have enough assets to pay in full the
amounts due on the convertible preferred stock and any other preferred stock
ranking on the same basis with the convertible preferred stock as to
liquidation, the holders of the convertible preferred stock and such other
preferred stock will share ratably in any such distributions of our assets:
|
|
|
first in proportion to the liquidation preferences until the
preferences are paid in full, and |
|
|
|
|
then in proportion to the amounts of accrued but unpaid dividends. |
33
After we pay any liquidation preference and accrued dividends, holders of
the convertible preferred stock will not be entitled to participate any
further in the distribution of our assets. The following events will not be
deemed to be a dissolution, liquidation or winding up of Cyclacel:
|
|
|
the sale of all or substantially all of the assets; |
|
|
|
|
our merger or consolidation into or with any other corporation; or |
|
|
|
|
our liquidation, dissolution, winding up or reorganization immediately
followed by a reincorporation as another corporation. |
Optional Redemption
On or after November 6, 2007 we may redeem the convertible preferred
stock, out of legally available funds, in whole or in part, at our option, at
the redemption prices listed below. The redemption price is as follows for the
12-month period beginning November 1 of the following years, beginning
November 6, 2007 and ending on October 31, 2008 in the case of the first
period:
|
|
|
|
|
|
|
Redemption |
Year |
|
Price |
2007 |
|
$ |
10.42 |
|
2008 |
|
|
10.36 |
|
2009 |
|
|
10.30 |
|
2010 |
|
|
10.24 |
|
2011 |
|
|
10.18 |
|
2012 |
|
|
10.12 |
|
2013 |
|
|
10.06 |
|
and $10.00 at November 1, 2014 and thereafter. In each case we will pay
accrued and unpaid dividends to, but excluding, the redemption date. We are
required to give notice of redemption not more than 60 and not less than 20
days before the redemption date.
If we redeem less than all of the shares of convertible preferred stock,
we shall select the shares to be redeemed by lot or pro rata or in some other
equitable manner in our sole discretion.
Exchange Provisions
We may exchange the convertible preferred stock in whole, but not in
part, for debentures on any dividend payment date on or after November 1, 2005
at the rate of $10 principal amount of debentures for each outstanding share
of convertible preferred stock. Debentures will be issuable in denominations
of $1,000 and integral multiples of $1,000, as discussed in the section
entitled Description of Debentures below. If the exchange results in an
amount of debentures that is not an integral multiple of $1,000, we will pay
in cash an amount in excess of the closest integral multiple of $1,000. We
will mail written notice of our intention to exchange the convertible
preferred stock to each record holder not less than 30 nor more than 60 days
prior to the exchange date.
We refer to the date fixed for exchange of the convertible preferred
stock for debentures as the exchange date. On the exchange date, the
holders rights as a stockholder of Cyclacel shall cease, the shares of
convertible preferred stock will no longer be outstanding, and will only
represent the right to receive the debentures and any accrued and unpaid
dividends, without interest. We may not exercise our option to exchange the
convertible preferred stock for the debentures if:
|
|
|
full cumulative dividends on the convertible preferred stock to the
exchange date have not been paid or set aside for payment, or |
|
|
|
|
an event of default under the indenture would occur on conversion, or
has occurred and is continuing. |
Voting Rights
You will have no voting rights except as described below or as required
by law. Shares held by us or any entity controlled by us will not have any
voting rights.
34
If we have not paid dividends on the convertible preferred stock or on
any outstanding shares of preferred stock ranking on the same basis as to
dividends with the convertible preferred stock in an aggregate amount equal to
at least six quarterly dividends whether or not consecutive, we will increase
the size of our board of directors by two additional directors. So long as
dividends remain due and unpaid, holders of the convertible preferred stock,
voting separately as a class with holders of preferred stock ranking on the
same basis as to dividends having like voting rights, will be entitled to
elect two additional directors at any meeting of stockholders at which
directors are to be elected. These directors will be appointed to classes on
the board as determined by our board of directors. These voting rights will
terminate when we have declared and either paid or set aside for payment all
accrued and unpaid dividends. The terms of office of all directors so elected
will terminate immediately upon the termination of these voting rights.
Without the vote or consent of the holders of at least a majority of the
shares of convertible preferred stock, we may not:
|
|
|
adversely change the rights, preferences and limitations of the
convertible preferred stock by modifying our certificate of
incorporation or bylaws, or |
|
|
|
|
authorize, issue, reclassify any of our authorized stock into,
increase the authorized amount of, or authorize or issue any
convertible obligation or security or right to purchase, any class of
stock that ranks senior to the convertible preferred stock as to
dividends or distributions of assets upon liquidation, dissolution or
winding up of the stock. |
No class vote on the part of convertible preferred stock shall be
required (except as otherwise required by law or resolution of our board of
directors) in connection with the authorization, issuance or increase in the
authorized amount of any shares of capital stock ranking junior to or on
parity with the convertible preferred stock both as to the payment of
dividends and as to distribution of assets upon our liquidation, dissolution
or winding up, whether voluntary or involuntary, including our common stock
and the convertible preferred stock.
In addition, without the vote or consent of the holders of at least a
majority of the shares of convertible preferred stock we may not:
|
|
|
enter into a share exchange that affects the convertible preferred stock, |
|
|
|
|
consolidate with or merge into another entity, or |
|
|
|
|
permit another entity to consolidate with or merge into us, |
unless the convertible preferred stock remains outstanding and its rights,
privileges and preferences are unaffected or it is converted into or exchanged
for convertible preferred stock of the surviving entity having rights,
preferences and limitations substantially similar, but no less favorable, to
the convertible preferred stock.
In determining a majority under these voting provisions, holders of
convertible preferred stock will vote together with holders of any other
preferred stock that rank on parity as to dividends and that have like voting
rights.
35
DESCRIPTION OF WARRANTS
The following description, together with the additional information we
may include in any applicable prospectus supplement, summarizes the material
terms and provisions of the warrants that we may offer under this prospectus
and the related warrant agreements and warrant certificates. While the terms
summarized below will apply generally to any warrants that we may offer, we
will describe the particular terms of any series of warrants in more detail in
the applicable prospectus supplement. If we so indicate in the prospectus
supplement, the terms of any warrants offered under that prospectus supplement
may differ from the terms described below.
General
We may issue warrants for the purchase of common stock and/or debt
securities in one or more series. We may issue warrants independently or
together with common stock and/or debt securities, and the warrants may be
attached to or separate from these securities.
We will evidence each series of warrants by warrant certificates that we
will issue under a separate agreement. We may enter into the warrant agreement
with a warrant agent. Each warrant agent will be a bank that we select which
has its principal office in the United States and a combined capital and
surplus in an amount as required by applicable law. We will indicate the name
and address of the warrant agent in the applicable prospectus supplement
relating to a particular series of warrants.
We will describe in the applicable prospectus supplement the terms of the
series of warrants, including:
|
|
|
the offering price and aggregate number of warrants offered; |
|
|
|
|
the currency for which the warrants may be purchased; |
|
|
|
|
if applicable, the designation and terms of the securities with which the warrants are issued
and the number if warrants issued with each such security or each principal amount of such
security; |
|
|
|
|
if applicable, the date on and after which the warrants and the related securities will be
separately transferable; |
|
|
|
|
in the case of warrants to purchase common stock, the number of shares of common stock
purchasable upon the exercise of one warrant and the price at which these shares may be
purchased upon such exercise; |
|
|
|
|
in the case of warrants to purchase debt securities, the principal amount of debt securities
purchasable upon exercise of one warrant and the price at, and currency in which, this
principal amount of debt securities may be purchased upon such exercise; |
|
|
|
|
the effect of any merger, consolidation, sale or other disposition of our business on the
warrant agreement and the warrants; |
|
|
|
|
the terms of any rights to redeem or call the warrants; |
|
|
|
|
any provisions for changes to or adjustments in the exercise price or number of securities
issuable upon exercise of the warrants; |
|
|
|
|
the dates on which the right to exercise the warrants will commence and expire; |
|
|
|
|
the manner in which the warrant agreement and warrants may be modified; |
|
|
|
|
federal income tax consequences of holding or exercising the warrants; |
|
|
|
|
the terms of the securities issuable upon exercise of the warrants; and |
|
|
|
|
any other specific terms, preferences, rights or limitations of or restrictions on the warrants. |
36
Before exercising their warrants, holders of warrants will not have any
of the rights of holders of the securities purchasable upon such exercise,
including:
|
|
|
in the case of warrants to purchase debt securities, the right to
receive payments of principal of, or premium, if any, or interest on,
the debt securities purchasable upon exercise or to enforce covenants
in the applicable indenture; or |
|
|
|
|
in the case of warrants to purchase common stock, the right to receive
dividends, if any, or, payments upon our liquidation, dissolution or
winding up or to exercise voting rights, if any. |
Exercise of Warrants
Each warrant will entitle the holder to purchase the securities that we
specify in the applicable prospectus supplement at the exercise price that we
describe in the applicable prospectus supplement. Unless we otherwise specify
in the applicable prospectus supplement, holders of the warrants may exercise
the warrants at any time up to 5:00 P.M. EST on the expiration date that we
set forth in the applicable prospectus supplement. After the close of business
on the expiration date, unexercised warrants will become void.
Holders of the warrants may exercise the warrants by delivering the
warrant certificate representing the warrants to be exercised together with
specified information, and paying the required amount to the warrant agent in
immediately available funds, as provided in the applicable prospectus
supplement. We will set forth on the reverse side of the warrant certificate
and in the applicable prospectus supplement the information that the holder of
the warrant will be required to deliver to the warrant agent upon exercise of
the warrants.
Upon receipt of the required payment and the warrant certificate properly
completed and duly executed at the corporate trust office of the warrant agent
or any other office indicated in the applicable prospectus supplement, we will
issue and deliver the securities purchasable upon such exercise. If fewer than
all of the warrants represented by the warrant certificate are exercised, then
we will issue a new warrant certificate for the remaining amount of warrants.
If we so indicate in the applicable prospectus supplement, holders of the
warrants may surrender securities as all or part of the exercise price for
warrants.
Enforceability of Rights By Holders of Warrants
Each warrant agent will act solely as our agent under the applicable
warrant agreement and will not assume any obligation or relationship of agency
or trust with any holder of any warrant. A single bank or trust company may
act as warrant agent for more than one issue of warrants. A warrant agent will
have no duty or responsibility in case of any default by us under the
applicable warrant agreement or warrant, including any duty or responsibility
to initiate any proceedings at law or otherwise, or to make any demand upon
us. Any holder of a warrant may, without the consent of the related warrant
agent or the holder of any other warrant, enforce by appropriate legal action
its right to exercise, and receive the securities purchasable upon exercise
of, its warrants.
Currently Outstanding Warrants
At September 30, 2006, we had outstanding warrants to purchase 1,124
shares of common stock with a weighted average exercise price of $138.72 per
share. These warrants expire at various dates from January 2007 to February
2009. These warrants exist as a result of our merger with Xcyte from March
2006.
We also currently have outstanding warrants to purchase 2,571,429 shares
of common stock that were issued in April 2006 in connection with a private
placement. These warrants expire in April 2013 and have an exercise price of
$7.00.
DESCRIPTION OF DEBT SECURITIES
The following description, together with the additional information we
include in any applicable prospectus supplement, summarizes the material terms
and provisions of the debt securities that we
37
may offer under this prospectus. While the terms we have summarized below will
apply generally to any future debt securities we may offer, we will describe
the particular terms of any debt securities that we may offer in more detail
in the applicable prospectus supplement. If we so indicate in a prospectus
supplement, the terms of any debt securities we offer under that prospectus
supplement may differ from the terms we describe below.
We will issue the senior notes under the senior indenture, which we will
enter into with a trustee to be named in the senior indenture. We will issue
the subordinated notes under the subordinated indenture, which we will enter
into with a trustee to be named in the subordinated indenture. We use the term
indentures to refer to both the senior indenture and the subordinated
indenture. The indentures will be qualified under the Trust Indenture Act. We
use the term debenture trustee to refer to either the senior trustee or
the subordinated trustee, as applicable.
The following summaries of material provisions of the senior notes, the
subordinated notes and the indentures are subject to, and qualified in their
entirety by reference to, all the provisions of the indenture applicable to a
particular series of debt securities. Except as we may otherwise indicate, the
terms of the senior indenture and the subordinated indenture are identical.
General
We will describe in each prospectus supplement the following terms
relating to a series of notes:
|
|
|
the title; |
|
|
|
|
any limit on the amount that may be issued; |
|
|
|
|
whether or not we will issue the series of notes in global form, the terms and who the depository will
be; |
|
|
|
|
the maturity date; |
|
|
|
|
the annual interest rate, which may be fixed or variable, or the method for determining the rate and the
date interest will begin to accrue, the dates interest will be payable and the regular record dates for
interest payment dates or the method for determining such dates; |
|
|
|
|
whether or not the notes will be secured or unsecured, and the terms of any secured debt; |
|
|
|
|
the terms of the subordination of any series of subordinated debt; |
|
|
|
|
the place where payments will be made; |
|
|
|
|
our right, if any, to defer payment of interest and the maximum length of any such deferral period; |
|
|
|
|
the date, if any, after which, and the price at which, we may, at our option, redeem the series of notes
pursuant to any optional redemption provisions; |
|
|
|
|
the date, if any, on which, and the price at which we are obligated, pursuant to any mandatory sinking
fund provisions or otherwise, to redeem, or at the holders option to purchase, the series of notes; |
|
|
|
|
whether the indenture will restrict our ability to pay dividends, or will require us to maintain any
asset ratios or reserves; |
|
|
|
|
whether we will be restricted from incurring any additional indebtedness; |
|
|
|
|
a discussion of any material or special United States federal income tax considerations applicable to
the notes; |
|
|
|
|
the denominations in which we will issue the series of notes, if other than denominations of $1,000 and
any integral multiple thereof; and |
|
|
|
|
any other specific terms, preferences, rights or limitations of, or restrictions on, the debt securities. |
38
Conversion or Exchange Rights
We will set forth in the prospectus supplement the terms on which a
series of notes may be convertible into or exchangeable for common stock or
other securities of ours. We will include provisions as to whether conversion
or exchange is mandatory, at the option of the holder or at our option. We may
include provisions pursuant to which the number of shares of common stock or
other securities of ours that the holders of the series of notes receive would
be subject to adjustment.
Consolidation, Merger or Sale
The indentures do not contain any covenant which restricts our ability to
merge or consolidate, or sell, convey, transfer or otherwise dispose of all or
substantially all of our assets. However, any successor to or acquirer of such
assets must assume all of our obligations under the indentures or the notes,
as appropriate.
Events of Default Under the Indenture
The following are events of default under the indentures with respect to
any series of notes that we may issue:
|
|
|
if we fail to pay interest when due and our failure continues for 90 days and
the time for payment has not been extended or deferred; |
|
|
|
|
if we fail to pay the principal, or premium, if any, when due and the time for
payment has not been extended or delayed; |
|
|
|
|
if we fail to observe or perform any other covenant contained in the notes or
the indentures, other than a covenant specifically relating to another series
of notes, and our failure continues for 90 days after we receive notice from
the debenture trustee or holders of at least 25% in aggregate principal amount
of the outstanding notes of the applicable series; and |
|
|
|
|
if specified events of bankruptcy, insolvency or reorganization occur as to us. |
If an event of default with respect to notes of any series occurs and is
continuing, the debenture trustee or the holders of at least 25% in aggregate
principal amount of the outstanding notes of that series, by notice to us in
writing, and to the debenture trustee if notice is given by such holders, may
declare the unpaid principal of, premium, if any, and accrued interest, if
any, due and payable immediately.
The holders of a majority in principal amount of the outstanding notes of
an affected series may waive any default or event of default with respect to
the series and its consequences, except defaults or events of default
regarding payment of principal, premium, if any, or interest, unless we have
cured the default or event of default in accordance with the indenture. Any
such waiver shall cure the default or event of default.
Subject to the terms of the indentures, if an event of default under an
indenture shall occur and be continuing, the debenture trustee will be under
no obligation to exercise any of its rights or powers under such indenture at
the request or direction of any of the holders of the applicable series of
notes, unless such holders have offered the debenture trustee reasonable
indemnity. The holders of a majority in principal amount of the outstanding
notes of any series will have the right to direct the time, method and place
of conducting any proceeding for any remedy available to the debenture
trustee, or exercising any trust or power conferred on the debenture trustee,
with respect to the notes of that series, provided that:
|
|
|
the direction so given by the holder is not in conflict with any law or the applicable indenture; and |
|
|
|
|
subject to its duties under the Trust Indenture Act, the debenture trustee need not take any action
that might involve it in personal liability or might be unduly prejudicial to the holders not
involved in the proceeding. |
39
A holder of the notes of any series will only have the right to institute
a proceeding under the indentures or to appoint a receiver or trustee, or to
seek other remedies if:
|
|
|
the holder has given written notice to the debenture trustee of a
continuing event of default with respect to that series; |
|
|
|
|
the holders of at least 25% in aggregate principal amount of the
outstanding notes of that series have made written request, and such
holders have offered reasonable indemnity, to the debenture trustee to
institute the proceeding as trustee; and |
|
|
|
|
the debenture trustee does not institute the proceeding, and does not
receive from the holders of a majority in aggregate principal amount
of the outstanding notes of that series other conflicting directions
within 60 days after the notice, request and offer. |
These limitations do not apply to a suit instituted by a holder of notes
if we default in the payment of the principal, premium, if any, or interest
on, the notes.
We will periodically file statements with the debenture trustee regarding
our compliance with specified covenants in the indentures.
Modification of Indenture; Waiver
We and the debenture trustee may change an indenture without the consent
of any holders with respect to specific matters, including:
|
|
|
to fix any ambiguity, defect or inconsistency in the indenture; and |
|
|
|
|
to change anything that does not materially adversely affect the
interests of any holder of notes of any series. |
In addition, under the indentures, the rights of holders of a series of
notes may be changed by us and the debenture trustee with the written consent
of the holders of at least a majority in aggregate principal amount of the
outstanding notes of each series that is affected. However, we and the
debenture trustee may only make the following changes with the consent of each
holder of any outstanding notes affected:
|
|
|
extending the fixed maturity of the series of notes; |
|
|
|
|
reducing the principal amount, reducing the rate of or extending the time of payment of
interest, or any premium payable upon the redemption of any notes; or |
|
|
|
|
reducing the percentage of notes, the holders of which are required to consent to any amendment. |
Discharge
Each indenture provides that we can elect to be discharged from our
obligations with respect to one or more series of debt securities, except for
obligations to:
|
|
|
register the transfer or exchange of debt securities of the series; |
|
|
|
|
replace stolen, lost or mutilated debt securities of the series; |
|
|
|
|
maintain paying agencies; |
|
|
|
|
hold monies for payment in trust; |
|
|
|
|
compensate and indemnify the trustee; and |
|
|
|
|
appoint any successor trustee. |
In order to exercise our rights to be discharged, we must deposit with
the trustee money or government obligations sufficient to pay all the
principal of, any premium, if any, and interest on, the debt securities of the
series on the dates payments are due.
40
Form, Exchange and Transfer
We will issue the notes of each series only in fully registered form
without coupons and, unless we otherwise specify in the applicable prospectus
supplement, in denominations of $1,000 and any integral multiple thereof. The
indentures provide that we may issue notes of a series in temporary or
permanent global form and as book-entry securities that will be deposited
with, or on behalf of, The Depository Trust Company or another depository
named by us and identified in a prospectus supplement with respect to that
series. See Legal Ownership of Securities for a further description of the
terms relating to any book-entry securities.
At the option of the holder, subject to the terms of the indentures and
the limitations applicable to global securities described in the applicable
prospectus supplement, the holder of the notes of any series can exchange the
notes for other notes of the same series, in any authorized denomination and
of like tenor and aggregate principal amount.
Subject to the terms of the indentures and the limitations applicable to
global securities set forth in the applicable prospectus supplement, holders
of the notes may present the notes for exchange or for registration of
transfer, duly endorsed or with the form of transfer endorsed thereon duly
executed if so required by us or the security registrar, at the office of the
security registrar or at the office of any transfer agent designated by us for
this purpose. Unless otherwise provided in the notes that the holder presents
for transfer or exchange, we will make no service charge for any registration
of transfer or exchange, but we may require payment of any taxes or other
governmental charges.
We will name in the applicable prospectus supplement the security
registrar, and any transfer agent in addition to the security registrar, that
we initially designate for any notes. We may at any time designate additional
transfer agents or rescind the designation of any transfer agent or approve a
change in the office through which any transfer agent acts, except that we
will be required to maintain a transfer agent in each place of payment for the
notes of each series.
If we elect to redeem the notes of any series, we will not be required
to:
|
|
|
issue, register the transfer of, or exchange any notes of that series
during a period beginning at the opening of business 15 days before
the day of mailing of a notice of redemption of any notes that may be
selected for redemption and ending at the close of business on the day
of the mailing; or |
|
|
|
|
register the transfer of or exchange any notes so selected for
redemption, in whole or in part, except the unredeemed portion of any
notes we are redeeming in part. |
Information Concerning the Debenture Trustee
The debenture trustee, other than during the occurrence and continuance
of an event of default under an indenture, undertakes to perform only those
duties as are specifically set forth in the applicable indenture. Upon an
event of default under an indenture, the debenture trustee must use the same
degree of care as a prudent person would exercise or use in the conduct of his
or her own affairs. Subject to this provision, the debenture trustee is
under no obligation to exercise any of the powers given it by the
indentures at the request of any holder of notes unless it is offered
reasonable security and indemnity against the costs, expenses and liabilities
that it might incur.
Payment and Paying Agents
Unless we otherwise indicate in the applicable prospectus supplement, we
will make payment of the interest on any notes on any interest payment date to
the person in whose name the notes, or one or more predecessor securities, are
registered at the close of business on the regular record date for the
interest.
We will pay principal of and any premium and interest on the notes of a
particular series at the office of the paying agents designated by us, except
that unless we otherwise indicate in the applicable prospectus supplement, we
will make interest payments by check which we will mail to the holder.
41
Unless we otherwise indicate in a prospectus supplement, we will designate the
corporate trust office of the debenture trustee in the City of New York as our
sole paying agent for payments with respect to notes of each series. We will
name in the applicable prospectus supplement any other paying agents that we
initially designate for the notes of a particular series. We will maintain a
paying agent in each place of payment for the notes of a particular series.
All money we pay to a paying agent or the debenture trustee for the
payment of the principal of or any premium or interest on any notes which
remains unclaimed at the end of two years after such principal, premium or
interest has become due and payable will be repaid to us, and the holder of
the security thereafter may look only to us for payment thereof.
Governing Law
The indentures and the notes will be governed by and construed in
accordance with the laws of the State of New York, except to the extent that
the Trust Indenture Act is applicable.
Subordination of Subordinated Notes
The subordinated notes will be unsecured and will be subordinate and
junior in priority of payment to certain of our other indebtedness to the
extent described in a prospectus supplement. The subordinated indenture does
not limit the amount of subordinated notes which we may issue. It also does
not limit us from issuing any other secured or unsecured debt.
LEGAL OWNERSHIP OF SECURITIES
We can issue securities in registered form or in the form of one or more
global securities. We describe global securities in greater detail below. We
refer to those persons who have securities registered in their own names on
the books that we or any applicable trustee maintain for this purpose as the
holders of those securities. These persons are the legal holders of the
securities. We refer to those persons who, indirectly through others, own
beneficial interests in securities that are not registered in their own names,
as indirect holders of those securities. As we discuss below, indirect
holders are not legal holders, and investors in securities issued in
book-entry form or in street name will be indirect holders.
Book-Entry Holders
We may issue securities in book-entry form only, as we will specify in
the applicable prospectus supplement. This means securities may be represented
by one or more global securities registered in the name of a financial
institution that holds them as depositary on behalf of other financial
institutions that participate in the depositarys book-entry system. These
participating institutions, which are referred to as participants, in turn,
hold beneficial interests in the securities on behalf of themselves or their
customers.
Only the person in whose name a security is registered is recognized as
the holder of that security. Securities issued in global form will be
registered in the name of the depositary or its participants. Consequently,
for securities issued in global form, we will recognize only the depositary as
the holder of the securities, and we will make all payments on the securities
to the depositary. The depositary passes along the payments it receives to its
participants, which in turn pass the payments along to their customers who are
the beneficial owners. The
depositary and its participants do so under agreements they have made
with one another or with their customers; they are not obligated to do so
under the terms of the securities.
As a result, investors in a book-entry security will not own securities
directly. Instead, they will own beneficial interests in a global security,
through a bank, broker or other financial institution that participates in the
depositarys book-entry system or holds an interest through a participant. As
long as the securities are issued in global form, investors will be indirect
holders, and not holders, of the securities.
42
Street Name Holders
We may terminate a global security or issue securities in non-global
form. In these cases, investors may choose to hold their securities in their
own names or in street name. Securities held by an investor in street name
would be registered in the name of a bank, broker or other financial
institution that the investor chooses, and the investor would hold only a
beneficial interest in those securities through an account he or she maintains
at that institution.
For securities held in street name, we will recognize only the
intermediary banks, brokers and other financial institutions in whose names
the securities are registered as the holders of those securities, and we will
make all payments on those securities to them. These institutions pass along
the payments they receive to their customers who are the beneficial owners,
but only because they agree to do so in their customer agreements or because
they are legally required to do so. Investors who hold securities in street
name will be indirect holders, not holders, of those securities.
Legal Holders
Our obligations, as well as the obligations of any applicable trustee and
of any third parties employed by us or a trustee, run only to the legal
holders of the securities. We do not have obligations to investors who hold
beneficial interests in global securities, in street name or by any other
indirect means. This will be the case whether an investor chooses to be an
indirect holder of a security or has no choice because we are issuing the
securities only in global form.
For example, once we make a payment or give a notice to the holder, we
have no further responsibility for the payment or notice even if that holder
is required, under agreements with depositary participants or customers or by
law, to pass the payment or notice along to the indirect holders but does not
do so. Similarly, we may want to obtain the approval of the holders to amend
an indenture, to relieve us of the consequences of a default or of our
obligation to comply with a particular provision of the indenture or for other
purposes. In such an event, we would seek approval only from the holders, and
not the indirect holders, of the securities. Whether and how the holders
contact the indirect holders is the responsibility of the holders.
Special Considerations for Indirect Holders
If you hold securities through a bank, broker or other financial
institution, either in book-entry form or in street name, you should check
with your own institution to find out:
|
|
|
how it handles securities payments and notices; |
|
|
|
|
whether it imposes fees or charges; |
|
|
|
|
how it would handle a request for the holders consent, if ever required; |
|
|
|
|
whether and how you can instruct it to send you securities registered in
your own name so you can be a holder, if that is permitted in the
future; |
|
|
|
|
how it would exercise rights under the securities if there were a
default or other event triggering the need for holders to act to protect
their interests; and |
|
|
|
|
if the securities are in book-entry form, how the depositarys rules and
procedures will affect these matters. |
Global Securities
A global security is a security held by a depositary which represents one
or any other number of individual securities. Generally, all securities
represented by the same global securities will have the same terms.
Each security issued in book-entry form will be represented by a global
security that we deposit with and register in the name of a financial
institution or its nominee that we select. The financial institution that we
select for this purpose is called the depositary. Unless we specify otherwise
in the
43
applicable prospectus supplement, The Depository Trust Company, New York, New
York, known as DTC, will be the depositary for all securities issued in
book-entry form.
A global security may not be transferred to or registered in the name of
anyone other than the depositary, its nominee or a successor depositary,
unless special termination situations arise. We describe those situations
below under Special Situations When a Global Security Will Be Terminated.
As a result of these arrangements, the depositary, or its nominee, will be the
sole registered owner and holder of all securities represented by a global
security, and investors will be permitted to own only beneficial interests in
a global security. Beneficial interests must be held by means of an account
with a broker, bank or other financial institution that in turn has an account
with the depositary or with another institution that does. Thus, an investor
whose security is represented by a global security will not be a holder of the
security, but only an indirect holder of a beneficial interest in the global
security.
If the prospectus supplement for a particular security indicates that the
security will be issued in global form only, then the security will be
represented by a global security at all times unless and until the global
security is terminated. If termination occurs, we may issue the securities
through another book-entry clearing system or decide that the securities may
no longer be held through any book-entry clearing system.
Special Considerations for Global Securities
As an indirect holder, an investors rights relating to a global security
will be governed by the account rules of the investors financial institution
and of the depositary, as well as general laws relating to securities
transfers. We do not recognize an indirect holder as a holder of securities
and instead deal only with the depositary that holds the global security.
If securities are issued only in the form of a global security, an
investor should be aware of the following:
|
|
|
An investor cannot cause the securities to be registered in his or her
name, and cannot obtain non-global certificates for his or her
interest in the securities, except in the special situations we
describe below; |
|
|
|
|
An investor will be an indirect holder and must look to his or her own
bank or broker for payments on the securities and protection of his or
her legal rights relating to the securities, as we describe under
Legal Ownership of Securities above; |
|
|
|
|
An investor may not be able to sell interests in the securities to
some insurance companies and to other institutions that are required
by law to own their securities in non-book-entry form; |
|
|
|
|
An investor may not be able to pledge his or her interest in a global
security in circumstances where certificates representing the
securities must be delivered to the lender or other beneficiary of the
pledge in order for the pledge to be effective; |
|
|
|
|
The depositarys policies, which may change from time to time, will
govern payments, transfers, exchanges and other matters relating to an
investors interest in a global security. We and any applicable
trustee have no responsibility for any aspect of the depositarys
actions or for its records of ownership interests in a global
security. We and the trustee also do not supervise the depositary in
any way; |
|
|
|
|
The depositary may, and we understand that DTC will, require that
those who purchase and sell interests in a global security within its
book-entry system use immediately available funds, and your broker or
bank may require you to do so as well; and |
|
|
|
|
Financial institutions that participate in the depositarys book-entry
system, and through which an investor holds its interest in a global
security, may also have their own policies affecting payments, notices
and other matters relating to the securities. There may be more than
one financial intermediary in the chain of ownership for an investor.
We do not monitor and are not responsible for the actions of any of
those intermediaries. |
44
Special Situations When a Global Security Will be Terminated
In a few special situations described below, the global security will
terminate and interests in it will be exchanged for physical certificates
representing those interests. After that exchange, the choice of whether to
hold securities directly or in street name will be up to the investor.
Investors must consult their own banks or brokers to find out how to have
their interests in securities transferred to their own name, so that they will
be direct holders. We have described the rights of holders and street name
investors above.
The global security will terminate when the following special situations
occur:
|
|
|
if the depositary notifies us that it is unwilling, unable or no longer qualified to
continue as depositary for that global security and we do not appoint another
institution to act as depositary within 90 days; |
|
|
|
|
if we notify any applicable trustee that we wish to terminate that global security; or |
|
|
|
|
if an event of default has occurred with regard to securities represented by that
global security and has not been cured or waived. |
The prospectus supplement may also list additional situations for
terminating a global security that would apply only to the particular series
of securities covered by the prospectus supplement. When a global security
terminates, the depositary, and not we or any applicable trustee, is
responsible for deciding the names of the institutions that will be the
initial direct holders.
PLAN OF DISTRIBUTION
We may sell the securities being offered hereby in one or more of the
following ways from time to time:
|
|
|
through dealers or agents to the public or to investors; |
|
|
|
|
to underwriters for resale to the public or to investors; |
|
|
|
|
directly to investors; or |
|
|
|
|
through a combination of such methods. |
We will set forth in a prospectus supplement the terms of the offering of
securities, including:
|
|
|
the name or names of any agents, dealers or underwriters; |
|
|
|
|
the purchase price of the securities being offered and the proceeds we will receive from the sale; |
|
|
|
|
any over-allotment options under which underwriters may purchase additional securities from us; |
|
|
|
|
any agency fees or underwriting discounts and other items constituting agents or underwriters
compensation; |
|
|
|
|
any initial public offering price; |
|
|
|
|
any discounts or concessions allowed or reallowed or paid to dealers; and |
|
|
|
|
any securities exchanges on which the securities may be listed. |
Underwriters, dealers and agents that participate in the distribution of
the securities may be deemed to be underwriters as defined in the Securities
Act and any discounts or commissions they receive from us and any profit on
their resale of the securities may be treated as underwriting discounts and
commissions under the Securities Act. The maximum commission or discount to be
received by any NASD member or independent broker/dealer will not be greater
than eight (8) percent for the sale or distribution of the securities.
We will identify in the applicable prospectus supplement any
underwriters, dealers or agents and will describe their compensation. We may
have agreements with the underwriters, dealers and agents
45
to indemnify them against specified civil liabilities, including liabilities
under the Securities Act. Underwriters, dealers and agents may engage in
transactions with or perform services for us or our subsidiaries in the
ordinary course of their businesses.
Certain persons that participate in the distribution of the securities
may engage in transactions that stabilize, maintain or otherwise affect the
price of the securities, including over-allotment, stabilizing and
short-covering transactions in such securities, and the imposition of penalty
bids, in connection with an offering. Certain persons may also engage in
passive market making transactions as permitted by Rule 103 of Regulation M.
Passive market makers must comply with applicable volume and price limitations
and must be identified as passive market makers. In general, a passive market
maker must display its bid at a price not in excess of the highest independent
bid for such security; if all independent bids are lowered below the passive
market makers bid, however, the passive market makers bid must then be
lowered when certain purchase limits are exceeded.
RATIO OF EARNINGS TO FIXED CHARGES AND
RATIO OF EARNINGS TO COMBINED FIXED CHARGES AND
PREFERRED STOCK DIVIDENDS
(in thousands)
We have not recorded earnings for any period in the financial periods
ended December 31, 2005 or nine-month period ended September 30, 2006.
Accordingly, our earnings were insufficient to cover fixed charges and
combined fixed charges and preferred stock dividends in such periods and we
are unable to disclose a ratio of earnings to fixed charges nor a ratio of
earnings to combined fixed charges and preferred stock dividends. The
following table sets forth, for each of the periods presented, the dollar
amount of the deficiency of earnings available to cover fixed charges and
combined fixed charges and preferred stock dividends. For purposes of these
computations, earnings have been calculated as the sum of (i) pretax income
and (ii) fixed charges. Fixed charges represent interest expense (whether
expensed or capitalized) and an estimate of the interest expense within rental
expense. Combined fixed charges and preferred stock dividends consist of fixed
charges, as calculated in
accordance with the immediately preceding sentence, and the amount of
pre-tax earnings required to pay the dividends on outstanding preference
securities of the company.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine Months |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ended |
|
Year Ended |
|
Year Ended |
|
Nine Months |
|
|
Year Ended |
|
Year Ended |
|
December |
|
December |
|
December |
|
Ended |
|
|
March 31, |
|
March 31, |
|
31, |
|
31, |
|
31, |
|
September 30, |
|
|
2002 |
|
2003 |
|
2003 |
|
2004 |
|
2005 |
|
2006 |
Deficiency of
earnings available
to cover fixed
charges |
|
$ |
14,853 |
|
|
$ |
19,939 |
|
|
$ |
16,463 |
|
|
$ |
25,198 |
|
|
$ |
19,948 |
|
|
$ |
25,382 |
|
Deficiency of
earnings available
to cover fixed
charges and
preferred stock
dividends |
|
$ |
18,142 |
|
|
$ |
24,593 |
|
|
$ |
20,888 |
|
|
$ |
36,251 |
|
|
$ |
31,824 |
|
|
$ |
28,209 |
|
LEGAL MATTERS
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., New York, New York,
will provide us with an opinion as to the legal matters in connection with the
securities we are offering.
EXPERTS
Ernst & Young LLP, independent registered public accounting firm, has
audited our consolidated financial statements included in both our Current
Report on Form 8-K dated May 16, 2006 and filed with the Securities and
Exchange Commission on May 16, 2006 and in our Amendment No. 1 to the Current
Report on Form 8-K/A dated June 9, 2006 and filed with the Securities and
Exchange Commission on June 9, 2006, as set forth in their report thereon
dated March 27, 2006, included
46
therein, and incorporated herein by reference. Our financial statements are
incorporated by reference in reliance upon Ernst & Young LLPs report, given
on their authority as experts in accounting and auditing.
The financial statements of XCYTE Therapies, Inc. appearing in XCYTE
Therapies, Inc.s Annual Report (Form 10-K) for the year ended December 31,
2005 have been audited by Ernst & Young LLP, independent registered public
accounting firm, as set forth in their report thereon included therein, and
incorporated herein by reference. Such financial statements are incorporated
herein by reference in reliance upon such report given on the authority of
such firm as experts in accounting and auditing.
WHERE YOU CAN FIND MORE INFORMATION
We are a public company and file annual, quarterly and current reports,
proxy statements and other information with the Securities and Exchange
Commission. You may read and copy any document we file at the SECs Public
Reference Room at Station Place, 100 F Street, N.E., Washington, D.C. 20549.
You can request copies of these documents by writing to the SEC and paying a
fee for the copying cost. Please call the SEC at 1-800-SEC-0330 for more
information about the operation of the public reference room. Our SEC filings
are also available to the public at the SECs web site at http://www.sec.gov ,
and on our web site at http://www.cyclacel.com . The information contained on
our web site is not included or incorporated by reference into this
prospectus. In addition, our common stock is listed for trading on the Nasdaq
Global Market under the symbol CYCC and our preferred stock is listed for
trading on the Nasdaq Capital Market under the symbol CYCCP. You can read
and copy reports and other information concerning us at the offices of the
National Association of Securities Dealers, Inc. located at 1735 K Street,
Washington, D.C. 20006.
This prospectus is only part of a Registration Statement on Form S-3 that
we have filed with the SEC under the Securities Act of 1933, as amended, and
therefore omits certain information contained in the Registration Statement.
We have also filed exhibits and schedules with the Registration Statement that
are excluded from this prospectus, and you should refer to the applicable
exhibit or schedule for a complete description of any statement referring to
any contract or other document. You may:
|
|
|
inspect a copy of the Registration Statement, including the exhibits and schedules, |
|
|
|
|
without charge at the public reference room, |
|
|
|
|
obtain a copy from the SEC upon payment of the fees prescribed by the SEC, or |
|
|
|
|
obtain a copy from the SECs web site or our web site. |
INCORPORATION OF DOCUMENTS BY REFERENCE
The SEC allows us to incorporate by reference the information we file
with it, which means that we can disclose important information to you by
referring you to those documents. The information incorporated by reference is
considered to be part of this prospectus and information we file later with
the SEC will automatically
update and supersede this information. We incorporate by reference the
documents listed below and any future filings made by us with the SEC under
Sections 13(a), 13(c), 14 or 15(d) of the Securities Exchange Act of 1934. The
documents we are incorporating by reference as of their respective dates of
filing are:
|
|
|
Annual Report on Form 10-K of XCYTE Therapies, Inc. filed on March 23,
2006 and as amended by Amendment No. 1 to the Annual Report on Form
10-K/A filed on May 1, 2006 (File No. 000-50626); |
|
|
|
|
Our Quarterly Report on Form 10-Q for the quarter ended March 31,
2006, filed on May 16, 2006 and as amended by the Form 10-Q/A filed on
July 7, 2006 (File No. 000-50626); |
|
|
|
|
Our Current Report on Form 8-K filed on March 30, 2006, and as amended
on June 9, 2006 and July 7, 2006 (File No. 000-50626); |
47
|
|
|
Our Current Report on Form 8-K filed on April 14, 2006, and as amended on April
19, 2006 (File No. 000-50626); |
|
|
|
|
Our Current Report on Form 8-K filed on April 28, 2006 (File No. 000-50626); |
|
|
|
|
Our Current Report on Form 8-K filed on May 18, 2006 (File No. 000-50626); |
|
|
|
|
Our Proxy Statement on Form DEF14A, filed on June 13, 2006 (File No. 000-50626); |
|
|
|
|
Our Quarterly Report on Form 10-Q for the quarter ended June 30, 2006, filed on
August 14, 2006 (File No. 000-50626); |
|
|
|
|
Our Current Report on Form 8-K filed on July 10, 2006 (File No. 000-50626); |
|
|
|
|
Our Quarterly Report on Form 10-Q for the quarter ended September 30, 2006,
filed on November 13, 2006 (File No. 000-50626); |
|
|
|
|
Our Current Report on Form 8-K filed on October 12, 2006 (File No. 000-50626); |
|
|
|
|
Our Current Report on Form 8-K filed on December 28, 2006 (File No. 000-50626); |
|
|
|
|
Our Current Report on Form 8-K filed on February 12, 2007 (File No. 000-50626); |
|
|
|
|
The description of our common stock contained in our Registration Statement on
Form 8-A, filed on March 8, 2004 (File No. 000-50626), which incorporates by
reference the description of the shares of our common stock contained in our
Registration Statement on Form S-1 (File No. 333-109653) filed on December 22,
2003 and declared effective by the SEC on March 17, 2004, and any amendment or
reports filed with the SEC for purposes of updating such description; and |
|
|
|
|
The description of our preferred stock contained in our Registration Statement
on Form 8-A, filed on October 27, 2004 (File No. 000-50626), which incorporates
by reference the description of the shares of our preferred stock contained in
our Registration Statement on Form S-1 (File No. 333-119585) filed on October
7, 2004 and declared effective by the SEC on November 1, 2004, and any
amendment or reports filed with the SEC for purposes of updating such
description. |
You may request, orally or in writing, a copy of these filings, which
will be provided to you at no cost, by contacting our investor relations
department our principal executive offices, which are located at 200 Connell
Drive, Suite 1500, Berkeley Heights, NJ 07922, Attention: Investor Relations,
Telephone: (908) 517-7330.
To the extent that any statements contained in a document incorporated by
reference are modified or superseded by any statements contained in this
prospectus, such statements shall not be deemed incorporated in this
prospectus except as so modified or superseded.
All documents subsequently filed by us pursuant to Sections 13(a), 13(c),
14 or 15(d) of the Exchange Act and prior to the termination of this offering
are incorporated by reference and become a part of this prospectus from the
date such documents are filed. Any statement contained in this prospectus or
in a document incorporated by reference is modified or superseded for purposes
of this prospectus to the extent that a statement contained in any subsequent
filed document modifies or supersedes such statement.
48
2,350,000 Shares of Common Stock
Warrants to Purchase 587,000 Shares of Common Stock
CYCLACEL PHARMACEUTICALS, INC.
PROSPECTUS SUPPLEMENT
Roth Capital Partners
January 21, 2010