Filed Pursuant to Rule 424(b)(5)
Registration No. 333-169847
Up to 6,000,000 Units Consisting of
One Share of Common Stock and
a Warrant to Purchase one Share of Common Stock
Placement Agent Warrant for the Purchase of up to 360,000 Shares of Common Stock
6,000,000 Shares of Common Stock Underlying the Warrants
360,000 Shares of Common Stock Underlying the Placement Agent Warrant
We are offering up to 6,000,000 units, with each unit consisting of one share of our common stock (“Share”) and a warrant to purchase one share of our common stock (“Warrant(s)”) (and the shares of common stock issuable from time to time upon exercise of the Warrants), to accredited investors pursuant to this prospectus supplement and the accompanying prospectus. Each unit will be sold at a negotiated price of $1.00. Each Warrant has an exercise price of $1.02 per share, and is exercisable 6 months after the closing date. Each Warrant has a term of 5 years from the date of initial exercise. The Shares and the Warrants will be issued separately but will be purchased together in this offering.
As partial compensation for its services in connection with this offering, we will be issuing the placement agent a warrant to purchase up to 360,000 common shares with an exercise price of $1.25 per share (“Placement Agent Warrant”). In addition to the Shares, Warrants and the Placement Agent Warrant, we are also registering the 6,360,000 common shares underlying the Warrants and Placement Agent Warrant.
Our common stock is listed on the NYSE AMEX under the symbol “CUR.” On February 2, 2012, the last reported sale price of our common stock on the NYSE AMEX was $1.02 per share. There is no market for the Warrants and none are expected to develop.
This investment involves a high degree of risk. Please see the section entitled “Risk Factors” beginning on page S-6 of this prospectus supplement and page 3 of the accompanying prospectus. |
T.R. Winston & Company, LLC (“Placement Agent”) acted as the placement agent on this transaction. The Placement Agent is not required to sell any specific number or dollar amount of securities. The placement agent has agreed to use its reasonable best efforts to sell the securities offered by this prospectus supplement. We have agreed to pay the placement agent the placement agent fees set forth in the table below.
Per Unit | Total | |||||||
Offering price | $ | 1.00 | $ | 6,000,000 | ||||
Placement agent fees(1) | $ | .05 | $ | 300,000 | ||||
Proceeds, before expenses, to Neuralstem, Inc.(2) | $ | .95 | $ | 5,700,000 |
(1) In addition, we have agreed to issue the placement agent warrants to purchase up to 360,000 shares of our common stock at an exercise price of $1.25 per share and to reimburse the placement agent for certain of its expenses as described under “Plan of Distribution” in this prospectus supplement.
(2) The proceeds shown exclude proceeds that we may receive upon exercise of the warrants.
Delivery of the units and the closing date is expected to be made on or about February 10, 2012, subject to customary closing conditions, against payment for such units to be received by us on the same date.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus supplement is February 6, 2012
TABLE OF CONTENTS
Prospectus supplement
Page | ||
Prospectus Summary | S-1 | |
Note Regarding Forward Looking Statements | S-1 | |
Our Business | S-2 | |
The Offering | S-5 | |
Risk Factors | S-6 | |
Use of Proceeds | S-8 | |
Dilution | S-9 | |
Material United States Federal Tax Consequences to Non-United States Holders | S-9 | |
Underwriting | S-9 | |
Legal Matters/Interest of Named Experts and Counsel | S-14 | |
Experts | S-14 | |
Where You Can Find More Information | S-14 | |
Incorporation of Certain Documents by Reference | ||
Page | ||
About This Prospectus | 1 | |
The Company | 2 | |
Risk Factors | 3 | |
Forward-Looking Statements | 4 | |
Use of Proceeds | 4 | |
Dividend Policy | 4 | |
Description of Securities to be Registered | 4 | |
Description of Capital Stock | 4 | |
Description of the Warrants | 6 | |
Description of the Units | 7 | |
Plan of Distribution | 7 | |
Legal Matters | 9 | |
Experts | 9 | |
Where You Can Find More Information | 9 | |
Information Incorporated by Reference | 9 |
You should rely only on the information contained or incorporated by reference in this prospectus supplement or the accompanying base prospectus. We have not authorized anyone to provide you with information that is different. We are not making an offer to sell these securities in any jurisdiction where the offer or sale of these securities is not permitted. This document may only be used where it is legal to sell these securities. You should assume that the information in this prospectus supplement and the accompanying base prospectus is accurate only as of their respective dates and that any information we have incorporated by reference is accurate only as of the date of the document incorporated by reference.
PROSPECTUS SUMMARY
This document is in two parts. The first part is this prospectus supplement, which describes the specific terms of this offering and also adds to and updates information contained in the accompanying prospectus and the documents incorporated by reference herein.
The second part, the accompanying prospectus, provides more general information. Generally, when we refer to this prospectus, we are referring to both parts of this document combined. To the extent there is a conflict between the information contained in this prospectus supplement and the information contained in the accompanying prospectus or any document incorporated by reference therein filed prior to the date of this prospectus supplement, you should rely on the information in this prospectus supplement; provided that if any statement in one of these documents is inconsistent with a statement in another document having a later date — for example, a document incorporated by reference in the accompanying prospectus — the statement in the document having the later date modifies or supersedes the earlier statement.
We further note that the representations, warranties and covenants made by us in any agreement that is filed as an exhibit to any document that is incorporated by reference herein were made solely for the benefit of the parties to such agreement, including, in some cases, for the purpose of allocating risk among the parties to such agreements, and should not be deemed to be a representation, warranty or covenant to you. Moreover, such representations, warranties or covenants were accurate only as of the date when made. Accordingly, such representations, warranties and covenants should not be relied on as accurately representing the current state of our affairs.
You should rely only on the information contained in this prospectus supplement and the accompanying prospectus, including the information incorporated by reference into this prospectus supplement and the accompanying prospectus, and any free writing prospectus that we have authorized for use in connection with this offering. We have not authorized, and the underwriter has not authorized, anyone to provide you with information that is different. The information contained in this prospectus supplement and the accompanying prospectus, including the information incorporated by reference into this prospectus supplement and the accompanying prospectus, and any free writing prospectus that we have authorized for use in connection with this offering is accurate only as of the respective dates thereof, regardless of the time of delivery of this prospectus supplement, the accompanying prospectus or free writing prospectus, if any, or of any sale of our common stock. It is important for you to read and consider all information contained in this prospectus supplement and the accompanying prospectus, including the information incorporated by reference into this prospectus supplement and the accompanying prospectus, and any free writing prospectus that we have authorized for use in connection with this offering in making your investment decision. You should also read and consider the information in the documents to which we have referred you in the sections entitled “Where You Can Find More Information” and “Incorporation of Certain Information by Reference” in this prospectus supplement.
We are offering to sell, and seeking offers to buy, our securities only in jurisdictions where offers and sales are permitted. The distribution of this prospectus supplement and the accompanying prospectus and the offering of securities in certain jurisdictions may be restricted by law. Persons outside the United States who come into possession of this prospectus supplement and the accompanying prospectus must inform themselves about, and observe any restrictions relating to, the offering of our securities and the distribution of this prospectus supplement and the accompanying prospectus outside the United States. This prospectus supplement and the accompanying prospectus do not constitute, and may not be used in connection with, an offer to sell, or a solicitation of an offer to buy, any securities offered by this prospectus supplement and the accompanying prospectus by any person in any jurisdiction in which it is unlawful for such person to make such an offer or solicitation.
References to, “we,” “us,” “our company,” “Neuralstem,” the “Company,” and similar terms refer to Neuralstem, Inc., a Delaware corporation, unless the context otherwise requires.
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Prospectus contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking. These forward-looking statements include, but are not limited to, statements about:
· | the success of our clinical trials, research and development activities, the development of a viable commercial product, and the speed with which regulatory authorizations and product launches may be achieved; |
S-1 |
· | whether or not a market for our product develops, and, if a market develops, the rate at which it develops; |
· | our ability to successfully sell or license our products if a market develops; |
· | our ability to attract and retain qualified personnel to implement our business plan and corporate growth strategies; |
· | our ability to develop sales, marketing, and distribution capabilities; |
· | our ability to obtain reimbursement from third party payers for our proposed products if they are developed; |
· | the accuracy of our estimates and projections; |
· | our ability to secure additional financing to fund our short-term and long-term financial needs; |
· | changes in our business plan and corporate strategies; and |
· | other risks and uncertainties discussed in greater detail in the section captioned “Risk Factors.” |
Each forward-looking statement should be read in context with, and in understanding of, the various other disclosures concerning our company and our business made elsewhere in this prospectus as well as our public filings with the SEC. You should not place undue reliance on any forward-looking statement as a prediction of actual results or developments. We are not obligated to update or revise any forward-looking statements contained in this report or any other filing to reflect new events or circumstances unless and to the extent required by applicable law.
OUR BUSINESS
This summary highlights selected information appearing elsewhere or incorporated by reference in this prospectus may not contain all of the information that is important to you. This summary is not complete and does not contain all of the information that you should consider before investing in our securities. To fully understand this offering and its consequences to you, you should read this entire prospectus supplement and the accompanying base prospectus carefully, including the information referred to under the heading “Risk Factors” in this prospectus supplement beginning on page S-6, and the financial statements and other information incorporated by reference in this prospectus supplement and the accompanying base prospectus when making an investment decision.
Overview
We are focused on the development and commercialization of treatments based on human neuronal stem cells and the development and commercialization of treatments using small molecule compounds.
We have developed and maintain a portfolio of patents and patent applications that form the proprietary base for our research and development efforts in the area of neural stem cell research. We own or exclusively license twenty-one (21) issued patents and twenty-two (22) patent pending applications in the field of regenerative medicine and related technologies. We believe our technology base, in combination with our know-how, and collaborative projects with major research institutions, provide a competitive advantage and will facilitate the development and commercialization of products for use in the treatment of a wide array of neurodegenerative conditions and in regenerative repair of acute disease.
Regenerative medicine is a young and emerging field. Regenerative medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to age, disease, damage, or congenital defects. There can be no assurances that our intellectual property portfolio will ultimately produce viable commercialized products and processes. Even if we are able to produce a commercially viable product, there are strong competitors in this field and our products may not be able to successfully compete against them.
S-2 |
All of our research efforts to date are at the pre-clinical or clinical stage of development. We are focused on leveraging our key assets, including our intellectual property, our scientific team and our facilities, to advance our technologies. In addition, we are pursuing strategic collaborations with members of academia.
Clinical Trials
Stem Cells
On September 21, 2009, the U.S. Food and Drug Administration (“FDA”) approved our first Investigational New Drug Application (“IND”) to begin Phase I clinical studies on our treatment for Amyotrophic Lateral Sclerosis (“ALS” or “Lou Gehrig’s disease”). In October of 2011 the Company announced that, after reviewing safety data from the first 12 patients, the FDA granted approval for the trial to advance to transplanting patients in the cervical (upper back) region for the last six patients in the trial. To date, we have treated 13 patients.
On August 22, 2010, we filed our second IND for our proposed Phase I clinical trials for chronic spinal cord injury. In October of 2010, we were notified that our IND for spinal cord injury had been placed on clinical hold. At the time, the FDA provided us with specific comments, questions and recommendations for modifications to our trial protocol as contained in our IND application. We expect to revisit this IND with the FDA with a review of the long term human safety data from our ALS trial as well as some additional long term animal safety data that was generated for the next phase of the ALS trial. We anticipate the study, if approved and commenced, will be a multi-site study in the United States.
Pharmaceutical Compounds
In February of 2011, we commenced a Phase Ia clinical trial of our drug compound, NSI-189, which is being developed for the treatment of major depressive disorder and other psychiatric indications. NSI-189 is the lead compound in our neurogenerative small molecule drug platform. The Phase Ia trial tested a single oral administration of NSI-189 in healthy volunteers. In October of 2011, we completed the Phase Ia portion of the trial. In December of 2011, we received approval from the FDA to commence the Phase Ib portion of the trial. The Phase Ib portion consists of patients with Major Depressive Disorder (“MDD”) receiving daily doses for 28 consecutive days. We plan on commencing the Phase Ib portion of the trial during the first quarter of 2012. It is still too early in the trials to make any determination as to its level of success, if any.
Technology
Stem Cells
Our technology enables the isolation and large-scale expansion of human neural stem cells from all areas of the developing human brain and spinal cord, thus enabling the generation of physiologically relevant human neurons of all types. Our two issued core patents entitled: (i) Isolation, Propagation, and Directed Differentiation of Stem Cells from Embryonic and Adult Central Nervous System of Mammals; and (ii) In Vitro Generation of Differentiated Neurons from Cultures of Mammalian Multipotential CNS Stem Cell contain claims which cover the process of deriving the cells as well as the cells created from this process.
To date we have focused our efforts on applications involving spinal cord stem cells. We believe we have established “proof of principle” for two important spinal cord applications: ALS, or Lou Gehrig’s disease, and Ischemic Spastic Paraplegia (a painful form of spasticity that may arise as a complication of surgery to repair aortic aneurysms). Of these applications, we have commenced Phase I trials with regard to ALS.
We intend to treat both chronic and acute spinal cord injury with the same spinal cord stem cells, utilizing the same injection devices we are using for ALS. We, therefore, add to our knowledge about the surgical route of entry for both the ALS patients and the spinal cord injury patients with each patient we treat in the ALS trial.
S-3 |
During 2011, we were selected as the primary subcontractor for a U.S. Department of Defense (“DOD”) contract, awarded to Loma Linda University, to develop its human neural stem cell technology for the treatment of cancerous brain tumors. Under the terms of the contract, we may receive up to $625,000 during the first year. The DOD has three one-year options to continue the program after the first year based upon milestones. The goal of the program is to have a therapeutic product for the treatment of cancerous brain tumors ready to submit to the FDA by the end of the fourth year (2015).
Pharmaceutical Compounds
The Company has developed and patented a series of small molecule compounds (low molecular weight organic compounds which can efficiently cross the blood/brain barrier). We believe that these small molecule compounds will stimulate the growth of new neurons in the hippocampus and provide a treatment for depression, and possibly other cognitive impact diseases. In July of 2009, the U.S. Patent and Trademark Office issued the patent covered by patent application 12/049,922, entitled “Use of Fused Nicotinamides to Promote Neurogenesis,” which claims four chemical entities and any pharmaceutical composition included in them. In October of 2011 the Company announced that it had received patent allowance for U.S. Patent 8,030,492, entitled: “Compositions to Effect Neuronal Growth.” The claims covered by the patent include both structure and method claims for inducing neurogenesis and the growth of new neurons, both in-vitro and in-vivo.
NSI-189 is the first in a class of compounds that we plan to develop into orally administered drugs for Major depressive disorder and other psychiatric disorders. In mice, NSI-189 both stimulated neurogenesis of the hippocampus and increased its volume. Additionally, NSI-189 stimulated neurogenesis of human hippocampus-derived neural stem cells in vitro. We believe NSI-189 may reverse the human hippocampal atrophy seen in major depression and other disorders.
Our small molecule platform results from discoveries made through our ability to generate stable human neural stem cell lines suitable for screening large chemical libraries. The platform complements our cell therapy platform, in which brain and spinal cord stem cells are transplanted directly into diseased areas to repair and/or replace diseased or dead cells.
Research
We have devoted substantial resources to our research programs in order to isolate and develop a series of neural stem cell banks that we believe can serve as a basis for our therapeutic products. Our efforts to date have been directed at methods to identify, isolate and culture large varieties of stem cells of the human nervous system, and to develop therapies utilizing these stem cells. This research is conducted internally, through the use of third party laboratories and consulting companies under our direct supervision, and through collaboration with academic institutes.
Operating Strategy
We employ an outsourcing strategy where we outsource all of our Good Laboratory Practices (“GLP”) preclinical development activities and GMP manufacturing and clinical development activities to contract research organizations (“CRO”) and contract manufacturing organizations (“CMO”) as well as all non-critical corporate functions. Manufacturing is also outsourced to organizations with approved facilities and manufacturing practices. This outsource model allows us to better manage cash on hand and eliminates non-vital expenditures. It also allows for us to operate with relatively fewer employees and lower fixed costs than that required by our competitors.
S-4 |
Employees
As of December 31, 2011, we had 14 full-time employees. Of these full-time employees, eight work on research and development and six in administration. We also use the services of numerous outside consultants in business and scientific matters.
Our Corporate Information
We were incorporated in Delaware. Our principal executive offices are located at 9700 Great Seneca Highway, Rockville, Maryland 20850, and our telephone number is (301) 366-4841. Our website is located at www.neuralstem.com. We have not incorporated by reference into this prospectus supplement or the accompanying base prospectus the information in, or that can be accessed through, our website, and you should not consider it to be a part of this prospectus supplement or the accompanying prospectus.
THE OFFERING
Common stock we are offering | Up to 6,000,000 shares | |
Investor Warrants | Warrants to purchase up to an aggregate of 6,000,000 shares of common stock at $1.02 per share will be issued to the investors. The Warrants have a term of 5 years from the initial exercise date and is exercisable 6 months after the closing date. | |
Common stock to be outstanding after this offering(1) | 54,682,118 shares | |
Use of proceeds | We intend to use the net proceeds of this offering for general corporate purposes, including working capital, product development and capital expenditures. See “Use of proceeds.” | |
Placement Agent Warrant | Warrants to purchase up to 360,000 shares of common stock will be issued to the Placement Agent as partial compensation for its services in connection with this offering. This prospectus supplement also relates to the offering of the shares of common stock issuable upon exercise of the placement agent warrants. | |
NYSE Amex symbol | CUR |
(1) The number of shares of our common stock to be outstanding after this offering is based on 48,682,118 shares outstanding as of September 30, 2011 and excludes as of such date:
· | 24,145,550 common shares reserved for issuance upon the exercise of current outstanding options, warrants, convertible securities at a weighted-average exercise price of $2.54. |
· | 394,351 common shares reserved for issuance upon the vesting and termination of certain transfer restrictions with regard to restricted stock units and restricted stock awards. |
· | 6,384,575 common shares reserved for issuance pursuant to future awards under our incentive stock plans. |
S-5 |
RISK FACTORS
Your investment in our shares of common stock is subject to certain risks. This prospectus does not describe all of those risks. You should consult your own financial and legal advisors about the risks entailed by an investment in our shares of common stock and the suitability of your investment in our shares of common stock in light of your particular circumstances. For a discussion of some of the factors you should carefully consider before deciding to purchase any of our shares of common stock that may be offered, please read “Risk Factors” in the documents incorporated by reference herein, as well as those risk factors included below. Additional risks and uncertainties not currently known to us or that we currently deem immaterial may also adversely affect our business and operations. If any of the matters described in the risk factors were to occur, our business, financial condition, results of operations, cash flows or prospects could be materially adversely affected. In such case, you could lose all or a portion of your investment.
Risks Related to the Offering
You will experience immediate and substantial dilution in the book value per share of the common stock you purchase.
The public offering price per share of our common stock being offered is substantially higher than the net tangible book value per share of our common stock outstanding prior to our offering. Therefore, if you purchase our common stock in this offering, you will incur immediate dilution of $0.83735 in net tangible book value per share from the price you paid. For a further description of the dilution that you will experience immediately after this offering, see the section titled “Dilution.”
Our management will have broad discretion over the use of proceeds from this offering and may not use the proceeds effectively.
Our management will have broad discretion as to the application of the net proceeds from this offering and could spend the proceeds in a variety of ways that may ultimately fail to improve our operating results or enhance the value of our common stock. Our failure to apply these funds effectively could have a negative effect on our business and cause the price of our common stock to decline.
Our publicly filed reports are subject to review by the SEC, and any significant changes or amendments required as a result of any such review may result in material liability to us and may have a material adverse impact on the trading price of our common stock.
The reports of publicly traded companies are subject to review by the SEC from time to time for the purpose of assisting companies in complying with applicable disclosure requirements, and the SEC is required to undertake a comprehensive review of a company’s reports at least once every three years under the Sarbanes-Oxley Act of 2002. SEC reviews may be initiated at any time. We could be required to modify, amend or reformulate information contained in prior filings as a result of an SEC review. Any modification, amendment or reformulation of information contained in such reports could be significant and result in material liability to us and have a material adverse impact on the trading price of our common stock.
Risks Related to Government Regulation and Approval of our Product Candidates
If our clinical trials fail to demonstrate to the FDA that any of our product candidates are safe and effective for the treatment of particular diseases, the FDA may require us to conduct additional clinical trials or may not grant us marketing approval for such product candidates for those diseases.
S-6 |
We are not permitted to market our product candidates in the United States until we receive approval of an NDA from the FDA. Before obtaining regulatory approvals for the commercial sale of any product candidate for a target indication, we must demonstrate with evidence gathered in preclinical and well-controlled clinical trials, and, with respect to approval in the United States, to the satisfaction of the FDA and, with respect to approval in other countries, similar regulatory authorities in those countries, that the product candidate is safe and effective for use for that target indication and that the manufacturing facilities, processes and controls used to produce the product are compliant with applicable statutory and regulatory requirements. Our failure to adequately demonstrate the safety and effectiveness of any of our product candidates for the treatment of particular diseases may delay or prevent our receipt of the FDA’s approval and, ultimately, may prevent commercialization of our product candidates for those diseases. The FDA has substantial discretion in deciding whether, based on the benefits and risks in a particular disease, any of our product candidates should be granted approval for the treatment of that particular disease. Even if we believe that a clinical trial or trials has demonstrated the safety and statistically significant efficacy of any of our product candidates for the treatment of a disease, the results may not be satisfactory to the FDA. Preclinical and clinical data can be interpreted by the FDA authorities in different ways, which could delay, limit or prevent regulatory approval. If regulatory delays are significant or regulatory approval is limited or denied altogether, our financial results and the commercial prospects for those of our product candidates involved will be harmed, and our prospects for profitability will be significantly impaired.
In addition, in the course of its review of an NDA or regulatory application, the FDA or other regulatory authorities may conduct audits of the practices and procedures of a company and its suppliers and contractors concerning manufacturing, clinical study conduct, non-clinical studies and several other areas. If the FDA and/or other regulatory authorities conducts an audit relating to an NDA or regulatory application submitted by us and finds a significant deficiency in any of these or other areas, the FDA or other regulatory authorities could delay or not approve our NDA or regulatory application. If regulatory delays are significant or regulatory approval is limited or denied altogether, our financial results and the commercial prospects for those of our products or product candidates involved will be harmed, and our prospects for profitability will be significantly impaired.
We are subject to extensive and rigorous governmental regulation, including the requirement of FDA or other regulatory approval before our product candidates may be lawfully marketed.
Both before and after the approval of our product candidates, we, our product candidates, our operations, our facilities, our suppliers, and our contract manufacturers, contract research organizations, and contract testing laboratories are subject to extensive regulation by governmental authorities in the United States and other countries, with regulations differing from country to country. In the United States, the FDA regulates, among other things, the pre-clinical testing, clinical trials, manufacturing, safety, efficacy, potency, labeling, storage, record keeping, quality systems, advertising, promotion, sale and distribution of therapeutic products. Failure to comply with applicable requirements could result in, among other things, one or more of the following actions: notices of violation, untitled letters, warning letters, fines and other monetary penalties, unanticipated expenditures, delays in approval or refusal to approve a product candidate; product recall or seizure; interruption of manufacturing or clinical trials; operating restrictions; injunctions; and criminal prosecution. We or the FDA, or an institutional review board, may suspend or terminate human clinical trials at any time on various grounds, including a finding that the subjects are being exposed to an unacceptable health risk. Our product candidates cannot be lawfully marketed in the United States without FDA approval. Any failure to receive the marketing approvals necessary to commercialize our product candidates could harm our business.
The regulatory review and approval process of governmental authorities, which includes the need to conduct nonclinical studies and clinical trials of each product candidate, is lengthy, expensive and uncertain, and regulatory standards may change during the development of a particular product candidate. We are not permitted to market our product candidates in the United States or other countries until we have received requisite regulatory approvals. For example, securing FDA approval requires the submission of an NDA to the FDA. The approval application must include extensive nonclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each indication. The approval application must also include significant information regarding the chemistry, manufacturing and controls for the product. The FDA review process typically takes significant time to complete and approval is never guaranteed. If a product is approved, the FDA may limit the indications for which the product may be marketed, require extensive warnings on the product labeling, impose restricted distribution programs, require expedited reporting of certain adverse events, or require costly ongoing requirements for post-marketing clinical studies and surveillance or other risk management measures to monitor the safety or efficacy of the product. Markets outside of the United States also have requirements for approval of drug candidates with which we must comply prior to marketing. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure we will be able to obtain regulatory approval in other countries, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in other countries. Also, any regulatory approval of any of our product candidates, once obtained, may be withdrawn.
S-7 |
In addition, we, our suppliers, our operations, our facilities, and our contract manufacturers, our contract research organizations, and our contract testing laboratories are required to comply with extensive FDA requirements both before and after approval of our products. For example, we are required to report certain adverse reactions and production problems, if any, to the FDA, and to comply with certain requirements concerning advertising and promotion for our product candidates and our products. Also, quality control and manufacturing procedures must continue to conform to current Good Manufacturing Practices, or cGMP, regulations after approval, and the FDA periodically inspects manufacturing facilities to assess compliance with cGMP. Accordingly, we and others with whom we work must continue to expend time, money, and effort in all areas of regulatory compliance, including manufacturing, production, and quality control. In addition, discovery of safety issues may result in changes in labeling or restrictions on a product manufacturer or NDA holder, including removal of the product from the market.
The results of pre-clinical studies and early-stage clinical trials, such as the results from our recent Phase I ALS trial, may not be predictive of the results of later-stage clinical trials.
A number of companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience than us, have suffered significant setbacks in Phase II and Phase III clinical trials, despite positive results from earlier-stage trials. The principal investigator of the Phase I safety trial of our human spinal cord stem cells (HSSC's) in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease), recently presented primary and secondary endpoint data on the first 12 patients in the study. The study was designed to assess the safety of intraspinal transplantation in ALS patients and was not intended to demonstrate efficacy. While no adverse events related to the surgical procedure or our neural stem cells were reported, the small sample size, limited time frame and preliminary nature of the study make it difficult to draw any conclusions from the results of the study. No assurance can be given that the surgical procedure or our neural stem cells will be deemed safe by the FDA or that efficacy in the treatment of ALS will be demonstrated in any future studies. Failure to demonstrate safety and efficacy results acceptable to the FDA in later stage trials could impair our development prospects and even prevent regulatory approval of our neuronal stem cells, NSI-189 or other future products.
Additional Risks Related to our Business, Industry and an Investment in our Common Stock
For a discussion of additional risks associated with our business, our industry and an investment in our common stock, see the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K (and as amended), as filed with the SEC on March 16, 2011, our most recent Quarterly Report on Form 10-Q, as filed with the SEC on August 9, 2011 and amended on September 23, 2011 and any other subsequently filed document that is also incorporated or deemed to be incorporated by reference in this prospectus supplement, including our Quarterly Reports on Form 10-Q.
USE OF PROCEEDS
We estimate that the net proceeds from the sale of the Units will be approximately $5,650,000, assuming that we sell the maximum number of securities we are offering pursuant to this prospectus supplement. Because there is no minimum offering amount required as a condition to the closing of this offering, the actual number of securities sold, placement agent fees and proceeds to us are not presently determinable and may be substantially less than the amount set forth above. In the event the Warrants and Placement Agent Warrant are exercised, we will receive an additional $6,570,000.
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We intend to invest the net proceeds in money market funds and/or short-term investment-grade securities until we are ready to use them. We intend to use the net proceeds from the sale of the securities covered by this prospectus for general corporate purposes, which may include working capital, capital expenditures, research and development expenditures, clinical trial expenditures, acquisitions of new technologies or businesses and investments.
The amounts and timing of these expenditures may vary significantly depending on numerous factors, such as the progress of our research and development efforts, actions of regulatory authorities, technological advances and the competitive environment for our products. As of the date of this prospectus supplement, we cannot specify with certainty all of the particular uses for the net proceeds to us from this offering. Accordingly, we will retain broad discretion over the use of these proceeds.
DETERMINATION OF OFFERING PRICE
We established the price following negotiations with prospective investors and with reference to the prevailing market price of our common stock, recent trends in such price, daily average trading volume of our common stock, our current stage of development, future capital needs and other factors.
DIVIDEND POLICY
We have never paid or declared cash dividends on our common stock, and we do not intend to pay or declare cash dividends on our common stock in the foreseeable future.
DILUTION
Our net tangible book value as of September 30, 2011 was approximately $3.244 million, or approximately $0.0663 per share. Net tangible book value per share is equal to the amount of our total tangible assets, less total liabilities, divided by the aggregate number of shares of our common stock outstanding as of September 30, 2011. Dilution in net tangible book value per share represents the difference between the amount per share paid by purchasers of shares of common stock in this public offering and the net tangible book value per share of our common stock immediately after this offering. After giving effect to the sale of 6,000,000 shares of common stock in this public offering at a public offering price of $1.00 per share, and after deducting underwriting discounts and commissions and estimated offering expenses payable by us of approximately $50,000, our as adjusted net tangible book value as of September 30, 2011 would have been approximately $8.894 million, or approximately $0.16265 per share. This represents an immediate dilution of $0.83735 per share to new investors purchasing shares of common stock in this public offering. The following table illustrates this dilution:
Offering price per share | $ | 1.00 | ||||||
$ | 123,000 | |||||||
Net tangible book value per share as of September 30, 2011 | $ | 3,243,908 | ||||||
Increase in net tangible book value per share attributable to new investors | $ | 5,650,000 | ||||||
As adjusted, net tangible book value per share as of September 30, 2011 after giving effect to this public offering | $ | 0.16265 | ||||||
Dilution per share to new investors | $ | 0.83735 |
The foregoing discussion and table do not take into account further dilution to new investors that could occur upon the exercise of outstanding options or warrants having a per share exercise price less than the per share offering price to the public in this offering. In addition, we may choose to raise additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. To the extent that additional capital is raised through the sale of equity or convertible debt securities, the issuance of these securities could result in further dilution to our stockholders.
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The foregoing discussion and table are based on 48,682,118 shares of common stock issued and outstanding as of September 30, 2011 and exclude:
· | 24,145,550 common shares reserved for issuance upon the exercise of current outstanding options, warrants, and convertible securities at a weighted-average exercise price of $2.54. |
· | 394,351 common shares reserved for issuance upon the vesting and termination of certain transfer restrictions with regard to restricted stock units and restricted stock awards. |
· | 6,626,300 common shares reserved for issuance pursuant to future awards under our incentive stock plans. |
The foregoing discussion and table also exclude the following stock and option transactions that were entered into subsequent to September 30, 2011:
· | 2,400 common shares previously reserved for issuance upon exercise of expired options which result in an increase in common shares reserved for issuance pursuant to future awards under our incentive stock plans and a decrease in common shares reserved for issuance upon exercise of current outstanding options, warrants and convertible securities. |
DESCRIPTION OF SECURITIES
In this offering, we are offering up to 6,000,000 Units to investors and a warrant to purchase up to 360,000 common shares as compensation to the placement agent for its services in connection with this offering. Each unit (“Unit”) consisting of: (i) one Share; and (ii) one Warrant. This prospectus supplement also relates to the offering of shares of our common stock issuable upon exercise, if any, of the Warrants.
Common Stock
The material terms and provisions of our common stock are described under the caption “Description of Common Stock” starting on page 4 of the accompanying prospectus.
Warrants.
The material terms and provisions of the Warrants being offered pursuant to this prospectus supplement and the accompanying prospectus are summarized below. This summary does not purport to be complete and is subject to, and qualified in its entirety by the warrants.
General. Investors will receive Warrants with a term of five years following the initial exercise date to purchase an aggregate of up to 6,000,000 shares of our common stock at an exercise price of $1.02 per share
Exercisability. The warrants are exercisable, in whole or in part, at any time and from time to time during the period commencing 6 months from the Closing and ending on the expiration of the Warrants term. The Warrants are exercisable for cash in the event there is a valid registration statement covering the underlying shares or on a cashless if there is not a valid registration statement.
Exercise Price. The exercise price per share of common stock underlying the warrants is $1.02, subject to adjustment as described below.
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Adjustments. In the event of stock splits, stock dividends on our common stock, stock combinations, or similar events, the exercise price of the warrants, and shares underlying warrants may be subject to adjustment. In addition, in the event we consummate any merger, consolidation, sale or other reorganization event in which our common stock is converted into or exchanged for securities, cash or other property, then following such event, the holders of the warrants will be entitled to receive upon exercise of the warrants the kind and amount of securities, cash or other property which the holders would have received had they exercised the warrants immediately prior to such reorganization event. The exercise price and number of shares underlying the warrants are not subject to adjustment in the event of a subsequent financing. In addition, as further described in the form of warrants filed an exhibit to a current report on Form 8-K that will be incorporated herein by reference, in the event of any fundamental transaction completed for cash, as a transaction under Rule 13e-3 of the Securities Exchange Act of 1934, or involving a person not trading on a national securities exchange, the holders of the warrants will have the right to require us to purchase the warrant for an amount in cash that is determined in accordance with a formula set forth in the warrants.
Fractional Shares. No fractional shares of common stock will be issued in connection with the exercise of a warrant. In lieu of fractional shares, we can elect to either pay the holder an amount in cash equal to the fractional amount multiplied by the market value of a share of common stock or round up the number of shares to the next whole share.
Transferability. The Warrants are transferable pursuant to their terms separately from the Shares being offering.
Ownership Cap and Exercise Restrictions. Under the terms of each warrant, at no time may a holder of a warrant exercise the warrant if the acquisition of the number of shares being purchased would result in the holder owning more than 4.99% of the common stock then outstanding. This maximum percentage may be increased, subject to sixty one (61) days prior notice to us by the holder, provided that the maximum percentage may not exceed 9.99% of our then outstanding shares of common stock following such exercise, excluding for purposes of such determination shares of common stock issuable upon exercise of the warrant that have not been exercised.
Additional Provisions. The above summary of certain terms and provisions of the warrants is qualified in its entirety by reference to the detailed provisions of the warrants, the form of which will be filed as an exhibit to a current report on Form 8-K that will be incorporated herein by reference. No holders of the warrants will possess any rights as a stockholder under those warrants until the holder exercises those warrants.
Placement Agent Warrant
The material terms and provisions of the warrants being offered pursuant to this prospectus supplement and the accompanying prospectus are summarized below. This summary does not purport to be complete and is subject to, and qualified in its entirety by reference to, all the provisions of the warrants.
General. The placement agent will receive warrants, which are exercisable 6 months from Closing and have a term of five years from the effective date of the registration statement of which this prospectus supplement is a part, to purchase an aggregate of 360,000 shares of our common stock at an exercise price of $1.25 per share which is equal to 125% of the offering price per share in the offering. The terms of the Placement Agent Warrant are substantially similar to those of the Warrants except as described herein.
Adjustments. In the event of stock splits, stock dividends on our common stock, stock combinations, or similar events, the exercise price of the warrants, and shares underlying warrants may be subject to adjustment. In addition, in the event we consummate any merger, consolidation, sale or other reorganization event in which our common stock is converted into or exchanged for securities, cash or other property, then following such event, the holders of the warrants will be entitled to receive upon exercise of the warrants the kind and amount of securities, cash or other property which the holders would have received had they exercised the warrants immediately prior to such reorganization event. The exercise price and number of shares underlying the warrants are not subject to adjustment in the event of a subsequent financing. In addition, as further described in the form of warrants filed as an exhibit to a current report on Form 8-K that will be incorporated herein by reference, in the event of any fundamental transaction completed for cash, as a transaction under Rule 13e-3 of the Securities Exchange Act of 1934, or involving a person not trading on a national securities exchange, the holders of the warrants will have the right to require us to purchase the warrant for an amount in cash that is determined in accordance with a formula set forth in the warrants.
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Fractional Shares. No fractional shares of common stock will be issued in connection with the exercise of a warrant. In lieu of fractional shares, we can elect to either pay the holder an amount in cash equal to the fractional amount multiplied by the market value of a share of common stock or round up the number of shares to the next whole share.
Transferability. Pursuant to FINRA Rule 5110(g)(1), neither the Placement Agent warrants nor any shares of common stock issued upon exercise of the Placement Agent warrants may be sold, transferred, assigned, pledged, or hypothecated, or be subject to any hedging, short sale, derivative, put, or call transaction that would result in the effective economic disposition of such securities by any person for a period of 180 days immediately following the date hereof, except the transfer of any security:
· | by operation of law or by reason of our reorganization; |
· | to any FINRA member firm participating in the offering and the officers and partners thereof, if all securities so transferred remain subject to the lock-up restriction described above for the remainder of the time period; |
· | if the aggregate amount of our securities held by the Placement Agent or related person does not exceed 1% of the securities being offered; |
· | that is beneficially owned on a pro-rata basis by all equity owners of an investment fund, provided that no participating member manages or otherwise directs investments by the fund, and participating members in the aggregate do not own more than 10% of the equity in the fund; or |
· | the exercise or conversion of any security, if all securities received remain subject to the lock-up restriction set forth above for the remainder of the time period. |
Ownership Cap and Exercise Restrictions. Under the terms of each warrant, at no time may a holder of a warrant exercise the warrant if the acquisition of the number of shares being purchased would result in the holder owning more than 4.99% of the common stock then outstanding. This maximum percentage may be increased, subject to sixty one (61) days prior notice to us by the holder, provided that the maximum percentage may not exceed 9.99% of our then outstanding shares of common stock following such exercise, excluding for purposes of such determination shares of common stock issuable upon exercise of the warrant that have not been exercised
Additional Provisions. The above summary of certain terms and provisions of the warrants is qualified in its entirety by reference to the detailed provisions of the warrants, the form of which will be filed as an exhibit to a current report on Form 8-K that will be incorporated herein by reference. No holders of the warrants will possess any rights as a stockholder under those warrants until the holder exercises those warrants.
PLAN OF DISTRIBUTION
We have engaged T.R. Winston & Company, LLC as our placement agent in connection with this offering. The placement agent is not purchasing or selling any of the Units we are offering, and it is not required to arrange the purchase or sale of any specific number of Units or dollar amount, but the placement agent agreed to use commercially reasonable efforts to arrange for the sale of the Units.
The terms of any such offering will be subject to market conditions and negotiations between us and prospective purchasers. The engagement agreement does not give rise to any commitment by the placement agent to purchase any of our Units, and the placement agent will have no authority to bind us by virtue of the placement agency agreement. Further, the placement agent does not guarantee that it will be able to raise new capital in any prospective offering.
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We will enter into securities purchase agreements directly with the purchasers in connection with this offering, and we will only sell to purchasers who have entered into securities purchase agreements.
We will deliver the Shares being issued to the purchasers electronically upon receipt of purchaser funds for the purchase of the Shares offered pursuant to this prospectus supplement. We expect to deliver the Shares being offered pursuant to this prospectus supplement on or about February 10, 2012, which will be deemed the closing date. We will deliver the Warrants and Placement Agent Warrant in physical form.
We have agreed to pay T.R. Winston & Company, LLC a placement agent fee equal to: (i) a cash fee equal to 5% of the gross proceeds of this offering or $300,000; and (ii) a Placement Agent Warrant equal to 6% of the number of Shares sold in this offering. The Placement Agent Warrant has an exercise price equal to $1.25, which is 125% of the offering price per share in the offering, will be exercisable 6 months following the closing and will expire on October 14, 2015, which is five years from the effective date of the registration statement of which this prospectus supplement is a part, and will otherwise comply with the rules of the Financial Industry Regulatory Authority, or FINRA. Additional terms of the placement agent warrants are set forth under “Description of Securities – Placement Agent Warrant” herein. In addition, we have agreed to reimburse the expenses of the placement agent in connection with the offering in the amount of $15,000.
The following table shows the per Unit and total commission we will pay to the placement agent in connection with the sale of Units pursuant to this prospectus supplement and the accompanying prospectus, assuming the purchaser of all of the Units offered hereby and excluding proceeds that we may receive upon exercise of the warrants.
Per Unit | Total | |||||||
Offering price | $ | 1.00 | $ | 6,000,000 | ||||
Placement agent fees (1) | $ | .05 | $ | 300,000 | ||||
Proceeds, before expenses, to Neuralstem, Inc | $ | .95 | $ | 5,700,000 |
(1) In addition, we have agreed to issue the placement agent warrants to purchase up to 360,000 shares of our common stock at an exercise price of $1.25 per share and to reimburse the placement agent for certain of its expenses as described herein.
In compliance with the guidelines of FINRA, the maximum consideration or discount to be received by the placement agent or any other FINRA member may not exceed 8% of the gross proceeds to us in this offering or any other offering in the United States pursuant to the Prospectus.
The engagement agreement with T.R. Winston & Company, LLC will be included as an exhibit to a Current Report on Form 8-K that we will file with the SEC and that will be incorporated by reference into the registration statement.
The estimated offering expenses payable by us, in addition to the placement agent fees of $300,000, are approximately $50,000, which includes legal, accounting and printing costs and various other fees associated with registering and listing the common stock. After deducting certain fees due to the placement agent and our estimated offering expenses, we expect the net proceeds from this offering to be approximately $5,650,000.
We have agreed to indemnify the placement agent and certain other persons against certain liabilities relating to or arising out of the placement agent's activities under the placement agency agreement. We have also agreed to contribute to payments the placement agent may be required to make in respect of such liabilities.
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The placement agent may be deemed to be an underwriter within the meaning of Section 2(a)(11) of the Securities Act, and any commissions received by it and any profit realized on the resale of the common stock and warrants sold by it while acting as principal might be deemed to be underwriting discounts or commissions under the Securities Act. As an underwriter, the placement agent would be required to comply with the requirements of the Securities Act and the Exchange Act, including, without limitation, Rule 415(a)(4) under the Securities Act and Rule 10b-5 and Regulation M under the Exchange Act. These rules and regulations may limit the timing of purchases and sales of shares of common stock and warrants by the placement agent acting as principal. Under these rules and regulations, the placement agent:
· | may not engage in any stabilization activity in connection with our securities; and |
· | may not bid for or purchase any of our securities or attempt to induce any person to purchase any of our securities, other than as permitted under the Exchange Act, until it has completed its participation in the distribution. |
LEGAL MATTERS
The validity of the issuance of the securities offered hereby will be passed upon for us by The Silvestre Law Group, P.C. Westlake Village, California. The Silvestre Law Group, P.C. or its affiliates or principals own 54,000 shares of common stock. Ellenoff Grossman & Schole LLP, New York, New York, is counsel for the Placement Agent in connection with this offering.
EXPERTS
The financial statements incorporated in this prospectus by reference from the Company’s Annual Report on Form 10-K have been audited by Stegman & Company, an independent registered public accounting firm, as stated in their report, which is incorporated herein by reference. Such financial statements have been so incorporated in reliance upon the report of such firm given upon their authority as experts in accounting and auditing. Stegman & Company has no interest in the shares being registered in this filing.
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 (“SEC”). You may read and copy any document we file at the SEC’s Public Reference Room at 100 F Street, N.E., Room 1580, 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 SEC’s web site at http://www.sec.gov.
In addition, we maintain a web site that contains information regarding our company, including copies of reports, proxy statements and other information we file with the SEC. The address of our web site is www.neuralstem.com. Except for the documents specifically incorporated by reference into this prospectus, information contained on our website or that can be accessed through our website does not constitute a part of this prospectus. We have included our website address only as an inactive textual reference and do not intend it to be an active link to our website.
This prospectus supplement and the accompanying prospectus are part of a registration statement on Form S-3 that we filed with the SEC registering the securities that may be offered and sold hereunder. The registration statement, including exhibits thereto, contains additional relevant information about us and these securities that, as permitted by the rules and regulations of the SEC, we have not included in this prospectus supplement or the accompanying prospectus. A copy of the registration statement can be obtained at the address set forth above. You should read the registration statement for further information about us and these securities.
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About This Prospectrus
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1
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The Company
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2
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Risk Factors
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3
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Forward-Looking Statements
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4
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Use of Proceeds
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4
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Dividend Policy
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4
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Description of Securities to be
Registered
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4
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Description of Capital
Stock
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4
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Description of the Warrants
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6
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Description of the Units
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7
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Plan of Distribution
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7
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Legal Matters
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9
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Experts
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9
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Where You Can Find More
Information
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9
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Information Incorporated by
Reference
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9
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•
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the
price of and maximum number of
shares;
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•
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the
designation of the shares;
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•
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the
annual dividend rate, if any, whether the dividend rate is fixed or
variable, the date or dates on which dividends will accrue, the dividend
payment dates, and whether dividends will be
cumulative;
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•
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the
price and the terms and conditions for redemption, if any, including
redemption at our option or at the option of the holders, including the
time period for redemption, and any accumulated dividends or
premiums;
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•
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the
liquidation preference, if any, and any accumulated dividends upon the
liquidation, dissolution or winding up of our
affairs;
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•
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any
sinking fund or similar provision, and, if so, the terms and provisions
relating to the purpose and operation of the
fund;
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•
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the
terms and conditions, if any, for conversion or exchange of shares of any
other class or classes of our capital stock or any series of any other
class or classes, or of any other series of the same class, or any other
securities or assets, including the price or the rate of conversion or
exchange and the method, if any, of
adjustment;
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the
voting rights; and
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•
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any
or all other preferences and relative, participating, optional or other
special rights, privileges or qualifications, limitations or
restrictions.
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•
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Prior
to the date of the transaction, the board of directors of the corporation
approved either the business combination or the transaction which resulted
in the stockholder becoming an interested
stockholder;
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The
stockholder owned at least 85% of the voting stock of the corporation
outstanding at the time the transaction commenced, excluding for purposes
of determining the number of shares outstanding (a) shares owned by
persons who are directors and also officers, and (b) shares owned by
employee stock plans in which employee participants do not have the right
to determine confidentially whether shares held subject to the plan will
be tendered in a tender or exchange offer;
or
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On
or subsequent to the date of the transaction, the business combination is
approved by the board and authorized at an annual or special meeting of
stockholders, and not by written consent, by the affirmative vote of at
least two-thirds of the outstanding voting stock that is not owned by the
interested stockholder.
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the
title of the warrants;
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the
exercise price of the warrants;
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the
offering price for the warrants, if
any;
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the
aggregate number of warrants;
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the
designation and terms of the common stock or preferred stock that may be
purchased upon exercise of the
warrants;
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if
applicable, the designation and terms of the securities with which the
warrants are issued and the number of warrants issued with each
security;
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if
applicable, the date from and after which the warrants and any securities
issued with the warrants will be separately
transferable;
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the
number of shares of common stock or preferred stock that may be purchased
upon exercise of a warrant and the exercise price for the
warrants;
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the
dates on which the right to exercise the warrants shall commence and
expire;
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if
applicable, the minimum or maximum amount of the warrants that may be
exercised at any one time;
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the
currency or currency units in which the offering price, if any, and the
exercise price are payable;
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if
applicable, a discussion of material U.S. federal income tax
considerations;
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the
antidilution provisions of the warrants, if
any;
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the
redemption or call provisions, if any, applicable to the
warrants;
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any
provisions with respect to the holder’s right to require us to repurchase
the warrants upon a change in control or similar event;
and
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any
additional terms of the warrants, including procedures, and limitations
relating to the exchange, exercise and settlement of the
warrants.
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to
vote, consent or receive dividends;
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receive
notice as stockholders with respect to any meeting of stockholders for the
election of our directors or any other matter;
or
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exercise
any rights of our stockholders.
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the
designation and terms of the units and of the securities comprising the
units, including whether and under what circumstances the securities
comprising the units may be held or transferred
separately;
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a
description of the terms of any agreement governing the
units;
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a
description of the provisions for the payment, settlement, transfer or
exchange of the units; and
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a
discussion of material federal income tax considerations, if
applicable; and
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to or through underwriters or
dealers;
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through one or more agents;
or
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directly to purchasers or to a
single purchaser.
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at a fixed price, or prices,
which may be changed from time to
time;
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at market prices prevailing at
the time of sale;
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at prices related to such
prevailing market prices; or
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at negotiated
prices.
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the
name or names of any underwriters, dealers or agents and the amounts of
securities underwritten or purchased by each of
them;
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the public offering price of the
securities and the proceeds to us and any discounts, commissions or
concessions allowed or reallowed or paid to dealers;
and
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any exchanges on which the
securities may be listed.
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Our
Annual Report on Form 10-K and 10-K/A filed with the Commission on March
31, 2010, for the year ended December 31, 2009 and as amended on
October 5 2010, respectively;
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Our
Quarterly Report on Form 10-Q for the fiscal quarter ended March 31,
2010, filed on May 17, 2010;
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Our
Quarterly Report on Form 10-Q for the fiscal quarter ended June 30,
2010, filed on August 16,
2010;
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Our
Current Reports on Form 8-K filed on June 11, 2010, June
29, 2010, and July 14, 2010 (excluding any information
furnished in such reports under Item 2.02, Item 7.01 or
Item 9.01);
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·
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Our
Definitive Proxy Statement on Form 14A for our 2010 Annual Meeting of
Stockholders, filed with the SEC on March 26, 2010;
and
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·
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The
description of our common stock contained in our Registration Statement on
Form SB-2 (Registration No. 333-142451), as amended (the
"Registration Statement"), filed under the Securities Act of 1933, as
amended, with the Commission on April 30, 2007 and declared effective May
4, 2007.
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