TransCode will use Signatera™ to identify MRD-positive patients eligible for enrollment

Natera, Inc. (Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, and TransCode Therapeutics, Inc. (Nasdaq: RNAZ), a clinical stage company pioneering immuno-oncology and RNA-based therapeutics for the treatment of high-risk and advanced cancers, today announced a strategic collaboration in colorectal cancer (CRC).

The collaboration will support enrollment for TransCode’s Phase 2a trial evaluating TTX-MC138 in patients with CRC. Patients will be eligible for enrollment if they have completed curative-intent therapy and remain positive for molecular residual disease (MRD), as detected by Natera’s Signatera test, with no radiographic evidence of disease. The collaboration aims to surface patient populations who meet the trial’s MRD-positive eligibility criteria more efficiently, streamline site-level identification, and optimize the pace and quality of enrollment for the study.

The patient population studied in the trial faces a significant risk of recurrence, yet there are currently no approved therapies for MRD-positive patients who remain disease-free on imaging. TTX-MC138 works to address this critical treatment gap by intervening earlier in the disease course.

“Identifying recurrence of colorectal cancer before it becomes clinically apparent, when it is potentially much easier to treat, is one of the central challenges in developing breakthrough therapies that help to answer unmet medical needs for this setting,” said Philippe P. Calais, PharmD, Ph.D., chairman and CEO, TransCode Therapeutics. “Leveraging one of the most established MRD testing footprints will help us identify high-risk patients faster and potentially intervene earlier, advancing a new treatment paradigm focused on addressing cancer at the molecular residual disease stage before recurrence becomes clinically apparent.”

“We are pleased to collaborate with TransCode to bring the power of Signatera to bear on one of the most difficult problems in clinical development: finding the right patients at the right time,” said Eric Matthews, general manager, biopharma, Natera. “By identifying Signatera MRD-positive patients for enrollment, we aim to support the advancement of this promising therapy for patients and build on the growing clinical and scientific momentum supporting MRD-guided strategies in colorectal cancer.”

TransCode’s study is being conducted by Quantum Leap Healthcare Collaborative within its PRE-I-SPY program, a leading platform for innovative oncology clinical trials. This trial represents the program’s first expansion beyond breast cancer into CRC. The PRE-I-SPY platform extends the clinically validated I-SPY trial model into early feasibility testing to accelerate biologically targeted therapies into the curative-intent setting. TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b (miR-10b), a biomarker widely linked to the emergence and progression of metastatic cancers, including CRC. More information can be found at clinicaltrials.gov (NCT05868226).

About Natera

Natera is a global leader in cell-free DNA and precision medicine, dedicated to oncology, women’s health, and organ health. We aim to make personalized genetic testing and diagnostics part of the standard-of-care to protect health and inform earlier, more targeted interventions that help lead to longer, healthier lives. Natera’s tests are supported by more than 400 peer-reviewed publications that demonstrate excellent performance. Natera operates ISO 13485-certified and CAP-accredited laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) in Austin, Texas, and San Carlos, California, and through Foresight Diagnostics, its subsidiary, operates an ISO 27001-certified and CAP-accredited laboratory certified under CLIA in Boulder, Colorado. For more information, visit www.natera.com.

About TransCode Therapeutics

TransCode Therapeutics is an immuno-oncology and targeted cancer therapy company with a focus on treating advanced malignancy. The company’s lead therapeutic candidate, TTX-MC138, is focused on treating metastatic tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis, and is currently being evaluated in a Phase 2a trial under the PRE-I-SPY program in collaboration with Quantum Leap Healthcare Collaborative. In addition, TransCode has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. For more information, visit www.transcodetherapeutics.com.

Forward-Looking Statements (for Natera)

All statements other than statements of historical facts contained in this press release are forward-looking statements and are not a representation that Natera’s plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release, and Natera disclaims any obligation to update the forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to our efforts to develop and commercialize new product offerings, whether the results of clinical or other studies will support the use of our product offerings, the impact of results of such studies, our expectations of the reliability, accuracy, and performance of our tests, or of the benefits of our tests and product offerings to patients, providers, and payers. Additional risks and uncertainties are discussed in greater detail in "Risk Factors" in Natera’s recent filings on Forms 10-K and 10-Q, and in other filings Natera makes with the SEC from time to time. These documents are available at www.natera.com/investors and www.sec.gov.

Forward-Looking Statements (for TransCode)

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning TransCode’s collaboration with Natera and anticipated use of Signatera to identify patients for its Phase 2a clinical trial; the anticipated patient enrollment and expected impact of the collaboration on enrollment; the timing, conduct and progress of the trial; and the development and therapeutic potential of TTX-MC138, including its potential to treat MRD-positive colorectal cancer. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risks associated with drug discovery and development; the risk that the results of clinical trials will not be consistent with TransCode’s preclinical studies or expectations or with results from previous clinical trials; risks associated with the conduct of clinical trials; risks associated with TransCode’s financial condition and its need to obtain additional funding to support its business activities, including TransCode’s ability to continue as a going concern; risks associated with the timing and outcome of TransCode’s planned regulatory submissions; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks of competition from other companies developing products for similar uses; risks associated with TransCode’s dependence on third parties; and risks associated with geopolitical events and pandemics. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode’s actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled “Risk Factors” in TransCode’s Annual Report on Form 10-K for the year ended December 31, 2025, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the U.S. Securities and Exchange Commission. All information in this press release is as of the date of this release; TransCode undertakes no duty to update this information unless required by law.

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