TTX-MC138 is delivered to glioblastoma tumors in murine models of the disease, following intravenous injection TTX-MC138 demonstrated suppression of miR-10b target and extended survival in aggressive glioblastoma models Study supports future clinical development of TTX-MC138 for patients with glioblastoma BOSTON, Jan. 6, 2026 /PRNewswire/ -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced can ...

"I am pleased to join the Board of TransCode as the company enters an exciting stage of development. I look forward to helping advance our mission to deliver a cancer-free future for patients," said Mr. Stover. Forward-Looking Statements 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 technology, collaborations, and team, and statements concerning the therapeutic po ...

Core Insights - TransCode Therapeutics, Inc. has announced a collaboration with Quantum Leap Healthcare Collaborative to evaluate its lead therapeutic candidate TTX-MC138 in the PRE-I-SPY clinical trial platform [1][2] Group 1: Clinical Trial Details - The PRE-I-SPY program will include TTX-MC138 in a Phase 2a dose-expansion clinical trial, enrolling up to 45 patients with colorectal cancer who are ctDNA positive after standard therapy [2][3] - The Phase 2a trial is set to begin in the first half of 2026 and will be led by Dr. Paula Pohlmann from MD Anderson Cancer Center [2] Group 2: Therapeutic Potential - The trial aims to assess the biological and clinical activity of TTX-MC138 in the Minimal Residual Disease (MRD) setting, targeting patients with a high risk of recurrence [3][4] - TTX-MC138 is designed to inhibit microRNA-10b, which is believed to play a critical role in the progression of metastatic cancers [5][6] Group 3: Company Background - TransCode Therapeutics is focused on developing immuno-oncology and RNA therapeutic treatments for high-risk and advanced cancers, with TTX-MC138 being its lead candidate [6] - The company has a portfolio of first-in-class therapeutic candidates aimed at mobilizing the immune system to combat cancer cells [6] Group 4: Collaborative Efforts - Quantum Leap Healthcare Collaborative sponsors the I-SPY Trials, which aim to rapidly screen promising treatments and identify effective therapies for specific patient subgroups [7][8] - The collaboration aims to accelerate the evaluation of TTX-MC138, with the goal of advancing effective and less toxic precision therapies into later trial phases [4][8]

Core Insights - TransCode Therapeutics has appointed Dr. Michel Janicot as Senior Development Officer to enhance its oncology pipeline and drug development efforts [1][3] - Dr. Janicot brings over 35 years of experience in pharmaceutical research and drug development, particularly in oncology [1][2] - The company focuses on innovative RNA-based therapies for advanced malignancies, with lead candidates TTX-MC138 and Seviprotimut-L targeting metastatic and recurrent cancers [1][5] Company Overview - TransCode Therapeutics specializes in immuno-oncology and targeted cancer therapies, aiming to treat advanced malignancies [5] - The lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a known biomarker for metastasis [5] - The company has a portfolio of first-in-class therapeutic candidates designed to activate the immune system against cancer cells [5] Leadership and Expertise - Dr. Janicot has a Ph.D. in Biochemistry and has held senior leadership roles in major pharmaceutical companies, including Janssen Pharmaceutica [1][4] - He has founded a consulting firm and co-founded a nonprofit focused on pediatric oncology drug development, showcasing his commitment to advancing cancer therapies [2][4] - His role at TransCode will involve supporting strategic R&D initiatives and clinical development strategies for investigational oncology programs [3][4]

Acquisition and Collaborations - The company acquired 100% of ABCJ, a subsidiary of DEFJ, for a total purchase price of approximately $25 million, which includes $20 million in cash and a $5 million promissory note[219]. - A five-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center was signed, with the company agreeing to fund up to $10 million for clinical trials[310]. Clinical Development and Trials - The company plans to advance TTX-MC138 in a Phase 2a clinical trial, with expectations to commence in the first half of 2026[226]. - Seviprotimut-L, developed by ABCJ, is a Phase 3-ready investigational vaccine for melanoma patients, having been safely administered in clinical trials involving over 1,000 patients[220][225]. - The company received a Fast-Track SBIR Award from the National Cancer Institute, totaling approximately $2.4 million, to fund research activities related to TTX-MC138[241]. - The 2024 Award from the National Cancer Institute is a Direct to Phase II SBIR Award for $1,999,972 to support IND-enabling and clinical trial activities for TTX-MC138[244]. - The Phase 0 clinical trial for TTX-MC138 demonstrated successful delivery to metastatic lesions, with results supporting further clinical evaluation[237][240]. - The FDA approved the IND application for the Phase I/II clinical trial of TTX-MC138, which commenced in Q3 2024 with 77 doses administered to 16 patients[245]. - The median treatment duration for patients in the trial was four months, with treatment cycles ranging from two to twelve, indicating good tolerability[246]. - The Phase 2a stage of the clinical trial for TTX-MC138 is expected to commence in the first half of 2026[246]. - The company is advancing the clinical development of TTX-MC138 and aims to establish manufacturing processes for preclinical and clinical drug materials[302]. Financial Performance and Funding - The company incurred net losses of approximately $21.1 million and $10.8 million for the nine months ended September 30, 2025, and 2024, respectively, with an accumulated deficit of approximately $84.3 million[255]. - The company received approximately $10 million in gross proceeds from the March 2025 equity financing, issuing 366,072 shares at an aggregate offering price of $27.44 per share[249]. - As of September 30, 2025, the company had cash of approximately $2.8 million and received an additional $20 million in equity in October 2025, expected to support operations into Q4 2026[259]. - The company has not generated any revenue from product sales and does not expect to do so in the foreseeable future[262]. - The company plans to manage costs by relocating R&D activities to Michigan State University and reducing headcount to seven employees as of September 30, 2025[253]. - The company anticipates significant increases in research and development expenses as it advances clinical trials and product candidate development[269]. - In the three months ended September 30, 2025, research and development expenses increased by $1,934 thousand compared to the same period in 2024, primarily due to increased clinical trial spending and drug production costs[284]. - General and administrative expenses increased by $462 thousand in the three months ended September 30, 2025, reflecting higher professional service fees and compensation costs[285]. - The net loss for the nine months ended September 30, 2025, was $21,219 thousand, compared to a net loss of $10,838 thousand for the same period in 2024, indicating a significant increase in losses[283]. - Cash used in operating activities for the nine months ended September 30, 2025, was $11,374 thousand, compared to $10,190 thousand in the same period in 2024[294]. - Grant income increased by $10 thousand and $485 thousand in the three and nine months ended September 30, 2025, respectively, compared to the same periods in 2024[288]. - The change in fair value of warrant liability was $279 thousand and $9,676 thousand for the three and nine months ended September 30, 2025, respectively, primarily due to a higher share price[286]. - The company anticipates a significant increase in general and administrative expenses as it prepares for potential commercial activities and increases its headcount to support R&D[276]. - The company has not generated any revenue from product sales and does not expect to do so for several years, relying on funding from equity financings and grants[298]. - The company incurred interest expense of $6 thousand in both the three and nine months ended September 30, 2025, a decrease from the previous year[290]. - The company anticipates requiring additional capital for research, development, and clinical trial costs as it seeks regulatory approval for its product candidates[303]. - Significant commercialization expenses are expected if regulatory approval is received for TTX-MC138, including costs related to manufacturing, sales, marketing, and distribution[304]. Operational and Market Risks - The company has identified material weaknesses in its internal control over financial reporting and is implementing new systems to improve these controls[330]. - The company is classified as an "emerging growth company" and a "smaller reporting company," with annual revenue below $100 million and market value of stock held by non-affiliates less than $700 million[331][333]. - The company relies on third parties for preclinical studies and clinical trial services, which affects the estimation of accrued research and development expenses[314]. - The company has issued warrants classified as equity under ASC 815, while some issued warrants were classified as liabilities due to not meeting equity classification criteria[326][325]. - The company may need to consider cost reduction strategies if it is unable to raise additional funds when needed, which could impact development programs[308]. - The company experienced a loss on foreign currency transactions of $32 thousand and $120 thousand for the three and nine months ended September 30, 2025, respectively[337]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk[340]. - As of September 30, 2025, and December 31, 2024, the company had no debt outstanding other than liabilities related to the right-of-use asset from a sublease in Newton, Massachusetts[336]. - The company does not believe that an immediate 10% change in interest rates would materially affect the fair market value of its investments or financial position[335]. - The company is subject to threats from cyber-attacks, including phishing and ransomware, and has taken steps to enhance cybersecurity defenses[334]. - The company recognizes that fluctuations in foreign currency exchange rates, particularly the Euro, may adversely affect its results of operations as it continues to develop its business[340]. - The company’s primary exposure to market risk is related to foreign exchange rate sensitivity to the Euro for certain major purchases[337]. - The company does not believe that an immediate 5% change in the Euro exchange rate would have a material effect on its results of operations[339].

Core Insights - Evaxion Biotech A/S (NASDAQ:EVAX) has a target price of -0.34, which is 104.29% below its current market price of 7.84, indicating a pessimistic outlook from analysts [1][3][5] - TransCode Therapeutics, Inc. (RNAZ) has a current stock price of 14.28 and a target price of 16.21, suggesting a growth potential of 13.52%, positioning it as a more favorable investment opportunity compared to EVAX [2][4][5] Company Analysis - The significant gap between EVAX's target and market prices raises concerns about its future performance and may impact investor confidence [3][5] - RNAZ's positive target price change reflects confidence in its growth prospects, making it an attractive option for investors in the biotech sector [4][5]

Core Insights - TransCode Therapeutics, Inc. has completed its Phase 1a clinical trial for TTX-MC138, an investigational inhibitor of microRNA-10b, achieving its primary safety endpoint and establishing a recommended Phase 2 dose [1][5] Group 1: Clinical Trial Results - The primary objectives of the trial included safety, tolerability, pharmacokinetics, and establishing a Phase 2 dose, with 16 patients treated across four escalating dose levels [2] - No significant treatment-related safety events or dose-limiting toxicities were observed during the trial [2] - The median treatment duration was four months, with a range of two to twelve cycles, indicating good tolerability and disease control [3] - 44% of patients (7 out of 16) exhibited stable disease lasting four months or longer [3][8] Group 2: Efficacy and Future Plans - Preliminary data showed positive pharmacodynamic effects across all dose levels, consistent with preclinical models [3] - A patient with thyroid cancer showed a reversal in thyroglobulin levels during treatment, reaching undetectable levels [3] - The observed safety profile and durability of TTX-MC138's anti-tumor effects support advancing to a Phase 2a clinical trial [5][8] Group 3: About TTX-MC138 - TTX-MC138 is a first-in-class therapeutic candidate targeting microRNA-10b, which is critical in the progression of many metastatic cancers [6][7] - The drug has shown evidence of delivery to metastatic lesions and pharmacodynamic activity even at microdoses, suggesting a broad therapeutic window [6]

Financial Data and Key Metrics Changes - The meeting discussed the election of directors and the approval of an amendment to the stock option plan, which included an increase of 166,724 shares available for issuance [4][7] - The appointment of Witham Smith and Brown P.C. as the independent registered public accounting firm for the fiscal year ending December 31, 2025, was ratified [7][8] Business Line Data and Key Metrics Changes - No specific financial data or metrics related to individual business lines were provided during the meeting [10] Market Data and Key Metrics Changes - No specific market data or metrics were discussed in the meeting [10] Company Strategy and Development Direction - The company is focused on advancing its Phase I clinical trial, which includes a wide range of tumor types [10] - Future announcements regarding specific results from the clinical trial are expected in September [11] Management's Comments on Operating Environment and Future Outlook - Management indicated that the trial is an all-comers clinical trial, allowing participation from patients with various solid tumors [10] - There is an ongoing interest in the company's clinical studies, with a total of 16 patients treated in the Phase I trial [11] Other Important Information - The meeting concluded with the acknowledgment of shareholder interest and the adjournment of the Annual Meeting of Stockholders [12] Q&A Session Summary Question: How many patients are currently undergoing Transcode clinical studies? How many have dropped out and for what reasons? Are there patients with demonstrated tumor regressions so far? - The company reported that a total of 16 patients have been treated in the Phase I clinical trial, with more details expected to be announced in September [10][11]

Financial Data and Key Metrics Changes - The meeting reported the election of directors and the approval of an amendment to the stock option plan, indicating a stable governance structure and potential for future growth [7][8]. Business Line Data and Key Metrics Changes - No specific financial data or metrics related to individual business lines were provided during the meeting [9]. Market Data and Key Metrics Changes - The company is currently conducting a Phase I clinical trial with a total of 16 patients treated, indicating ongoing research and development efforts in the market [10][11]. Company Strategy and Development Direction - The company is focused on advancing its clinical trials and plans to announce specific results in September, reflecting a commitment to transparency and progress in its research initiatives [11]. Management Comments on Operating Environment and Future Outlook - Management acknowledged the diverse range of tumor types represented in the clinical trial, suggesting a broad market approach and adaptability to various patient needs [10]. Other Important Information - The meeting concluded with a commitment to provide further details on clinical trial results in the near future, highlighting the company's proactive communication strategy [11]. Q&A Session Summary Question: How many patients are currently undergoing Transcode clinical studies? - The company reported that 16 patients have been treated in the Phase I clinical trial, with more details expected to be announced in September [10][11].

Financial Data and Key Metrics Changes - The meeting reported the election of directors and the approval of an amendment to the stock option plan, indicating a stable governance structure and potential for future growth [7][8]. Business Line Data and Key Metrics Changes - No specific financial data or metrics related to individual business lines were provided during the meeting [9]. Market Data and Key Metrics Changes - The company is currently conducting a Phase I clinical trial with a total of 16 patients treated, indicating ongoing engagement in clinical research [10][11]. Company Strategy and Development Direction - The company is focused on advancing its clinical trials and plans to announce specific results in September, reflecting a commitment to transparency and progress in research [11]. Management Comments on Operating Environment and Future Outlook - Management acknowledged the diverse range of tumor types represented in the clinical trial, suggesting a broad market approach and adaptability in research [10]. - Future announcements regarding trial results are anticipated, which may impact investor sentiment and market perception [11]. Other Important Information - The meeting concluded with a focus on shareholder engagement and the importance of upcoming trial results, highlighting the company's commitment to its stakeholders [12]. Q&A Session Summary Question: How many patients are currently undergoing Transcode clinical studies? - The company reported that 16 patients have been treated in the Phase I clinical trial, with more details expected in September [10][11]. Question: How many have dropped out and for what reasons? Are there patients with demonstrated tumor regressions so far? - The company did not provide specific dropout rates or reasons but confirmed that the trial is open to a wide range of tumor types, indicating a comprehensive approach to patient selection [10].