Core Viewpoint - TransCode Therapeutics has published a manuscript detailing a novel tumor-selective immunotherapy approach that activates innate immune signaling specifically within cancer cells, enhancing drug delivery imaging capabilities [1]. Group 1: Research and Development - The published study in the journal Molecular Imaging and Biology describes a template-driven RIG-I agonist strategy that selectively activates RIG-I signaling in tumor cells by utilizing overexpressed oncogenic microRNAs, such as miRNA-21, as assembly templates [1]. - This new approach aims to address challenges associated with RIG-I agonists, including off-target immune activation and inefficient systemic delivery [1]. - The findings suggest a method to engage innate immune pathways directly within tumor cells while minimizing systemic toxicity, potentially advancing RIG-I-based immunotherapy towards clinical relevance [1]. Group 2: Clinical Trials and Therapeutic Candidates - TransCode's TTX delivery platform, which is currently under evaluation in clinical trials, is expected to enhance the translational feasibility of this immunotherapy approach [1]. - The company's lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis [1]. - TransCode's portfolio includes other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells [1].

Core Insights - TransCode Therapeutics has submitted an Investigational New Drug (IND) application amendment to the FDA for a Phase 2a clinical trial of its lead candidate TTX-MC138, in collaboration with Quantum Leap Healthcare Collaborative [1][3] Group 1: Clinical Trial Details - The Phase 2a trial will enroll up to 45 patients with colorectal cancer who have completed standard therapy and have positive circulating tumor DNA (ctDNA) markers [2] - The trial aims to evaluate the biological and clinical activity of TTX-MC138 in the minimal residual disease (MRD) setting, which is believed to offer significant opportunities for improving long-term outcomes [2] - The 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: Collaboration and Program Expansion - The IND submission is a significant step in TransCode's clinical development program, enhancing the potential benefits of TTX-MC138 for patients [3] - The collaboration with Quantum Leap's PRE-I-SPY program marks the first expansion of this platform into colorectal cancer [3][4] - The clinical trial will be conducted at various sites within the PRE-I-SPY Platform Network, which includes members of the National Cancer Center Network [4] Group 3: Company Overview - TransCode Therapeutics is focused on immuno-oncology and RNA therapeutics for high-risk and advanced cancers, with TTX-MC138 targeting metastatic tumors that overexpress microRNA-10b [5] - The company has a portfolio of first-in-class therapeutic candidates aimed at mobilizing the immune system to combat cancer cells [5]

Core Insights - TransCode Therapeutics, Inc. announced preclinical research supporting its lead candidate TTX-MC138 for glioblastoma multiforme (GBM) treatment, published in the Journal of Functional Biomaterials [1][2] Group 1: Research Findings - Glioblastoma is identified as the most aggressive primary brain cancer, with a median survival of under two years despite current treatments [2] - The study demonstrated that TTX-MC138 can be delivered to human GBM tumors in murine models via intravenous injection, leading to sustained target engagement and a five-fold increase in apoptotic activity in tumors [3][9] - Treatment with TTX-MC138 resulted in a statistically significant increase in survival rates in the studied models [3][9] Group 2: Development and Future Plans - The findings support the capability of TransCode's TTX platform to deliver antisense oligonucleotides (ASOs) to brain tumors, overcoming delivery barriers such as nucleic acid degradation [4] - TTX-MC138 has completed IND enabling studies, pharmacokinetics, biodistribution, and toxicity studies, showing safety in Phase I clinical trials for non-CNS cancers, paving the way for future clinical evaluations in GBM patients [4][6] - A Phase 2a clinical trial for TTX-MC138 is anticipated to begin in the first half of 2026, highlighting the translational relevance of this therapeutic approach [6] Group 3: Company Overview - TransCode Therapeutics is focused on immuno-oncology and RNA therapeutics for high-risk and advanced cancers, with TTX-MC138 targeting metastatic tumors that overexpress microRNA-10b [7] - The company has a portfolio of first-in-class therapeutic candidates aimed at mobilizing the immune system to combat cancer cells [7]

Core Insights - TransCode Therapeutics, Inc. has appointed Jack E. Stover to its Board of Directors, enhancing its leadership team as it advances its immuno-oncology and RNA treatment pipeline for high-risk and advanced cancer [1][2]. Company Developments - Jack E. Stover brings over 30 years of executive leadership experience in life sciences, including drug development and diagnostics, which will be beneficial for TransCode's growth [1][2]. - Stover's previous roles include Chairman of Traws Pharma Inc., CEO of NorthView Acquisition Corp, and President of Interpace Biosciences, where he led significant mergers and acquisitions [2]. - The company is entering an exciting stage of development, with Stover expressing his commitment to advancing its mission to deliver a cancer-free future for patients [3].

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]