TransCode Therapeutics(US:RNAZ)2025-11-14 21:03Acquisition 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].