TransCode Therapeutics(US:RNAZ)2024-11-14 21:30Clinical Trials and Research - The company received an IND Study May Proceed notification from the FDA for a Phase I/II clinical trial with TTX-MC138, which commenced in Q3 2024[122]. - Preliminary results from the Phase 0 clinical trial indicated a 66% reduction in miR-10b levels in the patient's blood 24 hours post-administration of TTX-MC138[142]. - The Phase 0 trial was designed to quantify the delivery of a microdose of TTX-MC138 to metastatic lesions using PET-MRI[142]. - The Phase 0 trial demonstrated the ability to deliver TTX-MC138 to metastatic lesions, supporting further clinical evaluation[134]. - The Phase 1 clinical trial for TTX-MC138 commenced in Q3 2024 at multiple sites, including MD Anderson, with the first cohort receiving the lowest therapeutic dose level[144]. - The company closed enrollment in the Phase 0 trial to focus on advancing the Phase 1 clinical trial after receiving FDA notification to proceed[143]. - The company has multiple preclinical solid tumor programs, including TTX-siPDL1 and TTX-RIGA, targeting various cancer mechanisms[123]. - The TTX platform aims to improve delivery of RNA therapeutics, addressing challenges of stability, efficiency, and immunogenicity[126]. Financial Performance and Funding - The company has incurred net losses of approximately $10.8 million and $18.5 million for the nine months ended September 30, 2024, and the year ended December 31, 2023, respectively, with an accumulated deficit of approximately $57.3 million[154]. - As of September 30, 2024, the company had cash of approximately $1.9 million, which is expected to fund operating expenses into late 2024[159]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[163]. - The company anticipates significant increases in research and development expenses as it advances clinical trials and develops its product candidate pipeline[156]. - The company may need to seek additional funding through equity sales or collaborations to support ongoing operations and business strategy[157]. - The company signed a five-year strategic collaboration agreement with MD Anderson, committing up to $10 million for Phase I and II clinical trials[169]. - The company obtained cash of $9,319 thousand from the sale of common stock during the nine months ended September 30, 2024[192]. - The company anticipates requiring additional capital for research, development, clinical trials, and potential acquisitions, raising substantial doubt about its ability to continue as a going concern[196]. - Future funding requirements may increase significantly due to various factors, including the costs of clinical trials and regulatory reviews[198]. Operational Changes and Challenges - The company reduced its headcount from 19 employees at the end of 2022 to 8 employees by September 30, 2024, as part of a restructuring effort[151]. - The company entered into a collaboration agreement with Debiopharm to test new targeted nucleic acid delivery modalities, although results were insufficient to continue the collaboration[145]. - The company received letters from Nasdaq regarding non-compliance with listing rules, and an appeal for extension was granted by the Nasdaq Hearings Panel[147]. - The company has identified material weaknesses in its internal control over financial reporting, which remain unremediated[220]. - The company is classified as an "emerging growth company" and can take advantage of an extended transition period for complying with new accounting standards[221]. - The company expects to finance operations through a combination of equity offerings, debt financing, and collaborations, with no assurance that funding will be available on acceptable terms[199]. - The company may need to consider cost reduction strategies if unable to raise additional funds, which could include limiting or terminating development programs[201]. - The company is classified as a "smaller reporting company" with a market value of stock held by non-affiliates below $700 million and annual revenue under $100 million for the most recent fiscal year[224]. Market and Risk Management - The company’s primary exposure to market risk is interest income sensitivity, which is affected by changes in U.S. interest rates[226]. - An immediate 10% change in interest rates would not materially affect the fair market value of the company's investments[226]. - The company continues to monitor and adapt to market risks, including interest rate and foreign currency exchange risks[226]. - For the nine months ended September 30, 2024, the company recognized a loss of $285 thousand on foreign currency transactions, reflecting sensitivity to foreign exchange rates[227]. - An immediate 5% change in the Euro exchange rate would not materially affect the company's results of operations[227]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk[228]. - The company is enhancing cybersecurity measures to mitigate risks from cyberattacks, including phishing and ransomware threats[225]. - Despite cybersecurity enhancements, there is no assurance that the company will not suffer material adverse consequences from cyberattacks[225]. Expenses and Financial Obligations - Research and development expenses decreased by $2,115 thousand and $2,832 thousand for the three and nine months ended September 30, 2024, compared to the same periods in 2023[183]. - General and administrative expenses decreased by $1,030 thousand and $1,921 thousand for the three and nine months ended September 30, 2024, compared to the same periods in 2023[184]. - Grant income decreased by $15 thousand and $857 thousand for the three and nine months ended September 30, 2024, compared to the same periods in 2023[185]. - The company reported a net loss of $2,321 thousand for the three months ended September 30, 2024, compared to a net loss of $5,300 thousand for the same period in 2023[182]. - Cash used in operating activities was $10,190 thousand for the nine months ended September 30, 2024, compared to $12,411 thousand for the same period in 2023[190]. - The company has a future minimum lease payment obligation of approximately $154 thousand under a non-cancelable operating lease as of September 30, 2024[202]. - As of September 30, 2024, and December 31, 2023, the company had no outstanding debt, indicating no exposure to interest rate risk related to debt[227].