TransCode Therapeutics(US:RNAZ)2024-05-15 20:30Clinical Development - TransCode received FDA's IND Study May Proceed notification for TTX-MC138, allowing a Phase 0 clinical trial with one patient treated [155]. - The Phase I/II clinical trial for TTX-MC138 is expected to commence in mid-2024 following FDA approval [155]. - Preliminary results from imaging studies indicated TTX-MC138's accumulation in metastatic lesions, a circulation half-life of approximately 20 hours, and drug stability in circulation [181]. - TransCode's TTX delivery platform aims to overcome delivery challenges of RNA therapeutics, enhancing targeting and accumulation in tumors [163]. - The company is developing multiple therapeutic candidates, including TTX-siPDL1 and TTX-RIGA, targeting various cancer mechanisms [156]. - The TTX platform has undergone approximately 20 years of R&D, including 12 years at Harvard Medical School and Massachusetts General Hospital [165]. - The company entered into a collaboration agreement with Debiopharm to develop targeted nucleic acid delivery modalities for cancer treatment [186]. - The company signed a five-year strategic collaboration agreement with The University of Texas M. D. Anderson Cancer Center, committing up to $10 million for Phase I and II clinical trials [209][211]. Financial Performance - The company reported net losses of approximately $3.3 million for the three months ended March 31, 2024, and $18.5 million for the year ended December 31, 2023, with an accumulated deficit of approximately $49.7 million as of March 31, 2024 [194]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future [202]. - The company received approximately $51.7 million in net proceeds from its IPO and other financing activities since its inception [193]. - The company had cash of approximately $4.9 million as of March 31, 2024, which is expected to fund operations into the third quarter of 2024 [198]. - Cash used in operating activities was $3,937 thousand for the three months ended March 31, 2024, compared to $4,514 thousand in the same period in 2023 [231]. - Grant income decreased by $52 thousand to $27 thousand for the three months ended March 31, 2024, compared to the same period in 2023 [226]. - The company incurred interest expense of $10 thousand for the three months ended March 31, 2024, down from $13 thousand in the same period in 2023 [227]. - The company anticipates significant increases in research and development expenses as it progresses with clinical trials for its product candidates [207]. - The company anticipates significant increases in general and administrative expenses as it prepares for potential commercial activities and regulatory approvals [218]. Operational Changes - The company reduced its headcount from 19 employees at December 31, 2022, to 11 employees by December 31, 2023, following a restructuring initiative [184]. - The company is subject to a mandatory panel monitor through January 26, 2025, following its compliance with Nasdaq's equity rule [189]. - The company regained compliance with Nasdaq's minimum stockholders' equity requirement of $2,500,000 after completing a January offering [189]. - The company may need to seek additional capital to support its operations and business strategy, which could include equity sales or debt financing [196]. - The company may need to raise additional funds through various means, including equity offerings and collaborations, which could dilute ownership interests [242][243]. - The company has no assurance that funding from governmental sources or collaborations will be available on acceptable terms [242]. - The company may need to consider cost reduction strategies if unable to raise additional funds, which could include limiting or terminating development programs [244]. Internal Controls and Compliance - The company has identified material weaknesses in its internal control over financial reporting, which remain unremediated, potentially affecting the accuracy of financial reporting [268]. - Management concluded that the company's disclosure controls and procedures were not effective as of March 31, 2024, due to identified material weaknesses [281]. - The company is engaged in ongoing remediation efforts to address internal control deficiencies, including hiring additional finance and accounting personnel [283]. - There were no material changes in the company's internal control over financial reporting during the three months ended March 31, 2024 [287]. - The company plans to continue establishing more robust accounting policies and procedures to improve its internal controls [282]. Market and Industry Insights - The global mRNA therapeutics market was estimated at approximately $33.8 billion in 2023, projected to grow at nearly 25% CAGR, reaching approximately $158 billion by 2030 [165]. - The company relies on third parties for preclinical studies and clinical trial services, with accrued research and development expenses estimated based on progress towards completion of related projects [252][253]. - The company recognized that fluctuations in foreign currency exchange rates could adversely affect its results of operations as it continues to develop its business [278]. Cybersecurity and Risk Management - The company is currently enhancing its cybersecurity defenses to mitigate risks from cyberattacks, including phishing and ransomware [274]. - An immediate 10% change in U.S. interest rates would not materially affect the fair market value of the company's investments due to the short-term nature of its holdings [275]. - The company has not entered into any foreign currency hedging contracts to mitigate exposure to foreign currency exchange risk [278]. - The company experienced a loss of $55 thousand from foreign currency transactions for the three months ended March 31, 2024 [277]. - As of March 31, 2024, the company had no debt outstanding, indicating no exposure to interest rate risk related to debt [276].