BOSTON, July 22, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ), ("TransCode" or the "Company"), a clinical-stage RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced the pricing of a public offering of 10,000,000 shares of its common stock at a public offering price of $0.30 per share, for expected gross proceeds of $3,000,000, before deducting placement agent commissions and offering expenses. All of the shares of common stock are ...

BOSTON, July 22, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ) ("TransCode" or the "Company"), a clinical-stage RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-funded Warrants") in lieu thereof) in a best efforts public offering. All of the shares of common stock (and/or Pre-funded Warrants) are to be sold by the Company. ThinkEquity ...

BOSTON, July 22, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ) ("TransCode" or the "Company"), a clinical-stage RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants ("Pre-funded Warrants") in lieu thereof) in a best efforts public offering. All of the shares of common stock (and/or Pre-funded Warrants) are to be sold by the Company. ThinkEquity ...

About TransCode Therapeutics Forward-Looking Statements "The Company's regaining compliance with all Nasdaq's listing standards continues recent positive news for TransCode, following our announcement of positive blood test results in connection with our Phase 0 clinical trial and FDA authorization to proceed with our upcoming Phase 1 study. We believe our organization is prepared to continue to execute on our ambitious plans to swiftly advance our clinical development programs," said Tom Fitzgerald, TransC ...

BOSTON, May 29, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced new preliminary data from its Phase 0 clinical trial with radiolabeled TTX-MC138 suggesting antitumor activity. New results from the patient dosed in this trial indicate that a microdose of radiolabeled TTX-MC138 resulted in significant inhibition of the drug candidate's molecular target, miRNA-10b, in the patient ...

BOSTON, May 29, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced new preliminary data from its Phase 0 clinical trial with radiolabeled TTX-MC138 suggesting antitumor activity. New results from the patient dosed in this trial indicate that a microdose of radiolabeled TTX-MC138 resulted in significant inhibition of the drug candidate's molecular target, miRNA-10b, in the patient ...

Clinical 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].

FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Date of Report (Date of earliest event reported): April 3, 2024 TRANSCODE THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 001-40363 81-1065054 (State or other jurisdiction of incorporation) (Commission File Number) (I.R.S. Employer Identification No.) TransCode Therapeutics, Inc. 6 Liberty Square, #2382 Bosto ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM ___________ TO ___________ Commission File Number: 001-40363 TRANSCODE THERAPEUTICS, INC. (Exact Name of Registrant as Specified in Its Charter) ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ____________________________________________ FORM 10-Q ____________________________________________ ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ___________ Commission File Number 001-403 ...