Core Insights - TransCode Therapeutics, Inc. has initiated Cohort 3 of its Phase 1 clinical trial for TTX-MC138, with three patients enrolled and dosed, following unanimous approval from the Safety Review Committee based on prior cohorts' safety and pharmacokinetic data [1][2] - The trial has shown no significant safety or dose-limiting toxicities across the nine patients in the first two cohorts, with ongoing analyses indicating a pharmacokinetic and pharmacodynamic profile consistent with preclinical results [2][7] - TTX-MC138 is designed to inhibit microRNA-10b, which is implicated in the progression of metastatic cancers, and has demonstrated pharmacodynamic activity in previous trials, suggesting a broad therapeutic window [3][6] Company Overview - TransCode Therapeutics is a clinical-stage oncology company focused on RNA therapeutics for treating metastatic diseases, utilizing its proprietary TTX nanoparticle platform [6] - The lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis [6] - The Phase 1 clinical trial is structured as a multicenter, open-label, dose-escalation and dose-expansion study aimed at evaluating the safety and tolerability of TTX-MC138 in various metastatic solid cancers [4]

Core Viewpoint - TransCode Therapeutics has adjourned its Special Meeting originally scheduled for February 4, 2025, to February 25, 2025, to solicit additional votes on key proposals related to the issuance of shares and adjustments to warrants [1][3]. Group 1: Special Meeting Details - The Special Meeting was adjourned due to a lack of quorum, with only approximately 29.94% of the outstanding shares represented [2]. - The Adjourned Special Meeting will be held virtually, allowing stockholders to participate and vote online [3]. - Stockholders are encouraged to vote their shares by February 24, 2025, at 11:59 p.m. Eastern time [4][9]. Group 2: Proposals Overview - Proposal One seeks approval for the full issuance of shares of Common Stock upon the exercise of Series C and Series D Warrants, including adjustments to the exercise price and an alternative cashless exercise feature [6]. - Proposal Two is to adjourn the Special Meeting to allow further solicitation of proxies if there are insufficient votes for Proposal One [6]. Group 3: Voting Instructions - Stockholders can vote by mail, online, or by telephone, with all votes needing to be received by February 24, 2025, to be counted [7][14]. - Those who have already voted and do not wish to change their vote need not take any action [5]. Group 4: Company Overview - TransCode Therapeutics is focused on treating metastatic disease through RNA therapeutics, utilizing its proprietary TTX nanoparticle platform [10]. - The lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [10]. - The company has a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges [10].

Core Insights - TransCode Therapeutics has initiated dosing of the first patient in Cohort 3 of its Phase 1 clinical trial for TTX-MC138, following approval from the Safety Review Committee based on positive safety data from earlier cohorts [1][2][3] - The dosing in Cohort 3 is approximately double that of Cohort 2, with ongoing analyses indicating a favorable pharmacokinetic and pharmacodynamic profile consistent with preclinical results [2][4] - TTX-MC138 is designed to inhibit microRNA-10b, which is implicated in the progression of metastatic cancers, and has shown promising results in previous trials [4][7] Company Overview - TransCode Therapeutics is focused on developing RNA therapeutics for treating metastatic diseases, utilizing its proprietary TTX nanoparticle platform [7] - The company’s lead candidate, TTX-MC138, targets tumors that overexpress microRNA-10b, a known biomarker for metastasis [7] - TransCode has a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for cancer treatment [7] Clinical Trial Details - The Phase 1 clinical trial is a multicenter, open-label study designed to evaluate the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5] - The trial consists of a dose-escalation stage followed by a dose-expansion stage, with the primary objective of assessing safety and tolerability [5] - Preliminary results from the trial may provide early evidence of clinical activity for TTX-MC138, although this is not a primary endpoint [5]

Core Viewpoint - TransCode Therapeutics has received approval to open the third cohort of its Phase 1 clinical trial for TTX-MC138, a therapeutic candidate targeting microRNA-10b, after a favorable safety review of Cohort 2 data [1][3] Group 1: Clinical Trial Progress - The Safety Review Committee (SRC) has unanimously approved the opening of Cohort 3 based on the safety data from Cohort 2, which reported no significant safety or dose-limiting toxicities [1][3] - New patients are currently being evaluated for eligibility in Cohort 3, with the dose for this cohort being approximately double that of Cohort 2 [1] - Several patients from Cohort 1 and Cohort 2 remain on study for continued treatment, with ongoing analysis of pharmacokinetic (PK) and pharmacodynamic (PD) data [2] Group 2: Pharmacokinetic and Pharmacodynamic Data - Cohort 1 data suggests that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results, showing 66% inhibition of miR-10b at 24 hours post-infusion [2] - The concentration of TTX-MC138 in blood plasma was found to be higher than in nonclinical studies, indicating a favorable pharmacokinetic profile [2] Group 3: About TTX-MC138 - TTX-MC138 is a first-in-class therapeutic candidate targeting microRNA-10b, which is believed to drive metastatic disease [4] - The Phase 0 clinical trial provided evidence of the drug's delivery to metastatic lesions and pharmacodynamic activity, even at microdoses, suggesting a broad therapeutic window [4] Group 4: Trial Design - The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study aimed at evaluating the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5] - The trial includes an initial dose-escalation phase followed by a dose-expansion phase, with the primary objective of assessing safety and tolerability [5]

BOSTON, Nov. 29, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (Nasdaq: RNAZ) (“TransCode” or the “Company”), the RNA Oncology Company™ committed to more effectively treating cancer using RNA therapeutics, today announced that its Board of Directors has approved an effective time at 12:01 a.m. Eastern Standard Time December 4, 2024, for its 1-for-33 reverse stock split. TransCode’s common stock is expected to begin trading on a split-adjusted basis on the Nasdaq Capital Market on December 4, 2024, u ...

Core Viewpoint - TransCode Therapeutics, Inc. has entered into a securities purchase agreement with institutional investors, expecting to raise approximately $8 million for general corporate purposes and working capital [1][4]. Group 1: Private Placement Details - The company plans to issue a total of 21,220,160 shares of common stock along with Series C and Series D warrants, each allowing the purchase of the same number of shares [2]. - The combined purchase price for each share and accompanying warrants is set at $0.377, in accordance with Nasdaq rules [2]. - Series C warrants will have a term of 5 years with an exercise price of $0.475, while Series D warrants will have a term of 2.5 years, also with an exercise price of $0.475 [2]. Group 2: Closing and Regulatory Aspects - The closing of the private placement is anticipated to occur around November 29, 2024, pending customary closing conditions [3]. - The Benchmark Company, LLC is acting as the exclusive placement agent for this private placement, which is exempt from the registration requirements of the Securities Act of 1933 [4]. Group 3: Company Overview - TransCode Therapeutics is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics, utilizing its proprietary TTX nanoparticle platform [6]. - The lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker associated with metastasis [6]. - The company is also developing a portfolio of first-in-class RNA therapeutic candidates aimed at overcoming RNA delivery challenges to access novel genetic targets for cancer treatment [6].

Clinical 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].

Two patients dosed; several additional patients screened for enrollment Trial to evaluate safety and tolerability of TTX-MC138 in patients with metastatic cancer TTX-MC138 is an antisense oligonucleotide conjugated to TransCode's proprietary TTX delivery system designed to inhibit microRNA-10b, a known driver of metastasis in multiple cancers Phase 1 clinical trial follows evidence of delivery and pharmacodynamic activity in prior first-in-human Phase 0 clinical trial with radiolabeled TTX-MC138 BOSTON, Sep ...

BOSTON, Sept. 05, 2024 (GLOBE NEWSWIRE) -- TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, today announced that it has been awarded a $2 million Direct to Phase II Small Business Innovation Research (SBIR) grant from the National Institutes of Health (NIH) to support clinical evaluation of TTX-MC138, TransCode's lead therapeutic candidate. TransCode has recently activated three clinical trial sites to conduct a Phase ...

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 June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |------------------------------------------------------------------------------ ...