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].

Core Insights - TransCode Therapeutics has initiated a Phase 1 clinical trial for TTX-MC138, an antisense oligonucleotide aimed at treating metastatic cancer by inhibiting microRNA-10b, a known driver of metastasis [1][2] - The trial has successfully dosed the first two patients, marking a significant milestone in the development of TTX-MC138 [2] - TTX-MC138 is positioned as a first-in-class therapeutic candidate with the potential to improve outcomes across various cancers, including breast, pancreatic, ovarian, colon, and lung cancers [2] Trial Details - The Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate the safety and tolerability of TTX-MC138 in patients with metastatic solid cancers [3] - The trial consists of an initial dose-escalation phase followed by a dose-expansion phase, with the primary objective of assessing safety and tolerability [3] - While not an endpoint, the trial may provide early evidence of clinical activity for TTX-MC138 [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 [5] - The company aims to address the challenges of RNA delivery and unlock therapeutic access to novel genetic targets relevant to various cancers [5] - TTX-MC138 specifically targets tumors that overexpress microRNA-10b, a well-documented biomarker of metastasis [5]

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 ...

ThinkEquity acted as sole placement agent for the offering. About TransCode Therapeutics, Inc. This press release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. In some cases, you can identify forward-looking statements by terms such as "believe," "can," "could," "design," "estimate," "expect," "intend," "may," "might," "objective," "plan" "potential," "predict," "should," "will," "would," or the negative of thes ...

BOSTON, July 24, 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 closing of its previously announced public offering of 10,000,000 shares of its common stock at a public offering price of $0.30 per share, for gross proceeds of $3,000,000, before deducting placement agent fees and offering expenses. The offering was made pursuant ...

The Company intends to use the net proceeds from the offering primarily for product development activities, including one or more clinical trials with TTX-MC138, its lead therapeutic candidate, and related investigational new drug (IND) enabling studies, and for working capital and other general corporate purposes. The securities are being offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 268764), including a base prospectus, filed with the U.S. Securities and Exchange Commis ...

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 ...