Core Viewpoint - TransCode Therapeutics is advancing its Phase 1a clinical trial for TTX-MC138, a novel RNA therapeutic aimed at treating metastatic cancers, with positive safety and pharmacokinetic data supporting further development [1][3][5]. Group 1: Clinical Trial Progress - The third patient in Cohort 4 has received the initial dose of TTX-MC138, with all cohorts having at least three patients dosed [1]. - A total of 15 patients have been treated across four dose levels (0.8 mg/kg to 4.8 mg/kg), with no significant safety or dose-limiting toxicities reported [2][8]. - Ten patients remain on study, receiving doses every 28 days, with two patients showing stable disease after seven doses over approximately seven months [2][8]. Group 2: Safety and Efficacy Data - Preliminary pharmacokinetic (PK) and pharmacodynamic (PD) analyses indicate a predictable dose-response relationship, with evidence of miR-10b target engagement at 24 hours post-infusion [2][4][8]. - The observed tolerability profile supports the advancement of the trial into the Phase 1b dose expansion stage to further evaluate safety and potential anti-tumor activity [3]. Group 3: About TTX-MC138 - TTX-MC138 is designed to inhibit microRNA-10b, which is implicated in the progression of many metastatic cancers, and has shown promising delivery and activity in preclinical studies [4][7]. - The drug candidate has demonstrated a broad therapeutic window, suggesting potential for effective treatment of metastatic tumors [4]. Group 4: Trial Design - The Phase 1 clinical trial is a multicenter, open-label study aimed at evaluating the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5]. - The trial consists of an initial dose-escalation stage followed by a dose-expansion stage to further assess safety, tolerability, and anti-tumor activity [5].

Core Points - TransCode Therapeutics has announced a 1-for-28 reverse stock split effective at 12:01 a.m. Eastern Standard Time on May 15, 2025, to increase the per share trading price and meet Nasdaq listing requirements [1][2] - The reverse stock split will reduce the number of outstanding shares from approximately 23,341,336 to about 833,620 shares, with no fractional shares issued [2] - The company's CUSIP number will change to 89357L 501 as of the effective time of the reverse stock split [4] 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 lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker associated with metastasis [5] - 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 [5]

Core Viewpoint - TransCode Therapeutics has announced a 1-for-28 reverse stock split to comply with Nasdaq's minimum bid price requirements, aiming to increase the trading price of its common stock [1][2]. Group 1: Reverse Stock Split Details - The reverse stock split will convert twenty-eight current shares into one new share, reducing the total outstanding shares from approximately 23,341,336 to about 833,620 [2]. - No fractional shares will be issued; instead, stockholders will receive rounding up of fractional shares to the nearest whole number [2]. - Proportional adjustments will be made to the exercise prices of outstanding stock options and warrants, as well as to the shares issued under stock incentive plans [2]. Group 2: Implementation and Process - Vstock Transfer LLC will serve as the exchange agent for the reverse stock split, and stockholders of record will not need to take action to receive their post-split shares [3]. - Stockholders holding shares through banks or brokers will have their positions automatically adjusted, but they may need to check with their respective institutions for specific procedures [3]. - The effective date of the reverse stock split will be announced by the company at least two business days prior to implementation [4]. Group 3: Company Overview - TransCode Therapeutics is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics [5]. - The company's lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [5]. - TransCode 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 [5].

Financial Data and Key Metrics Changes - The proposal for a reverse stock split has been approved by a majority of votes, indicating a strategic move to potentially enhance the stock price and attract more investors [6] - The adjournment proposal was also approved, allowing for further solicitation of proxies if necessary [6] Business Line Data and Key Metrics Changes - No specific financial data or performance metrics for individual business lines were provided during the meeting [7] Market Data and Key Metrics Changes - There was no detailed market data or key metrics discussed in the meeting [7] Company Strategy and Development Direction - The company is focused on clinical trials and is committed to reporting data as it becomes available, emphasizing transparency in their research process [8] - The management is preparing to draw down NIH grant funding in the foreseeable future, indicating ongoing reliance on external funding sources [9] Management Comments on Operating Environment and Future Outlook - Management has not experienced adverse effects from NIH grant funding cuts to date, but they are cautious about future implications [9] - The company is optimistic about the nature of their grant and the timing, although uncertainties remain [9] Other Important Information - The meeting concluded with a commitment to report clinical trial data as expeditiously as possible, highlighting the importance of quality control and safety review processes [8] Q&A Session Summary Question: How often are clinical trial assessments done during the current clinical study? - Management stated that they report data as soon as it is available, emphasizing the need for quality control and committee checks before publishing results [8] Question: Has your NIH grant funding been affected by the recent funding cuts? - Management confirmed that there have been no adverse effects from NIH grant funding so far, but they are preparing to draw down funds soon, with future implications still uncertain [9]

Core Insights - TransCode Therapeutics is advancing its Phase 1a clinical trial of TTX-MC138, a first-in-class therapeutic candidate targeting microRNA-10b, which is believed to play a significant role in metastatic cancer progression [1][4][7] - The trial has treated 13 patients with doses ranging from 0.8 mg/kg to 4.8 mg/kg, with no significant safety issues reported [1][8] - Preliminary pharmacokinetic (PK) and pharmacodynamic (PD) data indicate a favorable profile for TTX-MC138, supporting its progression to the Phase 1b trial [2][3] Company Overview - TransCode Therapeutics focuses on RNA therapeutics for treating metastatic diseases, utilizing its proprietary TTX nanoparticle platform [7] - The lead candidate, TTX-MC138, aims to inhibit microRNA-10b, a biomarker associated with metastasis [7] Clinical Trial Details - The Phase 1 clinical trial is designed as a multicenter, open-label, dose-escalation and dose-expansion study to evaluate the safety and tolerability of TTX-MC138 in patients with various metastatic solid cancers [5] - The trial consists of an initial dose-escalation stage followed by a dose-expansion stage, with the primary objective of assessing safety and tolerability [5] Treatment Progress - Eight patients are currently receiving ongoing treatment, with two patients demonstrating stable disease after seven months of treatment [2][8] - The trial has shown a predictable dose-response relationship in PK data, with evidence of target engagement for miR-10b in 5 out of 6 patients analyzed [2][8]

Core Viewpoint - TransCode Therapeutics Inc. (RNAZ) has received an upgrade to a Zacks Rank 2 (Buy) due to an upward trend in earnings estimates, indicating a positive outlook for the company's stock price [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [2][4]. - Rising earnings estimates for TransCode Therapeutics suggest an improvement in the company's underlying business, likely leading to increased stock prices [5]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have averaged a +25% annual return since 1988 [7]. - The upgrade of TransCode Therapeutics to a Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10]. Earnings Estimate Revisions - For the fiscal year ending December 2025, TransCode Therapeutics is expected to earn -$1.63 per share, reflecting a 96.5% change from the previous year [8]. - Over the past three months, the Zacks Consensus Estimate for TransCode has increased by 62.7%, highlighting a positive trend in earnings estimates [8].

Financial Position and Capital Requirements - As of December 31, 2024, the company had cash of approximately $5.8 million, which is expected to support operating expenses into the middle of Q2 2025[287]. - The company incurred net losses of approximately $16.8 million and $18.5 million for the years ended December 31, 2024, and 2023, respectively, with an accumulated deficit of approximately $63.2 million as of December 31, 2024[289]. - The company plans to raise additional capital to continue operations, with a net proceeds expectation of approximately $8.8 million from equity financing completed on March 25, 2025[296]. - Future capital requirements will depend on various factors, including the costs of drug discovery, clinical trials, and regulatory reviews[299]. - The company anticipates ongoing significant losses and may not achieve profitability in the foreseeable future due to the speculative nature of oncology product development[288]. - The company may need to seek in-court or out-of-court restructuring of liabilities if unable to raise sufficient capital, which could lead to a total loss of investment for stockholders[287]. Clinical Development and Regulatory Challenges - The company has completed a Phase 0 clinical trial and initiated a Phase I/II study, successfully enrolling 10 patients in four treatment cohorts[288]. - TTX-MC138 is undergoing an open Phase I/II clinical trial designed to assess safety, pharmacokinetics, pharmacodynamics, and anti-tumor activity[323]. - The company has not yet demonstrated the ability to successfully complete clinical trials or obtain marketing approvals for any therapeutic candidates[305]. - The clinical development process is lengthy, complex, and expensive, with no assurance of success[322]. - The company faces significant uncertainties regarding the timing and success of clinical trials, regulatory approvals, and market demand for its therapeutic candidates[304]. - The success of TTX-MC138 is critical, as the company currently has no products approved for commercial sale[315]. - The company must navigate various risks, including competition, regulatory barriers, and the potential for undesirable side effects from its therapeutic candidates[319]. - The results of preclinical studies and early-stage clinical trials may not predict later-stage outcomes, leading to potential setbacks in development[322]. - Successful completion of clinical trials is a prerequisite for submitting marketing applications to the FDA and comparable foreign regulatory authorities[329]. - The company may experience negative or inconclusive results in clinical trials, potentially leading to additional studies or abandonment of product development programs[330]. - The company faces challenges in patient enrollment for clinical trials, which could delay development activities and increase costs[336]. - Quality issues could delay or prevent the delivery of products to clinical trials or the market, impacting regulatory approval[348]. - The company must comply with FDA's good clinical practice and current good manufacturing practice regulations[350]. - The company has received Orphan Drug Designations for TTX-MC138 and TTX-siPDL1 for pancreatic cancer, which may provide market exclusivity benefits[371]. - The FDA may grant Orphan Drug Exclusivity for a product if it is the first to receive approval for a specific disease, preventing other applications for the same indication for seven years[373]. - The company has limited experience in conducting clinical trials necessary for regulatory approvals, which may lead to unpredictable delays[359]. - Regulatory approval processes can vary significantly between the FDA and foreign authorities, potentially impacting the timeline for commercialization[367]. - The FDA's review timelines for New Drug Applications (NDAs) are flexible and can be extended based on workload, which may delay product approvals[364]. - The company may encounter unexpected delays or increased costs due to changes in government regulations or FDA policies during product development[361]. - Regulatory approvals may require costly post-marketing studies and compliance with ongoing requirements[389]. - Failure to comply with regulatory requirements may result in penalties or withdrawal of product approvals[390]. Market and Competitive Landscape - The company faces substantial competition from major biotechnology firms and academic institutions, which may impact its market position[433]. - Mergers and acquisitions in the biopharmaceutical industry could concentrate resources among competitors, increasing competitive pressures[436]. - The company currently lacks a marketing and sales organization, which may hinder its ability to generate product revenue if regulatory approvals are obtained[422]. - Coverage and reimbursement from third-party payors are critical for the commercial success of therapeutic candidates, with significant uncertainty regarding their availability[424]. - The company faces a lengthy sales cycle influenced by market conditions, perceived value of products, and competition, which may adversely affect market acceptance[440]. - The company is dependent on third-party organizations for conducting preclinical studies and clinical trials, which may lead to delays in obtaining regulatory approval[448]. Operational and Organizational Challenges - The company may encounter unforeseen expenses and complications as it transitions from a research-focused entity to one capable of supporting commercial activities[308]. - The company has moved its laboratory operations to new facilities, including a sublease in Newton, Massachusetts, which may affect R&D access[464]. - The company relies heavily on third-party services, and any disruption in these services could delay clinical trials and regulatory approvals[470]. - Failure to effectively expand the organization may hinder the development and commercialization of therapeutic candidates[471]. - Retaining key executives and attracting qualified personnel is critical for success in the competitive oncology industry[472]. - The company faces intense competition for hiring qualified personnel, which may impede research and development objectives[475]. Regulatory and Legislative Environment - Legislative changes, such as the ACA, have significantly impacted the U.S. biotechnology and biopharmaceutical industries, including increased Medicaid rebates and new Medicare discount programs[401]. - The company may experience pricing pressures due to legislative measures aimed at controlling pharmaceutical pricing and reimbursement levels[409]. - The Budget Control Act of 2011 triggered automatic reductions to Medicare payments, which could affect the company's revenue from government programs[403]. - The company is subject to U.S. and foreign trade laws, with violations potentially resulting in substantial fines, penalties, and reputational harm[410]. - Ongoing healthcare reform efforts may materially affect the company's revenue prospects and operational strategies[412]. - The ACA has introduced many programs and requirements that are still not fully understood, posing risks to reimbursement and operational volumes[414]. - The company anticipates that future healthcare reforms may lead to further reductions in Medicare and other healthcare funding, affecting pricing and demand for its products[409]. - The Inflation Reduction Act of 2022 allows CMS to negotiate prices for certain high-cost drugs under Medicare, starting with ten drugs in 2026 and increasing to 20 drugs by 2029[415]. - Medicare beneficiaries' annual out-of-pocket drug expenses are capped at $2,000, which may impact the company's pricing strategies[416]. - The expansion of group purchasing organizations and integrated delivery networks is expected to increase pricing pressure on approved products[420]. Risk Management and Compliance - The company may face substantial liabilities from product liability claims, which could inhibit the commercialization of its therapeutic candidates[357]. - The company may not obtain sufficient product liability insurance, which could further hinder the commercialization of its products[357]. - The company must navigate a complex regulatory landscape, with potential changes in healthcare spending and policies impacting its business[412]. - Compliance with animal welfare regulations could increase operating costs and impact product commercialization[478]. - The ability to utilize net operating loss carryforwards may be limited by ownership changes, potentially affecting future tax liabilities[479].

Core Insights - TransCode Therapeutics has initiated treatment for the first patient in Cohort 4 of its Phase I clinical trial for TTX-MC138, a therapeutic candidate targeting microRNA-10b, which is associated with metastatic cancer [1][3] - The trial has shown no significant safety or dose-limiting toxicities among the ten patients treated so far, with seven remaining on study for continued treatment [2][8] - The ongoing analysis of pharmacokinetic and pharmacodynamic data suggests that TTX-MC138 aligns with preclinical results, indicating a promising safety profile [2][4] Company Overview - TransCode Therapeutics is focused on developing RNA therapeutics to treat metastatic diseases, utilizing its proprietary TTX nanoparticle platform [7] - TTX-MC138 is the lead candidate designed to inhibit microRNA-10b, which is believed to drive metastatic disease [4][7] - The company aims to address challenges in RNA delivery to unlock therapeutic access to various genetic targets relevant for cancer treatment [9] Clinical Trial Details - 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 metastatic solid cancers [5] - The trial consists of an initial dose-escalation phase followed by a dose-expansion phase, with the primary objective of assessing safety and tolerability [5] - Cohort 4's treatment is expected to provide insights for dose expansion and initial evidence of clinical activity as the trial progresses [3][5]

Company Overview - TransCode Therapeutics, Inc. is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics [5] - The company's lead therapeutic candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker of metastasis [5] - TransCode has a portfolio of first-in-class RNA therapeutic candidates designed to improve RNA delivery and access novel genetic targets for cancer treatment [5] Recent Offering - The company announced the closing of a sale of 10,250,000 shares of common stock and warrants, generating gross proceeds of approximately $10 million at a price of $0.98 per share [1][2] - Proceeds from the offering will primarily be used for product development activities, including clinical trials for TTX-MC138 and general corporate purposes [2] - ThinkEquity acted as the sole placement agent for the offering [2] Regulatory Compliance - The offering was conducted under an effective shelf registration statement filed with the U.S. Securities and Exchange Commission (SEC) [3] - The final prospectus supplement related to the offering is available on the SEC's website [3]

Core Viewpoint - TransCode Therapeutics, Inc. has announced a public offering of 10,250,000 shares of common stock and warrants, aiming to raise approximately $10 million for product development and working capital [1][2]. Group 1: Offering Details - The shares are priced at $0.98 each, with warrants having an exercise price of $0.86, immediately exercisable for five years [1]. - The offering is expected to close on March 25, 2025, pending customary closing conditions [1]. Group 2: Use of Proceeds - The net proceeds from the offering will be allocated to product development activities, including clinical trials for TTX-MC138, the company's lead therapeutic candidate, and for general corporate purposes [2]. Group 3: Company Overview - TransCode is a clinical-stage oncology company focused on treating metastatic disease through RNA therapeutics, utilizing its proprietary TTX nanoparticle platform [6]. - The lead candidate, TTX-MC138, targets metastatic tumors that overexpress microRNA-10b, a biomarker associated with metastasis [6].