Transcode Therapeutics, Inc. SEC 10-K Report

Transcode Therapeutics, Inc., an RNA oncology company focused on developing RNA therapeutics to target previously undruggable genetic targets in cancer, has released its annual Form 10-K report. The report provides a comprehensive overview of the company's financial performance, business operations, strategic initiatives, and the challenges it faces.

Financial Highlights

• Net Loss: $16.8 million, a decrease of $1.8 million compared to the previous year, primarily due to reduced research and development expenses and general and administrative expenses.
• Net Loss Attributable to Common Stockholders: $16.8 million, reflecting a decrease from the previous year, driven by cost reductions and efficiency improvements.
• Operating Loss: $15.7 million, with operating expenses decreasing by $3.8 million, reflecting reduced research and development and general administrative expenses.
• Grant Income: $0.5 million, a decrease of $0.4 million compared to the previous year, recognized under NIH grants to fund clinical trials.
• Interest Expense: $27 thousand, decreased from the previous year due to reduced imputed interest expense and finance charges.

Business Highlights

• Business Overview: TransCode is an RNA oncology company focused on developing RNA therapeutics to target previously undruggable genetic targets in cancer, leveraging its proprietary TTX platform to overcome delivery challenges.
• Lead Therapeutic Candidate: TTX-MC138 targets microRNA-10b, a key regulator of metastatic cell viability in various cancers. The company has progressed to a Phase I/II clinical trial to evaluate its safety and efficacy.
• Clinical Trial Progress: The Phase I/II clinical trial for TTX-MC138 is underway, with multiple cohorts dosed and no significant safety issues reported. The trial aims to determine the maximum tolerated dose and explore anti-tumor activity.
• Preclinical Programs: TransCode is advancing preclinical programs including TTX-siPDL1, TTX-RIGA, and TTX-siMYC, targeting various cancer-related pathways and immune responses.
• MD Anderson Cancer Center Alliance: An amendment to the collaboration agreement with MD Anderson focuses solely on participation in the Phase I/II clinical trial, relieving TransCode from up to $10 million in collaboration payments.
• Proprietary TTX Drug Design Engine: The TTX platform is designed to deliver various therapeutic payloads, including oligonucleotides and proteins, to cancer cells, with potential applications in treating cancer and macrophage dysfunction.
• Modular Design Toolbox: TransCode employs a modular design engine to develop therapeutic candidates targeting specific RNA sequences, enhancing delivery and therapeutic efficacy.
• Future Outlook: The company aims to expand its TTX platform capabilities, build a diverse pipeline of oncology therapeutics, and explore strategic collaborations to enhance its market reach.
• Intellectual Property: TransCode holds a broad patent portfolio covering its therapeutic candidates and delivery technologies, with ongoing efforts to expand and protect its intellectual property rights.

Strategic Initiatives

• Clinical Development Programs: The company is advancing its clinical development programs, particularly focusing on TTX-MC138, with ongoing Phase I/II clinical trials.
• Strategic Collaborations: The collaboration with MD Anderson Cancer Center has been amended to focus on clinical trial participation, relieving the company from up to $10 million in collaboration payments.
• Capital Management: The company engaged in multiple financing activities, including a public offering in January 2024 raising approximately $6.2 million, a July 2024 offering raising $3.0 million, a November 2024 private placement raising approximately $8 million, and a March 2025 equity financing raising approximately $10 million. These funds are intended to support ongoing operations and clinical trials.
• Future Outlook: The company anticipates requiring additional capital to support its research, development, and clinical trials, as well as potential commercialization efforts. It plans to finance operations through a combination of equity offerings, debt financings, and strategic partnerships. The company is also exploring non-dilutive funding opportunities, such as government grants, to support its initiatives. There is a focus on managing costs, including relocating R&D activities to Michigan State University and reducing staff, to extend the financial runway into the fourth quarter of 2025.

Challenges and Risks

• Financial Position and Capital Needs: The company faces significant risks related to its financial position and the need for additional capital. It has been non-compliant with Nasdaq listing requirements, risking delisting, which would reduce stock liquidity and value. The company has substantial doubt about its ability to continue operations without additional funding, potentially leading to restructuring or bankruptcy.
• Ongoing Losses: The company has incurred significant losses since inception and expects to continue incurring losses, with no products currently approved for commercial sale. The development of oncology products is speculative, requiring substantial capital and facing high risks of failure.
• Capital Requirements: The company may need to raise substantial additional funding to continue operations, with current funds only supporting operations into the fourth quarter of 2025. Failure to secure additional capital could delay or halt development programs.
• Market Risks: The company’s quarterly and annual operating results may fluctuate significantly due to factors such as clinical trial success, regulatory approvals, and market conditions. This variability could result in stock price volatility.
• Management Strategies: Management acknowledges the challenges of sustaining operations without additional capital and the potential need for cost reduction strategies. The company is focused on advancing its lead therapeutic candidate, TTX-MC138, but faces significant risks in clinical development and regulatory approval processes.
• Market Risk Exposure: The company is exposed to market risks, including fluctuations in financial markets that could impact its ability to raise capital. Disruptions in financial markets may adversely affect fundraising efforts, potentially leading to unfavorable financing terms or dilution of stockholder value.

SEC Filing: Transcode Therapeutics, Inc. [ RNAZ ] - 10-K - Apr. 15, 2025