TransCode Therapeutics, Inc. (RNAZ) is a biopharmaceutical company dedicated to developing and commercializing innovative drugs and diagnostics for cancer treatment and identification. The company focuses on advancing its proprietary TTX platform and its lead therapeutic candidate, TTX-MC138, which aims to inhibit metastatic tumor cells. TransCode does not currently sell any products, as its offerings are still in the research and development phase and have not been approved for commercial sale.
- TTX-MC138 - A lead therapeutic candidate designed to inhibit the survival of metastatic tumor cells, aiming to achieve durable disease regression and long-term patient survival.
- TTX Platform - A proprietary platform used to identify and develop additional therapeutic and diagnostic candidates for oncology applications.
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| Name | Position | External Roles | Short Bio | |
|---|---|---|---|---|
Thomas A. Fitzgerald Executive | Interim Chief Executive Officer | Thomas A. Fitzgerald has served as the Interim Chief Executive Officer at RNAZ since January 2024. He has also held executive positions as CFO, Vice President, and Director at RNAZ since July 2018, demonstrating extensive financial leadership. | View Report → | |
Erik Manting Board | Director | CEO, Mendus AB; Supervisory Board Member, Synerkine Pharma BV; Founder, BioEntrepreneur BV | Erik Manting, PhD, has been a Director at RNAZ since December 2020 and plays a key role on the Compensation Committee and as Chair of the Nominating and Corporate Governance Committee. | |
Magda Marquet Board | Board Member | Co-Founder and Co-Chief Executive Officer at ALMA Life Sciences LLC; Co-Founder at AltheaDx; Board Member at Arcturus Therapeutics; Board Member at AnaptysBio; Board Member at Immix BioPharma; Chairman of the Board at Micronoma; Chairman of the Board at Matrisys Biosciences; Chairman of the Board at ProciseDx | Dr. Magda Marquet has served as a Board Member at RNAZ since January 2021 and chairs its Compensation Committee since 2023. She is recognized for her extensive expertise in the life sciences sector, having held various leadership roles both at RNAZ and across multiple companies. | |
Philippe P. Calais Board | Chairman of the Board | President, Chief Executive Officer, and Director at MatriSys Bioscience, Inc.; Executive Chairman and Founder at Phileas Pharma, Inc. | Philippe P. Calais, PharmD, PhD, brings over 38 years of expertise in the biotech and pharmaceutical industries, serving on RNAZ’s board since October 2018 and as Chairman since January 2021. |
- Given your plan to launch a Phase 0 trial to prove therapeutic delivery and define the minimum effective dose, could you elaborate on the specific metrics and success criteria that will trigger advancement to Phase 1?
- You claim your delivery system achieves 98% cellular uptake compared to the industry norm of 2%; what independent data or validation metrics support this dramatic improvement, and how robust are these findings across diverse tumor types?
- With a substantial increase in R&D expenses from $284K to $2.8M and G&A expenses from $440K to $3.4M, what measures are you taking to ensure these escalating costs translate into clear, value-driving milestones for the company?
- Your pipeline now includes six therapeutic candidates; how will you prioritize clinical advancement, and what criteria will determine the allocation of resources among these diverse RNA therapeutic approaches?
- Considering the innovative yet unproven nature of your Phase 0 design, what are the contingency steps if therapeutic concentrations in metastatic lesions fall short of anticipated levels, particularly regarding dose selection for subsequent phases?
Research analysts covering Transcode Therapeutics.
Competitors mentioned in the company's latest 10K filing.
| Company | Description |
|---|---|
Companies that we are aware of with targeted therapeutics in the treatment of various cancers include Ionis, which have therapeutic candidates in various stages of preclinical and clinical developments. | |
Companies that we are aware of with targeted therapeutics in the treatment of various cancers include Moderna, which have therapeutic candidates in various stages of preclinical and clinical developments. | |
Companies that we are aware of with targeted therapeutics in the treatment of various cancers include Alnylam, which have therapeutic candidates in various stages of preclinical and clinical developments. | |
Companies that we are aware of with targeted therapeutics in the treatment of various cancers include BioNTech, which have therapeutic candidates in various stages of preclinical and clinical developments. | |
Dicerna | Companies that we are aware of with targeted therapeutics in the treatment of various cancers include Dicerna, which have therapeutic candidates in various stages of preclinical and clinical developments. |
Siranomics | Companies that we are aware of with targeted therapeutics in the treatment of various cancers include Siranomics, which have therapeutic candidates in various stages of preclinical and clinical developments. |
Arrowhead Pharmaceuticals is a clinical stage company with a pipeline of investigational RNAi therapeutics. |
Recent press releases and 8-K filings for RNAZ.
- TransCode Therapeutics, Inc. (RNAZ) announced the completion of its Phase 1a clinical trial for TTX-MC138 in metastatic disease, with preliminary data to be presented at the ESMO Congress from October 17-21, 2025.
- The trial achieved its primary safety endpoint, observing no significant treatment-related safety events or dose-limiting toxicities across 16 patients treated with TTX-MC138.
- Preliminary data showed that 44% of patients (7 out of 16) demonstrated apparent stable disease lasting over 4 months, with a median treatment duration of 4 months.
- These results, including the definition of a recommended Phase 2 dose, support the advancement of TTX-MC138 to a Phase 2a clinical trial.
- TransCode Therapeutics (NASDAQ: RNAZ) has completed its Phase 1a clinical trial for TTX-MC138, an investigational inhibitor of microRNA-10b.
- The trial successfully met its primary safety endpoint, with no significant treatment-related safety events or dose-limiting toxicities observed in 16 patients.
- A recommended Phase 2 dose was established, and the company plans to advance TTX-MC138 into a Phase 2a clinical trial to evaluate its efficacy in metastatic diseases.
- Preliminary data indicated that 44% of patients (7 out of 16) achieved stable disease lasting 4 months or longer, with a median treatment duration of 4 months.
- TransCode Therapeutics (RNAZ) announced the acquisition of Polynoma LLC and a concurrent $25 million strategic financing from a subsidiary of CK Life Sciences.
- The $25 million financing, comprising $20 million in cash and a $5 million promissory note, is primarily designated to advance TransCode's lead microRNA asset, TTX-MC138, into a Phase 2 clinical trial.
- The acquisition expands TransCode's pipeline with Polynoma's Phase 3-ready seviprotimut-L, a novel polyvalent shed antigen vaccine for the adjuvant treatment of melanoma.
- Following these transactions, CK Life Sciences will hold approximately 91% of TransCode on a fully diluted basis, with a combined fully diluted equity value of approximately $165 million.
- Philippe Calais was appointed Chief Executive Officer, Tom Fitzgerald remains Chief Financial Officer, and Elizabeth Czerepak joined the board as an independent member and Chairperson of the Audit Committee.
- TransCode Therapeutics (RNAZ) has acquired Polynoma LLC, expanding its pipeline with Polynoma's Phase 3-ready seviprotimut-L, a novel polyvalent shed antigen vaccine for the adjuvant treatment of melanoma.
- Concurrent with the acquisition, TransCode received a $25 million equity investment from CK Life Sciences, which will primarily be used to advance its lead microRNA asset, TTX-MC138, into a Phase 2 clinical trial.
- The transaction results in CK Life Sciences holding approximately 91% of TransCode on a fully diluted basis, with a combined fully diluted equity value of approximately $165 million.
- Philippe Calais, PharmD, PhD, has been appointed Chief Executive Officer and remains Chairman of the Board, while Tom Fitzgerald remains Chief Financial Officer. Elizabeth Czerepak, MBA, was appointed as a new independent Board Member and Chairperson of the Audit Committee.
- Nasdaq notice issued: The company’s stock failed to maintain a minimum closing bid price of $1.00 per share for 30 consecutive business days between March 24, 2025, and May 5, 2025, triggering a delisting notice.
- Reverse split impact: Due to reverse stock splits executed in the prior year and over the previous two-year period with a cumulative ratio of 250:1, the company is not eligible for a compliance period.
- Panel hearing appeal: The company plans to request a hearing before a Nasdaq panel to address the deficiency and remain listed, with the appeal request due no later than May 13, 2025; the report was signed by Interim CEO/CFO Thomas A. Fitzgerald on May 7, 2025.
- The company’s Board approved a 1-for-28 reverse stock split effective at 12:01 a.m. Eastern Time on May 15, 2025
- The reverse split will convert every 28 shares into one share, reducing outstanding shares from 23,341,336 to approximately 833,620 with proportional adjustments to stock options and warrants
- Post-split, common stock will continue trading on the Nasdaq Capital Market under the symbol RNAZ and the CUSIP number will update to 89357L 501 effective upon execution
- The split is part of the company’s initiative to meet Nasdaq’s minimum bid price requirement
- Approval & Purpose: TransCode Therapeutics approved a 1-for-28 reverse stock split on May 2, 2025 to meet Nasdaq's minimum bid price requirement by converting 28 existing shares into 1 new share .
- Share Consolidation: The reverse split will reduce outstanding shares from 23,341,336 to approximately 833,620 .
- Adjustments: Options and warrants are adjusted proportionally , and stockholders will receive rounded-up whole shares when necessary .
- 13 patients have been treated at four escalating doses (0.8 to 4.8 mg/kg) with no significant dose-limiting toxicities reported; two patients maintained stable disease for approximately 7 months.
- Preliminary PK/PD analyses indicate a predictable dose-response relationship and effective miR-10b target engagement at 24 hours post-infusion, supporting advancement to Phase 1b.
- The Special Meeting originally scheduled for April 21, 2025 has been adjourned due to a lack of quorum (only about 12.73% of shares represented) and is rescheduled for May 2, 2025 at 9:30 a.m. Eastern Time.
- Voting instructions for mail, internet, live webcast, and telephone have been provided, with all votes needed by May 1, 2025 to be counted.
- Key proposals include implementing a reverse stock split (ranging from 1-for-10 to 1-for-40).
- A proposal is also on the agenda to authorize additional adjournments if needed for further proxy solicitation.
- TransCode Therapeutics completed a registered direct offering, selling 10,250,000 shares with accompanying warrants at $0.98 per share, generating approximately $10 million in gross proceeds.
- The offering was executed under Nasdaq rules.
- Warrants associated with the offering are exercisable at $0.86.
- Proceeds will fund clinical trials for TTX-MC138, drive product development, and support general corporate needs.