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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.
| 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?
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.
- 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.
- TransCode Therapeutics, Inc. will sell an aggregate of 10,250,000 shares and issue warrants to purchase an equal number of shares at $0.98 per share with the warrants exercisable immediately at $0.86 per share for a period of five years.
- The offering is expected to close on March 25, 2025, generating approximately $10 million in gross proceeds to fund TTX-MC138 clinical trials and general corporate purposes.
- ThinkEquity is acting as the exclusive placement agent for the offering.
- The Safety Review Committee approved opening Cohort 4 based on favorable safety data from Cohort 3, with a dose approximately 50% higher than in the previous cohort.
- Out of 9 patients treated in the first three cohorts, 6 remain on study without significant safety issues or disease progression.
- Ongoing PK/PD analyses in Cohorts 1 and 2 are consistent with preclinical findings and TransCode’s Phase 0 study, supporting further evaluation of TTX-MC138.
- TransCode Therapeutics held a Special Meeting on February 25, 2025, where shareholders voted on proposals detailed in the definitive proxy statement.
- Proposal One was approved, permitting issuance of common stock upon exercise of Series C and D Warrants with adjustments to exercise prices and terms, including a floor price of $2.4882 and cashless exercise features, confirming key capital structure adjustments.
- Proposal Two was approved to adjourn the meeting for further proxy solicitation if needed to ensure quorum and vote adequacy, although the adjournment was not executed due to sufficient votes already being cast.