STOCK TITAN

[8-K] Transcode Therapeutics, Inc. Reports Material Event

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

TransCode Therapeutics (RNAZ) reported via Form 8-K that it issued a press release announcing completion of its Phase 1a clinical trial with its lead candidate, TTX‑MC138. The company attached the press release as Exhibit 99.1 and a related scientific poster as Exhibit 99.2.

The filing includes forward‑looking statements related to potential future trials, regulatory submissions, intellectual property, competition, third‑party dependencies, and broader macro risks. It also references risks tied to funding needs and the company’s ability to continue as a going concern, directing readers to the latest Form 10‑K risk factors for additional detail.

TransCode Therapeutics (RNAZ) ha comunicato tramite Modulo 8-K che ha emesso un comunicato stampa annunciando il completamento del trial clinico di fase 1a con il suo candidato principale, TTX‑MC138. L'azienda ha allegato il comunicato stampa come Esibizione 99.1 e un poster scientifico correlato come Esibizione 99.2.

La relazione contiene dichiarazioni previsionali relative a potenziali prossimi studi, presentazioni regolatorie, proprietà intellettuale, concorrenza, dipendenze da terze parti e rischi macro più ampi. Rileva anche rischi legati alle esigenze di finanziamento e alla capacità dell'azienda di continuare come entità in funzionamento, invitando i lettori a consultare i fattori di rischio più recenti del Form 10-K per ulteriori dettagli.

TransCode Therapeutics (RNAZ) informó mediante el Formulario 8-K que emitió un comunicado de prensa anunciando la finalización de su ensayo clínico de fase 1a con su candidato principal, TTX‑MC138. La empresa adjuntó el comunicado de prensa como Anexo 99.1 y un póster científico relacionado como Anexo 99.2.

La presentación incluye declaraciones prospectivas relativas a posibles futuros ensayos, presentaciones regulatorias, propiedad intelectual, competencia, dependencias de terceros y riesgos macro más amplios. También hace referencia a riesgos vinculados a las necesidades de financiación y a la capacidad de la empresa para seguir operando como una entidad en funcionamiento, dirigiendo a los lectores a los factores de riesgo más recientes del Formulario 10-K para más detalles.

TransCode Therapeutics (RNAZ)가 형식 8-K를 통해 보도자료를 발표했다고 발표 완료를 알리며, 리드 후보 물질인 TTX‑MC1381상 초기 임상시험을 완료했습니다. 회사는 보도자료를 Exhibit 99.1로, 관련 과학 포스터를 Exhibit 99.2로 첨부했습니다.

이 제출에는 향후 잠재적 시험, 규제 제출, 지적 재산권, 경쟁, 제3자 의존성 및 더 넓은 거시적 위험과 관련된 미래 지향적 진술이 포함되어 있습니다. 또한 재정 필요성 및 계속 영업 가능성에 대한 위험을 언급하며, 추가 세부 정보는 최신 Form 10-K의 위험 요소를 참조하라고 독자들에게 안내합니다.

TransCode Therapeutics (RNAZ) a annoncé par le biais du formulaire 8-K la publication d'un communiqué indiquant l'achèvement de son essai clinique de phase 1a avec son candidat principal, TTX‑MC138. La société a joint le communiqué de presse en tant que Produit Annexé 99.1 et un poster scientifique lié en tant que Produit Annexé 99.2.

Le dossier contient des déclarations prospectives relatives à de potentiels futurs essais, des soumissions réglementaires, de la propriété intellectuelle, de la concurrence, des dépendances vis-à-vis de tiers et des risques macroéconomiques plus larges. Il fait également référence à des risques liés aux besoins de financement et à la capacité de l'entreprise à poursuivre ses activités, en dirigeant les lecteurs vers les facteurs de risque les plus récents du Formulaire 10-K pour plus de détails.

TransCode Therapeutics (RNAZ) hat via Form 8-K mitgeteilt, dass ein Pressemitteilung veröffentlicht wurde, die den Abschluss seiner Phase-1a-Studie mit dem führenden Kandidaten TTX‑MC138 bekannt gibt. Das Unternehmen fügte die Pressemitteilung als Anhang 99.1 und ein related wissenschaftliches Poster als Anhang 99.2 bei.

Die Einreichung enthält zukunftsgerichtete Aussagen zu potenziellen zukünftigen Studien, behördlichen Einreichungen, geistigem Eigentum, Wettbewerb, Abhängigkeiten von Drittparteien und breiten makroökonomischen Risiken. Sie verweist auch auf Risiken in Bezug auf Finanzierungsbedürfnisse und die Fähigkeit des Unternehmens, als fortbestehende Gesellschaft fortzufahren, und verweist die Leser auf die neuesten Risikofaktoren des Form 10-K für weitere Details.

TransCode Therapeutics (RNAZ) أصدرت عبر النموذج 8-K بياناً صحفياً يُعلن إكمال تجربتها السريرية من المرحلة 1a مع المرشح الرئيسي، TTX‑MC138. أرفقت الشركة البيان الصحفي كـ Exhibit 99.1 وملصق علمي ذي صلة كـ Exhibit 99.2.

يتضمن الإيداع تصريحات توجّمية تتعلق بتجارب مستقبلية محتملة، وتقديمات تنظيمية، وحقوق ملكية فكرية، ومنافسة، واعتماديات من طرف ثالث، ومخاطر كونية أوسع. كما يشير إلى مخاطر مرتبطة بالاحتياجات التمويلية وبقدرة الشركة على الاستمرار كمشروع قائم، موجهاً القراء إلى أحدث عوامل الخطر من النموذج 10-K لمزيد من التفاصيل.

TransCode Therapeutics (RNAZ) 通过表格8-K宣布发布新闻稿,宣布其1a阶段临床试验完成,候选药物为TTX‑MC138。公司将新闻稿作为附件99.1,以及相关科学海报作为附件99.2。

该备案包含前瞻性陈述,涉及未来潜在试验、监管提交、知识产权、竞争、对第三方的依赖以及更广泛的宏观风险。还提及与资金需求相关的风险以及公司能否继续作为持续经营实体的能力,并指示读者查阅最新的Form 10‑K风险因素以获取更多细节。

Positive
  • None.
Negative
  • None.

Insights

Clinical milestone reached, but no efficacy/safety data disclosed; significance depends on forthcoming details and next-step readiness.

TransCode Therapeutics reported completion of its Phase 1a trial for TTX-MC138 and furnished a press release (October 14, 2025) and a related poster. Completion signals the program advanced through initial human testing, a necessary step before later-phase studies. The filing does not include outcomes, so tolerability, target engagement, or signals of activity are not assessable here.

The company includes standard forward-looking language referencing potential Phase 2a and Phase 2 plans and highlights multiple risks, including clinical execution, regulatory timing, intellectual property, third-party dependencies, competition, and its financial condition with an explicit going-concern risk. These disclosures frame meaningful dependencies for any next-phase initiation.

Key items to watch: detailed Phase 1a results, regulatory feedback, and clarity on funding capacity to support subsequent trials. The attached materials (Exhibits 99.1 and 99.2) may contain data critical to interpreting this milestone. Over the near term (Q4 2025–H1 2026), confirmation of safety profile, any pharmacologic signals, and concrete next-step timelines will determine the practical impact of this completion.

TransCode Therapeutics (RNAZ) ha comunicato tramite Modulo 8-K che ha emesso un comunicato stampa annunciando il completamento del trial clinico di fase 1a con il suo candidato principale, TTX‑MC138. L'azienda ha allegato il comunicato stampa come Esibizione 99.1 e un poster scientifico correlato come Esibizione 99.2.

La relazione contiene dichiarazioni previsionali relative a potenziali prossimi studi, presentazioni regolatorie, proprietà intellettuale, concorrenza, dipendenze da terze parti e rischi macro più ampi. Rileva anche rischi legati alle esigenze di finanziamento e alla capacità dell'azienda di continuare come entità in funzionamento, invitando i lettori a consultare i fattori di rischio più recenti del Form 10-K per ulteriori dettagli.

TransCode Therapeutics (RNAZ) informó mediante el Formulario 8-K que emitió un comunicado de prensa anunciando la finalización de su ensayo clínico de fase 1a con su candidato principal, TTX‑MC138. La empresa adjuntó el comunicado de prensa como Anexo 99.1 y un póster científico relacionado como Anexo 99.2.

La presentación incluye declaraciones prospectivas relativas a posibles futuros ensayos, presentaciones regulatorias, propiedad intelectual, competencia, dependencias de terceros y riesgos macro más amplios. También hace referencia a riesgos vinculados a las necesidades de financiación y a la capacidad de la empresa para seguir operando como una entidad en funcionamiento, dirigiendo a los lectores a los factores de riesgo más recientes del Formulario 10-K para más detalles.

TransCode Therapeutics (RNAZ)가 형식 8-K를 통해 보도자료를 발표했다고 발표 완료를 알리며, 리드 후보 물질인 TTX‑MC1381상 초기 임상시험을 완료했습니다. 회사는 보도자료를 Exhibit 99.1로, 관련 과학 포스터를 Exhibit 99.2로 첨부했습니다.

이 제출에는 향후 잠재적 시험, 규제 제출, 지적 재산권, 경쟁, 제3자 의존성 및 더 넓은 거시적 위험과 관련된 미래 지향적 진술이 포함되어 있습니다. 또한 재정 필요성 및 계속 영업 가능성에 대한 위험을 언급하며, 추가 세부 정보는 최신 Form 10-K의 위험 요소를 참조하라고 독자들에게 안내합니다.

TransCode Therapeutics (RNAZ) a annoncé par le biais du formulaire 8-K la publication d'un communiqué indiquant l'achèvement de son essai clinique de phase 1a avec son candidat principal, TTX‑MC138. La société a joint le communiqué de presse en tant que Produit Annexé 99.1 et un poster scientifique lié en tant que Produit Annexé 99.2.

Le dossier contient des déclarations prospectives relatives à de potentiels futurs essais, des soumissions réglementaires, de la propriété intellectuelle, de la concurrence, des dépendances vis-à-vis de tiers et des risques macroéconomiques plus larges. Il fait également référence à des risques liés aux besoins de financement et à la capacité de l'entreprise à poursuivre ses activités, en dirigeant les lecteurs vers les facteurs de risque les plus récents du Formulaire 10-K pour plus de détails.

TransCode Therapeutics (RNAZ) hat via Form 8-K mitgeteilt, dass ein Pressemitteilung veröffentlicht wurde, die den Abschluss seiner Phase-1a-Studie mit dem führenden Kandidaten TTX‑MC138 bekannt gibt. Das Unternehmen fügte die Pressemitteilung als Anhang 99.1 und ein related wissenschaftliches Poster als Anhang 99.2 bei.

Die Einreichung enthält zukunftsgerichtete Aussagen zu potenziellen zukünftigen Studien, behördlichen Einreichungen, geistigem Eigentum, Wettbewerb, Abhängigkeiten von Drittparteien und breiten makroökonomischen Risiken. Sie verweist auch auf Risiken in Bezug auf Finanzierungsbedürfnisse und die Fähigkeit des Unternehmens, als fortbestehende Gesellschaft fortzufahren, und verweist die Leser auf die neuesten Risikofaktoren des Form 10-K für weitere Details.

false 0001829635 0001829635 2025-10-13 2025-10-13 iso4217:USD xbrli:shares iso4217:USD xbrli:shares

 

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): October 13, 2025

 

TRANSCODE THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware   001-40363   81-1065054
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)

 

TransCode Therapeutics, Inc.

6 Liberty Square, #2382
Boston, Massachusetts 02109

(Address of principal executive offices, including zip code)

 

(857) 837-3099

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered or to be registered pursuant to Section 12(b) of the Act.

 

Title of each class   Trading symbol(s)   Name of each exchange on which
registered
Common Stock, par value $0.0001 per share   RNAZ   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company  x

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ¨

 

 

 

 

 

 

Item 8.01 Other Events.

 

On October 14, 2025, TransCode Therapeutics, Inc. (“TransCode”) issued a press release announcing completion of its Phase 1a clinical trial with TTX-MC138. A copy of this press release is attached hereto as Exhibit 99.1 and incorporated herein by reference. A copy of the related poster is attached hereto as Exhibit 99.2 and incorporated herein by reference.

  

Note Regarding Forward-Looking Statements

 

This Current Report on Form 8-K contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements concerning the timing, conduct and results of TransCode’s Phase 1a clinical trial, TransCode’s Phase 2a clinical trial, and TransCode’s Phase 2 clinical trial, statements about microRNAs and their involvement in cancer, and statements concerning the therapeutic potential of TransCode's TTX-MC138 and other therapeutic candidates. Any forward-looking statements in this Current Report on Form 8-K are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: the risks associated with drug discovery and development; the risk that the results of clinical trials will not be consistent with TransCode's preclinical studies or expectations or with results from previous clinical trials; risks associated with the conduct of clinical trials; risks associated with TransCode's financial condition and its need to obtain additional funding to support its business activities, including TransCode's ability to continue as a going concern; risks associated with the timing and outcome of TransCode's planned regulatory submissions; risks associated with obtaining, maintaining and protecting intellectual property; risks associated with TransCode's ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties; risks of competition from other companies developing products for similar uses; risks associated with TransCode's dependence on third parties; and risks associated with geopolitical events and pandemics, including the COVID-19 coronavirus and military actions. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause TransCode's actual results to differ from those contained in or implied by the forward-looking statements, see the section entitled "Risk Factors" in TransCode's Annual Report on Form 10-K for the year ended December 31, 2024, as well as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the Securities and Exchange Commission. Forward-looking statements reflect TransCode’s analysis only on their stated date; TransCode undertakes no duty to update this information unless required by law.

 

 

 

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit No. Description
   
99.1 Press Release, dated October 14, 2025
   
99.2 Poster, dated October 13, 2025
   
104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURE

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

TransCode Therapeutics, Inc.
   
Date: October 14, 2025By: /s/ Philippe Calais
    Philippe Calais
    Chief Executive Officer

 

 

 

FAQ

What did TransCode Therapeutics (RNAZ) announce in this 8-K?

The company announced completion of its Phase 1a clinical trial with its candidate TTX‑MC138 and provided a press release (Exhibit 99.1) and a poster (Exhibit 99.2).

Which candidate is involved in the completed Phase 1a trial for RNAZ?

TTX‑MC138.

What exhibits were filed with the 8-K by RNAZ?

Exhibit 99.1: Press Release dated October 14, 2025; Exhibit 99.2: Poster dated October 13, 2025; Exhibit 104: Cover Page Inline XBRL data.

Does the filing discuss future clinical plans for RNAZ?

It contains forward‑looking statements referencing potential Phase 2a and Phase 2 trials.

What risks does RNAZ highlight in connection with this update?

Risks include clinical development uncertainty, regulatory outcomes, IP matters, competition, third‑party reliance, geopolitical/pandemic factors, and funding needs including going concern risk.

Where can investors find more detailed risk information for RNAZ?

In the Risk Factors section of the company’s Form 10‑K for the year ended December 31, 2024, and subsequent SEC filings.
Transcode Therapeutics Inc

NASDAQ:RNAZ

RNAZ Rankings

RNAZ Latest News

RNAZ Latest SEC Filings

RNAZ Stock Data

13.68M
915.71k
0.15%
4.43%
8.27%
Biotechnology
Pharmaceutical Preparations
Link
United States
BOSTON