TransCode (NASDAQ: RNAZ) plans Phase 2a trial for TTX-MC138

Rhea-AI Filing Summary

TransCode Therapeutics, Inc. filed a current report describing that, together with Quantum Leap Healthcare Collaborative, it has submitted an Investigational New Drug application amendment to the U.S. Food and Drug Administration for a planned Phase 2a clinical trial of its lead candidate, TTX-MC138.

The company explains that additional information is contained in a press release furnished as an exhibit, which is provided for informational purposes and is not treated as filed for liability purposes under federal securities laws.

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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): February 5, 2026

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 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 7.01 Regulation FD Disclosure.

On February 5, 2026, TransCode Therapeutics, Inc. (“TransCode”) issued a press release announcing, in collaboration with Quantum Leap Healthcare Collaborative, the submission to the U.S. Food and Drug Administration of an Investigational New Drug application amendment for a planned Phase 2a clinical trial with TransCode’s lead therapeutic candidate, TTX-MC138. A copy of this press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Item 7.01, including Exhibit 99.1 hereto, is being furnished herewith and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.	Description
99.1	Press Release, dated February 5, 2026
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: February 5, 2026	By:	/s/ Philippe P. Calais
		Philippe P. Calais
		Chief Executive Officer

FAQ

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

TransCode Therapeutics disclosed it has submitted an Investigational New Drug application amendment to the U.S. Food and Drug Administration for a planned Phase 2a clinical trial of its lead therapeutic candidate, TTX-MC138, with further details furnished in an accompanying press release.

Which drug candidate is involved in TransCode Therapeutics’ planned Phase 2a trial?

The planned Phase 2a clinical trial involves TransCode Therapeutics’ lead therapeutic candidate, TTX-MC138. The company notes that the trial is the subject of an Investigational New Drug application amendment submitted to the U.S. Food and Drug Administration in collaboration with Quantum Leap Healthcare Collaborative.

What role does the FDA play in TransCode Therapeutics’ latest update?

TransCode Therapeutics reports submitting an Investigational New Drug application amendment to the U.S. Food and Drug Administration. This submission relates to a planned Phase 2a clinical trial of TTX-MC138 and represents a regulatory step required before proceeding with the proposed clinical study.

Who is TransCode Therapeutics collaborating with on the TTX-MC138 trial plans?

TransCode Therapeutics states it is working with Quantum Leap Healthcare Collaborative on the planned Phase 2a clinical trial of TTX-MC138. Together, they submitted an Investigational New Drug application amendment to the U.S. Food and Drug Administration and described this collaboration in a furnished press release.

How is the press release about TTX-MC138 treated under securities laws?

The company specifies that the press release describing the planned Phase 2a trial and IND amendment is furnished, not filed. This means it is not subject to Section 18 liability under the Exchange Act and is only incorporated by reference when expressly stated in another filing.

Where can investors find more details on TransCode’s planned Phase 2a trial?

More details are contained in a press release attached as Exhibit 99.1. TransCode Therapeutics furnished this exhibit alongside the current report to provide additional information on the IND amendment and the planned Phase 2a clinical trial of TTX-MC138.