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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):
October 28, 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 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 28, 2026, TransCode Therapeutics, Inc.
(the “Company”) issued a press release announcing that its board of directors has initiated a formal strategic process to
evaluate opportunities designed to maximize the value of the Company and its oncology portfolio, including its lead product candidate,
TTX-MC138. A copy of this press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. |
|
Description |
| |
|
|
| 99.1 |
|
Press Release, dated October 28, 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: October 28, 2026 |
By: |
/s/ Philippe P. Calais |
| |
|
Philippe P. Calais |
| |
|
Chief Executive Officer |
Exhibit 99.1
TransCode Therapeutics Retains Tungsten
Advisors to Lead Formal Strategic Process Intended to Maximize Value of TTX-MC138 and its Oncology Portfolio
Lead program TTX-MC138 is in Phase 2a clinical development for ctDNA-positive
colorectal cancer following curative-intent treatment
TransCode will evaluate strategic alternatives including licensing
arrangements, development partnerships and other strategic transactions
BOSTON, Oct. 28, 2026 — TransCode Therapeutics, Inc. (Nasdaq:
RNAZ) ("TransCode" or the "Company"), a clinical-stage biopharmaceutical company developing RNA-based therapeutics
and immuno-oncology treatments for high-risk and advanced cancers, today announced that its Board of Directors has initiated a formal
strategic process to evaluate opportunities designed to maximize the value of the Company and its oncology portfolio, including its lead
product candidate, TTX-MC138.
The process will evaluate a broad range of potential transactions involving
the Company, its lead therapeutic candidate TTX-MC138 and its other oncology programs. Potential opportunities may include a licensing
or sale of individual assets, development and commercialization partnerships, portfolio transactions, business combinations or other strategic
transactions.
TransCode has engaged Tungsten Advisors as the Company’s exclusive
strategic financial advisor in connection with the process.
"TTX-MC138 has advanced into Phase 2a clinical development following
our Phase 1a study, which provided initial safety data and reports of stable disease," said Philippe P. Calais, PharmD, PhD., CEO
and Chairman. "We believe a formal strategic process will help us evaluate opportunities to support the continued development of
TTX-MC138 and our broader oncology portfolio, while seeking to maximize value for our stockholders."
TTX-MC138 is an investigational RNA-based therapeutic designed to inhibit
microRNA-10b (miR-10b), which is implicated in metastatic cancer cell survival and disease progression. The program is being evaluated
in a Phase 2a trial in patients with circulating tumor DNA (ctDNA)-positive colorectal cancer following curative-intent therapy, in collaboration
with Quantum Leap Healthcare Collaborative under its PRE-I-SPY program.
On October 13, 2026, TransCode and Natera, Inc. announced a collaboration
to support enrollment in the Phase 2a trial. TransCode will use Natera’s Signatera test to identify patients who have completed
curative-intent therapy and test positive for molecular residual disease despite having no radiographic evidence of disease. The collaboration
aims to improve identification of eligible patients at participating sites and support more efficient trial enrollment.
There can be no assurance that the strategic process will result in
any transaction or other strategic outcome. TransCode does not intend to provide updates on the process unless and until its Board of
Directors approves a specific transaction or course of action, or the Company otherwise determines that disclosure is appropriate or required.
About TransCode Therapeutics
TransCode Therapeutics is an immuno-oncology and targeted cancer therapy
company with a focus on treating advanced malignancy. The company's lead therapeutic candidate, TTX-MC138, is focused on treating metastatic
tumors that overexpress microRNA-10b, a unique, well-documented biomarker of metastasis, and is currently being evaluated in a Phase 2a
trial under the PRE-I-SPY program in collaboration with Quantum Leap Healthcare Collaborative. In addition, TransCode has a portfolio
of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy cancer cells. For more
information,visit www.transcodetherapeutics.com
About TTX-MC138
TTX-MC138 is TransCode’s lead therapeutic candidate and is designed
to inhibit miR-10b. Its Phase 1a dose-escalation study in patients with advanced solid tumors met its primary safety endpoint, with no
dose-limiting toxicities reported across the evaluated dose levels. In the Company’s September 2026 update, 10 of 14 efficacy-evaluable
patients achieved stable disease as their best overall response by investigator assessment. These preliminary findings require confirmation
in larger studies.
The Phase 2a trial is designed to evaluate TTX-MC138 in up to 45 patients
with colorectal cancer who have completed curative-intent treatment and have no radiographic evidence of disease but remain or become
ctDNA-positive, indicating minimal residual disease. TTX-MC138 remains investigational and has not been approved for commercial use.
Forward-Looking Statements
This press release contains “forward-looking
statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without limitation, statements
regarding the Company’s strategic process; its potential timing, structure, benefits and outcome; the possibility of any licensing
transaction, asset sale, partnership, business combination or other strategic transaction; the development, regulatory approval and commercialization
of TTX-MC138 and other product candidates; their potential therapeutic benefits and market opportunities; and the Natera collaboration,
including the anticipated use of Signatera and its expected impact on patient identification and trial enrollment. Any forward-looking
statements in this press release 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 possibility that the strategic process may not result in
a transaction; the Company’s ability to identify, negotiate and complete a transaction on acceptable terms; disruption to its business
during the process; its need for additional capital and ability to obtain financing; risks associated with clinical trials, including
whether early findings will be confirmed in later studies; regulatory review and approval; intellectual property protection; reliance
on third parties; the Company’s ability to maintain the listing of its common stock on Nasdaq, including compliance with the minimum
bid price requirement; and competition. 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, 2025, as well
as discussions of potential risks, uncertainties and other important factors in any subsequent TransCode filings with the U.S. Securities
and Exchange Commission. All information in this press release is as of the date of this release; TransCode undertakes no duty to update
this information unless required by law.
For
more information and partnering opportunities, please contact: TransCode Therapeutics, Inc., Tania Montgomery, VP of Business Development,
tania.montgomery@transcodetherapeutics.com
