false
0001829635
0001829635
2026-02-23
2026-02-23
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): February 23, 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 23, 2026, TransCode Therapeutics,
Inc. (“TransCode”) issued a press release announcing the publication of a manuscript titled Template-Directed RIG-I Agonist
Assembly for Image-guided Targeted Cancer Immunotherapy in the journal Molecular Imaging and Biology. 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
23, 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 23, 2026 |
By: |
/s/
Philippe P. Calais |
| |
|
Philippe P. Calais |
| |
|
Chief Executive Officer |
Exhibit 99.1
TransCode Therapeutics Announces Publication of Preclinical Testing
of RIG-I Immunotherapeutic Candidate Supporting Further Development
BOSTON, February 23, 2026 - TransCode Therapeutics, Inc.
(NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA therapeutics for the treatment of high risk and advanced cancers,
today announced the publication of a manuscript titled Template-Directed RIG-I Agonist Assembly for Image-guided Targeted Cancer Immunotherapy
in the journal Molecular Imaging and Biology. The paper, published February 19, 2026, reports on a novel tumor-selective immunotherapy
approach that activates innate immune signaling specifically within cancer cells while enabling non-invasive imaging of drug delivery.
The study was carried out in collaboration with Dr. Anna Moore, Professor, Director of the Precision Health Program, and Associate
Dean for Research Development at the College of Human Medicine at Michigan State University and scientific co-founder of TransCode.
The data describe a template-driven RIG-I agonist strategy to selectively
activate retinoic acid-inducible gene I (RIG-I) signaling inside tumor cells by leveraging overexpressed oncogenic microRNAs, such as
miRNA-21, as intracellular assembly templates. This approach directly addresses longstanding challenges associated with RIG-I agonists,
including off-target immune activation and inefficient systemic delivery.
“Our findings demonstrate a novel approach to precisely engage
innate immune pathways directly within tumor cells, while minimizing systemic toxicity,” said Zdravka Medarova, Ph.D., CSO of TransCode.
“We believe that combining tumor-specific RNA templating with our TTX nanoparticle delivery platform brings RIG-I-based immunotherapy
closer to clinical relevance.” TransCode’s TTX delivery platform is currently being evaluated in clinical trials, underscoring
the translational feasibility of this immunotherapy approach.
Molecular Imaging and Biology is a peer-reviewed scientific
journal and the official publication of the World Molecular Imaging Society, focused on translational research in molecular imaging and
image-guided therapies with clinical and commercial relevance.
About TransCode Therapeutics
TransCode
Therapeutics is a clinical stage company pioneering immuno-oncology and RNA therapeutic treatments for high risk and advanced cancers.
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. In addition, TransCode’s portfolio includes 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.
Forward-Looking Statements
This release contains
“forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including, without
limitation, statements concerning the effectiveness of TransCode’s TTX delivery platform and its therapeutic approaches and
strategies, statements concerning the timing, conduct and results of TransCode’s preclinical and clinical
studies, statements about microRNAs and their involvement in cancer, and statements concerning the therapeutic potential of TransCode’s
therapeutic candidates. 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 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. 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
