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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): March 2, 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)
|
| x |
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 3.02 | Unregistered Sales of Equity Securities. |
The information contained in Item 8.01 of this
Current Report is incorporated by reference into this Item 3.02.
The securities
to be issued as described in Item 8.01 will be issued in transactions not involving any public offering in reliance upon an exemption
from registration provided by Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”).
Pursuant
to the Unleash Registration Rights Agreement (as defined below) Unleash represented to TransCode Therapeutics, Inc., a Delaware
corporation (the “Company,” “we,” or “our”), among other things, that it is an “accredited investor”
(as such term is defined in Rule 501(a) of Regulation D under the Securities Act).
The
securities issued pursuant to the Unleash Registration Rights Agreement have not been registered under the Securities Act and none
of such securities may be offered or sold in the United States absent registration or an exemption from registration under the Securities
Act and any applicable state securities laws.
Neither this Current
Report on Form 8-K nor any of the exhibits attached hereto will constitute an offer to sell or the solicitation of an offer to buy
any securities of the Company.
| Item 3.03 | Material Modification to Rights of Securityholders. |
To the extent required by Item 3.03 of Form 8-K,
the information contained in Items 5.03 and 8.01 of this Current Report on Form 8-K is incorporated by reference into this Item 3.03.
| Item 5.03 | Amendments to Articles of Incorporation or Bylaws; Change in Fiscal Year. |
Certificate of Designation
On March 2, 2026, the Company filed a Certificate
of Designation of Preferences, Rights and Limitations (the “Certificate of Designation”) of the Series C Non-Voting Convertible
Preferred Stock, par value $0.0001 per share, (the “Series C Preferred Stock”) with the Secretary of State of the State
of Delaware in connection with the Unleash Registration Rights Agreement referenced in Item 8.01 below. The Certificate of Designation
provides for the designation of shares of the Series C Preferred Stock.
Holders of Series C Preferred Stock are not
entitled to receive dividends on shares of Series C Preferred Stock. Except as otherwise required by law, the Series C Preferred
Stock does not have voting rights. However, as long as any shares of Series C Preferred Stock are outstanding, the Company will not,
without the affirmative vote of the holders of a majority of the then-outstanding shares of the Series C Preferred Stock, (i) alter
or change adversely the powers, preferences or rights given to the Series C Preferred Stock or alter or amend the Certificate of
Designation, amend or repeal any provision of, or add any provision to, the Amended and Restated Certificate of Incorporation of the Company,
as amended (the “Charter”) or the Amended and Restated Bylaws of the Company, as amended, or file any articles of amendment,
certificate of designations, preferences, limitations and relative rights of any series of Preferred Stock, if such action would adversely
alter or change the preferences, rights, privileges or powers of, or restrictions provided for the benefit of the Series C Preferred
Stock, regardless of whether any of the foregoing actions shall be by means of amendment to the Charter or by merger, consolidation, recapitalization,
reclassification, conversion or otherwise, or (ii) issue further shares of Series C Preferred Stock, or increase or decrease
(other than by conversion) the number of authorized shares of Series C Preferred Stock.
The Series C Preferred Stock shall rank on
parity with the Company’s common stock, par value $0.0001 per share, (“Common Stock”), the Company’s Series A
Non-Voting Convertible Preferred Stock, par value $0.0001 per share, and the Company’s Series B Non-Voting Convertible
Preferred Stock, par value $0.0001 per share, as to distributions of assets upon liquidation, dissolution or winding-up of the Company,
whether voluntarily or involuntarily.
Each share of Series C Preferred Stock will
be convertible at any time and from time to time into one share of Common Stock following the third business day after the Unleash Stockholder
Approval (defined below), subject to certain limitations provided in the Certificate of Designation, including that the Company shall
not affect any conversion of Series C Preferred Stock into shares of Common Stock if, as a result of such conversion, such holder,
together with its affiliates, would beneficially own more than a specified percentage of the total number of shares of Common Stock issued
and outstanding immediately after giving effect to such conversion (the “Beneficial Ownership Limitation”). Notwithstanding
the foregoing, prior to receipt by the Company of the Unleash Stockholder Approval, the Company shall not be required to effect any conversion
of the Series C Preferred Stock.
The Company shall not effect any conversion of
any share of Series C Preferred Stock, to the extent that, after giving effect to such attempted conversion, such stockholder would
beneficially own a number of shares of Common Stock in excess of the Beneficial Ownership Limitation, which shall initially be set at
4.99% for each holder. Holders of the Series C Preferred Stock may adjust or waive the Beneficial Ownership Limitation upon written
notice to the Company upon the earlier of (i) the receipt of the Unleash Stockholder Approval and (ii) the consummation of a
Fundamental Transaction (as defined in the Certificate of Designation).
The foregoing description of the Series C
Preferred Stock and Certificate of Designation does not purport to be complete and is qualified in its entirety by reference to the full
text of the Certificate of Designation, a copy of which is filed as Exhibit 3.1 to this Current Report on Form 8-K and is incorporated
herein by reference.
| Item 7.01 | Regulation FD Disclosure. |
On March 3, 2026, the Company issued a press
release announcing its entering into the transactions with Unleash, as described more fully in Items 5.03 and 8.01 of this Current Report
on Form 8-K.
The information in this Item 7.01 of this Current
Report on Form 8-K, including the information in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K,
is furnished pursuant to Item 7.01 of Form 8-K and shall not be deemed “filed” for the purposes of Section 18 of
the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section. Furthermore,
the information in this Item 7.01 of this Current Report on Form 8-K, shall not be deemed to be incorporated by reference in the
filings of the Company under the Securities Act.
| Item 8.01 | Other Information |
On
March 2, 2026, the Company, entered into an Exclusive Licensing Agreement (the “Licensing Agreement”) with Unleash Immuno
Oncolytics, Inc., a Delaware corporation (“Unleash”), pursuant to which the Company acquired a pre-clinical candidate
program involving genetically-engineered adenoviruses to harness the immune system to fight cancer, as well as an exclusive, perpetual,
irrevocable, worldwide, fully-paid up, royalty-free, sublicensable right and license to related technology. As consideration for the Licensing
Agreement, pursuant to an Equity Issuance and Registration Rights Agreement with Unleash (the “Unleash Registration Rights
Agreement”), the Company agreed to issue 1,136,364 shares of its Series C Preferred Stock to Unleash. The Series C Preferred
Stock is not convertible until the Company’s stockholders approve the conversion of the Series C Non-Voting Preferred Stock
into shares of Common Stock in accordance with the listing rules of Nasdaq (the “Unleash Stockholder Approval”). Following
the Unleash Stockholder Approval, each share of Series C Preferred Stock is convertible into one share of the Company’s Common
Stock, as described above. The powers, preferences, rights, qualifications, limitations and restrictions applicable to the Series C
Preferred Stock are set forth in the Certificate of Designation. Pursuant to the Unleash Registration Rights Agreement, the Company agreed
to file a Form S-3 registration statement registering the shares issued under the Unleash Registration Rights Agreement and to use
commercially reasonable efforts to cause such registration statement to be declared effective by the Securities and Exchange Commission
as soon as practicable after such registration statement is filed. The Company also granted Unleash customary demand registration and
indemnification rights and entered into customary issuer covenants.
Tungsten Advisors (together with its affiliates,
“Tungsten”) acted as the financial advisor to the Company in connection with the Licensing Agreement. As compensation for
services rendered by Tungsten, the Company issued to Tungsten and its affiliates and designees an aggregate of 77,841 shares of Series C
Preferred Stock.
Important Information and Where to Find It
The Company expects to file a proxy statement
with the Securities and Exchange Commission (the “SEC”) regarding the approval of the issuance of Common Stock upon conversion
of the Series C Preferred Stock in accordance with the rules of the Nasdaq Stock Market LLC (the “Unleash Issuance Proposal”).
The definitive proxy statement will be sent to all Company stockholders. Before making any voting decision, investors and securityholders
of the Company are urged to read the proxy statement and all other relevant documents filed or that will be filed with the SEC in connection
with the stockholder meeting at which the Unleash Issuance Proposal will be considered as such documents become available because they
will contain important information about the Unleash Issuance Proposal to be voted upon. Investors and securityholders will be able to
obtain free copies of the proxy statement and all other relevant documents filed or that will be filed with the SEC by the Company through
the website maintained by the SEC at www.sec.gov.
Participants in Solicitation
The Company and its respective directors, executive
officers, and employees may be deemed to be participants in the solicitation of proxies in respect of the Unleash Issuance Proposal. Information
regarding the Company’s directors and executive officers is available in the Company’s Definitive Proxy Statement filed with
the SEC on July 15, 2025, under “Proposal No. 1 - Election of Directors” and in this Current Report on Form 8-K.
Information regarding the persons who may, under the rules of the SEC, be deemed participants in the proxy solicitation and a description
of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement and other relevant
materials to be filed with the SEC when they become available.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits.
| Exhibit Number |
|
Description |
| 3.1 |
|
Certificate of Designation of Series C Non-Voting Convertible Preferred Stock of TransCode Therapeutics, Inc., dated March 2, 2026. |
| |
|
|
| 99.1 |
|
Press Release of TransCode Therapeutics, Inc., dated March 3, 2026 (furnished herewith). |
| |
|
|
| 104 |
|
Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101) |
SIGNATURES
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. |
| |
|
|
| |
By: |
/s/ Thomas A. Fitzgerald |
| |
Name: |
Thomas A. Fitzgerald |
| |
Title: |
Chief Financial Officer and Secretary |
| March 3, 2026 |
|
|
Exhibit 99.1
TransCode Secures Exclusive, Worldwide, Fully Paid-Up Royalty-Free
License to Develop and Commercialize a Next-Generation Oncolytic Immunotherapy Platform in an All-Stock Transaction Underscoring the Company’s
Dedication to Improving the Lives of Cancer Patients
| · | TransCode adds a unique adenovirus technology platform to its early-stage pipeline that has the potential to address a difficult
to treat disease such as muscle-invasive bladder cancer. |
BOSTON, March 3, 2026 – TransCode Therapeutics, Inc.
(NASDAQ: RNAZ), a clinical stage company pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer, today
announced that it has entered into an exclusive, worldwide, fully paid-up royalty-free license agreement with Unleash Immuno Oncolytics, Inc.
(“Unleash”). TransCode obtained the rights to develop three Unleash drug candidates, UIO-524, UIO-525 and UIO-526, which includes
a license of all in-licensed rights held by Unleash to the Unleash drug candidates together with the acquisition of all rights to the
drug candidates owned by Unleash. Under the terms of the exclusive license agreement, Unleash will receive a one-time payment of 1,136,364
shares of a new series of non-voting convertible preferred stock of TransCode, convertible into an equal number of shares of common stock
of TransCode (the “Preferred Stock”). The Preferred Stock represents 6.8% of TransCode’s common stock on a fully diluted
basis assuming conversion of all TransCode preferred stock outstanding.
The lead candidate UIO-524 complements and expands TransCode’s
oncology pipeline by introducing a next-generation, biology-driven oncolytic immunotherapy platform designed to address solid tumor indications
with high-unmet medical need, beginning with muscle-invasive bladder cancer (MIBC).
MIBC is a significant unmet medical need indication with poor outcomes,
limited durable treatment options, and a highly immunosuppressive tumor microenvironment. Bladder cancer represents a multi-billion-dollar
global market, with muscle-invasive disease accounting for a disproportionate share of treatment intensity and healthcare costs, creating
what TransCode believes is a compelling opportunity for differentiated therapeutic approaches.
Dr. Philippe P. Calais, Pharm.D., Ph.D., Chairman and CEO of TransCode,
stated that “As we are advancing our lead asset, TTX-MC138, into a clinical Phase 2a trial, expanding our pipeline with an innovative
preclinical technology such as UIO-524 provides us with an additional shot on goal using a next generation oncolytic immunotherapy candidate
intended to address a large and attractive market in more aggressive settings such as MIBC.”
Tungsten Advisors acted as the exclusive financial advisor.
About Unleash and the Licensing Transaction
UIO-524 is a rationally designed oncolytic adenovirus engineered to
selectively replicate within both malignant cells and cancer-associated stroma. The virus delivers a multi-cytokine immune-activating
payload comprising CD40-L, 4-1BBL, and IL-21, intended to activate dendritic cells, T cells, and NK cells, and to drive a robust, systemic
anti-tumor immune response. UIO-524 is regulated by a proprietary SPARC promoter that is highly active in malignant cells and cancer-associated
stromal compartments and which enables biology-driven differentiation. This design enables selective viral replication and localized expression
of immune-activating cytokines within the tumor microenvironment.
UIO-524 builds on CG Oncology's CG0070, the most clinically advanced
and successful oncolytic adenovirus to date, demonstrating meaningful activity in non–muscle-invasive bladder cancer (NMIBC). UIO-524
contains a structurally related oncolytic adenovirus backbone, incorporates tumor- and stroma-targeted replication and contains a more
comprehensive, multi-cytokine immune payload. This design positions UIO-524 as a next-generation oncolytic immunotherapy candidate intended
to address more aggressive disease settings such as MIBC.
A more detailed description of the financing and licensing agreements
can be found in TransCode’s Form 8-K filed with the U.S Securities and Exchange Commission.
About TTX-MC138
TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit
microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode's
Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic
activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.
About TransCode Therapeutics
TransCode Therapeutics, Inc. is a clinical stage company
pioneering immuno-oncology and RNA for the treatment of high risk and advanced cancer. 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 has a portfolio of other first-in-class therapeutic candidates designed to mobilize the immune system to recognize and destroy
cancer cells.
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 TransCode’s technology and collaborations, statements concerning the therapeutic potential of TransCode’s TTX-MC138
and other therapeutic candidates, statements concerning the benefits of the licensing transaction and the opportunity in MIBC. 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
