TSBX Turnstone Biologics Corporation

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

Turnstone Biologics Corp.

(Exact name of Registrant as Specified in Its Charter)

(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:

Securities registered pursuant to Section 12(b) of the Act:

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 ☒

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 4, 2025, Turnstone Biologics Corp. (the “Company” or “Turnstone”) issued a press release related to the Company’s pursuit of strategic alternatives. The full text of the Company’s press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 attached hereto, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (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 or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01 Other Events.

On January 30, 2025, following a comprehensive evaluation of the Company’s business and the status of the Company’s programs, resources, and capabilities, the Company’s Board of Directors (the “Board”) approved the discontinuation of all clinical studies evaluating TIDAL-01 for all indications, and pursuit of strategic alternatives to enhance and preserve shareholder value, which may include exploration and evaluation of strategic options like a merger, reverse merger, other business combination, sale of assets, licensing, or other strategic transactions.

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. Forward-looking statements expressed or implied in this Current Report include, but are not limited to, statements including but not limited to statements regarding the Company’s plans to explore and evaluate strategic options to enhance and preserve shareholder value; and the Company’s ability to enter into any agreements or transactions in connection with the exploration of potential strategic alternatives, or if complete, that any such agreements or transactions will be successful or on attractive terms. All statements, other than statements of historical fact, contained in this Current Report, including statements regarding future events are forward-looking statements and can be identifies by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “may,” “plan,” “potential,” “should,” “target,” “will” or “would,” or the negative of these terms or other comparable terminology. These statements are based on the current plans, objectives, estimates, expectations and intentions, beliefs and assumptions of our management team, and on information currently available to such management team and are not guarantees of future performance and inherently involve numerous risks and uncertainties, many of which are beyond Turnstone’s control. Turnstone undertakes no obligation to update or revise publicly any of the forward-looking statements after the date hereof to conform the statements to actual results or changed expectations except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the Company’s ability to execute its planned exploration and evaluation of strategic alternatives; and unexpected demands on the Company’s cash resources; and other risks, including those described under the heading “Risk Factors” in Turnstone’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and other documents Turnstone has filed, or will file, with the SEC

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

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.

Turnstone Biologics Announces Plans to Explore Strategic Alternatives

SAN DIEGO, Feb. 04, 2025 (GLOBE NEWSWIRE) -- Turnstone Biologics Corp. (“Turnstone” or the “Company”) (Nasdaq: TSBX) today announced that it has completed an assessment of its business and operations, including the status of its program, resources, and capabilities. The Company has made the determination to discontinue all clinical studies evaluating TIDAL-01 and halt further development of the program. As a result, Turnstone’s management and its Board of Directors have initiated a process to explore and review strategic alternatives focused on maximizing shareholder value.

“Manufacturing for our Selected TIL therapy requires continued investment in process improvements. Due to these capital-intensive requirements and after careful review of future funding needs and the current financial markets, the Company has decided to discontinue development of TIDAL-01 and to conclude all clinical studies evaluating the program in solid tumors,” said Sammy Farah, M.B.A., Ph.D., Turnstone’s President and Chief Executive Officer.

Turnstone has engaged a financial advisor to assist in this process, and along with support from its other advisors, intends to explore potential strategic alternatives that may include, but are not limited to, an acquisition, merger, business combination, sale of assets, licensing, or other transactions. Turnstone does not intend to disclose further developments unless and until it is determined that further disclosure is appropriate or legally required.

In addition, Turnstone is reducing its workforce while also implementing further cost-containment and cash conservation measures. The Company intends to retain all employees essential for supporting value-realization as part of its strategic review.

“I would like to convey our deepest gratitude to the patients, investigators, and collaborators for their participation in our clinical development efforts. I also wish to sincerely thank the Turnstone team members who worked so tirelessly on this program, and our shareholders for their commitment to our Company,” concluded Dr. Farah.

About Turnstone

Turnstone Biologics is a clinical-stage biotechnology company with a differentiated approach to treat and cure patients with solid tumors by pioneering selected tumor-infiltrating lymphocyte (Selected TIL) therapy. Turnstone’s next-generation TIL therapy is based upon the identification, selection and expansion of the most potent tumor-reactive T cells, known as Selected TILs, and is designed to overcome the limitations of first-generation bulk TIL that have demonstrated objective responses only in limited tumor types. For additional information about Turnstone, please visit www.turnstonebio.com, and follow us on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding the Company’s plans to explore and evaluate strategic options to enhance and preserve shareholder value; the Company’s ability to enter into any agreements or transactions in connection with the exploration of potential strategic alternatives, or if complete, that any such agreements or transactions will be successful or on attractive terms; the Company’s plans to take such other actions as necessary to reduce cash burn, and potential benefits of its cash preservation activities. All statements, other than statements of historical fact, contained in this Current Report, including statements regarding future events are forward-looking statements and can be identifies by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “may,” “plan,” “potential,” “should,” “target,” “will” or “would,” or the negative of these terms or other comparable terminology. These statements are based on the current plans, objectives, estimates, expectations and intentions, beliefs and assumptions of our management team, and on information currently available to such management team and are not guarantees of future performance and inherently involve numerous risks and uncertainties, many of which are beyond Turnstone’s control. Turnstone undertakes no obligation to update or revise publicly any of the forward-looking statements after the date hereof to conform the statements to actual results or changed expectations except as required by law. The reader is cautioned not to place undue reliance on forward-looking statements. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these

risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: the Company’s ability to execute its planned exploration and evaluation of strategic alternatives; and unexpected demands on the Company’s cash resources; and other risks, including those described under the heading “Risk Factors” in Turnstone’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q and other documents Turnstone has filed, or will file, with the SEC.

Contact

Ahmed Aneizi

Investor Relations
Turnstone Biologics
(347) 897-5988
ahmed.aneizi@turnstonebio.com