SELLAS Life Sciences Group Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits
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| ITEM 7.01 | REGULATION FD DISCLOSURE. |
On December 10, 2024, SELLAS Life Sciences Group, Inc. (the “Company”) issued a press release (the “Press Release”) announcing the triggering of an interim analysis to be conducted by the Independent Data Monitoring Committee (“IDMC”) in its Phase 3 REGAL trial of galinpepimut-S (“GPS”) in acute myeloid leukemia (“AML”). A copy of the Press Release is included as Exhibit 99.1 hereto and is incorporated by reference herein.
Additionally, on December 10, 2024, the Company hosted a webcast to review the process leading up to the IDMC meeting and the potential outcomes of the REGAL interim analysis. The webcast is available athttps://viavid.webcasts.com/starthere.jsp?ei=1697841&tp_key=5e3028bd5c, and the transcript of the webcast is included as Exhibit 99.2 hereto.
The information disclosed under this Item 7.01, including Exhibits 99.1 and 99.2 hereto, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall they be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended, except as expressly set forth in such filing.
The Press Release and transcript contain forward-looking statements. Such forward-looking statements can be identified by the use of the words “expect,” “believe,” “will,” “anticipate,” “estimate,” “plan,” “project” and other words of similar import. These statements include, without limitation, statements related to the GPS clinical development program, including the REGAL study and the timing of future milestones related thereto. These forward-looking statements are based on current plans, objectives, estimates, expectations, and intentions, and inherently involve significant risks and uncertainties. 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, without limitation, risks and uncertainties with oncology product development and clinical success thereof, the uncertainty of regulatory approval, and other risks and uncertainties affecting the Company and its development programs as set forth under the caption “Risk Factors” in SELLAS’ Annual Report on Form 10-K filed on March 28, 2024 and in its other filings with the U.S. Securities and Exchange Commission. Other risks and uncertainties of which the Company is not currently aware may also affect the Company forward-looking statements and may cause actual results and the timing of events to differ materially from those anticipated. The forward-looking statements herein are made only as of the date hereof. The Company undertakes no obligation to update or supplement any forward-looking statements to reflect actual results, new information, future events, changes in its expectations, or other circumstances that exist after the date as of which the forward-looking statements were made.
| ITEM 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit Number |
Description | |
| 99.1 | Press Release, dated December 10, 2024. | |
| 99.2 | SELLAS Life Sciences Group, Inc. Transcript of the Webcast, dated December 10, 2024. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
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.
| SELLAS Life Sciences Group, Inc. | |||
| Date: December 10, 2024 | By: | /s/ John T. Burns | |
| Name: | John T. Burns | ||
| Title: | Senior Vice President, Chief Financial Officer | ||