Theriva Biologics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
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Item 7.01. Regulation FD Disclosure.
On October 16, 2024, Theriva Biologics, Inc. (the “Company”) issued a press release announcing that the European Commission has adopted the European Medicines Agency (“EMA”) recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, the Company’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma.
The information in this Item 7.01 and in the press release furnished as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended and shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. The press release furnished as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
Item 8.01. Other Events.
On October 16, 2024, the Company issued a press release announcing that the European Commission has adopted the EMA recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, the Company’s systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| Exhibit Number |
Description | |
| 99.1 | Press Release issued by Theriva Biologics, Inc., dated October 16, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the 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.
| Dated: October 16, 2024 | THERIVA BIOLOGICS, INC. | ||
| By: | /s/ Steven A. Shallcross | ||
| Name: | Steven A. Shallcross | ||
| Title: | Chief Executive Officer and Chief Financial Officer | ||