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 April 17, 2026, Theriva Biologics, Inc. (the “Company”) issued a press release announcing an upcoming poster presentation of new data and subgroup analyses from the VIRAGE Phase 2b clinical trial evaluating VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel in newly-diagnosed metastatic pancreatic cancer patients at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from 17-22 April 2026.
| · | Presenting author: Dr. Manuel Hidalgo, NYU Langone Health Perlmutter Cancer Center, New York, NY |
| · | Title: Analysis of tumor and biomarker responses in the VIRAGE Trial, a randomized Phase IIb, open-label, study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC) |
| · | Poster #: CT162 |
| · | Date and time: Monday April 20, 2026, 2:00-5:00 PM US PDT |
| · | Session: PO.CT01.05 - Phase II and Phase III Clinical Trials |
| · | Location: San Diego Convention Center, Hall B, Section 52, Board 26. |
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 April 17, 2026, the Company issued a press release announcing an upcoming poster presentation of new data and subgroup analyses from the VIRAGE Phase 2b clinical trial evaluating VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel in newly-diagnosed metastatic pancreatic cancer patients at the American Association for Cancer Research (AACR) Annual Meeting to be held in San Diego, CA from 17-22 April 2026.
Details of the poster presentation are below:
| · | Presenting author: Dr. Manuel Hidalgo, NYU Langone Health Perlmutter Cancer Center, New York, NY |
| · | Title: Analysis of tumor and biomarker responses in the VIRAGE Trial, a randomized Phase IIb, open-label, study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC) |
| · | Poster #: CT162 |
| · | Date and time: Monday April 20, 2026, 2:00-5:00 PM US PDT |
| · | Session: PO.CT01.05 - Phase II and Phase III Clinical Trials |
| · | Location: San Diego Convention Center, Hall B, Section 52, Board 26. |
Included in the poster presentation are the conclusions set forth below.
| · | Patients receiving VCN-01 + gemcitabine/nab-paclitaxel (“GnP”) had improved overall survival and progressive free survival compared to GnP alone. The late separation of survival curves may reflect an immune-mediated mechanism of action. |
| · | Treatment with VCN-01 + GnP resulted in later-emerging, higher magnitude, and more durable responses than GnP alone. |
| · | The OS benefit of VCN-01 + GnP was generally maintained across subgroups including liver metastases, despite a post-recruitment imbalance. |
| · | Patients receiving a second administration of VCN-01 revealed a greater benefit in OS and PFS. |
The full poster for the presentation has been released by the American Association for Cancer Research. A copy of the poster presentation titled Analysis of tumor and biomarker responses in the VIRAGE Trial, a randomized Phase IIb, open-label, study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC)is filed as exhibit 99.2 to this Current Report on Form 8-K. and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
| (d) | Exhibits. |
| The following exhibit is furnished with this Current Report on Form 8-K. |
| Exhibit Number |
Description | |
| 99.1 | Press Release issued by Theriva Biologics, Inc., dated April 17, 2026 | |
| 99.2 | Poster Presentation titled “Analysis of tumor and biomarker responses in the VIRAGE Trial, a randomized Phase IIb, open-label, study of nab-paclitaxel and gemcitabine with/without intravenous VCN-01 in patients with metastatic pancreatic cancer (mPDAC)” | |
| 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: April 17, 2026 | THERIVA BIOLOGICS, INC. | ||
| By: | /s/ Steven A. Shallcross | ||
| Name: | Steven A. Shallcross | ||
| Title: | Chief Executive Officer and Chief Financial Officer | ||