الإحصائيات الأساسية
| LEI | 529900RVC1I52VWB3G55 |
| CIK | 894158 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Theriva Biologics, Inc.
SEC Filings (Chronological Order)
توفر هذه الصفحة قائمة كاملة ومرتبة ترتيبًا زمنيًا لتصريحات هيئة الأوراق المالية والبورصات، باستثناء تصريحات الملكية التي نقدمها في مكان آخر.
| September 4, 2025 |
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): August 29, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| September 4, 2025 |
AMENDMENT NO. 3 TO THE THERIVA BIOLOGICS, INC. 2020 STOCK INCENTIVE PLAN Dated: August 29, 2025 Exhibit 10.1 AMENDMENT NO. 3 TO THE THERIVA BIOLOGICS, INC. 2020 STOCK INCENTIVE PLAN Dated: August 29, 2025 WHEREAS, the Board of Directors (the “Board”) of Theriva Biologics, Inc. f/k/a Synthetic Biologics, Inc. (the “Company”) heretofore established the Synthetic Biologics, Inc. 2020 Stock Incentive Plan (the “Plan”); and WHEREAS, the Board desires to amend the Plan to increase the maximum numb |
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| August 11, 2025 |
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): August 11, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| August 11, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| August 11, 2025 |
Exhibit 99.1 Theriva™ Biologics Reports Second Quarter 2025 Operational Highlights and Financial Results - Released positive topline data from the VIRAGE Phase 2b study of VCN-01 (zabilugene almadenorepvec); expanded data to be presented at the European Society for Medical Oncology (ESMO) 2025 Congress in October - - VCN-01 demonstrates potential in retinoblastoma with Phase 1 safety and clinical |
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| July 9, 2025 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defi |
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| June 25, 2025 |
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): June 25, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fil |
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| June 20, 2025 |
Financial Statements and Exhibits, Other Events 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): June 20, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fil |
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| June 20, 2025 |
Up to $2,534,352 of Shares Common Stock Filed Pursuant to Rule 424(b)(5) Registration Statement No. 333-279077 Prospectus Supplement (To Prospectus dated September 25, 2024) Up to $2,534,352 of Shares Common Stock We have entered into an Amended and Restated At Market Issuance Sales Agreement, dated February 9, 2021, as amended by Amendment No. 1 thereto, dated May 3, 2021, as further amended by Amendment No. 2 thereto, dated May 2, 202 |
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| June 2, 2025 |
Exhibit 99.1 P - 161: A PHASE I DOSE - ESCALATION STUDY TO ASSESS THE ONCOLYTIC VIRUS VCN - 01 SAFETY AND EFFICACY IN REFRACTORY RETINOBLASTOMA PATIENTS Jaume Catalá - Mora1,*, Jaume Mora 1,2 , Margarida Simao 1 , Francis Munier 3 , Livia Romero 4 , Ligia Fu 5 , Jesus Ardila 6 , Ida Russo 7 , Karina Senyase Zamarripa 8 , Jesús Díaz - Cascajosa 1 , Eduard Pedemonte - Sarrias 1 , Marina Barraso - Ro |
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| June 2, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): May 27, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 14, 2025 |
Exhibit 99.1 Theriva™ Biologics Reports First Quarter 2025 Operational Highlights and Financial Results - VCN-01 Achieves Primary Efficacy and Safety Endpoints for Pancreatic Ductal Adenocarcinoma in VIRAGE Phase 2b Clinical Trial - - Closed a public offering on May 8, 2025, raising the Company’s cash balance and extending its cash runway into the first quarter of 2026 - Rockville, MD, May 14, 202 |
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| May 14, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| May 14, 2025 |
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): May 14, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 8, 2025 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits, Other Events 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): May 7, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 8, 2025 |
Form of Securities Purchase Agreement Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of May 7, 2025, between Theriva Biologics, Inc., a Nevada corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set |
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| May 8, 2025 |
Exhibit 4.1 COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: May 8, 2025 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the “Initial Exercise D |
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| May 8, 2025 |
Exhibit 1.1 PLACEMENT AGENCY AGREEMENT May 7, 2025 Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, MD 20850 Attention: Steven A. Shallcross Dear Mr. Shallcross: This letter (the “Agreement”) constitutes the agreement between A.G.P./Alliance Global Partners, as placement agent (the “Placement Agent”), and Theriva Biologics, Inc., a company incorporated under the laws of the |
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| May 8, 2025 |
PROSPECTUS Filed Pursuant to Rule 424(b)(5) Registration No. 333-283722 1,990,900 Shares of Common Stock 6,818,180 Common Warrants to Purchase Up to 6,818,180 Shares of Common Stock 4,827,280 Pre-Funded Warrants to Purchase Up to 4,827,280 Shares of Common Stock 11,645,460 Shares of Common Stock Underlying the Common Warrants and Pre-Funded Warrants We are offering on a best efforts basis 1,990,90 |
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| May 8, 2025 |
Theriva Biologics Announces Pricing of $7.5 Million Public Offering Exhibit 99.1 Theriva Biologics Announces Pricing of $7.5 Million Public Offering ROCKVILLE, Md., May 7, 2025 (GLOBE NEWSWIRE) - Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the pricing of its “reasonable best efforts” publ |
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| May 8, 2025 |
Theriva Biologics Announces Closing of $7.5 Million Public Offering Exhibit 99.2 Theriva Biologics Announces Closing of $7.5 Million Public Offering ROCKVILLE, Md., May 8, 2025 (GLOBE NEWSWIRE) - Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the closing of its previously announced “reasonab |
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| May 8, 2025 |
Exhibit 4.2 PRE-FUNDED COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: May 8, 2025 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (t |
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| May 7, 2025 |
Exhibit 99.1 Theriva™ Biologics Announces Primary Endpoints for Efficacy and Safety Achieved in VIRAGE Phase 2b Clinical Trial of VCN-01 with Gemcitabine/nab-Paclitaxel in Newly-Diagnosed Metastatic Pancreatic Cancer Patients - Patients treated with VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy had increased overall survival, progression fre |
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| May 7, 2025 |
VIRAGE Phase 2b Clinical Trial of VCN - 01 in Pancreatic Cancer 07 May 2025 Exhibit 99.2 VIRAGE Phase 2b Clinical Trial of VCN - 01 in Pancreatic Cancer 07 May 2025 2 FORWARD LOOKING STATEMENTS This presentation contains forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . In some cases forward - looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates |
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| May 7, 2025 |
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): May 7, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 5, 2025 |
May 5, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tamika Sheppard Re: Theriva Biologics, Inc. Registration Statement on Form S-1 File No. 333-283722 Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations promulgated under the Securities Act of 1933, as amended (the “Act” |
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| May 5, 2025 |
May 5, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| March 31, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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 31, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| March 31, 2025 |
Exhibit 99.1 Theriva™ Biologics Announces Positive Outcomes from the Second Meeting of the Independent Data Monitoring Committee for VIRAGE, the Company’s Phase 2b Clinical Trial of VCN-01 in Combination with Chemotherapy for Metastatic Pancreatic Ductal Adenocarcinoma (PDAC) – The independent data monitoring committee (IDMC) considered VCN-01 to be well tolerated in metastatic PDAC patients treat |
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| March 21, 2025 |
As filed with the Securities and Exchange Commission on March 21, 2025 As filed with the Securities and Exchange Commission on March 21, 2025 Registration No. |
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| March 6, 2025 |
Exhibit 10.36 EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (the “Agreement”) between Theriva Biologics, Inc., a Nevada corporation, (the “Company”), and Steven A. Shallcross (the “Executive”) is effective as of March 3, 2025 (the “Effective Date”) and replaces and supersedes the employment agreement between the Executive and the Company dated January 3, 2022 as amended December 15, 2022 (the “Pr |
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| March 6, 2025 |
THERIVA BIOLOGICS, INC. SUBSIDIARIES Exhibit 21.1 THERIVA BIOLOGICS, INC. SUBSIDIARIES The following table lists all of the subsidiaries of Theriva Biologics, Inc. and the jurisdiction of incorporation of each subsidiary. Each subsidiary does business under its corporate name indicated in the table. Subsidiary Name Ownership Jurisdiction of Incorporation Pipex Therapeutics, Inc. Wholly owned Delaware Effective Pharmaceuticals, Inc. W |
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| March 6, 2025 |
Exhibit 19.1 AMENDED AND RESTATED CORPORATE TRADING POLICY March 1, 2025 THERIVA PHARMACEUTICALS, INC. CORPORATE TRADING POLICY I. PREAMBLE A. This document (this “Policy”) contains the policy of Theriva Biologics, Inc., a Nevada corporation, and its subsidiaries (the “Company,”“Theriva” or “we”), concerning the Trading of Theriva Securities, as defined below. This Policy is intended to preserve t |
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| March 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission file number: 001-12584 THERIVA BIOLOGICS, INC. |
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| March 6, 2025 |
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 6, 2025 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fil |
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| March 6, 2025 |
Exhibit 99.1 Theriva™ Biologics Reports Full-Year 2024 Operational Highlights and Financial Results – Enrollment completed in VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC); topline data expected in Q2 2025 – – VCN-01 development bolstered by FDA award of Fast Track designation for the treatment of PDAC and Rare Pediatric Disease designation for reti |
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| January 23, 2025 |
January 23, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tamika Sheppard Re: Theriva Biologics, Inc. Registration Statement on Form S-1 File No. 333-283722 Ladies and Gentlemen: Reference is made to our letter, filed as correspondence via EDGAR on January 21, 2025, in which we, as Sole Placement Agent fo |
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| January 23, 2025 |
January 23, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| January 21, 2025 |
Form of Placement Agency Agreement Exhibit 1.4 PLACEMENT AGENCY AGREEMENT [], 2025 Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, MD 20850 Attention: Steven A. Shallcross Dear Mr. Shallcross: This letter (the “Agreement”) constitutes the agreement between A.G.P./Alliance Global Partners, as placement agent (the “Placement Agent”), and Theriva Biologics, Inc., a company incorporated under the laws of the Sta |
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| January 21, 2025 |
As filed with the Securities and Exchange Commission on January 21, 2025 As filed with the Securities and Exchange Commission on January 21, 2025 Registration No. |
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| January 21, 2025 |
January 21, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| January 21, 2025 |
Form of Securities Purchase Agreement Exhibit 10.36 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of [●], 2025, between Theriva Biologics, Inc., a Nevada corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditions set f |
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| January 21, 2025 |
January 21, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Tamika Sheppard Re: Theriva Biologics, Inc. Registration Statement on Form S-1 File No. 333-283722 Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations promulgated under the Securities Act of 1933, as amended (the |
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| December 10, 2024 |
Exhibit 4.6 PRE-FUNDED COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: December [ ], 2024 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date he |
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| December 10, 2024 |
Consent of Parsons Behle & Latimer (included in Exhibit 5.1(a)) Exhibit 5.1(a) December 10, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center, Suite 270 Rockville, MD 20850 Re: Registration Statement on Form S-1 Gentlemen: We have acted as special Nevada counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with the preparation and filing with the Securities and Exchange Commission (the “Commission”) purs |
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| December 10, 2024 |
Form of Securities Purchase Agreement Exhibit 10.36 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of December [●], 2024, between Theriva Biologics, Inc., a Nevada corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditi |
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| December 10, 2024 |
Form of Placement Agency Agreement Exhibit 1.4 PLACEMENT AGENCY AGREEMENT December [], 2024 Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, MD 20850 Attention: Steven A. Shallcross Dear Mr. Shallcross: This letter (the “Agreement”) constitutes the agreement between A.G.P./Alliance Global Partners, as placement agent (the “Placement Agent”), and Theriva Biologics, Inc., a company incorporated under the laws o |
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| December 10, 2024 |
As filed with the Securities and Exchange Commission on December 10, 2024 As filed with the Securities and Exchange Commission on December 10, 2024 Registration No. |
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| December 10, 2024 |
Exhibit 107 Calculation of Filing Fee Table S-1 (Form Type) Theriva Biologics, Inc. |
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| December 10, 2024 |
Exhibit 4.5 COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: December [ ], 2024 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the “Initial Exe |
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| December 10, 2024 |
Consent of Blank Rome LLP (included in Exhibit 5.1(b)) Exhibit 5.1(b) 1271 Avenue of the Americas | New York, NY 10020 blankrome.com December 10, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center, Suite 270 Rockville, MD 20850 Re: Registration Statement on Form S-1 Ladies and Gentlemen: We have acted as counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with the preparation and filing with the |
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| December 5, 2024 |
Exhibit 99.1 Theriva™ Biologics Announces U.S. FDA Guidance on Design of Phase 3 Study of VCN-01 for the Treatment of Metastatic Pancreatic Cancer Rockville, MD, December 5, 2024 – Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the outcomes of a recent |
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| December 5, 2024 |
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): December 5, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| November 20, 2024 |
As filed with the Securities and Exchange Commission on November 20, 2024 As filed with the Securities and Exchange Commission on November 20, 2024 Registration No. |
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| November 20, 2024 |
Calculation of Filing Fee Table Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Theriva Biologics, Inc. |
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| November 12, 2024 |
Exhibit 99.1 Theriva™ Biologics Reports Third Quarter 2024 Operational Highlights and Financial Results Target patient enrollment of 92 evaluable patients achieved in the VIRAGE Phase 2b clinical trial of VCN-01 in patients with metastatic pancreatic ductal adenocarcinoma Manufacturing funding awarded by the Spanish Government’s National Knowledge Transfer Program Data and Safety Monitoring Commit |
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| November 12, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| November 12, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): November 12, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| November 1, 2024 |
Exhibit 10.1 AMENDMENT NO. 2 TO THE THERIVA BIOLOGICS, INC. 2020 STOCK INCENTIVE PLAN Dated: October 31, 2024 WHEREAS, the Board of Directors (the “Board”) of Synthetic Biologics, Inc. (the “Company”) heretofore established the Synthetic Biologics, Inc. 2020 Stock Incentive Plan (the “Plan”); and WHEREAS, the Board desires to amend the Plan to increase the maximum number of shares of common stock |
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| November 1, 2024 |
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): October 31, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| November 1, 2024 |
Exhibit 3.1 BARBARA K. CEGAVSKE Secretary of State 202 North Carson Street Carson City, Nevada 89701-4201 (775) 684-5708 Website: www.nvsos.gov Certificate of Change Pursuant to NRS 78.209 TYPE OR PRINT - USE DARK INK ONLY - DO NOT HIGHLIGHT INSTRUCTIONS: 1. Enter the current name as on file with the Nevada Secretary of State and enter the Entity or Nevada Business Identification Number (NVID). 2. |
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| October 16, 2024 |
Exhibit 99.1 Theriva Biologics Announces Orphan Medicinal Product Designation Granted by the European Commission to VCN-01 for the Treatment of Retinoblastoma Rockville, MD, October 16, 2024 – Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announ |
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| October 16, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): October 16, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| October 3, 2024 |
Exhibit 99.1 Theriva™ Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients DSMC has reviewed the safety and pharmacokinetic data from Cohort 2 and recommended that the study proceed to enroll patients into Cohort 3 Rockville, MD, October 03, 2024 – Ther |
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| October 3, 2024 |
EX-99.1 2 ea021664501ex99-1theriva.htm JOINT FILING AGREEMENT Exhibit 1 JOINT FILING AGREEMENT The undersigned acknowledge and agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the necessity of filing additional joint filing a |
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| October 3, 2024 |
TOVX / Theriva Biologics, Inc. / INTRACOASTAL CAPITAL, LLC - SCHEDULE 13G Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Theriva Biologics, Inc. (Name of Issuer) Common stock, par value $0.001 per share (Title of Class of Securities) 87164U5083 (CUSIP Number) September 26, 2024 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate th |
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| October 3, 2024 |
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): October 3, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| October 2, 2024 |
TOVX / Theriva Biologics, Inc. / CVI Investments, Inc. - SC 13G Passive Investment CUSIP No: 87164U508 SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G (Rule 13d-102) INFORMATION TO BE INCLUDED IN STATEMENTS FILED PURSUANT TO § 240.13d-1(b), (c) AND (d) AND AMENDMENTS THERETO FILED PURSUANT TO § 240.13d-2. (Amendment No. )* Theriva Biologics, Inc. (Name of Issuer) Common Stock, $0.001 par value per share (Title of Class of Securities) 87164U508 (CUSIP Numbe |
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| October 2, 2024 |
CUSIP No: 87164U508 Exhibit I LIMITED POWER OF ATTORNEY THIS LIMITED POWER OF ATTORNEY given on the 16th day of July, 2015 by CVI Investments, Inc. |
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| October 2, 2024 |
CUSIP No: 87164U508 EXHIBIT II JOINT FILING AGREEMENT This will confirm the agreement by and among the undersigned that the Schedule 13G filed with the Securities and Exchange Commission on or about the date hereof with respect to the beneficial ownership by the undersigned of the shares of common stock of Theriva Biologics, Inc. |
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| September 30, 2024 |
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): September 26, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commissio |
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| September 30, 2024 |
EXHIBIT 4.2 PRE-FUNDED COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: September 27, 2024 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date he |
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| September 30, 2024 |
Exhibit 1.1 PLACEMENT AGENCY AGREEMENT September 26, 2024 Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, MD 20850 Attention: Steven A. Shallcross Dear Mr. Shallcross: This letter (the “Agreement”) constitutes the agreement between A.G.P./Alliance Global Partners, as placement agent (the “Placement Agent”), and Theriva Biologics, Inc., a company incorporated under the laws |
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| September 30, 2024 |
EXHIBIT 4.1 COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: September 27, 2024 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date hereof (the “Initial Exe |
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| September 30, 2024 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of September 26, 2024, between Theriva Biologics, Inc., a Nevada corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and conditio |
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| September 30, 2024 |
Theriva Biologics Announces Pricing of $2.5 Million Public Offering Exhibit 99.1 Theriva Biologics Announces Pricing of $2.5 Million Public Offering ROCKVILLE, Md., Sept. 26, 2024 (GLOBE NEWSWIRE) - Theriva Biologics, Inc. (NYSE American: TOVX) (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the pricing of its “reasonable best effor |
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| September 30, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) x Definitive Proxy Sta |
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| September 27, 2024 |
Filed Pursuant to Rule 424(b)(5) PROSPECTUS Reg. No. 333-282024 918,600 Shares of Common Stock 1,428,600 Common Warrants to Purchase Up to 1,428,600 Shares of Common Stock 510,000 Pre-Funded Warrants to Purchase Up to 510,000 Shares of Common Stock Up to 1,938,600 Shares of Common Stock Underlying the Common Warrants and Pre-Funded Warrants We are offering on a best efforts basis 918,600 shares of |
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| September 26, 2024 |
$200,000,000 THERIVA BIOLOGICS, INC. Common Stock Preferred Stock Debt Securities Filed Pursuant to Rule 424(b)(5) PROSPECTUS Reg. No. 333-279077 $200,000,000 THERIVA BIOLOGICS, INC. Common Stock Preferred Stock Debt Securities Warrants Units We may, from time to time, offer and sell up to $200,000,000 of any combination of our common stock, par value $0.001 (the “common stock”), preferred stock, par value $0.001 (the “preferred stock”), debt securities, warrants or units descr |
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| September 23, 2024 |
Corporate Overview September 2024 Exhibit 99.1 Corporate Overview September 2024 2 FORWARD LOOKING STATEMENTS This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . In some cases forward - looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates ," "intends," "plans," "believes," "estim |
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| September 23, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): September 23, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commissio |
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| September 23, 2024 |
Exhibit 99.2 Theriva™ Biologics Achieves Target Patient Enrollment in the VIRAGE Phase 2b Trial of VCN-01 with Gemcitabine/nab-Paclitaxel for the Treatment of Metastatic Pancreatic Cancer - Target of 92 evaluable patients (46 in each of the control and VCN-01 treatment arms) enrolled across 15 sites in Spain and the USA within 21 months – Rockville, MD, September 23, 2024 – Theriva™ Biologics, Inc |
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| September 23, 2024 |
September 23, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| September 23, 2024 |
As filed with the Securities and Exchange Commission on September 23, 2024 As filed with the Securities and Exchange Commission on September 23, 2024 Registration No. |
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| September 20, 2024 |
September 20, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| September 18, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: x Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ¨ Definitive Proxy Sta |
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| September 16, 2024 |
Exhibit 99.1 Theriva™ Biologics Awarded Manufacturing Funding from the Spanish Government’s National Knowledge Transfer Program - Theriva Biologics and the Universitat Autònoma de Barcelona to receive a total of €2.28 Million to support the THERICEL project, a suspension cell platform for manufacturing viral-based therapies – Rockville, MD, September 16, 2024 – Theriva™ Biologics (NYSE American: T |
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| September 16, 2024 |
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): September 16, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commissio |
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| September 11, 2024 |
As filed with the Securities and Exchange Commission on September 11, 2024 As filed with the Securities and Exchange Commission on September 11, 2024 Registration Statement No. |
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| September 11, 2024 |
Consent of Blank Rome LLP (included in Exhibit 5.1(b)) Exhibit 5.1(b) 1271 Avenue of the Americas |New York, NY 10020 blankrome.com September 11, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, Maryland 20850 Re: Theriva Biologics, Inc. Ladies and Gentlemen: We have acted as counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with its filing on the date hereof with |
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| September 11, 2024 |
Consent of Parsons Behle & Latimer (included in Exhibit 5.1(a)) Exhibit 5.1(a) September 11, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, Maryland 20850 Re: Registration Statement on Form S-3 Gentlemen: We have acted as special Nevada counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with its filing on the date hereof with the Securities and Exchange Commission (the “C |
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| September 10, 2024 |
Form of Placement Agency Agreement Exhibit 1.4 PLACEMENT AGENCY AGREEMENT [•], 2024 Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, MD 20850 Attention: Steven A. Shallcross Dear Mr. Shallcross: This letter (the “Agreement”) constitutes the agreement between A.G.P./Alliance Global Partners, as placement agent (the “Placement Agent”), and Theriva Biologics, Inc., a company incorporated under the laws of the St |
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| September 10, 2024 |
Consent of Parsons Behle & Latimer (included in Exhibit 5.1(a)) Exhibit 5.1(a) September 9, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center, Suite 270 Rockville, MD 20850 Re: Registration Statement on Form S-1 Gentlemen: We have acted as special Nevada counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with the preparation and filing with the Securities and Exchange Commission (the “Commission”) purs |
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| September 10, 2024 |
Consent of Blank Rome LLP (included in Exhibit 5.1(b)) Exhibit 5.1(b) 1271 Avenue of the Americas | New York, NY 10020 blankrome.com September 10, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center, Suite 270 Rockville, MD 20850 Re: Registration Statement on Form S-1 Ladies and Gentlemen: We have acted as counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with the preparation and filing with th |
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| September 10, 2024 |
Exhibit 107 Calculation of Filing Fee Table S-1 (Form Type) Theriva Biologics, Inc. |
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| September 10, 2024 |
EXHIBIT 4.3 COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: [●], 2024 Initial Exercise Date: [●], 2029 THIS COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time on or after the date |
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| September 10, 2024 |
EXHIBIT 4.4 PRE-FUNDED COMMON STOCK PURCHASE WARRANT Theriva Biologics, Inc. Warrant Shares: Issue Date: [●], 2024 Initial Exercise Date: [●], 2024 THIS PRE-FUNDED COMMON STOCK PURCHASE WARRANT (the “Warrant”) certifies that, for value received, or its assigns (the “Holder”) is entitled, upon the terms and subject to the limitations on exercise and the conditions hereinafter set forth, at any time |
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| September 10, 2024 |
As filed with the Securities and Exchange Commission on September 10, 2024 As filed with the Securities and Exchange Commission on September 10, 2024 Registration No. |
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| September 10, 2024 |
Form of Securities Purchase Agreement Exhibit 10.34 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is dated as of September [•], 2024, between Theriva Biologics, Inc., a Nevada corporation (the “Company”), and each purchaser identified on the signature pages hereto (each, including its successors and assigns, a “Purchaser” and collectively the “Purchasers”). WHEREAS, subject to the terms and condit |
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| September 9, 2024 |
Financial Statements and Exhibits, Other Events 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): September 6, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| August 26, 2024 |
Exhibit 3.1 Filed in the Office of Secretary of State State Of Nevada Business Number E0776232008-6 Filing Number 20244272749 Filed On 8/22/2024 11:28:00 AM Number of Pages 1 |
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| August 26, 2024 |
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): August 22, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| August 16, 2024 |
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): August 15, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| August 16, 2024 |
Theriva Biologics Announces Reverse Stock Split Exhibit 99.1 Theriva Biologics Announces Reverse Stock Split Rockville, MD, August 16, 2024 – Theriva Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, announced today a reverse stock split of its issued and outstanding common stock, par value $0.001 per share, at a ratio of one (1) share of c |
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| August 13, 2024 |
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): August 13, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| August 13, 2024 |
Exhibit 99.1 Theriva™ Biologics Reports Second Quarter 2024 Operational Highlights and Financial Results - VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), is expected to complete enrollment in the third quarter of 2024- - Received Fast Track Designation (FTD) Granted by the U.S. Food and Drug Administration (FDA |
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| August 13, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| July 31, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): July 30, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fil |
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| July 31, 2024 |
Exhibit 99.1 Theriva™ Biologics Receives Rare Pediatric Drug Designation by the U.S. FDA for VCN-01 for the Treatment of Retinoblastoma Rockville, MD, July 31, 2024 – Theriva™ Biologics, Inc. (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Drug Admin |
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| May 23, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): May 23, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 23, 2024 |
Exhibit 99.1 Theriva™ Biologics Announces Fast Track Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Metastatic Pancreatic Cancer Rockville, MD, May 23, 2024 – Theriva™ Biologics (NYSE American: TOVX), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food and Dru |
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| May 16, 2024 |
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): May 13, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 7, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| May 7, 2024 |
Exhibit 99.1 Theriva™ Biologics Reports First Quarter 2024 Operational Highlights and Financial Results - Reported topline data from the investigator sponsored Phase 1 trial of intravitreal VCN-01 in pediatric patients with refractory retinoblastoma; trial results were determined to be positive by the study Monitoring Committee- -Presented preclinical data demonstrating the potential synergy betwe |
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| May 7, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): May 7, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 2, 2024 |
Consent of Blank Rome LLP (included in Exhibit 5.1(b)) Exhibit 5.1(b) 1271 Avenue of the Americas |New York, NY 10020 blankrome.com May 2, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, Maryland 20850 Re: Theriva Biologics, Inc. Ladies and Gentlemen: We have acted as counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with its filing on the date hereof with the Se |
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| May 2, 2024 |
Consent of Parsons Behle & Latimer (included in Exhibit 5.1(a)) Exhibit 5.1(a) May 2, 2024 The Board of Directors Theriva Biologics, Inc. 9605 Medical Center Drive, Suite 270 Rockville, Maryland 20850 Re: Registration Statement on Form S-3 Gentlemen: We have acted as special Nevada counsel to Theriva Biologics, Inc., a Nevada corporation (the “Company”), in connection with its filing on the date hereof with the Securities and Exchange Commission (the “Commissi |
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| May 2, 2024 |
Exhibit 10.3 AMENDMENT NO. 2 TO AMENDED AND RESTATED AT MARKET ISSUANCE SALES AGREEMENT May 2, 2024 A.G.P./Alliance Global Partners 590 Madison Ave. New York, NY 10022 Ladies and Gentlemen: Theriva Biologics, Inc. (formerly known as Synthetic Biologics, Inc.) (the “Company”) and A.G.P./Alliance Global Partners (the “Agent”) are parties to that certain Amended and Restated At Market Issuance Sales |
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| May 2, 2024 |
Calculation of Filing Fee Table Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) THERIVA BIOLOGICS, INC. |
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| May 2, 2024 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits 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): May 2, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 2, 2024 |
Exhibit 4.3 THERIVA BIOLOGICS, INC. Issuer AND [TRUSTEE], Trustee INDENTURE Dated as of , 202 Debt Securities TABLE OF CONTENTS PAGE ARTICLE 1 DEFINITIONS 1 Section 1.01 Definitions of Terms 1 ARTICLE 2 ISSUE, DESCRIPTION, TERMS, EXECUTION, REGISTRATION AND EXCHANGE OF SECURITIES 5 Section 2.01 Designation and Terms of Securities 5 Section 2.02 Form of Securities and Trustee’s Certificate 8 Sectio |
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| May 2, 2024 |
As filed with the Securities and Exchange Commission on May 2, 2024 As filed with the Securities and Exchange Commission on May 2, 2024 Registration Statement No. |
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| April 23, 2024 |
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): April 23, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| April 23, 2024 |
Exhibit 99.1 Theriva™ Biologics Announces Positive Topline Data from Investigator Sponsored Phase 1 Trial of Intravitreal VCN-01 in Pediatric Patients with Refractory Retinoblastoma –Phase 1 trial in collaboration with Sant Joan de Déu-Barcelona Children’s Hospital (SJD) determined to have a positive outcome by the study Monitoring Committee– –Safety and clinical outcomes support the therapeutic p |
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| April 22, 2024 |
2024 ASGCT Abstract, version 4 Exhibit 99.2 2024 ASGCT Abstract, version 4 Section F2: Cancer: Oncolytic Viruses Title: Enhanced Anti-Tumor Efficacy of Combination Therapy with the Oncolytic Adenovirus, VCN-01, and Liposomal Irinotecan in Human Pancreatic Mouse Xenografts Authors: Maria V. Maliandi1, Paz Moreno1, Ramon Alemany1,2, Manel Cascallo1, Sheila Connelly3, Ana Mato-Berciano1 Affiliations: 1Theriva Biologics, S.L., Barc |
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| April 22, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): April 22, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| April 22, 2024 |
Exhibit 99.1 Theriva™ Biologics to Present Preclinical Data Supporting the Potential Synergy of VCN-01 and First-Line Pancreatic Cancer Chemotherapy Regimens at the American Society for Cell and Gene Therapy 27th Annual Meeting – Lead product candidate, VCN-01 in combination with liposomal irinotecan demonstrated enhanced anti-tumor effects in a human pancreatic mouse xenograft– – The observed syn |
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| April 16, 2024 |
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): April 16, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| April 16, 2024 |
Exhibit 99.1 Corporate Overview April 2024 2 FORWARD LOOKING STATEMENTS This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . In some cases forward - looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates ," "intends," "plans," "believes," "estimates |
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| March 25, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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 25, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| March 25, 2024 |
Exhibit 99.1 Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results – The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma (PDAC), with no safety concerns raised - - VIRAGE remains on track to complete enrollment |
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| March 25, 2024 |
Exhibit 4.3 DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED Theriva Biologics, Inc. (the “Registrant,” “we,” “us,” and “our”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which is the Registrant’s common stock, par value $0.001 per share (the “Common St |
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| March 25, 2024 |
EXHIBIT 10.8 DATE OF LEASE EXECUTION: April 14, 2015 (To be completed by Landlord) ARTICLE I - REFERENCE DATA A.SUBJECTS REFERRED TO: Each reference in this Lease to any of the following subjects shall be construed to incorporate the data stated for that subject in this Section 1.1: LANDLORD: MCC3, LLC, a Delaware limited liability company MANAGING AGENT: Jones Lang LaSalle Americas, Inc. LANDLORD |
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| March 25, 2024 |
Exhibit 97.1 THERIVA BIOLOGICS, INC. CLAWBACK POLICY The Board of Directors (the “Board”) of Theriva Biologics, Inc. (the “Company”) has determined that it is in the best interests of the Company to adopt this Clawback Policy (this “Policy”), which provides for the recovery of certain incentive compensation in the event of an Accounting Restatement (as defined below). This Policy is designed to co |
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| March 25, 2024 |
Exhibit 19.1 AMENDED AND RESTATED CORPORATE TRADING POLICY March 4, 2024 THERIVA PHARMACEUTICALS, INC. CORPORATE TRADING POLICY I. PREAMBLE A. This document (this “Policy”) contains the policy of Theriva Biologics, Inc., a Nevada corporation, and its subsidiaries (the “Company,”“Theriva” or “we”), concerning the Trading of Theriva Securities, as defined below. This Policy is intended to preserve t |
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| March 25, 2024 |
Exhibit 21.1 THERIVA BIOLOGICS, INC. SUBSIDIARIES The following table lists all of the subsidiaries of Theriva Biologics, Inc. and the jurisdiction of incorporation of each subsidiary. Each subsidiary does business under its corporate name indicated in the table. Subsidiary Name Ownership Jurisdiction of Incorporation Pipex Therapeutics, Inc. Wholly owned Delaware Effective Pharmaceuticals, Inc. W |
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| March 25, 2024 |
EXHIBIT 10.26 EMPLOYMENT AGREEMENT This Employment Agreement (the “Agreement”), dated April 8, 2022 by and between Synthetic Biologics, Inc., a corporation organized under the laws of the State of Nevada (the “Corporation”) and Mary Ann Shallcross, an individual (the “Employee”). 1. EMPLOYMENT: DUTIES (a)General Duties. The Employee shall serve as the Director of Clinical Operations of the Corpora |
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| March 25, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission file number: 001-12584 THERIVA BIOLOGICS, INC. |
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| March 25, 2024 |
Exhibit 10.19 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [*****], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE THAT THE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. SECOND AMENDMENT TO LEASE THIS SECOND AMENDMENT TO LEASE (“this Second Amendment”) is dated as of May 6, 2021 (“Effective Date”), by and between ARE-MARYLAND NO. 50, LLC, a Dela |
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| February 7, 2024 |
Exhibit 99.1 Theriva Biologics Announces Positive Recommendation from the Independent Data Monitoring Committee of VIRAGE, the Phase 2b Clinical Trial of VCN-01 in Combination with Chemotherapy for Metastatic Pancreatic Ductal Adenocarcinoma – The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE with no safety concerns raised; VIRAGE remains on track to complete |
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| February 7, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): February 7, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| January 8, 2024 |
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): January 8, 2024 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| January 8, 2024 |
Corporate Overview 08 January 2024 Exhibit 99.1 Corporate Overview 08 January 2024 2 FORWARD LOOKING STATEMENTS This presentation includes forward - looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 . In some cases forward - looking statements can be identified by terminology such as "may," "should," "potential," "continue," "expects," "anticipates ," "intends," "plans," "believes," "esti |
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| November 13, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| November 13, 2023 |
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): November 13, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| November 13, 2023 |
Exhibit 99.1 Theriva™ Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results - VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for metastatic Pancreatic Ductal Adenocarcinoma remains on track to complete enrollment in the first half of 2024; multiple patients have received second doses of VCN-01, which continues to be well tolerated with a |
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| October 23, 2023 |
Exhibit 99.2 937P Survival outcomes in Phase I trial combining VCN-01 and Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma refractory to previous immunotherapy treatment. Background Jove Maria1 , Braña Irene2 , Oliva Marc1 , Hernando Alberto 2 , Erasun Carlos 1 , Assaf Juan David 2 , Mato-Berciano Ana 3 , Maliandi Maria Victoria 3 , Torres-Manjon Si |
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| October 23, 2023 |
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): October 23, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| October 23, 2023 |
Exhibit 99.1 Theriva™ Biologics Presents Survival Outcomes Data from Phase 1 Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck at ESMO Congress 2023 -Results show enhanced patient survival, correlating with VCN-01 mediated increases in the CPS score, a key determinant of outcomes with anti-PD-(L)1 checkpoint in |
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| October 17, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): October 16, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| October 17, 2023 |
Exhibit 99.2 Abstract 6207 Survival outcomes in Phase I trial combining VCN-01 and Durvalumab (MEDI4736) in Subjects With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma refractory to previous immunotherapy treatment Type: Abstract Category:Head and neck cancer, excl. thyroid Authors: M. Jové1, I. Braña2, M. Oliva Bernal1, A. Hernando Calvo2, C. Erasun Lecuona1, J.D. Assaf Pastrana2, A. |
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| October 17, 2023 |
Exhibit 99.1 Theriva™ Biologics Announces Presentation at ESMO Congress 2023 Featuring Survival Outcomes in Phase 1 Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck -Results from investigator-sponsored study in collaboration with the Institut Catala d’Oncologia (ICO) show enhanced patient survival, correlatin |
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| October 3, 2023 |
Financial Statements and Exhibits, Submission of Matters to a Vote of Security Holders 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): October 2, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| August 16, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A AMENDMENT NO. 1 Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) x Defini |
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| August 14, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ¨ Check the appropriate box: ¨ Preliminary Proxy Statement ¨ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) x Definitive Proxy State |
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| August 11, 2023 |
Exhibit 3.1 SECOND AMENDED AND RESTATED BY-LAWS OF THERIVA BIOLOGICS, INC. (a Nevada corporation) Adopted: August 9, 2023 Effective: October 3, 2023 ARTICLE 1 STOCKHOLDERS 1.01 Annual Meetings. An annual meeting of stockholders shall be held for the election of Directors at such date, time and place either within or without the State of Nevada as may be designated by the Board of Directors from ti |
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| August 11, 2023 |
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): August 9, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| August 8, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): August 8, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| August 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| August 8, 2023 |
Exhibit 99.1 Theriva™ Biologics Reports Second Quarter 2023 Operational Highlights and Financial Results - Initiated dosing at U.S. sites for VIRAGE, the Phase 2b clinical trial of VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma -Second doses of intravenous VCN-01 administered to patients in Spain and were well tolerated with a safety profile consistent with prior clin |
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| August 2, 2023 |
Exhibit 99.1 Theriva™ Biologics Announces Key Progress in VIRAGE, an Ongoing, Multinational Phase 2b Trial of VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma - Initiated dosing at U.S. sites for VIRAGE - -Second doses of intravenous VCN-01 administered to patients in Spain and were well tolerated - -VIRAGE remains on track to complete enrollment in the first quarter of |
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| August 2, 2023 |
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): August 2, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| June 27, 2023 |
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): June 27, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fil |
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| June 27, 2023 |
Exhibit 99.1 Theriva Biologics Announces Orphan Drug Designation Granted by the U.S. FDA for VCN-01 for the Treatment of Pancreatic Cancer Rockville, MD, July 27, 2023 – Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced that the U.S. Food |
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| May 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| May 11, 2023 |
EXHIBIT 10.2 CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS BOTH (I) NOT MATERIAL AND (II) IS THE TYPE REGISTRANT TREATS AS PRIVATE OR CONFIDENTIAL. CONSULTING AGREEMENT This Consulting Agreement (this “Agreement”), dated May 10, 2023 (the “Effective Date”), is by and between Theriva Biologics, Inc. (“Company”), and Francis Tufaro (“Ser |
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| May 11, 2023 |
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): May 11, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission File |
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| May 11, 2023 |
EX-99.1 2 tm2315037d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Theriva Biologics Reports First Quarter 2023 Operational Highlights and Financial Results - Continued to enroll patients in VIRAGE, the Phase 2b clinical trial of systemically administered VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma – - Presented data from the ongoing Phase 1b/2a clinical trial of SYN-004 (r |
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| May 11, 2023 |
EXHIBIT 10.1 SEPARATION AGREEMENT AND RELEASE This Separation Agreement and Release (“Agreement”), dated May 8, 2023, is made by and between Francis Tufaro (“Employee”) and Theriva Biologics, Inc. (“Theriva”, or the “Company”) (collectively referred to as the “Parties” or individually referred to as a “Party”). RECITALS WHEREAS, Employee was employed by the Company; WHEREAS, Employee signed an Emp |
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| March 30, 2023 |
Exhibit 99.1 Theriva Biologics Reports Fourth Quarter and Full-Year 2022 Operational Highlights and Financial Results - Dosed the first patient in VIRAGE, a Phase 2b clinical trial of systemically administered VCN-01 in combination with chemotherapy for Pancreatic Ductal Adenocarcinoma – -Dosed the first patient in the investigator sponsored Phase 1 clinical trial of VCN-01 for patients with brain |
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| March 30, 2023 |
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 30, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| March 30, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 For the transition period from to Commission file number: 001-12584 THERIVA BIOLOGICS, INC. |
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| March 30, 2023 |
Exhibit 21.1 THERIVA BIOLOGICS, INC. SUBSIDIARIES The following table lists all of the subsidiaries of Theriva Biologics, Inc. and the jurisdiction of incorporation of each subsidiary. Each subsidiary does business under its corporate name indicated in the table. Subsidiary Name Ownership Jurisdiction of Incorporation Pipex Therapeutics, Inc. Wholly owned Delaware Effective Pharmaceuticals, Inc. W |
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| March 30, 2023 |
Description of Securities of Theriva Biologics, Inc.(1) Exhibit 4.4 DESCRIPTION OF SECURITIES REGISTERED PURSUANT TO SECTION 12 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED Theriva Biologics, Inc. (the “Registrant,” “we,” “us,” and “our”) has one class of securities registered under Section 12 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which is the Registrant’s common stock, par value $0.001 per share (the “Common St |
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| March 10, 2023 |
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 8, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fil |
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| February 16, 2023 |
Exhibit 99.2 • SYN-004 is an orally administered, β-lactamase enzyme designed to preserve the intestinal microbiome in patients receiving IV β-lactam antibiotics. • A previous study among patients with lower respiratory tract infections receiving ceftriaxone plus SYN-004 vs. placebo found decreased risk of Clostridioides difficile infection (CDI) among the SYN-004 group.1 • Patients who received S |
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| February 16, 2023 |
Exhibit 99.1 Theriva Biologics Announces Presentation of Safety and Pharmacokinetic Data from Cohort 1 of the Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients - Data presented at the 2023 Tandem Meetings: Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR - -Analysis of patients receiving meropenem suggest that SYN-004 is well-t |
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| February 16, 2023 |
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): February 16, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| January 17, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): January 17, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| January 17, 2023 |
EX-99.1 2 tm233585d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Theriva Biologics Announces First Patient Dosed in VIRAGE, a Phase 2b Trial of Systemically Administered VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma -Initiation of Phase 2b trial follows clearance from the US Food and Drug Administration (FDA) and Spanish Agency for Medicines and Health Products (AEMPS)- -The |
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| January 9, 2023 |
Exhibit 99.1 Theriva Biologics Announces Dosing of First Patient in the Investigator Sponsored Phase 1 Trial of VCN-01, an Intravenous Oncolytic Adenovirus, in Patients with Brain Tumors -Clinical trial is being conducted at St. James’s University Hospital, United Kingdom, in collaboration with the University of Leeds- Rockville, MD, January 9, 2023 – Theriva Biologics (NYSE American: TOVX), (“The |
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| January 9, 2023 |
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): January 9, 2023 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| December 23, 2022 |
Exhibit 10.1? ? SHARE REPURCHASE AGREEMENT ? This Share Repurchase Agreement is entered into effective as of December?20, 2022, by and among Theriva Biologics,?Inc. located at 9605 Medical Center Drive, Suite?270, Rockville, Maryland 20850 (the ?Corporation?) and [] with an address at (the ?Selling Stockholder?). ? WHEREAS, Selling Stockholder desires to sell to the Corporation Two Hundred Forty T |
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| December 23, 2022 |
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): December 20, 2022 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| December 20, 2022 |
Exhibit 10.1 AMENDMENT NO. 1 TO EMPLOYMENT AGREEMENT This Amendment (this “Amendment”) dated as of December 15, 2022 (the “Effective Date”) amends the Employment Agreement, dated January 3, 2022 (the “Agreement”) by and between Theriva Biologics, Inc. f/k/a Synthetic Biologics, Inc. (the “Corporation”) and Steven A. Shallcross (“Executive”). Capitalized terms used herein without definition shall h |
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| December 20, 2022 |
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): December 15, 2022 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| December 20, 2022 |
Exhibit 10.2 AMENDMENT NO. 1 TO EMPLOYMENT AGREEMENT This Amendment (this “Amendment”) dated as of December 15, 2022 (the “Effective Date”) amends the Employment Agreement, dated March 22, 2022 (the “Agreement”) by and between Theriva Biologics, Inc. f/k/a Synthetic Biologics, Inc. (the “Corporation”) and Francis Tufaro (“Executive”). Capitalized terms used herein without definition shall have the |
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| December 5, 2022 |
Up to $5,986,000 of Shares Common Stock Filed Pursuant to Rule 424(b)(5) Registration Statement No. 333-255726 Prospectus Supplement (To Prospectus dated May 11, 2021) Up to $5,986,000 of Shares Common Stock We have entered into the Amended and Restated At Market Issuance Sales Agreement, dated February 9, 2021, as amended by Amendment No. 1 thereto, dated May 3, 2021 (the ?Sales Agreement?), with B. Riley Securities, Inc. (?B. Riley?), |
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| December 5, 2022 |
As filed with the Securities and Exchange Commission on December 5, 2022 As filed with the Securities and Exchange Commission on December 5, 2022 Registration No. |
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| November 10, 2022 |
Exhibit 99.1 Theriva Biologics Reports Third Quarter 2022 Operational Highlights and Financial Results -Reported encouraging clinical data supporting the differentiated mode-of action of Theriva?s novel oncolytic adenovirus (OV) platform- -Received clearance from the Federal Drug Administration (FDA) and Spanish Competent Authority (AEMPS) for the planned Phase 2 clinical trial of systemically adm |
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| November 10, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ? ? ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? For the quarterly period ended September 30, 2022 OR ? ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 ? For the transition period from to Commission File Number: 001-12584 THERIVA BIOLOGICS, INC. |
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| November 10, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): November 10, 2022 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| October 17, 2022 |
Calculation of Filing Fee Table EX-FILING FEES 5 tm2228292d1ex107.htm EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Theriva Biologics, Inc. (Exact Name of Registrant as Specified in its Charter) Table1 – Newly Registered Securities Security Type Security Class Title Fee Calculation Rule Amount Registered(1)(2) Proposed Maximum Offering Price per Unit(3) Maximum Aggregate Offering Price Fee Rate |
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| October 17, 2022 |
As filed with the Securities and Exchange Commission on October 17, 2022 As filed with the Securities and Exchange Commission on October 17, 2022 Registration No. |
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| October 12, 2022 |
Exhibit 99.1 Synthetic Biologics Rebrands as Theriva Biologics -Rebrand solidifies sharpened clinical development strategy to advance unique oncolytic viruses optimized for intravenous (IV) administration - Rockville, MD, October 12, 2022 ? Theriva Biologics, Inc. (NYSE American: TOVX), (?Theriva? or the ?Company?) is the new name of Synthetic Biologics, Inc. (NYSE American: SYN). The new name, lo |
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| October 12, 2022 |
Exhibit 3.3 AMENDED AND RESTATED BY-LAWS OF THERIVA BIOLOGICS, INC. (a Nevada corporation) Adopted and Effective: October 12, 2022 ARTICLE 1 STOCKHOLDERS 1.01 Annual Meetings. An annual meeting of stockholders shall be held for the election of Directors at such date, time and place either within or without the State of Nevada as may be designated by the Board of Directors from time to time. Any ot |
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| October 12, 2022 |
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): October 11, 2022 THERIVA BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| October 12, 2022 |
Exhibit 3.2 Filed in the Office of Secretary of State State Of Nevada Business Number E0776232008-6 Filing Number 20222683054 Filed On 10/11/2022 11:43:00 AM Number of Pages 1 |
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| October 12, 2022 |
Exhibit 3.1 Filed in the Office of Secretary of State State Of Nevada Business Number E0776232008-6 Filing Number 20222683090 Filed On 10/11/2022 11:43:00 AM Number of Pages 2 |
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| October 3, 2022 |
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): September 30, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commiss |
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| September 30, 2022 |
Exhibit 99.1 Synthetic Biologics Announces Presentation at SIOP International Society of Pediatric Oncology on New Preclinical Data Supporting Evaluation of VCN-01 and Topotecan for the Treatment of Refractory Retinoblastoma - Preclinical results demonstrated that topotecan treatment enhanced VCN-01 oncolytic activity against retinoblastoma- Rockville, MD, September 30, 2022 ? Synthetic Biologics, |
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| September 30, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): September 30, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commiss |
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| September 27, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): September 27, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commiss |
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| September 27, 2022 |
Exhibit 99.1 Synthetic Biologics Announces Positive Outcome of Data and Safety Monitoring Committee (DSMC) Review in Phase 1b/2a Clinical Trial of SYN-004 (ribaxamase) in Allogeneic Hematopoietic Cell Transplant Recipients - The DSMC has reviewed the safety and pharmacokinetic data from Cohort 1 and recommended that the study may proceed to enroll patients into Cohort 2 - Rockville, MD, September |
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| September 16, 2022 |
2,459,017 Shares of Common Stock Filed Pursuant to Rule 424(b)(3) Registration No. 333-267294 PROSPECTUS 2,459,017 Shares of Common Stock The selling stockholder of Synthetic Biologics, Inc. (?Synthetic,? ?we,? ?us? or the ?Company?) identified in this prospectus, including its pledgees, donees, transferees, assigns or other successors in interest, may offer and resell under this prospectus up to 2,459,017 shares of common stock, |
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| September 12, 2022 |
September 12, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N. |
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| September 12, 2022 |
Exhibit 99.1 0 - 1 C o nc o m ita n t Se q u e nti al 1 2 p=0,022 Value K ep ↑ K ep marker T2 relaxation time (n=20) No differences. The percentile 25% of T2, was close to be statistically significant, (p - value =0.06349) • DWI biomarkers (n=16) (D* & D, perfusion & diffusion components, respectively) No differences between treatment arms • DCE biomarkers (n=11): • V transfer constant plasm |
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| September 12, 2022 |
Financial Statements and Exhibits, Other Events 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): September 12, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commiss |
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| September 6, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): September 5, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commissi |
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| September 6, 2022 |
Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K/A AMENDMENT NO. 2 TO CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 6, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of inc |
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| September 6, 2022 |
Exhibit 99.1 Synthetic Biologics Announces Presentation at ESMO Congress 2022 Describing Phase 1 Investigator-sponsored Study Evaluating VCN-01 in Combination with Durvalumab in Patients with Recurrent/ Metastatic Squamous Cell Carcinoma of the Head and Neck -Treatment with VCN-01 in combination with durvalumab demonstrated an acceptable safety profile and encouraging biological activity- Rockvill |
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| September 6, 2022 |
Calculation of Filing Fee Tables Exhibit 107 Calculation of Filing Fee Tables S-3 (Form Type) Synthetic Biologics, Inc. |
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| September 6, 2022 |
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION Exhibit 99.3 UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION On December 14, 2021, Synthetic Biologics, Inc. (the ?Company? or the ?Buyer?) entered into a Share Purchase Agreement (the ?Agreement? or ?SPA?) with VCN Biosciences, S.L. (?VCN?) and each of VCN?s shareholders (the ?Sellers ?) pursuant to which the Company would purchase 100% of VCN?s capital stock in exchange for total co |
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| September 6, 2022 |
As filed with the Securities and Exchange Commission on September 6, 2022 As filed with the Securities and Exchange Commission on September 6, 2022 Registration No. |
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| August 16, 2022 |
TABLE OF CONTENTS UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? ? Conf |
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| August 11, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): August 11, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission |
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| August 11, 2022 |
EXHIBIT 10.2 Amendment No 1 to Securities Purchase Agreement This Amendment No. 1 to the Securities Purchase Agreement (the ?Amendment?) is dated as of August 9, 2022, between Synthetic Biologics, Inc., a Nevada corporation (the ?Company?), and MSD Credit Opportunity Master Fund, L.P. (including its successors and assigns, the ?Purchaser?) and amends the Securities Purchase Agreement (the ?Agreeme |
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| August 11, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of |
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| August 11, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ? ? ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? For the quarterly period ended June 30, 2022 OR ? ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 ? For the transition period from to Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. |
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| August 11, 2022 |
Exhibit 99.1 Synthetic Biologics Reports Second Quarter 2022 Operational Highlights and Financial Results -Prioritizing the advancement of novel oncolytic adenovirus (OV) platform- -Cash balance as of August 1, 2022 of $53.5 million, including the additional $3 million in gross proceeds from convertible preferred financing extends funding for business operations into Q1 2024- -Conference call and |
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| August 3, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A (RULE 14a-101) INFORMATION REQUIRED IN PROXY STATEMENT SCHEDULE 14A INFORMATION Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 Filed by the Registrant x Filed by a Party other than the Registrant ? Check the appropriate box: x Preliminary Proxy Statement ? Confidential, for Use of |
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| August 3, 2022 |
Material Modification to Rights of Security Holders, Financial Statements and Exhibits 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): July 29, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| August 1, 2022 |
Press Release issued by Synthetic Biologics, Inc., dated July 29, 2022 Exhibit 99.1 Synthetic Biologics Announces $3 Million Private Placement of Convertible Preferred Stock Rockville, MD., July 29, 2022 ? Synthetic Biologics, Inc.. (NYSE American: SYN) (?Synthetic Biologics? or the ?Company?), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announced the private placement of 275,000 shares of |
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| August 1, 2022 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of July 28, 2022, between Synthetic Biologics, Inc., a Nevada corporation (the ?Company?), and MSD Credit Opportunity Master Fund, L.P. ( including its successors and assigns, the ?Purchaser?). RECITALS A. The Company and the Purchaser are executing and delivering this Agreement in reliance |
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| August 1, 2022 |
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): July 28, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| August 1, 2022 |
Form of Certificate of Designation of Series C Convertible Preferred Stock Exhibit 3.1 SYNTHETIC BIOLOGICS, INC. CERTIFICATE OF DESIGNATION OF SERIES C CONVERTIBLE PREFERRED STOCK PURSUANT TO SECTION 78.1955 OF THE NEVADA REVISED STATUTES The following is a statement of the voting powers, designations, preferences, limitations, restrictions and relative rights of ?Series C Convertible Preferred Stock? of Synthetic Biologics, Inc., a Nevada corporation (the ?Corporation?) |
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| August 1, 2022 |
Form of Certificate of Designation of Series D Convertible Preferred Stock Exhibit 3.2 SYNTHETIC BIOLOGICS, INC. CERTIFICATE OF DESIGNATION OF SERIES D CONVERTIBLE PREFERRED STOCK PURSUANT TO SECTION 78.1955 OF THE NEVADA REVISED STATUTES The following is a statement of the voting powers, designations, preferences, limitations, restrictions and relative rights of ?Series D Convertible Preferred Stock? of Synthetic Biologics, Inc., a Nevada corporation (the ?Corporation?) |
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| July 29, 2022 |
EX-3.2 3 tm2222078d1ex3-2.htm EXHIBIT 3.2 Exhibit 3.2 SYNTHETIC BIOLOGICS, INC. CERTIFICATE OF DESIGNATION OF SERIES D CONVERTIBLE PREFERRED STOCK PURSUANT TO SECTION 78.1955 OF THE NEVADA REVISED STATUTES The following is a statement of the voting powers, designations, preferences, limitations, restrictions and relative rights of “Series D Convertible Preferred Stock” of Synthetic Biologics, Inc. |
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| July 29, 2022 |
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): July 28, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| July 29, 2022 |
Synthetic Biologics Announces $3 Million Private Placement of Convertible Preferred Stock EX-99.1 5 tm2222078d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Synthetic Biologics Announces $3 Million Private Placement of Convertible Preferred Stock Rockville, MD., July 29, 2022 – Synthetic Biologics, Inc.. (NYSE American: SYN) (“Synthetic Biologics” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, today announc |
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| July 29, 2022 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This Securities Purchase Agreement (this ?Agreement?) is dated as of July 28, 2022, between Synthetic Biologics, Inc., a Nevada corporation (the ?Company?), and MSD Credit Opportunity Master Fund, L.P. ( including its successors and assigns, the ?Purchaser?). RECITALS A. The Company and the Purchaser are executing and delivering this Agreement in reliance |
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| July 29, 2022 |
Exhibit 3.1 SYNTHETIC BIOLOGICS, INC. CERTIFICATE OF DESIGNATION OF SERIES C CONVERTIBLE PREFERRED STOCK PURSUANT TO SECTION 78.1955 OF THE NEVADA REVISED STATUTES The following is a statement of the voting powers, designations, preferences, limitations, restrictions and relative rights of ?Series C Convertible Preferred Stock? of Synthetic Biologics, Inc., a Nevada corporation (the ?Corporation?) |
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| July 25, 2022 |
Exhibit 3.1 Filed in the Office of Secretary of State State Of Nevada Business Number E0776232008-6 Filing Number 20222494678 Filed On 7/21/2022 1:30:00 AM Number of Pages 1 |
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| July 25, 2022 |
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): July 21, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| July 15, 2022 |
Amended and Restated By-laws of Synthetic Biologics, Inc. Exhibit 3.1 AMENDED AND RESTATED BY-LAWS OF SYNTHETIC BIOLOGICS, INC. (a Nevada corporation) Adopted and Effective: July 11, 2022 ARTICLE 1 STOCKHOLDERS 1.01 Annual Meetings .. An annual meeting of stockholders shall be held for the election of Directors at such date, time and place either within or without the State of Nevada as may be designated by the Board of Directors from time to time. Any o |
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| July 15, 2022 |
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): July 11, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission F |
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| July 15, 2022 |
Synthetic Biologics Announces Reverse Stock Split EX-99.1 3 tm2218235d2ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Synthetic Biologics Announces Reverse Stock Split Rockville, MD, July 15, 2022 – Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing therapeutics designed to treat diseases in areas of high unmet need, announced today a reverse stock split of its issued and outstanding common stock, par value $0.0 |
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| July 14, 2022 |
Financial Statements and Exhibits, Other Events 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): July 8, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| May 16, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q Table of Contents ? ? UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ? ? ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 ? For the quarterly period ended March 31, 2022 OR ? ? ? ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES ACT OF 1934 ? For the transition period from to Commission File Number: 001-12584 SYNTHETIC BIOLOGICS, INC. |
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| May 16, 2022 |
Exhibit 99.1 Synthetic Biologics Reports First Quarter 2022 Operational Highlights and Financial Results -Encouraging data further supports the development of novel oncolytic adenovirus (OV) platform; Announced a peer-reviewed publication highlighting positive clinical data on VCN-01 and an upcoming oral presentation on VCN-11, a novel oncolytic adenovirus designed to evade neutralizing antibodies |
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| May 16, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): May 16, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| May 16, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition 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): May 16, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| May 16, 2022 |
Exhibit 99.1 Oncolytic Adenovirus With Hyaluronidase Activity That Evades Neutralizing Antibodies And Allows Re - administration: VCN - 11 Ana Mato - Berciano , Maria V. Maliandi , Sara Morgado , Marti Farrera - Sal, Paz Moreno, Rafael Moreno, Luis A. Rojas, Gabriel Capell? , Miriam Bazan - Peregrino , Manel Cascallo , and Ramon Alemany Virotherapy Group Disclosures R. Alemany is advisor and owns |
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| May 10, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events 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): May 10, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorporation) (Commission Fi |
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| May 10, 2022 |
Exhibit 99.1 Synthetic Biologics Reports Positive Safety Data on SYN-020 Intestinal Alkaline Phosphatase Phase 1 Multiple Ascending Dose Clinical Trial -Orally administered SYN-020 observed to be well tolerated across all doses in healthy volunteers- ROCKVILLE, MD ? May 10, 2022 (GLOBE NEWSWIRE) - Synthetic Biologics, Inc. (NYSE American: SYN), a diversified clinical-stage company developing thera |
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| May 6, 2022 |
UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION Exhibit 99.2 UNAUDITED PRO FORMA CONDENSED COMBINED FINANCIAL INFORMATION On December 14, 2021, Synthetic Biologics, Inc. (the ?Company? or the ?Buyer?) entered into a Share Purchase Agreement (the ?Agreement? or ?SPA?) with VCN Biosciences, S.L. (?VCN?) and each of VCN?s shareholders (the ?Sellers?) pursuant to which the Company would purchase 100% of VCN?s capital stock in exchange for total con |
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| May 6, 2022 |
Financial Statements and Exhibits, Completion of Acquisition or Disposition of Assets UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K/A AMENDMENT NO. 1 TO 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 10, 2022 SYNTHETIC BIOLOGICS, INC. (Exact name of registrant as specified in its charter) Nevada 001-12584 13-3808303 (State or other jurisdiction of incorp |
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| May 6, 2022 |
EX-99.1 3 tm2214400d1ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 KPMG Auditores, S.L. Torre Realia Plaça d’Europa, 41-43 08908 L’Hospitalet de Llobregat (Barcelona) Independent Auditor’s Report To the shareholders of VCN Biosciences, S.L. Opinion We have audited the financial statements of VCN Biosciences, S.L. (the Company), which comprise the statements of financial position as of December 31, 2021 and |
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| March 23, 2022 |
Exhibit 99.1 Synthetic Biologics Announces Management Transitions in Support of Strategic Transformation -Frank Tufaro, Ph.D., appointed as Chief Operating Officer of Synthetic Biologics, transitioning from Chief Operating Officer of VCN Biosciences- -Manel Cascall?, Ph.D., appointed as General Director of Synthetic Biologics? European Subsidiary, transitioning from Chief Operating Officer of VCN |
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| March 23, 2022 |
Exhibit 10.1 EXECUTION COPY EMPLOYMENT AGREEMENT This EMPLOYMENT AGREEMENT (the ?Agreement?) between Synthetic Biologics, Inc., a Nevada corporation, (the ?Company?), and Frank Tufaro (the ?Executive?) is effective as of March 22, 2022 (the ?Effective Date?). W I T N E S S E T H: WHEREAS, the Company desires to employ the Executive as its Chief Operating Officer and the Executive desires to accept |
