Theriva Biologics Inc

Theriva Biologics, Inc. is a clinical stage company, which engages in the development of therapeutics to preserve the microbiome to protect and restore the health of patients. Its product portfolio includes SYN-020 and SYN-004. SYN-020 is intended to prevent the antibiotic-mediated microbiome damage, C. difficile infections (CDI), overgrowth of pathogenic organisms, the emergence of antimicrobial resistance (AMR) and acute graft-versus-host disease (aGVHD) in allogeneic HCT recipients. SYN-004 is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection, antibiotic-associated diarrhea, and the emergence of antimicrobial resistance. The company was founded by Steven H. Kanzer in January 2001 and is headquartered in Rockville, MD.

Earnings data Q1 2021

Earnings data Q2 2021

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

Earnings data Q3 2022

Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Revenue

Cost of revenue

Gross profit

Operating expenses

SG&A

Other

Operating income

EBITDA

Net income

Earnings per share

Total assets

Current assets

Cash & equivalents

Receivables

Inventory

Non-current assets

Net PPE

Intangibles

Total liabilities

Current liabilities

Short term debt

Income tax payable

Non-current liabilities

Long-term debt

Total equity

Stockholders equity

Minority interest

Total liabilities & equity

Total debt

Net debt

Book value per share

Cash from operations

Funds from operations

Change in working capital

Cash from investing

Capital expenditure

Purchase/sale of investments

Purchase/sale of business

Other sources

Cash from financing

Change in stock

Change in debt

Cash dividends paid

Cash from other sources

Net change in cash

Free cash flow

ROCKVILLE, Md., Dec. 05, 2024 (GLOBE NEWSWIRE) -- 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 Type D meeting with the U.S. Food and Drug Administration (FDA) to obtain guidance on the design of a Phase 3 clinical study of lead clinical candidate VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic pancreatic adenocarcinoma (PDAC). The Company recently announced the completion of target enrollment into the multinational VIRAGE Phase 2b clinical study evaluating intravenous VCN-01 in combination with gemcitabine/nab-paclitaxel as a first line therapy for PDAC patients.

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., Oct. 16, 2024 (GLOBE NEWSWIRE) -- 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 European Commission has adopted the European Medicines Agency (EMA) recommendation to grant orphan medicinal product designation to lead clinical candidate VCN-01, Theriva's systemic, selective, stroma-degrading oncolytic adenovirus, for the treatment of retinoblastoma. The United States Food and Drug Administration (FDA) has previously granted orphan drug designation and rare pediatric disease designation to VCN-01 for the treatment of retinoblastoma.

Theriva Biologics Announces Orphan Medicinal Product Designation Granted by the European Commission to VCN-01 for the Treatment of Retinoblastoma

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 efforts” public offering for the purchase and sale of up to 1,428,600 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 1,428,600 shares of common stock at a combined offering price of $1.75 per share and accompanying warrant (the “Offering”). The Company expects to receive aggregate gross proceeds of approximately $2.5 million, before deducting placement agent fees and other offering expenses, and assuming no exercise of the warrants. The warrants will have an exercise price of $2.00 per share, will be exercisable immediately and will expire five years from the issuance date.

Theriva Biologics Announces Pricing of $2.5 Million Public Offering

- 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 –

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

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 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

Theriva™ Biologics Awarded Manufacturing Funding from the Spanish Government's National Knowledge Transfer Program

ROCKVILLE, Md., Aug. 16, 2024 (GLOBE NEWSWIRE) -- 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 common stock for every twenty five (25) shares of common stock, effective as of 12:01 a.m. (Eastern Time) on August 26, 2024 (the “Effective Date”). The Company's common stock will begin trading on a split-adjusted basis when the market opens on August 26, 2024. The reverse stock split was authorized by the Company's Board of Directors on August 15, 2024. Pursuant to the laws of the State of Nevada, the Company's state of incorporation, the Company's Board of Directors has the authority to effect a reverse stock split without shareholder approval if the number of authorized shares of common stock and the number of outstanding shares of common stock are proportionally reduced. The Company will file a certificate of change to its articles of incorporation, as amended, with the Secretary of State of Nevada to effect the reverse stock split. The Company's common stock will continue to trade on the NYSE American under the stock ticker “TOVX” but will trade under the new CUSIP number 87164U 508.

Theriva Biologics Announces Reverse Stock Split

ROCKVILLE, Md., July 31, 2024 (GLOBE NEWSWIRE) -- 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 Administration (FDA) granted Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma. VCN-01, Theriva's lead product candidate, is a systemic, selective, stroma-degrading oncolytic adenovirus. Previously, the FDA granted orphan drug designation to VCN-01 for treatment of retinoblastoma.

Theriva™ Biologics Receives Rare Pediatric Drug Designation by the U.S. FDA for VCN-01 for the Treatment of Retinoblastoma

ROCKVILLE, Md., May 23, 2024 (GLOBE NEWSWIRE) -- 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 Drug Administration (FDA) has granted Fast Track Designation (FTD) to lead clinical candidate VCN-01 in combination with gemcitabine and nab-paclitaxel to improve progression-free survival and overall survival in patients with metastatic pancreatic adenocarcinoma. In VIRAGE, the ongoing multinational Phase 2b clinical study, intravenous VCN-01 is being evaluated in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with pancreatic ductal adenocarcinoma (PDAC). Previously, the FDA granted orphan drug designation to VCN-01 for treatment of PDAC.

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 14, 2024 (GLOBE NEWSWIRE) -- 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 Company's Management will provide a corporate update and participate in a fireside chat at the A.G.P. 2024 Virtual Healthcare Conference.

Theriva™ Biologics to Participate in the A.G.P. Virtual Healthcare Conference

- 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-

Theriva™ Biologics Reports First Quarter 2024 Operational Highlights and Financial Results

ROCKVILLE, Md., April 25, 2024 (GLOBE NEWSWIRE) -- 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, based on the strength of the science and its relevance, VIRAGE - the Phase 2b randomized, open-label, placebo-controlled, multicenter clinical trial of systemically administered VCN-01 in combination with standard-of-care (SoC) chemotherapy (gemcitabine/nab-paclitaxel) as a first line therapy for patients with newly-diagnosed metastatic pancreatic ductal adenocarcinoma (PDAC) - has been accepted for presentation as a trial-in-progress poster at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, being held in Chicago, IL, from May 31-June 4.

Theriva™ Biologics to Discuss the Trial Design for VIRAGE - a Phase 2b Clinical Study of Systemically Administered VCN-01 in Combination with Chemotherapy in Pancreatic Ductal Adenocarcinoma - at the 2024 American Society of Clinical Oncology (ASCO) Annua

–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–

Theriva™ Biologics Announces Positive Topline Data from Investigator Sponsored Phase 1 Trial of Intravitreal VCN-01 in Pediatric Patients with Refractory Retinoblastoma

– Lead product candidate, VCN-01 in combination with liposomal irinotecan demonstrated enhanced anti-tumor effects in a human pancreatic mouse xenograft –

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

ROCKVILLE, Md., April 08, 2024 (GLOBE NEWSWIRE) -- 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 presentation of preclinical data demonstrating the potential synergy between lead product candidate, VCN-01 and liposomal irinotecan in a human pancreatic mouse xenograft. Data will be featured in a poster presentation at the American Society for Cell and Gene Therapy (ASGCT) 27th Annual Meeting, being held both virtually and in Baltimore from May 7-11, 2024.

Theriva™ Biologics Announces Presentation at the American Society for Cell and Gene Therapy 27th Annual Meeting

Theriva Biologics, Inc. (TOVX) Q4 2023 Earnings Call Transcript

– 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 -

Theriva™ Biologics Reports Full-Year 2023 Operational Highlights and Financial Results

ROCKVILLE, Md., March 19, 2024 (GLOBE NEWSWIRE) -- 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 it plans to host a conference call on Monday, March 25, 2024, at 8:30 a.m. ET to discuss its financial results for the full year ended December 31, 2023 and provide a corporate update.

Theriva™ Biologics to Host Conference Call and Webcast to Discuss Full Year 2023 Operational Highlights and Financial Results

ROCKVILLE, Md., March 11, 2024 (GLOBE NEWSWIRE) -- 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 Company's Management will provide a corporate update and participate in one-on-one meetings at the BIO-Europe Spring Conference, to be held in Barcelona, Spain from March 18-20, 2024.

Theriva™ Biologics to Participate in the BIO-Europe Spring Conference

The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE with no safety concerns raised; VIRAGE remains on track to complete enrollment in the first half of 2024 The independent data monitoring committee (IDMC) recommended the continuation of VIRAGE with no safety concerns raised; VIRAGE remains on track to complete enrollment in the first half of 2024

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

ROCKVILLE, Md., Jan. 16, 2024 (GLOBE NEWSWIRE) -- 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 Company's Management will participate in a fireside chat at the B. Riley Securities Oncology Conference to be held virtually on Thursday, January 18, 2024 at 9:30 a.m. ET.

Theriva Biologics to Participate in the B. Riley Securities Annual Oncology Conference

Theriva Biologics, Inc. (NYSE:TOVX ) Q3 2023 Results Conference Call November 13, 2023 8:30 AM ET Company Participants Steve Shallcross - Chief Executive and CFO Dr. Manel Cascalló - General Director, European Subsidiary Dr. Vince Wacher - Head, Corporate and Product Development Conference Call Participants James Molloy - Alliance Global Partners Operator Greetings, and welcome to the Theriva Biologics, Inc. 2023 Third Quarter Operational Highlights and Financial Results. [Operator Instructions] As a reminder, this conference is being recorded.

Theriva Biologics, Inc. (TOVX) Q3 2023 Earnings Call Transcript

- 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 safety profile consistent with prior clinical trials -

Theriva™ Biologics Reports Third Quarter 2023 Operational Highlights and Financial Results

ROCKVILLE, Md., Nov. 06, 2023 (GLOBE NEWSWIRE) -- 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 it plans to host a conference call on Monday, November 13, 2023, at 8:30 a.m. ET to discuss its financial results for the quarter ended September 30, 2023 and provide a corporate update.

Theriva Biologics to Host Conference Call and Webcast to Discuss Third Quarter 2023 Operational Highlights and Financial Results

ROCKVILLE, Md., Nov. 02, 2023 (GLOBE NEWSWIRE) -- 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 Company's Management will provide a corporate update and participate in one-on-one meetings at the BIO-Europe Conference, to be held in Munich from November 6-8, 2023.

Theriva™ Biologics to Participate in the BIO-Europe Conference

- Theriva signs exclusive option to license intellectual property from Sant Joan de Déu-Barcelona Children's Hospital (SJD) to explore the therapeutic potential of VCN-01 in combination with topoisomerase I inhibitors -

Theriva™ Biologics and Sant Joan de Déu-Barcelona Children's Hospital Advance Strategic Collaboration to Explore the Combination of VCN-01 with Topoisomerase Inhibitors to Treat Cancer

News for Theriva Biologics Inc Stock (TOVX)