Theriva™ Biologics Reports First Quarter 2025 Operational Highlights and Financial Results
- VCN-01 achieved primary efficacy and safety endpoints in Phase 2b VIRAGE trial for pancreatic cancer
- Successfully raised $7.5M through public offering, extending cash runway into Q1 2026
- 25% reduction in G&A expenses to $1.4M in Q1 2025
- 14% decrease in R&D expenses to $3.0M in Q1 2025
- Significant dilution from public offering of 6.8M shares and warrants
- Declining interest income from $228,000 in Q1 2024 to $96,000 in Q1 2025
- Cash position decreased from $11.6M (Dec 2024) to $10M (Mar 2025) before offering
Insights
Theriva's VCN-01 shows promising survival benefits in pancreatic cancer trial while securing funding to advance to Phase 3.
Theriva Biologics has achieved a significant clinical milestone with their VCN-01 (zabilugene almadenorepvec) oncolytic virus therapy in the VIRAGE Phase 2b trial for metastatic pancreatic ductal adenocarcinoma (mPDAC). The trial met its primary endpoints for both efficacy and safety, demonstrating increased overall survival, progression-free survival, and duration of response when combined with standard-of-care gemcitabine/nab-paclitaxel chemotherapy.
What's particularly noteworthy is the enhanced survival benefit observed in patients receiving two doses of VCN-01 along with four or more cycles of chemotherapy, suggesting a dose-dependent response pattern. This provides a clear pathway for dosing strategy in future trials. The therapy demonstrated a favorable safety profile with only transient and reversible adverse events, which is crucial for pancreatic cancer patients who often struggle with tolerability of aggressive treatments.
The company is already taking concrete steps toward commercialization by scaling up manufacturing and designing a potential Phase 3 confirmatory trial. This aggressive advancement timeline reflects confidence in their data. The recent $7.5 million public offering provides critical funding to support these next steps, extending their cash runway into Q1 2026.
Pancreatic cancer remains one of the most lethal malignancies with dismal survival rates and limited treatment options. An oncolytic virus approach that enhances standard chemotherapy without adding significant toxicity could represent a meaningful advancement in this difficult-to-treat disease space. The company's focus on manufacturing scale-up suggests they're positioning themselves for potential commercial production if Phase 3 results prove successful.
Theriva secures crucial $7.5M funding while reducing operational expenses, extending runway to advance promising cancer therapy toward Phase 3.
Theriva's financial position has been significantly strengthened through their recent $7.5 million public offering that closed on May 8, 2025. This capital raise provides essential funding specifically earmarked for scaling up manufacturing of VCN-01 and preparing for a potential Phase 3 trial - critical steps in their clinical development pathway that require substantial investment.
The company has demonstrated effective expense management with G&A expenses decreasing 25% year-over-year to $1.4 million (down from $1.9 million in Q1 2024), driven by reductions in salary costs, travel expenses, and D&O insurance. Similarly, R&D expenses decreased 14% to $3.0 million (from $3.5 million), primarily due to lower manufacturing costs for VCN-01 and reduced expenses related to their SYN-004 clinical trial.
Their cash position stood at $10 million as of March 31, 2025, but more importantly, post-offering has increased to $14.1 million. This extended cash runway into Q1 2026 provides approximately 9-10 months of operational funding at current burn rates - a crucial window to advance their lead program through key development milestones.
While interest income has declined to $96,000 from $228,000 year-over-year (likely reflecting lower interest rates and/or reduced cash balances throughout the quarter), the company's overall financial discipline and strategic capital allocation appear focused on supporting their most promising clinical assets.
The timing of this offering immediately following positive clinical data from their VCN-01 VIRAGE trial represents opportunistic financing that capitalizes on positive momentum, though the share and warrant pricing at $1.10 suggests continued funding challenges typical of clinical-stage biotech companies without commercial products.
- 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, 2025 (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 reported financial results for the first quarter ended March 31, 2025, and provided a corporate update.
“We have started 2025 with outstanding clinical progress,” said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics. “The VIRAGE Phase 2b clinical trial of VCN-01 (zabilugene almadenorepvec) with gemcitabine/nab-paclitaxel in newly diagnosed metastatic pancreatic cancer patients achieved its primary survival and safety endpoints, highlighting the potential therapeutic benefits of our oncolytic virus platform. We are working to scale up manufacturing and finalize the design of a Phase 3 trial of VCN-01 with gemcitabine/nab-paclitaxel which if successful, may allow us to deliver this innovative treatment option to patients suffering this fatal disease.”
Recent Highlights and Anticipated Milestones
VCN-01
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC):
- As recently announced, mPDAC patients treated with VCN-01 (zabilugene almadenorepvec) plus gemcitabine/nab-paclitaxel standard-of-care (SoC) chemotherapy had increased overall survival (OS), progression free survival (PFS), and duration of response (DOR) compared to patients treated with gemcitabine/nab-paclitaxel SoC.
- VCN-01 was well-tolerated, with transient and reversible adverse events (AEs).
- The increase in OS was greater for patients who received 2 doses of VCN-01 and 4 or more cycles of gemcitabine/nab-paclitaxel compared with patients who received 4 or more cycles of gemcitabine/nab-paclitaxel SoC alone, suggesting that the second dose of VCN-01 (administered 3 months after the first dose) provides a meaningful additional benefit in this treatment subgroup.
- Theriva had hosted a virtual event featuring feature eminent pancreatic cancer clinician/researchers to review and discuss the data from the VIRAGE trial of VCN-01. To access the replay of the event, click HERE.
- The Company is currently working to scale up manufacturing of VCN-01 and finalizing the design of a potential Phase 3 confirmatory trial for VCN-01 in mPDAC.
SYN-004
Allogeneic hematopoietic cell transplant (HCT):
- As recently announced, data from a Phase 1b/2a trial investigating SYN-004 (ribaxamase) in allogeneic hematopoietic cell transplant (HCT) recipients for the prevention of acute graft-versus-host-disease (aGVHD) was presented at the Congress of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID Global) in April.
Corporate Updates
- As recently announced, Theriva closed a public offering of 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offering price of
$1.10 per share and accompanying warrant (the “Offering”). The Company received aggregate gross proceeds of approximately$7.5 million , before deducting placement agent fees and other offering expenses. The warrants have an exercise price of$1.10 per share, are exercisable immediately and expire five years from the issuance date. - The Company intends to use the net proceeds from the Offering primarily for working capital and general corporate purposes, including for research and development, and manufacturing scale-up of VCN-01 for a potential Phase 3 clinical trial.
First Quarter Ended March 31, 2025 Financial Results
General and administrative expenses decreased to
Research and development expenses decreased to
Other income was
Cash and cash equivalents totaled
About Pancreatic Ductal Adenocarcinoma
Cancer of the pancreas consists of two main histological types: cancer that arises from the ductal (exocrine) cells of the pancreas or, much less often, cancers may arise from the endocrine compartment of the pancreas. Pancreatic ductal adenocarcinoma (“PDAC”) accounts for more than
About VIRAGE
VIRAGE was a two-arm, Phase 2b open-label, randomized, controlled, multicenter clinical trial in patients with histologically confirmed, newly-diagnosed metastatic PDAC. Patients were enrolled at 5 sites in the U.S. and 9 sites in Spain. In both the control and VCN-01 (zabilugene almadenorepvec) treatment arms, patients received gemcitabine/nab-paclitaxel standard-of-care chemotherapy in repeated 28-day cycles until disease progression. In the VCN-01 treatment arm only, patients were also administered intravenous VCN-01 seven-days prior to starting the first and fourth cycles of gemcitabine/nab-paclitaxel treatment (study days 1 and ~92 respectively). Primary endpoints for the trial include overall survival and VCN-01 safety/tolerability. Additional endpoints include progression free survival, duration of response, and measures of VCN-01 biodistribution, replication, and immune response. More information about the trial is available on Clinicaltrials.gov (NCT05673811), through the Spanish Clinical Trials Registry and European Union Drug Regulating Authorities Clinical Trials Database (EudraCT Number: 2022-000897-24).
About VCN-01
VCN-01 (zabilugene almadenorepvec) is a systemically administered oncolytic adenovirus designed to selectively and aggressively replicate within tumor cells and degrade the tumor stroma that serves as a significant physical and immunosuppressive barrier to cancer treatment. This unique mode-of-action enables VCN-01 to exert multiple antitumor effects by (i) selectively infecting and lysing tumor cells; (ii) enhancing the access and perfusion of co-administered chemotherapy products; and (iii) increasing tumor immunogenicity and exposing the tumor to the patient’s immune system and co-administered immunotherapy products. Systemic administration enables VCN-01 to exert its actions on both the primary tumor and metastases. VCN-01 has been administered to 142 patients to date in clinical trials of different cancers, including PDAC (in combination with chemotherapy), head and neck squamous cell carcinoma (with an immune checkpoint inhibitor), ovarian cancer (with CAR-T cell therapy), colorectal cancer, and retinoblastoma (by intravitreal injection). More information on these clinical trials is available at Clinicaltrials.gov.
About Theriva™ Biologics, Inc.
Theriva™ Biologics (NYSE American: TOVX), is a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need. The Company is advancing a new oncolytic adenovirus platform designed for intravenous (IV), intravitreal and antitumoral delivery to trigger tumor cell death, improve access of co-administered cancer therapies to the tumor, and promote a robust and sustained anti-tumor response by the patient’s immune system. The Company’s lead candidates are: (1) VCN-01, an oncolytic adenovirus designed to replicate selectively and aggressively within tumor cells, and to degrade the tumor stroma barrier that serves as a significant physical and immunosuppressive barrier to cancer treatment; (2) SYN-004 (ribaxamase) which is designed to degrade certain commonly used IV beta-lactam antibiotics within the gastrointestinal (GI) tract to prevent microbiome damage, thereby limiting overgrowth of pathogenic organisms such as VRE (vancomycin resistant Enterococci) and reducing the incidence and severity of acute graft-versus-host-disease (aGVHD) in allogeneic hematopoietic cell transplant (HCT) recipients; and (3) SYN-020, a recombinant oral formulation of the enzyme intestinal alkaline phosphatase (IAP) produced under cGMP conditions and intended to treat both local GI and systemic diseases. For more information, please visit Theriva Biologics’ website at www.therivabio.com.
Forward-Looking Statement
This release 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,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to a number of risks and uncertainties, many of which are difficult to predict that could cause actual results to differ materially from current expectations and assumptions from those set forth or implied by any forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding having a cash runway into the first quarter of 2026; the potential therapeutic benefits of the Company’s oncolytic virus platform; the design of a Phase 3 trial of VCN-01 with gemcitabine/nab-paclitaxel if successful, allowing the Company to deliver this innovative treatment option to patients suffering this fatal disease; the intended use of net proceeds from the offering; the suggestion that the second dose of VCN-01 (administered 3 months after the first dose) provides a meaningful additional benefit in the treatment subgroup; a potential Phase 3 confirmatory trial for VCN-01 in PDAC; and research and development expense increasing as the Company completes its VIRAGE Phase 2b clinical trial of VCN-01and plans for its Phase 3 clinical trial of VCN-01 in PDAC, advances its VCN-01 program in retinoblastoma, expands GMP scale-up manufacturing activities for VCN-01, and continues supporting its other preclinical and discovery initiatives. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except as required under applicable law. Important factors that could cause actual results to differ materially from those in the forward-looking statements include the ability of VCN-01 to have therapeutic benefits and continue to do so in future trials; the Company’s cash being able to support increases in research and development expenses and the risk factors that are described in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and other documents filed by the Company from time to time with the SEC, including the Company’s subsequent Quarterly Reports on Form 10-Q filed with the SEC that are incorporated by reference therein. The Company does not undertake or accept any obligation to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.
For further information, please contact:
Investor Relations
Kevin Gardner
LifeSci Advisors, LLC
kgardner@lifesciadvisors.com
| Theriva Biologics, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (In thousands except share and par value amounts) (Unaudited) | ||||||||
| March 31, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 10,014 | $ | 11,609 | ||||
| Tax credit receivable | 1,587 | 3,228 | ||||||
| Prepaid expenses and other current assets | 875 | 1,444 | ||||||
| Total Current Assets | 12,476 | 16,281 | ||||||
| Non-Current Assets | ||||||||
| Property and equipment, net | 253 | 270 | ||||||
| Restricted cash | 100 | 96 | ||||||
| Right of use asset | 1,171 | 1,272 | ||||||
| In-process research and development | 18,084 | 17,358 | ||||||
| Deposits and other assets | 77 | 75 | ||||||
| Total Assets | $ | 32,161 | $ | 35,352 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 437 | $ | 859 | ||||
| Accrued expenses | 3,769 | 3,368 | ||||||
| Contingent consideration, current portion | 1,309 | — | ||||||
| Accrued employee benefits | 554 | 1,144 | ||||||
| Deferred research and development tax credit-current portion | 1,460 | 1,614 | ||||||
| Loans payable-current | 51 | 61 | ||||||
| Operating lease liability-current portion | 568 | 539 | ||||||
| Total Current Liabilities | 8,148 | 7,585 | ||||||
| Non-current Liabilities | ||||||||
| Non-current contingent consideration | 5,685 | 6,973 | ||||||
| Loan Payable - non-current | 1,504 | 92 | ||||||
| Non-current deferred research and development tax credit | 595 | 762 | ||||||
| Non-current operating lease liability | 732 | 873 | ||||||
| Total Liabilities | 16,664 | 16,285 | ||||||
| Commitments and Contingencies (Note 13) | ||||||||
| Stockholders’ Equity: | ||||||||
| Preferred Stock; 10,000,000 authorized; none issued or outstanding at March 31 ,2025 and December 31 ,2024 | — | — | ||||||
| Common stock, | 3 | 3 | ||||||
| Additional paid-in capital | 355,601 | 355,501 | ||||||
| Treasury stock at cost, 28,809 shares at March 31, 2025 and at December 31, 2024 | (288 | ) | (288 | ) | ||||
| Accumulated other comprehensive loss | (524 | ) | (1,178 | ) | ||||
| Accumulated deficit | (339,295 | ) | (334,971 | ) | ||||
| Total Stockholders’ Equity | 15,497 | 19,067 | ||||||
| Total Liabilities and Stockholders’ Equity | $ | 32,161 | $ | 35,352 | ||||
| Theriva Biologics, Inc. and Subsidiaries Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share amounts) (Unaudited) | ||||||||
| For the Three Months Ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Operating Costs and Expenses: | ||||||||
| General and administrative | $ | 1,449 | $ | 1,933 | ||||
| Research and development | 2,968 | 3,459 | ||||||
| Total Operating Costs and Expenses | 4,417 | 5,392 | ||||||
| Loss from Operations | (4,417 | ) | (5,392 | ) | ||||
| Other Income: | ||||||||
| Foreign currency exchange (loss) gain | (3 | ) | (1 | ) | ||||
| Interest income | 96 | 228 | ||||||
| Total Other Income | 93 | 227 | ||||||
| Net Loss before income taxes | (4,324 | ) | (5,165 | ) | ||||
| Income tax benefit | — | — | ||||||
| Net Loss Attributable to Common Stockholders | $ | (4,324 | ) | $ | (5,165 | ) | ||
| Net Loss Per Share - Basic and Dilutive | $ | (1.55 | ) | $ | (7.53 | ) | ||
| Weighted average number of shares outstanding during the period - basic and dilutive | 2,782,449 | 685,923 | ||||||
| Net Loss | (4,324 | ) | (5,165 | ) | ||||
| Gain (loss) on foreign currency translation | 654 | (569 | ) | |||||
| Total comprehensive loss | (3,670 | ) | (5,734 | ) | ||||
FAQ
What were the key results of TOVX's VCN-01 VIRAGE Phase 2b trial in pancreatic cancer?
How much did Theriva Biologics (TOVX) raise in their May 2025 public offering?
What is TOVX's current cash position after the May 2025 offering?
How did Theriva Biologics' (TOVX) expenses change in Q1 2025 compared to Q1 2024?
What are the next steps for TOVX's VCN-01 pancreatic cancer treatment?
