10-Q: Theriva Biologics Reports Q1 2025 Results, Highlights Positive Clinical Trial Data

Theriva Biologics reports a net loss for Q1 2025 but highlights positive topline outcomes from its VIRAGE Phase 2b clinical trial for VCN-01 in pancreatic cancer.

Summary

• Theriva Biologics, a clinical-stage company, announced its financial results for the first quarter of 2025.
• The company reported a net loss of $4.3 million, or ($1.55) per common share, compared to a net loss of $5.2 million, or ($7.53) per common share, for the same period in 2024.
• Research and development expenses decreased to $3.0 million from $3.5 million in the prior year.
• General and administrative expenses decreased to $1.4 million from $1.9 million in the prior year.
• The company's cash and cash equivalents totaled $10.0 million as of March 31, 2025.
• The company believes it can fund operations into the first quarter of 2026 with its current cash position of $14.1 million as of early May 2025.
• Theriva Biologics highlights positive topline outcomes from the VIRAGE Phase 2b clinical trial evaluating VCN-01 plus standard-of-care chemotherapy for metastatic pancreatic cancer.
• The VIRAGE trial showed a median overall survival (OS) of 10.8 months for patients treated with VCN-01 followed by chemotherapy, compared to 8.6 months for those treated with chemotherapy alone.
• The company completed a public offering in May 2025, raising approximately $7.5 million in gross proceeds.
• The company intends to use the proceeds of the Offering primarily for working capital and general corporate purposes, including for research and development and manufacturing scale-up and may use a portion of the proceeds to invest in or acquire other products, businesses or technologies.

Sentiment

Score: 6

Explanation: The document presents a mixed sentiment. While the company reports a net loss and expresses concerns about its ability to continue as a going concern, it also highlights positive clinical trial data and recent funding activities. The positive clinical data and successful capital raise provide some optimism, but the financial challenges remain a significant concern.

Positives

• The VIRAGE Phase 2b trial showed a statistically significant improvement in progression-free survival (PFS) for patients treated with VCN-01 followed by chemotherapy (median PFS 7.0 vs 4.6 months; HR = 0.55, p= 0.0105).
• The company received Fast Track Designation from the FDA for VCN-01 in combination with gemcitabine and nab-paclitaxel for metastatic pancreatic adenocarcinoma.
• The company received Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on the design of a Phase 3 clinical study of VCN-01 in combination with standard-of-care chemotherapy for the treatment of metastatic PDAC.
• The company received Rare Pediatric Drug Designation (RPDD) for VCN-01 for the treatment of retinoblastoma.
• The European Commission adopted the European Medicines Agency (EMA) recommendation to grant Orphan Medicinal Product Designation to VCN-01 for the treatment of retinoblastoma.

Negatives

• The company reported a net loss of $4.3 million for Q1 2025.
• The company has a significant accumulated deficit of $339.3 million as of March 31, 2025.
• The company's auditors report on the consolidated financial statements contains an explanatory paragraph regarding the company's ability to continue as a going concern.

Risks

• The company's ability to continue as a going concern is dependent on obtaining additional financing.
• The company may need to delay, reduce, or eliminate certain development programs if it cannot secure additional funding.
• Changes to trade policy, including tariff and customs regulations, may have an adverse effect on the company's business.
• The company's ability to raise capital through the sale of securities may be limited by the rules of the SEC and NYSE American.

Future Outlook

The company believes it can fund operations into the first quarter of 2026 with its current cash position of $14.1 million as of early May 2025. The company anticipates research and development expense to increase as it completes its VIRAGE Phase 2b clinical trial of VCN-01 and plans for its Phase 3 clinical trial of VCN-01 in PDAC, advance its VCN-01 program in retinoblastoma, expand GMP scale-up manufacturing activities for VCN-01, and continue supporting its other preclinical and discovery initiatives.

Management Comments

• Management believes its plan, which is focused on the advancement of VCN-01 will allow us to meet our financial obligations, further advance key products, and maintain our planned operations.

Industry Context

The company is operating in the competitive fields of oncology and virotherapy, where numerous companies are developing novel cancer treatments. The positive results from the VIRAGE trial could position VCN-01 as a promising therapy for pancreatic cancer, a disease with high unmet need.

Comparison to Industry Standards

• The reported median overall survival (OS) of 10.8 months in the VCN-01+SoC arm of the VIRAGE trial compares favorably to historical data for gemcitabine/nab-paclitaxel alone in metastatic pancreatic cancer.
• Companies like Celgene (now Bristol Myers Squibb) with Abraxane (nab-paclitaxel) have established chemotherapy regimens as standard of care.
• Other companies developing oncolytic viruses, such as Amgen with Imlygic (talimogene laherparepvec) for melanoma, provide a benchmark for regulatory and commercial pathways.
• The company's focus on intravenous delivery of oncolytic viruses differentiates it from some competitors that rely on direct intratumoral injection.

Related Party Transactions

• On December 13, 2024 the Company approved the compensation of MaryAnn Shallcross of $157,000 and a bonus of $45,000. During the three months ended March 31, 2025, the Company had $39,000 in compensation expense related to Ms. Shallcross.

Stakeholder Impact

• Shareholders: The positive clinical trial data could increase shareholder value, but the company's financial challenges and need for additional funding create uncertainty.
• Employees: The company's ability to continue operations and advance its programs depends on securing additional funding, which could impact job security.
• Patients: The positive clinical trial data for VCN-01 offers hope for improved treatment options for pancreatic cancer and retinoblastoma.
• Creditors: The company's ability to repay its debts depends on securing additional funding and generating revenue.

Next Steps

• The company plans to complete its VIRAGE Phase 2b clinical trial of VCN-01.
• The company plans for its Phase 3 clinical trial of VCN-01 in PDAC.
• The company plans to advance its VCN-01 program in retinoblastoma.
• The company plans to expand GMP scale-up manufacturing activities for VCN-01.
• The company plans to continue supporting its other preclinical and discovery initiatives.

Key Dates

Keywords

VCN-01, pancreatic cancer, clinical trial, Theriva Biologics, financial results, oncology, retinoblastoma, SYN-004, SYN-020, research and development