8-K: Theriva Biologics Reports Full-Year 2024 Financial Results and Provides Corporate Update

Theriva Biologics reports full-year 2024 financial results, highlighting clinical and regulatory achievements and providing a corporate update on its key programs.

Summary

• Theriva Biologics reported its full-year 2024 financial results and provided a corporate update on March 6, 2025.
• The company completed enrollment in the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma (PDAC), with topline data expected in Q2 2025.
• The FDA granted Fast Track designation for VCN-01 in PDAC and Rare Pediatric Disease designation for retinoblastoma.
• The company received guidance from the FDA and EMA on the Phase 3 pivotal trial design for VCN-01 in combination with standard-of-care chemotherapy for metastatic PDAC.
• As of December 31, 2024, Theriva Biologics reported $11.6 million in cash, expected to provide runway into Q3 2025.
• General and administrative expenses increased to $7.4 million for the year ended December 31, 2024, from $7.1 million for the year ended December 31, 2023.
• Research and development expenses decreased to $12.0 million for the year ended December 31, 2024, from $14.3 million for the year ended December 31, 2023.
• Other income was $693,000 for the year ended December 31, 2024, compared to $1,442,000 for the year ended December 31, 2023.
• The company recognized a tax credit receivable and offsetting deferred R&D tax credit of $1.8 million from the Spanish government.
• The audited financial statements for the year ended December 31, 2024 included in the Company's Annual Report on Form 10-K contain an audit opinion from the Company's independent registered public accounting firm that includes an explanatory paragraph related to the Company's ability to continue as a going concern.
• Net loss attributable to common stockholders was $(25.653) million, or $(19.03) per share, compared to $(18.349) million, or $(28.48) per share in the prior year.

Sentiment

Score: 5

Explanation: The sentiment is neutral. While there are positive developments such as regulatory designations and manufacturing funding, the company's financial position is concerning, with a limited cash runway and a going concern warning from its auditor. The decrease in R&D spending and increased net loss also contribute to the neutral sentiment.

Positives

• The VIRAGE Phase 2b clinical trial of VCN-01 in metastatic PDAC completed enrollment.
• VCN-01 received Fast Track designation from the FDA for PDAC and Rare Pediatric Disease designation for retinoblastoma.
• The company received guidance from the FDA and EMA on the Phase 3 pivotal trial design for VCN-01 in combination with standard-of-care chemotherapy for metastatic PDAC.
• The company was awarded manufacturing funding of approximately $1.48 million from the Spanish government.
• A $1.8 million tax credit receivable was recognized from the Spanish government for R&D expenses.
• Positive outcome from the DSMC review of results from the second Cohort of the Phase 1b/2a clinical trial of SYN-004.

Negatives

• The company's independent registered public accounting firm included an explanatory paragraph related to the Company's ability to continue as a going concern in the audited financial statements for the year ended December 31, 2024.
• Cash and cash equivalents decreased to $11.6 million as of December 31, 2024, compared to $23.2 million as of December 31, 2023.
• Net loss attributable to common stockholders was $(25.653) million, or $(19.03) per share.

Risks

• The company's ability to continue as a going concern is uncertain.
• The company's cash runway is only expected to last into Q3 2025.
• The company may not be able to obtain grant funding or find a licensee or partner for the SYN-004 development program.
• The company's research and development expenses are expected to increase.
• The topline data may not be positive for the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic pancreatic ductal adenocarcinoma.
• The company may not be able to effectively design the pivotal trial for VCN-01 in PDAC.
• The company may not be able to reach clinical milestones when anticipated.
• The company's product candidates may not demonstrate safety and effectiveness.
• The company may not be able to complete clinical trials on time and achieve the desired results and benefits.
• The company may not be able to obtain regulatory approval for commercialization of product candidates or to comply with ongoing regulatory requirements.
• Regulatory limitations may impact the company's ability to promote or commercialize their product candidates for the specific indications.
• Acceptance of product candidates in the marketplace and the successful development, marketing or sale of the company's products are uncertain.
• Developments by competitors may render such products obsolete or non-competitive.
• The company may not be able to maintain license agreements.
• The company may not be able to maintain and grow its patent estate.
• The company may not be able to continue to remain well financed.

Future Outlook

The company anticipates research and development expenses to increase as it completes the VIRAGE Phase 2 clinical trial of VCN-01 and 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.

Management Comments

• 'We are very pleased with our clinical and regulatory achievements in 2024,' said Steven A. Shallcross, Chief Executive Officer of Theriva Biologics.
• Shallcross stated that interactions with regulatory agencies have provided clear direction on the path forward to a potential pivotal trial for VCN-01 in PDAC, should the Phase 2b trial be successful.
• Shallcross noted the urgent need for new therapies to treat PDAC as its incidence increases worldwide.

Industry Context

Theriva Biologics is focused on developing therapeutics for cancer and related diseases in areas of high unmet need, reflecting a broader industry trend towards personalized medicine and targeted therapies. The company's focus on oncolytic viruses and microbiome modulation aligns with emerging approaches in cancer treatment and prevention of complications from standard therapies.

Comparison to Industry Standards

• The $11.6 million cash position is relatively low for a clinical-stage biotech company, especially considering the planned Phase 3 trial for VCN-01 in PDAC, which typically requires significant funding.
• Comparable companies like BioNTech and Moderna, which have successfully developed and commercialized novel therapies, have significantly larger cash reserves to support their extensive clinical development programs.
• The decrease in R&D expenses may be viewed negatively by investors, as it could indicate a slowdown in the company's pipeline development.
• However, the receipt of Fast Track and Orphan Drug designations for VCN-01 is a positive sign, as these designations can provide regulatory and financial benefits, such as expedited review and market exclusivity.

Stakeholder Impact

• Shareholders may be concerned about the company's financial position and the going concern warning from its auditor.
• Employees may be affected by potential cost-cutting measures or changes in the company's strategic direction.
• Patients with PDAC and retinoblastoma may benefit from the company's development of new therapies.
• Suppliers and creditors may be impacted by the company's financial challenges.

Next Steps

• The company expects topline data from the VIRAGE Phase 2b clinical trial of VCN-01 in metastatic PDAC in Q2 2025.
• The company plans to request an End-of-Phase 2 meeting with the FDA to discuss the proposed Phase 3 study before the end of 2025.
• The company will continue discussions with key opinion leaders to develop a potential pivotal trial protocol for retinoblastoma.
• The company will seek grant funding or a licensee/partner for the SYN-004 development program.
• The company will continue to advance its VCN-01 program in retinoblastoma and expand GMP scale-up manufacturing activities for VCN-01.

Key Dates

Keywords

Theriva Biologics, VCN-01, PDAC, Retinoblastoma, SYN-004, Clinical Trial, Financial Results, FDA, EMA, Phase 2b, Phase 3, Cash Runway