Synthetic Biologics(TOVX) - 2025 Q1 - Quarterly Results

Theriva™ Biologics First Quarter 2025 Report Recent Highlights and Anticipated Milestones Theriva Biologics achieved key clinical milestones in early 2025, including positive Phase 2b results for VCN-01 and SYN-004 data presentation - The VIRAGE Phase 2b clinical trial of VCN-01 achieved its primary survival and safety endpoints in patients with newly diagnosed metastatic pancreatic cancer[2] - The company is preparing for a potential Phase 3 trial of VCN-01 by scaling up manufacturing and finalizing the trial design[2][3] - Data from a Phase 1b/2a trial of SYN-004 for preventing acute graft-versus-host-disease (aGVHD) was presented at the ESCMID Global congress in April[4] VCN-01 for Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) The VIRAGE Phase 2b trial of VCN-01 showed improved survival and response rates in mPDAC patients, with good tolerability - Patients treated with VCN-01 plus standard-of-care chemotherapy showed increased overall survival (OS), progression-free survival (PFS), and duration of response (DOR) compared to the control group[3] - VCN-01 was well-tolerated, with adverse events being transient and reversible[3] - Patients receiving two doses of VCN-01 showed a greater increase in OS, suggesting an additional benefit from the second dose[3] SYN-004 for Allogeneic Hematopoietic Cell Transplant (HCT) Phase 1b/2a trial data for SYN-004 in preventing aGVHD in HCT recipients was presented at ESCMID Global - Data from a Phase 1b/2a trial of SYN-004 for the prevention of acute graft-versus-host-disease (aGVHD) in allogeneic HCT recipients was presented at the ESCMID Global congress[4] Q1 2025 Financial Results and Corporate Update Theriva Biologics reduced Q1 2025 net loss to $4.3 million and extended cash runway into Q1 2026 through a $7.5 million public offering Q1 2025 vs Q1 2024 Operating Expenses (in millions) | Expense Category | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | General and administrative | $1.4 | $1.9 | -25% | | Research and development | $3.0 | $3.5 | -14% | - Net loss for Q1 2025 was $4.3 million, compared to a net loss of $5.2 million for Q1 2024[20] - Closed a public offering on May 8, 2025, raising gross proceeds of approximately $7.5 million, increasing the cash balance to $14.1 million and expected to fund operations into Q1 2026[1][9][10] Financial Statements The Q1 2025 unaudited financial statements show total assets of $32.2 million, liabilities of $16.7 million, and a net loss of $4.3 million Condensed Consolidated Balance Sheets As of March 31, 2025, total assets were $32.2 million, total liabilities $16.7 million, and stockholders' equity $15.5 million Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,014 | $11,609 | | Total Current Assets | $12,476 | $16,281 | | Total Assets | $32,161 | $35,352 | | Total Current Liabilities | $8,148 | $7,585 | | Total Liabilities | $16,664 | $16,285 | | Total Stockholders' Equity | $15,497 | $19,067 | Condensed Consolidated Statements of Operations Q1 2025 net loss was $4.3 million ($1.55 per share), an improvement from $5.2 million ($7.53 per share) in Q1 2024 Statement of Operations Summary (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total Operating Costs and Expenses | $4,417 | $5,392 | | Loss from Operations | ($4,417) | ($5,392) | | Net Loss | ($4,324) | ($5,165) | | Net Loss Per Share - Basic and Dilutive | ($1.55) | ($7.53) | Company and Product Information This section details Pancreatic Ductal Adenocarcinoma, the VIRAGE trial design, VCN-01's mechanism, and Theriva's therapeutic pipeline About Pancreatic Ductal Adenocarcinoma (PDAC) PDAC, accounting for over 90% of pancreatic tumors, is often diagnosed late with high rates of metastasis - PDAC accounts for more than 90% of all pancreatic tumors and is often diagnosed late, with 50-60% of patients presenting with distant metastases[11] About VIRAGE Trial The VIRAGE trial was a Phase 2b, randomized, controlled study evaluating VCN-01 plus chemotherapy in mPDAC patients - The VIRAGE trial was a two-arm, Phase 2b, randomized, controlled study in newly-diagnosed metastatic PDAC patients, with primary endpoints of overall survival and safety[12] About VCN-01 VCN-01 is an oncolytic adenovirus that selectively targets tumor cells, degrades stroma, and enhances chemotherapy effects - VCN-01 is an oncolytic adenovirus that selectively lyses tumor cells, degrades the tumor stroma, and enhances the effect of co-administered therapies[13] About Theriva™ Biologics, Inc. Theriva Biologics is a clinical-stage company developing VCN-01, SYN-004, and SYN-020 for cancer and other diseases - Theriva's lead candidates are VCN-01 (oncolytic adenovirus), SYN-004 (ribaxamase for GI tract protection), and SYN-020 (recombinant oral IAP)[14]