Theriva Biologics, Inc. — Q1 2024 Form 10-Q
Reporting period: Three months ended March 31, 2024. Theriva is a clinical-stage biotechnology company focused primarily on oncology, led by its oncolytic virus candidate VCN-01. It is also evaluating options to partner or out-license legacy gastrointestinal programs SYN-004 and SYN-020. The company reported no revenue.
Financial highlights
| Metric | Q1 2024 | Q1 2023 / prior date |
|---|---|---|
| Revenue | None reported | None reported |
| Research and development expense | $3.459 million | $2.977 million |
| General and administrative expense | $1.933 million | $2.201 million |
| Operating loss | $5.392 million | $5.178 million |
| Net loss | $5.165 million | $4.478 million |
| Basic and diluted net loss per share | $0.30 | $0.30 |
| Operating cash used | $4.881 million | $5.610 million |
| Cash and cash equivalents at period end | $18.261 million | $23.177 million at Dec. 31, 2023 |
| Working capital | $15.6 million | $20.7 million at Dec. 31, 2023 |
Amounts are in U.S. dollars. Gross margin is not applicable given the absence of reported revenue. Total assets were $48.730 million and total liabilities $14.607 million at March 31. Loans payable totaled $221,000; operating lease liabilities totaled $1.797 million. The $6.476 million contingent-consideration liability is non-current. Series C and D preferred stock of $2.734 million is classified as temporary equity.
Changes and notable items
- Net loss increased by $687,000 year over year, as higher R&D and lower other income more than offset reduced G&A. R&D expense rose 16%, mainly from VCN-01 pancreatic cancer and retinoblastoma trials and SYN-004 work; G&A fell 12%.
- Cash and cash equivalents declined $4.916 million from year-end. Net cash used in operations improved from $5.610 million to $4.881 million; there was no investing or financing cash flow in Q1 2024.
- A Spanish R&D reimbursement reduced R&D expense by $223,000 in the quarter. The company recorded a $202,000 increase in the fair value of contingent consideration as expense.
- Foreign-currency translation reduced comprehensive results by $569,000. No impairment charges were recorded for goodwill or in-process R&D.
Outlook, risks and contingencies
- Funding and going concern: Management states that cash should support current plans through year-end 2024 and into Q1 2025, while also stating that cash is not sufficient to fund operations for 12 months from the filing date. The filing identifies substantial doubt about the company’s ability to continue as a going concern. Additional financing is uncommitted and may not be available on acceptable terms; later-stage trials will require significant financing or a partner. Equity financing could dilute shareholders.
- Clinical programs: The VIRAGE Phase 2b VCN-01 trial’s independent monitoring committee recommended continuing enrollment without protocol changes and raised no safety concerns; enrollment was expected to complete in Q3 2024. The company said it would defer new studies until it is confident it has funding to complete them.
- Post-quarter update: On April 23, 2024, Theriva announced positive topline results from its retinoblastoma Phase 1 study. The filing reports tolerability and preliminary antitumor activity; under the agreement, the positive outcome triggers a €320,000 payment in exchange for an exclusive worldwide technology license and related patents.
- Financial reporting controls: Management concluded disclosure controls and internal control over financial reporting were ineffective at March 31 due to continuing material weaknesses in review controls and IT general controls. Remediation is ongoing.
- Risks include dependence on external capital, clinical and regulatory uncertainty, potential trial delays or cancellations, dilution, manufacturing and supply-chain disruption, and exposure to foreign exchange and geopolitical events. The company reported no material pending legal proceedings and no off-balance-sheet arrangements.
Key facts for investors to verify
- Whether financing, partnership, or other capital is secured, and how the stated cash runway reconciles with the going-concern warning.
- Actual VIRAGE enrollment progress, timing, costs, and subsequent clinical safety or efficacy data.
- Terms, timing, and funding of the retinoblastoma license payment and any next-stage development plans.
- Progress in remediating the material weaknesses and whether management later concludes controls are effective.
- Potential dilution and financing capacity, including limitations on use of the at-the-market facility and other registered offerings.