Risk Factors Update Summary
- Auditor's report raises substantial doubt on ability to continue as a going concern. Cash may only fund operations until Q1 2025.
- The company's financial statements now assume continued operation for the next twelve months.
- Operating activities used net cash of $19 million in 2023. Cash and cash equivalents decreased from $418 million to $238 million in 2023.
- Material weaknesses in internal controls were identified, impacting financial reporting reliability.
- Accumulated deficit increased from approximately $291 million to $309.3 million in 2023.
- Transition to oncology focus with the acquisition of VCN Biosciences, now Theriva Biologics.
- Cash and cash equivalents will not be sufficient to complete planned clinical trials without additional capital.
- Lead product candidate VCN-01 now in Phase 2 clinical study for pancreatic cancer with 116 patients.
- Exploring value creation options for SYN-004 and SYN-020 assets to focus on oncology.
- Phase 1 trial results for VCN-01 in retinoblastoma and pancreatic cancer granted Orphan Drug Designation.
- Potential delay or impairment in clinical trials due to failure to maintain drug supply quality.
- Expansion of product pipeline to include SYN-006 and SYN-007 for GI health and microbiome.
- Cybersecurity risks pose a threat to the confidentiality and integrity of confidential information.
- Collaboration agreements with hospitals and universities for clinical trials and licensing agreements.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=894158&owner=exclude
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