Risk Factors Update Summary
- Identified substantial doubt regarding ability to continue as a going concern due to accumulated deficit of $144.5 million in 2023, up from $101.6 million in 2022.
- Addition of new products, including Infectimune®, to patent protection increases IP risks.
- Sales of common stock increased significantly from 238,642 shares in 2022 to 3,428,681 shares in the first quarter of 2024.
- Increase in common stock outstanding from 317M to 521M shares.
- Research and development expenses expected to increase significantly for Versamune-based products.
- Ongoing monitoring of geopolitical tensions, including the situation in Ukraine, and potential impacts.
- Clinical trials are expensive; enrollment and retention challenges may impact the development of PDS0101 and PDS01ADC.
- Executive orders regarding China may impact pharmaceutical industry and current manufacturing partners.
- Failure to comply with federal and state healthcare regulatory laws could lead to criminal prosecution and sanctions.
- Dependence on third-party manufacturers and CROs for clinical trials execution and commercialization may pose risks.
- Uncertainty in securing additional funding and accumulated deficit raise doubts about the ability to continue as a going concern.
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.
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