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Jun 30, 2021
PDS Biotechnology Q2 2021 Earnings Report
PDS Biotech reported a net loss and increased R&D expenses, while highlighting positive clinical trial data and a successful public offering.
Key Takeaways
PDS Biotech reported a net loss of $0.6 million for Q2 2021, a significant improvement compared to the $2.9 million loss in Q2 2020, primarily due to a $4.5 million gain from the sale of New Jersey tax benefits. Research and development expenses increased by 95% to $2.8 million, driven by clinical expenses related to VERSATILE-002. The company's cash balance as of June 30, 2021, was $74.7 million, supported by a $52 million public offering.
Net loss decreased to $0.6 million from $2.9 million year-over-year, benefiting from a $4.5 million gain.
Research and development expenses increased by 95% to $2.8 million due to VERSATILE-002 clinical trial costs.
Cash balance reached $74.7 million following a $52 million public offering.
Positive interim Phase 2 clinical data for PDS0101 showed tumor reduction in advanced HPV16-positive cancer patients.
PDS Biotechnology
PDS Biotechnology
Forward Guidance
PDS Biotech is focused on advancing its immuno-oncology pipeline, with preliminary data from the VERSATILE-002 trial expected in Q4 2021 or Q1 2022.
Positive Outlook
- Advancing PDS0102 and PDS0103 into human clinical trials.
- Preliminary data on the VERSATILE-002 trial is expected in Q4 2021 or Q1 2022.
- Capital raise of approximately $52M in June, further strengthens balance sheet.
- Company is well positioned and now has the momentum to move quickly to the next phase of growth
- Renowned experts in fields of prostate and MUC1 associated cancers joined Scientific Advisory Board to facilitate development of pipeline products.
Challenges Ahead
- The company's ability to protect its intellectual property rights
- The Company’s dependence on additional financing to fund its operations and complete the development and commercialization of its product candidates, and the risks that raising such additional capital may restrict the Company’s operations or require the Company to relinquish rights to the Company’s technologies or product candidates
- The Company’s limited operating history in the Company’s current line of business, which makes it difficult to evaluate the Company’s prospects, the Company’s business plan or the likelihood of the Company’s successful implementation of such business plan
- The timing for the Company or its partners to initiate the planned clinical trials for PDS0101, PDS0203 and other Versamune® based products
- The timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, the Company’s product candidates