PDS Biotechnology: Q3 Earnings Snapshot

PDS Biotechnology Corporation (PDSB) reported its third-quarter 2024 financial results and provided a business update, offering insights into the company's pipeline progress and financial performance. The late-stage immunotherapy company, focused on transforming how the immune system targets and kills cancers and developing infectious disease vaccines, demonstrated strategic advancements in its clinical pipeline and a slight improvement in its net loss.

PDS Biotech's net loss for the quarter stood at $10.7 million, a decrease from $10.8 million in Q3 2023. Research and development expenses increased to $6.8 million, up from $6.4 million in the previous year, reflecting the company's continued investment in its pipeline. General and administrative expenses decreased to $3.4 million. The company's cash position stood at $49.8 million as of September 30, 2024.

The company's clinical pipeline showed promising progress during the quarter. The VERSATILE-003 Phase 3 trial design was updated to include approximately 350 patients, with the amended IND submitted in November 2024. The trial aims to reduce overall costs and time required for interim data readouts and trial completion. The company expects an FDA clearance decision by mid-December, enabling site activation in the first quarter of 2025.

The IMMUNOCERV Phase 2 clinical trial evaluating Versamune® HPV with chemoradiation to treat locally advanced cervical cancer demonstrated promising clinical activity and a compelling safety profile. The data, presented at the American Society for Radiation Oncology (ASTRO) annual meeting, showed a rapid decline in HPV circulating cell-free DNA, with a 92% reduction in ctDNA with PDS0101 and SOC, compared to a 53% reduction with SOC alone at 5 weeks.



PDS Biotech's partnerships and collaborations have significantly influenced its financial performance and pipeline progress. Collaborations with Merck and the National Cancer Institute (NCI) have facilitated the advancement of PDS0101 and PDS01ADC in various clinical trials. The NCI-led triple Phase 2 combination trial demonstrated promising results, with 75% of ICI-naïve patients alive at 36 months. Additionally, the interim Phase 2 VERSATILE-002 trial showed a 2-year overall survival rate of 74% in HPV16-positive recurrent or metastatic head and neck cancer patients.

In conclusion, PDS Biotechnology's Q3 earnings snapshot reveals a company focused on strategic advancements in its clinical pipeline and a commitment to reducing costs and improving operational efficiency. The company's partnerships and collaborations have driven pipeline progress and enhanced its financial position. Despite a slight increase in research and development expenses, PDS Biotech managed to reduce its net loss per share, indicating a positive impact on financial results. As the company continues to invest in its pipeline and explore strategic partnerships, investors should monitor its progress and potential market opportunities.