PDS Biotechnology (PDSB) Q4 2024 earnings summary

Executive summary

• Initiated the VERSATILE-003 phase III trial for Versamune HPV plus pembrolizumab in HPV16-positive head and neck cancer, with first site activated in March 2025 and strong engagement from prior phase II sites.

• VERSATILE-002 phase II data showed median overall survival of 30 months, improved objective response rates (26%-36%), and increased complete response rates (3%-9%) compared to historical pembrolizumab data.

• Received FDA Fast Track designation for Versamune HPV and pembrolizumab in recurrent/metastatic HNSCC.

• FDA cleared IND for Versamune MUC1 and PDS01ADC combination in metastatic colorectal cancer, with the trial to be led by the National Cancer Institute.

• Ongoing collaborations with the National Cancer Institute and academic partners are advancing additional pipeline programs with limited internal funding requirements.

Financial highlights

• Net loss for 2024 was $37.6 million ($1.03 per share), down from $42.9 million ($1.39 per share) in 2023, primarily due to reduced operating expenses.

• Research and development expenses decreased to $22.6 million from $27.8 million year-over-year; general and administrative expenses fell to $13.8 million from $15.3 million.

• Total operating expenses for 2024 were $36.3 million, compared to $43 million in 2023.

• Net interest expense increased to $2.2 million from $1.3 million due to higher debt interest and lower cash interest income.

• Cash and cash equivalents at year-end 2024 were $41.7 million.

Outlook and guidance

• Focus remains on advancing the VERSATILE-003 phase III trial, with two interim analyses planned based on death events, potentially enabling early FDA discussions for accelerated approval.

• Enrollment rates for VERSATILE-003 are expected to be strong due to site familiarity, but precise timelines will be clearer after several months of recruitment.

• Additional pipeline programs, including MUC1 and TARP, are progressing primarily through external partnerships, with internal capital focused on VERSATILE-003.

• Plans to activate additional clinical sites for VERSATILE-003 in coming weeks.

• Funding for VERSATILE-003 is not yet sufficient for trial completion; capital will be raised in stages using both equity and non-dilutive sources.