On May 15, 2024 PDS Biotechnology Corporation, a late-stage immunotherapy company focused on transforming how the immune system targets and kills cancers and the development of infectious disease vaccines, reported a business update and reported financial results for the first quarter of 2024. The press release will be available in the Investor Relations section of the Company’s website at www.pdsbiotech.com (Press release, PDS Biotechnology, MAY 15, 2024, View Source [SID1234643337]).

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Recent Developments

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Hosted a Key Opinion Leader event on May 8, 2024 during which prominent experts in head and neck squamous cell cancer ("HNSCC") discussed positive, updated VERSATILE-002 data and the unmet need in HPV16-positive HNSCC. A replay of the event can be found here.

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Announced updated results from the VERSATILE-002 Phase 2 trial evaluating first line treatment of patients with HPV16-positive recurrent or metastatic HNSCC using Versamune HPV + KEYTRUDA (pembrolizumab) (n=53).

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Median overall survival is 30 months; Published results for immune checkpoint inhibitors are 7-18 months.

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The cohort met its primary endpoint of best overall response (BOR).

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BOR by investigator assessment is 34% (Combined Positive Score (CPS) ≥1; n=18/53); 48% (CPS≥20; n=10/21); Published results for ICIs are <20% (CPS>1) and <25% (CPS≥20).

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CPS is used to assess PD-L1 expression

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Progression free survival is 6.3 months (CPS≥1); 14.1 months (CPS≥20); Published results for immune checkpoint inhibitors 2-3 months.

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VERSATILE-002 data to date indicate a durable response in first line recurrent or metastatic HNSCC patients with CPS≥1.

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The combination of Versamune HPV + pembrolizumab was well tolerated.

Announced an updated clinical strategy with a two-part registrational trial focused on the triple combination of Versamune HPV + PDS01ADC + pembrolizumab as a first line treatment in HPV16-positive recurrent or metastatic HNSCC.

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PDS01ADC is the Company’s novel, investigational tumor-targeting IL-12-fused antibody-drug conjugate (ADC), which has shown promise in a clinical trial of Versamune HPV + PDS01ADC + an investigational ICI conducted by the National Cancer Institute.

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Part one of the clinical trial will focus on dose optimization with a data readout based on safety and objective response rate.

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The randomized second part of the trial will include an interim data readout with overall survival as its primary endpoint.

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Further strengthened management with the addition of Stephan Toutain, M.S., MBA, as Chief Operating Officer. Mr. Toutain brings extensive operational and commercial experience to PDS Biotech.

Versamune Platform Intellectual Property

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Company received patents granted by the Israel Patent Office and IP Australia that will extend protections for the Company’s novel investigational T cell activating Versamune platform through Dec. 2038 and Nov. 2036, respectively.

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The Israel Patent Office granted patent No. 275154 titled, "Methods and compositions comprising cationic lipids for stimulating type I interferon genes," extending protections for compositions using the Versamune platform and comprising of cationic lipid for activating type I interferons. This patent covers all formulations and compositions that include Versamune to activate a T cell response.

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IP Australia granted patent No. 2016354590 titled, "Lipids as synthetic vectors to enhance antigen processing and presentation ex-vivo in dendritic cell therapy." This patent covers the use of Versamune compositions that reduce the populations of immune suppressive cells in the tumor and its application for the development of dendritic cell-based approaches to immunotherapy.

First Quarter 2024 Financial Results
Reported net loss was approximately $10.6 million, or $0.30 per basic share and diluted share, for the three months ended March 31, 2024, compared to a net loss of $9.7 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2023. The increase was due to higher operating and net interest expenses.

Research and development expenses increased to approximately $6.7 million for the three months ended March 31, 2024, from $5.8 million for the three months ended March 31, 2023. The increase of $0.9 million was primarily attributable to an increase of $1.2 million in clinical studies and medical affairs offset by a decrease of $0.1 million in personnel costs, $0.1 million in professional fees and $0.1 million in manufacturing expenses.

General and administrative expenses decreased to approximately $3.4 million for the three months ended March 31, 2024, from approximately $3.6 million for the three months ended March 31, 2023. The decrease of $0.2 million was primarily attributable to an increase of $0.3 million in professional fees offset by a decrease of $0.5 million in personnel costs.

Total operating expenses increased to approximately $10.1 million for the three months ended March 31, 2024 from $9.4 million for the three months ended March 31, 2023.

Net interest expenses increased to approximately $0.5 million for the three months ended March 31, 2024 from $0.2 million for the three months ended March 31, 2023.

Cash and cash equivalents as of March 31, 2024, totaled approximately $66.6 million.