On March 28, 2023 PDS Biotechnology Corporation (NASDAQ: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported a business update and announced its financial results for the year ended December 31, 2022 (Press release, PDS Biotechnology, MAR 28, 2023, View Source [SID1234629408]).

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Fourth Quarter 2022 and Recent Business Highlights:

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PDS0101 Lead Drug Candidate

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VERSATILE-002 Phase 2 combination trial with Merck & Co. Inc.’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with human papillomavirus (HPV) 16-positive recurrent and/or metastatic head and neck cancer.

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Completed first stage of enrollment in checkpoint inhibitor refractory arm

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Presented initial data on methods for investigating efficacy of PDS0101 in combination with KEYTRUDA (pembrolizumab) with respect to T cell activation and functionality at the ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress 2023

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National Cancer Institute (NCI)-led Phase 2 triple combination trial in patients with advanced HPV-positive cancers.

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Successful meeting with U.S. Food and Drug Administration (FDA) to discuss regulatory pathway for triple combination of PDS0101, PDS0301, and an approved immune checkpoint inhibitor (ICI)

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Reported median overall survival (OS) of 21 months in advanced, ICI refractory cancer HPV-positive patients (N=29) having few remaining treatment options

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IMMUNOCERV Phase 2 clinical trial of PDS0101 with chemoradiotherapy (CRT) in patients with locally advanced cervical cancer.

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100% (9/9) clinical response (>60% tumor shrinkage at mid-point evaluation), and 89% (8/9) complete response based on preliminary data

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Study demonstrated strong infiltration of T cells into the tumors, elimination of circulating tumor DNA

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PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)

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Signed exclusive global license agreement for PDS0301, a novel, investigational, proprietary investigational tumor targeting, antibody-conjugated IL-12, developed by Merck KGaA, Darmstadt, Germany

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Publication of PDS0301 monotherapy study linking PDS0301-induced immune responses with clinical outcomes in International Immunopharmacology

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Infectimune Platform

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Publication of preclinical Infectimune study in the peer-reviewed journal Viruses showing complete protection in animal studies with PDS0202, a novel investigational recombinant protein-based Universal flu vaccine

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A second preclinical Infectimune publication in the peer-reviewed journal Viruses showing unique induction of higher levels of multifunctional CD4 T cells compared to leading commercial vaccine technologies

"This past quarter and year have been exciting for PDS Biotech as we have made significant progress on our strategic initiatives and substantial advances in the clinic, including key data and development milestones involving our lead oncology candidate, PDS0101," stated Dr. Frank Bedu-Addo, Chief Executive Officer of PDS Biotech. "We received FDA guidance on the regulatory pathway for the VERSATILE-002 Phase 2 trial and, most recently, the triple combination Phase 2 trial. We look forward to progressing PDS0101 into a registrational trial in 2023."

Dr. Bedu-Addo continued, "Additionally, we were pleased to have signed an exclusive global agreement with Merck KGaA, Darmstadt, Germany to advance the development of PDS0301, a novel, investigational, proprietary antibody-conjugated IL-12. We also continued progressing our Infectimune platform as well as our preclinical oncology candidates."

Full-Year 2022 Financial Results
Net loss for the year ended December 31, 2022 was approximately $40.9 million, or $1.43 per basic share and diluted share, compared to a net loss of approximately $16.9 million, or $0.66 per basic share and diluted share for the year ended December 31, 2021. The higher net loss was primarily the result of investment in research and development, including the clinical programs and the acquisition of PDS0301.

Research and development expenses for the year ended December 31, 2022, increased to approximately $29.4 million compared to approximately $11.3 million for the year ended December 31, 2021. The increase of $18.2 million was primarily attributable to an increase in personnel costs of $2.3 million, clinical costs of $2.3 million, quality and manufacturing costs of $3.6 million and $10 million for the rights to PDS0301 from Merck KGaA, Darmstadt Germany. Of the $10 million paid to Merck KGaA, Darmstadt Germany, $5 million was in cash and the balance in shares of the Company’s common stock.

General and administrative expenses for the year ended December 31, 2022 increased to approximately $12.2 million compared to approximately $10.2 million for the year ended December 31, 2021. The $2.0 million increase was primarily attributable to an increase in personnel costs of $1.3 million and an increase in professional fees of $0.7 million.

Total operating expenses for the year ended December 31, 2022, were approximately $41.7 million, an increase of approximately 94% compared to total operating expenses of approximately $21.4 million for the year ended December 31, 2021.

The Company’s cash balance as of December 31, 2022 was $73.8 million. Based on the Company’s available cash resources and cash flow projections, the Company believes that with the anticipated initiation of one registrational trial in 2023, this balance is sufficient to fund Company operations and research and development programs into the third quarter of 2024.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM ET today, March 28, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13736455. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.