On May 15, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported that it will discuss its financial results for the quarter ended March 31, 2023, and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 15, 2023, View Source [SID1234631742]).
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First Quarter and Recent Business Highlights:
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PDS0101 Lead Drug Candidate
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VERSATILE-002 Phase 2 open-label, multicenter study of PDS0101 in combination with Merck’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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Announced poster presentation of updated data from VERSATILE-002 trial during the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and its selection as a featured poster to be reviewed by an expert panel during the Head and Neck Cancer discussion session
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Announced plan to initiate the Phase 3 VERSATILE–003 trial, for PDS0101 in combination with KEYTRUDA in head and neck cancer in the fourth quarter of 2023
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Presented initial data on T cell activation and functionality for PDS0101 in combination with KEYTRUDA (pembrolizumab) 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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Reported 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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PDS0301 Antibody-Conjugated Interleukin 12 (IL-12)
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Hosted Key Opinion Leader (KOL) event focused on the potential use of IL-12 immunocytokine in oncology and the clinical results demonstrated to date with PDS0301
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Announced clinical study of PDS0301 monotherapy published by the NCI in peer-reviewed journal, International Immunopharmacology, linking induced changes in immune responses with clinical outcomes in advanced cancer patients
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Infectimune Platform
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Publication of preclinical Infectimune study in the peer-reviewed journal Viruses showed complete protection against influenza infection 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 showed induction of higher levels of multifunctional influenza-specific CD4 T cells compared to leading commercial vaccine technologies
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Business Highlights
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Received $1.4 million from the net sale of net operating loss tax benefits through the New Jersey economic development program
"PDS Biotech had another productive quarter progressing toward initiation of the upcoming Phase 3 trial, VERSATILE-003, for PDS0101 in combination with KEYTRUDA in HPV16-positive head and neck cancer patients," stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "We look forward to initiating our Phase 3 trial in the fourth quarter of this year and to provide an update on interim data from our VERSATILE-002 Phase 2 clinical trial this June at ASCO (Free ASCO Whitepaper). Additionally, the NCI-led triple combination, IMMUNOCERV, and Mayo Clinic neoadjuvant Phase 2 trials continue to progress. Furthermore, we continue to develop our novel antibody-conjugated IL-12 asset PDS0301 and look forward to providing an update on ongoing investigator-initiated Phase 2 trials at the NCI in several solid tumor indications."
First Quarter 2022 Financial Results
Reported net loss was approximately $9.7 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2023, compared to a net loss of $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022. The increase was due to personnel, clinical studies, medical affairs, and manufacturing expenses.
Research and development expenses increased to approximately $5.8 million for the three months ended March 31, 2023, from $5.2 million for the three months ended March 31, 2022. The increase of $0.6 million in 2023 was primarily attributable to an increase of $0.2 million in clinical studies and medical affairs, $0.8 million in personnel costs and $0.1 million in professional fees offset by a decrease of $0.5 million in manufacturing expenses.
General and administrative expenses increased to approximately $3.6 million for the three months ended March 31, 2023, from approximately $3.3 million for the three months ended March 31, 2022. The increase of $0.3 million is primarily attributable to an increase of $0.8 million in personnel, which is offset by a decrease of $0.5 million in professional fees.
Total operating expenses increased to approximately $9.4 million for the three months ended March 31, 2023 from $8.5 million for the three months ended March 31, 2022.
Cash and cash equivalents as of March 31, 2023, totaled approximately $65.2 million. Based on the Company’s cash resources with the anticipated initiation of one registrational trial in 2023, PDS Biotech believes this balance is sufficient to fund the Company’s 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 on Monday, May 15, 2023. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13738216. To access the webcast, please use the following link PDS Biotech Earnings Webcast. The event will be archived in the investor relations section of PDS Biotech’s website for six months.