On November 10, 2021 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing novel cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune T-cell activating technology, reported that it will discuss its financial results for the quarter ended September 30, 2021 and provide a business update on its conference call today (Press release, PDS Biotechnology, NOV 10, 2021, View Source [SID1234595219]).
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Recent Business Highlights:
Achieved several milestones in the VERSATILE-002 Phase 2 Combination Trial of PDS0101-KEYTRUDA for recurrent and/or metastatic human papillomavirus (HPV)16-associated head and neck cancer. These milestones include:
Achievement of the preliminary safety benchmark for the first 12 patients
Completion of enrollment for the first stage of the checkpoint inhibitor naïve arm (1st line treatment of recurrent or metastatic head and neck cancer).
Initiated enrollment of the second arm of the study addressing checkpoint inhibitor refractory patients (2nd line treatment of recurrent or metastatic head and neck cancer)
Completed a licensing agreement with the National Cancer Institute (NCI) for intellectual property related to the NCI’s proprietary T-cell receptor gamma alternate reading frame protein (TARP) tumor antigen for use in PDS0102.
PDS0102 is being developed to treat prostate cancer, breast cancer and acute myeloid leukemia or AML.
PDS0102 has demonstrated powerful induction of TARP-specific killer T-cells in preclinical studies.
Entered agreement to license COBRA (Computationally Optimized Broadly Reactive Antigen) antigens from the University of Georgia for use in the development of PDS0202, a novel Versamune-based universal flu vaccine.
Announced temporary administrative suspension of enrollment into the NCI-led study of the PDS0101 triple combination. PDS Biotech continues to be in contact with the NCI. Treatment of already enrolled patients has continued without interruption.
Announced the hiring of Matthew Hill as Chief Financial Officer, who has more than 25 years of experience in finance and operational leadership roles for life sciences companies.
"PDS Biotech has continued to build on its momentum from the interim data of the last quarter in 2nd and 3rd line treatment of HPV16-positive anal, cervical, head and neck, vaginal and vulvar cancers," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "We have achieved numerous clinical milestones, and formalized agreements with development partners to continue to progress both our Versamune-based oncology pipeline and our Versamune-based infectious diseases pipeline. We also welcomed Matthew Hill as our new Chief Financial Officer. Matt has decades of experience as a financial leader in publicly traded life sciences companies and will be a key player in our next phase of growth. The groundwork has been laid for the execution of multiple pipeline development milestones in 2022 and into 2023."
Third Quarter 2021 Financial Results
PDS Biotech reported a net loss of approximately $7.0 million, or $(0.24) per basic and diluted share, for the three months ended September 30, 2021, compared to a net loss of approximately $3.9 million, or $(0.21) per basic and diluted share, for the three months ended September 30, 2020.
Research and development expenses increased to approximately $3.7 million for the three months ended September 30, 2021 from approximately $2.1 million for the three months ended September 30, 2020. The increase of $1.6 million was primarily attributable to an increase of $0.7 million in personnel costs of which $0.5 million was stock compensation costs, and $0.9 million in costs related to clinical studies.
General and administrative expenses increased to approximately $3.2 million for the three months ended September 30, 2021 from approximately $1.8 million for the three months ended September 30, 2020. The increase of $1.4 million is primarily attributable to an increase in personnel costs of $1.6 million, of which $1.0 million was stock compensation costs and $0.4 million was severance, partially offset by a decrease in professional fees of $0.2 million.
PDS Biotech’s cash and cash equivalents as of September 30, 2021, were approximately $69.7 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 am ET on Wednesday, November 10, 2021. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and mention PDS Biotechnology. A live webcast of the conference call will also be available on the investor relations page of the Company’s corporate website at www.pdsbiotech.com.
After the live webcast, the event will be archived on PDS Biotech’s website for 6 months. In addition, a telephonic replay of the call will be available for 6 months. The replay can be accessed by dialing 877-660-6853 (United States) or 201-612-7415 (International) with confirmation code 13722558.