On May 11, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of molecularly targeted cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported that it will discuss its financial results for the quarter ended March 31, 2022, and provide a business update on its conference call today (Press release, PDS Biotechnology, MAY 11, 2022, View Source [SID1234614181]).
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"2022 is shaping up to be an incredibly productive year for PDS Biotech," commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of the Company. "As we continue to make significant clinical progress on our lead oncology candidate, PDS0101, we’re looking ahead to presentations of preliminary data from our two most advanced Phase 2 clinical trials at this year’s ASCO (Free ASCO Whitepaper) meeting in early June. We believe ASCO (Free ASCO Whitepaper)’s selection of the preliminary data from both trials for presentation at the June meeting is a testament to the quality of work being done by our team and our partners, as well as the potential demonstrated by PDS0101 in treating advanced HPV-associated cancers. We look forward to sharing these efficacy and safety data in the near term. In addition, we continue to leverage our proprietary platforms to advance our pre-clinical pipeline into clinical studies, focused on a variety of cancer targets and infectious diseases. Lastly, due to our partnering model and our financial discipline, we finished the quarter with a strong cash balance which we project to fund our current operations into 2024."
Recent Business Highlights:
Announced two abstracts accepted for poster presentation during the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place June 3-7 in Chicago:
The poster presentation of Abstract # 6041 will summarize updates to the preliminary efficacy and safety data from the PDS-sponsored VERSATILE-002 Phase 2 clinical trial, which is evaluating PDS0101 in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.
The poster presentation of Abstract # 2518 will summarize updates from last year’s ASCO (Free ASCO Whitepaper) presentation to efficacy and survival data, as well as new findings from the ongoing National Cancer Institute (NCI)-led Triple Combination Phase 2 clinical trial. This trial is evaluating PDS0101 in combination with two investigational immune-modulating agents across the range of HPV16-positive advanced relapsed refractory cancers.
In April, received $1.2 million from the net sale of tax benefits to an unrelated, profitable New Jersey corporation pursuant to the Company’s participation in the New Jersey Technology Business Tax Certificate Transfer Net Operating Loss (NOL) program for State Fiscal Year 2021.
Announced that the NCI achieved the enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the Triple Combination Phase 2 clinical trial for PDS0101.
First Quarter 2022 Financial Results
PDS Biotech reported a net loss of approximately $8.5 million, or $0.32 per basic share and diluted share, for the three months ended March 31, 2022 compared to a net loss of approximately $3.0 million, or $0.14 per basic share and diluted share, for the three months ended March 31, 2021.
Research and development (R&D) expenses increased to approximately $5.2 million for the three months ended March 31, 2022 from approximately $1.4 million for the three months ended March 31, 2021. The increase of approximately $3.7 million in 2022 was primarily attributable to an increase of $1.8 million in manufacturing services and quality costs, $1.04 million in clinical study and regulatory costs, $0.8 million in personnel costs and $0.06 million in facilities.
General and administrative expenses increased to approximately $3.3 million for the three months ended March 31, 2022 from approximately $1.6 million for the three months ended March 31, 2021. The increase of approximately $1.7 million is primarily attributable to an increase of $1.0 million in personnel costs, $0.6 million in legal fees and $0.1 in marketing expenses.
Total operating expenses increased to approximately $8.5 million for the three months ended March 31, 2022 from approximately $3.0 million for the three months ended March 31, 2021 for the reasons described above.
PDS Biotech’s cash balance as of March 31, 2022 was approximately $58.9 million.
Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT on Wednesday, May 11, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13728184. 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.