On August 8, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of 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 June 30, 2022 and provide a business update on its conference call today (Press release, PDS Biotechnology, AUG 8, 2022, View Source [SID1234617801]).

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Recent Business Highlights:

Granted Fast Track Designation by U.S. Food and Drug Administration (FDA) for PDS0101 in combination with KEYTRUDA (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

Presented data from 17 evaluable patients (efficacy) enrolled in the VERSATILE-002 Phase 2 clinical trial at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2022 Annual Meeting, demonstrating clinical efficacy (objective response rate [ORR] plus stable disease) in 76.5% of patients.

Announced acceptance of clinical trial application to expand VERSATILE-002 Phase 2 trial of PDS0101 in combination with KEYTRUDA (pembrolizumab) into the United Kingdom.

Presented data from 30 patients enrolled in National Cancer Institute-led triple combination Phase 2 clinical trial of PDS0101 in advanced, refractory HPV-positive cancers at ASCO (Free ASCO Whitepaper) 2022:

88% of checkpoint inhibitor (CPI)-naïve patients achieving an ORR (tumor shrinkage >30%). In published studies with CPI monotherapy, ORR ranged from 13-24%.

77% of CPI refractory patients were alive at a median of 12 months. In published studies, historical median survival rates for CPI refractory patients is 3-4 months.

Presented data from pre-clinical universal flu vaccine program at the American Society of Virology meeting, demonstrating the ability of PDS0202, the Company’s Infectimune candidate formulated with Computationally Optimized Broadly Reactive Antigens (or COBRA) influenza antigens, to neutralize multiple strains of influenza, including H1N1, and provide protection against infection with lethal challenge in animals.

Strengthened leadership team with addition of Spencer Brown as Senior Vice President and General Counsel, and Sanjay Zaveri as Senior Vice President, Business Development.
"We made tremendous progress this quarter with our lead candidate, PDS0101, across all four ongoing Phase 2 clinical trials, and also with our advancing oncology pipeline candidates PDS0102 and PDS0103," stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. "Our clinical data at this year’s ASCO (Free ASCO Whitepaper) meeting not only solidified our confidence in our Versamune platform, but also in the potential of PDS0101 to make a meaningful difference in the treatment of advanced HPV16-positive cancer patients with significant unmet needs. With these data, we are hopeful that our upcoming meetings with the FDA will clarify our regulatory path forward for PDS0101."

Dr. Bedu-Addo further commented, "We are also encouraged by the pre-clinical data from our PDS0202 universal flu vaccine candidate which we believe has the potential to transform the global approach to protecting the population against the flu virus. We believe we are well positioned to continue our drive to deliver significant value to both patients and our shareholders."

Second Quarter 2022 Financial Results
Net loss for the three months ended June 30, 2022 was approximately $5.8 million, or ($0.20) per basic share and diluted share, compared to a net loss of approximately $0.6 million, or ($0.03) per basic share and diluted share, for the three months ended June 30, 2021. The higher net loss reported for the three months ended June 2022 is primarily due to additional costs for expansion of the Company’s research and development, including costs associated with our ongoing clinical trials, additional general and administrative costs, and lower income tax benefit.

Research and development expenses increased to $3.8 million for the three months ended June 30, 2022 from $2.8 million for the three months ended June 30, 2021. The increase of $1.0 million in 2022 was primarily attributable to an increase of $0.4 million in clinical study and research costs, $0.7 million in personnel costs, and $0.1 million in facilities, partially offset by a decrease of $0.2 million in manufacturing services.

General and administrative expenses increased to $3.3 million for the three months ended June 30, 2022 from $2.3 million for the three months ended June 30, 2021. The increase of $1.0 million is primarily attributable to an increase of $0.8 million in personnel costs and $0.2 million in legal fees.

Total operating expenses were approximately $7.1 million for the three months ended June 30, 2022, from approximately $5.1 million for the three months ended June 30, 2021.

PDS Biotech’s cash balance as of June 30, 2022 was approximately $53.0 million.

Conference Call and Webcast
The conference call is scheduled to begin at 8:00 AM EDT today, August 8, 2022. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13731437. 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.

KEYTRUDA is a registered trademark of Merck Sharp and Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.