FLORHAM PARK, N.J., Nov. 11, 2020 (GLOBE NEWSWIRE) -- 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, today announced its financial results for the third quarter ended September 30, 2020 and provided a business update.
Third Quarter 2020 and Recent Business Highlights
- Successfully raised approximately $19 million via a public offering of common stock.
- Initiated VERSATILE-002, a Phase 2 trial of PDS0101, our investigational drug candidate, in combination with standard of care KEYTRUDA® for first-line treatment of patients with metastatic or recurrent HPV-positive head and neck cancer.
- Initiated a Phase 2 study of PDS0101 in combination with standard of care chemoradiotherapy at the MD Anderson Cancer Center for treatment of locally advanced cervical cancer.
- Continued development of PDS0103 in partnership with the National Cancer Institute.
- Advanced co-development program with Farmacore with plans to move the PDS0203 COVID-19 vaccine into clinical development with the support of the Brazilian government.
- Expanded Board of Directors with appointment of preeminent oncologist, Otis Brawley, M.D.
“As a result of our team’s dedicated efforts during the third quarter and our clinical partnerships with leading institutions in immuno-oncology, today PDS0101 is being evaluated in three phase 2 clinical trials for multiple HPV-associated cancers,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotechnology. “Furthermore, the successful equity raise we completed in August strengthened our balance sheet, ensuring we can continue to progress the clinical development of our oncology programs as well as expand both our oncology and infectious disease programs despite the challenges posed by the COVID-19 pandemic.”
Third Quarter 2020 Financial Review
For the third quarter of 2020, net loss was approximately $3.9 million, or $0.23 per basic share and diluted share, compared to a net loss of approximately $5.8 million, or $1.10 per basic share and diluted share for the third quarter of 2019.
Research and development expenses totaled approximately $2.1 million for the third quarter of 2020, compared to approximately $1.8 million for the same period in 2019, an increase of 12%. The increase was primarily attributable to an increase of $0.1 million in technical operations (manufacturing) and $0.3 million in clinical studies, offset by a decrease of $0.1 million in professional fees and $0.1 million in regulatory expenses.
For the third quarter of 2020, general and administrative expenses were approximately $1.8 million compared with approximately $3.0 million during the third quarter of 2019, a decrease of 40%. The decrease was primarily attributable to a decrease of $0.2 million in salary and benefits, $0.1 million in facilities and office expense, $0.3 million in insurance expense, $0.6 million in professional fees, and $0.1 million in legal fees offset by an increase of $0.1 million in licenses, taxes and fees.
Total operating expenses for the third quarter of 2020 were approximately $3.9 million, compared to total operating expenses of approximately $5.8 million during the same period of 2019, a decrease of 33%.
As of September 30, 2020, the Company’s cash balance was approximately $33.5 million.
About PDS Biotechnology
PDS Biotech is a clinical-stage immunotherapy company with a growing pipeline of cancer immunotherapies and infectious disease vaccines based on the Company’s proprietary Versamune® T-cell activating technology platform. Versamune® effectively delivers disease-specific antigens for in vivo uptake and processing, while also activating the critical type 1 interferon immunological pathway, resulting in production of potent disease-specific killer T-cells as well as neutralizing antibodies. PDS Biotech has engineered multiple therapies, based on combinations of Versamune® and disease-specific antigens, designed to train the immune system to better recognize disease cells and effectively attack and destroy them. To learn more, please visit www.pdsbiotech.com or follow us on Twitter at @PDSBiotech.