PDS Biotechnology (NASDAQ: PDSB) reported Q2 EPS of ($0.19), $0.04 better than the analyst estimate of ($0.23).

Second Quarter 2020 and Recent Business Highlights

• Announced publication of PDS0101 triple combination preclinical study by the National Cancer Institute;
• Initiated Phase 2 clinical trial of PDS0101 triple combination, led by the National Cancer Institute, for the treatment of advanced human papillomavirus (HPV)-associated cancers;
• Announced Phase 2 trial to evaluate PDS0101 in combination with standard of care for treatment of locally advanced cervical cancer at The University of Texas MD Anderson Cancer Center;
• Launched novel PDS Biotech-owned vaccine development programs for COVID-19, PDS0203, and universal influenza, PDS0202;
• Broadened existing co-development agreement with Farmacore Biotechnology to include development of a second COVID-19 vaccine candidate, PDS0204;
• Expanded existing Cooperative Research and Development Agreement with the National Cancer Institute to include preclinical and clinical development of PDS0103 in MUC-1 expressing- cancers including breast, colon, lung and ovarian cancers;
• PDS Biotech collaborator at the University of Kentucky School of Medicine granted NIAID award to accelerate Versamune®-based PDS0202 universal influenza vaccine;
• Published abstract on preclinical studies of PDS0102, a product for the treatment of breast and prostate cancers, at the American Society of Clinical Oncology; and
• Appointed Dr. Ilian Iliev to Board of Directors.

“PDS Biotech has made significant progress across both our immuno-oncology and infectious disease programs despite the challenging environment due to the global pandemic,” commented Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech. “We are pleased despite the pandemic to have recently initiated our first of three Phase 2 clinical studies of PDS0101. This study is being run by the National Cancer Institute for the treatment of advanced HPV-associated cancers. We anticipate initiation in the near term a second Phase 2 study for PDS0101 with standard of care chemoradiotherapy at the MD Anderson Cancer Center for the treatment of locally advanced cervical cancer. We believe these trials, partnered with leading organizations hold significant potential to demonstrate that our Versamune® platform, in combination with other anti-cancer agents, will provide improved clinical outcomes for patients with advanced HPV-associated cancers. We are evaluating the potential to initiate the VERSATILE-002 trial that was put on hold due to the COVID-19 epidemic by the end of the year if possible.”

“We have also been conducting preclinical studies of PDS0203, our COVID-19 vaccine program and recently announced an expanded development collaboration with Farmacore to advance PDS0204, a second COVID-19 vaccine candidate into Phase 1 clinical testing in Brazil, with initial financial support for preclinical work provided by the Brazilian Ministry of Science, Technology, Innovation and Communication (MCTIC). Furthermore, the grant by the NIAID to our long-term collaborator at The University of Kentucky School of Medicine to accelerate the Versamune®-based universal influenza vaccine program, PDS0202, further validates the potential value of Versamune® in infectious diseases. With these significant developments in both our cancer and infectious disease programs, we believe that PDS Biotech is well positioned to progress our programs through initial human clinical data generation over the next 12-18 months, barring any unforeseen events,” concluded Dr. Bedu-Addo.

For earnings history and earnings-related data on PDS Biotechnology (PDSB) click here.