Benzinga | Sep 28, 2020 07:32AM EDT

Oragenics Says Has Been Informed Of BARDA's Determination Not To Enter Negotiation With Co.; Says 'a combination of factors, including availability of funds, precluded the agency from entering into negotiations at this time.'

Oragenics, Inc. (NYSE:OGEN) ("Oragenics" or the "Company") provides an update on U.S. federal government and other funding options the Company is pursuing in order to advance its SARS-CoV-2 vaccine, Terra CoV-2.

Oragenics has been informed by the Biomedical Advanced Research and Development Authority ("BARDA") of BARDA's determination not to enter into negotiation with the Company. While BARDA noted the Company's submission aligned with its mission, a combination of factors, including availability of funds, precluded the agency from entering into negotiations at this time.

"We remain committed to our Terra CoV-2 vaccine candidate and expect to continue development through to the completion of a Phase 1 clinical trial," said Alan Joslyn, Ph.D., President and Chief Executive Officer. "We have completed analytical method feasibility and qualification activities with our contract manufacturer and have advanced in creation of our research cell bank. Although we are disappointed with BARDA's funding decision, we will continue to pursue other sources of non-dilutive funding of grants and corporate partnerships, and possibly equity capital to advance development of our promising vaccine.

BARDA noted that evaluation of vaccine development under the Operation Warp Speed ("OWS") program continues and can be an avenue for promising vaccine candidates, which the Company believes Terra CoV-2 to be. In addition, BARDA has suggested that if promising vaccine candidates are identified, there is also an opportunity for a potential partnership with the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND). BARDA is part of the U.S. Department of Health and Human Services, OWS is a public-private partnership initiated by the White House in May 2020 and JPEO-CBRND is part of the U.S. Department of Defense.

"Our focus is on the stabilized prefusion spike protein that may confer lifetime immunity to COVID-19 along with other significant points of differentiation including storage and distribution at refrigerated temperatures versus other vaccines currently in development. We will be holding a pre-IND meeting with the FDA in the near future that we expect will help clarify the requirements to advance our program into the clinic. We believe that additional government funds could be made available during the federal government's new fiscal year, which begins on October 1, that we can pursue for development of Terra CoV-2," Dr. Joslyn added.