On August 8, 2019 Vaxart, Inc., a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported financial results for the second quarter ended June 30, 2019 (Press release, Vaxart, AUG 8, 2019, View Source [SID1234538458]).

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"We have made significant progress this quarter, achieving a number of important milestones. We completed enrollment in our Phase 1b bivalent norovirus vaccine study and we expect to have topline results by October of this year," said Wouter Latour, M.D., chief executive officer of Vaxart. "Norovirus causes $60 billion in global healthcare related costs annually, and our oral tablet vaccine would be ideal to help protect vulnerable populations such as older adults and the very young. We remain committed to developing the norovirus vaccine, and we are now preparing to start a Phase 2 study with our bivalent norovirus vaccine in 2020, assuming we achieve positive results in the current Phase 1b trial."

"With regard to universal flu, the collaboration with Janssen is an important endorsement of our oral vaccine platform and could position us as a key player in the future of influenza vaccine development. In parallel, we continue our efforts to advance our own oral seasonal flu vaccine, which demonstrated the potential to provide better protection than currently marketed injectable vaccines, such as FluzoneTM, in a human challenge study. Given our focus on the bivalent norovirus and universal flu vaccine programs, we have deprioritized the monovalent norovirus vaccine challenge study and now plan to file our human papilloma virus (HPV) Investigational New Drug application (IND) in 2020," continued Dr. Latour.

Recent Corporate Highlights:

● Completed enrollment in the Phase 1b bivalent norovirus vaccine clinical trial. The vaccine consists of an oral norovirus GI.1 vaccine tablet and an oral norovirus GII.4 vaccine tablet administered concurrently. The trial is designed to evaluate safety and immunogenicity and Vaxart expects to report topline data in early Q4 2019.

● Entered into a research collaboration agreement with Janssen Vaccines & Prevention B.V. (Janssen) to evaluate Vaxart’s proprietary oral vaccine platform for the Janssen universal influenza vaccine program.

● Priced an underwritten public offering which closed in April. As of June 30, 2019, the aggregate gross proceeds were $10.0 million.

● Entered into an agreement with Lonza Houston to supply vaccine for the planned Phase 2 bivalent norovirus study in 2020.

● Presented preclinical data at the 29th European Congress of Clinical Microbiology and Infectious Diseases in Amsterdam which showed that Vaxart’s oral quadrivalent seasonal influenza vaccine conferred 100% protection against a lethal H5N1 pre-pandemic influenza challenge in ferrets, while in the Fluzone group only 62% of the animals survived.

● Published the comprehensive results from a preclinical trial of Vaxart’s chikungunya vaccine in the peer reviewed journal, Vaccine. The preclinical results demonstrated that Vaxart’s vaccine candidate induced significant neutralizing antibodies against chikungunya virus as well as protective efficacy against virus-induced pathologic changes.

● Presented preclinical results of Vaxart’s oral Respiratory Syncytial Virus (RSV) vaccine in a poster presentation at the American Society of Microbiology 2019, demonstrating the Vaxart vaccine induces respiratory mucosal memory and protection against RSV infection in cotton rats.

Following a review of the development strategy for norovirus, Vaxart has deprioritized the monovalent GI.1 challenge study. Consequently, the Company is preparing to initiate a Phase 2 safety and immunogenicity study with Vaxart’s bivalent norovirus vaccine in 2020, to be followed by a Phase 3 efficacy study, assuming FDA concurrence.

Financial Results for the Three Months Ended June 30, 2019

● Vaxart reported a net loss of $5.6 million for the second quarter of 2019 compared to $8.9 million for the second quarter of 2018. The principal reasons for the decrease were the absence of a $1.6 million one-off non-cash impairment charge recorded in the second quarter of 2018 and a reduction in research and development expenditure.

● Vaxart ended the quarter with cash and cash equivalents of $16.3 million compared to $8.4 million at March 31, 2019. The increase was primarily due to the $8.7 million net raised as a result of the underwritten offering in April 2019, partially offset by cash used in operations.

● Revenue for the quarter was $85,000 compared to $608,000 in the second quarter of 2018. The decrease was almost entirely due to the absence of revenue of $520,000 from the BARDA contract which ended in 2018.

● Research and development expenses were $3.7 million for the quarter compared to $5.0 million for the second quarter of 2018. The decrease was mainly due to the absence of clinical trials costs for teslexivir and costs incurred for the now-completed BARDA contract, partially offset by higher clinical trial and manufacturing costs incurred in the Company’s norovirus program.

● General and administrative expenses were $1.4 million for the quarter compared to $1.8 million for the second quarter of 2018. The decrease was mainly due to lower legal costs and a reduction in personnel costs.