On November 12, 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 third quarter ended September 30, 2019 and provided a corporate update (Press release, Aviragen Therapeutics, NOV 12, 2019, View Source [SID1234551034]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The positive topline results from the Phase 1b clinical trial were a major milestone for the norovirus program," said Wouter Latour, M.D., chief executive officer of Vaxart. "The vaccine was well tolerated and elicited robust mucosal responses in 90 – 93% of subjects for the new norovirus GII component, and 78 – 86% for the norovirus GI component. This data suggests that our oral norovirus vaccine is likely to provide mucosal immunity in the intestine, the actual site of norovirus infection. We believe this is the optimal approach to protect against norovirus disease and puts Vaxart in a unique position to develop an effective oral vaccine targeting an estimated $3+ billion US market."

The CDC estimates that norovirus causes $60 billion in global healthcare related costs annually.

Vaxart plans to focus its efforts and resources on progressing the clinical development of its oral tableted bivalent norovirus vaccine. The Company will also continue the development of its first therapeutic vaccine targeting cervical cancer and dysplasia caused by Human Papilloma Virus (HPV), and explore opportunities to apply its VAASTTM oral vaccine platform for indications such as influenza and RSV.

Recent Corporate Highlights:

Vaxart’s Tableted Oral Bivalent Norovirus Vaccine Meets Primary and Secondary Endpoints in Phase 1b Study

The study met all primary endpoints for safety and demonstrated robust immunogenicity, with response rates of 90 – 93% for norovirus GII.4 and 78 – 86% for norovirus GI.1 as measured by IgA Antibody Secreting Cells (ASC), a key marker for mucosal immunity and a potential correlate of protection for norovirus disease.

Manufacturing of Norovirus GI.1 and GII.4 vaccines is proceeding as planned at Lonza and the initiation of the Phase 2 Bivalent Norovirus study is on target for 2020.

Research collaboration with Janssen’s Universal Influenza Vaccine Program is proceeding with results expected in 2020.

Priced an underwritten public offering which closed in September. As of September 30, 2019, the aggregate gross proceeds were $9.0 million.

Vaxart presented a corporate overview and update to investors and strategic partners at the H.C. Wainwright 21st Annual Global Investment Conference, in New York City.

Scientific meeting presentations:

IDWeek – Washington, DC, Presentation Title: Oral Norovirus Vaccination in Humans Induces Plasmablast B Cell Expansion and Follicular T Cell Activation Comparable to Natural Infection

7th International Calicivirus Conference – Sydney, Australia, Presentation Title: Oral Vaccine to Prevent Norovirus Infection Induces Mucosal Homing Plasmablasts and T Follicular Cells in Humans

10th International Vaccines for Enteric Diseases Conference (VED 2019) – Lausanne, Switzerland, Presentation Title: Progress on the Development of an Oral, Bivalent Norovirus Vaccine

In mid-November, Vaxart will be hosting a Key Opinion Leader Meeting in New York City on the Health Economics of Norovirus.

Financial Results for the Three Months Ended September 30, 2019

Vaxart reported a net loss of $5.3 million for the third quarter of 2019 compared to $6.5 million for the third quarter of 2018. The principal reason for the decrease was a reduction in research and development expenditure.

Vaxart ended the quarter with cash and cash equivalents of $19.6 million compared to $16.3 million at June 30, 2019. The increase was primarily due to the $8.1 million net proceeds from equity financing, mostly from the underwritten offering in September 2019, partially offset by cash used in operations.

Revenue for the quarter was $454,000 compared to $281,000 in the third quarter of 2018. The increase was mostly due to non-cash royalty revenue related to the sale of future royalties.

Research and development expenses were $3.7 million for the quarter compared to $4.4 million for the third quarter of 2018. The decrease was mainly due to the absence of clinical trials costs for teslexivir and a reduction in amortization of intangibles, partially offset by higher clinical trial and manufacturing costs incurred in the Company’s norovirus program.

General and administrative expenses were $1.5 million for the quarter compared to $1.7 million for the third quarter of 2018. The decrease was mainly due to lower audit and accounting costs.