Vaxart Provides Business Update and Reports Third Quarter 2022 Financial Results
Growing body of clinical evidence supports transformational potential of Vaxart’s oral vaccine platform
Clinical trial programs on track for reporting key data milestones
Ended third quarter with
Conference call today at
“We are encouraged by the growing body of clinical evidence that supports the transformational potential of Vaxart’s oral pill vaccine platform with positive data from both our leading programs, COVID-19 and norovirus,” said
“Norovirus is a significant opportunity for
Vaxart’s oral vaccine platform has the potential to transform the vaccination paradigm globally, by providing significant advantages compared to injectable vaccines. One of the Company’s vaccine candidates was shown to be as protective as a leading injectable against a pandemic respiratory virus in a human flu challenge study. In addition, data from multiple programs suggest that by triggering mucosal immunity the platform could provide cross-reactivity against variants, reduce viral transmission, offer long duration of protection and offer a more tolerable safety profile.
“These potential advantages are in addition to those offered by the oral pill format, which could allow more people to be vaccinated painlessly, easily and faster all around the world. We are in a position to aggressively pursue our two leading clinical programs and are very excited looking into 2023 at the significant milestones for both programs – the readouts of two human challenge studies for norovirus and COVID-19,”
Recent Business Highlights
COVID-19 Vaccine Developments
September 2022, Vaxartreported positive top-line data from its Phase II COVID-19 trial supporting broad potential of the Company’s COVID-19 vaccine candidates to tackle the challenges of an evolving virus that continues to overcome the immune protection provided by approved vaccines. Vaxartis the only company with a mucosal vaccine candidate for COVID-19 that has produced Phase II clinical data that shows it stimulates mucosal immunity.
July 2022, the Company updated Phase I data showing Vaxart’s Spike/Nucleocapsid (S+N) candidate stimulated SARS-CoV-2-specific IgA antibodies in saliva and nasal samples from human subjects and was cross-reactive to many different coronaviruses that are more divergent than circulating variants of SARS-CoV-2.
Norovirus Vaccine Developments
June 2022, Vaxartreported positive top-line data about its norovirus vaccine candidate.
- The data from Vaxart’s Phase Ib trial in subjects aged 55-80 demonstrated that Vaxart’s oral norovirus vaccine candidate stimulated a robust immune response across all doses, with a dose-dependent production of IgA antibody secreting cells.
- Results were consistent with previous studies conducted in younger populations, which is typically not the case, as the immune system often weakens with age, and older people tend to have less robust responses to vaccination than younger people.
- No vaccine exists in
the United Statesto treat norovirus, a virus that causes up to 21 million cases, 109,000 hospitalizations and 900 deaths annually in the United States.
- Bolstered management and Board with three significant additions:
- In August, named
Ray Stapleton, Ph.D. as Chief Technology Officer. Dr. Stapletonjoins Vaxartfrom Genocea, where he served as CTO and Executive Vice President, working to develop next generation personalized immunotherapies in the forms of vaccines and cell therapies. His prior experience includes senior manufacturing and technical operations roles at a number of biotech companies after spending 15 years in positions of increasing responsibility in Merck and Company’s manufacturing organization.
- Also in August, appointed
Elaine J. Heron, Ph.D. and W. Mark Watsonto the Company’s Board of Directors. Dr. Heroncurrently serves on the boards of BioMarin Pharmaceutical, Inc., Palvella Therapeutics, Inc., Visgenx, Inc., and Watershed Medical, Inc.She also serves as an advisor to Kyto Technology and Life Science, Inc. Dr. Heronhas over 35 years of experience in the life science research and biotech development sectors. Mr. Watsonis a Certified Public Accountant with more than 40 years of experience in public accounting and auditing, having spent his entire career from January 1973to June 2013at Deloitte Touche Tohmatsuand its predecessor, most recently as Central Florida Marketplace Leader.
- In August, named
Planned Clinical Milestones in the COVID-19 and Norovirus Pipelines
- Start of Phase II trial of Vaxart’s bivalent norovirus vaccine candidate in Q4 2022 or Q1 2023.
- Top-line data from ongoing Phase II norovirus challenge study expected at the end of Q1 2023 or early Q2 2023.
- Selection of COVID-19 vaccine construct to be used in the
UKhuman challenge study expected in Q4 2022.
- After determining which COVID-19 vaccine candidate to advance,
Vaxartanticipates updating its plans for its Indiatrials.
- Omicron Human Challenge Trial in the
UKstarting in 2H 2023 using selected vaccine construct.
Financial Results for the Three Months Ended September 30, 2022
- Vaxart ended the third quarter with cash, cash equivalents and available-for-sale debt securities of $114.8 million, compared to $131.5 million as of June 30, 2022. The decrease was primarily due to
$14.6 millionof cash used in operations.
- The Company reported a net loss of $29.3 million for the third quarter of 2022, compared to $17.6 million for the third quarter of 2021. Net loss per share for the third quarter of 2022 was $0.23, compared to a net loss of $0.14 per share in the third quarter of 2021. The increase in net loss was primarily due to a significant increase in research and development costs.
- Research and development expenses were $22.5 million for the third quarter of 2022, compared to $12.4 million for the third quarter of 2021. The increase was mainly due to increases in headcount and related costs, and in manufacturing and clinical trial expenses related to our COVID-19 and norovirus vaccine candidates.
- General and administrative expenses were $7.0 million for the third quarter of 2022, compared to $5.0 million for the third quarter of 2021. The increase was mainly due to increases in headcount and related costs and in legal and professional costs.
The conference call can be accessed using the following information:
Webcast: Click here
Conference ID: 13733692
Investors may submit written questions in advance of the conference call to email@example.com.
A replay of the webcast will be available on the Company’s website at www.vaxart.com following the conclusion of the event.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding
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Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||50,768||$||143,745|
|Investments in debt securities||63,999||38,952|
|Prepaid and other assets||7,536||3,499|
|Property and equipment, net||12,280||6,601|
|Right-of-use assets, net||26,607||13,168|
|Intangible assets, net||9,611||10,624|
|Liabilities and stockholders’ equity|
|Operating lease liabilities||22,168||13,008|
|Liability related to sale of future royalties||12,358||11,522|
|Accrued and other liabilities||10,560||5,235|
|Total liabilities and stockholders’ equity||$||175,309||$||221,168|
|(1)||Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2021, included on the Form 10-K filed with the Securities and Exchange Commission on February 24, 2022.|
Condensed Consolidated Statements of Operations
| Three Months Ended
|| Nine Months Ended
| (in thousands, except share and per share amounts)
|Research and development||22,466||12,409||60,595||33,219|
|General and administrative||6,960||5,042||22,939||16,136|
|Total operating expenses||29,426||17,451||83,534||49,355|
|Loss from operations||(29,426||)||(17,251||)||(83,449||)||(48,537||)|
|Other income and (expense), net||133||(311||)||(340||)||(1,080||)|
|Loss before income taxes||(29,293||)||(17,562||)||(83,789||)||(49,617||)|
|Provision for income taxes||16||21||51||89|
|Net loss per share, basic and diluted||$||(0.23||)||$||(0.14||)||$||(0.66||)||$||(0.41||)|
|Shares used in computing net loss per
share, basic and diluted
Source: Vaxart, Inc.