Vaxart Provides Business Update and Reports Third Quarter 2021 Financial Results
Four clinical trials for COVID-19 and norovirus oral tablet vaccine candidates are currently ongoing
Company now operates two GMP manufacturing plants to support rapid clinical advancement of pipeline programs
Ended the quarter with
During the third quarter,
The Company also expanded its research and manufacturing capabilities, enhancing its ability to advance its pipeline of vaccine candidates.
“Vaxart made significant progress this quarter toward its goal of developing a next-generation oral tablet COVID-19 vaccine,” said
“Our view has been that an oral tablet vaccine could transform how the world is protected from COVID-19 and other infections because they are easy to distribute and administer. Now we added evidence suggesting the differentiated mucosal mechanism of action could be yet another improvement over injectable alternatives,” added
“The progress we made in our vaccine research this quarter was significant,” said Dr.
“The implications are significant because existing injected vaccines do not always protect against viral shedding and transmission to other people. A vaccine that reduces shedding and reduces the probability of infection could make a big difference in protecting lives and public health.”
Recent Business Highlights
Vaxartrecently brought online its own GMP manufacturing facility and is now producing vaccines at two GMP plants. This has allowed the Company to manufacture all of the COVID-19 vaccine oral tablets for the clinical trials started and planned to start this year, and to begin manufacturing vaccines for its upcoming norovirus Phase II trials. Vaxartscaled up its research, quality and manufacturing capabilities, increasing its R&D employee headcount by more than 35% during the quarter.
- The Company created two advisory boards, the
Scientific and Clinical Advisory Boardand the Manufacturing and Quality Advisory Board, to provide expertise as the Company grows its scientific and manufacturing capabilities. Vaxartnamed Dr. James F. Cummingsas its Chief Medical Officer. Dr. Cummingsis a board-certified infectious disease physician with extensive experience in vaccine, drug and diagnostics development, and will help guide the Company’s development of its vaccines.
- Widely respected biotech executive Dr.
Julie Cherringtonjoined Vaxart’s Board of Directors, deepening the pool of expertise on its board.
Preclinical and Clinical
Clinical COVID-19 Vaccine Developments
Vaxartbegan dosing subjects in October for its Phase II clinical trial in the United States, which is expected to enroll 96 subjects.
- The Company expects data from this study to be available during Q1 2022.
- The study will be conducted with subjects split evenly between COVID-19 naïve and mRNA vaccinated subjects.
- During Q4 2021,
Vaxartexpects to start Phase Ib clinical testing in India.
- The Company expects to launch additional international clinical trials in 1H 2022.
Preclinical COVID-19 Vaccine Developments
- A Duke University-led study published in bioRxiv in October showed that Vaxart’s investigational oral tablet vaccine candidate reduced the airborne transmission of SARS-CoV-2 virus in a hamster model.
- These results are consistent with those from Vaxart’s Phase II human flu challenge study, which showed that Vaxart’s oral tablet flu vaccine was better at reducing shedding than the injectable flu vaccine comparator.
- Vaxart’s preclinical study also demonstrated that the Company’s oral vaccine platform induces robust systemic and mucosal responses.
- The study suggested that mucosal vaccines may protect not only vaccinated, but also unvaccinated animals.
Vaxartwill submit the results of its nonhuman primate study for publication in Q4 2021. Results from that study prompted Vaxartto move forward with its S-only vaccine candidate in Phase II clinical trials. This S-only vaccine candidate produced better antibody responses and cross-reactivity against all variants tested than Vaxart’s S+N vaccine candidate.
Norovirus Vaccine Developments
Norovirus is a highly infectious illness that affects around 20 million Americans annually, with an annual economic impact of approximately
Vaxarthas almost completed enrollment in its Phase Ib placebo-controlled, dose-ranging, repeat dose trial investigating its oral norovirus vaccine candidate in elderly subjects aged 55 to 80 years. This study is designed to evaluate the safety and immunogenicity of Vaxart'svaccine candidate.
- The Company anticipates completing enrollment in its norovirus VXA-G1.1-104 study in Q4 2021.
Vaxartis also conducting an additional norovirus vaccine study to evaluate the optimal timing for boost administration under VXA-NVV-105. This study has completed enrollment.
- The Company expects initial data to be available from these studies in Q1 2022 and more complete data by Q2 2022.
Vaxartis preparing to launch its norovirus challenge study in Q1 2022 to evaluate the safety and clinical efficacy of its oral vaccine candidate.
- As noted above,
Vaxartis now producing vaccines at two GMP manufacturing plants in California, including its own GMP manufacturing facility.
- As a result,
Vaxarthas produced the tablets for its Phase II and Phase Ib COVID-19 studies and is starting to produce norovirus vaccine for additional clinical studies.
Financial Results for the Three Months Ended September 30, 2021
- Vaxart ended the quarter with cash, cash equivalents and available-for-sale debt securities of $204.0 million, compared to $198.9 million as of June 30, 2021. The increase was primarily due to net receipts of $20.3 million from the Company’s $250 million at-the-market facility entered into in October 2020 and $0.3 million from the exercise of warrants and options, partially offset by $14.2 million of cash used in operations and $1.3 million spent on property and equipment.
- The Company reported a net loss of $17.6 million for the third quarter of 2021, compared to $8.1 million for the third quarter of 2020. Net loss per share for the third quarter of 2021 was $0.14, compared to a net loss of $0.08 per share in the third quarter of 2020. The increase in net loss per share was primarily due to the increase in net loss, resulting from a significant increase in research and development expenses.
- Revenue for the third quarter of 2021 was $200,000, compared to $265,000 in the third quarter of 2020. The decrease was due to lower royalty revenue from sales of Inavir in
- Research and development expenses were $12.4 million for the third quarter of 2021, compared to $4.6 million for the third quarter of 2020. 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 $5.0 million for the third quarter of 2021, compared to $4.2 million for the third quarter of 2020. The increase was mainly due to an increase in headcount and related costs.
Note Regarding Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding
|Vaxart Media Relations:||Investor Relations:|
Condensed Consolidated Balance Sheets
|Cash and cash equivalents||$||167,231||$||126,870|
|Investments in debt securities||36,720||—|
|Prepaid and other assets||5,269||1,699|
|Property and equipment, net||5,427||1,480|
|Right-of-use assets, net||12,237||6,838|
|Intangible assets, net||14,062||15,361|
|Liabilities and stockholders’ equity|
|Accrued and other liabilities||4,543||4,908|
|Liability related to sale of future royalties||15,158||14,929|
|Operating lease liabilities||12,742||7,208|
|Total liabilities and stockholders’ equity||$||241,136||$||152,582|
(1) Derived from the audited consolidated financial statements of
Condensed Consolidated Statements of Operations
|Three Months Ended
||Nine Months Ended
|(in thousands, except share and per share amounts)|
|Research and development||12,409||4,616||33,219||11,272|
|General and administrative||5,042||4,190||16,136||10,076|
|Total operating expenses||17,451||7,854||49,355||20,499|
|Loss from operations||(17,251||)||(7,589||)||(48,537||)||(16,809||)|
|Other income and (expenses), net||(311||)||(470||)||(1,080||)||(1,345||)|
|Loss before income taxes||(17,562||)||(8,059||)||(49,617||)||(18,154||)|
|Provision for income taxes||21||26||89||205|
|Net loss per share, basic and diluted||$||(0.14||)||$||(0.08||)||$||(0.41||)||$||(0.23||)|
|Shares used in computing net loss per share, basic and diluted||123,984,141||107,718,578||120,110,780||81,121,045|
Source: Vaxart, Inc.