Vaxart Provides Business Update and Reports Second Quarter 2021 Financial Results
"By any measure,
Recent Business Highlights
Corporate Developments
Vaxart raised$36.2 million in net proceeds from its$250 million at-the-market facility in the three months endedJune 30, 2021 .Vaxart signed an exclusive worldwide licensing agreement withAltesa Biosciences, Inc. to allow Altesa to develop and commercializeVaxart's Vapendavir, a clinical-stage broad spectrum antiviral.- The licensing agreement provides for milestone payments up to
$130 million and royalties for global Vapendavir sales. - Building out the infrastructure necessary to support its groundbreaking research,
Vaxart added to its management team and strengthened its research, clinical, and manufacturing groups and R&D infrastructure. The number of R&D employees grew by 36% in the quarter to 49 full-time employees.
Pre-Clinical and Clinical
Platform-Wide Developments
Vaxart completed its first boosting study, which showed in clinical trials that its norovirus vaccine built on the VAAST™ platform can successfully boost immune responses in subjects previously vaccinated with aVaxart oral vaccine more than a year earlier.- The research supports the company's thesis that its oral tablet vaccines have the potential to be used annually for indications that may require a boost such as flu or COVID-19.
- The data announced that
Vaxart's vaccines may not suffer from certain antibody response challenges that can occur with viral vector-based vaccines.
COVID-19 Vaccine Developments
While the nation's death and illness tolls have fallen markedly since the beginning of the last quarter, new variants such as the Delta strain continue to worry national political and health leaders.
- The
U.S. Food and Drug Administration clearedVaxart to move to its next phase of COVID-19 testing with a study of its next generation S-1 construct. Vaxart is manufacturing the vaccine necessary to start the Phase 2 clinical study of itsS-Wuhan construct and expects to begin this study shortly.- A Non-Human Primate study of the S&N construct along with
S-Wuhan andS-South Africa constructs showed optimal performance by theS-Wuhan construct and also cross reactivity against all variants tested. The decision was made to theS-Wuhan vaccine construct into Phase 2.
Norovirus Vaccine Developments
Norovirus is a highly infectious illness that affects around 20 million Americans annually, with an annual economic impact of approximately $10.5 billion in the United States.
- In addition to its boosting study,
Vaxart enrolled the first subjects in a Phase 1b placebo-controlled, dose-ranging, repeat dose trial investigating its oral norovirus vaccine candidate in elderly subjects aged 55 – 80 years. - This study is designed to evaluate the safety and immunogenicity of
Vaxart's candidate, which is the only clinical stage norovirus oral tablet vaccine actively being developed.
Financial Results for the Three Months Ended June 30, 2021
- Vaxart ended the quarter with cash, cash equivalents, and available-for-sale debt securities of $198.9 million, compared to $177.3 million as of March 31, 2021. The increase was primarily due to net receipts of $36.2 million from the Company's $250 million at-the-market facility entered into in October 2020 and $0.9 million from the exercise of warrants and options, partially offset by $13.2 million of cash used in operations and $2.2 million spent on property and equipment.
- Vaxart reported a net loss of $16.1 million for the second quarter of 2021 compared to $9.0 million for the second quarter of 2020. Net loss per share for the second quarter of 2021 was $0.13, compared to a net loss of $0.12 in the second quarter of 2020. The small increase in net loss per share was due to the increase in net loss being mostly offset by the increase in the weighted average number of shares outstanding.
- Revenue for the second quarter of 2021 was $112,000 compared to $523,000 in the second quarter of 2020. The decrease was principally due to the absence of royalty revenue related to Relenza sales in Japan as a result of the patent expiring and a reduction in royalty revenue related to Inavir sales in Japan as a result of lower incidences of seasonal influenza.
- Research and development expenses were $10.7 million for the second quarter of 2021 compared to $5.1 million for the second quarter of 2020. The increase was mainly due to manufacturing and clinical trial expenses related to the COVID-19 and norovirus vaccine candidates.
- General and administrative expenses were $5.2 million for the second quarter of 2021 compared to $3.9 million for the second quarter of 2020. The increase was mainly due to higher insurance expenses and an increase in headcount and related costs.
About Vaxart
Vaxart is a clinical-stage biotechnology company developing a range of oral recombinant vaccines based on its proprietary delivery platform. Vaxart vaccines are designed to be administered using tablets that can be stored and shipped without refrigeration and eliminate the risk of needle-stick injury. Vaxart believes that its proprietary tablet vaccine delivery platform is suitable to deliver recombinant vaccines, positioning the company to develop oral versions of currently marketed vaccines and to design recombinant vaccines for new indications. Its development programs currently include tablet vaccines designed to protect against coronavirus, norovirus, seasonal influenza, and respiratory syncytial virus (RSV), as well as a therapeutic vaccine for human papillomavirus (HPV),
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
Contact
Vaxart Media Relations:
(203) 517-8957
mherr@vaxart.com
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||||||||
Condensed Consolidated Balance Sheets |
||||||||
|
|
|||||||
(Unaudited) |
(1) |
|||||||
(in thousands) |
||||||||
Assets |
||||||||
Cash and cash equivalents |
$ |
165,266 |
$ |
126,870 |
||||
Investments in debt securities |
33,657 |
— |
||||||
Accounts receivable |
107 |
334 |
||||||
Prepaid and other assets |
5,172 |
1,699 |
||||||
Property and equipment, net |
4,339 |
1,480 |
||||||
Right-of-use assets, net |
5,808 |
6,838 |
||||||
Intangible assets, net |
14,495 |
15,361 |
||||||
Total Assets |
$ |
228,844 |
$ |
152,582 |
||||
Liabilities and stockholders' equity |
||||||||
Accounts payable |
$ |
3,702 |
$ |
2,133 |
||||
Accrued and other liabilities |
4,279 |
4,908 |
||||||
Liability related to sale of future royalties |
14,927 |
14,929 |
||||||
Operating lease liabilities |
6,154 |
7,208 |
||||||
Total liabilities |
29,062 |
29,178 |
||||||
Stockholders' equity |
199,782 |
123,404 |
||||||
Total liabilities and stockholders' equity |
$ |
228,844 |
$ |
152,582 |
(1) Derived from the audited consolidated financial statements of |
|
||||||||||||||||
Condensed Consolidated Statements of Operations |
||||||||||||||||
(Unaudited) |
||||||||||||||||
Three Months Ended |
Six Months Ended |
|||||||||||||||
2021 |
2020 |
2021 |
2020 |
|||||||||||||
(in thousands, except share and per share amounts) |
||||||||||||||||
Revenue |
$ |
112 |
$ |
523 |
$ |
618 |
$ |
3,425 |
||||||||
Operating expenses: |
||||||||||||||||
Research and development |
10,737 |
5,114 |
20,810 |
6,656 |
||||||||||||
General and administrative |
5,150 |
3,896 |
11,094 |
5,886 |
||||||||||||
Restructuring costs |
— |
39 |
— |
103 |
||||||||||||
Total operating expenses |
15,887 |
9,049 |
31,904 |
12,645 |
||||||||||||
Loss from operations |
(15,775) |
(8,526) |
(31,286) |
(9,220) |
||||||||||||
Other income and (expenses), net |
(311) |
(425) |
(769) |
(875) |
||||||||||||
Loss before income taxes |
(16,086) |
(8,951) |
(32,055) |
(10,095) |
||||||||||||
Provision for income taxes |
30 |
26 |
68 |
179 |
||||||||||||
Net loss |
$ |
(16,116) |
$ |
(8,977) |
$ |
(32,123) |
$ |
(10,274) |
||||||||
Net loss per share, basic and diluted |
$ |
(0.13) |
$ |
(0.12) |
$ |
(0.27) |
$ |
(0. 15) |
||||||||
Shares used in computing net loss per share, basic |
120,925,570 |
74,675,131 |
118,174,099 |
67,676,138 |
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