Vaxart Provides Business Update and Reports Third Quarter 2023 Financial Results
November 02 2023 - 4:01PM
Vaxart, Inc. (Nasdaq: VXRT) today announced its business
update and financial results for the third quarter of 2023.
“During the third quarter, we took important
steps toward validating our mucosal vaccine platform with the
release of topline data from two Phase 2 trials of our norovirus
program,” said Andrei Floroiu, Vaxart’s Chief Executive Officer.
“Data from our Phase 2 challenge study indicated that our
monovalent norovirus candidate has the potential to reduce
norovirus infection, norovirus acute gastroenteritis, and viral
shedding and also stimulates norovirus-specific antibody responses
and neutralizing antibodies.
“With the rise in norovirus infections this
year, we believe the totality of our norovirus vaccine data
highlights the potential to address this need and the significant
disease burden that norovirus causes,” Floroiu added. “We are
currently conducting additional analyses of our norovirus data with
the objectives of defining the timing of a larger Phase 2b study
and identifying ways to reduce the size and duration of a
subsequent Phase 3 registration study.”
Recent Business Highlights
Norovirus Vaccine
Developments
- In October 2023, Vaxart dosed the
first subject in its Phase 1 clinical trial evaluating the
Company’s oral pill norovirus vaccine candidate focused on
lactating mothers. The study is designed to investigate immunity in
the breastmilk of nursing mothers who have received vaccine.
- In October 2023, Vaxart senior
management presented at the World Vaccine Congress Europe 2023 in
Barcelona, Spain.
- Dr. Sean Tucker, Vaxart’s Founder
and Chief Scientific Officer, presented on transmission-blocking
strategies via oral pill vaccination and mucosal immune
induction.
- Dr. James F. Cummings, Vaxart’s
Chief Medical Officer, discussed protection against norovirus
infection from an oral pill vaccine candidate in humans.
- In September 2023, Vaxart announced
topline data from the Phase 2 challenge study of its monovalent
norovirus oral pill vaccine candidate.
- The study met five of six primary
endpoints.
- The results showed a statistically
significant 29% relative reduction in the rate of norovirus
infection, a 21% relative reduction in the rate of norovirus acute
gastroenteritis that was not statistically significant, and an 85%
relative reduction in viral shedding. The latter was a prespecified
study endpoint in the vaccinated cohort compared with placebo.
- Vaxart believes this reduction in
shedding could potentially have an impact on transmission and have
important public health benefits.
- In July 2023, Vaxart reported
preliminary positive topline data from the dose-ranging Phase 2
clinical trial of its oral pill bivalent norovirus vaccine
candidate.
- Vaxart now has demonstrated robust
immunogenicity data in eight clinical trials including both young
adults and elderly populations.
- The Company’s norovirus oral
vaccine candidate has shown an attractive safety profile in trials
and has been well tolerated with no vaccine-related serious adverse
events.
COVID-19 Vaccine
Developments
- Vaxart continues to progress its COVID-19 vaccine program and
believes the cross-reactivity of the current constructs suggests a
pathway for developing a pan-betacoronavirus vaccine. The Company
is assessing next steps.
Financial Results for the Three Months
Ended September 30, 2023
- Vaxart ended the third quarter
of 2023 with cash, cash equivalents, restricted cash and marketable
securities of $53.0 million, compared to $67.9 million as
of June 30, 2023. The Company continues to anticipate it has
cash runway into the third quarter of 2024.
- Vaxart reported a net loss
of $17.4 million for the third quarter of 2023, compared
to $29.3 million for the third quarter of 2022. Net loss per
share for the third quarter of 2023 was $0.11 per share,
compared to a net loss of $0.23 per share in the third
quarter of 2022.
- Revenue for the third quarter of
2023 was $2.1 million, compared to no revenue in the
third quarter of 2022. Revenue in the third quarter of 2023 was
primarily from revenue recognized for work performed under Vaxart’s
grant from the Bill & Melinda Gates Foundation and non-cash
royalty revenue from increased sales of Inavir in Japan.
- Research and development expenses
were $15.0 million for the third quarter of 2023,
compared to $22.5 million for the third quarter of 2022. The
decrease is primarily due to decreases in manufacturing costs,
personnel related costs and clinical trial expenses related to our
COVID-19 vaccine candidates, partially offset by increased
depreciation expense.
- General and administrative expenses
were $4.9 million for the third quarter of 2023, compared
to $7.0 million for the third quarter of 2022. The decrease is
primarily due to a decrease in legal and professional fees,
directors' and officers' insurance and personnel related costs,
partially offset by an increase in personnel stock-based
costs.
Conference CallThe Vaxart
senior management team will host a conference call to discuss the
business update and financial results for the third quarter of 2023
today, beginning at 4:30 p.m. ET.
The conference call can be accessed using the
following information:
Webcast: Click hereDate: Thursday, November 2,
2023 – 4:30 p.m. ETDomestic: 877-407-0832International:
201-689-8433Conference ID: 13741880
Investors may submit written questions in
advance of the conference call to ir@vaxart.com.
A replay of the webcast will be available for 30
days on Vaxart’s website at www.vaxart.com following the conclusion
of the event.
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 pills that
can be stored and shipped without refrigeration and eliminate the
risk of needle-stick injury. Vaxart believes that its proprietary
pill 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. Vaxart’s development programs currently include
pill vaccines designed to protect against norovirus, coronavirus,
and seasonal influenza, as well as a therapeutic vaccine for human
papillomavirus (HPV), Vaxart’s first immune-oncology indication.
Vaxart has filed broad domestic and international patent
applications covering its proprietary technology and constructs for
oral vaccination using adenovirus and TLR3 agonists.
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's strategy, prospects, plans
and objectives, results from preclinical and clinical trials,
commercialization agreements and licenses, and beliefs and
expectations of management are forward-looking statements. These
forward-looking statements may be accompanied by such words as
"should," "believe," "could," "potential," "will," "expected,"
“anticipate,” "plan," and other words and terms of similar meaning.
Examples of such statements include, but are not limited to,
statements relating to Vaxart's ability to develop and
commercialize its product candidates, including its vaccine booster
products; Vaxart's expectations regarding clinical results and
trial data; and Vaxart's expectations with respect to the
effectiveness of its product candidates. Vaxart may not actually
achieve the plans, carry out the intentions, or meet the
expectations or projections disclosed in the forward-looking
statements, and you should not place undue reliance on these
forward-looking statements. Actual results or events could differ
materially from the plans, intentions, expectations, and
projections disclosed in the forward-looking statements. Various
important factors could cause actual results or events to differ
materially from the forward-looking statements that Vaxart makes,
including uncertainties inherent in research and development,
including the ability to meet anticipated clinical endpoints,
commencement, and/or completion dates for clinical trials,
regulatory submission dates, regulatory approval dates, and/or
launch dates, as well as the possibility of unfavorable new
clinical data and further analyses of existing clinical data; the
risk that clinical trial data are subject to differing
interpretations and assessments by regulatory authorities; whether
regulatory authorities will be satisfied with the design of and
results from the clinical studies; decisions by regulatory
authorities impacting labeling, manufacturing processes, and safety
that could affect the availability or commercial potential of any
product candidate, including the possibility that Vaxart's product
candidates may not be approved by the FDA or non-U.S. regulatory
authorities; that, even if approved by the FDA or non-U.S.
regulatory authorities, Vaxart's product candidates may not achieve
broad market acceptance; that a Vaxart collaborator may not attain
development and commercial milestones; that Vaxart or its partners
may experience manufacturing issues and delays due to events
within, or outside of, Vaxart's or its partners' control;
difficulties in production, particularly in scaling up initial
production, including difficulties with production costs and
yields, quality control, including stability of the product
candidate and quality assurance testing, shortages of qualified
personnel or key raw materials, and compliance with strictly
enforced federal, state, and foreign regulations; that Vaxart may
not be able to obtain, maintain, and enforce necessary patent and
other intellectual property protection; that Vaxart's capital
resources may be inadequate; Vaxart's ability to resolve pending
legal matters; Vaxart's ability to obtain sufficient capital to
fund its operations on terms acceptable to Vaxart, if at all; the
impact of government healthcare proposals and policies; competitive
factors; and other risks described in the "Risk Factors" sections
of Vaxart's Quarterly and Annual Reports filed with the SEC. Vaxart
does not assume any obligation to update any forward-looking
statements, except as required by
law. Contacts
Vaxart Media Relations: |
Investor Relations: |
Mark Herr |
Andrew Blazier |
Vaxart, Inc. |
Finn Partners |
mherr@vaxart.com |
IR@Vaxart.com |
(203) 517-8957 |
(646) 871-8486 |
|
|
Vaxart, Inc.Condensed
Consolidated Balance Sheets
|
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
|
|
(Unaudited) |
|
|
(1) |
|
|
|
|
|
(in
thousands) |
Assets |
|
|
|
|
|
Cash, cash equivalents and restricted cash (2) |
$ |
33,238 |
|
$ |
46,013 |
|
|
Investments in marketable debt securities |
|
19,799 |
|
|
49,704 |
|
|
Accounts receivable |
|
424 |
|
|
20 |
|
|
Prepaid expenses and other assets |
|
4,522 |
|
|
7,282 |
|
|
Property and equipment, net |
|
12,926 |
|
|
15,585 |
|
|
Right-of-use assets, net |
|
25,753 |
|
|
25,715 |
|
|
Intangible assets, net |
|
4,472 |
|
|
5,020 |
|
|
Goodwill |
|
4,508 |
|
|
4,508 |
|
|
|
Total assets |
$ |
105,642 |
|
$ |
153,847 |
|
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
Accounts payable |
$ |
1,339 |
|
$ |
5,514 |
|
|
Deferred grant revenue |
|
79 |
|
|
2,000 |
|
|
Accrued and other liabilities |
|
6,269 |
|
|
8,315 |
|
|
Operating lease liability |
|
20,459 |
|
|
21,705 |
|
|
Liability related to sale of future royalties |
|
5,975 |
|
|
5,716 |
|
|
Total liabilities |
|
34,121 |
|
|
43,250 |
|
|
Stockholders’ equity |
|
71,521 |
|
|
110,597 |
|
|
|
Total
liabilities and stockholders’ equity |
$ |
105,642 |
|
$ |
153,847 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1 |
) |
|
Derived from the audited consolidated financial statements of
Vaxart, Inc. for the year ended December 31, 2022, included on
the Form 10-K filed with the Securities and Exchange Commission on
March 15, 2023. |
|
|
|
|
|
|
(2 |
) |
|
Cash, cash equivalents and restricted cash includes $79,000 and
$2.0 million of restricted cash as of September 30, 2023 and
December 31, 2022, respectively. |
|
|
|
|
|
|
Vaxart, Inc. Condensed
Consolidated Statements of Operations
(Unaudited)
|
|
|
3 Months Ended September 30, |
|
9 Months Ended September 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
( in
thousands, except share and per share amounts ) |
|
|
|
|
|
|
|
|
|
|
Revenue |
$ |
2,101 |
|
|
$ |
- |
|
|
$ |
4,134 |
|
|
$ |
85 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Research and
development |
|
15,002 |
|
|
|
22,466 |
|
|
|
53,437 |
|
|
|
60,595 |
|
|
|
General and
administrative |
|
4,921 |
|
|
|
6,960 |
|
|
|
17,144 |
|
|
|
22,939 |
|
|
|
Total
operating expenses |
|
19,923 |
|
|
|
29,426 |
|
|
|
70,581 |
|
|
|
83,534 |
|
Loss from operations |
|
(17,822 |
) |
|
|
(29,426 |
) |
|
|
(66,447 |
) |
|
|
(83,449 |
) |
|
Other income (expense), net |
|
461 |
|
|
|
133 |
|
|
|
1,444 |
|
|
|
(340 |
) |
Loss before income taxes |
|
(17,361 |
) |
|
|
(29,293 |
) |
|
|
(65,003 |
) |
|
|
(83,789 |
) |
|
Provision for income taxes |
|
39 |
|
|
|
16 |
|
|
|
87 |
|
|
|
51 |
|
Net loss |
$ |
(17,400 |
) |
|
$ |
(29,309 |
) |
|
$ |
(65,090 |
) |
|
$ |
(83,840 |
) |
Net loss per share, basic and diluted |
$ |
(0.11 |
) |
|
$ |
(0.23 |
) |
|
$ |
(0.45 |
) |
|
$ |
(0.66 |
) |
Shares used in computing net loss per share, basic and diluted |
|
152,026,112 |
|
|
|
126,889,718 |
|
|
|
145,810,175 |
|
|
|
126,374,424 |
|
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