Vaxart Provides Business Update and Reports First Quarter 2023 Financial Results
04 Maio 2023 - 5:01PM
Vaxart, Inc. (NASDAQ: VXRT) today announced its business
update and financial results for the first quarter of 2023.
“During the first quarter, we continued to
advance our norovirus oral pill vaccine program and remain on track
to report two important clinical data readouts in 2023,” said
Andrei Floroiu, Vaxart’s Chief Executive Officer. “Norovirus
represents a significant public health issue with no approved
vaccine, and it places a tremendous economic burden on society.
More than 21 million people are infected in the U.S. each year,
creating an annual disease burden of more than $10 billion
domestically.
“Our innovative approach to addressing this
unmet medical need is supported by data from six completed
norovirus clinical trials that have enrolled nearly 350 subjects.
These data have shown immune responses from our vaccine to be
strong, long-lasting, comparable to natural infection and similar
in both elderly and young populations,” Mr. Floroiu added.
Recent Business Highlights
Norovirus Vaccine
Developments
- In April 2023, Vaxart presented
previously published research from its norovirus oral vaccine
program at the World Vaccine Congress in Washington, D.C. Dr. James
F. Cummings, Vaxart’s Chief Medical Officer, exhibited findings
demonstrating potent serum and mucosal immune responses to
norovirus with Vaxart’s oral bivalent norovirus vaccine
candidate.
- In March 2023, Vaxart provided a
detailed overview and reviewed data from its norovirus oral pill
vaccine program during presentations at its sponsored norovirus Key
Opinion Leader (KOL) event. Featured experts on the disease
explained the current disease burden posed by norovirus, as well as
its significant economic and societal costs that impact the U.S. on
an annual basis. A replay of the KOL event is available here.
- In February 2023, Vaxart initiated
a Phase 2 dose-ranging study of its bivalent norovirus oral vaccine
candidate and expects to report topline data from this study in
mid-2023.
COVID-19 Vaccine
Developments
- Vaxart continues to conduct
preclinical development of novel constructs for its COVID-19 oral
vaccine candidate. Based on the mucosal cross-reactivity data
reported to date in Vaxart’s clinical studies of its COVID-19
vaccine candidates, the Company believes it may be able to create
an oral pan-betacoronavirus vaccine. A pan-betacoronavirus vaccine
may provide more effective and flexible protection, positioned to
prevent both current and emerging coronavirus threats and other
beta-coronaviruses, making it a valuable tool for pandemic
preparedness.
- During the World Vaccine Congress,
Dr. Sean Tucker, Vaxart’s Founder and Chief Scientific Officer,
presented previously published data from Vaxart studies
demonstrating the platform’s ability to block transmission and
boost existing COVID-19 vaccines by oral tablet vaccination.
Anticipated 2023 Clinical
Milestones
Vaxart continues to make progress on its
anticipated milestones in 2023:
- Report topline data from the
ongoing Phase 2 dose-ranging study of Vaxart’s bivalent norovirus
vaccine candidate in mid-2023.
- Report topline data from the
ongoing Phase 2 challenge study of Vaxart’s monovalent norovirus
vaccine candidate in Q3 2023.
- Initiate Gates Foundation-funded
clinical trial to evaluate the ability of Vaxart’s norovirus
vaccine candidate to induce antibodies in breast milk and transfer
of antibodies to young infants.
Financial Results for the Three Months
Ended March 31, 2023
-
Vaxart ended the first quarter of 2023 with cash, cash
equivalents, restricted cash and marketable securities of $71.8
million, compared to $95.7 million as of December 31,
2022. The decrease was primarily due to cash used in
operations.
- Vaxart reported
a net loss of $25.1 million for the first quarter of
2023, compared to $25.1 million for the first quarter of 2022.
Net loss per share for the first quarter of 2023 was $0.19,
compared to a net loss of $0.20 per share in the first
quarter of 2022.
- Revenue for the
first quarter of 2023 was $675,000, compared
to $85,000 in the first quarter of 2022. The increase was due
to revenue recognition for services rendered in relation to
Vaxart’s grant from the Gates Foundation and higher royalty revenue
from sales of Inavir in Japan.
- Research and
development expenses were $19.6 million for the first
quarter of 2023, compared to $18.2 million for the first
quarter of 2022. The increase was mainly due to increases in
headcount and related costs and clinical trial expenses related to
the Company’s norovirus vaccine candidate.
- General and
administrative expenses were $6.6 million for the first
quarter of 2023, compared to $6.7 million for the first
quarter of 2022.
Conference Call
The Vaxart senior management team will host a
conference call to discuss the business update and financial
results for the first 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, May 4, 2023 –
4:30 p.m. ETDomestic: 888-272-8703International:
713-481-1320Conference ID: 13737884Investors 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,
seasonal influenza, and respiratory syncytial virus (RSV), 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 creations 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 |
|
|
|
|
March 31, 2023 |
|
December 31, 2022 |
|
|
(Unaudited) |
|
(1) |
|
|
(in thousands) |
Assets |
|
|
|
|
Cash, cash equivalents and restricted cash (2) |
$ |
48,434 |
|
|
$ |
46,013 |
|
|
Investments in marketable debt securities |
|
23,377 |
|
|
|
49,704 |
|
|
Accounts receivable |
|
264 |
|
|
|
20 |
|
|
Prepaid and other assets |
|
6,215 |
|
|
|
7,282 |
|
|
Property and equipment, net |
|
14,373 |
|
|
|
15,585 |
|
|
Right-of-use assets, net |
|
27,843 |
|
|
|
25,715 |
|
|
Intangible assets, net |
|
4,837 |
|
|
|
5,020 |
|
|
Goodwill |
|
4,508 |
|
|
|
4,508 |
|
|
Total Assets |
$ |
129,851 |
|
|
$ |
153,847 |
|
|
|
|
|
|
Liabilities and stockholders’ equity |
|
|
|
|
Accounts payable |
$ |
3,882 |
|
|
$ |
5,514 |
|
|
Deferred grant revenue |
|
1,603 |
|
|
|
2,000 |
|
|
Accrued and other liabilities |
|
7,223 |
|
|
|
8,315 |
|
|
Operating lease liabilities |
|
21,516 |
|
|
|
21,705 |
|
|
Liability related to sale of future royalties |
|
5,874 |
|
|
|
5,716 |
|
|
Total liabilities |
|
40,098 |
|
|
|
43,250 |
|
|
Stockholders’ equity |
|
89,753 |
|
|
|
110,597 |
|
|
Total liabilities and stockholders’ equity |
$ |
129,851 |
|
|
$ |
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 $1.6 million
and $2.0 million of restricted cash as of March 31, 2023 and
December 31, 2022, respectively. |
|
|
|
Vaxart, Inc. |
Condensed Consolidated Statements of
Operations |
(Unaudited) |
|
|
|
|
Quarter Ended March 31, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
(Unaudited) |
|
(1) |
|
|
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
Revenue |
$ |
675 |
|
|
$ |
85 |
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
19,622 |
|
|
|
18,203 |
|
|
|
General and administrative |
|
6,625 |
|
|
|
6,658 |
|
Total operating expenses |
|
26,247 |
|
|
|
24,861 |
|
Loss from operations |
|
(25,572 |
) |
|
|
(24,776 |
) |
|
Other income and (expenses), net |
|
461 |
|
|
|
(305 |
) |
|
|
|
|
|
|
Loss before income taxes |
|
(25,111 |
) |
|
|
(25,081 |
) |
|
Provision for income taxes |
|
29 |
|
|
|
20 |
|
Net loss |
$ |
(25,140 |
) |
|
$ |
(25,101 |
) |
Net loss per share, basic and diluted |
$ |
(0.19 |
) |
|
$ |
(0.20 |
) |
Shares used in computing net loss per share, basic and diluted |
|
135,213,196 |
|
|
|
125,795,255 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(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. |
|
|
|
|
|
|
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