On March 15, 2023 Vaxart, Inc. (NASDAQ: VXRT) issued its business update today for the full year 2022, during which Vaxart reported it is prioritizing development of the Company’s bivalent norovirus candidate (Press release, Vaxart, MAR 15, 2023, View Source [SID1234628890]).
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"After completing six norovirus clinical trials, we are encouraged by the robust immunogenicity data in both young adult and elderly populations and the encouraging safety profile of our oral norovirus program. We are therefore focusing our resources on our bivalent norovirus candidate and are excited about the two important upcoming data readouts from this program over the next two quarters. We believe this is the best strategy for advancing our oral vaccine platform while positioning Vaxart for future success," said Andrei Floroiu, Vaxart’s Chief Executive Officer. "There currently is no approved vaccine against norovirus, which sickens approximately 21 million people each year in the U.S. alone1 and is estimated to be responsible for more than $10 billion in annual disease burden2. The global annual burden is estimated at over $60 billion3. Vaxart is focused on providing an oral tablet vaccine to address this significant unmet need
Recent Business Highlights
Norovirus Vaccine Developments
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As part of the prioritization of its norovirus program, Vaxart is expanding the ongoing Phase 2 GI.1 norovirus challenge study to include additional challenge cohorts. Vaxart believes the expanded dataset will improve the likelihood of identifying a correlate of protection between immune responses to the vaccine and a reduction in risk of norovirus infection and / or acute gastroenteritis
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Vaxart expects that identifying novel correlates of protection may reduce the size and duration of a Phase 3 trial. With the inclusion of the additional cohorts, Vaxart expects to report topline efficacy data from its Phase 2 challenge study in Q3 2023
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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
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In December 2022, Vaxart announced it will commence a new study of Vaxart’s oral norovirus vaccine candidate focused on protecting breastfeeding mothers and their infants. The study has received significant funding and support from the Bill & Melinda Gates Foundation ("Gates Foundation") and is expected to be initiated in 2023
COVID-19 Vaccine Development
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Vaxart continues to conduct preclinical development of novel constructs for its COVID-19 oral vaccine candidate. Based on the mucosal cross-reactivity data seen in Vaxart’s clinical studies of its COVID-19 vaccine candidates, Vaxart believes it may be able to create an oral pan-betacoronavirus vaccine, which may provide improved protection against SARS-CoV-2 as the virus continues to evolve as well as protection against other types of betacoronaviruses, which include SARS-CoV-1 and Middle East respiratory syndrome coronavirus (MERS-CoV).
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Vaxart is postponing further COVID-19 clinical trials, including the Omicron Human Challenge Trial in the U.K. As Vaxart advances new vaccine candidates, it will determine the best development plan.
Corporate Updates
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Consistent with its prioritization, Vaxart reduced its workforce by 27 percent in Q1 2023.
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Vaxart has access to all cash and other deposits previously held at Silicon Valley Bank (SVB), and has decided to move these deposits to larger financial institutions. The Company does not anticipate any material impact as a result of SVB’s circumstances.
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Vaxart expects its cash on hand will extend into Q2 2024.
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Vaxart remains engaged in discussions with regulatory agencies, governments, non-governmental organizations and other potential strategic parties to maximize the value for all its vaccine candidates.
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In December 2022, Vaxart named Phillip Lee as Chief Financial Officer.
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Mr. Lee has almost 15 years of strategic finance and advisory experience in the biotechnology industry. During his career, he has helped raise over $1 billion of capital and worked on more than $20 billion of M&A transactions, including partnerships, asset acquisitions, mergers, spin-offs and royalty monetization. Most recently, he was CFO and Chief Operating Officer at Clover Biopharmaceuticals and prior to that held finance leadership positions at several biotechnology companies.
Anticipated 2023 Clinical Milestones
Vaxart expects to make progress on its anticipated milestones in 2023:
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Report topline data from the ongoing Phase 2 challenge study of Vaxart’s monovalent norovirus vaccine candidate in Q3 2023.
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Report topline data from the ongoing Phase 2 dose-ranging study of Vaxart’s bivalent norovirus vaccine candidate in mid-2023.
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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 Full Year Ended December 31, 2022
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Vaxart ended the year with cash, cash equivalents, restricted cash and marketable securities of $95.7 million
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Vaxart reported a net loss of $107.8 million for the full year 2022, compared to $70.5 million for the full year 2021. Net loss per share for 2022 was $0.84, compared to $0.58 for 2021.
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Revenue in 2022 was $0.1 million, compared to $0.9 million in 2021. The decrease was principally due to lower royalty revenue from sales of Inavir in Japan.
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Research and development expenses were $81.1 million for 2022, compared to $48.7 million for 2021. The increase was mainly due to a larger headcount and related costs, and in higher manufacturing and clinical trial expenses related to our norovirus and COVID-19 vaccine candidates.
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General and administrative expenses were $29.4 million for 2022, compared to $21.9 million for 2021. The increase was mainly due to a larger headcount and related costs and higher legal and professional costs.
Conference Call
The Vaxart senior management team will host a conference call to discuss the business update and financial results for the full year 2022 today, beginning at 4:30 p.m. ET.
The conference call can be accessed using the following information:
Webcast: Click here
Date: Wednesday, March 15, 2023 – 4:30 p.m. ET
Domestic: 888-407-0832
International: 201-689-8433
Conference ID: 13735958
Investors may submit written questions in advance of the conference call to [email protected].
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.
References
1)
CDC Website Norovirus Section
2)
Potential Clinical and Economic Value of Norovirus Vaccination in the Community Setting, Bartsch S et al., AJPM 2021
3)
Global Economic Burden of Norovirus, Bartsch S et al., PLOS ONE 2016