Vaxart Provides Business Update and Reports Full Year 2023 Financial Results

Rhea-AI Summary

Vaxart, Inc. announces significant progress in preparing for a Phase 2b study evaluating its oral pill XBB COVID-19 vaccine, appoints Steven Lo as President and CEO, and reports financial results for full year 2023. The company received a $9.27 million contract for a Phase 2b clinical study against an approved mRNA vaccine. Vaxart also published preclinical data showing immune responses against multiple SARS-CoV-2 variants. In the norovirus vaccine space, the company completed enrollment in a Phase 1 study in lactating mothers and expects topline data in mid-2024. Financially, Vaxart reported $39.7 million in cash and investments as of December 31, 2023, with a net loss of $82.5 million for 2023 compared to $107.8 million in 2022. Revenue for 2023 was $7.4 million, primarily from grants and royalties. Research and development expenses decreased to $68.1 million in 2023, while general and administrative expenses were $22.6 million.

Positive

• Vaxart made progress in preparing for a Phase 2b study for its oral pill XBB COVID-19 vaccine.
• Steven Lo was appointed as President, CEO, and Board Member of Vaxart.
• The company received a $9.27 million contract for a Phase 2b clinical study against an approved mRNA vaccine.
• Vaxart published preclinical data showing strong immune responses against multiple SARS-CoV-2 variants.
• Vaxart completed enrollment in a Phase 1 norovirus study in lactating mothers, expecting topline data in mid-2024.
• Financially, Vaxart reported $39.7 million in cash and investments as of December 31, 2023.
• Vaxart reported a net loss of $82.5 million for 2023, with revenue of $7.4 million primarily from grants and royalties.
• Research and development expenses decreased to $68.1 million in 2023, while general and administrative expenses were $22.6 million.

Negative

• None.

Financial Analyst

The announcement by Vaxart, Inc. regarding their progress in vaccine development and the appointment of a new CEO, Steven Lo, has several implications for investors. The financial performance of the company shows a reduction in net loss from $107.8 million in 2022 to $82.5 million in 2023, which indicates a potential improvement in operational efficiency. Furthermore, the increase in revenue from $0.1 million to $7.4 million, primarily driven by the grant from the Bill & Melinda Gates Foundation and royalty revenue, suggests a growing recognition of the company's vaccine candidates and could signal future revenue streams. However, investors should be mindful of the company's cash runway, which is anticipated to last into the fourth quarter of 2024. The successful completion of upcoming clinical trials and the subsequent commercialization of vaccine candidates will be critical to ensuring long-term financial stability and growth for Vaxart.

Medical Research Analyst

Vaxart's progress in advancing their oral pill XBB COVID-19 vaccine candidate into a Phase 2b study is noteworthy, especially considering the support from BARDA. This reflects confidence in the potential of Vaxart's platform, which could revolutionize vaccination methods by offering a non-invasive, scalable alternative to traditional injectables. The preclinical data demonstrating cross-reactive immune responses against SARS-CoV-2 variants is promising, but the true test will be the vaccine's performance in human clinical trials. Similarly, the Phase 1 norovirus study in lactating mothers, funded by the Bill & Melinda Gates Foundation, could have significant implications for infant health if the vaccine successfully induces transferable antibodies. The outcomes of these studies will be critical in assessing the efficacy and safety of Vaxart's vaccine candidates, which, if positive, could lead to substantial market opportunities and partnerships.

Market Research Analyst

The appointment of Steven Lo as CEO introduces new leadership at a pivotal time for Vaxart. His biopharma experience could be instrumental in navigating the company through the upcoming clinical trials and potential commercialization phases. The oral vaccine market has room for growth and Vaxart's differentiated approach could capture significant market share if their vaccine candidates prove to be effective and gain regulatory approval. However, the competitive landscape includes several established players with mRNA vaccines and Vaxart will need to demonstrate clear advantages in efficacy, safety and distribution to gain a foothold. Market reception to these developments will likely be reflected in stock performance, contingent on the successful execution of the company's strategic initiatives and clinical outcomes.

Significant progress made in preparing for a Phase 2b study evaluating Vaxart’s oral pill XBB COVID-19 vaccine against an approved mRNA vaccine comparator

Topline data from Phase 1 norovirus study in lactating mothers expected in mid-2024

Steven Lo appointed President, Chief Executive Officer and Board Member

Conference call today at 4:30 p.m. ET

SOUTH SAN FRANCISCO, Calif., March 14, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced its business update and financial results for the full year 2023.

“We are excited to welcome Steve Lo as Vaxart’s President and Chief Executive Officer. Steve brings extensive biopharma leadership experience, and we look forward to his contributions in executing on our strategy and creating value for our shareholders,” said Dr. Michael Finney, Vaxart’s Interim Chief Executive Officer.

“Steve’s arrival comes as we made important progress on our oral vaccine platform in 2023. We now have established proof of concept in two challenge studies, for both respiratory and GI viruses,” Dr. Finney said. “Our recent COVID-19 BARDA Project NextGen contract award is supportive of our differentiated approach. Our oral pill vaccines offer several advantages compared with injectables, including the ability to vaccinate more people faster, easier and painlessly. Steve’s leadership will guide Vaxart in accelerating the development of a platform that has the potential to revolutionize how people are vaccinated.”

Recent Business Highlights

COVID-19 Vaccine Developments

• The United States Biomedical Advanced Research and Development Authority (BARDA) awarded Vaxart a $9.27 million contract in January to prepare for a 10,000-subject, Phase 2b clinical study evaluating the Company’s oral pill XBB COVID-19 vaccine candidate against an approved mRNA vaccine comparator as part of its “Project NextGen” initiative designed to support the development of vaccines and treatments to stay ahead of COVID-19.
  • Vaxart believes the Phase 2b trial may initiate as soon as the second quarter of 2024.
• In February 2024, Vaxart published preclinical non-human primate (NHP) data showing strong cross-reactive immune responses, thus demonstrating the potential of its COVID-19 vaccine to protect against multiple SARS-CoV-2 variants of concern (VOC).
  

Norovirus Vaccine Developments

• Vaxart plans to meet with the U.S. Food and Drug Administration (“FDA”) in the second quarter of 2024 to discuss data on correlates of protection, which will inform potential next steps, such as potentially conducting a Phase 2b study and potentially a GII.4 challenge study.
  • The Company expects the Phase 2b study will generate sufficient safety data to have an End-of-Phase 2 meeting with the FDA. The End-of-Phase 2 meeting will allow the Company to gain concurrence on the scope and design of the Phase 3 pivotal efficacy study in adults over 18 years of age.
• In December 2023, Vaxart completed enrollment in the Phase 1 norovirus study in lactating mothers. With support from the Bill & Melinda Gates Foundation, the study is designed to evaluate the ability of Vaxart’s norovirus vaccine candidate to induce antibodies in breast milk and transfer of antibodies to young infants.
  • The Company expects to announce topline results in mid-2024.

Corporate Update

• In March 2024, Vaxart appointed Mr. Lo as President and Chief Executive Officer and a member of the Board of Directors, effective March 18, 2024. Dr. Finney will continue to serve as Chair of the Board of Directors.
  

Financial Results for the Full Year Ended December 31, 2023

• Cash, cash equivalents and investments totaled $39.7 million as of December 31, 2023. This cash balance does not include approximately $15 million in net proceeds raised in early 2024 from a registered direct offering and at-the-market equity offerings. Currently, the Company anticipates cash runway into the fourth quarter of 2024.
• Vaxart reported a net loss of $82.5 million for the full year 2023, compared to $107.8 million for the full year 2022. Net loss per share for 2023 was $0.57, compared to a net loss of $0.84 per share for 2022.
• Revenue for the full year 2023 was $7.4 million, compared to $0.1 million for 2022. Revenue in 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 $68.1 million for 2023, compared to $81.1 million for 2022. The decrease is primarily due to decreases in manufacturing costs, personnel related costs and clinical trial expenses related to Vaxart’s COVID-19 vaccine candidates, partially offset by increased facilities and depreciation expense.
• General and administrative expenses were $22.6 million for 2023, compared to $29.4 million for 2022. The decrease is primarily due to decreases in legal and professional fees, litigation settlement costs and directors' and officers' insurance, partially offset by an increase in personnel stock-based 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 2023 today, beginning at 4:30 p.m. ET.

The conference call can be accessed using the following information:

Webcast: Click here
Date: Thursday, March 14, 2024 – 4:30 p.m. ET
Domestic: 877-407-0832
International: 201-689-8433
Conference ID: 13744368

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 coronavirus, norovirus, and 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 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
				December 31,			December 31,
				2023			2022
				(Unaudited)			(1)
				(in thousands)
Assets
		Cash, cash equivalents and restricted cash (2)		$	34,755		$	46,013
		Investments in marketable debt securities			4,958			49,704
		Accounts receivable			3,008			20
		Prepaid expenses and other assets			3,741			7,282
		Property and equipment, net			11,731			15,585
		Right-of-use assets, net			24,840			25,715
		Intangible assets, net			4,289			5,020
		Goodwill			4,508			4,508
			Total assets	$	91,830		$	153,847
Liabilities and stockholders’ equity
		Accounts payable		$	1,584		$	5,514
		Deferred grant revenue			-			2,000
		Accrued and other liabilities			5,927			8,315
		Operating lease liability			20,088			21,705
		Liability related to sale of future royalties			6,426			5,716
		Total liabilities			34,025			43,250
		Stockholders’ equity			57,805			110,597
			Total liabilities and stockholders’ equity	$	91,830		$	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 $0 and $2.0 million of restricted cash as of December 31, 2023 and December 31, 2022, respectively.

Vaxart, Inc.
Condensed Consolidated Statement of Operations
				Year Ended December 31,
				2023				2022
				(Unaudited)				(1)
				(in thousands, except share and per share amounts)
Revenue				$	7,379			$	107
		Operating expenses:
			Research and development		68,142				81,054
			General and administrative		22,584				29,386
			Impairment of intangible assets		-				4,254
Total operating expenses					90,726				114,694
Operating loss					(83,347	)			(114,587	)
		Other income (expense), net			1,143				6,896
Loss before income taxes					(82,204	)			(107,691	)
		Provision for income taxes			261				67
Net loss				$	(82,465	)		$	(107,758	)
Net loss per share, basic and diluted				$	(0.57	)		$	(0.84	)
Shares used in computing net loss per share, basic and diluted					144,819,781				127,683,813
(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.

What progress did Vaxart announce regarding its COVID-19 vaccine?

Vaxart announced progress in preparing for a Phase 2b study for its oral pill XBB COVID-19 vaccine.

Who was appointed as President and CEO of Vaxart?

Steven Lo was appointed as President and CEO of Vaxart.

What was the value of the contract awarded to Vaxart for the Phase 2b clinical study?

Vaxart received a $9.27 million contract for the Phase 2b clinical study.

What type of data did Vaxart publish related to its COVID-19 vaccine?

Vaxart published preclinical data showing strong immune responses against multiple SARS-CoV-2 variants.

When does Vaxart expect to announce topline data from the Phase 1 norovirus study in lactating mothers?

Vaxart expects to announce topline data in mid-2024.

What was Vaxart's cash and investments balance as of December 31, 2023?

Vaxart reported $39.7 million in cash and investments as of December 31, 2023.

What was Vaxart's net loss for the full year 2023?

Vaxart reported a net loss of $82.5 million for the full year 2023.

What were Vaxart's revenue sources for 2023?

Vaxart's revenue for 2023 was $7.4 million, primarily from grants and royalties.

How much were Vaxart's research and development expenses in 2023?

Vaxart's research and development expenses were $68.1 million in 2023.

What were Vaxart's general and administrative expenses for 2023?

Vaxart's general and administrative expenses were $22.6 million for 2023.