Vaxart Provides Business Update and Reports Second Quarter 2024 Financial Results
Vaxart, Inc. (NASDAQ: VXRT) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. BARDA awarded Vaxart up to $453 million for a Phase 2b trial of its oral COVID-19 vaccine.
2. The company plans to initiate the 10,000-subject Phase 2b trial in H2 2024, pending FDA alignment.
3. Vaxart is in discussions with the FDA regarding norovirus vaccine data and potential next steps.
4. Q2 2024 financial results: $62.6 million in cash and investments, $6.4 million in revenue, and a net loss of $16.5 million ($0.09 per share).
5. The company received a $64.7 million BARDA payment post-Q2, extending cash runway into 2026.
Vaxart, Inc. (NASDAQ: VXRT) ha riportato i risultati finanziari per il secondo trimestre del 2024 e ha fornito un aggiornamento sulle attività. I punti salienti includono:
1. BARDA ha assegnato a Vaxart fino a 453 milioni di dollari per uno studio di Fase 2b del suo vaccino orale contro il COVID-19.
2. L’azienda prevede di avviare lo studio di Fase 2b con 10.000 partecipanti nella seconda metà del 2024, in attesa di un allineamento con la FDA.
3. Vaxart è in discussione con la FDA riguardo ai dati sul vaccino contro il norovirus e ai potenziali prossimi passi.
4. Risultati finanziari del secondo trimestre del 2024: 62,6 milioni di dollari in contante e investimenti, 6,4 milioni di dollari in ricavi e una perdita netta di 16,5 milioni di dollari (0,09 dollari per azione).
5. L’azienda ha ricevuto un pagamento di 64,7 milioni di dollari da BARDA dopo il secondo trimestre, estendendo la disponibilità di cassa fino al 2026.
Vaxart, Inc. (NASDAQ: VXRT) informó sobre sus resultados financieros del segundo trimestre de 2024 y proporcionó una actualización comercial. Los aspectos destacados incluyen:
1. BARDA otorgó a Vaxart hasta 453 millones de dólares para un ensayo de Fase 2b de su vacuna oral contra el COVID-19.
2. La compañía planea iniciar el ensayo de Fase 2b con 10,000 sujetos en la segunda mitad de 2024, pendiente de alineación con la FDA.
3. Vaxart está en discusiones con la FDA sobre los datos de la vacuna contra el norovirus y posibles próximos pasos.
4. Resultados financieros del segundo trimestre de 2024: 62.6 millones de dólares en efectivo e inversiones, 6.4 millones de dólares en ingresos y una pérdida neta de 16.5 millones de dólares (0.09 dólares por acción).
5. La empresa recibió un pago de 64.7 millones de dólares de BARDA después del segundo trimestre, extendiendo su liquidez hasta 2026.
Vaxart, Inc. (NASDAQ: VXRT)는 2024년 2분기 재무 결과를 보고하고 사업 업데이트를 제공했습니다. 주요 하이라이트는:
1. BARDA는 Vaxart에 4억 5,300만 달러를 지급하여 COVID-19 백신의 2b상 시험을 지원했습니다.
2. 회사는 FDA의 조율을 기다리며 2024년 하반기에 10,000명 대상의 2b상 시험을 시작할 계획입니다.
3. Vaxart는 norovirus 백신 데이터와 향후 단계에 대해 FDA와 논의 중입니다.
4. 2024년 2분기 재무 결과: 현금 및 투자 6,260만 달러, 매출 640만 달러, 순손실 1,650만 달러 (주당 0.09 달러)입니다.
5. 회사는 2분기 이후 BARDA로부터 6,470만 달러의 지급을 받아 2026년까지 현금 여유를 연장했습니다.
Vaxart, Inc. (NASDAQ: VXRT) a annoncé ses résultats financiers du deuxième trimestre 2024 et a fourni une mise à jour commerciale. Les points clés comprennent:
1. BARDA a récompensé Vaxart jusqu'à 453 millions de dollars pour un essai de phase 2b de son vaccin oral contre le COVID-19.
2. L'entreprise prévoit de lancer l'essai de phase 2b avec 10 000 participants au deuxième semestre 2024, sous réserve de l'approbation de la FDA.
3. Vaxart est en discussion avec la FDA concernant les données du vaccin contre le norovirus et les prochaines étapes potentielles.
4. Résultats financiers du deuxième trimestre 2024 : 62,6 millions de dollars en liquidités et investissements, 6,4 millions de dollars de revenus et une perte nette de 16,5 millions de dollars (0,09 dollar par action).
5. L'entreprise a reçu un paiement de 64,7 millions de dollars de BARDA après le deuxième trimestre, prolongeant sa liquidité jusqu'en 2026.
Vaxart, Inc. (NASDAQ: VXRT) hat seine finanziellen Ergebnisse für das zweite Quartal 2024 veröffentlicht und ein Update zu den Geschäftstätigkeiten gegeben. Wichtige Höhepunkte sind:
1. BARDA hat Vaxart bis zu 453 Millionen Dollar für eine Phase-2b-Studie seines oralen COVID-19-Impfstoffs zugesprochen.
2. Das Unternehmen plant, die Phase-2b-Studie mit 10.000 Probanden in der zweiten Hälfte von 2024 zu starten, vorbehaltlich einer Abstimmung mit der FDA.
3. Vaxart befindet sich im Gespräch mit der FDA hinsichtlich der Daten zu einem Norovirus-Impfstoff und möglichen nächsten Schritten.
4. Finanzielle Ergebnisse für Q2 2024: 62,6 Millionen Dollar in Bargeld und Investitionen, 6,4 Millionen Dollar Umsatz und ein Nettoverlust von 16,5 Millionen Dollar (0,09 Dollar pro Aktie).
5. Das Unternehmen erhielt nach dem zweiten Quartal eine Zahlung von 64,7 Millionen Dollar von BARDA, was die Cash-Reserven bis 2026 verlängert.
- Awarded up to $453 million BARDA contract for COVID-19 vaccine Phase 2b trial
- Received $64.7 million BARDA payment, extending cash runway into 2026
- Revenue increased to $6.4 million in Q2 2024 from $1.4 million in Q2 2023
- Net loss per share decreased to $0.09 in Q2 2024 from $0.16 in Q2 2023
- Research and development expenses decreased to $17.5 million from $18.8 million year-over-year
- Reported net loss of $16.5 million in Q2 2024
- Cash, cash equivalents, and investments decreased to $62.6 million as of June 30, 2024
Vaxart's Q2 2024 results show mixed signals. The $453 million BARDA contract for their COVID-19 oral vaccine is a significant positive, potentially extending cash runway and validating their technology. However, the net loss of
Revenue increased to
The extended cash runway into 2026 is positive, but Vaxart needs to demonstrate clinical progress to justify its valuation.
Vaxart's oral pill vaccine platform shows promise, particularly with the BARDA contract supporting a 10,000-subject Phase 2b comparative study against an mRNA vaccine. This large-scale trial could be a game-changer if successful, potentially revolutionizing vaccine distribution and uptake.
The norovirus program's progress is less clear. Ongoing discussions with the FDA regarding correlates of protection suggest the need for additional data, possibly delaying advancement. The potential for a Phase 2b study or GII.4 challenge study indicates a cautious approach by regulators.
While the COVID-19 program is advancing, the norovirus program's uncertainty and the need for further FDA discussions highlight the challenges in vaccine development. Investors should closely monitor upcoming regulatory decisions and trial initiations.
Vaxart's focus on oral pill vaccines addresses a important market need for easier vaccine administration and distribution. The BARDA contract not only provides substantial funding but also validates the potential of their platform in pandemic preparedness.
The planned comparison against an approved mRNA vaccine is strategically sound, potentially positioning Vaxart's technology as a next-generation approach. However, the vaccine market is highly competitive, with established players and emerging technologies.
The norovirus program, while facing regulatory hurdles, targets an unmet medical need. Success in this area could open significant market opportunities. Investors should weigh the potential of Vaxart's innovative approach against the inherent risks and long development timelines in vaccine development.
BARDA Project NextGen contract to support a Phase 2b trial potentially positions Vaxart’s oral pill vaccine platform as a next-generation approach to combating COVID-19 and future pandemic threats
Solid financial position enables Vaxart to execute on multiple regulatory and clinical milestones
Conference call today at 4:30 p.m. ET
SOUTH SAN FRANCISCO, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Vaxart, Inc. (Nasdaq: VXRT) today announced its business update and financial results for the second quarter of 2024.
“We achieved meaningful progress on our clinical, regulatory and operational goals during the first half of 2024,” said Steven Lo, Vaxart’s Chief Executive Officer. “Most significant was one of the largest Biomedical Advanced Research Development Authority (BARDA) contracts awarded to date for our COVID-19 program under Project NextGen, providing up to
“Through our focus on execution and continued constructive conversations with the U.S. Food and Drug Administration (FDA), we are well-positioned to initiate our COVID Phase 2b trial in the near-term and determine next steps in advancing our norovirus program,” Lo added. “Infectious diseases remain at the forefront of health challenges facing society, and we believe that by unlocking the potential of our oral pill vaccine platform, we will have a solution that can solve some of the greatest global health problems today.”
Recent Business Highlights
COVID-19 Vaccine Developments
- In June 2024, Vaxart received a project award valued at up to
$453 million through the Rapid Response Partnership Vehicle’s Consortium Management Firm funded by BARDA, in the U.S. Department of Health and Human Services. Funds from the BARDA award will be used to conduct a 10,000-subject Phase 2b comparative study evaluating Vaxart’s oral pill COVID-19 vaccine candidate against an FDA-approved mRNA vaccine comparator.- Vaxart plans to initiate enrollment in this trial as early as the second half of 2024, pending regulatory alignment with FDA.
- An interim analysis for vaccine efficacy compared to an approved mRNA comparator may occur when 255 symptomatic COVID-19 cases have been observed.
- The primary efficacy analysis will be performed when all participants have either discontinued or completed a study visit 12 months post-vaccination.
Norovirus Vaccine Developments
- Vaxart is in discussions with the FDA regarding our data for potential correlates of protection.
- After initial feedback, Vaxart is in the process of submitting additional requested information to the FDA and will determine next steps, such as potentially conducting a Phase 2b study and / or a GII.4 challenge study, based on discussions with the FDA.
Financial Results for the Second Quarter Ended June 30, 2024
- Cash, cash equivalents and investments totaled
$62.6 million as of June 30, 2024. Subsequent to the close of the quarter, Vaxart received a payment of approximately$64.7 million related to the BARDA contract awarded in June 2024. Proceeds will be used to continue study start-up activities for the COVID-19 Phase 2b clinical trial. Vaxart continues to anticipate cash runway into 2026. - Vaxart reported a net loss of
$16.5 million for the second quarter of 2024, compared to$22.6 million for the second quarter of 2023. Net loss per share for the second quarter of 2024 was$0.09 , compared to a net loss per share of$0.16 for the second quarter of 2023. - Revenue for the second quarter of 2024 was
$6.4 million , compared to$1.4 million for the second quarter of 2023. Revenue in the second quarter of 2024 was primarily from government contracts related to the BARDA contract awarded in January 2024. Revenue in the second quarter of 2023 was primarily from revenue recognized for work performed under Vaxart’s grant from the Bill & Melinda Gates Foundation. - Research and development expenses were
$17.5 million for the second quarter of 2024, compared to$18.8 million for the second quarter of 2023. The decrease was primarily due to decreases in clinical trial expenses related to Vaxart’s norovirus vaccine candidate, stock-based compensation expense, and personnel-related costs, partially offset by increases in clinical trial expenses and pre-clinical expenses related to Vaxart’s COVID-19 vaccine candidate. - General and administrative expenses were
$5.2 million for the second quarter of 2024, compared to$5.6 million for the second quarter of 2023. The decrease was primarily due to decreases in stock-based compensation expense and personnel-related costs and directors’ and officers’ insurance costs, partially offset by increases in legal and professional fees.
Conference Call
The Vaxart senior management team will host a conference call to discuss the business update and financial results for the second quarter of 2024 today, beginning at 4:30 p.m. ET.
The conference call can be accessed using the following information:
Webcast: Click here
Date: Thursday, August 8, 2024 – 4:30 p.m. ET
Domestic: 866-682-6100
International: 862-298-0702
Conference ID: 13747081
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, receipt of funding from BARDA for the Phase 2b study, results from preclinical and clinical trials and the timing of such results and such 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 receipt of funding from BARDA for the Phase 2b study (or for any other purpose); Vaxart's ability to develop and commercialize its product candidates, including its vaccine booster products; Vaxart's expectations regarding clinical results and trial data, including their design, and the timing of such trials and of receiving and reporting such clinical results and trial data; Vaxart’s expectations regarding timing of enrollment in studies; and Vaxart's expectations with respect to the effectiveness of its product candidates and the potential of its vaccine pill platform. 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 U.S. Securities and Exchange Commission. 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 | |||||||
| June 30, | December 31, | ||||||
| 2024 | 2023 | ||||||
| (Unaudited) | (1) | ||||||
| (in thousands) | |||||||
| Assets | |||||||
| Cash and cash equivalents | $ | 43,285 | $ | 34,755 | |||
| Investments in marketable debt securities | 19,308 | 4,958 | |||||
| Accounts receivable | 1,088 | 3,008 | |||||
| Unbilled receivable from government contracts | 3,689 | - | |||||
| Prepaid expenses and other assets | 5,016 | 3,741 | |||||
| Property and equipment, net | 10,280 | 11,731 | |||||
| Right-of-use assets, net | 22,652 | 24,840 | |||||
| Intangible assets, net | 3,923 | 4,289 | |||||
| Goodwill | 4,508 | 4,508 | |||||
| Total assets | $ | 113,749 | $ | 91,830 | |||
| Liabilities and stockholders’ equity | |||||||
| Accounts payable | $ | 3,587 | $ | 1,584 | |||
| Accrued and other liabilities | 7,016 | 5,927 | |||||
| Operating lease liability | 18,855 | 20,088 | |||||
| Liability related to sale of future royalties | 4,277 | 6,426 | |||||
| Total liabilities | 33,735 | 34,025 | |||||
| Stockholders’ equity | 80,014 | 57,805 | |||||
| Total liabilities and stockholders’ equity | $ | 113,749 | $ | 91,830 | |||
| (1) Derived from the audited consolidated financial statements of Vaxart, Inc. for the year ended December 31, 2023, included on the Form 10-K filed with the Securities and Exchange Commission on March 14, 2024. | |||||||
| Vaxart, Inc. Condensed Consolidated Statements of Operations (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| (in thousands, except share and per share amounts) | |||||||||||||||
| Revenue | $ | 6,401 | $ | 1,358 | $ | 8,582 | $ | 2,033 | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 17,480 | 18,813 | 36,493 | 38,435 | |||||||||||
| General and administrative | 5,177 | 5,598 | 12,415 | 12,223 | |||||||||||
| Total operating expenses | 22,657 | 24,411 | 48,908 | 50,658 | |||||||||||
| Operating loss | (16,256 | ) | (23,053 | ) | (40,326 | ) | (48,625 | ) | |||||||
| Other (expense) income, net | (189 | ) | 522 | (491 | ) | 983 | |||||||||
| Loss before income taxes | (16,445 | ) | (22,531 | ) | (40,817 | ) | (47,642 | ) | |||||||
| Provision for income taxes | 21 | 19 | 66 | 48 | |||||||||||
| Net loss | $ | (16,466 | ) | $ | (22,550 | ) | $ | (40,883 | ) | $ | (47,690 | ) | |||
| Net loss per share, basic and diluted | $ | (0.09 | ) | $ | (0.16 | ) | $ | (0.23 | ) | $ | (0.35 | ) | |||
| Shares used in computing net loss per share, basic and diluted | 184,703,003 | 139,594,238 | 176,757,049 | 137,403,416 | |||||||||||
FAQ
What was Vaxart's revenue for Q2 2024?
How much did BARDA award Vaxart for its COVID-19 vaccine trial?
When does Vaxart (VXRT) plan to start its COVID-19 Phase 2b trial?
What was Vaxart's (VXRT) net loss per share in Q2 2024?
How long does Vaxart expect its cash runway to last?
