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Vaxart, Inc. (symbol: VXRT) is a clinical-stage biotechnology company dedicated to transforming vaccine delivery through its innovative oral recombinant vaccine platform. Founded in 2004, Vaxart's primary focus is the development of vaccines in tablet form, offering a needle-free alternative that is easy to administer and store. This proprietary technology aims to revolutionize the global vaccine market, addressing common diseases such as Coronavirus, Norovirus, Seasonal Influenza, Respiratory Syncytial Virus (RSV), and Human Papillomavirus (HPV).
Headquartered in the United States, Vaxart operates in a single segment focused exclusively on the discovery and development of these groundbreaking oral recombinant protein vaccines. The company has made significant strides in the clinical development of its diverse pipeline, with several candidates currently undergoing trials. Vaxart’s oral vaccines are designed to simplify distribution and administration, potentially increasing vaccination rates and improving global health outcomes.
Recent achievements for Vaxart include the ongoing development and testing of its oral COVID-19 vaccine candidate, which has shown promise in preclinical studies and early-phase clinical trials. This innovation could play a crucial role in global vaccination efforts, especially in regions where cold-chain requirements pose logistical challenges. Other notable projects include the development of oral vaccines for Norovirus and Influenza, which are also advancing through various stages of clinical testing.
Financially, Vaxart remains focused on strategic partnerships and funding opportunities to support its research and development initiatives. The company's recent financial results for the full year ended December 31, 2023, and the first quarter ended March 31, 2024, reflect its ongoing commitment to advancing its oral vaccine candidates through clinical trials and towards regulatory approval.
For more information and the latest updates, contact Vaxart Media Relations: Mark Herr (mherr@vaxart.com, 203-517-8957) or Investor Relations: Andrew Blazier (IR@vaxart.com, 646-871-8486).
Vaxart (VXRT) has completed enrollment of a 400-participant sentinel cohort in its Phase 2b clinical trial comparing its oral pill COVID-19 vaccine candidate against an approved mRNA vaccine. The study includes 200 participants receiving Vaxart's vaccine and 200 receiving the mRNA comparator. Following DSMB and FDA review of 30-day safety data, and BARDA approval, the trial will expand to approximately 10,000 participants. The study will evaluate efficacy, safety, and immunogenicity in previously immunized adults. This project is funded under BARDA's Project NextGen initiative with an award valued up to $456 million.
Vaxart announced the granting of inducement equity awards to two new non-executive employees on November 15, 2024. The awards include 61,000 stock options that vest 25% after one year and 1/48th monthly thereafter, and 30,500 restricted stock units that vest 25% annually over four years. These awards were granted under Vaxart's 2024 Inducement Award Plan, complying with Nasdaq Listing Rule 5635(c)(4), specifically designed to attract new employees to the company.
Vaxart (VXRT) reported Q3 2024 financial results and business updates. The company expects to complete enrollment of 400 participants in its COVID-19 Phase 2b sentinel cohort study in November 2024. Q3 revenue was $4.9 million, up from $2.1 million in Q3 2023, primarily from BARDA contracts. Net loss decreased to $14.1 million ($0.06 per share) from $17.4 million ($0.11 per share) year-over-year. Cash position stands at $58.7 million, with runway expected into 2026. The company received FDA feedback on its norovirus program and created potentially more potent norovirus constructs.
Vaxart (NASDAQ: VXRT) has scheduled its third quarter 2024 business update and financial results conference call for November 13, 2024, after market close. The senior management team will host the call at 4:30 p.m. ET. Investors can participate via webcast or telephone, with domestic and international dial-in numbers provided. Written questions can be submitted in advance to ir@vaxart.com. A replay will be available on the company's website after the event.
Vaxart (VXRT) announced its participation in the World Vaccine Congress Europe 2024 in Barcelona, where it will present research on its COVID-19 and norovirus oral pill vaccine candidates. The company will deliver two presentations: a clinical update on their oral COVID vaccine's Phase 1 to Phase 2B trials by CMO Dr. James F. Cummings, and research on their oral norovirus vaccine's cross-reactivity and protection against infection by CSO Dr. Sean Tucker. Vaxart's platform has shown both systemic and mucosal immune responses with favorable safety profiles in clinical trials.
Vaxart (Nasdaq: VXRT) will present research on its norovirus oral pill vaccine candidate at IDWeek 2024 in Los Angeles. With no approved vaccines for norovirus, Vaxart's candidate is the most advanced in clinical development for oral administration and gastrointestinal delivery. Norovirus affects 21 million Americans annually, including 15% of children under 5, forcing 3 million parents to miss work. Adults ≥65 are at high risk for severe symptoms.
Two presentations are scheduled:
- A Phase 2 study on the oral tableted norovirus vaccine VXA-G1.1-NN, showing immunogenicity, efficacy, and reduced viral shedding.
- A Phase I study on the safety, tolerability, and immunogenicity of an orally administered bivalent GI.1/GII.4 norovirus vaccine in lactating females and their infants.
The annual disease burden from norovirus in the US is estimated at $10.6 billion.
Vaxart (Nasdaq: VXRT) has initiated the sentinel cohort of its Phase 2b clinical trial for its oral pill COVID-19 vaccine candidate. This 400-subject cohort will compare Vaxart's vaccine to an approved mRNA vaccine, evaluating safety, immunogenicity, and efficacy. The study is part of the U.S. government's Project NextGen, with funding up to $456 million.
The full Phase 2b trial aims to enroll 10,000 participants, measuring efficacy for symptomatic and asymptomatic disease, immune induction, and adverse events. The primary endpoint is relative efficacy compared to the mRNA vaccine for preventing symptomatic disease. The trial will strive to reflect U.S. demographics, including at least 25% of participants over 65.
This marks a significant step in Vaxart's goal to develop a sustainable solution to the COVID-19 threat, representing the first head-to-head comparison of their mucosal technology against an approved mRNA vaccine for this virus.
Vaxart, Inc. (Nasdaq: VXRT) has announced the granting of inducement equity awards to two new non-executive employees. The awards, approved by the Compensation Committee on August 26, 2024, include:
- 21,500 stock options vesting over 4 years
- 10,750 restricted stock units vesting over 4 years
These awards were granted under the Vaxart, Inc. 2024 Inducement Award Plan, in compliance with Nasdaq Listing Rule 5635(c)(4). The plan is exclusively used for granting equity awards to new employees as an inducement to join Vaxart.
Vaxart (NASDAQ: VXRT) has published preclinical data in Vaccines journal, showcasing the potential of its mucosal vaccine technology for treating HPV-related cervical dysplasia. The study demonstrated that Vaxart's HPV vaccine constructs can:
1. Stimulate specific T cell immune responses against HPV16 E6 and E7 proteins
2. Reduce tumor size in an animal model of HPV-related tumorigenesis
3. Increase survival in mice with HPV-expressing tumors
The results suggest that Vaxart's platform could enable a non-invasive treatment for HPV-related cervical dysplasia, potentially preventing progression to cervical cancer. The vaccine's ease of administration and room temperature stability could address global inequities in HPV-related cancer treatment.
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.
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