Vaxart Inc Stock Price, News & Analysis

Vaxart (VXRT) announced favorable results from an independent Data Safety Monitoring Board (DSMB) review of its COVID-19 Phase 2b clinical trial. The DSMB recommended the study continue without modifications after reviewing 30-day safety data from a sentinel cohort of 400 participants.

The company plans to expand the trial to 10,000 participants upon FDA review approval and BARDA authorization. This double-blind, multi-center study compares Vaxart's oral pill COVID-19 vaccine to an approved mRNA injectable vaccine in previously immunized adults, with at least 25% of participants over age 65.

The project is funded through BARDA's Project NextGen initiative, with Vaxart's award valued at up to $460.7 million. As a pioneer in oral vaccines, Vaxart was the first U.S. company to complete a Phase 2 trial of an oral COVID-19 vaccine.

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.