Virpax Pharmaceuticals, Inc. VRPX released its financial results for the twelve months ended December 31, 2022, and other recent developments.
FY 2022 Financial Highlights
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General and administrative expenses increased by $3.9 million, or 54%, to $11 million for the year ended December 31, 2022, from $7.2 million for the year ended December 31, 2021.
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Research and development expenses increased by $5.9 million or 122%, to $10.8 mllion for the year ended December 31, 2022, from $4.8 million for the year ended December 31, 2021.
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For the year ended December 31, 2022, cash used in operations was $17.8 million compared to $14.5 million for the year ended December 31, 2021.
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At December 31, 2022, Virpax had cash of approximately $19.0 million.
Recent Developments
On December 8, 2022, Virpax received Pre-Investigational New Drug (PIND) application guidance from the FDA for NobrXiol. The main purpose of a PIND submission is to obtain FDA guidance on the overall development plan for a new drug and to identify any need for further data prior to submitting an IND. NobrXiol is the company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults that utilizes Nanomerics’ Molecular Envelope Technology (MET) as its delivery system to cross the blood brain barrier, propelling the cannabidiol nanoparticles through the nose to the brain via the olfactory nerve.
On January 4, 2023, Virpax announced that it has engaged two leading physicians experienced in childhood epilepsy, Dr. Kenneth W. Sommerville and Dr. Lawrence Fried, to support the overall development plan for NobrXiol. Their involvement with this program is expected to include advising on trial design, regulatory pathway development and patient recruitment. Additionally, it is anticipated that they will support Virpax with patient advocacy groups and grant applications.
On February 13, 2023, Virpax announced that the company has completed FDA required preclinical toxicology studies for its licensed Molecular Envelope Technology. The company believes MET may enhance the delivery of Virpax’s Envelta and NobrXiol product candidates. MET is also utilized in the company’s AnQlar product candidate. These preclinical toxicology studies were performed to evaluate the safety of the MET platform and support the IND submission of each product candidate.
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