BERWYN, PA — Virpax Pharmaceuticals, Inc. (NASDAQ: VRPX) announced its financial results for the three and nine months ended September 30, 2021, and other recent developments.
“We continue to enhance our product pipeline, and because of our unique delivery technologies we have expanded our targeted indications beyond pain to include Central Nervous System (CNS) disorders and anti-viral indications. We recently raised $40 million in an underwritten public offering of our common stock which greatly strengthened our balance sheet and has allowed us to accelerate our development timelines related to our non-clinical studies. Our goal is to successfully complete our Investigational New Drug (IND) filings and begin first-in-human trials as soon as possible,” stated Anthony Mack, chairman and CEO of Virpax.
“With our cash on hand of $41.7 million as of September 30, 2021, we believe we have sufficient funds to advance our 505(b)(2) product candidates, Epoladerm™ and Probudur™, through to a New Drug Application (NDA) filing. For Epoladerm, our spray film product candidate, based on our non-clinical studies and research we believe that osteoarthritis of the knee is a better global market opportunity for the Company and will focus our efforts for Epoladerm on this indication. With Probudur, our injectable bupivacaine liposomal hydrogel for postoperative pain management, we are working on improving the formulation to increase stability so that manufacturing would be less complex. We also anticipate being able to extend the patent protection for this product candidate.
“Our current remaining product pipeline leverages our licensed Molecular Envelope Technology (MET) which delivers medication through an intranasal delivery device that both permeates the blood-brain barrier and may bypass the liver. Our lead product candidate is Envelta™, which utilizes MET to deliver enkephalin nanoparticles for acute and chronic pain including pain associated with cancer. This product candidate is being funded through a Cooperative Research and Development Agreement (CRADA) with the National Center for Advancing Translational Sciences (NCATS). We recently announced that under this CRADA, the National Institutes of Health has awarded multiple contracts to support the development and manufacturing of Envelta. We are looking forward to the completion of the required IND enabling studies and submitting our IND package to the FDA in anticipation of first-in-human trials,” continued Mr. Mack.
“Through ongoing work with our MET platform, we discovered that our product candidate, AnQlar™, may provide a molecular barrier to respiratory infections such as SARS-CoV-2 and influenza by binding to the surface of viruses which in turn prevents the virus from binding to cell surface receptors that mediate viral infection. Following the receipt of a written pre-IND response from the FDA, our plan for AnQlar is to complete all studies required for an NDA submission as an over-the-counter (OTC) product. We believe there is a very large market for AnQlar and we are developing this product candidate to be used as a once daily intranasal administration to inhibit the ability of viruses to replicate and prevent viral spread.
“Finally, we recently acquired the worldwide rights to VRP324, which is an intranasal pharmaceutical-grade cannabidiol product candidate for the management of epilepsy in children (rare pediatric disease) and adults. VRP324 represents our first CNS disorder product indication. VRP324 utilizes our novel MET intranasal delivery platform which, based on our early research, may bypass the liver and alleviate concerns related to drug-to-drug interaction compared to the currently available oral dosed cannabidiol product approved to manage seizure disorders.
“This is an exciting time at Virpax, and we believe that all of our product candidates have the potential to deliver significant improvements and benefits to currently existing treatment options,” concluded Mr. Mack.
- On July 30, 2021, Virpax announced the appointment of Gerald W. Bruce and Michael F. Dubin, CPA to its Board of Directors.
- On August 17, 2021, Virpax announced that it had received FDA response and guidance on AnQlar. The FDA has indicated that Virpax may pursue an NDA drug approval with the Office of Non-Prescription Drugs. The Company is developing this product candidate as a prophylactic treatment against SARS and influenza and has engaged Syneos Health to assist with the optimal clinical trial design.
- On September 9, 2021, Jeffrey A. Gudin, MD, Chief Medical Officer of Virpax, presented a poster on Leucine Enkephalin as a potential analgesic at PainWeek 2021 in Las Vegas, Nevada.
- On September 16, 2021, Virpax closed an underwritten public offering of 6,670,000 shares of its common stock for gross proceeds of $40,020,000 before the deduction of underwriting discounts and offering expenses. The Company intends to use substantially all of the net proceeds from the underwritten offering to fund research and development of all of its product candidates and other development programs and for working capital and other general corporate purposes.
- On September 20, 2021, Virpax announced that it had acquired the exclusive worldwide rights from Nanomerics Ltd., for its MET for the nasal delivery of cannabidiol (CBD) for the management of epilepsy in children (rare pediatric disease) and adults. VRP324 is being developed to treat seizures associated with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome, and Dravet syndrome in patients one year of age and older.
- On October 6, 2021, Virpax announced an agreement with Sinclair Research to initiate IND enabling studies for AnQlar as a daily OTC prophylactic for treatment against SARS and influenza. Sinclair is expected to begin the preclinical animal studies at the beginning of 2022 as part of the enabling trials for an IND application with the FDA.
- On June 21, 2021, Virpax announced that the IND enabling studies for Envelta being performed under a Cooperative Research and Development Agreement entered into by Virpax and NCATS for acute and chronic pain, will also be used as a source for INDs for two additional indications, for cancer pain and Post-Traumatic Stress Disorder. NCATS has commenced the IND enabling studies of Envelta to support Virpax’s future application for clearance from the FDA to initiate Virpax’s first-in-human clinical trials. The Company believes the same Phase I Single Ascending Dose /Multiple Ascending Dose study could be used to advance all three indications.
FINANCIAL RESULTS FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2021 AND 2020
Three Months Ended September 30, 2021 and 2020
General and administrative expenses increased by $0.7 million, or 91%, to $1.6 million for the three months ended September 30, 2021, from $0.8 million for the three months ended September 30, 2020. The primary reasons for the increase in general and administrative costs were (i) an increase in legal costs associated with litigation efforts and general corporate purposes of $0.6 million, (ii) an increase in insurance costs related to directors’ and officers’ insurance of $0.3 million, (iii) an increase in salaries and wages of $0.1 million attributable to new hires, and (iv) an increase in grant consulting of $47 thousand This was offset by a decrease in stock-based compensation of $0.3 million.
Research and development expenses increased by $0.8 million, or 99%, to $1.7 million for the three months ended September 30, 2021, from $0.9 million for the three months ended September 30, 2020. The increase was primarily attributable to an increase in pre-clinical activities related to Epoladerm of $0.6 million, Probudur of $12 thousand, VRP324 of $0.2 million, and AnQlar of $83 thousand. This was offset by a decrease in preclinical activity and milestone payments made for Envelta of $0.7 million.
As a result of the foregoing, the Company’s loss from operations for the three months ended September 30, 2021, was $3.2 million, compared to a loss from operations of $1.7 million for the three months ended September 30, 2020.
Nine Months Ended September 30, 2021 and 2020
General and administrative expenses increased by $2.5 million, or 107%, to $4.8 million for the nine months ended September 30, 2021, from $2.3 million for the nine months ended September 30, 2020. The primary reasons for the increase in general and administrative costs were (i) an increase in legal costs associated mainly with litigation efforts and legal costs associated with general corporate purposes of $1.9 million, (ii) an increase in insurance costs related to directors’ and officers’ insurance of $0.7 million, (iii) an increase in exchange listing fees of $0.1 million, and (iv) an increase in salaries and wages of $0.1 million. This was offset by a decrease in stock-based compensation of $0.3 million as compared to the prior period.
Research and development expenses increased by $1.9 million, or 160%, to $3.1 million for the nine months ended September 30, 2021, from $1.2 million for the nine months ended September 30, 2020. The increase was primarily attributable to (i) a $1.0 million milestone payment made to Nanomerics and preclinical activity of $0.1 million associated with AnQlar, (ii) increases in pre-clinical activity related to Epoladerm of $0.7 million, (iii) an increase in preclinical work in Probudur of $0.7 million, and (iv) a milestone payment of $0.2 million due to VRP324. This was slightly offset by a decrease of $0.7 million in pre-clinical activities associated with Envelta.
As a result of the foregoing, the Company’s loss from operations for the nine months ended September 30, 2021 was $7.9 million, compared to a loss from operations of $3.5 million for the nine months ended September 30, 2020.
Cash used in operations was approximately $9.6 million for the nine months ended September 30, 2021, compared to approximately $1.2 million for the nine months ended September 30, 2020. The increase in cash used in operations was primarily the result of the increase in net loss, decrease in accounts payables balances, and an increase in prepaid insurance premiums and prepaid research and development.
Cash provided by financing activities was $51.3 million during the nine months ended September 30, 2021, attributable primarily to net proceeds received from the Company’s initial public offering in February 2021 of $15.8 million and the underwritten offering in September 2021 of $37.0 million, after deducting underwriting discounts and offering expenses. These proceeds were offset by the repayment in full of the Company’s promissory note in the principal amount of $0.5 million in February 2021 and repayments of the Company’s promissory notes and PPP loan of an aggregate of $1.5 million. Cash provided by financing activities was $1.4 million during the nine months ended September 30, 2020, attributable to $1.4 million from the sale of 139,220 shares of the Company’s common stock as well as proceeds received from the PPP loan of $72,100.
At September 30, 2021, Virpax had cash of approximately $41.7 million.
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