VRPX Virpax Pharmaceuticals Inc.

1.91
-0.24  -11%
Previous Close 2.15
Open 2.17
52 Week Low 2.03
52 Week High 36
Market Cap $22,375,736
Shares 11,715,045
Float 8,798,377
Enterprise Value $17,549,929
Volume 1,005,417
Av. Daily Volume 1,111,295
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Drug Pipeline

Drug Stage Notes
Epoladerm
Pain associated with Osteoarthritis of the Knee
Phase 1
Phase 1
Phase 1 enrollment due in early 2Q 2022.
AnQlar (MMS019)
SARS and influenza
Phase 1
Phase 1
Preclinical animal studies to begin in early 2022.

Latest News

  1. Altasciences is pleased to have been chosen by Virpax® Pharmaceuticals, Inc. ("Virpax") (NASDAQ:VRPX) to conduct a first-in-human study of Epoladerm™ (diclofenac epolamine) for chronic pain associated with osteoarthritis of the knee. This treatment is supplied in a pre-filled device for administration as a topical spray film.

    The study will be conducted in Q2 2022 at Altasciences' clinical pharmacology unit in Montreal, Canada. "We look forward to working with Altasciences to accelerate the development of this analgesic treatment and provide robust data in support of the 505(b)(2) FDA approval pathway," stated Virpax's Chairman & CEO, Anthony P. Mack.

    Virpax's proprietary technology provides a pre-filled canister for the therapeutic application…

    Altasciences is pleased to have been chosen by Virpax® Pharmaceuticals, Inc. ("Virpax") (NASDAQ:VRPX) to conduct a first-in-human study of Epoladerm™ (diclofenac epolamine) for chronic pain associated with osteoarthritis of the knee. This treatment is supplied in a pre-filled device for administration as a topical spray film.

    The study will be conducted in Q2 2022 at Altasciences' clinical pharmacology unit in Montreal, Canada. "We look forward to working with Altasciences to accelerate the development of this analgesic treatment and provide robust data in support of the 505(b)(2) FDA approval pathway," stated Virpax's Chairman & CEO, Anthony P. Mack.

    Virpax's proprietary technology provides a pre-filled canister for the therapeutic application of a clear, fast-drying spray film that is thinner than a standard liquid bandage. This technology offers convenience and eliminates the need for messy creams or gels.

    Altasciences leverages decades of experience conducting first-in-human clinical trials, a vast database of study participants, and state-of-the-art bioanalytical facilities to provide expert guidance and personalized solutions. Ingrid Holmes, Altasciences' Vice President, Global Clinical Operations, says, "We are proud to partner with Virpax to help move this important therapeutic further along the path to regulatory approval."

    Altasciences transforms the traditional outsourcing paradigm by simplifying and streamlining drug development solutions, whether for a single service or a synchronized approach to CRO and CDMO services, from lead candidate selection to clinical proof of concept, and beyond.

    More information on Virpax® Pharmaceuticals, Inc.'s program can be found here.

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    About Altasciences

    Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

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  2. Well-tolerated with No Serious Adverse Findings

    Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS disorders, and anti-viral indications, reported positive results of four preclinical dermal safety studies for Epoladerm™ (diclofenac epolamine). Epoladerm is an investigational product candidate for the management of pain associated with osteoarthritis of the knee. From these recently concluded animal studies, researchers concluded that once daily dermal administration of Epoladerm for 28 days was well-tolerated with no serious adverse findings.

    The studies were performed by Charles River Laboratories, a well-known clinical research organization…

    Well-tolerated with No Serious Adverse Findings

    Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS disorders, and anti-viral indications, reported positive results of four preclinical dermal safety studies for Epoladerm™ (diclofenac epolamine). Epoladerm is an investigational product candidate for the management of pain associated with osteoarthritis of the knee. From these recently concluded animal studies, researchers concluded that once daily dermal administration of Epoladerm for 28 days was well-tolerated with no serious adverse findings.

    The studies were performed by Charles River Laboratories, a well-known clinical research organization. The studies included a skin irritation study in rabbits; a dermal sensitization assessment in guinea pigs; and a phototoxicity assay in mouse fibroblasts. Epoladerm was well- tolerated in each of the studies and no reportable dermal irritation, dermal sensitization or phototoxicity was observed.

    "These successful preclinical outcomes should further strengthen Virpax's planned Investigational New Drug Application for Epoladerm in advance of the anticipated start of first-in-human trials," said Anthony P. Mack, Chairman and CEO of Virpax.

    About Epoladerm™

    Virpax Pharmaceuticals is developing Epoladerm™ (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee. The Company's proprietary technology is intended to provide a convenient aerosol canister for application of the spray film to the knee. The resulting film is intended to be thinner than a standard liquid bandage, visibly clear and fast drying. The spray formulation is intended to avoid the inconvenient and messy application of creams or gels to the knee.

    About Virpax Pharmaceuticals

    Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a product candidate intended to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of epilepsy in children (a rare pediatric disease) and adults. For more information, please visit www.virpaxpharma.com.

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  3. Virpax® Pharmaceuticals, Inc. ("Virpax"), a company specializing in product candidates for pain management, CNS disorders and anti-viral indications, today announced that it will be presenting virtually at the upcoming H.C. Wainwright event from Monday, January 10th through Thursday, January 13th starting at 7:00 a.m. ET. Anthony Mack, Chairman & CEO of Virpax, will be giving the presentation. Management will also be hosting virtual one-on-one meetings on Monday, January 10th and Tuesday, January 11th.

    Event: Virpax Pharma Presentation at the H.C. Wainwright BioConnect Virtual Conference
    Date: Monday, January 10th through Thursday, January 13th
    Time: On Demand from 7:00 a.m. ET to 7:00 p.m. ET daily
    Webcast: Register Here

    A replay of the…

    Virpax® Pharmaceuticals, Inc. ("Virpax"), a company specializing in product candidates for pain management, CNS disorders and anti-viral indications, today announced that it will be presenting virtually at the upcoming H.C. Wainwright event from Monday, January 10th through Thursday, January 13th starting at 7:00 a.m. ET. Anthony Mack, Chairman & CEO of Virpax, will be giving the presentation. Management will also be hosting virtual one-on-one meetings on Monday, January 10th and Tuesday, January 11th.

    Event: Virpax Pharma Presentation at the H.C. Wainwright BioConnect Virtual Conference

    Date: Monday, January 10th through Thursday, January 13th

    Time: On Demand from 7:00 a.m. ET to 7:00 p.m. ET daily

    Webcast: Register Here

    A replay of the presentation will also be available for 90 days on the Virpax website.

    For more information on the H.C. Wainwright BioConnect Conference or to schedule a one-on-one meeting with Virpax management, please contact your conference representative or you may also email your request to or call (212) 661-2231.

    About Virpax Pharmaceuticals

    Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of epilepsy in children (a rare pediatric disease) and adults. For more information, please visit www.virpaxpharma.com.

    About H.C. Wainwright & Co.

    H.C. Wainwright is a full‐service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. H.C. Wainwright & Co. also provides research and sales and trading services to institutional investors. According to Sagient Research Systems, H.C. Wainwright's team is ranked as the #1 Placement Agent in terms of aggregate CMPO (confidentially marketed public offering), RD (registered direct offering) and PIPE (private investment in public equity) executed cumulatively since 1998.

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  4. Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX) achieved significant milestones relating to its pipeline of product candidates as of the end of 2021, which are summarized below.

    "I believe that Virpax has made significant progress this past year toward our stated goals," commented Anthony P. Mack, Chairman and CEO of Virpax. "These accomplishments include accelerated development of our existing product candidates, broadening our pipeline of product candidates, and utilizing grants where appropriate. We recently announced that we anticipate commencing our initial human trial for Epoladerm™ in the second quarter of 2022.

    "Virpax initially focused strictly on pain product candidates. However, our unique Molecular Envelope…

    Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX) achieved significant milestones relating to its pipeline of product candidates as of the end of 2021, which are summarized below.

    "I believe that Virpax has made significant progress this past year toward our stated goals," commented Anthony P. Mack, Chairman and CEO of Virpax. "These accomplishments include accelerated development of our existing product candidates, broadening our pipeline of product candidates, and utilizing grants where appropriate. We recently announced that we anticipate commencing our initial human trial for Epoladerm™ in the second quarter of 2022.

    "Virpax initially focused strictly on pain product candidates. However, our unique Molecular Envelope Technology (‘MET') delivery platform licensed from Nanomerics, Ltd. (‘Nanomerics') has enabled the development of product candidates for central nervous system (‘CNS') and anti-viral indications. In the second half of 2021, we advanced the development of AnQlar™, a prophylactic, over-the-counter (‘OTC') anti-viral product candidate formulated to prevent the spread of respiratory infections like influenza, SARS-CoV-2 and rhinovirus. We added VRP324 which is an intranasally delivered cannabidiol (‘CBD') formulation for the management of epilepsy in adults and children. Our Envelta™ IND-enabling studies, completed by the National Center for Advancing Translational Sciences (‘NCATS') as a part of our Cooperative Research and Development Agreement (‘CRADA'), determined that the MET intranasal delivery formulation bypasses the liver which we believe reduces drug-to-drug interaction concerns for treatments using this technology.

    "On the corporate front, we strengthened our Board by appointing two new members adding expertise in commercialization and financial strategy. Additionally, in 2021 we raised approximately $58 million in aggregate gross proceeds from our initial public offering and an underwritten follow-on public offering. These funds are being used for research and development activities of our product candidates. We are on track to add accomplishments in 2022 and I remain confident that we have the significant financial strength to continue advancing our pipeline," concluded Mr. Mack.

    Epoladerm™

    Epoladerm is a diclofenac topical spray film product candidate that is being developed for pain associated with osteoarthritis of the knee. Virpax recently reported successful results of a Charles River Laboratories single dose toxicology and pharmacokinetic study of dermal administration of Epoladerm in minipigs as part of the required Investigational New Drug Application (‘IND') enabling trials. Single-dose transdermal delivery of Epoladerm was well-tolerated in all minipigs. There were no treatment-related clinical observations, changes in body weight, or dermal irritation observed. The maximum plasma concentration (Cmax) was reached at 4 hours post-dose, and concentrations of plasma Epoladerm remained at 24-hour post-dose for all animals.

    Upon completion of all the required IND enabling studies and subsequent review by the FDA, Virpax intends to conduct a Phase 1 study to evaluate the relative bioavailability and pharmacokinetics of Epoladerm™. Virpax recently announced the execution of a clinical trial agreement with Altasciences Company, Inc., to conduct this study in Canada. Virpax anticipates enrollment of the first patient by early second quarter of 2022.

    Probudur™

    Probudur is an injectable bupivacaine liposomal hydrogel for postoperative pain management which Virpax believes has improved onset and extended duration of action compared to existing treatment options. Additional pre-clinical trials are being conducted with Lipocure, the product developer, to improve the formulation to potentially enhance manufacturing efficiencies, prolong duration and extend patent protection. Once completed, we plan to perform seven preclinical animal studies as part of required FDA IND enabling trials.

    Envelta™

    Envelta is an endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. This product leverages Nanomeric's MET platform technology which Virpax licensed to deliver the endogenous enkephalin formulation through an intranasal delivery enabling the enkephalin to permeate the blood-brain barrier while bypassing the liver. This product candidate is being funded through an in-kind CRADA with the NCATS.

    Virpax recently announced that under this CRADA, the National Institutes of Health has awarded multiple contracts to support the research, development and manufacturing of Envelta. These contracts are to support Good Manufacturing Practices (‘GMP') production of drug substance and drug product, as well as to support Good Laboratory Practices (‘GLP') toxicology, safety studies and preclinical efficacy studies. The NIH has contracted with a clinical research organization to conduct additional pre-clinical efficacy studies and has procured a device to be used with the manufactured GMP drug product for preclinical and clinical studies. The NIH has also engaged a firm to manufacture Leu-enkephalin (‘L-ENK'), the active ingredient in Envelta, and a company to manufacture the MET carrier that delivers L-ENK to the brain to promptly suppress pain.

    AnQlar™

    AnQlar (formerly MMS019) is a high-density intranasal molecular masking spray in development as an anti-viral OTC product for protection against respiratory infections, such as SARS-CoV-2 and influenza, that Virpax anticipates will be used as an adjuvant to barrier-based personal protective equipment. Virpax recently announced a manufacturing and supply agreement with Seqens to provide AnQlar for both clinical studies and the long-term commercial supply of AnQlar.

    Additionally, Virpax engaged Sinclair Research to initiate IND-enabling studies for AnQlar. The Company anticipates that these preclinical animal studies will begin in early 2022.

    VRP324

    Virpax has acquired the exclusive worldwide rights from Nanomerics to use its MET platform for the nasal delivery of CBD for the management of epilepsy in children (a rare pediatric disease) and adults.

    Under this agreement, Virpax has the global rights to develop, manufacture, market and sell VRP324, the first investigational formulation delivered via the nasal route to enhance CBD transport to the brain. This product candidate will be formulated to potentially treat seizures associated with tuberous sclerosis complex (‘TSC'), Lennox-Gastaut syndrome and Dravet syndrome in patients one year of age and older. Lennox-Gastaut syndrome and Dravet syndrome are rare CNS diseases considered serious epileptic encephalopathies that cause epileptic seizures, as well as cognitive and behavioral changes, and are generally resistant to treatment. Preclinical studies of VRP324 have been initiated by Nanomerics which it anticipates will be completed in the first quarter of 2022. Upon completion, Virpax will collaborate with RRD International, a clinical drug development company which Virpax has engaged, to prepare the pre-IND briefing documents for the FDA.

    About Virpax Pharmaceuticals

    Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology (MET) enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of epilepsy in children (a rare pediatric disease) and adults. For more information, please visit www.virpaxpharma.com.

    Forward-Looking Statement

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's planned clinical trials, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, on the Company's operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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  5. First Patient Expected to be Enrolled by Q2 of 2022

    Data To Support Regulatory Filings in the United States

    Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS disorders and anti-viral indications, signed a clinical trial agreement with Altasciences Company, Inc., a leading clinical trial services company, for a First in Human study investigating Epoladerm™ for pain associated with osteoarthritis of the knee. The study will take place in Canada with a CTA filing and enrollment of the first patient anticipated by Q2 of 2022.

    "Performing trials in Canada is an efficient and cost-effective way for Virpax to add robust data in support of the…

    First Patient Expected to be Enrolled by Q2 of 2022

    Data To Support Regulatory Filings in the United States

    Virpax® Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ:VRPX), a company specializing in developing product candidates for pain management, CNS disorders and anti-viral indications, signed a clinical trial agreement with Altasciences Company, Inc., a leading clinical trial services company, for a First in Human study investigating Epoladerm™ for pain associated with osteoarthritis of the knee. The study will take place in Canada with a CTA filing and enrollment of the first patient anticipated by Q2 of 2022.

    "Performing trials in Canada is an efficient and cost-effective way for Virpax to add robust data in support of the 505(b)(2) FDA approval pathway for Epoladerm™ . Through partners like Altasciences, we may strategically accelerate our optimized drug delivery therapeutic candidates through pre-clinical and clinical development," commented Chairman & CEO Anthony P. Mack.

    About Epoladerm™

    Virpax Pharmaceuticals is developing Epoladerm™ (diclofenac epolamine), an investigational analgesic supplied in a pre-filled device for administration as a topical spray film to manage chronic pain associated with osteoarthritis of the knee. Our proprietary technology provides a convenient aerosol canister for application of the spray film to the knee. The resulting film is thinner than a standard liquid bandage, is visibly clear on the knee and is fast-drying. The spray formulation avoids the inconvenient and messy application of creams or gels to the knee.

    About Virpax Pharmaceuticals

    Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval of its three patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage osteoarthritis pain. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular-Envelope Technology (MET) enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder (PTSD) under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax recently acquired global rights to VRP324, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of epilepsy in children (a rare pediatric disease) and adults. For more information, please visit www.virpaxpharma.com.

    About Altasciences

    Altasciences is an integrated drug development solution company offering pharmaceutical and biotechnology companies a proven, flexible approach to preclinical and clinical pharmacology studies, including formulation, manufacturing, and analytical services. For over 25 years, Altasciences has been partnering with sponsors to help support educated, faster, and more complete early drug development decisions. Altasciences' integrated, full-service solutions include preclinical safety testing, clinical pharmacology and proof of concept, bioanalysis, program management, medical writing, biostatistics, clinical monitoring, and data management, all customizable to specific sponsor requirements. Altasciences helps sponsors get better drugs to the people who need them, faster.

    Forward-Looking Statement

    This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's planned clinical trials, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.

    These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential," "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors, including the potential impact of the recent COVID-19 pandemic and the potential impact of sustained social distancing efforts, on the Company's operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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