Aankondiging • Jul 14
The Nasdaq Stock Market to Delist the Common Stock of Virpax Pharmaceuticals The Nasdaq Stock Market announced that it will delist the common stock of Virpax Pharmaceuticals, Inc. Virpax Pharmaceuticals' stock was suspended on April 4, 2025 and has not traded on Nasdaq since that time. Aankondiging • Apr 04
Virpax Pharmaceuticals, Inc.(NasdaqCM:VRPX) dropped from NASDAQ Composite Index Virpax Pharmaceuticals, Inc. has been removed from NASDAQ Composite Index . New Risk • Apr 03
New major risk - Revenue and earnings growth Earnings have declined by 24% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (19% average weekly change). Negative equity (-US$914k). Earnings have declined by 24% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 21x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$711.3k market cap). Aankondiging • Apr 03
Nasdaq Determines to Delist Virpax Pharmaceuticals' Securities from the Nasdaq Stock Market LLC Due to Non-Compliance with the Minimum Stockholders' Equity Requirement On April 2, 2025, Virpax Pharmaceuticals, Inc. (the ‘Company’) received a letter from the Nasdaq Hearings Panel (the ‘Panel’) indicating that the Panel has determined to delist the Company’s securities from The Nasdaq Stock Market LLC (‘Nasdaq’) as a result of the Company’s failure to regain compliance with the minimum stockholders’ equity requirement under Nasdaq Listing Rule 5550(b)(1) (the ‘Equity Rule’). Trading in the Company’s common stock on Nasdaq will be suspended effective at the open of business on April 4, 2025. Nasdaq will complete the delisting by filing a Form 25 Notification of Delisting with the Securities and Exchange Commission (the ‘SEC’) after all applicable appeal periods have lapsed. The Company does not intend to request a review of the Panel’s decision by the Nasdaq Listing and Hearing Review Council. As a result, the delisting is expected to become effective following the filing of the Form 25 with the SEC. Aankondiging • Mar 19
Virpax Receives Positive Probudur Results for Dose Range Study Moves Towards Next Steps in IND Virpax Pharmaceuticals, Inc. announced positive results from a beagle dog dose range finding study. Probudur is the company’s long-acting liposomal bupivacaine formulation injected at a wound site to provide both immediate and extended pain relief. The Company continues to work towards its Investigational New Drug application and this was another important step towards that milestone. The DRF study was conducted to evaluate the tolerance of Probudur when administered by subcutaneous injection to beagle dogs in a dose escalating manner. All the dogs in the DRF study demonstrated positive tolerance to Probudur and no adverse effects were noted. The results of this study suggest that doses of LBL100 up to 90 mg/kg are well tolerated by beagle dogs. Probudur is being developed to achieve the overall goal of safe and effective pain control during the perioperative period and to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channels, preventing pain signals from reaching the brain. In preclinical studies, Probudur has shown long duration pain control for at least 96 hours, with a rat incisional model demonstrating analgesia for up to five days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six days. Aankondiging • Mar 18
Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $5 million. Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $5 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrant
Security Type: Equity Warrant Board Change • Mar 02
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. No experienced directors. No highly experienced directors. Independent Director Katie Field is the most experienced director on the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Feb 28
Virpax Pharmaceuticals, Inc. Reports Positive Results in Human Study for Its Molecular Envelope Technology Virpax Pharmaceuticals, Inc. congratulated Nanomerics on completing a human study using the Molecular Envelope Technology (MET) and showing no moderate to severe adverse events. Virpax uses MET in its Envelta (NES100) and NobrXiol. Envelta is an enkephalin drug product based on a type of nanotechnology delivery approach. The MET is designed to protect and help carry the drug to the brain with the goal of promptly suppressing pain by binding to the delta opioid receptors. Envelta has demonstrated analgesic potential in animal models without the development of opioid tolerance or reward seeking behavior. It is currently being developed in a cooperative research and development agreement with the National Center for Advancing Translational Sciences (NCATS), an institute/center of the National Institutes of Health (NIH), U.S. Department of Health and Human Services. In addition, Virpax uses MET with NobrXiol. NobrXiol is being developed for delivery of cannabidiol in the management of epilepsy in children and adults. NobrXiol utilizes the 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. The drug has received pre-Investigational New Drug (PIND) application guidance from the U.S. Food and Drug Administration (FDA) Nanomerics’s Phase I trial, the SUNLIGHT trial, involved 28 days of administration of OC134, powered by the MET and MET alone as eye drops to healthy volunteers. Dosing twice daily (12 h apart) of the healthy study participants with MET eye drops and OC134 eye drops commenced in December 2024 and was completed in January 2025. The SUNLIGHT trial was a phase I clinical trial; these trials are used to test for the safety, side effects, best dose, and timing of a new treatment. It may also test the best way to give a new treatment (for example, by mouth, infusion into a vein, or injection) and how the treatment affects the body. All volunteers (n=10) completed the dosing schedule without dropouts and volunteers will report for follow up assessments in February 2025. There were no adverse events of moderate or severe severity reported during the clinical phase of the trial and there were no clinically significant individual changes from baseline or notable trends in safety assessments including safety bloods, vital signs, eye examination, 12 lead ECGs and urine analysis. The topical administration of MET and OC134 eye drops on 56 consecutive occasions were well tolerated by healthy volunteers under the condition of the trial. Aankondiging • Feb 14
Virpax Pharmaceuticals, Inc. Confirms Positive Results with US Army with Probudur™? for Combat Care Study Virpax Pharmaceuticals, Inc. announced the completion of the full study that followed the initial Probudur™? pilot study performed by the U.S. Army Institute of Surgical Research (USAISR) under an existing Cooperative Research and Development Agreement (CRADA). The USAISR is the U.S. Department of Defense's premier research organization for developing solutions foruma and critical care challenges in combat casualty. This study was designed to determine if Probudur reduces pain behaviors in a rat model of incisional pain. The surgical procedures and assessments were identical to those in the pilot study. The study compared Probudur with free bupivacaine and EXPAREL®?. Various concentrations of Probudur were injected into the tissue around the incision site as well as a saline solution for the control group. Probudur is being developed to achieve the overall goal of safe and effective pain control during theoperative period and to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channels, preventing pain signals from reaching the brain. In preclinical studies, Probudur has shown long duration pain control for at least 96 hours, with a rat incisional model demonstrating analgesia for up to five days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six (6) days. Aankondiging • Jan 31
Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $5.999735 million. Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $5.999735 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,450,000
Price\Range: $0.2
Discount Per Security: $0.005
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 26,550,000
Price\Range: $0.19999
Discount Per Security: $0.005 Board Change • Jan 02
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. No experienced directors. No highly experienced directors. Independent Director Katie Field is the most experienced director on the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Jan 01
Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $6 million. Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering in the amount of $6 million.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Aankondiging • Dec 14
Virpax Pharmaceuticals, Inc. Announces Resignation of Gary Herman as Member of the Board of Directors and from All Committees On December 6, 2024, Virpax Pharmaceuticals, Inc. accepted the resignation of Mr. Gary Herman as a member of the Board of Directors (the “Board”) and from all committees on which he served, effective immediately. Mr. Herman’s resignation was not due to any disagreement with the Company, its management, the Board, or any matter relating to the Company’s operations, policies, or practices. Board Change • Dec 01
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. No experienced directors. No highly experienced directors. Independent Director Katie Field is the most experienced director on the board, commencing their role in 2024. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • Nov 24
Virpax Pharmaceuticals Receives Letter from Nasdaq Regarding Non-Compliance with Nasdaq’s Independent Director and Audit Committee Requirements under Listing Rules 5605(b)(1) and 5605(c)(2) On November 19, 2024, Virpax Pharmaceuticals, Inc. (the ‘Company’) received a letter from The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that, as a result of the resignation of Dr. Eric Floyd from the Company’s Board of Directors (the ‘Board’) and Audit Committee on September 20, 2024, the Company was no longer in compliance with Nasdaq’s independent director and Audit Committee requirements under Listing Rules 5605(b)(1) and 5605(c)(2). The letter from Nasdaq confirmed that, in accordance with Listing Rules 5605(b)(1)(A) and 5605(c)(4), the Company has been provided a cure period to regain compliance. The cure period allows the Company to remedy the deficiencies by the earlier of (i) its next annual shareholders’ meeting or (ii) September 20, 2025. If the next annual shareholders’ meeting is held before March 19, 2025, the Company must provide evidence of compliance no later than March 19, 2025. On November 19, 2024, the Company appointed Ms. Esha Randhawa as an independent director and member of the Audit Committee. With Ms. Randhawa’s appointment, the Company believes it has regained compliance with Nasdaq’s independent director and Audit Committee composition requirements. The Company will notify Nasdaq of its compliance with these requirements. Aankondiging • Nov 22
Virpax Announces Positive Results for the Swine Model Dose Range Finding Study for Probudur Virpax Pharmaceuticals, Inc. announced results from a minipig Dose Range Finding (“DRF”) study for Probudur. Probudur is the company’s long-acting liposomal bupivacaine formulation injected at a wound site to provide both immediate and extended pain relief. The DRF study was conducted to evaluate the tolerance of Probudur in an incisional wound healing model in minipigs. Probudur was injected locally into the tissue surrounding the incision area. All of the minipigs demonstrated positive tolerance to Probudur and no adverse effects were noted. The development program for Probudur continues to support the Company’s belief that Probudur has the potential to provide both immediate and sustained pain relief at the incisional area. Probudur is being developed to achieve the overall goal of safe and effective pain control during the perioperative period and significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channel, preventing pain signals from reaching the brain. In preclinical studies, Probudur has shown long duration pain control for at least 96 hours, with a rat incisional model demonstrating analgesia for up to five days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six days. Aankondiging • Nov 16
Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $5.041561 million. Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $5.041561 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 3,200,000
Price\Range: $0.5
Discount Per Security: $0.0125
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 6,883,260
Price\Range: $0.49999
Discount Per Security: $0.01249 Aankondiging • Oct 05
Virpax Pharmaceuticals, Inc. Receives A Delist Determination Letter from the Listing Qualifications Department of the Nasdaq Stock Market As previously disclosed, on April 2, 2024, the Listing Qualifications department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notified Virpax Pharmaceuticals, Inc. (the Company", we" and us") that we did not comply with the minimum $2,500,000 stockholders' equity requirement for continued listing set in Nasdaq Listing Rule 5550(b) (the Rule"). Nasdaq provided the Company until May 17, 2024 to submit to Nasdaq a plan to regain compliance. We submitted the plan to regain compliance in a timely manner, and on July 29, 2024, Nasdaq advised the Company that it had determined to grant the Company an extension to regain compliance with the Rule. The Company was unable to regain compliance with the Rule prior to the end of the plan period (September 30, 2024). As a result, on October 3, 2024, the Company received a delist determination letter from the Staff advising the Company that the Staff had determined that the Company did not meet the terms of the extension. As a result, unless the Company requests an appeal of the Staff's determination, trading of the Company's common stock will be suspended at the opening of business on October 14, 2024, and a Form 25-NSE will be filed with the Securities and Exchange Commission, which will remove the Company's common stock from listing and registration on Nasdaq. The Company intends to submit a hearing request to the Nasdaq Hearings Panel (the Panel"), which request is expected to stay any delisting action by the Staff at least until the hearing process concludes and any extension granted by the Panel expires. Notwithstanding the foregoing, there can be no assurance that the Panel will grant the Company's request or an additional extension period, or that the Company will ultimately regain compliance with all applicable requirements for continued listing on The Nasdaq Capital Market. Board Change • Oct 03
High number of new and inexperienced directors There are 4 new directors who have joined the board in the last 3 years. The company's board is composed of: 4 new directors. 1 experienced director. No highly experienced directors. CEO & Director Gerald Bruce is the most experienced director on the board, commencing their role in 2021. The company’s lack of experienced directors is considered a risk according to the Simply Wall St Risk Model. Aankondiging • Jul 31
Nasdaq Grants Extension Through September 30 to Virpax Pharmaceuticals to Regain Compliance with Nasdaq Listing Rule 5550(b)(1) On July 29, 2024, Virpax Pharmaceuticals, Inc. (the Company"), received notice from the Listing Qualifications Staff (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") that it was granted an extension through September 30, 2024 to regain compliance with Nasdaq Listing Rule 5550(b)(1). As previously reported, on April 2, 2024, the Company received a notice of noncompliance (the Notice") from the Staff stating that the Company was not in compliance with Nasdaq Listing Rule 5550(b)(1) because the stockholders' equity of the Company of $1,934,321 as of December 31, 2023, as reported in the Company's Annual Report on Form 10-K filed with the SEC on March 26, 2024, was below the minimum requirement of $2,500,000. Aankondiging • Jul 30
Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering. Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Aankondiging • Jul 24
Virpax Pharmaceuticals Regains Compliance with Nasdaq Minimum Bid Price Virpax Pharmaceuticals, Inc. announced that it has received formal notice from the Listing Qualifications staff of The Nasdaq Stock Market LLC indicating that Virpax has regained compliance with the minimum bid price requirement set in Nasdaq Listing Rule 5550(a)(2). To regain compliance with the Rule, the Company's common shares were required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, which was achieved on July 19, 2024. As a result, this listing matter has been closed. New Risk • Jul 20
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 8.7% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (42% average weekly change). Negative equity (-US$1.2m). Earnings are forecast to decline by an average of 8.7% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (134% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.51m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$18m net loss in 3 years). Board Change • Jul 10
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 5 non-independent directors. Independent Director Vanila Singh was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Aankondiging • Jul 08
Virpax Pharmaceuticals, Inc. Announces the Changes to Its Board of Directors Virpax Pharmaceuticals, Inc. announced the changes to its Board of Directors with the appointments of Ms. Judy Su, Mr. Gary Herman, Mr. Jatinder Dhaliwal and Ms. Katharyn Field. Resignations from Virpax’s Board were tendered effective upon consummation of the financing by Dr. Jeffrey Gudin, Dr. Thanigavelan Jambulingam, Mr. Michael Dubin, Mr. Jerrold Sendrow and Dr. Barbara Ruskin. Ms. Judy Su was lead pharmacist at a national drug store for six years and has knowledge and experience of large-scale retail distribution of scheduled drugs and medications. Currently, Ms. Su works as a pharmacist in the public sector. She has years of experience serving as an independent director for multiple publicly traded companies listed in Canada. Judy graduated in 2012 at the University of British Columbia with a bachelor's degree in pharmacy. Mr. Gary Herman is a seasoned investor. From 2006 until 2021, he co-managed Strategic Turnaround Equity Partners, LP (Cayman), and from 2005 until 2020 he was affiliated with Arcadia Securities LLC. Gary’s expertise extended to his role as a managing member of Abacoa Capital Management, LLC from January 2011 until August 2013, where his focus centered on the Global-Macro investment strategy. His background also includes tenure as an investment banker at Burnham Securities, Inc., a managing partner of Kingshill Group, Inc., and as a director for various public company boards. Mr. Herman received a B.S. in Political Science from the University at Albany, with minors in Business and Music. Mr. Jatinder (Jay) Dhaliwal is a registered pharmacist and has served as CEO and director of multiple publicly traded companies listed on Canadian and American (Nasdaq) exchanges. Mr. Dhaliwal is currently a director of a Nasdaq listed leading seed to patient cannabis producer in Europe as well as serving as an independent director of a Nasdaq listed premier marketing agency specialized in the liquor industry. Previously, he worked in an upper management role in a large national pharmacy and has extensive knowledge in agricultural, medical and pharmaceutical operations. Mr. Dhaliwal holds a Bachelor of Pharmacy from the University of British Columbia and a Bachelor of Science in biology from the University of Victoria. Ms. Katharyn (Katie) Field’s background includes positions spanning both the private and public sectors and brings a wealth of experience and expertise in strategy consulting and executive leadership. Ms. Field is currently the CEO and Chairman of Halo Collective Inc., an Executive Director at Akanda Corporation, and the Chairperson of Aerwins Technology. She has held prominent positions at renowned organizations including in the White House in the office of the public liaison, the Brookings Institution as a manager of operations, and Bain & Company as a consultant. In 2014, Ms. Field entered the cannabis industry working with one of the original vertically integrated licensed medical marijuana treatment centers in Florida. Subsequently, she operated a strategy consulting practice focused on cannabis and served as Executive Vice President of Corporate Development at MariMed from 2018 to 2019. Ms. Field holds an MBA from Columbia Business School and a BA with honors from Stanford University. Aankondiging • Jul 04
Virpax Pharmaceuticals Receives Written Notice from Nasdaq Due to Non-Compliance with the Minimum Bid Price Requirement On June 28, 2024, Virpax Pharmaceuticals, Inc. (the ‘Company’) received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that for the preceding 30 consecutive business days (May 15, 2024 through June 27, 2024), the Company’s common stock did not maintain a minimum closing bid price of $1.00 (‘Minimum Bid Price Requirement’) per share as required by Nasdaq Listing Rule 5550(a)(2). The notice has no immediate effect on the listing or trading of the Company’s common stock and the common stock will continue to trade on The Nasdaq Capital Market under the symbol ‘VRPX.’ In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days, or until December 26, 2024, to regain compliance with Nasdaq Listing Rule 5550(a)(2). Compliance may be achieved without further action if the closing bid price of the Company’s common stock is at or above $1.00 for a minimum of ten consecutive business days at any time during the 180-day compliance period, in which case Nasdaq will notify the Company if it determines it is in compliance and the matter will be closed; however Nasdaq may require the closing bid price to equal or to exceed the $1.00 minimum bid price requirement for more than 10 consecutive business days before determining that a company complies. If, however, the Company does not achieve compliance with the Minimum Bid Price Requirement by December 26, 2024, the Company may be eligible for additional time to comply. In order to be eligible for such additional time, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Price Requirement, and must notify Nasdaq in writing of its intention to cure the deficiency during the second compliance period. The Company intends to actively monitor the bid price of its common stock and will consider available options to regain compliance with the Nasdaq listing requirements, including such actions as effecting a reverse stock split to maintain its Nasdaq listing. New Risk • Jun 27
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 134% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (25% average weekly change). Negative equity (-US$1.2m). Shareholders have been substantially diluted in the past year (134% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.36m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$9.4m net loss in 3 years). Aankondiging • Jun 15
Virpax Pharmaceuticals, Inc., Annual General Meeting, Jul 29, 2024 Virpax Pharmaceuticals, Inc., Annual General Meeting, Jul 29, 2024. Location: 1271 avenue of the americas, 16th floor ,new york , new york 10020, new york United States Aankondiging • May 18
Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $2.25 million. Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $2.25 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 937,034
Price\Range: $1.35
Discount Per Security: $0.08775
Security Name: Series A-1 Common Warrants
Security Type: Equity Warrant
Securities Offered: 1,666,667
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 729,633
Price\Range: $1.34999
Discount Per Security: $0.08775
Security Name: Series A-2 Common Warrants
Security Type: Equity Warrant
Securities Offered: 1,666,667 Aankondiging • Apr 30
Virpax Pharmaceuticals, Inc. Announces Results of Maximum Tolerated Dose Study for Probudur Virpax Pharmaceuticals, Inc. announced results for a Maximum Tolerated Dose (MTD) study in Sprague-Dawley Rats for Probudur. Probudur is Virpax’s injectable long-acting liposomal bupivacaine formulation that is injected at the wound site. Probudur is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications. Probudur is a local anesthetic that binds to the sodium channel, preventing pain signals from reaching the brain. In pre-clinical trials, Probudur has shown long duration pain control for at least 96 hours, with a rat incisional model demonstrating analgesia for up to five days and in vitro studies demonstrating a slow release of bupivacaine that lasted for up to six days. The study was designed to determine the MTD of free bupivacaine, Probudur, and Probudur plus free bupivacaine when administered as a single subcutaneous injection to the wound. Probudur, with its liposomal formulation, is intended to provide both immediate and extended pain relief at the wound site. The dosing ranges were selected based on a prior preliminary study. All doses of Probudur were well-tolerated. There were no noteworthy effects on body weight, clinical chemistry, hematology, or coagulation. It was also observed that bupivacaine appears to be less toxic in the presence of liposomes than when administrated as a free drug. Histopathology was conducted on the injection site and all treatment groups showed some changes which were minimal to moderate in severity. Effects were slightly more pronounced at the high dose of Probudur. In vivo MTD studies in rats indicated that Probudur provided a better therapeutic window as compared to free bupivacaine. Aankondiging • Apr 19
Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering. Virpax Pharmaceuticals, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Common Warrants
Security Type: Equity Warrant
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Aankondiging • Apr 04
Virpax Pharmaceuticals Receives Non-Compliance Letter from Nasdaq Related to Listing Rule 5550(b)(1) On April 2, 2024, Virpax Pharmaceuticals, Inc. (the ‘Company’) received a letter (the ‘Notification Letter’) from The Nasdaq Stock Market (‘Nasdaq’) stating that the Company was not in compliance with Nasdaq Listing Rule 5550(b)(1) (the ‘Rule’) because the stockholders’ equity of the Company of $1,934,321 as of December 31, 2023, as reported in the Company’s Annual Report on Form 10-K filed with the SEC on March 26, 2024, was below the minimum requirement of $2,500,000. As of the date of this Current Report on Form 8-K, the Company does not have a market value of listed securities of $35 million, or net income from continued operations of $500,000 in the most recently completed fiscal year or in two of the last three most recently completed fiscal years, the alternative quantitative standards for continued listing on the Nasdaq Capital Market. The notification received has no immediate effect on the Company's continued listing on the Nasdaq Capital Market, subject to the Company's compliance with the other continued listing requirements. Pursuant to Nasdaq’s Listing Rules, the Company has 45 calendar days (until May 17, 2024), to submit a plan to evidence compliance with the Rule (a ‘Compliance Plan’). The Company intends to submit a Compliance Plan within the required time, although there can be no assurance that the Compliance Plan will be accepted by Nasdaq. If the Compliance Plan is accepted by Nasdaq, the Company will be granted an extension of up to 180 calendar days from April 2, 2024 to evidence compliance with the Rule. In the event the Compliance Plan is not accepted by Nasdaq, or in the event the Compliance Plan is accepted but the Company fails to evidence compliance within the extension period, the Company will have the right to a hearing before Nasdaq’s Hearing Panel. The hearing request would stay any suspension or delisting action pending the conclusion of the hearing process and the expiration of any additional extension period granted by the panel following the hearing. The Company intends to submit the Compliance Plan on or before May 17, 2024, monitor its stockholders’ equity and, if appropriate, consider further available options to evidence compliance with the Stockholders’ Equity Requirement. New Risk • Mar 27
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$9.9m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$9.9m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$4.46m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$26m net loss in 3 years). Aankondiging • Mar 18
Virpax Pharmaceuticals Regains Compliance with Listing Rule 5550(a)(2) On March 15, 2024, Virpax Pharmaceuticals, Inc. (the ‘Company’), received a letter (the ‘Notification Letter’) from The Nasdaq Stock Market (‘Nasdaq’) stating that for the last 10 consecutive business days, from March 1, through 14, 2024, the closing bid price of the Company’s common stock has been at $1.00 per share or greater. Accordingly, the Company has regained compliance with Listing Rule 5550(a)(2) and this matter is now closed. Price Target Changed • Feb 22
Price target decreased by 50% to US$2.00 Down from US$4.00, the current price target is provided by 1 analyst. New target price is 567% above last closing price of US$0.30. Stock is down 71% over the past year. The company is forecast to post a net loss per share of US$1.20 next year compared to a net loss per share of US$1.85 last year. Price Target Changed • Feb 15
Price target decreased by 50% to US$2.00 Down from US$4.00, the current price target is provided by 1 analyst. New target price is 418% above last closing price of US$0.39. Stock is down 66% over the past year. The company is forecast to post a net loss per share of US$1.20 next year compared to a net loss per share of US$1.85 last year. Aankondiging • Nov 19
Virpax Pharmaceuticals, Inc. Announces CEO Changes Virpax Pharmaceuticals' CEO Anthony P. Mack has resigned, effective immediately, due to ongoing litigation. The board has appointed Gerald Bruce as the Berwyn company's CEO. Mack resigned as president of Scilex in March 2018. He founded Virpax in early 2017. Bruce has served as executive vice president of commercial operations at Virpax since August 2017 and as a member of the company's board since July 2021. He is also president and CEO of Novvae Pharmaceuticals, the company's wholly owned subsidiary focused on over-the-counter products formed during the summer. Bruce began his career at Johnson & Johnson and also worked at Bristol Myers Squibb, Nitromed and Danone Specialized Nutrition North America. Aankondiging • Nov 18
Virpax Pharmaceuticals Announces Leadership Transition Virpax Pharmaceuticals, Inc. announced that due to ongoing litigation it has accepted the resignation of Anthony P. Mack as CEO and Chairman effective immediately. The Board has appointed Gerald Bruce as CEO and Dr. Eric Floyd as Chairman. Mr. Bruce has served as the Company’s Executive Vice President of Commercial Operations since August 2017, as a member of the Company’s Board since July 2021 and as the President and CEO of the Company’s wholly owned subsidiary, Novvae Pharmaceuticals, Inc. since July 26, 2023. Prior to Virpax, Mr. Bruce served as Vice President of sales for Danone Specialized Nutrition North America, Danone’s medical nutrition division. Prior to this position, he has held roles of increasing responsibility at Nitromed, Inc. and Bristol-Meyers Squibb. Mr. Bruce began his career at Johnson and Johnson and moved up the ranks to become a Group Marketing Director in Analgesics. He has a BA from Lincoln University and a Master’s degree in Leadership from Georgetown University’s McDonough School of Business. Dr. Floyd is Senior Vice President of Regulatory Affairs and Quality Assurance at Silence Therapeutics. He has over 25 years of pharmaceutical and biotechnology experience in Regulatory Affairs roles of increasing responsibility at Merck, Aventis, Novartis, Lundbeck, Axovant Sciences, and Neurogene, Inc. Most recently, he served as founder and Chief Regulatory Officer at Neurogene, Inc. Neurogene is focused on developing life-changing genetic medicines for patients and their families affected by rare, devastating neurological diseases. Dr. Floyd previously served as the Global Head of Regulatory Affairs at Axovant Sciences and the U.S. Head of Regulatory Affairs at Lundbeck, where he was responsible for strategic regulatory and clinical development activities related to the company’s approvals of Sabril, Onfi, Northera (orphan approvals) as well as Anti-Depression and Schizophrenia drug approvals. Dr. Floyd serves as an adjunct faculty member in the Department of Neuroscience at Harvard Medical School and Wake Forest University School of Medicine. Aside from Virpax Pharmaceuticals, he also serves on the board of Advent Therapeutics Inc. and is a member of the Board of Trustees of Meharry Medical College. Dr. Floyd completed his undergraduate degree in Biology from the University of Illinois, a Master’s degree in Neuroscience from Tennessee State University, a Doctorate in Neurophysiology from Meharry Medical College, an Executive MBA in Pharmaceutical Marketing from Saint Josephs’ University and completed the Global Executive MBA in International Business from the INSEAD Business School in Fontainebleau, France. Aankondiging • Nov 17
Virpax Pharmaceuticals, Inc. announced delayed 10-Q filing On 11/15/2023, Virpax Pharmaceuticals, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Aankondiging • Nov 01
Virpax Pharmaceuticals Announces Envelta Remains on Track for Trial in Humans Following FDA Review Virpax®?Pharmaceuticals, Inc. announced that it expects to submit an Investigational New Drug Application (IND) for Envelta in mid-2024 following review of comments made by the US Food and Drug Administration on the Company's Pre-IND submission. If successful, that would allow clinical trials to begin by the middle of 2024. in. Envelta (MET-LENK) is the Company’s non-addictive pain product candidate for acute and chronic pain that is being funded under an in-kind grant from the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health (NIH). Envelta utilizes a novel and patented intranasal drug delivery system, Molecular Envelope Technology (MET) to bypass the blood-brain barrier. The MET was developed by Nanomerics Ltd., a UK-based nanotechnology research and development company that has licensed its MET-LENK to Virpax. The nose-to-brain MET platform protects molecules from biodegrading and enhances the bioavailability of product candidates on its transport to the brain. The initial Envelta dose ranging studies in rats and dogs have been completed. The 14-day rat dose range finding study (DRF) showed no treatment related clinical signs or mortality. In addition, there were no related findings in hematology, coagulation, and serum chemistry data. The 14-day DRF study in dogs also showed no treatment related mortality or findings in body temperature, body weight, food consumption, and ophthalmic exam. From an efficacy perspective, a dose-response with intranasal MET-LENK was noted in a Complete Freund’s Adjuvant (CFA) anti-hyperalgesia model versus an intranasal placebo and subcutaneous morphine. Administration of the high dose MET-LENK (30 mg/kg) significantly decreased hypersensitivity in treated animals compared to CFA control. Aankondiging • Oct 12
Nasdaq Grants Virpax Pharmaceuticals’ Request for 180-Day Extension to Regain Compliance with the Minimum Bid Price Requirement As previously reported, on April 10, 2023, Virpax Pharmaceuticals, Inc. (the ‘Company’) received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (‘Nasdaq’) notifying the Company that for the preceding 30 consecutive business days the Company’s common stock did not maintain a minimum closing bid price of $1.00 (‘Minimum Bid Price Requirement’) per share as required by Nasdaq Listing Rule 5550(a)(2). The Company was provided 180 calendar days, or until October 9, 2023, to regain compliance. The Company did not regain compliance with the Minimum Bid Price Requirement by October 9, 2023; however, on October 10, 2023, the Company received written notification from Nasdaq granting the Company’s request for a 180-day extension to regain compliance with Nasdaq Listing Rule 5550(a)(2). Compliance may be achieved if at any time prior to April 8, 2024 the closing bid price of the Company’s common stock is at least $1.00 for a minimum of ten consecutive business days, Nasdaq will notify the Company that it has regained compliance with the Minimum Bid Price Requirement and the matter will be closed; however, Nasdaq has discretion to require the Company to maintain a bid price of $1.00 for a period in excess of ten consecutive business days. If the Company does not regain compliance with the Minimum Bid Price Requirement by April 8, 2024, Nasdaq will provide written notification to the Company that its common stock will be delisted. At that time, the Company may appeal the relevant delisting determination to a hearings panel pursuant to the procedures set forth in the applicable Nasdaq Listing Rules. However, there can be no assurance that, if the Company does appeal the delisting determination by Nasdaq to the hearings panel, that such appeal would be successful. The Company intends to actively monitor the bid price of its common stock and is considering available options to regain compliance with the Nasdaq listing requirements, including such actions as effecting a reverse stock split to maintain its Nasdaq listing. Nasdaq’s extension notice has no immediate effect on the listing or trading of the Company’s common stock, which will continue to trade on the Nasdaq Capital Market under the symbol ‘VRPX’. Aankondiging • Oct 05
Novvae Pharmaceuticals Announces Executive Appointments Virpax®Pharmaceuticals, Inc. announced that Gerald W. Bruce has been appointed as President and CEO of Novvae™ Pharmaceuticals, Virpax’s wholly-owned subsidiary focused solely on advancing the Company’s OTC pipeline. Mr. Bruce has spent over 30 years in the pharmaceutical and medical nutrition industries. Most recently, he served as a Vice President of sales for Danone Specialized Nutrition North America, Danone’s medical nutrition division. Prior to this position, he has held roles of increasing responsibility at Nitromed, Inc. and Bristol-Meyers Squibb. Mr. Bruce began his career at Johnson and Johnson and spent 13 years there starting as a sales representative and moving up the ranks to become a Group Marketing Director in Analgesics. He has a BA from Lincoln University and an Executive Master’s Degree in Leadership from Georgetown University’s McDonough School of Business. Aankondiging • Sep 19
Virpax Pharmaceuticals, Inc Announces the Formation of Novvae™ Pharmaceuticals Virpax Pharmaceuticals, Inc. announced that it has formed a new wholly-owned subsidiary, Novvae™ Pharmaceuticals, Inc. (Novvae), which has been established to focus exclusively on advancing Virpax’s OTC pipeline. AnQlar™ will be the first asset added to the Novvae pipeline. AnQlar is being developed as a prophylactic once-a-day antiviral nasal spray. AnQlar utilizes a pre-filled intranasal device that is formulated using a chitosan derivative in a nanoparticle dispersion. Chitosan is a natural anti-microbial. In several preclinical studies, AnQlar demonstrated 24-hour anti-viral barrier activity against both Influenza and Covid. AnQlar has completed IND-enabling studies and Novvae will assume responsibility for future development leading to its first in human trials. Additionally, Virpax is in advanced discussions for global rights of first refusal on two differentiated non-prescription assets. Should the Company acquire these product candidates, they would be added to the Novvae pipeline. Aankondiging • Sep 07
Virpax Pharmaceuticals, Inc. Announces Update on Litigation Virpax Pharmaceuticals, Inc. announced that it has received a ruling on the lawsuit filed by Scilex Pharmaceuticals and Sorrento Therapeutics, the now bankrupt majority owner of Scilex Pharmaceuticals. The Court found in favor of the plaintiffs (on all but three counts deemed to have been waived). However, no damages judgment was specified in the ruling which called for additional proceedings to determine the remedy. Aankondiging • Aug 11
Virpax Pharmaceuticals, Inc. Files Provisional Patent Application for NSAID Formulation and Method Virpax Pharmaceuticals, Inc. announced that it has filed a new provisional patent application with the United States Patent and Trademark Office entitled "NSAID Formulation and Method" related to its Epoladerm™? product candidate. Epoladerm is an over-the counter (OTC) diclofenac topical spray film that Virpax is developing for pain associated with Osteoarthritis. Epoladerm is designed to be less messy than gels or creams which are applied by hand and which may contaminate public water supplies with the active pharmaceutical ingredients the gels or creams carry. New Risk • Jul 26
New major risk - Market cap size The company's market capitalization is less than US$10m. Market cap: US$9.84m This is considered a major risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Revenue is less than US$1m. Market cap is less than US$10m (US$9.84m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). New Risk • Jun 18
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 10% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$14m free cash flow). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Share price has been volatile over the past 3 months (10% average weekly change). Market cap is less than US$100m (US$12.7m market cap). Aankondiging • Jun 09
Virpax Pharmaceuticals, Inc., Annual General Meeting, Jul 24, 2023 Virpax Pharmaceuticals, Inc., Annual General Meeting, Jul 24, 2023, at 10:30 US Eastern Standard Time. Location: Nasdaq Marketsite, 151 West 43rd Street, 10th Flr, Edison Board Room, New York, NY 10017 New York United States Agenda: To consider the elect the three director nominees named herein to serve as ClassII directors for a three-year term expiring at the annual meeting of stockholders in 2026; to ratify the appointment of EisnerAmper LLP as the Companys independent registered public accounting firm for the year ending December31, 2023; to consider and vote upon any other matters that may properly come before the Annual Meeting or any adjournments or postponements thereof; and to consider other matters if any. Aankondiging • Jun 08
Virpax Pharmaceuticals, Inc. Appoints Barbara Ruskin as Class I Director On June 5, 2023, the board of directors of Virpax Pharmaceuticals, Inc. approved the appointment of Barbara Ruskin, PhD, J.D., as a Class I director, with such appointment to be effective immediately after Dr. Ruskin’s resignation as a Class III director. In connection therewith, Dr. Ruskin resigned as a Class III director on June 5, 2023, and effective immediately thereafter was appointed by the Board as a Class I director. The Company’s Class I directors continue in office until the 2025 annual meeting of stockholders. As a Class I director, Dr. Ruskin’s term as a director will continue until the 2025 annual meeting of stockholders and until her successor is duly elected and qualified, or until her earlier death, resignation or removal. As a Class III director, Dr. Ruskin’s term as a director would have otherwise continued until the 2024 annual meeting of stockholders. No other changes were made to the alignment of the classes of the Board. Aankondiging • Feb 14
Virpax Pharmaceuticals, Inc. Announces Positive Preclinical Toxicology Results in Support of Molecular Envelope Technology Virpax Pharmaceuticals, Inc. has completed FDA required preclinical toxicology studies for its licensed Molecular Envelope Technology (MET). MET enhances the delivery of Virpax’s non-addictive pain product and its epilepsy product candidate. MET is also utilized in the Company’s viral barrier product candidate. These preclinical toxicology studies were performed to evaluate the safety of the MET platform and to support the IND submission of each product candidate. The Molecular Envelope Technology was developed by Nanomerics Ltd. Nanomerics has licensed its technology to Virpax, which is utilizing the nose-to-brain MET platform to enhance drug delivery for certain of its product candidates. Aankondiging • Dec 30
Virpax Pharmaceuticals Receives A Written Notice from Nasdaq Regarding Bid Price Requirement On December 22, 2022, Virpax Pharmaceuticals, Inc. ("the Company") received a written notice (the Notice") from the Listing Qualifications Department of The Nasdaq Stock Market ("Nasdaq") indicating that the Company is not in compliance with the $1.00 Minimum Bid Price requirement set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Capital Market (the Bid Price Requirement"). The Notice does not result in the immediate delisting of the Company's common stock from The Nasdaq Capital Market. The Nasdaq Listing Rules require listed securities to maintain a minimum bid price of $1.00 per share and, based upon the closing bid price of the Company's common stock for the last 30 consecutive business days, the Company no longer meets this requirement. The Notice indicated that the Company will be provided 180 calendar days in which to regain compliance, or until June 20, 2023. If at any time during this period the bid price of the Company's common stock closes at or above $1.00 per share for a minimum of ten consecutive business days, the Nasdaq staff (the Staff") will provide the Company with a written confirmation of compliance and the matter will be closed. Alternatively, if the Company fails to regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, the Company may be eligible for an additional 180 calendar day compliance period, provided (i) it meets the continued listing requirement for market value of publicly held shares and all other applicable requirements for initial listing on The Nasdaq Capital Market (except for the Bid Price Requirement) and (ii) it provides written notice to Nasdaq of its intention to cure this deficiency during the second compliance period by effecting a reverse stock split, if necessary. In the event the Company does not regain compliance with Rule 5550(a)(2) prior to the expiration of the initial 180 calendar day period, and if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is not otherwise eligible, the Staff will provide the Company with written notification that its securities are subject to delisting from The Nasdaq Capital Market. At that time, the Company may appeal the delisting determination to a hearings panel. The Company intends to monitor the closing bid price of its common stock and is considering its options to regain compliance with the Bid Price Requirement. The Company's receipt of the Notice does not affect the Company's business, operations or reporting requirements with the Securities and Exchange Commission. Aankondiging • Dec 15
Virpax Pharmaceuticals, Inc. Reports on FDA Pre-IND Response for NobrXiol™ (Formerly Vrp324) Virpax®Pharmaceuticals, Inc. announced that it has received pre-Investigational New Drug (PIND) application guidance from the U.S. Food and Drug Administration (FDA) for NobrXiol™, the Company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults. NobrXiol utilizes the 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. The main purpose of a pre-IND 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 the IND. Aankondiging • Jul 06
Virpax Pharmaceuticals, Inc. Pursues OTC Medical Device Pathway for AnQlar Virpax Pharmaceuticals, Inc. announced it will pursue an OTC Intranasal Medical Device Consumer regulatory pathway for AnQlar, the Company’s product candidate being developed as a prophylactic antiviral barrier against influenza and SARS-CoV-2. To support the OTC Medical Device application, Virpax plans to submit AnQlar’s completed in-vitro study, ex-vivo study using human mucosal cells, in-vivo study in rats, toxicology study and its pharmacokinetics (PK) characteristics studies to the FDA. Additionally, the Company will include AnQlar’s completed safety-pharmacology studies, drug-drug interaction studies and its virology studies evaluating AnQlar’s antiviral properties against two variants of SARS-CoV-2 in a SARS-CoV-2 mouse model to the FDA. For the OTC medical device application, Virpax anticipates that it will have to complete stability testing, human factors testing for medical devices, safety studies and supplementary in-vitro studies. Aankondiging • Jun 28
Virpax Pharmaceuticals, Inc Will Pursue Direct to OTC Pathway for Epoladerm™ for Pain Associated with Osteoarthritis Virpax Pharmaceuticals, Inc. announced that it will pursue a direct to OTC regulatory pathway for Epoladerm™, the Company’s product candidate to treat pain associated with osteoarthritis. The direct to OTC, non-prescription regulatory pathway is expected to provide a faster drug development timeline and faster global approval track than the prescription pathway the Company had originally pursued for Epoladerm. To support the OTC application, the Company plans to submit Epoladerm’s completed dermal toxicity, sensitization, irritation, phototoxicity studies and its PK characteristics to FDA. In addition, Virpax anticipates it will have to complete a consumer preference assessment and a pivotal study required by the FDA’s Office of Non-prescription Drugs. Aankondiging • Jun 16
Virpax Pharmaceuticals, Inc., Annual General Meeting, Jul 25, 2022 Virpax Pharmaceuticals, Inc., Annual General Meeting, Jul 25, 2022, at 11:00 US Eastern Standard Time. Location: Lowenstein Sandler LLP at 1251 Avenue of the Americas 17th Floor, NewYork, NY 10020 New York United States Agenda: To elect two director nominees to serve as Class I directors for a three-year term expiring at the annual meeting of stockholders in 2025; to approve the 2022 Virpax Equity Incentive Plan; to ratify the appointment of EisnerAmper LLP as the Company’s independent registered public accounting firm for the year ending December 31, 2022; and to consider and vote upon any other matters that may properly come before the Annual Meeting or any adjournments or postponements thereof. Recent Insider Transactions • May 22
Chairman & CEO recently bought US$102k worth of stock On the 18th of May, Anthony Mack bought around 76k shares on-market at roughly US$1.34 per share. This was the largest purchase by an insider in the last 3 months. Anthony has been a buyer over the last 12 months, purchasing a net total of US$202k worth in shares. Aankondiging • Apr 27
Virpax Pharmaceuticals, Inc. Completes Initial Preclinical Studies for VRP324 Virpax Pharmaceuticals, Inc. reported preclinical pharmacokinetics (PK) results for VRP324 (MET-CBD), a nose-to-brain delivery platform for CBD for the management of seizures in children and adults. In this preclinical PK study, VRP324 was able to deliver cannabidiol (CBD) to the brain after nasal administration in a rodent model. Nasal delivery of VRP324 provided high concentrations of CBD in the brain and the preclinical studies confirm that there were higher levels of CBD in the brain versus the plasma. Virpax believes that VRP324 may achieve higher efficiency via the nasal route compared to the oral CBD product on the market since peripheral exposure via plasma may be reduced by the nose-to-brain delivery. Evidence suggests that compared to the commercialized oral-dosed CBD, the nose-to-brain CBD formulation may have negligible liver first-pass metabolism, thereby avoiding drug to drug interactions and potentially producing fewer side effects. By avoiding the first pass effect, intranasal VRP324 may also eliminate enzymatic degradation. VRP324 uses a preassembled device and cartridge to propel the MET-CBD powder formulation into the nose via the olfactory nerve/bulb. This product candidate has been 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 central nervous system diseases considered serious epileptic encephalopathies that cause different types of epileptic seizures, and cognitive and behavioral changes. These syndromes have historically been resistant to treatment. Aankondiging • Feb 11
Virpax Pharmaceuticals, Inc. Reports Favorable Preclinical Safety Data for Envelta™ for the Treatment of Acute and Chronic Pain Virpax Pharmaceuticals, Inc. reported promising results from preclinical dose range finding studies for Envelta (NES100), Virpax’s endogenous enkephalin intranasal spray for acute and chronic pain, including pain associated with cancer. These findings complement previous positive preclinical toxicology results and support the Company’s continuing development of this potential non-addictive treatment for acute and chronic pain. Investigational New Drug (IND) enabling studies for Envelta are being performed under a Cooperative Research and Development Agreement (CRADA) with the National Institutes of Health’s (NIH) National Center for Advancing Translational Sciences (NCATS) entered into by Virpax and the NIH in August of 2020. Under the cooperation agreement, the studies are performed and funded by the NIH. Pursuant to the CRADA, NCATS conducted a 14-day intranasal dose range finding toxicity study of Envelta in rats with a 14-day recovery period. This study showed no adverse related findings in hematology, coagulation and serum chemistry data, with no treatment related toxicology findings or mortality noted. A 14-day intranasal dose range finding toxicity study of Envelta in dogs with a 14-day recovery period was also conducted and showed no adverse toxicologic findings. Envelta is an investigational intranasal formulation intended to improve enkephalin transport to the brain. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. Envelta uses a preassembled device and cartridge to propel the enkephalin formulation through the nose to the brain by flowing along the olfactory nerve pathway. The Molecular Envelope Technology is designed to protect the drug and help carry it to the brain, enabling it to cross the blood-brain barrier to suppress pain by binding to the delta-opioid receptors. Envelta™ has demonstrated analgesic potential in animal models without developing opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with the use of morphine. Once the Envelta IND-enabling studies are submitted to the FDA, the data could potentially be cross-referenced to cancer pain and PTSD INDs. Aankondiging • Jan 19
Virpax Pharmaceuticals, Inc. Successfully Completes Preclinical Dermal Safety Studies for Epoladerm Virpax Pharmaceuticals, Inc. reported positive results of four preclinical dermal safety studies for Epoladerm. 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. 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. Aankondiging • Dec 21
Virpax Pharmaceuticals, Inc. Announces Clinical Trial Site in Canada for First in Human Study of Epoladerm for Pain Associated with Osteoarthritis of Knee Virpax Pharmaceuticals, Inc. 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 second quarter of 2022. Aankondiging • Dec 09
Virpax Pharmaceuticals, Inc. Reports Successful Results of Toxicology and Pharmacokinetic Study for Epoladerm™ Virpax®Pharmaceuticals, Inc. reported positive results following the completion of a toxicology and pharmacokinetic study designed to support clinical trials with Epoladerm™, one of its lead investigational product candidates for the management of pain associated with osteoarthritis of the knee. Charles River Laboratories, a renowned CRO engaged by Virpax to perform Food and Drug Administration (FDA) required pre-clinical studies, has completed a single dose 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 and no treatment-related clinical observations, changes in body weight, or dermal irritation were observed. All Epoladerm treated animals had plasma levels of Epoladerm confirming transdermal absorption. The maximum plasma concentration (Cmax) was reached at 4 hours post-dose, and plasma Epoladerm remained at 24-hour post-dose for all animals. This data should strengthen the Company’s IND filing in advance of the anticipated start of first-in-human clinical trials. Recent Insider Transactions • Nov 27
Chairman & CEO recently bought US$100k worth of stock On the 18th of November, Anthony Mack bought around 25k shares on-market at roughly US$3.99 per share. This was the largest purchase by an insider in the last 3 months. This was Anthony's only on-market trade for the last 12 months. Aankondiging • Sep 21
Virpax Pharmaceuticals, Inc. (NasdaqCM:VRPX) acquired Exclusive worldwide rights of Nanomerics Ltd. Virpax Pharmaceuticals, Inc. (NasdaqCM:VRPX) has signed an agreement to acquire Exclusive worldwide rights of Nanomerics Ltd on September 20, 2021.
Virpax Pharmaceuticals, Inc. (NasdaqCM:VRPX) completed the acquisition of Exclusive worldwide rights of Nanomerics Ltd on September 20, 2021. Aankondiging • Sep 15
Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $40.02 million. Virpax Pharmaceuticals, Inc. has completed a Follow-on Equity Offering in the amount of $40.02 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,670,000
Price\Range: $6 Aankondiging • Jun 22
Virpax Pharmaceuticals, Inc Announces That the Investigational New Drug Application Enabling Studies for Envelta Virpax®Pharmaceuticals, Inc. announced that the Investigational New Drug (IND) Application enabling studies for Envelta™ being performed under a Cooperative Research and Development Agreement (CRADA) entered into by Virpax and the National Center for Advancing Translational Sciences (NCATS) for chronic pain, will also be used as a source for INDs for two additional indications, for cancer pain and Post-Traumatic Stress Disorder (PTSD). NCATS has commenced the IND enabling studies of Envelta to support Virpax’s future application for clearance from the Food and Drug Administration (FDA) to initiate Virpax’s first-in-human clinical trials. Aankondiging • Feb 24
Virpax(R) Pharmaceuticals Inc., Virpax Begins Ind Enabling Studies of Envelta(Tm) Virpax Pharmaceuticals, Inc. announced that according to the Cooperative Research and Development Agreement ("CRADA") entered into between Virpax and the National Center for Advancing Translational Sciences ("NCATS"), an institute/center of the National Institutes of Health ("NIH"), U.S. Department of Health and Human Services, the NCATS has begun the Investigational New Drug ("IND") enabling studies of Envelta(TM) for Virpax to support Virpax's future application for clearance from the FDA to initiate its first-in-human ("FIH") clinical trials. Aankondiging • Feb 18
Virpax Pharmaceuticals, Inc. has completed an IPO in the amount of $18 million. Virpax Pharmaceuticals, Inc. has completed an IPO in the amount of $18 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,800,000
Price\Range: $10
Discount Per Security: $0.75