UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 3.01 Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing.
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.
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.
On November 19, 2024, the Company entered into an Independent Contractor Agreement (the “Agreement”) with Jatinder Dhaliwal, the Company’s Chief Executive Officer (the “CEO”) and a member of the Board, through his personal corporation, Jat Consulting Corp., a company incorporated under the laws of the Province of British Columbia, Canada.
Mr. Dhaliwal was appointed as the Company’s CEO on October 6, 2024. Under the Agreement, Mr. Dhaliwal will provide strategic leadership, oversight, and advisory services, including advancing the Company’s drug development programs and regulatory applications, achieving key regulatory milestones, and performing other responsibilities consistent with his position as CEO.
Mr. Dhaliwal brings extensive leadership experience in the pharmaceutical and biotechnology industries. His expertise positions him to lead the Company in achieving its strategic objectives.
There are no family relationships between Mr. Dhaliwal and any director, executive officer, or other significant person at the Company. Additionally, Mr. Dhaliwal has not been involved in any legal proceedings required to be disclosed under Item 401(e) of Regulation S-K in the past ten years.
Under the terms of the Agreement, the Company will pay Jat Consulting Corp. an annual fee of $200,000, payable in equal monthly installments, and milestone-based incentive payments tied to the achievement of key regulatory and clinical development objectives, including Investigational New Drug (IND) status, commencement of clinical trials, and FDA approval. The Agreement also includes confidentiality obligations that survive termination and provides for a severance payment equivalent to $200,000 in the event of termination without cause or resignation for good reason. A copy of the Agreement is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
As noted in Item 3.01, on November 19, 2024, the Board appointed Ms. Esha Randhawa to serve as an independent director of the Company, effective immediately. Ms. Randhawa will serve as a member of (1) the Audit Committee, alongside Mr. Gary Herman and Ms. Judy Su, (2) the Compensation Committee, where she will serve as Chair alongside Mr. Herman and Ms. Su, (3) the Nominating and Corporate Governance Committee, where she will also serve as Chair alongside Mr. Herman and Ms. Su, and (4) the Science and Technology Committee, where she will serve alongside Mr. Dhaliwal, Ms. Su, and Ms. Katharyn Field.
Ms. Randhawa is an experienced pharmacist and entrepreneur with a strong background in pharmaceutical sciences. She holds a Bachelor of Pharmacy (B.Pharm.Sci.) degree, with a focus in Pharmaceutical Sciences, and a Bachelor of Science in Biology, both completed at The University of British Columbia (UBC) in Vancouver. Ms. Randhawa is the Co-Founder of Green Light Cannabis, where she applies her extensive knowledge of the healthcare and retail industries to develop innovative solutions and strategic initiatives. Her expertise in pharmaceutical sciences and business operations brings a unique perspective to the Board and supports the Company’s commitment to advancing its mission.
In connection with her service on the Board, Ms. Randhawa will receive compensation as a non-employee director as determined by the Board. There are no arrangements or understandings between Ms. Randhawa and any other person pursuant to which she was appointed as a director. Additionally, there are no transactions involving Ms. Randhawa that are reportable under Item 404(a) of Regulation S-K.
Item 8.01 Other Events
On November 21, 2024, the Company issued a press release entitled, “Virpax Announces Agreement with the U.S. Department of Health and Human Services for the Developmental Extension for NES100 Towards IND for Acute and Chronic Non-Cancer Pain Alternative”. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
On November 22, 2024, the Company issued a press release entitled, “Virpax Announces Positive Results for the Swine Model Dose Range Finding Study for Probudur™”. A copy of the press release is attached hereto as Exhibit 99.2 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 10.1 | Form of Independent Contractor Agreement, dated November 19, 2024, by and between Virpax Pharmaceuticals, Inc. and Jat Consulting Corp., the personal corporation of Mr. Jatinder Dhaliwal. | |
| 99.1 | Press Release dated November 21, 2024 | |
| 99.2 | Press Release dated November 22, 2024 | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). |
Signature
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| VIRPAX PHARMACEUTICALS, INC. | ||
| Dated: November 22, 2024 | By: | /s/ Jatinder Dhaliwal |
| Jatinder Dhaliwal | ||
| Chief Executive Officer | ||
EXHIBIT 10.1
INDEPENDENT CONTRACTOR AGREEMENT
This Independent Contractor Agreement (the “Agreement”) is made and entered into as of this November 19, 2024, by and between Virpax Pharmaceuticals, Inc., a Delaware corporation, and Jatinder Dhaliwal (the “Contractor”), through his personal corporation, Jat Consulting Corp., a company incorporated under the laws of the Province of British Columbia, Canada.
1. Engagement and Scope of Services
1.1 The Company hereby retains Contractor as an independent contractor to provide strategic leadership, oversight, and advisory services as Chief Executive Officer (the “CEO”) of the Company.
1.2 Contractor’s services shall include, but are not limited to:
| · | Providing strategic advice and guidance to the Company’s executive team and Board of Directors. |
| · | Overseeing and advancing Company initiatives, including drug development, regulatory applications, and operations. |
| · | Leading efforts to achieve Investigational New Drug (“IND”) status and other regulatory milestones. |
| · | Performing other services as requested by the Board of Directors, which are consistent with the role of CEO. |
2. Term
This Agreement shall commence on November 19, 2024 and may be terminated by the Board of Directors of the Company at any time with or without notice, and with or without cause.
3. Compensation
3.1 Annual Fee: In consideration of the services provided, the Company shall pay Contractor $200,000 USD per annum, paid in equal monthly installments of $16,666.67 USD. Payments will be made no later than the 10th day of each month.
3.2 Incentive Payments: In addition to the annual fee, Contractor shall be eligible for milestone-based incentive payments as follows:
| · | IND Status: Upon achieving IND status for any drug candidate, Contractor will receive an incentive payment of $150,000 USD. |
| · | Commencement of Phase 1 Trial: Upon commencement of Phase 1 Trial for any drug candidate, Contractor will receive an incentive payment of $250,000 USD. |
| · | Commencement of Phase 2 Trial: Upon commencement of Phase 2 Trial for any drug candidate, Contractor will receive an incentive payment of $500,000 USD. |
| · | Commencement of Phase 3 Trial: Upon commencement of Phase 3 Trial for any drug candidate, Contractor will receive an incentive payment of $750,000 USD. |
| · | FDA Approval: Upon FDA approval any drug candidate, Contractor will receive an incentive payment of $1,000,000 USD. |
| · | Additional Milestones: Contractor shall receive additional incentive payments for achieving other mutually agreed-upon milestones. Such milestones and associated payments shall be documented in a written addendum to this Agreement. |
4. Independent Contractor Relationship
4.1 Contractor is and shall remain an independent contractor. This Agreement does not create an employer-employee, partnership, or joint venture relationship between the parties.
4.2 Contractor shall not be eligible for any benefits the Company provides to its employees, including health insurance, retirement plans, or paid leave. Contractor shall be solely responsible for all federal, state, and local taxes on payments received.
5. Availability and Resources
5.1 Contractor agrees to be reasonably available during business hours to fulfill the services under this Agreement. Contractor may perform services remotely or on-site as required and mutually agreed upon.
5.2 Contractor shall provide his own resources, equipment, and personnel necessary to fulfill his responsibilities unless otherwise agreed in writing by the Company.
6. Confidentiality
6.1 Contractor agrees to maintain the confidentiality of all non-public information regarding the Company, its affiliates, and its business operations, except as required by law or permitted with the Company’s prior written consent.
6.2 This confidentiality obligation shall survive the termination of this Agreement and remain in effect indefinitely.
7. Governing Law and Dispute Resolution
This Agreement shall be governed by and construed in accordance with the laws of the State of Delaware, excluding its conflict of law principles. Any disputes arising from or relating to this Agreement shall first be submitted to binding arbitration under the rules of the American Arbitration Association. Arbitration shall occur before a single arbitrator mutually selected by both parties. If arbitration does not fully resolve the matter, the parties agree that the exclusive jurisdiction for any remaining disputes shall be the courts of the Commonwealth of Pennsylvania.
9. Severance
In the event that Consultant is terminated by the Company without Cause, or in the event that the Consultant terminates this Agreement for Good Reason, the Company agrees to provide Consultant with a severance payment equivalent to $200,000
10. Entire Agreement
This Agreement, along with any exhibits or addenda attached hereto, constitutes the entire agreement between the parties and supersedes all prior agreements, understandings, and negotiations concerning the subject matter hereof.
11. Amendments
Any amendments to this Agreement shall be in writing and signed by both parties.
[Signature page to follow]
IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date first written above.
| For: Virpax Pharmaceuticals, Inc. | ||
| By: | ||
| Name: Gary Herman | ||
| Title: Member of Board of Directors | ||
| For: Contractor (Jatinder Dhaliwal) | ||
| By: | ||
| Name: Jatinder Dhaliwal | ||
| Title: Chief Executive Officer | ||
EXHIBIT 99.1
Virpax Announces Agreement with the U.S. Department of Health and Human Services for the Developmental Extension for NES100 Towards IND for Acute and Chronic Non-Cancer Pain Alternative
BERWYN, PA – November 21, 2024 – Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”), a company specializing in developing pharmaceutical products for pain management, announced that it has been granted an extension of its 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. This collaboration is for the continued development of Virpax’s product candidate, NES100, an intranasal peptide, for the management of acute and chronic non-cancer pain.
NES100 is an enkephalin drug product based on a type of nanotechnology delivery approach. Enkephalin is a naturally occurring (endogenous) peptide that is not easily administered in its original form. We believe that the nanotechnology may enable and enhance the delivery of this metabolically labile peptide drug into the brain. NES100 is the first investigational product formulation delivered via the nasal route with the potential to enhance enkephalin transport to the brain. NES100 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 (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. NES100 has demonstrated analgesic potential in animal models without the development of opioid tolerance, withdrawal, respiratory depression, euphoria, or addiction associated with use of opioids.
Jatinder Dhaliwal, Chief Executive Officer of Virpax, commented, “We are excited that this collaboration has been extended with NCATS and the NIH Helping to End Addiction Long-term (HEAL) initiative as we believe that it may help Virpax develop an effective and safe alternative to conventional opioids used by patients to manage acute and chronic pain. We believe that the NIH/NCATS collaborative agreement will enable our team to maintain momentum in both our pre-
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™, which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking partners for two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit https://www.virpaxpharma.com.and follow us on Twitter, LinkedIn and YouTube.
Forward-Looking Statements
This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. 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 and involve known and unknown risks, uncertainties, and other factors, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. 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.
Investor Contact:
info@virpaxpharma.com
EXHIBIT 99.2
Virpax Announces Positive Results for the Swine Model Dose Range Finding Study for Probudur™
BERWYN, PA – November 22, 2024 – Virpax Pharmaceuticals, Inc. (Nasdaq: VRPX) (“Virpax” or the “Company”), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and anti-viral barrier indications, today 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.
“These positive study results in our pharmacokinetics and safety studies for Probudur and continue to demonstrate both immediate relief as well as sustained relief at the wound site,” stated Jatinder Dhaliwal, Chief Executive Officer of Virpax. “The completion of these studies brings us another step closer to filing our Investigational New Drug Application (IND) for Probudur.”
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
About Virpax Pharmaceuticals
Virpax is developing branded, non-addictive pain management products candidates using its proprietary technologies to optimize and target drug delivery. Virpax is initially seeking FDA approval for two prescription drug candidates that employ two different patented drug delivery platforms. Probudur™ is a single injection liposomal bupivacaine formulation being developed to manage post-operative pain and Envelta™ is an intranasal molecular envelope enkephalin formulation being developed to manage acute and chronic pain, including pain associated with cancer. Virpax is also using its intranasal Molecular Envelope Technology (MET) to develop one other prescription product candidate, NobrXiol™, which is being developed for the nasal delivery of a pharmaceutical-grade cannabidiol (CBD) for the management of rare pediatric epilepsy. Virpax has competitive cooperative research and development agreements (CRADAs) for two of its prescription drug candidates, one with the National Institutes of Health (NIH) and one with the Department of Defense (DOD). Virpax is also seeking partners for two nonprescription product candidates: AnQlar, which is being developed to inhibit viral replication caused by influenza or SARS-CoV-2, and Epoladerm™, which is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis. For more information, please visit https://www.virpaxpharma.com.and follow us on Twitter, LinkedIn and YouTube.
Forward-Looking Statements
This press release contains certain forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, including those described below. 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 and involve known and unknown risks, uncertainties, and other factors, including the additional capital which will be necessary to complete studies and clinical trials that the Company plans to initiate and other factors listed under “Risk Factors” in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q that the Company has filed with the U.S. 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.
Investor Contact:
info@virpaxpharma.com
Cover |
Nov. 19, 2024 |
|---|---|
| Cover [Abstract] | |
| Document Type | 8-K |
| Amendment Flag | false |
| Document Period End Date | Nov. 19, 2024 |
| Entity File Number | 001-40064 |
| Entity Registrant Name | Virpax Pharmaceuticals, Inc. |
| Entity Central Index Key | 0001708331 |
| Entity Tax Identification Number | 82-1510982 |
| Entity Incorporation, State or Country Code | DE |
| Entity Address, Address Line One | 1055 Westlakes Drive |
| Entity Address, Address Line Two | Suite 300 |
| Entity Address, City or Town | Berwyn |
| Entity Address, State or Province | PA |
| Entity Address, Postal Zip Code | 19312 |
| City Area Code | (610) |
| Local Phone Number | 727-4597 |
| Written Communications | false |
| Soliciting Material | false |
| Pre-commencement Tender Offer | false |
| Pre-commencement Issuer Tender Offer | false |
| Title of 12(b) Security | Common Stock, par value $0.00001 per share |
| Trading Symbol | VRPX |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | true |
| Elected Not To Use the Extended Transition Period | false |