UNITED STATES
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FORM
CURRENT REPORT
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Item 7.01 Regulation FD Disclosure.
On October 21, 2021, Adial Pharmaceuticals, Inc. (the “Company”) issued a press release providing an update regarding certain advancements and positive pre-clinical data for its adenosine analog development platform being developed by Purnovate, Inc. (“Purnovate”), a division of the Company.
The information in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained in this Item 7.01 and in the press release attached as Exhibit 99.1 to this Current Report on Form 8-K shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
The press release attached as Exhibit 99.1 to this Current Report on Form 8-K includes “safe harbor” language pursuant to the Private Securities Litigation Reform Act of 1995, as amended, indicating that certain statements contained therein are “forward-looking” rather than historical.
The Company undertakes no duty or obligation to update or revise the information contained in this Current Report on Form 8-K, although it may do so from time to time if its management believes it is appropriate. Any such updating may be made through the filing of other reports or documents with the Securities and Exchange Commission, through press releases or through other public disclosures.
Item 8.01 – Other Events.
On October 21, 2021, the Company issued a press release providing an update regarding certain advancements and positive pre-clinical data for its adenosine analog development platform being developed by Purnovate. The information in the Press Release included the following:
| ● | Positive Pre-Clinical Data of Purnovate’s PNV-5030 suggest the potential of PNV-5030 as both a standalone therapy and opioid-combination therapy to achieve meaningful pain reduction. |
| ● | Solubility more than 50 times greater than other known selective adenosine compounds of the same class has been demonstrated. |
| ● | PNV-5030 was tested in a mouse model of somatic nociceptive pain. |
| - | Response groups of 12 mice were analyzed with a control group receiving vehicle alone (i.e., liquid dosing solution without any drug) and other groups receiving different doses of morphine alone, PNV-5030 alone or different doses of morphine and PNV-5030. |
| - | PNV-5030 alone exhibited a significant pain reduction as compared to the control group. |
| - | PNV-5030 also demonstrated a significant effect when administered with 1 mg/kg of morphine as compared to administering 1 mg/kg of morphine alone. |
| - | When combined with 1 mg/kg of morphine, PNV-5030 reached a similar level of pain reduction as the one obtained with 2mg of morphine which could indicate the possibility of lowering the opioid dose to achieve a similar pain reduction level. |
| ● | Purnovate intends to commence a clinical trial of PNV-5030 in 2022. |
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |
| 99.1 | Press Release issued by Adial Pharmaceuticals, Inc., dated October 21, 2021. | |
| 104 | Cover Page Interactive Data File (the cover page XBRL tags are embedded within the inline XBRL document) |
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SIGNATURES
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.
| Dated: October 22, 2021 | ADIAL PHARMACEUTICALS, INC. | |
| By: | /s/ William B. Stilley, III | |
| Name: | William B. Stilley | |
| Title: | President and Chief Executive Officer | |
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