8-K
Enveric Biosciences, Inc. (ENVB)
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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the Securities Exchange Act of 1934
March19, 2024
Date
of Report (Date of earliest event reported)
EnvericBiosciences, Inc.
(Exactname of registrant as specified in its charter)
| Delaware | 001-38286 | 95-4484725 |
|---|---|---|
| (State or other jurisdiction<br><br> <br>of incorporation) | (Commission<br><br> <br>File Number) | (I.R.S. Employer<br><br> <br>Identification No.) |
EnvericBiosciences, Inc.
4851Tamiami Trail N, Suite 200
Naples,FL 34103
(Addressof principal executive offices) (Zip code)
Registrant’stelephone number, including area code: (239) 302-1707
N/A
(Formername or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications<br> pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|---|---|
| ☐ | Soliciting material pursuant<br> to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communications<br> pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communications<br> pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common<br> stock, par value $0.01 per share | ENVB | The<br> Nasdaq Stock Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item7.01 Regulation FD Disclosure.
On March 19, 2024, Enveric Biosciences, Inc. (the “Company”) published a press release announcing entering into two non-binding term sheets to pursue the exclusive out-licensing of new chemical entities for pharmaceutical and non-pharmaceutical applications in joint disease. A copy of such press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein. The Company undertakes no obligation to update, supplement or amend the materials attached hereto as Exhibit 99.1.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as shall be expressly set forth by reference in such a filing. Furthermore, the furnishing of information under Item 7.01 of this Current Report on Form 8-K is not intended to constitute a determination by the Company that the information contained herein, including the exhibits hereto, is material or that the dissemination of such information is required by Regulation FD.
Item9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description |
|---|---|
| 99.1 | Press Release, dated March 19, 2024 (furnished pursuant to Item 7.01) |
| 104 | Cover Page Interactive<br> Data File (formatted as Inline XBRL) |
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.
| Date: March 19, 2024 | ENVERIC BIOSCIENCES, INC. | |
|---|---|---|
| By: | /s/ Joseph Tucker | |
| Joseph Tucker, Ph.D. | ||
| Chief Executive Officer |
Exhibit99.1
EnvericBiosciences Signs Non-Binding Term Sheets to Pursue the Exclusive
Out-Licensing of New Chemical Entities for Pharmaceutical and Non-PharmaceuticalApplications in Joint Disease
Secondbiotechnology company to potentially out-license novel compounds from
Enveric’s portfolio of assets with possible significant milestonepayments and royalties
CAMBRIDGE, Mass., March 19, 2024 – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders, is pleased to announce that it has signed two non-binding term sheets with an undisclosed biotechnology company to pursue the out-licensing of cannabinoid-COX-2 conjugate compounds for both pharmaceutical and non-pharmaceutical applications for treatment of joint diseases.
The term sheets contemplate that, for all human and animal joint pathology, such as osteoarthritis, rheumatoid arthritis, and other joint pathology applications, the undisclosed licensee would assume responsibility for all future product development efforts and in return would receive exclusive, royalty-bearing global licenses to develop, market and sublicense the compounds. The compounds are new chemical entities that include cannabinoids in conjugate form with COX-2 inhibitors and cannabinoids in conjugate form with selected steroids.
The pharmaceutical application term sheet provides that Enveric could be eligible to receive future development and sales milestone payments that in total could add up to approximately $61 million, assuming certain conditions are met, including receiving approval for the investigational new drug (IND) application and completing Phases I through III testing of the licensed product. Royalty rates could range from 2.5% up to 10% on future sales, depending on meeting certain sales criteria.
The non-pharmaceutical application term sheet provides that Enveric could be eligible to receive future development and sales milestone payments, which in total could add up to approximately $21 million and with royalty rates ranging from 0.25% up to 7%, assuming certain conditions are met, including successful product development and commercial launch and on meeting certain sales criteria.
Together, through the out-licensing of the two assets and meeting various development and sales milestones, Enveric could potentially receive milestone payments that total up to approximately $82 million.
“We are pleased to announce that a second biotechnology company has stepped forward looking to join Enveric in moving some of the Company’s promising assets forward,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We look forward to working with our partner, and we are confident in their leadership and capabilities to continue the development of these compounds for both pharmaceutical and non-pharmaceutical applications to advance joint disease treatment options for patients. Ultimately, we believe the definitive licensing agreements, once negotiated and finalized, could represent an excellent potential source of revenue for Enveric, and continue to demonstrate the value of Enveric’s extensive portfolio of assets.”
AboutEnveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. Enveric is headquartered in Naples, FL with offices in Cambridge, MA and Calgary, AB Canada. For more information, please visit www.enveric.com.
Forward-LookingStatements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans,” “expects” or “does not expect,” “proposed,” “is expected,” “budgets,” “scheduled,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include historical statements and statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on the any of its out-licensing term sheets, including the two identified herein, and perform pursuant to the terms thereof; carry out successful clinical programs in Australia; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. The two out-licensing term sheets identified herein are non-binding and may not result in definitive agreements or attainment of the licensing fees referenced therein.
A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
Contact
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Tiberend Strategic Advisors, Inc.
Daniel Kontoh-Boateng
(862) 213-1398
dboateng@tiberend.com
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Tiberend Strategic Advisors, Inc.
Casey McDonald
(646) 577-8520
cmcdonald@tiberend.com