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
Date of Report (Date of earliest event reported): March 5, 2021
ENVERIC BIOSCIENCES, INC.
(Exact name of Registrant as specified in its charter)
| Delaware | 001-38286 | 95-4484725 | ||
|
(State or other jurisdiction of incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
Enveric Biosciences, Inc.
4851 Tamiami Trail N, Suite 200
Naples, FL 34103
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code: (239) 302-1707
(Former name 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 pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
| [ ] | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
| [ ] | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
| [ ] | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common stock, par value $0.01 per share | ENVB | The 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. [ ]
Item 1.01 Entry Into a Material Definitive Agreement
On March 5, 2021, Enveric Biosciences, Inc. (the “Company”) entered into an Exclusive License Agreement (the “Agreement”) with Diverse Biotech, Inc. (“Diverse”), pursuant to which the Company has acquired an exclusive, perpetual license to develop five therapeutic candidates (collectively, the “Agents”) with the goal of alleviating the side effects that cancer patients experience. Under the terms of the Agreement, Diverse has granted the Company an exclusive license to its intellectual property rights covering the Agents and its products. In exchange, the Company has granted Diverse the right to information relating to the Agents developed for the express purpose of using such information to obtain patent rights, which right terminates upon the issuance or denial of the patent rights.
Under the Agreement, the Company will maintain sole responsibility and ownership of the development and commercialization of the Agents and its products. Diverse has agreed not to develop or commercialize any agent or product that would compete with the Agents, or its products containing the Agents, at any time during or after the term of the Agreement. If Diverse intends to license, sell, or transfer any other molecules linked with cannabinoids not granted to the Company under the terms of this Agreement, the Company will have the first right, but not the obligation, to negotiate an agreement with Diverse for such cannabinoids. The Company has also agreed to pay Diverse an up-front investment payment, as well as a running royalty starting with the first commercial sale by the Company to a third party in an arms’-length transaction.
The term of the Agreement shall continue for as long as the Company intends to develop or commercialize the new drugs, unless earlier terminated by either Party. The Agreement may be terminated by either party upon ninety (90) days written notice of an uncured material breach or in the event of bankruptcy or insolvency. In addition, the Company has the right to terminate the Agreement at any time upon sixty (60) days’ prior written notice to Diverse. The Agreement contains, among other provisions, representations and warranties, and confidentiality provisions in favor of each party that are customary for an agreement of this nature.
The description of the terms and conditions of the Agreement set forth herein do not purport to be complete and are qualified in their entirety by the full text of the Agreement, a copy of which will be filed as an exhibit to the Company’s Quarterly Report on Form 10-Q for the period ended March 31, 2021.
Item 8.01 Other Events.
On March 10, 2021, the Company issued a press release regarding the transaction described above under Item 1.01 of this Current Report on Form 8-K. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
|
Exhibit No. |
Description | |
| 99.1 | Press Release, dated March 10, 2021 |
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.
| ENVERIC BIOSCIENCES INC. | ||
| Date: March 11, 2021 | By: | /s/ John Van Buiten |
| John Van Buiten | ||
| Chief Financial Officer | ||
Exhibit 99.1
Enveric Biosciences Signs Definitive Agreement to
Acquire Exclusive License for Novel Molecules from Diverse Biotech
- License has the Potential to Expand Enveric’s Planned Capabilities to Address Cancer Treatment Side Effects -
- Innovative Conjugation Platform Aims to Provide Superior Therapeutic Outcomes for Patients by Leveraging Cannabinoids to Improve the Standard of Care and Reduce Side Effects Associated with Cancer Treatments -
NAPLES, Fla. – March 10, 2021 – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-first biotechnology company developing novel cannabinoid medicines to improve quality of life for cancer patients, announced today that it has acquired an exclusive, perpetual license from Diverse Biotech, a biopharmaceutical company focused on developing new molecules for treating oncology and other debilitating diseases. Enveric plans to research and develop these new drugs with the goal of alleviating the side effects that cancer patients experience. Through the conjugation of cannabidiol (CBD) with existing, standard-of-care drugs via Diverse Biotech’s patented, advanced chemistry drug delivery platform, Enveric intends to expand its pipeline of development candidates that seek to deliver superior therapeutic outcomes for patients.
“This exclusive licensing agreement with Enveric aims to expand our CBD conjugate platform into oncology supportive care indications for the first time,” said Brian Longstreet, Interim CEO, Diverse Biotech. “We believe that our collaboration has the potential to advance this science more efficiently, ultimately bringing therapies to market faster to help serve unmet medical needs in this large patient population.”
As part of the agreement, Enveric will add to the Company’s list of target indications by obtaining five molecules, four of which are dermatology-focused and one that is pain-focused. Enveric will also gain access to Diverse Biotech’s scientists and formulators to help synthesize and validate these drugs, as the company moves through pre-clinical and clinical activities.
“This is an exclusive, novel way of bringing together CBD and well-known, existing compounds that hold promise to create a new, improved drug class,” added David Johnson, Chairman and CEO, Enveric Biosciences. “As a patient-centric company, Enveric is constantly looking for new ways to eliminate or minimize cancer treatment side effects for patients in need. With its anti-inflammatory properties, CBD holds so much potential to help these patients, especially since status-quo treatments are not an adequate solution. We are confident that, with this impressive team of experts and Diverse Biotech’s conjugate technology platform, this relationship can help us to expand our potential treatment options for cancer patients who continue to suffer around the globe.”
Mr. Johnson concluded, “Enveric has a clear focus to serve cancer patients’ supportive care needs with our current pipeline consisting of innovative early-stage formulations. We intend to continue to add to that portfolio by moving forward internal development initiatives and targeted external business opportunities. Our new molecules from Diverse Biotech provide us with more options to address these difficult indications while building on our IP portfolio and expanding our access to leading scientific talent.”
About Enveric Biosciences
Enveric Biosciences is a patient-first biotechnology company developing rigorously tested, novel cannabinoid medicines to improve quality of life for cancer patients. Initial indications include radiodermatitis, a common and often severe side effect of radiation therapy, and chemotherapy-induced neuropathy. For more information, please visit https://www.enveric.com/.
About Diverse Biotech
Diverse Biotech is a US-based biopharmaceutical company, focused on medical discoveries and the development of new molecules for the treatment of Oncology and other debilitating diseases. Diverse Biotech’s focus is on discovering and developing novel therapeutics utilizing cannabidiol (CBD) as a core component and combining it through advanced conjugate chemistry with other targeted medicines to develop new chemical entities that are theoretically more efficacious and less toxic. Diverse Biotech’s initial focus is on hard-to-treat oncologic disorders including basal cell carcinoma and other Dermatology related cancers, Pancreatic cancer, and Glioblastoma, where targeted therapies have proven largely unsuccessful thus far and there is significant unmet need.
Further information about Diverse Biotech can be found at www.diversebiotech.com.
Forward-Looking Statements
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, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements 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 failure of the offering described in this press release to close; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s registration statement on Form S-4 filed on May 28, 2020, as amended. 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.
Investor Contacts
Valter Pinto / Allison Soss
KCSA Strategic Communications
212.896.1254 / 212.896.1267
valter@kcsa.com / asoss@kcsa.com
Media Contacts
Caitlin Kasunich / Raquel Cona
KCSA Strategic Communications
212.896.1241 / 516.779.2630
ckasunich@kcsa.com / rcona@kcsa.com