SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 22, 2021
ENVERIC BIOSCIENCES, INC.
(Exact name of Registrant as specified in its charter)
(State or other jurisdiction
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 February 22, 2021, Enveric Biosciences, Inc. (the “Company”) entered into a Development and Clinical Supply Agreement (the “Agreement”) with PureForm Global, Inc. (“PureForm”), pursuant to which PureForm will be the exclusive provider of synthetic cannabidiol (“API”) for the Company’s development plans for cancer treatment and supportive care. Under the terms of the Agreement, PureForm has granted the Company the exclusive right to purchase API and related product for cancer treatment and supportive care during the term of the Agreement (contingent upon an initial minimum order volume during the first thirty (30) days from the effective date) and has agreed to manufacture, package and test the API and related product in accordance with specifications established by the parties. All inventions that are developed jointly by the parties in the course of performing activities under the Agreement will be owned jointly by the parties in accordance with applicable law; however, if the Company funds additional research and development efforts by PureForm, the parties may enter into a further agreement whereby PureForm would assign any resulting inventions or technical information to the Company.
The initial term of the Agreement is three (3) years commencing on the effective date of the Agreement, subject to extension by mutual agreement of the parties. The Agreement may be terminated by either party upon thirty (30) days written notice of an uncured material breach or immediately in the event of bankruptcy or insolvency. The Agreement contains, among other provisions, representation and warranties, indemnification obligations 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 February 25, 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.
|99.1||Press Release, dated February 25, 2021|
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: February 26, 2021||By:||/s/ John Van Buiten|
|John Van Buiten|
|Chief Financial Officer|
Enveric Biosciences Launches Development Collaboration and Supply Agreement with PureForm Global to Support Cannabinoid Clinical Programs
Enveric and PureForm to Develop High-Quality, Consistent, Pure CBD Formulations and Delivery Technology for Treating Pain and Inflammation Resulting from Cancer Treatments
NAPLES, Fla. – February 25, 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 launched a strategic development collaboration and exclusive supply agreement with PureForm Global, Inc. (“PureForm”), a biotechnology company focused on the research, development and commercialization of synthesized CBD and other cannabinoids, for treating pain and inflammation resulting from cancer treatments. The agreement allows two leading edge companies to bring their focus and resources to bear on superior products to serve unmet medical needs.
“For the millions of cancer patients that continue to suffer from debilitating treatment side effects, the status quo in supportive care options is no longer acceptable,” said David Johnson, Chairman and CEO, Enveric Biosciences. “As a market leader in producing pure, consistent, synthetic CBD from non-cannabis plant sources, PureForm should complement Enveric’s supportive care expertise. Together, we intend to apply a high level of rigor in our scientific research, to create better treatment options that improve quality of life for cancer patients across the world.”
Under the terms of the agreement, PureForm will work exclusively to support Enveric’s development plans in the cancer treatment and supportive care space, with Enveric owning the intellectual property. With its work, Enveric is initially targeting supportive care indications that include radiodermatitis, chemotherapy-induced neuropathy, and glioblastoma.
“As Enveric’s exclusive synthetic, non-cannabis-based CBD supplier for all of the Company’s compounds, PureForm intends to work closely with the team to select and develop next-generation, cannabinoids to help serve physicians and patients,” added Richard Nanula, CEO, PureForm. “Through collaborating on this innovative discovery program, PureForm’s goal is to help Enveric fast-track its efforts to produce impactful, pharmaceutical-grade cannabinoid applications that benefit the global medical community as a whole in the near future. Additionally, Enveric gains a guaranteed long term supply of high quality CBD, making consistent product available for preclinical and clinical studies.”
“Next-generation medicines, including cannabinoids, may be beneficial in providing a solution for these patients with high unmet medical needs,” concluded Johnson. “By bringing the Enveric and PureForm teams’ expertise together to work on these novel compounds, we expect to not only advance our pipeline but also further our drug development efforts to benefit patients and their families.”
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 PureForm Global, Inc.
Headquartered in Los Angeles, California, PureForm is a biotechnology company focused on the research, development, and commercialization of synthesized CBD and other cannabinoids. The company’s synthetic cannabinoids are 100% chemically identical to their plant-based counterparts and are manufactured using a proprietary process that produces pure, consistent and stable compounds free from THC, pesticides, and impurities. PureForm produces CBD at commercial scale in cGMP and FDA compliant facilities in the US and UK. It was founded in 2016 with a commitment to bringing pure, consistent, cannabinoids to market economically and at commercial scale in service to the world’s most quality-conscious brands. To learn more about PureForm CBDTM or our other initiatives, please visit www.pureformglobal.com.
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 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.
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