Form 8-K - Current report

 

 

 

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

 

August 12, 2024

Date of Report (Date of earliest event reported)

 

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 Number)		(I.R.S. Employer Identification No.)

 

Enveric Biosciences, Inc.

4851 Tamiami Trail N, Suite 200

Naples, FL 34103

(Address of principal executive offices) (Zip code)

 

Registrant’s telephone number, including area code: [phone]

 

N/A

(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))

 

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 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 2.02 Results of Operations and Financial Condition.

 

On August 12, 2024, Enveric Biosciences Inc. issued a press release providing a corporate update and announcing its financial results for the second quarter ended June 30, 2024. A copy of this press release is furnished as Exhibit 99.1 hereto and is incorporated herein by reference.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, that is furnished pursuant to this Item 2.02 shall not be deemed to be “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, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit Number		Description
99.1		Press Release, dated August 12, 2024 (furnished pursuant to Item 2.02)
104		Cover Page Interactive 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: August 12, 2024	ENVERIC BIOSCIENCES, INC.
	By:	/s/ Joseph Tucker
		Joseph Tucker, Ph.D.
		Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

 

Enveric Biosciences Reports Second Quarter 2024 Financial and Corporate Results

 

Prioritized EB-003 as lead development candidate. EB-003 is a novel, non-hallucinogenic neuroplastogenic molecule designed to treat severe mental health disorders

 

Announced preclinical results confirming oral bioavailability and significant brain exposure of EB-003, supporting expedited development strategy

 

Expanded business development activities to maximize assets developed using AI-backed drug discovery engine, with multiple deals in advanced stages offering potential to contribute value to stockholders

 

CAMBRIDGE, Mass., August 12, 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, today provided a corporate update and reported financial results for the second quarter ended June 30, 2024.

 

“The second quarter of 2024 was marked by the prioritization of EB-003 as our lead development candidate. This strategic decision was made based on the potential for EB-003 to be a first-in-class neuroplastogenic molecule that can address multiple, difficult-to-treat mental health disorders without inducing the hallucinogenic effect common to N,N-Dimethyltryptamine (DMT) and related analogs,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “We believe EB-003’s differentiated properties set it apart from other drugs in this class and address many of the challenges facing psychedelic-derived drugs, including the ability to conduct truly blinded placebo-controlled clinical trials and the potential to administer the therapy in an outpatient setting without psychotherapy support. Adding to the excitement with EB-003, recently completed pre-clinical research indicated the potential for the drug candidate to be delivered via oral administration and penetrate the brain at levels expected to elicit the desired therapeutic effect.”

 

Dr. Tucker continued, “Given the value potential of EB-003, we are accelerating its evaluation in several in vivo animal efficacy models to determine the optimal therapeutic indication for clinical development and expected dose range as we prepare for a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration in early 2025. This timeline should then allow for the filing of an IND application by the third quarter of 2025 and initiation of a first-in-human clinical trial of EB-003 by the end of 2025.”

 

Dr. Tucker concluded, “Complementing our EB-003 development efforts, during the second quarter we expanded our initiative to secure out-licensing opportunities involving proprietary drug candidates identified through Enveric’s drug discovery engine and other compounds owned by the company. We were pleased to enter into a licensing agreement with Aries Science & Technology for our patented radiation dermatitis topical product and enter into a number of non-binding term sheets, which collectively have the potential to generate non-dilutive revenue, which could support Enveric’s ability to advance its lead asset, EB-003, and further build stockholder value.”

 

 

 

 

SECOND QUARTER AND RECENT UPDATES

 

Corporate, Product and Business Development Highlights:

 

	●	Signed non-binding term sheets to pursue the exclusive out-licensing of new chemical entities for pharmaceutical and non-pharmaceutical applications in joint disease
	●	Signed non-binding term sheet with undisclosed licensee for the exclusive license to patented methods of treating breast and other cancers using cannabinoids
	●	Provided strategic outlook and pipeline update, elevating EB-003 to lead development candidate
	●	Confirmed oral bioavailability and significant brain exposure preclinical studies of EB-003, supporting expedited development with IND filing and first patient dosed expected in 2025
	●	Announced patent granted for drug candidate
	●	Signed licensing agreement with Aries Science & Technology with plans to clinically develop and market Enveric’s patented product for radiation dermatitis

 

SECOND QUARTER FINANCIAL RESULTS

 

Net loss attributable to stockholders was $1.7 million for the second quarter ended June 30, 2024, including $0.4 million in net non-cash expense, with a basic and diluted loss per share of $0.23, as compared to a net loss of $6.40 million, including $1.6 million in net non-cash expense, with a basic and diluted loss per share of $3.04 for the quarter ended June 30, 2023. The Company had cash-on-hand of $3.5 million for the quarter ended June 30, 2024.

 

About Enveric 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-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,” “proposes,” “budgets,” “explores,” “schedules,” “seeks,” “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 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 and perform pursuant to the terms thereof; carry out successful clinical programs; 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.

 

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

 

Investor Relations

 

Tiberend Strategic Advisors, Inc.

David Irish

[phone]

[e-mail]

 

Media Relations

 

Tiberend Strategic Advisors, Inc.

Casey McDonald

[phone]

[e-mail]

 

Cover	Aug. 12, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 12, 2024
Entity File Number	001-38286
Entity Registrant Name	Enveric Biosciences, Inc.
Entity Central Index Key	0000890821
Entity Tax Identification Number	95-4484725
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	Enveric Biosciences, Inc.
Entity Address, Address Line Two	4851 Tamiami Trail N
Entity Address, Address Line Three	Suite 200
Entity Address, City or Town	Naples
Entity Address, State or Province	FL
Entity Address, Postal Zip Code	34103
City Area Code	(239)
Local Phone Number	302-1707
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 $0.01 per share
Trading Symbol	ENVB
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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