# EDGAR Filing Document

**Accession Number:** 0000890821
**File Stem:** 0001493152-23-008635
**Filing Date:** 2023-3
**Character Count:** 13917
**Document Hash:** 99497aef478b1b88eb2319d20213e983
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001493152-23-008635.hdr.sgml**: 20230323

**ACCESSION NUMBER**: 0001493152-23-008635

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20230323

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20230323

**DATE AS OF CHANGE**: 20230323

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Enveric Biosciences, Inc.
- **CENTRAL INDEX KEY:** 0000890821
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **IRS NUMBER:** 954484725
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38286
- **FILM NUMBER:** 23754490

**BUSINESS ADDRESS:**
- **STREET 1:** 4851 TAMIAMI TRAIL N, SUITE 200
- **CITY:** NAPLES
- **STATE:** FL
- **ZIP:** 34103
- **BUSINESS PHONE:** 239-302-1707

**MAIL ADDRESS:**
- **STREET 1:** 4851 TAMIAMI TRAIL N, SUITE 200
- **CITY:** NAPLES
- **STATE:** FL
- **ZIP:** 34103

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** AMERI Holdings, Inc.
- **DATE OF NAME CHANGE:** 20150527

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** SPATIALIZER AUDIO LABORATORIES INC
- **DATE OF NAME CHANGE:** 19950323

?xml version="1.0" encoding="utf-8"?

**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**

**March 23, 2023**

**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** <br> **of incorporation)** | **(Commission** <br> **File Number)** | **(I.R.S. Employer**<br> **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: (239) 302-1707**

**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 7.01 Regulation FD Disclosure.**

On March 23, 2023, Enveric Biosciences, Inc. (the "Company") issued a press release announcing the selection of Australian CRO, Avance Clinical, in preparation for Phase 1 Study of EB-373. 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.

**Item 9.01 Financial Statements and Exhibits.**

(d) Exhibits

---

| | |
|:---|:---|
| **Exhibit**<br> **Number** | **Description** |
| 99.1 | [Press Release, dated March 23, 2023 (furnished pursuant to Item 7.01)](ex99-1.htm) |
| 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: March 23, 2023 | **ENVERIC BIOSCIENCES, INC.** | **ENVERIC BIOSCIENCES, INC.** |
|  | By: | */s/ Joseph Tucker* |
|  |  | Joseph Tucker |
|  |  | Chief Executive Officer |

---

## Exhibit 99.1

**Exhibit 99.1**

![](ex99-1_001.jpg)

**Enveric Biosciences Selects Australian CRO, Avance Clinical, in Preparation for Phase 1 Study of EB-373** 

*EB-373, a proprietary psilocin prodrug, is on track to start its first-in-human clinical trial in the fourth quarter of 2023* 

 

CAMBRIDGE, Mass., March 23, 2023 – Enveric Biosciences, Inc. (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders, today announced that it has entered into an agreement with <u>Avance Clinical</u>, an Australia-based contract research organization (CRO) with US operations, for its planned Phase 1 clinical trial of EB-373, the company's lead candidate targeting the treatment of anxiety disorders. The Phase 1 clinical trial is expected to initiate in the fourth quarter of 2023.

Under the agreement, Avance Clinical will manage the Phase 1 clinical trial of EB-373 in coordination with Enveric's newly established Australian subsidiary, Enveric Therapeutics Pty, Ltd. The Phase 1 clinical trial is designed as a multi-cohort, dose-ascending study to measure the safety and tolerability of EB-373. EB-373, a next-generation proprietary psilocin prodrug, has been recognized as a New Chemical Entity (NCE) by Australia's Therapeutic Goods Administration (TGA) and is currently in preclinical development targeting the treatment of anxiety disorder.

"With our Australia subsidiary established, we are actively preparing to initiate the planned Phase 1 trial of EB-373 and are pleased to have Avance Clinical as our CRO partner, given the company's proven expertise and experience managing early-stage clinical programs in Australia," said Joseph Tucker, Ph.D., Director and CEO of Enveric Bioscience. "EB-373 has the potential to bring much-needed innovation to the treatment of anxiety disorder, which is underserved by current therapeutic options. We are eager to evaluate the potential of EB-373 in this first-in-human Phase 1 clinical trial as an initial step towards building a broader pipeline of proprietary psilocin prodrugs and other innovative, psychedelic-inspired compounds for a range of mental health conditions."

"We are excited to work with Enveric and are eager to leverage the expertise we've gained from managing early-stage clinical programs in Australia to empower the development of EB-373," said Dr. Jemma Lawson, Director of Clinical and Project Operations for Avance Clinical. "We look forward to being a valued partner to Enveric in the execution of the EB-373 clinical program and ensuring the highest quality data is generated to support global regulatory filings."

**About EB-373**

Enveric's lead drug candidate, EB-373, is a New Chemical Entity (NCE), designed as a next-generation proprietary psilocin prodrug and developed leveraging its Psybrary™ drug discovery platform to target anxiety disorders. In preclinical studies, EB-373 interacted effectively with different types of serotonin receptors, including the serotonin 5-HT2A receptor resulting in the induction of the characteristic head twitch response in mice. In an animal behavioral model of anxiety, the Marble Burying Test in chronically stressed mice, EB-373 was able to promptly rescue the rate of marble burying on day 1 in line with the control rate at baseline, with lasting benefits up to the end of the experiment 7 days post-dose.

**About Enveric Biosciences**

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel small-molecule therapeutics for the treatment of anxiety, depression, and addiction disorders. Leveraging its unique discovery and development platform, The Psybrary™, Enveric has created a robust Intellectual Property portfolio of New Chemical Entities for specific mental health indications. Enveric's lead program, EB-373, is a next-generation prodrug of psilocin, the active metabolite of psilocybin. EB-373 is the lead drug candidate from the EVM201 Series, currently advancing through preclinical development to treat anxiety disorders. Enveric is also advancing its third generation of therapeutics, the EVM301 Series, which aims to eliminate the psychedelic experience and remove unwanted effects, reduce safety concerns, and offer a novel and holistic approach to treating central nervous system disorders. Enveric is headquartered in Naples, FL, with offices in Cambridge, MA, and Calgary, AB, Canada. For more information, please visit <u>www.enveric.com</u>.

**About Avance Clinical**

Avance Clinical is the largest premium full-service Australian and US CRO delivering quality clinical trials, with globally accepted data, in Australia, New Zealand and the US for international biotechs. The company's clients are biotechs in their early phases of drug development that need fast, agile, and adaptive solution-oriented clinical research services. For more information, please visit www.avancecro.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 not purely historical statements, 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 ability of Enveric to successfully spin-off its cannabinoid assets; the ability to achieve the value creation contemplated by technical developments; 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 filings with the Securities and Exchange Commission (SEC), 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.

Daniel Kontoh-Boateng

(862) 213-1398

<u>dboateng@tiberend.com</u>

**Media Relations**

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

<u>cmcdonald@tiberend.com</u>