ENVB

EX-99.1

2 ex99-1.htm

EX-99.1

Exhibit 99.1

Enveric Biosciences Reports Financial Results and Provides Corporate Update for First Quarter 2026

Product Development Highlights:

●Continued advancement of lead candidate EB-003 with IND-enabling studies progressing toward planned first-in-human clinical trial

●Reported additional preclinical data for EB-003 demonstrating dual Gq and β-arrestin signaling at 5-HT2A, pathways linked in peer-reviewed studies to antidepressant and anxiolytic effects

Corporate and Business Development Highlights:

●Strengthened intellectual property portfolio with new patent issuances and allowances across EVM301 and EVM401 series

●Announced the withdrawal by AbbVie, Inc. of the Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276, which appears relevant to the bretisilocin molecule (GM-2505) acquired by AbbVie, Inc.

●Presented at and Participated in Panel Discussion at Sachs Associates 9th Annual Neuroscience Innovation Forum During “J.P. Morgan Week 2026”

CAMBRIDGE,

Mass., May 15, 2026 – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today reported financial results for the first quarter ended March 31, 2026, and provided a comprehensive business update.

CEO Commentary:

“Our progress in the first quarter of 2026 reflects continued execution against our core mission of developing therapeutics capable of addressing the significant unmet need in mental health,” said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric Biosciences. “We remain laser focused on advancing EB-003, Enveric’s lead drug candidate in developlment, toward an IND submission and first-in-human clinical trials.”

Dr. Tucker continued: “What differentiates Enveric is our commitment to harnessing the therapeutic potential of psychedelic-inspired mechanisms while designing our candidates to eliminate the hallucinogenic effects that limit scalability, safety, and broad patient access. Our growing body of preclinical data continue to support EB-003’s ability to promote neuroplasticity through selective receptor engagement, reinforcing our confidence in its potential to deliver rapid and durable antidepressant and anxiolytic effects.”

“Since the end of the first quarter, the broader policy environment appears to be increasingly supportive of innovation in mental health. Recent actions, including an Executive Order issued under President Donald Trump emphasizing the importance of advancing novel treatments for mental health conditions, underscore growing recognition of the therapeutic promise of psychedelic-inspired compounds. We believe the future of this field will be defined by non-hallucinogenic neuroplastogens like EB-003, which is designed to deliver the benefits of these pathways while avoiding the limitations associated with traditional psychedelic therapies.”

Dr. Tucker continued: “In parallel, we continue to view our intellectual property estate as a foundational driver of long-term value creation. The recent withdrawal of the Post-Grant Review petition by AbbVie further underscores the strength, breadth and strategic relevance of our patent portfolio. We believe our expanding IP position not only protects our innovations but also enhances our ability to create future partnering and monetization opportunities.”

Dr. Tucker concluded: “With IND-enabling activities underway and a strong intellectual property position, we believe Enveric is well positioned to generate meaningful value for stockholders as we transition toward the clinical phase of drug development.”

FIRST

QUARTER 2026 AND RECENT BUSINESS HIGHLIGHTS

Corporate, Product and Business Development Highlights:

EB-003

Development:

●Reported EB-003 BRET receptor engagement assay data, demonstrating dual Gq and β-arrestin signaling at 5-HT2A, pathways that have been linked in peer-reviewed studies to antidepressant and anxiolytic effects

●Subsequent to the end of the first quarter, highlighted positive results for EB-003 indicating a rapid reduction in conditioned fear response in a validated preclinical model of PTSD, supporting continued development for patient population with significant unmet need

Intellectual Property:

●Announced the withdrawal of the Post-Grant Review (PGR) petition, which had been filed by Gilgamesh Pharmaceuticals, pertaining to patents that appear relevant to the bretisilocin (GM-2505) molecule, which was acquired by AbbVie, Inc. in $1.2 billion deal

●Added depth to EVM301 intellectual property portfolio for non-hallucinogenic treatment of neuropsychiatric conditions, enhancing the patent claim coverage of Enveric’s N-heterocycle substituted tryptamine derivative molecules

●Registered five of the Company’s trademarks, including its house marks, Enveric and Enveric Biosciences, with the Canadian

EX-99.1

2 ex99-1.htm

EX-99.1

Exhibit 99.1

Enveric Biosciences Reports Financial Results and Provides Corporate Update for

Fourth Quarter and Fiscal Year Ended 2025

Product Development Highlights:

● Reported positive preclinical results for lead drug candidate EB-003, showing statistically significant improvements in animal models of severe chronic depression and despair and in post-traumatic stress disorder (PTSD)

● Identified neuroplastogen candidates with potential to promote brain-derived neurotrophic factor (BDNF) signaling, an established therapeutic target for neurodegenerative disease

Corporate and Business Development Highlights:

● Announced the withdrawal of the Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276, which appears relevant to the bretisilocin (GM-2505) molecule acquired by AbbVie, Inc.

● Continued to strengthen Enveric’s expansive IP portfolio directed to molecules intended to provide non-hallucinogenic treatment options. Multiple patents and notices of allowance were issued for its EVM301 Series, including a novel family of molecules including melatonin receptor-targeting compounds, and for its EVM401 Series

CAMBRIDGE,

Mass., March 27, 2026 – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a biotechnology company advancing next-generation neuroplastogenic small molecules to address psychiatric and neurological disorders, today provided a corporate update following the filing of its 10-K on Friday, March 27, 2026, which reported financial results for the fourth quarter and year ended December 31, 2025.

CEO Commentary:

“The year 2025 was a year of important scientific progress for Enveric as we further strengthened the mechanistic rationale for our lead candidate, EB-003, a non-hallucinogenic neuroplastogen, being developed for the treatment of underserved mental health conditions,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Our research team has continued to produce novel data, confirming EB-003’s dual-mechanism of action and its ability to promote neuroplasticity without hallucinogenic effects in animal models. We are now in the process of completing IND-supporting studies in preparation for submitting an IND application to the FDA, a key milestone that offers the potential to generate value for our stockholders and potentially deliver much-needed innovation to patients with severe and difficult to treat mental health disorders.”

Dr. Tucker added: “Our excitement around EB-003 has been further amplified by recent, independent academic research that has helped to provide additional mechanistic clarity for the field. Researchers have shown intracellular pathways downstream of 5-HT2A in the experimental models, with signal pathways potentially mediating antidepressant- and anxiolytic-like effects, distinct from pathways resulting in hallucinations. These findings from independent researchers are consistent with our strategy of designing non-hallucinogenic neuroplastogens intended to deliver therapeutic benefit without the safety, monitoring, and scalability constraints associated with psychedelic compounds.

“Also in 2025, we were gratified to see positive results from our decision to take a firm stance to defend our intellectual property and protect our discoveries. A Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals, and ultimately withdrawn by AbbVie, Inc., underscored the significance and breadth of our intellectual property footprint in the field. We believe that our patent portfolio will continue to generate value for our stockholders and support our efforts towards developing novel therapeutics to benefit patients with mental health conditions.”

Dr. Tucker concluded: “In 2026, we are working towards a streamlined IND application for EB-003 in preparation of the initiation of a first-in-human Phase 1 clinical trial. With the dual mechanism of action that engages both 5-HT2A and 5-HT1B receptors, we are optimistic that our research has the potential to profoundly impact mental health disease where innovation has been lacking for decades.”

FOURTH

QUARTER, YEAR END, AND RECENT UPDATES

Corporate, Product and Business Development Highlights:

EB-003

Development:

● Received FDA response allowing for streamlined plans for EB-003 IND submission

● Successfully completed pre-IND dose range finding studies for EB-003 establishing maximum tolerated dose, supporting progression of EB-003 toward IND-enabling studies and first-in-human clinical trials

● Reported positive preclinical results for lead drug candidate EB-003, showing statistically significant improvements in a preclinical model of severe chronic depression and despair

● Announced positive results in treatment in preclinical, exposure-based therapeutic model for post-traumatic stress disorder (PTSD) showing significantly decreased context-induced freezing behavior one-hour post-dose of EB-003

● Ach

false 0000890821

0000890821

2025-11-14 2025-11-14

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

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

November 14, 2025

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.

245 First Street, Riverview II, 18th Floor

Cambridge,

MA 02142

(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 2.02 Results of Operations and Financial Condition.

On November 14, 2025, Enveric Biosciences, Inc. issued a press release providing a corporate update and announcing its financial results for the third quarter ended September 30, 2025. 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 November 14, 2025 (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: November 14, 2025

ENVERIC

BIOSCIENCES, INC.

By: /s/ Joseph Tucker

Joseph Tucker

Chief Executive Officer