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

Key Terms

ind-enabling studies medical

Ind-enabling studies are early research efforts that test whether a new drug or treatment is safe and effective enough to move forward in development. They are like preliminary tests to ensure a product works as intended before investing more resources into large-scale trials. For investors, these studies are important because successful results can signal potential progress toward bringing a new product to market, impacting its future value.

first-in-human clinical trial medical

A first-in-human clinical trial is the first time a new drug or medical treatment is given to people rather than tested only in the lab or animals, aimed mainly at checking safety, appropriate dose, and initial side effects. For investors, it marks a major step from concept to real-world testing—like taking a prototype car onto a closed track—and carries high risk but also the potential to unlock significant value if results are favorable.

β-arrestin medical

A β-arrestin is a cellular protein that acts like a traffic cop for cell-surface receptors, stopping or redirecting signals that enter a cell when a drug or natural molecule binds those receptors. Investors care because β-arrestin-driven pathways can change a drug’s effectiveness, side-effect profile, and regulatory outlook; drugs designed to favor or avoid β-arrestin responses can become more competitive or risky in development and approval.

5-ht2a medical

5-HT2A is a specific protein on brain cells that acts like a lock for the chemical serotonin, helping control mood, perception, and cognition; when the lock is turned it changes how brain circuits behave. Investors care because many psychiatric and neurological drugs, including certain antidepressants, antipsychotics and experimental psychedelic therapies, target this receptor to produce therapeutic effects or side effects, so drug candidates that affect 5-HT2A can drive clinical value, regulatory risk, and market opportunity.

post-grant review (pgr) regulatory

Post-grant review is a formal process at the patent office that allows outside parties to challenge the validity of a recently issued patent by presenting evidence that the invention was not truly new or was obvious compared with earlier technology. For investors, it matters because a successful challenge can narrow or cancel a patent and erode a company’s exclusive market edge and future revenue, while an unsuccessful challenge can strengthen protection—either outcome affects litigation risk, licensing value, and valuation.

registered direct offering financial

A registered direct offering is a way for a company to sell new shares of its stock directly to select investors with regulatory approval. This method allows the company to raise funds quickly and efficiently without needing a public auction, similar to offering exclusive access to a limited number of buyers. For investors, it often provides an opportunity to purchase shares at a favorable price, while giving the company immediate access to capital.

private placement financial

A private placement is a sale of securities directly to a selected group of investors, typically institutions or accredited investors, instead of through a public offering. It lets a company raise money faster and with fewer regulatory steps; for existing shareholders it matters because the newly issued shares, often sold at a discount, increase the share count and can dilute their ownership.

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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-HT_2A, 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.--(BUSINESS WIRE)-- 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 development, 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-HT_2A, 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 Intellectual Property Office

Corporate & Financial:

• Raised gross proceeds of approximately $1.5 million through a registered direct offering, priced At-The-Market under Nasdaq rules
• Expanded collaboration with TOTEC Pharma through trademark license and option, out-licensing RCANN™ trademark portfolio
• Subsequent to the end of the first quarter:

• Raised an additional approximately $1.5 million from the exercise of warrants and;
• Closed a private placement, priced At-The-Market under Nasdaq rules, of up to $13.9 million, including $5 million upfront with up to approximately $8.9 million potential additional proceeds upon exercise in full of warrants

FIRST QUARTER FINANCIAL RESULTS

Net loss attributable to stockholders was $1.6 million for the first quarter ended March 31, 2026, including $0.1 million in net non-cash expense, with a basic and diluted loss per share of $1.08, as compared to a net loss of $2.2 million, including $0.3 million in net non-cash income, with a basic and diluted loss per share of $14.58 for the quarter ended March 31, 2025. The Company had cash-on-hand of $4.9 million for the quarter ended March 31, 2026. For the quarter ended March 31, 2026, the Company raised gross proceeds, through offerings, of $2.8 million.

“In April 2026, Enveric completed a private placement expected to generate gross proceeds of up to $13.9 million, including $5.0 million received at closing, and assuming full exercise of the warrants issued in the private placement.  In addition, the Company received $1.5 million from the exercise of Series G and H warrants at an exercise price of $4.16 per share,” said Kevin Coveney, CPA, Chief Financial Officer. “As of May 15, 2026, the Company’s cash balance was approximately $10.3 million. Enveric believes these funds will support the completion of preclinical development activities for EB-003, the planned filing of an IND application, and operations into the first quarter of fiscal year 2027.”

About Enveric Biosciences

Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company focused on developing next-generation, small-molecule neuroplastogenic therapeutics that address unmet needs in psychiatric and neurological disorders. By leveraging a differentiated drug discovery platform and a growing library of protected chemical structures, Enveric is advancing a pipeline of novel compounds designed to promote neuroplasticity without hallucinogenic effects. Enveric’s lead candidate, EB-003, is the first known compound designed to selectively engage both 5-HT_2A and 5-HT_1B receptors to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience. 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," “sees,” "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: finalize and submit its IND filing to the U.S. Food and Drug Administration; 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.

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Source: Enveric Biosciences