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ENVB

Enveric BiosciencesC
Nasdaq / Pharmaceuticals, Biotechnology & Life Sciences
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2026-08-14
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Investor releaseQuarter not tagged2026-08-14

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

Business Wire
EB-003 Development Highlights: Continued advancing IND-enabling studies supporting the planned submission of an Investigational New Drug (IND) application for EB-003 and expected initiation of Phase 1 clinical trial Reported preclinical data demonstrating that EB-003 consistently exhibited a non-hallucinogenic profile in a highly sensitive GloSensor™ assay, complementing previously reported BRET assay findings Announced promising results from preclinical in vitro experiments indicating no photoreactive potential for EB-003, further derisking its continued development as a potential treatment of neuropsychiatric disorders Initiated genotoxicity studies to evaluate the potential for EB-003 to interact with DNA and cause genetic mutations, a critical measure of safety required for IND submission Corporate and Business Development Highlights: Received a Notice of Allowance from the USPTO for a patent application covering the Company’s EVM401 Series of methylone-inspired neuroplastogens Secured U.S. Patent No. 12,605,361 pertaining to the Company’s EVM301 Series of molecules being developed as potential treatments for mental health disorders CAMBRIDGE, Mass., August 14, 2026--(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 second quarter ended June 30, 2026, and provided a comprehensive business update. CEO Commentary: "The second quarter was highlighted by important progress across the key activities supporting our planned first-in-human clinical trial of EB-003," said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric. "Over the past several months, we advanced multiple IND-enabling studies and generated additional preclinical data that support EB-003's potential non-hallucinogenic profile. Collectively, these accomplishments strengthen the scientific foundation of our lead program as we work toward an IND submission for the anticipated Phase 1 trial." Dr. Tucker continued: "The additional preclinical data announced during the quarter are particularly encouraging because they provide further validation of our differentiated development strategy. Our previously reported BRET assay findings were reinforced by independent GloSensor™ assay data, extendin…Read full document

EB-003 Development Highlights: Continued advancing IND-enabling studies supporting the planned submission of an Investigational New Drug (IND) application for EB-003 and expected initiation of Phase 1 clinical trial Reported preclinical data demonstrating that EB-003 consistently exhibited a non-hallucinogenic profile in a highly sensitive GloSensor™ assay, complementing previously reported BRET assay findings Announced promising results from preclinical in vitro experiments indicating no photoreactive potential for EB-003, further derisking its continued development as a potential treatment of neuropsychiatric disorders Initiated genotoxicity studies to evaluate the potential for EB-003 to interact with DNA and cause genetic mutations, a critical measure of safety required for IND submission Corporate and Business Development Highlights: Received a Notice of Allowance from the USPTO for a patent application covering the Company’s EVM401 Series of methylone-inspired neuroplastogens Secured U.S. Patent No. 12,605,361 pertaining to the Company’s EVM301 Series of molecules being developed as potential treatments for mental health disorders CAMBRIDGE, Mass., August 14, 2026--(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 second quarter ended June 30, 2026, and provided a comprehensive business update. CEO Commentary: "The second quarter was highlighted by important progress across the key activities supporting our planned first-in-human clinical trial of EB-003," said Joseph Tucker, Ph.D., Chief Executive Officer of Enveric. "Over the past several months, we advanced multiple IND-enabling studies and generated additional preclinical data that support EB-003's potential non-hallucinogenic profile. Collectively, these accomplishments strengthen the scientific foundation of our lead program as we work toward an IND submission for the anticipated Phase 1 trial." Dr. Tucker continued: "The additional preclinical data announced during the quarter are particularly encouraging because they provide further validation of our differentiated development strategy. Our previously reported BRET assay findings were reinforced by independent GloSensor™ assay data, extending the body of evidence supporting EB-003's differentiated pharmacological profile and its potential to preserve certain therapeutic benefits associated with neuroplasticity while avoiding the hallucinogenic effects." "The broader neuroplastogenic field also continued to gain momentum during the quarter," continued Dr. Tucker. "Recent FDA guidance addressing psychedelic drug development, together with strategic investment by major pharmaceutical companies, reflects increasing recognition of the therapeutic promise of these mechanisms. We believe these developments further support our long-held strategy of developing next-generation neuroplastogenic molecules intentionally designed to address many of the limitations associated with first-generation psychedelic-inspired therapies." Dr. Tucker added: "During the quarter, we also continued to expand Enveric's intellectual property portfolio. We secured a new U.S. patent covering methods of treating psychiatric disorders using compounds from our EVM301 Series and subsequently received a Notice of Allowance for our EVM401 Series of proprietary methylone-inspired neuroplastogens. Together, these achievements reflect our ongoing commitment to building a broad portfolio of differentiated neuroplastogenic compounds." Dr. Tucker concluded: "As we enter the second half of 2026, our priorities remain clear: complete the remaining IND-enabling activities, submit our planned IND application, and advance EB-003 into a first-in-human clinical trial. We believe the progress over the past several months has strengthened both our lead development program and the broader Enveric platform, positioning the Company to continue creating long-term strategic and shareholder value." SECOND QUARTER 2026 AND RECENT BUSINESS HIGHLIGHTS Corporate, Product and Business Development Highlights: EB-003 Development: Reported highly sensitive GloSensor™ cAMP assay demonstrating that EB-003 consistently exhibited a differentiated non-hallucinogenic profile. Announced favorable in vitro study results demonstrating that EB-003 did not exhibit photoreactive potential, supporting its continued development as a potential chronic therapy for patients with neuropsychiatric disorders. Advanced IND-enabling activities through the initiation of genotoxicity studies, an important component of the preclinical safety package required to support submission of an IND application. Intellectual Property: Secured a new U.S. patent covering methods of treating psychiatric disorders utilizing compounds from Enveric's EVM301 Series, further strengthening protection around the Company's proprietary tryptamine-derived neuroplastogenic compounds. Received a Notice of Allowance from the USPTO covering the Company's EVM401 Series of proprietary methylone-inspired neuroplastogens, expanding Enveric's growing intellectual property portfolio. Financial: Closed a private placement, priced at-the-market under Nasdaq rules, for approximately $5.0 million in upfront gross proceeds, with the potential for up to approximately $8.9 million in additional gross proceeds if the associated warrants are exercised in full. Raised an additional approximately $1.5 million from the exercise of warrants. SECOND QUARTER FINANCIAL RESULTS Net loss attributable to stockholders was $3.0 million for the second quarter ended June 30, 2026, including $0.3 million in net non-cash expense, with a basic and diluted loss per share of $0.76, as compared to a net loss of $2.5 million, including $0.5 million in net non-cash expense, with a basic and diluted loss per share of $11.65 for the quarter ended June 30, 2025. The Company had cash-on-hand of $8.3 million as of June 30, 2026. For the quarter ended June 30, 2026, the Company raised gross proceeds of $5.0 million through offerings and $1.5 million from the exercise of warrants. 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-HT2A and 5-HT1B receptors with the potential 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, including, without limitation, statements regarding Enveric’s development of EB-003, the Company’s planned IND submission and planned Phase 1 clinical development of EB-003, the potential implications of the preclinical GloSensor™ cAMP assay results and previously reported BRET assay results, the potential implications of EB-003’s design, receptor activity and preclinical profile, the potential for EB-003 to be non-hallucinogenic in humans, and Enveric’s beliefs regarding the potential implications of FDA guidance for psychedelic drugs to EB-003 and its planned clinical development. 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: finalize and submit its IND application to the U.S. Food and Drug Administration; receive clearance to initiate clinical trials; confirm in human clinical trials any non-hallucinogenic, safety, tolerability, efficacy, durability, dosing, treatment-delivery or outpatient-use profile suggested by preclinical studies; 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 sufficient future funding for product development, clinical development activities, working capital and other operating expenses on commercially reasonable terms, or at all; 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 or update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. View source version on businesswire.com: https://www.businesswire.com/news/home/20260814007152/en/ Contacts Investor RelationsTiberend Strategic Advisors, Inc. David Irish(231) [email protected] Media RelationsTiberend Strategic Advisors, Inc. Casey McDonald(646) [email protected]

Investor releaseQuarter not tagged2026-05-19

Enveric Biosciences Reports Positive Preclinical Results from Phototoxicity Analysis for Lead Neuroplastogen Candidate EB-003

Business Wire
Analysis showed no photoreactive potential for EB-003, further derisking its continued development for the treatment of neuropsychiatric disorders including depression, anxiety and PTSD. Phototoxicity testing is a part of preclinical safety assessment evaluating whether a novel pharmaceutical compound could become harmful when exposed to UV light. CAMBRIDGE, Mass., May 19, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced promising results from preclinical in vitro experiments evaluating the risk for phototoxicity, which indicated no photoreactive potential for EB-003, further derisking its continued development for the chronic treatment of neuropsychiatric disorders. This represents another preclinical safety assessment milestone for Enveric’s neuroplastogen EB-003, the first known compound designed to selectively engage both 5-HT2A and 5-HT1B receptors. EB-003 is intended to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience. Phototoxicity testing is mandated by regulatory agencies like the FDA under the ICH S10 guideline and is performed to evaluate whether a novel pharmaceutical compound could become harmful when exposed to UV light. Some photoactive chemicals can cause exaggerated sunburn-like reactions, rashes or blistering in sun-exposed tissues such as the eyes and skin, limiting the utility of pharmaceutical products. "The demonstration of limited potential for phototoxicity enhances the favorable safety profile of EB-003," said Joseph Tucker, Ph.D., CEO of Enveric Biosciences. "We continue to de-risk EB-003 as we look forward to initiating first-in-human Phase 1 clinical trials and remain committed to meeting the highest standards of safety as we progress towards the clinic." 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 hallu…Read full document

Analysis showed no photoreactive potential for EB-003, further derisking its continued development for the treatment of neuropsychiatric disorders including depression, anxiety and PTSD. Phototoxicity testing is a part of preclinical safety assessment evaluating whether a novel pharmaceutical compound could become harmful when exposed to UV light. CAMBRIDGE, Mass., May 19, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today announced promising results from preclinical in vitro experiments evaluating the risk for phototoxicity, which indicated no photoreactive potential for EB-003, further derisking its continued development for the chronic treatment of neuropsychiatric disorders. This represents another preclinical safety assessment milestone for Enveric’s neuroplastogen EB-003, the first known compound designed to selectively engage both 5-HT2A and 5-HT1B receptors. EB-003 is intended to deliver fast-acting, durable antidepressant and anxiolytic effects with outpatient convenience. Phototoxicity testing is mandated by regulatory agencies like the FDA under the ICH S10 guideline and is performed to evaluate whether a novel pharmaceutical compound could become harmful when exposed to UV light. Some photoactive chemicals can cause exaggerated sunburn-like reactions, rashes or blistering in sun-exposed tissues such as the eyes and skin, limiting the utility of pharmaceutical products. "The demonstration of limited potential for phototoxicity enhances the favorable safety profile of EB-003," said Joseph Tucker, Ph.D., CEO of Enveric Biosciences. "We continue to de-risk EB-003 as we look forward to initiating first-in-human Phase 1 clinical trials and remain committed to meeting the highest standards of safety as we progress towards the clinic." 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-HT2A and 5-HT1B 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," "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 application 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260519940575/en/ Contacts Investor RelationsTiberend Strategic Advisors, Inc. David Irish(231) [email protected] Media RelationsTiberend Strategic Advisors, Inc. Casey McDonald(646) [email protected]

Investor releaseQuarter not tagged2026-05-15

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

Business Wire
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--(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,…Read full document

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--(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-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 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-HT2A and 5-HT1B 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260515529130/en/ Contacts Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected]

Investor releaseQuarter not tagged2026-05-05

Enveric Biosciences Highlights Positive Results for EB-003 in PTSD Preclinical Model

Business Wire
Previously reported results support continued development of EB-003 for PTSD and other neuropsychiatric conditions Recent U.S. Executive Order supporting psychedelic-inspired therapies highlights growing focus on PTSD and reinforces opportunity for neuroplastogens such as EB-003 CAMBRIDGE, Mass., May 05, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today highlighted preclinical data for its lead candidate, EB-003, a dual 5-HT2A and 5-HT1B modulator, in which a single dose of EB-003 significantly reduced context-induced freezing behavior one hour post-dose (p < 0.05). These results indicate a rapid reduction in conditioned fear response in a validated preclinical model of post-traumatic stress disorder (PTSD). President Donald Trump’s April 18, 2026, Executive Order supporting research into psychedelic therapies for mental health conditions, including PTSD, highlights increasing recognition at the federal level of the urgent need for novel treatment approaches. President Trump stated, "In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression." Secretary of Health and Human Services Robert F. Kennedy Jr commented, "At the same time, millions of Americans living with depression, PTSD, addiction and other conditions do not respond to existing treatments." Joseph Tucker, Ph.D., CEO of Enveric Biosciences, stated: "We believe Enveric’s portfolio of neuroplastogenic compounds, such as EB-003, is well positioned to meet the challenges recognized by regulators and provide therapeutic solutions that fit within existing patient treatment approaches while avoiding real-world limitations of delivering traditional hallucinogenic psychedelic therapies, which may require specialized clinical infrastructure." "Enveric’s EB-003 findings in a model of PTSD highlight the potential importance of targeting both neuroplasticity and mood signaling pathways," Dr. Tucker continued. "We believe EB-003’s combined activity at 5-HT2A and 5-HT1B receptors may offer a differentiated approach to promoting neuroplasticity while restoring key signaling pathways involved in emotional regulation and stress response." EB-003 is designed…Read full document

Previously reported results support continued development of EB-003 for PTSD and other neuropsychiatric conditions Recent U.S. Executive Order supporting psychedelic-inspired therapies highlights growing focus on PTSD and reinforces opportunity for neuroplastogens such as EB-003 CAMBRIDGE, Mass., May 05, 2026--(BUSINESS WIRE)--Enveric Biosciences (NASDAQ: ENVB) ("Enveric" or the "Company"), a biotechnology company advancing novel neuroplastogenic small-molecule therapeutics to address psychiatric and neurological disorders, today highlighted preclinical data for its lead candidate, EB-003, a dual 5-HT2A and 5-HT1B modulator, in which a single dose of EB-003 significantly reduced context-induced freezing behavior one hour post-dose (p < 0.05). These results indicate a rapid reduction in conditioned fear response in a validated preclinical model of post-traumatic stress disorder (PTSD). President Donald Trump’s April 18, 2026, Executive Order supporting research into psychedelic therapies for mental health conditions, including PTSD, highlights increasing recognition at the federal level of the urgent need for novel treatment approaches. President Trump stated, "In many cases, these experimental treatments have shown life-changing potential for those suffering from severe mental illness and depression." Secretary of Health and Human Services Robert F. Kennedy Jr commented, "At the same time, millions of Americans living with depression, PTSD, addiction and other conditions do not respond to existing treatments." Joseph Tucker, Ph.D., CEO of Enveric Biosciences, stated: "We believe Enveric’s portfolio of neuroplastogenic compounds, such as EB-003, is well positioned to meet the challenges recognized by regulators and provide therapeutic solutions that fit within existing patient treatment approaches while avoiding real-world limitations of delivering traditional hallucinogenic psychedelic therapies, which may require specialized clinical infrastructure." "Enveric’s EB-003 findings in a model of PTSD highlight the potential importance of targeting both neuroplasticity and mood signaling pathways," Dr. Tucker continued. "We believe EB-003’s combined activity at 5-HT2A and 5-HT1B receptors may offer a differentiated approach to promoting neuroplasticity while restoring key signaling pathways involved in emotional regulation and stress response." EB-003 is designed as a next-generation neuroplastogen that combines partial agonism at the 5-HT2A receptor with concomitant agonism of the 5-HT1B receptor. Prior studies have reported that reduced 5-HT1B receptor expression and function in key brain regions is associated with increased severity of PTSD symptoms, enhanced comorbidity with major depressive disorder, and greater lifetime trauma burden. Activation of 5-HT2A receptors has been associated with increased neuroplasticity in brain regions involved in cognition, emotional regulation and decision making. Together, these mechanisms may enable differentiated therapeutic benefit in PTSD and other neuropsychiatric disorders. 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-HT2A and 5-HT1B 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," "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 application 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260505587393/en/ Contacts Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected]

Investor releaseQuarter not tagged2026-03-28

Enveric Biosciences Reports Financial Results and Provides Corporate Update for Fourth Quarter and Fiscal Year Ended 2025

Business Wire
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--(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 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 furt…Read full document

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--(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 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 Achieved key manufacturing milestones in the chemistry, manufacturing, and controls (CMC) development of EB-003, key steps in scaling production and preparing the drug for required regulatory activities Discovery: Identified neuroplastogen candidates with potential to promote BDNF signaling, an established therapeutic target for neurodegenerative disease Announced publication of two peer-reviewed articles highlighting novel bioproduction methods for neuropsychiatric drug discovery. Research published in ACS Chemical Biology and BioDesign Research describes new approaches for producing tryptamine and MDMA-derived compounds Intellectual Property: Vigorously defended intellectual property portfolio, highlighted by 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 Continued to strengthen expansive IP portfolio and the pipeline of opportunities, receiving multiple patents and notices of allowance Strengthened IP support for the EVM301 Series of compounds with multiple notices of allowance and U.S. patent issuances Unveiled EVM401 Series of compounds in 2025 with four issued U.S. Patents, two of which issued in Q4 alone, for potential next-generation, non-hallucinogenic mescaline derivatives Corporate & Financial: Executed two licensing agreements with Restoration Biologics LLC, a biotechnology company focused on the treatment of joint disease for cannabinoid-COX-2 conjugate compounds, for pharmaceutical and potential non-pharmaceutical applications Expanded collaboration with TOTEC Pharma LLC, a drug company focused on the development of topical cannabinoid pharmaceutical products, through a trademark license Relocated corporate headquarters to Cambridge, MA to leverage the Greater Boston biotech hub’s scientific and financial ecosystem During the fourth quarter of 2025, the Company raised at total of $4.9 million from a warrant inducement and an at-the-market offering. Total gross proceeds raised during fiscal year 2025 was $12.2 million Completed a reverse stock split of its common stock on October 28, 2025, at a ratio of 1 post-split share for every 12 pre-split shares FOURTH QUARTER & YEAR END FINANCIAL RESULTS Net loss attributable to stockholders was $4.0 million for the fourth quarter ended December 31, 2025, including $0.3 million in net non-cash expense, with a basic and diluted loss per share of $6.12, as compared to a net loss of $3.2 million, including $1.0 million in net non-cash income, with a basic and diluted loss per share of $58.06 for the quarter ended December 31, 2024. The Company had cash-on-hand of $4.7 million for the quarter ended December 31, 2025. For the year ended December 31, 2025, the Company raised gross proceeds, through offerings, of $12.2 million. Subsequent Events In January 2026, the Company raised gross proceeds of approximately $1.5 million from a registered direct offering and, in February 2026, raised gross proceeds of approximately $1.45 million from an at-the-market offering. 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-HT₂A and 5-HT₁B 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20260327524596/en/ Contacts Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected]

Investor releaseQuarter not tagged2025-11-15

Enveric Biosciences Reports Third Quarter 2025 Financial and Corporate Results

Business Wire
In Q3, Enveric continued toward clinical readiness for lead candidate EB-003, targeting neuropsychiatric indications, announcing additional positive data in a preclinical model of PTSD, successful completion of dose range finding studies, and receipt of FDA response to pre-IND meeting request. CAMBRIDGE, Mass., November 14, 2025--(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 announced financial results for the third quarter ended September 30, 2025, and provided a comprehensive business update. CEO Commentary: "The third quarter of 2025 marked another highly productive period as we continue to advance our lead candidate EB-003 towards clinical trials in 2026," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Importantly, we recently received a written response from the U.S. Food and Drug Administration (FDA) to our request for a Pre-Investigational New Drug (pre-IND) Type B meeting for EB-003, which we believe is consistent with our view that the preparations are sufficiently advanced to proceed to IND submission. Driving towards this significant inflection point, we also completed key chemistry, manufacturing, and controls (CMC) milestones, as well as dose range studies that helped to establish a maximum tolerated dose of EB-003." "In addition, our team continued to strengthen the profile of EB-003 across several neuropsychiatric indications, as we showed positive effects in a preclinical model of post-traumatic stress disorder (PTSD). Our research showed significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) indicating a positive therapeutic effect in a well-established translational rodent model for PTSD." Dr. Tucker continued, "Intellectual property remains a cornerstone of Enveric’s value proposition, and during the third quarter we pursued opportunities to expand and defend our patent estate. Notably, we announced plans to contest a Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276 entitled, ‘Halogenated Psilocybin Derivatives and Methods of Using.’ The IP in question concerns claims that may be relevant to the Bretisilocin molecule, which was recently acquired by AbbVie…Read full document

In Q3, Enveric continued toward clinical readiness for lead candidate EB-003, targeting neuropsychiatric indications, announcing additional positive data in a preclinical model of PTSD, successful completion of dose range finding studies, and receipt of FDA response to pre-IND meeting request. CAMBRIDGE, Mass., November 14, 2025--(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 announced financial results for the third quarter ended September 30, 2025, and provided a comprehensive business update. CEO Commentary: "The third quarter of 2025 marked another highly productive period as we continue to advance our lead candidate EB-003 towards clinical trials in 2026," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "Importantly, we recently received a written response from the U.S. Food and Drug Administration (FDA) to our request for a Pre-Investigational New Drug (pre-IND) Type B meeting for EB-003, which we believe is consistent with our view that the preparations are sufficiently advanced to proceed to IND submission. Driving towards this significant inflection point, we also completed key chemistry, manufacturing, and controls (CMC) milestones, as well as dose range studies that helped to establish a maximum tolerated dose of EB-003." "In addition, our team continued to strengthen the profile of EB-003 across several neuropsychiatric indications, as we showed positive effects in a preclinical model of post-traumatic stress disorder (PTSD). Our research showed significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) indicating a positive therapeutic effect in a well-established translational rodent model for PTSD." Dr. Tucker continued, "Intellectual property remains a cornerstone of Enveric’s value proposition, and during the third quarter we pursued opportunities to expand and defend our patent estate. Notably, we announced plans to contest a Post-Grant Review (PGR) petition filed by Gilgamesh Pharmaceuticals against Enveric’s issued U.S. Patent No. 12,138,276 entitled, ‘Halogenated Psilocybin Derivatives and Methods of Using.’ The IP in question concerns claims that may be relevant to the Bretisilocin molecule, which was recently acquired by AbbVie in $1.2 billion deal." "As we approach 2026, we are excited to be working towards a streamlined IND application for EB-003 in preparation of a first-in-human study. We believe EB-003 has the potential to uniquely address mental health disorders, where innovation has been lacking for decades, with its dual mechanism of action that potentially engages both 5-HT2A and 5-HT1B receptors. In addition to being designed to promote neuroplasticity without hallucinogenic effects, we are optimistic that the dual mechanism represents a potentially first-in-class therapeutic target with significant clinical opportunity." Third Quarter and Recent Corporate Highlights Preclinical Development, Manufacturing and Regulatory Progress Successfully completed pre-IND dose range finding studies for EB-003, establishing a maximum tolerated dose and supporting progression toward IND-enabling studies and first-in-human clinical trials Demonstrated positive effects in preclinical model of PTSD, showing significantly decreased context-induced freezing behavior one-hour post-dose (p < 0.05) and indicating a positive therapeutic effect in a well-established translational rodent model Successfully completed key CMC milestones including: Identification and production of pharmaceutically compatible salt form designed to potentially improve drug effectiveness and stability Development and implementation of a scalable, reproducible synthetic process suitable for both current and future manufacturing of EB-003 Successfully produced a 1-kilogram batch of EB-003 as a pharmaceutically compatible salt to support IND enabling activities, including GLP toxicology studies and drug product formulation work Continued plans for EB-003 IND submission in 2026, after receiving the FDA response to the pre-IND package and meeting request. Intellectual Property Activities Hired Fish and Richardson P.C. to defend U.S. Patent No. 12,138,276 with claims relevant to Bretisilocin, recently acquired by AbbVie in $1.2 billion deal Issued a U.S. Patent, broadening the patent coverage for aminated psilocybin derivatives in the EVM-301 Series Issued two U.S. Patents and received a U.S. Patent Allowance for potential next-generation, non-hallucinogenic mescaline derivatives in EVM401 Series Patent-protected methylone-inspired analogs support pipeline expansion Publications Announced publication of two peer-reviewed articles highlighting novel bioproduction methods for neuropsychiatric drug discovery. Research published in ACS Chemical Biology and BioDesign Research describes new approaches for producing tryptamine and MDMA-derived compounds Corporate/Operational Relocated corporate headquarters to Cambridge, MA aligning with Company’s vision to leverage the Greater Boston biotech hub’s scientific and financial ecosystem and advance EB-003 into first-in-human trial in 2026 Announced the closing of an exercise of certain outstanding series A warrants to purchase up to an aggregate of 101,042 shares of common stock of the Company and series B warrants to purchase up to an aggregate of 101,042 shares of common stock originally issued in February 2025, having an exercise price of $36.00 per share, at a reduced exercise price of $10.98 per share, adjusted for the reverse stock split. Gross proceeds to the Company from the exercise of the warrants were approximately $2.2 million, prior to deducting placement agent fees and estimated offering expenses After the end of the Third Quarter of 2025, the Company completed a reverse stock split of its common stock on October 28, 2025, at a ratio of 1 post-split share for every 12 pre-split shares. The Board determined the reverse split was in the best interest of the shareholders after receiving conditional approval at the Company’s annual meeting of stockholders on May 29, 2025 for an amendment to the Company’s Amended and Restated Certificate of Incorporation to effect a reverse stock if the Company were to receive a delisting determination from Nasdaq for failure to maintain the required minimum bid price. The Company received a bid price deficiency delisting determination from Nasdaq on October 22, 2025. Third Quarter 2025 Financial Results Net loss attributable to common stockholders was $3.4 million for the quarter ending September 30, 2025, or $10.81 per share, compared to a net loss of $2.1 million, or $43.10 per share, for the same period in 2024, adjusted for the reverse stock split. The net loss for the quarter included approximately $0.2 million in non-cash expenses related to stock-based compensation and other non-cash charges. As of September 30, 2025, Enveric had cash and cash equivalents of $3.8 million. The Company continues to fund its operations through the use of various financing tools. The Company has raised net proceeds of $7.9 million for the nine months ended September 30, 2025. 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-HT2A and 5-HT1B 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," "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: remain listed on Nasdaq, finalize and submit its IND filing to the U.S. Food and Drug Administration in 2026; achieve the value creation contemplated by technical developments; advance EB-003 toward clinical trials by 2026; 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20251113113066/en/ Contacts Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected]

Investor releaseQuarter not tagged2025-09-02

Enveric Biosciences Relocates Corporate Headquarters to Cambridge, MA

Business Wire
Move aligns with company’s vision to leverage the Greater Boston biotech hub’s scientific and financial ecosystem and advance EB-003 into first-in-human trial in 2026 CAMBRIDGE, Mass., September 02, 2025--(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 announced the relocation of its corporate headquarters to Cambridge, Massachusetts, 02142. Enveric believes the move will foster stronger collaborations, facilitate top-tier talent recruitment, and enhance visibility within one of the world’s most vibrant life sciences clusters where world-class scientific expertise, leading biopharma companies, premier academic institutions, and a dynamic investor community converge. "Relocating our headquarters to Cambridge represents an important step in Enveric’s growth trajectory," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "The Greater Boston biotech hub offers unparalleled access to scientific innovation, industry leadership, and capital markets. These advantages will be beneficial as we prepare to advance our lead molecule, EB-003, into first-in-human clinical trials and pursue our vision of transforming the treatment landscape for patients living with serious neuropsychiatric conditions." EB-003 is designed to deliver the therapeutic benefits of neuroplastogens while minimizing hallucinatory effects. Enveric recently unveiled that its lead development candidate, EB-003, is believed to be the first representative of a novel potential pharmacological class of neuroplastogens, defined by dual engagement of the 5-HT₂A and 5-HT₁B receptors. With encouraging preclinical data supporting its differentiated profile, the company is advancing EB-003 toward an Investigational New Drug (IND) submission, with first-in-human studies anticipated in 2026. 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 hallucin…Read full document

Move aligns with company’s vision to leverage the Greater Boston biotech hub’s scientific and financial ecosystem and advance EB-003 into first-in-human trial in 2026 CAMBRIDGE, Mass., September 02, 2025--(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 announced the relocation of its corporate headquarters to Cambridge, Massachusetts, 02142. Enveric believes the move will foster stronger collaborations, facilitate top-tier talent recruitment, and enhance visibility within one of the world’s most vibrant life sciences clusters where world-class scientific expertise, leading biopharma companies, premier academic institutions, and a dynamic investor community converge. "Relocating our headquarters to Cambridge represents an important step in Enveric’s growth trajectory," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "The Greater Boston biotech hub offers unparalleled access to scientific innovation, industry leadership, and capital markets. These advantages will be beneficial as we prepare to advance our lead molecule, EB-003, into first-in-human clinical trials and pursue our vision of transforming the treatment landscape for patients living with serious neuropsychiatric conditions." EB-003 is designed to deliver the therapeutic benefits of neuroplastogens while minimizing hallucinatory effects. Enveric recently unveiled that its lead development candidate, EB-003, is believed to be the first representative of a novel potential pharmacological class of neuroplastogens, defined by dual engagement of the 5-HT₂A and 5-HT₁B receptors. With encouraging preclinical data supporting its differentiated profile, the company is advancing EB-003 toward an Investigational New Drug (IND) submission, with first-in-human studies anticipated in 2026. 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-HT₂A and 5-HT₁B 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," "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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250902804078/en/ Contacts Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected]

Investor releaseQuarter not tagged2025-08-14

Enveric Biosciences Reports Second Quarter 2025 Financial and Corporate Results

Business Wire
Q2 marked a critical inflection point in EB-003 development with mechanism confirmation, therapeutic opportunity expansion, IND-enabling progress, and continued strengthening of Enveric’s differentiated neuroplastogen pipeline and IP platform. Q2 financial results were consistent with overall performance over the previous four quarters, and development costs were in line with budgeted IND-enabling activities. CAMBRIDGE, Mass., August 14, 2025--(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 announced financial results for the second quarter ended June 30, 2025, and provided a comprehensive business update. CEO Commentary "The second quarter of 2025 represented a period of focused execution across all key areas of our business, most notably with the advancement of EB-003, our lead drug candidate," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "We disclosed important new data demonstrating that EB-003 engages both the 5-HT₂A and 5-HT₁B receptors through a dual mechanism of action. We believe this receptor pairing forms the foundation for a novel pharmacological class. With this discovery, we believe EB-003 has emerged as a first-in-class therapeutic candidate with a dual mechanism that represents a unique therapeutic target with real-world clinical utility." "This new pharmacological class is defined by agonism at the 5-HT₁B receptor, which modulates affective tone, impulsivity, and reward pathways, as well as concurrent partial agonism at the 5-HT₂A receptor, which supports cortical neuroplasticity. We believe this novel and unique profile has the potential to promote adaptive rewiring of brain circuits (i.e. neuroplasticity) while stabilizing emotional reactivity, motivational control, and behavioral regulation (i.e., generally psychological stability). It is expected to unlock the therapeutic benefits of serotonin mediated plasticity and guide those effects toward outcomes that are durable, broadly accessible, and clinically relevant for real-world patient populations." "By targeting this specific set of neural receptors, the intent is for EB-003 to recalibrate emotional reactivity, facilitate extinction of maladaptive fear responses, and restore motivational tone. These are m…Read full document

Q2 marked a critical inflection point in EB-003 development with mechanism confirmation, therapeutic opportunity expansion, IND-enabling progress, and continued strengthening of Enveric’s differentiated neuroplastogen pipeline and IP platform. Q2 financial results were consistent with overall performance over the previous four quarters, and development costs were in line with budgeted IND-enabling activities. CAMBRIDGE, Mass., August 14, 2025--(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 announced financial results for the second quarter ended June 30, 2025, and provided a comprehensive business update. CEO Commentary "The second quarter of 2025 represented a period of focused execution across all key areas of our business, most notably with the advancement of EB-003, our lead drug candidate," said Joseph Tucker, Ph.D., Director and CEO of Enveric. "We disclosed important new data demonstrating that EB-003 engages both the 5-HT₂A and 5-HT₁B receptors through a dual mechanism of action. We believe this receptor pairing forms the foundation for a novel pharmacological class. With this discovery, we believe EB-003 has emerged as a first-in-class therapeutic candidate with a dual mechanism that represents a unique therapeutic target with real-world clinical utility." "This new pharmacological class is defined by agonism at the 5-HT₁B receptor, which modulates affective tone, impulsivity, and reward pathways, as well as concurrent partial agonism at the 5-HT₂A receptor, which supports cortical neuroplasticity. We believe this novel and unique profile has the potential to promote adaptive rewiring of brain circuits (i.e. neuroplasticity) while stabilizing emotional reactivity, motivational control, and behavioral regulation (i.e., generally psychological stability). It is expected to unlock the therapeutic benefits of serotonin mediated plasticity and guide those effects toward outcomes that are durable, broadly accessible, and clinically relevant for real-world patient populations." "By targeting this specific set of neural receptors, the intent is for EB-003 to recalibrate emotional reactivity, facilitate extinction of maladaptive fear responses, and restore motivational tone. These are mechanisms believed to support lasting recovery in conditions such as post-traumatic stress disorder (PTSD), treatment resistant depression, and generalized anxiety. The addition of 5-HT₁B agonism is intended to guide plasticity into emotionally grounded outcomes; thus, the designation of EB-003 as a first-in-class drug candidate." "With these advances, EB-003 continues to differentiate itself in a competitive neuropsychiatric drug development landscape, with pre-IND test data for EB-003 pointing to a fast acting, durable, and non-hallucinogenic treatment for serious mental health conditions where currently available therapies are either too slow, poorly tolerated, or not very effective." "Beyond EB-003, we made meaningful progress in expanding our intellectual property portfolio, which remains a foundational pillar of our strategy. During the second quarter, we secured an additional patent grant in our EVM-301 portfolio and patent allowances across multiple distinct chemical classes in our EVM-301 and EVM-401 portfolios, further reinforcing Enveric’s leadership in the discovery of rationally designed neuroplastogens. With a growing portfolio of issued patents and new filings underway, we are seeking to build a durable, competitive moat around our lead assets and future pipeline candidates." "Looking ahead to the remainder of 2025 and into 2026, we remain sharply focused on filing an Investigational New Drug (IND) application for EB-003 and preparing for its first-in-human study. We also continue to benefit from ongoing dialogue and growing interest from established pharmaceutical companies with a strategic focus in neuropsychiatry, which underscores the increasing relevance of our platform in a field that has lacked innovation for far too long." Second Quarter and Recent Corporate Highlights Clinical and Preclinical Development Revealed EB-003’s Dual Mechanism of Action: Enveric confirmed that EB-003, its lead compound, engages both 5-HT₂A (partial agonist) and 5-HT₁B (agonist) receptors, a dual mechanism not previously reported in clinical-stage neuropsychiatric drug candidates. This unique pharmacology forms the basis of a new pharmacological class designed to promote therapeutic neuroplasticity, emotional recalibration, and enhanced control over affective and behavioral responses without the need for hallucinogenic intervention. Progressed Toward IND Submission: IND-enabling studies for EB-003 remain on track, with submission to the U.S. FDA anticipated in early 2026. Enveric continues to generate data supporting EB-003’s safety, tolerability, and pharmacokinetic profile, including results supporting extended, repeat-dose oral use. Expanded Therapeutic Opportunity: PTSD: In a validated preclinical model, EB-003 produced rapid extinction of contextual fear responses following a single administration. Chronic Depression: Mice treated with EB-003 exhibited a statistically significant reduction in behavioral despair (p < 0.01) in the forced swim test, a standard model of antidepressant efficacy. Dosing Profile: Supporting data indicate EB-003 is well tolerated with daily oral administration, distinguishing it from hallucinogenic agents that require intensive supervision and infrequent dosing. Intellectual Property Expansion Broadened Patent Portfolio Across Two Molecular Classes: Filed a new patent application covering a novel chemical structure with potential relevance in neurodegenerative and cognitive indications. Received a Notice of Allowance from the U.S. Patent and Trademark Office for a second mescaline-derivative analogs patent, reinforcing Enveric’s leadership in modifying classical psychedelic frameworks into non-hallucinogenic, drug-like structures. Secured a composition of matter patent on N-Substituted Tryptamine Derivatives, extending the Company’s IP coverage of EVM-301 molecules into this new class of drugs and the serotonergic field. Second Quarter 2025 Financial Results Net loss attributable to common stockholders was $2.5 million for the quarter ending June 30, 2025, or $0.97 per share, compared to a net loss of $1.9 million, or $3.72 per share, for the same period in 2024. The net loss for the quarter included approximately $0.2 million in non-cash expenses related to stock-based compensation and other non-cash charges. As of June 30, 2025, Enveric had cash and cash equivalents of $2.8 million. The Company continues to fund its operations through the use of various financing tools. The Company has raised net proceeds of $4.9M for the six months ended June 30, 2025. 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-HT₂A and 5-HT₁B 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," "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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250814125233/en/ Contacts Investor Relations Tiberend Strategic Advisors, Inc. David Irish (231) 632-0002 [email protected] Media Relations Tiberend Strategic Advisors, Inc. Casey McDonald (646) 577-8520 [email protected]

Investor releaseQuarter not tagged2025-05-29

Enveric Biosciences announces results from EB-003 trial

TipRanks

Enveric Biosciences (ENVB) announced preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions. These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. Easily unpack a company's performance with TipRanks' new KPI Data for smart investment decisions Receive undervalued, market resilient stocks right to your inbox with TipRanks' Smart Value Newsletter Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on ENVB: Disclaimer & DisclosureReport an Issue Psychedelic: atai Life Sciences reports Phase 2a study data on BPL-003 Enveric Biosciences files new provisional patent application VA secretary wants to find answers on psychedelics therapies, Politico says Psychedelic: Atai, Enveric, Incannex and Relmada report quarterly results Psychedelic: Enveric, Filament Health report earnings results

Investor releaseQuarter not tagged2025-05-28

Enveric Biosciences Reports Positive Preclinical Results for Lead Drug Candidate EB-003

Business Wire
Statistically significant improvements in a preclinical model of severe chronic depression and despair Support for safe, extended, daily oral administration CAMBRIDGE, Mass., May 28, 2025--(BUSINESS WIRE)--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 psychiatric and neurological disorders, today announced positive preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a well-established psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions (statistical p-value < 0.01). These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. "We are encouraged by these statistically significant and biologically meaningful results in a severe chronic depression animal model," said Dr. Joseph Tucker, CEO of Enveric Biosciences. "EB-003 has now demonstrated strong behavioral efficacy and a clean safety profile in several animal models that are relevant to chronic treatment of severe depression. These data points validate the compound’s pharmacological des…Read full document

Statistically significant improvements in a preclinical model of severe chronic depression and despair Support for safe, extended, daily oral administration CAMBRIDGE, Mass., May 28, 2025--(BUSINESS WIRE)--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 psychiatric and neurological disorders, today announced positive preclinical results for its lead neuroplastogen drug candidate, EB-003, in the Open Space Forced Swim Test, a preclinical mouse model of severe depression and despair. The Open Space Forced Swim Test, a well-established psychiatric behavioral model, is designed to induce potent and enduring chronic depression-like states in mice, leading to reduced swim distance and increased periods of despair-induced immobility. In a study performed by a third-party lab, an oral dose of EB-003 at 30 mg/kg significantly reduced depression-like behavior within 30 minutes of administration. This was indicated by the enhanced distance travelled and reduced immobility of treated mice during forced swim sessions (statistical p-value < 0.01). These results were comparable to the therapeutic effects of Imipramine, an approved tricyclic antidepressant drug. A repeat study, conducted by the same third-party lab, produced consistent results, confirming 30 mg/kg as an efficacious oral dose for EB-003. The study also confirmed no adverse locomotor effects were observed at this dose. The study also performed a preliminary assessment of extended, daily dosing of EB-003 to determine any potential safety concerns for chronic therapeutic administration. Mice receiving a daily oral dose of EB-003 at 30 mg/kg for 22 days showed no adverse behavioral, physiological or neurological effects. These observations demonstrate acceptable tolerance to long-term systemic drug exposure and expand the range of EB-003 dosing strategies. "We are encouraged by these statistically significant and biologically meaningful results in a severe chronic depression animal model," said Dr. Joseph Tucker, CEO of Enveric Biosciences. "EB-003 has now demonstrated strong behavioral efficacy and a clean safety profile in several animal models that are relevant to chronic treatment of severe depression. These data points validate the compound’s pharmacological design and provide strong support for the planned Investigational New Drug (IND) application" EB-003 is the lead compound from Enveric’s proprietary EVM301 Series, a pipeline of next-generation neuroplastogens engineered to stimulate synaptic plasticity without incurring hallucinogenic liability. 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 psychiatric and neurological disorders. Leveraging its unique discovery and development platform Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. 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: 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250528103946/en/ Contacts Investor RelationsTiberend Strategic Advisors, Inc. David Irish(231) [email protected] Media RelationsTiberend Strategic Advisors, Inc. Casey McDonald(646) [email protected]

Investor releaseQuarter not tagged2025-05-15

Enveric Biosciences Reports First Quarter 2025 Financial and Corporate Results

Business Wire
Corporate, Business and Product Development Highlights: Unveiled EVM401 Series with new U.S. Patent for mescaline derivative compounds Added to suite of intellectual property for EB-003, a neuroplastogen targeting undertreated mental health indications Signed two licensing agreements for cannabinoid-COX-2 conjugate compounds, with potential to target joint pathologies, such as osteoarthritis and rheumatoid arthritis Announced closing of $5 million public offering CAMBRIDGE, Mass., May 14, 2025--(BUSINESS WIRE)--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 first quarter ended March 31, 2025. "The first quarter of 2025 was highlighted by continued progress in the development of EB-003, our neuroplastogenic molecule that is designed to address difficult-to-treat mental health disorders," said Joseph Tucker, Ph.D., CEO and Director of Enveric. "We continue to focus our development efforts on the completion of the data package to support filing an Investigational New Drug (IND) application for EB-003, which we aim to submit to the FDA by the end of the first quarter of 2026." Dr. Tucker said: "Ongoing development of EB-003 is supported by the data accumulated to date, which have demonstrated oral bioavailability and brain exposure in preclinical studies. Preclinical work has also shown encouraging pharmacology and safety results from in vitro pharmacology studies." Dr. Tucker added: "Enveric continues to expand the portfolio of intellectual property covering our proprietary technologies, including the recent receipt of a Notice of Allowance from the USPTO for claims covering EB-003 composition of matter. We also announced the issuance of a U.S. patent for our EVM401 Series, a collection of mescaline derivative compounds that broadens Enveric’s potential to develop additional neuroplastogenic therapeutics for addiction and neuropsychiatric disorders. Preliminary testing of our EVM401 series and their metabolites has demonstrated differentiated and encouraging patterns of brain receptor binding and/or activation." Dr. Tucker concluded: "As we look ahead to the remainder of 2025 and beyond, we ar…Read full document

Corporate, Business and Product Development Highlights: Unveiled EVM401 Series with new U.S. Patent for mescaline derivative compounds Added to suite of intellectual property for EB-003, a neuroplastogen targeting undertreated mental health indications Signed two licensing agreements for cannabinoid-COX-2 conjugate compounds, with potential to target joint pathologies, such as osteoarthritis and rheumatoid arthritis Announced closing of $5 million public offering CAMBRIDGE, Mass., May 14, 2025--(BUSINESS WIRE)--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 first quarter ended March 31, 2025. "The first quarter of 2025 was highlighted by continued progress in the development of EB-003, our neuroplastogenic molecule that is designed to address difficult-to-treat mental health disorders," said Joseph Tucker, Ph.D., CEO and Director of Enveric. "We continue to focus our development efforts on the completion of the data package to support filing an Investigational New Drug (IND) application for EB-003, which we aim to submit to the FDA by the end of the first quarter of 2026." Dr. Tucker said: "Ongoing development of EB-003 is supported by the data accumulated to date, which have demonstrated oral bioavailability and brain exposure in preclinical studies. Preclinical work has also shown encouraging pharmacology and safety results from in vitro pharmacology studies." Dr. Tucker added: "Enveric continues to expand the portfolio of intellectual property covering our proprietary technologies, including the recent receipt of a Notice of Allowance from the USPTO for claims covering EB-003 composition of matter. We also announced the issuance of a U.S. patent for our EVM401 Series, a collection of mescaline derivative compounds that broadens Enveric’s potential to develop additional neuroplastogenic therapeutics for addiction and neuropsychiatric disorders. Preliminary testing of our EVM401 series and their metabolites has demonstrated differentiated and encouraging patterns of brain receptor binding and/or activation." Dr. Tucker concluded: "As we look ahead to the remainder of 2025 and beyond, we are confident that Enveric is at the leading edge of a paradigm shift in the treatment of severe mental health conditions, an area that has seen minimal innovation for decades. We look forward to bringing our novel technologies to patients in need, while generating value for our shareholders as we capitalize on the substantial potential of the emerging field of neuroplastogenic therapeutics." FIRST QUARTER AND RECENT UPDATES Corporate, Product and Business Development Highlights: Unveiled EVM401 Series with new U.S. Patent for mescaline derivative compounds, broadening Enveric’s pipeline of neuroplastogen candidates for addiction and neuropsychiatric disorders Added to suite of intellectual property for EB-003, a neuroplastogen targeting undertreated mental health indications Signed two licensing agreements with Restoration Biologics LLC, for cannabinoid-COX-2 conjugate compounds, with plans to investigate potential to treat joint pathologies, such as osteoarthritis and rheumatoid arthritis, creating the potential for diversified future revenue streams Announced closing of $5 million public offering FIRST QUARTER FINANCIAL RESULTS Net loss attributable to stockholders was $2.2 million for the first quarter ended March 31, 2025, including $0.3 million in net non-cash expense, with a basic and diluted loss per share of $1.22, as compared to a net loss of $2.5 million, including $0.4 million in net non-cash income, with a basic and diluted loss per share of $9.21 for the quarter ended March 31, 2024. The Company had cash-on-hand of $4.3 million for the quarter ended March 31, 2025. 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, the Psybrary™, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ drug candidates to third-party licensees advancing non-competitive market strategies for patient care. 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: 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250514714986/en/ Contacts Investor RelationsTiberend Strategic Advisors, Inc. David Irish(231) [email protected] Media RelationsTiberend Strategic Advisors, Inc. Casey McDonald(646) [email protected]

Investor releaseQuarter not tagged2025-03-31

Enveric Biosciences Reports Financial Results and Provides Corporate Update for Fourth Quarter and Fiscal Year Ended 2024

Business Wire
Product Development Highlights: Advanced pre-IND and research activities including confirmation of oral bioavailability and significant brain exposure for EB-003, a novel potential first-in-class neuroplastogenic molecule designed to treat severe mental health disorders Announced positive pharmacology and preclinical safety data for EB-003 including targeting of serotonergic receptors, supporting the potential of the neuroplastogenic therapeutic effect Presented data highlighting development of EB-003 at European Behavioral Pharmacology Society Biennial Workshop and 7th Neuropsychiatric Drug Summit Broadened pipeline of potential non-hallucinatory molecules with new U.S. patent for EVM401 Series mescaline derivative compounds Corporate and Business Development Highlights: Conducted business development campaign with multiple classes of promising novel drug candidates Executed out-licensing deal of patented topical product to Aries Science & Technology for development in radiation dermatitis. Completed out-licensing agreement for EVM201 program to MycoMedica Life Sciences Executed two out-licenses to Restoration Biologics for the development and marketing of patented Cannabinoid-COX-2 conjugate compounds in joint disease CAMBRIDGE, Mass., March 31, 2025--(BUSINESS WIRE)--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 following the filing of its 10-K on Friday March 28, 2025 which reported financial results for the fourth quarter and year ended December 31, 2024. "Enveric is entering 2025 with a clear mission – enhance shareholder value by cementing our leadership position in the promising neuroplastogen field with the continued development of EB-003," stated Joseph Tucker, Ph.D., Director and CEO of Enveric. "With EB-003, we believe Enveric is at the forefront of redefining the treatment of severe mental health conditions, an area of medicine that has been without substantial innovation for many years. We are now focused on completing the data package needed to file an Investigational New Drug (IND) application for EB-003. After the completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA), and the…Read full document

Product Development Highlights: Advanced pre-IND and research activities including confirmation of oral bioavailability and significant brain exposure for EB-003, a novel potential first-in-class neuroplastogenic molecule designed to treat severe mental health disorders Announced positive pharmacology and preclinical safety data for EB-003 including targeting of serotonergic receptors, supporting the potential of the neuroplastogenic therapeutic effect Presented data highlighting development of EB-003 at European Behavioral Pharmacology Society Biennial Workshop and 7th Neuropsychiatric Drug Summit Broadened pipeline of potential non-hallucinatory molecules with new U.S. patent for EVM401 Series mescaline derivative compounds Corporate and Business Development Highlights: Conducted business development campaign with multiple classes of promising novel drug candidates Executed out-licensing deal of patented topical product to Aries Science & Technology for development in radiation dermatitis. Completed out-licensing agreement for EVM201 program to MycoMedica Life Sciences Executed two out-licenses to Restoration Biologics for the development and marketing of patented Cannabinoid-COX-2 conjugate compounds in joint disease CAMBRIDGE, Mass., March 31, 2025--(BUSINESS WIRE)--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 following the filing of its 10-K on Friday March 28, 2025 which reported financial results for the fourth quarter and year ended December 31, 2024. "Enveric is entering 2025 with a clear mission – enhance shareholder value by cementing our leadership position in the promising neuroplastogen field with the continued development of EB-003," stated Joseph Tucker, Ph.D., Director and CEO of Enveric. "With EB-003, we believe Enveric is at the forefront of redefining the treatment of severe mental health conditions, an area of medicine that has been without substantial innovation for many years. We are now focused on completing the data package needed to file an Investigational New Drug (IND) application for EB-003. After the completion of a pre-IND meeting with the U.S. Food and Drug Administration (FDA), and the filing of the IND, we will be poised to advance EB-003 into Phase 1 clinical trials and towards the goal of capitalizing on the estimated $35 billion future market opportunity for neuroplastogens."1 Dr. Tucker continued: "Expanding from this foundation, Enveric will work to identify and capture additional opportunities to build value through the discovery of new, potentially groundbreaking molecules and by harnessing our portfolios of patented technologies to secure additional licensing deals with strategic partners. Representative of this expansion was the recent unveiling of our EVM401 series of compounds. This new family of molecules offers the potential for Enveric to broaden our neuroplastogen program beyond addiction and neuropsychiatric disorders." Dr. Tucker concluded: "This is an exciting time for Enveric, and we believe the Company is well positioned to reinforce its leadership role in developing innovative, non-hallucinatory neuroplastogens for mental health diseases and other conditions that remain challenging to treat and devastating to patients." FOURTH QUARTER, YEAR END, AND RECENT UPDATES Corporate, Product and Business Development Highlights: Confirmed oral bioavailability and significant brain exposure in preclinical studies of EB-003, supporting elevation of EB-003 to lead neuroplastogen candidate for expedited development Announced positive pharmacology and safety data for EB-003 with in vitro pharmacology studies confirming targeting to desired serotonergic receptors, supporting the potential of the neuroplastogenic therapeutic effect Preclinical safety pharmacology studies showed no adverse cardiovascular or CNS events Presented data highlighting development of EB-003 at European Behavioral Pharmacology Society Biennial Workshop and 7th Neuropsychiatric Drug Summit Unveiled EVM401 series of compounds with new U.S. patent to support development of mescaline derivative compounds, broadening Enveric’s pipeline of potential non-hallucinogenic neuroplastogen drug candidates Expanded patent protection for EVM301 and EVM201 portfolio, including receipt of US Patent Notice of Allowance for lead drug candidate EB-003 Closed $5 million public offering Launched business development initiative with multiple classes of novel drug candidates discovered using Enveric’s Psybrary™ drug discovery platform Secured several out-licensing deals: Executed out-licensing deal of patented topical product to Aries Science & Technology for development in radiation dermatitis with aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales Completed out-licensing agreement for EVM201 program, which included EB-002 Candidate, to MycoMedica Life Sciences, with upfront, development, and sales milestones potentially totaling up to $62 million, plus tiered single digit royalties on all future sales Entered into two out-licensing agreements with Restoration Biologics, which expects to develop and market Enveric’s patented Cannabinoid-COX-2 conjugate compounds for use in treating joint disease with milestone payments that could potentially add up to a total of $61 million for the pharmaceutical license and $21 million for the non-pharmaceutical license FOURTH QUARTER & YEAR END FINANCIAL RESULTS Net loss attributable to stockholders was $3.2 million for the fourth quarter ended December 31, 2024, including $1.0 million in net non-cash expense, with a basic and diluted loss per share of $4.83, as compared to a net loss of $3.4 million, including $1.5 million in net non-cash income, with a basic and diluted loss per share of $21.90 for the quarter ended December 31, 2023. The Company had cash-on-hand of $2.2 million for the quarter ended December 31, 2024. References: 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, the Psybrary™ platform, which houses proprietary information on the use and development of existing and novel molecules for specific mental health indications, Enveric seeks to develop a robust intellectual property portfolio of novel drug candidates. Enveric’s lead molecule, EB-003, is a potential first-in-class neuroplastogen designed to promote neuroplasticity, without inducing hallucinations, in patients suffering from difficult-to-address mental health disorders. Enveric is focused on advancing EB-003 towards clinical trials for the treatment of neuropsychiatric disorders while out-licensing other novel, patented Psybrary™ platform drug candidates to third-party licensees advancing non-competitive market strategies for patient care. 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: 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. View source version on businesswire.com: https://www.businesswire.com/news/home/20250331730278/en/ Contacts Investor RelationsTiberend Strategic Advisors, Inc. David Irish(231) [email protected] Media RelationsTiberend Strategic Advisors, Inc. Casey McDonald(646) [email protected]

As of 2026-08-15 • Updated weeklySource: Earnings sourceIngestion runbook