Dimethyltryptamine

TORONTO, ON / ACCESSWIRE / November 20, 2024 / Biomind Labs Inc. (" Biomind " or the " Company ") (CBOE:BMND)(OTC PINK:BMNDF)(FRA:3XI) , a leading biotech company at the forefront of next-generation pharmaceuticals addressing the root causes of neurological disorders, is encouraged by the U.S. government's progressive stance on the psychedelic industry. The administration's decision to nominate a new Health Secretary with a history of supporting innovative mental health solutions marks a pivotal moment for the advancement of psychedelic-based therapies.The Company is optimistic that this policy shift will open new avenues for greater recognition and regulatory support of groundbreaking therapies, including its proprietary drug candidate BMND08 . In a Phase II clinical trial, BMND08 demonstrated remarkable efficacy, with 100% of participants responding to treatment and achieving remission from depression, anxiety, and stress by the end of the treatment period (week 5). The Company intends to enter in discussions with the U.S. Food and Drug Administration ("FDA") to pursue Breakthrough Therapy Designation for BMND08, a move that could accelerate the availability of transformative treatments for conditions like early-stage Alzheimer's, depression, and anxiety.Alejandro Antalich, CEO of Biomind Labs, commented: "The nomination of a Health Secretary in the U.S. who recognizes the transformative potential of psychedelic-based therapies and demonstrates a clear commitment to supporting their development marks a historic milestone for our industry. At Biomind, we are proud to be at the forefront of this movement with our groundbreaking 5-MeO-DMT-based candidate, BMND08 , which has the potential to revolutionize treatment options for neuropsychiatric disorders. We remain focused in our discussions with the FDA to advance BMND08, aiming for regulatory breakthroughs that will deliver life-changing therapies to those who need them most."Biomind Labs remains committed to driving innovation in psychedelic-based treatments while working closely with regulators and policymakers to create a sustainable and impactful future for mental health therapies:On November 14, 2022, the U.S. Food and Drug Administration ("FDA") granted Investigational New Drug ("IND") clearance for the Company's New Chemical Entity ("NCE"), Triptax™ .BMND01 (DMT): Optimized extraction and purification from natural sources under Good Laboratory Practices ("GLP"), with advanced inhaled and intramuscular formulations for efficient, precise, and patient-friendly delivery.BMND07 (5-MeO-DMT): Successfully developed a pharmaceutical-grade organic synthesis process, ensuring high-purity Active Pharmaceutical Ingredient (API).BMND02 (5-MeO-DMT Nasal): Introduced a thermosensitive nasal gel for enhanced mucosal permeation, supported by a pending patent application.BMND08 (5-MeO-DMT Sublingual): Developed a cost-effective, scalable, and non-invasive sublingual formulation.About Biomind Labs Inc.Biomind Labs is a biotech research and development company focused on transforming biomedical sciences knowledge into novel pharmaceutical drugs and innovative nanotech delivery systems for a variety of psychiatric and neurological conditions. Through its acceleration platform, Biomind Labs is developing novel pharmaceutical formulations of key endogenous substances which are occurring in the human body and an organic compound that includes many neurotransmitters for treating a wide range of therapeutic indications. Biomind Labs is dedicated to providing patients with access to affordable and contemporary treatments.For more information, please contact:Biomind Labs Inc.Alejandro AntalichChief Executive OfficerEmail: [email protected]Tel: + 598 97 702500Cautionary Note Regarding Forward-Looking StatementsThis press release contains statements that constitute "forward-looking information" ("forward-looking information") within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking information and are based on expectations, estimates and projections as at the date of this news release. Any statement that discusses predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as "expects", or "does not expect", "is expected", "anticipates" or "does not anticipate", "plans", "budget", "scheduled", "forecasts", "estimates", "believes" or "intends" or variations of such words and phrases or stating that certain actions, events or results "may" or "could", "would", "might" or "will" be taken to occur or be achieved) are not statements of historical fact and may be forward-looking information. Forward-looking statements in this document include, among others, statements relating to the Company's ability to scientifically harness the medicinal power of certain molecules to treat patients suffering from neurological and psychiatric disorders, future research and development in various therapeutic areas, the anticipated results and potential of the Company's future trials, the ability to obtain regulatory approvals, the marketability of the Company's products, ability to source raw materials in the formulation of products, ability to raise capital, and the Company's plan to engineer proprietary drug development platforms, innovative drug delivery systems, novel formulation approaches and treatment regimens for mental health conditions.By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors and risks include, among others: (a) the Company may require additional financing from time to time in order to continue its operations which may not be available when needed or on acceptable terms and conditions acceptable; (b) compliance with extensive government regulation; (c) domestic and foreign laws and regulations could adversely affect the Company's business and results of operations; (d) fluctuations in securities markets; (e) adverse changes in the public perception of tryptamine-based treatments and phenethylamine-based therapies; (f) fluctuations in general macroeconomic conditions; (g) expectations regarding the size of the targeted market; (h) the ability of the Company to successfully achieve its business objectives; (i) plans for growth; (j) political, social and environmental uncertainties; (k) employee relations; (l) the presence of laws and regulations that may impose restrictions in the markets where the Company operates; and (m) the risk factors set out in the Company's annual information form for the year ended December 31, 2023, which is available under the Company's Issuer profile on SEDAR+ at www.sedarplus.ca . Accordingly, readers should not place undue reliance on the forward-looking information contained in this press release.The Company makes no medical, treatment or health benefit claims about the Company's proposed products. The United States Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding tryptamine-based treatments or phenethylamine-based therapies. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of tryptamines, tryptamine derivatives or phenethylamines, phenethylamine derivatives can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not yet completed commercial clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy and safety of potential products do not imply that the Company verified such in commercial clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company's performance and operations.The forward-looking information contained in this news release represents the expectations of the Company as of the date of this news release and, accordingly, is subject to change after such date. Readers should not place undue importance on forward-looking information and should not rely upon this information as of any other date. The Company undertakes no obligation to update these forward-looking statements in the event that management's beliefs, estimates or opinions, or other factors, should change.The CBOE Exchange Inc. has neither approved nor disapproved the contents of this news release and is not responsible for the adequacy and accuracy of the contents herein.SOURCE: Biomind Labs Inc.

CAMBRIDGE, Mass.--( 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 third quarter ended September 30, 2024. “The third quarter of 2024 was highlighted by important progress in the development of EB-003, our neuroplastogenic molecule that is designed to address difficult-to-treat mental health disorders without inducing the hallucinogenic effect common to N,N-Dimethyltryptamine (DMT) and related analogs,” said Joseph Tucker, Ph.D., Director and CEO of Enveric. “Among the key achievements, data confirmed that EB-003 has the potential to be delivered via oral administration and penetrate the brain at levels expected to elicit the desired therapeutic effect. Additionally, preclinical safety and pharmacology studies confirmed that EB-003 targets desired serotonergic receptors while minimizing potentially harmful, off-target interactions common to serotonin-like drug compounds. These are clear differentiators for EB-003, which we believe will add to its value potential.” Dr. Tucker added: “Since the June FDA Advisory Committee hearing that raised numerous questions around the potential to approve MDMA for post-traumatic stress disorder, Enveric helped lead the discussion for how neuroplastogens with no or limited hallucinogenic effects might safely progress through clinical trials and gain approval for these patients in need while avoiding the challenges and complexities inherent to running trials with hallucination-inducing compounds. We chose to focus Enveric’s AI-backed drug development platform on reducing and removing hallucinations for our various candidates to mitigate these challenges during clinical development and to reduce barriers to wide adoption by physicians post approval.” Dr. Tucker continued: “In our opinion, drug technologies that minimize or eliminate the hallucinogenic effect in molecules targeting the 5-HT2A receptor have the potential to become the gold standard in one or more neuropsychiatric indications, given the advantages such compounds would offer, including the ability to conduct truly blinded placebo-controlled clinical trials and the potential to administer the therapy in an outpatient setting without psychotherapy support. Recognizing this, we are working to finalize the data package for the EB-003 Investigational New Drug (IND) application, which we anticipate submitting to the U.S. Food and Drug Administration in the second half of 2025.” Dr. Tucker concluded: “In parallel with our EB-003 development efforts, Enveric continues to seek to identify opportunities to secure out-licensing agreements for our other proprietary drug candidates. On this front, we were pleased to enter into separate licensing agreements with Aries Science & Technology and MycoMedica Life Sciences, and we anticipate announcing additional agreements over the coming months. These agreements not only validate the Company’s platform but also generate non-dilutive revenue to support the development of EB-003 and further building stockholder value.” THIRD QUARTER AND RECENT UPDATES Corporate, Product and Business Development Highlights: Confirmed oral bioavailability and significant brain exposure in preclinical studies of EB-003, supporting expedited development with IND filing and first patient dosed expected in 2025 Announced positive results from preclinical safety and pharmacology studies of EB-003, confirming the drug’s selective activity with desired serotonergic neuroreceptors and ability to minimize potential adverse cardiovascular and CNS events Presented foundational research involving EB-003 at the 7 th Neuropsychiatric Drug Summit and the European Behavioral Pharmacology Society Biennial Workshop Strengthened intellectual property estate for EVM301 portfolio and announced the issuance of five additional U.S. patents Executed licensing agreement with Aries Science & Technology to clinically develop and market Enveric’s patented product for radiation dermatitis Executed licensing agreement with MycoMedica Life Sciences to clinically develop and market Enveric’s EB-002 drug candidate THIRD QUARTER FINANCIAL RESULTS Net loss attributable to stockholders was $2.1 million for the third quarter ended September 30, 2024, including $0.5 million in net non-cash expense, with a basic and diluted loss per share of $0.24, as compared to a net loss of $2.8 million, including $0.2 million in net non-cash income, with a basic and diluted loss per share of $1.30 for the quarter ended September 30, 2023. The Company had cash-on-hand of $3.1 million for the quarter ended September 30, 2024. About Enveric Biosciences Enveric Biosciences (NASDAQ: ENVB) is a biotechnology company dedicated to the development of novel neuroplastogenic small-molecule therapeutics for the treatment of depression, anxiety, and addiction disorders. Leveraging its unique discovery and development platform, Psybrary™, Enveric has created a robust intellectual property portfolio of new chemical entities for specific mental health indications. Enveric’s lead program, EB-003, is a first-in-class approach to the treatment of difficult-to-address mental health disorders designed to promote neuroplasticity without inducing hallucinations in the patient. Enveric is 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,” “schedules,” “estimates,” “forecasts,” “intends,” “anticipates” or “does not anticipate,” or “believes,” or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, should, would, or might occur or be achieved. Forward-looking statements may include statements regarding beliefs, plans, expectations, or intentions regarding the future and are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability of Enveric to: negotiate and finalize definitive agreements based on any of its out-licensing term sheets and perform pursuant to the terms thereof; carry out successful clinical programs; achieve the value creation contemplated by technical developments; avoid delays in planned clinical trials; establish that potential products are efficacious or safe in preclinical or clinical trials; establish or maintain collaborations for the development of therapeutic candidates; obtain appropriate or necessary governmental approvals to market potential products; obtain future funding for product development and working capital on commercially reasonable terms; scale-up manufacture of product candidates; respond to changes in the size and nature of competitors; hire and retain key executives and scientists; secure and enforce legal rights related to Enveric’s products, including patent protection; identify and pursue alternative routes to capture value from its research and development pipeline assets; continue as a going concern; and manage its future growth effectively. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission, including Enveric’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.