(+)-Epicatechin

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 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 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: Coherent Market Insights. https://www.coherentmarketinsights.com/market-insight/neuroplasticity-market-6032/market-size-and-trends 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.

Tea contains flavonoids such as catechins, which have numerous health benefits. Now, researchers reveal that the glazing on ceramic tea sets plays a crucial role in retaining the beneficial components of tea. By examining the effects of different glazes on the catechin content in green tea, they find that the choice of glaze materials affects the concentration of these compounds, as well as the color and flavor of tea. Tea contains flavonoids such as catechins, which have numerous health benefits. Now, researchers from Nagoya Institute of Technology, Japan, reveal that the glazing on ceramic tea sets plays a crucial role in retaining the beneficial components of tea. By examining the effects of different glazes on the catechin content in green tea, they find that the choice of glaze materials affects the concentration of these compounds, as well as the color and flavor of tea. Introduced as a medicinal drink around 2700 B.C., tea has grown to be the one of the most popular beverages worldwide. One of the key reasons for its popularity is its rich content of flavonoids and polyphenols, which contribute to the antioxidant property, flavor, and aroma of tea, offering various potential health benefits. These compounds are extracted from tea leaves during brewing and can be influenced by several factors, such as water temperature, brewing time, and the materials used in tea preparation vessels. Recently, researchers from Nagoya Institute of Technology (NITech) in Japan have revealed, for the first time, that the choice of glazing on ceramic tea sets used to prepare tea plays a key role in the retention of catechin flavonoids. In their study published online in the journal Scientific Reports on June 28, 2023, Associate Professor Takashi Shirai, along with Dr. Yunzi Xin, Mr. Sota Shido, and Dr. Kunihiko Kato from the Advanced Ceramics Research Center at NITech, examined the impact of four different typical Japanese commercial glazes -- Oribe, Namako, Irabo, and Toumei -- on the content of catechins, the most abundant flavonoid found in green tea. While glaze coatings primarily consist of feldspar minerals, such as silicon, aluminum, sodium, and calcium oxides, they also contain distinct metal oxide species that impart a unique appearance and texture to the ceramic vessel. Oribe glaze predominantly contains copper (Cu) oxides and imparts a vibrant green color, while Namako glaze contains cobalt (Co) oxides for a dark blue appearance. Irabo glaze contains iron (Fe) oxides that impart orange tones, while Toumei glaze has a high titanium (Ti) content, providing a transparent finish. To examine the effect of the glaze on tea catechins, the researchers brewed a green tea solution using ion-exchanged water at 80°C for three minutes. The tea leaves were separated, and the supernatant (liquid lying above solid residue) was mixed with glaze powders coated on ceramic tiles. The glaze-tea mixture was then allowed to react for six hours, followed by the removal of the glaze powder through centrifugation and filtration. The researchers observed that the pristine tea solution had a clear bright yellow color, but after six hours of degradation, it turned into a yellowish-brown color. In contrast, the tea solutions degraded by different glazes exhibited darker black or brown colors. In other words, the extent of color change depended significantly on the type of glaze. Additionally, the researchers also observed a selective reduction in the amount of altered catechins in tea. The tea solutions mixed with Oribe, Namako, and Irabo glazes showed significantly lower concentrations of epicatechin, epicatechin gallate, epigallocatechin, and epigallocatechin gallate, while the Toumei glaze selectively degraded epigallocatechin gallate. The reduction in catechin concentration and the resulting color change can be attributed to the oxidation process of catechins, which forms brownish thearubigins and reddish-orange theaflavin and its oxide pigments. "During the degradation process, Cu-, Co-, Fe-, and Ti-oxides in glaze powders can act as a Lewis acid catalyst and promote the oxidation of catechin molecules to ortho-quinones, followed by further reaction to form thearubigins and/or theaflavin and its oxides. Another oxidation route is through the polymerization of intermediate free radical catechins," explains Dr. Shirai. "And it is very interesting that thearubigins and theaflavins are the main components of fermented tea like black tea. In other words, green tea brewed by specific ceramic tea sets can be turned into black tea." In summary, this study highlights that the choice of glaze materials used in ceramic tea sets can significantly affect the concentration of beneficial compounds such as catechins in tea. "The specific function of glazes on the degradation of catechins not only provides principal information for the design and development of functional materials but can also impact daily tea drinking and long-term human health-related issues," concludes Dr. Shirai.