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Aries Science & Technology and Enveric Biosciences Announce Issuance of Key US Patent Under Aries’ License for Treatment of Radiation Dermatitis and Other Conditions

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Enveric Biosciences (NASDAQ: ENVB) and Aries Science & Technology announced the issuance of Patent No. 12,059,393 to Enveric's subsidiary, Akos Biosciences, for a topical product aimed at treating radiation dermatitis. This condition affects approximately two million cancer patients annually, with a market opportunity estimated at $400 million. The patent issuance follows a Licensing Agreement between Aries and Akos for the clinical development of the CBD-based lotion. Aries is forming a subsidiary to advance this opportunity, with Dr. Hari Harikumar nominated as Chairman-elect. Under the agreement terms, Enveric could receive up to $61 million in milestone payments and tiered royalties ranging from 2.5% to 10% on future sales.

Enveric Biosciences (NASDAQ: ENVB) e Aries Science & Technology hanno annunciato l'emissione del Brevetto No. 12,059,393 per la sussidiaria di Enveric, Akos Biosciences, relativo a un prodotto topico destinato a trattare la dermatite da radiazione. Questa condizione colpisce circa due milioni di pazienti affetti da cancro ogni anno, con un'opportunità di mercato stimata in 400 milioni di dollari. L'emissione del brevetto segue un Accordo di Licenza tra Aries e Akos per lo sviluppo clinico della lozione a base di CBD. Aries sta formando una sussidiaria per avanzare in questa opportunità, con il Dott. Hari Harikumar nominato Presidente eletto. Sotto i termini dell'accordo, Enveric potrebbe ricevere fino a 61 milioni di dollari in pagamenti per traguardi e royalties scalari che vanno dal 2,5% al 10% sulle vendite future.

Enveric Biosciences (NASDAQ: ENVB) y Aries Science & Technology anunciaron la emisión del Patente No. 12,059,393 a la subsidiaria de Enveric, Akos Biosciences, para un producto tópico destinado al tratamiento de la dermatitis por radiación. Esta condición afecta aproximadamente a dos millones de pacientes con cáncer anualmente, con una oportunidad de mercado estimada de 400 millones de dólares. La emisión de la patente sigue un Acuerdo de Licencia entre Aries y Akos para el desarrollo clínico de la loción a base de CBD. Aries está formando una subsidiaria para avanzar en esta oportunidad, con el Dr. Hari Harikumar nominado como Presidente electo. Según los términos del acuerdo, Enveric podría recibir hasta 61 millones de dólares en pagos por hitos y regalías escalonadas que varían del 2.5% al 10% sobre las ventas futuras.

Enveric Biosciences (NASDAQ: ENVB)와 Aries Science & Technology가 Enveric의 자회사인 Akos Biosciences에 대해 특허 번호 12,059,393를 발부했다고 발표했습니다. 이는 방사선 피부염 치료를 위한 국소 제품에 해당합니다. 이 질환은 매년 약 200만 명의 암 환자에게 영향을 미치며, 시장 기회는 4억 달러로 추정됩니다. 특허 발급은 Aries와 Akos 간의 CBD 기반 로션 임상 개발을 위한 라이센스 계약에 따른 것입니다. Aries는 이 기회를 발전시키기 위해 자회사를 형성하고 있으며, 하리 하리쿠마 박사가 의장 후보로 지명되었습니다. 계약 조건에 따라 Enveric은 6,100만 달러의 이정표 지급금향후 판매에 대해 2.5%에서 10%까지의 단계별 로열티를 받을 수 있습니다.

Enveric Biosciences (NASDAQ: ENVB) et Aries Science & Technology ont annoncé l'émission du Brevet No. 12,059,393 à la filiale d'Enveric, Akos Biosciences, pour un produit topique visant à traiter la dermatite d'irradiation. Cette condition touche environ deux millions de patients atteints de cancer chaque année, avec une opportunité de marché estimée à 400 millions de dollars. L'émission du brevet fait suite à un Accord de Licence entre Aries et Akos pour le développement clinique de la lotion à base de CBD. Aries met en place une filiale pour faire avancer cette opportunité, avec Dr. Hari Harikumar nommé Président élu. Selon les termes de l'accord, Enveric pourrait recevoir jusqu'à 61 millions de dollars en paiements d'étapes et des redevances échelonnées allant de 2,5 % à 10 % sur les ventes futures.

Enveric Biosciences (NASDAQ: ENVB) und Aries Science & Technology haben die Erteilung des Patents Nr. 12,059,393 an Enverics Tochtergesellschaft, Akos Biosciences, für ein topisches Produkt zur Behandlung der Strahlungsdermatitis bekannt gegeben. Diese Erkrankung betrifft jährlich etwa zwei Millionen Krebspatienten, mit einer geschätzten Marktchance von 400 Millionen US-Dollar. Die Patenterteilung erfolgt im Rahmen einer Lizenzvereinbarung zwischen Aries und Akos für die klinische Entwicklung der CBD-basierten Lotion. Aries gründet eine Tochtergesellschaft, um diese Gelegenheit voranzutreiben, mit Dr. Hari Harikumar, der zum designierten Vorsitzenden ernannt wurde. Gemäß den Bedingungen des Vertrags könnte Enveric bis zu 61 Millionen US-Dollar an Meilensteinzahlungen und gestaffelte Lizenzgebühren von 2,5% bis 10% auf zukünftigen Verkäufen erhalten.

Positive
  • Patent No. 12,059,393 issued for topical product treating radiation dermatitis
  • Market opportunity for radiation dermatitis treatment estimated at $400 million annually
  • Potential for up to $61 million in milestone payments from licensing agreement
  • Tiered royalties ranging from 2.5% to 10% on future sales
  • Formation of Aries subsidiary to advance CBD-based lotion development
Negative
  • None.

Insights

The issuance of this key US patent significantly bolsters Enveric Biosciences' intellectual property portfolio, potentially enhancing its market position in the $400 million annual radiation dermatitis treatment market. The licensing agreement with Aries Science & Technology could generate up to $61 million in milestone payments and 2.5-10% in tiered royalties for Enveric. This deal structure allows Enveric to focus on its core neuroplastogen pipeline while still benefiting from the CBD-based radiation dermatitis treatment's potential success. However, investors should note that milestone payments and royalties are contingent on the product's successful development and commercialization, which carries inherent risks in the biotech sector.

The newly patented CBD-based topical product for radiation dermatitis addresses a significant unmet medical need, potentially benefiting approximately two million cancer patients annually. Early-stage animal tests have shown promising results, which is encouraging. However, it's important to remember that success in animal studies doesn't guarantee efficacy in human trials. The formation of a dedicated subsidiary by Aries to advance this product, along with the appointment of an experienced chairman, suggests a strong commitment to its development. This focused approach could accelerate the product's path to market, but investors should remain cautious as clinical trials and regulatory approvals are still pending.

The issuance of Patent No. 12,059,393 strengthens Enveric's competitive position in the radiation dermatitis treatment space. The patent likely covers novel formulation techniques or delivery mechanisms for CBD, which could provide a significant barrier to entry for competitors. Aries' expertise in encapsulation technologies complements this patent, potentially leading to a more effective or differentiated product. However, the CBD space is increasingly crowded and other companies may be developing competing technologies. Investors should monitor the broader patent landscape and emerging technologies in this field to assess the long-term value of this intellectual property.

Enveric and Aries recently announced a Licensing Agreement for patented topical product aimed at treating radiation dermatitis, which impacts approximately two million cancer patients per year and has a market opportunity estimated at $400 million annually

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Enveric Biosciences (NASDAQ: ENVB) (“Enveric”), a biotechnology company dedicated to the development of novel neuroplastogens for the treatment of neuropsychiatric disorders, and Aries Science & Technology (“Aries”), a developer of encapsulation technologies, today announced that Patent No. 12,059,393 was issued on August 13, 2024, to Enveric’s wholly-owned subsidiary, Akos Biosciences, Inc. (“Akos”).

We believe the newly issued intellectual property strengthens Enveric’s patent portfolio. On July 15, 2024, Enveric announced entering into a Licensing Agreement between Aries and Akos for the clinical development of Enveric’s now-patented topical product for radiation dermatitis and other conditions (“Licensing Agreement”).

“The additional patent issuance greatly enhances investment potential in the subsidiary being formed by Aries to advance a CBD-based lotion, which has demonstrated promising preliminary results in early-stage animal tests conducted by Enveric,” said Dr. Ramanathan Lalgudi, Founder and CEO of Aries. “We believe the newly issued patent is key to launching a protectable and proprietary formulation, as we work to develop treatments to reduce the side effects and increase the tolerance of radiation therapy and enhance the life of millions of cancer patients suffering from radiation dermatitis.”

Aries earlier announced its nomination of Hari Harikumar, Ph.D., as Chairman-elect of an Aries subsidiary being formed to advance this opportunity. Dr. Harikumar is a successful techno-commercial entrepreneur having experience with multiple companies.

“We believe the patent issuance and Aries’ commitment to this novel technology strongly validates both the potential economic and commercial benefit of Enveric’s innovations and our commitment to providing solutions that address patient needs,” said Joseph Tucker, Ph.D., CEO of Enveric. “We deeply value Enveric’s relationship with Aries and are confident in their ability to develop the CBD product and bring it to patients.”

“The out-licensing of the CBD-related technology, and our ongoing relationship with Aries, supports Enveric’s mission by allowing us to focus our resources on the development of our lead neuroplastogen drug candidate, EB-003, for the treatment of critical neuropsychiatric disorders,” said Dr. Tucker.

Under the terms of the Licensing Agreement with Aries, assuming success in meeting all conditions in the Licensing Agreement, Enveric will be eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales.

About Aries Science and Technology LLC

Aries has research laboratories In Columbus, Ohio and possesses deep technical expertise relevant to the envisioned product forms. Aries is planning to establish an investable subsidiary focused on completing development, commercialization and launch of the topical product and projects a potential product pipeline featuring multiple patented formulations.

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™, 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 also developing EB-002, formerly EB-373, a next generation synthetic prodrug of the active metabolite, psilocin, being studied as a treatment of psychiatric disorders. 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: negotiate and finalize definitive agreements based on the 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.

Investor Relations

Tiberend Strategic Advisors, Inc.

David Irish

(231) 632-0002

dirish@tiberend.com

Media Relations

Tiberend Strategic Advisors, Inc.

Casey McDonald

(646) 577-8520

cmcdonald@tiberend.com

Source: Enveric Biosciences

FAQ

What is the market size for Enveric Biosciences' (ENVB) radiation dermatitis treatment?

The market opportunity for Enveric Biosciences' radiation dermatitis treatment is estimated at $400 million annually, affecting approximately two million cancer patients per year.

What patent did Enveric Biosciences (ENVB) receive for its radiation dermatitis treatment?

Enveric Biosciences' subsidiary, Akos Biosciences, received Patent No. 12,059,393 on August 13, 2024, for their topical product aimed at treating radiation dermatitis and other conditions.

What are the potential financial benefits for Enveric Biosciences (ENVB) from the licensing agreement with Aries?

Under the licensing agreement with Aries, Enveric Biosciences is eligible to receive aggregate milestone payments of up to $61 million, as well as tiered royalties ranging from 2.5% to 10% on future sales.

Who has been nominated as Chairman-elect of the Aries subsidiary for Enveric Biosciences' (ENVB) radiation dermatitis treatment?

Dr. Hari Harikumar has been nominated as Chairman-elect of the Aries subsidiary being formed to advance the development of the CBD-based lotion for radiation dermatitis treatment.

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