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Awakn Life Sciences Provides Update on Aminoindane New Chemical Entity Patent Portfolio

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Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has provided an update on its aminoindane new chemical entity (NCE) patent portfolio. The company is developing novel small molecule empathogens with potential applications in trauma-related mental health disorders such as PTSD. Awakn's patent strategy, initiated in 2021, has progressed well across multiple jurisdictions:

- United States: Fast-tracked application under examination, with positive evaluations from the International Searching Authority.
- Europe: Application pending, with optimistic prospects for patent granting.
- Canada: Application pending examination, with potential for expedited process.

The European Patent Office examiner has confirmed the pharmaceutical composition and method of use claims for Awakn's lead compounds to be both novel and inventive. This progress indicates a promising path towards securing patent protection for Awakn's innovative therapeutics targeting substance use and mental health disorders.

Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) ha fornito un aggiornamento sul suo portafoglio di brevetti riguardanti nuove entità chimiche (NCE) a base di aminoindano. L'azienda sta sviluppando nuove piccole molecole empatiche con potenziali applicazioni nei disturbi mentali legati al trauma, come il PTSD. La strategia di brevetto di Awakn, avviata nel 2021, ha fatto progressi significativi in diverse giurisdizioni:

- Stati Uniti: Domanda accelerata in fase di esame, con valutazioni positive da parte dell'Autorità Internazionale di Ricerca.
- Europa: Domanda in attesa, con prospettive ottimistiche per l'assegnazione del brevetto.
- Canada: Domanda in attesa di esame, con potenziale per un processo accelerato.

Il perito dell'Ufficio Brevetti Europeo ha confermato che le rivendicazioni sulla composizione farmacologica e sul metodo d'uso dei composti di punta di Awakn sono sia nuove che inventive. Questo progresso indica un percorso promettente per ottenere la protezione brevettuale per le innovative terapie di Awakn mirate a disturbi legati all'uso di sostanze e alla salute mentale.

Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) ha proporcionado una actualización sobre su cartera de patentes de nuevas entidades químicas (NCE) de aminoindano. La empresa está desarrollando nuevas pequeñas moléculas empatógenas con aplicaciones potenciales en trastornos mentales relacionados con trauma, como el PTSD. La estrategia de patentes de Awakn, iniciada en 2021, ha progresado bien en múltiples jurisdicciones:

- Estados Unidos: Solicitud acelerada en examen, con evaluaciones positivas de la Autoridad Internacional de Búsqueda.
- Europa: Solicitud pendiente, con perspectivas optimistas para la concesión de patentes.
- Canadá: Solicitud pendiente de examen, con potencial para un proceso acelerado.

El examinador de la Oficina Europea de Patentes ha confirmado que las reivindicaciones sobre la composición farmacéutica y el método de uso de los compuestos líderes de Awakn son tanto nuevas como inventivas. Este progreso indica un camino prometedor hacia la obtención de protección de patentes para las innovadoras terapias de Awakn dirigidas a trastornos por uso de sustancias y de salud mental.

Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF)는 아미노인단 새 화학 물질(NCE) 특허 포트폴리오에 대한 업데이트를 제공했습니다. 이 회사는 PTSD와 같은 외상 관련 정신 건강 장애에 대한 잠재적 적용이 있는 새로운 소형 분자 공감 분자를 개발하고 있습니다. 2021년에 시작된 Awakn의 특허 전략은 여러 관할권에서 잘 진행되고 있습니다:

- 미국: 긍정적인 평가를 받은 신속 처리 신청이 진행 중입니다.
- 유럽: 특허 승인을 위한 희망적인 전망으로 신청이 대기 중입니다.
- 캐나다: 신속 처리 가능성이 있는 신청이 심사 대기 중입니다.

유럽 특허청 심사관은 Awakn의 주요 화합물에 대한 제약 조성과 사용 방법에 대한 청구가 모두 새롭고 발명적이라고 확인했습니다. 이러한 진전은 Awakn의 혁신적인 치료제가 물질 사용 및 정신 건강 장애를 목표로 하여 특허 보호를 확보하는 유망한 경로를 나타냅니다.

Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) a fourni une mise à jour sur son portefeuille de brevets concernant la nouvelle entité chimique (NCE) à base d'aminoindane. L'entreprise développe de nouvelles petites molécules empathogènes ayant des applications potentielles dans les troubles de la santé mentale liés au traumatisme, tels que le PTSD. La stratégie de brevet d'Awakn, lancée en 2021, a bien progressé dans plusieurs juridictions :

- États-Unis : Demande accélérée en cours d'examen, avec des évaluations positives de l'Autorité de Recherche Internationale.
- Europe : Demande en attente, avec des perspectives optimistes pour l'obtention du brevet.
- Canada : Demande en attente d'examen, avec un potentiel pour un processus accéléré.

Le spécialiste de l'Office Européen des Brevets a confirmé que les revendications concernant la composition pharmaceutique et le mode d'utilisation des composés principaux d'Awakn sont à la fois nouvelles et inventives. Ce progrès indique une voie prometteuse pour sécuriser la protection par brevet des thérapies innovantes d'Awakn ciblant l'usage de substances et les troubles de santé mentale.

Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) hat ein Update zu ihrem Patentportfolio für die neue chemische Substanz (NCE) Aminoindan bereitgestellt. Das Unternehmen entwickelt neue kleine Moleküle mit empathogenen Eigenschaften, die potenzielle Anwendungen bei traumaassoziierten psychischen Gesundheitsstörungen wie PTSD haben. Die Patentstrategie von Awakn, die 2021 initiiert wurde, hat sich in mehreren Jurisdiktionen gut entwickelt:

- Vereinigte Staaten: Beschleunigte Antragstellung in Prüfung, mit positiven Bewertungen von der Internationalen Suchbehörde.
- Europa: Antrag ausstehend, mit optimistischen Aussichten auf die Erteilung des Patents.
- Kanada: Antrag zur Prüfung ausstehend, mit Potenzial für einen beschleunigten Prozess.

Der Prüfer des Europäischen Patentamts hat bestätigt, dass die Ansprüche auf die pharmazeutische Zusammensetzung sowie das Verfahren zur Verwendung der führenden Verbindungen von Awakn sowohl neu als auch erfinderisch sind. Dieser Fortschritt deutet auf einen vielversprechenden Weg hin, um den Patentschutz für die innovativen Therapien von Awakn zu sichern, die auf Substanzgebrauch und psychische Gesundheitsstörungen abzielen.

Positive
  • Patent applications for Aminoindane NCEs progressing well in US, Europe, and Canada
  • Fast-tracked US application facilitated by Patent Prosecution Highway
  • European Patent Office examiner confirmed novelty and inventiveness of lead compounds
  • Potential application in PTSD, affecting approximately 33 million adults in US and key international markets
Negative
  • None.

Toronto, Ontario--(Newsfile Corp. - July 22, 2024) - Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder ("AUD"), is pleased to provide details of the status of the intellectual property ("IP") portfolio for its aminoindane new chemical entity ("NCE") series program (the "Aminoindane NCEs") being developed in commercial collaboration with Graft Polymer (UK) Plc (LSE: GPL) ("Graft"). Details of the commercial collaboration agreement with Graft were announced on July 18, 2024.

The Aminoindane NCEs

The Aminoindane NCEs are novel small molecule empathogens that promote the release of serotonin, dopamine, and noradrenaline while blocking their reuptake. These compounds have potential in trauma-related mental health disorders such as post-traumatic stress disorder ("PTSD"), which affects approximately 13 million[1] adults in the U.S. and 20 million[2,3,4] in key international markets.

Patent Status in the U.S. and Key International Markets

In 2021 Awakn filed provisional patent applications covering the Aminoindane NCEs, their pharmaceutical compositions, and innovative treatment methods for substance use and mental health disorders. The patent portfolio is now progressing well across multiple jurisdictions:

  • United States: The fast-tracked U.S. application, facilitated by the Patent Prosecution Highway ("PPH"), is under examination. Positive evaluations from the International Searching Authority ("ISA") suggest a promising path to a granted U.S. patent.

  • Europe: The European application is pending, with substantive examination expected to begin soon. European patent counsel is optimistic about securing a granted patent, particularly for claims deemed novel and inventive by the European Patent Office ("EPO") examiner.

  • Canada: The Canadian application, pending examination, also holds strong prospects for a granted patent. The examination process in Canada can be expedited using the PPH, enhancing IP protection efficiency.

IP Protection Progress to Date

In May 2021, Awakn initiated its IP protection strategy for the Aminoindane NCEs by filing two provisional patent applications. These applications cover the Aminoindane NCEs, their pharmaceutical compositions, and innovative methods for treating substance use disorders and mental health disorders. This foundational step laid the groundwork for subsequent advancements in IP protection.

In May 2022, Awakn filed a Patent Cooperation Treaty ("PCT") application, claiming the benefit of priority to both provisional applications.

In August 2022, an examiner from the EPO, acting as the ISA, issued a search report and written opinion, confirming the pharmaceutical composition and method of use claims for all of Awakn's lead compounds to be both novel and inventive.

In November 2022, the PCT application published as WO2022/238507A1.

In November 2023, the International Preliminary Report on Patentability was received and Awakn entered the PCT into national phase in the US and Canada, and in December, into European regional phase.

In April 2024, a petition to accept the U.S. application onto the PPH was granted based on the novel and inventive claims deemed allowable in the PCT written opinion, indicating a likely U.S. patent grant.

Prof. David Nutt, Awakn's Chief Scientific Officer, commented, "These advancements in our patent portfolio are a testament to the innovative potential of our Aminoindane NCEs. We are committed to progressing these compounds through the development pipeline to address the substantial unmet needs in mental health and addiction treatment."

About Awakn Life Sciences Corp.

Awakn Life Sciences Corp. is a clinical-stage biotechnology company developing therapeutics targeting substance use and mental health disorders. Awakn has a near-term focus on Alcohol Use Disorder, a condition affecting approximately 29 million adults in the US and approximately 40 million in the US and key European markets for which the current standard of care is inadequate. Our goal is to provide breakthrough therapeutics to addiction sufferers in desperate need and our strategy is focused on commercialising our R&D pipeline across multiple channels.

www.awaknlifesciences.com | LinkedIn | X (formerly Twitter)

About Graft Polymer (UK) Plc

Graft Polymer (UK) Plc (LSE: GPL) is an innovative developer of biopolymer drug delivery systems dedicated to assisting biopharmaceutical companies in enhancing the effectiveness of their therapeutics. Our proprietary patented platform, a bioabsorbable self-nanoemulsifying drug delivery system (SNEDDS), represents a cutting-edge solution in drug delivery technology. By integrating active pharmaceutical ingredients (APIs) into our novel, patented delivery systems, we enable clients to improve the bioavailability, pharmacokinetics, and stability of their therapeutics.

www.graftpolymer.co.uk | LinkedIn | X (formerly Twitter)

Notice Regarding Forward-Looking Information

This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.

Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.

Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.

Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony@awaknlifesciences.com

Sources

  1. US VA National Center for PTSD. US Department of Veterans Affairs.
  2. UK National Health Service (NHS), Adult Psychiatric Morbidity Survey: Survey of Mental Health and Wellbeing, England, 2014.
  3. Maercker, A., Forstmeier, S., Wagner, B. et al. Posttraumatische Belastungsstörungen in Deutschland. Nervenarzt 79, 577-586 (2008).
  4. Nemeroff, Charles B., and others, 'Trauma and PTSD in Europe', in Charles B. Nemeroff, and Charles Marmar (eds), Post-Traumatic Stress Disorder (New York, 2018; online edn, Oxford Academic, 1 Sept. 2018)

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/217376

FAQ

What is the current status of Awakn Life Sciences' (AWKNF) patent applications for Aminoindane NCEs?

Awakn's patent applications for Aminoindane NCEs are progressing well across multiple jurisdictions. The US application is under fast-tracked examination, the European application is pending with optimistic prospects, and the Canadian application is pending examination with potential for expedited process.

What potential market does Awakn Life Sciences (AWKNF) target with its Aminoindane NCEs?

Awakn's Aminoindane NCEs target trauma-related mental health disorders, particularly PTSD, which affects approximately 13 million adults in the US and 20 million in key international markets, totaling about 33 million potential patients.

When did Awakn Life Sciences (AWKNF) initiate its IP protection strategy for Aminoindane NCEs?

Awakn initiated its IP protection strategy for Aminoindane NCEs in May 2021 by filing two provisional patent applications covering the compounds, their pharmaceutical compositions, and innovative treatment methods.

What was the outcome of the European Patent Office examination for Awakn Life Sciences' (AWKNF) Aminoindane NCEs?

In August 2022, an examiner from the European Patent Office, acting as the International Searching Authority, confirmed that the pharmaceutical composition and method of use claims for all of Awakn's lead compounds were both novel and inventive.

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