Commercial Collaboration

23 July 2024

Graft Polymer (UK) plc

("Graft Polymer" or the "Company")

Update on collaboration with Awakn Life Sciences

Patent Authority evaluations indicate promising path to U.S. patents being granted

Further to the investment and commercial collaboration with Awakn Life Sciences ("Awakn") announced on 18 July 2024, the Company wishes to highlight the details of an announcement made by Awakn after markets closed yesterday  in Canada.

Awakn's announcement relates to Graft Polymer's interest in the aminoindane new chemical entity ("NCE") series (the "Aminoindane NCEs"), a novel treatment under development targeting trauma related mental health disorders such as Post Traumatic Stress Disorder (PTSD).

PTSD, for example, is thought to affect approximately 13^[1] million adults in the USA and 20 million^[2,3,4] in other key international markets. It is a growing and largely unresolved healthcare challenge.

The Aminoindane NCEs are small molecule empathogens that promote the release of serotonin, dopamine, and noradrenaline while blocking their reuptake.

Patent status in key international markets

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

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

·     Europe: The European patent application is pending, with substantive examination expected to begin soon. European patent counsel is optimistic about securing a granted patent,  as claims were already deemed novel and inventive by a European Patent Office ("EPO") examiner during the international stage,

·     Canada: The Canadian patent 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.

Prof. David Nutt, Awakn's Chief Scientific Officer, Awakn, commented,

"The advancements in Awakn's patent portfolio point towards the potential of our innovative Aminoindane NCEs. We are committed to progressing these compounds through the development pipeline, funded by Graft Polymer, to address the substantial unmet needs in mental health and addiction treatment."

IP protection progress to date

Following Awakn's patent applications in May 2021, Awakn filed a Patent Cooperation Treaty ("PCT") application, claiming the benefit of priority to both provisional applications in May 2022,

.

In August 2022, an EPO examiner, 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.

The PCT application published as WO2022/238507A1 in November 2022.

In November 2023, Awakn's PCT application entered the national phase in the US and Canada, and in December, the PCT application entered the European regional phase.

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

Anthony Tennyson, CEO, commented,

"I'm delighted with Awakn's continual progress and commitment to the deployment of our substantial investment and onward focus on our mutual collaboration.

"We wish to maintain regular market updates as they arise."

Enquiries:

Graft Polymer (UK) Plc
Anthony Tennyson, CEO and Executive Director
Email: anthonytennyson@graftpolymer.co.uk

Yifat Steuer, CFO and Executive Director
Email: yifat@graftpolymer.co.uk

Allenby Capital (Broker)

Nick Naylor / Liz Kirchner (Corporate Finance) | Guy McDougall (Sales) 

+44 (0) 20 3328 5656 

About Graft Polymer (UK) Plc

Graft Polymer plc ("Graft Polymer") (LSE:GPL) is an innovative biopolymer drug delivery systems development company dedicated to enabling biopharmaceutical companies to enhance the effectiveness of their therapeutics. Our proprietary 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 pharmacokinetics, bioavailability, and stability of their therapeutics..

For more information, please visit www.graftpolymer.co.uk.

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.

For more information, please visit 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)