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About Awakn Life Sciences Corp. (AWKNF)
Awakn Life Sciences Corp. is a clinical-stage biotechnology company dedicated to transforming the treatment landscape for substance use and mental health disorders. With a primary focus on Alcohol Use Disorder (AUD) and trauma-related mental health conditions such as Post-Traumatic Stress Disorder (PTSD), Awakn is addressing significant unmet medical needs in these areas. The company leverages cutting-edge research, innovative therapeutics, and strategic partnerships to develop breakthrough treatments that offer hope to millions globally.
Core Business Areas
1. Alcohol Use Disorder (AUD): Awakn is pioneering the development of novel medication-assisted therapies for AUD, a condition affecting approximately 29 million adults in the U.S. and 40 million across the U.S. and key European markets. Its flagship programs include:
- AWKN-001: A combination therapy involving intravenously delivered ketamine and cognitive behavioral therapy (CBT) for severe AUD. The Phase 3 trial, 'MORE-KARE,' is being conducted across multiple NHS sites in the UK, with promising Phase 2 results showing 86% abstinence over six months post-treatment.
- AWKN-002: A proprietary oral thin film (OTF) formulation of esketamine for sublingual and buccal administration, designed for moderate to severe AUD. Supported by the FDA's 505(b)(2) pathway, AWKN-002 is poised for Phase 2b trials in the U.S.
2. Trauma-Related Mental Health Disorders: Awakn is advancing its aminoindane new chemical entity (NCE) program, which targets PTSD and other trauma-related conditions. These novel compounds aim to enhance social cognition and pro-social behaviors, offering a potentially safer and more effective alternative to existing treatments.
Research and Development (R&D) Pipeline
Awakn's R&D efforts are driven by a robust pipeline that includes:
- AWKN-001: Currently in Phase 3 trials, this therapy combines ketamine with structured psycho-social support to address severe AUD.
- AWKN-002: A next-generation esketamine formulation aimed at improving accessibility and efficacy for AUD patients.
- AWKN-SND-14: A preclinical program exploring serotonin, dopamine, and noradrenaline modulators for PTSD and related disorders.
These programs are supported by strategic collaborations with leading research institutions, including the University of Exeter and the University of Nottingham, and partnerships with innovative companies like Graft Polymer.
Competitive Positioning
Awakn differentiates itself through its focus on high-efficacy, science-backed treatments for addiction and mental health. Its proprietary therapies, such as AWKN-001 and AWKN-002, have demonstrated superior outcomes compared to traditional treatments. Additionally, its aminoindane NCE program positions Awakn at the forefront of next-generation mental health therapeutics. The company’s strong intellectual property portfolio, validated by international patent filings, further reinforces its competitive edge.
Market Significance
The global addiction and mental health treatment markets are substantial, with the AUD treatment segment alone valued at billions annually. Despite this, current treatment options often fail to deliver long-term efficacy. Awakn’s innovative solutions aim to fill this gap, offering scalable, effective therapies that address both the medical and economic burdens of these conditions.
Strategic Vision
Awakn’s strategy is centered on commercializing its R&D pipeline through multiple channels, including licensing agreements, clinical partnerships, and direct commercialization. Recent licensing partnerships, such as the agreement with Rivus Wellness and Research Institute, highlight its scalable business model. By integrating advanced drug delivery systems and leveraging its proprietary protocols, Awakn aims to set a new standard in addiction and mental health care.
Conclusion
Awakn Life Sciences Corp. is redefining the approach to treating substance use and mental health disorders through groundbreaking science and strategic collaborations. With a robust pipeline, a focus on high-impact conditions like AUD and PTSD, and a commitment to innovation, Awakn is well-positioned to make a lasting impact in the biotechnology and mental health industries.
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has announced significant progress in its pre-clinical program for developing therapeutics for trauma-related mental health disorders, particularly Post-Traumatic Stress Disorder (PTSD). The program, executed in collaboration with Graft Polymer, has identified two chemical series as co-leads for further development and established their synthesis pathways. Awakn has selected Charnwood Discovery as its synthesis partner and filed a provisional patent for a new class of aminoindane chemical entities and their derivatives. This progress aims to address the needs of approximately 13 million adults in the U.S. and 20 million collectively in key international markets affected by PTSD.
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has announced the screening of the first patient in its landmark 'MORE-KARE' Phase 3 trial of AWKN-001 for severe Alcohol Use Disorder (AUD). This trial, co-funded by the UK's Medical Research Council, National Institute for Health and Care Research, and Awakn, aims to evaluate the effectiveness of ketamine-assisted therapy for AUD.
The study will assess the impact of a single treatment cycle of AWKN-001, which combines intravenous ketamine with psycho-social support. The primary endpoint is the reduction in heavy drinking days over six months post-treatment. With a total cost of £2.4 million (CAD 4.2 million), this is the largest study of its kind and could potentially revolutionize AUD treatment.
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has closed a third tranche of its non-brokered private placement, issuing 428,571 units at $0.46 per unit for additional gross proceeds of $197,143. Each unit comprises one common share and 0.75 of a warrant, with each whole warrant allowing the purchase of one common share at $0.63 for five years. The company has also extended the expiry date of 5,610,920 warrants with an exercise price of $0.68. Proceeds will fund general working capital. The securities are subject to a four-month hold period, and the warrant extension includes a related party transaction exempt from formal valuation and minority approval requirements.
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) has entered into a commercial collaboration agreement with Graft Polymer (UK) Plc (LON: GPL) to develop Awakn's novel aminoindane new chemical entity series programme. The collaboration aims to develop potential treatments for trauma-related mental health disorders, particularly post-traumatic stress disorder (PTSD).
Key points of the agreement include:
- Graft will initially contribute £300,000 and expertise in novel drug delivery systems
- Awakn will contribute intellectual property and development expertise
- Future funding will be split equally between the companies
- Graft will receive a 40% royalty of future net income generated by the Aminoindane NCEs
- The program will be led by Awakn's Chief Scientific Officer, Prof. David Nutt
Awakn Life Sciences announced the closing of a second tranche of its non-brokered private placement, raising an additional $394,285 by issuing 857,142 units at $0.46 per unit.
Each unit consists of one common share and 0.75 of a common share purchase warrant, allowing purchase of one common share at $0.63 for five years. The proceeds will fund the company's working capital. Securities from the offering are subject to a four-month plus one-day hold period.
The offering is not registered under the U.S. Securities Act and cannot be sold within the United States without proper registration or exemption.
Awakn Life Sciences Corp. is facing a potential cease-trade order due to the late filing of its audited annual financial statements and MD&A for the financial year ended January 31, 2024. The company delisted its common shares from Cboe Canada and listed them on the Canadian Securities Exchange, resulting in a condensed timeline for filing. If the financial statements are not filed by May 7, 2024, a cease-trade order may be issued by the Ontario Securities Commission. Awakn has applied for a management cease trade order to allow non-directors, officers, and insiders to continue trading in their securities.
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