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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 (AWKNF) has entered into an arrangement agreement with Solvonis Therapeutics for a complete acquisition. Under the deal, Awakn shareholders will receive 46.67 Solvonis shares for each Awakn share, representing a 53.52% premium to Awakn's closing price on December 13, 2024.
The transaction will result in existing Awakn and Solvonis shareholders owning approximately 47.47% and 52.53% of Solvonis respectively. The deal requires approval from both companies' shareholders, regulatory clearances, and completion of Solvonis' equity financing. The transaction is expected to close in Q2 2025.
Additionally, Awakn announced plans to settle CAD$160,000 in debt through the issuance of 1,000,000 shares and will issue 260,000 shares to Equasy Enterprises for intellectual property obligations.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) provided updates on three R&D programs targeting substance use and mental health disorders:
1. AWKN-001: A Phase 3 ketamine-based combination therapy with CBT for severe Alcohol Use Disorder (AUD) in the UK, co-funded with MRC/NIHR. Awakn's costs are capped at £800,000. Targeting 8-10 years market exclusivity.
2. AWKN-002: A proprietary oral thin film esketamine formulation for moderate to severe AUD in the US. FDA confirmed 505(b)(2) NDA pathway eligibility with no additional clinical data needed before Phase 2b trials. IND submission planned for H2 2025, with Phase 2b trial application in H1 2026.
3. AWKN-SND-14: Pre-clinical serotonin, dopamine, and noradrenaline modulators for trauma-related disorders, including PTSD, designed to promote pro-social behavior with potentially improved safety profile.
Awakn Life Sciences (CSE: AWKN, OTC: AWKNF) announces a positive Pre-IND meeting outcome with the FDA for AWKN-002, their proprietary oral thin film formulation of esketamine for Alcohol Use Disorder (AUD) treatment. The FDA meeting, held on December 16, 2024, confirmed that no additional clinical data is needed before initiating a Phase 2b trial.
The FDA agreed to review AWKN-002 under the 505(b)(2) New Drug Application pathway, allowing the use of data from an approved esketamine product once a scientific bridge between AWKN-002 and the reference product is established. The company plans to submit its IND application and begin Phase 2b clinical trials after establishing this scientific bridge.
Awakn Life Sciences (OTCQB: AWKNF) has secured an unsecured credit facility of up to US$535,000 from an arm's length creditor. The facility can be drawn in multiple advances and is evidenced by a grid promissory note. The principal will be due on December 5, 2026, bearing a 10% annual interest rate payable at maturity.
The funds will be used for general working capital purposes while the company advances its research and development projects. Awakn is currently progressing with AWKN-001 in phase 3 trials in the UK and AWKN-002 in phase 2 planning in the US.
Awakn Life Sciences (AWKNF) has entered into a binding letter of intent with Graft Polymer (UK) PLC for a proposed acquisition. Under the agreement, Graft will acquire all of Awakn's issued and outstanding common shares, RSUs, and DSUs. Shareholders will receive 46.67 Graft shares for each Awakn share, valuing Awakn shares at $0.20 each - a 110.54% premium to the December 13 closing price.
The total acquisition price is $8,890,194, with 2,074,378,592 consideration shares to be issued. The transaction must complete by June 15, 2025, and is subject to various approvals including shareholders, regulatory bodies, and court approval. Following completion, Awakn will delist from CSE and cease to be a reporting issuer in Canada.
Awakn Life Sciences has announced promising initial results from a preclinical study of its aminoindane series (AW21003) conducted at the University of Nottingham. The study focuses on developing new therapeutic options for trauma-related mental health disorders, particularly PTSD.
The compound AW21003 demonstrated enhanced social interaction and information transfer capabilities while showing a favorable safety profile compared to MDMA, with no observed stereotyped behaviors like flat body posture or lateral head weaving. The research targets a significant market, with PTSD affecting approximately 13 million adults in the U.S. and 20 million across the U.S., UK, and Europe.
Following these results, Awakn plans to expand its aminoindane program by synthesizing additional compounds in collaboration with Concept Life Sciences and conducting further preclinical behavioral studies at the University of Nottingham.
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has opened four additional clinical trial sites for its Phase 3 'MORE-KARE' trial of AWKN-001, a novel treatment for severe Alcohol Use Disorder (AUD). This brings the total active trial sites to 7 across the UK. AWKN-001 combines intravenous ketamine with psycho-social support.
The study, co-funded by the UK's Medical Research Council, National Institute for Health and Care Research, and Awakn, aims to evaluate the efficacy of a single treatment cycle of AWKN-001. Participants will receive varying doses of ketamine infusion and psycho-social support, with both participants and researchers blinded to the assignments.
This landmark trial is the largest of its kind investigating ketamine-assisted therapy for AUD, with an estimated total cost of £2.4 million / CAD 4.2 million. Awakn is contributing £0.8 million / CAD 1.4 million to the study, which is being conducted at eight NHS sites across the UK.
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has partnered with the University of Nottingham for in vivo testing of its aminoindane New Chemical Entity (NCE) pre-clinical program. The study, led by Dr. Madeleine King, will evaluate Awakn's co-lead aminoindane series for its potential to enhance social cognition and pro-social behaviors.
The research will use the Social Transmission of Food Preferences (STFP) test in rodent models over a two-month period, with results expected by the end of 2024. This collaboration follows Awakn's recent partnership with Eurofins Discovery for in vitro pharmacology testing of the same aminoindane series.
Awakn's aminoindane NCE program, developed with Graft Polymer (UK) Plc, aims to create new therapeutic options for trauma-related mental health disorders, particularly PTSD, which affects approximately 13 million adults in the U.S. and 20 million individuals across the U.S., UK, and Europe.
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has selected Eurofins Discovery to conduct initial pharmacology testing for its co-lead aminoindane series as part of its New Chemical Entity (NCE) pre-clinical program. This collaboration marks a significant milestone in Awakn's mission to develop next-generation therapeutics for substance use and mental health disorders, with a near-term focus on Alcohol Use Disorder (AUD).
The NCE program, developed in partnership with Graft Polymer (UK) Plc, aims to create a new class of therapeutics for trauma-related mental health disorders, such as Post-Traumatic Stress Disorder (PTSD). This condition affects approximately 13 million adults in the U.S. and 20 million collectively in the US, UK, and key European markets.
Prof. David Nutt, Awakn's Chief Research Officer, expressed confidence that this collaboration will accelerate their path to delivering groundbreaking treatments. CEO Anthony Tennyson emphasized the potential impact of the NCE program for patients across North America and beyond.
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) has announced an upsizing of its non-brokered private placement financing from $1,000,000 to $2,000,000. The company has closed a fourth tranche of the offering, issuing 857,143 units at $0.46 per unit, raising an additional $394,286 for a combined total of $1,117,142. Each unit consists of 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 proceeds will be used for general working capital. Securities issued are subject to a four-month hold period and applicable resale rules.
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