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Awakn Life Scien - AWKNF STOCK NEWS

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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.

Rhea-AI Summary
Awakn Life Sciences Corp. is set to list its common shares on the Canadian Securities Exchange (CSE) after receiving conditional approval, with the intention to delist from Cboe Canada. The company has also closed the fifth tranche of a non-brokered private placement financing, issuing 142,857 units for gross proceeds of $65,714 for this tranche and $3,030,377 in total for the Offering to date.
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Awakn Life Sciences Corp. has designated program AWKN-002 for Alcohol Use Disorders in the US market, focusing on a proprietary S-ketamine formulation administered sublingually via an oral thin film. The company has successfully completed an investigative study on the dissociative effect and reduction in alcohol cravings of the S-ketamine OTF, leading to the designation of AWKN-002. Additionally, Awakn has signed a global licensing agreement with LTS Lohmann Therapie-Systeme AG for a proprietary S-ketamine OTF, ensuring strong intellectual property protection and potential to rapidly progress to late clinical stage trials.
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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) announces global licensing agreement with LTS Lohmann Therapie-Systeme AG for a proprietary S-ketamine formulation to treat addiction, anxiety, and eating disorders. The agreement includes exclusive rights, access to Phase 1 data, and patents filed in the US and key international markets. The sublingual S-ketamine formulation offers potential advancements in addiction treatment, with faster onset of action, precise dosing, and reduced adverse effects. The agreement also includes terms related to milestone payments, royalties, and commercial manufacturing of the drug product by LTS.
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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) announces recent corporate updates, including regulatory approval for a phase III clinical trial for its lead program AWKN-P001 for the treatment of Severe Alcohol Use Disorder, completion of a feasibility study for its proprietary formulation of MDMA, and engagement with Orphan Insight Ltd. to develop market access for its lead program. The company also closed the fourth tranche of a private placement financing for gross proceeds of $230,000 and $2,964,663 in total for the Offering to date.
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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) announces clinical trial authorization from the MHRA and ethical approval from the Health Research Authority in the UK for a phase III clinical trial for its lead program AWKN-P001, a N-methyl-D-aspartate receptor-modulating drug used in combination with psycho-social support to treat Severe Alcohol Use Disorder (SAUD). The trial will be funded by Awakn, The University of Exeter, and a partnership between the NIHR and the MRC. Enrollment for the phase III is due to start in Q1 2024.
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Awakn Life Sciences Corp. (NEO: AWKN) (OTCQB: AWKNF) (FSE: 954) receives notice of non-compliance from Cboe Canada regarding its common stock listing, with 90 days to address the issue. The notice does not impact the company's operations or its focus on advancing psychedelic research and development.
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Awakn Life Sciences has engaged Orphan Insight to develop market access, pricing, and reimbursement for its lead program AWKN-P001, which targets Severe Alcohol Use Disorder (SAUD). AWKN-P001 achieved positive results in a phase II study, with 86% abstinence in the 6 months post-treatment and a 50% reduction in Heavy Drinking Days (HDD) versus placebo. Awakn has received an Innovation Passport from the UK Medicines and Healthcare products Regulatory Agency (MHRA) and has submitted a Clinical Trial Application (CTA) for a phase III trial of AWKN-P001 in the UK. The trial will be run by Awakn, The University of Exeter, and a partnership between NIHR and the MRC, and will be delivered across ten NHS sites.
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Awakn Life Sciences completes feasibility study confirming stability of MDMA on Catalent's Zydis ODT technology, potentially improving performance and benefiting patients compared to oral capsules.
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Awakn Life Sciences Corp. announces closing of third tranche of private placement and provides corporate update on recent progress.
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Awakn submits Clinical Trial Application for phase III trial of AWKN-P001 for Severe Alcohol Use Disorder (SAUD)
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FAQ

What is the current stock price of Awakn Life Scien (AWKNF)?

The current stock price of Awakn Life Scien (AWKNF) is $0.065 as of February 7, 2025.

What is the market cap of Awakn Life Scien (AWKNF)?

The market cap of Awakn Life Scien (AWKNF) is approximately 2.8M.

What does Awakn Life Sciences Corp. specialize in?

Awakn specializes in developing therapeutics for substance use and mental health disorders, with a primary focus on Alcohol Use Disorder (AUD) and Post-Traumatic Stress Disorder (PTSD).

What is AWKN-001?

AWKN-001 is a combination therapy involving intravenously delivered ketamine and cognitive behavioral therapy (CBT) for severe Alcohol Use Disorder. It is currently in Phase 3 clinical trials in the UK.

What is the significance of AWKN-002?

AWKN-002 is a proprietary oral thin film (OTF) formulation of esketamine designed for sublingual and buccal administration. It targets moderate to severe AUD and is supported by the FDA's 505(b)(2) pathway.

What is Awakn's aminoindane NCE program?

The aminoindane NCE program focuses on developing novel compounds that enhance social cognition and pro-social behaviors, targeting trauma-related mental health disorders like PTSD.

How does Awakn generate revenue?

Awakn generates revenue through licensing agreements, partnerships, and the potential commercialization of its proprietary treatments and protocols.

What makes Awakn's treatments unique?

Awakn's treatments, such as AWKN-001 and AWKN-002, offer higher efficacy rates compared to traditional therapies, leveraging innovative drug formulations and structured psycho-social support.

Who are Awakn's key collaborators?

Awakn collaborates with institutions like the University of Exeter, University of Nottingham, and Graft Polymer to advance its R&D efforts.

What is the market potential for Awakn's therapies?

The addiction and mental health treatment markets are substantial, with AUD alone affecting millions globally. Awakn's innovative solutions aim to address significant unmet needs in these markets.

What is Awakn's strategic vision?

Awakn aims to commercialize its R&D pipeline through licensing, partnerships, and direct commercialization, setting a new standard in addiction and mental health care.

What challenges does Awakn face?

Challenges include securing funding, navigating regulatory approvals, and competing in a highly regulated and competitive biotechnology market.
Awakn Life Scien

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