Awakn Life Scien - AWKNF STOCK NEWS

Awakn Life Sciences Corp. (AWKNF) has provided supplemental disclosure regarding its proposed arrangement with Solvonis Therapeutics PLC. The transaction involves Solvonis acquiring all outstanding common shares, RSUs, and DSUs of Awakn. The company addressed 'collateral benefits' requirements under MI 61-101, particularly concerning the accelerated vesting of RSUs for related parties.

The assessment revealed that Jonathan Held (CFO) and Prof. David Nutt (CRO) will receive collateral benefits, representing approximately 3.65% of issued and outstanding Common Shares. Their shares (1,565,404 total) will be excluded from minority approval voting. The transaction requires both two-thirds approval from Securityholders and majority approval excluding votes from parties receiving collateral benefits.

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.