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Compass management will host a conference call at 8:00 am ET (1:00pm UK)
March 02, 2025
Avecho Biotechnology Limited (ASX: AVE) (“Avecho” or the “Company”) today announced it has signed an exclusive ten-year development and licensing agreement with Sandoz Group AG (“Sandoz”) for the commercial rights to Avecho’s Phase III cannabidiol (“CBD”) capsule for insomnia in Australia. Avecho retains the rights to commercialise the product in all other territories, with Sandoz granted a first right of refusal for these markets. Avecho’s CBD capsule aims to be the first pharmaceutical CBD product registered with the Therapeutic Goods Administration (“TGA”) as an over-the-counter medicine, which market forecasts predict could generate sales surpassing US$125M per annum in Australia2.
Highlights:
- Avecho and Sandoz sign an exclusive ten-year development and license agreement (“Agreement”) for Avecho’s pharmaceutical cannabidiol capsule for insomnia in Australia
- Avecho to receive upfront, milestone and royalty payments:
- US$3M (~A$4.8M1) in upfront payment
- US$16M in development milestones prior to commercial sales
- Tiered royalties ranging from 14% to 19% on net sales
- Sandoz to purchase the product from Avecho for commercial sale
- Avecho retains the rights to commercialise the product in all other territories, with Sandoz granted a right of first refusal to exceed any commercial offers Avecho receives
- Market for over-the-counter cannabidiol registered in Australia forecast to grow to >US$125M per annum2
- CEO Dr Paul Gavin will discuss this announcement further during an investor webinar to be held at 11.00am (AEDT) on Tuesday 4 March 2025 – click here to register
Sandoz has agreed to an upfront licensing fee of US$3M (approx. A$4.8M1) for the exclusive commercial rights to the CBD product for insomnia in Australia. Avecho will continue to fund and oversee the ongoing Phase III clinical trial. Upon successful completion, Avecho and Sandoz will collaborate to secure TGA regulatory approval. Sandoz will purchase finished product from Avecho and assume responsibility for the product's commercialisation, including marketing and distribution in Australia. Avecho is eligible for development milestone payments totalling US$16M prior to commercialisation and will receive tiered royalties ranging from 14% to 19% on net sales once on market.
Avecho CEO, Dr Paul Gavin, said:“We are excited to announce this partnership with Sandoz, which underscores the commercial potential of Avecho’s drug delivery platform and our shared commitment to deliver innovative insomnia treatments. Nearly 9.5 million Australians experience symptoms of insomnia with approximately 3.6 million of those considered chronic3. Sandoz’s extensive reach and expertise in the Australian market will ensures our products are widely accessible to insomnia patients across Australia. This partnership provides Avecho with a strong commercial foundation for success.”
The Agreement as an initial term of 10 years, with automatic extensions for two further renewal terms of two years each, unless terminated by agreement between both parties. The Company also confirms that the Agreement is otherwise subject to standard terms and conditions typical of a contract of this nature.
Investor webinar
Avecho will hold an investor webinar for shareholders and all other interested parties to provide more detail on this major milestone for the company.
CEO, Dr Paul Gavin, will present at 11.00am (AEDT) on Tuesday 4 March 2025.
Register to attend the presentation at the following link: https://us02web.zoom.us/webinar/register/WN_t4VmfT8RTX-0FexBBLJ_6Q
A recording will be available at the above link shortly after the conclusion of the live session, and the replay will also be available via the Company’s website and social media channels.
Questions can be submitted on the day or sent in advance to matt@nwrcommunications.com.au.
Click here for the full ASX Release
This article includes content from Avecho Biotechnology, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
08 May
US Policy Momentum, Clinical Progress Fueling Psychedelics Market in 2025
When the US Food and Drug Administration (FDA) rejected Lykos Therapeutics’ new drug application for MDMA-assisted therapy last August, the initial disappointment cast a shadow over the psychedelics industry.
However, the sector is seeing a resurgence of optimism in 2025 on the back of various US developments.
“The psychedelic industry in 2025 will likely see significant advancements in clinical applications, particularly in treating PTSD, depression, and addiction, as research continues to validate their therapeutic potential,” Dr. Markus Ploesser, chief innovation officer at Open Mind Health, told Microdose in January.
This sentiment is underscored by a variety of recent positive developments, including the FDA's approval of Johnson & Johnson’s (NYSE:JNJ) ketamine-derived nasal spray to combat treatment-resistant depression, and an initiative to study MDMA-assisted therapy efficacy for post-traumatic stress disorder (PTSD) and alcohol use disorder in veterans.
In addition, alternative medicine advocate Robert F. Kennedy Jr.’s appointment as head of the US Department of Health and Human Services has created potential for further policy shifts related to mental health and psychedelics research.
Combined, these factors could make 2025 a pivotal year for the industry.
Legal state psychedelics markets take shape
Psychedelic compounds remain federally illegal in the US, but some states have pursued legalization and decriminalization. In November 2020, Oregon became the first state to legalize psilocybin for therapeutic use through the Oregon Psilocybin Services Act. From 2021 to 2022, the Oregon Health Authority and the Psilocybin Advisory Board created rules for the act and began taking applications on January 2, 2023.
Oregon also decriminalized personal possession of all drugs in 2020 through the Drug Addiction Treatment and Recovery Act, which went into effect in February 2021. Many of the provisions in that bill have since been reversed, with the possession of small amounts of hard drugs like fentanyl, methamphetamine and heroin being recriminalized as of September 1, 2024. However, psilocybin remains legal for therapeutic and facilitated use.
As of the end of March, Oregon Psilocybin Services counted 374 state-wide psilocybin facilitators, 29 service centers, 10 manufacturers and 808 worker permits. Satya Therapeutics, located in Ashland, is recognized as one of the state’s most experienced and successful service providers, with roughly 40 to 50 clients serviced monthly.
Publicly traded Florida-based cannabis company Kaya Holdings (OTCQB:KAYS) was awarded a license to operate a psilocybin service center in Oregon through its Fifth Dimension Therapeutics subsidiary in May 2024. Its treatment center, called the Sacred Mushroom, opened its doors in Portland on July 2, 2024.
In 2025, industry advocates are focused on analyzing outcomes from Oregon's psychedelics program in order to fine tune areas requiring improvement. In February, state lawmakers sought to expand psychedelic therapy through the introduction of HB 3817, which establishes an access pathway for individuals with PTSD to access ibogaine. At the time of this writing, the bill had not yet been scheduled for a public hearing or committee vote.
Despite its growth, affordability has been a barrier to the development of Oregon’s psilocybin therapy program, with sessions typically costing over US$1,500. Some communities in the state also voted to ban psilocybin and psilocybin businesses in 2024, reflecting ongoing public concerns about drug liberalization.
In Colorado, a series of legislative actions regarding psychedelic substances led to state legalization in November 2022. Proposition 122 legalized regulated access to psilocybin and psilocin in healing centers for adults over 21, decriminalized the personal use and cultivation of these substances and established a Natural Medicine Advisory Board.
SB 23-290, signed in May 2023, amended Proposition 122's regulations and created a legal framework for healing centers. HB 22-1344, passed in June 2022, paves the way for MDMA-assisted therapy for PTSD if federally approved.
The final rules for licensed psilocybin therapy centers were filed with the secretary of state and became effective on December 15, 2024. Colorado then began accepting applications for licenses. In March, the Department of Revenue issued its first healing center license to the Center Origin in Denver. As of May 2 of this year, there were over 50 pending applications for healing centers, cultivation facilities and manufacturers.
As the psychedelics industry begins to take shape in Colorado, Tasia Poinsatte, the state’s director of the nonprofit Healing Advocacy Fund, told Stateline that centers plan to offer sliding-scale rates and discounts for veterans, Medicaid enrollees and low-income individuals to help address the affordability problem.
New psychedelics laws and research initiatives
Apart from Oregon and Colorado, a wave of legislative activity concerning psychedelics is evident across the US, with states like Illinois, Indiana, Missouri, Maine and New York pursuing various forms of legalization, including decriminalization, research funding and regulated therapeutic programs. Additionally, several cities in Washington and Michigan have decriminalized certain substances, with Washington also considering bills to create a regulated psilocybin services market and to provide funding to study ibogaine for opioid use disorder.
Utah passed legislation in March 2024 to create a program for psilocybin and MDMA as alternative treatments at the University of Utah Health and Intermountain Health. The program began in May 2024 and will run for three years.
Multiple institutions in Maryland, Texas and North Carolina are also conducting studies to assess the efficacy of psychedelics in treating various mental health conditions.
Senate Bill 242 established a working group tasked with studying the therapeutic use of entheogens in Nevada in 2023. A recommendations report was delivered in December 2024, and has garnered support from key legislative figures.
Several cities in California have deprioritized the enforcement of laws against the personal use and possession of certain psychedelics, and the state is considering a psilocybin pilot program for veterans and first responders.
Massachusetts has multiple bills focused on decriminalization and therapeutic pilot programs. In April of this year, New Mexico's governor signed a bill for a therapeutic psilocybin program.
Meanwhile, Rhode Island has a bill that would legalize psilocybin possession if the federal government reschedules it, and Alaska established a task force in May 2024 to prepare for potential federal legalization of psychedelic therapies.
These actions reflect a shift in psychedelics sentiment and a growing trend of exploring their therapeutic potential.
Psychedelics investing options
To track the financial health of the psychedelic industry, investors can use the Psychedelic Invest Index, which monitors publicly traded companies in the space. Some of the top stocks in the index include Pasithea Therapeutics (NASDAQ:KTTA), MindMed (NASDAQ:MNMD), Compass Pathways (NASDAQ:CMPS) and Cybin (NYSEAMERICAN:CYBN), all of which are involved in developing psychedelic compounds for mental health treatments.
MindMed has developed a synthetic LSD analog, MM120, currently in Phase III trials for generalized anxiety disorder (GAD) and major depressive disorder (MDD). An oral tablet of MM120 was awarded a patent in July 2024.
Cybin has developed a proprietary deuterated psilocybin analog called CYB003, as well as CYB004, a proprietary deuterated DMT compound; both are protected by patents. The company also acquired SPL028, another deuterated DMT compound, through its merger with Small Pharma in 2023. Phase 2 CYB004 topline safety and efficacy data in GAD is expected in H1 2025. A pivotal study of CYB003 is scheduled for mid-2025.
Meanwhile, Compass Pathways' Phase 2b randomized controlled study evaluating its synthetic psilocybin therapy, COMP360, is the most extensive psilocybin clinical trial to date. With data presented in 2022, the trial found that one 25 milligram dose of COMP360 resulted in a decline in depressive symptoms after three weeks when combined with psychological guidance, with positive effects reportedly lasting for as long as 12 weeks.
Other key players in the psychedelics market include atai Life Sciences (NASDAQ:ATAI), GH Research (NASDAQ:GHRS), Bright Minds Biosciences (NASDAQ:DRUG) and Silo Pharma (NASDAQ:SILO).
Canadian companies in the sector include Numinus Wellness (TSX:NUMI,OTCQB:MTPLF), Optimi Health (CSE:OPTI,OTCQX:OPTHF), BetterLife Pharma (CSE:BETR,OTCQB:BETRF), Pharmala Biotech (CSE:MDMA,OTCQB:MDXXF) and Restart Life Science (CSE:REST,OTC Pink:NMLSF).
Other avenues for investors include strategic investments in specialized real estate ventures.
Healing Realty Trust (HRT) specializes in acquiring healthcare infrastructure assets, focusing on developing mental and behavioral healthcare facilities. The company established preferred real estate partnership agreements with providers like NeuroSpa, Cambridge Biotherapies and Cathexis in 2024. It has also secured the first tranche of a US$25 million Series A funding round, with the money earmarked to acquire healthcare facilities in Texas, Ohio and Connecticut.
HRT is reportedly preparing for an initial public offering, with a potential listing in late 2025 or early 2026.
Investor takeaway
Against this backdrop, the psychedelics market could see promising growth in 2025.
While challenges remain, the expansion of legalization and decriminalization, combined with ongoing research, positions the industry for growth and presents potential opportunities for investors.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold direct investment interest in some of the companies mentioned in this article.
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18 February
Compass Pathways to announce fourth quarter and year-end financial results on February 27th, 2025
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the fourth quarter 2024 ending December 31, 2024, and provide an update on recent developments, on February 27 th , 2025.
Compass management will host a conference call at 8:00 am ET (1:00pm UK) on February 27, 2025. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.
A live webcast of the call will be available on the Compass Pathways website at: Fourth Quarter 2024 Financial Results
The webcast will also be available on the Investors section of Compass Pathways website. The webcast will be archived for 30 days.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthesized psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has Breakthrough Therapy designation from the US Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p
Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. Our vision is a world of mental wellbeing.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250218839117/en/
Enquiries
Media: media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
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31 October 2024
Emyria and UWA in Partnership to Commercialise Novel Serotonin-Releasing Agents for Mental Health and Neurology
Emyria Limited (ASX: EMD) (“Emyria”, or the “Company”) has signed an exclusive licence agreement with UWA, granting worldwide rights to a rapidly growing portfolio of selective serotonin-releasing agents. (See Appendix for Key Commercial Terms). These novel compounds, realised through a UWA–Emyria research partnership launched in 2021,2 include potential next-generation treatments for mental health and neurological conditions such as PTSD and Parkinson’s disease.
HIGHLIGHTS
- Emyria has finalised an important licence agreement with the University of Western Australia (UWA) securing exclusive global rightsto a library of patented, MDMA-inspired selective serotonin-releasing agents.
- Lead compounds MX-100 and MX-200 are being prepared for advanced screening, targetingmental health conditions like Post-Traumatic StressDisorder (PTSD) and Parkinson’s disease.
Supported by a $499,411 WA government grant,1 Emyria is accelerating its drug discovery pipeline with key results set for early2025.
As leaders in MDMA-assisted therapy for PTSD, Emyria's pursuit of serotonin-selective compounds aligns with the Company’s commitment to improving treatment outcomes and safety for patients while building a valuable intellectual property portfolio to strengthen our therapeutic offerings.
Emyria and UWA’s drug discovery program has demonstrated significant technical breakthroughs in designing compounds with selective serotonin-releasing properties. Through advanced medicinal chemistry, the team has successfully created compounds that induce serotonin release without releasing dopamine or noradrenaline. This selectivity is critical for reducing side effects of MDMA such as euphoria and elevated blood pressure/heart rate, making the compounds better suited for clinical applications such as assisted psychotherapy and other neurological conditions.
Importantly, initial studies indicate that the half-life of these novel compounds can be reduced, allowing shorter therapeutic windows suited to psychotherapy. Long half-life requires extended MDMA-assisted therapy sessions, which increases the costs and complexity of delivery.
Dr Michael Winlo, CEO:
“This licence agreement formalises an important research partnership with UWA, allowing Emyria to unlock the commercial value of a growing portfolio of potential new treatments to address significant unmet needs in psychiatry and neurology, while we simultaneously strengthen our clinical services to address serious mental health challenges.
Backed by a $499,411 WA government grant, Emyria will fast-track preclinical testing of both compounds with key results expected by early 2025.
Current Lead Compounds and Target Markets
The lead compounds, MX-100 and MX-200 are designed to harness the therapeutic potential of selective serotonin release while minimising the unwanted effects linked to dopamine and noradrenaline release.
The program that delivered MX-100, targets PTSD, and aims to deliver prosocial benefits with a shorter-acting profile ideal for assisted psychotherapy. MX-200 is a lead for a treatment to enhance L-dopa therapy for patients with Parkinson’s, a treatment which can cause debilitating side effects.
The development program has also shown an ability to design compounds with selective receptor activity. MX-100 and MX-200 do not directly stimulate the 5-HT2B receptor, currently a major limitation of existing selective serotonin releasing agents like fenfluramine, as this activity causes valvular heart disease. 5 A broader assessment of the activity of these lead compounds on a panel of important brain targets is underway as selective serotonin activity is attracting significant research and investment. 6
Click here for the full ASX Release
This article includes content from Emyria Limited, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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22 October 2024
Quantum BioPharma Files a US Federal Lawsuit Against CIBC World Markets, RBC Dominion Securities and Others, Seeking Damages in Excess of $700,000,000 USD, for Possible Stock Price Manipulation/Spoofing
Christian Attar Law Firm and Freedman Normand Friedland LLP, in conjunction with forensic investigators, have uncovered evidence of a potential multi-year market manipulation scheme that has caused substantial damages to the Company and its shareholders
Quantum BioPharma Ltd. (NASDAQ: QNTM) (CSE: QNTM) (FSE: 0K91) ("Quantum BioPharma" or the "Company"), a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions, today announces the Company, on 20th October 2024, has filed a complaint in the United States District Court for the Southern District of New York alleging that CIBC World Markets (CIBC), RBC Dominion Securities (RBC), and others (the "Defendants") engaged in market manipulation schemes that violated Section 10(b) and Rule 10b-5(a) and (c) and Section 9(a) of the Securities Exchange Act of 1934. This lawsuit alleges that between 1st of January 2020, and 15th of August 2024 the Defendants and/or their customers used "spoofing" techniques to manipulate the share price of Quantum BioPharma shares. The Company is seeking damages of more than $700 Million USD.
FINRA has characterized spoofing as a form of market manipulation that undermines the transparency and integrity of the markets by distorting the true nature of supply and demand. Spoofing involves the submission and cancellation of non-bona fide buy and sell orders that have no legitimate economic purpose and are not intended to be executed. The actual purpose of these orders is to trick shareholders into placing their own orders at a time, price and quantity that they otherwise would not have.
The law firms Christian Attar and Freedman Normand Friedland LLP have decided to take and file this case on a contingency basis, so there will be no material financial pressure on the Company to bear the legal costs associated with this case. These law firms, working with industry experts, conducted an extensive investigation into the Defendants' conduct, and have concluded that there is sufficient evidence of market manipulation for the Company to pursue claims against the Defendants. The complaint details this evidence, which the Company alleges demonstrates that Defendants "spoofed" the market hundreds of times, thereby artificially depressing the price of the Company's stock again and again and harming both the Company and its many retail investors.
The Company's stock in January 2020 was trading over $460 USD (taking into consideration post-splits or present terms) per share with a market cap close to almost One Billion dollars. The Company's share price as of market close on Friday Oct 18th, 2024, was $7.55 USD per share with a market cap of less than $15 Million USD.
"In the 21 years our team has been prosecuting market manipulation cases against Wall Street, I believe this could be one of the top 5 biggest spoofing/market manipulation cases we have handled. After working with our consulting and investigative experts, I believe the damage model could be in excess of $700 Million dollars," said James Wes Christian of Christian Attar Group.
Velvel Freedman, partner at Freedman Normand Friedland LLP and co-lead counsel in this case, believes that, "This is an important lawsuit for our client for several reasons, including the enormous magnitude of the alleged spoofing activities; the potentially devastating adverse impact that activity on the price of Quantum Biopharma's shares; and the commitment of Quantum's management to protect the value of shareholder equity in the Company."
Zeeshan Saeed, Quantum's CEO and founder, states: "We believe that the Company and its shareholders have suffered immensely from Defendants' trading practices, including those described in the complaint. We will use all means available to us to get justice for our shareholders."
The Company believes that, besides CIBC and RBC, there are other banks/brokers who are also involved in this alleged market manipulation scheme in the company's stock. The Company will refrain from naming them at this point until more conclusive evidence has been gathered.
The Company is open to dialogue and will always remain open to finding an amicable solution with the banks and brokers involved.
About Christian Attar
Christian Attar engages in all types of civil litigation, including shareholder and partnership disputes, and stock fraud. The Group operates domestically and internationally, with its corporate headquarters based in Houston, Texas.
To learn more about Christian Attar, visit www.ChristianAttarLaw.com.
About Freedman Normand Friedland LLP
Freedman Normand Friedland is a high-end litigation boutique with offices in New York, Miami, and Boston. The firm and its attorneys have extensive experience in complex commercial litigation, including in path-breaking antitrust, securities, and market manipulation matters.
To learn more about Freedman Normand Friedland, LLP, visit www.fnf.law.
About Quantum BioPharma Ltd.
Quantum BioPharma is a biopharmaceutical company dedicated to building a portfolio of innovative assets and biotech solutions for the treatment of challenging neurodegenerative and metabolic disorders and alcohol misuse disorders with drug candidates in different stages of development. Through its wholly owned subsidiary, Lucid Psycheceuticals Inc. ("Lucid"), Quantum BioPharma is focused on the research and development of its lead compound, Lucid-MS. Lucid-MS is a patented new chemical entity shown to prevent and reverse myelin degradation, the underlying mechanism of multiple sclerosis, in preclinical models. Quantum BioPharma invented UNBUZZD™ and spun out its OTC version to a company, Celly Nutrition Corp. ("Celly Nutrition"), led by industry veterans. Quantum BioPharma retains ownership of 25.71% (as of June 30, 2024) of Celly Nutrition at www.unbuzzd.com. The agreement with Celly Nutrition also includes royalty payments of 7% of sales from unbuzzd™ until payments to Quantum BioPharma total $250 million. Once $250 million is reached, the royalty drops to 3% in perpetuity. Additionally, Quantum BioPharma retains a large tax loss carry forward of approximately C$130 million and could be utilized in the future to offset tax payable obligations against future profits. Quantum BioPharma retains 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses. Quantum BioPharma maintains a portfolio of strategic investments through its wholly owned subsidiary, FSD Strategic Investments Inc., which represents loans secured by residential or commercial property.
Forward-Looking Information
This press release contains certain "forward-looking statements" within the meaning of applicable Canadian securities law. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, identified by words or phrases such as "believes", "anticipates", "expects", "is expected", "scheduled", "estimates", "pending", "intends", "plans", "forecasts", "targets", or "hopes", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "would", "will", "should" "might", "will be taken", or "occur" and similar expressions) are not statements of historical fact and may be forward-looking statements. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Company's focus on the research and development of Lucid-MS to prevent and reverse myelin degradation; the Company's intention to utilize its large tax loss to offset future tax payable obligations against future profits; the Company's intention to retain 100% of the rights to develop products for pharmaceutical and medical uses; the Company's intention to maintain a portfolio of strategic investments through FSD Strategic Investments Inc.; the Company's belief that its share price does not current financial position and recent operational improvements; that certain amounts can be collected by the Company from the bond when all appeals of Dr. Bokhari are exhausted; and that a strong cash and cash equivalents provide a solid foundation for operations and potential growth opportunities.
Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Company's assessment of market conditions, its ability to gain market share, and its potential competitive edge are accurate; the Company will have the ability to carry out its plans with respect to its new innovation and offerings, including its ability to conduct research and development of Lucid-MS; the Company will retain 100% of the rights to develop similar product or alternative formulations specifically for pharmaceutical and medical uses; the Company will seek new business opportunities; the Company will increase efficiency in its processes and partnerships; the Company will have the ability to carry out its other goals and objectives; the Company is accurate in its belief that its share price does not current financial position and recent operational improvements; that certain amounts will be collected by the Company from the bond when all appeals of Dr. Bokhari are exhausted; and that a strong cash and cash equivalents will provide a solid foundation for operations and potential growth opportunities.
These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Company being inaccurate in its belief that its share price does not current financial position and recent operational improvements; that certain amounts will not be collectable by the Company from the bond when all appeals of Dr. Bokhari are exhausted; and that a strong cash and cash equivalents will not provide a solid foundation for operations and potential growth opportunities; the Company's inability to carry out its plans with respect to its new innovation and offerings; the Company's inability to utilize its tax loss; the Company's inability to retain 100% of the rights to develop products for pharmaceutical or medical uses; and the Company's inability to enhance its product development capabilities and/or maintain a portfolio of strategic investments; and the risks discussed in the Company's Annual Report on Form 20-F for the fiscal year ended December 31, 2023, final short form base shelf prospectus dated December 22, 2023 and registration statement on Form F-3 containing a base shelf prospectus, each under the heading "Risk Factors". These factors should be considered carefully, and readers should not place undue reliance on the forward-looking statements. Readers are cautioned that the foregoing list is not exhaustive. Although the forward-looking statements contained in this press release are based upon what management believes to be reasonable assumptions, the Company cannot assure readers that actual results will be consistent with these forward-looking statements. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Company's expectations as of the date hereof and are subject to change thereafter. The Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events, or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.
The reader is urged to refer to additional information relating to Quantum BioPharma, including its annual information form, can be located on the SEDAR+ website at www.sedarplus.ca and on the EDGAR section of the United States Securities and Exchange Commission's website at www.sec.gov for a more complete discussion of such risk factors and their potential effects.
Contacts:
Quantum BioPharma Ltd.
Zeeshan Saeed, Founder, CEO and Executive Co-Chairman of the Board
Email: Zsaeed@quantumbiopharma.com
Telephone: (416) 854-8884
Investor Relations
Email: ir@quantumbiopharma.com, info@quantumbiopharma.com
Website: www.quantumbiopharma.com
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22 October 2024
Awakn Announces Opening of Four Additional AWKN-001 Phase 3 Trial Sites
Awakn Life Sciences Corp. (CSE: AWKN) (OTCQB: AWKNF) (FSE: 954) ("Awakn" or the "Company"), a clinical-stage biotechnology company developing therapeutics for substance use and mental health disorders, announces the opening of four additional clinical trial sites: University Hospitals Sussex NHS Foundation Trust; South London and Maudsley NHS Foundation Trust; Greater Manchester Mental Health NHS Foundation Trust; and University Hospitals Plymouth NHS Trust. This brings the total active trial sites to 7 in the landmark 'MORE-KARE' Phase 3 trial of AWKN-001 for severe AUD.
AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support for severe AUD.
The MORE-KARE study, or the Multicentre Investigation of Ketamine for Reduction of Alcohol Relapse, is co-funded by a partnership between the UK's Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR), and Awakn Life Sciences Corp. It is managed by the Exeter Clinical Trials Unit at the University of Exeter.
The Phase 3 trial aims to evaluate the efficacy of a single treatment cycle of AWKN-001. Participants will be randomly allocated into a trial arm, receiving different doses of ketamine infusion along with psycho-social support sessions from a trial therapist. The specific dose and type of psychological support for each participant will be randomly assigned by a computer. Both participants and the research team will be blinded to the assigned dose/support.
Anthony Tennyson, CEO, Awakn, commented: "The expansion of trial sites marks a significant milestone in our mission to address the pressing need for innovative treatments for AUD. We are confident that AWKN-001, has the potential to change the standard of care for individuals suffering from severe alcohol use disorder in the UK, offering them a novel, more effective treatment pathway."
Prof. David Nutt, Chief Research Officer of Awakn, added: "The opening of these additional sites accelerates our ability to gather robust clinical data, essential for bringing this groundbreaking treatment to more patients. With the support of the UK's leading research institutions, we are well-positioned to demonstrate the effectiveness of AWKN-001."
This study is the largest of its kind investigating ketamine-assisted therapy for AUD. The total trial cost is estimated at £2.4 million / CAD 4.2 million, with Awakn contributing £0.8 million / CAD 1.4 million. The trial is being conducted at eight National Health Service (NHS) sites across the UK.
About AWKN-001
AWKN-001 is an investigational, novel medication-assisted treatment for severe AUD, consisting of an N-methyl-D-aspartate receptor-modulating drug (ketamine) delivered intravenously (IV) in combination with manualized psycho-social support in the UK market only.
A phase 2 trial was successfully completed with efficacy proven, achieving 86% abstinence on average over the 6 months post-treatment versus 2% pre-trial and a 50% reduction in Heavy Drinking Days versus placebo.
A phase 3 clinical trial ("MORE KARE") is being run by the University of Exeter. This trial is co-funded by the Efficacy and Mechanism Evaluation (EME) Programme - a partnership between the UK's National Institute for Health Research (NIHR) and the Medical Research Council (MRC) - and Awakn Life Sciences Corp.
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 AUD, 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.
www.awaknlifesciences.com | LinkedIn | X (formerly Twitter)
About the University of Exeter
The University of Exeter is the sponsor of this clinical trial with overall trial management, data management and statistical analysis provided in collaboration with the Exeter Clinical Trials Unit (University of Exeter). At the University of Exeter, we combine teaching excellence and high levels of student satisfaction with world class research at our campuses in Exeter and Cornwall. We are a member of the Russell Group of leading research-intensive universities.
About The National Institute for Health and Care Research (NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
- Funding high quality, timely research that benefits the NHS, public health and social care;
- Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
- Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
- Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
- Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
- Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.
About the Medical Research Council
The UKRI Medical Research Council is at the forefront of scientific discovery to improve human health. Founded in 1913 to tackle tuberculosis, the MRC now invests taxpayers' money in some of the best medical research in the world across every area of health. Thirty-three MRC-funded researchers have won Nobel prizes in a wide range of disciplines, and MRC scientists have been behind such diverse discoveries as vitamins, the structure of DNA and the link between smoking and cancer, as well as achievements such as pioneering the use of randomised controlled trials, the invention of MRI scanning, and the development of a group of antibodies used in the making of some of the most successful drugs ever developed.
Today, MRC-funded scientists tackle some of the greatest health problems facing humanity in the 21st century, from the rising tide of chronic diseases associated with ageing to the threats posed by rapidly mutating micro-organisms. The Medical Research Council is part of UK Research and Innovation.
Notice Regarding Forward-Looking Information
This news release contains certain forward-looking information and forward-looking statements, as defined in applicable securities laws (collectively referred to herein as "forward-looking statements"). Forward-looking statements reflect current expectations or beliefs regarding future events or the Company's future performance. All statements other than statements of historical fact are forward-looking statements. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "expects", "is expected", "budget", "scheduled", "estimates", "continues", "forecasts", "projects", "predicts", "intends", "anticipates", "targets" or "believes", or variations of, or the negatives of, such words and phrases or state that certain actions, events or results "may", "could", "would", "should", "might" or "will" be taken, occur or be achieved, including statements relating the business of the Company. All forward-looking statements, including those herein are qualified by this cautionary statement.
Although the Company believes that the expectations expressed in such statements are based on reasonable assumptions, such statements are not guarantees of future performance and actual results or developments may differ materially from those in the statements. There are certain factors that could cause actual results to differ materially from those in the forward-looking information. These include, but are not limited to: fluctuations in general macroeconomic conditions; the business plans and strategies of the Company; the ability of the Company to comply with all applicable governmental regulations in a highly regulated business; the inherent risks in investing in target companies or projects which have limited or no operating history and are engaged in activities currently considered illegal in some jurisdictions; changes in laws; limited operating history; reliance on management; requirements for additional financing; competition; fluctuations in securities markets; inconsistent public opinion and perception regarding the medical-use of psychedelic drugs; expectations regarding the size of the addiction market; and regulatory or political change. Readers are cautioned that the foregoing list of factors is not exhaustive of the factors that may affect forward-looking statements. Accordingly, readers should not place undue reliance on forward-looking statements. The forward-looking statements in this news release speak only as of the date of this news release or as of the date or dates specified in such statements.
Investors are cautioned that any such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking information. For more information on the Company, investors are encouraged to review the Company's public filings on SEDAR at www.sedar.com. The Company disclaims any intention or obligation to update or revise any forward- looking information, whether as a result of new information, future events or otherwise, other than as required by law.
Investor Enquiries:
Anthony Tennyson, CEO, Awakn Life Sciences
anthony.tennyson@awaknlifesciences.com
416-270-9566
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20 September 2024
FDA Finds Kratom Capsules Safe, but Questions About Concentrated Forms Remain
An initial US Food and Drug Administration (FDA) study on kratom, a plant-based substance long consumed in Southeast Asia, has found that the compound appears safe when used in capsule form, even at high doses.
However, a Tuesday (September 17) Bloomberg article notes that the FDA's research did not include kratom-infused drinks or concentrates, which are more common in the US and may carry different risks.
Kratom, a botanical product derived from the leaves of Mitragyna speciosa, has been used in Southeast Asia for centuries, with users traditionally chewing the leaves for its mind-altering effects.
The FDA study involved 40 participants divided into five groups, each receiving either a placebo or escalating doses of kratom capsules. Participants were monitored for adverse reactions over two days.
The scope also focused on kratom leaf material, which was dried, ground into powder and encapsulated. The product closely resembles the form used traditionally in Thailand and Malaysia.
As mentioned, the study did not examine the effects of more concentrated kratom products, such as beverages or extracts. These tend to have higher concentrations of the compound and have been linked to more severe side effects.
Kratom has rapidly gained popularity in the US due to its widespread availability in gas stations, bars and convenience stores. Bloomberg states that on an annual basis more than 1.7 million people in the country report using the plant or consuming kratom-infused drinks; some fatalities have been linked to its increasing consumption.
Despite its growing use, scientific understanding of its long-term effects remains limited, as kratom tends to have higher concentrations of active compounds when used in non-traditional formats like beverages.
Christopher McCurdy, a professor at the University of Florida’s College of Pharmacy and a researcher involved in the study, told Bloomberg that the results only scratch the surface of what needs to be known about kratom.
“It gives you a snapshot, at least now, of what ranges appear to be safe and not cause any toxicity in humans,” he said, adding that some people have been using it for decades or more, but the impact on them isn't known.
Despite these unanswered questions, the researchers found no severe or life-threatening adverse effects associated with kratom capsules in the doses tested, though vomiting was a common side effect, especially at higher doses.
Kratom is largely unregulated in the US, but concerns about its safety have led at least six states to ban the substance.
The FDA has repeatedly issued warnings about kratom, citing its opioid-like properties and potential for abuse.
In 2019, the Centers for Disease Control and Prevention reported nearly 100 deaths involving kratom; however, most of those cases also involved other substances, primarily fentanyl. The FDA continues to raise concerns about kratom's use in higher-concentration forms, particularly in beverages marketed as alcohol alternatives.
While the results of the FDA study mark a significant step toward gaining a better understanding of the substance, experts agree that more data on kratom’s effects, particularly in its more concentrated forms, is needed.
In the meantime, the agency continues to urge consumers to exercise awareness and caution regarding kratom’s use in higher-concentration forms, particularly in beverages marketed as alcohol alternatives.
Don't forget to follow us @INN_LifeScience for real-time updates!
Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.
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