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Compass management will host a conference call at 8:00 am ET (1:00pm UK)
April 30, 2024
Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to provide the following update on progress for the three month period ended 31 March 2024 (the ‘quarter’), as well as its Appendix 4C. All financial results are in Australian dollars and unaudited (unless otherwise stated).
Highlights:
- Q1 FY24 unaudited revenue of $4.4m – marks a 91% increase on the prior corresponding period (‘PCP’)
- Results underpinned by Mernova Medicinal Inc., which delivered $1.6m in revenue during Q1 FY24
- Wholly-owned operating division Health House International generated $2.4m in revenue during the quarter – highlighting the Company’s ability to deliver growth through strategic M&A
- Non HHI European operations also contributed $380k in revenue, more than 30x Q1 FY23 revenues, highlighting a good uptick on these operations
- Board and management remain committed to ongoing efforts to further reduce operating expenditure
- Follows total FY23 record revenues of $21.6m – a 148% rise on the PCP
Financial performance:
During Q1 FY24, Melodiol delivered $4.4m in unaudited revenue, which was a 91% increase on the previous corresponding period (‘PCP’) (Q1 FY23: $2.3m). The results follow record group revenues of $21.6m in FY23 and highlight the Company’s ability to identify high growth opportunities and capitalise.
Q1 FY24 revenue was underpinned by Melodiol’s 100%-owned Canadian subsidiary, Mernova Medicinal Inc. (‘Mernova’) which generated $1.6m in revenue for the period. Pleasingly, Mernova’s revenue continued was up 6% on the PCP (Q1 FY2024 revenue: $1.5m).
Further, wholly-owned operating division Health House International (‘HHI’ or ‘HHI International’) also contributed $2.4m in revenue. HHI’s ongoing contribution to the Company’s revenue since its acquisition has further underpinned Melodiol’s stated strategy of leveraging strategic M&A to bolster operations.
Receipts from customers for the period totalled $5m, a 94% rise on the PCP. Net cash used in operating activities was also reduced by 50% from $2.2m in Q4 FY23 to $1.1m in Q1 FY24.
Cash used in operating activities comprised mainly of product manufacturing and operating costs ($3.2m), advertising and marketing ($0.1m), staff costs ($1.5m), and administration and corporate costs ($1.1m).
At quarter end, the Company has cash at bank if $0.6m. Payments to related parties and their associates as detailed in section six of the attached Appendix 4C relates entirely to Directors Fees / expenses of $0.1m.
Melodiol remains resolutely focused on continuing to reduce operating costs, while pursuing high growth revenue opportunities to push towards profitability. The Company also continues to take active steps to refocus its efforts and resources into higher performing business units, whilst exploring opportunities to undertake a strategic divestment or closures of non performing business units.
Click here for the full ASX Release
This article includes content from Melodiol Global Health, 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.
ME1:AU
30 July
Psychedelics Market Update: H1 2025 in Review
The market for psychedelic drugs is emerging as a strategic investment opportunity in healthcare, with forecasts generally placing its value at around US$6.4 billion in 2025.
This burgeoning sector is set for robust, double-digit compound annual growth, significantly driven by North America, which is anticipated to account for approximately 45 to 50 percent of this market.
The first half of 2025 was characterized by clinical advancements and softening policy stances, furthering momentum and contributing to growing market interest.
Clinical progress, policy shifts drive interest in psychedelics
Interest in the space continued in H1 as drug candidates advanced into pivotal trials, particularly in the treatment of depression, anxiety and PTSD. Cybin (NYSEAMERICAN:CYBN) reported meaningful progress, citing investor and regulatory confidence in the therapeutic potential of psilocybin, LSD analogs and DMT derivatives.
Cybin’s results for its 2025 fiscal year, released on June 30, highlight significant progress in its lead programs, as well as its strong financial position, with C$135 million in cash reported. CEO Doug Drysdale emphasized the company's progress in building a strong foundation for anticipated clinical and regulatory milestones.
Key highlights include strengthened intellectual property with new patents for CYB003 and CYB004, strategic partnerships with Osmind and Thermo Fisher Scientific (NYSE:TMO) and promising Phase 2 efficacy data for CYB003 in MDD, showing 100 percent responder rates and 71 percent remission with two 16 milligram doses.
The Phase 2 study for CYB004 in GAD is underway and expected to be completed around mid-2025.
Likewise, COMPASS Pathways (NASDAQ:CMPS) announced that its COMP360 psilocybin treatment successfully met its primary goal in a Phase 3 trial for treatment-resistant depression on June 23.
A single 25 milligram dose of COMP360 significantly reduced depression symptoms compared to a placebo at six weeks, showing a clinically meaningful difference and strong statistical significance.
This marks the first Phase 3 efficacy data reported for a classic psychedelic, and Compass Pathways said it plans to discuss these positive results with the US Food and Drug Administration (FDA).
Policy signals were equally consequential. Notably, the Texas House and Senate passed SB 2308 in May, which will provide up to US$100 million in state funds for ibogaine trials.
The results of the trials will be presented to the FDA for potential approval of ibogaine for opioid use disorder, co-occurring substance use disorder and other neurological or mental health conditions. Governor Abbott signed the bill into law on June 11, representing a notable and progressive shift in the Republicans’ approach to drug policy.
However, the sector continues to face real challenges, such as costly clinical access and inconsistent regulatory frameworks that have resulted in a patchwork of state-level regulations. Despite these challenges, there are ongoing efforts towards federal reform and standardized guidelines.
Health Secretary Robert F. Kennedy Jr. recently told members of Congress that new therapeutics using psychedelic substances could revolutionize treatment for mental health challenges.
"This line of therapeutics has tremendous advantage if given in a clinical setting and we are working very hard to make sure that happens within 12 months,” he said during a House subcommittee meeting regarding the Trump administration's proposed budget for the US Department of Health and Human Services.
FDA head Marty Makary has likewise labeled the assessment of MDMA and other psychedelics as a “top priority,” announcing initiatives aimed at potentially expediting their approval.
One new program in particular aims to accelerate drug approval, potentially cutting review times from six months to one month. This initiative might relax requirements for some drugs, possibly waiving placebo-controlled studies, which have been a hurdle for psychedelic research because patients often know if they've received the drug.
Psychedelics market forecast for 2025
The National Psychedelic Landscape Assessment identifies 11 states with a high likelihood of future movement based on legislative viability, advocacy strength, public support, legislative momentum and strategic impact: New Mexico, Nevada, Texas, Illinois, Missouri, California, Massachusetts, Connecticut, Indiana, New York and Arizona.
The report also points to several key trends and persistent challenges in the current psychedelic market.
Decriminalization at the state level has seen an enactment rate of just 2 percent, despite being a frequent area of focus for legislators in the US, with 67 bills introduced since 2020. Movements have been hampered by public health and safety concerns, although local efforts are gaining momentum.
However, adult-use access has seen no legislative enactments through state legislatures, with existing programs in Oregon and Colorado being implemented predominantly via citizen-led ballot initiatives.
When it comes to medical access programs, New Mexico stands out as the sole state to successfully enact a licensed and regulated psilocybin therapy program through SB 219, battling hurdles such as regulatory complexity, affordability and securing sufficient provider participation.
The report also found that clinical trials have been gaining traction, particularly when state-funded and focused on vulnerable populations like veterans and first responders, with Indiana emerging as a leader in this area.
The state established a therapeutic psilocybin research fund in 2024 that compares psilocybin against existing treatments, and ensures transparent fund administration and research application processing.
A more moderate approach is seen in pilot programs, which offer a controlled environment for access and data collection. The crucial step of implementing legislation, necessary to operationalize enacted policies, shows a 50 percent success rate, according to the report’s findings.
The report also points to corporate influence and the strategic efforts by corporate entities to gain commercial advantage through state trigger laws and compound-specific legislation favoring patented compounds like COMP360.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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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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03 March
Avecho and Sandoz enter Exclusive License and Development Agreement to Commercialise CBD for Insomnia in Australia
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.
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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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23 January
Psychedelics Market Forecast: Top Trends for Psychedelics in 2025
The psychedelics investment landscape enters 2025 on a complex path marked by both progress and setbacks.
While the US Food and Drug Association (FDA) continues to support research into the therapeutic potential of psychedelics, translating promising findings into approved treatments and accessible care is proving challenging.
This is evident in the recent legislative failures in Massachusetts and California, where initiatives aimed at expanding legal access to psychedelics were met with resistance. The FDA's August 2024 rejection of Lykos Therapeutics' midomafetamine for PTSD treatment underscores the rigorous standards required for regulatory approval.
However, despite setbacks in 2024, the FDA remains supportive of research on psychedelic substances, according to Robert Sassoon, a senior research analyst at Water Tower Research.
In a report, he identifies five trends he expects to shape the psychedelics industry in 2025, including increased clinical trial activity, potential improvements in the funding environment due to interest rate changes and possible political shifts, as well as a shift in investor sentiment towards psychedelics amidst a persistent need for mental health solutions.
This is further evidenced by the Department of Veterans Affairs' recent decision to fund its first study on psychedelic-assisted therapy since the 1960s, signaling growing recognition of the potential benefits within key institutions.
As the industry navigates these complexities, 2025 is poised to be a defining year for the psychedelic investment landscape, shaped by ongoing research, evolving regulatory frameworks and increasing investor interest driven by the potential of psychedelics to address the growing mental health crisis.
Operators maneuver shifting psychedelics landscape
The potential impact of Robert F. Kennedy Jr.'s (RFK) nomination as secretary for the Department of Health and Human Services on the regulatory landscape around psychedelics is the industry’s biggest wild card heading into 2025.
Given his support for unconventional medical fields and his criticism of the FDA's handling of psychedelics, his appointment could lead to changes in the regulation of psychedelics as therapies, such as MDMA-assisted therapy for PTSD. In addition, RFK’s support for wellness initiatives and his stated goal of making significant changes to the healthcare system could benefit companies working in the psychedelic space.
This could be particularly true if he chooses to prioritize mental health and recognizes the potential of psychedelics to address conditions like treatment-resistant depression.
RFK’s nomination garnered mixed reactions, but he has enjoyed support from key figures. Former Texas Governor Rick Perry said Kennedy was a “great gift” for the psychedelics reform movement on Joe Rogan's podcast.
Under Secretary of Veterans Affairs for Health Shereef Elnahal told Politico, “I really appreciate Bobby Kennedy’s approach to trying to instill wellness as a bigger part of American life — I think veterans would benefit from that.”
State-level regulatory advances in psychedelics
While Federal reform has stalled for now, some states are forging ahead with their own regulatory frameworks for psychedelics, demonstrating a proactive approach to the evolving landscape.
Oregon was the first state to establish a legal framework for regulated psilocybin use.
The Oregon Health Authority, tasked with overseeing the Oregon Psilocybin Services Act, recently concluded a public comment period from October 1 to 21, 2024, allowing for public feedback on proposed rules and regulations surrounding the Act, which legalized therapeutic psilocybin use within the state.
The new guidance was published on November 22 and included provisions such as annual training for facilitators.
Colorado is also moving forward with its psychedelic-assisted therapy program, which should begin this year.
Regulators held a forum for potential business license applicants on November 12 and started accepting applications on December 31. In addition, bipartisan lawmakers introduced a bill to allow doctors to prescribe synthetic psilocybin if the FDA approves it, further demonstrating Colorado's dedication to a regulated industry.
Reform legislation could spread to other states in 2025 as well.
In Michigan, Representative Mike McFall introduced HB 5980 in September 2024 to legalize psilocybin mushrooms for therapeutic use under the supervision of a licensed therapist, with a focus on treating PTSD.
The New Jersey Senate also amended and approved S2283 in October 2024 to legalize psilocybin therapy, which now awaits voting in the full Senate and Assembly. The next Assembly session is scheduled for March 27, 2025.
Finally, New York introduced NY S00495 to the state House of Representatives on January 8, which would legalize psilocybin therapy for qualifying conditions and establish a program for licensed facilitators; and in Washington, a pre-filed bill would allow adults 21 and older to legally use psilocybin with the support of a trained facilitator, taking a dual approach that includes both clinical use and a “wellness track” for any adult.
These legislative developments across multiple states indicate a growing momentum towards greater acceptance and regulation of psychedelics, potentially paving the way for broader changes at the federal level in the future.
Psychedelics companies adapt
2025 is shaping up to be a year of transition and strategic maneuvering for key psychedelics players.
Lykos Therapeutics underwent significant changes after the FDA’s decision, including board member departures, staff layoffs and the resignation of CEO Amy Emerson. Compass Therapeutics (NASDAQ:CMPX) also adjusted its strategy, delaying the readout of its Phase III trial of COMP360 to the second half of 2025, underscoring the challenges of navigating the regulatory landscape and bringing psychedelic therapies to market.
Despite these hurdles, other companies are forging ahead with their research and development efforts.
Cybin (NYSEAMERICAN:CYBN) continues to advance its pipeline, exploring the therapeutic potential of various psychedelic compounds, as does Mind Medicine (NASDAQ:MNMD) which was added to the Nasdaq Biotechnology Index (INDEXNASDAQ:NBI) on December 23. Numinus Wellness (TSX:NUMI,OTCQB:NUMIF), meanwhile, made a strategic move by selling its five US clinics to focus on its business and research in Canada.
Looking ahead, industry experts like Sassoon anticipate that the first FDA-approved and rescheduled psychedelic-based therapy may not arrive until 2027 or 2028. This timeline provides a realistic framework for investors and highlights the long-term vision required in this exciting but still emerging field.
While the path to commercialization may be longer than initially anticipated, the companies navigating these challenges today are laying the groundwork for a future where psychedelic therapies play a significant role in mental healthcare.
This revised version provides a more specific update on the mentioned companies and their outlook for 2025, acknowledging the challenges while also highlighting their ongoing efforts and the long-term potential of the industry.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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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
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