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Effective immediately, Albert Labs International Corp. will be reinstated for trading.
The Company has rectified the situation that gave rise to the suspension.
CSE Bulletin: Reinstatement - Albert Labs International Corp.
_________________________________
Avec effet immédiat, Albert Labs International Corp. sera réintégré aux fins de négociation.
La Société a rectifié la situation ayant donné lieu à la suspension.
| Date : | Le 7 juillet/July 2023 |
| Symbol(s)/Symbole(s) : | ABRT |
If you have any questions or require further information please contact Listings at (416) 367-7340 or E-mail: Listings@thecse.com.
Si vous avez des questions ou si vous avez besoin d'informations supplémentaires, veuillez contacter le service des inscriptions au 416 367-7340 ou par courriel l'adresse: Listings@thecse.com.
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Canadian Investment Regulatory Organization Trade Resumption - ABRT
Trading resumes in:
Company: Albert Labs International Corp.
CSE Symbol: ABRT
All Issues: Yes
Resumption (ET): 12:00 PM
CIRO can make a decision to impose a temporary suspension (halt) of trading in a security of a publicly-listed company. Trading halts are implemented to ensure a fair and orderly market. CIRO is the national self-regulatory organization which oversees all investment dealers and trading activity on debt and equity marketplaces in Canada .
SOURCE Canadian Investment Regulatory Organization (CIRO) – Halts/Resumptions
View original content: https://www.newswire.ca/en/releases/archive/July2023/07/c3496.html
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Albert Labs Receives preliminary acceptance of 35 Novel Inventive Claims for Patent Protected Manufacturing Technology
- Albert Labs has received preliminary acceptance of 35 novel inventive claims as part of its published International PCT Patent Application (No. PCT/CA2022/051281).
- The Company's proprietary manufacturing methodology, developed and validated in-house at Albert Labs' Vancouver facility, facilitates the production and scaling of highly potent yields of its KRN Active Pharmaceutical Ingredient (API).
- This protected technology provides industry-leading outputs of psilocybin, with sixteen times the amount of psilocybin per mass unit of mycelia. It also ensures standardization, consistency, and a reduced risk of contamination from research to commercial GMP production levels.
- Albert Labs is at the forefront of pharmaceutical-grade psilocybin manufacturing, providing long-term value throughout targeted clinical milestones and across key jurisdictions and licence indications.
Albert Labs International Corp. (CSE: ABRT) (the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical drug discovery company bringing innovative medicines to patients with unmet mental health needs, is pleased to announce the preliminary acceptance of 35 novel inventive claims to comply with PCT 33(3) under its International PCT Patent Application (No. PCTCA2022051281).
Led by inventors Ali Gulamhusein , Dr. Jean Saayman , and Chand Jagpal , the Albert Labs team has validated a proprietary manufacturing technology that facilitates the production and scaling of highly potent yields of fungi biomass. It is currently used to manufacture the fungi biomass for KRN-101, a fixed-ratio unique medicine which contains a spectrum of key metabolites, including psilocybin and baeocystin.
The acceptance of novel inventive claims under the PCT is an important tool that secures effective and robust protection for their inventions in multiple countries.
This technology provides industry-leading outputs of psilocybin, with sixteen times the amount of psilocybin per mass unit of mycelia, while also ensuring standardization, consistency, and a reduced risk of contamination from research to commercial GMP production levels.
It is used for the production of fungi biomass in bioreactors and includes a novel method of increasing the yield of mycelium in a stirred tank with artificial substrates, providing protection from shear forces, and increasing growth. Furthermore, the novel methodology ensures less clumping and pelletization, with increased access to oxygen and nutrients encouraging large-scale biomass production.
There are several advantages to mycelium growth compared to farmed fruiting body growth for psilocybin production, including higher yields, faster growth, easier manipulation, lower contamination risk, and more sustainable production. This is an ideal production technology for a GMP laboratory facility compared to fruiting body growth.
This technology places Albert Labs at the forefront of pharmaceutical-grade psilocybin manufacturing, reducing the cost of production and increasing the ability to scale. This provides the Company with retained, long-term value throughout targeted clinical milestones and across key jurisdictions and licence indications.
Follow the links here to view our published Patent Application , and International Search Report and Written Opinion .
Business of Albert Labs International Corp.
Albert Labs is a fully-integrated biopharmaceutical drug discovery company bringing innovative medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which patient needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast-track clinical pathway focusing on Real World Evidence (RWE). RWE studies are a recognised clinical pathway, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.
Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.
The Company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .
You can find more details about Albert Labs on our website here .
ON BEHALF OF THE BOARD OF DIRECTORS
Albert Labs International Corp.
Dr. Michael Raymont
Chief Executive Officer, Chairman
Cautionary Statement
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
SOURCE Albert Labs International Corp.
View original content to download multimedia: https://www.newswire.ca/en/releases/archive/May2023/02/c1221.html
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Albert Labs announces Private Placement - April 24, 2023
- Albert Labs has announced a private placement for gross proceeds of up to CAD $3,000,000 , with the first tranche offered at CAD $0.08 /Unit
- 80% of the Company's First In-Human trial has funding arranged, including a cash rebate from the Australian Government for an estimated CAD $1,200,000 (43.5% of eligible trial costs) , and a CAD $830,000 strategic investment from Cantheon Capital LLC .
- Proceeds will be used for:
- KRN-101 Toxicology and First In-Human trials in 2023
- Clinical Trial Application for its late-stage Real World Evidence trials in the United Kingdom (MHRA)
- IND Filing (FDA)
- Implementation of Expanded Drug Discovery Pipeline
- OTC Quotation and Investor Relations Programme
- G&A
- If you are interested in participating in this financing round, please contact us at: ir@albertlabs.com
Albert Labs International Corp. (CSE: ABRT) (the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, has announced a non-brokered private placement for gross proceeds of up to CAD $3,000,000 (the "Offering").
The first tranche of the Offering is at a price of CAD $0.08 per Unit (the "Units"), with intermediate closings taking place as determined by the Company.
Gross proceeds raised will be used for pharmacokinetic and toxicology studies to advance the Company's primary drug target, the natural psilocybin-based KRN-101, towards it's Real World Evidence trial for regulatory approval in the United Kingdom and IND filing in the United States ; the proceeds will also be used for an OTC quotation, investor relations programme, general and administrative expenses and any financing fees.
Each Unit is comprised of one common share (the "Common Share") and one-half of one whole Common Share purchase warrant (each whole warrant, a "Warrant") with each whole Warrant entitling the holder to purchase one additional Common Share of the Company at a price of CAD $0.12 per Share for a period of 12 months from the date of issuance. In the event that the Company's common shares have a closing price on the CSE of greater than CAD $0.15 per common share for a period of 10 consecutive trading days, the Company may accelerate the expiry date of the Warrants by giving notice to the holders thereof and, in such case, the Warrants will expire on the 30th day after the date on which such notice is given to the holder by the Company.
All securities issued in connection with the Offering will be subject to a hold period of four months plus a day from the date of issuance and the resale rules of applicable securities legislation.
Business of Albert Labs International Corp.
Albert Labs is a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which patient needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast-track clinical pathway focusing on Real World Evidence (RWE). RWE studies are a recognised clinical pathway, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.
Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.
The company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE).
You can find more details about Albert Labs on our website here.
ON BEHALF OF THE BOARD OF DIRECTORS
Albert Labs International Corp.
Dr. Michael Raymont
Chief Executive Officer, Chairman
Cautionary Statement
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
SOURCE Albert Labs International Corp.
View original content to download multimedia: https://www.newswire.ca/en/releases/archive/April2023/24/c3868.html
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Albert Labs announces Strategic Investment from Cantheon Capital LLC for First In-Human Trials
Highlights:
- Cantheon Capital, one of the largest global pharmaceutical psychedelics venture capital firms, sign terms for ~CA$830,000 (£500,000) of funding to Albert Labs , allocated towards its first in-human clinical trials in 2023
- Albert Labs is nearing their first in-human studies on its primary drug candidate, KRN-101, a psilocybin-based, natural pharmaceutical product
- Albert Labs' first human trials, due to commence in Q2 2023, will be carried out in partnership with industry leading clinical research partner, iNGENu CRO as previously announced . The trials will take place in Australia , providing the Company with the additional benefit of access to a 43.5% cash reimbursement on all eligible related costs equating to a further benefit of ~CA$1.2 million
- Albert Labs recognised in Canadian Venture for "Revolutionizing Mental Health Drug Development"
Albert Labs International Corp. (CSE: ABRT), the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, has announced a strategic investment from prominent psychedelic pharmaceutical investment fund, Cantheon Capital LLC ("Cantheon Capital").
On 23 March 2023 , the Company entered into an agreement which sees Cantheon Capital sign funding terms for ~CA$830,000 (£500,000) of Convertible Debentures to support financing of Albert Labs' forthcoming clinical trials in 2023.
Cantheon Capital's investment mandate is focussed on pharmaceutical companies with near term catalysts for high-value generation, deploying capital to support with achieving major drug development milestones.
This investment comes on the cusp of the third major milestone for Albert Labs . The first, an extensive drug discovery programme, the second, the completion of pre-clinical studies, and the third, to be commenced shortly, being KRN-101 administered to humans for the first time.
KRN-101 is an IP-protected, psilocybin-based pharmaceutical product, for which Albert Labs will seek regulatory approval across global medical regulatory jurisdictions.
This investment will be entirely allocated towards Albert Labs' first in-human studies, to be conducted by iNGENu in Australia , which are due to take place in Q2 2023 .
- From commencement to completion (including clinical outputs), the study will run for 3-months
- The study will cost a total of ~CA$2.7 million, and will be funded through:
- Cantheon Capital investment of: ~CA$830,000
- Australian Government R&D rebate (43.5% of eligible costs): ~CA$1.2 million
- Albert Labs cash contribution: ~CA$670,000
- Upon completion KRN-101 will be validated as a safe pharmaceutical product
- This study will enable submissions for late-stage Real World Evidence trials in the United Kingdom and the United States , pursuing Special Access Programs' and accelerated licensing
Aaron Ray , General Partner of Cantheon Capital, commented: "We are pleased to partner with Albert Labs and excited by what we see as a huge growth proposition for 2023. First in-human studies are significant for any early-stage pharmaceutical company. Reaching this milestone is reflective of the incredible amount of work that has gone into delivering KRN-101. The company will benefit greatly from carrying out these trials in Australia with iNGENu, the leading CRO for the burgeoning entheogen drug development space.
Beyond the investment itself, we look forward to supporting the company with our deep expertise in pharmaceutical research and commercialization. We are highly selective in the companies we choose to invest into but in the case of Albert Labs , we were attracted by their ability to accelerate product through the regulatory channels and clinical trials pathways to hasten the timeline to commercialization."
Dr. Michael Raymont , CEO of Albert Labs , stated: "We are delighted to come to this agreement with Cantheon Capital, one of the most sophisticated later stage psychedelics venture capital firms in the world, and feel it serves as a real statement of confidence in our growth as a company and the upside potential of our product that will help improves the lives of millions of patients globally. We are a differentiated offering within the industry, holding extensive intellectual property protection and a unique regulatory strategy focussed on speed to market. We look forward to building upon the significant progress to date with some key clinical milestones in the year ahead."
Further to the announcement of this investment, Albert Labs has been recognised in Canadian Venture for "Revolutionizing Mental Health Drug Development".
Canadian Venture commented:
- " Albert Labs is a leading pharmaceutical drug development company that is revolutionizing mental health drug development."
- "It's team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs."
Are you an Albert Labs investor yet? Let's talk.
+1 877 859 3684
Convertible Debentures
Cantheon Capital has signed terms with Albert Labs for an aggregate investment of GB£500,000 (~CA$830,000), provided in two (2) tranches, relating to their upcoming first in-human clinical trials. The tranches of the Convertible Debentures will be triggered by the commencement and first dosing events in the trials, which will evaluate Albert Labs' proprietary psilocybin-based pharmaceutical product, KRN-101.
The Convertible Debenture conversion price, if executed, shall be at a 20% discount to the closing price of the Company's common stock 20-day VWAP trading average, as quoted on the Canadian Securities Exchange ("CSE") the effective day of the Convertible Debenture, subject to a minimum of $0.05 (the "Conversion Price"). They include a 10% interest rate paid in cash annually in arrears, with an option to pay at the Company's election within the first 6 months of closing, subject to a 3% prepayment penalty. The Convertible Debentures include 100% warrant cover, exercisable at the same conversion price as the common shares upon issue, as approved by the CSE. In accordance with the terms, the conversion price per Common Share shall be adjusted to ensure that Cantheon and its affiliates shall not beneficially own, or have control or direction over, Common Shares in excess of 19.99% of the number of Common Shares issued and outstanding immediately after giving effect to the issuance of Common Shares issuable under the applicable tranche.
Completion of the Convertible Debentures remain subject to the final agreement and regulatory approvals, including from the CSE.
Business of Albert Labs International Corp.
Albert Labs is a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which patient needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast-track clinical pathway focusing on Real World Evidence (RWE). RWE studies are a recognised clinical pathway, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.
Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.
The company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .
You can find more details about Albert Labs on our website here .
ON BEHALF OF THE BOARD OF DIRECTORS
Albert Labs International Corp.
Dr. Michael Raymont
Chief Executive Officer, Chairman
Cautionary Statement
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
SOURCE Albert Labs International Corp.
View original content to download multimedia: https://www.newswire.ca/en/releases/archive/March2023/28/c6495.html
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Psychedelics Outlook Report
Table of Contents:
|  |
A Sneak Peek At What The Insiders Are Saying
“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry."
— Naseem Husain, Horizons ETFs
"I see the US Food and Drug Administration approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025."
— Andrew DeAngelo, Forbes
Who We Are
The Investing News Network is a growing network of authoritative publications delivering independent, unbiased news and education for investors. We deliver knowledgeable, carefully curated coverage of a variety of markets including gold, cannabis, biotech and many others. This means you read nothing but the best from the entire world of investing advice, and never have to waste your valuable time doing hours, days or weeks of research yourself.
At the same time, not a single word of the content we choose for you is paid for by any company or investment advisor: We choose our content based solely on its informational and educational value to you, the investor.
So if you are looking for a way to diversify your portfolio amidst political and financial instability, this is the place to start. Right now.
Psychedelics Outlook 2024
Table of Contents
Psychedelics Market 2023 Year-End Review
Psychedelics Market Forecast: Top Trends That Will Affect Psychedelics in 2024
Psychedelics Market 2023 Year-End Review
The psychedelics industry is maturing after the investment boom of 2020 and 2021, and patient long-term investors looking for opportunities to diversify their portfolios have options when it comes to exposure.
As clinical trials and research continue to demonstrate the potential benefits of psychedelic-assisted therapy (PAT), companies in the space are attracting more attention. The Investing News Network (INN) spoke with Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs, to get his thoughts on 2023.
"Compared to the market fervor in 2020/2021, like (2022), 2023 was a quieter and colder year in the psychedelics marketplace. This past year, no major catalysts emerged and there was continued consolidation in the industry — a trend that will likely continue," the expert said during the interview, emphasizing the period's slowness.
"That being said, clinical trials take time, and participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression, alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry," Husain added.
According to Research Nester, the psychedelic drug market was worth US$3 billion in 2022. If it grows at the firm's estimated compound annual growth rate of 14 percent, the market will be worth more than US$12 billion by 2035.
“There are 22 million American adults suffering from depression, 300 million people worldwide. So unfortunately, there's a very large unmet need and a massive market opportunity,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale explained in an end-of-year conversation with INN. “The (depression and anxiety) market is maybe around a US$40 billion potential. If you add in other potential indications … like postpartum depression, alcohol use disorder or eating disorders, you're looking at a total addressable market of maybe US$100 billion annually.”
Here INN looks back on the psychedelics space in 2023 and highlights key developments and trends.
Regulatory developments in the US and elsewhere
As more people struggle with mental health and the addiction crisis worsens, a growing body of evidence suggests that psychedelic substances may offer much-needed relief. Researchers have continued to demonstrate that these treatments can be used to treat a variety of mental health disorders, and may reduce healthcare costs as well.
This has sparked a shift in the US legislative landscape, with increasing bipartisan support for psychedelic drug reform. At the federal level, President Joe Biden has expressed his expectation that psychedelic therapies will be approved in specific circumstances, and in 2023, the Food and Drug Administration (FDA) took steps to facilitate the development of psychedelic therapies when it released a comprehensive guide for clinical investigations.
At the state level, Oregon and Colorado have emerged as pioneers in the regulated use of psychedelics, with Oregon granting its first license for a healing center in March after officially legalizing PAT in January. Likewise, Colorado passed its Regulated Natural Medicine and Legalization Act in July, and will progressively implement various PATs.
While some states have introduced legislation to legalize or decriminalize psychedelics, the legislative process can be slow and outcomes uncertain. For example, while Oklahoma has approved HB 3414 to increase research, other legislation is still working its way through the system, such as New York's Psychedelic Law Enforcement Reform Act.
In October, California Governor Gavin Newsom signed a bill to immediately allow doctors to prescribe psychedelic treatments if the substances are rescheduled. However, he vetoed SB 58, which sought to decriminalize the possession and personal use of a selected group of psychedelics, after it had already passed through the Senate and Assembly. Newsom said his reason for vetoing the bill was that it failed to meet guidelines that would criminalize possession outside of medical clearance. It also didn’t satisfy the criteria for treatment guidelines, such as dose information.
Outside the US, other countries have also been taking steps to regulate and explore the therapeutic potential of psychedelics. Canada, the US' northern neighbor, is one example — on a provincial level, Alberta enacted a new policy at the start of 2023 that regulates psychedelic drugs for mental health treatment.
Federally, most psychedelic therapies remain illegal. However, Canadians continue to lobby for increased access to these treatments, and in rare cases can be approved for PATs that are undergoing clinical trials through the country’s Special Access Program. Last year, the Senate’s Subcommittee on Veteran Affairs published a report calling on governments at all levels to perform a large-scale research program on PATs, as the treatments have the potential to greatly help military veterans, an underserved demographic for which mental health struggles are common.
One company making this a focus is the veteran-founded Apex Labs, whose psilocybin product APEX-90 was recently approved for a 160 macro-dose clinical trial starting in the first quarter of 2024. However, ahead of the trial, a Canadian military veteran with treatment-resistant depression was approved for the treatment through the Special Access Program; they received a dose on November 2 in Vancouver accompanied by psychotherapy.
For its part, Australia has taken a different approach. On July 1, legalization took effect for MDMA and psilocybin for the medical treatment of post-traumatic stress disorder (PTSD) and depression, respectively, in tandem with therapy.
“Time will tell, but the Australian announcement is likely the biggest ‘positive’ event for the space and could provide a model for other jurisdictions to emulate,” Husain said. “If a major country like Australia is able to successfully administer psychedelic medicines, that could prove a catalyst for Canada and other Commonwealth nations.”
Which psychedelics clinical trials moved forward in 2023?
The use of psychedelics for therapeutic purposes continued building momentum in 2023 as clinical trials investigating the efficacy of these substances for treating a range of mental health conditions reached new milestones.
One of the more notable trials of 2023 was Compass Pathways' (NASDAQ:CMPS) investigation of the effectiveness of its product, COMP360, in treating bipolar II depression. This was the first study of PAT on bipolar disorder. The results, which were published in JAMA Psychiatry on December 6, suggest that psilocybin combined with psychotherapy could be an effective and safe treatment for bipolar II depression. The company is also studying the use of COMP360 to treat mental health disorders such as anorexia, PTSD and treatment-resistant depression, among others.
Another significant development in the field of psychedelic therapies was the publication of positive results from MindMed’s (NASDAQ:MNMD,NEO:MMED) Phase 2b trial of its LSD-based product MM-120, which was being investigated as a potential treatment for generalized anxiety disorder. According to the company’s website, there is also evidence to suggest that MM-120 could be effective for treating chronic pain and substance use disorders. MindMed’s share price rose by 7 percent following the news. The company plans to move on to Phase 3 trials in 2024.
Cybin, another player in the psychedelics industry, reported positive topline data from Phase 2 clinical trials of CYB003 for major depressive disorder. “(It’s) really unprecedented to see 80 percent of patients in remission after two doses. I don't think we've ever seen anything like that in depression, ever,” Cybin’s Drysdale commented to INN about the results. The US Patent and Trademark Office granted the company a patent for its product on December 6.
Finally, MAPS Public Benefit, a subsidiary of the Multidisciplinary Association for Psychedelic Studies (MAPS), submitted a new drug application to the FDA in December following positive results from Phase 3 trials that studied the efficacy of its MDMA-assisted therapy for treating PTSD. On January 5, MAPS Public Benefit announced it was changing its name to Lykos Therapeutics as it begins to focus on product commercialization pending FDA approval of its treatment.
Patenting and commercialization could be headwinds
The market for psychedelic therapies is evolving, and with the changing landscape there will be challenges that must be addressed. In a December 2022 research paper, experts explored the economic considerations surrounding PAT, including market dynamics and the potential for growth and consolidation in the space.
Bruce Campbell, president and portfolio manager at StoneCastle Investment Management, discussed MindMed in a market call with BNN Bloomberg: “One of the risks they obviously have with a company like (MindMed), they're going to need to continually raise money over time, much like the cannabis sector has done, to kind of build out their operations. So they're nowhere near the point where they're going to be cashflow positive. So you do have to be aware that if the stock runs up it could pull back on financing, and it's probably a position that you want to trade around.”
Campbell’s comments specifically address MindMed, but they also speak to the broader challenges and risks associated with investing in the psychedelics industry, including the need for ongoing funding and the potential volatility.
While some clinical trials have yielded promising results, companies must still overcome the complexities of patenting and commercializing their products. One issue that could hinder profitability is that psychedelic compounds are naturally occurring substances that may be difficult to protect under existing intellectual property laws.
To address this challenge, companies in the psychedelics industry are exploring a range of strategies, including developing novel formulations of compounds, combining them with other ingredients to create proprietary products and leveraging their expertise and data to establish a competitive advantage.
For example, Numinus Wellness (TSX:NUMI,OTCQX:NUMIF) made significant changes to its business in 2023 in order to increase its revenue, including launching a clinic licensing platform called Numinus Network, expanding its practitioner training programs and partnering with Healing Commercial Real Estate to find more clinics for its services. The company also closed operations at its non-revenue-producing Numinus Bioscience research lab.
After turning its focus to revenue-generating activities, Numinus reported significant growth in revenue in the fourth quarter of 2023, including US$5 million from the company’s wellness clinics.
As part of its focus on practitioner training, Numinus announced a partnership with MAPS in June, for which it submitted a clinical trial application to Health Canada. The purpose of the trial is to study how healthcare practitioners could establish protocols and procedures for MAPS’ MDMA-assisted therapy and identify any potential challenges. If successful, Numinus has plans to incorporate the therapy into its repertoire of PAT education and training programs.
While regulatory considerations are an important factor in the growth and development of the PAT industry, another trend affecting the sector is the increasing consolidation of the market through mergers and acquisitions.
“We've seen a huge amount of consolidation over the last couple of years, down from maybe 60 reported psychedelic companies to frankly only about a half a dozen now that are really focused on drug development,” Drysdale noted. Two such examples in 2023 were Cybin’s acquisition of Small Pharma and Otsuka’s (TSE:4578) acquisition of Mindset.
Psychedelics industry working to address ethical concerns
As the PAT sector develops, concerns are also arising, especially when it comes to the need for companies to balance affordable and equitable access to treatment as they pursue growth and expansion.
To this end, Beckley Waves, a venture studio that works exclusively with practitioners in the psychedelics space, established the New Ethics Council in June. The council is composed of experts who will be able to provide guidance on best practices. Among them is Beckley Waves founder Amanda Fielding, who has been an influential presence in the industry for generations, pouring over 55 years of research into the benefits of psychedelic experiences.
Investor takeaway
Looking back on recent developments in the psychedelics industry, it’s clear that in 2023 the field made significant strides in terms of clinical research, as well as some regulatory progress.
Of course, uncertainties still lie ahead in this young sector. “Despite positive broader market performance across other major indices, risk-off sentiment from 2022 persisted throughout 2023, which has led to a greater gulf between the psychedelic and biotech industries and other sectors,” said Husain.
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.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
Psychedelics Market Forecast: Top Trends That Will Affect Psychedelics in 2024
As research into psychedelic drugs continues to produce positive results, policymakers are taking note.
With promising clinical trials, increasing public acceptance and a growing desire for psychedelic-assisted therapies (PATs), the sector seems to be poised for significant growth in the coming years.
Heading into 2024, the Investing News Network (INN) turned to industry insiders to dig into what might be in store for the psychedelics market. Read on to learn what they had to say.
Institutions considering psychedelics investment
Psychedelics companies are seeing a growing influx of funding and support thanks to positive clinical trial results.
“I think we've seen a shift in the last maybe three or four months of the year where more institutions are starting to look back at the psychedelic space again,” Cybin (NYSEAMERICAN:CYBN) CEO Doug Drysdale said in an interview with INN. “We had Steven Cohen's fund, Point72, make a significant investment in Cybin. They came in on our (at-the-market offering), and a number of other institutions are paying attention now as the sector is maturing.”
In addition, Lykos Therapeutics, which just changed its name from MAPS Public Benefit, secured US$100 million in Series A funding from a group of private investors in January 2024.
Lykos was previously focused on developing PATs for a range of mental health disorders, but after completing Phase III trials for its MDMA-assisted therapy for post-traumatic stress disorder in 2023, and then submitting a new drug application (NDA) to the US Food and Drugs Administration (FDA) in December, the company has changed its focus to bringing its MDMA treatment to market. The funding will be used to support these ongoing efforts.
Several of the same investors also recently contributed to a US$3.3 million funding round for Beckley Waves, a venture studio formed exclusively for the development of the psychedelics industry.
Regulatory change key for psychedelics progress
The regulatory landscape for these psychedelic substances will play a crucial role in shaping the market, with drug reform and decriminalization efforts having the potential to unlock significant growth opportunities.
While the current legislative landscape for psychedelics bears some similarities to that of the cannabis industry, there are also key differences, namely psychedelics companies' sole focus on therapeutic applications.
“In my opinion, the psychedelics industry is completely different than the cannabis market,” said Naseem Husain, senior vice president and exchange-traded fund (ETF) strategist at Horizons ETFs. “One is a medical and biotechnology opportunity, while another is primarily focused on retail, at least in the North American market. While both have legal barriers to overcome that could result in growth, the psychedelic pipeline is about pharmaceutical and regulatory development and less so about marketing and distribution like we’ve seen in the hyper-competitive cannabis sector.”
This crucial distinction could create greater accessibility for the patients who need these treatments. More and more practitioners are being allowed to administer psychedelic drugs via trials, and certain US states and Canadian provinces have legalized PATs or developed regulatory mechanisms to make them accessible, such as Health Canada’s Special Access Program. Even Australia, a country that has maintained a strict stance on cannabis, has approved the legal therapeutic use of MDMA and psilocybin, although some scientists have called the decision rushed.
In some cases, patients are circumventing federal roadblocks either by procuring illicit substances on their own, or by seeking treatment through private institutions. For example, psychedelic integration therapy, which helps individuals process and integrate insights gained during a psychedelic experience, is available in Vancouver, BC, but often at an exorbitant cost, and patients are left to source psychedelic compounds on their own.
What Drysdale and other market participants hope to achieve through their therapies is affordable and effective treatment, which needs Health Canada or FDA approval to be accessible.
“What we're doing is we are creating and producing synthetic, modified molecules, GMP manufactured, hoping to be FDA approved, prescribed by a doctor, reimbursed by your insurance company,” he said. “And I think that's what you need to attract the attention of patients who are already depressed and dealing with stuff. I think that some may go seek natural mushrooms, but if we can make these treatments really accessible through this regulated route first, then I think that's the most reliable and less risky way of providing really significant access.”
Potential rescheduling on the horizon
Could 2024 be the year for psychedelic drug reform? Some experts think the answer could be yes.
“I see the FDA approving one or both of these compounds (psilocybin and MDMA) and a new medical model and industry will be birthed in 2024 and 2025,” Andrew DeAngelo said in a Forbes article on cannabis and psychedelics market predictions for 2024. However, he also acknowledged that the industry is often unpredictable.
That said, there has been some progress on that front.
As mentioned, Lykos has now submitted an NDA to the FDA for its MDMA treatment, and the company requested a priority review because of the FDA’s designation of MDMA as a breakthrough therapy. If the FDA accepts the application, the process will take six months with a priority review or 10 months with a regular review.
If the FDA ultimately approves the treatment, MDMA would need to be moved from Schedule I to Schedule II, opening the door for other practitioners who have potential therapies in their pipelines.
While legalization is widely expected in the future, opinions vary on how quickly it will come. For instance, the American Medical Association predicts that most states will have legalized psychedelics by 2037 — that means current investors might still need to wait a while before they start seeing high returns on investment.
“Participants and analysts have known that the psychedelic opportunity is ultimately a long game that requires public policy progression alongside pharmaceutical advancement and innovation. Ultimately, a watershed moment could lead to a waterfall effect across the industry,” Husain said.
Investor takeaway
The evidence suggests that the psychedelics industry could be on the brink of significant growth in the coming years, but with some caveats. While clinical trial results have been promising and public acceptance is growing, the regulatory landscape will play a critical role in shaping the future of the market.
With the right regulations and approvals in place, psychedelics could revolutionize mental health treatments by offering affordable and effective therapies to those who need them.
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.
Editorial Disclosure: The Investing News Network does not guarantee the accuracy or thoroughness of the information reported in the interviews it conducts. The opinions expressed in these interviews do not reflect the opinions of the Investing News Network and do not constitute investment advice. All readers are encouraged to perform their own due diligence.
Additional information on investing in psychedelics stocks — FREE
Compass Pathways to participate in upcoming 23rd Annual Needham Virtual Healthcare Conference
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will present at the 23 rd Annual Needham Virtual Healthcare Conference at 8:00am ET on April 9, 2024.
A live audio webcast of the presentation will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following such event. For more information, please visit investor section of compasspathways.com.
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 suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. 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 COMP 360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p www.compasspathways.com .
Availability of other information about Compass Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including, but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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Compass Pathways Board Chair and Co-Founder George Goldsmith and Co-Founder Ekaterina Malievskaia Step Down from Board of Directors
Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today announced that Board Chair and co-founder George Goldsmith and fellow co-founder Ekaterina Malievskaia have resigned their seats on the company's board of directors, effective March 29, 2024.
David Norton, lead independent director on the Compass board of directors, will become interim chair. Compass is running a global search for a permanent board chair, focused on recruiting a leader with a strong background in the biotechnology sector and broad strategic experience across the product lifecycle.
"When we started Compass eight years ago, we could not have imagined how the company would grow and mature," said George Goldsmith, outgoing board chair of Compass Pathways. "The company is on a strong, positive trajectory to develop psilocybin treatment under Kabir Nath's principled leadership. My commitment to transforming mental health care is unwavering. It is time to turn my attention to the next phase of making this vision a reality for patients, providers and health systems independent of any particular treatment modality."
"Everyone has a story, and too often this story includes the shortcomings of existing treatments and the pain and frustration of navigating the system," said Ekaterina Malievskaia. "I step down from the board convinced that the company is in good hands and on the right track financially, in its programs, and in preparation for a potential commercial launch to bring treatments to those in need. Innovation in mental health care remains as important to me as it was ten years ago, and I plan to continue to apply my experience and knowledge to the field."
"George and Katya leave an enduring legacy at Compass Pathways and across the field of mental health care," said David Norton. "Their leadership and compassion for people living with difficult-to-treat mental health conditions, their commitment to rigor and evidence, and their focus on ensuring broad and equitable access to innovation in mental health have moved us closer to achieving the vision they set when they launched the company: a world of mental wellbeing. Thanks to their leadership, Compass is in a strong position as it continues to execute its phase 3 program in treatment-resistant depression. We wish them all the best as they move into the next phase of their careers and continue their efforts to transform mental health care."
George and Ekaterina co-founded Compass Pathways in 2016. George served as Chief Executive Officer of the company from its founding until August 1, 2022, when Kabir Nath assumed the role. Ekaterina served as Chief Innovation Officer until she stepped down from her executive role in June 2023. This transition is a natural evolution as Compass has matured as a public company and progresses through late-stage clinical development and into commercial preparations.
Key accomplishments of their tenure at the company and on the board include:
- Building a mission driven, multi-disciplinary team of people committed to changing the patient experience of mental health care
- Achieving Breakthrough Therapy Designation from the US Food and Drug Administration and Innovative Licensing and Access Pathway designation in the UK for COMP360, Compass's proprietary formulation of synthetic psilocybin, in treatment-resistant depression (TRD)
- The design, launch and completion of the largest study of psilocybin ever conducted, the results of which were published in the New England Journal of Medicine and laid the groundwork for the company's phase 3 program in TRD
- Several rounds of successful financing, including a successful initial public offering on NASDAQ in September 2020
- The establishment of key partnerships, including the Centre for Mental Health Research and Innovation in collaboration with King's College London (KCL) and the South London and Maudsley NHS Foundation Trust
David Norton is a former Company Group Chairman of Global Pharmaceuticals for Johnson & Johnson. He began his career with J&J in 1979 and held several positions across the company, including Company Group Chairman, Worldwide Commercial and Operations for the CNS/internal medicine franchise, Company Group Chairman for the pharmaceutical businesses in Europe, the Middle East and Africa, and Company Group Chairman for the pharmaceutical businesses in North America. He has been a member of the Compass board of directors since 2018, serving as lead independent director. He also serves on the board of directors of Forepont Capital.
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 current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. 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 United States. Our vision is a world of mental wellbeing. www.compasspathways.com
Forward-looking statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. In some cases, forward-looking statements can be identified by terminology such as "will", "may", "might", "could", "would", "should", "expect", "intend", "plan", "objective", "anticipate", "believe", "contemplate", "estimate", "predict", "potential", "continue" and "ongoing," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things, Compass's expectations regarding its plans for a new board chair and Compass's expectations regarding its pivotal phase 3 program or other trials to support regulatory filings and approvals. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Compass's control and which could cause actual results, levels of activity, performance or achievements to differ materially from those expressed or implied by these forward-looking statements.
These risks, uncertainties, and other factors include, among others: market risks and other market conditions; the timing and outcome of the Company's search for a new board chair; clinical development is lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; we will require substantial additional funding to achieve our business goals and if we are unable to obtain this funding when needed and on acceptable terms, we could be forced to delay, limit or terminate our product development efforts; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any future product candidates may be unsuccessful; establishing, maintaining, defending and enforcing our patents and other intellectual property rights covering our investigational COMP360 psilocybin treatment may be challenging and costly and our efforts to protect our patents and other intellectual property rights may be unsuccessful; our efforts to commercialize and to obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; our ability to successfully manage leadership changes; economic and geopolitical uncertainties and those risks and uncertainties described under the heading "Risk Factors" in Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC"), which are available on the SEC's website at www.sec.gov . Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
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