Effective immediately, Albert Labs International Corp. will be reinstated for trading.
The Company has rectified the situation that gave rise to the suspension.
A cancer diagnosis is a challenge in and of itself, but a lack of effective psychiatric support makes it even worse. Patients report feelings of helplessness and a hastened desire for death, and researchers are now exploring how natural psychedelic compounds can be transformed into practical mental health treatments for cancer patients. Albert Labs (CSE:ABRT) is a Vancouver-based research and drug development company presently developing a psilocybin-based medication for patients with cancer-related distress. Albert Labs has a patented process for creating the active pharmaceutical ingredient (API) used in its inaugural medication.
Effective immediately, Albert Labs International Corp. will be reinstated for trading.
The Company has rectified the situation that gave rise to the suspension.
_________________________________
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.
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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 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 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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Highlights:
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 .
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:
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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.
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
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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An initial US Food and Drug Administration (FDA) study on kratom, a plant-based substance long consumed in Southeast Asia, has found that the compound appears safe when used in capsule form, even at high doses.
However, a Tuesday (September 17) Bloomberg article notes that the FDA's research did not include kratom-infused drinks or concentrates, which are more common in the US and may carry different risks.
Kratom, a botanical product derived from the leaves of Mitragyna speciosa, has been used in Southeast Asia for centuries, with users traditionally chewing the leaves for its mind-altering effects.
The FDA study involved 40 participants divided into five groups, each receiving either a placebo or escalating doses of kratom capsules. Participants were monitored for adverse reactions over two days.
The scope also focused on kratom leaf material, which was dried, ground into powder and encapsulated. The product closely resembles the form used traditionally in Thailand and Malaysia.
As mentioned, the study did not examine the effects of more concentrated kratom products, such as beverages or extracts. These tend to have higher concentrations of the compound and have been linked to more severe side effects.
Kratom has rapidly gained popularity in the US due to its widespread availability in gas stations, bars and convenience stores. Bloomberg states that on an annual basis more than 1.7 million people in the country report using the plant or consuming kratom-infused drinks; some fatalities have been linked to its increasing consumption.
Despite its growing use, scientific understanding of its long-term effects remains limited, as kratom tends to have higher concentrations of active compounds when used in non-traditional formats like beverages.
Christopher McCurdy, a professor at the University of Florida’s College of Pharmacy and a researcher involved in the study, told Bloomberg that the results only scratch the surface of what needs to be known about kratom.
“It gives you a snapshot, at least now, of what ranges appear to be safe and not cause any toxicity in humans,” he said, adding that some people have been using it for decades or more, but the impact on them isn't known.
Despite these unanswered questions, the researchers found no severe or life-threatening adverse effects associated with kratom capsules in the doses tested, though vomiting was a common side effect, especially at higher doses.
Kratom is largely unregulated in the US, but concerns about its safety have led at least six states to ban the substance.
The FDA has repeatedly issued warnings about kratom, citing its opioid-like properties and potential for abuse.
In 2019, the Centers for Disease Control and Prevention reported nearly 100 deaths involving kratom; however, most of those cases also involved other substances, primarily fentanyl. The FDA continues to raise concerns about kratom's use in higher-concentration forms, particularly in beverages marketed as alcohol alternatives.
While the results of the FDA study mark a significant step toward gaining a better understanding of the substance, experts agree that more data on kratom’s effects, particularly in its more concentrated forms, is needed.
In the meantime, the agency continues to urge consumers to exercise awareness and caution regarding kratom’s use in higher-concentration forms, particularly in beverages marketed as alcohol alternatives.
Don't forget to follow us @INN_LifeScience for real-time updates!
Securities Disclosure: I, Giann Liguid, hold no direct investment interest in any company mentioned in this article.
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 participate in the following September investor conferences:
A live audio webcast of these events 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 each event.
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 synthetic 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.
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: Sally Bain, media@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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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 participate in the Canaccord Genuity 44th Annual Growth Conference: presentation at 4:30pm ET on August 13, 2024 and host investor meetings.
A live audio webcast of this event will be accessible from the "Events" page of the Investors section of the Compass website. A replay of this 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 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 synthetic 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.
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: Sally Bain, media@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by GlobeNewswire via QuoteMedia
The global psychedelics market will likely experience continued growth and interest in the coming years.
According to findings from FactMR, the sector's value is projected to surpass US$603.1 million in 2024, with further growth expected at a CAGR of 7 percent. By 2034, the psychedelics industry is projected to be worth US$1.18 billion.
The field of psychedelics-based therapies has shown significant growth in the past few years as medical companies focus on developing alternative treatments for various mental health conditions, including depression, post-traumatic stress disorder (PTSD), major depressive disorder (MDD), generalized anxiety disorder (GAD), addiction and other ailments.
There are currently over 50 publicly traded psychedelics companies.
However, progress in the life science sector often unfolds at a measured pace, especially compared to rapidly advancing sectors like tech. Companies in the space must work within an intricate regulatory landscape and stringent approval process.
In a comprehensive wrap-up, the Investing News Network provides an overview of the most significant and impactful news events from the first half of 2024.
MAPS PBC's new drug application for an MDMA-assisted therapy for PTSD received much attention in H1. MAPS PBC, a subsidiary of MAPS, submitted its application to the US Food and Drug Administration (FDA) in December 2023 following results from several promising clinical trials and years of research into MDMA-assisted therapy for PTSD.
Shortly after the application was submitted, MAPS PBC rebranded as Lykos Therapeutics and raised US$100 million in Series A financing.
In February, the company's new drug application was accepted and granted priority review by the FDA, with a decision timeline set for August 2024. Lykos announced the completion of its European Phase 2 study for the same treatment on April 24.
Psychedelics sector momentum persisted in March, with the FDA granting breakthrough therapy designation to MindMed's MM120, tartrate salt form of lysergide, for treating GAD; and Cybin's CYB003, a psilocybin analog to be used as an adjunct therapy for MDD. Both companies have reported positive meetings with regulators. Within days of receiving its designation, Cybin had met with regulators to design a Phase 3 program, and MindMed reported a “constructive” meeting with the FDA on June 20. Phase 3 studies for both companies are set to begin in H2 2024.
The market had mixed reactions to news of the FDA’s decisions. While MindMed saw a 23.67 percent increase in its share price on March 7 when the company received its designation, Cybin’s share price dropped 13 percent on March 13 when it was granted the same recognition. Cybin also announced a proposed private placement on March 13, which earned it US$150 million.
On May 6, Lykos said the FDA would hold an advisory committee meeting regarding the investigational use of MDMA-assisted therapy on June 4. A public hearing session took place on this day, providing an opportunity for "interested parties" to share pertinent information that could impact the decision-making process. The session's primary objective was to address two pivotal questions:
After examining all the evidence, the panel acknowledged factors that complicated data interpretation. They noted that it was nearly impossible for participants and staff to remain fully blinded to the treatment. Panelists also remarked that it was difficult to judge the extent to which psychotherapy, rather than the drug, contributed to the reported decrease in symptoms of PTSD.
Furthermore, they expressed concerns about the drug's safety, citing insufficient data on its potential for abuse.
When taken to a vote, the majority of panel members did not agree that the data showed the treatment was effective, or that the risks outweighed the proposed benefits.
While a final decision is not due until August 11, it is unlikely that the FDA will go against the findings of the advisory committee and approve the drug. After the meeting, Lykos CEO Amy Emerson said, "We remain committed to working with the FDA to address outstanding questions so that we may find a path forward to ensure the responsible and careful introduction of MDMA-assisted therapy into the healthcare system, if approved.”
Although Lykos is privately traded, the news reverberated throughout the psychedelics sector.
Many of the most recognized publicly traded companies in the psychedelics sector, including MindMed, Cybin, Compass Pathways, ATAI Life Sciences and Numinus, all saw share price decline after the news broke.
Following a period of highly anticipated clinical trials and FDA decisions that dominated the first half of 2024, it's crucial to examine the financial performance of leading psychedelics companies as the industry continues to evolve and garner attention.
As clinical trials can span several years, the progress and financial health of companies are essential indicators of potential growth areas and future prospects in the sector.
Atai Life Sciences, which is in the early stages of testing five new psychedelics-based treatments, released its Q4 and full-year 2023 financial results on March 28, reporting US$40.2 million in net losses for the full year, a significant decrease from the US$152.4 million net loss from the same period a year prior.
On May 15, the company's Q1 results were disclosed, revealing a continued reduction in losses; Atai Life Sciences reported US$26.7 million in net losses compared to US$33.1 million during the same period a year before.
Compass Pathways’ Q4 2023 financial results were released on February 29. They show that its spending on research and development (R&D) increased by 25.4 percent in 2023 compared to 2022, which may have contributed to higher net losses for both the quarter and full year.
However, the company has announced multiple research collaboration agreements in 2024 in anticipation of future FDA approval of its COMP360 psilocybin treatment, including with Greenbrook TMS, Hackensack Meridian Health, Journey Clinical and Mindful Health Solutions. In its Q1 financial report, released on May 8, the company said it anticipates Phase 3 results for two clinical trials of its psilocybin formulation, COMP360, by Q4 2024 and mid-2025, respectively.
Cybin’s has reached notable milestones in 2024. On January 23, the company was granted FDA clearance to initiate a Phase 2a study of CYB004, a deuterated DMT molecule for treating GAD. In February, the company’s Q3 2023 quarterly earnings report included several optimistic updates on the various stages of its other trials.
Cybin has been actively pursuing intellectual property protection for its drug discovery platform, and its Q4 2024 report mentions four additional patents in jurisdictions in the US, Canada and China for CYB003 and CYB004.
MindMed has also made significant progress this year in terms of clinical programs and financial positioning. Its 2023 financial report includes multiple planned milestones, such as presenting 12-week Phase 2b data for its GAD treatment, MM120, and initiating a Phase 3 program in the second half of 2024.
Additionally, MindMed proposed an underwritten offering of common shares and a concurrent private placement, a higher cash balance in Q1 compared to Q4 2023 and decided to consolidate trading of its common shares on the NEO Exchange and Nasdaq, resulting in a voluntary delisting from Cboe Canada on April 1. MindMed's inclusion in the Russell 2000 and Russell 3000 Indexes on June 28 suggests its prominence in the US market could grow in Q3.
Finally, Numinus’ results for its first fiscal quarter of 2024 show an 18.8 percent increase in gross profits and a 3 percent decline in revenue compared to the previous quarter, a reduced cash burn rate of under US$1 million per month from October 2023 and over 700 new learners enrolled in its training programs.
The company was also approved to conduct a clinical trial by Health Canada that will assess the viability of a group model in MDMA-assisted psychotherapy on May 30.
On June 20, the company announced its intention to change its name to "Numinus Intelligence" after acquiring MedBright AI, a company that uses artificial intelligence to help medical professionals improve healthcare access and patient outcomes and reduce costs.
The acquisition involves merging MedBright's AI-powered clinical solutions with Numinus' data to optimize clinical operations and take advantage of reimbursable services.
The future of psychedelics and mental health treatment is evolving, and shareholders of companies pursuing psychedelics-based treatments will continue to advocate for their potential to play a considerable role in the future of mental health.
However, continued legislative action is necessary for psychedelics to become a more integrated part of mental health treatment, and to allow broader access and research. Currently, there are legislative developments happening in a few states.
In November, Massachusetts residents will have the opportunity to vote on a measure that would legalize the use of psychedelics in the state. The announcement was made by state officials after Massachusetts for Mental Health Options submitted 14,000 signatures to the office of Commonwealth Secretary William F. Galvin, who finalized the ballot questions on July 25.
In California, Senator Scott Wiener (D-CA) and State Assemblymember Marie Waldron (R-CA) introduced bipartisan legislation in February after Democratic Governor Gavin Newsom vetoed legislation that would have decriminalized psychedelic mushrooms last year. The new law would allow patients to consume psilocybin, dimethyltryptamine (DMT), MDMA and mescaline under the supervision of a licensed therapist.
The bill was approved by the Senate Business, Professions and Economic Development Committee on April 16, and by the Senate Public Safety Committee on April 23. However, on May 16, the Senate Appropriations Committee voted to hold the bill without taking further action, putting its future in question.
In New York, Assembly Bill 0375 was introduced on May 21. The bill is sponsored by Assemblymember Amy Paulin (D-NY), and is supported by New Yorkers for Mental Health Alternatives. It proposes the legal growth, cultivation and regulated adult use of psilocybin for certain health conditions. The bill has been referred to the Assembly Health Committee.
In Utah, SB 0266, a bipartisan bill sponsored by Senator Kirk Cullimore (D-UT) and Assemblymember Jim Dunnigan (R-UT) outlines a pilot program for hospitals to administer psilocybin and MDMA as an alternative treatment option for adults 18 and older. The bill became a law on March 21, although without Republican Governor Spencer Cox’s signature.
The financial health and progress of leading psychedelics companies indicate potential growth areas and future prospects in the sector.
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Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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 30 June 2024 (the ‘quarter’), as well as its Appendix 4C. All financial results are in Australian dollars and unaudited (unless otherwise stated).
Highlights:
Financial performance:
During Q2 FY24, Melodiol delivered $4.8m in unaudited revenue, which was a 9% increase on the previous quarter (Q1 FY24: $4.4m). H1 FY24 revenues of $9.3m are an increase of 33% vs. H1 FY23 ($7.0m). The results follow record group revenues of $21.6m in FY23, a 148% increase on the PCP.
Q1 FY24 revenue was underpinned by Melodiol’s 100%-owned Canadian subsidiary, Mernova Medicinal Inc. (‘Mernova’) which generated $2.0m in revenue for the period. Mernova’s revenue was up 25% on the PCP (Q1 FY2024 revenue: $1.5m).
Further, wholly-owned operating division Health House International (‘HHI’ or ‘HHI International’) also contributed $2.8m 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 $4.9m, in line with Q1 FY24 ($5.0m). Net cash used in operating activities was $1.9m. For H1 FY24, total cash used in operating activities was $3.0m, significantly lower than H1 FY23 ($6.6m).
Cash used in operating activities comprised mainly of product manufacturing and operating costs ($3.3m), advertising and marketing ($0.1m), staff costs ($1.5m), and administration and corporate costs ($1.7m).
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 $0.08m.
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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.
Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to advise that it has raised $1.1m in new capital in the form of an equity placement and a loan.
Highlights:
Equity Placement
The Company advises that it has received firm commitments to raise approximately $530,000 (before costs) through the issue of 181,683,449 new shares, representing a Placement price of $0.00292 per Share. Funds from the Placement will be applied towards select business unit growth opportunities, corporate costs and costs of the Placement.
Subject to shareholder approval, the Placement participants will receive one free attaching option (“New Option”) for every one new Share issued under the Placement. The New Options will have a term of 5 years and a strike price of $0.005. The Company will seek quotation of the New Options on the ASX.
At the Company’s Annual General Meeting on 31 May 2024, the Company received shareholder approval to conduct placements of shares to raise up to $3m at a 30.00% discount to the 10-day volume weighted average price (“VWAP”) prior to the date on which the issue price is agreed by the Company and participants under the Revised Placement. The issue price of the shares represents a 30.00% discount to the 10-day VWAP of $0.00417.
The Company notes that further capital will be required in the near term with the Company considering additional sources of capital, including but not limited to, other debt funding, further capital raising activities, and divestment of core assets.
Loan Funding
Simultaneous to the placement, the Company confirms that is has drawn down $600,000 from the $2,000,000 LTC loan facility, which was approved by shareholders at the Annual General Meeting on 31 May 2024 (refer to resolution 33 of the Company’s AGM notice dated 1 May 2024 for additional information). Per the terms of the facility, drawn amounts accrue interest at a rate of 20% per annum, and may be converted at a 30% discount to the Company’s 20-day VWAP prior to the date LTC elects to exercise its conversion right. The loan contains an establishment fee of $100,000 (which has been deferred 60 days) and $200,000 payable in shares (at an issue price equal to the 10-Day VWAP prior to the date the first monies are advanced).
Lead Manager
Oakley Capital Partners Pty Ltd (“Oakley”) acted as lead manager to the Placement. Oakley will earn a 6% cash fee on the gross cash amount raised under the placement and the loan. Subject to shareholder approval, Oakley will also receive 50 million broker shares and 181,683,449 New Options (being the same number as issued to Placement participants).
Management commentary:
CEO and Managing Director, Mr William Lay said: “We are grateful for the continued support of our investor base as we progress the business. Our revenues for the half year show that we have built a strong base at Melodiol, and the announced non-binding LOI for the sale of a core asset for $12m in initial cash consideration demonstrates the quality of the assets within the portfolio. We look forward to providing further updates in due course.”
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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.
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