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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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Compass Pathways Announces First Quarter 2025 Financial Results and Business Highlights
Highlights:
- 6-week top-line data from Part A of COMP005 phase 3 trial in treatment resistant depression on track for late June
- Phase 3 COMP006 in TRD on track for 26-week data second half of 2026
- Cash position of $260.1 million at March 31, 2025
- Conference call on May 8 at 8:00 am ET (1:00 pm UK)
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the first quarter 2025 and provided an update on recent progress across its business.
"We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression." said Kabir Nath, Chief Executive Officer. "Our continued progress reinforces Compass' leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation."
Business Highlights
COMP360 psilocybin treatment in TRD (Treatment Resistant Depression)
- The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest-to-date randomized, controlled, double-blind psilocybin treatment clinical program.
- All participants have completed dosing in part A of the COMP005 phase 3 trial for TRD and top-line 6-week (primary endpoint) data are expected in late June.
- 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial.
- COMP006 26-week data is expected in the second half of 2026.
- Recent 52-week data from an observational follow-up study published on COMP360 demonstrated a durable treatment response and a median time to depressive event of 92 days (n=252) on a single 25mg administration and 189 days (n=58) for the 25mg subgroup that continued into the COMP004 long-term extension
COMP360 psilocybin treatment in PTSD (Post Traumatic Stress Disorder)
- Company designing late-stage clinical trial program
- Phase 2 open label 12-week safety and tolerability study (n=22) announced in May 2024, showed COMP360 was well tolerated and demonstrated both rapid and durable improvement in symptoms from baseline observed following a single administration.
Financial highlights
- Net loss for the three months ended March 31, 2025, was $17.9 million, or $0.20 net loss per share: basic, $0.24 net loss per share: diluted, compared with $35.2 million, or $0.55 loss per share basic and diluted, during the same period in 2024. The decrease in net loss for the quarter was primarily driven by a $19.5 million non-cash gain on fair value adjustment related to our warrant liabilities. As the fair value of the warrants fluctuates with our share price and other market inputs, this adjustment can result in significant variability in our reported net loss.
- Non-cash share-based compensation for the three months ended March 31, 2025 was $3.9 million compared with $5.1 million for the same period in 2024.
- Research and development expenses were $30.9 million for the three months ended March 31, 2025, compared with $24.9 million during the same period in 2024. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials partially offset by decreased personnel and non-cash share-based compensation expenses due to decreased staffing levels associated with the strategic reorganization that took place in the fourth quarter of 2024.
- General and administrative expenses were $18.7 million for the three months ended March 31, 2025, compared with $13.7 million during the same period in 2024. The increase was primarily attributable to issuance costs related to the 2025 Financing as well as expenses associated with consulting, accounting and legal advice.
- Gain on change in fair value of warrants for the three months ended March 31, 2025, was $19.5 million compared with $0.0 million during the same period in 2024.
- Cash and cash equivalents were $260.1 million as of March 31, 2025, compared with $165.1 million as of December 31, 2024.
- An additional $140.4 million net cash raised in the first quarter of 2025.
Financial Guidance
Full year 2025 net cash used in operating activities is expected to be in the range of $120 million to $145 million. The cash position at March 31, 2025 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026.
Conference call
The management team will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025. A live webcast of the call will be available on the Compass Pathways website at First Quarter 2025 Financial Results .
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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).
Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.
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 "may", "might", "will", "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, statements regarding our expectations regarding our financial guidance; our business strategy and goals; our expectations and projections about the company's future cash needs and financial results; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD, PTSD, and anorexia nervosa; our ability to obtain regulatory approval and adequate coverage and reimbursement; our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained; and our expectations regarding the benefits of our investigational COMP360 psilocybin treatment. 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: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for 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 clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that our strategic collaborations will not continue or will not be successful; and our ability to retain key personnel; 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, the prospectus supplement related to the proposed public offering we plan to file 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.
Condensed Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(in thousands, except share and per share amounts) | |||||||
(expressed in U.S. Dollars, unless otherwise stated) | |||||||
March 31, | December 31, | ||||||
2025 | 2024 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 260,110 | $ | 165,081 | |||
Restricted cash | 379 | 389 | |||||
Prepaid expenses and other current assets | 44,979 | 35,821 | |||||
Total current assets | 305,468 | 201,291 | |||||
NON-CURRENT ASSETS: | |||||||
Operating lease right-of-use assets | 1,463 | 2,006 | |||||
Deferred tax assets | 4,028 | 3,774 | |||||
Long-term prepaid expenses and other assets | 8,176 | 6,595 | |||||
Total assets | $ | 319,135 | $ | 213,666 | |||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 8,584 | $ | 12,283 | |||
Accrued expenses and other liabilities | 11,194 | 14,495 | |||||
Debt, current portion | 8,988 | 5,513 | |||||
Operating lease liabilities - current | 1,233 | 1,725 | |||||
Total current liabilities | 29,999 | 34,016 | |||||
NON-CURRENT LIABILITIES | |||||||
Debt, non-current portion | 21,553 | 24,652 | |||||
Operating lease liabilities - non-current | 259 | 303 | |||||
Warrant liabilities | 71,857 | — | |||||
Total liabilities | $ | 123,668 | $ | 58,971 | |||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares, £0.008 par value; 92,848,326 and 68,552,215 shares authorized, issued and outstanding at March 31, 2025 and December 31, 2024, respectively | 938 | 702 | |||||
Additional paid-in capital | 763,436 | 704,919 | |||||
Accumulated other comprehensive loss | (16,311 | ) | (16,194 | ) | |||
Accumulated deficit | (552,596 | ) | (534,732 | ) | |||
Total shareholders' equity | 195,467 | 154,695 | |||||
Total liabilities and shareholders' equity | $ | 319,135 | $ | 213,666 | |||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||
(unaudited) | |||||||
(in thousands, except share and per share amounts) | |||||||
(expressed in U.S. Dollars, unless otherwise stated) | |||||||
Three Months ended March 31, | |||||||
2025 | 2024 | ||||||
OPERATING EXPENSES: | |||||||
Research and development | $ | 30,880 | $ | 24,901 | |||
General and administrative | 18,736 | 13,672 | |||||
Total operating expenses | 49,616 | 38,573 | |||||
Loss from operations: | (49,616 | ) | (38,573 | ) | |||
OTHER INCOME (EXPENSE), NET: | |||||||
Fair value change of warrant liabilities | 19,460 | — | |||||
Benefit from R&D tax credit | 8,448 | 3,101 | |||||
Interest income | 2,386 | 2,260 | |||||
Foreign exchange gains (losses) | 2,133 | (783 | ) | ||||
Interest expense | (1,124 | ) | (1,098 | ) | |||
Other income | 803 | 128 | |||||
Total other income, net | 32,106 | 3,608 | |||||
Loss before income taxes | (17,510 | ) | (34,965 | ) | |||
Income tax expense | (354 | ) | (222 | ) | |||
Net loss | $ | (17,864 | ) | $ | (35,187 | ) | |
Net loss per share attributable to ordinary shareholders: basic | $ | (0.20 | ) | $ | (0.55 | ) | |
Weighted average ordinary shares outstanding: basic | 89,192,252 | 64,222,178 | |||||
Net loss per share attributable to ordinary shareholders: diluted | $ | (0.24 | ) | $ | (0.55 | ) | |
Weighted average ordinary shares outstanding: diluted | 98,641,624 | 64,222,178 | |||||
Net loss | $ | (17,864 | ) | $ | (35,187 | ) | |
Other comprehensive loss: | |||||||
Foreign exchange translation adjustment | (117 | ) | (36 | ) | |||
Comprehensive loss | $ | (17,981 | ) | $ | (35,223 | ) | |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250508552210/en/
Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways Establishes Strategic Collaboration with HealthPort to Inform the Potential Delivery of COMP360 Synthesized Psilocybin Treatment in Underserved Communities
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation announced today it is entering into a strategic collaboration with HealthPort, a multi-site comprehensive community health organization. HealthPort employs an integrated model centered around social determinants of health and this collaboration will help inform the potential delivery of COMP360 synthesized psilocybin treatment in underserved communities, if FDA approved. This agreement with HealthPort expands the set of collaborations that Compass has established representing a broad spectrum of settings where people living with treatment resistant depression (TRD) receive their care in the United States.
HealthPort offers an integrated model of care aimed at helping those with behavioral health conditions and people impacted by poverty, disability and trauma. HealthPort is an evidence-based practice supporting thirteen dimensions of social determinants of health, including the coordination of an integrated outpatient mental health and addictions health clinic. HealthPort has been operating facility, residential, and mobile based interventions of care in the lower Eastern Shore of Maryland for the past 45 years.
Together, Compass and HealthPort will learn about the challenges and barriers to equitable access to new mental health treatments and they will conduct research into training and care reimbursement processes for COMP360, if approved. The companies will explore how investigational COMP360 synthesized psilocybin treatment might fit into an integrated health delivery practice similar to HealthPort. This exploration is designed to provide a template for potential future implementation and delivery of COMP360 within community care settings across the US. COMP360 is a synthesized, proprietary formulation of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions, including treatment resistant depression (TRD).
"We are proud to collaborate with Compass Pathways and to contribute to learning how COMP360 psilocybin treatment may be most effectively delivered to patients in underserved communities, if that treatment receives all necessary approvals for TRD," said Dimitrios Cavathas, CEO of HealthPort. "We are committed to addressing the social determinants of health that impact our community members and collaborating with Compass will help further our mission to serving the unique needs of our people."
"We strive to improve mental healthcare for every person who needs help, and we recognize the challenges to access for underserved populations and the potential for innovative treatments, such as COMP360, to lessen existing disparities, if approved," said Steve Levine, Chief Patient Officer of Compass Pathways. "We are thrilled to join forces with a leading integrated community health center, such as HealthPort, to further refine our understanding of how COMP360 psilocybin treatment could be delivered to patients in the future and, together, advance equitable access to mental healthcare."
About Compass Pathways' strategic collaborations
Compass is forming a comprehensive and diverse set of collaborations to inform how investigative COMP360 synthesized psilocybin treatment can be integrated into different types of healthcare delivery systems in the US.
Compass also has previously announced collaboration agreements with Greenbrook TMS, a leading provider of interventional psychiatric treatments such as Spravato and transcranial magnetic stimulation; Hackensack Meridian Health, a leading not-for-profit health care organization and the largest, most comprehensive and truly integrated network in New Jersey, addressing the full continuum of care for people living with TRD; Reliant Medical Group, an Optum company and integrated primary and specialty care organization; Journey Clinical, a leading psychedelic-assisted psychotherapy platform in the US; and Mindful Health Solutions, one of the US's leading providers of innovative behavioral health care.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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).
Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.
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 "may", "might", "will", "could", "should", "expect", "intend", "plan", "believe", "estimate", "predict", "possible", "potential" 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, the safety or efficacy of investigational COMP360 psilocybin treatment as a treatment for treatment-resistant depression, post-traumatic stress disorder or anorexia nervosa, the potential for the pivotal phase 3 program or other trials to support regulatory filings and approvals, Compass's business strategy and goals, Compass's plans, expectations and ability to achieve its goals related to this strategic collaboration agreement and its other collaborations; Compass's ability to continue to advance its research, obtain regulatory approval or develop plans to bring investigational COMP360 psilocybin treatment to patients, and Compass's expectations regarding the benefits of its investigational COMP360 psilocybin treatment. 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: clinical development is lengthy and outcomes are uncertain, and therefore Compass's clinical trials may be delayed or terminated; the results early-stage clinical trials of investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; the possibility of unfavorable results from additional clinical trials of investigational COMP360 psilocybin treatment or from subsequent analysis of existing data or new data received from additional ongoing and future studies of investigational COMP360 psilocybin treatment; Compass's efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for investigational COMP360 or any of future product candidates may be unsuccessful; Compass's efforts to obtain coverage and reimbursement for its investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; the risk that this collaboration with HealthPort or one or more of our previously announced collaborations will not continue or will not achieve the expected benefits; uncertainties regarding the ability to develop a scalable and cost-effective delivery model for investigational COMP360 psilocybin treatment, if approved; the risk that market adoption and access to investigational COMP360 psilocybin treatment, if approved, may be limited 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250429198140/en/
Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways to Announce First Quarter Financial Results on May 8, 2025
Compass management will host a conference call at 8:00 am ET (1:00 pm UK)
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the first quarter ended March 31, 2025, and provide an update on recent developments, on May 8, 2025.
Compass management will host a conference call at 8:00 am ET (1:00 pm UK) on May 8, 2025.
A live webcast of the call will be available on the Compass Pathways website at: First Quarter 2025 Financial Results. The webcast will be archived for 30 days.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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).
Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250428993513/en/
Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways Announces Dosing Complete for All Participants in Part A of Phase 3 COMP005 Trial of COMP360 Psilocybin for Treatment-Resistant Depression
Highlights:
- Participants received a single dose of either 25 mg of COMP360 or placebo
- On track for disclosure of top-line 6-week primary endpoint results in late June
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced that all participants have completed dosing in Part A of the COMP005 phase 3 trial for treatment resistant depression (TRD). Following pre-dosing activities, including washout from anti-depressant medications, if needed, participants received a single dose of either 25 mg of COMP360 or placebo. The Company is on track to disclose top-line 6-week primary endpoint results in late June.
"Completing dosing of all participants in Part A of our 005 trial marks a critical milestone in our mission to address the pressing unmet need in treatment resistant depression," said Kabir Nath, CEO Compass Pathways. "We are proud of this achievement which reflects our team's commitment to scientific rigor, operational excellence and potential to deliver a new treatment option to patients who have long been underserved. We are incredibly grateful to the participants, investigators and clinical sites that are making this study possible. We look forward to sharing the results of the 6-week primary endpoint in late June."
About the phase 3 COMP005 trial
To date, the COMP005 trial is the largest, multi-center study of an investigational, synthesized psilocybin to complete recruitment and will be the first pivotal program to report the efficacy of synthesized psilocybin for the treatment of TRD. In this randomized, double-blinded, placebo-controlled study, 258 participants with moderate-to-severe depression that have not responded to at least two or more prior treatments were dosed across 32 sites in the United States. This study aims to assess the efficacy and safety of a single dose of COMP360 25 mg versus placebo for reducing symptom severity in TRD.
The trial is comprised of three parts: Part A, which is blinded through 6 weeks, Part B, which remains blinded through week 26, and Part C, which is open-label from week 26 to week 52.
COMP360 is a synthesized, proprietary formulation of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions.
About treatment resistant depression (TRD)
Depression is one of the most common mental health disorders and the largest contributor to disability globally according to the World Health Organization. Approximately 300 million people , representing 5% of the adult population, suffer from major depressive disorder (MDD) worldwide.
Approximately one-third of patients with MDD aren't helped by existing therapies and are at high risk of developing treatment-resistant depression. TRD is generally defined as an inadequate response to two or more appropriate courses of approved medications. TRD has a significantly greater impact on individuals compared to MDD, leading to residual symptoms, poorer quality of life, increased comorbidities, higher mortality, and an increased risk of suicide.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 synthesized psilocybin treatment, potentially a first in class treatment. 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).
Compass is headquartered in London, UK, with offices in New York and San Francisco in the US. We envision a world where mental health means not just the absence of illness but the ability to thrive.
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 "may", "might", "will", "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, statements regarding our business strategy and goals; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the time periods during which the results of the two Phase 3 trials will become available; our expectations regarding the time periods during which results of other pivotal trials of synthesized psilocybin will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our ability to obtain regulatory approval and adequate coverage and reimbursement; and our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained. 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: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for 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 clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250422821349/en/
Enquiries
Media: Dana Sultan-Rothman, media@compasspathways.com , +1 484 432 0041
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Compass Pathways Announces Completion of Recruitment for the Phase 3 COMP005 Trial of COMP360 Psilocybin for Treatment-Resistant Depression
Highlights:
- Screening closed for all sites and final participants being scheduled for dosing
- On track for top-line 6-week primary endpoint results in late Q2
COMPASS Pathways Plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, today announced the completion of recruitment in the COMP005 phase 3 trial for treatment resistant depression (TRD). The final participants are completing pre-dosing activities, including washout from anti-depressant medications, if necessary, and those eligible will receive a dose of either 25 mg of COMP360 or placebo.
"We are pleased that recruitment is complete in the 005 trial, bringing us one-step closer to delivering COMP360 as a potential first-in-class psilocybin treatment for patients with treatment resistant depression," said Kabir Nath, Chief Executive Officer of Compass Pathways. "We await completion of dosing of the last participant, a milestone that we will also announce in the coming weeks, and we look forward to sharing the results of the 6-week primary endpoint in late Q2."
COMP360 is a synthetic form of psilocybin under investigation as a treatment for certain difficult-to-treat mental health conditions when administered with psychological support.
TRD is a condition in which individuals with major depressive disorder do not respond adequately to at least two different treatments. Depression is the leading cause of disability and ill health worldwide. Up to two-thirds of people with depression are not helped by the first antidepressant medication they try. Up to a third of people with depression are failed by multiple attempts at treatment.
The pivotal phase 3 clinical program of COMP360 psilocybin treatment in TRD is the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Top-line 6-week (primary endpoint) COMP005 data is expected late in the second quarter 2025 and 26-week COMP005 data is expected once all participants in the COMP006 trial have completed part A of the COMP006 trial. The COMP006 26-week data is expected in the second half of 2026.
About Compass Pathways
COMPASS Pathways Plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. We are motivated by the need to find better ways to help and empower people with serious mental health conditions who are not helped by existing treatments. We are pioneering a new paradigm for treating mental health conditions focused on rapid and durable responses through the development of our investigational COMP360 psilocybin treatment, potentially a first in class treatment. 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).
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.
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 "may", "might", "will", "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, statements regarding our business strategy and goals; our plans and expectations regarding our phase 3 trials in TRD, including our expectations regarding the number of participants that will be dosed and the time periods during which the dosing of all participants will be completed and the results of the two Phase 3 trials will become available; the potential for the pivotal phase 3 program in TRD, any future trials in PTSD, or other trials to support regulatory filings and approvals; our expectations regarding the safety or efficacy of our investigational COMP360 psilocybin treatment, including as a treatment for treatment of TRD; our ability to obtain regulatory approval and adequate coverage and reimbursement; and our ability to transition from a clinical-stage to a commercial-stage organization and effectively launch a commercial product, if regulatory approval is obtained. 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: uncertainties associated with risks related to clinical development which is a lengthy and expensive process with uncertain outcomes, and therefore our clinical trials may be delayed or terminated and may be more costly than expected; participants who have completed screening may not complete pre-dosing activities and enroll in our COMP005 trial; the results of early-stage clinical trials of our investigational COMP360 psilocybin treatment may not be predictive of the results of later stage clinical trials; our need for 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 clinical trials; our efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for our investigational COMP360 psilocybin treatment may be unsuccessful; our efforts to commercialize and obtain coverage and reimbursement for our investigational COMP360 psilocybin treatment, if approved, may be unsuccessful; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250326830443/en/
Enquiries
Media: Media, media@compasspathways.com
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia