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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.
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.
Company Highlights
- Albert Labs has an existing relationship with the largest oncology centre in Europe, setting the stage for rapid commercial deployment of its medication upon completion of clinical trials and receipt of regulatory approval.
- The usage of the Real-World Evidence clinical model will accelerate the clinical trials and allow the company to reach regulatory approval much faster than traditional trials.
- Albert Labs has a proprietary and provisionally patented process for producing the active ingredient in its medicines that allows improved scale and standardization.
- A diverse team of doctors, scientists, and managers are leading the company towards receiving approval for its inaugural medicine and beyond.
This Albert Labs profile is part of a paid investor education campaign.*
ABRT:CNX
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 to Participate in December Investor Conferences
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that members of the executive management team will participate in the following investor conferences in addition to hosting investor meetings:
- 7 th Annual Evercore ISI HealthCONx Conference: Fireside chat at 10:25am ET on December 3, 2024
- Piper Sandler 36 th Annual Healthcare Conference: Fireside chat at 3:30pm ET on December 4, 2024
A live audio webcast of these events will be accessible here for 30 days following the events.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241125241648/en/
Enquiries
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
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Compass Pathways to participate in Stifel 2024 Healthcare Conference
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will present at the Stifel 2024 Healthcare Conference at 10:55 am ET on November 19, 2024.
A live audio webcast of the presentation will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following 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 Announces Third Quarter 2024 Financial Results and Business Updates
- Top-line COMP005 data for COMP360 phase 3 pivotal program in treatment-resistant depression now expected in second quarter 2025
- COMP006 data will now be announced after 26-week time point, expected in the second half of 2026
- Strategic reorganization to focus all efforts on COMP360 program resulting in reduction of workforce of approximately 30%
- Cash position of $207 million
- Conference call October 31 at 8:00 am ET (12:00 pm UK)
Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating access to evidence-based innovation in mental health, today reported its financial results for the third quarter 2024 and an update on recent business progress.
"Ensuring the success of our lead COMP360 program is our absolute priority. We remain confident that COMP360 can be an effective therapy for patients with serious mental illness and our focus on delivering new treatment options for patients living with treatment-resistant depression remains paramount," said Kabir Nath, Chief Executive Officer of Compass Pathways. "The shift in the phase 3 pivotal program timeline has forced us to look carefully at our operations and ensure that every resource is focused on this goal. As such, we have made the difficult decision to reduce our workforce and exit activities that are not directly tied to the completion of the trials, regulatory filing and commercialization if approved. These are necessary strategic decisions that we believe will position the COMP360 program for success."
Business highlights
COMP360 psilocybin treatment in TRD
The 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 pivotal COMP005 trial data is expected in the second quarter 2025. In addition, as a result of the increased regulatory scrutiny on functional unblinding, the company has decided to shift the data release for COMP006 until after the 26-week time point and the completion of the blinded portion has been reached for all patients to protect against the risk of unblinding. With this change, Compass now expects data for COMP006 in the second half of 2026.
Prioritization of resources
As a result of changing timelines for the phase 3 trials, we will be reducing our workforce by approximately 30%, including eliminating some senior management positions, to further focus the organization and its capital resources on successfully delivering the COMP360 program. Our non-COMP360 preclinical efforts will be stopped and we are exploring a potential externalization for our digital health tools.
Financial highlights
- Net loss for the three months ended September 30, 2024, was $38.5 million, or $0.56 loss per share (including non-cash share-based compensation expense of $5.0 million), compared with $33.4 million, or $0.67 loss per share, during the same period in 2023 (including non-cash-share-based compensation expense of $4.4 million).
- Net loss for the nine months ended September 30, 2024, was $111.8 million, or $1.67 loss per share (including non-cash share-based compensation expense of $15 million), compared with $85.9 million, or $1.81 loss per share, during the same period in 2023 (including non-cash-share-based compensation expense of $13.1 million).
- Research and development expenses were $32.9 million for the three months ended September 30, 2024, compared with $21.5 million during the same period in 2023. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials and increased personnel expenses due to increased R&D headcount.
- Research and development expenses were $86.9 million for the nine months ended September 30, 2024, compared with $60.4 million during the same period in 2023. The increase was primarily attributable to development expenses associated with advancing our late-stage COMP360 phase 3 clinical trials and increased personnel expenses due to increased R&D headcount.
- General and administrative expenses were $15.0 million for the three months ended September 30, 2024, compared with $12.5 million during the same period in 2023. The increase was primarily attributable to increased personnel expenses due to increased headcount supporting our corporate functions and increased legal and professional fees due to consulting, legal advice and patent applications.
- General and administrative expenses were $42.9 million for the nine months ended September 30, 2024, compared with $38.1 million during the same period in 2023. The increase was primarily attributable to increased personnel expenses due to increased headcount supporting our corporate functions and increased legal and professional fees due to consulting, legal advice and patent applications.
- Cash and cash equivalents were $207 million as of September 30, 2024, compared with $220.2 million as of December 31, 2023.
- Debt was $29.8 million as of September 30, 2024, compared with $28.8 million as of December 31, 2023.
Financial Guidance
Fourth quarter 2024 net cash used in operating activities is expected to be in the range of $37 million to $43 million. The full-year 2024 net cash used in operating activities is expected to be in the range of $114 million to $120 million. The cash position at September 30, 2024, is expected to be sufficient to fund operating expenses and capital expenditure requirements at least into 2026.
Conference call
The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. A live webcast of the call will be available on the Compass Pathways website at Third Quarter 2024 Financial Results. The webcast will also be on the Investors section of the Compass Pathways website for 30 days.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of 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.
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", "will", "could", "would", "expect", "intend", "plan", "anticipate", "believe", "potential" and "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, our financial guidance; our business strategy and goals, our expectations and projections about the company's future cash needs and financial results; our plans for a strategic reorganization, including a reduction in workforce, and our expectations regarding impact and cost savings from our planned reduction in workforce; 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 expectations regarding the benefits of our investigational COMP360 psilocybin treatment; and our plans, expectations and ability to achieve our goals related to the research collaboration agreements. 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 our 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: we will require substantial additional funding to achieve our business goals, including to repay the term loan facility, 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 and research and development efforts; the availability of future tranches under the term loan facility is dependent, in part, on the approval of the lender, achievement of certain milestones and other factors; clinical development is lengthy and outcomes are uncertain, and therefore our phase 3 clinical trials in TRD and our other clinical trials may be delayed or terminated; 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 efforts to obtain marketing approval from the applicable regulatory authorities in any jurisdiction for COMP360 or any of future product candidates may be unsuccessful; the risk that our research collaborations will not continue or will not be successful; and our efforts to 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 our 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 . Except as required by law, we disclaim 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 our current expectations and speak only as of the date hereof.
COMPASS PATHWAYS PLC Condensed Consolidated Balance Sheets (unaudited) (in thousands, except share and per share amounts) (expressed in U.S. Dollars, unless otherwise stated) | |||||||
September 30, | December 31, | ||||||
2024 | 2023 | ||||||
ASSETS | |||||||
CURRENT ASSETS: | |||||||
Cash and cash equivalents | $ | 206,953 | $ | 220,198 | |||
Restricted cash | 389 | 440 | |||||
Prepaid expenses and other current assets | 26,319 | 40,658 | |||||
Total current assets | 233,661 | 261,296 | |||||
NON-CURRENT ASSETS: | |||||||
Operating lease right-of-use assets | 2,745 | 4,306 | |||||
Deferred tax assets | 4,414 | 3,336 | |||||
Long-term prepaid expenses and other assets | 6,518 | 7,049 | |||||
Total assets | $ | 247,338 | $ | 275,987 | |||
LIABILITIES AND SHAREHOLDERS' EQUITY | |||||||
CURRENT LIABILITIES: | |||||||
Accounts payable | $ | 8,233 | $ | 5,892 | |||
Accrued expenses and other liabilities | 13,522 | 11,301 | |||||
Debt, current portion | 2,156 | — | |||||
Operating lease liabilities - current | 2,300 | 2,411 | |||||
Total current liabilities | 26,211 | 19,604 | |||||
NON-CURRENT LIABILITIES | |||||||
Debt, non-current portion | 27,638 | 28,757 | |||||
Operating lease liabilities - non-current | 459 | 1,882 | |||||
Total liabilities | $ | 54,308 | $ | 50,243 | |||
SHAREHOLDERS' EQUITY: | |||||||
Ordinary shares, £0.008 par value; 68,409,068 and 61,943,471 shares authorized, issued and outstanding at September 30, 2024 and December 31, 2023, respectively | 699 | 635 | |||||
Additional paid-in capital | 700,273 | 621,645 | |||||
Accumulated other comprehensive loss | (16,542 | ) | (16,926 | ) | |||
Accumulated deficit | (491,400 | ) | (379,610 | ) | |||
Total shareholders' equity | 193,030 | 225,744 | |||||
Total liabilities and shareholders' equity | $ | 247,338 | $ | 275,987 | |||
COMPASS PATHWAYS PLC 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 September 30, | Nine Months ended September 30, | ||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
OPERATING EXPENSES: | |||||||||||||||
Research and development | $ | 32,928 | $ | 21,526 | $ | 86,898 | $ | 60,379 | |||||||
General and administrative | 14,968 | 12,536 | 42,893 | 38,135 | |||||||||||
Total operating expenses | 47,896 | 34,062 | 129,791 | 98,514 | |||||||||||
Loss from operations: | (47,896 | ) | (34,062 | ) | (129,791 | ) | (98,514 | ) | |||||||
OTHER INCOME (EXPENSE), NET: | |||||||||||||||
Benefit from R&D tax credit | 4,084 | 2,685 | 10,894 | 9,521 | |||||||||||
Interest income | 1,977 | 1,015 | 6,645 | 2,357 | |||||||||||
Interest expense | (1,137 | ) | (1,080 | ) | (3,347 | ) | (1,080 | ) | |||||||
Foreign exchange gains (losses) | 4,452 | (1,997 | ) | 3,894 | 2,064 | ||||||||||
Other income | 191 | 112 | 486 | 106 | |||||||||||
Total other income, net | 9,567 | 735 | 18,572 | 12,968 | |||||||||||
Loss before income taxes | (38,329 | ) | (33,327 | ) | (111,219 | ) | (85,546 | ) | |||||||
Income tax expense | (173 | ) | (62 | ) | (571 | ) | (386 | ) | |||||||
Net loss | $ | (38,502 | ) | $ | (33,389 | ) | $ | (111,790 | ) | $ | (85,932 | ) | |||
Net loss per share attributable to ordinary shareholders—basic and diluted | $ | (0.56 | ) | $ | (0.67 | ) | $ | (1.67 | ) | $ | (1.81 | ) | |||
Weighted average ordinary shares outstanding—basic and diluted | 68,395,343 | 49,633,104 | 67,001,326 | 47,355,992 | |||||||||||
Net loss | $ | (38,502 | ) | $ | (33,389 | ) | $ | (111,790 | ) | $ | (85,932 | ) | |||
Other comprehensive gain (loss): | |||||||||||||||
Foreign exchange translation adjustment | 339 | (738 | ) | 384 | (599 | ) | |||||||||
Comprehensive loss | $ | (38,163 | ) | $ | (34,127 | ) | $ | (111,406 | ) | $ | (86,531 | ) | |||
View source version on businesswire.com: https://www.businesswire.com/news/home/20241031740397/en/
Enquiries
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia
Seelos Announces Second Postponement of its Annual Meeting of Stockholders
Seelos Therapeutics, Inc. (OTCQB: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today announced that its 2024 Annual Meeting of Stockholders (the "Annual Meeting"), which was previously postponed to Friday, October 25, 2024 from its originally scheduled date of Friday, September 27, 2024 has been further postponed. The Annual Meeting is now scheduled to be held virtually, via live webcast at www.virtualshareholdermeeting.comSEEL2024 on Monday, November 25, 2024 at 8:00 a.m., Eastern Time . The record date for the Annual Meeting, August 19, 2024 is unchanged and applies to the postponed Annual Meeting.
The Annual Meeting has been postponed due to an anticipated lack of quorum, and to provide further time to solicit proxies from the Company's stockholders. Seelos' Board of Directors unanimously recommends that you vote FOR the Board of Director nominees and FOR all other proposals identified in the Company's proxy statement for the Annual Meeting. Stockholders who have already cast their votes do not need to take any action, unless they wish to change or revoke their prior proxy or voting instructions, and their votes will be counted at the postponed Annual Meeting. For stockholders who have not yet cast their votes, we urge them to vote their shares now, so they can be tabulated prior to the postponed Annual Meeting.
About Seelos Therapeutics
Seelos Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development and advancement of novel therapeutics to address unmet medical needs for the benefit of patients with central nervous system (CNS) disorders and other rare diseases.
For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.
IMPORTANT ADDITIONAL INFORMATION
Seelos has filed a definitive proxy statement with the Securities and Exchange Commission (the "SEC") on August 20, 2024 . STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO) FILED BY SEELOS AND ANY OTHER RELEVANT DOCUMENTS FILED WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN OR WILL CONTAIN IMPORTANT INFORMATION ABOUT ANY SOLICITATION. Stockholders may obtain a free copy of the proxy statement and the other relevant materials, and any other documents filed by Seelos with the SEC, at the SEC's web site at http://www.sec.gov or on the "SEC Filings" section of Seelos' website at https://seelostherapeutics.com .
Participants in the Solicitation
Seelos, its directors and executive officers and other members of management and employees will be participants in the solicitation of proxies with respect to a solicitation by Seelos. Information about Seelos' executive officers and directors, including information regarding the direct or indirect interests, by security holdings or otherwise, is available in Seelos' definitive proxy statement for its Annual Meeting, which was filed with the SEC on August 20, 2024 . To the extent holdings by our directors and executive officers of Seelos securities reported in the proxy statement for the Annual Meeting have changed, such changes have been or will be reflected on Statements of Change in Ownership on Forms 3, 4 or 5 filed with the SEC. These documents are or will be available free of charge at the SEC's website at http://www.sec.gov .
Forward-Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements related to Seelos for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on Seelos' current expectations and beliefs and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated with Seelos' business and plans described herein include, but are not limited to, the risk of not receiving stockholder approval of any of the proposals to be presented at the Annual Meeting, the risks related to raising capital to fund its development plans and ongoing operations and risks related to Seelos' current stock price, as well as other risk factors and matters set forth in our periodic filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2023 , subsequent Quarterly Reports on Form 10-Q, including Seelos' Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 . Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, even if subsequently made available by us on our website or otherwise. We do not undertake any obligation to update, amend or clarify these forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws.
Contact Information:
Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com
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SOURCE Seelos Therapeutics, Inc.
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Compass Pathways to Announce Third Quarter Financial Results on October 31, 2024
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 third quarter 2024 ending September 30, 2024, and provide an update on recent business developments, on October 31, 2024.
The management team will host a conference call at 8:00 am ET (12:00 pm UK) on October 31, 2024. To access the call, please register in advance here to obtain a local or toll-free phone number and your personal pin.
A live webcast of the call will be available on the Compass Pathways website at: Third Quarter 2024 Financial Results
The webcast will also be available on the Investors section of the Compass Pathways website. The webcast will be archived for 30 days.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are living with mental health challenges and who are not helped by existing standards of care. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241024060255/en/
Enquiries
Media: Sally Bain, sally.bain@compasspathways.com , + 1 781 458 0443
Investors: Stephen Schultz, stephen.schultz@compasspathways.com , +1 401 290 7324
News Provided by Business Wire via QuoteMedia