Effective immediately, Albert Labs International Corp. will be reinstated for trading.
The Company has rectified the situation that gave rise to the suspension.
A cancer diagnosis is a challenge in and of itself, but a lack of effective psychiatric support makes it even worse. Patients report feelings of helplessness and a hastened desire for death, and researchers are now exploring how natural psychedelic compounds can be transformed into practical mental health treatments for cancer patients. Albert Labs (CSE:ABRT) is a Vancouver-based research and drug development company presently developing a psilocybin-based medication for patients with cancer-related distress. Albert Labs has a patented process for creating the active pharmaceutical ingredient (API) used in its inaugural medication.
Effective immediately, Albert Labs International Corp. will be reinstated for trading.
The Company has rectified the situation that gave rise to the suspension.
_________________________________
Avec effet immédiat, Albert Labs International Corp. sera réintégré aux fins de négociation.
La Société a rectifié la situation ayant donné lieu à la suspension.
Date : | Le 7 juillet/July 2023 |
Symbol(s)/Symbole(s) : | ABRT |
If you have any questions or require further information please contact Listings at (416) 367-7340 or E-mail: Listings@thecse.com.
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.
News Provided by Newsfile via QuoteMedia
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
News Provided by Canada Newswire via QuoteMedia
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
News Provided by Canada Newswire via QuoteMedia
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
News Provided by Canada Newswire via QuoteMedia
Highlights:
Albert Labs International Corp. (CSE: ABRT), the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, has announced a strategic investment from prominent psychedelic pharmaceutical investment fund, Cantheon Capital LLC ("Cantheon Capital").
On 23 March 2023 , the Company entered into an agreement which sees Cantheon Capital sign funding terms for ~CA$830,000 (£500,000) of Convertible Debentures to support financing of Albert Labs' forthcoming clinical trials in 2023.
Cantheon Capital's investment mandate is focussed on pharmaceutical companies with near term catalysts for high-value generation, deploying capital to support with achieving major drug development milestones.
This investment comes on the cusp of the third major milestone for Albert Labs . The first, an extensive drug discovery programme, the second, the completion of pre-clinical studies, and the third, to be commenced shortly, being KRN-101 administered to humans for the first time.
KRN-101 is an IP-protected, psilocybin-based pharmaceutical product, for which Albert Labs will seek regulatory approval across global medical regulatory jurisdictions.
This investment will be entirely allocated towards Albert Labs' first in-human studies, to be conducted by iNGENu in Australia , which are due to take place in Q2 2023 .
Aaron Ray , General Partner of Cantheon Capital, commented: "We are pleased to partner with Albert Labs and excited by what we see as a huge growth proposition for 2023. First in-human studies are significant for any early-stage pharmaceutical company. Reaching this milestone is reflective of the incredible amount of work that has gone into delivering KRN-101. The company will benefit greatly from carrying out these trials in Australia with iNGENu, the leading CRO for the burgeoning entheogen drug development space.
Beyond the investment itself, we look forward to supporting the company with our deep expertise in pharmaceutical research and commercialization. We are highly selective in the companies we choose to invest into but in the case of Albert Labs , we were attracted by their ability to accelerate product through the regulatory channels and clinical trials pathways to hasten the timeline to commercialization."
Dr. Michael Raymont , CEO of Albert Labs , stated: "We are delighted to come to this agreement with Cantheon Capital, one of the most sophisticated later stage psychedelics venture capital firms in the world, and feel it serves as a real statement of confidence in our growth as a company and the upside potential of our product that will help improves the lives of millions of patients globally. We are a differentiated offering within the industry, holding extensive intellectual property protection and a unique regulatory strategy focussed on speed to market. We look forward to building upon the significant progress to date with some key clinical milestones in the year ahead."
Further to the announcement of this investment, Albert Labs has been recognised in Canadian Venture for "Revolutionizing Mental Health Drug Development".
Canadian Venture commented:
Are you an Albert Labs investor yet? Let's talk.
+1 877 859 3684
Cantheon Capital has signed terms with Albert Labs for an aggregate investment of GB£500,000 (~CA$830,000), provided in two (2) tranches, relating to their upcoming first in-human clinical trials. The tranches of the Convertible Debentures will be triggered by the commencement and first dosing events in the trials, which will evaluate Albert Labs' proprietary psilocybin-based pharmaceutical product, KRN-101.
The Convertible Debenture conversion price, if executed, shall be at a 20% discount to the closing price of the Company's common stock 20-day VWAP trading average, as quoted on the Canadian Securities Exchange ("CSE") the effective day of the Convertible Debenture, subject to a minimum of $0.05 (the "Conversion Price"). They include a 10% interest rate paid in cash annually in arrears, with an option to pay at the Company's election within the first 6 months of closing, subject to a 3% prepayment penalty. The Convertible Debentures include 100% warrant cover, exercisable at the same conversion price as the common shares upon issue, as approved by the CSE. In accordance with the terms, the conversion price per Common Share shall be adjusted to ensure that Cantheon and its affiliates shall not beneficially own, or have control or direction over, Common Shares in excess of 19.99% of the number of Common Shares issued and outstanding immediately after giving effect to the issuance of Common Shares issuable under the applicable tranche.
Completion of the Convertible Debentures remain subject to the final agreement and regulatory approvals, including from the CSE.
Albert Labs is a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs. Its team of experts leverage advanced culture technology and natural extraction, coupled with a comprehensive regulatory approach, to accelerate the development of mental health drugs, for which patient needs are both urgent and unmet. Albert Labs looks to develop solutions through an approved, fast-track clinical pathway focusing on Real World Evidence (RWE). RWE studies are a recognised clinical pathway, heavily used in oncology and recently, in the successful development of COVID-19 vaccines.
Through collaborations with research institutions, hospital centres and government agencies, Albert Labs uses existing clinical infrastructure to deliver and improve patient access to its treatment. Albert Labs' first drug target, KRN-101, is a potential solution for cancer-related anxiety, a market of over 15 million people with roughly 1 million new sufferers each year. From this initial focus, Albert Labs will address broader mental health concerns, reported to affect over a billion people worldwide.
The company's goal is to deliver effective medicines to those who suffer with their mental health in the shortest possible time without compromising safety and/or quality, while also providing significant returns to shareholders.
Albert Labs (CSE: ABRT) (FSE: VB50) is publicly listed on the Canadian Securities Exchange (CSE) .
You can find more details about Albert Labs on our website here .
ON BEHALF OF THE BOARD OF DIRECTORS
Albert Labs International Corp.
Dr. Michael Raymont
Chief Executive Officer, Chairman
This news release includes forward-looking statements that are subject to assumptions, risks, and uncertainties. Statements in this news release that are not purely historical are forward-looking statements, including without limitation any statements concerning the Company's intentions, plans, estimates, beliefs, or expectations regarding the future. Although the Company believes that any such intentions, plans, estimates, beliefs, and expectations in this news release are reasonable, there can be no assurance that any such intentions, plans, beliefs, and expectations will prove to be accurate.
The Company cautions readers that all forward-looking statements, including without limitation those relating to the Company's future operations and business prospects, are based on assumptions none of which can be assured, and are subject to certain risks and uncertainties that could cause actual events or results to differ materially from those indicated in the forward-looking statements. Readers are advised to rely on their evaluation of such risks and uncertainties and should not place undue reliance on forward-looking statements.
Any forward-looking statements are made as of the date of this news release, and the Company assumes no obligation to update the forward-looking statements or to update the reasons why actual events or results could or do differ from those projected in the forward-looking statements. The Company assumes no obligations to update any forward-looking statements, whether as a result of new information, future events, or otherwise unless required by the applicable securities laws.
SOURCE Albert Labs International Corp.
View original content to download multimedia: https://www.newswire.ca/en/releases/archive/March2023/28/c6495.html
News Provided by Canada Newswire via QuoteMedia
Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, today provided an update on top-line data of the Phase 23 HEALEY ALS Platform trial. This study was performed in collaboration with The Sean M. Healey and AMG Center, which is viewed as an influential force in ALS research and in caring for the ALS community. Their unique and innovative approach continues to be a benefit to the ALS community and its contributions have helped bring the last two FDA approved therapies for ALS to market.
The study was designed to evaluate SLS-005 (IV trehalose), a low molecular weight disaccharide that stabilizes misfolded proteins and activates autophagy, in decreasing the slope of the ALS Functional Rating Scale (ALSFRS-R) and separation from placebo in Function and Mortality in an all-comers population of Persons with ALS (PALS).
While the study did not meet statistical significance in the primary and secondary endpoint in the Full Analysis Set (FAS) 2 , by showing a 13% improvement in Function and Mortality with an 88% success probability (versus the pre-specified 98%), it showed a potential signal of efficacy in a pre-specified subgroup (ERF) 1 .
In the pre-specified subgroup of PALS treated with SLS-005, without RELYVRIO®, the top-line data favored SLS-005 versus placebo in efficacy measures in the Efficacy RELYVRIO® Free (ERF) 1 data set (n=130), including:
Additional analysis and information from these data accessible here.
"The HEALEY platform is designed to detect signals of efficacy and we believe the observed signal and success probability is competitive to other recently FDA-approved therapies for ALS which also failed to achieve statistical significance when measured for function and mortality on similar primary and efficacy endpoints," said Raj Mehra Ph.D., Chairman and Chief Executive Officer of Seelos. "We plan to request a meeting with the FDA to discuss potential next steps for the program and will continue our potential partner discussions."
Seelos has not yet received the full dataset and upon receiving it in the near future, Seelos plans to run additional analyses, including biomarkers of neurodegeneration, neurofilament light chain (NfL), exploratory efficacy results, subgroups and post-hoc analyses. SLS-005 was generally well-tolerated and comparable to placebo in safety. There was an imbalance of deaths/death equivalents observed in the study, with more events seen in the SLS-005 group compared to placebo, all were considered unrelated to the study drug.
Populations – ERF 1 , FAS 2 and ERO 3 :
Seelos received top-line results for Regimen E (RGE). This included a Full Analysis Set (FAS), an Efficacy Regimen Only (ERO) population and an Efficacy RELYVRIO® Free (ERF) population. FAS includes shared placebo from all regimens, including RGE (n=204) and the RGE SLS-005 participants (n=120). The Efficacy Regimen Only (ERO) population includes 120 RGE SLS-005 and 41 RGE placebo participants. 31 participants in the ERO population received RELYVRIO® during the SLS-005 RGE study, thus confounding results from this population. The ERF analyses exclude participants who initiated RELYVRIO® during the study. ERF represents the participants who followed the protocol as envisioned (n=130, i.e., the ERF population comprises 81% of ERO/RGE participants).
About SLS-005 (trehalose injection, 90.5 mg/mL for intravenous infusion)
SLS-005 is a low molecular weight disaccharide (0.342 kDa) that crosses the blood brain barrier and is thought to stabilize proteins and activate autophagy through the activation of Transcription Factor EB (TFEB), a key factor in lysosomal and autophagy gene expression. The activation of TFEB is an emerging therapeutic target for a number of diseases with pathologic accumulation of storage material. In animal models of several diseases associated with abnormal cellular protein aggregation or storage of pathologic material, SLS-005 has been shown to reduce aggregation of misfolded proteins and reduce accumulation of pathologic material. SLS-005 has previously received Orphan Drug Designation for the treatment of ALS from the U.S. Food and Drug Administration and from the European Medicines Agency in the EU. SLS-005 is an investigational treatment and is not currently approved by any health authority for medicinal use.
About Amyotrophic Lateral Sclerosis (ALS)
According to the National Institute of Neurological Disorders and Stroke, amyotrophic lateral sclerosis (ALS) is a group of rare neurological diseases that mainly involve the nerve cells (neurons) responsible for controlling voluntary muscle movement. In ALS, both the upper motor neurons and the lower motor neurons degenerate or die and stop sending messages to the muscles. Unable to function, the muscles gradually weaken, start to twitch (called fasciculations), and waste away (called atrophy). Eventually, the brain loses its ability to initiate and control voluntary movements. The disease is progressive, meaning the symptoms get worse over time. The majority of ALS cases (90 percent or more) are considered sporadic. This means the disease seems to occur at random with no clearly associated risk factors and no family history of the disease. Although family members of people with sporadic ALS are at an increased risk for the disease, the overall risk is very low, and most will not develop ALS.
Most people with ALS eventually die from respiratory failure, usually within 3 to 5 years from when the symptoms first appear. However, about 10 percent of people with ALS survive for 10 or more years. Currently, there is no cure for ALS and no effective treatment to halt or reverse the progression of the disease.
A 1-point change in the ALSFRS-R score can indicate a meaningful difference in a person's ability to function independently with activities of daily living (ADL's), including eating, bathing, dressing or walking. 4
4. FDA Center for Drug Evaluation and Research, Application Number 209176Orig1s000, Office Director Memo, Ellis F. Unger , MD, May 4, 2017 . Paganoni S, et al. New Eng J Med. 2020.
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. The Company's robust portfolio includes several late-stage clinical assets targeting indications including Acute Suicidal Ideation and Behavior (ASIB) in Major Depressive Disorder (MDD), amyotrophic lateral sclerosis (ALS) and spinocerebellar ataxia (SCA), as well as early-stage programs in Huntington's disease, Alzheimer's disease, and Parkinson's disease.
For more information, please visit our website: https://seelostherapeutics.com , the content of which is not incorporated herein by reference.
Forward Looking Statements
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, among others, those regarding the Phase 2/3 study of SLS-005, statements regarding the competitiveness of the results to recently approved FDA therapies for ALS, statements regarding any planned meetings and discussions with the FDA, statements regarding The Sean M. Healey and AMG Center's contributions to the ALS community, statements regarding the timing of Seelos's receipt of the full dataset for the trial, statements regarding additional analyses to be run by Seelos and statements regarding SLS-005's prospects and any future analyses that may be conducted. 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 successfully executing its preclinical and clinical studies, not being able to move forward with the development of SLS-005, and not gaining marketing approvals for SLS-005 and/or its other product candidates; the risk that prior clinical results may not be replicated in future studies and trials (including the risk that the results from the prior studies of SLS-005 may not be replicated or may be materially different from the results of the top-line data from the SLS-005 study); the risks that clinical study results may not meet any or all endpoints of a clinical study and that any data generated from such studies may not support a regulatory submission or approval; the risks associated with the implementation of Seelos' business strategy; the risks related to raising capital to fund its development plans and ongoing operations; the risks related to Seelos' current stock price; as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. 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:
Anthony Marciano
Chief Communications Officer
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Avenue, 2 nd Floor
New York , NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
https://seelostherapeutics.com/
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos
Mike Moyer
Managing Director
LifeSci Advisors, LLC
250 West 55th St., Suite 3401
New York , NY 10019
(617) 308-4306
mmoyer@lifesciadvisors.com
View original content to download multimedia: https://www.prnewswire.com/news-releases/seelos-therapeutics-provides-update-on-top-line-results-from-its-amyotrophic-lateral-sclerosis-als-study-with-sls-005-iv-trehalose-302092918.html
SOURCE Seelos Therapeutics, Inc.
News Provided by PR Newswire via QuoteMedia
Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to present its Preliminary Final Year Report.
PRELIMINARY FINAL REPORT
For the year ended 31 December 2023, previous corresponding period is 31 December 2022.
CHANGE OF COMPANY NAME
On 31 May 2023, the Company announced that at the Annual General Meeting held on that date a resolution was passed by shareholders to change the Company’s name from Creso Pharma Limited (ASX: CPH) to Melodiol Global Health Limited (ASX: ME1). The change of name took effect on ASX from the commencement of trading on 13 June 2023
RESULTS FOR ANNOUNCEMENT TO THE MARKET
DIVIDENDS
No dividends have been paid or declared by the Group during the year (2022: Nil). No dividend is recommended in respect of the current financial year (2022: Nil).
Click here for the full ASX Release
This article includes content from Melodiol Global Health, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
-
Highlights:
|
Compass Pathways plc (Nasdaq: CMPS) ("Compass"), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter 2023 and provided an update on recent progress across its business.
Kabir Nath, Chief Executive Officer, said, "We continue to progress our two phase 3 trials of COMP360 in treatment-resistant depression with top-line data expected this year and next. While our overall Phase 3 trial completion remains on track with the ‘006 study expected in mid-2025, we are experiencing some enrollment delays in the ‘005 trial, resulting in a slight delay to our guidance for that trial. In parallel, we are actively preparing for commercialization and have commenced a number of collaborations with mental health providers in the US to understand the patient care experience and to investigate models for the delivery of scalable COMP360 psilocybin treatment within various care settings, if approved by the FDA. We are also excited to provide a full data set from our phase 2 study in individuals living with post-traumatic stress disorder this Spring after an initial safety data readout late last year."
Business highlights
COMP360 psilocybin therapy in treatment-resistant depression (TRD):
Additional COMP360 development activities:
Leadership Update
Financial highlights
Financial Guidance
First quarter 2024 net cash used in operating activities is expected to be in the range of $17 million to $23 million. This range includes the amount receivable in respect of the 2022 R&D tax credit in the UK, confirmed by HMRC to be paid in full, but the timing for which is uncertain. The full-year 2024 net cash used in operating activities is expected to be in the range of $110 million to $130 million. The cash position at December 31, 2023, together with the net cash raised to date in the first quarter, is expected to be sufficient to fund operating expenses and capital expenditure requirements into late 2025.
Conference call
The Compass Pathways management team will host a conference call at 8.00am ET (1:00pm UK) on February 29, 2024.
Please register in advance here to access the call and obtain a local or toll-free phone number and personal pin.
A live webcast of the call will be available on Compass Pathway's website at: Fourth Quarter 2023 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. The call will also be webcast on the Compass Pathways website and archived for 30 days. For more information, please visit the Compass Pathways website (ir.compasspathways.com).
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin treatment in TRD, the largest randomised, 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 www.compasspathways.com
Availability of other information about COMPASS Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including but not limited to investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
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, COMPASS's financial guidance, Compass's business strategy and goals, its expectations and projections about the company's future cash needs and financial results, the anticipated proceeds to be received from the pending exercise of warrants issued in the private placement and future exercises, if any, of remaining warrants issued in the private placement; Compass's plans and expectations regarding its phase 3 trials in TRD, including its expectations that the phase 3 pivotal program is on track and the time periods during which the results of the two Phase 3 trials will become available, the potential for these phase 3 trials or other trials to support regulatory filings and approvals, the safety or efficacy of its investigational COMP360 psilocybin treatment, including for treatment of TRD, PTSD, anorexia nervosa, and bipolar II depression, Compass's expectations regarding its ongoing preclinical work and clinical trials, development efforts and innovation labs and Compass's plans, expectations and ability to achieve its goals related to the research collaboration agreements with Greenbrook TMS and Hackensack Meridian Health. 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: 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 product 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; the risk that the pending warrant exercises for approximately $9.0 million in proceeds will not settle; 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; full results from the phase 2 study in post-traumatic stress disorder or results from future studies may not be consistent with the initial 24-hour safety data; 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; our development efforts and our business strategy to set up research facilities and innovation labs involves significant costs and resources and may be unsuccessful; the risk that our research collaborations will not continue or will not be successful, including the risk that Greenbrook TMS's willingness or ability to complete its obligations under the research collaboration may be adversely affected by business combinations, restructurings or other corporate transactions, worsening of its financial position or significant changes in Greenbrook TMS's strategy 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 Compass's most recent annual report on Form 10-K or quarterly report on Form 10-Q and in other reports we have filed with the U.S. Securities and Exchange Commission ("SEC") , which are available on the SEC's website at www.sec.gov. Except as required by law, Compass disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Compass's current expectations and speak only as of the date hereof.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com, +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
COMPASS PATHWAYS PLC
Consolidated Balance Sheets
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
December 31, | |||
2023 | 2022 | ||
ASSETS | |||
CURRENT ASSETS: | |||
Cash and cash equivalents | $ 220,198 | $ 143,206 | |
Restricted cash | 440 | 175 | |
Prepaid income tax | 1,123 | 575 | |
Prepaid expenses and other current assets | 39,535 | 47,695 | |
Total current assets | 261,296 | 191,651 | |
NON-CURRENT ASSETS: | |||
Operating lease right-of-use assets | 4,306 | 2,006 | |
Deferred tax assets | 3,336 | 2,224 | |
Long-term prepaid expenses and other assets | 7,049 | 1,413 | |
Total assets | $ 275,987 | $ 197,294 | |
LIABILITIES AND SHAREHOLDERS' EQUITY | |||
CURRENT LIABILITIES: | |||
Accounts payable | $ 5,892 | $ 4,761 | |
Accrued expenses and other liabilities | 11,301 | 9,325 | |
Operating lease liabilities - current | 2,411 | 1,510 | |
Total current liabilities | 19,604 | 15,596 | |
NON-CURRENT LIABILITIES | |||
Long-term debt | 28,757 | — | |
Operating lease liabilities - non-current | 1,882 | 418 | |
Total liabilities | 50,243 | 16,014 | |
SHAREHOLDERS' EQUITY: | |||
Ordinary shares, £0.008 par value; 61,943,471 and 42,631,794 shares authorized, issued and outstanding at December 31, 2023 and 2022, respectively | 635 | 440 | |
Deferred shares, £21,921.504 par value; nil and 1 share authorized, issued and outstanding at December 31, 2023 and 2022, respectively | — | 28 | |
Additional paid-in capital | 621,645 | 458,825 | |
Accumulated other comprehensive loss | (16,926) | (16,867) | |
Accumulated deficit | (379,610) | (261,146) | |
Total shareholders' equity | 225,744 | 181,280 | |
Total liabilities and shareholders' equity | $ 275,987 | $ 197,294 |
COMPASS PATHWAYS PLC
Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
(expressed in U.S. Dollars, unless otherwise stated)
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||
2023 | 2022 | 2023 | 2022 | ||||
OPERATING EXPENSES: | |||||||
Research and development | $ 27,139 | $ 19,794 | $ 87,518 | $ 65,053 | |||
General and administrative | 11,266 | 12,397 | 49,401 | 45,350 | |||
Total operating expenses | 38,405 | 32,191 | 136,919 | 110,403 | |||
LOSS FROM OPERATIONS: | (38,405) | (32,191) | (136,919) | (110,403) | |||
OTHER INCOME (EXPENSE), NET: | |||||||
Other income | 2,415 | 481 | 4,878 | 4,061 | |||
Interest expense | (1,124) | — | (2,204) | — | |||
Foreign exchange gains | 1,622 | (3,566) | 3,686 | 821 | |||
Benefit from R&D tax credit | 3,354 | 4,442 | 12,875 | 14,424 | |||
Total other income, net | 6,267 | 1,357 | 19,235 | 19,306 | |||
Loss before income taxes | (32,138) | (30,834) | (117,684) | (91,097) | |||
Income tax expense | (394) | (92) | (780) | (408) | |||
Net loss | (32,532) | (30,926) | (118,464) | (91,505) | |||
Net loss per share attributable to ordinary shareholders—basic and diluted | $ (0.53) | $ (0.73) | $ (2.32) | $ (2.16) | |||
Weighted average ordinary shares outstanding—basic and diluted | 61,961,674 | 42,436,292 | 51,028,024 | 42,436,292 | |||
Net loss | (32,532) | (30,926) | (118,464) | (91,505) | |||
Other comprehensive loss: | |||||||
Foreign exchange translation adjustment | 540 | 13,776 | (59) | (25,707) | |||
Comprehensive loss | (31,992) | (17,150) | (118,523) | (117,212) | |||
News Provided by GlobeNewswire via QuoteMedia
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that management will participate in a panel discussion at the TD Cowen 44th Annual Health Care Conference at 12:50 pm ET on March 4, 2024.
A live audio webcast of the panel discussion will be accessible from the "Events" page of the Investors section of the Compass website. A replay of the webcast will be accessible for 30 days following such event. For more information, please visit investor section of compasspathways.com.
About Compass Pathways
Compass Pathways plc (Nasdaq: CMPS) is a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health. Our focus is on improving the lives of those who are suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin therapy, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD). We have commenced a phase 3 clinical program of COMP 360 psilocybin therapy in TRD, the largest randomized, controlled, double-blind psilocybin therapy clinical program ever conducted. Previously, we completed a phase 2b study with top line data showing a statistically significant (p www.compasspathways.com .
Availability of other information about Compass Pathways
Investors and others should note that we communicate with our investors and the public using our website (www.compasspathways.com), our investor relations website (ir.compasspathways.com), and on social media (LinkedIn), including, but not limited to, investor presentations and investor fact sheets, US Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in us to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include additional social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
News Provided by GlobeNewswire via QuoteMedia
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation in mental health, announced today that it will release financial results for the fourth quarter and year-end 2023 ending December 31, 2023, and provide an update on recent business developments, on February 29, 2024.
The management team will host a conference call at 8:00 am ET (1:00 pm UK) on February 29, 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: Fourth Quarter 2023 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 suffering with mental health challenges and who are not helped by current treatments. We are pioneering the development of a new model of psilocybin treatment, in which our proprietary formulation of synthetic psilocybin, COMP360, is administered in conjunction with psychological support. COMP360 has been designated a Breakthrough Therapy by the U.S. Food and Drug Administration (FDA) and has received Innovative Licensing and Access Pathway (ILAP) designation in the UK for treatment-resistant depression (TRD).
We have commenced a phase 3 clinical program of COMP360 psilocybin treatment in TRD, the largest randomized, controlled, double-blind psilocybin treatment clinical program ever conducted. Previously, we completed a phase 2b study with top-line data showing a statistically significant (p
Compass is headquartered in London, UK, with offices in New York and San Francisco in the United States. Our vision is a world of mental wellbeing. www.compasspathways.com
Availability of other information about Compass Pathways
Investors and others should note that Compass communicates with its investors and the public using its website (www.compasspathways.com), its 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 Compass posts on these channels and websites could be deemed to be material information. As a result, Compass encourages investors, the media, and others interested in Compass 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 Compass's investor relations website and may include additional social media channels. The contents of Compass's website or these channels, or any other website that may be accessed from Compass's website or these channels, shall not be deemed incorporated by reference in any filing under the United States Securities Act of 1933, as amended.
Enquiries
Media: Amy Lawrence, amy@compasspathways.com , +44 7813 777 919
Investors: Stephen Schultz, stephen.schultz@compasspathways.com, +1 401 290 7324
News Provided by GlobeNewswire via QuoteMedia
Melodiol Global Health Limited (ASX:ME1) (‘Melodiol’ or ‘the Company’) is pleased to advise it has received firm commitments to raise ~$1.08m (before costs) through the issue of approximately 106,415,113 new fully paid ordinary shares (‘Shares’) at an issue price of $0.01019 per Share (the ‘Placement’).
Highlights:
Funds from the Placement will be used towards near term growth opportunities across select business units, corporate costs (including the potential restructure or sale of businesses representing less than 10% of overall group revenue in order to accelerate profitability), general working capital and costs of the offer.
Subject to shareholder approval, Placement participants will receive two free attaching Options for every one new Share issued. The Company intends to create a new class of options, exercisable at $0.015 per Option and a 5 year time to maturity (the “New Options”). The Company will seek to quote the attaching Options, subject to meeting ASX listing requirements. The Company intends that these New Options will be provided to the Placement participants.
At the Company’s general meeting on 23 January, the Company received shareholder approval to conduct a Placement of up to $3m at a 30% discount to the 10-day volume weighted average price (“VWAP”) prior to the Placement.
The issue price of the new Shares from the Placement represents a 30% discount to the 10-day VWAP of
$0.014564 and therefore the Placement Shares will be issued based on the prior receipt of shareholder approval.
As previously disclosed to the market, the Company has taken steps to rationalise non-core assets in its portfolio, including the temporary pause of operations at Halucenex, Sierra Sage Herbs, and impACTIVE. Melodiol remains focused on accelerating a cash flow positive state via execution at both Mernova and Health House International, which represented 93% of group revenue (based on Q3 FY23).
In addition to these efforts, the Company continues to entertain possible additional sources of capital in addition to the proposed placement, and possible divestment of non-core and core assets. The Company may also consider steps to convert existing secured debt to equity as part of this process.
Management commentary:
CEO and Managing Director, Mr William Lay said: “I would like to take this opportunity to thank investors for their support of this Placement. This new capital comes at a critical juncture as the Company continues to drive strong operating results at Mernova and HHI. We look forward to providing updates on continued progress at these business units in due course.”
Lead Manager:
Oakley Capital Partners Pty Ltd (“Oakley”) acted as lead manager to the Placement. Oakley will earn a 6% fee on the gross cash amount raised by Oakley under the Placement. Subject to shareholder approval, this fee will be paid in shares (based on the placement price) with a one for one attaching New Option. Subject to shareholder approval, Oakley will also receive 25m Broker Shares, and 25m Broker New Options, if feasible. If the issue of these Options is not feasible, the Company has agreed to work with Oakley on a best efforts basis to come to an alternate arrangement. Where shareholder approval is not received, the cash equivalent of fees will be payable.
Click here for the full ASX Release
This article includes content from Melodiol Global Health, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
Investing News Network websites or approved third-party tools use cookies. Please refer to the cookie policy for collected data, privacy and GDPR compliance. By continuing to browse the site, you agree to our use of cookies.