Psychedelics

Seelos Therapeutics Announces Amendment of SLS-002 Agreement to Repurchase a Significant Portion of Royalties for SLS-002

Seelos Therapeutics, Inc. (Nasdaq: SEEL), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system disorders and rare diseases, announced today an amendment of the agreement with Vyera Pharmaceuticals AG ("Vyera") for the development of SLS-002 (intranasal racemic ketamine) to repurchase in cash a significant portion of the royalties payable on any future net sales of SLS-002.

(PRNewsfoto/Seelos Therapeutics, Inc.)

On March 6, 2018 , Seelos entered into an asset purchase agreement with Vyera, currently known as Phoenixus AG, to acquire the assets and liabilities of Vyera's intranasal racemic ketamine program, which Seelos now calls SLS-002. As additional consideration to certain upfront cash and equity payments and success-based milestone payments contemplated under the prior agreement, Seelos agreed to pay a mid-teens percentage royalty on any future net sales of SLS-002. Under this amendment, for additional cash payments, Seelos has agreed to repurchase 9% of the future royalties and reduce its royalty obligations to a mid-single digit percentage on any future net sales of SLS-002.

"We believe this repurchase of a significant portion of royalties due on SLS-002 has the potential to return meaningful future value to Seelos stockholders, assuming we are successful in the clinical development, FDA approval process, and commercialization of the intranasal ketamine program," said Raj Mehra Ph.D., Chairman and CEO of Seelos. "The current study of SLS-002 is dosing patients with major depressive disorder who are at imminent risk of suicide. We plan to further evaluate ketamine in front-line major depression and other related indications."

Seelos has begun dosing patients in Part A of its Proof-of-Concept study, which is a 16-patient, open-label cohort, using 90mg of SLS-002 in patients who are imminently suicidal. Part A of the Proof-of-Concept study precedes Part B, which is a registrational double blind placebo-controlled trial.

If you or a loved one are having thoughts of suicide, please seek immediate medical help, go to your nearest emergency room, or call the National Suicide Prevention Lifeline at 1-800-273-8255.

About SLS-002

SLS-002 is intranasal racemic ketamine with two investigational new drug applications for the treatment of Acute Suicidal Ideation and Behavior in Major Depressive Disorder or Post-Traumatic Stress Disorder. SLS-002 was originally derived from a Javelin Pharmaceuticals, Inc./Hospira, Inc. program with 16 clinical studies involving approximately 500 subjects. SLS-002 addresses an unmet need for a therapy to treat suicidality in the U.S. Traditionally, anti-depressants have been used in this setting but many of the existing treatments are known to contribute to an increased risk of suicidal thoughts in some circumstances, and if they are effective, it often takes weeks for the full therapeutic effect to be manifested. The clinical development program for SLS-002 included two parallel healthy volunteer studies (Phase I) and is being followed by pivotal registration studies after meeting with the FDA. Based on information gathered from the databases of the Agency for Healthcare Research and Quality, there were more than 1,000,000 visits to emergency rooms for suicide attempts in 2019 in the U.S. alone. Experimental studies suggest ketamine has the potential to be a rapid, effective treatment for depression and suicidality.

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) or Post-Traumatic Stress Disorder (PTSD), amyotrophic lateral sclerosis (ALS), Sanfilippo syndrome, Parkinson's Disease, other psychiatric and movement disorders plus orphan diseases.

For more information, please visit our website: http://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 Seelos' ability to repurchase future royalties under the asset purchase agreement with Vyera, the ability of the royalty repurchase to return meaningful future value to Seelos stockholders, Seelos' ability to succeed in the clinical development, FDA approval process and commercialization of its intranasal ketamine program (SLS-002), Seelos' plans to evaluate ketamine in front-line major depression and other related indications, the design of the Proof of Concept study, the expected timing for commencing Part B of the Proof of Concept study and the potential for ketamine to be a rapid, effective treatment for refractory depression and suicidality. These statements are based on Seelos' current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Risks associated to Seelos' business include, but are not limited to, the risk of not successfully executing its preclinical and clinical studies, including the Proof of Concept study of SLS-002, and not gaining marketing approvals for its product candidates, the risk that prior test results may not be replicated in future studies and trials, 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 a new business strategy, the risks related to raising capital to fund its development plans and ongoing operations, risks related to Seelos' current stock price, risks related to the global impact of COVID-19, as well as other factors expressed in Seelos' periodic filings with the U.S. Securities and Exchange Commission, including its 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
Head of Corporate Communications
Seelos Therapeutics, Inc. (Nasdaq: SEEL)
300 Park Ave., 12th Fl
New York, NY 10022
(646) 293-2136
anthony.marciano@seelostx.com
www.seelostherapeutics.com
https://twitter.com/seelostx
https://www.linkedin.com/company/seelos

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SOURCE Seelos Therapeutics, Inc.

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Albert Labs Validates Global Supply Chain for Controlled Substances

Albert Labs Validates Global Supply Chain for Controlled Substances

Albert Labs International Corp. (CSE: ABRT) (FSE: VB50), the "Company" or "Albert Labs"), a fully-integrated biopharmaceutical company bringing innovative prescription medicines to patients with unmet mental health needs, is pleased to announce the validation of their controlled substance supply chain through the successful global distribution of its psilocybin-based KRN Active Pharmaceutical Ingredient (API).

Albert Labs Logo, Validates Global Supply Chain for Controlled Substances (CNW Group/Albert Labs International Corp.)

Albert Labs have successfully distributed their proprietary KRN API from their Health Canada licensed laboratory in Vancouver . Only very few companies have the ability to globally distribute controlled substances of this classification, Schedule 1. This now enables the API to be used as part of their pre-clinical studies at its Infarmed licensed laboratory in Porto, Portugal . This distribution follows an extensive research and development programme allowing for the production and scaling of highly potent yields of its KRN API, for which IP protection has been achieved, using bioreactor technology to ensure the efficient and economical manufacture of its mycelium derived pharmaceutical product.

The company is nearing completion of their KRN-101 pre-clinical studies, which includes full analytical profiling, in-vivo, and in-vitro studies, allowing the medicine to be used in its first, in-human studies in Melbourne, Australia due to begin in Q2 2023 .

Dr. Michael Raymont , CEO of Albert Labs : "Validating our supply chain across two of our jurisdictions, North America and Europe , marks a valuable milestone in our operational program. We have demonstrated our ability to distribute KRN-101, a schedule 1 substance, to global, licensed facilities, and this achievement advances our progress by establishing the viability of our supply chain as we prepare for our first-in-human studies."

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 the 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 an increasingly recognised clinical route, 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.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/March2023/15/c5639.html

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Seelos Therapeutics, Inc. (Nasdaq: SEEL) ("Seelos"), a clinical-stage biopharmaceutical company focused on the development of therapies for central nervous system (CNS) disorders and rare diseases, announced today it has entered into an agreement with a life sciences-focused investment fund for the sale of 12,059,298 shares of its common stock, pre-funded warrants exercisable for an aggregate of 9,340,702 shares of common stock and common warrants exercisable for an aggregate of 26,750,000 shares of common stock. The shares of common stock and accompanying common warrants are being sold at a combined offering price of $0.525 per share, and the pre-funded warrants and accompanying common warrants are being sold at a combined offering price of $0.524 per pre-funded warrant. All of the shares of common stock, pre-funded warrants and accompanying warrants to be sold in the offering will be sold by Seelos. The pre-funded warrants will be immediately exercisable following the closing of the offering and will have an exercise price of $0.001 per share. The common warrants will not be exercisable until after the six-month anniversary of the closing of the offering, will have an exercise price of $0.60 per share and will expire on the date that is five and a half years following the closing of the offering.

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Live audio webcast of the panel and presentation will be accessible from the "Events" page of the Investors section of the COMPASS website. Each replay of the webcast will be accessible for 30 days following each event. For more information, please visit ir.compasspathways.com.

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COMPASS Pathways plc (Nasdaq: CMPS) ("COMPASS"), a mental health care company dedicated to accelerating patient access to evidence-based innovation in mental health, today reported its financial results for the fourth quarter and year-end 2022 and gave an update on recent progress across its business.

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Last week the Australian Medicines Authority, the Therapeutic Goods Administration (TGA), announced their ground-breaking decision to officially recognise the potential clinical benefit of psilocybin as a medicine, becoming the first to do so. A key factor referenced in this decision being a lack of effective medicinal options currently available to patients, as well as the large and growing amount of highly promising research in the field.

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