Albert Labs Validates Global Supply Chain for Controlled Substances

Albert Labs International Corp. ( Albert Labs (CSE: ABRT) (FSE: VB50), the "Company"), a pharmaceutical drug development company focused on gaining regulatory approval for novel medicines to treat various mental health conditions, signs a Letter of Intent (LOI) with full-service Contract-Research Organisation (CRO), iNGENū, to carry out the Company's first in-human study of its primary drug target, KRN-101.

This randomised, double-blind study will evaluate the safety and tolerability of KRN-101 in study participants and determine its full pharmacokinetic characterization. As a unique, natural medicine containing a range of bioactives, KRN-101 is required to have its own pharmacokinetic profile despite an extensive background of safety data to support psilocybin-based medicines. Profiling KRN-101 through this study will allow the Company to reap the long-term potential of having a differentiated product through extensive opportunities for intellectual property protection.

This study will take place in Melbourne, Australia , and including the collection of all clinical outputs, will be carried out over 8 weeks with an expected completion in Q3 2023. Upon completion, KRN-101 will be available for use in late-stage clinical trials, allowing the Company to proceed with its Real World Evidence trial in the United Kingdom , which will establish the efficacy of the treatment for cancer-related distress. This first in-human study also allows the Company to collect valuable data which will enable a future Investigational New Drug (IND) Application to be filed with the FDA, thus taking KRN-101 to the largest pharmaceutical market in the world.

The Company will also benefit from the Australian Federal Government's Research & Development incentive programme which will provide cash rebates for 43.5% of all eligible costs relating to the study.

The study will be carried out by iNGENū, a full-service CRO specialising in clinical trials for psychoactive pharmaceuticals, who work with a network of specialist consultants and research facilities across the South-East Pacific region to facilitate high quality and cost-effective research.

Dr. Sud Agarwal , CEO of iNGENū: "It's a privilege to have been selected as the CRO by Albert Labs' team of highly credentialed research experts to take the KRN-101 investigational product into first-in-human studies in Australia ."

"This study will be conducted by iNGENū CRO at a globally renowned research unit in Melbourne , and will yield critical data to help characterise the pharmacokinetics of KRN-101 and establish a recommended late-stage dose for future clinical trials."

Dr. Michael Raymont , CEO of Albert Labs : "We have carefully considered a range of partners for our first in-human study and are delighted to come to this agreement with iNGENū. We have been impressed by their capabilities and see a strong alignment with our core values as a company. We also greatly appreciate the assistance of the Australian Government for carrying out this research.  Through this partnership we will provide the highest standard of clinical due diligence, and risk mitigation for planned late-stage trials in the UK through expansion into the United States . We feel that this is a significant step forward in value creation for our shareholders."

Albert Labs is a pharmaceutical drug development company, focused on gaining regulatory approval for novel medicines for the treatment of mental health, and providing rapid access to effective prescription medicines for people suffering from mental health disorders. 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 recognized 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.

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.

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Albert Labs International Corp. ( Albert Labs (CSE: ABRT) (FSE: VB50), the "Company"), a pharmaceutical drug development company focussed on gaining regulatory approval for active compounds to treat various mental health conditions, has published a corporate update highlighting the progress that has been made since closing its Series A private placement and some information on its future plans and activities.

Albert Labs completed its Series A private placement in tranches between February 2021 and March 2022 , an offering of 18,947,500 shares and gross proceeds of CAD$4,736,875 , with senior management investing CAD$2,690,215 and the balance of CAD$2,690,215 coordinated with support from Chrystal Capital Partners. This placement took place concurrently with a reverse take-over transaction that would see Albert Labs' shares trade on the Canadian Securities Exchange (CSE), subject to restrictions with a large proportion of shares held under escrow terms.

The Company's key strategies were, and remain as follows: (i) to manufacture and deliver natural psilocybin in the form of a prescription drug known as KRN-101 to trial centres, and (ii) to initiate Real World Evidence (RWE) trials, including all necessary partnerships, to lead to a regulatory approved medication for treating anxiety and depression, initially in cancer patients.

The Company has made substantial progress, in spite of an economic environment that has presented widespread challenges to financial markets and business operations across all sectors.

Some of the most significant milestones that have been achieved by the Company over the last 6-months include:

March 2022 :

• Albert Labs International Corp. listing on Canadian Securities Exchange (CSE)
• Filing US Provisional Patent for standardised and scalable manufacturing of natural pharmaceuticals, including KRN-101

April 2022 :

• Established Pre-Clinical Advisory Board, chaired by globally-renowned toxicology expert, Dr Ricardo Dinis-Oliveira

May 2022 :

• Granted Health Canada Licence for production, sale (through the Special Access Programme) and export of Schedule 1 substances
• Successful technology transfer, procurement and implementation of pre-clinical programme at Schedule 1 analytical and toxicological laboratory in Porto, Portugal
• RWE Clinical Trial protocols written (with partners at the University of Manchester , Christie Hospital, and National Cancer Research Institute) for the study of KRN-101 as a treatment for cancer-related distress, including Albert Labs' psychotherapy protocols

June 2022 :

• Ethical approval received for Albert Labs' pre-clinical programme for KRN-101 toxicology studies at laboratory in Porto
• Professor Sara Tai appointed as Lead Clinical Researcher for RWE Clinical Trial, Senior Clinical Psychology Professor at the University of Manchester

July 2022 :

• Mike Thompson MBE, former CEO of the Association for the British Pharmaceutical Industry (ABPI) and Senior Vice-President of Commercial Strategy at GSK Global, and Katie Shelton-Innes , experienced UK growth company finance expert, appointed to Board of Directors

August 2022 :

• New International PCT Patent Application (No. PCT/CA2022/051281) filed for proprietary manufacturing method, providing industry-leading levels of scalable and consistent natural Psilocybin-based pharmaceuticals

September 2022 :

• Successful technology transfer and implementation of KRN-101 manufacturing process and quality assurance procedures ready for pre-clinical studies at laboratory in Porto

October 2022:

• Received Good Laboratory Practice (GLP) accreditation for pre-clinical programme allowing for submission of pre-clinical data to global regulatory authorities (including MHRA, EMA and FDA)

In the near future, the Company will continue work on:

• The completion of KRN-101 toxicology studies to GLP standards, ready for CTA, and available for licensing and Special Access Programmes;
• Third-party validation (to Good Manufacturing Practice standard) of KRN-101 data for Clinical Trial Application (CTA);
• Pre-CTA MHRA Scientific Advice Meeting
• Partnership negotiations to extend clinical research into further regulatory jurisdictions

Dr. Michael Raymont , CEO of Albert Labs : "We have made significant progress over the last 6-months, establishing our pharmaceutical operations across three jurisdictions, the United Kingdom , European Union and North America . As is inevitable with an early-stage company, especially in the drug development R&D area, some milestones are achieved as planned, while others require "workarounds" or extensions."

A key differentiator for Albert Labs is the growth, extraction and use of a mycelium extract, which includes a spectrum of key bio-actives present in its natural form. Mycelium is a complex, living organism and there may be therapeutic value from the combination of key bio-actives present in our primary drug target, KRN-101. Using patent-pending, bioreactor-based manufacturing technology, the Company has been able to produce consistent, standardised, and pharmacologically valuable APIs'; KRN-101 is a unique asset that meets the highest product requirements for global regulatory standards. Most importantly, KRN-101 strengthens the long-term value of the company, not only as a potential therapeutic to treat millions but also offers potential for extensive intellectual property protection.

"Developing and refining our standardised, "quality-regulated" API production process is a major accomplishment, and the additional time we took resulted in a robust production process with additional intellectual property potential," said Dr. Raymont.

The Company has also been working on expanding its market access programme. Albert Labs primary focus is still the treatment of patients in the United Kingdom , by aiming for the execution of a Real World Evidence clinical trial and pursuing all corresponding reimbursement mechanisms. In addition, however, the Company is now in a position to start the process to pursue, in parallel, an Investigational New Drug (IND) Application in the US.  If successful, this would take KRN-101 directly into the largest pharmaceutical market in the world, the United States.

"We feel that the strategy of parallel tracking work toward both UK and US regulatory approval reduces risk as compared to the single-track approach, while at the same time, increasing and accelerating our developments over the longer term.  We will need to augment our resources to allow for the increased scope of work", said Dr. Raymont, adding, "Over the next few months, we will be working on some key milestones, which we need to reach in order to deliver our treatment in the clinical setting."

Albert Labs is a pharmaceutical drug development company, focussed on gaining regulatory approval for active compounds in the treatment of mental health, and providing rapid access to effective prescription medicines for people suffering from mental health disorders. 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 suffers with mental health concerns 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.

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