MELBOURNE, Australia, May 17, 2022 /PRNewswire/ — Incannex Healthcare Limited (NASDAQ: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for unmet medical needs, is pleased to announce that it completed a highly constructive Pre-Investigational New Drug Application (‘pre-IND’) meeting with the U.S. Food and Drug Administration (‘FDA’) to discuss the development IHL-42X.

IHL-42X is a fixed dose combination of dronabinol and acetazolamide that is being developed as a treatment for obstructive sleep apnoea (‘OSA’) in adults. Incannex submitted a pre-IND meeting package and meeting request to the FDA in February 2022. The meeting package included an overview of the development program, and specific questions Incannex had on the regulatory requirements for opening an investigational new drug (‘IND’) application. Opening an IND is required to conduct clinical trials in the U.S and ensures that trials are designed so that they meet the data requirements necessary for FDA marketing approval.

The written responses, and the responses provided in a teleconference with FDA representatives, were constructive and supportive, with interest in the project underpinned by the significant cohort of people diagnosed with OSA and the absence of pharmacological treatment solutions.

FDA provided guidance on Incannex’s proposed long-term development strategy, including specific parameters to demonstrate safety and efficacy in phase 2 and 3 pivotal studies. Guidance provided by the FDA to the Company will inform adjustments to the clinical trial protocols to ensure that they generate the data required for a 505(b)(2) new drug application (NDA).

In a decision that will save Incannex time and cost, FDA agreed that Incannex does not need to conduct studies in animals. In particular, the agency confirmed that animal toxicology and animal pharmacokinetic (PK) studies are not required for opening an IND for IHL-42X. Therefore, the next step for the development of IHL-42X will be the adjustment of clinical trial designs and arrangement of operational imperatives necessary to open an IND with FDA.

Chief Scientific Officer for Incannex, Dr Mark Bleackley, said: “The FDA’s interest in IHL-42X as a potential therapy for OSA was extremely encouraging. The feedback they provided on the overall proposed development program was positive. The agency’s responses to the specific questions we posed allow us to revise our clinical trial protocols, to ensure that we are running highly efficient studies that generate the type and amount of data the FDA will require in a future marketing application. The results from the pre-IND meeting will shape the IHL-42X development program over the coming months.”

Incannex completed a phase 2 proof of concept clinical trial in 2021 to assess IHL-42X in patients with OSA. Preliminary results from the trial have been published, showing that 60% of trial participants experienced a reduction in apnea-hypopnea index (‘AHI’) of greater than 55% during at least one treatment compared to baseline. 20% of trial participants experienced a reduction in AHI of greater than 80%. The complete clinical study report is anticipated to be released in June 2022.

This announcement has been approved for release to ASX by the Incannex board of directors.

About Incannex Healthcare Limited

Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabinoid pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public.

Incannex has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners. Incannex is listed on the Australian Stock Exchange (ASX) with stock code “IHL” and also has American Depository Shares listed on NASDAQ under code “IXHL”.

Website: www.incannex.com.au
Investors: [email protected]

Forward-looking statements

This press release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.

Contact Information

Incannex Healthcare Limited
Mr Joel Latham
Managing Director and Chief Executive Officer
+61 409 840 786
[email protected]

US IR Contact
Rx Communications Group
Michael Miller
+1-917-633-6086
[email protected]

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

Toronto, Ontario, March 01, 2022 (GLOBE NEWSWIRE) — Ayurcann Holdings Corp. (CSE: AYUR, OTCQB: AYURF, FSE: 3ZQ0) (“Ayurcann” or the “Corporation”), a leading Canadian cannabis extraction company specializing in the processing and co-manufacturing of pharma grade cannabis and hemp to produce various derivative cannabis 2.0 and 3.0 products in the medical and recreational market, is pleased to announce its intention to initiate a normal course issuer bid (“NCIB”) through the facilities of the Canadian Securities Exchange (the “CSE”) or alternative trading systems

Under the NCIB, the Corporation intends to acquire up to 6,085,890 common shares in the capital of the Corporation (“Common Shares”), representing approximately 5% of its issued and outstanding Common Shares. As of February 28, 2022, there were 121,717,818 Common Shares issued and outstanding. On any given day, during the NCIB, the Corporation may only purchase up to 15,000 Common Shares, which is equivalent to 25% of the average daily trading volume of 60,000 calculated based on the trading volumes on the CSE over the past 12 months and may purchase once per calendar week, in a block trade, a greater number of Common Shares.

Purchases under the NCIB may commence as of March 1, 2022 and will end on the earlier of: (i) February 28, 2023; or (ii) the date on which the Corporation has purchased the maximum number of Common Shares to be acquired under the NCIB. The Corporation may terminate the NCIB earlier if it feels it is appropriate to do so.

The Corporation has appointed Canaccord Genuity Corp. to conduct the NCIB. The purchase and payment of the Common Shares will be made in accordance with the requirements of the CSE and applicable securities laws. The actual number of Common Shares purchased, timing of purchases and share price will depend upon market conditions at the time and securities law requirements. All Common Shares acquired will be returned to treasury and cancelled.

The Corporation’s Board of Directors believes that the market price of the Common Shares may from time to time not reflect the underlying value of the Corporation, specifically its growth opportunities, and that the proposed purchasing of its Common Shares is in the best interests of the Corporation and represents an appropriate use of corporate funds. It is expected that any purchases made by the Corporation could also enhance value and liquidity for its shareholders.

About Ayurcann

Ayurcann is a leading post-harvest solution provider with a focus on providing and creating custom processes and pharma grade products for the adult use and medical cannabis industry in Canada. Ayurcann is striving to become a partner of choice for leading Canadian and international cannabis brands by providing best-in-class, proprietary services including extraction, formulation, product development and custom manufacturing.

For additional information, please contact:

Ayurcann Holdings Corp.
Igal Sudman, Chief Executive Officer
905-492-3322
[email protected]

Investor Relations:

Email: [email protected]

Neither the Canadian Securities Exchange nor its Regulation Services Provider have reviewed or accept responsibility for the adequacy or accuracy of this release.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of applicable securities laws. All statements contained herein that are not clearly historical in nature may constitute forward-looking statements. Generally, such forward-looking information or forward-looking statements can be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “is expected”, “budget”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases or may contain statements that certain actions, events or results “may”, “could”, “would”, “might” or “will be taken”, “will continue”, “will occur” or “will be achieved”. The forward-looking information and forward-looking statements contained herein include, but are not limited to, statements regarding: the Corporation launching the NCIB and purchasing Common Shares for cancellation thereunder; and the ability of the Corporation to become the partner of choice for leading Canadian cannabis brands.

Forward-looking information in this news release are based on certain assumptions and expected future events, namely: the Corporation will expand and be able to maintain production capacity; the Corporation’s ability to continue as a going concern; continued approval of the Corporation’s activities by the relevant governmental and/or regulatory authorities; the continued growth of the Corporation; the Corporation’s successful implementation of its strategy to expand market share in extract and extract derivatives while providing exceptional products to consumers; the Corporation’s continuing ability to meet the requirements necessary to remain listed on the CSE and alternative exchanges; the Corporation repurchasing Common Shares under the NCIB and the ability of the Corporation to become the partner of choice for leading Canadian cannabis brands.

These statements involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance or achievements to differ materially from those expressed or implied by such statements, including but not limited to: the Corporation’s inability to expand and/or maintain production capacity; the potential inability of the Corporation to continue as a going concern; the risks associated with the cannabis industry in general; increased competition in the cannabis extraction market; the potential future unviability of the cannabis market; risks associated with potential governmental and/or regulatory action with respect to the cannabis industry; the Corporation’s inability to obtain continued regulatory approvals; the Corporation’s inability to successfully implement its strategy to expand market share in extract and extract derivatives while providing exceptional products to consumers; the Corporation’s inability to meet the requirements necessary to remain listed on the CSE and alternative exchange; the Corporation not repurchasing Common Shares under the NCIB; and the inability of the Corporation to become the partner of choice for leading Canadian cannabis brands.

Readers are cautioned that the foregoing list is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking statements, as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.

Forward-looking statements contained in this news release are expressly qualified by this cautionary statement and reflect the Corporation’s expectations as of the date hereof and are subject to change thereafter. The Corporation undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, estimates or opinions, future events or results or otherwise or to explain any material difference between subsequent actual events and such forward-looking information, except as required by applicable law.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful. The securities being offered have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements of the United States Securities Act of 1933, as amended, and applicable state securities laws.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.

BARRIE, Ontario, Nov. 15, 2021 (GLOBE NEWSWIRE) — MediPharm Labs Corp. (TSX: LABS) (OTCQX: MEDIF) (FSE: MLZ) (“MediPharm” or the “Company”) a pharmaceutical company specialized in precision-based cannabinoids today announced its financial results for the three and nine months ended September 30, 2021, a period of transition in establishing itself as an international pharmaceutical company specializing in cannabis.

Q3 2021 Key Highlights

• Received North America’s sole Drug Establishment Licence (“DEL”) amongst cannabis companies, which will allow MediPharm to conduct pharmaceutical manufacturing and sale of Active Pharmaceutical Ingredients and Finished Dose Goods containing cannabis. MediPharm’s current and future domestic Canadian cannabis partners will benefit from the DEL as MediPharm can now provide them a conduit to pharmaceutical and international markets. The DEL is a key enabler of the Company’s future successes.
• International sales increased 16.5% sequentially to $2.9 million and represented 53% of sales in Q3.
• Announced new CEO, Mr. Bryan Howcroft to drive international and pharmaceutical sales growth.
• Strong balance sheet position, with $38 million in cash and cash equivalents as at September 30, 2021.
• Succeeded in the Ontario Cannabis Store product call adding SKUs in oil and vape formats, particularly a high demand CBD vape product that contains only CBD and naturally derived terpenes. This CBD vape is more shelf stable versus current Canadian competitors.
• Achieved Major Pharmaceutical Milestone for global distribution, including in the U.S.
• New product development innovation for new areas of growth in CBN and other cannabinoids.

Q3 Overview

“In Q3 2021, we were awarded one of the most important licences in our Company’s history related to North American GMP certifications, the DEL. The DEL establishes the Company as a true pharmaceutical partner while continuing to deliver on our international medical cannabis sales,” said Keith Strachan, President, MediPharm. “We increased our international medical presence and sales by 16.5% q/q, which is a testament to our efforts to lead in this area. We view the international medical cannabis market to be a key driver of our future revenue growth. We also continue to innovate in new product development, with minor cannabinoids such as CBN, as well as our clinical trial program.”

“Looking ahead, efforts are well underway to ensure MediPharm maintains a leading position in the projected multibillion-dollar global cannabinoid-derived pharmaceuticals and international medical markets. This is where our unique licenses and professional expertise will make us the go-to partner for pharmaceutical companies around the globe with potential for material revenue growth for years to come.” To this end, we are delighted to welcome our new CEO to MediPharm, effective today, Mr. Bryan Howcroft. Mr. Howcroft’s deep expertise in navigating complex regulated international markets will enable MediPharm’s transition towards pharmaceutical and medical markets to reach new heights.

Balance Sheet Stability Supports Strategic Execution

• Cash and cash equivalents totaled $38 million at September 30, 2021 and the cash balance outstanding under the convertible notes was under $1.9 million. As of today, the balance outstanding under the convertible notes is only $0.5 million. This strong cash balance is sufficient to support the Company’s long-term growth strategy.

Financial Results Summary Table

(1) Adjusted Gross Profit is a non-IFRS measure. See Non-IFRS Measures section of this news release.

(2) Adjusted EBITDA is a non-IFRS measure. See Non-IFRS Measures section of this news release.

Q3 2021 FINANCIAL RESULTS CONFERENCE CALL

MediPharm executive management team will host a conference call and audio webcast to discuss the results and outlook for the three and nine month period ended September 30, 2021 on Monday, November 15, 2021, at 8:30 a.m. eastern time.

Audio Conference Call Dial in Details:

NON-IFRS MEASURES

Adjusted EBITDA and adjusted Gross Profit are not recognized performance measures under IFRS, do not have a standardized meaning and therefore may not be comparable to similar measures presented by other issuers. Adjusted EBITDA and adjusted Gross Profit are included as a supplemental disclosure because Management believes that such measurement provides a better assessment of the Company’s operations on a continuing basis by eliminating certain non-cash charges and charges or gains that are non-recurring. Adjusted EBITDA is defined as net loss excluding interest, taxes, depreciation and amortization expense, interest income and expense, finance fees, gain in revaluation of derivative liabilities, taxes, impairment losses on inventory, write down of deposits and share-based compensation. Adjusted EBITDA has limitations as an analytical tool as it does not include depreciation and amortization expense, interest income and expense, taxes, share-based compensation and transaction fees. Because of these limitations, Adjusted EBITDA should not be considered as the sole measure of the Company’s performance and should not be considered in isolation from, or as a substitute for, analysis of the Company’s results as reported under IFRS. The most directly comparable measure to Adjusted EBITDA calculated in accordance with IFRS is operating income (loss). The above is a reconciliation of the Company’s operating loss to Adjusted EBITDA. See “Reconciliation of non-IFRS measures” in the Company’s Management’s Discussion and Analysis for the period ended September 30, 2021 for additional information. Adjusted gross profit is defined as gross profit/(loss) excluding the adjustments for accelerated depreciation, write down of non-current deposits and write down of inventory. Adjusted gross profit is a useful measure as it represents gross profit for management purposes based on costs to manufacture, package and ship inventory sold, exclusive of any impairments due to changes in internal or external influences.

About MediPharm

Founded in 2015, MediPharm Labs specializes in the development and manufacture of purified, pharmaceutical-quality cannabis concentrates, active pharmaceutical ingredients (API) and advanced derivative products utilizing a Good Manufacturing Practices certified facility with ISO standard-built clean rooms. MediPharm Labs has invested in an expert, research driven team, state-of-the-art technology, downstream purification methodologies and purpose-built facilities with five primary extraction lines for delivery of pure, trusted and precision-dosed cannabis products for its customers. Through its wholesale and white label platforms, MediPharm Labs formulates, develops (including through sensory testing), processes, packages and distributes cannabis extracts and advanced cannabinoid-based products to domestic and international markets. As a global leader, MediPharm Labs has completed commercial exports to Australia and completed commercialization of its Australian extraction facility which generated its first revenues in H1 2020. MediPharm Labs Australia was established in 2017.

In 2021, MediPharm Labs received a Pharmaceutical Drug Establishment Licence from Health Canada, becoming the only company in North America to hold a domestic Good Manufacturing License for the extraction of natural cannabinoids.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING INFORMATION:

This news release contains “forward-looking information” and “forward-looking statements” (collectively, “forward-looking statements”) within the meaning of the applicable Canadian securities legislation. All statements, other than statements of historical fact, are forward-looking statements and are based on expectations, estimates and projections as at the date of this news release. Any statement that involves discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions, future events or performance (often but not always using phrases such as “expects”, or “does not expect”, “is expected”, “anticipates” or “does not anticipate”, “plans”, “budget”, “scheduled”, “forecasts”, “estimates”, “believes” or “intends” or variations of such words and phrases or stating that certain actions, events or results “may” or “could”, “would”, “might” or “will” be taken to occur or be achieved) are not statements of historical fact and may be forward-looking statements. In this news release, forward-looking statements relate to, among other things, statements regarding: the Company establishing itself as an international pharmaceutical company; a leading position in the projected multibillion-dollar global cannabis pharmaceutical market; becoming the go-to partner for pharmaceutical companies around the globe; potential for material revenue growth for years to come; and the Company’s transition towards pharmaceutical and medical markets reaching new heights. Forward-looking statements are necessarily based upon a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause the actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such factors include, but are not limited to: general business, economic, competitive, political and social uncertainties; the inability of MediPharm to obtain adequate financing; the delay or failure to receive regulatory approvals; and other factors discussed in MediPharm’s filings, available on the SEDAR website at www.sedar.com. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on the forward-looking statements and information contained in this news release. Except as required by law, MediPharm assumes no obligation to update the forward-looking statements of beliefs, opinions, projections, or other factors, should they change.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.