Kalytera Therapeutics, Inc. (TSXV:KALY, OTCQB:KALTF) (the “Company” or “Kalytera”) today announced that it has entered into an agreement with Beetlebung Pharma, Ltd. (“BPL”) for an option to acquire all rights to medical cannabis products in development by BPL for the treatment of both dermatologic diseases and women’s health.

Under this agreement, Kalytera will have the option to license from BPL certain proprietary medical cannabis formulations, which can initially be brought to market in jurisdictions that have already approved access to cannabis for medical purposes. Kalytera believes that this will provide a more near-term path to revenues, compared with the lengthier process required for commercialization following FDA approval.


The collaboration with BPL will bring together Kalytera’s expertise in clinical pharmaceutical development, with BPL’s proprietary cannabis technology. Kalytera is a leader in the development and commercialization of cannabinoid pharmaceuticals with a late-stage clinical program in the prevention and treatment of acute graft versus host disease, and BPL is an Israeli-based pharmaceutical discovery company conducting world-class research and development in the field of cannabinoid and cannabis-based therapeutics, with specific expertise in the development of novel formulations of cannabis extract.

“Research has demonstrated that medical cannabis possesses extraordinary therapeutic potential,” stated Robert Farrell, President and CEO of Kalytera. “However, many of the medical cannabis products currently available have not been shown to be safe and effective in treatment of specific diseases. There have been few, if any, clinical trials to date conducted in compliance with GCP standards supporting the safety and efficacy of these products. Kalytera and BPL intend to address these issues and bring to market proprietary medical cannabis formulations for the treatment of dermatologic diseases and women’s health that will meet the standards of the pharmaceutical industry.”

The strategic aim of the alliance is to expedite development and commercialization of efficacious and low cost medical cannabis products that can be marketed in jurisdictions such as Australia, Canada, Germany and Israel, where access to medical cannabis has been legalized.

Kalytera and BPL are already collaborating in the development of a novel cannabinoid-based compound for the treatment of acute and chronic pain. Patents for this compound have been filed in the U.S. and other jurisdictions, and Kalytera has obtained an exclusive, worldwide license for this compound from BPL (the “Pain Therapeutic License”).

BPL is in the process of preparing patent applications for Canada, the U.S. and other jurisdictions that will cover all compounds invented by BPL in the fields of dermatologic diseases and women’s health. Following each such patent filing, Kalytera may exercise its option to acquire from BPL an exclusive worldwide license for the patent pending compound.

The terms of such license will be substantially similar to the terms of the Pain Therapeutic License. To secure the exclusive option from BPL, Kalytera has paid BPL an initial fee of US$25,000. If it exercises its option to license, Kalytera will pay an additional US$25,000 plus any historical patent costs, royalties equal to a single-digit percentage of Net Sales (as defined in the license agreement), sublicensing fees in the event that Kalytera sublicenses its rights under the license and future contingent milestone payments payable in cash. Kalytera would also enter into a sponsored research contract with BPL under which BPL would design, manage and conduct a clinical study of patients (likely in Canada and/or Israel) designed to provide data to be used to market products covered by the license.

“We are pleased and excited to announce this new alliance,” said Robert Farrell. “BPL is doing world-class research and development work in the field of cannabinoid and cannabis-based therapeutics, and this alliance will expand our existing collaboration beyond the field of pain.”

Kalytera’s Exclusive Option to License Proprietary Medical Cannabis Formulation for the Treatment of Psoriasis

The initial dermatologic product that Kalytera has obtained an option to license from BPL for commercialization on a worldwide basis is a topical medical cannabis extract for the treatment of psoriasis. Kalytera expects to initially commercialize this product in Canada.

The global psoriasis drug market is expected to be valued at US$21.4 billion by 2022, according to a new market research report by Grand View Research, Inc., and the rising prevalence and incidence of psoriasis is anticipated to fuel the market’s growth.

Severe psoriasis is currently treated with monoclonal antibody therapeutics costing more than US$25,000 per year, and Kalytera will seek to bring to market a potentially safer, more effective, and less expensive medical cannabis extract for the treatment of severe psoriasis.

A research review conducted by researchers at the University of Colorado Anschutz Medical Campus, and recently published in the Journal of the American Academy of Dermatology, concluded that cannabinoids are effective against psoriasis. However, an obstacle to effective transdermal treatment of psoriasis is the barrier property of the stratum corneum, the outer layer of skin. The stratum corneum is a thick tissue layer comprising a structured lipid/protein matrix that acts as a barrier for uptake of topically administered agents. Drug formulations with a particle size exceeding 500 nanometers in diameter are unable to penetrate the stratum corneum. Most topical cannabis formulations, such as those prepared with coconut oil, which typically have a droplet size of 1,000–10,000 nanometers, are thus far too large to penetrate the stratum corneum barrier and are of no clinical benefit.

In contrast, medical cannabis extract for treatment of psoriasis developed by Kalytera is expected to have a particle size of approximately 80 nanometers. If successfully developed, this formulation would be the first in its class intended to allow the whole-plant resin to pass through the stratum corneum barrier, and to diffuse into the stratum basale (the lowest layer of the epidermis), where the cannabis compounds are expected to bind to the CB1 and CB2 receptors in the skin, muscle tissue, immune cells, and sensory nerves. Binding of cannabinoids to these receptors has been demonstrated to reduce inflammation and hyper proliferation of cells, both of which are the hallmarks of the psoriatic disease process.

To further improve uptake of the cannabis extract, Kalytera intends to enhance the formulation with select naturally-occurring terpene and sesquiterpene compounds from the cannabis plant that are often lost during the extraction process. This approach should allow large amounts of terpenes and sesquiterpenes to be co-administered along with the cannabis extract. These terpenes and sesquiterpenes may contribute to an entourage effect, thereby potentially improving the effectiveness of the cannabis extract.

Kalytera’s Exclusive Option to License Proprietary Sustained Release Medical Cannabis Formulation for the Treatment of Menstrual Cramps

In the area of women’s health, the initial product that Kalytera has obtained an option to license is a medical cannabis extract for the treatment of severe menstrual cramping, a condition known as dysmenorrhea. Kalytera intends to initially commercialize this product in Canada, and later on a worldwide basis. Later products in the field of women’s health that Kalytera may license include additional medical cannabis formulations for post-menopausal female sexual dysfunction, including vaginal dryness and dyspareunia (pain on intercourse).

According to a report by Market Research Future, the global market opportunity for treatment of dysmenorrhea is expected to reach US$8.40 billion in 2023 from US$5.68 billion in 2016, with a compound annual growth rate of approximately 12.28% during the forecast period 2017-2023. In addition to various medical cannabis products marketed for the treatment of dysmenorrhea, other pharmaceutical treatments include non-steroidal anti-inflammatory drugs (NSAIDs), and various hormonal based oral contraceptive drugs. As reported by Market Research Future, patients report high levels of dissatisfaction with the currently available therapeutics.

Extensive medical research has demonstrated that cannabis is effective in relieving pain associated with an array of conditions, including dysmenorrhea. A number of medical cannabis products are currently available for the treatment of dysmenorrhea, including vaginal suppositories containing 10 mg of tetrahydrocannabinol (“THC”) and 50 mg of cannabidiol (“CBD”). However, there have been no clinical trials to date supporting the safety and efficacy of these products. Furthermore, these suppositories are absorbed into the bloodstream rapidly, resulting in only a transient reduction in menstrual cramping reported to last for only an hour or so, whereas Kalytera believes a more sustained treatment is required.

The product in development for the treatment of dysmenorrhea is a vaginal suppository that will utilize a sustained release proprietary formulation intended to provide a smooth and consistent release of cannabinoids at steady levels over a period of 8 to 12 hours. Kalytera believes this product could make significant inroads in this market following completion of a clinical study demonstrating safety and efficacy in the treatment of dysmenorrhea.

If it exercises its option to license this technology, Kalytera expects to work with BPL to conduct an initial clinical study in Canada and Israel to provide marketing data in support of commercialization for this product in those and other jurisdictions that have legalized access to medical cannabis. Following initial market launch in these jurisdictions, Kalytera plans to conduct registration-directed clinical studies for FDA approval, in order to access larger commercial markets.

Kalytera’s Continuing Expansion and Diversification Within the Field of Cannabinoid Therapeutics

The strategic alliance announced today is another step in Kalytera’s expansion and diversification of its cannabinoid-based product development portfolio. Kalytera currently has an ongoing late-stage clinical program with cannabidiol (“CBD”) in the prevention and treatment of acute graft versus host disease, as well as a pre-clinical cannabinoid-based therapeutic program in the treatment of pain.

About Kalytera Therapeutics

Kalytera Therapeutics, Inc. is pioneering the development of CBD therapeutics. Through its proven leadership, drug development expertise, and intellectual property portfolio, Kalytera seeks to establish a leading position in the development of CBD medicines for a range of important unmet medical needs, with an initial focus on acute graft versus host disease and treatment of acute and chronic pain.

About Beetlebung Pharma

Beetlebung Pharma Limited (BPL), an Israeli affiliate of the Salzman Group, focuses on the discovery and development of novel cannabis-related pharmaceutical therapeutics. The Salzman Group provides clinical management and other services to Kalytera in connection with Kalytera’s programs evaluating CBD in the prevention and treatment of graft versus host disease. BPL has invented a broad range of cannabinoid new chemical entities in therapeutic areas encompassing pain, inflammation, autoimmunity, ischemia-reperfusion injury, trauma, and central nervous system injury. BPL is also active in the development of novel formulations of existing cannabinoids, terpenes, and sesquiterpenes that may contribute to the entourage effect. To provide scientific support for its pharmaceutical programs, BPL carries out biological research on terpenoid cell signaling and pharmacology in its basic research laboratories. BPL is a private, closely held corporation.

Cautionary Statements

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This press release may contain certain forward-looking information and statements (“forward-looking information”) within the meaning of applicable Canadian securities legislation, that are not based on historical fact, including without limitation in respect of its product candidate pipeline, planned clinical trials, regulatory approval prospects, intellectual property objectives and other statements containing the words “believes”, “anticipates”, “plans”, “intends”, “will”, “should”, “expects”, “continue”, “estimate”, “forecasts” and other similar expressions. Readers are cautioned to not place undue reliance on forward-looking information. Actual results and developments may differ materially from those contemplated by these statements depending on, among other things, the risk that future clinical studies may not proceed as expected or may produce unfavourable results, the risk that Kalytera may not be able to exercise the options described above in the event it is not able to fund the development of the optioned technology, the risk that development and commercialization of the formulations described herein may not be completed as expected, the risk that such formulations may not exhibit the expected mechanism of action and may not have the desired safety and efficacy profile, and other regulatory and market risks. Kalytera undertakes no obligation to comment on analyses, expectations or statements made by third parties, its securities, or financial or operating results (as applicable). Although Kalytera believes that the expectations reflected in forward-looking information in this press release are reasonable, such forward-looking information has been based on expectations, factors and assumptions concerning future events which may prove to be inaccurate and are subject to numerous risks and uncertainties, certain of which are beyond Kalytera’s control. The forward-looking information contained in this press release is expressly qualified by this cautionary statement and is made as of the date hereof. Kalytera disclaims any intention and has no obligation or responsibility, except as required by law, to update or revise any forward-looking information, whether as a result of new information, future events or otherwise.

Contacts

Kalytera Therapeutics, Inc.
Robert Farrell, 888-861-2008
President, CEO
info@kalytera.co
or
Colwell Capital Corp.
Graeme Dick, 1-403-561-8989
Graeme@colwellcapital.com

Click here to connect with Kalytera Therapeutics, Inc. (TSXV:KALY, OTCQB:KALTF) for an Investor Presentation. 

Source: www.businesswire.com

Bronstein, Gewirtz & Grossman, LLC notifies investors that a class action lawsuit has been filed against Aurora Cannibas, Inc. (“Aurora” or the “Company”) (NYSE:ACB) and certain of its officers, on behalf of shareholders who purchased or otherwise acquired Aurora securities between February 13, 2020, and September 4, 2020, inclusive (the “Class Period”). Such investors are encouraged to join this case by visiting the firm’s site: www.bgandg.comacb

This class action seeks to recover damages against Defendants for alleged violations of the federal securities laws under the Securities Exchange Act of 1934.

Keep reading... Show less

Hill Street Beverage Company Inc. (TSXV: BEER) (“Hill Street” or the “Company”) reported its first quarter results for period ended Sept 30, 2020. A complete set of financial statements and Management’s Discussion & Analysis has been filed at www.sedar.com. All dollar figures are quoted in Canadian dollars.

FY21 First Quarter Financial Highlights

Keep reading... Show less

Signed LOI for CAD$23 million sale to Ionic provides shareholder value

Lobe Sciences Ltd. (CSE: LOBE) (OTC Pink: GTSIF) (“Lobe” or the “Company”) is pleased to announce that it has received and signed a non-binding letter of intent dated November 30, 2020 with IONIC Brands Corp. (“Ionic”) for the proposed sale to Ionic of certain assets held by Lobe related to Cowlitz County Cannabis Cultivation Inc. (“Cowlitz”) (the “Transaction”). Cowlitz is one of the top five licensed cannabis producersprocessors located in Washington State.

The assets being sold to Ionic may include, but are not limited to, the assignment of all property leases relating exclusively to Cowlitz’s business, the assignment of Lobe’s option agreement to acquire all of the outstanding shares of Cowlitz, and the assignment of other contracts and rights related exclusively to Cowlitz including service contracts and equipment leases (the “Assets“).

The Transaction is subject to several closing conditions, including but not limited to: (i) satisfactory due diligence by both Ionic and Lobe; (ii) completion of a definitive agreement with binding terms and conditions for the Transaction, including finalization of the specific Assets that will be sold and certain Cowlitz assets that may be retained by Lobe; (iii) all respective directors and officers of Lobe and Ionic entering into support agreements for the Transaction; (iv) approval by the boards of directors of both Lobe and Ionic; (v) the completion of a share consolidation by Ionic on a minimum of one new Ionic common share for every four and a half (4.5) old Ionic common shares (the “Ionic Consolidation“); (vi) the conversion of all Ionic debentures (with principal amount of approximately CAD$14.7 million) into a secured equity or a similar instrument (“Debt Conversion“); (vii) completion of a concurrent financing by Ionic for gross proceeds of at least US$2 million (the “Ionic Concurrent Financing“); (viii) Ionic having all cease trade orders issued against it lifted(2); (ix) Ionic applying to the CSE for requalification and qualifying for listing and resumption of trading(2); and (x) the receipt of all required shareholder and regulatory approvals, including the approval of the CSE. Following the closing of the Transaction, Ionic’s board of directors is expected to be comprised of five (5) members and Lobe will have the right to appoint two (2) directors to the Ionic board.

The sale price for the Assets shall be a minimum of CAD$23 million, payable through the issuance of Ionic post-consolidation common shares (being approximately 49% of Ionic’s estimated $47 million capitalization post-restructuring (after giving effect to the Ionic Consolidation and Debt Conversion)), prior to giving effect to the Ionic Concurrent Financing. Following the closing of the Transaction, it is expected that the Lobe will own approximately 49% of Ionic’s common shares, on a post-consolidation and pre-Ionic Concurrent Financing basis. Ionic is expected to have a minimum total capitalization valuation of CAD$47 million, pre-Ionic Concurrent Financing.

As previously announced, Lobe has been pursuing strategic alternatives for Cowlitz, aimed at maximizing its value to the Company. Cowlitz reported over US$14.6 million in gross sales revenues for the nine month period ended September 30, 2020, according to data provided on reports to the Washington State Department of Revenues(1). Lobe generates revenues through licensing and leasing agreements in place with Cowlitz.

Ionic is listed on the Canadian Securities Exchange(2) (the “CSE“) (CSE: IONC) and is a growing US-based cannabis company that focuses on premium cannabis products with current operations in Washington and Oregon. Ionic has completed a number of strategic synergistic acquisitions since 2019 aimed at growing revenues as a multi-state operator, and increasing their overall product lines and intellectual property portfolio. Ionic’s strategy has been focused on building a regionalized multistate operation of cannabis brands in the Pacific Northwest markets with an eye to expansion into other recreational markets and aggressive national expansion.

John Gorst, CEO of Ionic said, “We are excited about this opportunity to expand our presence in Washington State. Cowlitz has tremendous brand presence and following in Washington State, which we feel is a natural fit, complementing our existing operations. The combination will make us one of the largest premier cannabis companies in the Pacific Northwest markets. The acquisition of the Cowlitz Assets will represent a complimentary synergistic acquisition that achieves our goal of operational expansion and growth of our product portfolio.”

“The proposed transaction with Ionic is accretive to both parties, successfully meets our M&A initiatives and keeps Lobe active in the cannabis and overall transformation psychedelic medicine space,” states Tom Baird, CEO of Lobe. “The Transaction provides Lobe with significant ownership and board presence in Ionic. With its already significant operations in Washington State and Oregon, we feel Ionic’s proposed product expansion initiatives together with the addition of the Cowlitz Assets can lead to aggressive growth.”

About Ionic Brands Corp.

Ionic is dedicated to building a regionally based multi-state consumer-focused cannabis concentrate brand portfolio with strong roots in the premium and luxury segments of vape concentrates and edibles. The cornerstone brand of the portfolio, IONIC, is the #3 vaporizer brand in Washington State and has aggressively expanded throughout the Pacific Northwest of the United States. The brand is currently operating in Washington and Oregon. Ionic’s strategy is to be the leader of the highest-value segments of the cannabis market.

About Lobe Sciences Ltd.

Lobe is a growth-oriented research, technology & services company that provides financial, management, IP and branding support to businesses. The Company operates a portfolio of companies focused on developing transformational medicines and applies refined strategies to help partner companies reach their full potential. Based in Vancouver, BC, Lobe Sciences creates value through acquisitions and development of assets, products and technologies by leveraging its scientific, engineering, branding and operational expertise supported by strong capital markets acumen.

For further information please contact:

Lobe Sciences Ltd.
Thomas Baird, CEO
info@lobesciences.com
Tel: (949) 505-5623

THE CSE HAS NOT REVIEWED AND DOES NOT ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.

Disclaimer for Forward Looking Statements

This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact included in this release, including statements regarding the future plans and objectives of the Company, the Company’s expectations surrounding its development of treatments and/or therapeutics for mTBI and PTSD, the proposed Transaction and terms with Ionic and estimated capitalization of Ionic and share value to Lobe, Ionic having its cease trader orders lifted and resumption for trading on the CSE, future sales and expected revenues of Cowlitz and enhancing its value to the Company, are forward looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the Company’s expectations are risks detailed from time to time in the filings made by the Company with securities regulations. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; and that the current Board and management may not be able to attain the Company’s corporate goals and objectives. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.

Keep reading... Show less

 Next Green Wave Holdings Inc. (CSE: NGW) (OTCQX: NXGWF) (“Next Green Wave“, “NGW” or the “Company”) is pleased to announce the following operational and financial milestones:

– In November 2020, the Company’s Adjusted EBITDA* was approximately US$1,000,000. This after already recording approximately US$1,000,000 in October 2020.

Keep reading... Show less

Wonder debuts in Illinois with low-dose Wonder Minis hard sweets for category newcomers to consume and control their experience with confidence

Cresco Labs (CSE:CL) (OTCQX:CRLBF) (“Cresco” or “the Company”), one of the largest vertically integrated multistate cannabis operators in the United States, announced today the launch of Wonder Wellness Co. (“Wonder”), the newest brand to join its expanding portfolio of national cannabis brands. Wonder addresses the direct needs of the large segment of consumers who are accepting of cannabis but have yet to enter the category. Created to take the guesswork out of cannabis, the portfolio offers low-dose, approachable forms that are simple to use with packaging that is easy to understand, so newcomers can explore the plant and control their experience with confidence. The brand debuts in Illinois with Wonder Minis, a line of 3 mg hard sweets focused on effects-driven benefits.

Keep reading... Show less