Kalytera Therapeutics, Inc. (TSXV:KALY, OTC:KALTF) (the “Company” or “Kalytera”) today announced that it has initiated a food effect study (“Study KAL-07”), as part of its lead product development program evaluating cannabidiol (“CBD”) for the prevention of acute graft versus host disease (“GVHD”).

Study KAL-07 is being initiated pursuant to written guidance received from U.S. Food and Drug Administration (the “FDA”). The FDA is requiring that the Company complete a study in healthy volunteers to assess the effect of food intake on the absorption of oral CBD, prior to initiation of a Phase 3 registration study. The initiation of Study KAL-07 will satisfy this FDA requirement, and bring the Company’s program in prevention of acute GVHD another step closer to initiation of the pivotal registration study.


“Study KAL-07 is an important part of our overall Phase 2 program,” stated Robert Farrell, President and CEO of Kalytera. “Our goal is to complete all prerequisite work required by the FDA so that we can initiate registration testing as soon as possible. We anticipate that we will complete Study KAL-07 by the end of the second quarter this year.”

Kalytera’s Phase 2 program in prevention of GVHD consists of three separate clinical studies: (1) Study KAL-05; (2) Study KAL-07; and (3) Study KAL-08.

Study KAL-05
Study KAL-05 is the Company’s ongoing open label, multicenter study to evaluate multiple doses of CBD for the prevention of acute GVHD following allogeneic hematopoietic cell transplantation, commonly referred to as bone marrow transplantation. The study is evaluating the PK profile, safety, and efficacy of CBD at doses of 75, 150, and 300 mg twice daily (“BID”). It is anticipated that Study KAL-05 will be complete later this year, and will provide support for the planned Phase 3 registration study required for regulatory approval by the FDA.

Study KAL-07
Study KAL-07, the “food effect study”, is a double blind, randomized, two period, two treatment, fixed sequence, crossover (fed versus fasted) study to evaluate the effect of food on the pharmacokinetics of CBD, along with robust ECG monitoring in 32 healthy volunteers. This study is being conducted at a single site in Melbourne, Australia.

FDA guidelines also require that a proposed new drug be evaluated for its effects on cardiac rhythm. This evaluation is typically done in a separate study known as a QT or QTc study. To save time and expense, Kalytera is including a robust ECG evaluation of each subject enrolled in Study KAL-07. By including this evaluation in the design of Study KAL-07, the Company will be able to complete another critical study evaluation on the pathway to registration, without having to initiate a separate QT or QTc study for this purpose.

Study KAL-08
Study KAL-08, the “drug-drug interaction study”, is a second healthy volunteer study that has been requested by the FDA. This drug-drug interaction study will measure the effect of certain anti-fungal drugs upon metabolism of CBD, and the Company anticipates that it will complete Study KAL-08 during the third quarter this year . This study will also be conducted at a single site in Melbourne, Australia.

GVHD
Patients receiving bone marrow transplants are at high risk of developing acute GVHD, a life-threatening complication that occurs when the transplanted donor cells attack the patient’s organs, including the skin, GI tract, liver, lungs, and eyes. It is estimated that up to 50% of patients who undergo a bone marrow transplant from a sibling donor, and up to 70% of patients who undergo a bone marrow transplant from an unrelated donor, will develop some level of GVHD. There are currently no FDA approved therapies for either the prevention or treatment of acute GVHD.

Kalytera’s Novel, Proprietary CBD Formulation for Prevention of GVHD
The CBD drug product that Kalytera is evaluating for prevention of GVHD is a novel and proprietary formulation designed to overcome issues of poor oral bioavailability and stability.

One of challenges seen in development of CBD as an orally administered pharmaceutical is the issue of poor oral bioavailability caused by first pass metabolism. First pass metabolism occurs when CBD is absorbed from the GI tract and is then delivered to the liver by the portal vein. A significant fraction of CBD is then metabolized in the liver before it reaches systemic circulation, thereby reducing the oral bioavailability of the drug.

To overcome this issue, Kalytera has developed a formulation of CBD that is intended to by-pass first pass liver metabolism. Kalytera’s formulation is designed to allow CBD to be absorbed directly into the circulatory system through the ileum intestine, without first passing through the liver, thereby greatly enhancing the oral bioavailability of this CBD formulation.

CBD is also known to be unstable, leading to drug degradation over time. Stability is a critical quality attribute directly linked to potency, purity and safety, and therefore it was important that Kalytera find a way to overcome the instability of CBD during storage. The company’s novel formulation is designed to overcome this important issue, and this has been successfully demonstrated in stability studies conducted by the Company.

CBD is a non-psychotropic ingredient of cannabis that does not cause euphoria or cognitive effects. Kalytera is the exclusive licensee of two issued U.S. patents covering the use of CBD in the prevention and treatment of GVHD, and is also the exclusive licensee of pending patent applications in other jurisdictions for the use of CBD in the prevention and treatment of GVHD.

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 GVHD and treatment of acute and chronic pain.

Website Home: https://kalytera.co/
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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. 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.

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

Donation will benefit veteran-focused organizations and nonprofits, including all TruVet Program partners

Trulieve Cannabis Corp. (CSE: TRUL) (OTCQX: TCNNF) (“Trulieve” or “the Company”), a United States -based leading medical cannabis company, announced today a donation for all TruVet Program partners year-to-date in honor of Veterans Day. A total of $15,000 representing a portion of the November proceeds from the Company’s limited-edition Freedom Pre-Roll product, will be shared among program partners, which are veteran-focused organizations andor nonprofits.

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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.

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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.

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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

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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.

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