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Finch Therapeutics Receives Fast Track Designation for the Investigation of Full-Spectrum Microbiota as a Treatment for Children with Autism Spectrum Disorder

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SOMERVILLE, Mass.–(BUSINESS WIRE)–Finch Therapeutics Group, Inc., a clinical-stage microbiome therapeutics
company, announced today that the U.S. Food and Drug Administration
(FDA) has granted Fast Track designation to its Full-Spectrum
Microbiota®
(FSM®) therapy for the treatment of children with
Autism Spectrum Disorder (ASD). Fast Track designation is intended to
facilitate development and expedite review of therapies designed to
treat serious conditions and fill an unmet medical need.

Studies have shown that individuals with ASD commonly suffer from GI
symptoms, such as constipation, diarrhea, and abdominal pain. Research
characterizing the gut microbiome of individuals with ASD has revealed
an abnormal gut microbiome compared to healthy controls. Previously,
Adams and Krajmalnik-Brown, Finch’s collaborators at Arizona State
University treated 18 children affected by ASD with Full-Spectrum
Microbiota
in an open-label study.
They found the treatment was well-tolerated and led to a 77% reduction
of GI symptoms and a 24% reduction of core ASD symptoms at eight weeks
post-treatment. A recently published study
that followed these 18 children for two years after initial treatment
reports sustained improvements in GI symptoms and core behavioral ASD
symptoms.

“With an estimated 1 in 59 children diagnosed with ASD and no
FDA-approved medications indicated for the core symptoms of ASD, there
is clearly a strong need to provide children and families impacted by
ASD with an effective therapy,” said Mark Smith, CEO of Finch. “We are
very encouraged by the preliminary clinical data in this field and look
forward to conducting the randomized, controlled clinical trials
necessary to fully assess the safety and efficacy of Full-Spectrum
Microbiota
therapy for the treatment of children with ASD.”

Finch is supporting an actively enrolling Phase II
investigator-initiated clinical study evaluating the safety and efficacy
of its Full-Spectrum Microbiota therapy in adults with ASD (NCT03408886).
Finch also plans to conduct a randomized, placebo-controlled, Phase II
clinical study in children with ASD (NCT03829878).
In both studies, the study drug is an oral capsule designed to contain a
diverse community of microbiota capable of restoring an unbalanced
microbiome. Finch’s FSM therapy is also being evaluated in PRISM3,
an actively enrolling Phase II study in patients with recurrent C.
difficile
infections (NCT03110133).

Full-Spectrum Microbiota therapy is not approved in any country. The FDA’s
Fast Track designation does not constitute or guarantee a future
approval and does not alter the standards for approval.

About Finch Therapeutics Group, Inc.
Finch
Therapeutics Group, Inc.
(Finch) is developing novel microbial
therapies to serve patients with serious unmet medical needs. Built on
30 years of translational research at OpenBiome, MIT, University of
Minnesota and the Center for Digestive Diseases, Finch uses Human-First
Discovery
™ to develop therapies from microbes that have
demonstrated clinically significant impacts on patient outcomes. Finch
is unique in having both a donor-derived Full-Spectrum Microbiota® (FSM®)
product platform and a Rationally-Selected Microbiota® (RSM™)
product platform based on microbes grown in pure culture. Finch’s lead
program, CP101, is an investigational FSM product for prevention
of recurrent C. difficile infections. Finch’s RSM platform
employs machine-learning algorithms to mine Finch’s unique clinical
datasets, reverse engineering successful clinical experience to identify
the key microbes driving patient outcomes. Finch has a strategic
partnership with Takeda to develop FIN-524, an investigational RSM product
for inflammatory bowel disease. Finch is also developing an FSM
product for the treatment of children with Autism Spectrum Disorder and
associated GI symptoms. Finch is using a rich foundation of clinical
data to advance its pipeline, leveraging proof-of-principle results to
evaluate target indications and inform the design of this new
therapeutic class.

Full-Spectrum MicrobiotaFSMRationally-Selected
Microbiota
RSM, and Human-First Discovery are
trademarks of Finch Therapeutics Group, Inc.

Contacts

Gabriella Linville-Engler
[email protected]


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Cannabis

Cannabis Concentrate Market to Cross US$2.4 Billion by 2030 amid Rising Medical and Recreational Demand

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IMC to transfer its Oranim Pharmacy shares back to the seller

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imc-to-transfer-its-oranim-pharmacy-shares-back-to-the-seller

TORONTO and GLIL YAM, Israel, April 16, 2024 /PRNewswire/ — IM Cannabis Corp. (CSE: IMCC) (NASDAQ: IMCC) (the “Company” or “IMC“), a leading medical cannabis company with operations in Israel and Germany, is announcing that, further to the news release dated January 12, 2024, the Company has decided not to make remaining installment payments installments (i.e. NIS 5,873K including interest or 2,154K CAD) by IMC Holdings Ltd., and as such will transfer the 51% shares held by IMC Holdings Ltd back to the  seller.

“With the April 1st cannabis legalization in Germany, we are focusing our resources on the German market, where we expect to see the biggest growth potential,” said Oren Shuster, CEO of IMC. “With both of our core markets, Germany and Israel, currently undergoing rapid evolution, we need to assure that we allocate our resources to the growth opportunities where we expect the best return on investment.”

About IM Cannabis Corp.

IMC (Nasdaq: IMCC) (CSE: IMCC) is an international cannabis company that provides premium cannabis products to medical patients in Israel and Germany, two of the largest medical cannabis markets. The Company has recently exited operations in Canada to pivot its focus and resources to achieve sustainable and profitable growth in its highest value markets, Israel and Germany. The Company leverages a transnational ecosystem powered by a unique data-driven approach and a globally sourced product supply chain. With an unwavering commitment to responsible growth and compliance with the strictest regulatory environments, the Company strives to amplify its commercial and brand power to become a global high-quality cannabis player.

The IMC ecosystem operates in Israel through its commercial relationship with Focus Medical Herbs Ltd., which imports and distributes cannabis to medical patients, leveraging years of proprietary data and patient insights. The Company also operates medical cannabis retail pharmacies, online platforms, distribution centers, and logistical hubs in Israel that enable the safe delivery and quality control of IMC’s products throughout the entire value chain. In Germany, the IMC ecosystem operates through Adjupharm GmbH, where it distributes cannabis to pharmacies for medical cannabis patients. Until recently, the Company also actively operated in Canada through Trichome Financial Corp and its wholly owned subsidiaries, where it cultivated, processed, packaged, and sold premium and ultra-premium cannabis at its own facilities under the WAGNERS and Highland Grow brands for the adult-use market in Canada. The Company has exited operations in Canada and considers these operations discontinued.

Disclaimer for Forward-Looking Statements

This press release contains forward-looking information or forward-looking statements under applicable Canadian and U.S. securities laws (collectively, “forward-looking statements”). All information that addresses activities or developments that we expect to occur in the future are forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “likely” and “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to,  the occurrence of growth opportunities and the likelihood of growth potential.

Forward-looking statements are based on assumptions that may prove to be incorrect, including but not limited to: the development and introduction of new products; continuing demand for medical and adult-use recreational cannabis in the markets in which the Company operates; the Company’s ability to reach patients through both e-commerce and brick and mortar retail operations; the Company’s ability to maintain and renew or obtain required licenses; the effectiveness of its products for medical cannabis patients and recreational consumers; and the Company’s ability to market its brands and services successfully to its anticipated customers and medical cannabis patients.

The above lists of forward-looking statements and assumptions are not exhaustive. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated or implied by such forward looking statements due to a number of factors and risks. These include: any failure of the Company to maintain “de facto” control over Focus Medical in accordance with IFRS 10; the failure of the Company to comply with applicable regulatory requirements in a highly regulated industry; unexpected changes in governmental policies and regulations in the jurisdictions in which the Company operates; the effect of the reform on the Company; the Company’s ability to continue to meet the listing requirements of the Canadian Securities Exchange and the NASDAQ Capital Market; any unexpected failure to maintain in good standing or renew its licenses; the ability of the Company and Focus Medical (collectively, the “Group”) to deliver on their sales commitments or growth objectives; the reliance of the Group on third-party supply agreements to provide sufficient quantities of medical cannabis to fulfil the Group’s obligations; the Group’s possible exposure to liability, the perceived level of risk related thereto, and the anticipated results of any litigation or other similar disputes or legal proceedings involving the Group; the impact of increasing competition; any lack of merger and acquisition opportunities; adverse market conditions; the inherent uncertainty of production quantities, qualities and cost estimates and the potential for unexpected costs and expenses; risks of product liability and other safety-related liability from the usage of the Group’s cannabis products; supply chain constraints; reliance on key personnel; the risk of defaulting on existing debt and war, conflict and civil unrest in Eastern Europe and the Middle East

Any forward-looking statement included in this press release is made as of the date of this press release and is based on the beliefs, estimates, expectations and opinions of management on the date such forward-looking information is made.

The Company does not undertake any obligation to update forward-looking statements except as required by applicable securities laws. Investors should not place undue reliance on forward-looking statements. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement.

Company Contacts:

Anna Taranko, Director Investor & Public Relations
IM Cannabis Corp.
+49 157 80554338
[email protected]

Oren Shuster, Chief Executive Officer
IM Cannabis Corp.
[email protected]

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Cannabis

Right on Brands Announces Major Product Line Expansion via HONEY® Brands

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GrassNews.net: Your premier portal for the latest developments in the cannabis industry. We provide timely news, insightful analysis, and in-depth features on everything from legislation changes and business trends, to scientific research and lifestyle topics. Stay informed and navigate the rapidly evolving cannabis landscape with GrassNews.net..

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