Entry into a Material Definitive Agreement

On June 23, 2022, Replimune Group, Inc. (the "Company") reported that entered into a Sales Agreement (the "Sales Agreement") with SVB Securities LLC (the "Agent"), pursuant to which the Company may sell, from time to time, at its option, up to an aggregate of $100,000,000 of shares of the Company’s common stock, $0.001 par value per share (the "Shares"), through the Agent, as the Company’s sales agent (Filing, 8-K, Replimune, JUN 23, 2022, View Source [SID1234616230]).

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Any Shares to be offered and sold under the Sales Agreement will be issued and sold (i) by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if authorized by the Company, in negotiated transactions or block trades and (ii) pursuant to, and only upon the effectiveness of, a registration statement on Form S-3 filed by the Company with the Securities and Exchange Commission on June 23, 2022 for an offering of up to $400,000,000 of various securities, including shares of the Company’s common stock, preferred stock, debt securities, warrants and/or units for sale to the public in one or more public offerings.

Subject to the terms of the Sales Agreement, the Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company cannot provide any assurances that it will issue any Shares pursuant to the Sales Agreement. The Company will pay the Agent a commission of up to 3.0% of the gross proceeds from the sale of the Shares, if any. The Company has also agreed to provide the Agent with customary indemnification rights.

Pursuant to the Sales Agreement, the parties mutually agreed to terminate that certain sales agreement, dated August 11, 2020, by and between the Company and the Agent (as amended, the "2020 Sales Agreement") with respect to the Company’s previous at-the-market offering program (the "2020 ATM Program").

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, which is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

Almac Diagnostic Services collaborates with AstraZeneca to Develop and Commercialise Companion Diagnostics (CDx)

On June 23, 2022 Almac Diagnostic Services, a member of the Almac Group, reported it has signed a Master Collaboration Agreement (MCA) with AstraZeneca to develop and commercialise multiple companion diagnostic (CDx) products (Press release, Almac, JUN 23, 2022, View Source [SID1234616199]). Almac will work to support AstraZeneca in its drive to bring new therapies to patients globally in disease areas of high unmet need.

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Under the terms of the agreement, Almac will develop and validate specific CDx assays for patient selection in various AstraZeneca clinical trials across a range of therapeutic areas including kidney disease, non-alcoholic steatohepatitis, and respiratory disease. Almac will seek regulatory approval for individual CDx assays in agreed jurisdictions in tandem with linked AstraZeneca therapeutics. To date, a number of programmes have already been initiated under this model.

Professor Paul Harkin, President & Managing Director, Almac Diagnostic Services, commented: "We are delighted to have signed this CDx master collaboration agreement, which represents a further strategic alignment with AstraZeneca, and enhancement of an already strong relationship. We are looking forward to working collaboratively together to develop and commercialise these companion diagnostic tests to help identify the right patient populations that will benefit from future AstraZeneca targeted therapies."

Maria Orr, Head of Precision Medicine, BioPharmaceuticals R&D, AstraZeneca said: "Precision medicine is at the heart of AstraZeneca’s ambition to dramatically improve patients’ lives globally; it is an interconnected cycle from early research, innovative pharmacology and drug modalities, to clinical trial design and diagnostic development. Through collaborating with our partners we can lead the way in a new era of precision medicines for complex chronic diseases. We are committed to matching life-changing medicines to patients most likely to benefit and we believe our collaboration with Almac will help us achieve this."

Patients with Uveal Melanoma Tested with DecisionDx®-UM Report Gaining Value from Test Results In Study Conducted In Collaboration with the Melanoma Research Foundation’s CURE OM Initiative

On June 23, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported findings from a study that evaluated uveal melanoma (UM) patients’ attitudes toward prognostic testing and specifically with respect to DecisionDx-UM (Press release, Castle Biosciences, JUN 23, 2022, View Source [SID1234616215]). Highlights from the study were shared in a poster presentation at the 20th congress of the International Society of Ocular Oncology (ISOO), recently held in Leiden, The Netherlands.

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The poster, titled "Uveal Melanoma Patient Attitudes Towards Prognostic Testing Using Gene Expression Profiling" and presented by Basil K. Williams, Jr., M.D., assistant professor in the Department of Ophthalmology and Mary Knight Asbury Chair of Ocular Oncology at the University of Cincinnati College of Medicine, can be viewed here.

"Most patients impacted by the rare but quite deadly disease, uveal melanoma, want and expect to play an active role in their care to ensure the best possible outcome," said Williams. "We believe the survey data supported this sentiment and found that regardless of their overall prognosis, patients value the information provided by their DecisionDx-UM test results."

Study highlights:

An online questionnaire was distributed by the Melanoma Research Foundation’s CURE OM (Ocular Melanoma) initiative to capture anonymous information regarding patient-reported experiences following prognostic testing.
Patients were asked questions regarding the decision to undergo prognostic testing and the extent to which they felt decision regret.
Of the 177 survey participants, 90% reported wanting prognostic information at diagnosis.
Of the patients who received prognostic testing with DecisionDx-UM, there was no significant difference in decision regret levels among those receiving a low- (Class 1A), intermediate- (Class 1B) or high-risk (Class 2) test result (Kruskal-Wallis rank sum test, X2=4.1, p=0.13).
Patients tested with DecisionDx-UM reported gaining value from their test result, including:
Increased knowledge and understanding of their disease
More personalized treatment options
Information relevant to life planning
Relief from uncertainty about the future
About DecisionDx-UM

DecisionDx-UM is Castle Biosciences’ 15-gene expression profile (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis in patients with uveal melanoma. DecisionDx-UM is the standard of care in the management of newly diagnosed uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies, and it has been shown to be a superior predictor of metastasis compared to other prognostic factors, such as chromosome 3 status, mutational status, AJCC stage and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their diagnostic workup.

Kuraray Publishes the Kuraray Report 2022

On June 23, 2022 Kuraray Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President: Hitoshi Kawahara; hereinafter "Kuraray") reported that it has published the Kuraray Report 2022, an integrated report (A4 size, 58 pages, full color) (Press release, Kuraray, JUN 23, 2022, View Source [SID1234616231]).

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The aim of the Kuraray Report is to help shareholders, investors, and all other stakeholders better understand the value that the Kuraray Group creates over the medium to long term by providing a comprehensive overview of financial and non-financial information, including environmental, social and governance data.
Going forward, the Kuraray Group will continue to hold constructive dialogues with its stakeholders while also enhancing the content of the report.

Front cover of the Kuraray Report 2022
Cover of the Kuraray Report 2022
Overview of the Kuraray Report 2022
This year’s report focuses on the initiatives under the medium-term management plan "PASSION 2026," which started in fiscal 2022. The "PASSION 2026" is a medium-term management plan to realize the long-term vision "Kuraray Vision 2026," which was revised for Kuraray’s 100th anniversary, and our newly articulated sustainability long-term vision. In "PASSION 2026", the Kuraray Group has identified "Our Challenges," three areas that must be addressed in order to achieve sustainable growth, and these are introduced along with messages from top management. Under "Our Challenges," Sustainability as an Opportunity (Sustainability medium-term plan), we adopt the 3P model, which is defined by the three Ps of Planet, Product, and People. In this report, we explain each measure being taken in concrete terms to clearly convey the Kuraray Group’s approach and efforts toward sustained development.
To read this report, please click on the following link:

View Source
Sustainability Section of Kuraray’s Corporate Website
The sustainability section of Kuraray’s corporate website features detailed sustainability-related information about initiatives, activities and their results for fiscal 2021 not fully covered in the report. The site uses responsive web design, making it easy to view on smartphones and tablets.
In addition, the sustainability section reports are created in line with the GRI Standards, international guidelines for sustainability reports.

Entry into a Material Definitive Agreement

On June 23, 2022, DiaMedica USA Inc. (the "Tenant"), a Delaware corporation and wholly owned subsidiary of DiaMedica Therapeutics Inc., a corporation existing under the laws of British Columbia, Canada (the "Company"), entered into an office lease (the "Lease") with Medica Services Company, LLC, a Delaware limited liability company (the "Landlord"), whereby the Tenant agreed to lease approximately 6,175 square feet at 301 Carlson Parkway, Suite 210, Minnetonka, Minnesota, USA 55305 (the "Premises") (Filing, 8-K, DiaMedica, JUN 23, 2022, View Source [SID1234616393]). The Lease has an initial term of five years and five months, commencing on September 1, 2022, and the Tenant has the option to extend the Lease for an additional five years. The Company intends to relocate its principal executive offices, together with its research and development operations, to the Premises on September 1, 2022 following the expiration of the Tenant’s current lease in August 2022.

Under the Lease, the Tenant has agreed to pay rent, after an initial five-month abatement period, in an initial amount equal to approximately $9,000 per month, plus its pro rata share of operating expenses and real estate taxes. The Lease contains customary representations, warranties, covenants, indemnification provisions, default provisions, and other provisions.

As an inducement to the Landlord to enter into the Lease with the Tenant, on June 22, 2022, the Company entered into a lease guaranty agreement (the "Lease Guarantee Agreement") pursuant to which the Company agreed to fulfill and perform or cause the Tenant to fulfill and perform all of the terms and every payment, covenant and condition which the Tenant is required to make or perform under the Lease. The Lease Guarantee Agreement terminates once full payment of all sums due under the Lease and full performance of all terms, covenants and conditions therein have been kept, observed or performed by the Tenant.

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