Nykode Therapeutics to announce financial results for the first half of 2022 and host webcast presentation on August 24, 2022

On August 22, 2022 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported it will report its financial results for the first half of 2022 on August 24, 2022 before market open and subsequently host a webcast presentation at 4 p.m. CET / 10 a.m. ET (Press release, Nykode Therapeutics, AUG 22, 2022, View Source [SID1234618534]).

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A live and archived webcast of the presentation can be accessed in the Investors section of the Company’s website: View Source

Concert Pharmaceuticals Announces Exercise of Warrants Under Existing Financing Arrangement

On August 22, 2022 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that BVF Partners L.P. and RA Capital Management have exercised their remaining tranche 1 warrants issued in connection with the Company’s November 2021 financing, resulting in proceeds of $20.9 million to the Company (Press release, Concert Pharmaceuticals, AUG 22, 2022, View Source [SID1234618533]). Concert has the potential to receive an additional $49.2 million if the tranche 2 warrants issued to BVF and RA Capital in connection with the same financing are exercised in full by their October 31, 2022 expiration date. If the tranche 2 warrants are fully exercised, under its current operating plan, Concert would expect its cash, cash equivalents and investments to fund the Company beyond the anticipated submission of its New Drug Application (NDA) for CTP-543, which is expected in the first half of 2023.

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The exercise period of the tranche 1 and tranche 2 warrants was tied to the clinical success of the Company’s CTP-543 THRIVE-AA1 and THRIVE-AA2 Phase 3 trials for alopecia areata. Concert reported positive topline results from the THRIVE-AA1 and THRIVE-AA2 trials in May 2022 and August 2022, respectively. In June 2022, Concert received $18.9 million from the partial exercise of the tranche 1 warrants issued to BVF and RA Capital.

Chugai and Noile-Immune Biotech Enter into a License Agreement for Noile-Immune’s PRIME CAR-T Technology

On August 22, 2022 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) and Noile-Immune Biotech Inc. reported that the companies entered into a license agreement for Noile-Immune’s proprietary PRIME (Proliferation-Inducing and Migration-Enhancing) CAR-T technology (Press release, Chugai, AUG 22, 2022, View Source [SID1234618532]).

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In recent years, cancer immunotherapy has been widely recognized as a new approach to cancer treatment by enhancing the immune system to attack cancer cells. Chimeric antigen receptor T cell (CAR-T cell) therapy is a type of cancer immunotherapy, in which a patient’s immune cells (T cells) are collected, transfected with a gene for an artificial chimeric antigen receptor (CAR), which recognizes a cancer antigen, expanded in large numbers and returned to the patient’s body. The therapy is currently used as a new treatment for hematologic cancers. Noile-Immune’s PRIME technology is expected to open up the possibility of CAR-T cell therapy not only for hematologic cancers but also for solid tumors. PRIME technology is a platform designed to enhance the function of immune cells through the expression of the cytokine*1 IL-7 and the chemokine*2 CCL19 from CAR-T cells, exerting anti-tumor effects.1,2 Preclinical studies (mouse, in vivo) have shown that the PRIME technology increases the expression of IL-7 and CCL19 and boosts the proliferation and migration into solid tumors of both CAR-T cells as well as the patient’s own immune cells.

*1 Cytokine is a bioactive substance secreted from cells, and mainly controls the proliferative activity, function, survival, etc. of immune cells.
*2 Chemokine is a type of a bioactive substance that control the migration of immune cells, including white blood cells, into tissues.
The agreement is based on the evaluation results for PRIME technology under the previous technology assessment agreement between Chugai and Noile-Immune in June 2020. Under the newly executed license agreement, Noile-Immune grants Chugai the rights to use PRIME technology for the creation and research of PRIME CAR-T cells, as well as the rights to develop, manufacture and commercialize PRIME CAR-T cell products for certain targets. Chugai will pay Noile-Immune an upfront payment and technology transfer fees. Also, Chugai may potentially pay over ¥20 billion in total if predetermined development or sales milestones are achieved. If Chugai successfully launch a product using PRIME technology, it will also pay royalties on sales in addition to the aforementioned sales milestones.

"Chugai is focusing efforts to establish new modalities following small molecules, antibodies and mid-size molecules under its multi-modality drug discovery strategy. We will challenge ourselves to make an innovative modality available for solid tumors by combining Noile-Immune’s PRIME technology and Chugai’s scientific and technical capabilities," said Dr. Osamu Okuda, Chugai’s President and CEO.

"I am very pleased that the evaluation for our PRIME technology, which was initiated in 2020, resulted in this license agreement. We hope that this agreement will accelerate the development of safe and effective cancer immunotherapies for solid tumors, deliver new treatment options to patients suffering from cancer worldwide as soon as possible, and lead to the creation of a society that can overcome cancer," said Koji Tamada, M.D., Ph.D, Noile-Immune’s President & CEO and scientific founder.

Bausch Health Continuing Process Toward Separating Bausch + Lomb

On August 22, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that it has transferred common shares in an amount equal to approximately 38.6% of the issued and outstanding shares of Bausch + Lomb Corporation ("Bausch + Lomb") to an existing wholly-owned unrestricted subsidiary of the Company (the "Internal Transfer") (Press release, Bausch Health, AUG 22, 2022, View Source [SID1234618531]).

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Common shares in an amount equal to approximately 50.1% of Bausch + Lomb continue to be held by a wholly-owned restricted subsidiary of the Company, and Bausch + Lomb itself remains a restricted subsidiary of the Company. The Company, through its subsidiaries, continues to hold the same number of shares of Bausch + Lomb as it did prior to the Internal Transfer, which in the aggregate comprises approximately 88.7% of the issued and outstanding shares of Bausch + Lomb.

The Internal Transfer is consistent with the Company’s commitment to the separation of Bausch + Lomb and provides the Company with strategic flexibility while it evaluates all relevant factors and considerations relating to the separation of Bausch + Lomb. Further, the Company has engaged Houlihan Lokey and White & Case LLP as financial and legal advisors, respectively, to assist the Company in evaluating potential strategic alternatives.

The separation of Bausch + Lomb is contingent on the expiry of customary lockups related to the initial public offering of Bausch + Lomb, the achievement of targeted debt leverage ratios and the receipt of applicable shareholder and other necessary approvals.

Transactions in connection with share buy-back program

On August 22, 2022 Genmab A/S (Nasdaq: GMAB) reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, AUG 22, 2022, View Source [SID1234618529]).

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The share buy-back program is expected to be completed no later than August 31, 2022 and comprises up to 370,000 shares.

The following transactions were executed under the program from August 15, 2022 to August 19, 2022:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 521,883 shares as treasury shares, corresponding to 0.79% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 22 dated June 17, 2022.