Entry into a Material Definitive Agreement

On January 31, 2023 CASI Pharmaceuticals, Inc. (the "Company") and CASI Pharmaceuticals Holdings, Inc., an exempted company incorporated under the laws of the Cayman Islands and a wholly owned subsidiary of the Company ("CASI Cayman") entered into a definitive agreement and plan of merger (the "Merger Agreement") related to a proposed merger transaction (Filing, 8-K, CASI Pharmaceuticals, JAN 31, 2023, View Source [SID1234626673]). The Merger Agreement provides that, upon the terms and subject to the conditions set forth therein, the Company will merge with and into CASI Cayman (the "Redomicile Merger"), with CASI Cayman surviving and changing its name to CASI Pharmaceuticals, Inc. Following the Redomicile Merger, CASI Cayman, together with its subsidiaries, will own and continue to conduct the Company’s business in substantially the same manner as is currently being conducted by the Company and its subsidiaries.

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Subject to the terms and conditions of the Merger Agreement, upon completion of the Redomicile Merger, each share of common stock of the Company issued and outstanding immediately prior to the effective time of the Redomicile Merger (the "Effective Time") will be converted into the right to receive one ordinary share of CASI Cayman, credited as fully paid.

At the Effective Time, all existing equity compensation plans of the Company, as may be amended, will be adopted and assumed by CASI Cayman. Each outstanding option and other equity award issued under the equity compensation plans of the Company for the purchase or receipt of, or payment based on, each share of the Company’s common stock will represent the right to purchase or receive, or receive payment based on, one ordinary share in the capital of CASI Cayman on substantially the same terms. In addition, as part of the Redomicile Merger, CASI Cayman has agreed to assume all of the Company’s rights and obligations of any warrant, convertible debentures or other convertible securities that may convert in the Company’s common stock. All rights to purchase or receive, or receive payment based on, each share of the Company’s common stock arising under the Company’s warrants, convertible debentures or other convertible securities will entitle the holder thereof to purchase or receive, or receive payment based on, as applicable, one ordinary share of CASI Cayman.

At the Effective Time, the obligations of the Company under or with respect to every plan, trust, program and benefit then in effect or administered by the Company for the benefit of the directors, officers and employees of the Company or any of its subsidiaries will become the obligations of CASI Cayman and will be implemented and administered in the same manner and without interruption until the same are amended or otherwise altered or terminated.

Additionally, at the Effective Time, CASI Cayman will adopt and assume the obligations of the Company under or with respect to certain contracts or agreements as described in the Merger Agreement. The contracts and agreements will become the obligations of CASI Cayman and will be performed in the same manner and without interruption until the same are amended or otherwise lawfully altered or terminated.

The Merger Agreement contains customary closing conditions, including, among others, approval of the Redomicile Merger by the Company’s stockholders, the effectiveness of the registration statement on Form F-4 to be filed by CASI Cayman related to the Redomicile Merger and receipt of required regulatory approvals.

The consent of the holders of a majority of the outstanding shares of the Company’s common stock entitled to vote is required to approve and adopt the Merger Agreement. The board of directors of the Company believes that the Redomicile Merger, to be effected by the Merger Agreement, is advisable and in the best interests of the Company and its stockholders.

Pursuant to the Merger Agreement, the board of directors of the Company may exercise its discretion to terminate the Merger Agreement, and therefore abandon the Redomicile Merger, at any time prior to the Effective Time, including after the adoption of the Merger Agreement by the Company’s stockholders.

Upon the Effective Time, the director and officer nominees set forth in the plan of merger attached to the Merger Agreement shall be appointed as the directors and offciers of the suriving company of the Redomicile Merger.

The Merger Agreement has been approved by the board of directors of the Company and the sole director of CASI Cayman. Subject to the required approval of the Company’s stockholders, requisite regulatory approvals, the effectiveness of the registration statement on Form F-4 to be filed by CASI Cayman related to the Redomicile Merger, and other customary closing conditions, the Redomicile Merger is expected to be completed during the first quarter of 2023.

The foregoing summary of the Merger Agreement does not purport to be complete and is qualified in its entirety by reference to the complete text of the Merger Agreement, which is attached hereto as Exhibit 2.1, and is incorporated herein by reference.

Additional information about the Redomicile Merger and where to find it

In connection with the proposed Redomicile Merger, CASI Cayman will file with the United States Securities and Exchange Commission (the "SEC") a registration statement on Form F-4 to register the ordinary shares of CASI Cayman to be issued to the stockholders of the Company. The registration statement will include a proxy statement/prospectus of the Company which will be sent to the stockholders of the Company seeking their approval of the Redomicile Merger and related matters in addition to other matters. In addition, the Company may file other relevant documents concerning the proposed Redomicile Merger with the SEC.

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. Stockholders of the Company are urged to read the registration statement on Form F-4 and the proxy statement/prospectus included within the registration statement and any other relevant documents to be filed with the SEC in connection with the proposed Redomicile Merger because they will contain important information about the Company, CASI Cayman and the proposed transaction.

Bellicum Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On January 31 , 2023 Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in developing novel, controllable cellular immunotherapies for cancers, reported equity inducement grants to 1 new employee consisting of an aggregate of 45,000 stock options (Press release, Bellicum Pharmaceuticals, JAN 31, 2023, View Source [SID1234626672]). The Compensation Committee of the Board of Directors approved the grants with an effective date of January 31, 2023. The stock options were granted as inducements material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

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The stock options have an exercise price of $1.14 per share and vest over four years, with 25% of the shares vesting on the one-year anniversary of the applicable vesting commencement date and 1/48 of the shares vesting monthly thereafter, subject to the new employee’s continued service relationship with the Company. The stock options are subject to the terms and conditions of the Company’s 2019 Equity Incentive Plan and a stock option agreement covering the grant.

Entry into a Material Definitive Agreement.

On January 31, 2023 BeiGene, Ltd. (the "Company") reported that it has entered into a Share Purchase Agreement dated October 31, 2019, as amended, by and between the Company and Amgen Inc. ("Amgen") pursuant to which, among other things, (i) the Company issued 206,635,013 ordinary shares in the form of 15,895,001 American Depositary Shares ("ADSs"), to Amgen for aggregate gross proceeds of approximately $2.78 billion, and (ii) subject to certain qualifications, the Company granted Amgen the right to appoint a designated director to the Company’s board of directors (such agreement, the "Share Purchase Agreement") (Filing, 8-K, BeiGene, JAN 31, 2023, View Source [SID1234626671]). On January 30, 2023, on account of the Company’s global growth, Amgen elected to relinquish its right to appoint a designated director to the Company’s board of directors, pursuant to an Amendment No. 3 to the Share Purchase Agreement (the "Amendment"). The Company will retain Anthony C. Hooper, who was Amgen’s director designee on the Company’s board of directors until Amgen relinquished its right to appoint a designated director. Mr. Hooper was most recently re-elected by shareholders in 2022 to serve a three-year term ending 2025.

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The foregoing description of the terms of the Amendment does not purport to be complete and is qualified in its entirety by reference to the full text of the agreement, which the Company intends to file as an exhibit to a subsequent periodic report or on an amendment to this Current Report on Form 8-K.

Artiva Biotherapeutics Receives FDA Fast Track Designation for AB-101

On January 31 2023 Artiva Biotherapeutics, Inc., a clinical stage company whose mission is to deliver highly effective, off-the-shelf, allogeneic natural killer (NK) cell-based therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Artiva’s lead program AB-101 (Press release, Artiva Biotherapeutics, JAN 31, 2023, View Source [SID1234626670]).

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"We are excited to announce this advantageous regulatory designation as we continue our clinical evaluation of the AB-101/rituximab combination in the treatment of relapsed/refractory B-cell NHL, including in patients who have failed prior CAR-T treatment," said Thorsten Graef, M.D., Chief Medical Officer of Artiva. "We are encouraged by the early clinical data we are seeing with AB-101 and look forward to expanding its evaluation in this indication as well as with additional biologic therapy combinations through internal and partnered clinical programs."

"We are committed to our mission of delivering AB-101 as an off-the-shelf cell therapy with an efficacy and tolerability profile suitable for administration and management in the community setting," stated Fred Aslan, M.D., Chief Executive Officer of Artiva. "Given the maturity of our highly scalable manufacturing process, we believe we are well positioned to pursue a first-in-class allogeneic NK cell therapy registration in either non-Hodgkin lymphoma in combination with rituximab, or in Hodgkin lymphoma in combination with Affimed’s AFM13."

About AB-101

AB-101 is a non-genetically modified, cord blood-derived, allogeneic, cryopreserved, ADCC-enhancing NK cell therapy candidate for use in combination with monoclonal antibodies or innate-cell engagers in the out-patient setting. Artiva selects cord blood units with the high affinity variant of the receptor CD16 and a KIR-B haplotype for enhanced product activity. Using the Company’s AlloNKTM platform, Artiva can generate thousands of doses of pure, cryopreserved, infusion-ready NK cells from a single umbilical cord blood unit while retaining the high and consistent expression of CD16 and other tumor-engaging receptors, without the need for engineering. We believe this makes AB-101 an optimal adjunct therapy to targeted, ADCC-mechanistic biologics.

Artiva is conducting a Phase 1/2 multicenter clinical trial (ClinicalTrials.gov Identifier: NCT04673617) to assess the safety and clinical activity of AB-101 alone and in combination with the anti-CD20 monoclonal antibody, rituximab, in patients with relapsed or refractory B-cell-non-Hodgkin lymphoma (NHL) who have progressed beyond two or more prior lines of therapy including CAR-T therapy. This study is progressing at multiple clinical sites across the U.S. and AB-101 is administered weekly in the out-patient setting over one month cycles and with up to four cycles to assess therapeutic efficacy and durability. Artiva is also collaborating with Affimed N.V. in developing a combination therapy comprised of AB-101 and the Innate Cell Engager AFM13, for the treatment of patients with relapsed/refractory CD30-positive lymphomas.

About Fast Track Designation

Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fulfill an unmet medical need, enabling drugs to potentially reach patients earlier. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

8-K – Current report

On January 31, 2023 Adaptimmune Therapeutics plc ("Adaptimmune") reported that it has received notice of termination of the Amended and Restated Research Collaboration and License Agreement Relating to Gene Editing and HLA Engineering Technology dated January 13, 2020 between Universal Cells, Inc. ("Universal Cells") and Adaptimmune Limited ("Agreement") (Filing, 8-K, Adaptimmune, JAN 31, 2023, View Source [SID1234626669]). Termination of the Agreement is effective 30 days following the receipt of notice of termination. Termination follows Adaptimmune’s decision to change the cell line being used to develop its MAGE-A4 allogeneic cell therapy due to the presence of a chromosomal abnormality in the original cell line provided by Universal Cells under the Agreement. As a result of termination, all licenses between the parties to the Agreement will cease and each party is requried to return all confidential information of the other party. A separate Collaboration and License Agreement dated January 13, 2020 for the co-development and co-commercialisation of allogeneic T-cell therapies remains ongoing between the parties.

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