BEIGENE, LTD. (NASDAQ:BGNE) Files An 8-K Regulation FD Disclosure
Item 7.01. Regulation FD Disclosure.
BeiGene, Ltd. (the “Company” or “BeiGene”) hosted an investor conference call and webcast of mid-2019 clinical data updates on June 20, 2019. A copy of the Company’s presentation used during the conference call and webcast is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein. The information in Item 7.01 of this Current Report on Form 8-K, including the presentation, is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing or this Current Report.
Item 8.01. Other Events.
On June 18, 2019, the Company issued a joint press release with SpringWorks Therapeutics, Inc. (“SpringWorks”) announcing the formation of MapKure, LLC (“MapKure”), a newly created entity that is jointly owned by the Company and SpringWorks. MapKure intends to develop BGB-3245, an investigational, oral, selective small molecule inhibitor of monomer and dimer forms of activating B-RAF mutations including V600 BRAF mutations, non-V600 B-RAF mutations, and RAF fusions. These mutations and fusions have been identified in a number of solid tumors to be drivers of cancer growth, including in non-small cell lung cancer, colorectal cancer, thyroid cancer, and brain tumors. BGB-3245 was discovered by BeiGene scientists and is currently in preclinical development. Under the terms of the agreements, SpringWorks has made an equity investment into MapKure and BeiGene has contributed an exclusive royalty and milestone-bearing license to develop and commercialize BGB-3245 outside of Asia, but including rights to Japan, in exchange for a majority ownership position in MapKure. MapKure will form a joint steering committee that will oversee clinical development and operations for BGB-3245, as well as a Board of Directors. Both the joint steering committee and the Board will include members from BeiGene, SpringWorks and MapKure’s CEO. Further terms of the agreements were not disclosed. The full text of this press release is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
On June 19, 2019, the Company issued a press release announcing the results from two ongoing clinical studies of its investigational BTK inhibitor zanubrutinib in patients with mantle cell lymphoma (MCL) in two presentations at the 15th International Conference on Malignant Lymphoma (ICML), taking place June 18-22, 2019 in Lugano, Switzerland. The full text of this press release is filed as Exhibit 99.3 to this Current Report on Form 8-K and is incorporated herein by reference.
On June 20, 2019, the Company issued a press release announcing results from an ongoing pivotal Phase 2 clinical study of its investigational BTK inhibitor zanubrutinib being conducted in China in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in an oral presentation at the ICML. The full text of this press release is filed as Exhibit 99.4 to this Current Report on Form 8-K and is incorporated herein by reference.
On June 20, 2019, the Company issued a press release announcing results from an ongoing Phase 1b clinical study of its investigational BTK inhibitor zanubrutinib in combination with GAZYVA®>(obinutuzumab) in patients with R/R or treatment naïve CLL or SLL, and patients with R/R follicular lymphoma (FL). These data were included in an oral presentation at the ICML. The full text of this press release is filed as Exhibit 99.5 to this Current Report on Form 8-K and is incorporated herein by reference.
In connection with the conference call and webcast described above under Item 7.01, the Company provided an update on the enrollment status of tislelizumab’s development programs as set forth on Page 7 of Exhibit 99.1, which is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
BeiGene, Ltd. Exhibit
EX-99.1 2 a991bgnemid19confwrapup2.htm EXHIBIT 99.1 a991bgnemid19confwrapup2 Exhibit 99.1 BeiGene Mid-Year 2019 Clinical Data Wrap-Up June 20,…
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About BEIGENE, LTD. (NASDAQ:BGNE)
BeiGene, Ltd. is a biopharmaceutical company. The Company is engaged in the discovery and development of molecularly targeted and immuno-oncology drugs for the treatment of cancer. It is developing its product candidate, BGB-3111, a potent and selective small molecule Bruton’s tyrosine kinase (BTK) inhibitor, as a monotherapy and in combination with other therapies for the treatment of a range of lymphomas. It is developing its product candidate, BGB-A317, a humanized monoclonal antibody against the immune checkpoint receptor programmed cell death protein 1 (PD-1), as a monotherapy and as a combination agent for various solid-organ and blood-borne cancers. It is developing BGB-290, a molecularly targeted, orally available, potent and selective inhibitor of poly ADP ribose polymerase 1 (PARP1) and PARP2, as a monotherapy and in combination with other therapies for the treatment of homologous recombination deficient cancers. It is also developing BGB-283 for the treatment of cancers.
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