UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
 
FORM 6-K
 
 
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
 
Date of Report: December 8, 2022
 
Commission File Number: 001-39307
 
 
Legend Biotech Corporation
(Exact Name of Registrant as Specified in its Charter)


 
2101 Cottontail Lane
Somerset, New Jersey 08873
(Address of principal executive office)


Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
 
Form 20-F  ☒            Form 40-F  ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

Legend Biotech Reports Updated Pipeline of Product Candidates

Legend Biotech Corporation (the “Company”) is updating its pipeline of product candidates, as set forth in Exhibit 99.1.

This Form 6-K, including Exhibit 99.1 hereto, is hereby incorporated by reference into the Registration Statements of the Company on Form F-3 (File Nos. 333-257625 and 333-257609) and the Company’s Registration Statement on Form S-8 (File No. 333-239478).
 
Cautionary Note Regarding Forward-Looking Statements

Statements in this report on Form 6-K about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the Company’s strategies and objectives; statements relating to CARVYKTI®, including the Company’s expectations for CARVYKTI®; statements about submissions for cilta-cel to, and the progress of such submissions with, the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the Chinese Center for Drug Evaluation of National Medical Products Administration (CDE) and other regulatory authorities; and statements about the Company’s pre-clinical and clinical product candidates, such as the anticipated timing of, and our ability to progress, pre-clinical projects and clinical trials, the submission of Investigational New Drug (IND) applications to, and maintenance of such applications with, regulatory authorities, the ability to generate, analyze and present data from clinical trials, and potential indications for, and benefits of, the Company’s product candidates. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. The Company’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to the Company’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general public pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of the Company’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2022. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this Form 6-K as anticipated, believed, estimated or expected. Any forward-looking statements contained in this Form 6-K speak only as of the date of this Form 6-K. The Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.



EXHIBIT INDEX

Exhibit        Title

99.1              Pipeline


SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
 
 
LEGEND BIOTECH CORPORATION
 
 
 
 
 
Date: December 8, 2022
By:
/s/ Ying Huang
 
 
Name:
Ying Huang, Ph.D.
 
 
Title:
Chief Executive Officer
 

Exhibit 99.1


 Preclinical  Phase 1  GASTRIC, ESOPHAGEAL & PANCREATICt  (CLAUDIN 18.2)  Auto logous NCT04467853  RRMM (BCMA)  LEGEND-2t  Auto logous NCT03090659  IGlobal  IUS I  China  Phase 2  MMt  (BCMA)  Al logeneic - CAR-NK NCT05498545  MMt  (BCMA)  A llogeneic - CAR-yo T NCT05376345  NHLt /ALLt  (CD19 X CD20 X CD22}t  Auto logous NCT05318963 NCT05292898  Hect  (GPC3)  Auto logous NCT05352542  The safety and efficacy of the agents and/or uses under investigation have not been established.  There is no assurance that the agents will receive health authority approval or become commercially available in any country for the uses being investigated. Additionally, as some programs are still confidential, certain candidates may not be included in this list.  *In collaboration with Janssen, Pharmaceutical Companies of Johnson & Johnson. tPhase 1 llT in China.  :t:IND applications have been cleared by the U.S. FDA.  ALL, acute lymphoblastic leukemia; AML, acute myeloid leukemia; BCMA, B-cell maturation antigen; DLL3, delta-like ligand 3; GPC3, glypican-3; GCC, guanylyl cyclase C; HCC, hepatocellular carcinoma; llT, investigator-initiated trial; MM, multiple myeloma; ND, newly diagnosed; NHL, non-Hodgkin lymphoma; NSCLC, non small cell lung cancer; RRMM, relapsed or refractory multiple myeloma; SCLC, small cell lung cancer.  Phase 3  RRMM (BCMA)*  1-3 Prior Lines CARTITUDE-4  Autologous NCT04181827  NDMM (BCMA)*  Transplant Not Intended CARTITUDE-5  Autologous NCT04923893  NDMM (BCMA)*  Transplant Eligible CARTITUDE-6  Autologous NCT05257083  GASTRIC, ESOPHAGEAL & PANCREATIC*  (CLAUDIN 18.2)  Autologous  SCLC*  (DLL3)  Autologous  NSCLC  (GPC3)  Auto logous  COLORECTAL  (GCC)  A utologous  AML  (CLL 1/CD33 )  A llogeneic  RRMM (BCMA)*  CARTIFAN-1  Auto logous NCT03758417  RRMM (BCMA)*  CARTITUDE-1  Auto logous NCT03548207  MM (BCMA)*  CARTITUDE-2  Auto logous NCT04133636