INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K
On December 30, 2022, Connect Biopharma Holdings Limited (the Company) provided a business and clinical development
program update.
The Company disclosed that it had determined, in light of the current macroeconomic climate and challenging funding
environment, to commence its Global Phase 3 program for CBP-201 in moderate-to-severe atopic dermatitis (AD) after it
has secured the partnership necessary to fully complete the program.
Based on this development, the Company anticipates its cash and
investments will enable it to meet milestones for its ongoing clinical trials and advance its preclinical assets toward the clinic, while it continues to evaluate partnership opportunities.
The status of the Companys pivotal CBP-201 AD trial in China remains on track. In October 2022,
the Company announced positive topline Stage 1 data on the primary analysis population of 255 patients and is currently conducting the 36-week Stage 2 period, which includes a potentially differentiated once a
month dose regimen. The Company expects to have pre-New Drug Application (NDA) interactions with the Center for Drug Evaluation of the Chinese National Medical Products Administration in the first
quarter of 2023 to discuss the Companys CBP-201 data package.
The information in the
paragraphs above under Information Contained in this Report on Form 6-K in this Report on Form 6-K is hereby incorporated by reference into the
Companys Registration Statements on Form F-3 (File No. 333- 264340) and Form S-8 (File No. 333-266006).
On December 30, 2022, the Company issued the press release attached hereto as Exhibit 99.1, which is incorporated herein by reference.
The furnishing of the attached press release is not an admission as to the materiality of any information therein. The information
contained in the press release is summary information that is intended to be considered in the context of more complete information included in the Companys filings with the Securities and Exchange Commission (the SEC) and other
public announcements that the Company has made and may make from time to time. The Company undertakes no duty or obligation to update or revise the information contained in this report, although it may do so from time to time as its management
believes is appropriate. Any such updating may be made through the filing or furnishing of other reports or documents with the SEC or through other public disclosures.
Forward-Looking Statements
The Company
cautions that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as may, could, will, would, should,
expect, plan, anticipate, believe, estimate, intend, predict, seek, contemplate, potential, continue or
project or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Companys expectations with respect to how long its current cash position will
support its operation needs and capital expenditure requirements, the Companys plans to advance the development of its product candidates, the Companys ability to out-license any of its product
candidates or to obtain partnership funding for any of its development programs, the timing of achieving any development or regulatory milestones, and the potential of such product candidates, including to achieve any benefit or profile or any
product approval. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the
risks and uncertainties inherent in the Companys business and other risks described in the Companys filings with the SEC, including the Companys Annual Report on Form 20-F filed with the SEC
on March 31, 2022, and its other reports. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company undertakes no obligation to revise or update this report
to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in the Companys filings with the SEC which are available from the SECs website (www.sec.gov) and on the
Companys website (www.connectbiopharm.com) under the heading Investors. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of
Section 21E of the Private Securities Litigation Reform Act of 1995.