Report of Foreign Issuer Pursuant to Rule 13a-16 or 15d-16 (6-k)

 

	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
	UNDER THE SECURITIES EXCHANGE ACT OF 1934
	For the month of June 2023
	Commission File Number: 001-40212
	Connect Biopharma Holdings Limited
	(Translation of registrant's name into English)
	12265 El Camino Real, Suite 350
	San Diego, CA 92130, USA
	(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): ☐

 

 

 

 

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INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

On June 1, 2023, Connect Biopharma Holdings Limited (the “Company”) announced positive long-term data through Week 48 of CN002 Phase 2 trial for icanbelimod (formerly known as CBP-307) in patients with moderate-to-severe ulcerative colitis.

CN002 Phase 2 trial for icanbelimod (formerly known as CBP-307) is a once-daily, orally administered, selective sphingosine 1-phosphate receptor 1 (S1P1) modulator in development for the treatment of ulcerative colitis. The maintenance period of CN002 was a 36-week treatment period that followed the 12-week induction period (N=145), where icanbelimod 0.2 mg, was administered orally once daily (PO QD). In the induction period, icanbelimod showed statistically significant improvements in clinical remission and response compared to placebo, and a numerical improvement in change from baseline in adapted Mayo score. During the maintenance period, icanbelimod demonstrated sustained clinical remission through Week 48 in 80% of patients who achieved clinical remission at Week 12 of the induction period, and icanbelimod continued to be well-tolerated, consistent with observed induction period safety data. Most treatment emergent adverse events were mild to moderate in severity with no new safety signals noted.

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 Company’s Registration Statements on Form F-3 (File No. 333-264340) and Form S-8 (File Nos. 333-254524 and 333-266006).

On June 1, 2023, the Company issued the press release attached hereto as Exhibit 99.1, which is incorporated herein by reference.

The furnishing of the attached press releases is not an admission as to the materiality of any information therein. The information contained in the press releases is summary information that is intended to be considered in the context of more complete information included in the Company’s 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 Company’s plans to advance the development of its product candidates, the timing of achieving any development or regulatory milestones or reporting data or whether such milestones or data will be achieved or generated, the potential of such product candidates, including to achieve any benefit, improvement, differentiation or profile or any product approval or be effective, and the Company’s ability to identify and enter into a strategic partnership. 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 data may differ materially from those set forth in this release due to the risks and uncertainties inherent in the Company’s business and other risks described in the Company’s filings with the SEC, including the Company’s Annual Report on Form 20-F filed with the SEC on April 11, 2023, 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

 

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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 Company’s filings with the SEC which are available from the SEC’s website (www.sec.gov) and on the Company’s 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.

 

 

 

 

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Exhibit Index
Exhibit No.		Description
99.1		Press Release issued on June 1, 2023: Connect Biopharma Announces Positive Long-Term Data from the Maintenance Period Through Week 48 of CN002 Phase 2 Icanbelimod Trial in Patients with Moderate-to-Severe Ulcerative Colitis

 

 

 

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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.

 

Dated: June 1, 2023
		CONNECT BIOPHARMA HOLDINGS LIMITED
		By		/s/ Steven Chan
				Name:		Steven Chan
				Title:		Chief Financial Officer

 

 

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