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UNITED STATES |
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SECURITIES AND EXCHANGE COMMISSION |
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Washington, D.C. 20549 |
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FORM 6-K |
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REPORT OF FOREIGN PRIVATE ISSUER |
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PURSUANT TO RULE 13a-16 OR 15d-16 |
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UNDER THE SECURITIES EXCHANGE ACT OF 1934 |
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For the month of February 2023 |
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Commission File Number: 001-40212 |
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Connect Biopharma Holdings Limited |
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(Translation of registrant's name into English) |
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12265 El Camino Real, Suite 350 |
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San Diego, CA 92130 |
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(Address of principal executive office) |
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Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F. |
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Form 20-F ☒ Form 40-F ☐ |
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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): ☐ |
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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 |
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On February 9, 2023, Connect Biopharma Holdings Limited (the “Company”) reported that its CBP-201 Phase 2 global trial in patients with moderate-to-severe asthma with Type 2 inflammation has reached its full targeted enrollment of 306 patients. |
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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 to be incorporated by reference into the Company's Registration Statements on Form F-3 (File No. 333-264340) and Form S-8 (File No. 333-266006). |
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On February 9, 2023, the Company issued the press release attached hereto as Exhibit 99.1, which is incorporated herein by reference. |
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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 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. |
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Forward-Looking Statements |
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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, and the potential of such product candidates, including to achieve any benefit or profile or any product approval or be effective. 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 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 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 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. |
Exhibit Index |
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Exhibit No. |
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Description |
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99.1 |
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SIGNATURES |
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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. |
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Dated: February 9, 2023 |
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CONNECT BIOPHARMA HOLDINGS LIMITED |
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By |
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/s/ Steven Chan |
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Name: |
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Steven Chan |
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Title: |
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Chief Financial Officer |
Exhibit 99.1
Connect Biopharma Reports CBP-201 Global Phase 2 Asthma Trial Achieves Full Enrollment
SAN DIEGO and TAICANG, SUZHOU, China – February 9, 2023 – Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma or the Company), a global clinical-stage biopharmaceutical company developing T cell-driven therapies to treat inflammatory diseases, today announced that its CBP-201 Phase 2 global trial in patients with moderate-to-severe asthma with Type 2 inflammation (WW002) has reached its full targeted enrollment of 306 patients.
“We are pleased that we have reached the full targeted enrollment in the Phase 2 global clinical trial of our lead candidate, CBP-201 in its second indication, asthma,” said Chief Medical Officer of Connect Biopharma, Chin Lee, MD, MPH. “We continue to believe that CBP-201 could be an extremely effective new treatment for asthma and other Type 2 inflammatory diseases, such as atopic dermatitis, where CBP-201 is currently in an ongoing pivotal clinical trial in China.”
The CBP-201 Phase 2 global study is a multicenter, randomized, double-blind, parallel group, placebo-controlled study to assess the efficacy and safety of two dose levels of CBP-201 administered to eligible patients with moderate-to-severe persistent asthma with Type 2 inflammation compared to placebo. CBP-201 is administered as a subcutaneous (SC) injection. The study is divided into a treatment period of 24 weeks and a follow-up period of 8 weeks. The primary endpoint of the study is a change from baseline in forced expiratory volume (FEV1) at week 12. Secondary endpoints include: Change from baseline in lung function at other timepoints, exacerbation of asthma, patient reported outcomes (ACQ-6, symptom diary), phamacodynamic markers (FENO, eosinophils, ECP, periostin, TARC) and use of rescue medication.
About Connect Biopharma Holdings Limited
Connect Biopharma is a global, clinical-stage biopharmaceutical company applying its expertise in T cell biology and deep knowledge of the drug discovery industry to develop innovative therapies to treat chronic inflammatory diseases with the goal of improving the lives of millions of those affected around the world. The Company is building a rich pipeline of proprietary small molecules and antibodies, using functional T cell assays, to screen and discover potent product candidates against validated immune targets. The Company’s lead product candidate, CBP-201, is an antibody designed to target interleukin-4 receptor alpha (IL-4Rα) in development for the treatment of atopic dermatitis (AD) and asthma. The Company’s second most advanced product candidate, CBP-307, is a modulator of S1P1 T cell receptor and is in development for the treatment of ulcerative colitis (UC). The Company’s third product candidate, CBP-174, is a peripherally acting antagonist of histamine receptor 3, in development for the treatment of pruritus associated with AD.
For more information, please visit: https://www.connectbiopharm.com/
Forward-Looking Statements
Connect Biopharma cautions that statements included in this press release 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, and the potential of such product candidates, including to achieve any benefit or profile or any product approval or be effective. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma 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 Company’s business and other risks described in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s 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 Connect Biopharma undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included in Connect Biopharma’s filings with the SEC which are available from the SEC’s website (www.sec.gov) and on Connect Biopharma’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.
# # #
INVESTOR CONTACT:
Ina McGuinness
805.427.1372
imcguinness@connectpharm.com
MEDIA CONTACT:
Deanne Eagle
917.837.5866
Deanne@mcguinnessIR.com