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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 April 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, USA |
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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 April 11, 2023, Connect Biopharma Holdings Limited issued a press release announcing its financial results for the fiscal year ended December 31, 2022. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference. |
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In accordance with General Instruction B of Form 6-K, the information in this report on Form 6-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (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, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing. |
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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: April 11, 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 |
Connect Biopharma Reports Full Year 2022 Financial Results
and Provides Business Update
CDE’s Pre-NDA Feedback Confirms CBP-201 for Atopic Dermatitis on Track
for NDA Submission in China by End of First Quarter 2024
SAN DIEGO and TAICANG, SUZHOU, China – April 11, 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 financial results for the year ended December 31, 2022 and recent corporate highlights.
“Based on feedback from China’s Center for Drug Evaluation (CDE), we are on track with our timeline and look forward to advancing our lead drug candidate CBP-201 for moderate-to-severe atopic dermatitis (AD),” said Chief Executive Officer and Co-founder of Connect Biopharma Zheng Wei, Ph.D. “We plan to submit a New Drug Application (NDA) by the end of the first quarter of 2024, which could lead to potential regulatory approval in China as early as 2025. We also remain encouraged by the CBP-201 results from our China pivotal trial and post-hoc analyses from the global Phase 2b data presented last month at the American Association of Dermatology (AAD) Annual Meeting. We remain confident in the efficacy profile of CBP-201, which showed rapid and sustained improvements and has the potential to be an effective new treatment for AD. Beyond AD, we continue to focus on treating other inflammatory-mediated diseases, including ulcerative colitis and asthma, both of which also have the potential to address large patient populations with persistent unmet medical needs.”
Recent Corporate Highlights
Anticipated Upcoming Milestones
CBP-201 in AD:
CBP-201 in Asthma:
CBP-307 Phase 2 trial in moderate-to-severe Ulcerative Colitis (UC):
2022 Financial Results
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 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 or reporting results or whether such milestones or results 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, the Company’s ability to identify and enter into strategic partnerships as well as the sufficiency of the Company’s cash, cash equivalents, and investments to continue to support operations. 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 April 11, 2023, and its other reports, which are available from the SEC’s website (www.sec.gov) and on Connect Biopharma’s website (www.connectbiopharm.com) under the heading “Investors.” 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. 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.
Connect Biopharma Holdings Ltd.
Condensed Consolidated Statements of Loss (Unaudited)
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Year Ended December 31, |
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2021 |
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2022 |
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2022 |
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RMB’000 |
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RMB’000 |
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USD’000(1) |
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Research and development expenses |
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(518,021 |
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(652,211 |
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(93,646 |
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Administrative expenses |
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(122,445 |
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(139,444 |
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(20,022 |
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Net impairment losses |
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— |
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(32,805 |
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(4,710 |
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Other income |
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18,996 |
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6,438 |
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924 |
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Other (losses)/gains—net |
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(9,966 |
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12,433 |
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1,785 |
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Operating loss |
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(631,436 |
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(805,589 |
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(115,669 |
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Finance income |
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622 |
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10,715 |
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1,538 |
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Finance cost |
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(44 |
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(144 |
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(21 |
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Finance (cost)/income—net |
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578 |
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10,571 |
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1,517 |
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Fair value loss of financial instruments with preferred rights |
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(674,269 |
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— |
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— |
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Net loss before income tax |
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(1,305,127 |
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(795,018 |
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(114,152 |
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Income tax expense |
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(1,697 |
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(2,037 |
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(292 |
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Net loss |
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(1,306,824 |
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(797,055 |
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(114,444 |
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Net loss attributable to: |
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Owners of the Company |
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(1,306,824 |
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(797,055 |
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(114,444 |
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RMB |
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RMB |
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USD |
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Net loss per share |
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Basic and diluted |
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(25.0 |
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(14.5 |
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(2.1 |
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Connect Biopharma Holdings Ltd.
Selected Consolidated Balance Sheet Data (Unaudited)
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As of December 31, |
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2021 |
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2022 |
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2022 |
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RMB’000 |
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RMB’000 |
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USD'000(1) |
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Cash, cash equivalents, short-term and long-term investments |
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1,706,880 |
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1,127,268 |
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161,857 |
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Total assets |
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1,855,659 |
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1,211,930 |
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174,013 |
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Total liabilities |
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119,828 |
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115,060 |
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16,521 |
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Accumulated losses |
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(2,378,165 |
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(3,175,220 |
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(455,908 |
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Total shareholders’ equity |
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1,735,831 |
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1,096,870 |
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157,492 |
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(1) Translations of the selected consolidated balance sheet data and the condensed consolidated statement of loss from RMB into USD as of and for the year ended December 31, 2022, are solely for the convenience of the readers and calculated at the rate of USD1.00=RMB 6.9646, representing the exchange rate as of December 31, 2022, set forth in the China Foreign Exchange Trade System. No representation is made that the RMB amounts could have been, or could be, converted, realized or settled into USD at that rate, or at any other rate, on December 31, 2022, or any other date.
# # #
INVESTOR CONTACT:
Ina McGuinness
805.427.1372
imcguinness@connectpharm.com
MEDIA CONTACT:
Deanne Eagle
917.837.5866
Deanne@mcguinnessIR.com