Connect Biopharma Holdings Limited filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits
$CNTB
Biotechnology: Pharmaceutical Preparations
Health Care
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 1, 2025
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Item 7.01 Regulation FD Disclosure.
On April 1, 2025, Connect Biopharma Holdings Limited (the “Company”) issued a press release announcing positive feedback from its Type C meeting with the U.S. Food and Drug Administration (“FDA”), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation (the “Type C Meeting”). A copy of the press release is filed herewith as Exhibit 99.1 and is incorporated herein by reference. The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is intended to be furnished and 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, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
Based on advice from the FDA at the Type C Meeting, the Company plans to begin enrolling patients in parallel Phase 2 trials of rademikibart in patients with moderate-to-severe asthma or chronic obstructive pulmonary disease (“COPD”) experiencing an acute exacerbation during the second quarter of 2025.
The two parallel Phase 2 randomized, double-blind, placebo-controlled trials are expected to each enroll approximately 160 patients and include patients with uncontrolled, moderate-to-severe asthma or COPD with eosinophils ≥300 cells/µL who are experiencing an acute exacerbation. The trials are designed to evaluate the benefits of a single 600 mg subcutaneous dose of rademikibart in patients over 28 days following an acute exacerbation. The Company expects to report data from both rademikibart Phase 2 trials in the first half of 2026.
Forward-Looking Statements
This disclosure, including the press release furnished herewith as Exhibit 99.1, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Current Report on Form 8-K. Forward-looking statements contained herein include, but are not limited to, statements regarding the Company’s strategy and plans, the potential clinical effects, benefits, safety and efficacy of rademikibart, the timing, nature and significance of enrollment and data from the Company’s trials evaluating rademikibart, the timing of any further releases of data or of any presentations or investor conference calls, the Company’s plans and expectations for its asthma and COPD program, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by the Company’s competitors; changes in expected or existing competition; delays in or disruptions to the Company’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements herein are discussed in the Company’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein, including in our annual report on Form 10-K for the year ended December 31, 2024, and any subsequent filings with the SEC. Except as required by law, the Company assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
| 99.1 | ||||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
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 hereunto duly authorized.
| CONNECT BIOPHARMA HOLDINGS LIMITED | |||||||||||
| Date: | April 1, 2025 | By: | /s/ David Szekeres | ||||||||
| Name: | David Szekeres | ||||||||||
| Title: | President | ||||||||||