CNTB 8-K
Connect Biopharma Holdings Ltd (CNTB)
8-K
2025-03-31
For: 2025-03-31
View Original
Added on
April 10, 2026
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): March 31, 2025
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(Exact name of Registrant as Specified in Its Charter)
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| (State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | ||||||
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| (Former Name or Former Address, if Changed Since Last Report) | (Zip Code) | |||||||
Registrant’s Telephone Number, Including Area Code: (858 ) 727-1040
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company ☒
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o
Item 2.02 Results of Operations and Financial Condition.
On March 31, 2025, Connect Biopharma Holdings Limited (the “Company”) issued a press release announcing its financial results for the fiscal year ended December 31, 2024. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Item 2.02, including the attached Exhibit 99.1, is being furnished and shall not be deemed “filed” for the 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 into any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such filing.
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: | March 31, 2025 | By: | /s/ Lisa Peraza | ||||||||
| Name: | Lisa Peraza | ||||||||||
| Title: | Vice President, Finance | ||||||||||
Exhibit 99.1
Connect Biopharma Reports 2024 Full-Year Financial Results and Provides Business Update
Strengthened leadership team with key appointments, including Barry Quart, Pharm.D. as CEO, and David Szekeres as President, bringing deep clinical, regulatory, operational and strategic expertise
Unveiled rapid clinical development program for rademikibart initially targeting acute care in asthma and COPD; expect to initiate parallel Phase 2 trials in 2Q 2025 with data expected in 2H 2026
Strong balance sheet with cash runway into 2027 and through key clinical catalysts
SAN DIEGO, March 31, 2025, (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (“Connect Biopharma”, “Connect” or the “Company”), a clinical-stage biopharmaceutical company focused on transforming acute and chronic care in asthma and chronic obstructive pulmonary disease (COPD), today reported financial results for the year ended December 31, 2024, and provided a business update.
“2024 was a transformative year for Connect as we strengthened our leadership team, made significant progress in becoming more U.S.-centric, and unveiled a rapid clinical development strategy for rademikibart initially focused on the treatment of acute asthma and COPD exacerbations, an area where no biologic therapies have been approved. To date, rademikibart has demonstrated a differentiated clinical profile in Phase 2 clinical trials achieving rapid improvement in pulmonary function in less than 24 hours, which was sustained through 24 weeks, highlighting its potential in both acute and chronic care,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We are on track to initiate parallel Phase 2 trials of rademikibart as an adjunct to standard of care for the treatment of acute asthma and COPD exacerbations in the second quarter of 2025, with data expected in the second half of 2026. We believe rademikibart has the potential to fundamentally alter the treatment paradigm for millions of asthma and COPD patients who experience acute exacerbations every year.”
Recent Highlights
Clinical Program Highlights
•Parallel acute exacerbation trials of rademikibart as an adjunct to standard of care in asthma and COPD are on track to be initiated in the second quarter of 2025, with data expected in the second half of 2026.
Corporate Highlights
•The Company continued making progress in becoming more U.S.-centric, including by:
oassembling an experienced U.S. management team with deep expertise in drug development and regulatory execution, including having collectively received U.S. Food and Drug Administration (FDA) marketing approval for 16 therapeutic
products, and with deep expertise in business development, corporate strategy, finance and operations;
orelocating its corporate headquarters to San Diego, California, a leading global hub for innovative biopharmaceutical companies;
otransferring the initial manufacturing process for rademikibart to a U.S.-based contract manufacturing organization; and
otransitioning to a U.S.-based independent registered accounting firm and voluntarily electing to become a domestic filer with the U.S. Securities and Exchange Commission (SEC), beginning with the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and on an ongoing basis with the regular filing of Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
Financial Results for the Year Ended December 31, 2024
•Cash, cash equivalents and short-term investments were $93.7 million as of December 31, 2024. Based on its current operating plans, the Company expects that its cash, cash equivalents and short-term investments will be sufficient to fund operations into 2027.
•Revenue for the year ended December 31, 2024, totaled $26.0 million, which included revenue recognized for the upfront fee, development milestones and cost reimbursements in connection with the license agreement with Simcere Pharmaceutical Co., Ltd. There was no comparable activity for the year ended December 31, 2023.
•Research and Development expense for the year ended December 31, 2024, was $29.3 million, compared with $53.0 million for the same period in 2023, a decrease of $23.7 million. The decrease in Research and Development expense was primarily due to the completion in late 2023 of the rademikibart global Phase 2b program in patients with chronic asthma and the rademikibart China pivotal trials for patients with atopic dermatitis.
•General and Administrative expense for the year ended December 31, 2024, was $19.2 million, compared with $16.1 million for the same period in 2023, an increase of $3.1 million. The increase in General and Administrative expense was primarily due to costs associated with executive departures, including cash severance and non-cash, share-based compensation expense related to certain stock option modifications.
•Net loss was $15.6 million, or $0.28 per share, for the year ended December 31, 2024, compared with a net loss of $62.1 million, or $1.13 per share, for the same period in 2023.
About Connect Biopharma and Rademikibart
Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody. With an initial focus on acute exacerbations—an area with significant unmet need—rademikibart has the potential to also drive chronic utilization in asthma and COPD amongst the millions of asthma and COPD patients in the U.S. who experience acute exacerbations annually. In a Phase 2 trial for asthma, rademikibart demonstrated strong efficacy and safety, with clinically meaningful reductions in exacerbations and rapid, statistically significant improvements in forced expiratory volume in one second, observed within one week—and in most cases, within 24 hours via home spirometry. For more information, visit www.connectbiopharm.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the “Act”). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our cash balance, financial guidance, future financial and operating results and related expectations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, and adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the timing and amount of actual expenses, including, without limitation, our anticipated combined U.S. GAAP R&D and G&A expenses; the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we will need expanded or additional trials in order to obtain regulatory approval for our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the People’s Republic of China, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community.
Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these
identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. 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 are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements.
This press release discusses product candidates that are under clinical study, and which have not yet been approved for marketing by the FDA or by any other regulatory agency. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.
Connect Biopharma Holdings Limited
Condensed Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
| Years Ended December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Revenue: | |||||||||||
| License and collaboration revenues | $ 26,033 | $ - | |||||||||
| Total revenue | 26,033 | - | |||||||||
| Operating expenses: | |||||||||||
| Research and development expense | 29,256 | 53,002 | |||||||||
| General and administrative expense | 19,229 | 16,054 | |||||||||
| Total operating expenses | 48,485 | 69,056 | |||||||||
| Loss from operations | (22,452) | (69,056) | |||||||||
| Total other income, net | 7,047 | 7,070 | |||||||||
| Net loss before income tax | (15,405) | (61,986) | |||||||||
| Income tax expense | 223 | 120 | |||||||||
| Net loss | $ (15,628) | $ (62,106) | |||||||||
| Basic and diluted net loss per ordinary share | $ (0.28) | $ (1.13) | |||||||||
| Weighted-average ordinary shares outstanding, basic and diluted | 55,213 | 55,067 | |||||||||
Connect Biopharma Holdings Limited
Condensed Consolidated Balance Sheet Data
(in thousands)
(unaudited)
| December 31, | |||||||||||
| 2024 | 2023 | ||||||||||
| Cash, cash equivalents and short-term investments | $ 93,708 | $ 118,303 | |||||||||
| Total assets | $ 101,284 | $ 127,375 | |||||||||
| Total shareholders' equity | $ 92,166 | $ 101,497 | |||||||||
Investor Relations Contact:
Alex Lobo
Precision AQ
(212) 698-8802
Media Contact:
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
[email protected]
[email protected]
(858) 717-2310 or (646) 942-5604
Russo Partners, LLC
[email protected]
[email protected]
(858) 717-2310 or (646) 942-5604