Connect Biopharma Holdings Ltd
For the period ended Jun 30, 2025. Filed Aug 13, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Jun 30, 2025 · Filed Aug 13, 2025
CNTB$0.73-0.4%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001835268-25-000035
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-13.
0001835268-25-000052
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 54 previous paragraphs and 59 current paragraphs.
38 unchanged; 11 reworded; 10 added; 5 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 1 previous and 1 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (10)
Current report
During the second quarter of 2025, we presented clinical and preclinical data supporting the development of rademikibart at the American Thoracic Society 2025 International Conference and the European Academy of Allergy and Clinical Immunology 2025 Annual Congress. In this data, rademikibart was observed to significantly improve airway function, as measured by forced expiratory volume in one second, within a day and significantly reduce acute exacerbations in patients with inflammation-mediated chronic asthma, which we believe strongly supports ongoing Phase 2 acute exacerbation studies in asthma and COPD. We expect to report topline data for our ongoing Phase 2 acute exacerbation studies in the first half of 2026. In addition, we believe that the preclinical data presented demonstrates rademikibart’s differentiated structural and molecular dynamics, including potentially enhanced IL-4Rα inhibition compared to dupilumab. These findings provide a molecular basis for the distinct efficacy and safety data observed with rademikibart.
Current report
In July 2025, we announced that the Company’s collaborator and exclusive licensee in China, Simcere, had submitted its New Drug Application for rademikibart to the National Medical Products Administration of China for the treatment of AD in adults and adolescents. As part of our License Agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately $110 million upon the achievement of certain development, regulatory and commercial milestones. We are also eligible to receive royalties at tiered percentage rates up to low double-digit percentages on net sales in Greater China. The AD market in China represents considerable opportunity, with an estimated 70 million patients with AD.
Current report
In July 2025, we announced our plans to terminate the Deposit Agreement dated March 18, 2021, as amended, among the Company, Deutsche Bank Trust Company Americas (the “Depositary”), and the holders and beneficial owners of ADSs evidenced by ADRs issued thereunder (the “Deposit Agreement”). The ADR program and the Deposit Agreement are expected to terminate on or about September 2, 2025. At such time, the Company’s ADRs will be mandatorily cancelled and exchanged for ordinary shares at a one-for-one ratio. Immediately following the termination of the ADR program, we plan to list our ordinary shares on Nasdaq in substitution for our ADSs. Upon the effectiveness of the Substitution Listing, our ADSs will cease to be listed on Nasdaq and the ordinary shares represented by the ADRs will commence trading on Nasdaq under the Company’s existing symbol “CNTB”.
Current report
In July 2025, we announced the expansion of the size of our Board of Directors from six to seven directors and the appointment of James A. Schoeneck as a director. Mr. Schoeneck is an accomplished biotech leader with more than 40 years of experience developing and commercializing breakthrough medicines and guiding companies through significant transformation, including both organic and inorganic growth. He currently serves as Chairman of the Board of Directors of each of FibroGen, Inc. and Calidi Biotherapeutics, Inc. Mr. Schoeneck previously served as Chief Executive Officer and a member of the Board of Directors of each of Depomed, Inc., BrainCells Inc., ActivX Biosciences, Inc. and Prometheus Laboratories Inc., and Chairman of the National Board of Directors of the Asthma and Allergy Foundation of America. Mr. Schoeneck began his career at Rhone-Poulenc Rorer Inc. He holds a B.S. from Jacksonville State University.
Current report
License and Collaboration Revenues
Current report
License and collaboration revenues relate to the Simcere License Agreement under which Simcere has been granted exclusive rights to develop, manufacture, and commercialize rademikibart for all indications in Greater China, including mainland China, Hong Kong, Macau, and Taiwan.
Current report
License and collaboration revenues for both the three and six months ended June 30, 2025 were $48,000 for cost reimbursements for clinical materials. License and collaboration revenues for both the three and six months ended June 30, 2024 were $24.1 million for the upfront license fee, achievement of certain development milestones and cost reimbursements.
Current report
For the three months ended June 30, 2025, general and administrative expense was $4.7 million, compared to $5.1 million for the same period in 2024. The decrease in general and administrative expense was primarily due to a decrease in non-cash, share-based compensation expense.
Current report
Our net loss for the three and six months ended June 30, 2025 was $12.9 million, or $0.23 per share, and $23.2 million, or $0.42 per share, respectively, compared to net income of $14.8 million, or $0.27 per share, and $6.2 million, or $0.11 per share, respectively, for the same periods in 2024.
Current report
Our net cash provided by financing activities for the six months ended June 30, 2025 was $0.2 million, compared to $0.1 million for the same period in 2024. The increase in net cash provided by financing activities was mainly due to an increase in net proceeds from purchases under the ESPP.
Removed paragraphs (5)
Previous report
In March 2025, we announced the publication of positive data from our global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma in the American Journal of Respiratory and Critical Care Medicine. These data highlight rademikibart’s potential as a novel biologic treatment option for patients with asthma and Type 2 inflammation, demonstrating rapid onset of action, sustained improvement in forced expiratory volume in one second and clinically important reductions in annual exacerbation rates.
Previous report
In April 2025, we announced positive feedback from our Type C meeting with the U.S. Food and Drug Administration (the “FDA”), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation. We obtained the FDA’s alignment on the design of our two parallel Phase 2 trials evaluating rademikibart in patients experiencing an acute exacerbation of asthma or COPD. This treatment setting is of particular interest because available Standard of Care (“SoC”) therapy in the acute setting shows insufficient long-term treatment effect on symptoms and lung function, with frequent exacerbations leading to re-visits by patients to the acute care setting for respiratory critical care treatment. Preventing and delaying recurrent exacerbations in the first 28 days following an exacerbation is a significant unmet medical need and a crucial therapeutic goal in asthma and COPD. Despite current guideline recommendations, treatment with systemic corticosteroids and antibiotics is not wholly adequate.
Previous report
In May 2025, we announced enrollment of the first patient in our rademikibart Phase 2 clinical trial in patients experiencing an acute exacerbation of asthma or COPD. The Phase 2 acute asthma trial, Seabreeze STAT ASTHMA, and the acute COPD trial, Seabreeze STAT COPD, will evaluate rademikibart plus SoC compared to SoC plus placebo in patients with asthma or COPD and Type 2 inflammation who are having an acute exacerbation. The primary endpoint of these two trials is treatment failure over 28 days after randomization. Treatment failure includes: death (any cause), (re)admission to the hospital, an urgent visit to an outpatient or emergency department provider for symptoms that are worsening, or the necessity to intensify pharmacologic treatment. Key secondary efficacy endpoints of these trials include the rate of new exacerbations, time to first new exacerbation, change in symptoms, and change in lung function in the 28 days after randomization. Exploratory endpoints include time-to-discharge in hospitalized patients and disease-specific patient-reported outcomes.
Previous report
Our net loss for the three months ended March 31, 2025 was $10.3 million, or $0.19 per share, compared to a net loss of $8.7 million, or $0.16 per share, for the same period in 2024.
Previous report
Our net cash provided by financing activities for the three months ended March 31, 2025 was $2,000, which consisted of proceeds from stock option exercises. There was no comparable activity during the three months ended March 31, 2024.
Reworded paragraphs (11)
Previous wording
Connect Biopharma, headquartered in San Diego, California, is a clinical-stage biopharmaceutical company focused on advancing rademikibart, a potentially best-in-class next generation IL-4Rα antibody, to transform acute and chronic care in asthma and COPD.
Current wording
Connect Biopharma, headquartered in San Diego, California, is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. The Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα.
Previous wording
The following is a summary of significant developments affecting our business that occurred since the filing of our 2024 Annual Report. For additional information or for a more comprehensive discussion of our product candidate, rademikibart, see our 2024 Annual Report.
Current wording
The following is a summary of significant developments affecting our business that occurred since the filing of our Quarterly Report on Form 10-Q for the three months ended March 31, 2025, filed with the SEC on May 15, 2025 (“Q1 2025 Form 10-Q”). For additional information or for a more comprehensive discussion of our product candidate, rademikibart, see our 2024 Annual Report and Q1 2025 Form 10-Q.
Previous wording
Comparison of the Three Months Ended March 31, 2025 and 2024
Current wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Previous wording
For the three months ended March 31, 2025, research and development expense was $6.6 million, compared to $8.7 million for the same period in 2024. The decrease in research and development expense was primarily due to a decrease in costs related to the development of rademikibart.
Current wording
For the three and six months ended June 30, 2025, research and development expense was $8.8 million and $15.4 million, respectively, compared to $5.3 million and $14.0 million, respectively, for the same periods in 2024. The increase in research and development expense was primarily due to an increase in costs related to the development of rademikibart. During the second quarter of 2025, we initiated two rademikibart Phase 2 clinical trials in patients experiencing an acute exacerbation of asthma or COPD.
Previous wording
For the three months ended March 31, 2025, general and administrative expense was $4.8 million, compared to $4.0 million for the same period in 2024. The increase in general and administrative expense was primarily due to an increase in professional fees to support our efforts to become more U.S.-centric, as well as an increase in personnel and related costs.
Current wording
For the six months ended June 30, 2025, general and administrative expense was $9.5 million, compared to $9.1 million for the same period in 2024. The increase in general and administrative expense was primarily due to an increase in professional fees to support our efforts to become more U.S.-centric, as well as an increase in personnel and related costs. These increases were partially offset by a decrease in non-cash, share-based compensation expense.
Previous wording
For the three months ended March 31, 2025, other income, net was $1.2 million, compared to $4.0 million for the same period in 2024. The decrease in other income, net was primarily due to a decrease in government subsidies and interest income earned on our invested cash balances.
Current wording
For the three and six months ended June 30, 2025, other income, net was $0.6 million and $1.8 million, respectively, compared to $1.2 million and $5.2 million, respectively, for the same periods in 2024. The decrease in other income, net was primarily due to a decrease in government subsidies and interest income earned on our invested cash balances.
Previous wording
As of March 31, 2025, we had cash, cash equivalents and short-term investments of $84.0 million. Based on our current operating plan and projections, management believes that the Company’s existing cash, cash equivalents and short-term investments will be sufficient to meet the Company’s anticipated cash requirements for a period of at least one year from the date this Quarterly Report on Form 10-Q is filed with the SEC.
Current wording
As of June 30, 2025, we had cash, cash equivalents and short-term investments of $71.8 million. Based on our current operating plan and projections, management believes that the Company’s existing cash, cash equivalents and short-term investments will be sufficient to meet the Company’s anticipated cash requirements for a period of at least one year from the date this Quarterly Report on Form 10-Q is filed with the SEC.
Previous wording
Our net cash used in operating activities for the three months ended March 31, 2025 was $10.0 million, compared to $0.6 million for the same period in 2024. The increase in net cash used in operating activities was primarily due to net changes in our operating assets and liabilities of $7.3 million and an increase in net loss of $1.6 million.
Current wording
Our net cash used in operating activities for the six months ended June 30, 2025 was $22.6 million, compared to $8.3 million for the same period in 2024. The increase in net cash used in operating activities was primarily due to an increase in net loss of $29.3 million, partially offset by net changes in our operating assets and liabilities of $16.9 million.
Previous wording
Our net cash used in investing activities for the three months ended March 31, 2025 was $20.6 million, compared to net cash provided by investing activities of $9.3 million for the same period in 2024. The decrease in cash provided by investing activities was primarily due to net purchases of short-term investments of $20.6 million for the three months ended March 31, 2025, compared to net maturities of $9.3 million for the three months ended March 31, 2024.
Current wording
Our net cash used in investing activities for the six months ended June 30, 2025 was $15.5 million, compared to net cash provided by investing activities of $12.5 million for the same period in 2024. The decrease in cash provided by investing activities was primarily due to net purchases of short-term investments of $15.1 million for the six months ended June 30, 2025, compared to net maturities of $12.8 million for the six months ended June 30, 2024.
Previous wording
Historically, we have financed our operations, including technology and product research and development, primarily through sales of our ordinary shares and ADSs, including our IPO that we completed on March 23, 2021 for total cash consideration of $219.9 million before underwriting discounts and commissions, and, through up-front payments, research funding and milestone payments under collaborative arrangements.
Current wording
Historically, we have financed our operations, including technology and product research and development, primarily through sales of our ordinary shares and ADSs, including our IPO that we completed in March 2021 for total cash consideration of $219.9 million before underwriting discounts and commissions, and, through up-front payments, research funding and milestone payments under collaborative arrangements.
Previous wording
In addition, as of March 31, 2025, we had a lease for 3,628 square feet of office space in San Diego, California, with a lease term that expired on April 30, 2025. We also have a lease for 25,476 square feet of laboratory and office space in Taicang, China, with a lease term that expires on April 30, 2026. As of March 31, 2025, we had total operating lease obligations of $1.1 million, with $0.3 million due during the remainder of fiscal year 2025 and $0.8 million due within the following two to three years.
Current wording
In addition, as of June 30, 2025, we had a lease for 25,476 square feet of laboratory and office space in Taicang, China, with a lease term that expires on April 30, 2026. As of June 30, 2025, we had total operating lease obligations of $1.0 million, with $0.2 million due during the remainder of fiscal year 2025 and $0.8 million due within the following two to three years.