Connect Biopharma Holdings Ltd
For the period ended Sep 30, 2025. Filed Nov 12, 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.
Sep 30, 2025 · Filed Nov 12, 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 2025-06-30; filed 2025-08-13.
0001835268-25-000052
ITEM 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-12.
0001835268-25-000058
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 59 previous paragraphs and 57 current paragraphs.
40 unchanged; 15 reworded; 2 added; 3 removed; 1 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 (2)
Current report
In August 2025, we teamed with Ickey Woods and the Jovante Woods Foundation to raise awareness of acute asthma attacks.
Current report
During the third quarter of 2025, we presented data supporting the development of rademikibart at the European Respiratory Society Congress 2025. Rapid and significant improvement in lung function and asthma control was observed across a broad range of type 2 inflammatory markers with the greatest improvements observed in those with elevated baseline levels of blood eosinophil counts of ≥300 cells/μL and fractional exhaled nitric oxide levels of>25 ppb. We believe this data supports our ongoing Phase 2 acute exacerbations 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.
Removed paragraphs (3)
Previous 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.
Previous 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.
Previous 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.
Reworded paragraphs (15)
Previous 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.
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 and six months ended June 30, 2025, filed with the SEC on August 13, 2025 (“Q2 2025 Form 10-Q”). For additional information or for a more comprehensive discussion of our product candidate, rademikibart, see our 2024 Annual Report, 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”), and Q2 2025 Form 10-Q.
Previous wording
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 wording
On September 2, 2025, we terminated each of (i) the Deposit Agreement dated March 18, 2021, as amended, by and among the Company, Deutsche Bank Trust Company Americas and the holders and beneficial owners from time to time of American Depositary Shares, each representing an Ordinary Share, and evidenced by American Depositary Receipts (“ADRs”) issued thereunder and (ii) the related ADR program. At such time, our ADRs were cancelled and exchanged for Ordinary Shares at a one-for-one ratio. We subsequently listed our Ordinary Shares on Nasdaq under our existing symbol “CNTB”.
Previous wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024
Current wording
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024
Previous wording
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 wording
License and collaboration revenues for both the three and nine months ended September 30, 2025 were $16,000 and $64,000, respectively, for cost reimbursements for clinical materials. License and collaboration revenues for the three and nine months ended September 30, 2024 were $1.2 million and $25.3 million, respectively, for the upfront license fee, achievement of certain development milestones and cost reimbursements.
Previous 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.
Current wording
For the three and nine months ended September 30, 2025, research and development expense was $11.1 million and $26.5 million, respectively, compared to $9.0 million and $23.0 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. This increase was partially offset by a decrease in non-cash, share-based compensation expenses.
Previous 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.
Current wording
For the three and nine months ended September 30, 2025, general and administrative expense was $6.6 million and $16.1 million, respectively, compared to $6.1 million and $15.1 million, respectively, for the same periods 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. This increase was partially offset by a decrease in non-cash, share-based compensation expense.
Previous 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.
Current wording
For the three and nine months ended September 30, 2025, other income, net was $0.5 million and $2.3 million, respectively, compared to $1.0 million and $6.2 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 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.
Current wording
As of September 30, 2025, we had cash, cash equivalents and short-term investments of $54.8 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 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 wording
Our net loss for the three and nine months ended September 30, 2025 was $17.2 million, or $0.31 per share, and $40.4 million, or $0.73 per share, respectively, compared to $12.9 million, or $0.23 per share, and $6.7 million, or $0.12 per share, respectively, for the same periods in 2024.
Previous 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.
Current wording
Our net cash used in operating activities for the nine months ended September 30, 2025 was $40.0 million, compared to $21.3 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 $33.6 million, partially offset by net changes in our operating assets and liabilities of $18.1 million.
Previous 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.
Current wording
Our net cash used in investing activities for the nine months ended September 30, 2025 was $1.2 million, compared to net cash provided by investing activities of $12.3 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 $0.8 million for the nine months ended September 30, 2025, compared to net maturities of $12.8 million for the nine months ended September 30, 2024.
Previous wording
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.
Current wording
Our net cash provided by financing activities for the nine months ended September 30, 2025 was $0.4 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 stock option exercises and purchases under the ESPP.
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 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.
Current wording
Historically, we have financed our operations, including technology and product research and development, primarily through sales of our securities, 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 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.
Current wording
In addition, 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 September 30, 2025, we had total operating lease obligations of $0.9 million, with $0.1 million due during the remainder of fiscal year 2025 and $0.8 million due within the following two to three years.
Previous wording
Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, monetization transactions, government contracts or other strategic transactions. To the extent that we raise additional capital through the sale of equity, ownership interests of existing holders of our ADSs and ordinary shares will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders of our ADSs or ordinary shares. If we raise additional funds through collaboration agreements, strategic alliances, licensing arrangements, monetization transactions, or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves. Future debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or equity financing that we raise may contain terms that are not favorable to us or our shareholders.
Current wording
Until such time, if ever, that we can generate product revenue sufficient to achieve profitability, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, monetization transactions, government contracts or other strategic transactions. To the extent that we raise additional capital through the sale of equity, ownership interests of existing holders of our ordinary shares will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders of our ordinary shares. If we raise additional funds through collaboration agreements, strategic alliances, licensing arrangements, monetization transactions, or marketing and distribution arrangements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves. Future debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or equity financing that we raise may contain terms that are not favorable to us or our shareholders.
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
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.