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Connect Biopharma Holdings Limited reports clinical and corporate developments for a clinical-stage biopharmaceutical company focused on inflammatory diseases. Its principal program is rademikibart, an antibody designed to target interleukin-4-receptor alpha, with company updates centered on asthma, chronic obstructive pulmonary disease and moderate-to-severe atopic dermatitis.
Recurring news includes rademikibart clinical data, Seabreeze STAT asthma and COPD study updates, Data Monitoring Committee and regulatory-related disclosures, partner activity involving Simcere in China, financial results, financing activity, investor conference participation and governance matters.
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Connect Biopharma (Nasdaq: CNTB) announced that it is on track to submit a New Drug Application (NDA) for its lead drug candidate, CBP-201, for the treatment of moderate-to-severe atopic dermatitis in China by the end of Q1 2024. The submission could lead to potential approval by 2025. Encouraging results from pivotal trials in China and global data presented at the AAD Annual Meeting support the efficacy of CBP-201. Connect Biopharma has also completed enrollment for a Phase 2 global trial in asthma and reported positive topline data from the ongoing China pivotal trial for CBP-201. However, the company reported a net loss of RMB 797.1 million in 2022, a decrease from RMB 1,306.8 million in 2021, while its cash reserves declined to RMB 1,127.3 million. R&D expenses increased to RMB 652.2 million due to advancing clinical trials.
Connect Biopharma Holdings Limited (Nasdaq: CNTB) presented data from Stage 1 of a pivotal trial for CBP-201 at the American Academy of Dermatology Annual Meeting. The trial, involving 255 adults with moderate-to-severe atopic dermatitis, met all primary and secondary endpoints, showing rapid symptom relief—some within a week—and no efficacy plateau by Week 16. Notably, 30.3% of treated patients achieved clear or almost clear skin. The drug demonstrated a favorable safety profile with mostly mild-to-moderate adverse effects. CEO Zheng Wei highlighted CBP-201's potential for flexible dosing and high unmet medical need in dermatology.
Connect Biopharma Holdings Limited (NASDAQ: CNTB) announced promising findings from a Phase 2b global trial for its drug, CBP-201, aimed at treating moderate-to-severe atopic dermatitis (AD). The results, presented at the American Academy of Dermatology Annual Meeting, demonstrated significant improvements in AD symptoms across multiple body regions as early as Week 2, with sustained results observed up to Week 16. Notably, the study showed a substantial decrease in EASI scores, with improvements in erythema and other signs of AD. The trial supports CBP-201's potential as an effective treatment option with flexible dosing regimens.
Connect Biopharma (NASDAQ: CNTB) announced that two abstracts from its CBP-201 clinical development program for atopic dermatitis (AD) have been accepted for presentation at the American Academy of Dermatology (AAD) meeting in New Orleans, March 17-21, 2023. The global Phase 2b CBP-201 trial data will be shared as an online e-poster with an oral presentation on March 17, while the China trial data will feature in a late-breaking oral presentation on March 18. CEO Zheng Wei expressed enthusiasm over the acceptance of these findings, which are expected to highlight CBP-201's differentiation in treating AD.
Connect Biopharma Holdings Limited (Nasdaq: CNTB), a clinical-stage biopharmaceutical firm focused on T cell-driven therapies, will present at several conferences in February and March 2023. Notable events include the SVB Securities Global Biopharma Conference on February 15 at 4:10 PM Eastern and the BioCom Global Partnering and Investor Conference from February 28 to March 2. The company is advancing a pipeline of therapies for chronic inflammatory diseases, targeting conditions like atopic dermatitis, asthma, and ulcerative colitis. Key product candidates include CBP-201 and CBP-307.
Connect Biopharma (CNTB) announced a revised timeline for its global Phase 3 program of CBP-201 in atopic dermatitis, now expected to start after securing partnerships. The cash runway is projected to extend into at least 2025, allowing ample time for ongoing trials and potential partnerships. The pivotal trial in China is on track, with Stage 2 completion expected in H2 2023. The company is also moving forward with CBP-307 in ulcerative colitis, with a Phase 2 maintenance phase expected to complete soon. Positive interactions with regulatory bodies are planned for early 2023.
Connect Biopharma (Nasdaq: CNTB) will present a corporate update led by CEO Zheng Wei, PhD, on January 9, 2023, at 9:00 am PST during the Biotech Showcase. The event takes place in San Francisco from January 9-11, 2023. Key executives, including CFO Steven Chan and CMO Chin Lee, will also be available for investor meetings. Connect Biopharma focuses on developing T cell-driven therapies for inflammatory diseases, with product candidates like CBP-201 for atopic dermatitis, CBP-307 for ulcerative colitis, and CBP-174 for pruritus.
Connect Biopharma Holdings Limited (Nasdaq: CNTB) received a letter from Nasdaq on November 28, 2022, indicating that its American Depositary Shares (ADSs) have been below the minimum bid price of $1.00 for 30 consecutive business days. The company has until May 29, 2023, to regain compliance with Listing Rule 5550(a)(2). If compliance is not achieved, it may qualify for an additional 180-day period after transitioning to the Nasdaq Capital Market. The letter is a notification only and does not affect the trading of ADSs.