Connect Biopharma Holdings Ltd Stock Price, News & Analysis

Connect Biopharma Holdings Limited (Nasdaq: CNTB) announced the successful completion of its first-in-human Phase 1 study for CBP-174, an oral H3 receptor antagonist aimed at treating pruritus linked to allergic and inflammatory skin diseases, including atopic dermatitis. The trial demonstrated that CBP-174 was safe and well-tolerated with no serious adverse events reported. Vital signs and laboratory results showed no clinically notable safety findings. The Company aims to further evaluate CBP-174, intending to improve the quality of life for patients suffering from skin conditions worldwide.

CANbridge Pharmaceuticals, Inc. (1228.HK) reported its financial results for H1 2022, showcasing a revenue increase to RMB34.7 million, up RMB22.5 million from the prior year, largely driven by sales from Hunterase® and Nerlynx®. R&D expenses decreased to RMB158.3 million, leading to a reduced loss of RMB249.0 million. The company initiated three Phase II trials and announced positive Phase I results for CAN106, alongside advancements in its gene therapy platform. Upcoming milestones include potential NDA approval for CAN108 in H1 2023.

Connect Biopharma announced that it can conduct primary analysis of its pivotal trial for CBP-201, targeting moderate-to-severe atopic dermatitis, based on 255 enrolled patients. Top-line results are expected by year-end 2022, earlier than planned. The company aims to initiate pre-NDA discussions in 2024, targeting potential approval in China by 2025. The trial's secondary endpoints include EASI response rates, adding to the anticipation for CBP-201's efficacy against current treatments. The Phase 3 program timeline remains unchanged, with patient enrollment expected by late 2022.

Connect Biopharma Holdings Limited (Nasdaq: CNTB) received notification from Nasdaq regarding a deficiency in its share price, which closed below $1.00 for thirty consecutive business days. The company has until December 13, 2022, to regain compliance with Nasdaq Listing Rule 5550(a)(2). If the share price closes above $1.00 for ten consecutive business days within this period, compliance will be achieved. The company may also be eligible for an additional compliance period if necessary, provided certain conditions are met.

Connect Biopharma Holdings Limited (Nasdaq: CNTB) announced that Dr. Zheng Wei and CFO Steven Chan will participate in a fireside chat at the Jefferies Healthcare Conference on June 10, 2022, at 10:30 am ET. A live webcast will be available on the Company’s Investor Relations page, with a replay post-event. Connect Biopharma focuses on therapies for chronic inflammatory diseases, leveraging T cell-driven research, including its lead product CBP-201 for treating atopic dermatitis and asthma. The company is advancing multiple candidates targeting T cell biology in the U.S. and China.

Connect Biopharma (Nasdaq: CNTB) will present data on CBP-201 at the Society for Investigative Dermatology Annual Conference from May 18-21, 2022. Preclinical experiments show CBP-201 effectively reduces Th2-driven inflammation biomarkers and exhibits a stronger binding affinity compared to dupilumab. The antibody targets interleukin-4 receptor alpha (IL-4Rα), with promising results from a Phase 2b clinical trial indicating potential for treating moderate-to-severe atopic dermatitis. The ongoing pivotal trial in China further supports its clinical significance.

CANbridge Pharmaceuticals has appointed Dr. Pauline Li as Senior Vice President of Clinical Development and Operations, effective May 8. Dr. Li previously held leadership roles at Connect Biopharma, overseeing significant clinical trial achievements. With a robust background in drug development across various markets, her experience is expected to enhance CANbridge's clinical programs targeting rare diseases and oncology. The company has three approved drugs and a pipeline of 11 assets, reflecting its commitment to addressing unmet medical needs.

Connect Biopharma (Nasdaq: CNTB) announced Phase 2 trial results for CBP-307, a treatment for ulcerative colitis. The 0.2 mg dosage showed a numerical decrease in the adapted Mayo Score at Week 12, but did not reach statistical significance (p=0.103). However, it achieved significant clinical remission rates compared to placebo: 28.3% vs. 9.6% (p=0.016). Lymphocyte count reductions confirmed pharmacodynamic activity. CBP-307 was generally well tolerated, with a 66% incidence of drug-related adverse events. The company is considering partnerships for further development while advancing lead candidate CBP-201.

Connect Biopharma reported financial results for the year ended December 31, 2021, highlighting a cash balance of RMB 1,706.9 million (USD 267.7 million). The company advanced its clinical development projects, announcing a Phase 3 trial for CBP-201 in atopic dermatitis set to start in H2 2022 and completion of enrollment for CBP-307's Phase 2 trial in ulcerative colitis. Research and development expenses surged to RMB 518.0 million (USD 81.2 million), contributing to a net loss of RMB 1,306.8 million (USD 205.0 million) for the year.