Connect Biopharma Holdings Limited

For the six months ended June 30, 2022, cash, cash equivalents, short-term and long-term investments were $212.9 million (RMB1,429.1 million), versus RMB1,706.9 million at December 31, 2021. R&D expense was $50.8 million (RMB340.8 million), up from RMB217.8 million, and administrative expense was $10.7 million (RMB71.8 million), up from RMB48.0 million. Net loss was $59.8 million (RMB401.3 million) versus a net loss of RMB942.5 million in the prior-year period, with the year-over-year improvement mainly reflecting prior fair value adjustments on preferred stock. Looking ahead, management said CBP-201 China Stage 1 topline data should be reported in October, the global Phase 3 AD study should start before year-end 2022, asthma enrollment should complete in the first half of 2023, and asthma topline data should follow in the second half of 2023. They also said CBP-201 China data could support an NDA filing in 2024 and potential approval as early as 2025 if results are positive.

Dr. Zheng Wei emphasized CBP-201 as the company’s main value driver, saying the China CDE interaction could accelerate the BLA timeline and that the October readout may become a key catalyst for partnering discussions. He framed the AD market as crowded but argued that IL-4R-alpha biology remains compelling and that CBP-201 could differentiate via efficacy and longer maintenance dosing every four weeks. On CBP-307, he said the Phase 2 package supports a partnering story because the drug appears to hit its target and achieved statistically significant clinical remission at a higher dose.

Steven Chan focused on liquidity and expense trends, noting $212.9 million in cash and investments at June 30, 2022, which he said should fund operations into at least 2024 based on the current plan. He attributed the higher R&D spend to clinical trial costs for CBP-201 in AD and asthma, CBP-307 in UC, plus additional R&D headcount, while admin costs rose due to personnel, stock-based compensation, professional services, and public-company infrastructure. He also explained that the prior-year net loss was inflated by RMB674.3 million of fair value adjustments on preferred stock that was converted in last year’s IPO.

Analysts asked how CBP-201 can stand out in the crowded AD field, whether CBP-307 could be partnered this year, and what the asthma opportunity looks like. Management said the AD strategy is to compete on efficacy plus convenient maintenance dosing, and that there has been continued partner interest in CBP-307, though no timing was given. On China regulation, management said the CDE’s feedback and the ability to hold a pre-BLA meeting after the 16-week data are positive signs, but approval will depend on the pivotal China data; on the October topline, they said they expect to disclose the primary week-16 endpoint, key secondary endpoints such as IGA and itch, and safety in more detail than the prior Phase 2b release.