Connect Biopharma Holdings Limited Q2 FY2022 earnings call

• Clinical progress: Lead candidate CBP-201 in Phase 2b global AD trial met endpoints; China-only pivotal trial data reviewed by CDE, planning October top line report; plan to enroll first patient in global Phase 3 AD study by end 2022; CBP-201 in asthma: anticipate full enrollment in first half 2023, report Phase 2 results in second half 2023.
• CBP-307: Global Phase 2 trial in UC reported 12-week data; has proven mechanism, higher S1P1 binding affinity, biomarker benefits; potential partnering opportunity.
• CBP-174: Phase 1 trial in healthy adults showed safe, well-tolerated profile with rapid absorption; first-in-human data promising.

No detailed breakdown of product segment financial performance with revenue contributions provided in the transcript. Financials noted: Cash, cash equivalents, short-term and long-term investments were $212.9 million as of June 30, 2022; R&D expenses increased to $50.8 million; administrative expenses totaled $10.7 million; net loss was $59.8 million.

• CBP-201 AD: Plan to report China-only pivotal trial top line data in October; enroll first patient in global Phase 3 AD study by end 2022.
• CBP-201 asthma: Complete enrollment in first half 2023, report Phase 2 results in second half 2023.
• CBP-307: Phase 2 maintenance phase in UC to complete in second half 2022.

• Clinical trial enrollment challenges: Nasal polyp trial terminated due to operational issues (pandemic, Ukraine conflict).
• Regulatory and partnership uncertainties: Uncertainties in regulatory approvals and timing of partnerships.
• Risks associated with forward-looking statements: Subject to market and operational uncertainties as per safe harbor statements.

Q: Atopic dermatitis is a crowded space, what's differentiation of CBP-201?

A: CBP-201 is a different molecule with potential efficacy and dosing frequency advantages, aiming for differentiation in efficacy and dosing convenience compared to existing treatments.

Q: Timing for CBP-307 partner?

A: Ongoing discussions with partners, but no specific update on timing; will announce when ready.

Q: CBP-201 in asthma?

A: CBP-201 is a potential competitive molecule for asthma, with results expected in the first half of 2023 after full enrollment in the global Phase 2 trial.

Q: Regulatory interactions with CDE?

A: Positive interactions with CDE; data from China-only pivotal trial review led to pre-BLA meeting plan if results are positive.

Q: Future plans for CBP-174?

A: Next study will consider formulation optimization and may involve a multiple ascending dose study in patients with skin inflammation after evaluating first-in-human data.

Q: Nasal polyp trial termination?

A: Trial terminated due to operational issues (pandemic, Ukraine conflict); may resume in future if operational challenges are resolved.

Q: Launch of global Phase 3 AD program?

A: Plan to launch the global Phase 3 AD study by the end of 2022 regardless of partnership status.

Q: October readout disclosure?

A: Plan to disclose primary endpoint (EC75), key secondary endpoints (IGA, itch), and safety results, similar to previous top line disclosures but with relevant details.