BeyondSpring Inc. Q2 FY2021 earnings call

• Plinabulin is a first-in-class SIMBA with dual benefits: extending overall survival and reducing severe neutropenia from chemotherapy. - Positive data from DUBLIN-3 trial showed plinabulin in combination with docetaxel significantly improved overall survival, with 10.6% full year OS rate vs 0% for docetaxel alone. - Strategic partnership with Hengrui for commercialization and co-development of plinabulin in Greater China, with favorable terms including upfront payment, milestone payments, and cost sharing. - Upcoming ESMO presentation on September 20 with late-breaking data from DUBLIN-3 Phase 3. - Clinical development focus on IO combinations, including Phase 1 data with plinabulin and nivolumab/ipilimumab in small cell lung cancer showing improved results. - Commercial preparations for plinabulin launch in US in early 2022, including market preparation, reimbursement support, and KOL development.

R&D expenses in Q2 2021 were $11.3 million, an increase of $0.3 million compared to Q2 2020, primarily due to higher personnel costs and noncash stock-based compensation expense, partially offset by lower clinical trial expense. G&A expenses in Q2 2021 were $9.0 million, a significant increase of $6.4 million compared to Q2 2020, driven by higher personnel costs, noncash stock-based compensation, and pre-commercialization activities for plinabulin. Net loss in Q2 2021 was $19.3 million, up from $12.8 million in Q2 2020. Cash balance at the end of Q2 was $51.3 million with $25.0 million in short-term investments, sufficient to support ongoing clinical programs over the next year.

• PDUFA date for plinabulin in CIN prevention is November 30, 2021. - Planned NDA filing for plinabulin in non-small cell lung cancer in the first half of 2022. - Continued development of pipeline, including plinabulin in triple IO combo in various cancers.

Q: What type of information should we be booking for from the DUBLIN-3 trial at ESMO and about the DUBLIN-3 trial's relevance to US population and partnership discussions?

A: At ESMO, they will show the whole ITT population data and subset analysis including PD-1/PD-L1 exposed and Western patient subsets. Regarding the trial's relevance to US population, they think the patient population captures the current treatment landscape and plan to discuss with FDA in pre-NDA meeting. On partnership, no details can be disclosed yet.

Q: Can you walk through the history of the DUBLIN-3 trial, primary endpoint, and protocol changes?

A: DUBLIN-3 has been ongoing for almost 6 years with 559 patients enrolled globally. Primary endpoint has always been overall survival, not changed. Protocol was updated to include PD-1/PD-L1 failed patients. Will show median OS and restricted mean survival time in ESMO and NDA filing.

Q: To tie the subset analysis together for PK bridging data between Western and China patients, can you disclose PK bridging data?

A: They have extensive population PK data from CIN and lung cancer studies, submitted to regulatory agencies. PK comparison data won't be discussed at ESMO but is consistent and they're confident in comparability between Asian and Western patients.

Q: For the CIN NDA under Priority Review, can you talk about regulatory interactions and label discussions?

A: FDA has been in frequent communication, had AOM meeting and mid-cycle review. Label discussion hasn't started yet, usually happens 1-2 months before PDUFA date (November 30).

Q: How is DUBLIN-3 conducted from quality control and data integrity standpoint?

A: Conducted under US GCP using quality CROs like ICON, Covance, ICON PV, CRT. Data is trustworthy with independent statistical analysis and single-blinded study. P-values in topline were ranges as they were saving detailed data for ESMO.

Q: For Hengrui partnership, what are rate-limiting steps and how to account for milestone payments?

A: China team is actively working with Hengrui since signing, focusing on medical science and messaging. Regarding milestone payments, they are discussing with auditor on booking and accounting treatments, expecting normal accounting for milestones.