CASI

Business Update - COVID Impact: COVID-related lockdowns in large Chinese cities limited access to hospitals, impacting EVOMELA sales, but revenues still increased 19% y-o-y. - Reverse Split: In May, a ten-to-one reverse split of common shares was effectuated to meet Nasdaq Capital Market listing requirements. - Sub-license Agreement: Entered into a sub-license agreement with Precision Autoimmune Therapeutics, granting exclusive worldwide license for anti-CD38 monoclonal antibody for autoimmune diseases, with $10 million upfront payment and CASI holding 15% equity in the new company. - Pipeline Progress: Anticipate start of BI-1206 Phase 1 trial in China soon; expect CB-5339 to receive CTA approval from NMPA in 2022; CID-103 Phase 1 study ongoing; CNCT19 CAR-T program expected to file China NDA in second half of 2022; BI-1206 trial initiated with first patient dosing expected in second half of 2022. - Financials: Ended Q2 with $18.9 million cash and cash equivalents; entered into a revolving line of credit up to $10 million from East West Bank.

Forward-Looking Statements - Anticipate start of BI-1206 Phase 1 trial in China very soon. - Expect CB-5339 to receive CTA approval from the NMPA during 2022. - CID-103 Phase 1 study continues. - Sub-license agreement with Precision Autoimmune Therapeutics brings $10 million upfront and potential future payments, allowing CASI to focus on hematology-oncology market.

The main product segment is EVOMELA. In the second quarter of 2022, revenues from sales of EVOMELA increased by 19% compared to the same period last year, with EVOMELA sales revenue being $8.6 million. EVOMELA is approved in China for use as a high dose conditioning agent prior to hematopoietic stem cell transplant patients in multiple myeloma, with patent protection until at least 2030 and being the only cyclodextrin enabled formulation of injectable melphalan commercially available in China.

Risks - COVID-related lockdowns and restrictions in large Chinese cities have impacted sales, with unpredictability in future lockdowns potentially affecting revenue again. - Uncertainty around the impact of COVID control policies on business operations and sales.

Q: Could you provide additional clarity on the challenges due to COVID and if you believe this will be resolved in the near future? And what did you find attractive about the deal with Precision Autoimmune Therapeutics and why choose them as a partner?

A: COVID situation, especially Shanghai shutdown for two months, impacted Q2 revenues. COVID is unpredictable in China. For the Precision Autoimmune deal, CASI focuses on hematology-oncology market, CD38 has encouraging data in autoimmune diseases, Precision Autoimmune is a local venture capital-backed company with expertise in single cell technology, and the deal brings $10 million upfront and allows CASI to avoid clinical development burden for CD38 in autoimmune diseases while benefiting from potential advancements.

Q: Anticipated availability of CNCT19, timing on potential NDRL listing and status of other anti-CD19 CAR-T cell therapies in China?

A: Juventas is on track to file NDA for CNCT19 in 2022, approval likely in 2023. There might be up to four or five CAR-T19 approvals in China, and CASI's commercial team, experienced from EVOMELA, is well-prepared for CNCT19 launch.

Q: With upcoming results for CNCT19 and potential approval next year, any additional steps needed before launch in terms of manufacturing or commercial structure? And timeline for data expectations for BI-1206 and Thiotepa development?

A: Sufficient manufacturing capacity for at least first year (5 to 1,000 patients), but additional capacity might be needed if demand exceeds. On BI-1206, CTA approved in China, working towards first patient dosing; on Thiotepa, working with partner to address CDE questions, anticipating submission shortly with feedback expected in 4-6 months.