CASI Pharmaceuticals, Inc. Q1 FY2022 earnings call

• Business Challenges: Significant challenges in Q1 2022 due to COVID-19 lockdowns in China, particularly Shanghai, affecting sales of products and patient enrollment for CNCT-19 Phase 2 studies.
• Product Updates:
  • EVOMELA sales increased by 58% yoy.
  • CNCT-19 NDA submission to NMPA is on track with potential minor delay due to COVID-19 lockdowns.
  • Anticipate start of BI-1206 Phase 1 trial in China.
  • CB-5339 expected to receive Clinical Trial Application approval from NMPA in 2022.
  • CID-103 Phase 1 study ongoing.
  • Thiotepa in process of regulatory submissions for two indications.
• Commercial Strategy: Experienced specialty sales and marketing team in hematology/oncology market in China, access to key opinion leaders to address unmet medical needs in multiple myeloma treatment.

EVOMELA generated revenue of $9 million for the quarter ended March 31, 2022, which is a 58% increase compared to $5.7 million in the same period of 2021. Cost of revenue was $3.8 million in Q1 2022 compared to $2.4 million in Q1 2021, including royalty payments of $1.8 million in Q1 2022 and $1.1 million in Q1 2021. EVOMELA's revenue contribution is derived from its product sales in the hematology/oncology market in China.

• CNCT-19 NDA filing by Juventus expected within the next 12 months barring substantial additional COVID-19 disruption in China.
• Anticipate start of BI-1206 Phase 1 trial in China in Q2 2022 with first patient enrolled in Q4 2022.
• CB-5339 expected to receive CTA approval from NMPA in 2022.
• CID-103 Phase 1 study ongoing, with potential early evidence of clinical activity from the trial.

• COVID-19 Impact: Lockdowns in China affecting sales, patient enrollment, and trial timelines.
• NASDAQ Listing: Consideration of reverse stock split due to NASDAQ listing requirements.
• Holding Foreign Companies Accountable Act (HSCA): Pending resolution with U.S. regulators regarding audit cooperation, with potential impact on company operations.

Q: Justin Zelin asked about CNCT-19 NDA timeline and COVID impact.

A: Slight delay possible for CNCT-19 NDA filing but confident in 12-month filing unless substantial COVID disruption; EVOMELA sales growth expected but COVID impact on sales monitored.

Q: Sean Lee asked about CID-103 study timeline and clinical milestones.

A: CID-103 Phase 1 study ongoing, BI-1206 Phase 1 trial expected in Q2 2022 with first patient in Q3, CB-5339 regulatory applications submitted, Thiotepa in regulatory submission discussions with CDE.

Q: Trevor Allred asked about CID-103 and CNCT-19 enrollment sites and COVID impact on BI-1206.

A: CID-103 sites in France and UK, BI-1206 sites selected in China, CNCT-19 sites in prestigious institutions in China, slight COVID impact but optimistic on meeting timelines for filings and trials