Overview

We are a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI, and a pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our commercial product is LOQTORZI, a novel next-generation PD-1 inhibitor. We are developing an innovative immuno-oncology pipeline that is expected to bring forward new potential indications for LOQTORZI in the U.S. and the development of new product candidates.

We previously owned UDENYCA, which was launched commercially in a pre-filled syringe presentation in the United States in January 2019, followed by the launch of UDENYCA in an autoinjector presentation in May 2023 and the launch of UDENYCA ONBODY in February 2024. On December 2, 2024, we divested the UDENYCA Business to Intas for upfront, all-cash consideration of $483.4 million.

On October 27, 2023, LOQTORZI was approved by the FDA in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy. We announced the launch of LOQTORZI in the U.S. on January 2, 2024.

Our pipeline comprises earlier stage clinical and preclinical immuno-oncology programs that we plan to develop in combination with LOQTORZI as well as in partnership with other companies. Our clinical stage product candidates include casdozokitug (CHS-388), an investigational antagonist antibody targeting IL-27, and CHS-114, an investigational antibody targeting CCR8.

Business Update

Closing of UDENYCA Sale

On December 2, 2024, we divested the UDENYCA Business to Intas for upfront, all-cash consideration of $483.4 million, inclusive of $118.4 million for UDENYCA product inventory. We are also eligible to receive two additional Earnout Payments of $37.5 million each, provided that certain minimum UDENYCA Net Sales thresholds are met during specified periods after the closing.

Revenue Purchase and Sale Agreement

On April 15, 2025, we paid $47.7 million to buy out the Purchaser Group’s right to receive the Revenue Payments with respect to UDENYCA.

2026 Convertible Notes

In April 2025, we repurchased approximately $170 million aggregate principal amount of the 2026 Convertible Notes and offered to repurchase the remaining $60 million.

Product and Product Candidates

Oncology

• LOQTORZI was approved in October 2023 and launched in the U.S. in January 2024. It is approved in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced NPC, and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.
• Casdozokitug (CHS-388) is an investigational antibody targeting IL-27, an immune regulatory cytokine. It is in Phase ¹⁄₂ and Phase 2 studies in advanced solid tumors and hepatocellular carcinoma.
• CHS-114 is an investigational antibody targeting CCR8, a chemokine receptor highly expressed on Treg cells in the tumor microenvironment. It is in Phase 1b studies in combination with toripalimab in second-line head and neck squamous cell carcinoma and advanced solid tumors.

License Agreement with Junshi Biosciences

In 2021, we entered into a collaboration agreement with Junshi Biosciences for the co-development and commercialization of LOQTORZI in the U.S. and Canada.

Financial Operations Overview

• Revenue from LOQTORZI, which launched in December 2023, increased in the first quarter of 2025 compared to the prior year period.
• Cost of goods sold increased due to higher LOQTORZI sales volume.
• Research and development expense decreased due to reduced costs for toripalimab and CHS-006, partially offset by increased spending on CHS-114 and casdozokitug.
• Selling, general and administrative expense decreased primarily due to lower professional fees, employee-related costs, and stock-based compensation.
• Interest expense decreased due to repayment of the 2027 Term Loans.
• Net income from discontinued operations, primarily related to the CIMERLI and YUSIMRY divestitures, decreased compared to the prior year period.

Liquidity and Capital Resources

As of March 31, 2025, we had $82.4 million in cash and cash equivalents. We believe our available cash, cash from divestitures, product sales, and ATM Offering proceeds will be sufficient to fund our planned expenditures for at least the next 12 months.

Key liquidity events include:

• Completed the $483.4 million divestiture of the UDENYCA Business in April 2025
• Repurchased $170 million of the 2026 Convertible Notes in April 2025
• Entered into a $38.7 million 2029 Term Loan and the Revenue Purchase and Sale Agreement in May 2024

We have various contingent milestone and royalty obligations related to our partnerships and collaborations. We also have non-cancelable purchase commitments of $59.0 million as of March 31, 2025.

Overall, our financial position has been strengthened by the UDENYCA divestiture, allowing us to focus on the commercialization of LOQTORZI and advancement of our immuno-oncology pipeline.