CStone Pharmaceuticals Reports 2023 Interim Results and Updates

SUZHOU - CStone Pharmaceuticals ('CStone', HKEX: 2616), a leading biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology therapies and precision medicines, today reported 2023 interim results and recent business updates.

'In the first half of 2023, CStone delivered robust growth and positive results. Our three precision medicines achieved a 53% year-on-year increase in sales revenue with significant improvement of gross profit margin. Our cash reserves amount to RMB 1,005.4 million, and we significantly reduced our net losses.' said Dr. Jason Yang, CEO of CStone.

'We made remarkable progress in our global product pipeline. We expanded the First-in-Human (FIH) global study of CS5001, a key product of our CStone Pipeline 2.0 Strategy, to China from the United States and Australia, accelerating its development. The phase I clinical trial completed safety evaluation of several dose levels. CS5001, one of the most advanced ROR1 ADCs in global clinical development, showed promising safety, stability, and preliminary anti-tumor activity in hematological and solid malignancies.

We are awaiting the approval of sugemalimab (PD-L1) as first-line treatment of Stage IV NSCLC in the UK and the EU, with the GCP inspection notification from the EMA received recently. We expect the approval in the first half of 2024. We are also actively looking for partners to develop and commercialize sugemalimab and nofazinlimab (PD-1) outside of the Greater China, to advance the global commercialization of these assets.

Going forward, we will continue to strengthen our research and development capabilities for innovative products, optimize the commercial potential of existing products, and improve our global strategic positioning, to create more growth opportunities for the company and more value for investors, partners, and stakeholders.'

Financial highlights

International Financial Reporting Standards ('IFRS') Measures

Revenue was RMB 261.5 million for the six months ended June 30, 2023, composed of RMB 246.9 million in sales of pharmaceutical products (avapritinib, pralsetinib and ivosidenib) and RMB14.6 million in royalty income of sugemalimab, representing an increase of pharmaceutical products sales of RMB85.5 million, or 53%, from RMB161.4 million for the six months ended June 30, 2022 and an increase of royalty income of RMB1.5 million, or 11%, from RMB13.1 million for the six months ended June 30, 2022.

Research and development expenses were RMB186.8 million for the six months ended June 30, 2023, representing a decrease of RMB79.8 million from RMB266.6 million for the six months ended June 30, 2022, primarily due to the decrease in milestone fee and third party contracting costs and the decrease in employee costs.

Administrative expenses were RMB89.2 million for the six months ended June 30, 2023, representing a decrease of RMB 45.6 million from RMB134.8 million for the six months ended June 30, 2022, primarily due to the decrease in employee costs.

Selling and marketing expenses were RMB131.4 million for the six months ended June 30, 2023, representing a decrease of RMB15.0 million from RMB146.4 million for the six months ended June 30, 2022, primarily attributable to the decrease in employee costs and professional fees.

Loss for the period was RMB 209.2 million for the six months ended June 30, 2023, representing a decrease of RMB152.4 million, or 42%, from RMB361.6 million for the six months ended June 30, 2022, primarily attributable to the decrease in research and development expenses and decrease in employee costs.

Non-International Financial Reporting Standards ('Non-IFRS') Measures

Research and development expenses excluding the share-based payment expenses were RMB198.1 million for the six months ended June 30, 2023, representing a decrease of RMB20.8 million from RMB218.9 million for the six months ended June 30, 2022, primarily due to the decrease in milestone fee and third party contracting costs and the decrease in employee costs.

Administrative and selling and marketing expenses excluding the share-based payment expenses were RMB183.1 million for the six months ended June 30, 2023, representing a decrease of RMB41.3 million from RMB224.4 million for the six months ended June 30, 2022, primarily attributable to the decrease in employee costs and professional fees.

Loss for the period excluding the share-based payment expenses was RMB183.0 million for the six months ended June 30, 2023, representing a decrease of RMB74.1 million, or 29%, from RMB257.1 million for the six months ended June 30, 2022, primarily attributable to the decrease in research and development expenses and the decrease in employee costs.

About CStone

CStone (HKEX: 2616) is a biopharmaceutical company focused on research, development, and commercialization of innovative immuno-oncology and precision medicines to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline of 14 drug candidates with a strategic emphasis on immuno-oncology combination therapies. Currently, CStone has received eleven NDA approvals for its four drugs. Multiple late-stage drug candidates are now under pivotal clinical trials or registration. CStone's vision is to bring innovative oncology therapies to cancer patients worldwide.

Forward-looking statements

The forward-looking statements made in this article only relate to events or information as of the date when the statements are made in this article. Except as required by law, we undertake no obligation to update or publicly revise any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. All statements in this article are made on the date of publication of this article and may change due to future developments.

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