New Risk • May 18
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 16% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$50m free cash flow). Earnings are forecast to decline by an average of 16% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$77m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$35.1m market cap). New Risk • May 11
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$50m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$50m free cash flow). Shareholders have been substantially diluted in the past year (54% increase in shares outstanding). Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$49m net loss in 3 years). Share price has been volatile over the past 3 months (13% average weekly change). Market cap is less than US$100m (US$35.2m market cap). Announcement • May 05
Nextcure, Inc. and Simcere Zaiming Pharmaceutical Co., Ltd. Initiate Dose Optimization for SIM0505 (CDH6 ADC) in Gynecologic Cancers NextCure, Inc. and Simcere Zaiming Pharmaceutical Co., Ltd. announced initiation of the dose optimization portion of the Phase 1 study of SIM0505, focusing on patients with platinum-resistant ovarian cancer. SIM0505 is an investigational antibody drug conjugate (ADC) comprised of an antibody that targets Cadherin-6 (CDH6) and a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The dose optimization study is intended to help finalize dose selection and further de-risk advancement toward registrational studies. The number of U.S. and China trial sites is being increased and the clinical site footprint is expanding into Canada and Europe. Phase 1 data will be presented at the 2026 American Society of Clinical Oncology (ASCO) conference. SIM0505 is a novel antibody drug conjugate (ADC) directed to cadherin-6 (CDH6 ADC), featuring a proprietary topoisomerase 1 inhibitor (TOPOi) payload. The ADC is designed for broad anti-tumor activity, fast systemic clearance and an improved potential therapeutic window. SIM0505 is being evaluated in an open-label, Phase 1 study (NCT06792552) for the potential treatment of advanced solid tumors, including ovarian cancer with an emphasis on platinum resistant ovarian cancer. The Food and Drug Administration granted Fast Track to SIM0505 for platinum-resistant ovarian cancer. NextCure holds exclusive global rights for SIM0505, excluding China, Hong Kong, Macau, and Taiwan which are retained by Simcere Zaiming Pharmaceutical Co., Ltd.