Context Therapeutics Inc. SEC 10-Q Report

Context Therapeutics Inc., a clinical-stage biopharmaceutical company focused on developing novel treatments for solid tumors, has released its Form 10-Q report for the third quarter of 2025. The report provides a comprehensive overview of the company's financial performance and significant business developments during the period.

Financial Highlights

• Net Loss: $4.6 million, reflecting a 25% increase compared to the same period in 2024 due to higher research and development expenses.
• Loss from Operations: $5.5 million, a 45% increase from the prior year, driven by increased spending on clinical trials and personnel-related costs.
• Net Loss Per Common Share, Basic and Diluted: $0.05, compared to $0.23 in the same period in 2024, reflecting a significant increase in weighted average shares outstanding.
• Interest Income: $0.96 million, a substantial increase of 529% from the previous year, primarily due to higher cash and cash equivalent balances.
• Research and Development Expenses: $3.5 million, up 76% from the prior year, mainly due to increased clinical trial activities and personnel costs.

Business Highlights

• [Product Development]: Context Therapeutics is advancing its portfolio of TCE bispecific antibodies for solid tumors, including CTIM-76, CT-95, and CT-202. CTIM-76 is in a Phase 1 trial for CLDN6-positive cancers, CT-95 has begun a Phase 1 trial, and CT-202 is expected to have an IND application filed by mid-2026.
• [Clinical Trials]: The company has initiated a Phase 1 trial for CTIM-76 in January 2025 and for CT-95 in April 2025. Initial data for these trials are expected in the first half and middle of 2026, respectively.
• [Licensing and Acquisitions]: Context Therapeutics entered into a license agreement with BioAtla for CT-202 and acquired CT-95 from Link. These strategic moves are aimed at expanding their pipeline of TCE bispecific antibodies.
• [Operational Strategy]: The company plans to continue scaling up its manufacturing capacity to meet clinical trial and potential commercialization needs. It is also focused on expanding its operations and infrastructure to support future growth.
• [Future Outlook]: Context Therapeutics expects to have sufficient cash to fund operations into 2027, including the dose escalation portions of its CTIM-76 and CT-95 Phase 1 trials and the expenses through IND filing for CT-202.
• [Personnel Changes]: Dr. Karen Smith has been appointed as interim chief medical officer following the termination of Dr. Claudio Dansky Ullmann, effective May 10, 2025.
• [Research and Development Focus]: The company is heavily investing in research and development, with significant increases in personnel-related costs and other R&D expenses to support its growing pipeline and clinical activities.

SEC Filing: Context Therapeutics Inc. [ CNTX ] - 10-Q - May. 07, 2025