Context Therapeutics Inc. (NASDAQ:CNTX) is a biopharmaceutical company advancing medicines for solid tumors. The company's clinical-stage product candidate, CTIM-76, is an anti-Claudin 6 (CLDN6) x anti-CD3 bispecific antibody (bsAb) that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues.
Business Overview
Context Therapeutics was incorporated in April 2015 and is headquartered in Philadelphia, Pennsylvania. The company is focused on developing CTIM-76, its lead product candidate, for the treatment of CLDN6-positive solid tumors. CTIM-76 is designed to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6, a target that is highly expressed in various solid tumors but absent or expressed at low levels in healthy adult tissues.In addition to CTIM-76, the company was previously developing onapristone extended release (ONA-XR), a potentially first-in-class small molecule that inhibits the progesterone receptor. However, in March 2023, the company announced its decision to discontinue the development of ONA-XR and focus its efforts on the advancement of CTIM-76.
CTIM-76 Development Progress
Context Therapeutics has completed IND-enabling studies for CTIM-76 and on May 2, 2024, announced that the FDA cleared the company's Investigational New Drug (IND) application to support the initiation of a Phase 1 dose escalation and expansion trial of CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. The company anticipates enrolling the first patient in the dose escalation portion of the clinical trial in mid-2024.Financials
For the fiscal year ended December 31, 2023, Context Therapeutics reported an annual net loss of $23,964,211, with no revenue generated. The company's annual operating cash flow and free cash flow were both -$21,047,618.For the first quarter of 2024, the company reported a net loss of $3,667,797. Research and development expenses for the quarter were $1,973,209, while general and administrative expenses were $1,850,292. The company had cash and cash equivalents of $10,089,207 as of March 31, 2024.
Liquidity
As of March 31, 2024, Context Therapeutics had $10.1 million in cash and cash equivalents. On May 1, 2024, the company entered into a securities purchase agreement for a private placement that raised approximately $100 million in gross proceeds. The company expects that the net proceeds from the private placement, together with its existing cash and cash equivalents, will fund its operations into 2028, including the estimated duration of the planned CTIM-76 Phase 1 clinical trial.Risks and Challenges
Context Therapeutics faces several risks and challenges in the development and commercialization of CTIM-76. These include the need for additional financing to complete clinical trials and potential regulatory approval, the inherent risks of drug development, competition from other therapies, and the ability to successfully manufacture and commercialize CTIM-76 if approved.Additionally, the company is aware of issued patents in the United States and certain foreign jurisdictions that potentially cover certain of the intellectual property included in CTIM-76. While the company believes it will have reasonable defenses against any potential claim of infringement, it may not be successful in such efforts, and it also may not be able to obtain a license to such patent on commercially reasonable terms, or at all.