Context Therapeutics Announces First Patient Dosed in Phase 1 Trial of CT-202

CT-202 is a Nectin-4 x CD3 T cell engaging bispecific antibody

Phase 1 trial is evaluating CT-202 as a monotherapy treatment in patients with urothelial, colorectal, and triple-negative breast cancers

PHILADELPHIA, Sept. 09, 2026 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors, today announced that the first patient has been dosed in the Phase 1 clinical trial of CT-202, a Nectin-4 x CD3 TCE bispecific antibody.

“Dosing the first patient in the Phase 1 trial of CT-202 marks an important milestone as we advance our differentiated Nectin-4 x CD3 program into the clinic,” said Martin Lehr, Chief Executive Officer of Context. “CT-202 is being evaluated as a potential monotherapy for patients with Nectin-4-positive tumors, where substantial unmet needs exist. We believe this study will provide important insights into CT-202’s safety, tolerability, pharmacokinetics and preliminary antitumor activity, and we look forward to reporting initial Phase 1a data in the second half of 2027.”

The Phase 1 study (NCT07545122) is an open-label, dose escalation trial designed to evaluate safety, tolerability, and preliminary efficacy in patients with Nectin-4 expressing recurrent, unresectable or metastatic refractory/resistant urothelial, colorectal and triple-negative breast cancers.

About CT-202

CT-202 is a Nectin-4 x CD3 TCE bispecific antibody that targets Nectin-4, a cell surface protein that is highly and frequently overexpressed in a variety of solid tumors, including bladder, colorectal, lung and breast. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate, but it is also associated with certain adverse events, including neuropathy and rash. CT-202 is a pH-dependent TCE that is designed to be preferentially active within the tumor microenvironment. More information about the CT-202 clinical trial (NCT07545122) can be found on https://clinicaltrials.gov/.

About Context Therapeutics^®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context’s goal is to build an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, a Claudin 6 x CD3 TCE and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia, PA. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn.

Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company’s strategy, future operations, prospects, and plans and objectives of management, are forward-looking statements. These statements may be identified by words such as “may,” “will,” “expect,” “believe,” “could,” “estimate,” “potential,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions.

Forward-looking statements in this press release include, without limitation, statements regarding: (i) plans related to the Company’s research and development activities, and the expected timing and potential results thereof; and (ii) other non-historical statements.

These forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied, and the Company cannot assure that its plans, intentions, expectations, or strategies will be achieved. These risks and uncertainties include, without limitation: (i) uncertainties regarding the Company’s expectations, projections, and estimates of future costs and expenses, capital requirements, the availability of additional financing and the Company’s capital requirements; (ii) the timing, progress, and results of the Company’s discovery, preclinical and clinical development activities; (iii) uncertainties regarding the Company’s ability to successfully implement its portfolio prioritization and capital allocation strategy, including the discontinuation of internal development of CT-95, and the possibility that the Company’s estimates of the costs, expenses, savings or other financial impacts associated with such prioritization may be incorrect or may change; (iv) clinical trial site activation and enrollment; (v) unexpected safety or efficacy data observed during preclinical studies or clinical trials; (vi) the risk that results from nonclinical or clinical studies may not be predictive of future results, and that interim data are subject to further analysis; (vii) uncertainties related to the regulatory approval process; (viii) the Company’s reliance on third parties; (ix) macroeconomic conditions; and (x) whether the Company has sufficient funding to meet future operating expenses and capital expenditure requirements. Additional factors that may cause actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the U.S. Securities and Exchange Commission (the “SEC”), and in the Company’s other filings with the SEC, including future reports.

Investor Relations Contact:
Jennifer Minai-Azary, Chief Financial Officer
Context Therapeutics Inc.
IR@contexttherapeutics.com