Announcement • 5h
Context Therapeutics Announces Positive Interim Efficacy and Safety Results from Ongoing Phase 1 Clinical Trial for Ctim-76 Context Therapeutics Inc. announced positive interim Phase 1 clinical data for its CLDN6 x CD3 T cell engaging bispecific antibody, CTIM-76, in advanced, late-line platinum-resistant ovarian cancer. The data are as of a May 29, 2026 data cutoff from the ongoing CTIM-76 Phase 1 study. CTIM-76 has been granted FDA Fast Track Designation in platinum-resistant ovarian cancer. 21 patients with platinum-resistant ovarian cancer (n=14), testicular (n=4), and endometrial (n=3) cancer were treated with CTIM-76 at doses ranging from 22.5µg to 560µg every week. At the active doses of 140µg to 280µg, 13 patients were treated in total, 10 of whom were efficacy evaluable, having had at least one post-baseline tumor assessment as of the data cutoff. 560µg exceeded target exposures with weekly dosing and was not pursued further. Patients (n=9) received a median of 7 prior lines of therapy (range 5-16). Prior patient treatments included ADC (89%), checkpoint inhibitor (55%), VEGF (100%), or DNA repair agent (78%). 44% of patients had liver metastases. As of the data cutoff, 7 platinum-resistant ovarian cancer patients were efficacy-evaluable at doses of 140µg to 280µg. Overall response rate: 29% of platinum-resistant ovarian cancer patients (2/7) achieved confirmed partial RECIST v. 1.1 responses. Disease control rate: 57% (4/7). In early cohort patients who achieved confirmed stable disease or partial response, treatment durability was sustained for at least 6 months (n=3). At active dose levels, CTIM-76 produced a favorable safety profile that is consistent with the expected mechanism of action for a T cell engager and supports continued clinical development. Adverse events generally occurred during the first or second dose and were predominantly low grade, with the majority of events reported as Grade 1 or Grade 2 and reversible with standard management. Cytokine Release Syndrome events were infrequent and limited to Grade 1 (11%, n=1/9) at active dose levels in platinum-resistant ovarian cancer patients, which may be supportive of outpatient dosing in future trials. Approximately dose-dependent increases in CTIM-76 exposure with increasing dose level. Preliminary pharmacokinetic supports exploration of every three weeks dosing schedule. CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric, and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on clinicaltrials.gov. Disease Control Rate: Patients achieving a confirmed response of stable disease, partial response, or complete response. New Risk • May 22
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 12% 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 Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Revenue is less than US$1m. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$67m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Announcement • Apr 02
Context Therapeutics Announces Ctim-76 Receives Fda Fast Track Designation for the Treatment of Platinum-Resistant Ovarian Cancer Context Therapeutics Inc. announced that the U.S. Food and Drug Administration has granted Fast Track Designation to CTIM-76, a CLDN6 x CD3 T cell engaging bispecific antibody, for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies. Context is currently evaluating CTIM-76 in a Phase 1 clinical trial designed to evaluate the safety and efficacy of CTIM-76 in subjects with CLDN6-positive advanced or metastatic ovarian, endometrial and testicular cancers. The dose escalation and dose expansion portions of the trial are expected to evaluate safety, tolerability and pharmacokinetics, as well as anti-tumor activity by overall response rate, duration of response and disease control rate. The FDA’s Fast Track Designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need. CTIM-76 is a CLDN6 x CD3 T cell engaging bispecific antibody. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, gastric and testicular. Preclinical research suggests the potential for convenient dosing with low immunogenicity risk and scalable manufacturing to address the significant number of patients who are potentially eligible for CTIM-76 therapy. More information about the CTIM-76 clinical trial (NCT06515613) can be found on clinicaltrials.gov. 
