Phase 1a interim data for ongoing trial of CTIM-76 (CLDN6 x CD3) expected in
Phase 1a interim data for ongoing trial of CT-95 (MSLN x CD3) expected in
Cash and cash equivalents of
“We believe 2025 was a year of significant progress for Context as we advanced our pipeline of T cell-engaging bispecific antibodies for solid tumors. We are on track to provide Phase 1a interim data for our CTIM-76 trial in
“Supported by an expected cash runway extending into mid-2027, we remain focused on execution and believe we are positioned to deliver multiple clinical updates throughout the remainder of 2026.” concluded
Recent and Upcoming Business Highlights
Pipeline Highlights
- CTIM-76: CLDN6 x CD3 bispecific TCE in Phase 1 dose escalation for patients with ovarian, endometrial or testicular cancer. Context anticipates completing the weekly (QW) dose escalation phase of the trial in the first half of 2026 and plans to evaluate every three week (Q3W) dosing in the second half of 2026. Context plans to host a company webinar to present CTIM-76 interim Phase 1a data in
June 2026 .
InNovember 2025 , Context presented early efficacy, safety, and pharmacokinetic data from Cohorts 1-4 in the ongoing Phase 1a dose escalation study of CTIM-76. As of theOctober 30, 2025 cutoff date, 12 patients received CTIM-76. Preliminary signs of anti-tumor activity, including an ongoing RECIST response (Response Evaluation Criteria in Solid Tumors), had been observed. No Cytokine Release Syndrome (“CRS”) greater than Grade 1 had been observed in any cohort. No dose limiting toxicity (“DLT”) had been observed and a maximum tolerated dose (“MTD”) had not been reached.
- CT-95: MSLN x CD3 bispecific TCE in Phase 1 dose escalation for patients with pancreatic, non-small cell lung, ovarian, mesothelioma and colorectal cancer. Context is evaluating CT-95 in a Phase 1a dose escalation study. Context plans to host a company webinar to present CT-95 interim Phase 1a data in
September 2026 . - CT-202: Nectin-4 x CD3 bispecific TCE in preclinical development for patients with bladder, non-small cell lung, colorectal, breast, and head and neck cancer. Context completed necessary regulatory filings to support the initiation of a first-in-human trial in
March 2026 and expects to dose the first patient in its CT-202 Phase 1 trial the third quarter of 2026. - In
November 2025 , Context presented a Trial in Progress poster for the Phase 1 clinical trial evaluating CT-95 as well as a poster for preclinical efficacy, safety and pharmacokinetic data for CT-202 at theSociety for Immunotherapy of Cancer’s (SITC) 40th Annual Meeting.
Corporate Highlights
- In
March 2026 , presented at theTD Cowen 46th AnnualHealth Care Conference , theCitizens Life Sciences Conference and theLeerink Partners Global Healthcare Conference . - In
February 2026 , presented at theGuggenheim Emerging Outlook Conference . - In
November 2025 , presented at the Guggenheim 2nd AnnualHealthcare Innovation Conference and the Stifel 2025 Healthcare Conference.
Fiscal Year 2025 Financial Results
- Cash and cash equivalents were
$66.0 million atDecember 31, 2025 , compared to$94.4 million atDecember 31, 2024 . The Company expects its cash and cash equivalents will be sufficient to fund its operations into mid-2027. - Research and development (“R&D”) expenses were
$31.9 million for 2025, as compared to$22.7 million in 2024. The increase in R&D expenses was primarily driven by higher CT-202 expense of$4.4 million , higher CTIM-76 expense of$1.3 million , and higher personnel-related costs of$3.3 million . R&D expense for 2024 included in-process research and development charges of$14.75 million related to the acquisition of CT-95 and in-licensing of CT-202 in that year. - General and administrative expenses were
$7.8 million for 2025, as compared to$7.2 million for 2024. The increase was primarily driven by increases in salaries and personnel-related costs, including share-based compensation. - Other income was
$3.6 million for 2025, as compared to$3.2 million for 2024, primarily due to higher interest income earned on cash and cash equivalent balances. - Context reported a net loss of
$36.1 million for 2025, as compared to$26.7 million for 2024.
About
Forward-looking Statements
This press release contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, included in this press release regarding strategy, future operations, prospects, plans and objectives of management, including words such as “may,” “will,” “expect,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are forward-looking statements. These include, without limitation, statements regarding (i) the Company’s expectation to provide Phase 1a interim data, and host a webinar to present data, for CTIM-76 in
| Condensed Statements of Operations | |||||||
| (Unaudited) | |||||||
| Year Ended | |||||||
| 2025 | 2024 | ||||||
| Operating Expenses | |||||||
| Research and development | $ | 31,856,252 | $ | 22,701,335 | |||
| General and administrative | 7,846,379 | 7,222,565 | |||||
| Loss from operations | (39,702,631 | ) | (29,923,900 | ) | |||
| Other income (expense), net | 3,579,016 | 3,198,796 | |||||
| Net loss | $ | (36,123,615 | ) | $ | (26,725,104 | ) | |
| Net loss per common share, basic and diluted | $ | (0.38 | ) | $ | (0.46 | ) | |
| Weighted average shares outstanding, basic and diluted | 95,185,683 | 58,416,141 | |||||
| Condensed Balance Sheets Data | |||||||
| (Unaudited) | |||||||
| 2025 | 2024 | ||||||
| Cash and cash equivalents | $ | 65,995,228 | $ | 94,429,824 | |||
| Other assets | 2,498,540 | 3,696,935 | |||||
| Total assets | $ | 68,493,768 | $ | 98,126,759 | |||
| Total liabilities | $ | 8,020,041 | $ | 2,860,497 | |||
| Total stockholders' equity | 60,473,727 | 95,266,262 | |||||
| Total liabilities and stockholders' equity | $ | 68,493,768 | $ | 98,126,759 | |||
Investor Relations Contact:
IR@contexttherapeutics.com
Source: 