Phase 1a interim data for ongoing trial of CTIM-76 (CLDN6 x CD3) expected in June 2026
Phase 1a interim data for ongoing trial of CT-95 (MSLN x CD3) expected in September 2026
Cash and cash equivalents of $66.0 million as of December 31, 2025 expected to fund operations into mid-2027
PHILADELPHIA, March 23, 2026 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. ("Context" or the "Company") (Nasdaq: CNTX), a clinical-stage biopharmaceutical company advancing T cell engaging bispecific antibodies for solid tumors, today announced its financial results for the year ended December 31, 2025, and reported on recent and upcoming business highlights.
"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 June 2026. We are also continuing dose escalation for CT-95 toward target dose levels and expect to provide Phase 1a interim data for this trial in September 2026. Looking ahead, we anticipate dosing the first patient in our CT-202 Phase 1 trial in the third quarter of 2026," said Martin Lehr, CEO of Context.
"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 Mr. Lehr.
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.In November
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 the October 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 the
Society for Immunotherapy of Cancer's $(SITC)$ 40th Annual Meeting.
Corporate Highlights
-- In March 2026, presented at the TD Cowen 46th Annual Health Care
Conference, the Citizens Life Sciences Conference and the Leerink
Partners Global Healthcare Conference.
-- In February 2026, presented at the Guggenheim Emerging Outlook
Conference.
-- In November 2025, presented at the Guggenheim 2nd Annual Healthcare
Innovation Conference and the Stifel 2025 Healthcare Conference.
Fiscal Year 2025 Financial Results
-- Cash and cash equivalents were $66.0 million at December 31, 2025,
compared to $94.4 million at December 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 Context Therapeutics(R)
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, CT-95, a Mesothelin x CD3 TCE, and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia. 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" 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 June 2026, (ii) the Company's expectation to provide Phase 1a interim data, and host a webinar to present data, for CT-95 in September 2026, (iii) the Company's expectation to dose the first patient in its Phase 1 trial for CT-202 in the third quarter of 2026, (iv) the Company's expectation to have sufficient cash and cash equivalents to fund its operations into mid-2027, (v) the Company's expectation to deliver clinical updates throughout the remainder of 2026, (vi) the potential benefits, characteristics, and side effect profile of the Company's product candidates, (vii) the ability of the Company's product candidates to have benefits, characteristics, and a side effect profile that is differentiated and/or better than third party product candidates, (viii) the likelihood data will support future development, and (ix) the likelihood of obtaining regulatory approval of the Company's product candidates. Forward-looking statements in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and the Company therefore cannot assure the reader that its plans, intentions, expectations, or strategies will be attained or achieved. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in the Company's filings with the U.S. Securities and Exchange Commission, including the section titled "Risk Factors" contained therein. Except as otherwise required by law, the Company disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events, or circumstances or otherwise.
Context Therapeutics Inc.
Condensed Statements of Operations
(Unaudited)
Year Ended December 31,
------------------------------
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
Context Therapeutics Inc.
Condensed Balance Sheets Data
(Unaudited)
December 31, December 31,
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:
Jennifer Minai
Context Therapeutics Inc.
IR@contexttherapeutics.com
(END) Dow Jones Newswires
March 23, 2026 16:16 ET (20:16 GMT)
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