CTIM-76 and CT-95 Phase 1 dose-escalation studies ongoing
Cash and cash equivalents of $83.5 million as of June 30, 2025
Company expects its cash and cash equivalents will continue to fund operations into 2027
PHILADELPHIA, Aug. 06, 2025 (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 second quarter ended June 30, 2025, and reported on recent and upcoming business highlights.
“We remain focused on progressing our clinical pipeline — CTIM-76, a selective Claudin 6 (“CLDN6”) x CD3 bispecific antibody, and CT-95, an avidity enhanced mesothelin (“MSLN”) x CD3 bispecific antibody,” said Martin Lehr, CEO of Context. “We expect to share initial dose escalation data for the CTIM-76 trial in the second quarter of 2026 and for the CT-95 trial by mid-2026.”
“We also expect to complete necessary regulatory filings to support the initiation of a first-in-human trial for CT-202, a potential best-in-class Nectin-4 x CD3 bispecific antibody, in the second quarter of 2026,” Mr. Lehr continued. “With cash runway into 2027, we believe we are well-positioned to achieve our goal of advancing our portfolio of innovative T cell-engaging therapies for solid tumors.”
Second Quarter 2025 Highlights
Pipeline Updates
- In June 2025, presented a Trial in Progress poster for the Phase 1 clinical trial evaluating CTIM-76 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
- In April 2025, presented preclinical and translational data for CT-95, a MSLN targeting T cell engager, at the American Association for Cancer Research (AACR) Annual Meeting 2025.
- In April 2025, announced the first patient dosed in our Phase 1 clinical trial evaluating CT-95 in patients with MSLN-expressing advanced solid tumors, including ovarian, pancreatic, lung, and mesothelioma cancers.
Corporate Updates and Presentations
- In June 2025, announced the appointment of Dr. Karen Chagin as Chief Medical Officer
- In May 2025, presented at the Citizens Life Sciences Conference.
- In April 2025, participated in the 24th Annual Needham Virtual Healthcare Conference.
Second Quarter 2025 Financial Results
- Cash and cash equivalents were $83.5 million at June 30, 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 2027.
- Research and development (“R&D”) expenses were $7.8 million for the second quarter of 2025, as compared to $1.4 million for the second quarter of 2024. The increase in R&D expenses was primarily driven by higher CT-202 expense of $3.1 million, higher CT-95 expense of $1.5 million and higher CTIM-76 expense of $0.1 million. CT-95 was acquired in July 2024 and CT-202 was in-licensed in September 2024. In addition, personnel-related costs increased by $1.6 million primarily due to higher headcount over the prior year period as well as termination benefits incurred related to employee departures.
- General and administrative expenses were $1.9 million for the second quarter of 2025, as compared to $1.7 million for the second quarter of 2024. The increase was primarily driven by a $0.2 million increase in personnel-related costs, including share-based compensation, mainly due to higher headcount and compensation adjustments.
- Other income was approximately $0.9 million for the second quarter of 2025, as compared to other income of $0.8 million for the second quarter of 2024, primarily due to higher interest income earned on cash and cash equivalent balances.
- Context reported a net loss of $8.8 million for the second quarter of 2025, as compared to a loss of $2.3 million for the second quarter of 2024.
About Context Therapeutics®
Context Therapeutics Inc. (Nasdaq: CNTX) is a biopharmaceutical company advancing T cell engaging (“TCE”) bispecific antibodies for solid tumors. Context is building 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) our expectation to share initial dose escalation data from the Phase 1 trials of CTIM-76 and CT-95 in the second quarter of 2026 and mid-2026, respectively, (ii) our expectation to complete necessary regulatory filings to support the initiation of a first-in-human trial for CT-202 in the second quarter of 2026, (iii) having sufficient cash and cash equivalents to fund our operations into 2027, (iv) the potential benefits, characteristics, and side effect profile of our product candidates, (v) the ability of our product candidates to have benefits, characteristics, and a side effect profile that is differentiated and/or better than third party product candidates, (vi) the likelihood data will support future development, and (vii) the likelihood of obtaining regulatory approval of our 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 we therefore cannot assure you that our 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 our filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as otherwise required by law, we disclaim 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) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating Expenses | |||||||||||||||
| Research and development | $ | 7,830,544 | $ | 1,384,553 | $ | 11,293,535 | $ | 3,357,762 | |||||||
| General and administrative | 1,927,818 | 1,703,996 | 3,993,970 | 3,554,288 | |||||||||||
| Loss from operations | (9,758,362 | ) | (3,088,549 | ) | (15,287,505 | ) | (6,912,050 | ) | |||||||
| Other income | 930,852 | 834,043 | 1,882,734 | 989,747 | |||||||||||
| Net loss | $ | (8,827,510 | ) | $ | (2,254,506 | ) | $ | (13,404,771 | ) | $ | (5,922,303 | ) | |||
| Net loss per common share, basic and diluted | ($0.09 | ) | ($0.04 | ) | ($0.14 | ) | ($0.17 | ) | |||||||
| Weighted average shares outstanding, basic and diluted | 95,186,935 | 54,958,635 | 95,186,935 | 35,462,344 | |||||||||||
| Context Therapeutics Inc. | |||||||||||||||
| Condensed Balance Sheets Data | |||||||||||||||
| (Unaudited) | |||||||||||||||
| June 30, | December 31, | ||||||||||||||
| 2025 | 2024 | ||||||||||||||
| Cash and cash equivalents | $ | 83,517,047 | $ | 94,429,824 | |||||||||||
| Other assets | 3,635,054 | 3,696,935 | |||||||||||||
| Total assets | $ | 87,152,101 | $ | 98,126,759 | |||||||||||
| Total liabilities | $ | 4,607,779 | $ | 2,860,497 | |||||||||||
| Total stockholders' equity | 82,544,322 | 95,266,262 | |||||||||||||
| Total liabilities and stockholders' equity | $ | 87,152,101 | $ | 98,126,759 | |||||||||||
Investor Relations Contact:
Jennifer Minai-Azary
Context Therapeutics
IR@contexttherapeutics.com
