Phase 1a interim data for ongoing CTIM-76 (CLDN6 x CD3) trial expected in June 2026
Phase 1a interim data for ongoing CT-95 (MSLN x CD3) trial expected in September 2026
Phase 1 initiation for CT-202 (Nectin-4 x CD3) trial expected in third quarter of 2026
Cash and cash equivalents of $54.5 million as of March 31, 2026 expected to fund operations into mid-2027
PHILADELPHIA, May 06, 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 its financial results for the first quarter ended March 31, 2026, and reported on recent and upcoming business highlights.
"We continue to execute across our pipeline and believe we are making meaningful scientific and operational progress," said Martin Lehr, Chief Executive Officer of Context Therapeutics. "We remain on track to report Phase 1a interim clinical data from our lead program, CTIM-76, in June 2026. This update is expected to include preliminary safety, efficacy, and other correlative results. In addition, we continue to anticipate reporting Phase 1a clinical data from our CT-95 program in September 2026."
Mr. Lehr added, "In April, we received approval in Australia to advance the development of CT-202, marking an important milestone as we prepare to initiate a first-in-human clinical study later this year. We look forward to evaluating CT-202 in the clinic, and we believe this program further supports our strategy of advancing differentiated T cell engaging therapeutics for patients with significant unmet medical needs."
Recent and Upcoming Business Highlights
Pipeline Highlights
- In April 2026, Context announced that the U.S. Food and Drug Administration ("FDA") granted Fast Track Designation to CTIM-76, a CLDN6 x CD3 TCE bispecific antibody, for the treatment of platinum-resistant ovarian cancer in patients that have received all standard of care therapies.
- In April 2026, Context presented preclinical data for CT-202, a Nectin-4 x CD3 TCE bispecific antibody, at the American Association for Cancer Research (AACR) Annual Meeting 2026.
- In April 2026, Context received Human Research Ethics Committee ("HREC") approval and Clinical Trial Notification ("CTN") acknowledgement by the Australian Therapeutic Goods Administration ("TGA") to initiate a first-in-human Phase 1 clinical trial of CT-202.
Corporate Highlights
- In March 2026, Context 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, Context presented at the Guggenheim Emerging Outlook Conference.
First Quarter 2026 Financial Results
- Cash and cash equivalents were $54.5 million at March 31, 2026, compared to $66.0 million at December 31, 2025. 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 $7.0 million for the first quarter of 2026, as compared to $3.5 million for the first quarter of 2025. The increase in R&D expenses was primarily driven by higher CTIM-76 expense of $1.2 million, higher CT-202 expense of $0.9 million, higher personnel-related costs of $0.8 million, and higher CT-95 expense of $0.6 million.
- General and administrative expenses were $2.3 million for the first quarter of 2026, as compared to $2.1 million for the first quarter of 2025. The increase was primarily driven by increases in salaries and personnel-related costs, including share-based compensation. Professional fees also increased by approximately $0.1 million as compared to the same period in 2025.
- Other income was $0.7 million for the first quarter of 2026, as compared to $1.0 million for the first quarter of 2025, primarily due to lower interest income earned on cash and cash equivalent balances.
- Context reported a net loss of $8.7 million for the first quarter of 2026, as compared to $4.6 million for the first quarter of 2025.
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, 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 for CTIM-76 in June 2026, (ii) the Company's expectation to provide Phase 1a interim 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 include preliminary safety, efficacy, and other correlative results in its Phase 1a interim data for CTIM-76 in June 2026; (v) the Company's belief that it is advancing differentiated T cell engaging therapeutics; (vi) the Company's expectation that its cash and cash equivalents will fund its operations into mid-2027, (vii) the potential benefits, characteristics, and side effect profile of the Company's product candidates, (viii) 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, (ix) the likelihood data will support future development, and (x) 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) | ||||||||||
| Three Months Ended March 31, | ||||||||||
| 2026 | 2025 | |||||||||
| Operating Expenses | ||||||||||
| Research and development | - | 7,015,299 | - | 3,462,991 | ||||||
| General and administrative | 2,328,500 | 2,066,152 | ||||||||
| Loss from operations | (9,343,799 | - | (5,529,143 | - | ||||||
| Other income, net | 663,227 | 951,882 | ||||||||
| Net loss | - | (8,680,572 | - | - | (4,577,261 | - | ||||
| Net loss per common share, basic and diluted | ($0.09 | - | ($0.05 | - | ||||||
| Weighted average shares outstanding, basic and diluted | 95,183,718 | 95,186,935 | ||||||||
| Context Therapeutics Inc. | ||||||||||
| Condensed Balance Sheets Data | ||||||||||
| (Unaudited) | ||||||||||
| March 31, | December 31, | |||||||||
| 2026 | 2025 | |||||||||
| Cash and cash equivalents | - | 54,528,596 | - | 65,995,228 | ||||||
| Other assets | 4,330,497 | 2,498,540 | ||||||||
| Total assets | - | 58,859,093 | - | 68,493,768 | ||||||
| Total liabilities | - | 6,656,718 | - | 8,020,041 | ||||||
| Total stockholders' equity | 52,202,375 | 60,473,727 | ||||||||
| Total liabilities and stockholders' equity | - | 58,859,093 | - | 68,493,768 | ||||||
Investor Relations Contact:
Jennifer Minai
Context Therapeutics Inc.
IR@contexttherapeutics.com
