CNTX
Context TherapeuticsBDocument history
Earnings documents stored for CNTX.
Investor releaseQuarter not tagged2026-08-05Context Therapeutics Reports Second Quarter 2026 Operating and Pipeline Progress
GlobeNewswire
Context Therapeutics Reports Second Quarter 2026 Operating and Pipeline Progress
Prioritization of CTIM-76 and CT-202 clinical programs, with initial clinical readouts expected beginning in Q2 2027 Cash and cash equivalents of $43.0 million as of June 30, 2026 expected to fund operations into Q4 2027 PHILADELPHIA, Aug. 05, 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 second quarter ended June 30, 2026, and reported on recent and upcoming business highlights. “During the second quarter, we advanced our pipeline and reported interim Phase 1a data from CTIM-76 in a limited number of heavily pretreated patients with platinum-resistant ovarian cancer (“PROC”) receiving weekly dosing,” said Martin Lehr, Chief Executive Officer of Context. “These data demonstrated encouraging interim efficacy and safety findings. We intend to evaluate CTIM-76 with every-three-week (“Q3W”) dosing in less heavily pretreated PROC patients in the second half of 2026, aiming to further characterize its clinical profile in a larger and more commercially relevant dataset.” Mr. Lehr added, “We also expect to dose the first patient in our Phase 1 clinical trial evaluating CT-202 in patients with Nectin-4-positive urothelial, colorectal, and triple-negative breast cancers in the third quarter of 2026, marking an important step in the clinical advancement of our Nectin-4 x CD3 TCE program.” Recent Pipeline Progress and Upcoming Milestones of Prioritized Clinical Programs: CTIM-76: CLDN6 x CD3 TCE Context is evaluating CTIM-76 as a monotherapy in a Phase 1 trial in patients with PROC. Recent Progress: April 2026: The U.S. Food and Drug Administration granted Fast Track Designation for the treatment of PROC in patients that have received all standard of care therapies June 2026: Presented interim Phase 1a safety, tolerability and efficacy data with weekly dosing in PROC patients Upcoming Expected Milestones: Q1 2027: Initiation of Phase 1b dose expansion trial Q2 2027: Phase 1a initial safety, tolerability and efficacy data with Q3W dosing in PROC patients CT-202: Nectin-4 x CD3 TCE Context is evaluating CT-202 as a monotherapy in a Phase 1 trial in patients with urothelial, colorectal, and triple-negative breast cancers. Recent Progress: April 2026: Human Researc…Read full documentShow less
Prioritization of CTIM-76 and CT-202 clinical programs, with initial clinical readouts expected beginning in Q2 2027 Cash and cash equivalents of $43.0 million as of June 30, 2026 expected to fund operations into Q4 2027 PHILADELPHIA, Aug. 05, 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 second quarter ended June 30, 2026, and reported on recent and upcoming business highlights. “During the second quarter, we advanced our pipeline and reported interim Phase 1a data from CTIM-76 in a limited number of heavily pretreated patients with platinum-resistant ovarian cancer (“PROC”) receiving weekly dosing,” said Martin Lehr, Chief Executive Officer of Context. “These data demonstrated encouraging interim efficacy and safety findings. We intend to evaluate CTIM-76 with every-three-week (“Q3W”) dosing in less heavily pretreated PROC patients in the second half of 2026, aiming to further characterize its clinical profile in a larger and more commercially relevant dataset.” Mr. Lehr added, “We also expect to dose the first patient in our Phase 1 clinical trial evaluating CT-202 in patients with Nectin-4-positive urothelial, colorectal, and triple-negative breast cancers in the third quarter of 2026, marking an important step in the clinical advancement of our Nectin-4 x CD3 TCE program.” Recent Pipeline Progress and Upcoming Milestones of Prioritized Clinical Programs: CTIM-76: CLDN6 x CD3 TCE Context is evaluating CTIM-76 as a monotherapy in a Phase 1 trial in patients with PROC. Recent Progress: April 2026: The U.S. Food and Drug Administration granted Fast Track Designation for the treatment of PROC in patients that have received all standard of care therapies June 2026: Presented interim Phase 1a safety, tolerability and efficacy data with weekly dosing in PROC patients Upcoming Expected Milestones: Q1 2027: Initiation of Phase 1b dose expansion trial Q2 2027: Phase 1a initial safety, tolerability and efficacy data with Q3W dosing in PROC patients CT-202: Nectin-4 x CD3 TCE Context is evaluating CT-202 as a monotherapy in a Phase 1 trial in patients with urothelial, colorectal, and triple-negative breast cancers. Recent Progress: April 2026: Human Research Ethics Committee approval and Clinical Trial Notification acknowledgement by the Australian Therapeutic Goods Administration to initiate a first-in-human Phase 1 clinical trial May 2026: Entered into a License Agreement Amendment with BioAtla, Inc. removing all future milestones and royalty obligations owed Upcoming Expected Milestones: 3Q 2026: First patient dosed in Phase 1 trial 2H 2027: Phase 1a initial topline safety, tolerability and early efficacy data CT-95: MSLN x CD3 TCE As part of a portfolio prioritization and capital allocation strategy, Context is discontinuing the development of CT-95 and will focus its development efforts on CTIM-76 and CT-202. Second Quarter 2026 Financial Results Cash and cash equivalents were $43.0 million at June 30, 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 the fourth quarter of 2027. Research and development (“R&D”) expenses were $12.5 million for the second quarter of 2026, as compared to $7.8 million for the second quarter of 2025. The increase in R&D expenses compared to the second quarter was primarily driven by higher CT-202 expense of $4.4 million and higher CTIM-76 expense of $0.8 million. The increase in CT-202 expense was primarily a result of a higher in-process research and development charge of $6.5 million related to consideration paid to amend the BioAtla license agreement for CT-202, offset by lower contract manufacturing and preclinical expenses. These increases were partially offset by lower personnel-related costs of $0.5 million. General and administrative expenses were $2.4 million for the second quarter of 2026, as compared to $1.9 million for the second quarter of 2025. The increase was primarily driven by higher professional fees of $0.3 million and an increase of $0.2 million in salaries and personnel-related costs, including share-based compensation as compared to the same period in 2025. Other income was $0.4 million for the second quarter of 2026, as compared to $0.9 million for the second quarter of 2025, primarily due to lower interest income earned on cash and cash equivalent balances. Context reported a net loss of $14.6 million for the second quarter of 2026, as compared to $8.8 million for the second 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 and CT-202, a Nectin-4 x CD3 TCE. Context is headquartered in Philadelphia, PA. For more information, please visit www.contexttherapeutics.com or follow the Company on X (formerly Twitter) and LinkedIn. Forward-looking StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company’s strategy, future operations, prospects, and plans and objectives of management, are forward-looking statements. These statements may be identified by words such as “may,” “will,” “expect,” “believe,” “could,” “estimate,” “potential,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions. Forward-looking statements in this press release include, without limitation, statements regarding: (i) plans related to the Company’s research and development activities, and the expected timing and potential results thereof; (ii) the Company’s expectations regarding its portfolio prioritization and capital allocation strategy, including the discontinuation of internal development of CT-95; (iii) the Company’s expectation regarding the sufficiency of its cash and cash equivalents; (iv) the Company’s expectation to dose less heavily pretreated PROC patients in the CTIM-76 Phase 1a trial and characterize its clinical profile; and (v) other non-historical statements. These forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied, and the Company cannot assure that its plans, intentions, expectations, or strategies will be achieved. These risks and uncertainties include, without limitation: (i) uncertainties regarding the Company’s expectations, projections, and estimates of future costs and expenses, capital requirements, the availability of additional financing and the Company’s capital requirements; (ii) the timing, progress, and results of the Company’s discovery, preclinical and clinical development activities; (iii) uncertainties regarding the Company’s ability to successfully implement its portfolio prioritization and capital allocation strategy, including the discontinuation of internal development of CT-95, and the possibility that the Company’s estimates of the costs, expenses, savings or other financial impacts associated with such prioritization may be incorrect or may change; (iv) clinical trial site activation and enrollment; (v) unexpected safety or efficacy data observed during preclinical studies or clinical trials; (vi) the risk that results from nonclinical or clinical studies may not be predictive of future results, and that interim data are subject to further analysis; (vii) uncertainties related to the regulatory approval process; (viii) the Company’s reliance on third parties; (ix) macroeconomic conditions; and (x) whether the Company has sufficient funding to meet future operating expenses and capital expenditure requirements. Additional factors that may cause actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the U.S. Securities and Exchange Commission (the “SEC”), and in the Company’s other filings with the SEC, including future reports. Investor Relations Contact:Jennifer Minai-Azary, Chief Financial OfficerContext Therapeutics [email protected]
Investor releaseQuarter not tagged2026-06-15Context Therapeutics Announces Positive Interim Efficacy and Safety Results from Ongoing Phase 1 Clinical Trial for CTIM-76
GlobeNewswire
Context Therapeutics Announces Positive Interim Efficacy and Safety Results from Ongoing Phase 1 Clinical Trial for CTIM-76
29% confirmed overall response rate per RECIST v1.1 in patients with platinum-resistant ovarian cancer (“PROC”) who progressed on a median of 7 prior lines of therapy Cytokine Release Syndrome (“CRS”) in PROC limited to Grade 1 in 11% of patients Pharmacokinetic (“PK”) profile supports exploration of Q3W dosing in 2H 2026 CTIM-76 has been granted FDA Fast Track Designation in PROC Company to host conference call on Monday, June 15 at 8:00 a.m. ET PHILADELPHIA, June 15, 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 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 (“PROC”). The data are as of a May 29, 2026 data cutoff from the ongoing CTIM-76 Phase 1 study. “We are encouraged by the continued development of CTIM-76 as a potentially best-in-class CLDN6 T cell engager that may offer a much-needed new therapeutic approach for patients with platinum-resistant ovarian cancer,” said Martin Lehr, Chief Executive Officer of Context. “In our first clinical presentation of dose-escalation data, weekly administration of CTIM-76 produced compelling anti-tumor activity and a well-tolerated safety profile in heavily pretreated patients, many of whom had extensive prior exposure to antibody-drug conjugates. Building on this encouraging data, we have advanced into the next phase of development, where we will evaluate CTIM-76 administered every three weeks (“Q3W”). These results are expected to inform subsequent Phase 1b dose expansion in 2027.” CTIM-76 Phase 1a Interim Data Summary: 21 patients with PROC (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 (“QW”). 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 QW dosing and was not pursued further. PROC Patient Characteristics: 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%)…Read full documentShow less
29% confirmed overall response rate per RECIST v1.1 in patients with platinum-resistant ovarian cancer (“PROC”) who progressed on a median of 7 prior lines of therapy Cytokine Release Syndrome (“CRS”) in PROC limited to Grade 1 in 11% of patients Pharmacokinetic (“PK”) profile supports exploration of Q3W dosing in 2H 2026 CTIM-76 has been granted FDA Fast Track Designation in PROC Company to host conference call on Monday, June 15 at 8:00 a.m. ET PHILADELPHIA, June 15, 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 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 (“PROC”). The data are as of a May 29, 2026 data cutoff from the ongoing CTIM-76 Phase 1 study. “We are encouraged by the continued development of CTIM-76 as a potentially best-in-class CLDN6 T cell engager that may offer a much-needed new therapeutic approach for patients with platinum-resistant ovarian cancer,” said Martin Lehr, Chief Executive Officer of Context. “In our first clinical presentation of dose-escalation data, weekly administration of CTIM-76 produced compelling anti-tumor activity and a well-tolerated safety profile in heavily pretreated patients, many of whom had extensive prior exposure to antibody-drug conjugates. Building on this encouraging data, we have advanced into the next phase of development, where we will evaluate CTIM-76 administered every three weeks (“Q3W”). These results are expected to inform subsequent Phase 1b dose expansion in 2027.” CTIM-76 Phase 1a Interim Data Summary: 21 patients with PROC (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 (“QW”). 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 QW dosing and was not pursued further. PROC Patient Characteristics: 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. Efficacy Results: As of the data cutoff, 7 PROC patients were efficacy-evaluable at doses of 140µg to 280µg. Overall response rate (ORR): 29% of PROC patients (2/7) achieved confirmed partial RECIST v. 1.1 responses. Disease control rate (DCR)1: 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). Safety Results: 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. CRS events were infrequent and limited to Grade 1 (11%, n=1/9) at active dose levels in PROC patients, which may be supportive of outpatient dosing in future trials. Pharmacokinetic Results: Approximately dose-dependent increases in CTIM-76 exposure with increasing dose level. Preliminary PK supports exploration of Q3W dosing schedule. Investor Webcast and Conference Call InformationThe Company will host a conference call to discuss these data at 8:00 a.m. ET today, June 15, 2026. Participants may access the live webcast of the conference call from the “News & Events” page of the Company’s website at www.contexttherapeutics.com. Participants may register for the conference call here and are advised to do so at least 10 minutes prior to joining the call. The webcast will be available for replay for at least 90 days on the Company’s website. About CTIM-76CTIM-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 https://clinicaltrials.gov/. About Context Therapeutics®Context Therapeutics Inc. (Nasdaq: CNTX) is a clinical-stage 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 StatementsThis press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact, including statements regarding the Company’s strategy, future operations, prospects, and plans and objectives of management, are forward-looking statements. These statements may be identified by words such as “may,” “will,” “expect,” “believe,” “could,” “estimate,” “potential,” “anticipate,” “look forward,” “plan,” “intend,” and similar expressions. Forward-looking statements in this press release include, without limitation, statements regarding (i) expectations of CTIM-76 Q3W dosing in the second half of 2026 and that CTIM-76 Q3W data will be available to inform subsequent dose expansion, (ii) expectations of CTIM-76 Phase 1b clinical trial development to occur in 2027; (iii) expectations that CTIM-76 may potentially be a best-in-class CLDN6 T cell engager; (iv) expectations that CTIM-76 could be a new therapeutic approach for patients with platinum-resistant ovarian cancer; and (v) other non-historical statements. These forward-looking statements involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied, and the Company cannot assure that its plans, intentions, expectations, or strategies will be achieved. These risks and uncertainties include, without limitation: (i) uncertainties regarding the Company’s expectations, projections, and estimates of future costs and expenses, capital requirements, the availability of additional financing and the Company’s capital requirements; (ii) the timing, progress, and results of the Company’s discovery, preclinical and clinical development activities; (iii) clinical trial site activation and enrollment; (iv) unexpected safety or efficacy data observed during preclinical studies or clinical trials; (v) the risk that results from nonclinical or clinical studies may not be predictive of future results, and that interim data are subject to further analysis; (vi) uncertainties related to the regulatory approval process; (vii) the Company’s reliance on third parties; (viii) macroeconomic conditions; and (ix) whether the Company has sufficient funding to meet future operating expenses and capital expenditure requirements. Additional factors that may cause actual results to differ materially from those expressed or implied in the forward-looking statements in this press release are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the U.S. Securities and Exchange Commission (the “SEC”), and in the Company’s other filings with the SEC, including future reports. Except as required by law, the Company undertakes no obligation to update or revise any forward-looking statements, which speak only as of the date of this press release, whether as a result of new information, future events or otherwise. Investor Relations Contact:Jennifer Minai-AzaryChief Financial OfficerContext [email protected] 1 Disease Control Rate: Patients achieving a confirmed response of stable disease, partial response, or complete response.
Investor releaseQuarter not tagged2026-05-07Context Therapeutics Reports First Quarter 2026 Operating and Financial Results
GlobeNewswire
Context Therapeutics Reports First Quarter 2026 Operating and Financial Results
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…Read full documentShow less
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. Investor Relations Contact: Jennifer Minai Context Therapeutics Inc. [email protected]
Investor releaseQuarter not tagged2026-03-24Context Therapeutics Reports Full Year 2025 Operating and Financial Results
GlobeNewswire
Context Therapeutics Reports Full Year 2025 Operating and Financial Results
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 t…Read full documentShow less
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® 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. Investor Relations Contact: Jennifer Minai Context Therapeutics Inc. [email protected]
Investor releaseQuarter not tagged2025-11-14BioAtla Inc (BCAB) Q3 2025 Earnings Call Highlights: Strategic Partnerships and Promising Trial ...
GuruFocus.com
BioAtla Inc (BCAB) Q3 2025 Earnings Call Highlights: Strategic Partnerships and Promising Trial ...
This article first appeared on GuruFocus. Release Date: November 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioAtla Inc (NASDAQ:BCAB) is in advanced stages of finalizing a strategic transaction with a potential partner by year-end. The company achieved FDA alignment on the phase three OSV registrational trial design for treating second-line plus oropharyngeal squamous cell carcinoma (OPSCC). BioAtla Inc (NASDAQ:BCAB) presented compelling data from multiple programs, validating the potential of their CAB platform for treating difficult cancers. A development milestone was achieved under a license agreement with Context Therapeutics, providing non-dilutive capital and validating the CAB T-cell engager platform. The company estimates worldwide peak sales of their product for OPSCC to be approximately $800 million, with the total market projected to reach $3 billion by 2032. BioAtla Inc (NASDAQ:BCAB) reported a net loss of $15.8 million for the third quarter of 2025, an increase from the $10.6 million loss in the same quarter of 2024. The company's cash and cash equivalents stood at $8.3 million as of September 30, 2025, indicating limited financial resources. There was a $2.1 million non-cash loss on warrant liability recorded in the third quarter of 2025. Research and development expenses decreased by $6.9 million due to reduced program development costs and workforce reduction, which may impact future innovation. General and administrative expenses decreased by $1.7 million, primarily due to reduced personnel costs, which could affect operational efficiency. Warning! GuruFocus has detected 3 Warning Signs with BCAB. Is BCAB fairly valued? Test your thesis with our free DCF calculator. Q: Could you provide more details on the patient numbers required for accelerated approval in the RR2 program's phase 3 study, and is there any stratification for the control arm? A: (Dr. Eric Sievers, Chief Medical Officer) For full approval, we are looking at approximately 300 patients that are prospectively randomized and stratified. For accelerated approval, there will be an interim analysis around the time of full enrollment. Stratification factors, such as P16 status and local regional disease presence, will ensure equal distribution of patients across the two arms. Q: What kind of data can we expect for th…Read full documentShow less
This article first appeared on GuruFocus. Release Date: November 13, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. BioAtla Inc (NASDAQ:BCAB) is in advanced stages of finalizing a strategic transaction with a potential partner by year-end. The company achieved FDA alignment on the phase three OSV registrational trial design for treating second-line plus oropharyngeal squamous cell carcinoma (OPSCC). BioAtla Inc (NASDAQ:BCAB) presented compelling data from multiple programs, validating the potential of their CAB platform for treating difficult cancers. A development milestone was achieved under a license agreement with Context Therapeutics, providing non-dilutive capital and validating the CAB T-cell engager platform. The company estimates worldwide peak sales of their product for OPSCC to be approximately $800 million, with the total market projected to reach $3 billion by 2032. BioAtla Inc (NASDAQ:BCAB) reported a net loss of $15.8 million for the third quarter of 2025, an increase from the $10.6 million loss in the same quarter of 2024. The company's cash and cash equivalents stood at $8.3 million as of September 30, 2025, indicating limited financial resources. There was a $2.1 million non-cash loss on warrant liability recorded in the third quarter of 2025. Research and development expenses decreased by $6.9 million due to reduced program development costs and workforce reduction, which may impact future innovation. General and administrative expenses decreased by $1.7 million, primarily due to reduced personnel costs, which could affect operational efficiency. Warning! GuruFocus has detected 3 Warning Signs with BCAB. Is BCAB fairly valued? Test your thesis with our free DCF calculator. Q: Could you provide more details on the patient numbers required for accelerated approval in the RR2 program's phase 3 study, and is there any stratification for the control arm? A: (Dr. Eric Sievers, Chief Medical Officer) For full approval, we are looking at approximately 300 patients that are prospectively randomized and stratified. For accelerated approval, there will be an interim analysis around the time of full enrollment. Stratification factors, such as P16 status and local regional disease presence, will ensure equal distribution of patients across the two arms. Q: What kind of data can we expect for the 3,182 program next year? A: (Dr. Eric Sievers, Chief Medical Officer) We anticipate a comprehensive data output in the first half of next year, reporting on additional dose and schedule evaluations. This will provide a thorough account of the patient experience. Q: Can you elaborate on the strategic transaction you mentioned? A: (Dr. Jay Short, Chairman, CEO, and Co-founder) We are in advanced stages to finalize a strategic transaction with a potential partner by year-end. This aligns with our goal of advancing our programs and represents a significant opportunity for BioAtla. Q: What is the market opportunity for the OSV program? A: (Sherri Leyck, Chief Commercial Officer) The OSV program targets a significant unmet need in OPSCC, with worldwide peak sales estimated at approximately $800 million for second-line and later OPSCC alone. The total worldwide OPSCC market is projected to reach $3 billion by 2032, with the broader HPV-positive solid tumor market exceeding $7 billion globally. Q: How is the financial outlook for BioAtla, considering recent developments? A: (Richard Waldron, Chief Financial Officer) As of September 30, 2025, we had $8.3 million in cash and cash equivalents. We received a $2 million milestone payment from Context Therapeutics, reflecting progress in our T-cell engager platform. We expect R&D expenses to decline as we focus on prioritized programs. For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2025-11-14BioAtla Reports Third Quarter 2025 Financial Results and Highlights Recent Progress
GlobeNewswire
BioAtla Reports Third Quarter 2025 Financial Results and Highlights Recent Progress
Company achieved FDA alignment on Phase 3 Oz-V trial for the treatment of 2L+ OPSCC, which will evaluate dual primary endpoints with potential of achieving accelerated approval followed by full approval Company is in advanced stages to finalize a strategic transaction with a potential partner and we remain on track to complete the transaction by year end BA3182 trial in advanced adenocarcinomas is currently ongoing and evaluating various dosing and treatment schedules with a readout expected in the first half of 2026 Achieved milestone with Context Therapeutics under the license agreement for the CAB-Nectin4-TCE reflecting continued progress and validation of BioAtla’s differentiated CAB T-cell engager platform Management to host a conference call and webcast today at 4:30 p.m. Eastern Time SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced its financial results for the third quarter ended September 30, 2025 and provided highlights on its clinical programs. “We remain on track for completing a partnership transaction by year end.” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla. “In addition, we’ve achieved FDA alignment on our Phase 3 registrational Oz-V trial design, and we continue to be encouraged by our CAB T-cell engagers progress with the achievement of the recent CAB-Nectin4-TCE milestone and the promising data from CAB-EpCAM-TCE, or BA3182, recently presented at ESMO.” Key Developments, Operational Updates and Upcoming Milestones Key Outcomes from end of Phase 2 FDA Type B Meeting and other updates for Fast Track Designated Oz-V (CAB-ROR2-ADC) (NCT05271604) As announced in September (HERE for news release), the Company achieved FDA alignment on the planned Phase 3 Oz-V trial design, dosing regimen, the comparator arm and approval endpoints for the treatment of 2L+ OPSCC – which represents a sizable and steadily growing patient population poorly served by EGFR inhibitors and other standard of care regimens This randomized, Phase 3 trial will evaluate dual primary endpoints of overall response rate and overall survival (OS) with the potential of achieving accelerated approval followed by full approval Continu…Read full documentShow less
Company achieved FDA alignment on Phase 3 Oz-V trial for the treatment of 2L+ OPSCC, which will evaluate dual primary endpoints with potential of achieving accelerated approval followed by full approval Company is in advanced stages to finalize a strategic transaction with a potential partner and we remain on track to complete the transaction by year end BA3182 trial in advanced adenocarcinomas is currently ongoing and evaluating various dosing and treatment schedules with a readout expected in the first half of 2026 Achieved milestone with Context Therapeutics under the license agreement for the CAB-Nectin4-TCE reflecting continued progress and validation of BioAtla’s differentiated CAB T-cell engager platform Management to host a conference call and webcast today at 4:30 p.m. Eastern Time SAN DIEGO, Nov. 13, 2025 (GLOBE NEWSWIRE) -- BioAtla, Inc. (Nasdaq: BCAB), a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics for the treatment of solid tumors, today announced its financial results for the third quarter ended September 30, 2025 and provided highlights on its clinical programs. “We remain on track for completing a partnership transaction by year end.” said Jay M. Short, Ph.D., Chairman, Chief Executive Officer and co-founder of BioAtla. “In addition, we’ve achieved FDA alignment on our Phase 3 registrational Oz-V trial design, and we continue to be encouraged by our CAB T-cell engagers progress with the achievement of the recent CAB-Nectin4-TCE milestone and the promising data from CAB-EpCAM-TCE, or BA3182, recently presented at ESMO.” Key Developments, Operational Updates and Upcoming Milestones Key Outcomes from end of Phase 2 FDA Type B Meeting and other updates for Fast Track Designated Oz-V (CAB-ROR2-ADC) (NCT05271604) As announced in September (HERE for news release), the Company achieved FDA alignment on the planned Phase 3 Oz-V trial design, dosing regimen, the comparator arm and approval endpoints for the treatment of 2L+ OPSCC – which represents a sizable and steadily growing patient population poorly served by EGFR inhibitors and other standard of care regimens This randomized, Phase 3 trial will evaluate dual primary endpoints of overall response rate and overall survival (OS) with the potential of achieving accelerated approval followed by full approval Continue preparations for initiation of the Oz-V Phase 3 study in 2L+ OPSCC; on track to advance with a strategic partner in early 2026. Dose-escalation for dual conditionally binding BA3182 (CAB-EpCAM x CAB-CD3-TCE) (NCT05808634) in heavily pretreated patients with unresectable or metastatic adenocarcinoma Preliminary data were presented at ESMO 2025 (HERE for more details) from the ongoing dose -escalation portion of the Phase 1 study in advanced adenocarcinomas Observed prolonged tumor control with increasing BA3182 doses; a confirmed partial response (cPR) at 0.6 mg is ongoing for more than six months in a patient with intrahepatic cholangiocarcinoma Adverse events were generally transient and readily manageable; only two cases of cytokine release syndrome (CRS) were reported as of the September 10, 2025 cut-off The trial is currently ongoing and evaluating various dosing and treatment schedules with a readout expected in the first half of 2026 Additional readouts from the expansion portion of the study are expected later in 2026 Phase 2 study of conditionally active mecbotamab vedotin (Mec-V) (CAB-AXL-ADC) (NCT03425279) alone and in combination with nivolumab in adult and adolescent patients with soft tissue sarcomas Data were from 44 evaluable patients with leiomyosarcoma, liposarcoma, and undifferentiated pleomorphic sarcoma were presented at SITC 2025 (HERE for more details) with encouraging median OS of 21.5 months The 12-month OS rate was 73%, compared to approximately 50% historically reported for approved agents in similar populations Adverse events were generally low-grade, transient, and manageable; no treatment-related deaths were reported as of the March 25, 2025 cut-off These encouraging OS observations are directionally consistent with prior experience in mKRAS NSCLC from the ongoing Phase 2 trial of Mec-V (NCT04681131; HERE for more information) in mKRAS NSCLC (median of 3 prior lines of treatment) Recent Poster Presentations at: Society for Immunotherapy of Cancer (SITC) 2025 Annual Meeting in National Harbor, MD in November titled “Median OS of 21.5 Months Among 44 Patients with Treatment-Refractory Leiomyosarcoma, Liposarcoma, and Undifferentiated Pleomorphic Sarcoma Treated with Mecbotamab Vedotin, an AXL-targeting ADC” 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany in October titled “Results from a Phase 1 Dose Escalation Study of BA3182, a Dual-Conditionally Active Biologic (CAB) EpCAM x CD3 Bispecific T-cell Engager in Patients with Treatment Refractory Metastatic Adenocarcinoma” Annual Conference of the International Papillomavirus Society (IPVS) in Bangkok, Thailand in October titled “Targeting HPV E6/E7 Upregulation of the Transmembrane Receptor Tyrosine Kinase ROR2 with the ADC Ozuriftamab Vedotin in Patients with Advanced HPV+ Oropharyngeal Squamous Cell Carcinoma” A copy of these presentation materials can be accessed on the “Publication” section of the Company’s website at www.bioatla.com. Third Quarter 2025 Financial Results Research and development (R&D) expenses were $9.5 million for the quarter ended September 30, 2025, compared to $16.4 million for the same quarter in 2024. The $6.9 million decrease was primarily driven by lower program development costs due to prioritization of clinical programs, lower headcount-related expenses following the workforce reduction announced in March 2025, and lower non-cash stock-based compensation. We continue to expect R&D expenses to decline through the remainder of 2025 as we concentrate resources on our prioritized programs. In October 2025, Context Therapeutics triggered a $2 million milestone payment under the license agreement for the CAB-Nectin4-TCE program. The payment was received recently and reflects continued progress and validation of BioAtla’s differentiated T-cell engager platform. General and administrative (G&A) expenses were $4.2 million for the quarter ended September 30, 2025, compared to $5.9 million for the same quarter in 2024. The $1.7 million decrease was primarily attributable to reduced personnel costs related to the workforce reduction in March 2025, and lower stock-based compensation expense. Net loss for the quarter ended September 30, 2025 was $15.8 million, compared to a net loss of $10.6 million for the same quarter in 2024 which included $11.0 million in collaboration revenue from our license with Context Therapeutics. The increase in net loss was primarily due to the collaboration revenue recorded in 2024, a $2.1 million non-cash loss on warrant liability recorded in Q3 2025 related to warrants issued in our December 2024 financing, offset by decreases in R&D and G&A expense described above. Cash and cash equivalents as of September 30, 2025 were $8.3 million, not including the $2 million milestone payment or any R&D funding from the collaboration. The Company is in advanced stages to finalize a strategic transaction with a potential partner and we remain on track to complete the transaction by year end. Third Quarter 2025 Conference Call and Webcast Details The management of BioAtla, Inc. will host a conference call and webcast for the investment community today, November 13, 2025, at 4:30 p.m. Eastern Time. A live webcast may be accessed here: BioAtla Third Quarter 2025 Earnings Conference Call. The conference call can be accessed by dialing toll-free (800)-343-4136 (domestic) or (203)-518-9843 (international). The passcode for the conference call is BIOATLA. A replay of the webcast and slides with topline interim clinical data referenced on the call will be available under “Events & Presentations” in the Investors section of the Company’s website after the conclusion of the presentation and will be archived on the BioAtla website for one year. About CAB-EpCAM x CAB-CD3 Bispecific T-cell Engager Antibody BioAtla is developing BA3182 as a potential anticancer therapy for patients with advanced adenocarcinoma. BA3182 is a (CAB) EpCAM x (CAB) CD3 bispecific T cell engager antibody that contains two binding sites for EpCAM and two binding sites for CD3ε. The binding sites for EpCAM and CD3ε have been designed to bind their respective targets specifically and reversibly under the conditions found in the TME and to have reduced binding outside of the TME. The CAB selective binding to both the CAB EpCAM and CAB CD3ε arms are required to activate the T cell engagement against the tumor, thus enabling the combined selectivity of each CAB binding arm in the bispecific antibody. BioAtla continues to advance the ongoing Phase 1 study to evaluate the safety, pharmacokinetics, and efficacy of BA3182 in advanced adenocarcinoma patients. About Ozuriftamab Vedotin (Oz-V) Ozuriftamab vedotin (Oz-V), CAB-Platform-ROR2-ADC, is a conditionally and reversibly active antibody drug conjugate directed against ROR2, a transmembrane receptor tyrosine kinase that is present across many different solid tumors including head and neck, lung, triple-negative breast cancer and melanoma. Overexpression of ROR2, a noncanonical wnt5A signaling receptor, is driven by oncoproteins associated with HPV infection and forms a cancer axis that is associated with poor prognosis and resistance to chemo- and immunotherapies. This Phase 3 ready clinical asset is targeting multiple solid tumor indications, including the treatment of patients with HPV+ OPSCC who have previously experienced progression on PD-1/L1 therapies and platinum chemotherapy. The FDA granted Fast Track Designation to ozuriftamab vedotin for the treatment of patients with recurrent or metastatic SCCHN. About Mecbotamab Vedotin (Mec-V) Mecbotamab vedotin (Mec-V), CAB-Platform-AXL-ADC, is a conditionally and reversibly active antibody drug conjugate targeting the receptor tyrosine kinase AXL. This Phase 2 stage clinical asset is targeting multiple solid tumor indications, including the treatment of mKRAS NSCLC and soft tissue sarcoma. About BioAtla®, Inc. BioAtla is a global clinical-stage biotechnology company with operations in San Diego, California, and in Beijing, China through its contractual relationship with BioDuro-Sundia, a provider of preclinical development services. Utilizing its proprietary CAB platform technology, BioAtla develops novel, reversibly active monoclonal and bispecific antibodies and other protein therapeutic product candidates. CAB product candidates are designed to have more selective targeting, greater efficacy with lower toxicity, and more cost-efficient and predictable manufacturing than traditional antibodies. BioAtla has extensive and worldwide patent coverage for its CAB platform technology and products with greater than 780 active patent matters, more than 500 of which are issued patents. Broad patent coverage in all major markets include methods of making, screening and manufacturing CAB product candidates in a wide range of formats and composition of matter coverage for specific products. To learn more about BioAtla, Inc., visit www.bioatla.com. About Context Therapeutics Worldwide License Agreement for CAB-Nectin-4 x CD3 TCE In September 2024, BioAtla and Context Therapeutics announced an exclusive worldwide license agreement to develop and commercialize BA3362, a Nectin-4 x CD3 TCE antibody. Under the terms of the agreement, BioAtla is eligible to receive up to $133.5 million in aggregate payments, as well as tiered royalties on net sales. BA3362 targets Nectin-4, which is highly and frequently overexpressed in a variety of cancers. Nectin-4 is a clinically validated target for cancer therapy using a traditional antibody-drug conjugate (ADC), but it is also associated with certain adverse events, including neuropathy and rash. BA3362 is a CAB T cell engager that is designed to be preferentially active within the tumor microenvironment. Forward-looking Statements Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "expect," "believe," "will," "may," "should," "estimate," "project," "outlook," "forecast" or other similar words. Examples of forward-looking statements include, among others, statements we make regarding BioAtla’s business plans and prospects; whether our clinical trials will support registration; achievement of milestones; results, progress and timing of our research and development programs and clinical trials; expectations with respect to enrollment and dosing in our clinical trials; the anticipated clinical benefits, safety, efficacy, and market potential of our product candidates; plans and expectations regarding future data updates, clinical trials, regulatory meetings and regulatory submissions; the timing of and the ability to establish collaborations or other strategic partnerships for selected assets; the potential regulatory approval path for our product candidates; expectations about the sufficiency of our cash and cash equivalents to fund operations and expectations regarding R&D expenses and cash burn, and expected cost reductions from our workforce reduction. Forward-looking statements are based on BioAtla's current expectations and are subject to inherent uncertainties, risks and assumptions, many of which are beyond our control, difficult to predict and could cause actual results to differ materially from what we expect. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. Factors that could cause actual results to differ include, among others: factors that raise substantial doubt about our ability to continue as a going concern and that we will need additional funding to continue development of our CAB technology platform and our CAB product candidates; the risk that preliminary or interim clinical results may not be indicative of results from later cohorts or larger populations; potential delays in clinical and preclinical trials; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for clinical trials, regulatory submission dates, or regulatory approval dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from the clinical studies or take favorable regulatory actions based on results from the clinical studies; our dependence on the success of our CAB technology platform; our ability to enroll patients in our ongoing and future clinical trials; the successful selection and prioritization of assets to focus development on selected product candidates and indications; our ability to form collaborations and partnerships with third parties and the success of such collaborations and partnerships; our reliance on third parties for the manufacture and supply of our product candidates for clinical trials; our reliance on third parties to conduct our clinical trials and some aspects of our research and preclinical testing; potential adverse impacts due to geopolitical or macroeconomic events outside of our control, including health epidemics or pandemics; and those other risks and uncertainties described in the section titled "Risk Factors" in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 27, 2025, our Quarterly Reports on Form 10-Q filed with the SEC on May 6, 2025, August 7, 2025 and November 13, 2025 and our subsequent filings with the SEC. Forward-looking statements contained in this press release are made as of this date, and BioAtla undertakes no duty to update such information except as required under applicable laws. Internal Contact: Richard Waldron Chief Financial Officer BioAtla, Inc. [email protected] 858.356.8945 External Contact: Joyce Allaire LifeSci Advisors, LLC [email protected]
Investor releaseQuarter not tagged2025-11-06Context Therapeutics Reports Third Quarter 2025 Operating and Financial Results
GlobeNewswire
Context Therapeutics Reports Third Quarter 2025 Operating and Financial Results
Ongoing Phase 1 trial of CTIM-76 (CLDN6 x CD3) demonstrates encouraging antitumor activity and safety Ongoing Phase 1 trial of CT-95 (MSLN x CD3) is approaching target dose levels Cash and cash equivalents of $76.9 million as of September 30, 2025 PHILADELPHIA, Nov. 05, 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 provided a clinical update and reported its financial results for the third quarter ended September 30, 2025. “We believe the early clinical data for CTIM-76 provides encouraging early signs of antitumor activity for Context’s T cell engagers (“TCE”) in solid tumors where many other approaches have failed due to material safety issues or lack of efficacy,” said Martin Lehr, CEO of Context. “We look forward to continuing to advance Context’s clinical trials and providing more detailed updates in 2026.” Pipeline Updates CTIM-76: CLDN6 x CD3 bispecific TCE in Phase 1 dose escalation for patients with ovarian, endometrial, or testicular cancer. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, and testicular. CTIM-76 is a fully humanized bispecific TCE that is engineered to bind with high selectivity to CLDN6 and redirect the immune system’s T cells to recognize and kill CLDN6-expressing cancer cells. More information about the CTIM-76 clinical trial (NCT06515613) can be found on https://clinicaltrials.gov/. Clinical update: Context has enrolled 12 patients as of the October 30, 2025 cutoff, and is currently enrolling Cohort 5 with a priming dose of 140 micrograms and a full dose of 560 micrograms. Preliminary signs of anti-tumor activity, including an ongoing RECIST response (Response Evaluation Criteria in Solid Tumors), have been observed beginning at Cohort 3 in the ongoing Phase 1 study. No Cytokine Release Syndrome (“CRS”) greater than Grade 1 has been observed in any cohort. No dose limiting toxicity (“DLT”) has been observed and a maximum tolerated dose (“MTD”) has not been reached. Guidance: Based on this safety profile, we are continuing dose escalation for CTIM-76 with the goal of further deepening RECIST responses, while maintaining a favorable safety profile. Context anticipates providing updated interim Phase 1a data and Phase 1b dose se…Read full documentShow less
Ongoing Phase 1 trial of CTIM-76 (CLDN6 x CD3) demonstrates encouraging antitumor activity and safety Ongoing Phase 1 trial of CT-95 (MSLN x CD3) is approaching target dose levels Cash and cash equivalents of $76.9 million as of September 30, 2025 PHILADELPHIA, Nov. 05, 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 provided a clinical update and reported its financial results for the third quarter ended September 30, 2025. “We believe the early clinical data for CTIM-76 provides encouraging early signs of antitumor activity for Context’s T cell engagers (“TCE”) in solid tumors where many other approaches have failed due to material safety issues or lack of efficacy,” said Martin Lehr, CEO of Context. “We look forward to continuing to advance Context’s clinical trials and providing more detailed updates in 2026.” Pipeline Updates CTIM-76: CLDN6 x CD3 bispecific TCE in Phase 1 dose escalation for patients with ovarian, endometrial, or testicular cancer. CLDN6 is enriched in a wide range of solid tumors, including ovarian, endometrial, lung, and testicular. CTIM-76 is a fully humanized bispecific TCE that is engineered to bind with high selectivity to CLDN6 and redirect the immune system’s T cells to recognize and kill CLDN6-expressing cancer cells. More information about the CTIM-76 clinical trial (NCT06515613) can be found on https://clinicaltrials.gov/. Clinical update: Context has enrolled 12 patients as of the October 30, 2025 cutoff, and is currently enrolling Cohort 5 with a priming dose of 140 micrograms and a full dose of 560 micrograms. Preliminary signs of anti-tumor activity, including an ongoing RECIST response (Response Evaluation Criteria in Solid Tumors), have been observed beginning at Cohort 3 in the ongoing Phase 1 study. No Cytokine Release Syndrome (“CRS”) greater than Grade 1 has been observed in any cohort. No dose limiting toxicity (“DLT”) has been observed and a maximum tolerated dose (“MTD”) has not been reached. Guidance: Based on this safety profile, we are continuing dose escalation for CTIM-76 with the goal of further deepening RECIST responses, while maintaining a favorable safety profile. Context anticipates providing updated interim Phase 1a data and Phase 1b dose selection in the second quarter of 2026. 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. Mesothelin (“MSLN”) is a membrane protein overexpressed in approximately 30% of cancers. CT-95 is a fully humanized bispecific TCE that is engineered to have moderate affinity but high avidity for membrane-bound MSLN, that is intended to minimize the impact of the shed MSLN that can serve as a decoy or sink for MSLN-targeting antibodies. More information about the CT-95 clinical trial (NCT06756035) can be found on https://clinicaltrials.gov/. Clinical update: Context has enrolled 6 patients as of the October 30, 2025 cutoff, and is currently enrolling Cohort 3 with a priming dose of 0.18 µg/kg and a full dose of 0.6 µg/kg. Based on preclinical data, CT-95 is projected to achieve target dose exposure starting at Cohort 4. No CRS greater than Grade 2 has been observed in any cohort. No DLT has been observed and an MTD has not been reached. Guidance: Based on this safety profile, we are continuing dose escalation for CT-95 toward target dose levels. Context anticipates providing initial Phase 1a data in the middle of 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. Overexpression of Nectin-4 has been observed in many tumors, including bladder, lung, colorectal, and breast cancer, and is associated with tumor progression. CT-202 incorporates pH dependency to drive localized activity of CT-202 to the tumor microenvironment. CT-202 has shown in preclinical studies to exhibit little to no binding to CD3 or the target antigen in healthy tissue (normal alkaline microenvironment). However, in acid conditions that mirror the tumor microenvironment (high glycolysis), the binding of the antibodies to their target molecules is strong. Guidance: Context expects to complete necessary regulatory filings to support the initiation of a first-in-human trial in the second quarter of 2026. Third Quarter 2025 Financial Results Cash and cash equivalents were $76.9 million at September 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 $8.7 million for the third quarter of 2025, as compared to $16.8 million for the third quarter of 2024. The decrease in R&D expenses was primarily driven by lower CT-202 expense of $6.2 million and lower CT-95 expense of $2.8 million, partially offset by higher personnel-related costs of $0.7 million and higher CTIM-76 expense of $0.2 million. R&D expense for the third quarter of 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 the third quarter of 2024. General and administrative expenses were $1.9 million for the third quarter of 2025 and the third quarter of 2024. Other income was approximately $0.9 million for the third quarter of 2025, as compared to other income of $1.2 million for the third quarter of 2024. This decrease was primarily due to lower interest income earned on lower average cash and cash equivalent balances. Context reported a net loss of $9.7 million for the third quarter of 2025, as compared to a net loss of $17.5 million for the third 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’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) our expectation to provide updated interim Phase 1a data and Phase 1b dose selection for CTIM-76 in the second quarter of 2026, (ii) our expectation to provide initial Phase 1a data for CT-95 in the middle of 2026, (iii) 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, (iv) our expectation that our cash and cash equivalents will be sufficient to fund our operations into 2027, (v) our expectations regarding the target dose levels and target dose exposure of CTIM-76 and CT-95, (vi) the potential benefits, characteristics, safety and side effect profile of our product candidates, (vii) the likelihood data and the current safety profile will support future development, and (viii) the likelihood of obtaining regulatory approval for 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. Investor Relations Contact: Jennifer Minai-Azary Context Therapeutics [email protected]
Investor releaseQuarter not tagged2025-08-07Context Therapeutics Reports Second Quarter 2025 Operating and Financial Results
GlobeNewswire
Context Therapeutics Reports Second Quarter 2025 Operating and Financial Results
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…Read full documentShow less
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. Investor Relations Contact: Jennifer Minai-Azary Context Therapeutics [email protected]
Investor releaseQuarter not tagged2025-05-08Context Therapeutics Reports First Quarter 2025 Operating and Financial Results
GlobeNewswire
Context Therapeutics Reports First Quarter 2025 Operating and Financial Results
CTIM-76 and CT-95 in Phase 1 Clinical Trials Cash and cash equivalents of $89.4 million as of March 31, 2025 Company expects its cash and cash equivalents will continue to fund operations into 2027 PHILADELPHIA, May 07, 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 first quarter ended March 31, 2025, and reported on recent and upcoming business highlights. Martin Lehr, CEO of Context, commented, “We continue to advance our clinical pipeline and are pleased to have two product candidates now in Phase 1 clinical trials — CTIM-76, a selective Claudin 6 (“CLDN6”) x CD3 bispecific antibody, and CT-95, a potential first-in-class mesothelin (“MSLN”) x CD3 bispecific antibody. We expect to report initial clinical data for CTIM-76 in the first half of 2026 and for CT-95 by mid-2026. Notably, we ended the first quarter of 2025 with $89.4 million in cash and cash equivalents, which we expect will provide the resources to fund our clinical programs into 2027. Looking ahead, we also plan to file an IND for CT-202, a potential best-in-class Nectin-4 x CD3 bispecific antibody, in mid-2026 as we continue to advance our portfolio of innovative T cell-engaging therapies for solid tumors.” First Quarter 2025 Highlights and Subsequent Events In May 2025, announced Context board member, Dr. Karen Smith, to serve as Interim Chief Medical Officer in connection with Dr. Claudio Dansky Ullmann’s planned departure. 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. In January 2025, announced the first patient dosed in our Phase 1 trial evaluating CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. In January 2025, announced the appointment of Andy Pasternak as Chairman of Context’s Board of Directors following Richard Berman’s resignation. Upcoming Corporate Presentations The Company will present at the Citizen…Read full documentShow less
CTIM-76 and CT-95 in Phase 1 Clinical Trials Cash and cash equivalents of $89.4 million as of March 31, 2025 Company expects its cash and cash equivalents will continue to fund operations into 2027 PHILADELPHIA, May 07, 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 first quarter ended March 31, 2025, and reported on recent and upcoming business highlights. Martin Lehr, CEO of Context, commented, “We continue to advance our clinical pipeline and are pleased to have two product candidates now in Phase 1 clinical trials — CTIM-76, a selective Claudin 6 (“CLDN6”) x CD3 bispecific antibody, and CT-95, a potential first-in-class mesothelin (“MSLN”) x CD3 bispecific antibody. We expect to report initial clinical data for CTIM-76 in the first half of 2026 and for CT-95 by mid-2026. Notably, we ended the first quarter of 2025 with $89.4 million in cash and cash equivalents, which we expect will provide the resources to fund our clinical programs into 2027. Looking ahead, we also plan to file an IND for CT-202, a potential best-in-class Nectin-4 x CD3 bispecific antibody, in mid-2026 as we continue to advance our portfolio of innovative T cell-engaging therapies for solid tumors.” First Quarter 2025 Highlights and Subsequent Events In May 2025, announced Context board member, Dr. Karen Smith, to serve as Interim Chief Medical Officer in connection with Dr. Claudio Dansky Ullmann’s planned departure. 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. In January 2025, announced the first patient dosed in our Phase 1 trial evaluating CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. In January 2025, announced the appointment of Andy Pasternak as Chairman of Context’s Board of Directors following Richard Berman’s resignation. Upcoming Corporate Presentations The Company will present at the Citizens Life Sciences Conference in New York City on Thursday, May 8, 2025, at 2:30 PM ET and participate in one-on-one meetings. The Company will attend and participate in one-on-one meetings at the D. Boral Capital Inaugural Global Conference in New York City on Wednesday, May 14, 2025. First Quarter 2025 Financial Results Cash and cash equivalents were $89.4 million at March 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 2027. Research and development (“R&D”) expenses were $3.5 million for the first quarter of 2025, as compared to $2.0 million for the first quarter of 2024. The increase in R&D expenses was primarily driven by higher CT-202 expense of $1.0 million and higher CT-95 expense of $0.8 million. CT-95 was acquired in July 2024 and CT-202 was in-licensed in September 2024. These increases were partially offset by lower CTIM-76 expense of $0.8 million, which was mainly the result of lower contract manufacturing costs and preclinical costs, partially offset by higher clinical costs. In addition, personnel-related costs increased by $0.5 million primarily due to higher headcount over the prior year period. General and administrative expenses were $2.1 million for the first quarter of 2025, as compared to $1.9 million for the first quarter of 2024. The increase was primarily driven by a $0.1 million increase in salaries and personnel related costs, mainly due to higher headcount and compensation adjustments. Professional fees also increased by approximately $0.1 million as compared to the same period in 2024. Other income was approximately $1.0 million for the first quarter of 2025, as compared to other income of $0.2 million for the first quarter of 2024, primarily due to higher interest income earned on cash and cash equivalent balances. Context reported a net loss of $4.6 million for the first quarter of 2025, as compared to a loss of $3.7 million for the first 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 StatementsThis 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 report initial clinical data from the Phase 1 trials of CTIM-76 and CT-95 in the first half of 2026 and mid-2026, respectively, (ii) our expectation to file an IND for CT-202 in mid-2026, (iii) having sufficient cash and cash equivalents to fund our operations into 2027, (iv) the ability of the Company and its employees to participate in and present at conferences, (v) the potential benefits, characteristics, and side effect profile of our product candidates, (vi) 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, (vii) the likelihood data will support future development, and (viii) 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. Investor Relations Contact:Jennifer Minai-AzaryContext [email protected]
Investor releaseQuarter not tagged2025-03-21Context Therapeutics Reports Full Year 2024 Operating and Financial Results
GlobeNewswire
Context Therapeutics Reports Full Year 2024 Operating and Financial Results
CTIM-76 first patient dosed in January 2025 Cash and cash equivalents of $94.4 million as of December 31, 2024 Company expects its cash and cash equivalents will continue to fund operations into 2027 PHILADELPHIA, March 20, 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 year ended December 31, 2024, and reported on recent and upcoming business highlights. Martin Lehr, CEO of Context, commented, “We believe 2024 was a transformative year for Context, marked by strategic acquisitions, a strengthened financial position, and enhancements to our leadership team, all aligning with our mission to develop innovative T cell-engaging bispecific antibodies for solid tumors. With the expansion of our pipeline through the acquisition of CT-95 and the in-licensing of CT-202, as well as significant progress in our candidate, CTIM-76, we have positioned ourselves to make meaningful advancements in the treatment of solid tumors. As we entered 2025, we achieved a major milestone with the first patient dosed in our Phase 1 clinical trial of CTIM-76, a critical step in assessing its potential as a novel T cell-engaging bispecific antibody for CLDN6-positive ovarian, endometrial, and testicular cancers.” “We ended the year with cash and cash equivalents of $94.4 million, providing the financial resources needed to further advance our clinical programs. Looking ahead, we anticipate dosing the first patient in our Phase 1 clinical trial of CT-95, targeting mesothelin-expressing cancers, in Q2 2025. Additionally, we expect to share initial clinical data from the CTIM-76 Phase 1 trial in the first half of 2026 and from the CT-95 Phase 1 trial in mid-2026. As we continue to progress, our focus remains on delivering innovative therapies that address critical unmet medical needs in oncology," concluded Mr. Lehr. Recent and Upcoming Business Highlights Pipeline Highlights In January 2025, announced the first patient dosed in its Phase 1 trial evaluating CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. In September 2024, announced an exclusive worldwide license agreement with BioAtla, Inc. to develop and commercialize CT-202, a Nectin-4 x CD3 T cell engaging…Read full documentShow less
CTIM-76 first patient dosed in January 2025 Cash and cash equivalents of $94.4 million as of December 31, 2024 Company expects its cash and cash equivalents will continue to fund operations into 2027 PHILADELPHIA, March 20, 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 year ended December 31, 2024, and reported on recent and upcoming business highlights. Martin Lehr, CEO of Context, commented, “We believe 2024 was a transformative year for Context, marked by strategic acquisitions, a strengthened financial position, and enhancements to our leadership team, all aligning with our mission to develop innovative T cell-engaging bispecific antibodies for solid tumors. With the expansion of our pipeline through the acquisition of CT-95 and the in-licensing of CT-202, as well as significant progress in our candidate, CTIM-76, we have positioned ourselves to make meaningful advancements in the treatment of solid tumors. As we entered 2025, we achieved a major milestone with the first patient dosed in our Phase 1 clinical trial of CTIM-76, a critical step in assessing its potential as a novel T cell-engaging bispecific antibody for CLDN6-positive ovarian, endometrial, and testicular cancers.” “We ended the year with cash and cash equivalents of $94.4 million, providing the financial resources needed to further advance our clinical programs. Looking ahead, we anticipate dosing the first patient in our Phase 1 clinical trial of CT-95, targeting mesothelin-expressing cancers, in Q2 2025. Additionally, we expect to share initial clinical data from the CTIM-76 Phase 1 trial in the first half of 2026 and from the CT-95 Phase 1 trial in mid-2026. As we continue to progress, our focus remains on delivering innovative therapies that address critical unmet medical needs in oncology," concluded Mr. Lehr. Recent and Upcoming Business Highlights Pipeline Highlights In January 2025, announced the first patient dosed in its Phase 1 trial evaluating CTIM-76 in patients with CLDN6-positive gynecologic and testicular cancers. In September 2024, announced an exclusive worldwide license agreement with BioAtla, Inc. to develop and commercialize CT-202, a Nectin-4 x CD3 T cell engaging bispecific antibody. Context expects to file an Investigational New Drug (“IND”) application for CT-202 in mid-2026. In July 2024, completed the acquisition of CT-95, a potentially first-in-class Mesothelin x CD3 T cell engaging bispecific antibody that has received IND clearance from the U.S. Food and Drug Administration. The Company anticipates dosing the first patient in its Phase 1 trial evaluating CT-95 in the second quarter of 2025. Corporate Highlights In April 2025, Context will present a poster highlighting first dose selection and preclinical results for CT-95 at the upcoming American Association for Cancer Research (AACR) Annual Meeting 2025. In January 2025, announced the appointment of Andy Pasternak as Chairman of Context’s Board of Directors. In November 2024, Context presented a poster titled “Determination of First in Human Dose of the T Cell-redirecting Bispecific Antibody CTIM-76 Targeting Claudin 6” at the Society for Immunotherapy of Cancer’s (SITC) 39th Annual Meeting. In September 2024, appointed Dr. Karen Smith and Dr. Luke Walker to Context’s Board of Directors. In August 2024, appointed Claudio Dansky Ullmann, M.D. as Chief Medical Officer. In May 2024, completed $100 million private placement. Fiscal Year 2024 Financial Results Cash and cash equivalents were $94.4 million at December 31, 2024, compared to $14.4 million at December 31, 2023. The Company expects its cash and cash equivalents will be sufficient to fund its operations into 2027. Research and development (“R&D”) expenses were $22.7 million for 2024, as compared to $17.8 million in 2023. The increase in R&D expenses was primarily driven by higher in-process research and development charges of $14.75 million related to the acquisition of CT-95 and the in-licensing of CT-202 in 2024. This increase was partially offset by lower CTIM-76 expense of $9.0 million, which was mainly the result of lower contract manufacturing costs and preclinical costs. General and administrative expenses were $7.2 million for 2024, as compared to $7.3 million for 2023. The decrease was primarily driven by a decrease in insurance expense and compensation costs, partially offset by an increase in other administrative costs. Other income was $3.2 million for 2024, as compared to $1.1 million for 2023, primarily due to higher interest income earned on cash and cash equivalent balances. Context reported a net loss of $26.7 million for 2024, as compared to $24.0 million for 2023. 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 StatementsThis 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 dose the first patient in the Phase 1 clinical trial for CT-95 in the second quarter of 2025, (ii) our expectation to file an IND for CT-202 in mid-2026, (iii) our expectation to share initial data from the Phase 1 trials of both CTIM-76 and CT-95 in the first half of 2026 and mid-2026, respectively, (iv) the ability of the Company and its employees to participate in and present at conferences, (v) having sufficient cash and cash equivalents to fund our operations into 2027, (vi) the potential benefits, characteristics, and side effect profile of our product candidate, (vii) the ability of our product candidate 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 our product candidate. 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. Investor Relations Contact:Jennifer MinaiContext Therapeutics [email protected]

