CNTX

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...

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...

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...

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...

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...

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...

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 Scie...

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 bi...