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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission file number 001-40654 CONTEXT THERAPEUTICS INC. (Exact name of registrant as specified in its charter) Delaware 86-3738787 (State of other jurisdiction of incorporation or organization) (I.R.S. ...

Advancing T Cell Engagers for Solid Tumors Corporate Presentation March 2026 Executive Summary Forward Looking Statement Except for statements of historical fact, any information contained in this presentation may be a forward-looking statement that reflects the Company's current views about future events and is subject to risks, uncertainties, assumptions and changes in circumstances that may cause events or the Company's actual activities or results to differ significantly from those expressed in any forw ...

PHILADELPHIA, March 19, 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 a poster presentation at the American Association for Cancer Research (AACR) Annual Meeting 2026, taking place April 17-22, 2026 in San Diego, CA. The presentation will highlight preclinical data regarding the Company’s asset, CT-202, a Nectin-4 x CD3 TCE. Po ...

Summary of Context Therapeutics Conference Call Company Overview - **Company**: Context Therapeutics (NasdaqCM:CNTX) - **Focus**: Development of T-cell engagers for solid tumors, specifically targeting ADC (antibody-drug conjugate) resistance [3][4] Strategic and Pipeline Priorities - **Current Programs**: Three programs targeting claudin 6, mesothelin, and nectin-4 - Claudin 6 and mesothelin are in clinical trials, with data expected in Q2 2026 - Nectin-4 program is about to enter the clinic [3][4] Core Points and Arguments T-cell Engagers and ADC Resistance - T-cell engagers are positioned to address ADC resistance, which is a significant issue as large pharma invests heavily in ADCs [3][4] - T-cell engagers are potent but carry the risk of cytokine release syndrome (CRS), which can be managed through step dosing and steroid prophylaxis [4][11] Claudin 6 Program - **Target Selection**: Claudin 6 is oncofetal and selectively found in tumors, allowing for aggressive dosing [5][6] - **Clinical Focus**: Targeting ovarian cancer patients who are ADC-exposed, with a goal of achieving a 30% response rate compared to standard care (5%-10% response rate) [40][41] - **Competitive Landscape**: Competing with other T-cell engagers and ADCs, but believes in the unique efficacy due to high-affinity CD3 binding [8][12] Mesothelin Program - Currently the only T-cell engager for mesothelin after competitors shut down their programs due to safety concerns [76][79] - Plans to explore combinations with other therapies, particularly in pancreatic cancer, where there is a significant unmet need [85][86] Nectin-4 Program - Utilizes a pH-sensitive masking approach to mitigate off-target effects, aiming for a safer profile [92] - Anticipated to have significant market potential, with peak sales potential exceeding $5 billion [93] Important but Overlooked Content - **CRS Management**: The narrative around CRS management has evolved, with a focus on traditional drug development risks rather than solely on CRS [11][27] - **Dosing Strategies**: Exploring longer dosing intervals (e.g., every three weeks) to improve patient convenience and potentially enhance efficacy [24][41] - **Patient Population Insights**: High prevalence of claudin 6 positivity in late-line ovarian cancer patients, which was underestimated in initial projections [61][62] Future Expectations - Upcoming data in Q2 2026 is expected to provide insights into the therapeutic window and safety profile, which could support outpatient dosing and longer intervals [41][42] - The company is cautious about discussing accelerated approval but remains open to opportunities if data supports it [67][68] This summary encapsulates the key points discussed during the conference call, highlighting the strategic direction, pipeline developments, and market positioning of Context Therapeutics.

Context Therapeutics FY Conference Summary Company Overview - **Company Name**: Context Therapeutics (NasdaqCM:CNTX) - **Focus**: Development of T-cell engagers, a class of antibodies that enhance the immune system's ability to target cancer cells [2][3] Core Programs - **Programs**: - **CT-76 (Claudin 6)**: Targeting ovarian, endometrial, and testicular cancers, with a focus on ovarian [3][4] - **CT-95 (Mesothelin)**: Targeting pancreatic, ovarian, and mesothelioma cancers [3][21] - **CT-202 (Nectin-4)**: Targeting a broad range of tumors including triple-negative breast cancer, bladder cancer, and colorectal cancer [4][28] Clinical Development and Data Updates - **Claudin 6**: Phase I data expected in Q2 2026, aiming for 10-12 ovarian patients at target dose levels [4][34] - **Mesothelin**: Data expected mid-2026, with a focus on pancreatic and ovarian cancers [21][34] - **Nectin-4**: Anticipated to enter the clinic in Q2 2026, with a significant market opportunity [28][34] Mechanism of Action and Safety Profile - **T-cell Engagers**: Designed to bridge T-cells and cancer cells, enhancing immune response [2][10] - **Safety Considerations**: - High-affinity CD3 format believed to mitigate cytokine release syndrome (CRS) risks [6][20] - Claudin 6 shows low risk for CRS due to its expression only in cancer cells [13][14] - Mesothelin program employs a lower affinity binder to minimize lung toxicity [23][24] Market Position and Competitive Landscape - **Market Opportunity**: - Claudin 6 and mesothelin represent significant market opportunities due to their expression in various cancers [21][26] - Nectin-4 is highlighted as a top target for treatment-eligible patients [33] - **Competitive Analysis**: - Context Therapeutics differentiates itself from competitors like Xencor and Third Rock by focusing on high-affinity CD3 and a clean safety profile [19][20] Financial Position - **Funding**: Raised $115 million in 2025, providing sufficient cash flow through key inflection points in 2026 [34] Key Takeaways - Context Therapeutics is positioned at an exciting inflection point with multiple clinical updates expected in the near future, particularly in T-cell engagers targeting solid tumors. - The company emphasizes a strong safety profile and innovative mechanisms of action, which may provide a competitive edge in the oncology market. - The upcoming data releases are critical for assessing the efficacy and market potential of their pipeline programs.

Core Insights - Several biotechnology and pharmaceutical companies experienced significant stock price increases in after-hours trading due to clinical trial updates, regulatory advancements, and investor anticipation for upcoming data releases [1] Company Updates - Alumis Inc. (ALMS) saw a surge of 17.33% to $9.75, gaining $1.44 after announcing that topline data from its Phase 3 ONWARD clinical program for envudeucitinib in moderate-to-severe plaque psoriasis will be reported on January 6, 2026, along with a conference call to discuss the results [2] - Genelux Corp. (GNLX) climbed 10.92% to $3.86, up $0.38, following interim results from ongoing trials evaluating Olvi-Vec in patients with progressive small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC) [3] - Bright Minds Biosciences Inc. (DRUG) rose 8.42% to $86.75, gaining $6.74, and announced a conference call on January 6, 2026, to report topline results from its Phase 2 trial of BMB-101 in patients with drug-resistant Absence Seizures [4] - Context Therapeutics Inc. (CNTX) shares increased by 8.36% to $1.68, adding $0.13, despite no specific news released [4] - BioAtla, Inc. (BCAB) gained 3.95% to $0.44, up $0.017, after announcing a special purpose vehicle transaction to advance ozuriftamab vedotin in a Phase 3 study for oropharyngeal squamous cell carcinoma, receiving $5 million in initial funding [5] - Femasys Inc. (FEMY) added 7.09% to $0.6223, up $0.04, with no new updates reported [5] - Acumen Pharmaceuticals, Inc. (ABOS) jumped 11.62% to $2.21, gaining $0.23, also without new corporate updates [6] - Alpha Tau Medical Ltd. (DRTS) rose 5.36% to $5.50, up $0.28, after submitting the first module of its pre-market approval application to the FDA for Alpha DaRT in treating recurrent cutaneous squamous cell carcinoma [7]

Summary of Context Therapeutics FY Conference Call Company Overview - **Company**: Context Therapeutics (NasdaqCM:CNTX) - **Focus**: Development of T cell engagers for solid tumors, specifically targeting Claudin-6, Mesothelin, and Nectin-4 [3][4] Core Points and Arguments T Cell Engagers - Context Therapeutics specializes in T cell engagers, a class of antibodies designed to bind tumor antigens and activate immune responses [3] - The company utilizes high affinity CD3 as the immune activator, which has been successful in all approved T cell engagers [3][4] - The company does not conduct in-house research; all programs are externally sourced [3] Claudin-6 Program (CTIM-76) - Claudin-6 is considered a compelling target due to its restricted expression in tumors, allowing for targeted therapy without affecting normal cells [5][6] - The company aims to treat ADC resistance and has a lower cutoff for Claudin-6 expression, allowing for broader patient eligibility compared to existing therapies [9][10] - Early clinical data shows promise, with a patient achieving a confirmed partial response after prior treatments [12] Management of Cytokine Release Syndrome (CRS) - CRS is a concern due to the overlap of Claudin-6 with Claudin-3 and 4, which are found in the liver [14] - The company employs strategies such as step dosing and prophylactic steroids to manage CRS effectively [15][16] Mesothelin Program (CT-95) - Mesothelin is a target found in 30% of all cancers, but previous attempts to develop therapies have faced challenges [23] - The company’s approach involves a unique antibody design that binds to a stable portion of mesothelin, minimizing side effects [24][25] - Enrollment is focused on pancreatic, ovarian, and mesothelioma cancers, with a low bar for clinical expectations due to the historical challenges in this space [27][29] Nectin-4 Program (CT202) - Nectin-4 is seen as a significant opportunity due to its expression in various cancers, but it has been dominated by ADCs [31] - The company believes T cell engagers can provide a more potent alternative, especially in combination with existing therapies [32][33] - The antibody design is pH-dependent, which may reduce skin-related side effects commonly associated with Nectin-4 therapies [34] Additional Important Insights - The company plans to provide more comprehensive data updates in Q2 2026, including insights on dosing and patient enrollment [12][18] - There is a clear market need for therapies targeting Claudin-6 and Nectin-4, particularly in ovarian and bladder cancers [21][36] - The company is exploring partnerships for indications like cervical cancer, which may require expertise in specific geographies [36] Conclusion Context Therapeutics is strategically positioned in the oncology space with a focus on T cell engagers, targeting specific tumor antigens. The company is advancing its clinical programs with promising early data and a clear strategy for managing safety concerns, while also exploring potential partnerships to expand its reach in underserved cancer markets.

Core Insights - Context Therapeutics Inc. is advancing T cell engaging bispecific antibodies for solid tumors, specifically highlighting its CT-95 and CT-202 programs at the SITC 40th Annual Meeting [1][2] Group 1: CT-95 Program - CT-95 is a mesothelin x CD3 bispecific TCE designed to redirect T-cell-mediated lysis towards malignant cells expressing mesothelin, which is overexpressed in approximately 30% of cancers [4] - The clinical trial for CT-95 is ongoing in the US, with 6 patients enrolled as of October 30, 2025, and currently enrolling Cohort 3 with a priming dose of 0.18 µg/kg and a full dose of 0.6 µg/kg [7] - No cytokine release syndrome greater than Grade 2 has been observed, and no dose limiting toxicity has been reported, allowing for continued dose escalation towards target levels [7] Group 2: CT-202 Program - CT-202 targets Nectin-4, a protein overexpressed in various solid tumors, including bladder, colorectal, lung, and breast cancers, and is designed to be preferentially active within the tumor microenvironment [5] - Preclinical data supports CT-202's best-in-class potential, demonstrating potent activity with a favorable pharmacokinetic and safety profile [7] - The company expects to complete regulatory filings to initiate a first-in-human trial for CT-202 in the second quarter of 2026 [7] Group 3: Company Overview - Context Therapeutics aims to build an innovative portfolio of TCE bispecific therapeutics, including CTIM-76, CT-95, and CT-202 [6] - The company is headquartered in Philadelphia and provides updates on its research and clinical trials through its website and social media [6]

Core Insights - Context Therapeutics Inc. is advancing T cell engaging bispecific antibodies for solid tumors, with promising early clinical data for CTIM-76 and CT-95 [1][2][5][6] Pipeline Updates - **CTIM-76**: Currently in Phase 1 dose escalation for patients with ovarian, endometrial, or testicular cancer, showing preliminary signs of anti-tumor activity and a favorable safety profile [2][5] - **CT-95**: Also in Phase 1 dose escalation for various cancers, including pancreatic and non-small cell lung cancer, with expected target dose exposure starting at Cohort 4 [3][6] - **CT-202**: In preclinical development for multiple cancers, with plans for a first-in-human trial expected to begin in the second quarter of 2026 [4][7] Financial Results - As of September 30, 2025, cash and cash equivalents were $76.9 million, down from $94.4 million at the end of 2024, but expected to fund operations into 2027 [11][14] - Research and development expenses for Q3 2025 were $8.7 million, a decrease from $16.8 million in Q3 2024, primarily due to lower expenses related to CT-202 and CT-95 [11][13] - The net loss for Q3 2025 was $9.7 million, compared to a net loss of $17.5 million in Q3 2024, indicating improved financial performance [11][13]