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]

Core Points - Context Therapeutics Inc. has granted non-qualified stock option awards to a new employee as an inducement for accepting employment, totaling 30,000 shares of common stock [1][2] - The stock options were granted outside of the company's 2021 Long-Term Performance Incentive Plan, with an exercise price of $0.97 per share, equal to the closing price on the grant date [2] - The stock options have a 10-year term and will vest over four years, with one-fourth vesting on the first anniversary and the remainder vesting in thirty-six equal monthly installments [3] Company Overview - Context Therapeutics Inc. is a biopharmaceutical company focused on advancing T cell engaging bispecific antibodies for solid tumors [4] - The company is developing a portfolio of TCE bispecific therapeutics, including CTIM-76, CT-95, and CT-202 [4] - Context Therapeutics is headquartered in Philadelphia and provides additional information on its website and social media platforms [4]

Core Insights - Context Therapeutics Inc. is advancing CTIM-76, a Claudin 6 x CD3 T cell engager, in a Phase 1 clinical trial targeting ovarian, endometrial, and testicular cancers, with initial data expected in the first half of 2026 [1][7]. Group 1: Clinical Trial Details - The Phase 1 trial is an open-label, dose escalation and expansion study aimed at evaluating the safety and efficacy of CTIM-76 in patients with CLDN6-positive advanced or metastatic cancers [2]. - The trial plans to enroll up to 70 patients and will assess safety, tolerability, pharmacokinetics, and anti-tumor activity through various metrics [2]. Group 2: Presentation Information - A poster presentation titled "A phase 1, first-in-human study of CTIM-76" will be showcased at the 2025 ASCO Annual Meeting on June 2, 2025 [3]. - The presentation will be available on the company's website under the "Publications and Posters" section [3]. Group 3: Product Overview - CTIM-76 is a bispecific antibody that targets CLDN6, which is prevalent in various solid tumors, including ovarian and endometrial cancers [4]. - Preclinical studies indicate that CTIM-76 may offer convenient dosing with low immunogenicity risk and scalable manufacturing capabilities [4]. Group 4: Company Background - Context Therapeutics Inc. is focused on developing T cell engaging bispecific antibodies for solid tumors, with a portfolio that includes CTIM-76, CT-95, and CT-202 [5]. - The company is headquartered in Philadelphia and actively engages with the investment community through various channels [5].

Core Insights - Context Therapeutics Inc. has appointed Dr. Karen Chagin as Chief Medical Officer, effective June 9, 2025, succeeding Dr. Karen Smith who will remain on the Board of Directors [1][4] - Dr. Chagin has over a decade of experience in clinical development and regulatory strategy for T cell therapies, having previously held senior roles at Adaptimmune and Tmunity [2][3] - The company is focused on advancing T cell engaging bispecific antibodies for solid tumors, with a portfolio that includes CTIM-76, CT-95, and CT-202 [7] Leadership Transition - Dr. Chagin's appointment is seen as pivotal for the company's growth, bringing valuable insights from her experience in moving programs from early development to approval [4] - Dr. Smith's interim leadership has been acknowledged, highlighting her contributions during the transition [4] Stock Option Grant - As part of her employment, Dr. Chagin will receive a non-qualified stock option award of 153,000 shares, with the exercise price based on the closing price of the company's stock on her start date [5][6] - The stock option will vest over four years, with 25% vesting on the first anniversary and the remainder in equal monthly installments [6] Company Overview - Context Therapeutics is a biopharmaceutical company headquartered in Philadelphia, specializing in T cell engaging bispecific antibodies for solid tumors [7]

Core Insights - Context Therapeutics Inc. is advancing its clinical pipeline with two product candidates, CTIM-76 and CT-95, currently in Phase 1 clinical trials, with initial clinical data expected in 2026 [2][3] - The company reported cash and cash equivalents of $89.4 million as of March 31, 2025, which is projected to fund operations into 2027 [2][10] - Research and development expenses increased to $3.5 million in Q1 2025 from $2.0 million in Q1 2024, primarily due to costs associated with CT-202 and CT-95 [5][9] Financial Performance - For the first quarter of 2025, Context reported a net loss of $4.6 million, compared to a loss of $3.7 million in the same period of 2024 [6][9] - General and administrative expenses rose to $2.1 million in Q1 2025 from $1.9 million in Q1 2024, driven by increased personnel costs [5][9] - Other income for Q1 2025 was approximately $1.0 million, up from $0.2 million in Q1 2024, mainly due to higher interest income [5][9] Upcoming Developments - The company plans to file an Investigational New Drug (IND) application for CT-202, a potential best-in-class Nectin-4 x CD3 bispecific antibody, in mid-2026 [2][3] - Context will present at the Citizens Life Sciences Conference on May 8, 2025, and participate in one-on-one meetings at the D. Boral Capital Inaugural Global Conference on May 14, 2025 [5][4]

Core Insights - Context Therapeutics Inc. announced preclinical and translational data for CT-95, a T cell engaging bispecific antibody targeting mesothelin, presented at the AACR Annual Meeting 2025 [2][3] - The company emphasizes the high unmet need for effective treatments in mesothelin-expressing cancers, including pancreatic, ovarian, and mesothelioma [3] - Initial clinical data from the ongoing Phase 1 trial of CT-95 is expected to be shared in mid-2026 [3] Preclinical Data - CT-95 has demonstrated a unique binding location on mesothelin, avoiding binding to shed mesothelin, which is a challenge in developing MSLN-targeted therapies [1][6] - Preclinical studies indicate that CT-95 can selectively bind to mesothelin-expressing cells and activate T cells without inducing broad cytokine release [4][9] - The drug has shown high activity and good tolerance across in vivo models [9] Clinical Development - The Phase 1 clinical trial for CT-95 is currently underway in the US, with the first patient recently dosed [3][6] - CT-95 is designed to redirect T-cell-mediated lysis toward malignant cells expressing mesothelin, which is overexpressed in approximately 30% of cancers [6] Company Overview - Context Therapeutics is focused on advancing T cell engaging bispecific antibodies for solid tumors, with a portfolio that includes CTIM-76 and CT-202 alongside CT-95 [7] - The company is headquartered in Philadelphia and is publicly traded on Nasdaq under the ticker CNTX [7]