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]

Financial Performance - The net loss for the nine months ended September 30, 2025, was $23.1 million, with an accumulated deficit of $117.9 million as of the same date[107]. - The net loss for the three months ended September 30, 2025, was $9.7 million, a reduction of $7.8 million or 44% compared to a net loss of $17.5 million in the same period in 2024[130]. - Research and development expenses for the nine months ended September 30, 2025, were $20.0 million, a slight decrease of $0.2 million or 1% compared to $20.2 million in the same period in 2024[136]. - General and administrative expenses increased by approximately $0.5 million, from $5.4 million in the nine months ended September 30, 2024, to $5.9 million in the same period in 2025, an increase of 8%[139]. - Cash used in operating activities for the nine months ended September 30, 2025, was $17.4 million, compared to $9.6 million in the same period in 2024[149]. - Interest income decreased by approximately $0.4 million, from $1.2 million in Q3 2024 to $0.8 million in Q3 2025, a decline of 33%[134]. - Other income for the nine months ended September 30, 2025, was approximately $104,000, compared to an expense of approximately $5,000 in the same period in 2024, primarily due to higher foreign currency gains[141]. Cash Position and Funding - Cash and cash equivalents as of September 30, 2025, were $76.9 million, expected to fund operations into 2027[118]. - The company expects its cash and cash equivalents to fund operations into 2027, covering ongoing clinical trials and operational expenses[143]. - The company plans to finance operations through equity offerings, debt financings, and collaborations, with no assurance of obtaining adequate financing[119]. - The company entered into a private placement agreement on May 1, 2024, raising approximately $100 million before expenses[121]. - Financing activities provided $94.8 million during the nine months ended September 30, 2024, from the sale of common stock and Pre-Funded Warrants in a Private Placement[153]. Research and Development - CTIM-76, a CLDN6 x CD3 TCE, has completed IND-enabling studies, with the first patient dosed in January 2025, and interim data expected in Q2 2026[104]. - CT-95, an MSLN x CD3 TCE, had its first patient dosed in April 2025, with initial Phase 1a data anticipated in mid-2026[105]. - CT-202, a Nectin-4 x CD3 TCE, is expected to initiate a first-in-human trial in Q2 2026[106]. - The development and regulatory milestone payments for CTIM-76 were reduced from $55 million to $15 million, and sales milestone payments from $130 million to $12.5 million[110]. - The company expects to incur significant operating losses and expenses as it advances its product candidates through clinical trials and seeks regulatory approval[116]. Accounting and Reporting - There were no material changes to critical accounting policies and estimates during the three and nine months ended September 30, 2025, compared to the previous year[155]. - The company is classified as an "emerging growth company," allowing it to delay the adoption of certain accounting standards until they apply to private companies[157]. - The market value of the company's stock held by non-affiliates is less than $700.0 million, qualifying it as a "smaller reporting company" with annual revenue below $100.0 million[159]. - The company will continue to be a smaller reporting company as long as the market value of its stock held by non-affiliates remains below $250.0 million or annual revenue stays below $100.0 million[159]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company[160]. Investment Activities - Cash used in investing activities for the nine months ended September 30, 2024, included a one-time payment of $3.75 million for acquiring CT-95 assets and $11.0 million under the BioAtla License Agreement for CT-202 development[152]. - The company did not engage in off-balance sheet financing arrangements, indicating no material exposure to financing, liquidity, market, or credit risk[154].

Core Insights - Step Pharma has appointed Dr. Karen L. Smith as Chief Medical Officer, effective immediately, to enhance its leadership in targeted cancer treatment through CTPS1 inhibition [1][10] - Dr. Smith brings over 25 years of experience in the healthcare industry, having held senior executive roles in major pharmaceutical companies and successfully overseen over 100 clinical trials and 20 regulatory approvals [2][10] - The appointment follows Step Pharma's recent €38 million Series C financing, positioning the company to advance its clinical development plans for dencatistat across multiple indications [5][10] Company Overview - Step Pharma is a leader in CTPS1 inhibition, focusing on targeted therapies that selectively kill cancer cells while sparing healthy cells [7] - The company was founded in 2014 and is based in Saint-Genis-Pouilly, France, supported by a strong syndicate of investors [8] Leadership and Strategy - Dr. Smith's expertise in clinical development and regulatory affairs is expected to accelerate Step Pharma's 'pipeline in a product' strategy, which aims to provide new treatment options for patients [5][10] - The company aims to transform cancer and blood disorder treatment through innovative approaches, leveraging Dr. Smith's experience to enhance its clinical programs [5][10]

Core Insights - Context Therapeutics Inc. is set to present two posters at the Society for Immunotherapy of Cancer's 40th Annual Meeting, focusing on their T cell engaging bispecific antibodies for solid tumors [1][2] Presentation Details - The first poster will detail a Phase 1 clinical trial of CT-95, a mesothelin x CD3 TCE, scheduled for presentation on November 8, 2025 [3] - The second poster will present preclinical data on CT-202, a Nectin-4 x CD3 TCE, to be showcased on November 7, 2025 [3] Product Information - CT-95 targets mesothelin, a protein overexpressed in approximately 30% of cancers, and aims to minimize the impact of shed MSLN that can interfere with treatment [4] - CT-202 targets Nectin-4, which is overexpressed in various solid tumors, and is designed to be preferentially active in the tumor microenvironment [5] Company Overview - Context Therapeutics is focused on developing T cell engaging bispecific antibodies, including CTIM-76, CT-95, and CT-202, and is headquartered in Philadelphia [6]

Core Insights - Context Therapeutics Inc. is advancing T cell engaging bispecific antibodies for solid tumors and will present two posters at the Society for Immunotherapy of Cancer's 40th Annual Meeting in November 2025 [1][2] Presentation Details - The first poster is titled "Trial in Progress: A Phase 1, First-in-Human Study of CT-95, a mesothelin (MSLN)-Directed Bispecific T Cell engager (TCE) in Subjects with Advanced Solid Tumors," scheduled for November 8, 2025, at 10:00 AM ET [3] - The second poster is titled "CT-202: a dual pH-dependent Nectin-4 x CD3 bispecific T cell engager," scheduled for November 7, 2025, at 10:00 AM ET [3] Product Information - CT-95 targets mesothelin, a protein overexpressed in approximately 30% of cancers, and is designed to minimize the impact of shed MSLN that can interfere with treatment [4] - CT-202 targets Nectin-4, which is overexpressed in various solid tumors, and is designed to be preferentially active within the tumor microenvironment [5] Company Overview - Context Therapeutics is headquartered in Philadelphia and is focused on developing a portfolio of TCE bispecific therapeutics, including CTIM-76, CT-95, and CT-202 [6]

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 its clinical pipeline with two bispecific antibodies, CTIM-76 and CT-95, and expects to share initial dose escalation data in 2026 [2][3] - The company reported cash and cash equivalents of $83.5 million as of June 30, 2025, which is projected to fund operations into 2027 [1][10] - The net loss for the second quarter of 2025 was $8.8 million, compared to a loss of $2.3 million in the same period of 2024 [6][9] Pipeline Updates - CTIM-76 is a selective Claudin 6 x CD3 bispecific antibody, while CT-95 is an avidity enhanced mesothelin x CD3 bispecific antibody [2][7] - The company plans to initiate a first-in-human trial for CT-202, a Nectin-4 x CD3 bispecific antibody, in the second quarter of 2026 [2] Financial Performance - Research and development expenses for Q2 2025 were $7.8 million, significantly higher than $1.4 million in Q2 2024, driven by increased costs associated with CT-202, CT-95, and CTIM-76 [5][9] - General and administrative expenses rose to $1.9 million in Q2 2025 from $1.7 million in Q2 2024, primarily due to higher personnel-related costs [5][9] - Other income for Q2 2025 was approximately $0.9 million, slightly up from $0.8 million in Q2 2024, mainly due to increased interest income [5][9] Corporate Updates - The company appointed Dr. Karen Chagin as Chief Medical Officer in June 2025 [5] - Context Therapeutics presented at several conferences, including the ASCO Annual Meeting and the AACR Annual Meeting in 2025 [5]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark one) ý QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________ to ______________. Commission file number: 001-40654 CONTEXT THERAPEUTICS INC. (Exact name of registrant as specified in its charter) ________________ ...