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) ________________ ...

Group 1 - Ms. Fiakas has extensive experience in investment banking and research analysis, focusing on equity capital markets, particularly in emerging growth companies within technology, energy, and conservation sectors [1] - Ms. Fiakas is the Managing Member of Crystal Equity Research, LLC, which specializes in analyzing small-cap companies [1] - The article emphasizes the importance of understanding the dynamics of emerging growth companies for potential investment opportunities [1] Group 2 - Crystal Equity Research does not have a beneficial interest in the companies mentioned, ensuring an unbiased analysis [2] - The Prime series underwriters may have a beneficial interest in the companies discussed, indicating potential conflicts of interest [2]

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]

[Part I – FINANCIAL INFORMATION](index=6&type=section&id=Part%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents Context Therapeutics Inc.'s unaudited condensed consolidated financial statements as of March 31, 2025, and for the three months then ended, including Balance Sheets, Statements of Operations, Statements of Changes in Stockholders' Equity, and Statements of Cash Flows, showing a net loss of **$4.6 million** and total assets of **$93.0 million** [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to **$93.0 million** from **$98.1 million** at year-end 2024, primarily due to reduced cash, with total liabilities at **$2.0 million** and stockholders' equity at **$91.0 million** Condensed Consolidated Balance Sheet Highlights (Unaudited) | | March 31, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $89,352,227 | $94,429,824 | | Total current assets | $92,730,827 | $97,895,984 | | **Total assets** | **$92,965,483** | **$98,126,759** | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $1,900,157 | $2,748,433 | | **Total liabilities** | **$1,982,765** | **$2,860,497** | | **Total stockholders' equity** | **$90,982,718** | **$95,266,262** | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) For the three months ended March 31, 2025, the net loss increased to **$4.6 million** or **($0.05) per share**, from **$3.7 million** or **($0.23) per share** in 2024, primarily due to higher research and development expenses Condensed Consolidated Statements of Operations (Unaudited) | | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :--- | :--- | :--- | | Research and development | $3,462,991 | $1,973,209 | | General and administrative | $2,066,152 | $1,850,292 | | Loss from operations | ($5,529,143) | ($3,823,501) | | Interest income | $958,517 | $152,351 | | **Net loss** | **($4,577,261)** | **($3,667,797)** | | Net loss per common share | ($0.05) | ($0.23) | [Condensed Consolidated Statements of Cash Flows](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the three months ended March 31, 2025, net cash used in operating activities was **$5.0 million**, with a **$34,000** use in investing activities, resulting in a **$5.1 million** net decrease in cash and an ending balance of **$89.4 million** Summary of Cash Flows (Unaudited) | | Three months ended March 31, 2025 ($) | Three months ended March 31, 2024 ($) | | :--- | :--- | :--- | | Cash used in operating activities | ($5,028,381) | ($4,360,620) | | Cash used in investing activities | ($33,948) | $— | | Cash used in financing activities | ($15,268) | $— | | **Net decrease in cash and cash equivalents** | **($5,077,597)** | **($4,360,620)** | | Cash and cash equivalents at end of period | $89,352,227 | $10,089,207 | [Notes to the Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the company's clinical-stage biopharmaceutical business, liquidity, accounting policies, and commitments, with **$89.4 million** in cash expected to fund operations for at least 12 months, though substantial additional funding will be required for future development - The company is a clinical-stage biopharmaceutical company developing T cell engaging (TCE) bispecific antibodies (bsAb) for solid tumors, with key product candidates being CTIM-76, CT-95, and CT-202[34](index=34&type=chunk) - The company has an accumulated deficit of **$99.4 million** as of March 31, 2025, and management believes its cash and cash equivalents of **$89.4 million** are sufficient to fund operations for at least the next 12 months[36](index=36&type=chunk) - In February 2024, the company amended its license agreement with Integral Molecular for CTIM-76, reducing future potential milestone payments from a total of **$185 million** to **$27.5 million** and changing the royalty rate to a flat **6%** starting no sooner than February 2034[93](index=93&type=chunk) - In May 2024, the company raised approximately **$100 million** in gross proceeds through a private placement of common stock and pre-funded warrants[77](index=77&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's analysis of the company's financial condition and Q1 2025 operating results, detailing clinical program progress and financing activities, with **$89.4 million** in cash expected to fund operations into 2027, though substantial additional capital is required for continued development [Overview](index=21&type=section&id=MD%26A%20Overview) Context Therapeutics, a clinical-stage biopharmaceutical company, focuses on developing TCE bispecific antibodies for solid tumors, with pipeline progress including initiated Phase 1 trials for CTIM-76 and CT-95, and recent financing activities - The first patient in the CTIM-76 Phase 1 trial was dosed in January 2025, with initial data expected in the first half of 2026[101](index=101&type=chunk) - The first patient in the CT-95 Phase 1 trial was dosed in April 2025, with initial data expected in the middle of 2026[107](index=107&type=chunk) - The company expects to file an IND application for CT-202 in the middle of 2026[104](index=104&type=chunk) - As of March 31, 2025, the company had an accumulated deficit of **$99.4 million**, and cash and cash equivalents are expected to fund operations into 2027[114](index=114&type=chunk)[115](index=115&type=chunk) [Results of Operations](index=25&type=section&id=MD%26A%20Results%20of%20Operations) For Q1 2025, the net loss increased to **$4.6 million** from **$3.7 million** in Q1 2024, driven by a **$1.5 million** rise in R&D expenses for new programs and personnel, partially offset by lower CTIM-76 manufacturing costs, alongside a **$0.2 million** increase in G&A expenses and higher interest income Comparison of Operations (Three Months Ended March 31) | | 2025 ($) | 2024 ($) | $ Change ($) | % Change | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,462,991 | $1,973,209 | $1,489,782 | 76% | | General and administrative | $2,066,152 | $1,850,292 | $215,860 | 12% | | Loss from operations | ($5,529,143) | ($3,823,501) | ($1,705,642) | 45% | | Interest income | $958,517 | $152,351 | $806,166 | 529% | | **Net loss** | **($4,577,261)** | **($3,667,797)** | **($909,464)** | **25%** | R&D Expense Breakdown (Three Months Ended March 31) | Program | 2025 ($) | 2024 ($) | $ Change ($) | | :--- | :--- | :--- | :--- | | CTIM-76 | $1,060,759 | $1,890,091 | ($829,332) | | CT-95 | $765,030 | $— | $765,030 | | CT-202 | $983,573 | $— | $983,573 | | Personnel-related costs | $590,037 | $78,869 | $511,168 | | **Total R&D** | **$3,462,991** | **$1,973,209** | **$1,489,782** | [Liquidity and Capital Resources](index=27&type=section&id=MD%26A%20Liquidity%20and%20Capital%20Resources) As of March 31, 2025, the company held **$89.4 million** in cash and equivalents, projected to fund operations into 2027 for key clinical milestones, though substantial additional capital will be required for continued development and growth - The company had **$89.4 million** in cash and cash equivalents and an accumulated deficit of **$99.4 million** as of March 31, 2025[134](index=134&type=chunk) - Current cash is expected to fund operations into 2027, covering key clinical milestones for CTIM-76, CT-95, and CT-202[135](index=135&type=chunk) Summary of Cash Flows (Three Months Ended March 31) | | 2025 ($) | 2024 ($) | | :--- | :--- | :--- | | Cash used in operating activities | ($5,028,381) | ($4,360,620) | | Cash used in investing activities | ($33,948) | $— | | Cash used in financing activities | ($15,268) | $— | | **Net decrease in cash** | **($5,077,597)** | **($4,360,620)** | - Future operations will be financed through a combination of equity offerings, debt financings, collaborations, or other strategic transactions, as the company has no committed sources of capital[138](index=138&type=chunk)[139](index=139&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company is a smaller reporting company and is therefore not required to provide the information for this item - As a smaller reporting company as defined in Rule 12b-2 of the Exchange Act, the company is not required to provide the information otherwise required under this item[156](index=156&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes in internal control over financial reporting during the quarter - The principal executive officer and principal financial officer concluded that the company's disclosure controls and procedures were effective as of March 31, 2025[158](index=158&type=chunk) - There were no changes in internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[159](index=159&type=chunk) [Part II – OTHER INFORMATION](index=32&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - The company is not presently a party to any material legal proceedings[161](index=161&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section highlights new risk factors, including potential adverse impacts from changes in U.S. trade policy like tariffs and disruptions from changes at U.S. federal regulatory agencies such as the FDA, which could delay product approvals - A new risk factor has been added concerning changes in U.S. trade policy, including tariffs, which could increase the cost and difficulty of research and development[163](index=163&type=chunk) - A new risk factor addresses potential disruptions and delays in government approval processes due to restructuring or budget cuts at federal agencies like the FDA, citing proposed workforce reductions and policy changes[165](index=165&type=chunk)[166](index=166&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) During Q1 2025, the company issued inducement stock options for **46,000** common shares to new employees, granted outside the 2021 Incentive Plan and exempt from registration under Section 4(a)(2) of the Securities Act - In Q1 2025, the company granted inducement stock options for **46,000** shares to new employees with a weighted average exercise price of **$0.83 per share**[167](index=167&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) The company states that during the first quarter of 2025, none of its directors or officers adopted or terminated a Rule 10b5-1 trading plan or any other non-Rule 10b5-1 trading arrangement - During the three months ended March 31, 2025, no directors or officers adopted or terminated any Rule 10b5-1 trading plan[171](index=171&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, including the Amended and Restated Certificate of Incorporation, bylaws, an amendment to a manufacturing agreement, and certifications by the CEO and CFO - Key exhibits filed include CEO and CFO certifications (31.1, 31.2, 32.1) and corporate governance documents[172](index=172&type=chunk)

Company Announcement - Context Therapeutics Inc. has appointed Dr. Karen Smith as interim Chief Medical Officer, replacing Dr. Claudio Dansky Ullmann, who will leave the company on May 10, 2025 [1] - Dr. Smith will maintain her role on the Board of Directors while serving as interim CMO, ensuring continuity in the company's clinical development programs [1][3] Leadership Experience - Dr. Smith has over 20 years of experience in the biopharmaceutical industry, previously serving as Global Head of Research & Development and CMO at Jazz Pharmaceuticals [2] - She has held senior leadership positions at Allergan, AstraZeneca, and Bristol Myers Squibb, contributing to her expertise in drug development [2] Company Focus - Context Therapeutics is focused on advancing T cell engaging bispecific antibodies for solid tumors, with a portfolio that includes CTIM-76, CT-95, and CT-202 [3] - The company is headquartered in Philadelphia and aims to innovate in the field of T cell engaging therapeutics [3]

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]

Core Insights - Context Therapeutics has initiated a Phase 1 clinical trial for CT-95, a bispecific antibody targeting mesothelin-expressing cancers, with the first patient dosed in April 2025 [1][4] - CT-95 is designed to treat advanced cancers associated with mesothelin expression, which is overexpressed in approximately 30% of all cancers [3][5] - The company is advancing its clinical pipeline with both CT-95 and CTIM-76, another bispecific antibody currently in trials [2][4] Company Overview - Context Therapeutics Inc. is a biopharmaceutical company focused on developing T cell engaging bispecific antibodies for solid tumors [6] - The company is headquartered in Philadelphia and is building a portfolio that includes CT-95, CTIM-76, and CT-202 [6] Clinical Trial Details - The Phase 1 trial for CT-95 (NCT06756035) is an open-label, dose escalation and expansion study aimed at evaluating safety and efficacy in patients with MSLN-expressing advanced solid tumors [4] - The trial will assess safety, tolerability, pharmacokinetics, and anti-tumor activity through various metrics, with an expected enrollment of up to 30 patients in the dose escalation phase [4][5]