text Therapeutics (US:CNTX)2025-05-07 20:05Part I – FINANCIAL INFORMATION Item 1. Financial Statements 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 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 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 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 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-20234 - 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 months36 - 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 203493 - In May 2024, the company raised approximately $100 million in gross proceeds through a private placement of common stock and pre-funded warrants77 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 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 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 2026101 - The first patient in the CT-95 Phase 1 trial was dosed in April 2025, with initial data expected in the middle of 2026107 - The company expects to file an IND application for CT-202 in the middle of 2026104 - 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 2027114115 Results of Operations 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 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 $99.4 million as of March 31, 2025134 - Current cash is expected to fund operations into 2027, covering key clinical milestones for CTIM-76, CT-95, and CT-202135 Summary of Cash Flows (Three Months Ended March 31) | | 2025 ($) | 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 capital138139 Item 3. Quantitative and Qualitative Disclosures About Market Risk 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 item156 Item 4. Controls and Procedures 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, 2025158 - 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 controls159 Part II – OTHER INFORMATION Item 1. Legal Proceedings 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 proceedings161 Item 1A. Risk Factors 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 development163 - 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 changes165166 Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 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 share167 Item 5. Other Information 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 plan171 Item 6. Exhibits 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 documents172