cntx-20251231

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


☐			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. Employer Identification Number)

2001 Market Street, Suite 3915, Unit #15

Philadelphia, Pennsylvania 19103

(Address of principal executive offices, including zip)

(267) 225-7416

(Registrant’s telephone number, including area code)


Securities registered pursuant to Section 12(b) of the Act:
Title of Each Class	Trading Symbol(s)	Name of Each Exchange on Which Registered
Common Stock, par value $0.001 per share	CNTX	The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No ☒

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No ☒

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ☒ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

☐

Accelerated filer

☐

Non-accelerated filer

☒

Smaller reporting company

☒

Emerging growth company

☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C 7262(b)) by the registered public accounting firm that prepared or issued its audit report.

If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b).

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒

As of June 30, 2025 (the last business day of the registrant's most recently completed second fiscal quarter), the aggregate market value of the registrant's common stock held by non-affiliates was approximately $57.9 million based on the last reported sale price of the registrant's common stock on The Nasdaq Stock Market on June 30, 2025.

As of March 19, 2026, the registrant had 91,879,177 shares of common stock, $0.001 par value per share, outstanding.

DOCUMENTS INCORPORATED BY REFERENCE

Portions of the registrant’s definitive Proxy Statement for its 2026 Annual Meeting of Stockholders to be filed with the Securities and Exchange Commission pursuant to Regulation 14A not later than 120 days after the end of the fiscal year covered by this Annual Report on Form 10-K are incorporated by reference in Part III, Items 10-14 of this Annual Report on Form 10-K.

TABLE OF CONTENTS


Risk Factor Summary			ii
Note Regarding Forward-Looking Statements			iv
Market, Industry and Other Data			vii

Part I
Item 1. Business			1
Item 1A. Risk Factors			21
Item 1B. Unresolved Staff Comments			58
Item 1C. Cybersecurity			58
Item 2. Properties			59
Item 3. Legal Proceedings			59
Item 4. Mine Safety Disclosures			59
Part II
Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities			60
Item 6. [Reserved]			60
Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations			61
Item 7A. Quantitative and Qualitative Disclosures About Market Risk			70
Item 8. Financial Statements and Supplementary Data			71
Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure			92
Item 9A. Controls and Procedures			92
Item 9B. Other Information			93
Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections			93
Part III
Item 10. Directors, Executive Officers and Corporate Governance			94
Item 11. Executive Compensation			94
Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters			94
Item 13. Certain Relationships and Related Transactions, and Director Independence			94
Item 14. Principal Accountant Fees and Services			94
Part IV
Item 15. Exhibits and Financial Statement Schedules			95
Item 16. Form 10-K Summary			98
Signatures			99

_________________________

Unless the context otherwise requires, all references in this Form 10-K to "Context," the "Company," "we," "us," and "our" refer to Context Therapeutics Inc. and its subsidiaries.

_________________________

Trademark Notice

This Form 10-K contains references to our trademarks and to trademarks belonging to other entities. Context Therapeutics® is a registered trademark of Context in the United States. All other trademarks, trade names and service marks appearing in this Form 10-K are the property of their respective owners. We do not intend our use or

display of other companies' trade names or trademarks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.

RISK FACTOR SUMMARY

The risk factors summarized below could materially harm our business, operating results and/or financial condition, impair our future prospects and/or cause the price of our common stock to decline. For more information, see “Item 1A. Risk Factors” in this Annual Report on Form 10-K for the year ended December 31, 2025. Material risks that may affect our business, operating results and financial condition include, but are not necessarily limited to, the following:

Risks Related to Our Business and Industry

•We have never been profitable and may never achieve or maintain profitability.

•We will need to raise additional funding, which may not be available on acceptable terms, or at all. Failure to obtain this necessary capital when needed may force us to delay, limit or terminate our product development efforts or other operations.

•If we are unable to raise substantial additional capital on acceptable terms, or at all, we may be forced to delay, reduce or eliminate some or all of our research programs, product development activities and commercialization efforts.

•We may not be able to successfully integrate recent and future acquisitions.

•We have a limited operating history, which makes it difficult to evaluate our current business and future prospects and may increase the risk of your investment.

•We may expend our limited resources pursuing particular research programs or product candidates that may be less successful or profitable than other programs or product candidates.

•Fluctuating foreign exchange rates could increase our operating expenses and adversely affect our results of operations.

•Inflation, geopolitical developments, global supply chain disruptions and public health concerns could adversely affect our business and results of operations.

•Changes in U.S. trade policy, including the imposition of tariffs and the resulting consequences, may have a material adverse impact on our business, financial condition, and results of operations.

Risks Related to Our Product Candidates

•Our business is dependent on the successful development, regulatory approval and commercialization of our therapeutic product candidates, CTIM-76, CT-95 and CT-202, which are in the early stages of development.

•Results of preclinical studies, early clinical trials or analyses may not be indicative of results obtained in later trials.

•Interim “top-line” and preliminary data from our clinical trials that we announce or publish from time to time may change as more patient data becomes available and are subject to audit and verification procedures that could result in material changes in the final data.

•Any product candidate may cause serious adverse events or undesirable side effects, which may delay or prevent marketing approval, or, if approved, require it to be taken off the market, require it to include safety warnings or otherwise limit its sales.

•We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties or delays enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.

•The success of our business depends primarily upon our ability to identify, develop and commercialize products using our proprietary technologies.

Risks Related to Our Organization, Structure and Operations

•Our reliance on a central team consisting of a limited number of employees and consultants who provide various administrative, research and development, and other services across our organization presents operational challenges that may adversely affect our business.

•Our future success depends on our ability to retain our executive officers and other key executives and to attract, retain and motivate qualified personnel.

Risks Related to Our Reliance on Third Parties


Selected Cancer indications	Incidence (US Only)	R/R Incidence	CLDN6 Positive	CLDN6 Med/High	Patient Population Based on R/R Incidence
Ovarian	19,900	12,800	75%1	35%1	9,600
Endometrial	65,900	14,000	50%1	22%1	7,000
Testicular	9,910	400	100%3	>95%3	400
Non-Small Cell Lung	201,229	110,653	26%2	6%2	28,769
Colon	152,810	53,010	43%3	0%3	22,794
Breast	290,600	43,800	40%3	0%3	17,520


Selected Cancer indications	Incidence (US Only)	R/R Incidence	MSLN Positive	MSLN Med/High	Patient Population Based on R/R Incidence
Non-Small Cell Lung	201,229	110,653	55%	36%	60,859
Pancreatic	66,440	51,750	80%	61%	41,400
Colon	152,810	53,010	41%	17%	21,734
Ovarian	19,900	12,800	90%	80%	11,520
Mesothelioma	3,000	2,500	70%	60%	1,750
Esophageal	22,370	16,130	41%	26%	6,613
Endometrial	65,900	14,000	45%	23%	6,300
Gastric	26,380	11,090	49%	23%	5,434


Selected Cancer indications	Incidence (US Only)	R/R Incidence	Nectin-4 Positive	Nectin-4 Med/High	Patient Population Based on R/R Incidence
Colon	152,810	53,010	87%1	78%2	46,119
Bladder (urothelial)	83,190	20,000	83%3	60%3	16,600
Breast (TNBC)	62,054	15,500	78%3	58%5	12,090
Non-Small Cell Lung	201,229	110,653	64%3	58%6	70,818
Pancreatic	66,440	51,750	71%3	37%3	36,743
Head and Neck	54,000	12,000	59%3	18%3	7,080
Esophageal	22,370	16,130	55%3	24%3	8,872
Gastric	26,890	12,000	94%7	60%4	11,280

SEC Form 10-K filed by Context Therapeutics Inc.