Context Therapeutics Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Context Therapeutics Inc. has filed its annual 10-K report for the fiscal year ended December 31, 2023.</b>

AI Summary

Context Therapeutics Inc. (CNTX) filed a Annual Report (10-K) with the SEC on March 21, 2024. Context Therapeutics Inc. filed its 2023 Form 10-K on March 21, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 2001 Market Street, Suite 3915, Philadelphia, PA 19103. Context Therapeutics Inc. was formerly known as Context Therapeutics LLC, with a name change on January 28, 2021. The company operates in the Pharmaceutical Preparations industry (SIC code 2834).

Why It Matters

For investors and stakeholders tracking Context Therapeutics Inc., this filing contains several important signals. This filing provides a comprehensive overview of the company's financial performance, operations, and risk factors for the fiscal year 2023, crucial for investors to assess the company's current standing and future prospects. As a pharmaceutical preparations company, the details within the 10-K are vital for understanding its research and development activities, regulatory compliance, and market position within the healthcare sector.

Risk Assessment

Risk Level: medium — Context Therapeutics Inc. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight, lengthy development cycles, and substantial R&D investment, as indicated by the filing's focus on these aspects.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Context Therapeutics' financial health and strategic direction.

Key Numbers

• 2023-12-31 — Fiscal Year End (The end date of the reporting period for the 10-K.)
• 2024-03-21 — Filing Date (The date the 10-K was filed with the SEC.)
• 2834 — SIC Code (Standard Industrial Classification code for Pharmaceutical Preparations.)

Key Players & Entities

• Context Therapeutics Inc. (company) — Filer of the 10-K report.
• 2001 Market Street, Suite 3915 (location) — Business and mailing address of the company.
• Philadelphia, PA (location) — City and state of the company's principal executive offices.
• Context Therapeutics LLC (company) — Former name of Context Therapeutics Inc.

FAQ

Risk Factors

• Regulatory Risks [high — regulatory]: The pharmaceutical industry is subject to extensive government regulation, which can impact product development, manufacturing, and marketing.
• Funding and Liquidity [medium — financial]: The company's ability to fund its operations and development activities depends on its access to capital and its financial resources.
• Research and Development [high — operational]: The success of the company's product candidates is dependent on the outcome of research and development efforts.

Key Dates

• 2023-12-31: Fiscal Year End — Marks the end of the reporting period for the 2023 10-K.
• 2024-03-21: 10-K Filing Date — Date Context Therapeutics Inc. submitted its annual report.

Glossary

10-K

An annual report required by the U.S. Securities and Exchange Commission (SEC), which gives a comprehensive summary of a company's financial performance. (This filing provides the official annual financial and business overview for Context Therapeutics Inc.)

SIC Code

Standard Industrial Classification code used to classify businesses based on their primary activity. (Indicates Context Therapeutics Inc. operates in the Pharmaceutical Preparations sector.)

Key Financial Figures

• $0.001 — ich Registered Common Stock, par value $0.001 per share CNTX The Nasdaq Stock Market

Filing Documents

• cntx-20231231.htm (10-K) — 1118KB
• exhibit32context-arbylawsm.htm (EX-3.2) — 237KB
• cntx-ex43to2023form10xk.htm (EX-4.3) — 23KB
• cntx-231cohnreznick10xkcon.htm (EX-23.1) — 3KB
• cntx2023ex311certification.htm (EX-31.1) — 10KB
• cntx2023ex312certification.htm (EX-31.2) — 10KB
• cntx2023ex321certification.htm (EX-32.1) — 6KB
• cntx-ex97compensationrecov.htm (EX-97) — 36KB
• cntx-20231231_g1.jpg (GRAPHIC) — 59KB
• cntx-20231231_g2.jpg (GRAPHIC) — 67KB
• cntx-20231231_g3.jpg (GRAPHIC) — 586KB
• cntx-20231231_g4.jpg (GRAPHIC) — 408KB
• cntx-20231231_g5.jpg (GRAPHIC) — 432KB
• cntx-20231231_g6.jpg (GRAPHIC) — 384KB
• 0001842952-24-000011.txt (&nbsp;) — 9409KB
• cntx-20231231.xsd (EX-101.SCH) — 30KB
• cntx-20231231_cal.xml (EX-101.CAL) — 39KB
• cntx-20231231_def.xml (EX-101.DEF) — 113KB
• cntx-20231231_lab.xml (EX-101.LAB) — 456KB
• cntx-20231231_pre.xml (EX-101.PRE) — 298KB
• cntx-20231231_htm.xml (XML) — 390KB

Risk Factors

Item 1A. Risk Factors 17

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 52 I tem 1C . Cybersecurity 52

Properties

Item 2. Properties 53

Legal Proceedings

Item 3. Legal Proceedings 53

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 53 Part II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 54

[Reserved]

Item 6. [Reserved] 54

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 55

Quantitative and Qualitative Disclosures About Market Risk

Item 7A. Quantitative and Qualitative Disclosures About Market Risk 63

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 64

Changes in and Disagreements With Accountants on Accounting and Financial Disclosure

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosure 82

Controls and Procedures

Item 9A. Controls and Procedures 82

Other Information

Item 9B. Other Information 83

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 83 Part III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 84

Executive Compensation

Item 11. Executive Compensation 84

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 84

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 84

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 84 Part IV

Exhibits and Financial Statement Schedules

Item 15. Exhibits and Financial Statement Schedules 85

Form 10-K Summary

Item 16. Form 10-K Summary 88

Signatures

Signatures 89 _________________________ 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 i 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, 2023. 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. There is substantial doubt regarding our ability to continue as a going concern. 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 have a limited operating history, which makes it difficult

Business

Item 1. Business Overview We are a biopharmaceutical company advancing medicines for solid tumors. Profound advancements in oncology drug development have expanded the treatment options available to cancer patients, yet the need for additional treatment options exists. Our preclinical program, CTIM-76, is an anti-Claudin 6 ("CLDN6") x anti-CD3 bispecific antibody ("bsAb") that is intended to redirect T-cell-mediated lysis toward malignant cells expressing CLDN6. CLDN6 is a tight junction membrane protein target expressed in multiple solid tumors and absent from or expressed at low levels in healthy adult tissues. CTIM-76 investigational new drug ("IND")-enabling studies are ongoing, with an IND filing to support human clinical trials expected by the end of March 2024. We plan to initiate a Phase 1 trial to focus on CLDN6-positive gynecologic and testicular cancers upon receiving IND clearance from the FDA. We expect to have sufficient cash and cash equivalents to fund our operations into late 2024. We will require additional funding for our planned Phase 1 trial, other research and development expenditures, and general and administrative expenses. On March 22, 2023, we announced a portfolio prioritization and capital allocation strategy, including discontinuing the development of ONA-XR and focusing on the development of CTIM-76. Based upon the challenging market conditions for emerging companies, the increasingly competitive landscape for breast cancer treatments, recent study findings, and other factors, we decided to cease development and explore strategic options for ONA-XR. As a result, we no longer primarily focus on female cancers. Beyond these product candidates, we continue to evaluate opportunities to expand our pipeline. We believe our team and capabilities position us to be a leader in developing novel therapies targeting solid tumors. We retain full worldwide development and commercialization rights to certain CTIM-76 patents in the field of bisp

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View this 10-K filing on SEC EDGAR