Curis, Inc. Files 2023 Annual Report on Form 10-K

TL;DR

<b>Curis, Inc. filed its 2023 10-K, detailing financial performance, including revenue concentration with Genentech Inc., and asset valuations.</b>

AI Summary

CURIS INC (CRIS) filed a Annual Report (10-K) with the SEC on February 8, 2024. Curis, Inc. filed its 2023 Form 10-K on February 8, 2024, reporting on the fiscal year ending December 31, 2023. The company is incorporated in Delaware and operates in the Biological Products sector. Key financial statement elements like Common Stock, Additional Paid-In Capital, Retained Earnings, and Accumulated Other Comprehensive Income are detailed for fiscal years 2021, 2022, and 2023. Customer concentration risk related to Genentech Inc. is noted for sales revenue in 2022 and 2023. Fair value measurements for money market funds and U.S. government debt securities are categorized by input levels (Level 1, Level 2, Level 3) as of December 31, 2023.

Why It Matters

For investors and stakeholders tracking CURIS INC, this filing contains several important signals. The filing provides a comprehensive overview of Curis's financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. Specific disclosures on customer concentration and fair value of investments offer insights into potential revenue stability and the management of financial assets.

Risk Assessment

Risk Level: medium — CURIS INC shows moderate risk based on this filing. The company's reliance on a single major customer (Genentech Inc.) for sales revenue presents a medium risk, as a disruption in this relationship could significantly impact financial performance.

Analyst Insight

Investors should closely monitor the company's customer diversification strategies and the ongoing relationship with Genentech Inc. to gauge future revenue stability.

Key Numbers

• 2023-12-31 — Fiscal Year End (CONFORMED PERIOD OF REPORT)
• 2024-02-08 — Filing Date (FILED AS OF DATE)
• 2836 — Standard Industrial Classification (BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES))

Key Players & Entities

• CURIS INC (company) — COMPANY CONFORMED NAME
• Genentech Inc (company) — customer concentration risk

Forward-Looking Statements

• CURIS INC's revenue will remain highly dependent on Genentech Inc. in the near term. (CURIS INC) — high confidence, target: 2024-12-31
• Any negative change in the relationship with Genentech Inc. could lead to a significant decline in CURIS INC's stock price. (CURIS INC) — high confidence, target: 2024-12-31

FAQ

Risk Factors

• Customer Concentration Risk [medium — financial]: The company's sales revenue is significantly dependent on a major customer, Genentech Inc., posing a risk to financial stability if this relationship is disrupted.

Industry Context

Curis, Inc. operates within the biotechnology sector, focusing on the development of novel cancer therapeutics.

Regulatory Implications

The filing adheres to SEC regulations for annual reports (Form 10-K), providing standardized financial and operational disclosures.

What Investors Should Do

1. Review detailed financial statements for revenue trends and profitability.
2. Analyze risk factors, particularly customer concentration, and management's mitigation strategies.
3. Examine disclosures on asset valuations, including fair value measurements of investments.

Key Dates

• 2023-12-31: Fiscal Year End — Reporting period for the 10-K filing.
• 2024-02-08: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This 10-K filing provides the annual overview for the fiscal year ending December 31, 2023, superseding previous quarterly and annual reports.

Key Financial Figures

• $0.01 — ange on Which Registered Common Stock, $0.01 par value per share CRIS Nasdaq Capital
• $9.9 million — y payments from Genentech accounted for $9.9 million and $10.3 million, or 99% and 100% of o
• $10.3 m — enentech accounted for $9.9 million and $10.3 million, or 99% and 100% of our gross rev
• $24.5 million — gene waived payment of up to a total of $24.5 million in potential milestones and other payme
• $2.0 million — rmed by Aurigene, we will provide up to $2.0 million of additional funding for each of the t
• $42.5 million — paid or unwaived payment obligations of $42.5 million per program, related to regulatory appr

Filing Documents

• cris-20231231.htm (10-K) — 1726KB
• cris-12312023x10kexx42.htm (EX-4.2) — 27KB
• employmentagtzung_amendedx.htm (EX-10.3) — 94KB
• exhibit1045amendmentno1tos.htm (EX-10.45) — 34KB
• cris-12312023x10kexx21.htm (EX-21) — 4KB
• cris-12312023x10kexx231.htm (EX-23.1) — 3KB
• cris-12312023x10kexx311.htm (EX-31.1) — 11KB
• cris-12312023x10kexx312.htm (EX-31.2) — 11KB
• cris-12312023x10kexx321.htm (EX-32.1) — 5KB
• cris-12312023x10kexx322.htm (EX-32.2) — 5KB
• curisclawbackpolicy_adopte.htm (EX-97) — 19KB
• image_0.jpg (GRAPHIC) — 29KB
• 0001108205-24-000010.txt (&nbsp;) — 7223KB
• cris-20231231.xsd (EX-101.SCH) — 51KB
• cris-20231231_cal.xml (EX-101.CAL) — 64KB
• cris-20231231_def.xml (EX-101.DEF) — 193KB
• cris-20231231_lab.xml (EX-101.LAB) — 710KB
• cris-20231231_pre.xml (EX-101.PRE) — 424KB
• cris-20231231_htm.xml (XML) — 723KB

RISK FACTORS

ITEM 1A. RISK FACTORS 39

UNRESOLVED STAFF COMMENTS

ITEM 1B. UNRESOLVED STAFF COMMENTS 77

CYBERSECURITY

ITEM 1C. CYBERSECURITY 77

PROPERTIES

ITEM 2. PROPERTIES 78

LEGAL PROCEEDINGS

ITEM 3. LEGAL PROCEEDINGS 78

MINE SAFETY DISCLOSURES

ITEM 4. MINE SAFETY DISCLOSURES 78 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 78

[RESERVED]

ITEM 6. [RESERVED] 78

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 78

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK 88

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA 88

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 109

CONTROLS AND PROCEDURES

ITEM 9A. CONTROLS AND PROCEDURES 109

OTHER INFORMATION

ITEM 9B. OTHER INFORMATION 110

DISCLOSURE R EGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

ITEM 9C. DISCLOSURE R EGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS 110 PART III

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE 110

EXECUTIVE COMPENSATION

ITEM 11. EXECUTIVE COMPENSATION 110

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 111

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE 111

PRINCIPAL ACCOUNTANT FEES AND SERVICES

ITEM 14. PRINCIPAL ACCOUNTANT FEES AND SERVICES 111 PART IV

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES 111

FORM 10-K SUMMARY

ITEM 16. FORM 10-K SUMMARY 116

SIGNATURES

SIGNATURES 116 2 Table of Conten t s PART I Cautionary Note Regarding Forward-Looking Statements and Industry Data This Annual Report on Form 10-K contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. All statements other than statements of historical fact contained in this Annual Report are statements that could be deemed forward-looking statements, including without limitation any statements with respect to the plans, strategies and objectives of management for future operations; statements concerning product research, development and commercialization plans, timelines and anticipated results; statements of expectation or belief; statements with respect to clinical trials and studies; statements with respect to royalties and milestones; statements with respect to the therapeutic potential of drug candidates; expectations of revenue, expenses, earnings or losses from operations, or other financial results; and statements of assumptions underlying any of the foregoing. Without limiting the foregoing, the words "anticipate(s)", "believe(s)", "focus(es)", "could", "estimate(s)", "expect(s)", "intend(s)", "may", "plan(s)", "seek(s)", "will", "strategy", "mission", "potential", "should", "would" and other similar language, whether in the negative or affirmative, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of future preclinical studies and clinical trials, and our research and development program for emavusertib; our estimates of the period in which we anticipate that existing cash, cash equivalents, and investments will enable us to fund our current and planned operations; our ability to continue as a going concern; our ability to obtain addition

BUSINESS

ITEM 1. BUSINESS Overview Emavusertib We are a biotechnology company focused on the development of emavusertib (CA-4948), an orally available, small molecule inhibitor of Interleukin-1 receptor associated kinase, or IRAK4. IRAK4 plays an essential role in the toll-like receptor, or TLR, and interleukin-1 receptor, or IL-1R, signaling pathways, which are frequently dysregulated in patients with cancer. TLRs and the IL-1R family signal through the adaptor protein Myeloid Differentiation Primary Response Protein 88, or MYD88, which results in the assembly and activation of IRAK4, initiating a signaling cascade that induces cytokine and survival factor expression mediated by the NF-B protein complex. Preclinical studies targeting IRAK4 in combination with FMSlike tyrosine kinase 3, or FLT3, have demonstrated the ability of emavusertib to overcome the adaptive resistance incurred when targeting FLT3 alone. Further, emavusertib has shown anti-tumor activity across a broad range of hematologic malignancies including monotherapy activity in patient-derived xenografts and synergy with both azacitidine and venetoclax. The FDA placed partial clinical holds on our TakeAim Leukemia Phase 1/2 study and our TakeAim Lymphoma Phase 1/2 study in April 2022 after we reported a serious adverse event in the TakeAim Leukemia Phase 1/2 study. In August 2022, the FDA lifted the partial clinical hold on the TakeAim Lymphoma Phase 1/2 study. In July 2023, we announced that the FDA lifted the partial clinical hold on the TakeAim Leukemia Phase 1/2 study. Both studies are actively recruiting patients, within and outside the U.S. TakeAim Leukemia Emavusertib is currently undergoing testing in a Phase 1/2 open-label, single arm expansion study in patients with relapsed or refractory, or R/R, AML, and high risk myelodysplastic syndromes, or hrMDS, also known as the TakeAim Leukemia Phase 1/2 study. In January and December 2022, and July and December 2023, we presented clinical data for pati

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