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

TL;DR

<b>Capricor Therapeutics, Inc. filed its 2023 10-K, detailing financial performance and corporate history.</b>

AI Summary

CAPRICOR THERAPEUTICS, INC. (CAPR) filed a Annual Report (10-K) with the SEC on March 11, 2024. Capricor Therapeutics, Inc. filed its 2023 Form 10-K on March 11, 2024. The company's fiscal year ends on December 31st. Capricor Therapeutics, Inc. was formerly known as Nile Therapeutics, Inc. and SMI PRODUCTS INC. The company's business address is 8840 Wilshire Blvd, 2nd Floor, Beverly Hills, CA 90211. The filing includes information on common stock, additional paid-in capital, retained earnings, and comprehensive income for fiscal years 2021, 2022, and 2023.

Why It Matters

For investors and stakeholders tracking CAPRICOR THERAPEUTICS, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Capricor's financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The inclusion of historical company names and incorporation details offers context on the company's evolution and identity.

Risk Assessment

Risk Level: medium — CAPRICOR THERAPEUTICS, INC. shows moderate risk based on this filing. The company is in the pharmaceutical preparations industry, which is subject to significant regulatory oversight and market volatility, as indicated by its SIC code and the nature of its business.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to understand Capricor's current financial position and potential risks.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reported period)
• 2024-03-11 — Filing Date (Date of submission)
• 2023 — Fiscal Year (Reporting year)
• 26778360 — Value (Associated with a registered direct offering member)
• 24552688 — Value (Associated with a registered direct offering member)
• 31148320 — Value (Associated with a registered direct offering member)
• 25241402 — Value (Associated with a registered direct offering member)
• 001-34058 — SEC File Number (Company's SEC file number)

Key Players & Entities

• CAPRICOR THERAPEUTICS, INC. (company) — Filer name
• Nile Therapeutics, Inc. (company) — Former company name
• SMI PRODUCTS INC (company) — Former company name
• 8840 WILSHIRE BLVD (company) — Business address street
• BEVERLY HILLS (company) — Business address city
• CA (company) — Business address state
• 90211 (company) — Business address zip
• Michael Kelliher (person) — Consulting agreement

FAQ

Risk Factors

• Regulatory Oversight [high — regulatory]: The pharmaceutical industry is subject to extensive regulation by government agencies, impacting product development, approval, and marketing.
• Market Volatility [high — market]: The market for biotechnology and pharmaceutical products can be highly volatile, influenced by scientific breakthroughs, clinical trial results, and competitive pressures.
• Research and Development Risks [high — operational]: The success of Capricor's business depends heavily on its ability to successfully develop and commercialize its product candidates, which involves significant R&D risks.

Key Financial Figures

• $0.001 — ch Registered Common Stock, par value $0.001 per share CAPR The Nasdaq Capital M
• $4.78 — sdaq Capital Market on June 30, 2023 of $4.78 per share. As of March 7, 2024, there
• $145.0 million — icor have together raised approximately $145.0 million in equity capital (both privately and p
• $90.0 million — and publicly) as well as approximately $90.0 million in non-dilutive funding from our partne

Filing Documents

• capr-20231231x10k.htm (10-K) — 2137KB
• capr-20231231xex4d1.htm (EX-4.1) — 22KB
• capr-20231231xex21d1.htm (EX-21.1) — 4KB
• capr-20231231xex23d1.htm (EX-23.1) — 3KB
• capr-20231231xex31d1.htm (EX-31.1) — 9KB
• capr-20231231xex31d2.htm (EX-31.2) — 10KB
• capr-20231231xex32d1.htm (EX-32.1) — 6KB
• capr-20231231xex32d2.htm (EX-32.2) — 6KB
• capr-20231231xex97.htm (EX-97) — 28KB
• capr-20231231x10k005.jpg (GRAPHIC) — 35KB
• capr-20231231x10k006.jpg (GRAPHIC) — 19KB
• capr-20231231x10k007.jpg (GRAPHIC) — 16KB
• 0001558370-24-002861.txt (&nbsp;) — 7390KB
• capr-20231231.xsd (EX-101.SCH) — 49KB
• capr-20231231_cal.xml (EX-101.CAL) — 38KB
• capr-20231231_def.xml (EX-101.DEF) — 213KB
• capr-20231231_lab.xml (EX-101.LAB) — 391KB
• capr-20231231_pre.xml (EX-101.PRE) — 321KB
• capr-20231231x10k_htm.xml (XML) — 956KB

Business

Business 4 Item 1A.

Risk Factors

Risk Factors 30 Item 1B. Unresolved Staff Comments 71 Item 1C. Cybersecurity 71 Item 2.

Properties

Properties 71 Item 3.

Legal Proceedings

Legal Proceedings 71 Item 4 Mine Safety Disclosures 71 Part II 72 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 72 Item 6. Reserved 72 Item 7.

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

Management's Discussion and Analysis of Financial Condition and Results of Operations 73 Item 7A.

Quantitative and Qualitative Disclosures About Market Risk

Quantitative and Qualitative Disclosures About Market Risk 87 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 88 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 115 Item 9A.

Controls and Procedures

Controls and Procedures 115 Item 9B. Other Information 116 Part III 116 Item 10. Directors, Executive Officers and Corporate Governance 116 Item 11.

Executive Compensation

Executive Compensation 116 Item 12.

Security Ownership of Certain Beneficial Owners and Management

Security Ownership of Certain Beneficial Owners and Management 116 Item 13. Certain Relationships and Related Transactions, and Director Independence 116 Item 14. Principal Accountant Fees and Services 116 Part IV 116 Item 15. Exhibits and Financial Statement Schedules 116 Item 16. Form 10-K Summary 121

SIGNATURES

SIGNATURES 122 INDEX OF EXHIBITS FILED WITH THIS REPORT 2 Table of Contents References to "the Company," "Capricor Therapeutics," "we," "us" or "our" in this Annual Report on Form 10-K refer to Capricor Therapeutics, Inc., a Delaware corporation, and its subsidiaries, unless the context indicates otherwise. References to "Capricor" in this Annual Report on Form 10-K refer to our wholly owned subsidiary, Capricor, Inc., unless the context indicates otherwise.

FORWARD-LOOKING STATEMENTS

FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, or the Exchange Act. The forward-looking statements are only predictions and provide our current expectations or forecasts of future events and financial performance and may be identified by the use of forward-looking terminology, including the terms "believes," "estimates," "anticipates," "expects," "plans," "potential," "projects," "intends," "may," "will" or "should" or, in each case, their negative, or other variations or comparable terminology, though the absence of these words does not necessarily mean that a statement is not forward-looking. Forward-looking statements include all matters that are not historical facts and include, without limitation, statements about the development of our product candidates, including when we expect to undertake, initiate and complete clinical trials of our product candidates; expectation of or dates for commencement of clinical trials; timing of study or trial results; manufacturing capabilities, investigational new drug filings, similar plans or projections; the regulatory approval of our drug candidates and dates for regulatory meetings; our ability to achieve product milestones and to receive milestone payments from commercial partners; our use of clinical research centers, third-party manufacturers and other contractors; our ability to find collaborative partners for research, development and commercialization of potential products; our or a designated third-party's ability to manufacture products for clinical and commercial use; our ability to protect our patents and other intellectual property; our ability to market any of our products; our projected operating losses and ability to operate as a going concern; the impact of taxes on our business, including our ability to utilize net

BUSINESS

ITEM 1. BUSINESS Overview Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy ("DMD"), a rare form of muscular dystrophy which results in muscle degeneration and premature death, and other diseases with high unmet medical needs. Technology and Platforms Cell Therapy Platform Our core program is focused on the development and commercialization of a cell therapy (referred to herein as CAP-1002) comprised of cardiosphere-derived cells ("CDCs"), which are a population of stromal cells isolated from donated cells of healthy human hearts currently being developed for the treatment of DMD. DMD is a rare, monogenic, X-linked muscle disease driven by the impaired production of functional dystrophin, which normally functions as a structural protein in muscle. The reduction of functional dystrophin in muscle cells leads to significant cell damage and ultimately causes muscle cell death and fibrotic replacement. CAP-1002 is designed to slow disease progression in DMD through the immunomodulatory, anti-inflammatory, and anti-fibrotic actions of CDCs, which are mediated by secreted exosomes laden with bioactive cargo. Among the cargo elements known to be bioactive in CDC-exosomes are microRNAs. Collectively, these non-coding RNA species alter gene expression in macrophages and other target cells, dialing down generalized inflammation and stimulating tissue regeneration in DMD (and in a variety of other inflammatory diseases). This mechanism of action, consistent with the changes observed in clinical studies to date in circulating inflammatory biomarkers, contrasts with that of exon-skipping oligonucleotides and gene therapy approaches that aim to restore dystrophin expression. Our CAP-1002 cell therapy program for the treatment of DMD is currently in Phase 3 clinical development in the United States, for which we expect to have top-li

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View this 10-K filing on SEC EDGAR