Capricor Therapeutics, Inc. (CAPR) SEC Filing 10-K Annual Report for the fiscal year ending Saturday, December 31, 2022

Capricor Therapeutics, Inc.

CIK: 1133869 Ticker: CAPR


Exhibit 99.1

Capricor Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update

-Enrollment Continues to Progress in HOPE-3, the Phase 3 Clinical Trial of CAP-1002 in Duchenne Muscular Dystrophy (DMD); Plan to Report on Interim Analysis in Q4 2023-

-Held Type-B CMC Meeting with U.S. Food and Drug Administration (FDA) Regarding Pathway Towards Biologics License Application (BLA) for CAP-1002 in DMD-

-Expanded Partnership with Nippon Shinyaku to Japan to Leverage Commercial DMD Franchise with $12 Million Upfront and Additional Potential Milestone Payments of up to $89 Million-

-To Host Conference Call and Webcast Today at 4:30 p.m. ET-

SAN DIEGO, Calif., March 15, 2023 (GLOBE NEWSWIRE) --

Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today its financial results for the fourth quarter and full year ended December 31, 2022 and provided a corporate update.

“In 2022, we continued to advance our clinical development program for CAP-1002 in patients with Duchenne Muscular Dystrophy (DMD), highlighted by the initiation of our HOPE-3 Phase 3 trial and are well positioned to deliver on multiple value-driving milestones throughout 2023,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “As CAP-1002 continues to advance towards potential commercialization, we recently met with the FDA in a Type-B CMC meeting and discussed our manufacturing plans in anticipation of a Biologics License Application (BLA). We are pleased that the FDA continues to work with us under our RMAT designation and we will provide further updates on our plans as they become available. Furthermore, enrollment for HOPE-3 continues to progress and with patient dosing underway, we plan to report the results of our interim analysis in the fourth quarter of 2023. This trial builds on the recently presented statistically significant 18-month results from our ongoing HOPE-2 open label extension study (OLE), which further positions CAP-1002 as a potential anchor therapy for DMD. These results suggest that patients accumulate benefit over time with steady preservation of skeletal muscle functions, highlighting the potential disease modifying effect and long-term benefit of CAP-1002. They also contribute to the safety profile of the therapy. Further, we continue to explore opportunities for additional strategic partnerships outside of the United States and Japan to maximize the value of our asset and ensure rapid therapy availability to the global patient community.”

Dr. Marbán continued, “In parallel, we are pleased with the steady progress across our exosome program, designed to support the advancement of next generation vaccines and innovative therapeutics. We recently published preclinical data from our proprietary StealthXTM platform, which generated two vaccine candidates that induced a strong, long-lasting immune response against two SARS-CoV-2 proteins, spike and nucleocapsid. We look forward to exploring the potential therapeutic utility of these vaccine candidates, and more broadly, expanding our pipeline and partnership opportunities with this platform.”

Fourth Quarter 2022 and Recent Operational Developments

HOPE-3, our Phase 3 clinical trial of CAP-1002 in DMD continues to progress well. The multi-center, randomized, double-blind, placebo-controlled study (NCT05126758) is designed to treat up to 68 patients in the United States. At this time, we have treated over 30% of the patients in the currently designed study with 11 active sites.
Met with the FDA in a Type-B CMC meeting to discuss our commercial planning in anticipation of a potential BLA submission. The meeting was very constructive and provides us with increased visibility on the expectations the FDA has for the HOPE-3 trial and commercial scale manufacturing of CAP-1002 in support of a future BLA.

The following information was filed by Capricor Therapeutics, Inc. (CAPR) on Wednesday, March 15, 2023 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Capricor Therapeutics, Inc.'s 10-K Annual Report:

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Document And Entity Information
Consolidated Balance Sheets
Consolidated Balance Sheets (Parenthetical)
Consolidated Statements Of Cash Flows
Consolidated Statements Of Changes In Stockholders' Equity
Consolidated Statements Of Operations And Comprehensive Loss
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Details)
Commitments And Contingencies - Future Minimum Rental Payments (Details)
Concentrations (Details)
Government Grant Awards
Government Grant Awards (Details)
License Agreements (Details)
License And Distribution Agreements
Note Payable
Note Payable (Details)
Organization And Summary Of Significant Accounting Policies
Organization And Summary Of Significant Accounting Policies (Policies)
Organization And Summary Of Significant Accounting Policies (Tables)
Organization And Summary Of Significant Accounting Policies - Additional Information (Details)
Organization And Summary Of Significant Accounting Policies - Fair Value Measurements By Levels (Details)
Organization And Summary Of Significant Accounting Policies - Property And Equipment (Details)
Related Party Transactions
Related Party Transactions (Details)
Stock Awards, Warrants And Options
Stock Awards, Warrants And Options (Tables)
Stock Awards, Warrants And Options - Additional Information (Details)
Stock Awards, Warrants And Options - Assumptions (Details)
Stock Awards, Warrants And Options - Outstanding Warrants (Details)
Stock Awards, Warrants And Options - Stock Option Activity (Details)
Stock Awards, Warrants And Options - Stock Options Outstanding And Exercisable (Details)
Stock Awards, Warrants And Options - Stock-Based Compensation Expense (Details)
Stock Awards, Warrants And Options - Warrants (Details)
Stockholder's Equity
Stockholder's Equity (Details)
Subsequent Events
Subsequent Events (Details)
Ticker: CAPR
CIK: 1133869
Form Type: 10-K Annual Report
Accession Number: 0001558370-23-004124
Submitted to the SEC: Fri Mar 17 2023 5:00:56 PM EST
Accepted by the SEC: Fri Mar 17 2023
Period: Saturday, December 31, 2022
Industry: Pharmaceutical Preparations

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