CAPR

EX-99.1

2 capr-20260512xex99d1.htm

EX-99.1

Exhibit 99.1

Capricor Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update

●Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected to commence soon

●HOPE-3 Phase 3 trial met its primary endpoint (PUL v2.0; upper limb function) and all Type I error-controlled secondary endpoints

●GMP manufacturing facility fully operational; second-floor expansion well underway

●Chief Commercial Officer with direct DMD commercial experience expected to join the Company in the coming weeks

●Filed suit against Nippon Shinyaku Co., Ltd. and NS Pharma, Inc. seeking rescission of U.S. distribution agreement and preliminary injunction; FDA review and PDUFA date unaffected

●Cash balance of approximately $279 million expected to support operations into Q4 2027

●Eligible for a Priority Review Voucher upon approval; PRV is transferable and monetizable, offering potential non-dilutive capital

●Conference call and webcast today at 4:30 p.m. ET

SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) — Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced its financial results for the first quarter ended March 31, 2026, and provided a corporate update.

"Capricor enters this pivotal moment with important regulatory and clinical momentum as we work toward potential approval of Deramiocel for the treatment of Duchenne muscular dystrophy," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "With the FDA review of our BLA underway and a PDUFA target action date of August 22, 2026, our highest priority is execution: working closely with the Agency, preparing for potential launch, and continuing to build the capabilities of a commercial-stage company. We remain focused on ensuring that Deramiocel reaches every eligible patient as quickly as possible, which is why we took necessary legal action against NS Pharma to remove a structural barrier to patient access created by a flawed pricing arrangement and to address our distributor's failure to fulfill its commercial obligations."

“Our thesis is straightforward: a potential first-in-class approval in a defined rare disease population, proprietary in-house manufacturing, a growing pipeline, and a leadership team with the conviction and the capital to execute,” said Dr. Marbán. “We are building something that will create meaningful and durable value for patients, for this company, and for the shareholders who have believed in this mission.”

First Quarter 2026 and Recent Highlights

●Deramiocel BLA Under FDA Review: Capricor's Biologics License Application (BLA) seeking approval of Deramiocel for the treatment of DMD is currently under review by the U.S. Food and Drug Administration. The FDA accepted the Company's Class 2 resubmission as complete, resuming its full review of the BLA, with a PDUFA target action date of August 22, 2026. There has been a significant number of information requests from FDA to Capricor, all of which the Company has been able to address. The Company looks forward to continuing an active dialogue with the FDA and expects labeling discussions to commence soon.

●Additional HOPE-3 Late-Breaking Data Presented at MDA, AAN, and ASGCT (2026): HOPE-3 data were selected as one of only four late-breaking oral presentations at the 2026 MDA Clinical & Scientific Conference. Data were also presented at the 2026 AAN Annual Meeting and the 2026 ASGCT Annual Meeting. Cardiac MRI analyses showed a significant reduction in myocardial fibrosis by late gadolinium enhancement (LGE) versus placebo, a clinically meaningful finding given that fibrosis is cumulative and irreversible. The Duchenne Video Assessment (DVA) "eat 10 bites" measure, a home-based, caregiver-captured assessment of upper limb function and daily living activities, demonstrated statistically significant improvement versus placebo, directly correlated with patient independence and quality of life. The full HOPE-3 dataset has been submitted for publication to a peer-reviewed journal.

●Commercial Launch Preparations Underway: The Company's GMP manufacturing facility in San Diego successfully completed an FDA Pre-License Inspection, with all Form 483 observations addressed. The facility is

operational and positioned to support initial commercial launch. Second-floor expansion adding additional cleanrooms is well underway, scaling to approximately 2,000–2,500 patients per year, roughly 10,000 doses annually, at full capacity, with full facility validation and FDA approval targeted for the first half of 2027. The Company will begin stockpiling commercial doses once guidance on the label is received. Planning is underway across all critical launch functions, including patient support, market access, reimbursement planning, medical affairs and physician education.

CAPRICOR THERAPEUTICS, INC._March 12, 2026 0001133869false00011338692026-03-122026-03-12 ​ ​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

​

FORM 8-K

​

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 ​ Date of Report (Date of earliest event reported) ​ March 12, 2026

​

CAPRICOR THERAPEUTICS, INC.

(Exact name of Registrant as Specified in its Charter) ​ ​ ​ ​ ​ ​

Delaware ​ ​ ​ 001-34058 ​ ​ ​ 88-0363465

(State or other jurisdiction of incorporation) ​ (Commission File Number) ​ (I.R.S. Employer Identification No.)

​ ​ ​ ​

10865 Road to the Cure, Suite 150, San Diego, California (Address of principal executive offices) ​ ​ ​ 92121 (Zip Code)

​ (858) 727-1755 (Registrant’s telephone number, including area code) ​ Not Applicable (Former name or former address, if changed since last report) ​ Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ​ ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

​ ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

​ ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

​ ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

​ Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). ​ 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. ◻ ​ 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

CAPR

The Nasdaq Capital Market

​ ​ ​ ​ ​

Item 2.02 Results of Operations and Financial Condition.

​ On March 12, 2026, Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the quarter and full year ended December 31, 2025. A copy of the press release is being furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. ​ The information under Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing. ​ Item 9.01Financial Statements and Exhibits. ​ (d) Exhibits ​

99.1 ​ Press Release, titled “Capricor Therapeutics Reports Fourth Quarter and Full Year 2025 Results and Provides Corporate Update”, dated March 12, 2026.

​ ​ ​

104 ​ Cover Page Interactive Data File (formatted as inline XBRL).

​ ​

2

​

SIGNATURES

​ Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. ​

CAPRICOR THERAPEUTICS, INC.

Date: March 12, 2026 By: /s/ Linda Marbán, Ph.D.

Linda Marbán, Ph.D.

Chief Executive Officer

​ ​

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CAPRICOR THERAPEUTICS, INC._November 10, 2025 0001133869false00011338692025-11-102025-11-10 ​ ​

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

​

FORM 8-K

​

CURRENT REPORT

Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 ​ Date of Report (Date of earliest event reported) ​ November 10, 2025

​

CAPRICOR THERAPEUTICS, INC.

(Exact name of Registrant as Specified in its Charter) ​

​ ​

Delaware

001-34058

88-0363465

(State or other jurisdiction of incorporation) ​ (Commission File Number) ​ (I.R.S. Employer Identification No.)

​

10865 Road to the Cure, Suite 150, San Diego, California (Address of principal executive offices)

92121 (Zip Code)

​ (858) 727-1755 (Registrant’s telephone number, including area code) ​ Not Applicable (Former name or former address, if changed since last report) ​ Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions: ​ ☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

​ ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

​ ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

​ ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

​ Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2). ​ 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. ◻ ​ 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

CAPR

The Nasdaq Capital Market

​ ​ ​ ​ ​

Item 2.02 Results of Operations and Financial Condition.

​ On November 10, 2025, Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), issued a press release announcing its financial results for the quarter ended September 30, 2025. A copy of the press release is being furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K. ​ The information under Item 2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto is being furnished and shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be incorporated by reference into any of the Company’s filings under the Exchange Act, unless expressly set forth as being incorporated by reference into such filing. ​ Item 9.01Financial Statements and Exhibits. ​ (d) Exhibits ​

99.1 ​ Press Release, titled “Capricor Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update”, dated November 10, 2025.

​ ​ ​

104 ​ Cover Page Interactive Data File (formatted as inline XBRL).

​ ​

2

​

SIGNATURES

​ Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, hereunto duly authorized. ​

CAPRICOR THERAPEUTICS, INC.

Date: November 10, 2025 By: /s/ Linda Marbán, Ph.D.

Linda Marbán, Ph.D.

Chief Executive Officer

​ ​

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