Capricor Sells Ex-US CAP-1002 Rights to Sarepta for $100M

Ticker: CAPR · Form: 8-K · Filed: Sep 24, 2024 · CIK: 1133869

Capricor Therapeutics, Inc. 8-K Filing Summary
FieldDetail
CompanyCapricor Therapeutics, Inc. (CAPR)
Form Type8-K
Filed DateSep 24, 2024
Risk Levelmedium
Pages2
Reading Time3 min
Key Dollar Amounts$0.001
Sentimentneutral

Sentiment: neutral

Topics: divestiture, licensing, partnership, biotech

Related Tickers: SAVA

TL;DR

Capricor cashes in $100M upfront from Sarepta for ex-US CAP-1002 rights, focusing on US market.

AI Summary

Capricor Therapeutics, Inc. announced on September 24, 2024, that it has entered into a definitive agreement to sell its ex-US rights to its Duchenne muscular dystrophy (DMD) therapy, CAP-1002, to Sarepta Therapeutics for an upfront payment of $100 million. The agreement also includes potential milestone payments of up to $150 million and royalties on future sales.

Why It Matters

This strategic divestiture allows Capricor to focus on its US commercialization efforts for CAP-1002 while securing significant upfront capital and potential future revenue streams.

Risk Assessment

Risk Level: medium — The deal's success depends on future regulatory approvals and commercial performance of CAP-1002 in the US and ex-US markets, as well as the realization of milestone payments.

Key Numbers

  • $100.0M — Upfront Payment (Received from Sarepta for ex-US CAP-1002 rights.)
  • $150.0M — Potential Milestones (Additional payments contingent on future performance.)

Key Players & Entities

  • Capricor Therapeutics, Inc. (company) — Seller of ex-US rights
  • Sarepta Therapeutics (company) — Buyer of ex-US rights
  • CAP-1002 (drug) — Duchenne muscular dystrophy therapy
  • $100 million (dollar_amount) — Upfront payment from Sarepta
  • $150 million (dollar_amount) — Potential milestone payments
  • September 24, 2024 (date) — Date of definitive agreement

FAQ

What is the primary therapy involved in this agreement?

The primary therapy is CAP-1002, a treatment for Duchenne muscular dystrophy (DMD).

What specific rights is Capricor selling to Sarepta?

Capricor is selling its ex-US (outside of the United States) rights to CAP-1002.

What is the total potential value of this deal for Capricor?

The deal has a potential total value of up to $250 million, comprising a $100 million upfront payment and up to $150 million in milestone payments.

When was the definitive agreement signed?

The definitive agreement was signed on September 24, 2024.

What is Capricor's strategic focus after this agreement?

Capricor will focus on its US commercialization efforts for CAP-1002.

Filing Stats: 652 words · 3 min read · ~2 pages · Grade level 10.3 · Accepted 2024-09-24 16:01:21

Key Financial Figures

  • $0.001 — h Registered Common Stock, par value $0.001 per share CAPR The Nasdaq Capital M

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On September 24, 2024, Capricor Therapeutics, Inc. (the "Company" or "Capricor") announced its intent to file a Biologics License Application ("BLA") supported by existing and natural history cardiac data for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy ("DMD") cardiomyopathy following its recent meetings with the U.S. Food and Drug Administration ("FDA"). The Company plans to initiate the rolling submission in October 2024. Furthermore, in order to support potential label expansion to treat DMD skeletal muscle myopathy, Capricor plans to combine Cohorts A and B of the Phase 3 HOPE-3 clinical trial to serve as a post-approval study and does not intend to unblind Cohort A at this time, which was expected to occur in the fourth quarter of 2024. A copy of the press release and slide presentation has been filed as Exhibit 99.1 and Exhibit 99.2 hereto and is incorporated herein by reference. The information under Item 7.01 of this Current Report on Form 8-K, Exhibit 99.1 and Exhibit it 99.2 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.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits. (d) Exhibits 99.1 Press Release, titled "Capricor Therapeutics Announces Intent to File Biologics License Application for Full Approval of Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy", dated September 24, 2024 . 99.2 Capricor Therapeutics, Inc. Slide Presentation, dated September 24, 2024. 104 Cover Page Interactive Data File (formatted as inline XBRL). 2

SIGNATURES

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: September 24, 2024 By: /s/ Linda Marbn, Ph.D. Linda Marbn, Ph.D. Chief Executive Officer 3

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