Capricor Therapeutics, Inc. (CAPR) SEC Filings & Earnings Calls

Regulatory delay risk: FDA extended review by 3 months due to major amendment, increasing uncertainty around approval timeline.

“FDA has classified the submission as a major amendment, which extends the review period by three months.” · word for word

FDA approval risk for lead product candidate

“On July 29, 2026, the Cellular, Tissue and Gene Therapies Advisory Committee voted 3 in favor and 9 against on whether available evidence provides substantial evidence of effectiveness of Deramiocel for the treatment of cardiomyopathy in patients with DMD.” · word for word

Litigation with distribution partner

“The Complaint alleges a fundamental pricing flaw in the U.S. Distribution Agreement and that the defendants named therein, NS, have failed to adequately prepare for the commercial launch of the Company's product Deramiocel in the United States” · word for word

Cash burn and need for additional funding

“We expect to incur significant expenses and operating losses for the foreseeable future. As we seek to develop and commercialize Deramiocel or any other product candidates including those related to our exosomes program, we anticipate that our expenses will increase significantly and that we will need additional funding to support our continuing operations.” · word for word

FDA advisory committee voted against Deramiocel effectiveness; BLA approval uncertain.

“Advisory Committee voted 3 in favor and 9 against on whether available evidence provides substantial evidence of effectiveness.” · word for word

Cash burn continues with no revenue; cash decreased by $80.2M in H1 2026.

“Cash decreased from $318.1M to $237.9M in H1 2026.”

NS Pharma dispute unresolved; arbitration pending.

“Capricor withdrew the motion for preliminary injunction without prejudice; arbitration expected this fall.”

FDA advisory committee negative vote increases regulatory risk for Deramiocel approval

“Advisory Committee voted 9-3 that available evidence did not support effectiveness; non-binding but negative signal.”

Weakened LVEF endpoint and FDA BIMO inspection with Form 483 increase regulatory risk for Deramiocel approval

“LVEF p-value revised from 0.04 to 0.09; FDA issued Form 483 with one observation regarding SOPs, documentation, vendor oversight, audit report timeliness.”

Lease contingent on FDA approval; significant financial obligation if approval obtained

“Lease may be terminated if FDA approval not obtained by Dec 31, 2026; initial monthly rent ~$958k with 3% annual increases.”

Regulatory risk: Advisory Committee outcome uncertain; could delay or deny approval.

“Advisory Committee meeting scheduled; outcome not guaranteed.”

Regulatory approval risk

“In July 2025, we received a Complete Response Letter ('CRL') from the FDA stating that the application did not meet the statutory requirement for substantial evidence of effectiveness and requesting additional clinical data.” · word for word

Litigation risk with distributor

“The Company has filed a Complaint for Equitable Relief and Application for Preliminary Injunction... alleging a fundamental pricing flaw in the U.S. Distribution Agreement and that the defendants named therein, NS, have failed to adequately prepare for the commercial launch.” · word for word

Cash burn / going concern risk

“We expect to incur significant expenses and operating losses for the foreseeable future. As we seek to develop and commercialize Deramiocel or any other product candidates... we anticipate that our expenses will increase significantly and that we will need additional funding to support our continuing operations.” · word for word

Regulatory risk: BLA approval not guaranteed; litigation with Nippon Shinyaku adds uncertainty.

“Filed suit against Nippon Shinyaku seeking rescission of distribution agreement; FDA review unaffected.”

Litigation risk: contract dispute could delay or prevent Deramiocel commercial launch, impacting future revenue.

“Company seeks rescission of U.S. Distribution Agreement; NS alleged to have failed to prepare for launch.”

Dependence on partner for commercialization; breach allegations create uncertainty.

“Deramiocel is key pipeline asset; distribution agreement with Nippon Shinyaku is critical.”

Regulatory Approval Risk for Deramiocel

“Additionally, there is another potential milestone of $80.0 million due to Capricor upon receipt of marketing approval.” · word for word

Dependence on Nippon Shinyaku Partnership

“Nippon Shinyaku Co., Ltd. ("Nippon Shinyaku"), a Japanese corporation, is a beneficial owner of approximately 12% of our outstanding common stock as of February 28, 2026, and is therefore a related party.” · word for word

European Agreement Not Finalized

“At this time, Capricor and Nippon Shinyaku have entered into various amendments to the Term Sheet, pursuant to which the parties agreed to extend the date during which the parties shall negotiate the definitive agreement to April 1, 2026, which at this time has not been extended further.” · word for word

Significant Net Losses

“Net Income/(Loss) (4) 2025 $ (105,043,946)”

Regulatory risk: BLA approval not guaranteed; prior CRL history.

“FDA previously issued Complete Response Letter; now lifted.”

Regulatory risk: BLA approval still not guaranteed; prior CRL indicates past issues.

“CRL previously issued; now lifted but approval uncertain.”

Dilution risk for existing shareholders.

“6M shares offered; potential additional 900K shares if underwriters exercise option.”

Execution risk on product development; proceeds used for development and manufacturing.

“Proceeds for continued development of product candidates and manufacturing.”

Clinical trial risk: HOPE-3 topline results pending; failure could impair BLA resubmission and stock value.

“Topline results from HOPE-3 Phase 3 study expected in coming weeks; BLA resubmission contingent on positive data.” · word for word

Cash burn: Operating expenses increased 72% YoY; net loss widening; reliance on partnership milestones.

“Operating expenses $26.3M in Q3 2025 vs $15.3M in Q3 2024; net loss $24.6M vs $12.6M.”

Going concern risk

“Based on our current cash resources and projected operating plan, we do not have sufficient funds to support operations for at least twelve months from the filing date of this Quarterly Report on Form 10-Q. Accordingly, substantial doubt exists about our ability to continue as a going concern.” · word for word

Regulatory approval risk

“In July 2025, the Company received a Complete Response Letter ("CRL") from the FDA stating that the current BLA did not meet the statutory requirement for substantial evidence of effectiveness and that additional clinical data would be required.” · word for word

Clinical trial risk

“Positive results from the HOPE-3 trial, if achieved, are expected to provide confirmatory evidence to support BLA resubmission and FDA review.” · word for word

Funding risk

“We may be unable to raise additional funds or enter into such agreements or arrangements when needed on favorable terms, if at all. If we fail to raise capital or other potential funding or enter into such agreements as and when needed, we may have to significantly delay, scale back or discontinue the development or commercialization of Deramiocel or our oth” · word for word

Dilution risk

“Moreover, to the extent that we raise additional funds by issuing equity securities, our stockholders may experience significant dilution, and debt financing, if available, may involve restrictive covenants.” · word for word