1Q26: Just Three Months Into Deramiocel PDUFA

研报英文原文证据摘录

1Q26: Just Three Months Into Deramiocel PDUFA

Biotechnology

Capricor Therapeutics, Inc. (CAPR)

EQUITY RESEARCH Company Update

May 12, 2026

1Q26: Just Three Months Into Deramiocel PDUFA Price: $31.52

Price Target: $62.00 What Happened?

Rating: Overweight

●CAPR reported 1Q26 earnings today and provided more color on the Key Statistics: call related to the lawsuit against Nippon Shinyaku (NC) and its U.S. Symbol NASDAQ: CAPR

52-Week Range 4.30 - 40.37 subsidiary, NS Pharma.

Market Cap 1,823.1 ●Additionally, the company shared updates on the ongoing regulatory ADV (3 mo) 1,299,543

Shares Out (M) 57.8 review as CAPR gears up for a potential approval for deramiocel

(cardiosphere-derived cell therapy) in DMD (PDUFA: August 22).

Research Analysts: ●This includes that CAPR has hired a CCO with direct DMD commercial

Kristen Kluska experience; 2) company expects labeling discussions to start soon; and 212-915-1927

Kristen.Kluska@cantor.com 3) details on FDA information requests (see our notes below).

Ayan Hussein, PhD ●Cash of $279M supports operations into 4Q27 which does NOT factor 212-915-1122

Ayan.Hussein@cantor.com in any potential commercial sales or a PRV voucher sale.

Ross Fladeland

212-915-1803 What Did We Learn From the Call Related to the Ongoing FDA Review?

ross.fladeland@cantor.com

●Capricor noted there has been a significant number of information

REV ($M) requests from the FDA, all of which they've been able to address.

FYE Dec 2025A 2026E 2027E There will not be a mid-cycle review meeting.

1Q $0.0 $0.0A $15.4

2Q $0.0 $0.0E $22.6 ●The company highlighted that this has been prolific on the CMC side,

3Q $0.0 $184.0E $28.7 most being standard forms, asking for more data, clarification on

4Q $0.0 $7.3E $35.9 clinical/statistical side, blinding protocols, etc.