Mission Statement, Vision, & Core Values of Capricor Therapeutics, Inc. (CAPR)

A company's Mission Statement, Vision, and Core Values are not just marketing fluff; for a clinical-stage biotech like Capricor Therapeutics, Inc. (CAPR), they are the bedrock against which a volatile financial reality must be measured.

You're looking at a firm that reported a net loss of approximately $24.6 million in the third quarter of 2025, with $0 in revenue, so how exactly does a mission focused on delivering groundbreaking therapies translate into actionable strategy when the financial runway is critical?

As of September 30, 2025, Capricor held approximately $98.6 million in cash, a position that makes their goal-to redefine treatment for Duchenne muscular dystrophy (DMD) with their lead candidate, Deramiocel-a high-stakes, near-term binary event. Does a patient-first value system truly guide capital allocation when topline data from the pivotal HOPE-3 Phase 3 trial is expected this quarter?

Capricor Therapeutics, Inc. (CAPR) Overview

Capricor Therapeutics, Inc. is a publicly traded biotechnology company, founded in 2005 and headquartered in San Diego, California, with a clear mission: to develop groundbreaking therapies for rare diseases. The company focuses on biologics, primarily using cell and exosome-based technologies (nanosized particles secreted by cells that direct the activities of other cells) to treat conditions with high unmet medical needs. This is a clinical-stage company, so you won't see massive commercial sales yet, but the potential is huge.

The core of their work revolves around two platforms. The lead product is Deramiocel (also known as CAP-1002), an allogeneic cardiosphere-derived cell therapy currently in late-stage development for Duchenne muscular dystrophy (DMD). DMD is a severe genetic disorder, and Deramiocel is specifically designed to address the cardiomyopathy (heart muscle disease) that is often fatal for these patients. Plus, they are advancing their StealthX™ exosome platform for vaccines and targeted drug delivery.

Their business model is focused on research and development (R&D) and strategic partnerships, not commercial product sales right now. As a result of this stage in the development cycle, the trailing twelve-month (TTM) revenue as of September 30, 2025, stood at $11.13 million, which primarily represents the last of the recognized collaboration revenue, not product sales.

• Founded: 2005 in San Diego, California.
• Lead Candidate: Deramiocel for Duchenne muscular dystrophy cardiomyopathy.
• Platform: StealthX™ exosome technology.

Latest Financial Performance: Q3 2025 Snapshot

Looking at the latest financial report, which covers the third quarter of 2025 and was released on November 10, 2025, the numbers reflect a clinical-stage biotech that has fully recognized its upfront collaboration revenue. Capricor Therapeutics reported $0 in revenue for the third quarter of 2025, which is a significant drop from the $2.3 million reported in the same quarter of 2024. Honestly, this zero-revenue figure is expected and not a cause for panic, as the prior revenue came from the ratable recognition of a $40.0 million upfront payment and milestone payments from Nippon Shinyaku, all fully recognized by the end of 2024.

The company's focus is on advancing its pipeline, which is why operating expenses increased. The net loss for Q3 2025 was approximately $24.6 million, or $0.54 per share, compared to a net loss of $12.6 million in Q3 2024. Here's the quick math: the cash burn is up due to late-stage clinical trials and manufacturing scale-up, but the company is well-capitalized. As of September 30, 2025, the cash, cash equivalents, and marketable securities totaled approximately $98.6 million, which they expect will support planned operations into the fourth quarter of 2026.

Capricor Therapeutics: A Leader in Exosome Technology

Capricor Therapeutics is defintely positioning itself as a leader, particularly in the emerging field of exosome-based therapeutics. They are one of the few companies with a lead product, Deramiocel, in a pivotal Phase 3 study for a rare disease like Duchenne muscular dystrophy. This is a critical stage that few biotechs ever reach.

The near-term opportunity is clear: topline results from the pivotal HOPE-3 Phase 3 study of Deramiocel are expected in the coming weeks, specifically in the fourth quarter of 2025. This data is crucial, as the company plans to leverage it to resubmit its Biologics License Application (BLA) to the U.S. FDA, aiming for a potential commercial launch in 2026. They even completed a successful Pre-License Inspection of their San Diego GMP facility, meaning the manufacturing side is ready to go. This readiness, combined with the groundbreaking nature of their cell and exosome platforms, is what makes them a company to watch. To understand the full financial implications of this pivotal period, you should look deeper into their balance sheet and R&D spend. Breaking Down Capricor Therapeutics, Inc. (CAPR) Financial Health: Key Insights for Investors

Capricor Therapeutics, Inc. (CAPR) Mission Statement

You're looking for a clear map of where Capricor Therapeutics, Inc. is going, and the mission statement is exactly that compass. The company's core mission is to develop groundbreaking therapies that make a meaningful impact on patients' lives, which is a powerful driver in the volatile biotech space. This statement isn't just corporate fluff; it guides every major decision, from allocating their $26.3 million in Q3 2025 operating expenses to selecting their clinical trial endpoints.

The mission is further sharpened by their focus on Duchenne muscular dystrophy (DMD), specifically aiming to deliver the first approved therapy for Duchenne cardiomyopathy. That's a clear, high-stakes goal.

Pillar 1: Developing Transformative Cell and Exosome-Based Therapeutics

The first key component of the mission is the commitment to developing transformative therapies, which means they are not chasing incremental improvements but seeking to redefine treatment landscapes. This is anchored in their proprietary cell and exosome-based technologies. They are focused on biologics, which are complex, large-molecule drugs, and this requires serious capital investment.

Here's the quick math: Capricor's trailing twelve-month (TTM) Research and Development (R&D) expenses, as of June 30, 2025, hit roughly $67 million (or $0.067 billion). That significant spend shows they are defintely putting money where their mission is. This R&D focus is split between their lead cell therapy, Deramiocel, and their innovative StealthX™ exosome platform, which is also advancing with a Phase 1 clinical trial underway.

• Invest in proprietary cell and exosome technology.
• Advance Deramiocel for Duchenne muscular dystrophy.
• Initiate StealthX™ exosome-based vaccine trials.

Pillar 2: Making a Meaningful Impact on Rare Diseases

The mission is patient-centric, specifically targeting diseases with high unmet medical needs. For Capricor Therapeutics, that means Duchenne muscular dystrophy (DMD), a severe, life-limiting condition. Their work is a direct response to the fact that Duchenne cardiomyopathy, a complication of DMD, has no approved treatments.

The most concrete evidence of this commitment is the pivotal HOPE-3 Phase 3 clinical trial for Deramiocel, which enrolled 105 patients. The trial's completion of the 12-month treatment phase in Q4 2025 is a massive milestone, with topline results expected imminently. The goal is to show durable improvements in both cardiac and skeletal muscle function, which would fundamentally change the lives of these patients. You can read more about the context of their development pathway here: Capricor Therapeutics, Inc. (CAPR): History, Ownership, Mission, How It Works & Makes Money.

Pillar 3: Scientific Rigor and Commercial Readiness

For a clinical-stage biotech, a mission is only as good as its execution, and that requires scientific rigor and a clear path to market. Capricor Therapeutics emphasizes a translational approach, building on a strong research foundation and academic partnerships. This focus on reproducible science is what gives investors confidence.

The company's operational strategy in 2025 highlights this readiness. They successfully completed the FDA Pre-License Inspection (PLI) for their San Diego GMP manufacturing facility, resolving all 483 observations. This means the facility is now operational and ready to support the initial commercial launch of Deramiocel, should the HOPE-3 data lead to approval. Their cash balance of approximately $99 million as of November 2025 also provides runway into the fourth quarter of 2026, which is crucial for funding the BLA resubmission and commercial preparations. They are ready to move from a development-stage company to a commercial one.

Next Step: Investor Relations: Monitor for the HOPE-3 topline data announcement in Q4 2025 to assess the probability of BLA resubmission success.

Capricor Therapeutics, Inc. (CAPR) Vision Statement

You're looking at Capricor Therapeutics, Inc. (CAPR) right now, trying to map their future value, and the core takeaway is simple: their vision is a high-stakes, near-term bet on one asset, Deramiocel, but it's backed by a platform technology that provides a crucial second act.

The company is in a pivotal period, facing a net loss of $24.6 million in the third quarter of 2025, but with a cash balance of approximately $98.6 million as of September 30, 2025, which gives them a runway into the fourth quarter of 2026. That runway is essential because their mission is about to hit its biggest test.

Mission: Targeting the Life-Limiting Aspect of Duchenne Muscular Dystrophy

The mission here is defintely clear: bring forward the first approved therapy for Duchenne muscular dystrophy (DMD) cardiomyopathy, which is the heart condition that ultimately claims the lives of nearly all DMD patients. This isn't just about slowing the disease; it's about specifically addressing the cardiac failure that has no approved treatments.

Their lead candidate, Deramiocel, an allogeneic cardiac-derived cell therapy, is the vehicle for this mission. The entire investment thesis hinges on the outcome of the pivotal HOPE-3 Phase 3 study, which enrolled 105 patients. Topline results are expected in the coming weeks, in the fourth quarter of 2025, and will drive the resubmission of their Biologics License Application (BLA).

Here's the quick math on the focus: the company reported $0 in revenue for the first nine months of 2025, meaning all their financial burn is R&D and commercial prep, underscoring the singular focus on getting this therapy across the finish line.

Vision: Redefining the Treatment Landscape for Rare Diseases

Capricor Therapeutics' broader vision is to redefine the treatment landscape for rare diseases using transformative cell and exosome-based therapeutics. This vision is split into two distinct, yet complementary, technology platforms.

First, there's the cell therapy approach with Deramiocel, focusing on DMD. Second, they are leveraging their proprietary StealthX™ exosome technology, which uses nanosized particles (exosomes) to deliver therapeutic cargo like nucleic acids and proteins. This is their future pipeline, and it's already in a NIAID-sponsored Phase 1 clinical trial, with initial topline data expected in the first quarter of 2026.

The vision is about creating a new class of medicines, not just a single drug. They've already completed their FDA Pre-License Inspection for their San Diego GMP facility, addressing all 483 observations and making it commercially ready to manufacture Deramiocel upon approval. That's a major step toward realizing the commercial part of their vision for 2026.

Core Values: Patient-Focused Precision Science

The company's actions and statements point to core values centered on patient-first development and scientific rigor. They are patient-focused first, advancing precision medicine to optimize treatments. This translates into a commitment to pushing the boundaries of possibility for those in need.

This value system is what drives the heavy investment in R&D, even while reporting zero revenue for most of 2025. The trailing 12-month revenue as of September 30, 2025, was $11.1 million, mostly from prior milestone payments, but the current operations are all about the science.

• Accelerate development of precision science.
• Develop groundbreaking therapies with meaningful impact.
• Maintain scientific rigor and reproducibility.

You can see this commitment in their partnership with Nippon Shinyaku Co., Ltd. for the commercialization and distribution of Deramiocel in the U.S. and Japan, which de-risks the commercial launch post-approval. For a deeper dive into who is betting on this value proposition, you should be Exploring Capricor Therapeutics, Inc. (CAPR) Investor Profile: Who's Buying and Why?

Capricor Therapeutics, Inc. (CAPR) Core Values

You're looking past the stock ticker and into the operational DNA of Capricor Therapeutics, Inc., which is smart. For a clinical-stage biotech, their values aren't just posters on a wall; they dictate how they spend capital and manage regulatory risk. The direct takeaway is that Capricor's core values map directly to their focus on rare diseases, specifically Duchenne Muscular Dystrophy (DMD), and their massive 2025 investment in getting Deramiocel to market.

Their mission is clear: develop groundbreaking therapies that make a meaningful impact on patients' lives. This commitment breaks down into three actionable values that drive their spending and strategic decisions, especially as they navigate the final regulatory hurdles for their lead product.

Patient-Centric Dedication

This value is about putting the patient, often those with rare and life-threatening conditions like DMD, at the center of every decision. It's not just a nice sentiment; it's a business imperative in rare disease development. The focus is on delivering a first-approved therapy for Duchenne cardiomyopathy, a serious complication that currently has no approved treatments.

The most concrete example of this dedication in 2025 is the relentless pursuit of approval for Deramiocel (CAP-1002), their allogeneic cell therapy. Even after receiving a Complete Response Letter (CRL) from the FDA in July 2025, the company immediately held a Type A meeting in August 2025 to define a clear path for resubmission. This shows the team is defintely focused on the end goal for the patients, not just the setback. The clinical data supports this drive, with positive 4-year results from the HOPE-2 Open-Label Extension (OLE) study announced in June 2025, which showed sustained preservation of cardiac function (Left Ventricular Ejection Fraction, or LVEF) and slowed skeletal muscle disease progression (Performance of the Upper Limb, or PUL v2.0).

• Sustained cardiac function for up to four years in HOPE-2 OLE.
• HOPE-3 Phase 3 trial enrolled 105 subjects, a significant investment in the patient population.

Scientific Innovation & Precision

For a biotech firm, innovation means committing capital to high-risk, high-reward science like cell and exosome-based therapies (nanosized particles secreted by cells that carry bioactive cargo). Capricor's financial commitment backs this up: their trailing 12-month (TTM) Research and Development (R&D) expenses as of June 30, 2025, stood at approximately $67 million. That's a serious spend on advancing the pipeline.

Here's the quick math on their dual-platform approach: Deramiocel, their lead candidate, is a cell therapy that works by secreting exosomes that target inflammation and stimulate tissue regeneration. But they also have a second, distinct platform, StealthX™, which engineers exosomes for targeted delivery of other therapeutics. The FDA cleared an Investigational New Drug (IND) application for the StealthX™ exosome-based vaccine in 2025, with the National Institute of Allergy and Infectious Diseases (NIAID) initiating the Phase 1 clinical trial. This parallel development shows they aren't a one-trick pony; they are building a new class of therapeutic medicines. Exploring Capricor Therapeutics, Inc. (CAPR) Investor Profile: Who's Buying and Why?

Operational Excellence & Perseverance

In the biotech world, perseverance is the core value that gets a drug from the lab bench to the patient. It requires an operational framework that can withstand regulatory and clinical setbacks. The increase in operational expenses in 2025 clearly shows the company is scaling up for a potential commercial launch, not just research.

Total operating expenses for the third quarter of 2025 were approximately $26.3 million, a sharp increase from the $15.3 million in the same quarter of 2024. This jump reflects their operational push, including the critical milestone of commercial manufacturing readiness. Their Good Manufacturing Practice (GMP) facility in San Diego successfully completed its FDA Pre-License Inspection (PLI) in 2025, addressing all 483 observations and becoming operational to support an initial commercial launch. What this estimate hides is the sheer complexity of getting a cell therapy manufacturing process to pass FDA muster; it's a huge operational win. The company is poised for a potential 2026 market introduction, backed by a cash balance of approximately $123 million as of Q2 2025, which is expected to support operations into the fourth quarter of 2026.