Capricor to Present Positive Five-Year HOPE-2 OLE Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2026 Annual Conference

- Deramiocel demonstrates durable skeletal and cardiac muscle benefit over five years in the HOPE-2 OLE study

- PUL 2.0 year-over-year decline attenuated to approximately 1 point

- Findings to be presented alongside previously reported HOPE-3 Phase 3 results, which met its primary and key secondary endpoints with statistical significance

- Deramiocel maintains a favorable safety profile across both studies, with no new safety signals

-

HOPE-2 OLE data featured in a late-breaking session; HOPE-3 in a cardiac care session

SAN DIEGO, June 26, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive five-year data from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel, the Company’s lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD). The data will be presented at the Parent Project Muscular Dystrophy (PPMD) 2026 Annual Conference, taking place June 25-27, 2026, in Orlando, Florida, alongside previously reported results from the Company’s HOPE-3 Phase 3 trial.

Five-Year HOPE-2 OLE Results – June 27, 2026, Session: Late-Breaking News

Among the patients who remain enrolled in the HOPE-2 OLE study (n=9), treatment with Deramiocel continued to attenuate disease progression over five years, as measured by Performance of the Upper Limb (PUL 2.0). Patients experienced a mean total-score decline of less than 5 points over five years. By comparison, a cohort-matched external comparator of standard-of-care DMD patients showed a modeled decline of roughly 2.4 points per year, which if continued would project to approximately 12 points over five years. A separately published natural-history analysis (Coratti, et al., J Neuromuscular Dis, 2025) reported a decline in non-ambulant patients of approximately 8.1 points over three years, consistent with a meaningful treatment benefit.

Cardiac function, as measured by left ventricular ejection fraction (LVEF) on cardiac MRI, remained stable over the full five-year period, in contrast to the modeled decline of approximately 3.2% per year observed in a propensity-matched external cardiac comparator. Deramiocel continued to demonstrate a favorable safety profile throughout the study, consistent with over 800 intravenous infusions administered to date across the Deramiocel clinical development program.

HOPE-3 Phase 3 Results – June 26, 2026, Session: The Heart of the Matter: A Cardiac Care Panel

Dr. Chet Villa (Cincinnati Children’s Hospital Medical Center) will present previously reported results from the HOPE-3 Phase 3 trial at the conference. The multicenter, randomized, double-blind, placebo-controlled trial enrolled 106 patients with DMD and met its primary endpoint (PUL 2.0, p=0.03) and key secondary cardiac endpoint (LVEF, p=0.04), along with all other Type I error-controlled secondary endpoints – consistent with the durable skeletal and cardiac muscle benefit observed in the HOPE-2 OLE study.

“Together, these five-year OLE data and our HOPE-3 Phase 3 results represent the totality of our clinical evidence for Deramiocel, and they tell a consistent story: durable, statistically significant benefit to both skeletal and cardiac muscle function in Duchenne, with a favorable safety profile sustained over time,” said Linda Marbán, Ph.D., CEO of Capricor. “With our BLA under FDA review, we are focused on presenting this full body of evidence to the patient community and to regulators as we work with focus and urgency toward a potential approval ahead of our August 22, 2026, PDUFA target action date. We thank the patients, families, and clinicians who have been instrumental in advancing this program.”

The PPMD Annual Conference is the largest international event focused on Duchenne and Becker muscular dystrophy research and care; Capricor’s presentations will be available afterward in the publications section of the Company’s website.

About Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneration affecting the skeletal, respiratory, and cardiac muscles. It is caused by the absence of functional dystrophin, a key structural protein in muscle cells. DMD affects approximately 15,000 individuals in the United States and primarily impacts boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD. There is no cure, and treatment options remain limited.

About Deramiocel

Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing rather than pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials.

Deramiocel has received Orphan Drug Designation for the treatment of DMD from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher upon approval.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing cell and exosome-based therapeutics for the treatment of rare diseases. Our lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD), shown in clinical studies to preserve cardiac and skeletal muscle function. Capricor is also advancing its proprietary StealthX™ exosome platform for the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics across a range of diseases. At Capricor, we are committed to delivering new therapies for patients with rare diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval, revenue and reimbursement estimates, projected terms of definitive agreements, our financial position, our possible uses of existing cash and investment resources, and statements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS Pharma, Inc., including the nature of the dispute, our expectations regarding any legal proceedings, and our ability to commercialize Deramiocel independent of our existing distribution agreement and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 17, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on May 13, 2026. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Deramiocel and the StealthX™ exosome platform are investigational and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:

Caitlin Kasunich

KCSA Strategic Communications

ckasunich@kcsa.com

212.896.1241

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer

abergmann@capricor.com

858.727.1755

Source: Capricor Therapeutics

Released June 26, 2026

Capricor Therapeutics Announces FDA Advisory Committee Meeting to Review BLA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy

–Advisory Committee meeting scheduled for July 29, 2026–

–Company's Biologics License Application on track with PDUFA target action date of August 22, 2026–

SAN DIEGO, June 26, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the Cellular, Tissue, and Gene Therapies Advisory Committee (CTGTAC) of the U.S. Food and Drug Administration (FDA) is planning to convene an advisory committee meeting to discuss the Company's Biologics License Application (BLA) seeking approval of Deramiocel, an investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). The BLA is supported by the Company's Phase 2 HOPE-2 trial and long-term outcomes from the HOPE-2-OLE trial, as well as positive results from the Phase 3 HOPE-3 trial, which achieved statistical significance on its primary endpoint (PUL v2.0), the key secondary cardiac endpoint (LVEF), and all other Type I error-controlled secondary endpoints. The date for the Advisory Committee meeting is July 29, 2026, and the meeting will be available for live streaming.

"We are encouraged by the opportunity to bring Deramiocel before the Advisory Committee and engage directly with the FDA, the DMD patient community, and the physicians who care for them," said Linda Marbán, Ph.D., CEO of Capricor. "We have confidence in the totality of evidence supporting Deramiocel, which has demonstrated clinically meaningful, statistically significant skeletal and cardiac benefits with a consistent safety profile, across multiple studies supporting its potential as a first-in-class therapy for Duchenne muscular dystrophy. Our focus remains on supporting the Agency's review and preparing for this meeting, with the urgent needs of the DMD community guiding every step, and we remain committed to bringing this therapy to the families who need it."

For additional information on the meeting, please visit the Federal Register or the Company's website.

About Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneration affecting the skeletal, respiratory, and cardiac muscles. It is caused by the absence of functional dystrophin, a key structural protein in muscle cells. DMD affects approximately 15,000 individuals in the United States and primarily impacts boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD. There is no cure, and treatment options remain limited.

About Deramiocel

Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing rather than pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials.

Deramiocel has received Orphan Drug Designation for the treatment of DMD from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher upon approval.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing cell and exosome-based therapeutics for the treatment of rare diseases. Our lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD), shown in clinical studies to preserve cardiac and skeletal muscle function. Capricor is also advancing its proprietary StealthX™ exosome platform for the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics across a range of diseases. At Capricor, we are committed to delivering new therapies for patients with rare diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval, revenue and reimbursement estimates, projected terms of definitive agreements, our financial position, our possible uses of existing cash and investment resources, and statements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS Pharma, Inc., including the nature of the dispute, our expectations regarding any legal proceedings, and our ability to commercialize Deramiocel independent of our existing distribution agreement and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 17, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on May 13, 2026. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:

Caitlin Kasunich

KCSA Strategic Communications

ckasunich@kcsa.com

212.896.1241

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer

abergmann@capricor.com

858.727.1755

Source: Capricor Therapeutics

Released June 26, 2026

Following the Money: Stablecoin Transfers Under $100 Account for 77% of Activity, While Large Transactions Move Two-Thirds of Value, Mercuryo and BNB Chain Report Finds

LONDON, Oct. 19, 2026 /PRNewswire/ -- Global payments infrastructure platform Mercuryo and BNB Chain, the community-driven blockchain ecosystem, have published a joint report highlighting the versatility of stablecoins, which facilitate activity ranging from low-value remittances to transactions made by 'crypto whales' moving digital assets across capital markets.

The research found that 77.4% of stablecoin transfers on BNB Chain in Q3 2026 were valued at under $100, while transfers of $10,000 or more accounted for 66.2% of total transfer value.

Combining Mercuryo's fiat-to-crypto and crypto-to-fiat transaction data with BNB Chain's on-chain data for Q3 2026, Stablecoins on BNB Chain: Fiat to Crypto and Back offers a complementary view of how stablecoins move. The findings show the versatility and usability of stablecoins and how they can serve very different purposes on the same permissionless blockchain infrastructure.

Everyday Transfers & Large-Scale Capital Movements

The findings point to a market serving multiple purposes simultaneously. While stablecoins remain an important component of digital asset markets, the data also highlights patterns consistent with their growing role in everyday stablecoin payments such as cross-border remittances. Most on-chain transfers are low-value, and stablecoins are frequently being converted between local currencies and digital dollars.

The median network fee for a stablecoin transfer on BNB Chain was just *$0.0068:Low costs matter both to people sending remittances and to institutions settling high-value payments.Together, these figures demonstrate how the same blockchain infrastructure can accommodate frequent, low-value transfers alongside large-scale movements of capital.

"The research by Mercuryo and BNB Chain sheds light on one of the defining features of stablecoins, that being their versatility," said Arthur Firstov, Chief Business Officer at Mercuryo. "The same permissionless blockchain infrastructure that facilitates small-value transfers and cross-border payments is underpinning large-scale trading and liquidity across capital markets. Stablecoins were designed as a place to hold value between trades for those taking positions on Bitcoin. We now see the tokens being used for a host of different purposes as the efficiencies and lower costs of blockchain technology bring benefits to the masses."

Local Currencies & Familiar Payment Methods

The report found that in Q3 2026, 70% of the value used to purchase dollar-denominated stablecoins on BNB Chain through Mercuryo was paid in non-US dollar currencies. The US accounted for just 9.8% of purchase value, with Asia the largest regional market at 39.3%, followed by Europe at 33.4%.

Payment preferences also resemble mainstream online shopping behaviour. Everyday shopping patterns are mirrored on-chain, with Apple Pay and Google Pay accounting for 69.5% of stablecoin purchases and 57.7% of purchase value through Mercuryo. Their combined share of purchases increased from 42.3% in Q3 2025, while 87.2% of purchases with a recorded device were made on a phone.

Worldpay's Global Payments Report 2026 found that digital wallets collectively accounted for 56% of global e-commerce value in 2025. The comparison suggests that stablecoin purchases are increasingly compatible with the familiar checkout experiences consumers already use online, rather than requiring every user to adopt specialist crypto payment methods.

Self-Custody Leads

Self-custody leads at every stage of a stablecoin's usage examined in the report. Through Mercuryo, 59.5% of stablecoin purchase value went to self-custody wallet channels. Across BNB Chain, individual addresses held 63.3% of stablecoin value, while 59.8% of off-ramp value processed through Mercuryo originated from self-custody wallet channels.

Although the datasets use different measures of wallet activity, the findings point to the continued importance of self-custody wallets in accessing and managing stablecoins. These wallets allow users to hold and transfer assets directly, while providing access to applications and services across the on-chain ecosystem.

Stablecoins in Active Circulation

The report also found that 64.3% of stablecoin value on BNB Chain had moved within the previous 30 days, suggesting that much of the value was actively circulating. The findings highlight stablecoins' dual role, facilitating the movement of value while continuing to support trading, decentralised finance (DeFi) and broader on-chain activity.

Taken together, the findings of this report show stablecoins as more than digital tokens held on a blockchain. They form part of a broader financial lifecycle connecting fiat currencies, self-custody wallets, on-chain applications, and traditional payment infrastructure, serving a wider range of financial needs than trading alone.

* Stablecoin transfers on BNB Chain are $0.0068. Additional fees for the purchase, sale or conversion into stablecoins may apply.

Stablecoins carry risks, including potential loss of value, issuer and redemption risks, and risks associated with the underlying blockchain. They are not equivalent to bank deposits or cash, and are not be covered by deposit protection schemes.

About Mercuryo

Mercuryo is a leading payment infrastructure platform in the digital token space. Standing out in the decentralized ecosystem by enhancing payment use case growth and on-chain integration, Mercuryo's intuitive and robust solutions are powering the next generation of Web3 payment services. Mercuryo's innovative payment products such as Spend, bridge the gap between TradFi, Web2 and Web3. Mercuryo is the proud partner of leading pillars in the digital token economy such as Trust Wallet and MetaMask, along with Revolut, Mastercard and Visa. Driven by an evolving product suite, Mercuryo is expanding further and continuing to innovate with a diversified stack of payment services.

Media Contact    

Joe Morgan, PR Manager, Mercuryo    

[email protected]  

SOURCE Mercuryo

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Capricor Comments on Briefing Materials Ahead of July 29 FDA Advisory Committee Meeting for Deramiocel

SAN DIEGO, July 27, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today provided an update ahead of the Company's upcoming FDA Advisory Committee meeting, at which an independent advisory committee will discuss Capricor's Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD), as part of the FDA's ongoing review of the application.

“Capricor has engaged fully and transparently with the FDA throughout the review process for our Biologics License Application for Deramiocel and has been responsive to every request from the FDA. Our results are governed by the final analysis plan, SAP version 3.0, which was finalized prior to unblinding. It is critical to understand that the post-hoc analyses in the FDA’s briefing materials rely on SAP version 1.1, an unsigned incomplete internal draft which became obsolete with the addition of cohort B and did not include content specifically requested by FDA. The Phase 3 HOPE-3 results demonstrate a statistically significant benefit on the primary endpoint, PUL 2.0, with supportive benefits in cardiac function, and we believe Deramiocel offers a meaningful treatment option for boys and young men living with Duchenne, who continue to face a significant unmet medical need. Ahead of the meeting, we have posted a portion of our slides to accurately frame the discussion for stakeholders on our website,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor Therapeutics.

These materials will be available in the Investors section of the Company’s website shortly.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing cell and exosome-based therapeutics for the treatment of rare diseases. Our lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD), shown in clinical studies to preserve cardiac and skeletal muscle function. Capricor is also advancing its proprietary StealthX™ exosome platform for the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics across a range of diseases. At Capricor, we are committed to delivering new therapies for patients with rare diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval, revenue and reimbursement estimates, projected terms of definitive agreements, our financial position, our possible uses of existing cash and investment resources, and statements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS Pharma, Inc., including the nature of the dispute, our expectations regarding any legal proceedings, and our ability to commercialize Deramiocel independent of our existing distribution agreement and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 17, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on May 13, 2026. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:

Caitlin Kasunich

KCSA Strategic Communications

ckasunich@kcsa.com

212.896.1241

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer

abergmann@capricor.com

858.727.1755

Source: Capricor Therapeutics

Released July 27, 2026

The Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy

--Independent Peer Review Provides External Validation of the Trial's Design, Statistical Methodology and Findings--

--Randomized, Double-Blind, Placebo-Controlled HOPE-3 Phase 3 Trial (n=106) Met Primary Endpoint, with Deramiocel Slowing Upper Limb Function Decline by 54 Percent versus Placebo (PUL 2.0, p=0.03) and Showing Clinically Meaningful Cardiac Benefit--

--Deramiocel BLA Remains Under Active FDA Review, with PDUFA Target Action Date of August 22, 2026--

SAN DIEGO, July 29, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that The Lancet, one of the most selective and highly regarded peer-reviewed journals in medicine, has published results from the Company’s pivotal Phase 3 HOPE-3 clinical trial evaluating Deramiocel, its investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). The manuscript underwent independent expert peer review, providing external validation of the trial’s design, statistical methodology and findings. The results are based on the Company’s prespecified Statistical Analysis Plan version 3.0 (SAP 3.0). The paper, titled “Deramiocel heart-derived cellular therapy in advanced Duchenne muscular dystrophy (HOPE-3): a phase 3, randomised, double-blind, placebo-controlled trial” can be accessed here.

“The HOPE-3 results are a landmark moment for the Duchenne community, demonstrating a significant benefit on skeletal muscle function alongside compelling data shown in cardiac function,” said Craig McDonald, M.D., Distinguished Professor of Physical Medicine & Rehabilitation and Pediatrics at UC Davis Health, National PI of the HOPE-2 and HOPE-3 trials and lead author of the publication. “A 54 percent slowing of upper limb disease progression (p=0.03) is a substantial, meaningful effect in a population where functional decline is typically relentless and irreversible. HOPE-3 is the first Phase 3 trial to demonstrate a significant benefit on function in a largely non-ambulatory DMD population, and the concurrent benefits in several cardiac measures lend biological support to a consistent treatment effect across skeletal and cardiac muscle. After many years of work, seeing a therapy deliver at this level has been a profound privilege.”

“The totality of evidence for Deramiocel is strong, with clinically meaningful benefits now published in The Lancet, one of medicine's most highly regarded journals," said Linda Marbán, Ph.D., CEO of Capricor. “The Lancet's rigorous, independent peer review process further validates these results. This is the same body of evidence that forms the foundation of our BLA and will be discussed at our Advisory Committee meeting. The publication reinforces our confidence in the strength and durability of these results in advance of Deramiocel's PDUFA target action date of August 22. We have continued to work with the FDA throughout its review, and we firmly believe this evidence supports approval. Deramiocel can change the course of this disease, and we are focused on our goal of bringing it to patients as the first approved cell therapy for Duchenne.”

About Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneration affecting the skeletal, respiratory, and cardiac muscles. It is caused by the absence of functional dystrophin, a key structural protein in muscle cells. DMD affects approximately 15,000 individuals in the United States and primarily impacts boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD. There is no cure, and treatment options remain limited.

About Deramiocel

Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing rather than pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials.

Deramiocel has received Orphan Drug Designation for the treatment of DMD from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher upon approval.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing cell and exosome-based therapeutics for the treatment of rare diseases. Our lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD), shown in clinical studies to preserve cardiac and skeletal muscle function. Capricor is also advancing its proprietary StealthX™ exosome platform for the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics across a range of diseases. At Capricor, we are committed to delivering new therapies for patients with rare diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval, revenue and reimbursement estimates, projected terms of definitive agreements, our financial position, our possible uses of existing cash and investment resources, and statements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS Pharma, Inc., including the nature of the dispute, our expectations regarding any legal proceedings, and our ability to commercialize Deramiocel independent of our existing distribution agreement and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 17, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on May 13, 2026. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:

Caitlin Kasunich / Raquel Cona

KCSA Strategic Communications

ckasunich@kcsa.com / rcona@kcsa.com

212.896.1241 / 516.779.2630

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer

abergmann@capricor.com

858.727.1755

Source: Capricor Therapeutics

Released July 29, 2026

From a moving chanting ceremony by Thai schoolgirls and the teachings of a revered Buddhist monk to immersive movement and breathtaking nature films, the 20th-anniversary Summit will celebrate the deeper human dimensions of wellness.

MIAMI, Oct. 19, 2026 /PRNewswire/ -- As longevity science, medical breakthroughs and new technologies continue to transform the wellness industry, the Global Wellness Summit (GWS) is making an equally powerful statement: Wellness is about more than what can be measured.

At its milestone 20th-anniversary gathering, taking place November 10–13 at Angsana Laguna Phuket in Thailand, the Summit will explore "The Science, Art and Soul of Wellness"—a theme that recognizes that the future of wellness must embrace not only scientific innovation, but also the ancient wisdom, spirituality, beauty and human connection that have always been central to wellbeing.

While groundbreaking science will be a major pillar of the 2026 agenda, the "soul" of wellness will be experienced firsthand through an extraordinary collection of speakers, cultural ceremonies, immersive movement experiences and moments of reflection.

Thailand provides a particularly meaningful setting for this exploration. With its deeply rooted Buddhist traditions, reverence for nature, and long-held understanding of the connection between body, mind and spirit, the country embodies many of the values at the heart of the Summit's theme.

"There's never been a more important time to talk about the soul of wellness," said Nancy Davis, chief creative officer and executive director of the Global Wellness Summit. "We're living in a time of extraordinary scientific advances that are helping us living longer, healthier lives. But wellness is also about connection, compassion, beauty, purpose and belonging—things that aren't always easy to quantify, but that are fundamental to our wellbeing. Thailand is the perfect place to explore this, because these values are so deeply woven into its culture. We want delegates to leave not only with new knowledge and ideas, but with experiences that move them, connect them and remind them why wellness matters."

A Moving Ceremony Celebrating Compassion, Gratitude and Community

One of the Summit's most meaningful moments will be a traditional Buddhist chanting ceremony performed by students from Thailand's Dhammajarinee Witthaya School, sharing a centuries-old cultural practice rooted in gratitude, compassion and inner peace. This powerful experience is made possible through BuDhaGirl and GWS co-chair Jessica Jesse.

Dhammajarinee Witthaya School serves more than 1,000 underserved girls from across Thailand, providing education and opportunities to young women who might otherwise face significant barriers. The school has also won multiple first-place honors in Thailand's national Buddhist chanting competitions.

"I'm so honored that BuDhaGirl can help bring these extraordinary young women to the Summit," said Jessica Jesse, founder and CEO of BuDhaGirl and a co-chair of the 2026 conference. "There is something incredibly moving about the collective voices of these girls, and the discipline, devotion and sense of community behind their chanting. The Dhammajarinee Witthaya School is doing remarkable work to create opportunities for young women across Thailand. To me, this is exactly what the soul of wellness is about—gratitude, compassion, connection and the recognition of our shared humanity."

A Revered Buddhist Monk on the Wisdom of the Thai Forest Tradition

One of the Summit's most significant spiritual voices will be Ajahn Jayasāro, a highly respected Buddhist monk, teacher and author whose life has been devoted to sharing the teachings of the Thai Forest Tradition, a branch of Theravada Buddhism focused on strict monastic discipline, meditation and simple living in nature.

Born in England, Ajahn Jayasāro traveled to Thailand in the late 1970s and was ordained under the renowned meditation master Ajahn Chah. He served as abbot of Wat Pah Nanachat, an international monastery in northeastern Thailand, and now lives in a hermitage near the Khao Yai Mountains, where he continues his spiritual practice, teaching and writing.

In July 2026, he received one of Thailand's highest ecclesiastical honors from King Maha Vajiralongkorn, becoming the first foreign-born monk to receive the prestigious Somdej title. His participation will bring a perspective rooted in centuries of Buddhist wisdom to a gathering examining the most advanced developments in modern health and medicine.

Sanctum Brings the Power of Collective Movement to Phuket

The Summit will also explore the soul of wellness through two immersive early-morning experiences from Sanctum, the global mindful movement concept known for combining music, breathwork, martial arts, somatic release and collective energy.

Led by Sanctum founder Luuk Melisse on the beach at Angsana Laguna Phuket, the experiences will use movement, music and rhythm to foster connection, release and a sense of belonging, exploring the relationship between the individual and the collective.

Louie Schwartzberg: Finding Awe and Connection in Nature

Another expression of the Summit's focus on soul will come through the extraordinary work of Louie Schwartzberg, the award-winning filmmaker whose breathtaking nature cinematography has become a signature element of Global Wellness Summit gatherings.

Known for his pioneering time-lapse photography, Schwartzberg has a remarkable ability to reveal the beauty and complexity of the natural world, inviting audiences to slow down, experience wonder and reconnect with nature—and their own place within it.

The Human Side of Wellness

As the wellness economy has grown into a $6.8 trillion global industry, its scope has expanded dramatically—from spas and fitness to longevity medicine, precision health and beyond. But alongside these advances has come a renewed recognition of the importance of social connection, spirituality, creativity, purpose and our relationship with nature.

For 20 years, the Global Wellness Summit has brought together leaders from around the world to exchange ideas, forge relationships and shape the future of wellness. This year's gathering will also celebrate the moments that cannot easily be measured—the conversations, cultural experiences and shared sense of humanity that delegates carry home long after the conference ends.

Apply to attend the Summit.

Accredited media can apply to attend here.

About the Global Wellness Summit: The Global Wellness Summit brings together leaders and visionaries to positively shape the future of the $6.8 trillion global wellness economy. In addition to an annual conference held at a different location around the globe, GWS also hosts annual in-person events such as the Wellness Real Estate & Communities Symposium and the New York Media Event, where its Future of Wellness report is unveiled, a prediction of the top wellness trends for the year that is oft-quoted in the media. The GWS also hosts virtual gatherings, including Wellness Master Classes. The 20th annual Global Wellness Summit will be held in Phuket, Thailand, November 10-13, 2026.

SOURCE Global Wellness Summit

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Capricor Therapeutics Provides Update on FDA Advisory Committee Meeting for Deramiocel

SAN DIEGO, July 30, 2026 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the U.S. Food and Drug Administration's Cellular, Tissue and Gene Therapies Advisory Committee voted that available evidence did not support the effectiveness of Deramiocel for the treatment of cardiomyopathy in patients with Duchenne muscular dystrophy (DMD), a rare and life-threatening disease for which no approved cardiomyopathy treatment currently exists (3 for, 9 against, 0 abstain). The Committee's vote is non-binding.

The Committee's voting question addressed a narrower indication than Capricor had proposed and did not include a vote on Deramiocel's overall benefit-risk profile. In a separate discussion on upper limb function, the Committee's feedback was directionally supportive of the clinical evidence from the Phase 3 HOPE-3 trial, including results on its primary endpoint, PUL 2.0.

"We remain committed to Deramiocel and to the patients who could benefit from it," said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. "The Advisory Committee gave us an important opportunity to present the clinical evidence, and we were encouraged by the Committee's discussion of Deramiocel's impact on skeletal muscle. We remain confident in the strength of the HOPE-3 data. In a moving open public hearing, patients, families, and clinicians shared their experience with the therapy, underscoring the unmet need within the Duchenne community. We remain focused on working with the FDA toward potential approval ahead of our August 22, 2026, PDUFA target action date."

About Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneration affecting the skeletal, respiratory, and cardiac muscles. It is caused by the absence of functional dystrophin, a key structural protein in muscle cells. DMD affects approximately 15,000 individuals in the United States and primarily impacts boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD. There is no cure, and treatment options remain limited.

About Deramiocel

Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing rather than pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials.

Deramiocel has received Orphan Drug Designation for the treatment of DMD from both the U.S. FDA and the European Medicines Agency (EMA). In addition, it has been granted Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S., Advanced Therapy Medicinal Product (ATMP) designation in Europe, and Rare Pediatric Disease Designation from the FDA, which may qualify Capricor for a Priority Review Voucher upon approval.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing cell and exosome-based therapeutics for the treatment of rare diseases. Our lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD), shown in clinical studies to preserve cardiac and skeletal muscle function. Capricor is also advancing its proprietary StealthX™ exosome platform for the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics across a range of diseases. At Capricor, we are committed to delivering new therapies for patients with rare diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval, revenue and reimbursement estimates, projected terms of definitive agreements, our financial position, our possible uses of existing cash and investment resources, and statements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS Pharma, Inc., including the nature of the dispute, our expectations regarding any legal proceedings, and our ability to commercialize Deramiocel independent of our existing distribution agreement and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 17, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on May 13, 2026. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Deramiocel and the StealthX™ platform are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:

Caitlin Kasunich / Raquel Cona

KCSA Strategic Communications

ckasunich@kcsa.com / rcona@kcsa.com

212.896.1241 / 516.779.2630

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer

abergmann@capricor.com

858.727.1755

Source: Capricor Therapeutics

Released July 30, 2026

Capricor Therapeutics to Report Second Quarter 2026 Financial Results and Provide Recent Corporate Update on August 13

– Company to Host Conference Call on August 13, 2026, at 4:30 p.m. ET –

SAN DIEGO, Aug. 10, 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 that it will release its financial results for the second quarter ended June 30, 2026, after the market close on Thursday, August 13, 2026. Management will host a conference call and webcast at 4:30 p.m. ET that same day.

A replay of the webcast will be available shortly after the conclusion of the live event and will be accessible in the Investors section of the Company’s website at www.capricor.com.

About Capricor Therapeutics

Capricor Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing cell and exosome-based therapeutics for the treatment of rare diseases. Our lead product candidate, Deramiocel, is an allogeneic cardiac-derived cell therapy in late-stage development for Duchenne muscular dystrophy (DMD), shown in clinical studies to preserve cardiac and skeletal muscle function. Capricor is also advancing its proprietary StealthX™ exosome platform for the targeted delivery of oligonucleotides, proteins, and small-molecule therapeutics across a range of diseases. At Capricor, we are committed to delivering new therapies for patients with rare diseases. For more information, visit capricor.com, and follow Capricor on Facebook, Instagram and X.

Cautionary Note Regarding Forward-Looking Statements

Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor’s product candidates; the initiation, conduct, size, timing and results of clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including future interactions with regulatory authorities and the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval, revenue and reimbursement estimates, projected terms of definitive agreements, our financial position, our possible uses of existing cash and investment resources, and statements regarding our litigation with Nippon Shinyaku Co., Ltd. and NS Pharma, Inc., including the nature of the dispute, our expectations regarding any legal proceedings, and our ability to commercialize Deramiocel independent of our existing distribution agreement and any other statements about Capricor’s management team’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “could,” “anticipates,” “expects,” “estimates,” “should,” “target,” “will,” “would” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor’s business is set forth in Capricor’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the Securities and Exchange Commission on March 17, 2026 and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, as filed with the Securities and Exchange Commission on May 13, 2026. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

Deramiocel and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any indication.

For more information, please contact:

Capricor Media Contact:

Caitlin Kasunich / Raquel Cona

KCSA Strategic Communications

ckasunich@kcsa.com / rcona@kcsa.com

212.896.1241 / 516.779.2630

Capricor Company Contact:

AJ Bergmann, Chief Financial Officer

abergmann@capricor.com

858.727.1755

Source: Capricor Therapeutics

Released August 10, 2026

VANCOUVER, BC, Oct. 19, 2026 /PRNewswire/ -- Nevada Organic Phosphate Inc. ("NOP" or the "Company") (CSE: NOP) (OTCQB: NOPFF) (FSE: ZV8), a B.C. based leader in organic sedimentary phosphate exploration, is pleased to report that Hole MM26-11 intersected a strong 28.7 metres (94.2 feet) of the target Meade Peak Member. Oolitic zones typical of the Upper Phosphate Zone were noted during core logging. True thickness and the phosphate content of the Upper Phosphatic Zone will be confirmed by assay.

MM26-11 is approximately 315 metres (1,037 feet) further along trend to the southwest from MM26‑10, which adds to the 1.5‑kilometre (4,921 feet) step‑out along strike from MM26-9. As reported previously, MM26-10 intersected 27 metres (88.6 feet) of Meade Peak including an excellent intersection of 10.89% P2O5 over 3.60 metres.

Robin Dow, CEO, commented: "MM26‑11 intersecting the Meade Peak, with visual indications of the Upper Phosphate Zone, extends our confirmed strike length of phosphate mineralization to over 3.3 kilometres, marking continued and meaningful progress de‑risking our geological model."

Garry Smith, P.Geo., Director, added: "we have been asked why our 2026 drilling has not reported assay results in as timely a manner as our 2025 program did. There are several reasons, but the main one is that we are drilling through greater intervals of the Murdock Mountain Formation (MM) before we get to the target Meade Peak Member (MP). The MM is a heterogeneous, silica-cemented, dolomitic mudstone containing numerous thin chert horizons and nodules. The driller often experiences blocked core barrel, reduced recovery, short runs, and excessive reaming and trip time. A driller with experience in this terrain can adapt to these changing conditions and still complete the hole, it just takes longer sometimes."

Drill Collars and Proposed Drill Pad Locations

(all values are UTM NAD83, and in metres, "decimals" denote surveyed)

Qualified Person

The interpretive technical information in this news release has been reviewed and approved by Garry K Smith, P.Geo., a Director and Qualified Person, as defined in "National Instrument 43-101, Standards of Disclosure for Mineral Projects.

Nevada Organic Phosphate Inc. (CSE: NOP) (OTCQB: NOPFF) (FSE: ZV8)

NOP is a junior exploration company with an organic certifiable sedimentary raw rock phosphate bed, 6.6 kilometres long, in northeast Nevada. Additional applications extend the potential strike of rock phosphate to over 30 kilometres. This is believed to be the only known large-scale organic certifiable sedimentary phosphate project in North America. It is situated close to the main highway to Montello/Elko, Nevada, and the rail head to California or the East Coast.

Neither the Canadian Securities Exchange nor its regulations services providers have reviewed or accept responsibility for the adequacy or accuracy of this release.

This news release may contain forward-looking statements and information ("FLSI") within the meaning of applicable securities laws. FLSI may include expectations, anticipations, beliefs, opinions, plans, intentions, estimates, forecasts, projections, guidance or other similar statements and information that are not historical facts. All statements which are not historical statements are considered FLSI. All FLSI is based on assumptions, which may prove inaccurate, and subject to certain risks and uncertainties, including without limitation those risks and uncertainties identified in the Company's public securities filings, which may cause actual events or results to differ materially from those indicated or implied in FLSI. Accordingly, readers should not place undue reliance or value on FLSI. Although the Company believes that the expectations reflected in any FLSI in this news release are reasonable at the present time, it can give no assurance that such FLSI will prove to be correct. Any FLSI in this news release is made as of the date hereof and the Company undertakes no obligations to publicly update or revise any FLSI, whether as a result of new information, future events or otherwise, unless required by applicable securities laws. Any FLSI in this news release is expressly qualified in its entirety by this cautionary statement.

SOURCE Nevada Organic Phosphate Inc.

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

- Deramiocel Biologics License Application (BLA) under active FDA review

- HOPE-3 Phase 3 results published in The Lancet; primary endpoint of upper limb function achieved at p=0.029

- Cash, cash equivalents and marketable securities of approximately $238 million as of June 30, 2026

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

SAN DIEGO, Aug. 13, 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 second quarter ended June 30, 2026, and provided a corporate update.

“Our priority is, and always has been, to get Deramiocel to the patients and families living with Duchenne who need it most,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “The Advisory Committee outcome was not the one we hoped for. The indication we requested in 2024 was the treatment of cardiomyopathy in DMD, and that is the question the Committee was asked to vote on, not the HOPE-3 primary endpoint. HOPE-3 was designed and powered to demonstrate efficacy in upper limb function; cardiac function was a key secondary endpoint, measured across all patients enrolled rather than only those with established cardiomyopathy. The full dataset has since been published in The Lancet following extensive and independent peer review, and we continue to believe there is a path to approval for Deramiocel.”

Dr. Marbán continued, “The most powerful part of the Advisory Committee was the open public hearing, where patients, families and clinicians described what this therapy has meant, or could mean, to them. That testimony is on the public record, and it is a reminder of how urgent the unmet need in Duchenne remains. We are continuing to work with the Agency on a path forward.”

Second Quarter 2026 and Recent Highlights

- Deramiocel BLA Under FDA Review: Capricor is continuing to work with the FDA on the review of its BLA. The Company plans to provide a regulatory update on its conference call today and will provide further updates as they become available.

- FDA Advisory Committee Outcome: 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. The Committee was not asked to vote on the HOPE-3 primary endpoint or on overall benefit-risk, and in a separate discussion of upper limb function its feedback was directionally supportive of the HOPE-3 clinical evidence. The recommendation is advisory and non-binding.

- HOPE-3 Results Published in The Lancet: The full HOPE-3 Phase 3 dataset was published in The Lancet in July following extensive and independent peer review. Deramiocel demonstrated a statistically significant slowing of upper limb disease progression as measured by PUL 2.0 (p=0.029), with supportive results across additional functional and cardiac measures, which are characterized as nominally significant under the applicable hierarchical testing procedures. In connection with the peer review, Capricor identified an issue with the statistical model in the clinical study report and reverted to the statistical analysis plan in place prior to unblinding. The only endpoint affected was left ventricular ejection fraction, which yields (p=0.09) and a 1.8 percentage point treatment difference, compared to (p=0.04) and a 2.4 percentage point difference reported as topline data. The pre-specified cardiomyopathy subgroup was unchanged at (p=0.02), nothing else changed in the data or its analysis, and the HOPE-3 primary endpoint was unaffected.

- FDA Bioresearch Monitoring Inspection: As part of the review process, the FDA conducted a BIMO inspection in July 2026 and issued a Form 483 citing one observation. The Company has submitted its responses and is currently awaiting feedback.

- Commercial and Manufacturing Readiness: The Company's GMP manufacturing facility in San Diego is operational and positioned to support an initial commercial launch, if Deramiocel is approved. The second-floor expansion is targeted for full validation and FDA inspection in 2027, as planned. Michael Maurer joined as Chief Commercial Officer, bringing direct DMD and rare disease experience, and has been judiciously building out the launch organization. Capricor is advancing commercial readiness at a slower pace pending regulatory clarity.

- NS Pharma Dispute: The state court was scheduled to hear Capricor's motion for preliminary injunction on August 10, 2026, ahead of the PDUFA action date. Capricor withdrew the motion, without prejudice, having determined that resolving this contractual dispute in arbitration following the FDA's decision would give the parties a more complete regulatory record to work from. The Company estimates arbitration to begin this fall. Capricor's position on the underlying dispute has not changed: it continues to believe the pricing structure in the U.S. Distribution Agreement is fundamentally flawed in a way that would impede patient access, and continues to seek rescission.

- Long-Term Safety and Efficacy Experience: Capricor has administered approximately 1,300 intravenous infusions of Deramiocel to over 200 patients with DMD across three separate clinical trials. More than 80 patients are enrolled in the Company's collective open-label extension studies, with some receiving continuous infusions for more than five years, and the long-term safety profile is consistent and well characterized.

- Pipeline and Lifecycle Management: Capricor has initiated regulatory engagement in Europe and Japan for Deramiocel. Expansion into younger DMD patients and Becker muscular dystrophy remains a priority, with trial initiations stage-gated to the U.S. regulatory pathway for Deramiocel. Programs not directly related to Deramiocel, including the Company's exosome-based platform, are on hold pending further regulatory clarity.

Second Quarter 2026 Financial Results

- Cash position: Cash, cash equivalents and marketable securities totaled approximately $237.9 million as of June 30, 2026, compared to approximately $318.1 million as of December 31, 2025.

- Revenues: There was no revenue recognized for the first half of 2026 or 2025.

- Costs and Expenses: Total operating expenses for the second quarter of 2026 were approximately $42.9 million, compared to approximately $27.7 million for the second quarter of 2025. Total operating expenses for the first half of 2026 were approximately $79.7 million, compared to approximately $52.7 million for the first half of 2025.

- Net loss: The Company reported a net loss of approximately $40.7 million, or $0.70 per share, for the second quarter of 2026, compared to a net loss of approximately $25.9 million, or $0.57 per share, for the second quarter of 2025. The net loss for the first half of 2026 was approximately $74.7 million, or $1.29 per share, compared to a net loss of approximately $50.3 million, or $1.10 per share, for the first half of 2025.

-

Financial Outlook: The Company believes that, based on its current operating plan and financial resources, its available cash, cash equivalents and marketable securities are sufficient to fund its operating capital requirements for at least the next twelve months. The Company expects to provide additional guidance on its longer-term financial outlook following greater regulatory clarity, which will inform future strategic and capital allocation decisions. This outlook excludes any potential revenue from product sales, the potential monetization of a Priority Review Voucher, if received, or other non-operating sources of capital.

Upcoming Investor Events

- 2026 Wells Fargo Healthcare Conference, September 8-10, 2026, Boston, MA

- Cantor Global Healthcare Conference 2026, September 9-11, 2026, New York, NY

- H.C. Wainwright 28th Annual Global Investment Conference, September 14-16, 2026, New York, NY

Conference Call and Webcast

To participate in the conference call, please dial 1-800-717-1738 (Domestic) or 1-646-307-1865 (International) and reference the conference ID: 91880. Participants may dial in using the numbers above and ask to be joined to the call or click the Call Me™ link for instant telephone access to the event. To participate via a webcast, please click here. A replay of the webcast will be available shortly after the conclusion of the live event and will be accessible in the Investors section of the Company’s website.

About Duchenne Muscular Dystrophy

Duchenne Muscular Dystrophy (DMD) is a severe, X-linked genetic disorder characterized by progressive muscle degeneration affecting the skeletal, respiratory, and cardiac muscles. It is caused by the absence of functional dystrophin, a key structural protein in muscle cells. DMD affects approximately 15,000 individuals in the United States and primarily impacts boys. Over time, deterioration of the heart muscle leads to cardiomyopathy and heart failure, which is the leading cause of death in DMD. There is no cure, and treatment options remain limited.

About Deramiocel

Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in the preservation of cardiac and skeletal muscle function in muscular dystrophies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing rather than pro-inflammatory phenotype. CDCs have been investigated in more than 250 peer-reviewed scientific publications and administered to over 250 human subjects across multiple clinical trials.