Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA

– New PDUFA target action date of November 22, 2026 follows submission of additional Phase 3 HOPE-3 data and analyses supporting a refined proposed indication –

SAN DIEGO, Aug. 24, 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 the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) target action date for its Biologics License Application (BLA) for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy (DMD), from August 22, 2026 to November 22, 2026.

As part of its ongoing discussions with the FDA following the July 2026 Advisory Committee meeting, Capricor submitted an amendment to the BLA that includes 24-month open-label extension data from its pivotal Phase 3 HOPE-3 study and additional robustness analyses, with a request that the FDA review the existing and new data in support of a refined proposed indication focused on upper limb function, the primary endpoint of HOPE-3. The FDA's Center for Biologics Evaluation and Research (CBER) accepted the amendment for review, citing the significant unmet medical need in DMD. The FDA has classified the submission as a major amendment and extended the PDUFA target action date by three months to allow additional time to review the information.

“With an additional year of follow-up from HOPE-3, we now have one of the most extensive clinical datasets evaluating upper limb function in Duchenne,” said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. “HOPE-3 met its primary endpoint, demonstrating a statistically significant benefit in upper limb function, and we believe the additional open-label data and further analyses included in the amendment strengthen the evidence supporting a refined proposed indication. We appreciate the FDA’s continued engagement and look forward to working constructively with the agency as it completes its review.”

Marbán continued, “The powerful testimony shared by patients, families and clinicians at the July Advisory Committee meeting underscored the importance of preserving upper limb function and the independence it provides for people living with Duchenne. In a progressive disease where function, once lost, cannot be recovered, we believe preservation of upper limb function has the potential to translate into meaningful differences in patients' independence and daily lives. That impact reinforces the urgency of our work and our commitment to bringing Deramiocel to the Duchenne community as soon as possible.”

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 immunomodulatory and anti-fibrotic actions in the preservation of skeletal and cardiac 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. For the treatment of DMD, Deramiocel holds Orphan Drug, RMAT and Rare Pediatric Disease designations in the U.S., and Orphan Drug and ATMP designations in Europe. The Rare Pediatric Disease Designation 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), evaluated in clinical studies for its potential to preserve skeletal and cardiac 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; results of securities litigation; 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 June 30, 2026, as filed with the Securities and Exchange Commission on August 14, 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 24, 2026

Resilience: The Life-or-Death Trek Across Snowy Peaks and Marsh Grasslands

BEIJING, Oct. 19, 2026 /PRNewswire/ -- An interview from China.org.cn with Wang Xiaohui and David Ferguson on the Long March:

Wang Xiaohui:

When your path ahead is beset with obstacles and filled with lurking dangers, like boundless marshlands with no path to follow, no food to eat, one misstep could drag you into deep mire, the sudden drop of temperature could easily cause fatal hypothermia — how long could you endure in such utter despair?

David Ferguson:

To survive and continue to move forward in such a hostile environment would take extraordinary courage, the will and the ability to set aside all thoughts of life and death. Personally, with no idea of what lay ahead, I might never have chosen to venture into such danger in the first place.

Wang Xiaohui:

In August 1935, the Central Committee of the Communist Party of China (CPC) resolved to march north and establish revolutionary base areas in the northwestern provinces of Shaanxi and Gansu. Blockaded by enemy troops externally and divided by disagreements internally, the sparsely populated grassland became the only viable route forward.

As the vanguard unit, the 4th Regiment of the 2nd Division, 1st Corps of the Red Army ventured into the vast Songpan Grasslands. This terrain proved far more horrifying than anticipated — dry solid ground was almost impossible to find, replaced by tufts of wild grass, winding watercourses, and swamps hidden beneath the meadow surface. A single heavy footstep sank soldiers knee-deep in the swamp, and every further struggle dragged them further down, leaving them reliant on comrades for rescue. The Tibetan guide instructed them to tread only where grass grew thick, following each other closely in single file.

The grasslands also saw erratic weather. Temperatures plummeted at dusk, and heavy downpours mixed with hailstones pelted the soldiers without mercy. Worse still, nearly all firewood was soaked by rainstorms, making it impossible to start fires. Soldiers could only huddle back-to-back, drawing warmth from each other's bodies.

Morale sank low. Then, Zheng Jinyu, a young soldier from the publicity department, magically pulled out several matches he had kept pressed close to his chest, sheltered from the rain, and lit a crackling blaze. Quick-witted and buoyant, Zheng always marched at the head of the column, grinning as he cheerfully sang songs and told stories to lift spirits. The warm orange firelight washed over every weary face. Some boiled a basin of hot water, sharing small cups that instantly chased away their cold. Others mixed a pinch of qingke (highland barley) flour with plain water — a single mouthful seemed to melt away a long day's hunger and fatigue.

Later, Zheng fell ill. When Yang Chengwu, the regiment commander learned of his condition, he immediately sent his own horse, a portion of his reserved rations, and his water bottle to the young soldier.

But Zheng never made it out of the deadly grasslands. In his last moments, he shed tears and said: "May the CPC's path prevail, and the revolution soon achieve victory… When that day comes, please tell my family I laid down my life for revolutionary triumph!"

The day after he passed away, the 4th Regiment made it out of the marshlands.

The regiment tried their best to leave clear trail markers to guide troops following behind. But relentless rainfall washed away some signs, while others sank beneath the mire. With no defined pathways, soldiers often trampled through knee-deep, toxic, muddy water. Many lost their way or collapsed from exhaustion, and were silently swallowed by the unforgiving swamps.

Harsh as the natural conditions were, the gravest challenge was a crippling food shortage. Most units had barely enough provisions for two days at most.

At first, they still had qingke barley flour to live on. Later, they turned to anything remotely edible: horse mounts, grass roots, tree bark, wild tubers, even undigested qingke grains picked from horse manure…

Later, when even these meager resources vanished too, soldiers resorted to leather goods — belts, leather shoes, even animal hide covering military drums. They cut off strips and roasted them over the fire; the leather sizzled and bubbled, turning tender and golden with a faint roasted aroma. Each soldier would get a tiny share, chewing slowly and swallowing gently. Some said they tasted like "fried millet cakes, far from unpleasant."

The path to survival for China's Red Army and the Chinese nation was soaked with the blood of these soldiers. They had no idea how far they could reach or how much longer they could survive. Then, what sustained them?

The answer lies in resilience, unbreakable under pressure, and growing firmer with heavier weight borne. This resilience was rooted in the Party's founding aspiration to serve the people and nation, nourished by unshakable faith in ultimate victory amid adversity, and ultimately merged into the torrent of the Long March spirit.

They embraced sacrifice fearlessly: neither the agonies of crossing snow-capped mountains and vast grasslands nor enemy forces outnumbering them many times could intimidate them. All Red Army officers and soldiers understood one ingrained truth: revolution demands sacrifice.

They dared to face up to mistakes. Every setback encountered along the Long March became a steppingstone toward the right course. The Communist Party of China has always possessed the courage to confront and rectify its own mistakes.

They consistently relied on the people, upheld mutual solidarity, and maintained revolutionary optimism even in adversity.

David Ferguson:

When I was crossing the Jiajin Mountain Pass, I heard a story.

During the Long March, some of the Red Army soldiers were approaching the summit — more than 4,000 meters above sea level — they fed themselves on snow and they pretended it was Guanshengyuan "ice cream".

What struck me most about that story was the fact that these soldiers were able to maintain a sense of humor in such hardship. If I were part of an army equipped with a clear direction, extraordinary courage and optimism — I believe that I could commit myself to the journey and see it through. I don't know how long I would endure, but one thing is certain: giving up is not an option. As long as I was still standing on my feet, I would keep moving forward.

Wang Xiaohui:

From June 1935 to July 1936, the three main forces of the Red Army crossed more than 20 snow-capped mountain ranges and traversed the Songpan Grasslands which stretches roughly 500 li (about 250 km). Tens of thousands laid down their lives along the way. Yet, this arduous trek, almost unparalleled in global warfare history, did not crush the Red Army soldiers. Instead, it tempered their will and steeled their faith.

For nearly a century, the stories of the Red Army crossing snow mountains and marshlands have inspired generations of Chinese people. The spirit of enduring hardship without fear, the readiness to embrace sacrifices, and the determination to carve out a path to survival from utter despair have continued to inspire those who followed, urging steady, resolute progress along new journeys.

Today, the historic mission of building a strong country and advancing national rejuvenation has been passed on to a new generation of Chinese people. This new expedition has new "snow-capped mountains and grasslands" to conquer — in the form of key technological challenges, reforms in critical sectors, and the trials that no one has ever tried. Yet the spirit of the Long March, forged through fire and blood, tells us that step by step, even the longest trek can reach its destination. Such a spirit continues to guide us to seek truth from facts, take concrete action, and surmount all difficulties.

The Chinese people are marching forward with confidence and resolve along the new Long March of the new era.

China Mosaic 

http://www.china.org.cn/video/node_7230027.htm 

Resilience: The Life-or-Death Trek Across Snowy Peaks and Marsh Grasslands

http://www.china.org.cn/2026-10/18/content_118738296.shtml 

SOURCE China.org.cn

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Capricor Therapeutics to Present HOPE-3 and HOPE-3 Open-Label Extension Data at 2026 World Muscle Society Congress

– Late-Breaking Data to Include HOPE-3 Delayed-Start and Natural History Analyses Submitted in the Recent Major Amendment to the Deramiocel BLA –

– PDUFA Target Action Date of November 22, 2026 –

SAN DIEGO, Sept. 17, 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 data from HOPE-3 and its open-label extension (OLE) of Deramiocel, the Company’s lead asset for the treatment of Duchenne muscular dystrophy (DMD), will be presented in a late-breaking poster and an oral presentation at the 31st Annual Congress of the World Muscle Society (WMS 2026), taking place September 29 – October 3, 2026, in Hiroshima, Japan. The presentations will report skeletal muscle and cardiac outcomes through 24 months, building on the previously reported 12-month HOPE-3 results. Of the 106 patients randomized in HOPE-3, 82 reached the 24-month time point, comprising 40 originally assigned to Deramiocel and 42 to placebo.

“These HOPE-3 24-month data, along with additional analyses supporting Deramiocel’s potential safety and efficacy, were part of our recent major amendment to the Deramiocel BLA,” said Linda Marbán, Ph.D., CEO of Capricor. “We look forward to presenting these results at the World Muscle Society Congress.”

Beyond the Deramiocel program, Capricor will also present two preclinical posters from its StealthX™ exosome platform.

WMS Presentations

Title: Deramiocel slows upper limb decline in the HOPE-3 OLE: cross-phase delayed-start analysis and 2-year comparison with natural history

Presenting author: Dr. Craig McDonald, University of California, Davis

Details: Late-breaking poster session

Title: HOPE-3, a phase 3 study of deramiocel, an allogeneic cell therapy, in advanced Duchenne muscular dystrophy: evidence to support both musculoskeletal and cardiac efficacy

Presenting author: Dr. Craig McDonald

Details: Oral presentation, clinical trial updates session, October 3, 2026

Title: Engineered muscle-targeting extracellular vesicles for systemic delivery of micro-dystrophin: novel redosable strategy for Duchenne muscular dystrophy

Presenting author: Mafalda Cacciottolo, Ph.D., Capricor Therapeutics

Details: Poster session 2, DMD treatments, September 30, 2026

Title: Delivery of acid α-glucosidase by muscle-targeting extracellular vesicles: a new road for Pompe disease treatment

Presenting author: Mafalda Cacciottolo, Ph.D.

Details: Poster session 3, Glycogenoses, October 2, 2026

Copies of the presentations and posters will be added to the publications section of the Capricor website following each presentation. The full WMS 2026 program is available at https://www.wms2026.com/page/programme.

About the HOPE-3 Study

HOPE-3 is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating Deramiocel in patients with Duchenne muscular dystrophy. The study enrolled 106 patients, randomized to receive Deramiocel or placebo administered intravenously every three months over a 12-month treatment period. HOPE-3 met its primary endpoint, with Deramiocel slowing decline in upper limb function by 54 percent versus placebo as measured by Performance of the Upper Limb (PUL) version 2.0 (p=0.03). One-year results were published in The Lancet in July 2026. Patients who completed the randomized portion of the study were eligible to continue receiving Deramiocel in an open-label extension.

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, 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 immunomodulatory and anti-fibrotic actions in the preservation of skeletal and cardiac 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. For the treatment of DMD, Deramiocel holds Orphan Drug, RMAT and Rare Pediatric Disease designations in the U.S., and Orphan Drug and ATMP designations in Europe. The Rare Pediatric Disease designation 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), evaluated in clinical studies for its potential to preserve skeletal and cardiac 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; results of securities litigation; 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 June 30, 2026, as filed with the Securities and Exchange Commission on August 14, 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 Capricor’s StealthX™ exosome therapeutics are investigational 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 September 17, 2026

Health Innovation South West and Helfie AI announce partnership to evaluate digital-first hypertension screening

Findings from real-world settings will add to the evidence base for preventing cardiovascular disease

MELBOURNE, Australia, Oct. 19, 2026 /PRNewswire/ -- Helfie AI and UK-based Health Innovation South West have announced a partnership to explore how digital-first approaches to hypertension screening can support earlier identification of people at risk of high blood pressure and cardiovascular disease. The collaboration will test and evaluate the potential of smartphone-based screening technology to engage people in prevention, particularly those who may face barriers to accessing traditional healthcare services.

Hypertension remains one of the leading modifiable risk factors for cardiovascular disease, yet many people remain undiagnosed until they experience serious health problems. By combining Helfie's technology with Health Innovation South West's expertise in implementation and evaluation, the partnership will explore how smartphone-enabled screening can be integrated into healthcare pathways and assessed in real-world settings, with a particular focus on improving access for underserved and hard-to-reach populations. Insights generated through the programme will contribute to the evidence base for innovative approaches to prevention and population health.

Rania Awad, Chief Strategy Officer, Helfie AI, said: "Prevention only works if it reaches people where they are. Our mission is early detection, proactive prevention and optimised wellbeing for all eight billion-plus humans, and that has to include the person who cannot easily get to a clinic."

Christelle Kelley, Population Health Lead, Helfie AI, said: "Population health is about understanding the needs of communities and shaping prevention around the people and places we serve. Digital innovation brings opportunities to reach beyond traditional healthcare settings and support place-based care. I'm excited to explore not only how we can identify and support more people at risk of hypertension, but how we translate that opportunity into meaningful, equitable improvements in cardiovascular health."

ABOUT HELFIE

Helfie is a global health platform for early detection, proactive prevention and optimised wellbeing for all humans. Science-backed and AI-powered, it delivers 30+ easy, instant and affordable health checks via smartphone, working with governments and businesses to make preventive health accessible to everyone.

More details: www.helfie.ai

Helfie AI has part-funded this project, including elements of the work to evaluate the impact of incorporating the platform within cardiovascular disease prevention pathways. The outputs and findings arising from this partnership should not be interpreted as an endorsement, recommendation, or procurement guidance from Health Innovation South West in relation to any specific product, technology, or manufacturer.

SOURCE Helfie AI

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Capricor Therapeutics Presents Positive HOPE-3 Open-Label Extension Data on Upper Limb Function in Duchenne Muscular Dystrophy at 2026 World Muscle Society Congress

-24-Month Crossover Analysis: Patients Starting Deramiocel After a Year on Placebo Slowed Upper Limb Decline by 76% Compared with Their Own Prior Year-

-At 24 Months, Both Groups Showed Slower Decline in Upper Limb Function Than Natural History Predicts-

-Data Included in Deramiocel BLA Major Amendment; PDUFA Target Action Date November 22, 2026-

-Webinar Scheduled for October 7, 2026, at 1:00 p.m. ET in Collaboration with PPMD to Discuss the Data-

SAN DIEGO, Oct. 05, 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 positive new data from its ongoing HOPE-3 open-label extension (OLE) study for its lead asset, Deramiocel, for the treatment of upper limb impairment in Duchenne muscular dystrophy (DMD). The data were highlighted in a late-breaking poster presentation at the 31st Annual Congress of the World Muscle Society (WMS) in Hiroshima, Japan, supporting HOPE-3’s previously reported 12-month results, which were also presented in a separate oral session on Deramiocel's musculoskeletal and cardiac efficacy.

Key results from the late-breaking abstract are summarized below.

HOPE-3 Open-Label Extension: Upper Limb Function (PUL 2.0)

ITT population: 106 randomized; 98 entered the OLE (49 per arm). Negative values indicate decline. 95% CIs are two-sided. No alpha was allocated to these open-label analyses, and the extension was not powered for Month 24 comparisons.

aLeast-squares mean change from a mixed model for repeated measures, with each year measured from its own starting point (Day 0 or Month 12) and adjusted for starting score, cohort, site and slow-progressor status.

bGroups are named by original randomized assignment.

cDifference as a percentage of the Year 1 decline on placebo.

dObserved mean change (unadjusted) vs a natural history model (Michaëls 2025; Niks 2026) that predicts each patient’s decline from baseline score, age and ambulatory status. In its untreated year, the Placebo arm tracked the model (−2.7 observed vs −2.9 predicted at Month 12) and a published non-ambulant cohort (about −2.7 points per year; Coratti 2025). Descriptive only; no matching or statistical testing.

ePatients assessed at Month 24: n=42 (Placebo arm), n=40 (Deramiocel arm).

“Upper limb function is critical to quality of life for young men with DMD because it is directly tied to their independence,” said Craig McDonald, MD, Principal Investigator of the HOPE-3 trial at UC Davis Health. “When the young men who had been declining on placebo started Deramiocel, their rate of upper limb loss dropped by roughly 75% in their first year of treatment. Just as important, patients who were on Deramiocel both years declined at a similar rate in year 1 and year 2, which suggests that the slower decline was triggered by starting treatment, not the passage of time. Being able to follow the same young man before and after he starts treatment is a powerful way to see a treatment effect, and what we saw was consistent with the randomized, placebo-controlled period. As a clinician seeing these patients, I have had very little to offer them that could meaningfully slow the progression of upper limb functional loss once they were non-ambulant. These data suggest there could be a way to treat this aspect of the disease. Their arms are how they feed themselves, control their wheelchairs and use their phones, and how they stay independent. Time is muscle, and slowing that loss means more time doing the things that matter most to them.”

“These results add to a growing body of evidence for Deramiocel,” said Linda Marbán, Ph.D., CEO of Capricor. “What we saw in the HOPE-3 open-label extension aligns with our previous clinical studies, which together show the same pattern across multiple years of treatment. The FDA has received these data as part of the recent major amendment to the Deramiocel Biologics License Application, along with extensive sensitivity and robustness analyses we produced to support the results of the HOPE-3 randomized clinical trial. We will continue to work with the FDA through the remainder of the review, ahead of the November 22, 2026, PDUFA target action date.”

Copies of all Capricor WMS presentations will be made available in the publications section of the Capricor website. The full WMS program is available at wms2026.com/page/programme.

Webinar Information

A webinar is scheduled for Wednesday, October 7, 2026, at 1:00 p.m. ET in collaboration with Parent Project Muscular Dystrophy (PPMD) to discuss these results in more detail. To register for the webinar, please click here. For additional details, please visit Parent Project Muscular Dystrophy's website.

About the HOPE-3 Study

HOPE-3 is a Phase 3, randomized, double-blind, placebo-controlled trial evaluating Deramiocel in patients with Duchenne muscular dystrophy. The study enrolled 106 patients, randomized to receive Deramiocel or placebo administered intravenously every three months over a 12-month treatment period. One-year results were published in The Lancet in July 2026. Patients who completed the randomized portion of the study were eligible to continue receiving Deramiocel in an open-label extension (OLE).

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, 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 immunomodulatory and anti-fibrotic actions in the preservation of skeletal and cardiac 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. For the treatment of DMD, Deramiocel holds Orphan Drug, RMAT and Rare Pediatric Disease designations in the U.S., and Orphan Drug and ATMP designations in Europe. The Rare Pediatric Disease designation 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 the treatment of Duchenne muscular dystrophy (DMD), evaluated in clinical studies for its potential to preserve skeletal and cardiac 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; results of securities litigation; 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 June 30, 2026, as filed with the Securities and Exchange Commission on August 14, 2026.

Lilly's Omvoh (mirikizumab-mrkz) meets primary endpoint of clinical remission and is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis

Building on Omvoh's approved use and durable efficacy in adults, Lilly plans to submit these data to global regulators to support a potential label expansion for pediatric ulcerative colitis

More than 80% of patients responded to Omvoh induction, and half of responders, ages 6 to 17, were in clinical remission at one year in Phase 3 SHINE-2 study

In key secondary outcomes, 71.2% of patients who responded to Omvoh induction achieved symptomatic remission and 50% achieved corticosteroid-free clinical remission at one year without surgery

INDIANAPOLIS, Oct. 19, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive late-breaking one-year results from the Phase 3 SHINE-2 study of Omvoh (mirikizumab-mrkz) in pediatric patients ages 6 to 17 with moderately to severely active ulcerative colitis (UC), including clinical, symptomatic and endoscopic outcomes. In the single-arm, open-label study, 81% of patients achieved clinical response to Omvoh induction at Week 12. Among responders, 50% achieved clinical remission at Week 52, meeting the study's primary endpoint.* Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric UC. These results were presented as a late-breaking oral presentation at United European Gastroenterology (UEG) Week 2026.1

Omvoh is currently approved for adults with moderately to severely active UC. The safety and effectiveness of Omvoh in pediatric patients are currently being evaluated in clinical studies. Lilly plans to submit these data to global regulators to support a potential label expansion. If approved, Omvoh would be the first IL-23p19 inhibitor indicated for pediatric UC.

"For children and adolescents, the persistent bowel urgency, abdominal pain and unpredictability of ulcerative colitis can make a normal childhood feel out of reach, especially when symptoms return after previous treatments," said Mark Genovese, M.D., senior vice president of Lilly Immunology development. "Already approved for adults with ulcerative colitis, Omvoh is the first IL-23p19 inhibitor to report one-year Phase 3 results in pediatric ulcerative colitis. We look forward to working with regulators to potentially make Omvoh available to children and adolescents living with this disease, who continue to face substantial disease burden and ongoing unmet needs."

Unmet need in pediatric ulcerative colitis

UC affects more than 26,000 children and adolescents in the U.S.3 Although relatively uncommon, pediatric-onset UC is often more extensive and severe than disease that begins in adulthood.4 Up to half of children treated with corticosteroids become dependent on them, and up to one-third require surgery within a year.4

SHINE-2 evaluated Omvoh in a pediatric population with high disease burden and significant unmet need, including 54% of enrolled patients who had previously experienced biologic treatment failure. Half entered the study with severe disease activity as measured by the Pediatric Ulcerative Colitis Activity Index.1

"For children with ulcerative colitis, every year spent relying on corticosteroids or facing the possibility of surgery can have important implications for growth, development and quality of life," said Marla C. Dubinsky, M.D., Professor of Pediatrics and Medicine at the Icahn School of Medicine at Mount Sinai, Chief of Pediatric Gastroenterology and Nutrition at Mount Sinai Kravis Children's Hospital. "Considering these challenges, the finding that half of the pediatric patients who responded to Omvoh achieved corticosteroid-free clinical remission without surgery at one year is particularly meaningful, especially in a population where many patients had previously experienced treatment failure with advanced therapies."

One-year results from SHINE-2 in children and adolescents with ulcerative colitis

Of the patients enrolled in SHINE-2, 81% achieved clinical response at Week 12. Among responders, ages 6 to 17, efficacy was sustained across multiple clinical, symptomatic and endoscopic outcomes at Week 52, including:

- 50% clinical remission (primary endpoint)*

- 50% corticosteroid-free clinical remission without surgery†

- 73.1% clinical response‡

- 71.2% symptomatic remission¶

- 53.8% endoscopic improvement#

- 44.2% endoscopic remission**

The pediatric Week 52 clinical remission rate was similar to that observed among adult Week 12 responders treated with Omvoh in LUCENT-2 (50.7%).1 This descriptive observation was separate from the primary endpoint analysis and should not be interpreted as a direct comparison between studies.

These one-year findings build on the early clinical, symptomatic and endoscopic improvements observed at Week 12, which were presented as a late-breaking oral presentation at the American College of Gastroenterology 2026 Annual Scientific Meeting.5

Safety findings from SHINE-2

Through Week 52 in SHINE-2, the safety profile of Omvoh in children and adolescents was consistent with its established safety profile in adults, with no new safety signals identified. The most common treatment-emergent adverse events in SHINE-2 were upper respiratory tract infection, injection site reaction, UC, headache, nasopharyngitis and anemia. Most treatment-emergent adverse events were mild to moderate in severity. Through Week 52, four patients (6.3%) experienced a serious adverse event; none was considered related to study treatment. Two patients (3.2%) discontinued treatment because of UC flare. No deaths, malignancies, opportunistic infections or growth-related safety concerns were reported through Week 52.1

Omvoh has received regulatory approvals for the treatment of moderately to severely active UC and moderately to severely active Crohn's disease in adults and has been approved in 47 countries around the world. In UC, Omvoh is also approved as a single-injection maintenance regimen in several countries around the world including the U.S., EU, Canada and Japan.

Lilly continues to study mirikizumab in pediatric inflammatory bowel disease, including a long-term extension study in UC and Crohn's disease (NCT04844606) and an ongoing Phase 3 study in pediatric Crohn's disease (NCT05509777). Lilly is also evaluating mirikizumab through combination approaches and novel mechanisms aimed at delivering breakthrough induction efficacy while maintaining long-term remission and safety. These include studies in UC with eltrekibart (NCT06598943), a monoclonal antibody that targets neutrophil-driven inflammation, and with zotemtegrast (NCT07186101), an oral α4β7 integrin inhibitor. In Crohn's disease, Lilly is studying mirikizumab in combination with an FXR agonist (NCT07483099). The COMMIT-UC (NCT06937086) and COMMIT-CD (NCT06937099) trials are investigating the concomitant use of mirikizumab and an incretin-based therapy in adults with UC or Crohn's disease and obesity or overweight with at least one additional weight-related comorbid condition.

Disclosure: Dr. Dubinsky is a paid consultant for Lilly. She has not been compensated for any media work.

About SHINE-2

SHINE-2 is a Phase 3, multicenter, single-arm, open-label study evaluating mirikizumab in pediatric patients with moderately to severely active UC. A total of 63 participants, ages 4 to 17, were enrolled and received weight-based intravenous induction every four weeks for three doses (300 mg for patients >40 kg; 5 mg/kg for patients ≤40 kg). At Week 12, 52 patients entered the maintenance period as clinical responders and received weight-based subcutaneous mirikizumab every four weeks through Week 52. The primary endpoint was evaluated against a pre-specified benchmark derived from the adult placebo remission rate in the Phase 3 LUCENT-2 study.* The Week 52 efficacy results are reported for the Week 12 responder population (N=52; ages 6 to 17); safety results are based on all enrolled patients (N=63).

Patients completing SHINE-2 may be eligible to continue in SHINE-ON, an ongoing long-term extension study evaluating mirikizumab in pediatric patients with UC or Crohn's disease.

About Omvoh

Omvoh (mirikizumab-mrkz) is an interleukin-23p19 (IL-23p19) antagonist indicated for the treatment of moderately to severely active ulcerative colitis and Crohn's disease in adults. Omvoh selectively targets the p19 subunit of IL-23 and inhibits the IL-23 pathway. Inflammation due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of inflammatory bowel disease.2  The safety and effectiveness of Omvoh have not been established in pediatric patients.

Omvoh and its delivery device base are trademarks owned by Eli Lilly and Company.

Endnotes and References

*Clinical remission was defined as stool frequency (SF) subscore=0 or 1, rectal bleeding (RB) subscore=0 and endoscopic subscore (ES)=0 or 1 (excluding friability). The primary endpoint was met by exceeding a pre-specified benchmark based on the placebo remission rate in adults from the Phase 3 LUCENT-2 study. The lower bound of the 80% credible interval for the Week 52 pediatric remission rate among Week 12 responders (42.8%) exceeded the upper bound of the 90% credible interval for the adult placebo remission rate in LUCENT-2 (32.6%). Week 52 efficacy was assessed among the 52 patients who entered the maintenance period as Week 12 clinical responders, based on response status recorded by study sites.  

†Corticosteroid-free clinical remission without surgery: clinical remission at Week 52 without surgery, and no corticosteroid use for at least 12 weeks prior to Week 52. 

‡Clinical response: a decrease in the MMS of ≥2 points and ≥30% decrease from induction baseline plus a decrease of ≥1 point in the RB subscore from induction baseline or an RB subscore of 0 or 1.

Sobi to present new Aspaveli®/Empaveli® data at ASN Kidney Week 2026

STOCKHOLM, Oct. 19, 2026 /PRNewswire/ -- Sobi® today announced that seven abstracts on Aspaveli/Empaveli (pegcetacoplan) have been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2026, taking place from 21–25 October in Denver, Colorado, USA. The programme includes two oral and five poster presentations covering longer-term clinical outcomes, renal safety and treatment experience, alongside the phase IV PRISM-C3 study, reflecting Sobi's commitment to generating real-world evidence.

The two oral presentations will report 76-week outcomes with Aspaveli/Empaveli in C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), demonstrating maintenance of proteinuria reduction and eGFR stabilisation. These include a paediatric subgroup analysis from VALIANT and its VALE extension.

"Longer-term follow-up is important to deepen our understanding of treatment outcomes for people living with C3G and primary IC-MPGN," said Lydia Abad-Franch, MD, Head of R&D and Medical Affairs and Chief Medical Officer at Sobi. "The 76-week analyses, including findings in adolescent patients, continue to build the evidence base for Aspaveli/Empaveli. Alongside research into renal safety, treatment experience and use in kidney transplant recipients, the presentations at ASN reflect our commitment to addressing the needs of people living with these rare kidney diseases."

All times are local to Denver. Oral presentation times refer to the full sessions.

About Aspaveli®/Empaveli® (pegcetacoplan)

Aspaveli/Empaveli (pegcetacoplan) is a targeted C3 and C3b therapy designed to regulate excessive activation of the complement cascade, part of the body's immune system, which can lead to the onset and progression of many serious diseases. It is the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older approved in the United States, European Union, and other countries globally. Aspaveli/Empaveli is also approved for the treatment of adults with paroxysmal nocturnal haemoglobinuria (PNH) in the United States, European Union, and other countries globally.

About the Sobi® and Apellis (now part of Biogen) collaboration

Apellis (now part of Biogen) and Sobi have global co-development rights for systemic pegcetacoplan. Sobi has exclusive ex-U.S. commercialisation rights for systemic pegcetacoplan. Apellis (now part of Biogen) has exclusive U.S. commercialisation rights for systemic pegcetacoplan and worldwide commercial rights for ophthalmological pegcetacoplan, including for geographic atrophy.

Sobi®

Sobi is a global biopharma company unlocking the potential of breakthrough innovations, transforming everyday life for people living with rare diseases. Sobi has approximately 2,000 employees across Europe, North America, the Middle East, Asia and Australia. In 2025, revenue amounted to SEK 28 billion. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm. More about Sobi at sobi.com and LinkedIn.

Contacts

For details on how to contact the Sobi Investor Relations Team, please click here. For Sobi Media contacts, click here.

CONTACT: Visiting address

Norra Stationsgatan 93A, Stockholm

+46 8 697 20 00

[email protected] 

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HiBy Launches RS2 II Portable Hi-Fi Player with Flagship DARWIN III Architecture

LEWES, Del., Oct. 19, 2026 /PRNewswire/ -- HiBy has officially launched the RS2 II, a compact portable Hi-Fi player featuring the company's third-generation DARWIN III audio architecture, the same architecture used in the flagship RS8 II. Designed for audiophiles seeking flagship-level sound in a smaller and more portable form, the RS2 II combines HiBy's proprietary R2R technology, a fully balanced analog stage, HiByOS, and flexible connectivity.

At the heart of the RS2 II is the DARWIN III architecture, powered by a newly developed FPGA digital engine featuring more than 35K logic units and 40 high-speed, high-performance DSP units. This processing platform provides the computing power required for HiBy's adjustable pure FIR filters, multiple DARWIN filters, harmonic control, NOS/OS switching, and native DSD processing.

Digital-to-analog conversion is handled by a high-precision R2R resistor network. High-speed electronic switches drive the resistor network to convert digital signals into corresponding analog voltage levels, helping reduce high-frequency noise introduced by digital modulation while delivering a natural, transparent, and musical presentation.

The analog stage uses a four-stage OPA1612 signal chain. One OPA1612 performs low-pass filtering after the DAC stage, another provides current amplification after volume control, while two additional OPA1612 devices form a fully balanced voltage amplification stage. At the headphone output, four flagship-grade OPA1622 amplifiers provide independent four-channel current amplification for improved dynamics, control, and compatibility with multi-driver earphones.

The RS2 II is also more compact than its predecessor. The standard aluminum alloy edition weighs just 156g and features a dark green finish with a houndstooth-pattern rear panel. Compared with the original RS2, the display area has increased by 45% and resolution by 122%. The new 3.55-inch 480 × 800 display, together with narrower bezels, provides a significantly improved visual experience. An upgraded X1600E dual-core platform further enhances system responsiveness.

Running HiBy's dedicated HiByOS, the RS2 II supports coaxial output, Line Out, and USB DAC functionality. Dual microSD card slots support up to 4TB of total expandable storage.

The HiBy RS2 II Aluminum Alloy Edition is priced at US$439 and is available as a standard production model. The Limited Brass Edition is priced at US$549 and is expected to become available in October, with worldwide production restricted to just 500 units.

Contact

William Yueng

[email protected]

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INSPIRED LAUNCHES HAPPY MONEY HENS™, AN EGG-CITING NEW GAME

22 July 2026 – Inspired Entertainment, Inc. (“Inspired” or the “Company”) (NASDAQ: INSE), a leading B2B provider of gaming content, systems, and solutions, today announced the launch of Happy Money Hens™ in the UK B3/LBO market, with a Cat C release scheduled for autumn.

Happy Money Hens brings a fresh farmyard theme to the reels, combining vibrant visuals with feature-rich gameplay. Featuring Inspired’s proven Triple Hit Combo mechanic, the game delivers engaging gameplay through pseudo-persistent bags and dynamic feature combinations. Building on the success of its predecessor, Zeus Legends of Olympus, Happy Money Hens.

Happy Money Hens builds on the familiar Win & Spin bonus enhanced by three Feature Pots, each linked to a coloured hen. Every Hen Symbol collected adds to its matching Feature Pot, giving players the chance to activate powerful bonus features within the Win & Spin Bonus. Landing multiple Hen Symbols increases the chance of triggering one or more features, with combined activations unlocking even bigger rewards.

The Blue Hen can award, double coins either as matching cash values or Pot Fill coins. The Red Hen can award Pot Fill symbols that collect letters towards one of four jackpot prizes; Mini, Minor, Major and Grand, with the opportunity to collect double letters when combined with the Blue Hen’s double feature.

The Golden Hen can boost the value of one or more cash coins on active or inactive rows, increasing prizes up to £100. It can also combine with either or both of the other Hen features, for more rewarding gameplay.

The Win & Spin Bonus begins on a 5×3 grid of mini reels, with four additional locked rows waiting to be unlocked. Each locked row features a countdown that decreases whenever coins land on active rows, gradually opening additional reel positions and creating more chances to win. The bonus starts with three lives that reset whenever a coin lands on an active row. The feature ends when all lives have been exhausted, awarding all cash coins collected on unlocked rows, while Pot Fill prizes are awarded immediately.

The Dual Wheel Gamble provides an additional opportunity to boost winnings, allowing players to either increase their winnings by up to 10x or trigger the Win & Spin Bonus.

“We’re delighted to bring Happy Money Hens to our UK retail customers,” said Ian Shreeve, Vice President and General Manager Gaming Sales. “Building on the success of Zeus Legends of Olympus and featuring our proven Triple Hit Combo and Win & Spin mechanics, Happy Money Hens introduces three bonus features that work together to deliver rewarding gameplay and exciting bonus combinations. With its fun farmyard theme and feature-rich design , we’re confident it will be a popular addition to gaming venues across the UK””

Happy Money Hens™ is available now in the UK B3/LBO market, with a Cat C launch scheduled for autumn.

About Inspired Entertainment, Inc.

With a proven track record of innovation, Inspired is a leading provider of content, technology, hardware and services for licensed gaming, betting and lottery operators around the world. Inspired’s proprietary games resonate with players and deliver consistent performance for gaming operators across interactive, virtual sports, and retail gaming environments. Inspired’s content and gaming systems are designed to work together across digital and retail channels, enabling scalable deployment and a consistent player experience. Through this integrated content-led approach, Inspired helps operators strengthen their offerings, drive engagement, and deliver compelling player experiences.

Additional information can be found at www.inseinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “will,” “would” and “project” and other similar expressions that indicate future events or trends or are not statements of historical matters. These statements are based on Inspired’s management’s current expectations and beliefs, as well as a number of assumptions concerning future events.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside of Inspired’s control and all of which could cause actual results to differ materially from the results discussed in the forward-looking statements. Accordingly, forward-looking statements should not be relied upon as representing Inspired’s views as of any subsequent date and Inspired does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as required by law. You are advised to review carefully the “Risk Factors” section of Inspired’s annual report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent quarterly reports on Form 10-Q, which are available, free of charge, on the U.S. Securities and Exchange Commission’s website at www.sec.gov and on Inspired’s website at www.inseinc.com.

Contact:

For Investors

IR@inseinc.com

For Press and Sales

inspiredsales@inseinc.com

INSPIRED LAUNCHES PIGGY MANSION, GOLDEN WINNER BONUS CHERRIES & WOLF IT UP! 3 REELER ACROSS MOBILE & ONLINE

JULY 29, 2026 – Inspired Entertainment, Inc. (NASDAQ: INSE), a leading B2B provider of gaming content, systems and solutions, has announced the launch of Piggy Mansion™, Golden Winner Bonus Cherries™ and Wolf It Up! 3 Reeler™, across the UK and Malta iGaming markets.

The latest releases combine some of Inspired’s most recognisable player-favourite brands with exciting gameplay mechanics and engaging bonus features designed to boost player engagement.

Piggy Mansion™ featuring Cash Bank™ is the newest addition to Inspired’s popular Cash Bank series, bringing a new pig-themed adventure packed with proven cash collection gameplay, expanding reels and rewarding multiplier features. The game introduces enhanced Collect symbols, expanding reels and stacked Multiplier Collectors that can boost a player’s win potential. Prize Pots and multipliers add further excitement, while the Cash Bank Free Spins Bonus features an evolving trail that awards additional free spins and unlocks multiplier opportunities. Combining engaging progression mechanics and feature-rich gameplay, Piggy Mansion delivers operators a compelling new addition to the Cash Bank portfolio.

Golden Winner Bonus Cherries™ builds on the success of Inspired’s popular Golden Winner™ formula, introducing colourful progressive cherries, dynamic reel modifiers and enhanced cash collection mechanics for an exciting new player experience. Green, blue and purple cherries above the reels unlock a bonus modifier, creating multiple reward paths and the potential to trigger up to three progressive features simultaneously. The Bonus game delivers even more excitement with additional spins, Mystery Pot prizes, respins and Golden Bell Wild symbols that collect visible cherry values. Additional features including reel modifiers, Gamble, Fortune Spins, Fortune Bet and a four-tier Bonus Buy feature provide even more engagement opportunities. Combining layered progression and rewarding gameplay, Golden Winner Bonus Cherries is a fresh evolution of a popular title designed to maximise player excitement and win potential.

Wolf It Up! 3 Reeler™ featuring Cash Bank™ reimagines one of Inspired’s top-performing player-favourite brands in a fast-paced 3×3 reel format designed to deliver accessible, engaging gameplay across markets. Retaining the charm of the original enchanted forest adventure, the game introduces a simplified symbol set and a three Cash Symbol Bonus entry mechanic, alongside the proven Cash Bank collection feature with exciting bonus opportunities. Players can build anticipation by collecting Collect and Bonus symbols that trigger the Wheel Bonus game for rewarding surprises and enjoy the Cash Bank Free Spins Bonus featuring a thrilling Prize Pot collection mechanic. Combining familiar appeal, streamlined gameplay and feature-rich entertainment, Wolf It Up! 3 Reeler delivers a fresh take on a proven performer with strong player engagement potential.

Claire Osborne, Managing Director of Interactive at Inspired Entertainment, said: “These latest launches highlight Inspired’s commitment to evolving proven player-favourite brands with fresh mechanics, engaging features and exciting new gameplay experiences. Our Cash Bank and Golden Winner games have established themselves as hugely popular franchises across multiple markets, and these new titles build on that success by delivering the themes, characters and rewarding features that players know and love. By combining trusted mechanics with exciting enhancements, we continue to create compelling content that drives player engagement, supports operator growth and strengthens Inspired’s reputation as a leading provider of entertaining, high-performing iGaming experiences.”

For more information on Inspired’s latest iGaming content, visit: inseinc.com/interactive/games

Ends

About Inspired Entertainment

With a proven track record of innovation, Inspired is a leading provider of content, technology, hardware and services for licensed gaming, betting and lottery operators around the world. Inspired’s proprietary games resonate with players and deliver consistent performance for gaming operators across interactive, virtual sports, and retail gaming environments. Inspired’s content and gaming systems are designed to work together across digital and retail channels, enabling scalable deployment and a consistent player experience. Through this integrated content-led approach, Inspired helps operators strengthen their offerings, drive engagement, and deliver compelling player experiences.

Additional information can be found at www.inseinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “anticipate,” “believe,” “expect,” “estimate,” “plan,” “will,” “would” and “project” and other similar expressions that indicate future events or trends or are not statements of historical matters. These statements are based on Inspired’s management’s current expectations and beliefs, as well as a number of assumptions concerning future events.

Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside of Inspired’s control and all of which could cause actual results to differ materially from the results discussed in the forward-looking statements. Accordingly, forward-looking statements should not be relied upon as representing Inspired’s views as of any subsequent date and Inspired does not undertake any obligation to update forward-looking statements to reflect events or circumstances after the date they were made, whether as a result of new information, future events or otherwise, except as required by law. You are advised to review carefully the “Risk Factors” section of Inspired’s annual report on Form 10-K for the fiscal year ended December 31, 2024, and in subsequent quarterly reports on Form 10-Q, which are available, free of charge, on the U.S. Securities and Exchange Commission’s website at www.sec.gov and on Inspired’s website at www.inseinc.com.

Contacts:

Investor Relations

IR@inseinc.com

+1 646 277 1285

For Press and Sales

inspiredsales@inseinc.com

www.inseinc.com

@Inspired_News