CAPR

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 4:30 p.m. ET Chief Executive Officer - Linda Marbn Executive Vice President and Chief Financial Officer - Anthony J. Bergmann Chief Commercial Officer - Michael Maurer Operator: Good afternoon, ladies and gentlemen, and welcome to the Capricor Therapeutics second quarter 2 thousand 26 Conference Call. Please press 0 for the operator. This call is being recorded on Thursday, 08/13/2026. And I would now like to turn the conference over to CFO, AJ Bergmann, for the forward-looking statement. Thank you. Please go ahead. Anthony J. Bergmann: Thank you very much. Before we begin, I would like to remind you that any statements made during today's call that are not historical are considered to be forward looking statements. Actual results may differ materially from those indicated by these statements as a result of various important factors, including those discussed in the Risk Factors section of our company's most recent annual report on Form 10 ks, and our most recent quarterly reports on Form 10 Q as well as other reports filed with the SEC, Any forward looking statements may represent our views as of today, 08/13/2026 only. Replay of the call will be available on our website following its completion. That, I will turn the call over to Linda Marbán, CEO. Linda Marbán: Good afternoon, everyone, and thank you for joining Capricor's second quarter 26 Earnings Call. Our BLA for Daramycin remains under review with the FDA with a current PDUFA target action date of August 22, Because that review is ongoing, there is a limit to what I can say about our interactions with the agency, but I wanted to provide an update across 3 main topics: our regulatory status, and pathway for Daramycin, our commercial and manufacturing readiness, and our dispute with NS Pharma. I will then briefly address our pipeline programs before turning it back to AJ. On 07/29/2026, the FDA convened the Cellular Tissue and Gene Therapies Advisory Committee to review our BLA. The committee was presented with a single voting question. Does the available evidence provide substantial evidence of effectiveness of Daramycin for the treatment of cardiomyopathy in patients with DMD. The vote was 3 in favor 9 against, with no abstentions. That is not the outcome we had planned for. And we are, of course, disappointed. But we remain committed to working with the FDA on the next steps for this program our priority is and always has been to get Deramiocel to those who need it most. I would like to provide some color and our perspective about why we continue to believe in the potential of Deramiocel and DMD patients. First, the indication we originally requested in the BLA going back to 2024 was the treatment of cardiomyopathy and DMD. Therefore, the focus of the FDA and the advisory committee was on whether Daramycin should be approved to treat cardiomyopathy. However, the measurement of Derremia cell's effect on cardiomyopathy was a key secondary endpoint rather than the primary end point of the HOPE-3 study. And it measured change in ejection fraction across the full DMD population rather than in patients with an established cardiomyopathy. The population the proposed indication addresses By contrast, HOPE-3 was actually designed with a skeletal functional primary endpoint and was powered to assess efficacy in upper limb function. Importantly, the advisory committee was not asked to vote on whether they believed the data on the HOPE-3 primary efficacy endpoint could support approval of the product. Nor whether the overall benefitrisk profile of daratomyosil was favorable, we continue to believe that the data on the primary as well as multiple other endpoints support a finding of effectiveness on these measures. It is worth noting that in a separate discussion on upper limb function during the AdCom, the committee's feedback was directionally supportive of the clinical evidence for the primary endpoint in upper limb function. The discussion was substantive and the full record is public for anyone who wants to review it. Now this brings me to an update that I am very pleased to share. We are continuing to work closely with FDA on a potential path forward for Daramycin focused on an upper limb skeletal muscle indication reflected in the primary efficacy endpoint of HOPE-3. To that end, following discussions with the agency, subsequent to our advisory committee meeting, we plan to submit an amendment to our BLA that includes the 24 month open label extension data from the HOPE-3 study along with additional analyses on the existing data package in order to support a refined indication focused on the primary endpoint. FDA has indicated it is willing to review this amendment and upon receipt to extend the PDUFA action date accordingly. We are finalizing the timing of that submission and will provide an update as appropriate. We appreciate the FDA's engagement throughout this process and its shared commitment to addressing the major unmet need in Duchenne muscular dystrophy. Now there were 2 other developments in the review this quarter. In July, we were proud to report that the results of the HOPE-3 clinical trial were published in The Lancet following extensive and independent peer review. The first publication of the full Phase 3 data set is an important milestone for this program and for the field. The publication highlights the efficacy of Daramycin, and the supplement highlights the mechanism of action as well as the individual patient level data. There is a lot of information available publicly and we are confident that this highly regarded publication will help support continued progress for our Deramiocel program. In connection with that peer review, and as part of our dialogue with the agency and the SAP 3.0 put in place prior to unblinding. That model the 1 underlying our top line release, included an interaction term combining 2 independent variables, age and baseline. Which were part of the prespecified plan. The only endpoint directly impacted by this was left ventricular ejection fraction in all patients, the key secondary endpoint of the HOPE-3 study. At top line, we reported a 2.4 percentage point treatment difference with a p value of 0.04. As published in The Lancet, under the pre specified model, the measure of the left ventricular ejection fraction in all patients was a 1.8 percentage point treatment difference with a p value of 0.09. We took the most conservative approach available to us in the publication and in interactions with FDA. Nothing else changed in the data or its analysis. Let me remind you in the prespecified cardiomyopathy subgroup the result was unchanged at p equals 0.02 with a 2.8 percentage point treatment difference. The endpoints below left ventricular ejection fraction in the testing hierarchy are characterized now as nominally significant with treatment effects unchanged. Now let me be clear. That the HOPE-3 primary endpoint was unaffected and is significant both statistically and clinically Deramycin demonstrated a statistically significant slowing of upper limb disease progression as measured by PUL 2.0 with a mean difference of 4.5% in favor of Deramiocel with a p value of 0.029 which corresponds to a 1.2 absolute change in total PUL 2.0. We believe the efficacy and safety data supporting the potential for Daramycin is strong. We have administered approximately 1.3 thousand intravenous infusions across our clinical program to over 200 patients with DMD in 3 separate clinical trials. More than 80 patients are in our collective open label extension studies with some receiving continuous infusions for more than 5 years and the long term safety profile is consistent and well characterized. The open public hearing part of the advisory committee included testimony from patients, families, and clinicians living with Duchenne muscular dystrophy. We were grateful that their experience is part of the record, and we look forward to continuing with the FDA on a path forward for Daramycin. Also, in July, as part of the review process, the FDA conducted a Bioresearch Monitoring inspection or BIMO, and issued a 483 citing 1 observation. We have submitted our responses and are currently awaiting feedback. Second, let me talk a little bit about our commercial readiness and manufacturing. We are continuing our commercial readiness activities, but at a slower pace until we have further regulatory clarity and although the scope and timing of some of them may change, depending on the outcome of the review, we are controlling our cash against this. Our in house GMP manufacturing facility in San Diego is operational and positioned to support an initial commercial launch if approved. The expansion to the second floor of that same facility continues, and our goal remains full validation and FDA approval of the expanded space estimated to be in 2027. The space is ideal for early commercialization and allows for the most flexibility as we continue to scale our CMC capacity to account for potential demand. On the commercial side, Michael Maurer joined us as our Chief Commercial Officer bringing direct DMD and rare disease commercial experience. And he has judiciously been building out the launch organization alongside our market access leadership. Now let me talk for a minute about our dispute with NS Pharma. The state court, which was scheduled to hear our motion for preliminary injunction on August 10 ahead of the FDA's expected PDUFA date. However, we determined that resolving this contractual dispute and arbitration following the agency's decision would give the parties a more complete regulatory record to work from. Therefore, we withdrew the motion without prejudice. In terms of timeline, we estimate the arbitration process to begin to fall to begin this fall to address the contract dispute while continuing to pursue commercial readiness activities for Daramycin. Now let me be clear that our position on the underlying dispute has not changed. We continue to believe that the pricing structure in the US distribution agreement is fundamentally flawed, in a way that would impede patient access, and we continue to seek rescission. What changed is the current process by which we are pursuing a remedy. Our view of the merits of the case has not changed. Now very quickly turning to our pipeline, I would like to state that all pipeline work is that is not directly related to Daramycin is on hold right now, until we have further regulatory clarity. Having said that, in terms of lifecycle management of Daramycin, we have initiated regulatory engagement in Europe and Japan. Our expansion plans, including those for younger DMD patients and for Becker muscular dystrophy remain priorities and the timing of those clinical trial initiations will be stage-gated by the timeline of our regulatory pathway for Daramycin in the U.S. to treat those with Duchenne muscular dystrophy. Later stage. With that, I will now turn the call over to AJ to review the financial results. Anthony J. Bergmann: Thank you, Linda. As of 06/30/2026, Capricor had cash, cash equivalents and marketable securities totaling $237.9 million and there was no revenue recognized for the second quarter of 26 or 2025. Total operating expenses for the second quarter of 2026 were $42.9 million compared to $27.7 million for the second quarter of 2025. Increase was primarily driven by continued investment in clinical regulatory and manufacturing activities, as well as commercial infrastructure supporting our Duchenne program. Net loss for the second quarter of 2026 was approximately $40.7 million or $0.70 per share compared to a net loss of approximately $25.9 million or $0.57 per share for the second quarter of 2025. And for the 6 months ended 06/30/2026, our net loss was $74.7 million compared to $50.3 million for the same period in 2025. As of 06/30/2026, we had an accumulated deficit of approximately $379.6 million Our expense profile this quarter reflects investment across our 3 main areas regulatory and clinical activities in support of our DMD program, manufacturing capacity expansion efforts, and commercial readiness activities. As Linda noted, we are pacing certain commercial expenditures as the regulatory timeline develops and becomes more clear. And we continue to have flexibility in how we deploy capital across the remainder of the year. With that, I will turn the call back over to Linda for closing. Linda Marbán: Thank you, AJ. As all of you know, the last year has been 1 of highs and lows for Capricor. We were stunned by the CRL and pleased by the HOPE-3 data. We were encouraged by the acceptance of the HOPE-3 data for resubmission in response to the CRL and disappointed by the advisory committee's recommendation. Although we understood it, based on the narrow voting question and the disparity between the indication we had previously asked for and the data from HOPE-3 which was powered to assess skeletal muscle as its primary goal. We have previously stated this. We are reassured by the strength of our data by its publication in The Lancet, and we were amazed by the outpouring of support for Daramycin by the DMD community. We hear their voices as well and will continue to work tirelessly to try and get Deramiocel to every eligible patient based on their physician's recommendation. We are grateful to FDA for their flexibility and for their collaborative approach. We will be submitting updated data to the FDA as soon as possible and look forward to their review. Lastly, due to the sensitivity of our ongoing discussions with the Food and Drug Administration, we are not holding a Q and A today. And we look forward to providing updates to you as they become available. Thank you for your time. We look forward to positive updates in the future. Operator: Guests, you may now disconnect. Thank you. And this concludes today's call. Thank you all for participating. You may now disconnect. Before you buy stock in Capricor Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Capricor Therapeutics wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. 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Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Management attributes the negative 3-9 Advisory Committee vote to a narrow focus on the cardiomyopathy indication, which was a secondary endpoint in the HOPE-3 study. The company is shifting its regulatory strategy to focus on an upper limb skeletal muscle indication, aligning with the HOPE-3 study's primary efficacy endpoint. A BLA amendment is being prepared to include 24-month open-label extension data and additional analyses to support this refined indication. Management clarified that while the p-value for the secondary heart function endpoint was adjusted to 0.09 in The Lancet publication, the primary skeletal muscle endpoint remains statistically significant at p=0.029. Operational focus has shifted to cash preservation, with all non-Deramiocel pipeline programs placed on hold until regulatory clarity is achieved. The company maintains its stance that the current U.S. distribution agreement with NS Pharma is fundamentally flawed and is seeking rescission through arbitration. The FDA has indicated a willingness to review the BLA amendment, which will result in an extension of the current August 22, 2026, PDUFA action date. Commercial launch activities and expenditures are being paced and slowed to align with the developing regulatory timeline and preserve capital. Manufacturing expansion at the San Diego facility remains on track for full validation and FDA approval in 2027 to support long-term demand. Arbitration regarding the NS Pharma contract dispute is estimated to begin in the fall of 2026 to provide a more complete regulatory record for the proceedings. Future clinical trials for younger DMD patients and Becker muscular dystrophy are stage-gated by the successful regulatory outcome of the current BLA. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. The FDA issued a Form 483 with one observation following a Bioresearch Monitoring inspection in July; the company has submitted its response. Net loss increased to $40.7 million in Q2 2026, driven by heavy investment in manufacturing capacity and commercial infrastructure. The company withdrew its motion for a preliminary injunction against NS Pharma without prejudice, choosing to pursue a remedy through arbitration instead. Management noted that the interaction term used in the original top-line data analysis was adjusted for the peer-reviewed publication to reflect a more conservative approach.

This article first appeared on GuruFocus. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Capricor Therapeutics Inc (NASDAQ:CAPR) is actively working with the FDA to amend its BLA for deramiocel, focusing on the upper limb skeletal muscle indication, which was the primary endpoint of the HOPE-3 study and showed statistically significant results. The HOPE-3 trial results were published in The Lancet, a prestigious peer-reviewed journal, providing strong external validation of the efficacy data. The company has a robust safety database, with over 1,300 infusions administered to more than 200 DMD patients, including some treated for over five years, demonstrating a well-characterized long-term safety profile. Capricor Therapeutics Inc (NASDAQ:CAPR) maintains a strong cash position of approximately $237.9 million, providing financial flexibility to support ongoing regulatory and manufacturing activities. The company's in-house GMP manufacturing facility is operational and positioned to support an initial commercial launch, with expansion plans on track for 2027. The FDA has shown flexibility and willingness to review the proposed BLA amendment, indicating a collaborative approach to finding a path forward for deramiocel. The FDA's Advisory Committee voted 9 to 3 against the effectiveness of deramiocel for treating cardiomyopathy in DMD patients, a significant setback for the original indication. The statistical model for the key secondary endpoint (left ventricular ejection fraction) was revised, resulting in a less favorable p-value (0.09 vs. 0.04), which may raise concerns about data robustness. The company's dispute with NS Pharma over the US pricing agreement remains unresolved, with arbitration not expected to begin until fall, creating ongoing legal and commercial uncertainty. All pipeline programs not directly related to deramiocel are on hold, limiting diversification and future growth opportunities until regulatory clarity is achieved. The company reported a net loss of $40.7 million for Q2 2026, an increase from $25.9 million in the prior year, reflecting rising operating expenses and no revenue. The BLA review process has been extended due to the amendment, delaying the potential approval and commercial launch of deramiocel. Warning! GuruFocus has detected 3 Warning Signs with CAPR. Is CAPR fairly valued? Test your thesis with our free DCF calculator. Q: What was the outcome of the FDA's Advisory Committee meeting regarding deramiocel, and what is the company's next step?A: Linda Marban, CEO, reported that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee voted 3 in favor and 9 against on whether the available evidence provides substantial evidence of effectiveness for deramiocel in treating cardiomyopathy in DMD patients. Despite this disappointment, the company is working with the FDA on a potential path forward focused on an upper limb skeletal muscle indication, which was the primary endpoint of the HOPE-3 study. They plan to submit an amendment to the BLA including 24-month open-label extension data and additional analyses, with the FDA indicating willingness to review and extend the PDUFA date accordingly. Q: How did the statistical model change for the HOPE-3 trial's key secondary endpoint, and what was the impact?A: Linda Marban, CEO, explained that an issue with the statistical model in the clinical study report was identified during peer review with The Lancet and the FDA. The company reverted to the pre-specified statistical analysis plan version 3.0, which included an interaction term for age and baseline. This change only impacted the left ventricular ejection fraction endpoint in all patients, shifting the treatment difference from 2.4 percentage points (p=0.04) to 1.8 percentage points (p=0.09). The pre-specified cardiomyopathy subgroup result remained unchanged at p=0.02 with a 2.8 percentage point treatment difference. The primary endpoint was unaffected and remains statistically significant. Q: What is the status of the company's dispute with NS Pharma?A: Linda Marban, CEO, stated that the company withdrew its motion for a preliminary injunction without prejudice, choosing to resolve the contractual dispute in arbitration following the FDA's decision to have a more complete regulatory record. The arbitration process is estimated to begin this fall. The company's position remains unchanged, believing the US pricing structure is fundamentally flawed and impedes patient access, and they continue to seek rescission of the agreement. Q: What were the key financial results for the second quarter of 2026?A: CFO Anthony Bergmann reported that as of June 30, 2026, the company had approximately $237.9 million in cash, cash equivalents, and marketable securities. Total operating expenses for Q2 2026 were approximately $42.9 million, up from $27.7 million in Q2 2025, driven by investments in clinical, regulatory, manufacturing, and commercial infrastructure. The net loss for Q2 2026 was approximately $40.7 million, or $0.70 per share, compared to a net loss of $25.9 million, or $0.57 per share, in Q2 2025. Q: What is the status of the company's manufacturing and commercial readiness activities?A: Linda Marban, CEO, noted that commercial readiness activities are continuing but at a slower pace until regulatory clarity is achieved. The in-house GMP manufacturing facility in San Diego is operational and positioned to support an initial commercial launch. The expansion to the second floor continues, with a goal of full validation and FDA approval estimated in 2027. Michael Moore has joined as Chief Commercial Officer to build out the launch organization. Q: What is the company's plan for its pipeline programs outside of deramiocel?A: Linda Marban, CEO, stated that all pipeline work not directly related to deramiocel is on hold until further regulatory clarity. Life cycle management for deramiocel, including regulatory engagement in Europe and Japan, has been initiated. Expansion plans for younger DMD patients and Becker muscular dystrophy remain priorities, but the timing of clinical trial initiations will be stage-gated by the US regulatory pathway timeline. Q: What was the outcome of the FDA's bioresearch monitoring (BIMO) inspection?A: Linda Marban, CEO, reported that the FDA conducted a BIMO inspection in July and issued a Form 483 citing one observation. The company has submitted its responses and is currently awaiting feedback from the agency. Q: What is the significance of the HOPE-3 trial publication in The Lancet?A: Linda Marban, CEO, highlighted that the full Phase 3 dataset was published in The Lancet following extensive independent peer review. The publication highlights the efficacy of deramiocel and includes the mechanism of action and individual patient-level data. The company believes this highly regarded publication will help support continued progress for the deramiocel program. Q: What is the company's cash runway and how are they managing expenses?A: CFO Anthony Bergmann noted that the company is pacing certain commercial expenditures as the regulatory timeline develops. The expense profile reflects investment across regulatory and clinical activities, manufacturing capacity expansion, and commercial readiness. The company continues to have flexibility in how it deploys capital across the remainder of the year. Q: Why did the company decide not to hold a Q&A session on this call?A: Linda Marban, CEO, explained that due to the sensitivity of ongoing discussions with the FDA, the company is not holding a Q&A session today. They look forward to providing updates as they become available. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

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. 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), 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 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 ConaKCSA Strategic [email protected] / [email protected] / 516.779.2630 Capricor Company Contact:AJ Bergmann, Chief Financial [email protected]

Interested in Capricor Therapeutics, Inc.? Here are five stocks we like better. FDA review remains ongoing: Capricor plans to amend deramiocel’s application to pursue an upper-limb skeletal muscle indication in DMD, supported by HOPE-3 data. The FDA’s Aug. 22 action date may be extended to review the amendment after an advisory panel voted against the cardiomyopathy indication. HOPE-3 showed positive upper-limb results: Deramiocel statistically slowed disease progression on the PUL 2.0 measure, with a 4.55% treatment difference and a P value of 0.029. Capricor said the primary endpoint was unaffected by a statistical-model issue. Higher spending and losses: Capricor ended June with approximately $237.9 million in cash and marketable securities, while second-quarter operating expenses rose to $42.9 million and net loss increased to $40.7 million, or $0.70 per share. Commercial preparations are being slowed pending regulatory clarity. Capricor Therapeutics Is Up Over 100%, Could Rise Even Higher Capricor Therapeutics (NASDAQ:CAPR) said its biologics license application for deramiocel remains under U.S. Food and Drug Administration review, while the company prepares to submit an amendment seeking a refined indication centered on upper limb skeletal muscle function in Duchenne muscular dystrophy, or DMD. The FDA’s current target action date for the application is Aug. 22. However, Chief Executive Officer Linda Marbán said the agency has indicated it is willing to review the planned amendment and extend the PDUFA action date after receiving it. Capricor is finalizing the timing of its submission, which will include 24-month open-label extension data from the HOPE-3 study as well as additional analyses of its existing data package. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The update follows a July 29 meeting of the FDA’s Cellular, Tissue, and Gene Therapies Advisory Committee. The panel voted 3-9, with no abstentions, against finding that available evidence provided substantial evidence of deramiocel’s effectiveness for treating cardiomyopathy in patients with DMD. Marbán said the advisory committee’s voting question focused narrowly on cardiomyopathy, while the HOPE-3 study’s primary endpoint measured upper limb function. The company’s original requested indication in its BLA, dating to 2024, was for DMD cardiomyopathy. → Nebius’ Q2 Beat Shows the AI Bottleneck Is Capacity, Not Demand According to Marbán, the study’s measure of cardiomyopathy was a key secondary endpoint and evaluated changes in ejection fraction across the overall DMD study population rather than solely among patients with established cardiomyopathy. HOPE-3 was designed and powered to assess a skeletal functional endpoint involving upper limb function, she said. “We are continuing to work closely with FDA on a potential path forward for deramiocel focused on an upper limb skeletal muscle indication reflected in the primary efficacy endpoint of HOPE-3,” Marbán said. → On Holding's Price Stumble May Be an Opening for a Company Built to Run Capricor said the HOPE-3 primary endpoint was unaffected by a statistical-model issue identified during peer review and discussions with the FDA and The Lancet. The company reverted to Statistical Analysis Plan version 3.0, which had been established before unblinding and included an interaction term for age and baseline variables. Under the pre-specified model published in The Lancet, the treatment difference for left ventricular ejection fraction among all patients was 1.8 percentage points, with a P value of 0.09. Capricor had previously reported a 2.4-percentage-point difference with a P value of 0.04. Marbán said the result in the pre-specified cardiomyopathy subgroup was unchanged, showing a 2.8-percentage-point treatment difference with a P value of 0.02. For the primary upper limb endpoint, Capricor said deramiocel demonstrated a statistically significant slowing of disease progression measured by PUL 2.0. The company reported a 4.55% mean difference in favor of deramiocel, with a P value of 0.029, corresponding to a 1.2-point absolute change in total PUL 2.0. Capricor said it will continue commercial-readiness activities at a slower pace pending greater regulatory clarity. Its San Diego GMP manufacturing facility is operational and positioned to support an initial commercial launch if deramiocel is approved, according to Marbán. The company is continuing expansion work on the facility’s second floor, with full validation and FDA approval of the expanded space estimated in 2027. Capricor also appointed Michael Maurer as chief commercial officer. Marbán said Maurer has DMD and rare-disease commercial experience and has been building the launch organization with the company’s market-access leadership. The FDA also conducted a Bioresearch Monitoring Inspection in July and issued a Form 483 with one observation. Capricor said it submitted its response and is awaiting agency feedback. Capricor withdrew, without prejudice, its motion for a preliminary injunction in its dispute with NS Pharma. The state court had been scheduled to hear that motion on Aug. 10, ahead of the then-expected PDUFA date. Marbán said the company concluded that pursuing arbitration after the FDA decision would provide a more complete regulatory record for both parties. Capricor expects arbitration to begin this fall. The company continues to seek rescission of its U.S. distribution agreement with NS Pharma, maintaining that the agreement’s pricing structure is fundamentally flawed and could impede patient access, Marbán said. Chief Financial Officer A.J. Bergmann said Capricor held approximately $237.9 million in cash equivalents and marketable securities as of June 30. The company reported no revenue for either the second quarter of 2026 or the same period in 2025. Total operating expenses were approximately $42.9 million in the second quarter, compared with $27.7 million a year earlier. Second-quarter net loss was approximately $40.7 million, or $0.70 per share, compared with a loss of $25.9 million, or $0.57 per share, in the prior-year period. Net loss for the first six months of 2026 was approximately $74.7 million, compared with $50.3 million in the prior-year period. Capricor’s accumulated deficit stood at approximately $379.6 million as of June 30. Bergmann attributed higher expenses primarily to clinical, regulatory, manufacturing and commercial-infrastructure investments for the company’s DMD program. Capricor said it has flexibility in deploying capital for the remainder of the year and is pacing certain commercial expenditures as its regulatory timeline develops. Marbán added that pipeline work not directly related to deramiocel is on hold pending regulatory clarity. The company has initiated regulatory engagement in Europe and Japan, while potential expansion into younger DMD patients and Becker muscular dystrophy will be staged according to the U.S. regulatory path for deramiocel. Capricor Therapeutics, Inc is a clinical-stage biotechnology company focused on the development of cell and exosome-based therapeutics for cardiovascular and rare diseases. Headquartered in Beverly Hills, California, the company leverages proprietary cardiosphere-derived cell (CDC) technology to address conditions characterized by inflammation, fibrosis, and tissue degeneration. Since its founding, Capricor has advanced its lead candidate through multiple clinical trials and has built a pipeline that spans both cell therapy and extracellular vesicle (exosome) platforms. The company's leading product candidate, CAP-1002, comprises allogeneic CDCs and is being evaluated in indications such as Duchenne muscular dystrophy (DMD) and COVID-19-related heart injury. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Capricor Therapeutics Q2 Earnings Call Highlights" was originally published by MarketBeat. 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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 NewsAmong 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 PanelDr. 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 KasunichKCSA Strategic [email protected] Capricor Company Contact:AJ Bergmann, Chief Financial [email protected]

Image source: The Motley Fool. Tuesday, May 12, 2026 at 4:30 p.m. ET Chief Executive Officer — Linda Marbán Chief Financial Officer — Anthony J. Bergmann Need a quote from a Motley Fool analyst? Email [email protected] Anthony J. Bergmann: Thank you, and good afternoon, everyone. Before we start, I would like to state that we will be making certain forward looking statements during today's presentation. These statements may include statements regarding among other things, the efficacy, safety and intended utilization of our product candidates potential regulatory developments involving our product candidates, our future R&D plans, our anticipated conduct and timing of preclinical and clinical studies, enrollment of patients in our clinical studies, our plans to present or report additional data, our plans regarding regulatory filings, potential regulatory revenue and reimbursement estimates, projected terms of definitive agreements, manufacturing capabilities, our financial position, our possible uses of existing cash investment resources, and statements regarding our litigation with Nippon Shinyaku 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. These forward looking statements are based on our current information, assumptions, expectations that are subject to change. And involve a number of risks and uncertainties that may cause actual results to differ materially from those contained in the forward looking statements These and other risks are described in our periodic filings with the SEC including our quarterly and annual reports. You are cautioned not to place undue reliance on these forward looking statements, and we disclaim any obligation to update such statements. With that, I will turn the call over to Linda Marbán, CEO. Linda Marbán: Good afternoon, everyone, and thank you for joining Capricor First Quarter 2026 earnings call. To our investors, collaborators, the Capricor team and especially the Duchenne patient community, thank you for your continued support and belief in our mission. We are at a truly defining moment in this company's history and I want to take a few minutes to give you a clear picture of where we stand across our 3 most important priorities. Our regulatory path to approval, our commercial readiness, and our legal action against NS Pharma and Nippon Shinyaku. I will start with the most significant development. Our Biologics License Application or BLA, for deramiocel is currently under active review by the FDA with a PDUFA target action date of August 22, 2026. As a reminder, following receipt of the complete response letter, in July 2025, we moved quickly and decisively We submitted our response based on the HOPE-3 Phase 3 trial results which we believe represent 1 of the most compelling data sets generated for DMD to date. The FDA accepted our response as complete and classified the resubmission as class 2, resuming its full review of the BLA. There has been a significant number of information requests from the FDA to Capricor all of which we have been able to provide answers to. We look forward to continuing our active dialogue with the FDA and are looking forward to labeling discussions in the very near future. As this is a BLA resubmission review, there will not be a mid cycle review meeting. Now, the data submitted as a response to the CRL demonstrated statistical as well as clinical significance across a variety of endpoints. To remind you, HOPE-3 was a pivotal phase 3, multicenter, randomized, double blind, placebo controlled study that enrolled 106 patients in a 1 to 1 randomization scheme. The trial met its primary efficacy endpoint which was the performance of the upper limb otherwise known as the PUL version 2.0, with an approximate 54% reduction in disease severity at 12 months and a p value of 0.029. As well as all type 1 error controlled secondary endpoints also hitting significance. As the current BLA was for the indication of cardiomyopathy, it was very important that the key secondary endpoint of left ventricular ejection fraction demonstrated an approximate 91% slowing of disease progression in all evaluable patients. Further, in a subset of patients with a confirmed diagnosis of cardiomyopathy, the LVEF effect showed an approximate 1 hundred and 20 percent slowing of disease and achieved a p-value of 0.01. Further supporting deromyosil's potential to address the DMD associated cardiomyopathy. We are also pleased that we presented additional HOPE-3 data at the 26 MDA Muscular Dystrophy Association Clinical and Scientific Conference also at the American Academy of Neurology, and the American Society of Cell and Gene Therapy being held this week. 2 highlights are worth emphasizing. The 10-point measure a home based, caregiver captured video assessment of upper limb function. These showed statistically significant improvement in treated patients versus placebo. This is a real world home based, outcome measure that directly reflects independence and quality of life. In addition, the cardiac MRI data demonstrated a significant stabilization in the progression of cardiac fibrosis in treated patients versus placebo. Fibrosis is cumulative and irreversible. Its attenuation before functional symptoms appear 1 of the most clinically meaningful things we can demonstrate. These data will be central to labeling discussions and support the case for early treatment initiation. The full HOPE-3 data set has been submitted for publication in a major peer reviewed journal and we look forward to that publication following acceptance in due course. On safety, we have now completed more than 800 intravenous infusions across multiple clinical studies. Deramiocel continues to demonstrate a consistent and well tolerated safety profile. Several of our young men in the HOPE-2 open label extension have been receiving continuous infusions for up to 5 years. With approximately 90 patients in our collective OLE studies. Importantly, the long term safety profile of deramiocel is supported by these 5 years of open label extension data. This is reassuring for the DMD community as well as supportive of regulatory approval. Lastly, we also expect to be eligible to receive a priority review voucher upon potential approval. PRVs are transferable and can be monetized through sale. Representing a meaningful potential source of non dilutive capital. We will continue to provide updates to the market on the progress toward the path to approval for deramiocel to treat DMD. Now I would like to turn your attention to directly address our legal action against Nippon Shinyaku and its U. S. Subsidiary, NS Pharma, which we announced last week on May 7, 2026. We filed suit seeking rescission of our US distribution agreement through an expedited process. Requesting a preliminary injunction that would allow Capricor to distribute daramycin to patients either on our own or through other distributors pending FDA approval. Now let me be clear about what drove this decision and why we believe it is both necessary and correct. The core problem is related to pricing. The pricing structure embedded in our commercialization and distribution agreement with NS Pharma contains a fundamental flaw that if left unaddressed would make it economically impossible to deliver Deramiocel to patients covered by Medicare, Medicaid or private insurance. Providers would face potentially hundreds of thousands of dollars in reimbursement shortfalls per dose. This is not a commercial preference. It is a structural barrier to patient access. We try to fix the pricing structure. But NS Pharma refused to address the flaw on acceptable terms. After we identified this issue, we engaged in good faith negotiations with senior leaders at NS Pharma to find a resolution acceptable to both parties. But NS Pharma refused to compromise and demanded that Capricor agree to a structure that would result in Capricor ceding all control of the product we developed, our regulatory relationships, and our commercial and brand identity as a condition for resolution. That arrangement was just not acceptable to us. At the point of the CRL, in July 2025, it was clear that NS Pharma failed to continue the commercial investments needed to ensure a successful launch of daramycin upon regulatory approval. NS Pharma did not provide status updates to inform Capricor on their launch planning efforts specific to the commercial interest of deramiocel patients caregivers, HCPs, and payers. These were core requirements of our partnership that they did not uphold. With the PDUFA date of August 22, 2026 approaching, we could not allow a flawed contract and a distributor who was unwilling to fix it stand between DMD patients and daramycin. Every month of delay for boys and young men with DMD means irreversible loss of muscle destroyed, cardiac function permanently diminished or independence that may never be returned. We did not rush this decision. After exhausting every alternative to address NS Pharma's inaction, we concluded that litigation was our only acceptable option. The FDA review process and the PDUFA date are unaffected by this law lawsuit. And as I mentioned earlier, our BLA remains under active review. Capricor has hired and continues to hire key individuals to support the successful commercialization of deramiocel. We have been working to ensure that our commercial readiness and a product launch plan that considers patients, healthcare providers and payers with a focus on seamless patient access. We are thoughtfully scaling our manufacturing capacity to meet the needs of those patients exiting our clinical trials and in preparation for commercialization. Now, our regulatory pathway is only meaningful when we deliver the therapy directly to patients. And that is exactly what we are building towards, with the same discipline and urgency we have applied to the science over the past 2 decades. Now let me walk you through some of the specifics with respect to manufacturing. First, our in house GMP manufacturing facility in San Diego successfully completed its FDA pre license inspection or PLI last year. All Form 483 observations were addressed. The facility's operational and positioned to support initial commercial launch for approximately 200 to 250 patients per year. Additionally, we are also well underway with our expansion to the 2nd Floor of that same facility adding several additional clean rooms. At full capacity, this expansion will support treatment of approximately 2,000 to 2.5 thousand patients per year. Roughly 10 thousand doses annually. We are staging the build out deliberately. My goal is to have the facility fully validated and approved by the FDA in 2027. During the FDA review period, we will continue to produce material and increase capacity as we move through 2027. Finally, our primary manufacturing priority will begin stockpiling commercial doses once we have guidance on the label from the FDA. Since Deramiocel is an ultra cold chain product, it has to be labeled before it is frozen. FDA has been apprised of this and is working with us on a temporary label solution so that we can begin production of commercial doses. Based on current planning, we will have ample product to support our future launch if approved. While the litigation against NS Pharma probably came as a surprise to many of you, We had become increasingly aware that not only was the deal structure impossible from an economic perspective, but they were seriously lagging behind in commercial planning as I just mentioned. I have guided multiple times that we were building a small commercial team to provide support to NS when they were going to be the sole distributor. Now that we are gearing up to launch on our own, subject to the court's decision, we have accelerated those efforts and are in the process of building a fully functional commercial team. We already have a senior vice president of market access with significant rare disease experience, who is actively preparing the market for Deramiocel. In addition, I am pleased to inform you that we have now secured a chief commercial officer who will join us in the next few weeks. This executive brings direct DMD and rare disease commercial experience and will be an integral member of our launch leadership team. We look forward to introducing him to the investment and DMD community shortly. To that end, we are actively working towards approval and commercialization of deramiocel and our current deliverables are: to continue to work on hiring key individuals to support the successful commercialization of deramiocel, to support patients and their caregivers. We are building to ensure commercial readiness and a product launch plan that considers all. With a focus on seamless patient access across all payer segments, We are rapidly building the physician education and disease awareness infrastructure required to support responsible and rapid adoption consistent with our expected label and other rare disease patient populations. And lastly, the building of our patient support and distribution services is underway with a strong commitment to patients and their families. While enabling access across all channels for as many eligible patients as possible. The DMD community is small, defined, and engaged, and we know who the prescribers are. Now turning to our pipeline. Over many years, Capricor has been focused on translating the science of deramiocel into a potential commercial therapy, marshaling the majority of our resources to advance it from discovery to this pivotal stage. We have developed deep expertise in product development, manufacturing, and clinical development. While we are proud of these accomplishments, pipeline expansion has not been our first priority. However, we have worked at a slow but steady pace in developing exosomes as therapeutic agents, taking advantage of their biological role as cellular delivery vehicles. We continue to explore and develop opportunities for pipeline expansion with CDC based exosomes, and our patented StealthX technology made from HEK293 cell exosomes. And now being used in vaccine studies in collaboration with the National Institutes of Allergy or Infectious Disease, NIAID, for COVID prevention. It is important to note that there is been a lot of instability in vaccine development over the past year. And so this program has moved a bit more slowly than originally planned. However, the most important milestones were reached, which were manufacturing of clinical grade vaccine exosomes and an approved CMC from FDA for large scale manufacturing. As well as showing that an exosome based vaccine is safe. We are moving away now from vaccine development at this time, and will focus on developing therapeutics with both classes of exosomes. We are actively presenting and publishing our rapidly expanding pipeline of exosome based therapeutics and look forward to providing updates on the clinical development program as they become available throughout this year. In terms of lifecycle management of daramycin, we have spent 20 years developing our therapy and now will be actively looking to expand it to other indications. Our first target will likely be expansion to the younger DMD patients we are working on now. In addition, we plan to initiate the clinical pathway for Becker Muscular Dystrophy which we plan to begin discussing with the FDA immediately following PDUFA for DMD. Expansion of deramiocel outside The United States is also underway. And we expect to meet with the EMA and PMDA later this year. We believe deramiocel should be available to all patients worldwide and that will be a goal that we actively work towards this year. In addition, we are evaluating opportunities in other rare neuromuscular diseases where inflammation and fibrosis are the primary pathologies. And now with that, I will turn the call over to AJ to review our financial results. AJ? Anthony J. Bergmann: Thanks, Linda. As of 03/31/2026, we maintained a strong balance sheet with approximately $279 million in cash, cash equivalents and marketable securities. We believe our current capital is sufficient to fund anticipated operating expenses and capital expenditures into the 2027. That expectation excludes potential product revenue or a priority review voucher monetization upon potential approval. There was no revenue recognized for the first quarter of 2026 or 2025. Our total operating expenses for the first quarter of 2020 were approximately $36.8 million compared to approximately $25 million for the first quarter of 2025. The increase was primarily driven by continued investment in clinical, regulatory and manufacturing activities, as well as infrastructure expenditures supporting our Duchenne program. Net loss for the first quarter 26 was approximately $33.9 million or $0.59 per share. Compared to a net loss of approximately $24.4 million or $0.53 per share for the first quarter of 2025. Our operating expense profile reflects a calibrated investment across our 3 priority areas of regulatory and clinical activities in support of our BLA, manufacturing capacity expansion, and commercial infrastructure build out. All align with our path towards potential approval, and our balance sheet provides the runway for us to execute. With that, operator, let's please open up the line for questions. Thank you. Ladies and gentlemen, We will now begin the question and answer session. Operator: Should you have a question, please press the star followed by the 1 on your touch tone phone. You will hear a prompt that your hand has been raised. Should you wish to decline from the polling process, Please press the star followed by the 2. If you are using a speaker phone, please lift the handset before pressing any key. Your first question comes from Leland with Oppenheimer. Please go ahead. Analyst (Leland Gershell): Thank you. Linda. As we continue to digest the news on the lawsuit, Wondering if you could share more color. Nippon Shinyaku a large company with many products. But NS Pharma, is a much more focused company. You know, with 1 product which is for Duchenne and is complementary to deramycin. So they would seem to be very well set up to enter the market with your product. And would be motivated to do so given the money to be made. So I am just curious if you could share more color or insight on your discussions with NS Pharma as to their reluctance to move at all toward what could be a resolution that would enable daramycin to be sold in such a way that DSP based pricing would, work for the system. And given that NS Pharma would not be able to have any return on deramiocel until that is worked out to follow-up. Linda Marbán: Thank you. Thank you, Leland. I think that was your longest question ever. So I appreciate the clarity and the depth to which it is gone. So the answer is a little bit of a scratcher for us as well. As I have been guiding since the filing of the suit on May 7, we actually entered negotiations with them regarding this very issue in March 2025. So it is been over a year that we went back and forth and proposed a number of solutions that we believed and several sets of lawyers, including some of the lawyers that represented NS Pharma believes would be a reasonable structure that would allow us to keep the economics essentially in place, the way that they had been divided in the original agreement. We do not have a clear answer as to why they were so intransigent on accepting any of these other opportunities, but what I can tell you is that within about 1 week before we filed the suit, they conferred by email that the that they proposed, which essentially eviscerated Capricor's brand, and daromyosol in future indications, was the only structure that they would accept. So they really left us with no opportunity. Now having said that, while we would never break an agreement that was being enacted upon appropriately, this gives a great opportunity for capital to become the distributor of deramiocel. And I think all of you know how passionate we are about deramiocel, spending nearly 20 or more than 20 developing it. We know the patients, we know the community, we know the doctors, We know the networks. And so I am excited by this opportunity as well as we are respectful of the terms of the original agreement which are no longer applicable. Analyst (Leland Gershell): In your statements, said that Capricor determined that this would be a nonviable pricing structure. Do you have evidence or admission on NS Pharma's part or Nippon Shinyaku's part that they also did not were not they were not aware of the implications of this when they signed the agreement? Linda Marbán: Well, I am assuming that they did not know the implications of it because they signed the agreement. So I think what you know, I do not know what was in their head or, you know, most people do not typically go into agreement that is non-transactable if they know that there is a sort of a killer clause in there. Having said that, you know, we were all made aware of this problem based on the ASP at the exact same time by an independent consultant in the field So we know that they knew that this was a problem, as I said, starting from March 2025. So there is definitely not an ignorance is bliss kind of opportunity here. Analyst (Leland Gershell): Alright. And lastly, in terms of your planning for commercial. So, you know, you are getting going. You do have, you know, a few months until a presumed approval, but most companies would be well ahead of that in terms of time to market for these various preparations. Could you maybe share kind of where you expect to be assuming approval in August in terms of launch readiness relative to where you would ideally be. To be launching a rare disease product like deramiocel? Thank you. Linda Marbán: Yeah, so thanks, Leland. So I think I have stated pretty clearly that we were very disappointed with NS Pharma's approach to launch planning over the past few months especially since the CRL. They had stated they were putting pencils down. They did not pick them back up theoretically again until March of this year, just a few months ago. They were egregiously behind in some of the very critical launch activities, which typically take place 12 to 18 months before and also paves the way whether or not you have responses from FDA. Having said that, we knew a launch was coming. I have been laying the groundwork quietly. Behind the scenes for many months now. We are building out not only a commercial team with a newly hired Chief Commercial Officer, but we have been working on market access, advocacy, the patient journey, the product journey, getting a distributor, which we believe that we will be able to secure very quickly. And so I have high hopes for a very strong launch. Most importantly, we have nearly 100 open label extension patients that we will be actively working to get over to commercial products and working with the payers to do so. And we remain committed to providing daramycin to as many eligible patients as possible, as soon as possible post PDUFA. Thank you. Operator: Thank you. Your next question comes from Ted with Piper Sandler. Please go ahead. Analyst (Ted Tenthoff): Great. Thank you very much and appreciate all the color on the priorities to get approval launch and then the lawsuit. I have a question just sort of what the steps are from here with respect to the lawsuit. You know, you mentioned that you had requested an expedited lawsuit or I forget the exact word you used. How does that play out? And if it should go past PDUFA approval or PDUFA or the approval comes ahead of PDUFA, you are in a position where you are manufacturing the drug and you are putting your own sales force in place. So you are just gonna launch it yourselves. Is that accurate? Linda Marbán: So our current plan is to launch deramiocel. Yes, we have the drug. Yes, we manufacture it, and that is what we are working towards here at Capricor. In terms of the timing, it is dependent upon the court for which we have very little, in fact we have no control. Having said that, the reason our lawyers filed a motion for preliminary injunction was they typically act very quickly on those and will give us some guidance and hopefully will be heard on an expedited basis. We cannot provide any other details on the litigation but what we can tell you is that my plan now is to distribute deramiocel on time and in a well, you know, thought out and strategic fashion while this is continuing either in the background or has been resolved. Great. Well, I wish you all the luck because I do think this drug is best served to patients in your hands. So thank you for that update. Thank you, Ted. Operator: Thank you. Your next question comes from Kristen with Cantor. Please go ahead. Analyst (Kristen Kluska): Hi. Good afternoon, everybody. Thank you for the questions and for all the transparency today. So when the press release first came out last week, I think some investors initially read it as they were not preparing for a commercial launch appropriately because they did not have conviction in an approval. But then on the other hand, myself and others read it as well, if they truly believe that, they would happily just give the deramiocel back to you and move on their way. I guess, can you just clarify that in no way is this, in your opinion, based on them lacking conviction in an approval? Linda Marbán: Yeah. Thanks. You know, that sort of is icing on the cake in the sense that, you know, we are disappointed in the progress they were making. We believe that it shows a lack of belief in deramiocel. From their perspective and a lack of focus on their part. Having said all that, that would not have been the foundation nor the basis of an action at this point. We would have tried to work with them, and I think as I guided and have answered in a previous question, we would have just shadow boxed behind them with our own commercial efforts, trying to support and help them get this to patients as quickly as possible. I think all of you know that we have, you know, great connections within the Duchenne space and relationships with patients and advocates and providers. So no, the foundation of the lawsuit is really this contractual basis which really gives us good potential evidence for rescission which is a decision that each party sort of went about the contract in good faith. It did not work out. And everybody goes back to square 1 and does their own thing, which would then allow us to have the rights and we would be fully engaged as the sole distributor of deramiocel. But, you know, stay tuned, we do not have any answers from the court yet. Obviously this is material, so we will provide updates as soon as they become available. Analyst (Kristen Kluska): Okay. Thanks, Linda. And then maybe just on the review side, you made the com-- sorry. You made the comment that your nearing potential labeling discussions seems a little bit quick. it is usually like a month or 2 before the PDUFAs. I recognize we are 3 months out here. So is that just kind of based on the trajectory of the questions that you have been getting? Have they, told you 1 way or another whether these labeling discussions are happening? And then again, appreciate the transparency around the information request that requests been giving you. Can you just provide more color on, like, understanding the data, anything specific you can give us there. Thank you so much. Linda Marbán: Yeah, so thanks, Kristi. it is always a pleasure to hear from you. So, my regulatory lead advises us that information around labeling should be coming within the next few weeks. We are already in an interim label conversation with them because as I mentioned in my prepared remarks, when you use an ultra cold chain product, you have to put a label on before you freeze it. We want to start stockpiling for commercial. So they know that this is something we are interested in and working on. And we look forward to providing updates, you know, as those labeling conversations come to fruition. In terms of the information requests, they have been quite prolific coming from the CMC side, most of them sort of standard form types of things, asking for extra data or asking for extra clarification. On the clinical side and the statistical side as well, additional data clarification. When analyses were done, blinding protocols, that kind of information that you would expect FDA to be digging into at this time. So we remain very optimistic about the review process for daromyosil and DMD. Thanks, Linda. All the best. Thanks, Kristi. Take care. Operator: Thank you. Your next question comes from Madison with B. Riley Securities. Please go ahead. Analyst (Madison El-Saadi): Hi, thanks for taking our question. Maybe a couple from us. Maybe could you help us understand any commercial readiness activities that you have either started or plan to start rather that were previously being conducted by your partner, For example, payer discussions, has Capricor engaged any third party logistic distributor things like that, and then maybe a follow-up afterwards. Linda Marbán: Yeah, Madison. Absolutely. Great to hear from you. Yeah. So as I mentioned, because we were concerned about the speed and efficiency at which NS was going about, commercial planning, we were shadow boxing behind them the whole time. So, yes, we have a 3PL identified. We could enter into an independent contract with them, and we are in the process of doing that at this time. Most of the other parameters of launch preparation were being either bird dogs by Capricor or, in fact, led by Capricor. So there is not really any areas right now that we have identified where NS, you know, had really taken the lead and we were sort of running behind or need to play some catch up ball. My general hunch is that we are up to speed and moving as quickly as possible with PDUFA coming right up. Analyst (Madison El-Saadi): Got it. Understood. And then on the I guess, internal label related to the cold storage So if you are able to manufacture around 250-patient doses per year currently. Do you have a sense of how many you could complete between finalizing that interim label and the actual PDUFA date. Thanks. Linda Marbán: Yeah, we have not disclosed that number. We are actively working now starting to prepare for commercial manufacturing. The lag in time will be that each lot has to be reviewed and approved by FDA, and we expect to do that prior to and getting ready for launch. So what is most important is we will not delay dosing on any level of our open label extension patients. And we will continue to make sure that we provide access to them and have no plans on delay based on commercial manufacturing. We are up to speed there. Just 1 quick correction. it is 200 to 250 patients, and who each receive 4 doses, so it will be 1 thousand doses per year from our downstairs facility here in San Diego. Got it. Thanks for that clarification. You are welcome. Operator: Thank you. Your next question comes from Michael with Maxim Group. Please go ahead. Analyst (Michael): Hey there. Thank you so much for taking my questions today and I mean, lots of interesting stuff going on here. I would like to see if you could just provide a bit more color on what the basis for a suspension or an injunction of the commercial agreement would be And then if there is any sort of precedent for a court issuing an injunction to allow the manufacturer to distribute the drug while the IP or the some sort of licensing agreement is under dispute. Linda Marbán: Yeah. Thanks. Those are really clear questions. I am going to take the second 1. I might ask you to repeat the first 1 because the second 1 was kind of intense. Yeah, so there are precedent cases of rescission, not exactly similarly where you have a product, a drug product that is allowed to be manufactured in the distributed while the other 1 is not able to. Part of the reason for that is the structure proposed to us has literally never been done in U.S. biopharma. it is only been done in generics once the drugs are off patent. A patented product has never been a type of agreement that NS had proposed. Our current plan is to continue to wait to hear the results of the injunction. Typically, situations like this where the drug is potentially life saving, life extending, or certainly disease modifying, the lawyers think that the courts pretty much would not stop the distribution of the drug because of the need by patients, and we provided up to 5 affidavits with our lawsuit from patients and physicians stating deramiocel should be available to patients regardless of who distributes it. Because of its importance to patients. So we do not need anticipate being shut down on that level and we look forward to the results of the preliminary injunct injunction and also to potential rescission. That was your second question. What was your first 1 again, Michael? I am sorry, I forgot. Analyst (Michael): Hi there. I am not sure if you can hear me. I think my connection might be a little bit bad here. But I just I think you actually answered the first part of that question with the second part of the question. So Okay. I think we are clear enough. Linda Marbán: Well, I will take it as a 2-for-1 special. Thank you so much. Operator: Thank you. Your next question comes from Catherine with Jones Trading. Please go ahead. Analyst (Catherine): Hi. I guess, you know, can you expand on the definition of the private label distributor? Linda Marbán: What would that entail for Capricor whether this would, in your view, constitute a breach of contract? Contract on their part? Analyst (Catherine): So we do not have a private label distributor agreement in place. We never did. The agreement that we have in place was a sales, marketing, and distribution agreement and the foundational aspect of it, has led to this lawsuit is the transfer price that was originally built into the deal where NS Pharma would give Capricor a port a portion, and just a portion, by the way, of the COGS in order to defray expenses. And then NS Pharma will take x number of doses, distribute them, and then give us back our share of the royalties minus that small transfer price. Pretty clear opportunity, Seemed like a rational deal structure at the time, except this transfer price would then set the average sale price, which would be disastrous as I have said many So there is no PLD relationship or agreement in place, and therefore, there is no be breach. The problem is that we cannot agree on the structure. They want a PLD, and we would have liked a co commercial agreement. Linda Marbán: Okay. Got it. Analyst (Catherine): And then if I recall, there were some milestone payments that they were owed that were owed to you on approval. They are unwilling to walk away from the contract are they still required to pay those milestones? What happens if they choose not to? If, you know, if the lawsuit is going on? Linda Marbán: So, well, and I am not a lawyer. So I will say that please, you know, take my answers not from the perspective of a lawyer. But from the CEO guiding the company through this very challenging but exciting time. And so what we have been made to understand from the lawyers is that the agreement as it stands is non That means everything in the agreement is, at this point, not able to be acted upon. So we are assuming that they are not going to be paying the milestones. We are not expecting them to pay the milestones. And in fact, you know, 1 of the things that we have actively discussed is if there is rescission, we will probably pay them back the $50 million that they have paid us in initial upfront payments and then the 2 milestone payments. So we are ready to do that. Happy to do that actually if that becomes necessary, and we are not expecting any future payments from them at this time. Got it. Thanks. Operator: Thank you. Your next question comes from Matthew Venezia with Alliance Global Partners. Please go ahead. Analyst (Matthew): Hey guys, thank you for taking my questions. So first, is $60 million kind of a fair estimate of what would need to be paid back to NS Pharma in the event that both of you guys just kind of shake hands, you know, as you put it divorce and walk away? Or would it maybe be a little bit less? I know they have already paid you the $50 million. So color on that would be great. Linda Marbán: We are expecting if we have to pay something back, it would be the $50 million but we do not know. We do not know what agreement we are going to come to. We do not know what the court is going to say. We stand ready to do so, certainly, if that becomes part of the ruling in the case. Analyst (Matthew): Understood. And then just pivoting a little bit to the opportunity in Becker. If you could give us just an idea of the market size, what your work already has been in reaching out maybe to patients or providers for Becker. And givinostat, which is in, you know, Phase 3 clinical studies right now for Becker. Would deramiocel be an additive onto this potentially approvable drug, and has that been something that you guys have been looking into in Becker? Linda Marbán: Yeah. So we are very much looking forward to the opportunity. Becker muscular dystrophy. I have been kind of eyeballing it for a bit. You know, the pathophysiology of Becker is literally identical to DMD. it is just the slower progressor. The primary cause of death in those men with Becker is the cardiomyopathy In our cardiology, key opinion leaders tell us that if you give them an MRI of a Becker patient, and 1 of a Duchenne patient, you cannot tell them apart. So we have a drug that treats the cardio as well as the skeletal muscle myopathy, and therefore, I think it would be ideal for Becker. The market size in the U.S. is about 5 thousand patients per year, so I think it is considered an ultra rare group and it is a very slow progressor. So I have some idea of what I would like to go after with FDA. 1 of my first goals post PDUFA will be to meet with to meet about Becker. The reason that I am waiting till after PDUFA is strategic because we qualify for a PRV, and for a PRV, a priority review voucher, you have to be treating solely of pediatric conditions. So I do not want to sort of cloud with an adult based disease until we have clarity on our PDUFA for Duchenne and get our PRV and are able to use that to provide a source of nondilutive capital to the country to the company. Analyst (Matthew): Great. Thanks. And just on the givinostat question very quickly, is that yeah, is that something you guys are looking at, or, you know, is that part of the plan? Linda Marbán: So Any yeah. We feel like deramiocel is additive to literally any of the other products that are on the market right now or could be on the market and, you know, in the clinical evaluation stage. Given its activity, bioactivity, and efficacy in the heart, and that is in patients, by the way, with a diagnosed cardiomyopathy, not just healthy hearts. And then in addition to that, you know, the ability to control inflammation and fibrosis can only help those other therapies be more effective. So we look forward to partnering with the other drugs that will become part of the polypharmacy to treat DMD and of course Becker in the future. Great. Thank you, guys, for taking my questions, and best of luck. Going forward. Thanks, Matthew. Have a good day. Operator: Thank you. Thank you. Your next question comes from Gubalan Pachayapan with ROTH Capital. Please go ahead. Analyst (Gubalan Pachayapan): Hi, good afternoon, and thanks for taking my questions. So maybe a couple from us. Firstly, I wanted to start or maybe delve a little deeper between ASP, and AMP. So maybe can you provide some context in terms of what the difference between average selling price and the maximum FAMP price for a drug like deramiocel or maybe for rare disease drugs in general. Linda Marbán: Yeah, we have not really been disclosing any of that information yet. We are still working on gathering that information. As I said, we are working now actively to build our commercial planning strategies and so please stay tuned for more information on ASP, AMP kind of thing as it becomes available. Analyst (Gubalan Pachayapan): Alright. And then I think somewhere in your press release, it states that NS Pharma demanded that Capital would give up the control of regulatory relationships So my understanding is that MS Pharma brought in to sell, market, or distribute deramiocel in the hospital setting. So why are they heavy handed on regulatory relationship? Because it looks like I mean, I do not know whether they just woke up 1 day and decided to meddle in regulatory aspects of deramiocel as well? So maybe any color on that. Linda Marbán: Yeah. So it was really a situation where Oh, the AJ can take this question. Anthony J. Bergmann: Yeah. I think they were focused, thanks, Gubalan, on with respect to the PLD that they were looking to propose for us, some of the regulatory relationships would fall under the guise of that potential agreement, which of course we are not comfortable with. So that is kind of the root of your question, I believe. And so that is fundamentally 1 of the reasons why, of course, it did not work for us. Analyst (Gubalan Pachayapan): And then maybe 1 last I think somewhere in the 8-K, it says that although the distribution agreement is no longer binding, blah, and then the distributor may interfere with Capital's relationship with third parties. So I just feel that this text, it appears NS Pharma has been the driver's seat throughout the process. Capricor is playing a defensive game even though, you know, Capricor is the innovator of the drug. So curious, you know, why if the distribution agreement is no longer binding, that is the concern of interference come from Linda Marbán: Yeah. First off, we do not feel like we are on the defensive. We feel like we are equal weighted partners that we are actively interested in commercializing daramycin together, each of us playing to our individual strengths. Unfortunately, that relationship is no longer possible based on the existing agreement, and we are prepared now to launch on our own. In terms of interaction with vendors, of course, in an 8-K, it is incumbent upon the company to put forth all of the potential risk factors Boots on the ground, we have not really had any problems with any vendors. In fact, they like working with us. We are efficient. We are smart. We are we are well informed and strategic. So in practice, we are not seeing any problems with offenders. In theory, if 1 occurred, we would just find a different vendor to work with. there is there is lots of different vendors out there to take advantage of for commercializing a product. Alright. Thank you. Have a great day. Operator: Thank you. Your next question comes from Michael. With Maxim Group. Please go ahead. Analyst (Michael): Hey there. Sorry. I got bumped off there before. I just had 1 follow-up I wanted to ask. You seem to be making great progress on prepping the commercial force, but you know, the pretty quick time window that you have before the PDUFA date. So my question is, first, are you expecting that you will be able to hit the ground running, assuming this gets approved right on time and launch shortly thereafter. And then what gives you confidence that you will be able to build a Salesforce capable of addressing this market? Linda Marbán: So I think the second part first, the Salesforce becomes a relatively easy question to answer. In a rare disease, especially like Duchenne, with a very connected set of patients, physicians, providers, It really becomes less about getting a big sales force. We are not going after adult heart disease, but what we are going after is efficiency. And so I have a lot of confidence that we will be able to build a good force, we have a good reputation in the community, and get it out there. In terms of the distribution of, we are the ones that have been getting ready to do so. We expect that we will launch in a time-efficient manner. We announced a date for launch and by the way neither had NS, so we are not gearing or guiding towards an actual launch date as yet. We are working towards PDUFA. We are guaranteeing drug in an uninterrupted format to the open label extension patients and perhaps the other patients as you know, the information becomes available, and we will update the street on our potential launch date as we get some clarity there. Alright. Thank you very much, and best of luck. I think, you know, it is abundantly clear anyone who is seen the data just how important getting access to this is as quick as possible. Thank you so much, Michael. That means a lot. We feel the same way. Thank you. Operator: I will now turn the call back to Capricor management for final thoughts. Linda Marbán: Yeah, thank you again for joining us today for your continued support. And for the boys and young men living with Duchenne, and their families who have waited alongside them, we are eagerly and anticipating the approval of deramiocel to treat DMD. The science is strong, the data are strong and before the FDA, and we are wholly focused on ensuring that when approved, deramiocel will be made available to every eligible patient as quickly and as broadly as possible. For our investors, the thesis is straightforward. A potential first in class approval in defined rare disease populations, proprietary in house manufacturing, a growing pipeline, and a leadership team with the conviction and capital to execute. We believe that we are building something that will create meaningful value for patients and for this company and for shareholders who have believed in this mission. We look forward to a transformational summer. Operator: Thank you. You may now disconnect. Ladies and gentlemen, this concludes today's conference. call. Thank you for participating. You may now disconnect. Before you buy stock in Capricor Therapeutics, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Capricor Therapeutics wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $472,205!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,384,459!* Now, it’s worth noting Stock Advisor’s total average return is 999% — a market-crushing outperformance compared to 208% for the S&P 500. 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Interested in Capricor Therapeutics, Inc.? Here are five stocks we like better. Deramiocel remains under active FDA review, with a PDUFA decision due Aug. 22, 2026. Capricor says the FDA accepted its resubmission as complete and is moving toward labeling discussions after positive HOPE-3 Phase 3 data. Capricor is also pursuing litigation against NS Pharma and Nippon Shinyaku to unwind its U.S. distribution deal, saying the current pricing structure could block patient access and make commercialization uneconomical. The company plans to launch deramiocel itself if approval comes through. The company is building out commercial and manufacturing capacity ahead of a possible launch, including expanding its San Diego GMP facility and hiring market access and commercial leadership. Capricor ended Q1 with about $279 million in cash and said it has enough funding into Q4 2027, excluding product revenue or voucher sales. Capricor Therapeutics Is Up Over 100%, Could Rise Even Higher Capricor Therapeutics (NASDAQ:CAPR) said its Duchenne muscular dystrophy therapy candidate deramiocel remains under active FDA review, while the company is preparing to commercialize the product itself amid a legal dispute with distribution partner NS Pharma and parent company Nippon Shinyaku. On the company’s first-quarter 2026 earnings call, Chief Executive Officer Linda Marbán said Capricor is at “a truly defining moment” as it advances deramiocel toward a potential approval, builds commercial infrastructure and pursues litigation seeking to unwind its U.S. distribution agreement. → MercadoLibre Boldly Invests in Growth: Discount Deepens The company’s biologics license application for deramiocel has a PDUFA target action date of Aug. 22, 2026. Marbán said the FDA has accepted Capricor’s response to a July 2025 complete response letter as complete and classified the resubmission as Class 2, resuming full review of the application. She said Capricor has responded to “a significant number” of FDA information requests and expects labeling discussions “in the very near future.” Marbán said Capricor’s response to the complete response letter was based on results from the HOPE-3 Phase 3 trial, which she described as “one of the most compelling data sets generated for DMD to date.” HOPE-3 enrolled 106 patients in a multicenter, randomized, double-blind, placebo-controlled study. → Rocket Lab Just Hit a New All-Time High—Time to Buy or Let It Breathe? According to Marbán, the trial met its primary endpoint, the Performance of the Upper Limb version 2.0, with an approximately 54% reduction in disease severity at 12 months and a P value of 0.029. She also said all type 1 error-controlled secondary endpoints reached statistical significance. Because the current BLA is for cardiomyopathy, Marbán highlighted left ventricular ejection fraction as a key secondary endpoint. She said deramiocel showed an approximately 91% slowing of disease progression in all evaluable patients. In a subset of patients with a confirmed diagnosis of cardiomyopathy, she said the LVEF effect showed an approximately 120% slowing of disease and achieved a P value of 0.01. → 3 Small-Cap Stocks to Buy as the Russell 2000 Extends Its Rally Marbán also pointed to additional HOPE-3 data presented at medical meetings, including the Muscular Dystrophy Association Clinical and Scientific Conference, the American Academy of Neurology and the American Society of Gene & Cell Therapy. She said a home-based caregiver-captured video assessment of upper limb function showed statistically significant improvement in treated patients versus placebo, and cardiac MRI data showed significant stabilization in the progression of cardiac fibrosis. On safety, Marbán said Capricor has completed more than 800 intravenous infusions across multiple clinical studies and that deramiocel continues to show a “consistent and well-tolerated safety profile.” She said some participants in the HOPE-2 open-label extension have received continuous infusions for up to five years, with approximately 90 patients in collective open-label extension studies. The company also expects to be eligible for a priority review voucher upon potential approval, which Marbán said could be sold and represent a source of non-dilutive capital. A major focus of the call was Capricor’s May 7 lawsuit against Nippon Shinyaku and its U.S. subsidiary, NS Pharma. Marbán said Capricor filed suit seeking rescission of its U.S. distribution agreement through an expedited process and requested a preliminary injunction that would allow Capricor to distribute deramiocel to patients on its own or through other distributors, pending FDA approval. Marbán said the dispute centers on pricing. She said the pricing structure in the commercialization and distribution agreement contains “a fundamental flaw” that would make it “economically impossible” to deliver deramiocel to patients covered by Medicare, Medicaid or private insurance. She said providers could face reimbursement shortfalls “per dose” and characterized the issue as a structural barrier to patient access rather than a commercial preference. Marbán said Capricor attempted to resolve the issue with NS Pharma, beginning discussions in March 2025, but said NS Pharma refused to address the structure on acceptable terms. She also said NS Pharma sought terms that would require Capricor to cede control of the product, regulatory relationships and commercial identity, which she called unacceptable. “The FDA review process and the PDUFA date are unaffected by this lawsuit,” Marbán said. In response to analyst questions, Marbán said Capricor’s current plan is to launch deramiocel itself, though timing of the litigation is dependent on the court. She said Capricor is not expecting milestone payments from NS Pharma at this time and may repay the $50 million it has already received if rescission requires it. Marbán said Capricor has been hiring and building infrastructure to support commercialization, with a focus on patient access, physician education, payer readiness and distribution services. She said the company has a senior vice president of market access with rare disease experience and has secured a chief commercial officer expected to join in the coming weeks. Capricor’s in-house GMP manufacturing facility in San Diego completed its FDA pre-license inspection last year, Marbán said, adding that all Form 483 observations were addressed. The facility is operational and positioned to support an initial commercial launch for approximately 200 to 250 patients per year, which she later clarified equates to about 1,000 doses annually. The company is also expanding to a second floor at the same facility with additional clean rooms. At full capacity, Marbán said the expansion could support treatment of approximately 2,000 to 2,500 patients per year, or roughly 10,000 doses annually. She said her goal is to have the expanded facility fully validated and approved by the FDA in the first half of 2027. Because deramiocel is an ultra-cold chain product that must be labeled before freezing, Marbán said Capricor is working with the FDA on a temporary label solution that would allow the company to begin producing commercial doses. She said Capricor’s planning indicates it will have sufficient product to support a launch if approved. Marbán said Capricor has historically focused most of its resources on deramiocel, but continues to explore exosome-based therapeutic programs. She said the company is moving away from vaccine development “at this time” and will focus on therapeutics using CDC-based exosomes and its StealthX technology. She said Capricor’s exosome-based vaccine work with the National Institute of Allergy and Infectious Diseases moved more slowly than originally planned amid instability in vaccine development, but noted that the program achieved clinical-grade vaccine exosome manufacturing, FDA-approved CMC for large-scale manufacturing and evidence that an exosome-based vaccine is safe. For deramiocel lifecycle management, Marbán said Capricor’s first target will likely be younger DMD patients. The company also plans to begin discussing a clinical pathway for Becker muscular dystrophy with the FDA after the DMD PDUFA date. She said Capricor expects to meet with the EMA and PMDA later this year as it explores deramiocel outside the United States. Chief Financial Officer Anthony J. Bergmann said Capricor had approximately $279 million in cash, cash equivalents and marketable securities as of March 31, 2026. He said the company believes its current capital is sufficient to fund anticipated operating expenses and capital expenditures into the fourth quarter of 2027, excluding potential product revenue or priority review voucher monetization. The company recognized no revenue in the first quarter of 2026 or the first quarter of 2025. Total operating expenses were approximately $36.8 million in the first quarter of 2026, compared with approximately $25 million a year earlier. Bergmann said the increase was primarily driven by investment in clinical, regulatory and manufacturing activities, along with infrastructure spending supporting the Duchenne program. Capricor reported a first-quarter net loss of approximately $33.9 million, or $0.59 per share, compared with a net loss of approximately $24.4 million, or $0.53 per share, in the prior-year period. Bergmann said Capricor’s expense profile reflects investment across three priority areas: regulatory and clinical activities supporting the BLA, manufacturing capacity expansion and commercial infrastructure build-out. Capricor Therapeutics, Inc is a clinical-stage biotechnology company focused on the development of cell and exosome-based therapeutics for cardiovascular and rare diseases. Headquartered in Beverly Hills, California, the company leverages proprietary cardiosphere-derived cell (CDC) technology to address conditions characterized by inflammation, fibrosis, and tissue degeneration. Since its founding, Capricor has advanced its lead candidate through multiple clinical trials and has built a pipeline that spans both cell therapy and extracellular vesicle (exosome) platforms. The company's leading product candidate, CAP-1002, comprises allogeneic CDCs and is being evaluated in indications such as Duchenne muscular dystrophy (DMD) and COVID-19-related heart injury. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Capricor Therapeutics Q1 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for May 2026.

This article first appeared on GuruFocus. Cash and Equivalents: Approximately $279 million as of March 31, 2026. Operating Expenses: Approximately $36.8 million for Q1 2026, up from $25 million in Q1 2025. Net Loss: Approximately $33.9 million or $0.59 per share for Q1 2026, compared to $24.4 million or $0.53 per share for Q1 2025. Revenue: No revenue recognized for Q1 2026 or Q1 2025. Warning! GuruFocus has detected 4 Warning Signs with CAPR. Is CAPR fairly valued? Test your thesis with our free DCF calculator. Release Date: May 12, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Capricor Therapeutics Inc (NASDAQ:CAPR) has a strong balance sheet with approximately $279 million in cash equivalents and marketable securities, providing sufficient capital to fund operations into the fourth quarter of 2027. The HOPE-3 Phase III trial results for Daramicel demonstrated significant efficacy, with a 54% reduction in disease severity at 12 months and a 91% slowing of disease progression in cardiomyopathy patients. The FDA has accepted the Biologics License Application (BLA) for Daramicel as complete, and the review is actively progressing with a PDUFA target action date of August 22, 2026. Capricor Therapeutics Inc (NASDAQ:CAPR) has completed over 800 intravenous infusions of Daramicel, showing a consistent and well-tolerated safety profile. The company is expanding its manufacturing capacity, with plans to support treatment for approximately 2,000 to 2,500 patients per year by 2027, ensuring readiness for commercial launch. Capricor Therapeutics Inc (NASDAQ:CAPR) is involved in a legal dispute with NS Pharma and Nippon Shinyaku over a flawed pricing structure in their distribution agreement, which could delay the commercialization of Daramicel. The company has not recognized any revenue for the first quarter of 2026, reflecting ongoing financial challenges. Operating expenses increased significantly to $36.8 million in Q1 2026 from $25 million in Q1 2025, driven by investments in clinical, regulatory, and manufacturing activities. The lawsuit with NS Pharma may impact Capricor Therapeutics Inc (NASDAQ:CAPR)'s ability to distribute Daramicel efficiently, depending on the court's decision. Capricor Therapeutics Inc (NASDAQ:CAPR) is still in the process of building a commercial team and infrastructure, which may affect the timing and effectiveness of the product launch. Q: Linda, could you provide more insight into the lawsuit with NS Pharma and their reluctance to resolve the pricing issue? A: Linda Marban, CEO, explained that negotiations with NS Pharma began in March 2025, but NS Pharma was unwilling to accept any proposed solutions that would maintain the economic structure of the original agreement. This led to Capricor's decision to file a lawsuit, as NS Pharma's proposed structure would have undermined Capricor's brand and future indications. Q: What are the next steps regarding the lawsuit, and how does it affect your plans for launching Daramicel? A: Linda Marban stated that Capricor plans to launch Daramicel independently. The timing of the lawsuit's resolution depends on the court, but Capricor is preparing to distribute the drug regardless of the lawsuit's outcome, ensuring that patients receive the treatment promptly. Q: Can you clarify if NS Pharma's lack of commercial launch preparation was due to a lack of confidence in Daramicel's approval? A: Linda Marban noted that while NS Pharma's lack of preparation was disappointing, it was not the basis for the lawsuit. The lawsuit is primarily due to the contractual issues, and Capricor is prepared to take over the distribution and commercialization of Daramicel. Q: What commercial readiness activities has Capricor undertaken in preparation for Daramicel's launch? A: Linda Marban confirmed that Capricor has been preparing for the launch by identifying a third-party logistics provider and building a commercial team. Capricor has been actively involved in market access, advocacy planning, and securing a distributor to ensure a smooth launch. Q: How does Capricor plan to handle the manufacturing and distribution of Daramicel given the current legal situation? A: Linda Marban stated that Capricor is ready to manufacture and distribute Daramicel, with plans to start stockpiling commercial doses once they receive guidance on labeling from the FDA. The company is committed to ensuring uninterrupted access for patients in open-label extension studies. For the complete transcript of the earnings call, please refer to the full earnings call transcript.