CAPRICOR THERAPEUTICS, INC.

10865 Road to the Cure, San Diego, California · September 30, 2033 · Corporate headquarters: manufacturing, laboratory and office space · 34,348

10865 Road to the Cure, Room 7, San Diego, California · December 31, 2026 · Laboratory space(vivarium) · 234

8840 Wilshire Blvd., 2nd Floor, Beverly Hills, California · April 22, 2026 · Office space · 1,627

8700 Beverly Blvd., Davis Building, Los Angeles, California · July 31, 2026 · Laboratory, manufacturing and office space · 1,892

10835 Road to the Cure, Suite 140, San Diego, California · June 30, 2026 · Laboratory and office space · 11,173

(1) · Certain leases have specific options for potential renewal or extensions.

• Tariffs imposed by foreign governments in retaliation for U.S. trade measures could adversely affect our international sales, results of operations, and financial condition.
• A breakdown, corruption or breach of our information technology systems or computer systems, or those used or hosted by our CROs, contractors, consultants or third-party vendors could subject us to liability or interrupt the operation of our business.
• If we achieve our near-term product development milestones, we may not be able to manage any subsequent growth.
• Our success depends upon the viability of our product candidates and we cannot be certain any of them will receive regulatory approval to be commercialized.
• We have limited experience in conducting late-stage clinical trials, which are complex and subject to strict regulatory oversight.
• As the results of earlier preclinical studies or clinical trials are not necessarily predictive of future results, any product candidate we advance into clinical trials may not have favorable results in later clinical trials or receive regulatory approval.
• Even if our preclinical studies and clinical trials are completed as planned, we cannot be certain that their results will support the claims of our product candidates. Positive results in preclinical testing and early clinical trials do not ensure that results from later clinical trials will also be positive, and we cannot be sure that the results of later clinical trials will replicate the results of prior clinical trials and preclinical testing.
• Despite the results reported in earlier clinical trials for our product candidates, we do not know whether any Phase 2, Phase 3 or other clinical trial which we may conduct will demonstrate adequate efficacy and safety to result in regulatory approval to market our product candidates. A number of companies in the pharmaceutical industry, including those with greater resources and experience, have suffered significant setbacks in Phase 2 or Phase 3 clinical trials, even after seeing promising results in earlier clinical trials.
• Our exosome technologies are based on a novel therapeutic approach which makes it difficult to predict the time and cost of development and the probability of subsequently obtaining regulatory approval, if at all.
• Negative developments in the field of exosomes could damage public perception of any product candidates that we develop, which could adversely affect our ability to conduct our business or obtain regulatory approvals for such product candidates.
• We may not be able to file INDs to commence additional clinical trials on the timelines we expect, and even if we are able to do so, the FDA may not permit us to proceed.
• Delays in the commencement, enrollment, and completion of clinical testing, as well as reduced government funding of certain clinical trials, could result in increased costs to us and delay or limit our ability to obtain regulatory approval for our product candidates.
• The biopharmaceutical industry is subject to extensive regulatory obligations and policies that may be subject to significant and abrupt change, including due to judicial challenges, election cycles, and resulting regulatory updates and changes in policy priorities.
• The outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, interim results of a clinical trial do not necessarily predict final results, and the results of our clinical trials may not satisfy the requirements of the FDA or comparable foreign regulatory authorities.
• The regulatory pathway for COVID-19 or other infectious disease vaccines is continually evolving and may result in unexpected or unforeseen challenges.
• We may not be successful in our efforts to identify or discover additional potential product candidates or additional indications for our existing product candidates.
• If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability, or that of any future distributors or collaborators, to market the drug could be compromised.
• Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, healthcare payors and others in the medical community necessary for commercial success.
• We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
• The FDA has granted orphan drug status and an RMAT designation to Deramiocel for the treatment of DMD, but we may be unable to maintain or receive the benefits associated with orphan drug status, including market exclusivity, or an RMAT designation.
• Even if we were to obtain approval for Deramiocel for the treatment of DMD with the rare pediatric disease designation, the Rare Pediatric Disease Priority Review Voucher Program may no longer be in effect at the time of such approval.
• Providing product for use in third-party trials or for compassionate use poses risks to our product candidates.
• Our products face a risk of failure due to adverse immunological reactions.
• Our business faces significant government regulation, and there is no guarantee that our product candidates will receive regulatory approval.
• There are additional risks involved in conducting clinical trials internationally.
• Even if our product candidates receive regulatory approval, we may still face future development and FDA regulatory difficulties.
• If we or current or future collaborators, manufacturers, or service providers fail to comply with healthcare laws and regulations, we or they could be subject to enforcement actions and substantial penalties, which could affect our ability to develop, market, and sell our products and may harm our reputation.
• Any drugs we develop may become subject to unfavorable pricing regulations, third-party coverage, and reimbursement practices or healthcare reform initiatives, thereby harming our future business prospects.
• Our risk mitigation measures cannot guarantee that we effectively manage all operational risks and that we are in compliance with all potentially applicable U.S. federal and state regulations and all potentially applicable foreign regulations and other requirements.
• Our employees and consultants may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
• Our ability to obtain reimbursement or funding for our programs from the federal government may be impacted by possible reductions in federal spending.
• Vaccines carry unique risks and uncertainties, which could have a negative impact on future results of operations.
• Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models could impact our future product revenues and materially harm our business.
• We have limited commercial manufacturing experience and our manufacturing facilities may not receive or maintain the regulatory approvals required to support commercialization.
• The manufacture of cell-based therapies such as Deramiocel is complex, highly regulated and subject to multiple operational and technical risks.
• We will need to increase our manufacturing capacity in the future and we may encounter problems at our current manufacturing facilities.
• Cell therapy medicines are complex biologic products that may be difficult to manufacture consistently. We could experience delays in satisfying regulatory authorities or production problems that result in delays in our development or commercialization programs, limit the supply of our product candidates we may develop, or otherwise harm our business.
• We may need to rely exclusively on third parties to formulate and manufacture our product candidates and provide us with the devices and other products necessary to administer such a product.
• Disruptions in our supply chain or failure to adequately forecast product demand could result in significant delays or lost sales.
• Even if our product candidates receive regulatory approval, they may still face future development and regulatory difficulties.
• The third parties we use in the manufacturing process for our product candidates may fail to comply with cGMP regulations.
• We may face uncertainty and difficulty in obtaining and enforcing our patents and other proprietary rights.
• It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection. If we fail to protect or enforce our intellectual property rights adequately or secure rights to patents of others, the value of our intellectual property rights and product candidates would diminish.
• If any of our trade secrets, know-how or other proprietary information is improperly disclosed, the value of our trade secrets, know-how and other proprietary rights would be significantly impaired and our business and competitive position would suffer.
• We may incur substantial costs as a result of litigation or other adversarial proceedings relating to patent and other intellectual property rights and we may be unable to protect our rights to, or use of, our technology.
• We may be subject to claims that we or our employees, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties.
• We depend on intellectual property licensed from third parties and termination of any of these licenses could result in the loss of significant rights, which would harm our business.
• We will depend on our exclusive distributor, Nippon Shinyaku, for the commercial sale of Deramiocel in Duchenne muscular dystrophy (“DMD”) in the United States and Japan, if regulatory approval is obtained in those territories.
• If we enter into strategic partnerships, we may be required to relinquish important rights to and control over the development of our product candidates or otherwise be subject to terms unfavorable to us.
• Our results of operations could be materially harmed if we or our distributor are unable to accurately forecast customer demand for our products and manage our inventory.
• We are dependent on our relationships with our licensors and collaborators and there is no guarantee that such relationships will be maintained or continued.
• We have received government grants and a loan award which impose certain conditions on our operations.
• We rely and will rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval of or commercialize our product candidates.
• As we advance our programs through potential commercial launch, we have substantial fixed costs associated with third party contracts that will increase and will not be able to be terminated, even if our product candidates are not ultimately approved.
• Our products will likely face intense competition.
• If we are unable to retain and recruit qualified scientists and advisors, or if any of our key executives, key employees or key consultants discontinues his or her employment or consulting relationship with us, it may delay our development efforts or otherwise harm our business. In addition, several of our consultants render services on a part-time basis to other entities which may result in the creation of intellectual property rights in favor of those entities.
• If we do not establish strategic partnerships, we will have to undertake development and commercialization efforts on our own, which would be costly and delay our ability to commercialize any future products or product candidates.
• We have no experience selling, marketing, or distributing products and no current internal capability to do so.
• If any of our product candidates for which we receive regulatory approval do not achieve broad market acceptance, the revenues that we generate from their sales, if any, will be limited.
• Our development of a potential vaccine for COVID-19 or other indications is at an early stage and is subject to significant risks.
• Even if our product candidates are approved, our ability to generate product revenues will be diminished if our products sell for inadequate prices or patients are unable to obtain adequate levels of reimbursement.
• Our products may expose us to potential product liability, and there is no guarantee that we will be able to obtain and maintain adequate insurance to cover these liabilities.
• Our business involves risk associated with handling hazardous and other dangerous materials.
• Our business depends on compliance with ever-changing environmental and human health and safety laws.
• We expect that our stock price will continue to fluctuate significantly.
• We have never paid dividends and we do not anticipate paying dividends in the future.
• We may issue shares of blank check preferred stock without stockholder approval in the future.
• Market and economic conditions may adversely affect our industry, business and ability to obtain financing.