Financial Data and Key Metrics Changes - As of September 30, 2021, the company's cash and cash equivalents totaled approximately $40.8 million, compared to approximately $32.7 million on December 31, 2020, indicating a positive cash flow situation [40] - For the first nine months of 2021, the net cash used in operating activities was approximately $11.2 million, with a net loss of approximately $13.8 million compared to a net loss of approximately $9.5 million for the same period in 2020 [41][42] Business Line Data and Key Metrics Changes - The research and development expense for Q3 2021, excluding stock-based compensation, was approximately $2.4 million, a decrease from approximately $2.6 million in Q3 2020 [41] - General and administrative expenses for Q3 2021, excluding stock-based compensation, were approximately $1.1 million, compared to approximately $900,000 in Q3 2020, indicating an increase in administrative costs [42] Market Data and Key Metrics Changes - The company is focused on two main pipeline programs: CAP-1002 for Duchenne muscular dystrophy (DMD) and severe COVID-19, and an emerging platform technology involving exosomes as drug delivery vehicles [5][22] Company Strategy and Development Direction - The company is committed to advancing CAP-1002 for DMD and has received FDA clearance to proceed with the HOPE-3 trial, aiming to enroll approximately 70 patients [10][11] - The company is also developing an exosome platform technology for drug delivery, which is seen as a cornerstone for future vaccine development and other therapeutic applications [26][34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the data from the HOPE-2 trial and is actively working on initiating the HOPE-3 study [44] - The company is in a strong position regarding manufacturing readiness and supply chain management, indicating no expected issues for the upcoming studies [45][46] Other Important Information - The company has secured important regulatory designations, including RMATs for CAP-1002, and is working closely with the FDA to ensure commercial supply readiness [11][46] - The company has relocated its R&D headquarters to San Diego, California, and has assembled a strong team to advance its exosome platform [35] Q&A Session Summary Question: Update on HOPE-3 study and potential partnership - Management is encouraged by HOPE-2 data and is developing plans to initiate HOPE-3, with a focus on enrolling patients [44] Question: Manufacturing readiness and supply chain impacts - Management confirmed that they are well-prepared for manufacturing and do not anticipate issues related to global supply chain challenges [45] Question: Next steps pending INSPIRE trial data - Management will evaluate next steps based on the data from the INSPIRE trial and will keep stakeholders updated [47] Question: Visibility on exosome platform development - Management indicated that they have several targets in development and will provide updates on the exosome platform in early 2022 [49]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended June 30, 2021 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State or ot ...

Financial Data and Key Metrics Changes - As of June 30, 2021, the company's cash and cash equivalents totaled approximately $38.1 million, an increase from approximately $32.7 million on December 31, 2020, indicating a positive cash flow situation [21] - The net cash used in operating activities for the first half of 2021 was approximately $7.8 million, with a net loss of approximately $9.9 million compared to a net loss of approximately $5.6 million for the first half of 2020 [22] Business Line Data and Key Metrics Changes - Research and development expenses for Q2 2021 were approximately $3.4 million, up from approximately $1.8 million in Q2 2020, reflecting increased investment in clinical programs [22] - General and administrative expenses for Q2 2021 were approximately $1.2 million, compared to approximately $1 million in Q2 2020, indicating a slight increase in operational costs [22] Market Data and Key Metrics Changes - The company is planning to expand its footprint to San Diego, California, to enhance its research capabilities and attract talent, which is expected to support its clinical programs [5][19] - The company is engaging with payers regarding the reimbursement potential for CAP-1002, with projected price targets in line with other cell and gene therapies for rare diseases [10] Company Strategy and Development Direction - The company plans to proceed with a Phase 3 pivotal trial for CAP-1002 in Duchenne muscular dystrophy (DMD) after a productive end-of-phase meeting with the FDA [7] - The company is also advancing its engineered exosome platform technology, with plans to develop a multivalent COVID-19 vaccine and explore other therapeutic indications [14][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the potential impact of CAP-1002 in treating severe COVID-19, citing positive data from previous studies and ongoing enrollment in the INSPIRE trial [13][12] - The company is committed to securing a partner for the commercialization of CAP-1002 and is actively discussing potential partnerships [10][36] Other Important Information - The company has recruited a team of experienced scientists for its exosome platform technology, which is expected to drive innovation in vaccine development [15] - The company anticipates submitting an IND for its COVID-19 vaccine in the fourth quarter of 2021, despite delays due to supply chain challenges [18] Q&A Session Summary Question: Details on trial endpoints for CAP-1002 - The primary efficacy endpoint for the Phase 3 trial will be the PUL 2.0, with secondary endpoints including cardiac measures [24] Question: Eligibility of HOPE-2 patients for HOPE-3 - Patients from HOPE-2 will not roll directly into HOPE-3 but will continue in an open-label extension study [25] Question: Estimated cost of HOPE-3 study - The estimated cost for the HOPE-3 study is around $15 million, which is considered low for a Phase 3 trial [28] Question: Clinical development of the booster vaccine - The company is actively exploring the booster vaccine strategy and has received supportive feedback from the U.S. government [29] Question: Route of administration for the booster vaccine - The booster vaccine will be administered via intramuscular injection, similar to existing vaccines [32] Question: Plans for EUA submission if COVID-19 trial data is positive - The company is open to all possibilities regarding EUA submission based on the trial data [33] Question: Epigenetic modification profile of CAP-1002 exosomes - Preclinical work has shown that CAP-1002 may suppress certain cytokines, but further data from the current study is being analyzed [34] Question: Focus of the INSPIRE trial - The company is currently focused on severe COVID-19 but may explore broader applications for respiratory distress in the future [42] Question: Manufacturing costs and scalability of exosomes - The company is confident in solving manufacturing challenges for engineered exosomes and is in scale-up mode [44]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 2021 or ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State or o ...

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q1 2021 Earnings Conference Call May 13, 2021 4:30 PM ET Company Participants AJ Bergmann - Chief Financial Officer Linda Marbán - Chief Executive Officer Conference Call Participants Alan Leong - BioWatch News Operator Greetings. And welcome to Capricor Therapeutics First Quarter 2021 Earnings and Corporate Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions ...

Financial Performance - Grant income for the years ended December 31, 2020 and 2019 was approximately $0.2 million and $0.5 million, respectively, indicating a decrease of approximately 60% in 2020 compared to 2019[535]. - General and Administrative (G&A) expenses for the years ended December 31, 2020 and 2019 were approximately $5.5 million and $3.6 million, respectively, reflecting an increase of approximately 52.8% in 2020[537]. - The increase in G&A expenses in 2020 was primarily due to a $1.2 million increase in stock-based compensation expense and a $0.5 million increase in salaries and recruiting related expenses[537]. - Investment income decreased from $94,791 in 2019 to $32,943 in 2020, a decline of approximately 65.3% due to reduced interest rates[540]. - The company reported a net loss of approximately $13.7 million for the year ended December 31, 2020, compared to a net loss of $10.4 million in 2019[548]. - Cash used in operating activities rose to approximately $10.1 million in 2020 from $6.8 million in 2019, an increase of about 48.5%[548]. - The company raised approximately $33.0 million from the sale of common stock in 2020, compared to $9.2 million in 2019, marking an increase of about 258.7%[550]. Research and Development - Research and Development (R&D) expenses increased from approximately $5.1 million in 2019 to $8.5 million in 2020, a rise of about 66.7%[539]. - R&D expenses primarily include salaries, clinical trial costs, and manufacturing costs, with expenses recognized as incurred[583]. - The accrual policy for R&D activities aims to match expenses with actual services received, with variations in payment flows due to contract negotiations[585]. - The company monitors activity levels through communication with CROs and vendors, ensuring expenses align with budgeted amounts[584]. - The clinical trial accrual process is designed to reflect appropriate expenses in financial statements based on the progress of trials[592]. Clinical Trials and Product Development - The company has completed the Phase II clinical trial (HOPE-2) for CAP-1002, showing improvements in multiple measures of upper limb, cardiac, and respiratory functions[507]. - The FDA has encouraged the company to conduct a Phase III study for CAP-1002, although discussions regarding the pathway forward are still ongoing[507]. - The INSPIRE trial for CAP-1002 in severe or critical COVID-19 patients is a Phase II, randomized, double-blind, placebo-controlled study enrolling up to 60 patients[509]. - The company is developing two vaccine candidates for COVID-19, including a tripartite exosome-mRNA vaccine, with plans to file an IND by the third quarter of 2021[510]. - The company has submitted an IND for CAP-2003 to investigate its use in patients with Duchenne Muscular Dystrophy (DMD) and is evaluating the next steps for this program[514]. Funding and Grants - The Company received a CIRM Grant Award of approximately $3.4 million for its Phase I/II clinical trial, requiring a co-funding of about $2.3 million from the Company[565]. - As of December 31, 2020, the liability balance for the CIRM Award was approximately $3.4 million, with all milestones completed by June 2019[567]. - The NIH grant for CAP-2003 amounted to approximately $4.2 million, with $0.7 million incurred by June 30, 2019, and the award was closed in Q2 2019[568]. - The Department of Defense grant totaled approximately $2.4 million, with about $2.3 million utilized, and a no-cost extension granted until September 29, 2020[569]. Cash and Investments - Cash, cash equivalents, and marketable securities increased from approximately $9.9 million in 2019 to $32.7 million in 2020, a growth of about 230.5%[544][550]. - The net increase in cash and cash equivalents for 2020 was approximately $28.8 million, compared to a decrease of $646,000 in 2019[547]. - The fair value of cash and cash equivalents as of December 31, 2020, was approximately $32.7 million[598]. - The investment portfolio primarily consists of money market funds and short-term U.S. treasuries, aiming to limit credit exposure and default risk[598]. - The company does not hedge interest rate exposure and believes that a hypothetical 100 basis point change in interest rates would not significantly impact the fair value of its investment portfolio[599]. Stock-Based Compensation - Stock-based compensation expense is recognized over the vesting period, with significant future non-cash compensation expenses expected[591]. - The company accounts for stock options using the Black-Scholes option-pricing model, requiring assumptions about various variables[589].

Financial Data and Key Metrics Changes - As of December 31, 2020, the company's cash, cash equivalents, and marketable securities totaled approximately $32.7 million, compared to approximately $9.9 million on December 31, 2019, indicating significant growth in liquidity [47] - The net loss for the fourth quarter of 2020 was approximately $4.2 million, compared to a net loss of approximately $1.5 million for the fourth quarter of 2019, reflecting increased operational costs [49] - For the full year of 2020, the net loss was approximately $13.7 million, compared to a net loss of approximately $7.6 million for the full year 2019, highlighting a trend of increasing losses [49] Business Line Data and Key Metrics Changes - The research and development expense for Q4 2020 was approximately $2.7 million, up from approximately $800,000 in Q4 2019, indicating a substantial increase in investment in R&D [48] - General and administrative expenses also rose to approximately $1.1 million in Q4 2020 from approximately $800,000 in Q4 2019, reflecting higher operational costs [48] Market Data and Key Metrics Changes - The company is focused on becoming a leading exosome RNA company, with plans to develop engineered exosomes and synthetic mRNAs for therapeutic applications [13][35] - The exosome platform is positioned to address a broad spectrum of diseases, leveraging the success of mRNA vaccines as a market opportunity [9][10] Company Strategy and Development Direction - The company is pivoting from traditional cell therapy towards an exosome platform, which is expected to provide significant opportunities in vaccine and therapeutic development [72] - The strategy includes developing a multi-antigen exosome-mRNA vaccine, with plans to initiate a Phase 1 clinical trial in Q3 of 2021, pending FDA approval [37] - The company aims to optimize its exosome platform for both vaccine and therapeutic applications, with a focus on monogenic diseases and other infectious diseases [35][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in 2020 and the potential of the exosome platform to revolutionize therapeutic delivery [5][45] - The company is awaiting FDA feedback on its pre-IND package and is prepared to move into clinical trials based on that feedback [37][57] - Management emphasized the importance of CAP-1002 for Duchenne muscular dystrophy and the ongoing discussions with the FDA regarding its approval pathway [41][42] Other Important Information - The company has entered into a Sponsored Research Agreement with Johns Hopkins University to support its exosome program, enhancing its research capabilities [6] - The company is exploring partnerships for CAP-1002, targeting corporate partners with existing products in the Duchenne muscular dystrophy space [61] Q&A Session Summary Question: How should Capricor be viewed going forward? - Management sees Capricor positioned between traditional cell therapy companies and those focused on engineered exosomes, emphasizing the shift towards RNA medicines in exosomes [52] Question: Will the mRNA strategy focus on internal development or partnerships? - The plan includes both internal programs and attracting partners for collaborative development, aiming for a plug-and-play model [54] Question: What is the expected cold chain requirement for the exosome-based mRNA vaccine? - Current expectations are for similar cold chain requirements as existing mRNA vaccines, with potential for a single-dose option being explored [55] Question: What work is still required for entering the clinic with the vaccine? - The company is ready to proceed into the clinic based on FDA feedback, leveraging its experience with regulatory processes [57] Question: What is the regulatory pathway for exosome-based therapeutics? - Management believes the regulatory process will be relatively straightforward, drawing on previous experiences with biologics [59] Question: What is the ideal partner for CAP-1002 development? - An ideal partner would have activity or commercial products in the Duchenne muscular dystrophy space, with ongoing discussions with multiple parties [61] Question: Plans for label expansion on post-COVID patients in the INSPIRE trial? - The company is open to label expansion based on trial data and the evolving landscape of COVID-19 treatment [63] Question: What additional studies are being conducted with CAP-1002? - The company is working with consultants and statisticians to analyze the impact of CAP-1002 in Duchenne muscular dystrophy [65] Question: Insights on the exosome platform compared to lipid nanoparticles? - The exosome platform shows promise in safety, repeat dosing, and targeting capabilities, with ongoing research to optimize these aspects [68][70]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q x Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended September 30, 2020 or ¨ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to Commission File Number: 001-34058 CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) Delaware 88-0363465 (State or other jurisdict ...

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q3 2020 Earnings Conference Call November 12, 2020 4:30 PM ET Company Participants A.J. Bergmann - Chief Financial Officer Linda Marbán - President, Chief Executive Officer and Director Steve Gould - Executive Consultant Conference Call Participants Emanuela Branchetti - H.C. Wainwright Jason McCarthy - Maxim Group Alan Leong - BioWatch News Operator Greetings, and welcome to the Capricor Therapeutics Inc Third Quarter 2020 Earnings Call. [Operator Instructions]. As ...

Corporate & Investor Presentation Capricor Therapeutics, Inc. Developing Transformative Therapies from Bench to Bedside NASDAQ: CAPR August 2020 Forward-Looking Statements Statements in this presentation regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulator ...