Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q4 2023 Earnings Conference Call February 29, 2024 4:30 PM ET Company Participants AJ Bergmann - Chief Financial Officer Linda Marban - Chief Executive Officer Conference Call Participants Joseph Pantginis - H.C. Wainright Kristen Kluska - Cantor Fitzgerald Aydin Huseynov - Ladenburg Operator Good afternoon, ladies and gentlemen, and welcome to Capricor Therapeutics Fourth Quarter 2023 Earnings Call. At this time, all lines are in listen-only mode. Following the pre ...

Financial Performance - Capricor reported total revenue of approximately $12.1 million for Q4 2023, a significant increase from approximately $1.0 million in Q4 2022, representing a growth of over 1,100%[10] - The company’s total operating expenses for Q4 2023 were approximately $13.2 million, compared to approximately $9.0 million in Q4 2022, reflecting a year-over-year increase of about 46%[14] - Capricor's net loss for Q4 2023 was approximately $0.8 million, or $0.02 per share, a substantial improvement from a net loss of approximately $7.7 million, or $0.31 per share, in Q4 2022[15] - For the full year 2023, Capricor reported a net loss of approximately $22.3 million, or $0.83 per share, compared to a net loss of approximately $29.0 million, or $1.18 per share, for the full year 2022[15] Cash and Milestone Payments - The company’s cash, cash equivalents, and marketable securities totaled approximately $39.5 million as of December 31, 2023, down from approximately $41.4 million on December 31, 2022[13] - Capricor received its first milestone payment of $10.0 million under its U.S. Distribution and Commercialization Agreement with Nippon Shinyaku in January 2024[13] - Positive outcome from interim futility analysis triggered a $10 million milestone payment under the U.S. Distribution and Commercialization Agreement with Nippon Shinyaku[32] - Potential for $90 million in additional milestone payments prior to approval and $605 million post-approval based on sales targets[32] Clinical Trials and FDA Meetings - The company plans to have a Type-B meeting with the FDA in Q1 2024 to discuss commercial manufacturing planning for CAP-1002[1] - Capricor plans to report topline data from the HOPE-3 (Cohort A) study in Q4 2024[1] - Enrollment completed in Cohort A of Phase 3 HOPE-3 trial with 61 subjects randomized in a 1:1 ratio[32] - Cohort B enrollment underway, aiming for approximately 44 subjects, expected to complete by Q2 2024[32] - FDA Type-B meeting in Q1 2024 to discuss expedited BLA pathway for CAP-1002[26] Partnerships and Collaborations - The company is exploring additional partnerships outside of the U.S. and Japan to support the commercialization of CAP-1002 for DMD[1] - Collaboration with NIAID for a Phase 1 clinical trial of an exosome-based multivalent vaccine for SARS-CoV-2[26] Product Development - Capricor's proprietary StealthX™ exosome-based vaccine for SARS-CoV-2 is part of Project NextGen, with a Phase 1 clinical trial to be conducted by NIAID[23] - New San Diego manufacturing facility established to scale up CAP-1002 production for commercial use[32] - Capricor's proprietary StealthX™ platform technology is being developed for targeted delivery of therapeutics[33] Trial Outcomes - Positive data from HOPE-2 OLE trial showing a delta change of 4.9 points (p=0.021) after 24 months of treatment[32] - Anticipated top-line data from Cohort A to be reported in Q4 2024[32]

SAN DIEGO, Feb. 27, 2024 (GLOBE NEWSWIRE) -- – Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, announced today that the Company has been granted an in-person Type-B meeting with the U.S. Food & Drug Administration (FDA) scheduled for late March. In the upcoming meeting with the FDA, the Company intends to discuss its proposed chemistry, manufacturing and controls (CMC) plans for comm ...

-Project NextGen Collaboration will Support Capricor's StealthX™ Exosome Platform and Provide Non-Dilutive Support for Advancement into the Clinic- SAN DIEGO, Jan. 24, 2024 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ:CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor's proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has ...

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q3 2023 Results Conference Call November 14, 2023 4:30 PM ET Company Participants AJ Bergmann - CFO Linda Marbán - CEO Conference Call Participants Joe Pantginis - H.C. Wainwright Aydin Huseynov - Ladenburg Operator Good afternoon, ladies and gentlemen and welcome to the Capricor’s Third Quarter 2023 Financial Results and Corporate Update Call. This conference call is being recorded. I would now like to turn the conference call over to our host, Mr. AJ Bergmann, Cap ...

Financial Performance - For the three months ended September 30, 2023, clinical development income was approximately $6.2 million, up from $1.6 million in the same period of 2022, representing a significant increase [112]. - The company reported net losses of approximately $6.4 million for both the three months ended September 30, 2023, and 2022, and approximately $21.5 million for the nine months ended September 30, 2023, compared to $21.3 million in 2022 [92]. - Net loss for the nine months ended September 30, 2023, was $21,525,453 compared to a net loss of $21,298,620 for the same period in 2022 [191]. - The company recorded a comprehensive loss of approximately $6.5 million for the three months ended September 30, 2023, compared to $6.3 million for the same period in 2022 [226]. Research and Development Expenses - Research and development (R&D) expenses for the nine months ended September 30, 2023, increased by approximately $10.9 million, or 70%, compared to the same period in 2022, primarily driven by ongoing clinical trials and expanded manufacturing efforts [114]. - Research and development (R&D) expenses for the three months ended September 30, 2023 increased by approximately $4.5 million, or 82%, compared to the same period in 2022, totaling $10,028,964 [126]. - Research and development costs for the three months ended September 30, 2023, were approximately $10.0 million, compared to approximately $5.5 million for the same period in 2022 [233]. - For the nine months ended September 30, 2023, research and development costs totaled approximately $26.5 million, up from approximately $15.6 million in 2022 [233]. - CAP-1002 program for Duchenne muscular dystrophy (DMD) incurred expenses of $5,616,093 for the nine months ended September 30, 2023, representing a 174% increase compared to $2,045,997 in the same period in 2022 [126]. Cash Flow and Liquidity - Total cash, cash equivalents, and marketable securities as of September 30, 2023 were approximately $28.5 million, down from approximately $41.4 million as of December 31, 2022 [144]. - Cash used in operating activities for the nine months ended September 30, 2023 was approximately $14.0 million, compared to cash provided of approximately $11.8 million in the same period in 2022 [136]. - Cash and cash equivalents balance at the end of the period was $8,984,667, a decrease from $34,885,274 at the beginning of the period [191]. - The company’s principal uses of cash include research and development expenses, general and administrative expenses, and capital expenditures [185]. - The company’s future capital requirements may be substantial, with potential financing options including equity or debt securities and government grants [198]. Offerings and Financing - The company completed a registered direct offering on October 3, 2023, raising approximately $23.0 million through the sale of 4,935,621 shares at a price of $4.66 per share [107]. - On October 3, 2023, the company entered into Securities Purchase Agreements to issue 4,935,621 shares at a price of $4.66 per share, raising approximately $23.0 million [151]. - The company has sold an aggregate of 2,620,703 shares under its ATM Program at an average price of approximately $5.74 per share for gross proceeds of approximately $15.0 million [152]. - Capricor received an upfront payment of $30.0 million from Nippon Shinyaku under the U.S. Distribution Agreement for CAP-1002, with potential milestones totaling up to $100.0 million [157]. Clinical Trials and Development - CAP-1002's HOPE-3 clinical trial has reached its target enrollment of 58 patients, with Cohort B expected to commence enrollment in the fourth quarter of 2023 [102]. - The company plans to report the outcome from the interim futility analysis of the CAP-1002 program in the fourth quarter of 2023 and top-line data from Cohort A in the fourth quarter of 2024 [93]. - The FDA affirmed alignment on the current HOPE-3 clinical trial design during a Type-B clinical meeting held in the third quarter of 2023, supporting the submission of a Biologics License Application (BLA) for CAP-1002 [94]. General and Administrative Expenses - General and administrative (G&A) expenses for the three months ended September 30, 2023 increased by approximately $0.5 million, or 18%, compared to the same period in 2022, totaling $3,021,450 [122]. - Total general and administrative expenses for Q3 2023 were $1,235,219, compared to $943,075 in Q3 2022, representing a 31% increase [276]. Other Financial Metrics - The company has an accumulated deficit of approximately $158.6 million as of September 30, 2023, and expects to incur significant expenses and operating losses for the foreseeable future [92]. - Total liabilities as of September 30, 2023 were approximately $38.9 million, with $26.4 million related to deferred revenue [144]. - The company has a liability balance of approximately $3.4 million related to the CIRM Award as of September 30, 2023 [154]. - The company has not recognized an income tax benefit due to uncertainty regarding realization [260].

Capricor Therapeutics, Inc. (NASDAQ:CAPR) Q2 2023 Earnings Call Transcript August 7, 2023 4:20 PM ET Company Participants AJ Bergmann - CFO Linda Marban - CEO Conference Call Participants Joe Pantginis - H.C. Wainwright Operator Good afternoon, ladies and gentlemen and welcome to the Capricor Therapeutics Second Quarter 2023 Financial Results and Corporate Update Call. At this time all lines are in a listen-only mode. Following the presentation we’ll conduct a question-and-answer session. [Operator Instruct ...

Leases will be classified as financing or operating, which will drive the expense recognition pattern. The Company elects to exclude short-term leases if and when the Company has them. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilizes its incremental borrowing rate, which reflects the fixed rate at which the Company could 38 For real estate leases, the Company has elected the practical expedient under ASC 842 to account for the lease and n ...

Financial Data and Key Metrics Changes - As of March 31, 2023, the company's cash, cash equivalents, and marketable securities totaled approximately $45.2 million, an increase from approximately $41.4 million on December 31, 2022 [26] - The net cash provided by operating activities for Q1 2023 was approximately $4.2 million, while the net loss for both Q1 2023 and Q1 2022 was approximately $7.8 million [27][28] Business Line Data and Key Metrics Changes - Research and development expenses, excluding stock-based compensation, were approximately $7.2 million in Q1 2023, compared to approximately $4.9 million in Q1 2022 [27] - General and administrative expenses, excluding stock-based compensation, were approximately $1.8 million in Q1 2023, slightly down from approximately $1.9 million in Q1 2022 [27] Market Data and Key Metrics Changes - The company is focused on securing partnerships and non-dilutive funding opportunities to expand its exosome pipeline and support the commercialization of CAP-1002 [6][20] Company Strategy and Development Direction - The company aims to work closely with the FDA to expedite the filing of a Biologics License Application (BLA) for CAP-1002, with plans to present 24-month follow-up data from the HOPE-2 study in Q2 2023 [13][15] - The company has entered into a second agreement with Nippon Shinyaku for the distribution rights to CAP-1002 in Japan, receiving a $12 million upfront payment and potential milestone payments of up to approximately $89 million [20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the FDA's attention to CAP-1002 and the potential for the product to benefit patients with Duchenne muscular dystrophy (DMD) [33] - The company believes that combination therapies will be necessary for long-term disease progression management in DMD, positioning CAP-1002 as a complementary treatment alongside gene therapies [19][40] Other Important Information - The company is on track to release GMP CAP-1002 doses in Q3 2023, which is expected to enhance margins and support the early launch of the product [8] - The company is exploring business development and partnering strategies for its exosome platform, which is focused on developing innovative therapeutic applications [24] Q&A Session Summary Question: Are there any additional rate limiting steps regarding CAP-1002 commercialization? - Management stated that there are no known rate limiting steps at this time and expressed encouragement from the FDA's engagement [33] Question: Any updates on the clinical development timeline for the exosome platform? - Management indicated that internal work is ongoing, with encouraging data regarding targeting specific cell types and exploring partnerships and funding opportunities [34] Question: Will the FDA AdComm meeting for DMD gene therapy affect CAP-1002? - Management believes the entire biotechnology industry will be impacted and emphasized the importance of CAP-1002 as a combination therapy for DMD [40] Question: Any updates on European partnerships and Nippon Shinyaku's interest in Europe? - Management confirmed a strong relationship with Nippon Shinyaku and is considering various options for European rights, potentially including Nippon Shinyaku [50] Question: Will the company commercialize any product independently? - Management plans to take CAP-1002 to the door of commercialization before partnering, ensuring the right partner is selected for rapid market entry [51]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ☒ Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the quarterly period ended March 31, 2023 ☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the transition period from to CAPRICOR THERAPEUTICS, INC. (Exact Name Of Registrant As Specified In Its Charter) 10865 Road to the Cure, Suite 150, San Diego, California 92121 (Address of principal executive o ...