Capricor Therapeutics

Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of first-in-class biological therapies for the treatment of cardiac and other serious medical conditions. Its product candidate consists of CAP-1002, Cenderitide, Exosomes, CAP-1001, CU-NP and CSps. The company was founded on June 17, 1996 and is headquartered in San Diego, CA.

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Capricor Therapeutics reports strong Q4 performance and advances DMD therapy

Capricor Therapeutics showcased strong financial performance, progress in DMD therapy, and strategic partnerships with Nippon Shinyaku and NS Pharma.
The company faces challenges in FDA interactions, share sales, and potential acquisition decisions, but opportunities lie in market expansion and community engagement.
Overall, Capricor's confidence in its therapies and partnerships positions it well for future growth and impact in the Duchenne Muscular Dystrophy space.
The call concluded with gratitude towards participants, supporters, and the Capricor team, highlighting a positive outlook for the company's future endeavors.

Capricor Therapeutics advances DMD programs and secures Japan distribution

Capricor Therapeutics made significant progress in Q1 2023 with advancements in DMD programs, manufacturing, and clinical trials.
While facing financial losses, the company's strategic strengths include FDA discussions, partnerships, and international expansion.
Challenges in financial stability and operational efficiency need to be addressed, but opportunities in funding, market expansion, and innovation are promising.

Capricor Therapeutics reports Q2 progress with positive clinical outcomes

Capricor Therapeutics showcased solid financial performance amid ongoing R&D investments, with a focus on advancing innovative therapies for Duchenne muscular dystrophy.
The company's strengths lie in positive clinical trial outcomes, regulatory support, and strategic board additions, positioning Capricor for future growth and success.
Challenges include financial sustainability, trial coordination, and manufacturing scalability, which require careful management to navigate effectively.
Opportunities in new indications, partnerships, upcoming milestones, and technology advancement offer avenues for expansion, value creation, and competitive differentiation.

Capricor Therapeutics achieves enrollment goal, eyes FDA approval acceleration

Capricor Therapeutics is making significant strides in its clinical trials and manufacturing capabilities, supported by a strong financial position. While challenges exist in managing expenses and navigating regulatory processes, the company is well-positioned to capitalize on growth opportunities in the biopharmaceutical sector.

Capricor Therapeutics reports positive trial results and strategic partnerships for growth

Capricor Therapeutics' Q4 2023 performance reflects a strong financial position but with a net loss, driven by positive trial results for CAP-1002 in DMD.
The company's strengths include successful trial outcomes, strategic partnerships, and advancements in exosome technology development.
Challenges include operational losses, regulatory hurdles, and market competition, while opportunities exist in partnerships, FDA interactions, and technology development.
Overall, Capricor Therapeutics is poised for growth with a focus on commercialization, regulatory progress, and expanding therapeutic applications.

Capricor Therapeutics excels in Q1 2024, poised for market expansion

Capricor Therapeutics shows strong financial performance and progress in DMD trial, positioning CAP-1002 favorably in the market.
Strategic focus on regulatory alignment, commercial readiness, and potential expansions highlight growth opportunities.
Challenges in regulatory compliance, operational execution, and market competition require proactive management strategies.
Overall, Capricor's advancements in therapy development and market positioning indicate a promising outlook for future growth.

Capricor Therapeutics reports Q3 progress, eyes market expansion opportunities

Capricor Therapeutics demonstrated financial resilience with steady revenue growth and a strong cash position, despite a net loss.
The company's focus on product development, market expansion, and strategic collaborations underscores a commitment to innovation and growth.
While facing challenges in managing expenses and navigating regulatory complexities, Capricor is well-positioned to capitalize on opportunities in new therapeutic areas and market access.
Overall, Capricor's progress on deramiocel, manufacturing scale-up, and future development plans signal a promising trajectory for sustained growth and market success.

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Capricor Therapeutics, Inc. engages in the discovery, development and commercialization of biological therapies for the treatment of cardiac and other serious medical conditions. Its product candidate consists of CAP-1002, Cenderitide, Exosomes, CAP-1001, CU-NP and CSps. The company was founded on June 17, 1996 and is headquartered in San Diego, CA.

-Project NextGen Collaboration will Support Capricor's StealthX™ Exosome Platform and Provide Non-Dilutive Support for Advancement into the Clinic-

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2

--Favorable Interim Futility Analysis Results-- --Successful Completion Triggers First Milestone Payment Under U.S. Agreement with Nippon Shinyaku--

Capricor Therapeutics Announces Continuation of Phase 3 HOPE-3 Trial of CAP-1002 in Duchenne Muscular Dystrophy Based on Completion of Interim Futility Analysis

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.

Capricor Therapeutics, Inc. (CAPR) Q3 2023 Earnings Call Transcript

-Completed Targeted Enrollment for HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy- -On Track to Report Interim Futility Analysis in Fourth Quarter of 2023; Successful Outcome Would Trigger Milestone Payment to Capricor Under Commercialization and Distribution Deal with Nippon Shinyaku- -Positive FDA Feedback on the Proposed Key Clinical and Regulatory Requirements Confirms CAP-1002's Path Towards a Biologics License Application Submission- -Conference Call and Webcast Today at 4:30 p.m. ET- SAN DIEGO, Nov. 14, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics  (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today its financial results for the third quarter ended September 30, 2023 and provided a corporate update.

Capricor Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update

SAN DIEGO, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, will release its financial results for the third quarter ended September 30, 2023, after the market close on Tuesday, November 14, 2023. Management will then host a webcast and conference call at 4:30 p.m.

Capricor Therapeutics to Present Third Quarter 2023 Financial Results and Recent Corporate Update on November 14

Sarepta Therapeutics

Recent dip in CAPR's stock price following update on regulatory pathway for CAP-1002 and cash raise represents a buying opportunity. Completion of enrollment of Cohort A of ongoing Phase 3 trial of CAP-1002 is expected in Q4 2023, topline results in Q4 2024 and BLA submission in 2025. Risks for CAPR include; failure of ongoing Phase 3 trial, regulatory delays and need for more dilutive cash raise by the end of 2024.

Capricor Therapeutics, Sarepta Therapeutics: A Promising Clinical-Stage Biotech And A Commercial-Stage Leader In Duchenne Muscular Dystrophy

Capricor (CAPR) has become technically an oversold stock now, which implies exhaustion of the heavy selling pressure on it. This, combined with strong agreement among Wall Street analysts in revising earnings estimates higher, indicates a potential trend reversal for the stock in the near term.

After Plunging -52.01% in 4 Weeks, Here's Why the Trend Might Reverse for Capricor (CAPR)

The heavy selling pressure might have exhausted for Capricor (CAPR) as it is technically in oversold territory now. In addition to this technical measure, strong agreement among Wall Street analysts in revising earnings estimates higher indicates that the stock is ripe for a trend reversal.

After Plunging -50.99% in 4 Weeks, Here's Why the Trend Might Reverse for Capricor (CAPR)

SAN DIEGO, Oct. 19, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, announced today that the Company will host a webinar with the nonprofit organization Parent Project Muscular Dystrophy (PPMD) to review key regulatory details and provide clinical updates that support the advancement of its ongoing HOPE-3, Phase 3 clinical trial of CAP-1002 for treating Duchenne muscular dystrophy (DMD). The webinar will be held on Wednesday, October 25, 2023 at 1:00 p.m.

Capricor Therapeutics and Parent Project Muscular Dystrophy to Host Webinar to Review Latest Developments of CAP-1002 Program

-24-Month Open Label Extension Data from HOPE-2 Study Supports CAP-1002's Sustained Efficacy and Safety in Treating Duchenne Muscular Dystrophy-

Capricor Therapeutics Announces Late-Breaking Presentations at 28th Annual Congress of the World Muscle Society

SAN DIEGO, Sept. 29, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced that it has entered into definitive agreements with its commercial partner, Nippon Shinyaku, Co., Ltd. and funds associated with Highbridge Capital Management, LLC. for the issuance and sale of 4,935,621 shares of its common stock in a registered direct offering. Each share of common stock offered was sold with a warrant to purchase one share of common stock at an exercise price of $5.70 per share. Each warrant will be exercisable beginning six months after issuance and will expire seven years from the date of issuance. The combined offering price per share of common stock and accompanying warrant is $4.66. The closing of the offering is expected to occur on or about October 3, 2023, subject to the satisfaction of customary closing conditions.

Capricor Therapeutics Announces $23 Million Registered Direct Offering

-FDA Feedback on the Proposed Key Clinical and Regulatory Requirements Confirms CAP-1002's Path Towards a Biologics License Application (BLA)-

Capricor Therapeutics Announces Positive Type-B Meeting with the FDA to Discuss Pathway to BLA for CAP-1002 in Duchenne Muscular Dystrophy

SAN DIEGO, Calif., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced that the Company has appointed Michael Kelliher to its Board of Directors, effective immediately. Mr. Kelliher, Group Vice President of M&A and Business Development at Horizon Therapeutics, brings to Capricor extensive expertise in business development, strategy, finance and operational leadership across the life sciences industry.

Capricor Therapeutics Appoints Michael Kelliher to Board of Directors

There is an ongoing phase 3 study, known as HOPE-3, deploying the use of CAP-1002 for the treatment of patients with Duchenne Muscular Dystrophy; Interim analysis expected Q4 of 2023. A Type-B FDA meeting was held between the company and the FDA; Minutes from this FDA meeting are going to be released when available. The global Duchenne Muscular Dystrophy Drugs market size is expected to reach $10.92 billion by 2028.

Capricor: Q4 2023 Interim Analysis For DMD Treatment Makes This A Must Watch

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.

Capricor Therapeutics, Inc. (CAPR) Q2 2023 Earnings Call Transcript

-Presented Statistically Significant 24-Month HOPE-2 Open Label Extension Data at the PPMD Annual Conference- -Enrollment Continues to Progress in HOPE-3, the Phase 3 Trial of CAP-1002 in Duchenne Muscular Dystrophy; On Track to Complete Enrollment and Report Interim Analysis in Fourth Quarter of 2023- -Held Type-B Clinical Meeting with the FDA to Discuss CAP-1002's Pathway Towards Potential Biologics License Application Submission- -Conference Call and Webcast Today at 4:30 p.m. ET- SAN DIEGO, Calif.

Capricor Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update

SAN DIEGO, Aug. 02, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, will release its financial results for the second quarter ended June 30, 2023, after the market close on Monday, August 7, 2023. Management will then host a webcast and conference call at 4:30 p.m.

Capricor Therapeutics to Present Second Quarter 2023 Financial Results and Recent Corporate Update on August 7

SAN DIEGO, July 24, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced the appointment of Philip J. Gotwals, Ph.D., to its Board of Directors, effective immediately. Dr. Gotwals, most recently the Global Head, Vice President of Business Development and Licensing at Novartis Institutes for Biomedical Research, brings his strategic vision for research, innovation for drug development and valuable industry experience to the Company.

Capricor Therapeutics Announces Appointment of Philip J. Gotwals, Ph.D.

-John Hopkins School of Medicine Clinical Director Joins Capricor's Board of Directors with over 30 Years of Internal Medicine and Infectious Disease Experience-

Capricor Therapeutics Announces Appointment of Paul Auwaerter, M.D. to its Board of Directors

-Improvements in Left Ventricular Ejection Fraction (LVEF) for the Majority of Patients Suggest Preservation of Cardiac Function-

Capricor Therapeutics Announces Positive 24-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy

Safety and Efficacy Results to be Presented at 2023 Parent Project Muscular Dystrophy Annual Conference Safety and Efficacy Results to be Presented at 2023 Parent Project Muscular Dystrophy Annual Conference

Capricor Therapeutics to Present 24-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy

Upcoming Meeting Planned in Early Q3 2023 to Discuss CAP-1002's Pathway Towards Potential Biologics License Application Submission Upcoming Meeting Planned in Early Q3 2023 to Discuss CAP-1002's Pathway Towards Potential Biologics License Application Submission

Capricor Therapeutics Announces Follow-up Type-B Clinical Meeting with the FDA for CAP-1002 for the Treatment of Duchenne Muscular Dystrophy

Capricor Therapeutics, Inc. (NASDAQ:CAPR ) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants AJ Bergmann - CFO Linda Marban - CEO Conference Call Participants Aydin Huseynov - Ladenburg Operator Good afternoon, ladies and gentlemen, this is the conference operator. Welcome to Capricor First Quarter 2023 Financial Results and Corporate Update Call.

Capricor Therapeutics, Inc. (CAPR) Q1 2023 Earnings Call Transcript

-Enrollment Continues to Progress in HOPE-3, the Phase 3 Clinical Trial of CAP-1002 in Duchenne Muscular Dystrophy (DMD); On Track to Report Interim Analysis in Fourth Quarter of 2023-

Capricor Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update

SAN DIEGO, May 04, 2023 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, will release its financial results for the first quarter ended March 31, 2023, after the market close on Thursday, May 11, 2023. Management will then host a webcast and conference call at 4:30 p.m.

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