Capricor DMD Spezialist (Seite 2)
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ISIN: US14070B3096 · WKN: A2PLU4 · Symbol: 4LN2
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Antwort auf Beitrag Nr.: 75.311.932 von bonDiacomova am 20.02.24 15:37:02Endlich mal wieder Bewegung in der Aktie
gab heute die Ausweitung der Produktionskapazität von CAP-1002 auf seine neue, hochmoderne Produktionsanlage in San Diego bekannt, die vorbehaltlich der behördlichen Genehmigung für die kommerzielle Nutzung vorgesehen ist. Darüber hinaus gab das Unternehmen bekannt, dass die Rekrutierung für Kohorte B seiner klinischen Phase-3-Studie HOPE-3 schnell voranschreitet und die vollständige Rekrutierung (n=44) voraussichtlich im zweiten Quartal 2024 abgeschlossen sein wird.
“We are extremely pleased with the progress of our manufacturing scale-up efforts in connection with our new San Diego facility which brings us one step closer towards a successful launch of CAP-1002, should we obtain approval, to meet the significant unmet need in this broad and underserved patient population. This facility was designed to be a versatile and cost-effective way to bring CAP-1002 to market efficiently and it is expected that our enhanced manufacturing capacity to increase our supply capabilities and improve our margins,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Furthermore, with Cohort A of the HOPE-3 trial being fully enrolled and topline data readout expected in the fourth quarter of 2024, we plan to meet with the U.S. Food & Drug Administration (FDA) with the aim to discuss possible expedited pathways to approval.”
https://finance.yahoo.com/news/capricor-therapeutics-announc…
“We are extremely pleased with the progress of our manufacturing scale-up efforts in connection with our new San Diego facility which brings us one step closer towards a successful launch of CAP-1002, should we obtain approval, to meet the significant unmet need in this broad and underserved patient population. This facility was designed to be a versatile and cost-effective way to bring CAP-1002 to market efficiently and it is expected that our enhanced manufacturing capacity to increase our supply capabilities and improve our margins,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Furthermore, with Cohort A of the HOPE-3 trial being fully enrolled and topline data readout expected in the fourth quarter of 2024, we plan to meet with the U.S. Food & Drug Administration (FDA) with the aim to discuss possible expedited pathways to approval.”
https://finance.yahoo.com/news/capricor-therapeutics-announc…
Capricor Therapeutics Announces Collaboration with the National Institutes of Health
for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2
...today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19.
As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study.
...Im Rahmen des Projekts NextGen wird das National Institute of Allergy and Infectious Diseases (NIAID), Teil der National Institutes of Health, vorbehaltlich der behördlichen Genehmigung eine klinische Phase-1-Studie mit dem StealthX™-Impfstoff von Capricor durchführen. Die Abteilung für Mikrobiologie und Infektionskrankheiten (DMID) des NIAID würde die Studie beaufsichtigen.
https://finance.yahoo.com/news/capricor-therapeutics-announc…
for Clinical Trial of Novel Exosome-Based Multivalent Vaccine for SARS-CoV-2
...today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19.
As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study.
...Im Rahmen des Projekts NextGen wird das National Institute of Allergy and Infectious Diseases (NIAID), Teil der National Institutes of Health, vorbehaltlich der behördlichen Genehmigung eine klinische Phase-1-Studie mit dem StealthX™-Impfstoff von Capricor durchführen. Die Abteilung für Mikrobiologie und Infektionskrankheiten (DMID) des NIAID würde die Studie beaufsichtigen.
https://finance.yahoo.com/news/capricor-therapeutics-announc…
On January 11, 2024, Capricor Therapeutics, Inc., a Delaware corporation (the “Company”), announced that it has received its first milestone payment of $10.0 million from Nippon Shinyaku, Co., Ltd. under its U.S. Exclusive Commercialization and Distribution Agreement dated January 24, 2022.
The milestone payment was triggered by the receipt of results of the interim futility analysis, reviewed by the Data Safety Monitoring Board, resulting in a favorable recommendation to continue the HOPE-3 trial as planned.
https://de.advfn.com/borse/NASDAQ/CAPR/nachrichten/93019543/…
The milestone payment was triggered by the receipt of results of the interim futility analysis, reviewed by the Data Safety Monitoring Board, resulting in a favorable recommendation to continue the HOPE-3 trial as planned.
https://de.advfn.com/borse/NASDAQ/CAPR/nachrichten/93019543/…
Antwort auf Beitrag Nr.: 74.974.516 von bonDiacomova am 16.12.23 06:10:28Freue mich auch über langsam stetige Entwicklung, kann nur noch besser werden.
Trading Spotlight
gute entwicklung nach den Favorable Interim Futility Analysis Results
dazu gestern - auf einem freitag
nach us boersebschluss
16:10:58 4.34 $ 22635 st
16:05:21 4.3397 $ 4885 st
16:01:32 4.34 $ 49301 st
dazu gestern - auf einem freitag
nach us boersebschluss
16:10:58 4.34 $ 22635 st
16:05:21 4.3397 $ 4885 st
16:01:32 4.34 $ 49301 st
F & F
--Favorable Interim Futility Analysis Results----Successful Completion Triggers First Milestone Payment Under U.S. Agreement with Nippon Shinyaku--
--HOPE-3 (Cohort A) Enrollment Complete; Topline Data Expected in the Fourth Quarter of 2024; Cohort B Enrollment Initiated--
--Company Plans to Request a Meeting with FDA in the First Quarter of 2024 to Further Discuss Opportunities for Expedited Approval Pathways--
today announced a positive outcome of the interim futility analysis for HOPE-3, the pivotal Phase 3 trial evaluating CAP-1002 in patients with Duchenne muscular dystrophy (DMD). The results of the interim futility analysis, reviewed by the Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the HOPE-3 trial as planned. This interim futility analysis triggers the first milestone payment under the Company’s U.S. Commercialization and Distribution Agreement with Nippon Shinyaku Co., Ltd.
https://finance.yahoo.com/news/capricor-therapeutics-announc…
Q3 2023 Earnings Call Transcript
This afternoon’s press release provided a summary of our third quarter 2023 financials on a GAAP basis, and you may also refer to our quarterly report on Form 10-Q, which we expect to become available shortly and will be accessible on the SEC website, as well as the financial section of our website. Turning to the financials, let me start with our cash position. We ended September 30, 2023 with cash, cash equivalents and marketable securities of approximately $28.5 million. This excludes the $23 million in gross proceeds from the registered direct offering we completed in October that bolstered our cash position. Based on our recent operating results and current projections, we now expect our cash runway to extend into 2025, an extension from our prior guidance.Die Pressemitteilung von heute Nachmittag enthielt eine Zusammenfassung unserer Finanzzahlen für das dritte Quartal 2023 auf GAAP-Basis. Sie können sich auch auf unseren Quartalsbericht auf Formular 10-Q beziehen, der voraussichtlich in Kürze verfügbar sein wird und auf der SEC-Website verfügbar sein wird sowie den Finanzbereich unserer Website. Was die Finanzen betrifft, möchte ich mit unserer Liquiditätsposition beginnen. Wir schlossen am 30. September 2023 mit Bargeld, Zahlungsmitteläquivalenten und marktfähigen Wertpapieren in Höhe von etwa 28,5 Millionen US-Dollar ab. Darin nicht enthalten sind die Bruttoerlöse in Höhe von 23 Millionen US-Dollar aus der registrierten Direktemission, die wir im Oktober abgeschlossen haben und die unsere Liquiditätsposition stärkte. Basierend auf unseren jüngsten Betriebsergebnissen und aktuellen Prognosen gehen wir nun davon aus, dass sich unsere Cash Runway bis ins Jahr 2025 erstrecken wird, eine Verlängerung unserer vorherigen Prognose.
https://finance.yahoo.com/news/capricor-therapeutics-inc-nas…
Third Quarter 2023 Financial Results and Provides Corporate Update
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
Next steps for Cohort A:
Plan to report the outcome from the interim futility analysis in the fourth quarter of 2023. A successful outcome from the analysis will trigger the first milestone payment under our U.S. Exclusive Distribution and Commercialization Agreement with Nippon Shinyaku.
Plan to report top-line data from Cohort A in the fourth quarter of 2024.
Held a positive Type-B clinical meeting with FDA in the third quarter of 2023. The FDA affirmed alignment on the current HOPE-3 clinical trial design. Based on the feedback from FDA, we plan to submit a Biologics License Application (BLA), supported by results from Cohort A using product manufactured from our Los Angeles site.
Anticipated Milestones and Events
The Company has set forth the following guidance for pipeline progression:
Plan to report outcome from interim futility analysis of HOPE-3 (Cohort A) in the fourth quarter of 2023.
Plan to initiate HOPE-3 (Cohort B) enrollment in the fourth quarter of 2023.
Capricor plans to request a meeting with FDA in the first quarter of 2024 to discuss our CAP-1002 program for DMD.
Plan to report topline data from HOPE-3 (Cohort A) in the fourth quarter of 2024.
Continue to explore opportunities for additional partnerships outside of the U.S. and Japan to support the potential commercialization of CAP-1002 in DMD.
Continue to explore opportunities for partnerships and non-dilutive sources of funding to support advancement of our StealthX™ exosome platform technology.
The Company’s cash, cash equivalents and marketable securities totaled
approximately $ 28.5 million as of September 30, 2023
Financial Outlook
Capricor believes that based on the current operating plan and financial resources, its available cash, cash equivalents and marketable securities will be sufficient to cover anticipated expenses and capital requirements into 2025. This expectation includes the recent registered direct offering which closed in October 2023 for approximately $23.0 million in gross proceeds and excludes any additional potential milestone payments under its exclusive commercialization and distribution agreements with Nippon Shinyaku, as well as any strategic use of capital not currently in the Company’s base-case planning assumptions.
https://finance.yahoo.com/news/capricor-therapeutics-reports…
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