Associated tags: Fast track (FDA), Buddha's hand, Injury, Patient, HUMA, Tissue, Moyamoya disease, HAV, Medicine, Pharmaceutical industry, Vibration, Defense, Food, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration
Locations: NEW YORK, NY, DURHAM, NC, US, UKRAINE, COLUMBUS, UNITED STATES, NEW YORK CITY
In addition, in April 2023 Humacyte completed enrollment in a Phase 3 trial in AV Access comparing the HAV to the current standard of care, autologous arteriovenous fistula.
Key Points:
- In addition, in April 2023 Humacyte completed enrollment in a Phase 3 trial in AV Access comparing the HAV to the current standard of care, autologous arteriovenous fistula.
- Top-line results are planned to be available during 2024.
- A live question and answer session will follow the formal presentations.
- A replay will be made available here after the call.
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PDUFA,
Pharmaceutical industry DURHAM, N.C., March 22, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the fourth quarter and year ended December 31, 2023 and highlighted recent corporate accomplishments in advancing the investigational Human Acellular Vessel (HAV) closer to planned U.S. market launch.
Key Points:
- There was no revenue for either the fourth quarter of 2023 or the fourth quarter of 2022, and there was no revenue for the year ended December 31, 2023.
- Research and development expenses were $20.2 million for the fourth quarter of 2023, compared to $15.0 million for the fourth quarter of 2022, and were $76.6 million for the year ended December 31, 2023, compared to $63.3 million for the year ended December 31, 2022.
- General and administrative expenses were $6.0 million for the fourth quarter of 2023, compared to $5.8 million for the fourth quarter of 2022, and were $23.5 million for the year ended December 31, 2023, compared to $22.9 million for the year ended December 31, 2022.
- The 2023 increases in net loss resulted from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above.
DURHAM, N.C., March 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2023, on Friday, March 22, 2024.
Key Points:
- DURHAM, N.C., March 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the fourth quarter and year ended December 31, 2023, on Friday, March 22, 2024.
- Management will host a webcast and conference call at 8:00 a.m.
- ET to provide a corporate and financial update.
Retrieved on:
Tuesday, December 12, 2023
Food,
Priority review,
Infection,
HUMA,
Injury,
FDA,
File,
HAV,
Tissue,
MD,
Doctor of Philosophy,
Biologics license application,
Defense,
Amputation,
Public law,
Patient,
Food and Drug Administration,
BLA,
Pharmaceutical industry DURHAM, N.C., Dec. 12, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that it has submitted a Biologics License Application (BLA) to U.S. Food and Drug Administration (FDA) seeking approval of the Human Acellular Vessel (HAV) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated, and when autologous vein use is not feasible. The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine. The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.
Key Points:
- The BLA submission is supported by positive results from the V005 Phase 2/3 clinical trial as well as from the treatment of wartime injuries in Ukraine.
- The HAV was observed to have higher rates of patency (blood flow), and lower rates of amputation and infection, as compared to historic synthetic graft benchmarks.
- Humacyte has requested Priority Review of the application and, if granted, the review should be completed within six months of the filing acceptance date.
- In May 2023 the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation for use of the HAV in urgent arterial repair following extremity vascular trauma.
Retrieved on:
Friday, November 24, 2023
DURHAM, N.C., Nov. 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the Piper Sandler 35th Annual Healthcare Conference, in New York, NY on November 30, 2023.
Key Points:
- DURHAM, N.C., Nov. 24, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the Piper Sandler 35th Annual Healthcare Conference, in New York, NY on November 30, 2023.
- Management will also be available for one-on-one meetings.
- Location: The Lotte New York Palace, New York, NY
A replay will be available for a limited time following the presentation on the Events & Presentations portion of the Humacyte website.
Retrieved on:
Friday, November 17, 2023
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HAV,
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HUMA,
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File,
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MD,
Patient,
Safety DURHAM, N.C., Nov. 17, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced the presentation of positive V005 Phase 2/3 clinical trial results of the investigational Human Acellular Vessel (HAV) in the treatment of vascular trauma, as well as results from the treatment of wartime injuries in Ukraine. The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City. Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks. Humacyte plans to file a Biologics License Application (BLA) for the HAV for an indication in vascular trauma patients with the U.S. Food and Drug Administration (FDA) during the current quarter.
Key Points:
- The two presentations were made at the VEITHsymposium, a major vascular surgery conference in New York City.
- Results showed the HAV had higher rates of patency (blood flow), and lower rates of amputation and infection, compared to historic synthetic graft benchmarks.
- Fox, MD, FACS, Director of Vascular Surgery at the University of Maryland Capital Region, a clinical investigator in the V005 trial.
- Common adverse events reported were anemia, vascular graft thrombosis, blood loss anemia, pyrexia, thrombocytopenia, constipation, nausea peripheral edema, and tachycardia.
Retrieved on:
Thursday, November 9, 2023
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Tetralogy of Fallot DURHAM, N.C., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced financial results for the third quarter ended September 30, 2023 and highlighted recent corporate accomplishments advancing the investigational, universally implantable Human Acellular Vessel (HAV) closer to planned U.S. market launch.
Key Points:
- In addition, we recently published preclinical results of our small caliber HAV in a juvenile heart disease model.
- Planned BLA Filing this Quarter – Humacyte plans to file a BLA for the HAV for the treatment of vascular trauma with the FDA during the current quarter.
- There was no revenue for the third quarter of 2023 and nine months ended September 30, 2023.
- The decrease in other net expense for the third quarter of 2023 compared to 2022 resulted primarily from an increase in interest income due to rate increases.
Retrieved on:
Thursday, November 2, 2023
DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the third quarter ended September 30, 2023, on Thursday, November 9, 2023.
Key Points:
- DURHAM, N.C., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, will release its financial results for the third quarter ended September 30, 2023, on Thursday, November 9, 2023.
- Management will host a webcast and conference call at 4:30 p.m.
- ET to provide a corporate and financial update.
Patent,
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The Journal of Thoracic and Cardiovascular Surgery,
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Dentistry The publication in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open), entitled “ Evaluation of tissue-engineered human acellular vessels as a Blalock–Taussig–Thomas shunt in a juvenile primate model, ” describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital (Columbus, OH) implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease.
Key Points:
- The publication in the open-access Journal of Thoracic and Cardiovascular Surgery (JTCVS Open), entitled “ Evaluation of tissue-engineered human acellular vessels as a Blalock–Taussig–Thomas shunt in a juvenile primate model, ” describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital (Columbus, OH) implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease.
- The study assessed the HAV’s patency, structure, and blood flow from one week to six months after the implant.
- This study also demonstrates the successful extension of Humacyte’s manufacturing platform, from the production of 6.0mm vessels to 3.5mm vessels.
- The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Retrieved on:
Thursday, September 21, 2023
DURHAM, N.C., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the Cantor Global Healthcare Conference, in New York, NY on September 28, 2023.
Key Points:
- DURHAM, N.C., Sept. 21, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will present at the Cantor Global Healthcare Conference, in New York, NY on September 28, 2023.
- Management will also be available for one-on-one meetings.
- Location: InterContinental New York Barclay Hotel, New York, NY
A replay will be available for a limited time following the presentation on the Events & Presentations portion of the Humacyte website.
