8-K - Humacyte, Inc. (0001818382) (Filer)

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8-K - Humacyte, Inc. (0001818382) (Filer)

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8-K - Humacyte, Inc. (0001818382) (Filer)

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8-K - Humacyte, Inc. (0001818382) (Filer)

8-K - Humacyte, Inc. (0001818382) (Filer)

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8-K - Humacyte, Inc. (0001818382) (Filer)

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DURHAM, N.C., March 19, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has received a minimum purchase commitment of $1.475 million of the Symvess acellular tissue engineered vessel to facilitate a clinical evaluation and outreach program in hospitals within the Kingdom of Saudi Arabia (KSA). The planned clinical evaluation program is to be conducted in parallel with ongoing negotiations with a KSA-based entity for establishment of a joint venture and license to commercialize Symvess within the country. Humacyte will provide

Net proceeds from the offering will fund the commercialization of Symvess® in the vascular trauma indication and provide funding beyond key milestones such as the upcoming read-out of Phase 3 results in hemodialysis The offering was led by a new life science dedicated investor and a long-only mutual fund  DURHAM, N.C., March 19, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has entered into a securities purchase agreement with several new institutional investors for the purchase and sale of 25,000,000 shares of common

- Humacyte is also pursuing a mechanism for making Symvess available in Israel on a hospital-by-hospital basis in advance of MAA approval -  - Preparation is underway for expansion of Symvess into other countries, including in the Middle East - DURHAM, N.C., March 17, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it submitted a Marketing Authorization Application (MAA) with the Israel Ministry of Health for approval of the acellular tissue engineered vessel (ATEV, or Symvess) for arterial trauma repair. In response to surgeo

DURHAM, N.C., March 02, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the Company's management team will be participating in the following investor conferences during the month of March. TD Cowen 46th Annual Healthcare ConferencePresentation: Wednesday March 4, 2026, 10:30-11:00 am Eastern TimeWebcast Link: Click Here Barclays 28th Annual Global Healthcare ConferencePresentation: Fireside Chat Time 1:00-1:25 pm Eastern TimeWebcast Link: Click Here About Humacyte Humacyte, Inc. (NASDAQ:HUMA) is developing a disruptive biotec

- Data presented at Annual Winter Meeting 2026 for the Vascular & Endovascular Surgery Society -  - After up to 36 months of follow-up, extremity arterial trauma patients had high rates of limb salvage, low rates of infection, and no unprovoked structural failures - - Long-term durability results showed no dilatation nor narrowing of Symvess diameter out to 36 months - DURHAM, N.C., Feb. 18, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the presentation of long-term data assessing the durability of Symvess in extremity arterial

DURHAM, N.C., Feb. 09, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the recently adopted FY 2026 U.S. Department of Defense (DoD) Appropriations Act includes dedicated funding to support the evaluation and incorporation of biologic vascular repair technologies for the warfighters suffering from traumatic vascular injuries. The FY2026 National Defense Authorization Act (NDAA), enacted in December 2025, stated in report language that DoD should "integrate FDA-approved breakthrough vascular repair technologies in traumatic extre

- Data is from comprehensive review of hospital charges and all-payer claims over five years -  - Preventable complications such as amputation and conduit infection increased initial hospital charges by approximately $493,000 and $590,000 per patient respectively – - Humacyte's Symvess® has consistently demonstrated low rates of infection and high rates of limb salvage – DURHAM, N.C., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the results of a five-year retrospective analysis of hospital charges, payer costs, and hea

- Expansion plans are based on requests for product access received from surgeons and hospitals in Israel -  - Expansion of Symvess into other territories, including those in Europe and the Middle East, is also planned - DURHAM, N.C., Jan. 05, 2026 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it plans to file a Marketing Authorization Application (MAA) with the Israel Ministry of Health for approval of the acellular tissue engineered vessel (ATEV™ or Symvess) for arterial trauma repair during the first quarter of 2026. The Compa

- Results published in Journal of Vascular Surgery Cases, Innovations and Techniques (JVS-CIT) -  - After up to 36 months of follow-up, patients demonstrated high limb salvage, low rates of infection, no unprovoked structural failures - - Results represent first prospective long-term data in traumatic arterial repair using an off-the-shelf biologic conduit - DURHAM, N.C., Dec. 22, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced the publication of new, long-term data assessing the durability of Symvess in extremity arterial trauma

DURHAM, N.C., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has entered into a credit facility with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group, providing up to $77.5 million in principal amount of new financing. The credit agreement, which has a term of four years, includes an initial tranche of $40 million fully funded at close, and an additional two tranches of up to an aggregate of $37.5 million available to Humacyte, subject to the satisfaction of certain revenue, regulatory appro

Barclays initiated coverage of Humacyte with a rating of Overweight and set a new price target of $3.50

H.C. Wainwright resumed coverage of Humacyte with a rating of Buy and set a new price target of $4.00

H.C. Wainwright reiterated coverage of Humacyte with a rating of Buy and set a new price target of $15.00 from $12.00 previously

H.C. Wainwright initiated coverage of Humacyte with a rating of Buy and set a new price target of $6.00

Piper Sandler upgraded Humacyte from Underweight to Neutral and set a new price target of $3.50 from $2.75 previously

Cantor Fitzgerald initiated coverage of Humacyte with a rating of Overweight and set a new price target of $6.00

Piper Sandler downgraded Humacyte from Overweight to Underweight and set a new price target of $4.00 from $10.00 previously

Cowen & Co. initiated coverage of Humacyte with a rating of Outperform and set a new price target of $17.00

Oppenheimer initiated coverage of Humacyte with a rating of Outperform and set a new price target of $16.00

BTIG initiated coverage of Humacyte with a rating of Buy and set a new price target of $19.00

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- Total revenues of $753,000 for third quarter, and $1,571,000 for first nine months of 2025, from sales and collaborative research agreement -  - Major advances in pipeline as Humacyte moves closer to planned BLA filing in dialysis and first-in-human studies in cardiac bypass graft surgery – – IND submitted to the FDA for the CABG indication – - Symvess™ and pipeline programs highlighted in multiple scientific publications and presentations - - Conference call today at 8:00 am ET - DURHAM, N.C., Nov. 12, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercia

DURHAM, N.C., Nov. 06, 2025 (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 quarter ended September 30, 2025, on Wednesday, November 12, 2025. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update. Title:Humacyte Third Quarter 2025 Financial Results and Corporate UpdateDate:November 12, 2025Time:8:00 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13756236 (Conference ID)Call me™ Feature

DURHAM, N.C., Aug. 07, 2025 (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 quarter ended June 30, 2025, on Monday, August 11, 2025. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update. Title:Humacyte Second Quarter 2025 Financial Results and Corporate UpdateDate:August 11, 2025Time:8:00 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13754596 (Conference ID)Call meTM Feature: Click Here

DURHAM, N.C., May 09, 2025 (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 quarter ended March 31, 2025, on Tuesday, May 13, 2025. Management will host a webcast and conference call at 8:30 a.m. ET to provide a corporate and financial update. Title:Humacyte First Quarter 2025 Financial Results and Corporate UpdateDate:May 13, 2025Time:8:30 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13753487 (Conference ID)Call meTM Feature: Click HereWebc

DURHAM, N.C., March 26, 2025 (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, 2024, on Friday, March 28, 2025. Management will host a webcast and conference call at 8:30 a.m. ET. Title:Humacyte Fourth Quarter and Full Year 2024 Financial Results and Corporate UpdateDate:March 28, 2025Time:8:30 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13751524 (Conference ID)Call meTM Feature: Click HereWebcast:C

DURHAM, N.C., Aug. 12, 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 second quarter ended June 30, 2024, on Tuesday, August 13, 2024. Management will host a webcast and conference call at 8:30 a.m. ET to discuss recent corporate updates from its acellular tissue engineered vessel (ATEV) programs. Title:Humacyte Second Quarter 2024 Financial Results and Corporate UpdateDate:August 13, 2024Time:8:30 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investor

– 2nd quarter conference call to be held Tuesday, August 13th, at 8:30 a.m. ET – DURHAM, N.C., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that the U.S. Food and Drug Administration (FDA) will require additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication. The ATEV trauma program BLA was submitted to FDA in December 2023, and the FDA granted a Priority Review in February 2024 and assigned a PDUFA date of

DURHAM, N.C., May 06, 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 first quarter ended March 31, 2024, on Friday, May 10, 2024. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update. Title:Humacyte First Quarter 2024 Financial Results and Corporate UpdateDate:May 10, 2024Time:8:00 AM Eastern TimeConference Call Details:1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13746046 (Conference ID)Call me™ Feature: Click HereWe

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. Title:Humacyte Fourth Quarter and Year-End 2024 Earnings Conference CallDate:March 22, 2024Time8:00 AM Eastern TimeConference Call Details1-877-704-4453 (U.S. Investors Dial)1-201-389-0920 (International Investors Dial)13744046 (Conference ID)Call meTMFeat

– Positive top line results from the V005 Phase 2/3 trial of the Human Acellular Vessel™ (HAV™) in vascular trauma repair – – BLA for an indication in vascular trauma planned to be filed with the FDA during the current quarter – - Conference call and live webcast at 4:30 p.m. ET today - 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 implan

BioAesthetics Corporation announced today the appointment of Juliana Blum, PhD as its new Chief Executive Officer, effective August 12, 2024. Dr. Sandra Coufal, MD, Director of BioAesthetics and CEO of Toragen, Inc. said, "This is an important milestone for BioAesthetics. During the development of every successful biotech company, there comes a time when the founding CEO transitions to a different role and a new CEO with different skill sets is needed for product advancement and commercialization. Dr. Blum's experience with novel products as co-founder of Humacyte will help guide further progress at BioAesthetics." Dr. Blum joins BioAesthetics following her 20 years spent as Co-founder

DURHAM, N.C., June 27, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Diane Seimetz, Ph.D., to its board of directors. "Diane is an innovator and strategist with extensive experience in the biopharmaceutical industry, and we are delighted to welcome her to the Humacyte board," said Kathleen Sebelius, Chair of Humacyte's board of directors. "Her expertise in guiding companies with innovative products to the market will be invaluable as Humacyte moves toward commercialization of the Human Acellular VesselTM (HAV). We al

--Seasoned physician, scientist and life science executive brings expertise in clinical research and development across product life cycle-- --Key appointment as Humacyte advances HAV through multiple late-stage clinical trials in initial vascular applications-- DURHAM, N.C., April 05, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Shamik J. Parikh, M.D., as Chief Medical Officer. In this role, Dr. Parikh will lead the company's global clinical development strategy, including oversight of the preclinical and clinical

DURHAM, N.C., Dec. 31, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ:HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced the appointment of Surgical Key Opinion Leaders (KOLs) Alan P. Kypson, M.D., FACS; Luigi Pascarella, M.D., FACS; and Todd E. Rasmussen, M.D., FACS, (Col, ret. USAF MC), to new advisory positions. In these roles, the KOLs will lend their expertise and support to guide the education and clinical advancement efforts of the Human Acellular VesselTM (HAV) and help identify opportunities to advance the Company's early stage complex tissue constructs pipeline and platform.