Humacyte

Humacyte, Inc. engages in the manufacture of human acellular matrix products for vascular and non-vascular applications. It offers its products to the cardiovascular, cosmetic, soft tissue reconstruction, neurosurgical, and orthopedic markets. The company was founded by Laura E. Niklason and Juliana L. Blum in October 13, 2004 and is headquartered in Durham, NC.

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Humacyte reports progress in trials and collaborations, poised for growth

Humacyte's Q4 2022 performance reflects a strong cash position, progress in key trials, and preparations for commercial activities. The company's strengths lie in innovative programs, strategic collaborations, and promising trial outcomes. Challenges include enrollment disruptions, regulatory complexities, and strategic planning considerations.
Opportunities for Humacyte include expanding its product portfolio, pursuing accelerated approvals, and leveraging successful trial outcomes for partnerships and market entry. With a focus on commercial readiness and visibility enhancement, Humacyte is poised for growth and advancement in the biotechnology sector.

Humacyte advances HAV trials, secures funding for commercial launch

Humacyte's Q1 2023 performance reflects promising advancements in vascular trauma treatments and strategic collaborations for product development.
While the company faces challenges in financing and regulatory processes, opportunities lie in market expansion and innovative partnerships.
Overall, Humacyte's progress in trials and financial stability position it well for future growth and potential market success.

Humacyte progresses HAV program, eyes growth through strategic collaborations

Humacyte's Q2 2023 earnings call highlighted advancements in the HAV program, positive outcomes in trauma indications, and strategic collaborations. While facing financial challenges with no revenue generated, the company's strong partnerships and funding support present opportunities for future growth and innovation.

Humacyte plans BLA submission for HAV after positive trial results

Humacyte's Q3 2023 performance reflected no revenue, a net loss of $26.0 million, and $100 million in cash and cash equivalents.
The Human Acellular Vessel (HAV) demonstrated superior outcomes in clinical trials and real-world applications, positioning it well for market adoption.
While financial challenges exist, the company's strategic focus on commercial launch preparation and real-world evidence collection presents growth opportunities.
Navigating market acceptance, reimbursement, and competition will be key for Humacyte's success in the biologics space.

Humacyte achieves FDA milestone with HAV, eyes market expansion

Humacyte made significant progress with FDA acceptance of BLA for HAV, showcasing superior outcomes and cost-saving potential.
Financially, the company had a strong cash position and aims for improved margins despite increased expenses in 2024.
Challenges include managing increased expenses and achieving superiority across patient groups, while opportunities lie in market expansion and operational efficiencies.
Overall, Humacyte's performance, strengths, challenges, and opportunities position it for growth and impact in the medical field.

Humacyte reports improved financials and advances FDA approval for HAV

Humacyte's Q1 2024 performance reflects a decrease in net loss, strong financial management, and progress in key clinical trials and product development.
The company's strengths lie in FDA milestones, strategic funding, research focus on high-impact areas, and financial stability.
Challenges include managing operating expenses, financial pressures, trial outcomes uncertainty, and successful market entry post-approval.
Opportunities abound in FDA approval prospects, market expansion, product diversification, and leveraging financial resources for growth initiatives.

Humacyte reports progress in key programs despite FDA delay

Humacyte's Q2 2024 earnings call highlighted progress in key programs, financial challenges due to FDA delay, and optimism for future growth. The company's strong financial position and strategic additions to the Board of Directors bode well for upcoming commercialization efforts.

Humacyte reports Q3 losses, highlights innovation and growth opportunities

Humacyte's Q3 2024 performance reflected significant investment in R&D and G&A expenses, resulting in a net loss of $39.2 million.
Positive trial outcomes and patent approvals underscore the company's innovation and potential for future revenue streams.
While facing financial challenges and regulatory uncertainties, Humacyte's strong cash position and ongoing trials offer opportunities for growth and market expansion.

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Humacyte, Inc. engages in the business of developing and manufacturing off-the-shelf, universally implantable, bioengineered human tissues, advanced tissue constructs, and organ systems with the goal of improving the lives of patients and transforming the practice of medicine. The company was founded by Laura E. Niklason, Shannon Dahl, and Juliana L. Blum on October 13, 2004 and is headquartered in Durham, NC.

-- First shipment of HAVs to six Ukrainian hospitals made today -- -- Product candidate to be used for civilian and military vascular trauma repair, the HAV's lead investigational indication --

Humacyte to Provide Human Acellular Vessels™ (HAVs™) to Front-line Hospitals in Ukraine for Treatment of Vascular Trauma Injuries

DURHAM, N.C., May 06, 2022 (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, 2022, on Friday, May 13, 2022. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update.

Humacyte to Present First Quarter 2022 Financial Results and Provide Recent Corporate Update on May 13, 2022

--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--

Humacyte Expands Leadership Team with Appointment of Shamik Parikh, M.D., as Chief Medical Officer

DURHAM, N.C., April 04, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that its 2022 annual meeting of shareholders will be held virtually on Thursday, June 9, 2022, at 7:30 AM eastern time.

Humacyte Announces Date of Annual Shareholder Meeting

Humacyte, Inc. (HUMA) CEO Laura Niklason on Q4 2021 Results - Earnings Call Transcript

-- Advancing late-stage clinical and preclinical programs of the Human Acellular Vessel™ (HAV™) and other engineered tissues across several indications –

Humacyte Reports Fourth Quarter and Year End 2021 Financial Results and Provides Business Update

DURHAM, N.C., March 21, 2022 (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 full year ended December 31, 2021, on Tuesday, March 29, 2022. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update.

Humacyte to Present Fourth Quarter and Full Year 2021 Financial Results and Provide Corporate Update on March 29, 2022

-- Five-year data demonstrate the potential of the Human Acellular Vessel TM (HAV) to be a durable and safe option for vascular access for routine, long-term hemodialysis -- -- Results published in EJVES Vascular Forum --

Humacyte Announces Publication of Positive Long-Term Follow-Up Data from Phase 2 Trial of HAV™ for Hemodialysis

Humacyte Inc (NASDAQ: HUMA) announced five-year data from a Phase 2 trial of Human Acellular Vessel (HAV) for arteriovenous (AV) access in hemodialysis. In the Phase 2 long-term follow-up data, the HAV was observed to provide routine and functional hemodialysis access for patients.

Humacyte's Human Acellular Vessel Shows Long Term Benefit In Hemodialysis Patients

DURHAM, N.C., Feb. 09, 2022 (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., Chief Executive Officer, and Dale Sander, Chief Financial Officer, will participate in a virtual fireside chat at the BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Feb. 15, 2022, at 9 a.m. EST.

Humacyte to Participate in Fireside Chat at BTIG MedTech, Digital Health, Life Science & Diagnostic Tools Conference

– Outcomes of first eight compassionate use cases presented at 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society –

Humacyte Announces Clinical Case Series Demonstrating Potential of Human Acellular Vessel™ (HAV™) to Expand Opportunities for Limb Salvage in Multiple Complex Vascular Reconstruction Scenarios

Humacyte Inc HUMA has announced results from the first preclinical study of Humacyte's small-diameter (3.5mm) Human Acellular Vessel (HAV) in coronary artery bypass grafting (CABG).  [ALERT] Matt Maley just released his latest pick with an upside of over 100% in 2 years.

Humacyte Posts Preclinical Data Of Small-Diameter Human Acellular Vessel In Bypass Grafting

-- HAV remained patent and host-cell remodeling was observed in non-human primate model -- -- Preclinical study represents milestone in the development of small-diameter HAVs for use in cardiac bypass surgery --

Humacyte Announces Preclinical Results of Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting

DURHAM, N.C., Jan. 06, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that results from the first series of compassionate use cases of Humacyte's Human Acellular VesselTM (HAV) will be presented at the 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society (VESS) in Snowmass, Colo. at 7:56 a.m. MST on January 28, 2022. The presentation will describe the outcomes of HAV implantation into eight patients for the treatment of critical limb ischemia, under the U.S. Food and Drug Administration's (FDA) Expanded Access Program (EAP). The presentation, titled “Real World Experience with the Human Acellular Vessel: A Bioengineered Implant for Arterial Repair That Expands Limb Salvage Options,” will be made by Alexander Kersey, M.D., of the Uniformed Services University of the Health Sciences and Walter Reed National Military Medical Center in Bethesda, MD.

Humacyte Announces Presentation of First Eight Expanded Access Cases Using Human Acellular Vessel™ (HAV) for Treatment of Critical Limb Ischemia at 46th Annual Winter Meeting of the Vascular and Endovascular Surgery Society

DURHAM, N.C., Jan. 04, 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 first preclinical results of the use of Humacyte's Human Acellular Vessel™ (HAV) in coronary artery bypass grafting (CABG) will be presented at the Advanced Therapies Week conference in Miami, Fla. at 9:20 a.m. EST on January 28, 2022. The presentation, titled “Bioengineering and the Future of Cardiac Surgery,” will be made by Alan P. Kypson, M.D., FACS. Dr. Kypson is a cardiothoracic surgeon at the University of North Carolina Rex Hospital in Raleigh, N.C., and a thought leader in the field of cardiac surgery who has led the large animal preclinical development of Humacyte's vessels in CABG for more than a decade. The presentation by Dr. Kypson will include the results of the use of the HAV in a primate CABG model, including six-month outcomes.

Humacyte Announces Presentation of First Preclinical Results of the HAV™ in Coronary Artery Bypass Grafting at Advanced Therapies Week Conference

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.

Humacyte Announces the Appointments of Three Surgical and Cardiovascular Opinion Leaders to Advisory Roles

The stock price of Humacyte Inc (NASDAQ: HUMA) fell in the most recent trading session. This is why it happened.

Humacyte Stock (HUMA): Why The Price Fell

-- Vanderbilt University Medical Center patient received the HAV under the U.S. Food and Drug Administration's (FDA) Expanded Access Program (EAP) in April 2019 -- -- After replacement, the patient resumed regular physical activity with no signs of infection of the HAV implant observed --

Humacyte Announces Publication Highlighting the First Use of the Human Acellular Vessel (HAV™) as Arterial Bypass Conduit for Replacement of Infected Prosthetic Graft

-- Patency and host cell remodeling of the HAV were observed in all study implants –

Humacyte Presents Preclinical Results of Small-Diameter HAV™ for Use as a BTT Shunt in Pediatric Heart Disease at American Heart Association's Scientific Sessions 2021

– Performance of HAVs produced in the LUNA200™  commercial-scale system demonstrated efficacy that is similar to prior HAV performance in dialysis access trials –

Humacyte Presents New 12-Month Data from HAVs™ Produced Using Commercial-Scale Manufacturing System

-- Completed business combination with Alpha Healthcare Acquisition Corp. and raised $242M in proceeds -- -- Progressed advanced-stage clinical- and early-stage programs of the human acellular vessel (HAV™) and other engineered tissue platform applications --

Humacyte Reports Third Quarter 2021 Financial Results and Provides Business Highlights

DURHAM, N.C., Nov. 09, 2021 (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., Chief Executive Officer, will present at the Credit Suisse 30th Annual Healthcare Conference taking place virtually, on Nov. 10, 2021, at 1 p.m. EST.

Humacyte Leadership to Present at Credit Suisse 30th Annual Healthcare Conference

DURHAM, N.C., Nov. 08, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that leadership will present new data and additional information on its programs at several scientific events in November 2021.

Humacyte Leadership to Present at Multiple Scientific Events in November

DURHAM, N.C., Oct. 05, 2021 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced that senior leadership will present at seven scientific and industry events in October 2021.

Humacyte Leadership to Present at Seven Scientific and Industry Events in October

DURHAM, N.C., Sept. 20, 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 issuance of three additional U.S. patents covering its proprietary technology platform. Included in the new patents are additional claims related to the Human Acellular Vessels (HAVs), engineered, off-the-shelf replacement vessels initially being developed for vascular repair, reconstruction and replacement. New U.S. Patents 10,934,532 and 10,947,498, both titled “Tissue-engineered constructs,” expand upon existing patents encompassing methods of producing the Company's HAVs and other human tissues, including the scaffolds and methods used to make these product candidates. New U.S. Patent 11,058,534, titled “Tubular prothesis,” covers biologic replacements for diseased or damaged anatomical conduits, including the trachea.

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