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.

Earnings data Q3 2021

Earnings data Q4 2021

Earnings data Q1 2022

Earnings data Q2 2022

Earnings data Q3 2022

Earnings data Q4 2022

Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

Earnings data Q4 2023

Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

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.

Revenue

Cost of revenue

Gross profit

Operating expenses

SG&A

Other

Operating income

EBITDA

Net income

Earnings per share

Total assets

Current assets

Cash & equivalents

Receivables

Inventory

Non-current assets

Net PPE

Intangibles

Total liabilities

Current liabilities

Short term debt

Income tax payable

Non-current liabilities

Long-term debt

Total equity

Stockholders equity

Minority interest

Total liabilities & equity

Total debt

Net debt

Book value per share

Cash from operations

Funds from operations

Change in working capital

Cash from investing

Capital expenditure

Purchase/sale of investments

Purchase/sale of business

Other sources

Cash from financing

Change in stock

Change in debt

Cash dividends paid

Cash from other sources

Net change in cash

Free cash flow

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.

-- Human Acellular Vessels™ (HAVs™) successfully implanted in wounded Ukrainian citizens and reported to be functioning, saving limbs –

Humacyte Second Quarter 2022 Financial Results and Business Update

DURHAM, N.C., Aug. 05, 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 second quarter ended June 30, 2022, on Friday, August 12, 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 Second Quarter 2022 Financial Results and Provide Recent Corporate Update on August 12, 2022

-- Preclinical model data expected to support development of small diameter HAV to treat patients with coronary artery disease-- -- Small-diameter HAV observed to maintain patency and exhibit host-cell remodeling at six months post-implantation in a non-human primate model–

Humacyte Preclinical Data on Small-Diameter Human Acellular Vessel™ (HAV™) in Coronary Artery Bypass Grafting (CABG) Presented at American Heart Association Meeting

DURHAM, N.C., July 19, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues, today announced that six-month outcomes from a preclinical study of a small diameter Human Acellular Vessel™ (HAVTM) in coronary artery bypass grafting will be presented at the Basic Cardiovascular Sciences (BCVS) Scientific Sessions taking place in Chicago, IL July 25-28, 2022.

Humacyte Announces Presentation of Preclinical Data on the HAV™ in Coronary Artery Bypass Grafting at the Basic Cardiovascular Sciences Scientific Sessions

Thursday, July 14, 2022 @ 11:30 a.m. ET Thursday, July 14, 2022 @ 11:30 a.m. ET

Humacyte Hosting Key Opinion Leader Webinar on Human Acellular Vessels™ in the Treatment of Vascular Trauma

-- HAV implanted in nearly 500 patients with more than 1,000 patient-years of follow up to date, for treatment of peripheral arterial disease, arteriovenous access for hemodialysis, and trauma –

Humacyte Announces JAMA Surgery Publication Highlighting Potential of Human Acellular Vessel™ (HAV™) to Expand Vascular Trauma Reconstruction and Bypass Treatment Options

Industry leader brings deep expertise in international drug development, strategic leadership, and corporate partnering for biopharmaceutical companies Industry leader brings deep expertise in international drug development, strategic leadership, and corporate partnering for biopharmaceutical companies

Humacyte Expands Board of Directors with Appointment of Diane Seimetz, Ph.D.

-- Successful first two HAV implantations in wounded Ukrainian citizens

Humacyte Provides Update on Patients Treated at Front-Line Hospitals in Ukraine with the Human Acellular Vessel™ (HAV™) for Repair of Vascular Trauma Injuries

-- Data indicate HAV does not stimulate increase in panel reactive antibodies, an adaptive immune response correlated with increased risk of implant failure -- -- Data presented today in IMPACT session at American Transplant Congress (ATC) 2022 --

Humacyte Presents New Immunogenicity Data on Human Acellular Vessels™ (HAVs™)

DURHAM, N.C., May 16, 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 Dale Sander, Chief Financial Officer, and Heather Prichard, Ph.D., Chief Operating Officer, will deliver a corporate presentation in-person at the H.C. Wainwright Global Investment Conference taking place both virtually and in-person at the Fontainebleau Hotel in Miami, on May 24, 2022, at 10:30 a.m. ET.

Humacyte to Present at the H.C. Wainwright Global Investment Conference

Humacyte, Inc. (NASDAQ:HUMA ) Q1 2022 Earnings Conference Call May 13, 2022 8:00 AM ET Company Participants Lauren Marek - Investor Relations Laura Niklason - President and Chief Executive Officer Dale Sander - Chief Financial Officer and Chief Corporate Development Officer Heather Prichard - Chief Operating Officer Conference Call Participants Ryan Zimmerman - BTIG Suraj Kalia - Oppenheimer Matthew O'Brien - Piper Sandler Bruce Jackson - The Benchmark Company Operator Good morning, ladies and gentlemen and welcome to the Humacyte First Quarter 2022 Results Conference Call. Currently, all participants are in a listen-only mode.

Humacyte, Inc. (HUMA) CEO Laura Niklason on Q1 2022 Results - Earnings Call Transcript

-- Human Acellular Vessels™ (HAVs™) shipped to six hospitals in Ukraine for treatment of civilian and military vascular trauma injuries -- -- Strengthened leadership team with appointment of Shamik Parikh M.D., as Chief Medical Officer --

Humacyte First Quarter 2022 Financial Results and Business Update

-- 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 --

News for Humacyte Stock (HUMA)