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.

DURHAM, N.C., March 01, 2024 (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 TD Cowen 44th Annual Health Care Conference, in Boston, MA on Monday, March 4, 2024. Management will also be available for one-on-one meetings.

Humacyte, Inc. to Present at the TD Cowen 44th Annual Health Care Conference

DURHAM, N.C., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced today announced the pricing of an underwritten public offering of 13,400,000 shares of its common stock at a public offering price of $3.00 per share. The aggregate gross proceeds from this offering are expected to be $40.2 million, before deducting underwriting discounts and commissions and other offering expenses payable by Humacyte. The closing of the offering is expected to occur on or about March 5, 2024, subject to the satisfaction of customary closing conditions. In addition, Humacyte has granted the underwriters an option for a period of 30 days to purchase up to an additional 2,010,000 shares of Humacyte's common stock at the public offering price, less underwriting discounts and commissions. All of the shares of common stock are being sold by Humacyte.

Humacyte, Inc. Announces Pricing of $40.2 Million Public Offering of Common Stock

DURHAM, N.C., Feb. 29, 2024 (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 commenced an underwritten public offering of its common stock. In addition, Humacyte intends to grant the underwriters an option for a period of 30 days to purchase up to an additional 15% of the number of shares of common stock sold in connection with the offering. All of the shares are being offered by Humacyte.

Humacyte, Inc. Announces Proposed Public Offering of Common Stock

Humacyte (HUMA) gains 16% as the FDA accepts its BLA for the HAV bioengineered tissue to treat vascular trauma under Priority Review. A final decision is expected in August 2024.

Humacyte (HUMA) Up on HAV BLA Priority Tag for Vascular Trauma

– BLA submission supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a Humanitarian Aid Program to treat wartime trauma injuries in Ukraine –

Human Acellular Vessel™ (HAV™) Biologics License Application Granted Priority Review by U.S. FDA for the Treatment of Vascular Trauma

– BLA supported by results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime trauma injuries in Ukraine –

Humacyte Submits Biologics License Application (BLA) to U.S. FDA Seeking Approval of Human Acellular Vessel™ (HAV™) for the Treatment of Vascular Trauma

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.

Humacyte to Present at the Piper Sandler 35th Annual Healthcare Conference

Humacyte is a developer of implantable regenerative human tissue for trauma and other uses. Their core technology, Human Acellular Vessel, has shown higher rates of patency, lower amputation rates, and lower infection rates compared to synthetic grafts. The company has upcoming BLA submissions and a pivotal trial in progress, with potential approvals expected in the next year.

Humacyte: Upcoming BLA, Pivotal Data, Decent Cash, Excellent Opportunity

– Presentations included results from Phase 2/3 clinical trial and outcomes of real-world use of the HAV under a humanitarian aid program to treat wartime injuries in Ukraine –

Humacyte Announces Two Presentations at the VEITHsymposium® of Positive Clinical Results of the Human Acellular Vessel™ (HAV™) in the Treatment of Vascular Trauma

Humacyte, Inc. (NASDAQ:HUMA ) Q3 2023 Earnings Conference Call November 9, 2023 4:30 PM ET Company Participants Lauren Marek - Investor Relations, LifeSci Advisors Laura Niklason - President and Chief Executive Officer Dale Sander - Chief Financial Officer and Chief Corporate Development Officer Conference Call Participants Suraj Kalia - Oppenheimer Bruce Jackson - The Benchmark Company Operator Good afternoon, ladies and gentlemen, and welcome to the Humacyte Third Quarter Results Conference Call. Currently, all participants are in a listen-only mode.

Humacyte, Inc. (HUMA) Q3 2023 Earnings Call Transcript

– Positive top line results from the V005 Phase 2/3 trial of the Human Acellular Vessel™ (HAV™) in vascular trauma repair –

Humacyte Third Quarter 2023 Financial Results and Business Update

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.

Humacyte to Present Third Quarter Financial Results and Provide Corporate Update on November 9, 2023

-Outcomes exhibit potential of HAV for palliative treatment of congenital heart disease- -Outcomes exhibit potential of HAV for palliative treatment of congenital heart disease-

Humacyte Publishes Preclinical Results Showing Human Acellular Vessel™ (HAV™) Patency as Modified Blalock–Taussig–Thomas Shunt in Juvenile Primate Model

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.

Humacyte to Present at the Cantor Global Healthcare Conference

DURHAM, N.C., Sept. 18, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced it will host an in-person KOL event on Wednesday, September 20, 2023 at 3:00pm ET at The New York EDITION Hotel.

Humacyte to Host In-Person KOL Event at the New York EDITION on September 20, 2023

-- Single-arm clinical trial was a success and showed the HAV had higher rates of patency, and lower rates of amputation and infection, compared to historic synthetic graft benchmarks -- -- BLA planned to be filed with FDA in 4 th Quarter 2023 --

Humacyte Announces Positive Top Line Results from Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) in Treatment of Patients with Vascular Trauma

Virtual Webinar to Include Key Opinion Leader Perspectives on the Potential of the HAV in Vascular Trauma Repair Virtual Webinar to Include Key Opinion Leader Perspectives on the Potential of the HAV in Vascular Trauma Repair

Humacyte to Announce Top Line Data from Phase 2/3 V005 Trial in Vascular Trauma Evaluating its Human Acellular Vessel™ (HAV™) Tuesday, September 12, 2023 at 8:00 AM ET

-Researchers concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage- -Researchers concluded that in the clinical study the HAV was a safe, resilient, and effective conduit for arterial bypass and limb salvage-

Results From Mayo Clinic Clinical Study of Humacyte's Human Acellular Vessel™ (HAV™) in Treatment of Patients with Chronic Limb Ischemia Presented at Midwestern Vascular Conference

Humacyte develops regenerative human tissue for various medical uses, with upcoming BLAs and interest from the US military. Their core technology, Human Acellular Vessel (HAV), addresses problems with current standards of care and has low infection and amputation rates. The company has completed enrollment in a pivotal trial for HAV in vascular trauma and a Phase 3 trial for HAV in hemodialysis access.

Humacyte: Major Catalysts Ahead, Solid Prospects, Low Prices

-Clinical outcomes presented at Military Health System Research Symposium (MHSRS)- -Results will be included in Biologics License Application (BLA) planned for fourth quarter 2023- DURHAM, N.C., Aug. 15, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, presented yesterday at MHSRS the clinical results of a year-long humanitarian program in Ukraine.

Humacyte Presents Clinical Performance of Human Acellular Vessel™ (HAV™) From Ukrainian Humanitarian Program

Humacyte Inc. (NASDAQ:HUMA ) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET Company Participants Dr. Laura Niklason - President & CEO Dale Sander - CFO & Chief Corporate Development Officer Dr. Heather Prichard - COO Laura Marek - LifeSci Advisors, IR Conference Call Participants Ryan Zimmerman - BTIG Josh Jennings - TD Cowen Matthew O'Brien - Piper Sandler Suraj Kalia - Oppenheimer & Company Bruce Jackson - The Benchmark Company. Operator Good morning, ladies and gentlemen, and welcome to the Humacyte Second Quarter Results Conference Call.

Humacyte Inc. (HUMA) Q2 2023 Earnings Call Transcript

– Completed Enrollment in Phase 2/3 V005 Trial of HAV™ in Vascular Trauma Repair; Top-Line Results on Track for Q3 2023 –

Humacyte Second Quarter 2023 Financial Results and Business Update

DURHAM, N.C., Aug. 07, 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 second quarter ended June 30, 2023, on Monday, August 14, 2023. 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 Financial Results and Provide Corporate Update on August 14, 2023

Results published in Journal of Vascular Surgery – Vascular Science

Humacyte Announces Publication of Biological Mechanism Explaining Low Rates of Infection Observed in Clinical Study of Human Acellular Vessel™ (HAV™)

-Top-line results planned to be released in third quarter 2023- -Trial results are intended to support Biologics License Application (BLA) planned for fourth quarter 2023- DURHAM, N.C., July 26, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced completion of enrollment of its Phase 2/3 vascular trauma trial (V005) that is expected to support a BLA filing for Humacyte's HAV in vascular trauma repair.

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