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., 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.

Humacyte Completes Enrollment in Phase 2/3 Trial of Human Acellular Vessel™ (HAV™) for Vascular Trauma Repair

DURHAM, N.C., June 05, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), 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 Jefferies Healthcare Conference, in New York, NY on June 9, 2023. Management will also be available for one-on-one meetings.

Humacyte to Present at the Jefferies Healthcare Conference

Humacyte Inc. (NASDAQ:HUMA ) Q1 2023 Results Conference Call May 12, 2023 8:00 AM ET Company Participants Lauren Marek - LifeSci Advisors Laura Niklason - Founder, President, CEO and Director Dale Sander - CFO, Chief Corporate Development Officer and Treasurer Conference Call Participants Phil Dantoin - Piper Sandler Ryan Zimmerman - BTIG Joshua Jennings - TD Cowen Suraj Kalia - Oppenheimer & Company Bruce Jackson - Benchmark Company Operator Good morning, ladies and gentlemen, and welcome to the Humacyte First Quarter Results Conference Call. Currently, all participants are in a listen-only mode.

Humacyte Inc. (HUMA) Q1 2023 Earnings Call Transcript

Humacyte, Inc. (HUMA) came out with a quarterly loss of $0.22 per share in line with the Zacks Consensus Estimate. This compares to loss of $0.22 per share a year ago.

Humacyte, Inc. (HUMA) Reports Q1 Loss, Misses Revenue Estimates

- Human Acellular Vessel™ (HAV™) granted second RMAT designation by the FDA, for Vascular Trauma - - Completion of enrollment in Phase 3 trial of HAV in Hemodialysis Access in End-Stage Renal Disease Patients - - Conference call and live webcast at 8:00 a.m. ET today - DURHAM, N.C.

Humacyte First Quarter 2023 Financial Results and Business Update

- $40 million upfront, $20 million upon FDA acceptance of HAV BLA in vascular trauma, $40 million upon FDA approval of HAV in vascular trauma, $50 million upon achievement of certain sales milestones, and $10 million equity option -

Humacyte and Oberland Capital Announce Funding Arrangement Totaling Up to $160 Million

First regenerative medicine technology used in battlefield trauma Ukrainian surgeons trained on HAV procedures over video conferencing DURHAM, N.C., May 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 the publication in The Lancet Regional Health - Europe detailing the encouraging experience of Humacyte's investigational Human Acellular Vessel (HAV) in treating battlefield and other vascular trauma injuries suffered in Ukraine-Russia conflict.

Humacyte Announces Publication in Lancet Regional Health - Europe Presenting Use of Human Acellular Vessel™ (HAV™) to Treat Vascular Injuries in Ukraine

DURHAM, N.C., May 05, 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 first quarter ended March 31, 2023, on Friday, May 12, 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 First Quarter Financial Results and Provide Corporate Update on May 12, 2023

HAV granted second RMAT designation by the FDA RMAT will support Humacyte's lead indication in Vascular Trauma

Humacyte's Human Acellular Vessel™ (HAV™) Receives FDA's Regenerative Medicine Advanced Therapy (RMAT) Designation for Urgent Arterial Repair Following Vascular Trauma

DURHAM, N.C., April 28, 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 participate in a company presentation and one-on-one investor meetings at the H.C. Wainwright BioConnect Investor Conference, which will take place in-person at NASDAQ World Headquarters on May 2nd, 2023.

Humacyte to Present at the H.C. Wainwright BioConnect Investor Conference at NASDAQ

NEW YORK, N.Y. and DURHAM, N.C., April 27, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a biotechnology company pioneering the development and manufacturing of off-the-shelf, universally implantable bioengineered human tissues and organ systems, and JDRF International (JDRF), the leading global organization funding type 1 diabetes (T1D) research, today announced a new collaboration to advance the development of Humacyte's Biovascular Pancreas (BVP) product candidate.

Humacyte, JDRF Collaborating to Develop Insulin-Producing Biovascular Pancreas to Treat Type 1 Diabetes

Results published in Journal of Trauma and Acute Care Surgery Company also provides update on enrollment progress in Phase 2/3 vascular trauma trial DURHAM, N.C., April 18, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, announced the publication of a preclinical study in the Journal of Trauma and Acute Care Surgery comparing the use of its Human Acellular Vessel (HAV) to expanded polytetrafluorethylene (ePTFE) grafts for vascular repair following arterial trauma.

Humacyte Announces Publication of Preclinical Study Comparing Human Acellular Vessel™ (HAV™) to Expanded Polytetrafluoroethylene (ePTFE) Graft in Vascular Trauma

Humacyte (HUMA) surges as it completes patient enrollment in a late-stage clinical study on the human acellular vessel product for vascular access in hemodialysis patients.

Humacyte (HUMA) Completes Enrollment in HAV Technology Study

DURHAM, N.C., April 11, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced it has completed enrollment of a Phase 3 trial in hemodialysis access. The “V007 Trial” is designed to assess the efficacy and safety of the Human Acellular Vessel (HAV) in establishing vascular access for hemodialysis patients with end-stage renal disease (ESRD) as compared to autogenous arteriovenous (AV) fistulas.

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