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.

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.

Humacyte Completes Enrollment in Phase 3 Trial of Human Acellular Vessel™ (HAV™) for Hemodialysis Access in End-Stage Renal Disease Patients

Humacyte, Inc. (NASDAQ:HUMA ) Q4 2022 Earnings Conference Call March 24, 2023 8:00 AM ET Company Participants Lauren Marek - LifeSci Advisors, 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 Phillip Paul Dantoin - Piper Sandler Josh Jennings - TD Cowen Suraj Kalia - Oppenheimer Bruce Jackson - The Benchmark Company Operator Good morning, ladies and gentlemen, and welcome to the Humacyte Fourth Quarter and Year-End 2022 Results Conference Call. Currently, all participants are in a listen-only mode.

Humacyte, Inc. (HUMA) Q4 2022 Earnings Call Transcript

Humacyte, Inc. (HUMA) delivered earnings and revenue surprises of 12.50% and 100%, respectively, for the quarter ended December 2022. Do the numbers hold clues to what lies ahead for the stock?

Humacyte, Inc. (HUMA) Reports Q4 Loss, Misses Revenue Estimates

-- Enrollment Nearing Completion in Human Acellular Vessel™ (HAV™) Phase 2/3 Trial in Vascular Trauma and Phase 3 Trial in Arteriovenous (AV) Access in Hemodialysis Patients

Humacyte Announces Fourth Quarter and Year End 2022 Financial Results and Business Update

DURHAM, N.C., March 21, 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 fourth quarter and year ended December 31, 2022, on Friday, March 24, 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 Fourth Quarter and Full Year Financial Results and Provide Corporate Update on March 24, 2023

DURHAM, N.C., Feb. 27, 2023 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and advanced tissue constructs and organ systems at commercial scale, today announced that Laura Niklason, M.D., Ph.D., Chief Executive Officer, and Dale Sander, Chief Financial Officer, will represent Humacyte at the following investor conferences in March.

Humacyte to Present at Upcoming Investor Conferences in March

Humacyte, Inc. develops universally implantable regenerative human tissue for trauma and other uses. The company has solid science, and data is being generated slowly.

Humacyte: With 2 BLAs Ahead, Solid Cash, Current Lows Make It Undervalued

- HAVs observed to provide long-term perfusion to patients with critical limb ischemia

Humacyte Publication in the Journal of Vascular Surgery – Vascular Science Reports the Human Acellular Vessel™ (HAV™) Remains Durable at Six Years in Patients with Peripheral Artery Disease

Thursday, December 15, 2022 @ 8:00 AM ET Thursday, December 15, 2022 @ 8:00 AM ET

Humacyte Hosting Key Opinion Leader Webinar on Vascular Trauma: Ukrainian Surgeons Discuss Use of Human Acellular Vessels™ (HAV™) in Wartime

Ukrainian surgeon collaborators will present at the VI Congress of Vascular Surgeons, Phlebologists, and Angiologists of Ukraine and the 11th Munich Vascular Conference Ukrainian surgeon collaborators will present at the VI Congress of Vascular Surgeons, Phlebologists, and Angiologists of Ukraine and the 11th Munich Vascular Conference

Humacyte Human Acellular Vessel™ (HAV™) Ukraine Humanitarian Results to be Presented at Multiple Vascular Conferences in December 2022

DURHAM, N.C., Nov. 23, 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., Founder, President, and Chief Executive Officer, and Dale Sander, Chief Financial Officer, will participate in a fireside chat at the 34th Annual Piper Sandler Healthcare Conference taking place at the Lotte New York Palace in New York, NY, on Thursday, December 1, 2022 at 12 PM ET.

Humacyte to Present at the 34th Annual Piper Sandler Healthcare Conference

Humacyte, Inc. (NASDAQ:HUMA ) Q3 2022 Earnings Conference Call November 10, 2022 8:00 AM ET Company Participants Lauren Marek - LifeSci Advisors, IR Laura Niklason - President & CEO Dale Sander - CFO & Chief Corporate Development Officer Conference Call Participants Eric Anderson - Cowen Suraj Kalia - Oppenheimer Bruce Jackson - The Benchmark Company Ryan Zimmerman - BTIG Operator Good morning, ladies and gentlemen, and welcome to the Humacyte Third Quarter 2022 Results Conference Call. Currently, all participants are in a listen-only mode.

Humacyte, Inc. (HUMA) Q3 2022 Earnings Call Transcript

Humacyte, Inc. (HUMA) delivered earnings and revenue surprises of -19.05% and 88.08%, respectively, for the quarter ended September 2022. Do the numbers hold clues to what lies ahead for the stock?

Humacyte, Inc. (HUMA) Reports Q3 Loss, Misses Revenue Estimates

-- Progress Continues in Clinical Development of Human Acellular Vessel™ (HAV™) for Vascular Trauma; BLA Filing Anticipated mid 2023 –

Humacyte Third Quarter 2022 Financial Results and Business Update

Six-month primate HAV CABG model demonstrates patency, recellularization and remodeling resembling native blood vessels

Humacyte Presents Six-Month Human Acellular Vessel™ (HAV™) Coronary Artery Bypass Graft (CABG) Data at the American Heart Association Scientific Sessions 2022 Meeting

DURHAM, N.C., Nov. 03, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue, complex tissue systems, and organs at commercial scale, will release its financial results for the third quarter ended September 30, 2022, on Thursday, November 10, 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 Third Quarter Financial Results and Provide Corporate Update on November 10, 2022

Shares of tissue regeneration firm Humacyte, Inc. are down over 70% from their opening trade post-SPAC merger in August 2021, dogged by a lack of news and slow trial enrollments. Those dynamics should change as Phase 3 data from its human acellular vessel candidate in the treatment of trauma should be forthcoming near YE22.

Humacyte: Intriguing Potential

HAV™ was utilized to treat multiple patients suffering from shrapnel, gunshot wounds, and mine blast injuries HAV™ was utilized to treat multiple patients suffering from shrapnel, gunshot wounds, and mine blast injuries

Humacyte Announces Presentations by Ukrainian Surgeons on Use of the Human Acellular Vessel™ to Treat Wartime Vascular Trauma at the European Society for Vascular Surgery Annual Meeting

Lt. General Bruce Green, M.D., USAF-ret. Joins Board of Directors

Humacyte Expands Board of Directors and Leadership Team with New Appointments

Dr. Todd E. Rasmussen provides HAV™ clinical update and surgical skills workshop at ICMM Dr. Todd E. Rasmussen provides HAV™ clinical update and surgical skills workshop at ICMM

Humacyte Announces Presentation on Investigational Human Acellular VesselTM for Treatment of Vascular Trauma at the International Committee of Military Medicine World Congress

DURHAM, N.C., Sept. 08, 2022 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissues and complex tissue and organ systems at commercial scale, today announced an oral presentation on the Company's Human Acellular Vessel (HAV) by Todd E. Rasmussen, M.D., FACS, (Col, ret. USAF MC) at the 44th International Committee on Military Medicine (ICMM) World Congress was given on September 7, 2022. In addition, company management will represent Humacyte at the HC Wainwright 24th Annual Global Investment Conference on September 14, 2022. Details of the conferences are as follows:

Humacyte Presents at Multiple Conferences in September 2022

The consensus price target hints at an 84.8% upside potential for Humacyte, Inc. (HUMA). While empirical research shows that this sought-after metric is hardly effective, an upward trend in earnings estimate revisions could mean that the stock will witness an upside in the near term.

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