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.

Humacyte is developing HAVs for multiple indications, showing promising clinical outcomes, and receiving FDA RMAT designation for faster approval processes. The market for vascular repairs is large and growing, with Humacyte's HAVs positioned as a potentially superior option to traditional treatments. Financially, Humacyte holds sufficient short-term assets but faces significant long-term liabilities and a potential cash crunch within a year.

Humacyte: Pioneering Vascular Solutions With High-Stakes Potential

DURHAM, N.C., July 16, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, announced the addition of pharmaceutical industry veteran Dr. John P. Bamforth and distinguished health system and academic physician Dr. Keith Anthony (Tony) Jones to the Company's Board of Directors.

Humacyte Board of Directors Strengthened with Addition of John P. Bamforth and Keith Anthony Jones

SEATTLE--(BUSINESS WIRE)--Pluristyx, a leading provider of tools, technologies, and services for the development of cellular therapies, is pleased to announce a license agreement with Humacyte, Inc., a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale. Humacyte has licensed Pluristyx's clinical-grade PluriBank™ induced Pluripotent Stem Cell (iPSC) line as starting materials for manufacturing insulin-producing cells f.

Pluristyx Announces License Agreement with Humacyte to Develop BioVascular Pancreas using iPSCs

Humacyte Inc (NASDAQ: HUMA) opened close to 25% up on Monday after the Food & Drug Administration granted its ATEV a special advanced-therapy designation.  Shares of the biotech firm are still down some 30% versus their year-to-date high.

Humacyte wins special advanced-therapy designation for ATEV

– Third RMAT designation by FDA for ATEV – – RMAT will expedite development of ATEV in PAD – DURHAM, N.C., July 01, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, has been granted the U.S. Food and Drug Administration's (FDA's) Regenerative Medicine Advanced Therapy (RMAT) designation for patients with advanced peripheral artery disease (PAD).

Humacyte Acellular Tissue Engineered Vessel (ATEV™) Receives FDA's Regenerative Medicine Advanced Therapy (RMAT) Designation for Patients with Advanced Peripheral Artery Disease (PAD)

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This week in Cheap Seats: Stocks Under $20 segment, we're taking a look at two stocks that are soaring today: Humacyte Inc (NYSE:HUMA) and American Semiconductor Corp (NASDAQ:AMSC).

2 Stocks Under $20 Making Outsized Moves

Humacyte (NASDAQ: HUMA) stock price has surged hard since I wrote about it in April. It soared to a high of $9.35 on Thursday and is now trading at its highest point since December 2021.

Humacyte (HUMA) stock price is pumping but 1 key risk remain

DURHAM, N.C., May 30, 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, will present at the Jefferies Global Healthcare Conference, in New York, NY on Thursday, June 6, 2024. Management will also be available for one-on-one meetings.

Humacyte to Present at the Jefferies Global Healthcare Conference

While Nancy Pelosi often dominates discussions on insider trades in the US, the year 2024 has seen a shift in focus to her Republican counterpart, Tommy Tuberville. His series of trades, particularly notable for their insider nature, have sparked significant interest.

This stock surged 100% since US Senator bought it 2 months ago

Humacyte's stock price has recently been on an impressive bull run, jumping from $4.50 to $6.50 after management announced Q1 2024 earnings. The company's market cap valuation is currently around $765 million - I believe this could rise >$1bn if the company secures a first commercial approval this year, as is likely. Humacyte focuses on regenerative medicine technology, specifically bioengineered human tissues, and has a Biologics License Application accepted by the FDA for its Human Acellular Vessels.

Humacyte: A Strong Opportunity In Wound Healing - A 'Buy' Before Price Gets Too High

DURHAM, N.C., May 13, 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, Dale Sander, Chief Financial Officer, and B.J. Scheessele, Chief Commercial Officer, will represent Humacyte at the following conferences in May.

Humacyte to Participate at Upcoming Investor Conferences in May

Humacyte, Inc. (NASDAQ:HUMA ) Q1 2024 Earnings Conference Call May 10, 2024 8:00 AM ET Company Participants Tom Johnson - Investor Relations, LifeSci Advisors Laura Niklason - Founder, President, Chief Executive Officer Dale Sander - Chief Financial Officer, Chief Corporate Development Officer, Treasurer Heather Prichard - Chief Operating Officer Conference Call Participants Ryan Zimmerman - BTIG Kristen Kluska - Cantor Fitzgerald Bruce Jackson - The Benchmark Company Josh Jennings - TD Cowen Operator Good morning, ladies and gentlemen, and welcome to the Humacyte First Quarter 2024 Results Conference Call. Currently all participants are in a listen-only mode.

Humacyte, Inc. (HUMA) Q1 2024 Earnings Call Transcript

-Biologics License Application (BLA) for HAV™ Accepted by FDA- -BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024- -Raised approximately $43 million in net proceeds from public offering of common stock- -Conference call and live webcast at 8:00 a.m. ET today- DURHAM, N.C.

Humacyte First Quarter 2024 Financial Results and Business Update

DURHAM, N.C., May 06, 2024 (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, 2024, on Friday, May 10, 2024. 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 10, 2024

Members of the U.S. Senate and Congress are no strangers to making highly lucrative and frequently unorthodox stock picks, with their timing and success rates being such that many firmly believe they are acting on insider information.

Suspicious Congressional stock trade up 44% in 2 weeks

U.S. Senator Tommy Tuberville disclosed the purchase of Humacyte Inc. (NASDAQ: HUMA) stocks on April 15. Four days later, HUMA's stock saw a 43% price surge, raising alerts of suspicious trading activity.

U.S. Senator trading alert: This stock surged 40% within 4 days of disclosure

Humacyte (NASDAQ: HUMA) stock price is pumping this week. It jumped by over 10% on Friday, continuing a spectacular rally that started last week.

Here's why the Humacyte (HUMA) stock price is pumping

As the stock market fluctuates, potentially wiping out recent gains, insider trading persists. Senator Tommy Tuberville is among those making moves ahead of the curve.

This US politician just made a really suspicious trade

Tommy Tuberville, a Republican Senator from the state of Alabama, disclosed 19 new stock trades on April 15th, and one trade in particular is causing big movements in the underlying stock.

A U.S. Senator Just Bought this Tiny Stock – It's Up 15% Today

DURHAM, N.C., March 26, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, today announced it will host a virtual KOL event on Thursday, March 28, 2024 at 8:00 AM ET, featuring Timmy Lee, MD, MSPH (University of Alabama at Birmingham) and Prabir Roy-Chaudhury MD, PhD, FRCP (University of North Carolina School of Medicine) who will discuss the profiles of patients receiving an AV Access who have higher rates of complications and the associated costs of treating them. To register, click here.

Humacyte to Host Virtual KOL Event “Hemodialysis Access: A Crossroads of Care,” on March 28, 2024

Humacyte, Inc. (HUMA) Q4 2023 Earnings Call Transcript

-Biologics License Application (BLA) for HAV™ Accepted by FDA on February 8, 2024- -BLA Granted Priority Review for Vascular Trauma Indication; PDUFA date set for August 10, 2024- -Raised approximately $43.1 million in net proceeds from public offering of common stock- -Conference call and live webcast at 8:00 a.m. ET today- DURHAM, N.C.

Humacyte Fourth Quarter and Year End 2023 Financial Results and Business Update

Humacyte (HUMA) is seeing favorable earnings estimate revision activity and has a positive Zacks Earnings ESP heading into earnings season.

Should You Buy Humacyte (HUMA) Ahead of Earnings?

DURHAM, N.C., March 18, 2024 (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, 2023, on Friday, March 22, 2024. Management will host a webcast and conference call at 8:00 a.m. ET to provide a corporate and financial update.

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