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.

ATLANTA, Nov. 19, 2024 (GLOBE NEWSWIRE) -- A shareholder class action lawsuit has been filed against Humacyte, Inc. (“Humacyte” or “the Company”) (NASDAQ: HUMA). The lawsuit alleges that Defendants made materially false and/or misleading statements, and/or failed to disclose material adverse facts about the Company's business, operations, and prospects, including allegations that: (1) the Company's Durham, North Carolina facility failed to comply with good manufacturing practices, including quality assurance and microbial testing; (2) the FDA's review of the Biologic License Application would be delayed while Humacyte remediated these deficiencies; and (3) as a result, there was a substantial risk to FDA approval of the acellular tissue engineered vessel (“ATEV”) for vascular trauma.

SHAREHOLDER ALERT: Class Action Lawsuit Filed on Behalf of Humacyte, Inc. (HUMA) Investors – Holzer & Holzer, LLC Encourages Investors With Significant Losses to Contact the Firm

NEW YORK CITY, NY / ACCESSWIRE / November 19, 2024 / Bronstein, Gewirtz & Grossman, LLC, a nationally recognized law firm, notifies investors that a class action lawsuit has been filed against Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA) and certain of its officers. Class Definition This lawsuit seeks to recover damages against Defendants for alleged violations of the federal securities laws on behalf of all persons and entities that purchased or otherwise acquired Humacyte securities between May 10, 2024 and October 17, 2024 inclusive (the "Class Period").

HUMA SHAREHOLDER ALERT: Bronstein, Gewirtz and Grossman, LLC Announces that Humacyte, Inc. Shareholders with Substantial Losses Have Opportunity to Lead Class Action Lawsuit!

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces that a class action lawsuit has been filed on behalf of investors who purchased Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) securities between May 10, 2024 and October 17, 2024, inclusive (the “Class Period”). Humacyte investors have until January 17, 2025 to file a lead plaintiff motion. Investors suffering losses on their Humacyte investments are encouraged to contact the Law Offices of Howard G. Smith to.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces the Filing of a Securities Class Action on Behalf of Humacyte, Inc. (HUMA) Investors

NEW YORK , Nov. 18, 2024 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Humacyte, Inc. ("Humacyte" or the "Company") (NASDAQ: HUMA). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Humacyte, Inc. - HUMA

SAN FRANCISCO, Nov. 18, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (NASDAQ: HUMA) and certain of its executives are now defendants in a class action lawsuit filed in the U.S. District Court for the Middle District of North Carolina. The suit, Cutshall v. Humacyte, Inc., et al., alleges that the company misled investors about the status of its Biologic License Application (BLA) for its acellular tissue engineered vessel (ATEV) and the regulatory compliance of its manufacturing facilities.

Humacyte (HUMA) Faces Class Action Lawsuit After FDA Inspection Reveals Manufacturing Issues– Hagens Berman

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”), announces that it has filed a class action lawsuit in the United States District Court for the Middle District of North Carolina, captioned Cutshall v. Humacyte, Inc., et al., Case No. 1:24-cv-00954, on behalf of persons and entities that purchased or otherwise acquired Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) securities between May 10, 2024 and October 17, 2024, inclusive (the “Class Period”). Plaintiff p.

HUMA CLASS ACTION NOTICE: Glancy Prongay & Murray LLP Files Securities Fraud Lawsuit Against Humacyte, Inc.

NEW YORK CITY, NY / ACCESSWIRE / November 15, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Humacyte, Inc. (HUMA) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Investors to Contact the Firm to Learn More About the Investigation

NEW YORK CITY, NY / ACCESSWIRE / November 14, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Bronstein, Gewirtz & Grossman, LLC Encourages Humacyte, Inc. (HUMA) Shareholders to Inquire about Securities Investigation

NEW YORK CITY, NY / ACCESSWIRE / November 13, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Bronstein, Gewirtz & Grossman, LLC Is Investigating Humacyte, Inc. (HUMA) And Encourages Shareholders to Connect

NEW YORK, Nov. 12, 2024 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, is investigating potential claims against Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) on behalf of Humacyte stockholders. Our investigation concerns whether Humacyte has violated the federal securities laws and/or engaged in other unlawful business practices.

HUMACYTE ALERT: Bragar Eagel & Squire, P.C. is Investigating Humacyte, Inc. on Behalf of Humacyte Stockholders and Encourages Investors to Contact the Firm

NEW YORK CITY, NY / ACCESSWIRE / November 12, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Bronstein, Gewirtz & Grossman, LLC Initiates an Investigation into Allegations Against Humacyte, Inc. (HUMA) And Encourages Shareholders to Reach Out

SAN FRANCISCO, Nov. 11, 2024 (GLOBE NEWSWIRE) -- On October 17, 2024, the U.S. Federal Food & Drug Administration (“FDA”) published its April 5, 2024 report addressed to Humacyte's Chief Operating Officer (Heather Prichard) detailing problems with Humacyte's facilities. The FDA's April 5, 2024 report submitted to Prichard appears to potentially contradict her assurances to investors at an earnings call on May 12, 2024 in response to analyst questions.

Humacyte (HUMA) Faces Questions After FDA Inspection – Hagens Berman

NEW YORK CITY, NY / ACCESSWIRE / November 11, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Bronstein, Gewirtz & Grossman, LLC Encourages Humacyte, Inc. (HUMA) Stockholders to Inquire about Securities Investigation

NEW YORK, NY / ACCESSWIRE / November 11, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Humacyte, Inc. ("Humacyte, Inc.") (NASDAQ:HUMA) concerning possible violations of federal securities laws. On October 17, 2024, the FDA revealed that it had identified several violations at Humacyte's North Carolina facility, including "no microbial quality assurance" and "no microbial testing," and "that quality oversight is inadequate.

ATTENTION Humacyte, Inc. Investors: You May Have Been Affected by Fraud- Contact Levi & Korsinsky to Discuss Your Rights

NEW YORK CITY, NY / ACCESSWIRE / November 10, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Bronstein, Gewirtz & Grossman, LLC Announces an Investigation Against Humacyte, Inc. (HUMA) and Encourages Investors to Learn More About the Investigation

Humacyte, Inc. (NASDAQ:HUMA ) Q3 2024 Earnings Conference Call November 8, 2024 8:30 AM ET Company Participants Lauren Marek - LifeSci Advisors Laura Niklason - President and CEO Dale Sander - CFO and Chief Corporate Development Officer Conference Call Participants Ryan Zimmerman - BTIG Josh Jennings - TD Cowen & Company Kristen Kluska - Cantor Fitzgerald Bruce Jackson - Benchmark Company Vernon Bernardino - H.C. Wainwright Operator Good morning, ladies and gentlemen, and welcome to the Humacyte Third Quarter 2024 Results Conference Call.

Humacyte, Inc. (HUMA) Q3 2024 Earnings Call Transcript

NEW YORK CITY, NY / ACCESSWIRE / November 8, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Humacyte, Inc. (HUMA) Investigation: Bronstein, Gewirtz & Grossman, LLC Encourages Shareholders to Contact the Firm to Learn More About the Investigation

- FDA review of acellular tissue engineered vessel (ATEV™) BLA for the  Treatment of Vascular Trauma is ongoing -

Humacyte Third Quarter 2024 Financial Results and Business Update

NEW YORK, NY / ACCESSWIRE / November 8, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Humacyte, Inc. ("Humacyte, Inc.") (NASDAQ:HUMA) concerning possible violations of federal securities laws. On October 17, 2024, the FDA revealed that it had identified several violations at Humacyte's North Carolina facility, including "no microbial quality assurance" and "no microbial testing," and "that quality oversight is inadequate.

HUMA ALERT: Levi & Korsinsky Reminds Investors of an Investigation Involving Possible Securities Fraud Violations by Humacyte, Inc.

NEW YORK CITY, NY / ACCESSWIRE / November 7, 2024 / Bronstein, Gewirtz & Grossman, LLC is investigating potential claims on behalf of purchasers of Humacyte, Inc. ("Humacyte" or "the Company") (NASDAQ:HUMA). Investors who purchased Humacyte securities are encouraged to obtain additional information and assist the investigation by visiting the firm's site: bgandg.com/HUMA.

Bronstein, Gewirtz & Grossman, LLC Is Investigating Humacyte, Inc. (HUMA) And Encourages Investors to Connect

NEW YORK, NY / ACCESSWIRE / November 7, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Humacyte, Inc. ("Humacyte, Inc.") (NASDAQ:HUMA) concerning possible violations of federal securities laws. On October 17, 2024, the FDA revealed that it had identified several violations at Humacyte's North Carolina facility, including "no microbial quality assurance" and "no microbial testing," and "that quality oversight is inadequate.

Shareholder Rights Advocates at Levi & Korsinsky Investigate Humacyte, Inc. (HUMA) Regarding Possible Securities Fraud Violations

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz Continues Its Investigation of Humacyte, Inc. (HUMA) on Behalf of Investors.

The Law Offices of Frank R. Cruz Continues Its Investigation of Humacyte, Inc. (HUMA) on Behalf of Investors

SAN FRANCISCO, CA / ACCESSWIRE / November 6, 2024 / On October 17, 2024, the U.S. Federal Food & Drug Administration ("FDA") published its April 5, 2024 report addressed to Humacyte's Chief Operating Officer (Heather Prichard) detailing problems with Humacyte's facilities. The FDA's April 5, 2024 report submitted to Prichard appears to potentially contradict her assurances to investors at an earnings call on May 12, 2024 in response to analyst questions.

Humacyte (HUMA) Faces Questions After FDA Inspection - Hagens Berman

DURHAM, N.C., Nov. 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 third quarter ended September 30, 2024, on Friday, November 8, 2024. Management will host a webcast and conference call at 8:30 a.m. ET to discuss recent corporate updates from its acellular tissue engineered vessel (ATEV) programs.

Humacyte to Present Third Quarter Financial Results and Provide Corporate Update on November 8, 2024

NEW YORK, NY / ACCESSWIRE / November 6, 2024 / Levi & Korsinsky notifies investors that it has commenced an investigation of Humacyte, Inc. ("Humacyte, Inc.") (NASDAQ:HUMA) concerning possible violations of federal securities laws. On October 17, 2024, the FDA revealed that it had identified several violations at Humacyte's North Carolina facility, including "no microbial quality assurance" and "no microbial testing," and "that quality oversight is inadequate.

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