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, 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.

Did Humacyte, Inc. Mislead Investors? Shareholder Rights Advocates at Levi & Korsinsky Investigate - HUMA

NEW YORK CITY, NY / ACCESSWIRE / November 5, 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) Investors to Inquire about Securities Investigation

NEW YORK, NY / ACCESSWIRE / November 5, 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.

Humacyte, Inc. Investigation Ongoing: Contact Levi & Korsinsky About Potential Securities Fraud Allegations - HUMA

NEW YORK CITY, NY / ACCESSWIRE / November 4, 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 Investors to Reach Out

NEW YORK CITY, NY / ACCESSWIRE / November 3, 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 Stockholders to Reach Out

NEW YORK CITY, NY / ACCESSWIRE / November 1, 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 Stockholders to Connect

NEW YORK, NY / ACCESSWIRE / November 1, 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.

Humacyte, Inc. Investigated by Shareholder Rights Advocates - Investors Should Contact Levi & Korsinsky Regarding Potential Securities Law Violations - HUMA

NEW YORK CITY, NY / ACCESSWIRE / October 31, 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 Stockholders to Contact the Firm to Learn More About the Investigation

Humacyte, Inc. (HUMA) closed at $5.05 in the latest trading session, marking a -1.94% move from the prior day.

Humacyte, Inc. (HUMA) Declines More Than Market: Some Information for Investors

NEW YORK, NY / ACCESSWIRE / October 30, 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.

Levi & Korsinsky Reminds Humacyte, Inc. Investors of the Ongoing Investigation into Potential Violations of Securities Laws - HUMA

PHILADELPHIA, PA / ACCESSWIRE / October 30, 2024 / Kehoe Law Firm, P.C. is investigating potential securities claims on behalf of investors of Humacyte, Inc. ("Humacyte" or the "Company") (NASDAQ: HUMA).

Humacyte Stock - Investors of Humacyte Encouraged to Contact Kehoe Law Firm, P.C. - HUMA

NEW YORK, NY / ACCESSWIRE / October 29, 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.

Lost Money on Humacyte, Inc.(HUMA)? Contact Levi & Korsinsky Regarding an Ongoing Investigation

NEW YORK, NY / ACCESSWIRE / October 28, 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.

Levi & Korsinsky Reminds Shareholders of an Investigation into Humacyte, Inc. (HUMA) Regarding Potential Securities Fraud Allegations

– ATEV™ demonstrated superiority at six and 12 months (co-primary endpoints) compared to autogenous fistula, the current standard of care for hemodialysis access –

Humacyte Announces Presentation of Positive Results from V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology's Kidney Week 2024

In the most recent trading session, Humacyte, Inc. (HUMA) closed at $5.82, indicating a +1.75% shift from the previous trading day.

Humacyte, Inc. (HUMA) Laps the Stock Market: Here's Why

NEW YORK--(BUSINESS WIRE)---- $HUMA #INVESTOR--The law firm of Kirby McInerney LLP is investigating potential claims against Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA). The investigation concerns whether Humacyte and/or certain of its officers have violated the federal securities laws and/or engaged in other unlawful business practices. [Click here to learn more about the investigation] On August 9, 2024, Humacyte disclosed that the U.S. Food and Drug Administration (FDA) needed “additional time t.

Kirby McInerney LLP Announces Investigation of Shareholder Claims Against Humacyte, Inc. (HUMA)

LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”), a leading national shareholder rights law firm, today announced that it has commenced an investigation on behalf of Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) investors concerning the Company's possible violations of the federal securities laws. If you suffered a loss on your Humacyte investments or would like to inquire about potentially pursuing claims to recover your loss under the federal securities laws.

Glancy Prongay & Murray LLP, a Leading Securities Fraud Law Firm, Announces Investigation of Humacyte, Inc. (HUMA) on Behalf of Investors

BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) investors concerning the Company's possible violations of federal securities laws. On August 9, 2024, after market hours, Humacyte disclosed that the FDA needed “additional time to complete its review of its Biologic License Application (BLA) for the acellular tissue engineered vessel (ATEV) in the vascular trauma indication,” stating.

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of Humacyte, Inc. (HUMA) on Behalf of Investors

LOS ANGELES--(BUSINESS WIRE)--The Law Offices of Frank R. Cruz announces an investigation of Humacyte, Inc. (“Humacyte” or the “Company”) (NASDAQ: HUMA) on behalf of investors concerning the Company's possible violations of federal securities laws. If you are a shareholder who suffered a loss, click here to participate. On August 9, 2024, after market hours, Humacyte disclosed that the FDA needed “additional time to complete its review of its Biologic License Application (BLA) for the acellular.

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

Humacyte, Inc. (HUMA) closed at $5.70 in the latest trading session, marking a +0.53% move from the prior day.

Humacyte, Inc. (HUMA) Advances While Market Declines: Some Information for Investors

DURHAM, N.C., Oct. 08, 2024 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable, bioengineered human tissue at commercial scale, announced that its late-breaking abstract on the V007 Phase 3 clinical trial of the acellular tissue engineered vessel (ATEV™) in arteriovenous access for patients with end-stage renal disease was accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024. The late-breaking abstract titled “Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access” will be presented at the ASN meeting in San Diego on October 26, 2024.

Humacyte Late-Breaking Abstract Accepted for Oral Presentation on V007 Phase 3 AV Access Clinical Trial at the American Society of Nephrology's Kidney Week 2024

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