DURHAM, N.C., Dec. 16, 2025 (GLOBE NEWSWIRE) -- Humacyte, Inc. (Nasdaq: HUMA), a commercial-stage biotechnology platform company developing universally implantable, bioengineered human tissues at commercial scale, today announced that it has entered into a credit facility with Avenue Venture Opportunities Fund II, L.P., a fund of Avenue Capital Group, providing up to $77.5 million in principal amount of new financing. The credit agreement, which has a term of four years, includes an initial tranche of $40 m ...

Core Insights - Humacyte, Inc. announced positive two-year results from the V007 Phase 3 clinical trial of its acellular tissue engineered vessel (ATEV) for hemodialysis access, demonstrating superior performance compared to the current gold standard, autogenous fistula, particularly in high-need subgroups [1][2][5] Group 1: Clinical Trial Results - The V007 Phase 3 trial showed that ATEV had a superior duration of use over 24 months compared to autogenous fistula in female, obese, and diabetic patients, who typically have poor outcomes with AV fistula procedures [2][4] - In female patients (n=70), the average duration of ATEV usage was 15.8 months compared to 10.0 months for AV fistula (p<0.0137) [4] - In the target population of females and males with obesity and diabetes (n=110), ATEV had an average duration of access use of 14.8 months versus 9.1 months for AV fistula (p=0.0114) [4] Group 2: Clinical Significance - The ATEV provided a clinically meaningful advantage in early usability and functional patency, enabling faster and more reliable dialysis initiation, especially in high-risk patients [3][5] - The results indicate that ATEV could significantly reduce reliance on catheters for arteriovenous access, which is a major cause of complications and treatment costs in patient care [3][6] Group 3: Safety Profile - After 24 months of follow-up, no unexpected side effects were observed in patients implanted with the ATEV, showing a comparable safety profile to AV fistula with low rates of infection [7] - Although ATEV patients experienced more thrombosis and stenosis events requiring interventions, most cases were successfully treated [7] Group 4: Company Overview - Humacyte is developing a biotechnology platform for universally implantable bioengineered human tissues and has received FDA approval for the ATEV in vascular trauma [9] - The company is also conducting late-stage clinical trials for other vascular applications, including AV access for hemodialysis and peripheral artery disease [9]

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q3 2025 on November 12, 2025, and will provide a corporate and financial update during a webcast and conference call [1][2]. Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at a commercial scale [1][3]. - The company manufactures acellular tissues aimed at treating various diseases, injuries, and chronic conditions [3]. - The FDA approved the Biologics License Application for Humacyte's acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 [3]. - ATEVs are currently in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3]. - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3]. - Humacyte's 6mm ATEV for AV access in hemodialysis is notable for being the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation [3]. - The ATEV has received priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]. Financial Results Announcement - The financial results for the quarter ending September 30, 2025, will be announced on November 12, 2025, at 8:00 AM ET [2]. - A conference call will be available for U.S. and international investors, with specific dial-in numbers provided [2]. - The webcast will be accessible 15 minutes prior to the call and will be available for replay for at least 30 days [2].

Core Viewpoint - Humacyte, Inc. has entered into a securities purchase agreement to raise approximately $60 million through an oversubscribed registered direct offering of common stock and warrants [1][3]. Group 1: Offering Details - The company will sell 28,436,018 shares of common stock along with warrants to purchase an equal number of shares [2]. - The exercise price for the warrants is set at $2.11 per share, with the warrants becoming exercisable 180 days after issuance and expiring on April 7, 2031 [2]. - The gross proceeds from the offering are estimated to be around $60 million before deducting fees and expenses, with the closing expected on or about October 8, 2025 [3]. Group 2: Regulatory and Legal Framework - The offering is conducted under a "shelf" registration statement on Form S-3, which was filed with the SEC and became effective on September 22, 2025 [4]. - A prospectus supplement detailing the terms of the offering will be filed with the SEC and will be part of the effective registration statement [5]. Group 3: Company Overview - Humacyte, Inc. is focused on developing bioengineered human tissues and advanced tissue constructs aimed at improving patient outcomes and transforming medical practices [8]. - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for extremity vascular trauma and is conducting late-stage clinical trials for other vascular applications [8]. - Humacyte's ATEV has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations [8].

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q2 2025 on August 11, 2025, and will provide a corporate and financial update during a conference call [1] Group 1: Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [2] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 and is conducting late-stage clinical trials for other vascular applications [2] - Humacyte's ATEV has received multiple designations, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA [2] Group 2: Financial and Conference Call Details - The financial results for the quarter ended June 30, 2025, will be released on August 11, 2025, with a conference call scheduled for 8:00 a.m. ET [1] - Investors can access the conference call via specific dial-in numbers and a conference ID, with a webcast available 15 minutes prior to the call [1]

Core Insights - Humacyte, Inc. is a biotechnology company focused on developing universally implantable, bioengineered human tissues at a commercial scale [1][3] - The company will present at the H.C. Wainwright 3rd Annual BioConnect Investor Conference on May 20, 2025, with management available for one-on-one meetings [1][2] Company Overview - Humacyte is developing a disruptive biotechnology platform aimed at improving patient lives and transforming medical practices through acellular tissues for various diseases and conditions [3] - The FDA approved Humacyte's Biologics License Application for the acellular tissue engineered vessel (ATEV) in December 2024, specifically for vascular trauma [3] - ATEVs are in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3] - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3] - Humacyte's 6mm ATEV for AV access in hemodialysis received the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation [3] - The ATEV has also received RMAT designations for urgent arterial repair following extremity vascular trauma and advanced PAD, along with priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]

Core Viewpoint - Humacyte, Inc. is set to release its financial results for Q1 2025 on May 13, 2025, and will provide a corporate and financial update during a webcast and conference call [1][2]. Company Overview - Humacyte, Inc. is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3]. - The company manufactures acellular tissues aimed at treating various diseases, injuries, and chronic conditions [3]. - The FDA approved the Biologics License Application for Humacyte's acellular tissue engineered vessel (ATEV) for vascular trauma in December 2024 [3]. - ATEVs are currently in late-stage clinical trials for additional vascular applications, including arteriovenous access for hemodialysis and peripheral artery disease [3]. - Preclinical development is ongoing for coronary artery bypass grafts, pediatric heart surgery, type 1 diabetes treatment, and other novel cell and tissue applications [3]. - Humacyte's 6mm ATEV for AV access in hemodialysis is notable for being the first product to receive the FDA's Regenerative Medicine Advanced Therapy (RMAT) designation and has also received Fast Track designation [3]. - The ATEV has received priority designation for vascular trauma treatment from the U.S. Secretary of Defense [3]. Financial Results Announcement - The financial results for the quarter ended March 31, 2025, will be announced on May 13, 2025, at 8:30 AM ET [2]. - A conference call will be available for U.S. and international investors, with specific dial-in numbers provided [2]. - The webcast will be accessible 15 minutes prior to the call and will be available for replay for at least 30 days [2].

Core Insights - Humacyte, Inc. is set to release its financial results for Q4 and the full year of 2024 on March 28, 2025, with a conference call scheduled for 8:30 AM ET [1][2] Company Overview - Humacyte is a clinical-stage biotechnology platform company focused on developing universally implantable, bioengineered human tissues at commercial scale [1][3] - The company has received FDA approval for its acellular tissue engineered vessel (ATEV) for extremity vascular trauma in December 2024 and is conducting late-stage clinical trials for other vascular applications [3] - Humacyte's ATEV has received multiple designations from the FDA, including Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations, highlighting its potential in urgent arterial repair and advanced peripheral artery disease [3] Upcoming Events - The financial results webcast will be accessible 15 minutes prior to the conference call, with a replay available for at least 30 days on the company's investor website [2]