Humacyte Inc Stock Price, News & Analysis

Humacyte reported Q3 2024 financial results and business updates. The FDA review of their acellular tissue engineered vessel (ATEV) BLA for vascular trauma treatment continues without a specified timeline. The company presented positive results from their V007 Phase 3 clinical trial for hemodialysis access at Kidney Week 2024, showing superior performance over standard treatment. Financial highlights include: no revenue for Q3 2024, R&D expenses of $22.9M, G&A expenses of $7.3M, and a net loss of $39.2M. The company reported $71M in cash and equivalents, with an additional $29.6M raised post-quarter through stock and warrant sales.

Humacyte (Nasdaq: HUMA), a clinical-stage biotechnology platform company focused on bioengineered human tissue development, has scheduled its third quarter 2024 financial results release for November 8, 2024. The company will host a conference call and webcast at 8:30 a.m. ET to discuss financial performance and provide updates on its acellular tissue engineered vessel (ATEV) programs. The presentation will be accessible via phone and webcast, with replay available on the company's investor website for 30 days.

Humacyte (HUMA) presented positive Phase 3 clinical trial results for their ATEV (acellular tissue engineered vessel) in arteriovenous access for hemodialysis patients. The trial demonstrated superior performance compared to standard autogenous fistula, with 81.3% functional patency at 6 months versus 66.4%, and 68.3% secondary patency at 12 months versus 62.2%. Notable improvements were seen in high-risk groups: female patients achieved 8.3 vs 5.0 months of dialysis duration, obese patients 7.7 vs 4.5 months, and diabetic patients 7.4 vs 5.5 months. While infection rates were similar between groups, ATEV showed higher thrombosis rates (52.1% vs 9.1%), though 94% of cases were successfully treated.

Humacyte (Nasdaq: HUMA) announced a virtual KOL event scheduled for October 31, 2024, at 8:00 AM ET, focusing on their acellular tissue engineered vessel (ATEV™) for hemodialysis access. The event will feature expert speakers from Brigham and Women's Hospital and the University of Alabama at Birmingham who will discuss the current treatment landscape for arteriovenous (AV) access in hemodialysis patients.

The speakers will present case studies and highlight V007 Phase 3 clinical results comparing ATEV to arteriovenous fistula (AVF) in end-stage kidney disease patients. ATEV is an investigational, first-in-class bioengineered human tissue designed as a universally implantable vascular conduit, pending FDA approval.

Humacyte, Inc. (Nasdaq: HUMA) 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 has been accepted for an oral presentation at the American Society of Nephrology's (ASN) Kidney Week 2024. The presentation, titled "Prospective Randomized Trial of Humacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access," will be delivered by Dr. Mohamad A. Hussain on October 26, 2024, in San Diego. Humacyte plans to provide additional details from the presentation in a future press release. The ATEV is still an investigational product and has not been approved for sale by the FDA or any other regulatory agency.

Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company, has announced a $30.0 million registered direct offering of common stock and warrants. The company will sell 5,681,820 shares of common stock and warrants to purchase an equal number of shares. The warrants are divided into two tranches, both with an exercise price of $5.28 per share, expiring at different intervals. The purchase price for one share and one warrant is set at $5.28. The offering is expected to close around October 7, 2024, subject to customary conditions. EF Hutton is acting as the exclusive placement agent for this offering, which is being made under a previously filed and effective shelf registration statement.

Humacyte (Nasdaq: HUMA) has announced a virtual Key Opinion Leader (KOL) event scheduled for September 30, 2024 at 8:00 AM ET. The event will focus on case studies evaluating Humacyte's acellular tissue engineered vessel (ATEV) product candidate for vascular trauma treatment.

Featured speakers include Dr. Charles Fox and Dr. Rishi Kundi from the University of Maryland School of Medicine, and Dr. YingWei Lum from Johns Hopkins School of Medicine. They will discuss the unmet medical needs and current treatment landscape for urgent arterial repair after extremity vascular trauma.

The event will highlight case studies from a Phase 3 trial conducted in the United States and Israel, as well as treatments of warfighters under a humanitarian program in Ukraine. Humacyte's ATEV is described as an investigational, first-in-class bioengineered human tissue designed as a universally implantable vascular conduit for arterial replacement and repair.

Humacyte (Nasdaq: HUMA) announced the allowance of a U.S. Patent for its BioVascular Pancreas (BVP) product candidate, designed to treat type 1 diabetes. The patent covers the BVP's design and composition, which uses Humacyte's acellular tissue engineered vessel (ATEV™) to deliver insulin-producing islets inside the body. Positive preclinical results support the BVP's potential:

1. Stem cell-derived islets restored normal blood sugar in diabetic mice
2. Successful BVP implantation in non-human primates showed islet survival and continued insulin production for three months

With 1.45 million Americans living with type 1 diabetes and 64,000 new diagnoses annually, the BVP could potentially overcome current hurdles in islet implantation for diabetic patients.

Humacyte (Nasdaq: HUMA), a clinical-stage biotechnology company, has announced its participation in two upcoming investor conferences in September 2024. The company, which focuses on developing universally implantable, bioengineered human tissue at commercial scale, will be represented by Laura Niklason, M.D., Ph.D., Founder, President, and CEO, and Dale Sander, CFO.

The conferences are:

• H.C. Wainwright 26th Annual Global Investment Conference on Tuesday, September 11, 2024, from 8:30 - 9 AM ET
• Cantor Global Healthcare Conference on Wednesday, September 18, 2024, from 9:10 - 9:40 AM ET

Both events will feature company presentations, with webcasts available for interested parties to view online.