Humacyte Inc. (NASDAQ:HUMA) Q2 2023 Earnings Conference Call August 14, 2023 8:00 AM ET

Company Participants

Dr. Laura Niklason - President & CEO

Dale Sander - CFO & Chief Corporate Development Officer

Dr. Heather Prichard - COO

Laura Marek - LifeSci Advisors, IR

Conference Call Participants

Ryan Zimmerman - BTIG

Josh Jennings - TD Cowen

Matthew O'Brien - Piper Sandler

Suraj Kalia - Oppenheimer & Company

Bruce Jackson - The Benchmark Company.

Operator

Good morning, ladies and gentlemen, and welcome to the Humacyte Second Quarter Results Conference Call. Currently, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. As a reminder, this conference is being recorded.

I'll now turn the call over to Laura Marek with LifeSci Advisors. Please go ahead.

Laura Marek

Thank you, operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ from statements made on this call is contained in our periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements, except as required by law. Information presented on this call is contained in the press release we issued this morning and in our Form 10-Q, which after filing may be accessed from the Investors page of the Humacyte website.

Joining me on today's call from Humacyte are Dr. Laura Niklason, President and Chief Executive Officer; Dale Sander, Chief Financial Officer and Chief Corporate Development Officer; and Dr. Heather Prichard, Chief Operating Officer. Dr. Niklason will provide a summary of the company's progress during the quarter and recent weeks, and Dale will review the company's financial results for the quarter ended June 30, 2023. Following their prepared remarks, the management team will be available for your questions.

I will now turn the call over to Dr. Niklason.

Dr. Laura Niklason

Thank you, Laura. Good morning, everyone, and thank you so much for joining our second quarter 2023 financial results and business update call. As we enter into the second half of 2023, we continue to be excited about the progress we've made so far this year in advancing our universally implantable bio-engineered human tissue product candidate, the Human Acellular Vessel, or HAV, in multiple indications. As a recognition of the groundbreaking nature of the HAV, the FDA issued a Regenerative Medicine Advanced Therapy, or RMAT, designation for the trauma indication in May. In July, we announced completion of enrollment of our Phase 3 trial in vascular trauma. Based on the 30-day endpoint of this pivotal trial, we will present topline results for the trial during Q3 of this year. We remain on target for filing our Biologics Licensing Application, or BLA, with the FDA during Q4 of this year. Reinforcing the importance of the HAV in wartime scenarios, we're proud of the highly successful outcomes to date with our humanitarian program in Ukraine. And lastly, we recently announced our collaboration with the Juvenile Diabetes Research Foundation, or JDRF, to advance our biovascular pancreas product candidate.