– Human Acellular Vessel™ (HAV™) granted second RMAT designation by the FDA, for Vascular Trauma –
– Completion of enrollment in Phase 3 trial of HAV in Hemodialysis Access in End-Stage Renal Disease Patients –
– Conference call and live webcast at 8:00 a.m. ET today –
DURHAM, N.C., May 12, 2023 (GLOBE NEWSWIRE) — Humacyte, Inc. (Nasdaq: HUMA), a clinical-stage biotechnology platform company developing universally implantable bioengineered human tissue at commercial scale, today announced financial results for the first quarter ended March 31, 2023, and highlighted recent corporate accomplishments.
“We are off to a fast start in 2023 and have moved closer to our planned filing of a Biologics License Application (BLA) for accelerated approval with the U.S. Food and Drug Administration (FDA) of our Human Acellular Vessel (HAV) for an indication in extremity vascular trauma,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “We were pleased to receive our second RMAT designation from the FDA, for use of the HAV in urgent arterial repair following extremity vascular trauma. The RMAT designation provides a higher likelihood for priority review of our planned BLA filing. We were delighted to see the potential benefits of the HAV reflected in two recent publications, The Lancet Regional Health – Europe and the Journal of Trauma and Acute Care Surgery. Lastly, I wanted to acknowledge JDRF International for their support of our Biovascular Pancreas (BVP) preclinical program in Type 1 diabetes.”
First Quarter 2023 and Recent Corporate Highlights
Clinical Updates
Publications and Presentations
The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Corporate Updates
First Quarter 2023 Financial Highlights
Conference Call and Webcast Details
Date: | Friday, May 12, 2023 |
Time: | 8:00 a.m. ET |
Conference Call Details: | Toll-Free: 1-877-704-4453 International: +1-201-389-0920 Conference ID : 13738048 |
Call meTM Feature: | Click here |
Webcast: | Q1 2023 Earnings Conference Call – Click Here |
A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the investors section of the Company’s website for at least 30 days.
About Humacyte
Humacyte, Inc. (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, AV access for hemodialysis, and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm HAV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm HAV for urgent arterial repair following extremity vascular trauma also has received RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.
Forward-Looking Statements
This press release contains forward-looking statements that are based on beliefs and assumptions and on information currently available. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties, and other factors that may cause actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Forward-looking statements in this press release include, but are not limited to, statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials; the anticipated characteristics and performance of our HAVs; our ability to successfully complete, preclinical and clinical trials for our HAVs; the anticipated benefits of our HAVs relative to existing alternatives; the anticipated commercialization of our HAVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; the timing or likelihood of regulatory filings and approvals; timing, scope, and rate of reimbursement for our HAVs; the outcome of our ongoing discussions with the FDA concerning the design of our ongoing V005 Phase 2/3 clinical trial, including determination of trial size, and the scope of any approved indication for our HAVs; and our estimated available market opportunity. We cannot assure you that the forward-looking statements in this press release will prove to be accurate. These forward-looking statements are subject to a number of significant risks and uncertainties that could cause actual results to differ materially from expected results, including, among others, changes in applicable laws or regulations, the possibility that Humacyte may be adversely affected by other economic, business, and/or competitive factors, and other risks and uncertainties, including those included under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022, filed by Humacyte with the SEC and in future SEC filings. Most of these factors are outside of Humacyte’s control and are difficult to predict. Furthermore, if the forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. The forward-looking statements in this press release represent our views as of the date of this press release. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we have no current intention of doing so except to the extent required by applicable law. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Humacyte Investor Contact:
Joyce Allaire
LifeSci Advisors LLC
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
Humacyte, Inc. | |||||||
Condensed Consolidated Statements of Operations and Comprehensive Loss | |||||||
(unaudited) | |||||||
(in thousands except for share and per share amounts) | |||||||
Three Months Ended March 31, |
|||||||
2023 | 2022 | ||||||
Grant revenue | $ | — | $ | 233 | |||
Operating expenses: | |||||||
Research and development | 17,278 | 16,314 | |||||
General and administrative | 5,234 | 5,682 | |||||
Total operating expenses | 22,512 | 21,996 | |||||
Loss from operations | (22,512 | ) | (21,763 | ) | |||
Other income (expense), net | |||||||
Change in fair value of contingent earnout liability | (14,191 | ) | 3,258 | ||||
Other expense (net) | (266 | ) | (1,327 | ) | |||
Total other income (expense), net | (14,457 | ) | 1,931 | ||||
Net loss and comprehensive loss | $ | (36,969 | ) | $ | (19,832 | ) | |
Net loss per share, basic and diluted | $ | (0.36 | ) | $ | (0.19 | ) | |
Weighted-average shares outstanding, basic and diluted | 103,263,528 | 103,004,088 | |||||
Humacyte, Inc. | |||||||
Condensed Consolidated Balance Sheets | |||||||
(unaudited) | |||||||
(in thousands) | |||||||
March 31, 2023 |
December 31, 2022 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 129,570 | $ | 149,772 | |||
Short-term investments | 2,107 | 2,107 | |||||
Prepaid expenses and other current assets | 2,178 | 2,329 | |||||
Total current assets | 133,855 | 154,208 | |||||
Property, plant and equipment, net | 29,593 | 30,039 | |||||
Lease right-of-use assets, net | 19,528 | 20,055 | |||||
Total assets | $ | 182,976 | $ | 204,302 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 1,954 | $ | 1,595 | |||
Accrued expenses | 6,411 | 7,108 | |||||
SVB loan payable, current portion | 12,857 | 8,571 | |||||
Other current liabilities | 2,379 | 2,306 | |||||
Total current liabilities | 23,601 | 19,580 | |||||
Contingent earnout liability | 42,084 | 27,893 | |||||
SVB loan payable, net of current portion | 16,410 | 20,336 | |||||
Finance lease obligation, net of current portion | 18,252 | 18,853 | |||||
Other long-term liabilities | 742 | 712 | |||||
Total liabilities | 101,089 | 87,374 | |||||
Stockholders’ equity | |||||||
Common stock and additional paid-in capital | 545,394 | 543,466 | |||||
Accumulated deficit | (463,507 | ) | (426,538 | ) | |||
Total stockholders’ equity | 81,887 | 116,928 | |||||
Total liabilities and stockholders’ equity | $ | 182,976 | $ | 204,302 |
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