DURHAM, N.C., Nov. 09, 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 third quarter ended September 30, 2023 and highlighted recent corporate accomplishments advancing the investigational, universally implantable Human Acellular Vessel (HAV) closer to planned U.S. market launch.
“The major milestones reached during the third quarter of 2023 set the stage for our planned Biologics License Application (BLA) filing of the HAV for the vascular trauma indication with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2023,” said Laura Niklason, M.D., Ph.D., Chief Executive Officer of Humacyte. “A key event supporting the planned BLA filing was our announcement of positive top line results from the V005 trial in vascular trauma repair. We are also proud that our humanitarian efforts in Ukraine, which will supplement the V005 results in our BLA filing, have resulted in successful outcomes including saving lives and limbs in a wartime setting. Finally, we are pleased that the potential of the HAV pipeline has also been observed in other clinical studies this quarter, including the presentation of Phase 2 results in severe peripheral arterial disease (PAD). In addition, we recently published preclinical results of our small caliber HAV in a juvenile heart disease model. The remainder of 2023 will be exciting, and we thank the medical professionals, patients, researchers and employees for their contribution to the advancement of the HAV.”
Third Quarter 2023 Corporate Highlights
Clinical and Regulatory Updates
Presentations and Publications
The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Third Quarter 2023 Financial Highlights
Conference Call and Webcast Details
Title: | Humacyte Third Quarter 2023 Financial Results and Corporate Update | |
Date: | Thursday, November 9, 2023 | |
Time: | 4:30 p.m. ET | |
Conference Call Details: | Toll-Free: 1-888-999-5318 International: 1-848-280-6460 Conference ID #: 13741924 | |
Call meTM Feature (avoid waiting for operator): | Click Here | |
Webcast: | Webcast Link - 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 an 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, including the BLA for our V005 clinical trial; timing, scope, and rate of reimbursement 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 described under the header “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2022 and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, each 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. Except as required by law, we have no current intention of updating any of the forward-looking statements in this press release. 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
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Humacyte Media Contact:
Rich Luchette
Precision Strategies
+1-202-845-3924
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Humacyte, Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands except for share and per share amounts) | |||||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||||
Grant revenue | $ | — | $ | 31 | $ | — | $ | 1,565 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 18,552 | 17,337 | 56,370 | 48,303 | |||||||||||
General and administrative | 6,070 | 6,188 | 17,495 | 17,050 | |||||||||||
Total operating expenses | 24,622 | 23,525 | 73,865 | 65,353 | |||||||||||
Loss from operations | (24,622 | ) | (23,494 | ) | (73,865 | ) | (63,788 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Change in fair value of contingent earnout liability | (1,144 | ) | (962 | ) | (11,708 | ) | 58,649 | ||||||||
Other expense (net) | (229 | ) | (825 | ) | (97 | ) | (3,106 | ) | |||||||
Total other income (expense), net | (1,373 | ) | (1,787 | ) | (11,805 | ) | 55,543 | ||||||||
Net loss and comprehensive loss | $ | (25,995 | ) | $ | (25,281 | ) | $ | (85,670 | ) | $ | (8,245 | ) | |||
Net loss per share, basic and diluted | $ | (0.25 | ) | $ | (0.25 | ) | $ | (0.83 | ) | $ | (0.08 | ) | |||
Weighted-average shares outstanding, basic and diluted | 103,444,246 | 103,031,980 | 103,357,087 | 103,014,009 |
Humacyte, Inc. Condensed Consolidated Balance Sheets (unaudited) (in thousands) | |||||||
September 30, 2023 | December 31, 2022 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 99,986 | $ | 149,772 | |||
Prepaid expenses and other current assets | 2,865 | 2,329 | |||||
Short-term investments | — | 2,107 | |||||
Total current assets | 102,851 | 154,208 | |||||
Property and equipment, net | 27,851 | 30,039 | |||||
Finance lease right-of-use assets, net | 17,828 | 19,373 | |||||
Other long-term assets | 855 | 682 | |||||
Total assets | $ | 149,385 | $ | 204,302 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,018 | $ | 1,595 | |||
Accrued expenses | 9,586 | 7,108 | |||||
Other current liabilities | 2,533 | 2,306 | |||||
SVB loan payable, current portion | — | 8,571 | |||||
Total current liabilities | 15,137 | 19,580 | |||||
Contingent earnout liability | 39,601 | 27,893 | |||||
Revenue interest liability | 37,286 | — | |||||
Finance lease obligation, net of current portion | 16,960 | 18,853 | |||||
Other long-term liabilities | 3,408 | 712 | |||||
SVB loan payable, net of current portion | — | 20,336 | |||||
Total liabilities | 112,392 | 87,374 | |||||
Stockholders’ equity | |||||||
Common stock and additional paid-in capital | 549,201 | 543,466 | |||||
Accumulated deficit | (512,208 | ) | (426,538 | ) | |||
Total stockholders’ equity | 36,993 | 116,928 | |||||
Total liabilities and stockholders’ equity | $ | 149,385 | $ | 204,302 |
Last Trade: | US$5.27 |
Daily Change: | -0.21 -3.83 |
Daily Volume: | 1,698,986 |
Market Cap: | US$628.970M |
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