Humacyte Second Quarter 2024 Financial Results and Business Update
-FDA requires additional time to complete its review of ATEV™ (acellular tissue engineered vessel) BLA for the Treatment of Vascular Trauma-
-Reported Positive Topline Results from Phase 3 Trial of ATEV in Hemodialysis Access-
-ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA in Advanced Peripheral Artery Disease-
-Conference call and live webcast at
“We were surprised to be notified by the FDA that they will require additional time to complete their review of the BLA for our ATEV (acellular tissue engineered vessel) in vascular trauma,” said
“The ATEV continues to make significant progress in its other investigational indications, including in hemodialysis access,” continued
Second Quarter 2024 and Recent Corporate Highlights
ATEV (acellular tissue engineered vessel)
- FDA extension of time to complete review of BLA for ATEV in the Treatment of Vascular Trauma– On
August 9, 2024 , in a phone call,Center for Biologics Evaluation and Research (CBER) leadership from theU.S. Food and Drug Administration (FDA) notified the Company that the FDA will require additional time to complete its review of the Company’s Biologics License Application (BLA) for the ATEV in the vascular trauma indication. The ATEV trauma BLA was submitted to FDA inDecember 2023 , FDA granted a Priority Review inFebruary 2024 , and assigned a PDUFA date ofAugust 10, 2024 .
- Positive Topline Results of ATEV in Hemodialysis Access – In
July 2024 ,Humacyte reported positive topline results from the V007 Phase 3 clinical trial (NCT03183245) of the ATEV in arteriovenous (AV) access for patients on hemodialysis. The V007 trial is prospective, multi-center, randomized clinical study in 242 hemodialysis patients inthe United States . Participants were randomly assigned to receive either the ATEV or an AV fistula for hemodialysis access and are being followed for up to 24 months. In the trial, the ATEV was observed to provide superior functional patency at six and 12 months (co-primary endpoints; p=0.0071) compared to autogenous fistula, which is the current standard of care for hemodialysis patients. Patients on ATEV also achieved a significantly longer duration of hemodialysis using the ATEV over the first 12 months, as compared to autogenous fistula (p=0.0162).Humacyte anticipates that detailed results from the trial will be presented at upcoming medical meetings.
- ATEV Received Third Regenerative Medicine Advanced Therapy (RMAT) Designation from FDA – In
July 2024 , the FDA granted RMAT designation of the ATEV for patients with advanced peripheral artery disease (PAD). This RMAT designation is granted at the same time as FDA cleared a new Investigational New Drug (IND) application for the PAD indication. This is the third RMAT designation granted by the FDA for Humacyte’s ATEV, in addition to previous RMAT designations for vascular trauma repair and AV access in hemodialysis.
Medical and
- PAD Publication: In
June 2024 , Dr.Todd Rasmussen and colleagues at theMayo Clinic inRochester MN published outcomes of arterial bypass using the ATEV in patients with chronic limb ischemia (severe PAD). In this paper, appearing in theJournal of Vascular Surgery in June, all patients treated with the ATEV for severe PAD had no suitable vein of their own for bypass, and were treated under an investigator-sponsored protocol. Outcomes for ATEV patency (or blood flow) and limb salvage in patients with severe PAD and no vein were compared to historical control patients, having similar disease but receiving a bypass using their own vein at theMayo Clinic . Mayo investigators reported that patency and limb salvage were similar for patients receiving ATEV, and patients receiving bypass with their own vein. This result highlights the potential impact that Humacyte’s ATEV may have on patients suffering from severe PAD and having no vein of their own to perform a bypass operation. - Presentations Highlighting Advancement of Diabetes Program – In
June 2024 ,Humacyte presented positive results from ongoing preclinical studies supporting the potential of Humacyte’s BioVascular Pancreas (BVP™) product candidate to enable the delivery and survival of insulin-producing islets as a potential treatment for type 1 diabetes:- At a presentation at the Breakthrough T1D (formerly, JDRF) Beta Cell Consortium Meeting in
New York City , scientists presented data in which stem cell-derived islets, manufactured atHumacyte , were observed to restore normal blood sugar in diabetic mice. In the mice, the stem cell-derived islets survived and continued to produce insulin, with no evidence of adverse safety events from the stem cell-derived islets. These experiments were performed in collaboration with theDiabetes Research Institute (DRI) at theUniversity of Miami . - At the
American Diabetes Association annual meeting inOrlando, Florida ,Humacyte reported successful implantation of BVPs into non-human primate recipients. In the study, also performed in collaboration with the DRI, primate BVP implants showed islet survival and continued insulin production throughout the three-month duration of the study. Islets also developed capillaries to support survival of the insulin-producing cells.
- At a presentation at the Breakthrough T1D (formerly, JDRF) Beta Cell Consortium Meeting in
- CABG Preclinical Remodeling Results – Preclinical six-month studies have been conducted in non-human primates to support the planned advancement of the small-diameter ATEV into human clinical trials in coronary artery bypass graft (CABG) surgery.
Humacyte has observed remodeling of the ATEV to a diameter that closely matches that of the native coronary vessels in non-human primates, which is an outcome not observed with any other conduit and highlights the potential adaptability of the ATEV in vivo. These promising results of ATEV patency and remodeling were presented at theTissue Engineering and Regenerative Medicine (TERM-2024) Conference onJune 11-12, 2024 .
Corporate Updates
- Strengthened Board of Directors – In
July 2024 ,Humacyte announced the addition of pharmaceutical industry veteran Dr.John P. Bamforth and distinguished health system and academic physician Dr.Keith Anthony (Tony) Jones to the Company’s Board of Directors.
Second Quarter 2024 Financial Highlights
- There was no revenue for either the second quarter of 2024 or the second quarter of 2023, and there was no revenue for the six months ended
June 30, 2024 and 2023. - Research and development expenses were
$23.8 million for the second quarter of 2024, compared to$20.5 million for the second quarter of 2023, and were$45.0 million for the six months endedJune 30, 2024 , compared to$37.8 million for the six months endedJune 30, 2023 . The current-period increases resulted primarily from increased materials and personnel expenses to support expanded research and development initiatives and our clinical trials, including the expansion of manufacturing activities and support of the FDA review of the BLA in vascular trauma. - General and administrative expenses were
$5.7 million for the second quarter of 2024, compared to$6.2 million for the second quarter of 2023, and were$11.1 million for the six months endedJune 30, 2024 , compared to$11.4 million for the six months endedJune 30, 2023 . The slight decreases during 2024, resulted primarily from a decrease in non-cash stock compensation expense, partially offset by increased personnel expenses and increased professional fees. - Other net income (expense) was net expense of
$27.2 million for the second quarter of 2024, compared to net income of$4.0 million for the second quarter of 2023, and other net expense of$32.5 million for the six months endedJune 30, 2024 , compared to other net expense of$10.4 million for the six months endedJune 30, 2023 . The increase in other net expense for the second quarter of 2024 and the six months endedJune 30, 2024 compared to 2023 resulted primarily from the non-cash remeasurement of the contingent earnout liability associated with the Company’sAugust 2021 merger withAlpha Healthcare Acquisition Corp. - Net loss was
$56.7 million for the second quarter of 2024, compared to$22.7 million for the second quarter of 2023, and net loss was$88.6 million for the six months endedJune 30, 2024 , compared to$59.7 million for the six months endedJune 30, 2023 . The current-period increase in net loss resulted primarily from the non-cash remeasurement of the contingent earnout liability, and operating expense increases, described above. - The Company reported cash and cash equivalents of
$93.6 million as ofJune 30, 2024 . Total net cash provided was$13.1 million for the first six months of 2024, compared to net cash used of$35.2 million for the first six months of 2023. The increase in net cash provided resulted primarily from the receipt of approximately$43.0 million in net proceeds from an underwritten public offering of Humacyte’s common stock inMarch 2024 , and$20 million in proceeds from an additional draw under its funding arrangement withOberland Capital Management .
Conference Call and Webcast Details
Title: | Humacyte Second Quarter 2024 Financial Results Corporate Update |
Date: | |
Time: | |
Conference Call Details: | Toll-Free: 1- 877-704-4453 International: 1-201-389-0920 Conference ID #: 13747913 |
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
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
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, the outcome of the FDA’s review of our BLA seeking approval of the ATEV in the vascular trauma indication; the statements regarding the initiation, timing, progress, and results of our preclinical and clinical trials, the anticipated characteristics and performance of our ATEV; our ability to successfully complete preclinical and clinical trials for our ATEVs; the anticipated benefits of the ATEV relative to existing alternatives; the anticipated commercialization of our ATEVs and our ability to manufacture at commercial scale; the implementation of our business model and strategic plans for our business; and the timing or likelihood of regulatory filings, acceptances, and approvals. 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 Investor Contact:
+1-617-435-6602
jallaire@lifesciadvisors.com
investors@humacyte.com
Humacyte Media Contact:
Precision Strategies
+1-202-845-3924
rich@precisionstrategies.com
media@humacyte.com
Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) (in thousands except for share and per share amounts) |
|||||||||||||||
Three Months Ended |
Six Months Ended |
||||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||||
Revenue | $ | — | $ | — | $ | — | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 23,753 | 20,540 | 45,017 | 37,818 | |||||||||||
General and administrative | 5,746 | 6,191 | 11,060 | 11,425 | |||||||||||
Total operating expenses | 29,499 | 26,731 | 56,077 | 49,243 | |||||||||||
Loss from operations | (29,499 | ) | (26,731 | ) | (56,077 | ) | (49,243 | ) | |||||||
Other income (expense), net: | |||||||||||||||
Change in fair value of contingent earnout liability | (25,571 | ) | 3,627 | (30,164 | ) | (10,564 | ) | ||||||||
Other income (expense) (net) | (1,593 | ) | 398 | (2,318 | ) | 132 | |||||||||
Total other income (expense), net | (27,164 | ) | 4,025 | (32,482 | ) | (10,432 | ) | ||||||||
Net loss and comprehensive loss | $ | (56,663 | ) | $ | (22,706 | ) | $ | (88,559 | ) | $ | (59,675 | ) | |||
Net loss per share, basic and diluted | $ | (0.48 | ) | $ | (0.22 | ) | $ | (0.78 | ) | $ | (0.58 | ) | |||
Weighted-average shares outstanding, basic and diluted | 119,174,681 | 103,361,501 | 113,710,344 | 103,312,785 |
Condensed Consolidated Balance Sheets (unaudited) (in thousands) |
|||||||
2024 |
2023 |
||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 93,563 | $ | 80,448 | |||
Prepaid expenses and other current assets | 2,547 | 2,830 | |||||
Total current assets | 96,110 | 83,278 | |||||
Property and equipment, net | 24,820 | 26,791 | |||||
Finance lease right-of-use assets, net | 16,536 | 17,313 | |||||
Other long-term assets | 815 | 841 | |||||
Total assets | $ | 138,281 | $ | 128,223 | |||
Liabilities and Stockholders’ Equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 6,005 | $ | 6,490 | |||
Accrued expenses | 8,950 | 9,340 | |||||
Other current liabilities | 2,802 | 2,613 | |||||
Total current liabilities | 17,757 | 18,443 | |||||
Contingent earnout liability | 68,080 | 37,916 | |||||
Revenue interest liability | 60,078 | 38,600 | |||||
Finance lease obligation, net of current portion | 15,123 | 16,293 | |||||
Other long-term liabilities | 5,530 | 3,425 | |||||
Total liabilities | 166,568 | 114,677 | |||||
Stockholders’ equity | |||||||
Common stock and additional paid-in capital | 597,586 | 550,860 | |||||
Accumulated deficit | (625,873 | ) | (537,314 | ) | |||
Total stockholders’ equity | (28,287 | ) | 13,546 | ||||
Total liabilities and stockholders’ equity | $ | 138,281 | $ | 128,223 |
Source: Humacyte, Inc