Humacyte Third Quarter 2024 Financial Results and Business Update
HUMA 11.08.2024
Drug:ATEV-vascular_trauma ATEV
Diseases:vascular trauma
Date of Upcoming Event:2024-10-26
Name of Upcoming Event:American Society of Nephrology’s Kidney Week 2024
About Gravity Analytica
Recent News
- 01.21.2025 - Humacyte Announces Planned IND Filing in 2025 to Support First-In-Human Clinical Study of Small-Diameter ATEV™ for Coronary Artery Bypass Grafting
- 01.13.2025 - Humacyte Provides Update on Commercial Launch and Pricing of Symvess™ (acellular tissue engineered vessel-tyod) for Extremity Vascular Trauma
- 12.20.2024 - Humacyte Announces FDA Approval of SYMVESS™ (acellular tissue engineered vessel-tyod) for the Treatment of Extremity Vascular Trauma
Recent Filings
- FDA review of acellular tissue engineered vessel (ATEVTM) BLA for theTreatment of Vascular Trauma is ongoing -
-Results from the V007 Phase 3 clinical trial of the ATEV in arteriovenous (AV) access for hemodialysis patients presented at
-Long-term results from the humanitarian program where the ATEV was used to treat vascular injuries suffered during the
- Conference call and live webcast at
“Our biologics license application (BLA) for our ATEV in vascular trauma remains under review by the
“We continue to make progress with the ATEV in its other investigational indications, including hemodialysis access, and with the advancement of our broader pipeline,” continued
ThirdQuarter2024and Recent Corporate Highlights
ATEV (acellular tissue engineered vessel)
- FDA requires additional 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 the FDA notifiedHumacyte that the FDA will require additional time to complete its review of the Company’s 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 an original PDUFA date ofAugust 10, 2024 . The FDA has not provided a timeline for the completion of their review. - NTAP Application– To support reimbursement for the ATEV if approved by the FDA in the vascular trauma indication, in
October 2024 Humacyte submitted an application for an NTAP reimbursement to CMS. The window for filing NTAP applications occurs once annually, with decisions being made the following year. Humacyte’s application is for the fiscal year 2026 NTAP cycle, which if approved would make the NTAP effective startingOctober 1, 2025 . Receiving the NTAP reimbursement can allow hospitals to receive up to approximately 65% of the sales price of a biologic product. Requirements for receiving NTAP reimbursement are several, including technological novelty as well as clear evidence of clinical improvement for patients.
- Presentation atKidney Week 2024– Positive results from the V007 Phase 3 clinical trial of the ATEV in AV access for patients with end-stage renal disease were presented on
October 26, 2024 at theAmerican Society of Nephrology’s (ASN)Kidney Week 2024, the premier nephrology meeting. In the Phase 3 trial, the ATEV was observed to have superior function and patency at six and 12 months (co-primary endpoints) compared to autogenous fistula, which is the current standard of care for hemodialysis patients. The ATEV was also observed to have superior function and patency in female, obese, and diabetic patients, each of which is a high-need subgroup with historically poor outcomes with AV fistula procedures. The late-breaking podium presentation, titled “Prospective Randomized Trial ofHumacyte's Acellular Tissue Engineered Vessel Versus Autologous Arteriovenous Fistula for Hemodialysis Access,” was presented byMohamad A. Hussain , MD, PhD, RPVI, FAHA, FRCSC, FACS, Vascular and Endovascular Surgeon-Scientist at Brigham and Women’s Hospital, Core Faculty at theCenter for Surgery and Public Health , and Assistant Professor of Surgery atHarvard Medical School . - Presentation of Long-Term Results from Treatment of Ukraine War Injuries– Positive long-term results from the humanitarian program conducted in
Ukraine under which the ATEV was used to treat vascular injuries suffered during the conflict were presented onAugust 26, 2024 at the Military Health System Research Symposium (MHSRS), theU.S. Department of Defense’s foremost scientific meeting. Patients treated with the ATEV included those injured due to mine blasts, shrapnel, and high velocity ballistics. In long-term follow-up, the ATEV was observed to have high rates of patency (blood flow) and the avoidance of amputation and infection despite the severe nature of the wartime injuries treated.
- 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 was granted at the same time as the 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. - Vascular Trauma Key Opinion Leader Webinar– On
September 30, 2024 ,Humacyte held an event featuringCharles Fox , MD (University of Maryland School of Medicine ),Rishi Kundi MD, RPVI, FACS, FSVS (University of Maryland School of Medicine ), andYingWei Lum , MD, MPH (Johns Hopkins School of Medicine ), who discussed unmet clinical needs in treating urgent arterial repair after extremity vascular trauma. The event highlighted the potential civilian applications and military usage of the ATEV as a treatment for vascular trauma through patient case studies.
The ATEV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
Earlier-Stage Pipeline and Corporate Updates
- Patent Allowance for BioVascular Pancreas– In
September 2024 , theU.S. Patent Office allowed a patent covering Humacyte’s BVP product candidate for the treatment of type 1 diabetes. The BVP is designed to enable the delivery and survival of insulin-producing islets inside the body using the ATEV as a carrier for the islets. The newU.S. Patent, titled “Bioartificial Vascular Pancreas,” covers the design and composition of the BVP. - Completion of Registered Direct Offering– In
October 2024 ,Humacyte completed a transaction with an institutional investor to purchase approximately$30.0 million worth of its common stock and warrants in a registered direct offering.
ThirdQuarter 2024 Financial Highlights
- There was no revenue for either the third quarter of 2024 or the third quarter of 2023, and there was no revenue for the nine months ended
September 30, 2024 and 2023. - Research and development expenses were
$22.9 million for the third quarter of 2024, compared to$23.8 million for the second quarter of 2024. The decrease in expenses compared to the prior quarter was due to a reduction in clinical trial costs. Research and development expenses for the third quarter of 2024 were$22.9 million compared to$18.6 million for the third quarter of 2023, and were$67.9 million for the nine months endedSeptember 30, 2024 , compared to$56.4 million for the nine months endedSeptember 30, 2023 . The year-over-year 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
$7.3 million for the third quarter of 2024, compared to$5.7 million for the second quarter of 2024. The increase in expenses compared to the prior quarter was due to increased sales and marketing expenses in anticipation of the planned commercial launch of the ATEV in vascular trauma. General and administrative expenses for the third quarter of 2024 were$7.3 million compared to$6.1 million for the third quarter of 2023, and were$18.4 million for the nine months endedSeptember 30, 2024 , compared to$17.5 million for the nine months endedSeptember 30, 2023 . The increases during 2024 resulted primarily from preparation for the planned commercial launch of the ATEV. Major changes in expenses included increases in personnel expenses, external services and professional fees, partially offset by decreases in non-cash stock compensation expense and insurance expense. - Other net expense was
$9.0 million for the third quarter of 2024, compared to$27.2 million for the second quarter of 2024. The decrease in other net expense compared to the prior quarter was due to a reduction in the non-cash remeasurement of the contingent earnout liability associated with the Company’sAugust 2021 merger withAlpha Healthcare Acquisition Corp. Other net expense for the third quarter of 2024 was$9.0 million compared to$1.4 million for the third quarter of 2023, and other net expense of$41.5 million for the nine months endedSeptember 30, 2024 , compared to$11.8 million for the nine months endedSeptember 30, 2023 . The year-over-year increases in other net expense resulted primarily from the non-cash remeasurement of the contingent earnout liability. - Net loss was
$39.2 million for the third quarter of 2024, compared to$56.7 million for the second quarter of 2024. The decrease in net loss compared to the prior quarter was due to the reduction in the non-cash remeasurement of the contingent earnout liability and the net effect of operating expense changes described above. Net loss was$39.2 million for the third quarter of 2024 compared to$26.0 million for the third quarter of 2023, and net loss was$127.8 million for the nine months endedSeptember 30, 2024 , compared to$85.7 million for the nine months endedSeptember 30, 2023 . The year-over-year increases 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, cash equivalents and restricted cash of
$71 million as ofSeptember 30, 2024 . Subsequent toSeptember 30, 2024 , the Company received an additional$29.6 million in net proceeds from sales of common stock and warrants. Total net cash used was$9.9 million for the first nine months of 2024, compared to net cash used of$49.4 million for the first nine months of 2023. The decrease in net cash used 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 Third Quarter 2024 Financial Results and Corporate Update |
| Date: | |
| Time: | |
| Conference Call Details: | Toll-Free: 1-877-704-4453International: 1-201-389-0920Conference ID #: 13749485 |
| Call meTMFeature (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
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
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| Three Months Ended | Nine Months Ended | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Revenue | $ | — | $ | — | $ | — | $ | — | |||||||
| Operating expenses: | |||||||||||||||
| Research and development | 22,926 | 18,552 | 67,943 | 56,370 | |||||||||||
| General and administrative | 7,307 | 6,070 | 18,367 | 17,495 | |||||||||||
| Total operating expenses | 30,233 | 24,622 | 86,310 | 73,865 | |||||||||||
| Loss from operations | (30,233 | ) | (24,622 | ) | (86,310 | ) | (73,865 | ) | |||||||
| Other income (expense), net: | |||||||||||||||
| Change in fair value of contingent earnout liability | (8,489 | ) | (1,144 | ) | (38,653 | ) | (11,708 | ) | |||||||
| Other expense (net) | (480 | ) | (229 | ) | (2,798 | ) | (97 | ) | |||||||
| Total other expense, net | (8,969 | ) | (1,373 | ) | (41,451 | ) | (11,805 | ) | |||||||
| Net loss and comprehensive loss | $ | (39,202 | ) | $ | (25,995 | ) | $ | (127,761 | ) | $ | (85,670 | ) | |||
| Net loss per share, basic and diluted | $ | (0.33 | ) | $ | (0.25 | ) | $ | (1.10 | ) | $ | (0.83 | ) | |||
| Weighted-average shares outstanding, basic and diluted | 119,408,565 | 103,444,246 | 115,623,616 | 103,357,087 | |||||||||||
| Assets | |||||||
| Current assets: | |||||||
| Cash and cash equivalents | $ | 20,571 | $ | 80,448 | |||
| Prepaid expenses and other current assets | 2,434 | 2,830 | |||||
| Total current assets | 23,005 | 83,278 | |||||
| Restricted cash | 50,209 | 209 | |||||
| Property and equipment, net | 24,250 | 26,791 | |||||
| Finance lease right-of-use assets, net | 16,013 | 17,313 | |||||
| Other long-term assets | 1,287 | 632 | |||||
| Total assets | $ | 114,764 | $ | 128,223 | |||
| Liabilities and Stockholders’ Equity (Deficit) | |||||||
| Current liabilities: | |||||||
| Accounts payable | $ | 6,903 | $ | 6,490 | |||
| Accrued expenses | 11,151 | 9,340 | |||||
| Other current liabilities | 2,888 | 2,613 | |||||
| Total current liabilities | 20,942 | 18,443 | |||||
| Contingent earnout liability | 76,569 | 37,916 | |||||
| Revenue interest liability | 62,117 | 38,600 | |||||
| Finance lease obligation, net of current portion | 14,379 | 16,293 | |||||
| Other long-term liabilities | 4,478 | 3,425 | |||||
| Total liabilities | 178,485 | 114,677 | |||||
| Stockholders’ equity (deficit) | |||||||
| Common stock and additional paid-in capital | 601,354 | 550,860 | |||||
| Accumulated deficit | (665,075 | ) | (537,314 | ) | |||
| Total stockholders’ equity (deficit) | (63,721 | ) | 13,546 | ||||
| Total liabilities and stockholders’ equity (deficit) | $ | 114,764 | $ | 128,223 | |||
Source: Humacyte, Inc