Humacyte Third Quarter 2023 Financial Results and Business Update
-- Positive top line results from the V005 Phase 2/3 trial of the Human Acellular Vessel$(TM)$ (HAV(TM)) in vascular trauma repair --
-- BLA for an indication in vascular trauma planned to be filed with the FDA during the current quarter --
- Conference call and live webcast at 4:30 p.m. ET today -
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 $(HAV.AU)$ 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 $(BLA.SI)$ 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
-- Positive Phase 2/3 Trauma Results -- In September 2023, Humacyte
announced positive top line results from its V005 Phase 2/3 trial of the
HAV in vascular trauma repair. In this single-arm clinical trial, the HAV
had higher rates of patency, and lower rates of amputation and infection,
compared to historic synthetic graft benchmarks. A total of 69 patients
were enrolled in the V005 trial, of which 51 had vascular injury of the
extremities and comprised the primary evaluation group for the study. The
30-day patency (presence of blood flow) for the HAV in the clinical trial
was 90.2% for the extremity patients compared to approximately 81%
historically reported for synthetic grafts. The HAV demonstrated lower
amputation rates, with a rate of 9.8% compared to over 20% historically
reported for synthetic grafts. The HAV also demonstrated lower rates of
infection, with a rate of 2.0% compared to over 8% historically reported
for synthetic grafts.
-- Planned BLA Filing this Quarter -- Humacyte plans to file a BLA for the
HAV for the treatment of vascular trauma with the FDA during the current
quarter.
Presentations and Publications
-- Upcoming Presentations at a Major Vascular Surgery Symposium -- Multiple
presentations are expected to be made at the VEITH Symposium, a major
vascular surgery meeting, in New York City on November 15-18, 2023. These
include an expanded presentation of the results of the V005 vascular
trauma trial, and the outcome of research which seeks to identify which
dialysis patients experience the most difficulties with their dialysis
access, and which patients may most benefit from an access that is
durable and resists infection.
-- Publication of Preclinical Results in Juvenile Heart Disease Study -- In
October 2023, a publication in the Journal of Thoracic and Cardiovascular
Surgery described a preclinical study showing the potential for the
investigational small-diameter HAV to treat tetralogy of Fallot, a heart
condition that affects one in every 2,000 babies born each year. In the
preclinical study, researchers from Nationwide Children's Hospital
(Columbus, OH) and Humacyte implanted 3.5mm diameter HAVs into a juvenile
large-animal model of pediatric heart disease. The 3.5mm HAVs remained
patent for up to six months, and evidence of HAV repopulation by host
cells was observed, similar to what has been observed in human patients.
This study also demonstrates the extension of Humacyte's manufacturing
platform, adding production of the 3.5mm vessels in the same
manufacturing platform used to produce Humacyte's 6 mm HAVs that are in
current clinical use.
-- Presentation of Results from Phase 2 Study in PAD -- In September 2023,
results were presented from an FDA-regulated, investigator-sponsored
clinical study conducted at the Mayo Clinic of the HAV in patients with
chronic limb-threatening ischemia, the end stage of peripheral artery
disease (PAD). In the presentation at the Midwestern Vascular Conference
in Minneapolis, MN, researchers observed that in the clinical study the
HAV was a safe, resilient, and effective conduit for arterial bypass and
limb salvage. This is an important result since approximately 40% of
patients requiring lower extremity bypass do not have saphenous vein
available, which is the standard of care for treating this challenging
disease state.
-- Presentation of Success in Treating Wartime Injured in Ukraine -- Results
of the real-world use of the HAV under the humanitarian aid program to
treat war-induced vascular trauma injuries in Ukraine were presented in
August at the 2023 Military Health System Research Symposium (MHSRS) in
Kissimmee, Florida. The 19 patients treated under the program suffered
from a range of traumatic injuries, including gunshots, shrapnel, blast
injuries and accidents. Clinicians reported that the rate of success in
treating patients with the HAV was high, with an observed 30-day HAV
patency of 95%, 30-day limb salvage of 100%, 30-day survival of 100%, and
zero cases of infection of the HAV. Ukrainian clinicians concluded that
the HAV has the potential to offer combat surgical teams an off-the-shelf
and universally implantable therapy that is resistant to infection,
potentially offering durable performance to military personnel and
helping with limb salvage. Results from the Ukraine program will be
included in Humacyte's planned BLA filing with the FDA.
-- Publication Supporting Infection Resistance of HAV -- In July 2023, a
preclinical study demonstrated a possible scientific basis for the low
rates of infection that have been observed in clinical trials of the HAV.
The report was published in the Journal of Vascular Surgery -- Vascular
Science. This work compared the infection resistance of the HAV to
synthetic polytetrafluorethylene (ePTFE) grafts, which are made of
plastic. The laboratory results suggest that the bioengineered human
tissue of the HAV may have superior compatibility with the body's own
white blood cells as compared to ePTFE. While human white blood cells die
when they come in contact with ePTFE, the cells survive and function in
contact with the HAV material, which may improve the ability of the HAV
to fight dangerous infections once implanted in the body.
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
-- The Company reported cash and cash equivalents of $100.0 million as of
September 30, 2023. In May 2023, Humacyte reported the completion of a
funding arrangement of up to $160 million with Oberland Capital
Management, $40 million of which has been received. Total net cash used
was $49.4 million for the first nine months of 2023, compared to $53.8
million for the first nine months of 2022. Humacyte believes that its
cash and cash equivalents and expected funding from the Oberland
arrangement are adequate to finance operations past the currently
anticipated timelines for FDA approval and commercialization of the HAV
in the vascular trauma indication.
-- There was no revenue for the third quarter of 2023 and nine months ended
September 30, 2023. Revenue was $31 thousand for the third quarter of
2022 and $1.6 million for the nine months ended September 30, 2022.
Revenue for 2022 was related to a grant supporting the development of the
HAV.
-- Research and development expenses were $18.6 million for the third
quarter of 2023, compared to $17.3 million for the third quarter of 2022,
and were $56.4 million for the nine months ended September 30, 2023,
compared to $48.3 million for the nine months ended September 30, 2022.
The current-period increases resulted primarily from increased personnel
and external services expenses to support expanded research and
development initiatives and our clinical trials, including preparation
for the HAV vascular trauma trial completion and planned BLA filing for
the vascular trauma indication, and expansion of clinical development of
the HAV in AV access for hemodialysis.
-- General and administrative expenses were $6.1 million for the third
quarter of 2023, compared to $6.2 million for the third quarter of 2022,
and were $17.5 million for the nine months ended September 30, 2023,
compared to $17.1 million for the nine months ended September 30, 2022.
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November 09, 2023 16:01 ET (21:01 GMT)
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