Full Press Release Details
Reports Third Quarter 2021 Financial Results and Provides Business Highlights
-- Completed business combination with Alpha
Healthcare Acquisition Corp. and raised $242M in proceeds --
-- Progressed advanced-stage clinical- and early-stage
programs of the human acellular vessel (HAV ) and other engineered tissue platform applications --
DURHAM, N.C. - Nov. 12, 2021 - 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, 2021, and highlighted recent corporate accomplishments.
"Humacyte has made great strides advancing our bioengineered
tissue platform to create novel human acellular tissues and organs. This quarter was marked with significant corporate progress, including
the closing of our business combination agreement with Alpha Healthcare and our debut on Nasdaq. We are excited about our transition to
a public company, and we are laying a strong foundation of clinical, technical and infrastructure progress to support our continued advancement
toward commercialization," said Laura Niklason, M.D., Ph.D., Founder, President and Chief Executive Officer of Humacyte. "This
month we will be sharing late-breaking data on the performance of HAVs manufactured with our commercial-scale LUNA200TM platform.
We look forward to continued progress of our HAV for vascular trauma, AV access and peripheral arterial disease toward late-stage clinical
readouts, while advancing our earlier stage work in treatments for heart disease and diabetes."
Third Quarter 2021 and Recent Corporate Highlights
Third Quarter Financial Highlights
Humacyte, Inc., (Nasdaq: HUMA) is developing a disruptive biotechnology
platform to deliver universally implantable bioengineered human tissues and organs 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 human acellular vessels (HAVs), is currently in late-stage clinical
trials targeting multiple vascular applications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral
arterial disease. Pre-clinical 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 HAVs were the first product to receive the FDA's
Regenerative Medicine Advanced Therapy (RMAT) expedited review designation and 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 clinical trials; the anticipated characteristics
and performance of our HAVs; our ability to successfully complete, pre-clinical 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; our rights and obligations under our partnership
with Fresenius Medical Care; the scope of protection we are able to establish and maintain for intellectual property rights covering
our HAVs and related technology; the timing or likelihood of regulatory filings and approvals; 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, the impact of COVID-19 on Humacyte's
business, 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
the registration statement on Form S-4 filed by Humacyte with the SEC. 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.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share amounts)
| Three Months Ended September 30, | ||||||||
| 2021 | 2020 | |||||||
| Grant revenue | $ | 241 | $ | 914 | ||||
| Operating expenses: | ||||||||
| Research and development | 15,386 | 14,692 | ||||||
| General and administrative | 5,398 | 3,435 | ||||||
| Total operating expenses | 20,784 | 18,127 | ||||||
| Loss from operations | (20,543 | ) | (17,213 | ) | ||||
| Other expenses, (net): | ||||||||
| Change in fair value of contingent earnout liability | (9,768 | ) | - | |||||
| Other income (expenses) (net) | (1,252 | ) | (547 | ) | ||||
| Total other expenses, net | (11,020 | ) | (547 | ) | ||||
| Net loss and comprehensive loss | $ | (31,563 | ) | $ | (17,760 | ) | ||
| Net loss per share, basic and diluted | $ | (0.72 | ) | $ | (3.07 | ) | ||
| Weighted-average shares outstanding, basic and diluted | 43,950,856 | 5,788,130 |
Condensed Consolidated
| September 30, | December 31, | |||||||
| 2021 | 2020 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 240,449 | $ | 39,929 | ||||
| Prepaid expenses and other current assets | 3,730 | 1,520 | ||||||
| Total current assets | 244,179 | 41,449 | ||||||
| Property, plant and equipment, net | 36,499 | 40,978 | ||||||
| Lease right-of-use assets, net | 22,685 | 24,261 | ||||||
| Total assets | $ | 303,363 | $ | 106,688 | ||||
| Liabilities, Redeemable Convertible Preferred Stock and Stockholders' Equity (Deficit) | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 5,830 | $ | 2,274 | ||||
| Accrued expenses | 9,422 | 4,592 | ||||||
| SVB loan payable, current portion | 3,889 | - | ||||||
| Other current liabilities | 2,104 | 4,367 | ||||||
| Total current liabilities | 21,245 | 11,233 | ||||||
| Contingent earnout liability | 169,200 | - | ||||||
| Finance lease obligation, net of current portion | 21,627 | 23,090 | ||||||
| SVB loan payable, net of current portion | 14,038 | - | ||||||
| Other long-term liabilities | 1,392 | 1,693 | ||||||
| Total liabilities | 227,502 | 36,016 | ||||||
| Redeemable convertible preferred stock | - | 420,989 | ||||||
| Stockholders' equity (deficit) | ||||||||
| Common stock and additional paid-in capital | 533,019 | 37,779 | ||||||
| Accumulated deficit | (457,158 | ) | (388,096 | ) | ||||
| Total stockholders' equity (deficit) | 75,861 | (350,317 | ) | |||||
| Total liabilities, redeemable convertible preferred stock and stockholders' equity (deficit) | $ | 303,363 | $ | 106,688 |
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