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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
___________________________________________________________________________________________________________________________
FORM 10-Q
(Mark One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2022
OR
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from ______ to ______.
Commission File Number: 001-39532
___________________________________________________________________________________________________
Humacyte, Inc.
(Exact name of registrant as specified in its charter)
___________________________________________________________________________________________________
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Delaware |
85-1763759
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(State or other jurisdiction of
incorporation or organization) |
(I.R.S. Employer Identification No.) |
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2525 East North Carolina Highway 54
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Durham, |
NC |
27713 |
(Address of principal executive offices) |
(Zip code) |
(919) 313-9633
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed
since last report)
___________________________________________________________________________________________________
Securities registered pursuant to 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
Common Stock, par value $0.0001 per share |
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HUMA |
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The Nasdaq Stock Market LLC |
Redeemable Warrants, each whole warrant exercisable for one share
of Common Stock at an exercise price of $11.50 |
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HUMAW |
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The Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant (1) has filed all
reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing requirements
for the past 90 days. Yes
x
No
o
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter)
during the preceding 12 months (or for such shorter period that the
registrant was required to submit such files). Yes
x
No
o
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer, a
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act.
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Large accelerated filer |
o |
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Accelerated filer |
o |
Non-accelerated filer |
x |
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Smaller reporting company |
x |
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Emerging growth company |
x |
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act.
o
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act). Yes
o
No
x
As of August 5, 2022, 103,006,803 shares of common stock, par
value $0.0001, were issued and outstanding.
Humacyte, Inc.
Quarterly Report on Form 10-Q
Table of Contents
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (“Quarterly Report”) contains
forward-looking statements that involve substantial risks and
uncertainties. “Forward-looking statements,” as that term is
defined in the Private Securities Litigation Reform Act of 1995,
Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934 (the “Exchange Act”) are statements
that are not historical facts and involve a number of risks and
uncertainties. These statements include, without limitation,
statements regarding the financial position, business strategy and
the plans and objectives of management for future operations. These
statements constitute projections, forecasts and forward-looking
statements, and are not guarantees of performance. Such statements
can be identified by the fact that they do not relate strictly to
historical or current facts. When used therein, words such as
“anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“intend,” “may,” “might,” “plan,” “possible,” “potential,”
“predict,” “project,” “should,” “strive,” “would” and similar
expressions may identify forward-looking statements, but the
absence of these words does not mean that a statement is not
forward-looking. Such statements are based on the beliefs of, as
well as assumptions made by and information currently available to,
our management.
Forward-looking statements may include, for example, statements
about:
•our
plans and ability to execute product development, process
development and preclinical development efforts successfully and on
our anticipated timelines;
•our
plans and ability to obtain marketing approval from the U.S. Food
and Drug Administration (“FDA”) and other regulatory authorities,
including the European Medicines Agency (“EMA”), for our
bioengineered human acellular vessels (“HAVs”) and other product
candidates;
•our
ability to design, initiate and successfully complete clinical
trials and other studies for our product candidates and our plans
and expectations regarding our ongoing or planned clinical trials,
including for our ongoing V005 Phase II/III clinical trial and V007
Phase III clinical trial;
•the
outcome of our ongoing discussions with the FDA concerning the
design of our ongoing V005 Phase II/III clinical trial, including
determination of trial size;
•our
anticipated growth rate and market opportunities;
•the
potential liquidity and trading of our securities;
•our
ability to raise additional capital in the future;
•our
ability to use our proprietary scientific technology platform to
build a pipeline of additional product candidates;
•the
characteristics and performance of our bioengineered human,
acellular vessels (“HAVs”);
•our
plans and ability to commercialize our HAVs and other product
candidates, if approved by regulatory authorities;
•the
expected size of the target populations for our product
candidates;
•the
anticipated benefits of our HAVs relative to existing
alternatives;
•our
assessment of the competitive landscape;
•the
degree of market acceptance of HAVs, if approved, and the
availability of third-party coverage and
reimbursement;
•our
ability to manufacture HAVs and other product candidates in
sufficient quantities to satisfy our clinical trial and commercial
needs;
•our
expectations regarding our strategic partnership with Fresenius
Medical Care Holdings, Inc. (“Fresenius Medical Care”) to sell,
market and distribute our 6 millimeter HAV for certain specified
indications and in specified markets;
•the
performance of other third parties on which we rely, including our
third-party manufacturers, our licensors, our suppliers and the
organizations conducting our clinical trials;
•our
ability to obtain and maintain intellectual property protection for
our product candidates as well as our ability to operate our
business without infringing, misappropriating or otherwise
violating the intellectual property rights of others;
•our
ability to maintain the confidentiality of our trade secrets,
particularly with respect to our manufacturing
process;
•our
compliance with applicable laws and regulatory requirements,
including FDA regulations, healthcare laws and regulations, and
anti-corruption laws;
•our
ability to attract, retain and motivate qualified personnel and to
manage our growth effectively;
•our
future financial performance and capital requirements;
•our
ability to implement and maintain effective internal controls;
and
•the
impact of the COVID-19 pandemic on our business, including our
manufacturing efforts, and our preclinical studies and clinical
trials.
We caution readers not to place undue reliance on any such
forward-looking statements, which speak only as of the date they
are made. Any forward-looking statement is based on information
current as of the date of this Quarterly Report and speaks only as
of the date on which such statement is made. Actual events or
results may differ materially from the results, plans, intentions
or expectations anticipated in these forward-looking statements as
a result of a variety of factors, many of which are beyond our
control. More information on factors that could cause actual
results to differ materially from those anticipated is included
from time to time in our reports filed with the Securities and
Exchange Commission (the “SEC”), including, but not limited to,
those described in the sections titled “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” included in this Quarterly Report and our
Annual Report on Form 10-K for the year ended December 31, 2021,
which we filed with the SEC on March 29, 2022. We disclaim any
obligation, except as specifically required by law, to publicly
update or revise any such statements to reflect any change in our
expectations or in events, conditions or circumstances on which any
such statements may be based, or that may affect the likelihood
that actual results will differ from those set forth in the
forward-looking statements.
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
Humacyte, Inc.
Condensed Consolidated Balance Sheets
(unaudited)
(in thousands except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022 |
|
December 31,
2021 |
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
181,035 |
|
|
$ |
217,502 |
|
Short-term investments |
8,000 |
|
|
8,000 |
|
Accounts receivable |
1,301 |
|
|
176 |
|
Prepaid expenses and other current assets |
2,694 |
|
|
3,662 |
|
Total current assets |
193,030 |
|
|
229,340 |
|
|
|
|
|
Finance lease right-of-use assets, net |
20,403 |
|
|
21,432 |
|
Operating lease right-of-use assets, net |
705 |
|
|
727 |
|
Property and equipment, net |
32,227 |
|
|
35,034 |
|
Total assets |
$ |
246,365 |
|
|
$ |
286,533 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
2,537 |
|
|
$ |
2,094 |
|
Accrued expenses |
6,186 |
|
|
6,757 |
|
Finance lease obligation, current portion |
2,115 |
|
|
1,981 |
|
|
|
|
|
Deferred payroll tax, current portion |
173 |
|
|
173 |
|
Operating lease obligation, current portion |
47 |
|
|
45 |
|
|
|
|
|
Total current liabilities |
11,058 |
|
|
11,050 |
|
|
|
|
|
Contingent earnout liability |
44,049 |
|
|
103,660 |
|
SVB loan payable |
28,132 |
|
|
27,361 |
|
Finance lease obligation, net of current portion |
20,018 |
|
|
21,109 |
|
Operating lease obligation, net of current portion |
658 |
|
|
682 |
|
Common stock warrant liabilities |
190 |
|
|
497 |
|
|
|
|
|
|
|
|
|
Total liabilities |
104,105 |
|
|
164,359 |
|
|
|
|
|
Commitments and contingencies (Note 11) |
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
|
Preferred stock, $0.0001 par value; 20,000,000 shares designated as
of June 30, 2022 and December 31, 2021; 0 shares issued
and outstanding as of June 30, 2022 and December 31,
2021
|
— |
|
|
— |
|
Common stock, $0.0001 par value; 250,000,000 shares authorized as
of June 30, 2022 and December 31, 2021; 103,006,803 and
103,003,646 shares issued and outstanding as of June 30, 2022
and December 31, 2021, respectively
|
10 |
|
|
10 |
|
Additional paid-in capital |
539,787 |
|
|
536,737 |
|
Accumulated deficit |
(397,537) |
|
|
(414,573) |
|
Total stockholders' equity |
142,260 |
|
|
122,174 |
|
Total liabilities and stockholders’ equity |
$ |
246,365 |
|
|
$ |
286,533 |
|
The accompanying notes are an integral part of these financial
statements.
Humacyte, Inc.
Condensed Consolidated Statements of Operations and Comprehensive
Income (Loss)
(unaudited)
(in thousands except for share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the
Three Months Ended June 30,
|
|
For the
Six Months Ended June 30,
|
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
Grant revenue |
$ |
1,301 |
|
|
$ |
690 |
|
|
$ |
1,534 |
|
|
$ |
845 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
14,652 |
|
|
14,568 |
|
|
30,966 |
|
|
29,705 |
|
General and administrative |
5,180 |
|
|
5,391 |
|
|
10,862 |
|
|
10,178 |
|
Total operating expenses |
19,832 |
|
|
19,959 |
|
|
41,828 |
|
|
39,883 |
|
Loss from operations |
(18,531) |
|
|
(19,269) |
|
|
(40,294) |
|
|
(39,038) |
|
|
|
|
|
|
|
|
|
Other income (expense), net: |
|
|
|
|
|
|
|
Interest income |
301 |
|
|
2 |
|
|
332 |
|
|
3 |
|
Change in fair value of contingent earnout liability |
56,353 |
|
|
— |
|
|
59,611 |
|
|
— |
|
Change in fair value of common stock warrant
liabilities |
233 |
|
|
— |
|
|
307 |
|
|
— |
|
Gain on PPP loan forgiveness |
— |
|
|
3,284 |
|
|
— |
|
|
3,284 |
|
Interest expense |
(1,488) |
|
|
(1,215) |
|
|
(2,920) |
|
|
(1,748) |
|
|
|
|
|
|
|
|
|
Total other income, net |
55,399 |
|
|
2,071 |
|
|
57,330 |
|
|
1,539 |
|
Net income (loss) and comprehensive income ( loss) |
$ |
36,868 |
|
|
$ |
(17,198) |
|
|
$ |
17,036 |
|
|
$ |
(37,499) |
|
|
|
|
|
|
|
|
|
Net income (loss) per share attributable to common stockholders,
basic |
$ |
0.36 |
|
|
$ |
(2.89) |
|
|
$ |
0.17 |
|
|
$ |
(6.35) |
|
Weighted-average shares outstanding used in computing net income
(loss) per share attributable to common stockholders,
basic |
103,005,651 |
|
|
5,941,675 |
|
|
103,004,874 |
|
|
5,908,372 |
|
|
|
|
|
|
|
|
|
Net income (loss) per share attributable to common stockholders,
diluted |
$ |
0.35 |
|
|
$ |
(2.89) |
|
|
$ |
0.16 |
|
|
$ |
(6.35) |
|
Weighted-average shares outstanding used in computing net income
(loss) per share attributable to common stockholders,
diluted |
103,908,440 |
|
|
5,941,675 |
|
|
103,923,138 |
|
|
5,908,372 |
|
The accompanying notes are an integral part of these financial
statements.
Humacyte, Inc.
Condensed Consolidated Statements of Changes in Redeemable
Convertible Preferred Stock and Stockholders’ Equity
(Deficit)
(unaudited)
(in thousands except for share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible
Preferred Stock |
|
|
Common Stock |
|
Additional
Paid-in Capital |
|
Accumulated
Deficit |
|
Total Stockholders'
Equity |
|
Shares |
|
Amount |
|
|
Shares |
|
Amount |
|
|
|
Balance as of December 31, 2021
|
— |
|
|
$ |
— |
|
|
|
103,003,646 |
|
|
$ |
10 |
|
|
$ |
536,737 |
|
|
$ |
(414,573) |
|
|
$ |
122,174 |
|
Proceeds from the exercise of stock options |
— |
|
|
— |
|
|
|
926 |
|
|
— |
|
|
1 |
|
|
— |
|
|
1 |
|
Stock-based compensation |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
1,547 |
|
|
— |
|
|
1,547 |
|
Net loss |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
(19,832) |
|
|
(19,832) |
|
Balance as of March 31, 2022 |
— |
|
|
$ |
— |
|
|
|
103,004,572 |
|
|
$ |
10 |
|
|
$ |
538,285 |
|
|
$ |
(434,405) |
|
|
$ |
103,890 |
|
Proceeds from the exercise of stock options |
— |
|
|
— |
|
|
|
2,231 |
|
|
— |
|
|
11 |
|
|
— |
|
|
11 |
|
Stock-based compensation |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
1,491 |
|
|
— |
|
|
1,491 |
|
Net income |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
36,868 |
|
|
36,868 |
|
Balance as of June 30, 2022 |
— |
|
|
$ |
— |
|
|
|
103,006,803 |
|
|
$ |
10 |
|
|
$ |
539,787 |
|
|
$ |
(397,537) |
|
|
$ |
142,260 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Redeemable Convertible
Preferred Stock |
|
|
Common Stock |
|
Additional
Paid-in Capital |
|
Accumulated
Deficit |
|
Total Stockholders'
(Deficit) Equity |
|
Shares |
|
Amount |
|
|
Shares |
|
Amount |
|
|
|
Balance as of December 31, 2020 |
69,613,562 |
|
|
$ |
420,989 |
|
|
|
5,822,396 |
|
|
$ |
1 |
|
|
$ |
37,778 |
|
|
$ |
(388,096) |
|
|
$ |
(350,317) |
|
Proceeds from the exercise of stock options |
— |
|
|
— |
|
|
|
116,149 |
|
|
— |
|
|
206 |
|
|
— |
|
|
206 |
|
Stock-based compensation |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
2,528 |
|
|
— |
|
|
2,528 |
|
Issuance of warrants in conjunction with debt |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
2,360 |
|
|
— |
|
|
2,360 |
|
Net loss |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
(20,301) |
|
|
(20,301) |
|
Balance as of March 31, 2021 |
69,613,562 |
|
|
$ |
420,989 |
|
|
|
5,938,545 |
|
|
$ |
1 |
|
|
$ |
42,872 |
|
|
$ |
(408,397) |
|
|
$ |
(365,524) |
|
Proceeds from the exercise of stock options |
— |
|
|
— |
|
|
|
5,204 |
|
|
— |
|
|
30 |
|
|
— |
|
|
30 |
|
Stock-based compensation |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
2,930 |
|
|
— |
|
|
2,930 |
|
Net loss |
— |
|
|
— |
|
|
|
— |
|
|
— |
|
|
— |
|
|
(17,198) |
|
|
(17,198) |
|
Balance as of June 30, 2021 |
69,613,562 |
|
|
$ |
420,989 |
|
|
|
5,943,749 |
|
|
$ |
1 |
|
|
$ |
45,832 |
|
|
$ |
(425,595) |
|
|
$ |
(379,762) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
Humacyte, Inc.
Condensed Consolidated Statements of Cash Flows
(unaudited)
(in thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
For the
Six Months Ended June 30, 2022,
|
|
2022 |
|
2021 |
Cash flows from operating activities |
|
|
|
Net income (loss) |
$ |
17,036 |
|
|
$ |
(37,499) |
|
Adjustments to reconcile net income (loss) to net cash used in
operating activities: |
|
|
|
Depreciation expense |
3,032 |
|
|
3,106 |
|
Stock-based compensation expense |
3,038 |
|
|
5,458 |
|
Change in fair value of contingent earnout liability |
(59,611) |
|
|
— |
|
Change in fair value of common stock warrant
liabilities |
(307) |
|
|
— |
|
|
|
|
|
Amortization expense |
1,029 |
|
|
1,030 |
|
Non-cash operating lease costs |
22 |
|
|
21 |
|
Amortization of SVB debt discount |
771 |
|
|
313 |
|
Accrued interest on PPP loan obligation |
— |
|
|
11 |
|
Gain on PPP loan forgiveness |
— |
|
|
(3,284) |
|
|
|
|
|
Changes in operating assets and liabilities: |
|
|
|
Accounts receivable |
(1,125) |
|
|
(576) |
|
Prepaid expenses and other current assets |
968 |
|
|
(75) |
|
Accounts payable |
374 |
|
|
769 |
|
Accrued expenses |
(571) |
|
|
1,524 |
|
Operating lease obligation |
(22) |
|
|
(21) |
|
|
|
|
|
Net cash used in operating activities |
(35,366) |
|
|
(29,223) |
|
|
|
|
|
Cash flows from investing activities |
|
|
|
Purchase of short-term investments (certificates of
deposit) |
(8,000) |
|
|
— |
|
Proceeds from maturity of short-term investments (certificates of
deposit) |
8,000 |
|
|
— |
|
Purchase of property and equipment |
(156) |
|
|
(92) |
|
|
|
|
|
Net cash used in investing activities |
(156) |
|
|
(92) |
|
|
|
|
|
Cash flows from financing activities |
|
|
|
|
|
|
|
|
|
|
|
Proceeds from the exercise of stock options |
12 |
|
|
236 |
|
Payment of finance lease principal |
(957) |
|
|
(834) |
|
Proceeds from SVB loan |
— |
|
|
19,659 |
|
|
|
|
|
Payment of deferred offering costs |
— |
|
|
(706) |
|
Net cash (used in) provided by financing activities |
(945) |
|
|
18,355 |
|
|
|
|
|
Net decrease in cash and cash equivalents |
(36,467) |
|
|
(10,960) |
|
Cash and cash equivalents at the beginning of the
period |
217,502 |
|
|
39,929 |
|
Cash and cash equivalents at the end of the period |
$ |
181,035 |
|
|
$ |
28,969 |
|
|
|
|
|
Supplemental disclosure |
|
|
|
Cash paid for interest on SVB loan |
$ |
1,165 |
|
|
$ |
258 |
|
|
|
|
|
Supplemental disclosure of noncash activities: |
|
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment in accounts payable |
$ |
90 |
|
|
$ |
— |
|
Issuance of warrants in conjunction with debt |
$ |
— |
|
|
$ |
2,360 |
|
Unpaid deferred offering costs |
$ |
— |
|
|
$ |
2,536 |
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these financial
statements.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
1. Organization and Description of Business
Organization
Humacyte, Inc. and subsidiary (the “Company”) is pioneering the
development and manufacture of off-the-shelf, universally
implantable, bioengineered human tissues, complex tissue systems,
and organs designed to improve the lives of patients and transform
the practice of medicine. The Company is leveraging its technology
platform to develop proprietary, bioengineered, acellular human
tissues, complex tissue systems, and organs for use in the
treatment of diseases and conditions across a range of anatomic
locations in multiple therapeutic areas.
On August 26, 2021 (the
“Closing
Date”),
Alpha Healthcare Acquisition Corp. (“AHAC”)
consummated a merger pursuant to a
Business Combination Agreement, dated as of February 17, 2021 (the
“Merger Agreement”), by and among Humacyte, Inc., a Delaware
Corporation (“Legacy Humacyte”), AHAC and Hunter Merger Sub, Inc.
(“Merger Sub”), a Delaware corporation and wholly owned subsidiary
of AHAC. As contemplated by the Merger Agreement, Merger Sub merged
with and into Legacy Humacyte, with Legacy Humacyte continuing as
the surviving corporation and as a wholly owned subsidiary of AHAC
(such transactions, the “Merger,” and, collectively with the other
transactions described in the Merger Agreement, the “Reverse
Recapitalization”). On the Closing Date, AHAC changed its name to
Humacyte, Inc. (“New Humacyte”) and Legacy Humacyte changed its
name to Humacyte Global, Inc. The Merger is accounted for as a
reverse recapitalization in accordance with accounting principles
generally accepted in the United States of America (“U.S. GAAP”),
and under this method of accounting, AHAC is treated as the
acquired company for financial reporting purposes and Legacy
Humacyte is treated as the acquirer. Operations prior to the Merger
are those of Legacy Humacyte.
Refer to Note 3 — Reverse Recapitalization for further details of
the Merger.
Liquidity and Going Concern
Since its inception in 2004, the Company has generated no product
revenue and has incurred operating losses and negative cash flows
from operations in each year. To date, the Company has financed its
operations primarily through the sale of equity securities and
convertible debt, proceeds from the Reverse Recapitalization,
borrowings under loan facilities and, to a lesser extent, through
governmental and other grants. At June 30, 2022 and
December 31, 2021, the Company had an accumulated deficit of
$397.5 million and $414.6 million, respectively. The
Company’s
operating losses were $40.3 million and $39.0 million for
the six months ended June 30, 2022 and 2021, respectively. Net
cash flows used in operating activities were $35.4 million and
$29.2 million during the six months ended June 30, 2022 and
2021, respectively. Substantially all of the
Company’s
operating losses resulted from costs incurred in connection with
the Company’s
research and development programs and from general and
administrative costs associated with the Company’s
operations. The Company expects to incur substantial operating
losses and negative cash flows from operations for the foreseeable
future as the Company advances its product candidates.
As of June 30, 2022, the Company had cash and cash equivalents
and short-term investments of $189.0 million. The Company believes
its combined cash and cash equivalents and short-term investments
on hand will be sufficient to fund operations, including clinical
trial expenses and capital expenditure requirements, for at least
12 months from the issuance date of these interim financial
statements.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Impact of COVID-19
The COVID-19 pandemic has caused many governments to implement
measures to slow the spread of the outbreak, including
shelter-in-place orders and the mandatory shutdown of certain
businesses. The outbreak and government measures taken in response
have had a significant impact, both direct and indirect, on the
Company’s
business, as supply chains have been disrupted, and facilities and
production have been suspended. The future progression of the
pandemic and its effects on the Company’s
business and operations are uncertain. The COVID-19 pandemic may
affect the Company’s
ability to initiate and complete preclinical studies, delay its
clinical trials or future clinical trials, disrupt regulatory
activities, or have other adverse effects on its business and
operations. The pandemic has already caused significant disruptions
in the financial markets, and may continue to cause such
disruptions, which could impact the Company’s
ability to raise additional funds to support its operations.
Moreover, the pandemic has significantly impacted economies
worldwide and could result in adverse effects on the
Company’s
business and operations.
To date, there have been no material financial impacts or
impairment losses in the carrying values of the
Company’s
assets as a result of the pandemic and the Company is not aware of
any specific related event or circumstance that would require it to
revise the estimates reflected in these financial statements. The
extent to which the COVID-19 pandemic will directly or indirectly
impact the Company’s
business, results of operations and financial condition, including
current and future clinical trials and research and development
costs, will depend on future developments that are highly
uncertain, including as a result of new information that may emerge
concerning COVID-19, the actions taken to contain or treat it, the
emergence of new virus variants, and the duration and intensity of
the related economic impact of the pandemic.
2. Summary of Significant Accounting Policies
Basis of Presentation
The Company has prepared the accompanying financial statements in
conformity with U.S. GAAP. The Company’s
condensed consolidated financial statements reflect the operations
of the Company and its wholly owned subsidiaries. All intercompany
accounts and transactions have been eliminated in
consolidation.
Unless otherwise noted, the Company has retroactively adjusted all
common and preferred share and related price information to give
effect to the exchange ratio established in the Merger Agreement.
Operations prior to the Merger are those of Legacy
Humacyte.
Use of Estimates
The preparation of financial statements in conformity with U.S.
GAAP requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the
financial statements and the reported amounts of revenues and
expenses during the reporting period. Significant estimates in the
financial statements include stock-based compensation costs,
right-of-use assets, accruals for research and development
activities, contingent earnout liability, fair value of common
stock warrants, redeemable convertible preferred stock and income
taxes. The Company evaluates its estimates and assumptions on an
ongoing basis using historical experience and other factors and
adjusts those estimates and assumptions when facts and
circumstances dictate. Actual results could differ from those
estimates.
Unaudited Interim Condensed Consolidated Financial
Statements
The accompanying interim condensed consolidated financial
statements and the related footnote disclosures are unaudited.
These unaudited interim financial statements have been prepared on
the same basis as the audited financial statements and, in
management’s
opinion, include all adjustments, consisting of only normal
recurring adjustments, necessary for the fair statement of the
Company’s
financial position as of June 30, 2022 and its results of
operations for the three and six months ended June 30, 2022
and 2021, and cash flows for the six months ended June 30,
2022 and 2021. The results of operations for the three and six
months ended June 30, 2022 are not necessarily indicative of
the results to be expected for the year ended December 31,
2022 or any other period. The December 31, 2021 year-end
condensed consolidated balance sheet was derived from audited
annual financial statements but does not include all disclosures
from the annual financial statements.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Certain information and footnote disclosures normally included in
consolidated financial statements prepared in accordance with U.S.
GAAP have been condensed or omitted pursuant to such rules and
regulations. Accordingly, these condensed consolidated financial
statements should be read in conjunction with the audited
consolidated financial statements for the year ended
December 31, 2021 and the related notes included in the
Company’s Annual Report on Form 10-K, filed with the SEC on March
29, 2022 (the “Annual Report”), which provides a more complete
discussion of the Company’s accounting policies and certain other
information. There have been no significant changes to the
significant accounting policies disclosed in Note 2 of the audited
consolidated financial statements as of and for the years ended
December 31, 2021 and 2020 included in the
Company’s
Annual Report.
Segments
The Company operates and manages its business as one reportable and
operating segment. The Company is developing proprietary,
bioengineered, acellular human tissues, complex tissue systems, and
organs that are designed to be used in the treatment of diseases
and conditions across a range of anatomic locations in multiple
therapeutic areas. The Company’s
chief executive officer, who is the chief operating decision maker,
reviews financial information on an aggregate basis for purposes of
evaluating financial performance and allocating
resources.
Concentration of Credit Risk
Financial instruments which potentially subject the Company to
concentrations of credit risk consist principally of cash and cash
equivalents and short-term investments consisting of certificates
of deposit (“CDs”). Total cash balances exceeded insured balances
by the Federal Deposit Insurance Corporation (“FDIC”) as of
June 30, 2022 and December 31, 2021. The Company has cash
equivalents that are invested in highly rated money market funds
invested only in obligations of the U.S. government and its
agencies.
As of both
June 30, 2022 and
December 31, 2021, the Company had approximately
$10.0 million
in CDs. These cash deposits are deposited at a bank that is a
member of the Certificate of Deposit Account Registry Service
(“CDARS”), in which large deposits are divided into smaller amounts
and placed with other FDIC insured banks which are also members of
the CDARS network. Those members issue CDs in amounts under
$250,000, so that the entire deposit balance is eligible for FDIC
insurance. As of both
June 30, 2022 and December 31, 2021, the
Company classified
$2.0 million
of its certificates of deposit as cash and cash equivalents
and
$8.0 million
of its certificates of deposit as short-term investments on its
condensed consolidated balance sheets.
During the three and six months ended June 30, 2022 and 2021,
100% of the Company’s total revenue relates to an award it received
from the Department of Defense (“DoD”) in August 2017. As of
June 30, 2022 and December 31, 2021, 100% of the
Company’s accounts receivable relates to the DoD
grant.
Net Income (Loss) per Share Attributable to Common
Stockholders
Basic net income (loss) per share attributable to common
stockholders is computed by dividing net income (loss) attributable
to common stockholders by the weighted-average number of common
shares outstanding during the period without consideration of
potentially dilutive common stock. Diluted net income (loss) per
share attributable to common stockholders reflects the potential
dilution that could occur if securities or other contracts to issue
common stock were exercised or converted into common stock or
resulted in the issuance of common stock that then shared in the
earnings of the Company unless inclusion of such shares would be
anti-dilutive.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
The following table presents the calculation of basic and diluted
net income (loss) per share for the periods presented:
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|
|
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|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
($ in thousands, except share and per share amounts) |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
Numerator: |
|
|
|
|
|
|
|
|
Net income (loss) attributable to common shareholders |
|
$ |
36,868 |
|
|
$ |
(17,198) |
|
|
$ |
17,036 |
|
|
$ |
(37,499) |
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding - basic |
|
103,005,651 |
|
|
5,941,675 |
|
|
103,004,874 |
|
|
5,908,372 |
|
Dilutive effect of assumed conversion of options to purchase common
stock |
|
902,789 |
|
|
— |
|
|
918,264 |
|
|
— |
|
Weighted-average common shares outstanding - diluted |
|
103,908,440 |
|
|
5,941,675 |
|
|
103,923,138 |
|
|
5,908,372 |
|
|
|
|
|
|
|
|
|
|
Net income (loss) attributable to common shareholders -
basic |
|
$ |
0.36 |
|
|
$ |
(2.89) |
|
|
$ |
0.17 |
|
|
$ |
(6.35) |
|
Net income (loss) attributable to common shareholders -
diluted |
|
$ |
0.35 |
|
|
$ |
(2.89) |
|
|
$ |
0.16 |
|
|
$ |
(6.35) |
|
The potential shares of common stock that were excluded from the
computation of diluted net income (loss) per share for each period
because including them would have had an antidilutive effect were
as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three and Six Months Ended
June 30, |
|
|
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
Shares issuable upon conversion of Series A redeemable convertible
preferred stock |
|
|
|
— |
|
|
18,421,897 |
|
Shares issuable upon conversion of Series B redeemable convertible
preferred stock |
|
|
|
— |
|
|
24,137,647 |
|
Shares issuable upon conversion of Series C redeemable convertible
preferred stock |
|
|
|
— |
|
|
11,241,283 |
|
Shares issuable upon conversion of Series D redeemable convertible
preferred stock |
|
|
|
— |
|
|
15,812,735 |
|
Exercise of options under stock plan |
|
|
|
5,347,250 |
|
|
6,520,690 |
|
Warrants to purchase common stock |
|
|
|
5,588,506 |
|
|
287,704 |
|
The 15,000,000 Contingent Earnout Shares, as defined in Note 3, are
excluded from the anti-dilutive table for the three and six months
ended June 30, 2022 as such shares are contingently issuable
until the share price of the Company exceeds specified thresholds
that have not yet been achieved, or upon the occurrence of a change
in control.
Other Risks and Uncertainties
The Company is subject to risks and uncertainties common to
early-stage companies in the biotechnology industry, including, but
not limited to, successful discovery and development of its product
candidates, the success of clinical trials and other studies for
its product candidates, including for its ongoing V005 Phase II/III
clinical trial and V007 Phase III clinical trial, the regulatory
approval and commercialization of its HAVs and other product
candidates,
the expected size of the target populations for the
Company’s
product candidates, the degree of market acceptance of the HAVs, if
approved, the availability of third-party coverage and
reimbursement, development by competitors of new technological
innovations, the ability to manufacture HAVs and other product
candidates in sufficient quantities, expectations regarding the
Company’s
strategic partnerships, dependence on third parties, key personnel
and the ability to attract and retain qualified employees,
protection of proprietary technology and confidentiality of trade
secrets, compliance with governmental regulations, the impact of
the COVID-19 pandemic, the Company’s
implementation and maintenance of effective internal controls, and
the ability to secure additional capital to fund operations and
commercial success of its product candidates.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Product candidates currently under development will require
extensive preclinical and clinical testing and regulatory approval
prior to commercialization. These efforts require significant
amounts of additional capital, adequate personnel, and
infrastructure and extensive compliance-reporting capabilities.
Even if the Company’s
commercialization efforts are successful, it is uncertain when, if
ever, the Company will realize significant revenue from product
sales, and the Company may depend on certain strategic
relationships to distribute its products, including the
Company’s
strategic partnership with Fresenius Medical Care, to sell, market
and distribute its 6 millimeter HAV for certain specified
indications outside the United States.
Recently Adopted Accounting Pronouncements
In May 2021, the Financial Accounting Standards Board (the “FASB”)
issued Accounting Standards Update (“ASU”) No. 2021-04, “Earnings
Per Share (Topic 260), Debt-Modifications and Extinguishments
(Subtopic 470-50), Compensation-Stock Compensation (Topic 718), and
Derivatives and Hedging-Contracts in Entity’s Own Equity (Subtopic
815-40): Issuer’s Accounting for Certain Modifications or Exchanges
of Freestanding Equity-Classified Written Call Options” (“ASU
2021-04”). The FASB issued this update to clarify and reduce
diversity in an issuer’s accounting for modifications or exchanges
of freestanding equity classified written call options (for
example, warrants) that remain equity classified after modification
or exchange. ASU 2021-04 is effective for all entities for fiscal
years beginning after December 15, 2021, including interim periods
within those fiscal years. An entity should apply the amendments
prospectively to modifications or exchanges occurring after the
effective date of the amendments.
The Company adopted ASU 2021-04 as of January 1, 2022. The adoption
of this ASU had no impact on the Company’s
financial statements and related disclosures.
In November 2021, the FASB issued ASU No. 2021-10, “Government
Assistance (Topic 832): Disclosures by Business Entities about
Government Assistance” (“ASU 2021-10”) to improve financial
reporting by requiring annual disclosures that increase the
transparency of transactions with a government accounted for by
applying a grant or contribution model by analogy, including (i)
the types of transactions, (ii) an entity’s accounting for those
transactions, and (iii) the effect of those transactions on an
entity’s financial statements. ASU 2021-10 is effective for all
entities within their scope for financial statements issued for
annual periods beginning after December 15, 2021, and an entity can
elect to apply the amendments in this guidance prospectively or
retrospectively. The Company adopted ASU 2021-10 effective January
1, 2022, and does not expect a material impact to its annual
consolidated financial statement disclosures.
3. Reverse Recapitalization
On August 26, 2021, Merger Sub, a wholly-owned subsidiary of
AHAC, merged with Legacy Humacyte, with Legacy Humacyte surviving
as a wholly-owned subsidiary of AHAC. At the effective time of the
Merger:
•each
outstanding share of Legacy Humacyte common stock was converted
into approximately 0.26260 shares of New Humacyte’s common stock,
par value $0.0001 (“Common Stock”);
•each
outstanding share of preferred stock of Legacy Humacyte was
cancelled and converted into the aggregate number of shares of New
Humacyte’s common stock that would be issued upon conversion of the
shares of Legacy Humacyte preferred stock based on the applicable
conversion ratio immediately prior to the effective time,
multiplied by approximately 0.26260; and
•each
outstanding option or warrant to purchase Legacy Humacyte common
stock was converted into an option or warrant, as applicable, to
purchase a number of shares of New Humacyte’s common stock equal to
the number of shares of Legacy Humacyte common stock subject to
such option or warrant multiplied by approximately 0.26260, at an
exercise price per share equal to the current exercise price per
share for such option or warrant divided by approximately
0.26260;
in each case, rounded down to the nearest whole share.
In addition, upon the closing of the merger (the “Closing”),
2,500,000 Class B shares of AHAC (the “Founder Shares”)
automatically converted into shares of Common Stock on a
one-for-one basis.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Former holders of the Legacy Humacyte common stock and Legacy
Humacyte preferred stock are eligible to receive up to an aggregate
of 15,000,000 additional shares of Common Stock (the “Contingent
Earnout Shares”) in the aggregate, comprised of two equal tranches
of 7,500,000 shares per tranche if the volume-weighted average
closing sale price of the Common Stock is greater than or equal to
$15.00 and $20.00, respectively, for any 20 trading days within any
30 consecutive trading day period. At the Closing on
August 26, 2021, the Company recorded a liability (“Contingent
Earnout Liability”) of $159.4 million, based on the estimated fair
value of the 15,000,000 Contingent Earnout Shares with a
corresponding reduction of additional paid-in capital in the equity
section of the Company’s condensed consolidated balance
sheet.
Concurrently with the execution of the Merger Agreement, AHAC
entered into subscription agreements (the “Subscription
Agreements”) with certain investors (the “PIPE Investors”).
Pursuant to the Subscription Agreements, the PIPE Investors
purchased an aggregate of 17,500,000 shares of Common Stock (the
“PIPE Shares”) in a private placement at a price of $10.00 per
share for an aggregate purchase price of $175 million (the “PIPE
Financing”). The PIPE Financing was consummated in connection with
the Closing.
The number of shares of Common Stock outstanding immediately
following the consummation of the Merger was:
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|
|
|
|
Shares |
|
Common stock of AHAC, outstanding prior to Merger |
10,355,000 |
|
|
Less redemption of AHAC shares |
(3,008,551) |
|
|
Common stock of AHAC |
7,346,449 |
|
|
AHAC Founder Shares |
2,500,000 |
|
|
New Humacyte shares issued to PIPE Investors |
17,500,000 |
|
|
Issuance of common stock upon reverse recapitalization and PIPE
Financing |
27,346,449 |
|
|
New Humacyte shares issued in Merger to Legacy Humacyte
stockholders |
75,656,935 |
|
(1) |
Total shares of Common Stock immediately after Merger |
103,003,384 |
|
|
________________
(1)Includes
69,613,562 shares of Common Stock issued upon conversion of Legacy
Humacyte’s redeemable convertible preferred stock.
The Merger is accounted for as a reverse recapitalization in
accordance with U.S. GAAP. Under this method of accounting, AHAC is
treated as the acquired company for financial reporting purposes
and Legacy Humacyte is treated as the acquirer. This determination
is primarily based on the fact that subsequent to the Merger, the
Legacy Humacyte stockholders hold a majority of the voting rights
of the combined company, Legacy Humacyte comprises all of the
ongoing operations of the combined company, Legacy Humacyte
comprises a majority of the carryover governing body of the
combined company, and Legacy Humacyte’s senior management comprises
all of the senior management of the combined company. Accordingly,
for accounting purposes, the Merger was treated as the equivalent
of Legacy Humacyte issuing shares for the net assets of AHAC,
accompanied by a recapitalization. The net assets of AHAC were
stated at historical costs. No goodwill or other intangible assets
were recorded. Operations prior to the Merger are those of Legacy
Humacyte.
In connection with the Merger, the Company received $242.4 million
in proceeds from the Merger and related PIPE Financing. The Company
incurred $3.9 million of transaction costs, consisting of banking,
legal, and other professional fees, of which $3.9 million was
recorded as a reduction of proceeds to additional paid-in capital,
and less than $0.1 million related to the Private Placement
Warrants, which are classified as liabilities in the condensed
consolidated balance sheets, was expensed in the condensed
consolidated statements of operations and comprehensive income
(loss) during the three months ended September 30, 2021. All
transaction costs were paid as of December 31, 2021. Legacy
Humacyte assumed $15.2 million of liabilities, including PIPE
Financing fees and legal fees, and $0.1 million of assets from
AHAC. Of the $15.2 million of liabilities assumed from AHAC, $0.1
million was included in accrued expenses as of December 31, 2021,
and there were no unpaid liabilities as of June 30,
2022.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
4. Fair Value Measurements
Fair value is defined as the price that would be received to sell
an asset or paid to transfer a liability in the principal or most
advantageous market in an orderly transaction between market
participants at the measurement date. Accounting Standards
Codification (“ASC”) 820,
Fair Value Measurement and Disclosures,
establishes a hierarchy whereby inputs to valuation techniques used
in measuring fair value are prioritized, or the fair value
hierarchy. There are three levels to the fair value hierarchy based
on reliability of inputs, as follows:
•Level
1 — Observable inputs that reflect unadjusted quoted prices for
identical assets or liabilities in active markets.
•Level
2 — Inputs other than quoted prices included in Level 1 that are
observable for the asset or liability, such as quoted prices for
similar assets or liabilities, quoted prices in markets that are
not active, or other inputs that are observable or can be
corroborated by observable market data for substantially the full
term of the assets or liabilities.
•Level
3 — Unobservable inputs in which little or no market data exists,
therefore requiring the Company to develop its own
assumptions.
The Company evaluates assets and liabilities subject to fair value
measurements on a recurring basis to determine the appropriate
level at which to classify them for each reporting period,
utilizing valuation techniques that maximize the use of observable
inputs and minimize the use of unobservable inputs to the extent
possible. The determination requires significant judgments to be
made by the Company.
The Company’s assets and liabilities that were measured at fair
value on a recurring basis were as follows:
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands) |
|
Fair Value Measured as of June 30, 2022
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
|
Cash equivalents (money market funds) |
|
$ |
176,446 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
176,446 |
|
Cash equivalents (certificates of deposit) |
|
— |
|
|
2,005 |
|
|
— |
|
|
2,005 |
|
Short-term investments (certificates of deposit) |
|
— |
|
|
8,000 |
|
|
— |
|
|
8,000 |
|
Total financial assets |
|
$ |
176,446 |
|
|
$ |
10,005 |
|
|
$ |
— |
|
|
$ |
186,451 |
|
Liabilities: |
|
|
|
|
|
|
|
|
Contingent Earnout Liability |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
44,049 |
|
|
$ |
44,049 |
|
Private Placement Warrants liability |
|
— |
|
|
— |
|
|
190 |
|
|
190 |
|
Total financial liabilities |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
44,239 |
|
|
$ |
44,239 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands) |
|
Fair Value Measured as of December 31, 2021
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
Assets: |
|
|
|
|
|
|
|
|
Cash equivalents (money market funds) |
|
$ |
208,821 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
208,821 |
|
Cash equivalents (certificates of deposit) |
|
— |
|
|
2,000 |
|
|
— |
|
|
2,000 |
|
Short-term investments (certificates of deposit) |
|
— |
|
|
8,000 |
|
|
— |
|
|
8,000 |
|
Total financial assets |
|
$ |
208,821 |
|
|
$ |
10,000 |
|
|
$ |
— |
|
|
$ |
218,821 |
|
Liabilities: |
|
|
|
|
|
|
|
|
Contingent Earnout Liability |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
103,660 |
|
|
$ |
103,660 |
|
Private Placement Warrants liability |
|
— |
|
|
— |
|
|
497 |
|
|
497 |
|
Total financial liabilities |
|
$ |
— |
|
|
$ |
— |
|
|
$ |
104,157 |
|
|
$ |
104,157 |
|
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
The following tables present a summary of the changes in the fair
value of the Company’s Level 3 financial instruments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands) |
|
Contingent Earnout Liability |
|
Three Months Ended June 30, 2022 |
|
Six Months Ended June 30, 2022 |
|
|
|
|
|
Fair value as of beginning of period |
|
$ |
(100,402) |
|
|
$ |
(103,660) |
|
|
|
|
|
|
|
|
|
|
|
Change in fair value included in other income, net |
|
56,353 |
|
|
59,611 |
|
Fair value as of end of period |
|
$ |
(44,049) |
|
|
$ |
(44,049) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Private Placement Warrants |
($ in thousands) |
|
Three Months Ended June 30, 2022 |
|
Six Months Ended June 30, 2022 |
|
|
|
|
|
Fair value as of beginning of period |
|
$ |
(423) |
|
|
$ |
(497) |
|
|
|
|
|
|
|
|
|
|
|
Change in fair value included in other income, net |
|
233 |
|
|
307 |
|
Fair value as of end of period |
|
$ |
(190) |
|
|
$ |
(190) |
|
The fair value of the Contingent Earnout Liability and Private
Placement Warrants (as defined in Note 8 — Stockholders’ Equity
(Deficit)) liability are based on significant unobservable inputs,
which represent Level 3 measurements within the fair value
hierarchy.
In determining the fair value of the Contingent Earnout Liability,
the Company used the Monte Carlo simulation value model using a
distribution of potential outcomes on a monthly basis over a
10-year period prioritizing the most reliable information
available. The assumptions utilized in the calculation were based
on the achievement of certain stock price milestones, including the
current Common Stock price, expected volatility, risk-free rate,
expected term and expected dividend yield (see Note 8 —
Stockholders’ Equity (Deficit)). Contingent earnout payments
involve certain assumptions requiring significant judgment and
actual results can differ from assumed and estimated
amounts.
In determining the fair value of the Private Placement Warrants
liability, the Company used the Monte Carlo simulation valuation
model to estimate the fair value utilizing assumption including the
current Company stock price, expected volatility, risk-free rate,
expected term and expected dividend yield (see Note 8 —
Stockholders’ Equity (Deficit)).
The Company’s money market funds are classified within Level 1 of
the fair value hierarchy because they are valued using quoted
market prices. Certificates of deposit are carried at amortized
cost in the Company’s condensed consolidated balance sheets, which
approximates their fair value based on Level 2 inputs. The carrying
values of other receivables, accounts payable and accrued expenses
as of June 30, 2022 and December 31, 2021 approximated
their fair values due to the short-term nature of these
items.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
5. Property and Equipment, Net
Property and equipment, net consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands) |
|
June 30,
2022 |
|
December 31,
2021 |
|
|
|
|
|
Scientific equipment(1)
|
|
$ |
27,789 |
|
|
$ |
27,641 |
|
Computer equipment |
|
232 |
|
|
155 |
|
Software |
|
335 |
|
|
335 |
|
Furniture and fixtures |
|
988 |
|
|
988 |
|
Leasehold improvements |
|
26,355 |
|
|
26,355 |
|
|
|
55,699 |
|
|
55,474 |
|
Accumulated depreciation |
|
(23,472) |
|
|
(20,440) |
|
Property and equipment, net |
|
$ |
32,227 |
|
|
$ |
35,034 |
|
___________________________
(1)Includes
$3.6 million
as of both
June 30, 2022
and December 31, 2021 related to scientific equipment not placed
into service and therefore not being depreciated.
Depreciation expense totaled $1.5 million and $3.0 million for the
three and six months ended June 30, 2022 and $1.6 million and
$3.1 million for the three and six months ended June 30, 2021,
respectively. All long-lived assets are maintained in the
United
States.
6. Accrued Expenses
Accrued expenses consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands) |
|
June 30,
2022 |
|
December 31,
2021 |
|
|
|
|
|
Accrued external research, development and manufacturing
costs |
|
$ |
2,203 |
|
|
$ |
2,520 |
|
Accrued employee compensation and benefits |
|
3,589 |
|
|
3,943 |
|
Accrued professional fees |
|
394 |
|
|
294 |
|
Total |
|
$ |
6,186 |
|
|
$ |
6,757 |
|
7. Debt
On March 30, 2021, the Company entered into a term loan agreement
with Silicon Valley Bank and SVB Innovation Credit Fund VIII, L.P.,
as amended in June 2021 and September 2021 (the “Loan Agreement”),
which provides a term loan facility of up to $50.0 million with a
maturity date of March 1, 2025. The Company’s
obligations under the Loan Agreement are secured by substantially
all of its assets except for its intellectual property. The Loan
Agreement contains certain customary covenants, including, but not
limited to, those relating to additional indebtedness, liens, asset
divestitures, and affiliate transactions. If a minimum liquidity
amount is not maintained, 50% of the outstanding principal and
interest will become cash collateralized. As of June 30, 2022,
the Company was in compliance with all covenants. The Company may
use the proceeds of borrowings under the Loan Agreement as working
capital and to fund its general business requirements.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
The Loan Agreement provides that the term loans will be distributed
in tranches. The initial term loan tranche of $20.0 million was
drawn on March 31, 2021, and on October 13, 2021, the Company
borrowed an additional $10.0 million under the Loan Agreement.
Borrowings under the Loan Agreement are accounted for net of
issuance costs which are being accreted to interest expense over
the term of the loan using the effective interest method. As of
June 30, 2022, two subsequent $10.0 million term loan tranches
will be eligible to be drawn at the request of the Company during
specified draw periods prior to March 31, 2023, subject to the
achievement of certain business milestones and other requirements
by the dates specified in the Loan Agreement. Borrowings bear
interest at the greater of 7.5% or the Wall Street Journal Prime
Rate plus 4.25% (9.00% as of June 30, 2022). Interest only
payments on the principal amount outstanding are due monthly
beginning in the first month after the loan is dispersed. Repayment
of principal may begin as soon as July 1, 2023 under the level of
borrowing outstanding at June 30, 2022, and no later than
April 1, 2024 if the remaining two loan tranches are drawn. The
term loans may only be prepaid in full, and such prepayment
requires 30 days’
advance notice and was subject initially to a prepayment fee of
3.00% that was decreased to 2.00% after March 30, 2022 (with a
further decrease to 1.00% after March 30, 2023). The Company is not
obligated to pay a prepayment fee if the Company makes a prepayment
after March 30, 2024.
In connection with the Loan Agreement, the Company granted warrants
to the lenders to purchase shares of Common Stock at an exercise
price of $10.28 per share, of which 287,704 warrants were
immediately exercisable. The warrants are classified within
stockholders’
equity as the settlement of the warrants is indexed to the
Company’s
own stock. The Company recognized the fair value of the warrants
immediately exercisable within stockholders’
equity using a Black-Scholes valuation model at
issuance.
At issuance, the Company initially determined that the funding of
an additional tranche was not probable, and therefore no value was
ascribed to the remaining 123,302 warrants that were only
exercisable upon the funding of the additional tranche. As a result
of the Company’s additional $10.0 million borrowings under the Loan
Agreement on October 13, 2021, the warrants to purchase the
additional 123,302 shares of Common Stock became exercisable at an
exercise price of $10.28 per share and the value of the warrants
was recorded as of that date. The additional warrants are
classified within stockholders’ equity using a Black-Scholes
valuation model, as the settlement of the warrants is indexed to
the Company’s own stock.
As of June 30, 2022, the fair value of warrants ($3.3
million), a 5% final payment fee ($1.5 million) and debt issuance
costs ($0.3 million) are being accreted to interest expense over
the term of the loan using the effective interest
method.
SVB loan payable and net discount or premium balances are as
follows:
|
|
|
|
|
|
|
|
|
($ in thousands) |
|
June 30,
2022 |
Principal amount of SVB loan payable |
|
$ |
30,000 |
|
Final payment amount of SVB loan payable |
|
1,500 |
|
Net premium associated with accretion of final payment and other
debt issuance costs |
|
(3,368) |
|
SVB loan payable, current and noncurrent |
|
28,132 |
|
Less SVB loan payable, current portion |
|
— |
|
SVB loan payable, noncurrent portion |
|
$ |
28,132 |
|
Future minimum payments of principal on the
Company’s
outstanding variable rate borrowings as of June 30, 2022 are
as follows:
|
|
|
|
|
|
|
|
|
Year ending December 31:
|
|
($ in thousands) |
2022 (remainder)
|
|
$ |
— |
|
2023 |
|
8,571 |
|
2024 |
|
17,143 |
|
2025 |
|
4,286 |
|
|
|
|
Total future payments |
|
$ |
30,000 |
|
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
On April 30, 2020, the Company received loan proceeds in the
amount of approximately $3.3 million under the Paycheck Protection
Program (“PPP”)
established under the Coronavirus Aid, Relief, and Economic
Security Act. All or a portion of this loan and any accrued
interest was eligible to be forgiven after a twenty-four week
period as long as the borrower used the loan proceeds for eligible
purposes, including payroll, benefits, rent and utilities, and
maintained its payroll levels. On May 25, 2021, the PPP loan was
forgiven and the Company recognized a gain from loan extinguishment
in the amount of $3.3 million during the three months ended June
30, 2021.
8. Stockholders’
Equity (Deficit)
Redeemable Convertible Preferred Stock
Immediately prior to the Merger, Legacy Humacyte had outstanding
series A redeemable convertible preferred stock, series B
redeemable convertible preferred stock, series C redeemable
convertible preferred stock and series D redeemable convertible
preferred stock, which are collectively referred to as
“redeemable
convertible preferred stock.”
In connection with the Merger, all previously issued and
outstanding redeemable convertible preferred stock was converted
into an equivalent number of shares of Common Stock of the Company
on a one-for-one basis, then multiplied by the exchange ratio
pursuant to the Merger Agreement and the amounts were reclassified
as additional paid-in capital.
Common Stock
On August 26, 2021, the Merger and related PIPE Financing was
consummated and the Company issued 27,346,449 shares of common
stock for proceeds of $242.4 million. The Company incurred $3.9
million of transaction costs, consisting of banking, legal, and
other professional fees. Legacy Humacyte assumed $15.2 million of
liabilities, including PIPE Financing fees and legal fees, and $0.1
million of assets from AHAC. Immediately following the Merger,
there were 103,003,384 shares of Common Stock outstanding with a
par value of $0.0001.
As of June 30, 2022, the Company’s
Second Amended and Restated Certificate of Incorporation authorized
the Company to issue 250,000,000 shares of Common Stock. The number
of authorized shares of Common Stock may be increased or decreased
(but not below the number of shares thereof then outstanding or
reserved for issuance) by the affirmative vote of the holders of a
majority of the capital stock of the Company entitled to vote and
may require a separate class vote of the Common Stock.
The holders of Common Stock are entitled to receive dividends from
time to time as may be declared by the Company’s
board of directors. Through June 30, 2022, no dividends have
been declared.
The holders of Common Stock are entitled to one vote for each share
held with respect to all matters voted on by the common
stockholders of the Company.
In the event of a reorganization of the Company, after payment to
the preferred stockholders of their liquidation preferences,
holders of Common Stock are entitled to share ratably in all
remaining assets of the Company.
As of June 30, 2022, the Company had reserved Common Stock for
future issuances as follows:
|
|
|
|
|
|
|
June 30,
2022 |
Common stock reserved for Contingent Earnout Shares |
15,000,000 |
|
Exercise of options under stock plans |
6,899,995 |
|
Issuance of options under stock plans |
7,226,977 |
|
Shares available for grant under ESPP |
1,030,033 |
|
Warrants to purchase Common Stock |
5,588,506 |
|
|
35,745,511 |
|
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Preferred Stock
The Company’s
Second Amended and Restated Certificate of Incorporation provides
the Company’s
board of directors with the authority to issue $0.0001 par value
preferred stock in one more series and to establish from time to
time the number of shares to be included in each such series, by
adopting a resolution and filing a certification of designations.
Voting powers, designations, powers, preferences and relative,
participating, optional, special and other rights shall be stated
and expressed in such resolutions. There were 20,000,000 shares
designated as preferred stock and none were outstanding as of
June 30, 2022 and December 31, 2021.
Warrants
The Company had the following common stock warrants outstanding as
of June 30, 2022 and December 31, 2021:
|
|
|
|
|
|
|
Common Stock Warrants Outstanding |
|
|
Legacy Humacyte Common Stock Warrants |
411,006 |
|
Private Placement Warrants |
177,500 |
|
Public Warrants |
5,000,000 |
|
Total Common Stock Warrants |
5,588,506 |
|
See Note 7 — Debt for a discussion of common stock warrants issued
in conjunction with the Company’s
Loan Agreement in 2021 (such warrants, “Legacy Humacyte Common
Stock Warrants”). There were no issuances, exercises or expirations
of warrants during the six months ended June 30, 2022. During
the six months ended June 30, 2021 there were 32,961 of
warrants exercised that were issued in conjunction with a long-term
debt agreement repaid in a prior reporting period. There were no
expirations of warrants during the six months ended June 30,
2021.
In connection with the Merger, the Company assumed 5,000,000
publicly-traded warrants (“Public
Warrants”)
and 177,500 private placement warrants issued to AHAC Sponsor LLC
(the
“Sponsor”),
Oppenheimer & Co. Inc. and Northland Securities, Inc, in
connection with AHAC’s
initial public offering (“Private
Placement Warrants”
and, together with the Public Warrants, the
“Common
Stock Warrants”).
The Common Stock Warrants entitle the holder to purchase one share
of Common Stock at an exercise price of $11.50 per share. The
Company evaluated the Common Stock Warrants to determine the
appropriate financial statement classification upon the
consummation of the Merger. The Common Stock Warrants are not
mandatorily redeemable and are considered to be freestanding
instruments as they are separately exercisable into common shares.
As such, the Common Stock Warrants were not classified as
liabilities under FASB ASC Topic 480,
Distinguishing Liabilities from Equity
(“ASC 480”). The Company then evaluated the Common Stock Warrants
under FASB ASC Topic 815,
Derivatives and Hedging.
Public Warrants
The Public Warrants are publicly traded and are exercisable for
cash unless certain conditions occur, such as the failure to have
an effective registration statement related to the shares issuable
upon exercise or redemption by the Company under certain
conditions, at which time the warrants may be eligible for a
cashless exercise. The Public Warrants may only be exercised for a
whole number of shares and will expire five years after the
completion of the Merger. The Public Warrants became exercisable 30
days after the completion of the Merger.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
The Public Warrants are considered to be “indexed to the Company’s
own stock”. The agreement provides that in the event of a tender or
exchange offer made to and accepted by holders of more than 50% of
the outstanding shares of the Company’s
Common Stock, all holders of the Common Stock Warrants (both the
Public Warrants and the Private Placement Warrants) would be
entitled to receive cash for all of their Common Stock Warrants. As
the Company has a single class of Common Stock, a qualifying cash
tender offer of more than 50% of the Company’s
Common Stock will always result in a change in control and would
not preclude permanent equity classification of the Public
Warrants. Based on this evaluation, the Company concluded that the
Public Warrants meet the criteria to be classified within
stockholders’
equity. The Public Warrants were initially recognized as equity on
the Closing Date at a fair value of $2.80 per share.
Private Placement Warrants
The Private Placement Warrants are non-redeemable for cash so long
as they are held by the initial purchasers or their permitted
transferees. If the Private Placement Warrants are held by someone
other than the initial purchasers or their permitted transferees,
the Private Placement Warrants are redeemable by the Company and
exercisable by such holders on the same basis as the Public
Warrants.
The agreement governing the Common Stock Warrants includes a
provision, the application of which could result in a different
settlement value for the Private Placement Warrants depending on
their holder. Because the holder of an instrument is not an input
into the pricing of a fixed-for-fixed option on the
Company’s
ordinary shares, the Private Placement Warrants are not considered
to be
“indexed
to the Company’s
own stock”
and therefore are not classified in stockholders’
equity. As the Private Placement Warrants meet the definition of a
derivative, the Company recorded these warrants as liabilities on
the condensed consolidated balance sheet at fair value, with
subsequent changes in their respective fair values recognized in
the condensed consolidated statements of operations and
comprehensive income (loss) at each reporting date.
The Private Placement Warrants were initially recognized as a
liability on the Closing Date, at a fair value of $0.6 million, and
the liability was remeasured to an estimated fair value of $0.5
million as of December 31, 2021. See Note 4 — Fair Value
Measurements for a summary of the change in the fair value of the
Private Placement Warrants during the three and six months ended
June 30, 2022. The remeasurement of the Private Placement
Warrant liability to a fair value of $0.2 million as of
June 30, 2022 resulted in a non-cash gain of $0.2 million and
$0.3 million for the three and six months ended June 30, 2022,
respectively, classified within Change in fair value of common
stock warrant liabilities in the condensed consolidated statements
of operations and comprehensive income (loss).
The Private Placement Warrants were valued using the following
assumptions under the Monte Carlo simulation value
model:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022 |
|
December 31,
2021 |
Market price of public stock |
$ |
3.21 |
|
$ |
7.25 |
Exercise price |
$ |
11.50 |
|
$ |
11.50 |
Expected term (years) |
4.16 |
|
4.65 |
Expected share price volatility |
79.0 |
% |
|
61.0 |
% |
Risk-free interest rate |
3.00 |
% |
|
1.21 |
% |
Estimated dividend yield |
0 |
% |
|
0 |
% |
Contingent Earnout Liability
Following the Closing, former holders of Legacy Humacyte common and
preferred shares may receive up to 15,000,000 additional shares of
Common Stock in the aggregate, in two equal tranches of 7,500,000
shares of Common Stock per tranche. The first and second tranches
are issuable if the closing volume weighted average price
(“VWAP”)
per share of Common Stock quoted on Nasdaq (or the exchange on
which the shares of Common Stock are then listed) is greater or
equal to $15.00 and $20.00, respectively, over any 20 trading days
within any 30 consecutive trading day period.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
Upon the Closing, the contingent obligation to issue Contingent
Earnout Shares was accounted for as a liability because the
triggering events that determine the number of Contingent Earnout
Shares required to be issued include events that are not solely
indexed to the Common Stock. The Contingent Earnout Shares are
subsequently remeasured at each reporting date with changes in fair
value recorded as a component of other (expense) income, net in the
condensed consolidated statements of operations and comprehensive
income (loss). The estimated fair value of the total Contingent
Earnout Shares at the Closing on August 26, 2021 was $159.4
million based on a Monte Carlo simulation valuation model using a
distribution of potential outcomes on a monthly basis over a
ten-year period using the most reliable information available. The
estimated fair value of the total Contingent Earnout Shares at
December 31, 2021 was $103.7 million.
See Note 4 — Fair Value Measurements for a summary of the change in
the fair value of the Contingent Earnout Liability during the three
and six months ended June 30, 2022. The remeasurement of the
Contingent Earnout Liability to a fair value of $44.0 million as of
June 30, 2022 resulted in a non-cash gain of $56.4 million and
$59.6 million for the three and six months ended June 30,
2022, respectively, classified within Change in fair value of
contingent earnout liability in the condensed consolidated
statements of operations and comprehensive income (loss). The
assumptions utilized in the calculations of fair value were based
on the achievement of certain stock price milestones, including the
current Common Stock price, expected volatility, risk-free rate,
expected term and expected dividend yield.
Assumptions used in the valuations are described
below:
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30,
2022 |
|
December 31,
2021 |
Current stock price |
$ |
3.21 |
|
$ |
7.25 |
Expected share price volatility |
89.2 |
% |
|
85.8 |
% |
Risk-free interest rate |
2.98 |
% |
|
1.52 |
% |
Estimated dividend yield |
0.0 |
% |
|
0 |
% |
Expected term (years) |
10.00 |
|
10.00 |
9. Stock-based Compensation
At Closing, the 2021 Long-Term Incentive Plan, (the “2021 Plan”),
and the 2021 Employee Stock Purchase Plan, (the “ESPP”), became
effective. As of June 30, 2022, 7,226,977 and 1,030,033 shares
of Common Stock were available under the 2021 Plan and ESPP,
respectively. The 2021 Plan and ESPP provide that on January 1 of
each year commencing January 1, 2022, the 2021 Plan and the ESPP
reserve will automatically increase in an amount equal to the
lesser of (a) 5% and 1%, respectively, of the number of shares of
the Company’s
Common Stock outstanding on December 31 of the preceding year
and (b) a number of shares of Common Stock determined by the
Company’s
board of directors. In December 2021, the Company’s board of
directors determined that there would be no automatic increase in
the number of shares reserved under the 2021 Plan or the ESPP on
January 1, 2022.
Under the 2021 Plan, the Company can grant non-statutory stock
options (“NSOs”), incentive stock options (“ISOs), stock
appreciation rights, restricted stock, restricted stock units,
unrestricted stock, performance awards and other forms of awards.
Under the ESPP, when and if implemented, eligible employees will be
permitted to purchase shares of the Company’s Common Stock at the
lower of 85% of the closing trading price per share of the
Company’s Common Stock on the first day of the offering or 85% of
the closing trading price per share on the exercise date, which
will occur on the last day of each offering.
Prior to the Closing, Legacy Humacyte had two equity incentive
plans, the 2015 Omnibus Incentive Plan, as amended (the “2015
Plan”), and the 2005 Stock Option Plan (the “2005 Plan”). As a
result of the Merger, no further awards may be granted under either
the 2015 Plan or the 2005 Plan. All awards previously granted and
outstanding as of the effective date of the Merger, were adjusted
to reflect the impact of the Merger as set forth in the Merger
Agreement, but otherwise remain in effect pursuant to their
original terms. The shares underlying any award granted under the
2021 Plan or the 2015 Plan that are forfeited, cancelled or
reacquired by the Company prior to vesting, that expire or that are
paid out in cash rather than shares will become available for grant
and issuance under the 2021 Plan. As of June 30, 2022,
5,640,354 and 517,506 shares of Common Stock remain reserved for
outstanding options issued under the 2015 Plan and 2005 Plan,
respectively.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
The Company’s
stock option plans allow for the grant of awards that the Company
believes aid in aligning the interests of award recipients with
those of its stockholders. The Company’s
board of directors or compensation committee determines the
specific terms of equity incentive grants, including the exercise
price per share and vesting period for option awards. Option awards
are granted with an exercise price equal to the fair market value
of the Company’s
Common Stock at the date of grant.
The Company has granted options that include either a service-based
or performance-based vesting condition, or both, and a 10-year
contractual term. The service-based vesting condition for the plans
is generally satisfied over 36 to 48 months from the date of grant.
The performance-based vesting conditions are satisfied upon the
attainment of certain product development milestones. The Company
recognizes stock-based compensation expense based on the grant date
fair value of the awards measured using the Black-Scholes option
pricing model. Compensation expense related to awards with
service-based vesting conditions is recognized on a straight-line
basis over the requisite service period. Option valuation models,
including the Black-Scholes option-pricing model, require the input
of highly subjective assumptions, and changes in the assumptions
used can materially affect the grant-date fair value of an award.
These assumptions include the risk-free rate of interest, expected
dividend yield, expected volatility, the expected term of the
award, and the fair value of the underlying Common Stock on the
date of grant. Forfeitures are accounted for as they
occur.
Compensation expense related to awards with performance-based
vesting conditions is recognized over the requisite service period
using the accelerated attribution method to the extent achievement
of the performance-based condition is probable. The Company does
not recognize compensation expense related to awards with
performance-based vesting conditions until it is probable that the
performance-based vesting condition will be achieved. Forfeitures
are accounted for as they occur.
Option awards under the Company’s
option plans generally provide for accelerated vesting of the
unvested portions of any option award in the event of an
involuntary termination, as such term is defined in the relevant
stock option agreement, of a grantee’s
employment during the period that commences 30 days prior to the
effective date of a corporate transaction and that ends 12 months
following the effective date of such transaction. Additionally, the
Company’s
board of directors may, in its sole discretion, accelerate the
vesting of any unvested stock options in the event of a corporate
transaction.
The Company estimated the fair value of the stock options on the
date of grant using the following assumptions in the Black-Scholes
option-pricing model:
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|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2022
|
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
Estimated dividend yield |
0 |
% |
|
0 |
% |
|
0 |
% |
|
0 |
% |
Expected share price volatility (weighted average and range, if
applicable) |
93.9% (89.0% to 99.8%)
|
|
91.0 |
% |
|
95.5% (89.0% to 100.0%)
|
|
91.4% (91.0% to 92.1%)
|
Risk-free interest rate (weighted average and range, if
applicable) |
2.86% (2.53% to 3.23%)
|
|
0.99% (0.98% to 1.02%)
|
|
2.61% (1.89% to 3.23%)
|
|
0.68% (0.62% to 1.02%)
|
Expected term of options (in years) |
6.25 |
|
6.00 |
|
6.25 |
|
6.00 |
•Fair
Value of Common Stock.
Prior to the Merger, as the Company’s
common stock was not publicly traded, the fair value of the shares
of its common stock underlying the options was determined by the
Company’s
board of directors with input from management, after considering
independent third-party valuation reports. Subsequent to the
Merger, the fair value of the Common Stock has been determined
based on the closing price of the shares on the Nasdaq
market.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
•Expected
Term.
The expected term represents the period that stock options are
expected to be outstanding. The Company calculated the expected
term using the simplified method for options, which is available
where there is insufficient historical data about exercise patterns
and post-vesting employment termination behavior. The simplified
method is based on the vesting period and the contractual term for
each grant, or for each vesting-tranche for awards with graded
vesting. The mid-point between the vesting date and the maximum
contractual expiration date is used as the expected term under this
method. For awards with multiple vesting-tranches, the times from
grant until the mid-points for each of the tranches may be averaged
to provide an overall expected term.
•Expected
Volatility.
The expected volatility was based on the historical share
volatility of several publicly traded peer companies over a period
of time equal to the expected term of the options, as the Company
has a limited trading history to use the volatility of its Common
Stock. For purposes of identifying these peer companies, the
Company considered the industry, stage of development, size and
financial leverage of potential comparable companies.
•Risk-Free
Interest Rate.
The risk-free interest rate was based on the yields of U.S.
Treasury zero-coupon securities with maturities similar in duration
to the expected term of the options.
•Expected
Dividend Yield.
The Company has not paid dividends on its Common Stock nor does it
expect to pay dividends in the foreseeable future. Accordingly, the
Company has estimated the dividend yield to be zero.
At June 30, 2022, there were 7,226,977 options remaining
available for grant under the 2021 Plan. The Company has sufficient
authorized and unissued shares to make all issuances currently
available under the 2021 Plan.
The following tables show a summary of stock-based compensation
expense included in the condensed consolidated statements of
operations and comprehensive income (loss) for the three and six
months ended June 30, 2022 and 2021, and remaining
unrecognized cost as of June 30, 2022 and December 31,
2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
($ in thousands) |
|
2022 |
|
2021 |
|
2022 |
|
2021 |
Research and development |
|
$ |
185 |
|
|
$ |
715 |
|
|
$ |
466 |
|
|
$ |
1,351 |
|
General and administrative |
|
1,306 |
|
|
2,215 |
|
|
2,572 |
|
|
4,107 |
|
Total |
|
$ |
1,491 |
|
|
$ |
2,930 |
|
|
$ |
3,038 |
|
|
$ |
5,458 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
($ in thousands) |
|
June 30,
2022 |
|
December 31,
2021 |
|
|
|
|
|
Unrecognized share-based compensation cost |
|
$ |
10,974 |
|
|
$ |
13,346 |
|
Expected weighted average period compensation costs to be
recognized (years) |
|
2.1 |
|
2.3 |
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
A summary of option activity under the Company’s
stock option plans during the six months ended June 30, 2022
is presented below:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of Shares |
|
Weighted
Average Exercise
Price Per Share |
|
Weighted
Average
Remaining
Contractual Term
(years) |
|
Aggregate
Intrinsic Value
(in thousands) |
Options outstanding at December 31, 2021
|
6,711,192 |
|
|
$ |
7.48 |
|
|
5.3 |
|
$ |
8,276 |
|
Granted |
432,577 |
|
|
$ |
5.56 |
|
|
|
|
|
Exercised |
(3,157) |
|
|
$ |
3.67 |
|
|
|
|
|
Forfeited |
(240,617) |
|
|
$ |
9.34 |
|
|
|
|
|
Options outstanding at June 30, 2022
|
6,899,995 |
|
|
$ |
7.29 |
|
|
5.0 |
|
$ |
1,471 |
|
Vested and exercisable, June 30, 2022
|
4,754,151 |
|
|
$ |
6.39 |
|
|
3.2 |
|
$ |
1,471 |
|
Vested and expected to vest, June 30, 2022
|
6,899,995 |
|
|
$ |
7.29 |
|
|
5.0 |
|
$ |
1,471 |
|
10. Income Taxes
The Company’s
tax provision for interim periods is determined using an estimate
of its annual effective tax rate, adjusted for discrete items, if
any, that arise during the period. Each quarter, the Company
updates its estimate of the annual effective tax rate and, if the
estimated annual effective tax rate changes, the Company makes a
cumulative adjustment in such period. No such adjustment was made
as of June 30, 2022. The Company’s
effective federal tax rate for the three and six months ended
June 30, 2022 and 2021 was 0%, primarily as a result of
estimated tax losses for the fiscal year to date offset by the
increase in the valuation allowance in the net operating loss
carryforwards.
The Company did not record any income tax expense or benefit during
the three and six months ended June 30, 2022 and 2021. The
Company has a net operating loss and has provided a valuation
allowance against net deferred tax assets due to uncertainties
regarding the Company’s
ability to realize these assets. All losses before income taxes
arose in the United States.
11. Commitments and Contingencies
Patent License Agreements
Duke University
In March
2006, the Company entered into a license agreement with Duke
University (“Duke”), which was subsequently amended in 2011, 2014,
2015, 2018, 2019 and January 2022. Under this license agreement,
Duke granted the Company a worldwide, exclusive, sublicensable
license to certain patents related to decellularized tissue
engineering, referred to as the patent rights, as well as a
non-exclusive license to use and practice certain know-how related
to the patent rights. The relevant licensed patent on
decellularization of tissue expired in 2021. The Company has agreed
to use commercially reasonable efforts to develop, register, market
and sell products utilizing the patent rights, referred to as the
licensed products. Any services provided to a third party utilizing
licensed products are referred to as licensed services. The Company
has also agreed to meet certain benchmarks in its development
efforts, including as to development events, clinical trials,
regulatory submissions and marketing approval, within specified
timeframes. Under the license agreement, Duke retains the right to
use the patent rights for its own educational and research
purposes, and to provide the patent rights to other non-profit,
governmental or higher-learning institutions for non-commercial
purposes without paying royalties or other fees.
In connection with the Company’s
entry into the license agreement, the Company granted equity
consideration to Duke in the form of 52,693 shares of the
Company’s
common stock. Under the license agreement, the Company also agreed
to pay Duke:
•a
low single-digit percentage royalty on eligible sales of licensed
products and licensed services, plus a low double-digit percentage
of any sublicensing revenue;
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
•an
annual minimum royalty beginning in 2012, which increases in the
calendar year immediately following the first commercial sale of
licensed products or licensed services (whichever occurs first);
and
•an
additional amount in license fees, as certain milestones are
met.
The license agreement remains effective until the later of (i) the
last of the patent rights expires or (ii) four years after the
Company’s
first commercial sale, unless terminated earlier. Either party may
terminate the agreement for fraud, willful misconduct or illegal
conduct, or uncured material breach. Duke may terminate the
agreement if the Company becomes insolvent. Duke may also terminate
the license, convert the license into a non-exclusive license or
seek assignment of any sublicense if the Company fails to reach
diligence milestones within the applicable time period. If the
Company abandons any claim, patent or patent application, its
rights under the license with respect to such patent rights will be
terminated in the territory in which the Company abandons such
rights. The Company may terminate the license agreement
unilaterally upon three months’
prior notice to Duke. The Company agrees to indemnify Duke against
certain third-party claims. Payments to Duke under the license
agreement were immaterial during the periods
presented.
Yale University
In February 2014, the Company entered into a license agreement with
Yale University (“Yale”) that granted the Company a worldwide
license to the patents related to coatings for small-diameter
vessels to inhibit clotting. The license granted under the
agreement is exclusive in the field of engineered vascular tissues
and tissues and extracellular matrix-based implants used for
vascular repair, reconstruction and replacement (provided that all
uses are vascular tissues within the range of 1
–
12mm in diameter), except that it is subject to
Yale’s
non-exclusive right, on behalf of itself and all other non-profit
academic institutions, to use the licensed products for research,
teaching, and other non-commercial purposes. The Company has agreed
to pay to Yale an annual maintenance fee, increasing between the
first and fourth anniversaries of the agreement up to a maximum of
less than $0.1 million per year for this license.
In August 2019, the Company entered into a license agreement with
Yale, that granted the Company a worldwide license to the patents
related to Bioartificial Vascular Pancreas (“BVP”). The license
granted under the agreement is exclusive in the field of engineered
vascular tissues that deliver pancreatic islet cells to patients,
except that it is subject to Yale’s
non-exclusive right, on behalf of itself and all other non-profit
academic institutions, to use the licensed products for research,
teaching, and other non-commercial purposes. The Company has agreed
to pay to Yale an annual maintenance fee, increasing between the
first and fourth anniversaries of the agreement up to a maximum of
less than $0.1 million per year for this license.
In August 2019, the Company entered into a license agreement with
Yale that granted the Company a worldwide license to the patents
related to tubular prostheses. The license granted under the
agreement is exclusive in the field of engineered urinary conduits,
engineered tracheas/airways, and engineered esophagi, except that
it is subject to Yale’s
non-exclusive right, on behalf of itself and all other non-profit
academic institutions, to use the licensed products for research,
teaching, and other non-commercial purposes. The Company has agreed
to pay to Yale an annual maintenance fee, increasing between the
first and fourth anniversaries of the agreement up to a maximum of
less than $0.1 million per year for this license.
The Company has agreed to use reasonable commercial efforts to
develop and commercialize the licensed patents and any licensed
products and methods, and to use reasonable efforts to make the
licensed products available to patients in low and low-middle
income countries. The Company is also obligated to provide Yale
periodically an updated and revised copy of its plan for each
license, which must indicate progress of its development and
commercialization. The Company may also sublicense the
Company’s
rights without Yale’s
prior written consent, but such sublicense is subject to certain
conditions.
In connection with its entry into the license agreement, the
Company paid Yale upfront cash fees. The Company has also agreed to
pay Yale:
•annual
maintenance fees, increasing between the first anniversary of the
agreement until the fifth anniversary for the coating and BVP
licenses and until the fourth anniversary for the tubular
prostheses license up to a maximum of less than $0.1 million per
year;
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
•milestone
payments upon achievement of certain regulatory and commercial
milestones of $0.2 million and $0.6 million,
respectively;
•a
low single-digit percentage royalty on worldwide net sales, subject
to reductions for third-party license fees; and
•a
low double-digit percentage of sublicensing income.
If the Company or any of its future sublicensees bring a patent
challenge against Yale or assists another party in bringing a
patent challenge against Yale, the license fees described above
will be subject to certain increases and penalties.
The agreements expire on a country-by-country basis on the date on
which the last of the patents in such country expires, lapses or is
declared invalid. Yale may terminate the agreements if the Company
fails to (i)
provide written diligence reports, (ii)
provide commercially reasonable diligence plans, (iii)
implement the plans in accordance with the obligations under the
agreements, or (iv)
reach certain research and development milestones within the
scheduled timeframe set forth in the agreements; however, any such
termination right would be limited in scope to the country to which
such failure relates. Yale may also terminate for the
Company’s
non-payment, uncured material breach, failure to obtain adequate
insurance, bringing or assisting in bringing of a patent challenge
against Yale, abandonment of the research and development of the
Company’s
products or insolvency. The Company may terminate the license
agreements (i)
on 90 days’
prior written notice to Yale, provided the Company is not in breach
of the license agreements and has made all required payments to
Yale thereunder and (ii)
on written notice to Yale following an uncured material breach.
With respect to the license agreements related to small-diameter
vessels and BVP, the Company’s
rights under the license agreements will also terminate
automatically with respect to a patent application or patent within
the licensed patents in a specified country if, upon receipt of
written notice from Yale, the Company does not agree to pay the
patent filing, prosecution and maintenance fees incurred by Yale
for such patent applications or patents in the specified country.
Under certain circumstances, Yale may, at its option, convert the
exclusive licenses to non-exclusive licenses if the Company
declines to initiate certain infringement or interference
proceedings with respect to the licensed patents. The Company has
agreed to indemnify Yale against certain third-party claims.
Payments to Yale under the license agreement were immaterial during
the periods presented.
Legal Matters
The Company currently is not aware of any legal proceedings or
claims that management believes will have, individually or in the
aggregate, a material adverse effect on the
Company’s
business, financial condition, results of operations, or cash
flows.
Indemnification
To the extent permitted under Delaware law, the Company has agreed
to indemnify its directors and officers for certain events or
occurrences while the director or officer is, or was serving, at
the Company’s
request in such capacity. The indemnification period covers all
pertinent events and occurrences during the
director’s
or officer’s
service. The maximum potential amount of future payments the
Company could be required to make under these indemnification
arrangements is not specified in such arrangements; however, the
Company has director and officer insurance coverage that is
intended to reduce its exposure and enable the Company to recover a
portion of any potential future amounts the Company could be
required to make. To date, the Company has not incurred any costs
as a result of such obligations and has not accrued any liabilities
related to such obligations in the condensed consolidated financial
statements.
12. Related Party Transactions
Fresenius Medical Care investments and distribution
agreement
In June 2018, the Company completed a $150 million financing
transaction pursuant to which Fresenius Medical Care purchased
shares of series D redeemable convertible preferred stock that at
the Closing of the Merger converted into 15,812,735 shares of the
Company’s
common stock. In August 2021, Fresenius Medical Care invested $25
million as part of the PIPE Financing and received an additional
2.5 million shares of the Company’s
common stock.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
In addition, the Company entered into a distribution agreement with
Fresenius Medical Care in June 2018 which, as amended as of
February 16, 2021, granted Fresenius Medical Care and its
affiliates exclusive rights to develop outside the United States
and European Union (the “EU”) and commercialize outside of the
United States the Company’s
6 millimeter x 42 centimeter HAV and all improvements thereto, and
modifications and derivatives thereof (including any changes to the
length, diameter or configuration of the foregoing), for use in
vascular creation, repair, replacement or construction, including
renal replacement therapy for dialysis access, the treatment of
peripheral arterial disease, and the treatment of vascular trauma,
but excluding coronary artery bypass graft, pediatric heart
surgery, or adhering pancreatic islet cells onto the outer surface
of the distribution product for use in diabetic patients. Within
the United States, Fresenius Medical Care will collaborate with the
Company in its commercialization of the product in the field,
including adoption of the distribution product as a standard of
care in patients for which such use is supported by clinical
results and health economic analyses.
The Company is responsible for developing and seeking regulatory
approval for the distribution product in the field in the United
States. For countries outside the United States, the parties agreed
to use commercially reasonable efforts to satisfy certain agreed
minimum market entry criteria for the distribution product in the
field in such country. For the EU, once such criteria have been
satisfied for the applicable country, or if the parties otherwise
mutually agree to obtain regulatory approval for the distribution
product in the field in the applicable country, the Company agreed
to use commercially reasonable efforts to obtain such regulatory
approval (other than pricing approval), and Fresenius Medical Care
agreed to use commercially reasonable efforts to obtain the
corresponding pricing approval. For the rest of the world (i.e.,
outside the United States and the EU), once such criteria have been
satisfied for the applicable country, or if the parties otherwise
mutually agree to obtain regulatory and pricing approval for the
distribution product in the field in the applicable country,
Fresenius Medical Care agreed to use commercially reasonable
efforts to obtain such approvals, and the Company agreed to use
commercially reasonable efforts to support Fresenius Medical Care
in its efforts.
Under the distribution agreement, the Company grants an exclusive,
sublicensable license to Fresenius Medical Care under the patents,
know-how and regulatory materials controlled by the Company during
the term to commercialize the distribution product in the field
outside the United States, subject to the
Company’s
retained rights to carry out its obligations under the distribution
agreement. The Company also grants a non-exclusive, sublicensable
license to Fresenius Medical Care under the patents, know-how and
regulatory materials controlled by the Company during the term to
develop the distribution product in accordance with the terms of
the distribution agreement. In addition, the Company grants to
Fresenius Medical Care, among other things, a perpetual,
irrevocable, non-exclusive sublicensable license under the patents
and know-how that primarily relate to the distribution product or
its manufacture and that were created, conceived or developed
solely or jointly by or on behalf of Fresenius Medical Care in the
performance of its activities under the distribution
agreement.
The distribution agreement provides that the Company will own all
know-how and patents that primarily relate to the distribution
product or its manufacture that are created, conceived or developed
by or on behalf of either party in the performance of activities
under the distribution agreement. Ownership of all other know-how,
patents, materials and other intellectual property created,
conceived or developed during the performance of activities under
the distribution agreement will be determined in accordance with
U.S. patent laws for determining inventorship.
The Company is obligated to make payments to Fresenius Medical Care
based on a share of aggregate net sales by or on behalf of the
Company of the distribution product in the United States in the
field. Such revenue-share payments will be a percentage of net
sales in the low double digits, without regard to the calendar year
in which such net sales are attributable, until such time that the
Company has paid to Fresenius Medical Care a certain total amount,
at which time the revenue-share will decrease to a percentage of
net sales in the mid-single digits. The amounts that Fresenius
Medical Care will be obligated to pay the Company under the
distribution agreement for sales of the distribution product in the
field outside of the United States will vary. Fresenius Medical
Care agreed to pay the Company initially, on a country-by-country
basis for sales outside of the United States, the amount equal to
the average cost of manufacturing the Company’s
distribution product plus a fixed dollar amount per unit. Following
a specified period, on a country-by-country basis outside of the
United States, Fresenius Medical Care will pay the Company a fixed
percentage of net sales for each unit sold in such country, such
that the Company will receive more than half of such net
sales.
Humacyte, Inc.
Notes to Condensed Consolidated Financial Statements
(unaudited)
The distribution agreement will generally continue on a
country-by-country basis until the later of (a) the tenth
anniversary of the launch date of the distribution product in the
relevant country or (b) the expiration of the last-to-expire valid
claim of specified patents in such country. Each party is permitted
to terminate the distribution agreement for insolvency of, or,
under certain circumstances, including various cure periods,
material breach by the other party. Subject to a cure period,
Fresenius Medical Care may also terminate the distribution
agreement in its entirety or on a country-by-country basis (i) for
certain withdrawals of regulatory approval or (ii) for termination
or expiration of any of our in-licenses that is necessary for the
exercise of Fresenius Medical Care’s
rights, or the satisfaction of its obligations, under the
distribution agreement. In addition, Fresenius Medical Care may
terminate the distribution agreement for convenience on a
country-by-country basis upon not less than 12
months’
written notice to the Company, although Fresenius Medical Care is
not permitted to give such notice prior to the end of the second
year following launch of the distribution product in such country.
Each party is required to indemnify one another for certain
third-party claims.
Arrangements with Yale University
The Company’s President and Chief Executive Officer, Laura Niklason
M.D., PhD., serves as an Adjunct Professor in Anesthesia at Yale
University. As of June 30, 2022 and December 31, 2021,
the Company was a party to license agreements with Yale University
as described in Note 11
—
Commitments and Contingencies, above.
The following table shows a summary of related party expenses
included in the statements of operations and comprehensive income
(loss) for the three and six months ended June 30, 2022 and
2021:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
($ in thousands) |
2022 |
|
2021 |
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
License expenses |
$ |
— |
|
|
$ |
35 |
|
|
$ |
50 |
|
|
$ |
85 |
|
Other |
6 |
|
|
46 |
|
|
8 |
|
|
81 |
|
Total |
6 |
|
|
81 |
|
|
58 |
|
|
166 |
|
Item 2. Management’s Discussion and Analysis of Financial Condition
and Results of Operations
The following discussion and analysis of our financial condition
and results of operations should be read in conjunction with our
unaudited condensed consolidated financial statements and related
notes appearing elsewhere in this Quarterly Report on Form 10-Q
(“Quarterly Report”) and with our audited financial statements and
the notes thereto included in our Annual Report on Form 10-K for
the year ended December 31, 2021 (“Annual Report”), filed with the
Securities and Exchange Commission (the “SEC”) on March 29, 2022.
In addition, you should read the “Risk Factors” and “Information
Regarding Forward-Looking Statements” sections of this Quarterly
Report and our Annual Report for a discussion of important factors
that could cause actual results to differ materially from the
results described in or implied by the forward-looking statements
contained in the following discussion and analysis.
Unless the context indicates otherwise, references in this
Quarterly Report to the “Company,” “Humacyte,” “we,” “us,” “our”
and similar terms refer to Humacyte, Inc. (formerly known as Alpha
Healthcare Acquisition Corp.) and its consolidated subsidiaries
(including Humacyte Global, Inc.) following the Merger (defined
below); references to “Legacy Humacyte” refer to Humacyte, Inc.
prior to the Merger; and references to “AHAC” refer to Alpha
Healthcare Acquisition Corp. prior to the Merger.
Overview
We are pioneering the development and manufacture of off-the-shelf,
universally implantable, bioengineered human tissues, complex
tissue systems, and organs with the goal of improving the lives of
patients and transforming the practice of medicine. We believe our
technology has the potential to overcome limitations in existing
standards of care and address the lack of significant innovation in
products that support tissue repair, reconstruction and
replacement. We are leveraging our novel, scalable technology
platform to develop proprietary, bioengineered, acellular human
tissues, complex tissue systems, and organs for use in the
treatment of diseases and conditions across a range of anatomic
locations in multiple therapeutic areas.
We are initially using our proprietary, scientific technology
platform to engineer and manufacture human, acellular vessels
(“HAVs”). Our investigational HAVs are designed to be easily
implanted into any patient without inducing a foreign body response
or leading to immune rejection. We are developing a portfolio, or
“cabinet”, of HAVs with varying diameters and lengths. The HAV
cabinet would initially target the vascular repair, reconstruction
and replacement market, including use in vascular trauma;
arteriovenous (“AV”) access for hemodialysis, peripheral arterial
disease (“PAD”); and coronary artery bypass grafting (“CABG”). In
addition, we are developing our HAVs for pediatric heart surgery
and the delivery of cellular therapies, including pancreatic islet
cell transplantation to treat Type 1 diabetes (our biovascular
pancreas). We will continue to explore the application of our
technology across a broad range of markets and indications,
including the development of urinary conduit, trachea, esophagus
and other novel cell delivery systems.
We believe there is substantial clinical demand for safe and
effective vascular conduits to replace and repair blood vessels
throughout the body. Vascular injuries resulting from trauma are
common in civilian and military populations, frequently resulting
in the loss of either life or limb. Existing treatment options in
the vascular repair, reconstruction and replacement market include
the use of autologous vessels and synthetic grafts, which we
believe suffer from significant limitations. For example, the use
of autologous veins to repair traumatic vascular injuries can lead
to significant morbidity associated with the surgical wounds
created for vein harvest and prolonged times to restore blood flow
to injured limbs leading to an increased risk of amputation and
infection. Synthetic grafts are often contraindicated in the
setting of vascular trauma due to higher infection risk that can
lead to prolonged hospitalization and limb loss. Given the
competitive advantages our HAVs are designed to have over existing
vascular substitutes, we believe that HAVs have the potential to
become the standard of care and lead to improved patient outcomes
and lower healthcare costs.
We have generated no product revenue and incurred operating losses
and negative cash flows from operations in each year since our
inception in 2004. As of June 30, 2022 and December 31,
2021, we had an accumulated deficit of $397.5 million and $414.6
million, respectively, and working capital of $182.0 million and
$218.3 million, respectively. Our operating losses were
approximately $18.5 million and $40.3 million for the three and six
months ended June 30, 2022, respectively, and $19.3 million
and $39.0 million for the three and six months ended June 30,
2021, respectively. Net cash flows used in operating activities
were $35.4 million and $29.2 million during the six months ended
June 30, 2022 and 2021, respectively. Substantially all of our
operating losses resulted from costs incurred in connection with
our research and development programs and from general and
administrative costs associated with our operations. We expect to
incur substantial operating losses and negative cash flows from
operations for the foreseeable future as we advance our product
candidates.
As of June 30, 2022, we had cash and cash equivalents and
short-term investments of $189.0 million. We believe our cash and
cash equivalents and short-term investments on hand will be
sufficient to fund operations, including clinical trial expenses
and capital expenditure requirements, for at least 12 months from
the date of this Quarterly Report. See Note 1 — Organization and
Description of Business in the notes to our unaudited condensed
consolidated financial statements included elsewhere in this
Quarterly Report for additional information regarding this
assessment.
Our need for additional capital will depend in part on the scope
and costs of our development and commercial manufacturing
activities. To date, we have not generated any revenue from the
sale of commercialized products. Our ability to generate product
revenue will depend on the successful development and eventual
commercialization of one or more of our product candidates. Until
such time, if ever, we expect to finance our operations through the
use of existing cash and cash equivalents and short-term
investments, the sale of equity or debt, borrowings under credit
facilities, or through potential collaborations, other strategic
transactions or government and other grants. Adequate capital may
not be available to us when needed or on acceptable terms. If we
are unable to raise capital, we could be forced to delay, reduce,
suspend or cease our research and development programs or any
future commercialization efforts, which would have a negative
impact on our business, prospects, operating results and financial
condition. See “Risk Factors” for additional
information.
We expect to continue to incur significant expenses and to increase
operating losses for at least the next several years. We anticipate
that our expenses will increase substantially as we seek
to:
•obtain
marketing approval for our 6 millimeter HAV for vascular repair,
reconstruction and replacement, including for vascular trauma and
AV access for hemodialysis;
•commercialize
the HAV via U.S. market launches in vascular trauma and
hemodialysis AV access;
•scale
out our manufacturing facility to the extent required to satisfy
potential demand following any receipt of marketing
approval;
•continue
our preclinical and clinical development efforts;
•maintain,
expand and protect our intellectual property
portfolio;
•add
operational, financial and management information systems and
personnel to support, among other things, our product development
and commercialization efforts and operations; and
•continue
operating as a public company, which includes higher costs
associated with hiring additional personnel, director and officer
insurance premiums, audit and legal fees, and expenses for
compliance with public company reporting requirements under the
Securities Exchange Act of 1934 (the “Exchange Act”) and rules
implemented by the SEC and The Nasdaq Stock Market LLC
(“Nasdaq”).
Merger and Public Company Costs
On August 26, 2021 (the “Closing Date”), Legacy Humacyte and AHAC
consummated a merger pursuant to that certain Business Combination
Agreement, dated as of February 17, 2021 (the “Merger Agreement”),
by and among Legacy Humacyte, AHAC and Hunter Merger Sub, Inc.
(“Merger Sub”), a Delaware corporation and wholly owned subsidiary
of AHAC. As contemplated by the Merger Agreement, Merger Sub merged
with and into Legacy Humacyte, with Legacy Humacyte continuing as
the surviving corporation and as a wholly owned subsidiary of AHAC
(the “Merger”). On the Closing Date, AHAC changed its name to
Humacyte, Inc. and Legacy Humacyte changed its name to Humacyte
Global, Inc. Operations prior to the Merger included in this
Quarterly Report are those of Legacy Humacyte.
Pursuant to the terms of the Merger Agreement, at the effective
time of the Merger (the “Effective Time”), (1) each outstanding
share of common stock of Legacy Humacyte (“Legacy Humacyte common
stock”) was cancelled and converted into the right to receive
approximately 0.26260 shares of the Company’s common stock, par
value $0.0001 per share (“Common Stock”), and (2) each outstanding
share of preferred stock of Legacy Humacyte (“Legacy Humacyte
preferred stock”) was cancelled and converted into the aggregate
number of shares of Common Stock that would be issued upon
conversion of the shares of Legacy Humacyte preferred stock based
on the applicable conversion ratio immediately prior to the
Effective Time, multiplied by approximately 0.26260, resulting in
the issuance of a total of 75,656,935 shares of Common Stock. Prior
holders of shares of Legacy Humacyte common stock and Legacy
Humacyte preferred stock also received the contingent right to
receive certain Contingent Earnout Shares (as defined below), for
each share owned by each such Legacy Humacyte stockholder that was
outstanding immediately prior to the closing of the Merger (the
“Closing”). In addition, certain investors purchased an aggregate
of 17,500,000 shares of Common Stock (such investors, the “PIPE
Investors”) in a private placement that closed concurrently with
the Closing for an aggregate purchase price of $175 million (the
“PIPE Financing”). Additionally, at the Closing, 2,500,000 shares
of AHAC’s Class B common stock (“Founder Shares”) automatically
converted into shares of Common Stock on a one-for-one
basis.
Following the Closing Date, former holders of Legacy Humacyte
common stock and Legacy Humacyte preferred stock may receive up to
15,000,000 additional shares of Common Stock (“Contingent Earnout
Shares”) in the aggregate in two equal tranches if the
volume-weighted average closing sale price of our Common Stock is
greater than or equal to $15.00 and $20.00, respectively, for any
20 trading days within any 30 consecutive trading day
period.
Unless otherwise noted, the Company has retroactively adjusted all
common and preferred share and related price information to give
effect to the exchange ratio established in the Merger
Agreement.
Impact of COVID-19
The COVID-19 pandemic, which began in December 2019 and has spread
worldwide, has caused many governments to implement measures to
slow the spread of the outbreak, including shelter-in-place orders
and the mandatory shutdown of certain businesses. The outbreak and
government measures taken in response have had a significant
impact, both direct and indirect, on our business, as supply chains
have been disrupted, and facilities and production have been
suspended. The future progression of the COVID-19 pandemic,
including any existing or potential variants of the virus which
causes COVID-19, and its effects on our business and operations are
uncertain. The COVID-19 pandemic may affect our ability to initiate
and complete preclinical studies, delay our clinical trials or
future clinical trials, disrupt regulatory activities, or have
other adverse effects on our business and operations. The pandemic
has already caused significant disruptions in the financial
markets, and may continue to cause such disruptions, which could
impact our ability to raise additional funds to support our
operations. Moreover, the pandemic has significantly impacted
economies worldwide and could result in adverse effects on our
business and operations.
To date, the COVID-19 pandemic has not resulted in material
financial impacts or impairment losses in the carrying values of
our assets and we are not aware of any specific related event or
circumstance that would require us to revise the estimates
reflected in our financial statements. The extent to which the
COVID-19 pandemic will directly or indirectly impact our business,
results of operations and financial condition, including current
and future clinical trials and research and development costs, will
depend on future developments that are highly uncertain, including
as a result of new information that may emerge concerning COVID-19,
the actions taken to contain or treat it, the emergence of new
virus variants, and the duration and intensity of the related
economic impact of the COVID-19 pandemic.
Components of Results of Operations
Revenue
To date, we have not generated revenue from the sale of any
products. All of our revenue has been derived from government and
other grants. Since inception we have been awarded grants from the
California Institute of Regenerative Medicine (“CIRM”), the
National Institutes of Health (“NIH”), and the Department of
Defense (“DoD”), to support our development, production scaling and
clinical trials of our product candidates. We may generate revenue
in the future from government and other grants, payments from
future license or collaboration agreements and, if any of our
product candidates receive marketing approval, from product sales.
We expect that any revenue we generate will fluctuate from quarter
to quarter. If we fail to complete the development of, or obtain
marketing approval for, our product candidates in a timely manner,
our ability to generate future revenue, and our results of
operations and financial position, would be materially adversely
affected.
Research and Development Expenses
Since our inception, we have focused our resources on our research
and development activities, including conducting preclinical
studies and clinical trials, developing our manufacturing process
and activities related to regulatory filings for our product
candidates. We recognize research and development expenses as they
are incurred. Our research and development expenses consist
primarily of:
•salaries
and related overhead expenses for personnel in research and
development functions, including stock-based compensation and
benefits;
•fees
paid to consultants and clinical research organizations (“CROs”),
including in connection with our clinical trials, and other related
clinical trial fees, such as for investigator grants, patient
screening, laboratory work and statistical compilation and
analysis;
•allocation
of facility lease and maintenance costs;
•depreciation
of leasehold improvements, laboratory equipment and
computers;
•costs
related to purchasing raw materials and producing our product
candidates for clinical trials;
•costs
related to compliance with regulatory requirements;
•costs
related to our manufacturing development and expanded-capabilities
initiatives; and
•license
fees related to in-licensed technologies.
The majority of our research and development resources are
currently focused on our Phase III clinical trials for our 6
millimeter HAV and other work needed to obtain marketing approval
for our 6 millimeter HAV for use for vascular repair,
reconstruction and replacement, including vascular trauma and AV
access in hemodialysis in the United States. We have incurred and
expect to continue to incur significant expenses in connection with
these and our other clinical development efforts, including
expenses related to regulatory filings, trial enrollment and
conduct, data analysis, patient follow up and study report
generation for our Phase II and Phase III clinical trials. We do
not allocate all of our costs by each research and development
program for which we are developing our cabinet of HAVs, as a
significant amount of our development activities broadly support
multiple programs that use our technology platform. We plan to
further increase our research and development expenses for the
foreseeable future as we continue the development of our
proprietary scientific technology platform and our novel
manufacturing paradigm.
The successful development of our preclinical and clinical product
candidates is highly uncertain. At this time, we cannot estimate
with any reasonable certainty the nature, timing or costs of the
efforts that will be necessary to complete the remainder of the
development of any of our preclinical or clinical product
candidates or the period, if any, in which material net cash
inflows from these product candidates may commence. This is due to
the numerous risks and uncertainties associated with the
development of our product candidates, including:
•the
scope, rate of progress, expense and results of our preclinical
development activities, our ongoing clinical trials and any
additional clinical trials that we may conduct, and other research
and development activities;
•successful
patient enrollment in and the initiation and completion of clinical
trials;
•the
timing, receipt and terms of any marketing approvals from
applicable regulatory authorities including the U.S. Food and Drug
Administration (“FDA”) and non-U.S. regulators;
•the
extent of any required post-marketing approval commitments to
applicable regulatory authorities;
•development
of clinical and commercial manufacturing capabilities or making
arrangements with third-party manufacturers in order to ensure that
it or its third-party manufacturers are able to successfully
manufacture our product;
•obtaining,
maintaining, defending and enforcing patent claims and other
intellectual property rights;
•significant
and changing government regulations;
•launching
commercial sales of our product candidates, if approved, whether
alone or in collaboration with others;
•the
degree of market acceptance of any product candidates that obtain
marketing approval; and
•maintaining
a continued acceptable safety profile following approval, if any,
of our product candidates.
A change in the outcome of any of these variables could lead to
significant changes in the costs and timing associated with the
development of our product candidates. For example, if the FDA or
another regulatory authority were to require us to conduct clinical
trials beyond those that we currently anticipate being required to
conduct in order to complete the clinical development of any of our
product candidates, or if we experience significant delays in the
enrollment or the conduct of any of our clinical trials, we could
be required to expend significant additional financial resources
and time on the completion of clinical development.
General and Administrative Expenses
General and administrative expenses consist primarily of salaries
and related costs for employees in executive, finance, human
resources, commercialization, and administrative support functions,
which also include stock-based compensation expenses and benefits
for such employees. Other significant general and administrative
expenses include facilities costs, professional fees for accounting
and legal services and expenses associated with obtaining and
maintaining patents.
We expect our general and administrative expenses will continue to
increase for the foreseeable future to support our expanded
infrastructure and increased costs of operating as a public company
and as we prepare for our anticipated commercial launch of the HAV.
These increases are expected to include increased employee-related
expenses, increased sales and marketing expenses, and increased
director and officer insurance premiums, audit and legal fees, and
expenses for compliance with public company reporting requirements
under the Exchange Act and rules implemented by the SEC, as well as
Nasdaq rules.
Other Income (Expense), Net
Total other income (expense), net consists of (i) the change in
fair value of the contingent earnout liability that was accounted
for as a liability as of the date of the Merger, and is remeasured
to fair value at each reporting period, resulting in a non-cash
gain or loss, (ii) interest income earned on our cash and cash
equivalents and short-term investments, (iii) interest expense
incurred on our term loan agreement with Silicon Valley Bank and
SVB Innovation Credit Fund VIII, L.P. (the “Loan Agreement”),
finance leases, and our Paycheck Protection Program (“PPP”) loan
during the periods each were outstanding, (iv) a change in fair
value of private placement common stock warrant liabilities related
to private placement warrants originally issued in a private
placement to AHAC Sponsor LLC (“Private Placement Warrants”), which
we assumed in connection with the Merger, and which are subject to
remeasurement to fair value at each balance sheet date resulting in
a non-cash gain or loss, and (v) a non-cash gain on PPP loan
forgiveness during the three months ended June 30,
2021.
Results of Operations
Comparison of the Three Months Ended June 30, 2022 and
2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Change |
($ in thousands) |
2022 |
|
2021 |
|
$ |
|
% |
Revenue |
$ |
1,301 |
|
|
$ |
690 |
|
|
$ |
611 |
|
|
89 |
% |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
14,652 |
|
|
14,568 |
|
|
84 |
|
|
1 |
% |
General and administrative |
5,180 |
|
|
5,391 |
|
|
(211) |
|
|
(4) |
% |
Total operating expenses |
19,832 |
|
|
19,959 |
|
|
(127) |
|
|
(1) |
% |
Loss from operations |
(18,531) |
|
|
(19,269) |
|
|
738 |
|
|
(4) |
% |
|
|
|
|
|
|
|
|
Other income (expense), net |
|
|
|
|
|
|
|
Change in fair value of contingent earnout liability |
56,353 |
|
|
— |
|
|
56,353 |
|
|
100 |
% |
Interest expense |
(1,488) |
|
|
(1,215) |
|
|
(273) |
|
|
22 |
% |
Gain on PPP loan forgiveness |
— |
|
|
3,284 |
|
|
(3,284) |
|
|
(100) |
|
Other income |
534 |
|
|
2 |
|
|
532 |
|
|
* |
Total other income, net |
55,399 |
|
|
2,071 |
|
|
53,328 |
|
|
* |
Net income (loss) |
$ |
36,868 |
|
|
$ |
(17,198) |
|
|
$ |
54,066 |
|
|
(314) |
% |
* Not meaningful
Grant Revenue
For the three months ended June 30, 2022 and 2021, revenue was
approximately $1.3 million and $0.7 million, respectively, and
related to our grant from DoD. The increase in revenue of $0.6
million, or 89%, relates to the timing of reimbursement of certain
allowable costs related to our grant from DoD.
Research and Development Expenses
The following table discloses the breakdown of research and
development expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Change |
($ in thousands) |
2022 |
|
2021 |
|
$ |
|
% |
External services |
$ |
3,810 |
|
|
$ |
3,881 |
|
|
$ |
(71) |
|
|
(2) |
% |
Materials and supplies |
1,838 |
|
|
1,993 |
|
|
(155) |
|
|
(8) |
% |
Payroll and personnel expenses |
5,911 |
|
|
5,907 |
|
|
4 |
|
|
— |
% |
Other research and development expenses |
3,093 |
|
|
2,787 |
|
|
306 |
|
|
11 |
% |
|
$ |
14,652 |
|
|
$ |
14,568 |
|
|
$ |
84 |
|
|
1 |
% |
Research and development expenses increased by $0.1 million, or 1%,
from $14.6 million for the three months ended June 30, 2021 to
$14.7 million for the three months ended June 30, 2022. The
increase was primarily driven by (i) increased salaries and
benefits of $0.5 million to support our expanding research and
development initiatives, (ii) a $0.3 million increase in other
research and development expenses, partially offset by (i) a $0.5
million decrease in non-cash stock compensation expense, and (ii) a
$0.2 million decrease in the purchase of materials and
supplies.
General and Administrative Expenses
General and administrative expenses were $5.2 million and $5.4
million for the three months ended June 30, 2022 and 2021,
respectively. The decrease in general and administrative expenses
during this period of $0.2 million, or 4%, was primarily driven by
a $0.9 million decrease in non-cash stock compensation expense due
to higher costs in 2021 resulting from restructuring of the
management team to accommodate the transition to being a public
company, partially offset by (i) a $0.3 million increase in
insurance costs, and (ii) a $0.4 million increase in salaries and
benefits and recruiting costs due to higher headcount.
Total Other Income, net
Total other income was $55.4 million and $2.1 million for the three
months ended June 30, 2022 and 2021, respectively. The
increase of $53.3 million in income resulted from a $56.4 million
non-cash gain primarily related to the remeasurement of the
contingent earnout liability as of June 30, 2022, partially
offset by a non-cash $3.3 million gain on PPP loan forgiveness we
recognized during the three months ended June 30,
2021.
Comparison of the Six Months Ended June 30, 2022 and
2021
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Change |
($ in thousands) |
2022 |
|
2021 |
|
$ |
|
% |
Revenue |
$ |
1,534 |
|
|
$ |
845 |
|
|
689 |
|
|
82 |
% |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
30,966 |
|
|
29,705 |
|
|
1,261 |
|
|
4 |
% |
General and administrative |
10,862 |
|
|
10,178 |
|
|
684 |
|
|
7 |
% |
Total operating expenses |
41,828 |
|
|
39,883 |
|
|
1,945 |
|
|
5 |
% |
Loss from operations |
(40,294) |
|
|
(39,038) |
|
|
(1,256) |
|
|
3 |
% |
Other income (expense), net: |
|
|
|
|
|
|
|
Change in fair value of contingent earnout liability |
59,611 |
|
|
— |
|
|
59,611 |
|
|
100 |
% |
Interest expense |
(2,920) |
|
|
(1,748) |
|
|
(1,172) |
|
|
67 |
% |
Gain on PPP loan forgiveness |
— |
|
|
3,284 |
|
|
(3,284) |
|
|
(100) |
% |
Other income, net |
639 |
|
|
3 |
|
|
636 |
|
|
* |
Total other income, net |
57,330 |
|
|
1,539 |
|
|
55,791 |
|
|
* |
Net income (loss) |
$ |
17,036 |
|
|
$ |
(37,499) |
|
|
$ |
54,535 |
|
|
(145) |
% |
* Not meaningful
Grant Revenue
For the six months ended June 30, 2022 and 2021, revenue was
approximately $1.5 million and $0.8 million, respectively, and
related to our grant from DoD. The increase in revenue of $0.7
million, or 82%, relates to the timing of reimbursement of certain
allowable costs related to our grant from DoD.
Research and Development Expenses
The following table discloses the breakdown of research and
development expenses for the periods indicated:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
Change |
($ in thousands) |
2022 |
|
2021 |
|
$ |
|
% |
External services |
$ |
7,660 |
|
|
$ |
7,733 |
|
|
$ |
(73) |
|
|
(1) |
% |
Materials and supplies |
5,575 |
|
|
5,194 |
|
|
381 |
|
|
7 |
% |
Payroll and personnel expenses |
11,552 |
|
|
11,228 |
|
|
324 |
|
|
3 |
% |
Other research and development expenses |
6,179 |
|
|
5,550 |
|
|
629 |
|
|
11 |
% |
|
$ |
30,966 |
|
|
$ |
29,705 |
|
|
$ |
1,261 |
|
|
4 |
% |
Research and development expenses increased from $29.7 million for
the six months ended June 30, 2021 to $31.0 million for the
six months ended June 30, 2022. The increase of $1.3 million,
or 4%, was primarily driven by (i) increased salaries and benefits
of $1.2 million to support our expanding research and development
initiatives, (ii) a $0.4 million increase in the purchase of
materials and supplies, and (iii) a $0.6 million increase in other
research and development expenses, partially offset by a $0.9
million decrease in non-cash stock compensation
expense.
General and Administrative Expenses
General and administrative expenses were $10.9 million and $10.2
million for the six months ended June 30, 2022 and 2021,
respectively. The increase in general and administrative expenses
during this period of $0.7 million, or 7%, was primarily driven by
expenses associated with the transition to public company status,
including (i) a $0.9 million increase in salaries and benefits and
recruiting costs primarily due to higher headcount, (ii) increased
professional fees of $0.6 million primarily related to increased
legal and audit fees, and (iii) a $0.5 million increase in
insurance costs, partially offset by a $1.5 million decrease in
non-cash stock compensation expense due to higher costs in 2021
resulting from restructuring of the management team to accommodate
the transition to being a public company.
Total Other Income, net
Total other income was $57.3 million and $1.5 million for the six
months ended June 30, 2022 and 2021, respectively. The
increase of $55.8 million in income resulted from (i) a $59.6
million non-cash gain related to the remeasurement of the
contingent earnout liability as of June 30, 2022, (ii) a $0.3
million increase in interest income, and a $0.3 million non-cash
gain related to the remeasurement of our private placement warrant
liability, partially offset by (i) a $3.3 million gain on PPP loan
forgiveness we recognized during the six months ended June 30, 2021
and (ii) a $1.2 million increase in interest expense related to our
loan facility with Silicon Valley Bank, which commenced in March
2021.
Liquidity and Capital Resources
Sources of Liquidity
To date, we have financed our operations primarily through the sale
of equity securities and convertible debt, proceeds from the Merger
and related PIPE Financing, borrowings under loan facilities and,
to a lesser extent, through grants from governmental and other
agencies. Since our inception, we have incurred significant
operating losses and negative cash flows. As of June 30, 2022
and December 31, 2021, we had an accumulated deficit of $397.5
million and $414.6 million, respectively.
As of June 30, 2022 and December 31, 2021, we had cash and
cash equivalents and short-term investments of $189.0 million and
$225.5 million, respectively. We believe our cash and cash
equivalents and short-term investments will be sufficient to fund
operations, including clinical trial expenses and capital
expenditure requirements for at least 12 months from the date of
this Quarterly Report. See Note 1 — Organization and Description of
Business to our accompanying unaudited condensed consolidated
financial statements included elsewhere in this Quarterly Report
for additional information regarding our assessment. We believe
that our longer-term working capital, planned research and
development, capital expenditures and other general corporate
funding requirements will be satisfied through the sale of equity,
debt, borrowings under credit facilities or through potential
collaborations with other companies, other strategic transactions
or government or other grants. Our liquidity plans are subject to a
number of risks and uncertainties, including those described in the
sections entitled “Forward-Looking Statements” and “Risk Factors”
in this Quarterly Report and our Annual Report.
As of June 30, 2022 and December 31, 2021, we had working
capital of
$182.0 million
and
$218.3 million,
respectively. As of June 30, 2022, we had
$30.0 million
outstanding principal and
$20.0 million
of contingent borrowing capacity under our Loan Agreement. We do
not currently have any committed external source of funds beyond
the Loan Agreement.
Material Cash Requirements
Our known material cash requirements include: (1) the purchase of
supplies and services that are primarily for research and
development; (2) debt repayments (for additional information, see
below and Note 7 — Debt to our accompanying unaudited condensed
consolidated financial statements contained elsewhere in this
Quarterly Report); (3) employee wages, benefits, and incentives;
and (4) financing and operating lease payments (for additional
information see below). We have also entered into contracts with
CROs primarily for clinical trials. These contracts generally
provide for termination upon limited notice, and therefore we
believe that our non-cancellable obligations under these agreements
are not material. Moreover, we may be subject to additional
material cash requirements that are contingent upon the occurrence
of certain events, for example, legal contingencies, uncertain tax
positions, and other matters.
As of June 30, 2022, we had non-cancellable purchase
commitments
of $16.1 million for supplies and services that are primarily
for research and development. We have existing license agreements
with Duke University and Yale University and have a distribution
agreement with Fresenius Medical Care Holdings, Inc. The amount and
timing of any potential milestone payments, license fee payments,
royalties and other payments that we may be required to make under
these agreements are unknown or uncertain at June 30, 2022.
For additional information regarding our agreement with Fresenius
Medical Care, and our agreements with Duke University and Yale
University, see Note 12 — Related Party Transactions and Note 11 —
Commitments and Contingencies, respectively, to our accompanying
unaudited condensed consolidated financial statements contained
elsewhere in this Quarterly Report.
Debt
In March 2021, we entered into the Loan Agreement with Silicon
Valley Bank and SVB Innovation Credit Fund VIII, L.P., as amended
in June and September 2021, which provides a term loan facility of
up to $50.0 million, with a maturity date of March 1, 2025. The
initial term loan tranche of $20.0 million was funded upon the
closing of the Loan Agreement, and on October 13, 2021, we borrowed
an additional $10.0 million under the Loan Agreement. The
additional $20.0 million becomes accessible in two tranches of
$10.0 million each contingent on the achievement of certain
business and clinical development milestones. As a result of the
additional borrowing in October 2021, the commencement of repayment
of principal was deferred until no earlier than July 2023 and
potentially later if the remaining tranches are drawn. As of
June 30, 2022, principal of $30.0 million was outstanding
under the Loan Agreement and we were in compliance with all
covenants in all material respects. Assuming no additional
borrowings under the Loan Agreement, we expect to make interest
payments of approximately $5.2 million under the Loan
Agreement from July 1, 2022 through March 1, 2025, approximately
$2.7 million of which we expect to pay within one year of
June 30, 2022.
Our obligations under the Loan Agreement are secured by
substantially all of our assets, except for our intellectual
property. The Loan Agreement contains certain customary covenants,
including, but not limited to, those relating to additional
indebtedness, liens, asset divestitures, and affiliate
transactions. We may use the proceeds of borrowings under the Loan
Agreement as working capital and to fund our general business
requirements.
Borrowings under the Loan Agreement bear interest at a rate of 7.5%
or the sum of the Wall Street Journal Prime Rate plus 4.25%,
whichever is greater. In addition, the lenders were granted
warrants to purchase common stock. Interest-only payments on the
principal amount outstanding are due monthly beginning in the first
month after the loan is dispersed. We are required to repay
principal beginning on July 1, 2023, unless we draw the remaining
two loan tranches, in which case repayment of the outstanding
principal amount will begin no later than April 1, 2024.
Additionally, we are obligated to pay to the lenders a final
payment fee of $1.5 million upon the maturity of the
loan.
Our contractual obligations under the Loan Agreement as of
June 30, 2022 include no cash payments related to principal
within one year and $30.0 million of principal payments within
one to three years.
In April 2020, we received loan proceeds in the amount of
approximately $3.3 million under the PPP. The loan and accrued
interest were forgivable after a 24-week period as long as we used
the loan proceeds for eligible purposes, including payroll,
benefits, rent and utilities, and maintained its payroll levels. On
May 25, 2021, the Small Business Administration approved the
forgiveness of the outstanding amount of the PPP loan and we
recognized a gain from loan extinguishment in the amount of $3.3
million during the three months ended June 30, 2021.
Leases
Our finance lease relates to our headquarters facility containing
our manufacturing, research and development and general and
administrative functions, which was substantially completed in June
2018 and leased through May 2033, and our operating lease relates
to the land lease associated with our headquarters. Our future
contractual obligations under our lease agreements as of
June 30, 2022 are as follows:
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|
($ in thousands) |
Total |
|
Less than
1 year |
|
1 – 3 years
|
|
3 – 5 years
|
|
More than
5 years |
Finance leases
|
$ |
31,080 |
|
|
$ |
3,916 |
|
|
$ |
8,130 |
|
|
$ |
7,938 |
|
|
$ |
11,096 |
|
Operating leases
|
1,047 |
|
|
105 |
|
|
211 |
|
|
211 |
|
|
520 |
|
Future Funding Requirements
We expect to incur significant expenses in connection with our
ongoing activities as we seek to (i) continue clinical development
of our 6 millimeter HAV for use in vascular trauma and hemodialysis
AV access and submit biologics license applications for FDA
approval, (ii) if marketing approval is obtained, to launch and
commercialize our HAVs for hemodialysis AV access and vascular
repair in the U.S. market, including subsequent launches in key
international markets, (iii) advance our pipeline in major markets,
including PAD Phase III trials and continue preclinical development
and advance to planned clinical studies in CABG and biovascular
pancreas for diabetes, and (iv) scale out our manufacturing
facility as required to satisfy potential demand if our HAVs
receive marketing approval. We will need additional funding in
connection with these activities.
Our future funding requirements, both short-term and long-term,
will depend on many factors, including:
•the
progress and results of our clinical trials and interpretation of
those results by the FDA and other regulatory
authorities;
•the
cost, timing and outcome of regulatory review of our product
candidates, particularly for marketing approval of our HAVs in the
United States;
•the
scope, progress, results and costs of preclinical development,
laboratory testing and clinical trials for our additional product
candidates;
•the
cost and timing of our future commercialization activities,
including product manufacturing, marketing and distribution for our
HAVs if approved by the FDA, and any other product candidate for
which we receive marketing approval in the future;
•the
amount and timing of revenues, if any, that we receive from
commercial sales of any product candidates for which we receive
marketing approval;
•the
costs and timing of preparing, filing and prosecuting patent
applications, maintaining and enforcing our intellectual property
rights and defending any intellectual property-related claims;
and
•the
costs of operating as a public company, including hiring additional
personnel as well as increased director and officer insurance
premiums, audit and legal fees, and expenses for compliance with
public company reporting requirements under the Exchange Act and
rules implemented by the SEC and Nasdaq.
Until such time, if ever, as we are able to successfully develop
and commercialize one or more of our product candidates, we expect
to continue financing our operations through the sale of equity,
debt, borrowings under credit facilities or through potential
collaborations with other companies, other strategic transactions
or government or other grants. Adequate capital may not be
available to us when needed or on acceptable terms. We do not
currently have any committed external source of funds beyond the
Loan Agreement. To the extent that we raise additional capital
through the sale of equity or convertible debt securities, the
ownership interest of our stockholders will be diluted, and the
terms of these securities may include liquidation or other
preferences that adversely affect the rights of stockholders. Debt
financing and preferred equity financing, if available, may involve
agreements that include covenants limiting or restricting our
ability to take specific actions, such as incurring additional
debt, making acquisitions or capital expenditures. Debt financing
would also result in fixed payment obligations. If we are unable to
raise capital, we could be forced to delay, reduce, suspend or
cease our research and development programs or any future
commercialization efforts, which would have a negative impact on
our business, prospects, operating results and financial
condition.
Our principal use of cash in recent periods has been primarily to
fund our operations, including the clinical and preclinical
development of our product candidates. Our future capital
requirements, both short-term and long-term, will depend on many
factors, including the progress and results of our clinical trials
and preclinical development, timing and extent of spending to
support development efforts, cost and timing of future
commercialization activities, and the amount and timing of
revenues, if any, that we receive from commercial
sales.
See the section of this Quarterly Report entitled “Risk Factors”
for additional risks associated with our substantial capital
requirements.
Cash Flows
The following table shows a summary of our cash flows for each of
the periods shown below:
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|
Six Months Ended June 30, |
|
|
($ in thousands) |
2022 |
|
2021 |
|
|
Net income (loss) |
$ |
17,036 |
|
|
$ |
(37,499) |
|
|
|
Non-cash adjustments to reconcile net loss to net cash used in
operating activities(1):
|
(52,026) |
|
|
6,655 |
|
|
|
|
|
|
|
|
|
Changes in operating assets and liabilities: |
(376) |
|
|
1,621 |
|
|
|
Net cash used in operating activities |
(35,366) |
|
|
(29,223) |
|
|
|
Net cash used in investing activities |
(156) |
|
|
(92) |
|
|
|
Net cash (used in) provided by financing activities |
(945) |
|
|
18,355 |
|
|
|
Net decrease in cash and cash equivalents |
$ |
(36,467) |
|
|
$ |
(10,960) |
|
|
|
Cash and cash equivalents at the beginning of the
period |
$ |
217,502 |
|
|
$ |
39,929 |
|
|
|
Cash and cash equivalents at the end of the period |
$ |
181,035 |
|
|
$ |
28,969 |
|
|
|
___________________________
(1)
Includes depreciation, amortization related to our leases and our
debt discount, stock-based compensation expense, in 2022 includes
the change in fair value of our contingent earnout liability and
our common stock warrant liabilities, and in 2021 includes a gain
on PPP loan forgiveness.
Cash Flow from Operating Activities
The
increase in net cash used in operating activities from the six
months ended June 30, 2021 to the six months ended
June 30, 2022 was primarily due to
increased spending on pre-clinical, clinical and pre-commercial
activities as well as payroll and personnel expenses.
Cash Flow from Investing Activities
Net cash used in investing activities for each of
the six months ended June 30, 2022 and 2021 consisted of the
purchases of laboratory equipment.
Cash Flow from Financing Activities
The
decrease in net cash provided by financing activities for the six
months ended June 30, 2022 was primarily due to $19.7 million
of net proceeds in connection with
draws under our loan facility with Silicon Valley Bank in March
2021.
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not
currently have, any off-balance sheet arrangements, as defined in
SEC rules and regulations.
Critical Accounting Estimates
Our discussion and analysis of our financial condition and results
of operations are based upon our unaudited condensed consolidated
financial statements, which have been prepared in accordance with
U.S. generally accepted accounting principles. The preparation of
our unaudited condensed consolidated financial statements requires
us to make estimates, assumptions and judgments that affect the
reported amounts of assets, liabilities, revenues, and expenses,
and disclosure of contingent liabilities. We base our estimates and
assumptions on historical experience and other factors that we
believe to be reasonable under the circumstances. We evaluate our
estimates and assumptions on an ongoing basis. Although we believe
that our estimates, assumptions, and judgments are reasonable, they
are based upon information presently available. Actual results may
differ significantly from these estimates based on different
assumptions, judgments, or conditions.
An accounting estimate or assumption is considered critical if both
(a) the nature of the estimate or assumption involves a significant
level of estimation uncertainty, and (b) the impact within a
reasonable range of outcomes of the estimate and assumption is
material to our financial condition. There have been no material
changes to our critical accounting policies and estimates as
compared to those disclosed in our audited consolidated financial
statements as of and for the years ended December 31, 2021 and
2020, included in our Annual Report.
Emerging Growth Company and Smaller Reporting Company
Status
We are an “emerging growth company” as defined in the Jumpstart our
Business Startups Act of 2012 (the “JOBS Act”), and may take
advantage of certain exemptions from various reporting requirements
that are applicable to other public companies that are not emerging
growth companies until it is no longer an emerging growth company.
Section 107 of the JOBS Act provides that an emerging growth
company can take advantage of the extended transition period
afforded by the JOBS Act for the implementation of new or revised
accounting standards. We expect to use the extended transition
period and, therefore, while we are an emerging growth company we
will not be subject to new or revised accounting standards at the
same time that they become applicable to other public companies
that are not emerging growth companies, unless we choose to early
adopt a new or revised accounting standard. This may make it
difficult or impossible to compare our financial results with the
financial results of another public company because of the
potential differences in accounting standards used.
Additionally, we are a “smaller reporting company” as defined in
Item 10(f)(1) of Regulation S-K under the Exchange Act (“Regulation
S-K”). Smaller reporting companies may take advantage of certain
reduced disclosure obligations, including, among other things,
providing only two years of audited financial statements. We will
remain a smaller reporting company if (1) the market value of
Common Stock held by non-affiliates is less than $250 million as of
the last business day of the second fiscal quarter, or (2) our
annual revenues in its most recent fiscal year completed before the
last business day of its second fiscal quarter are less than $100
million and the market value of Common Stock held by non-affiliates
is less than $700 million as of the last business day of the second
fiscal quarter.
Item 3. Quantitative and Qualitative Disclosures About Market
Risk
We qualify as a smaller reporting company, as defined by Item 10 of
Regulation S-K and, thus, are not required to provide the
information required by this Item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are designed to ensure that
information required to be disclosed in our reports filed or
submitted under the Exchange Act is (i) recorded, processed,
summarized, and reported within the time periods specified in the
SEC’s rules and forms and (ii) accumulated and communicated to our
management, including our Chief Executive Officer and Chief
Financial Officer, to allow timely decisions regarding required
disclosure.
As of June 30, 2022, our management, under the supervision and
with the participation of our Chief Executive Officer and Chief
Financial Officer, evaluated the effectiveness of our disclosure
controls and procedures (as defined in Rules 13a-15(e) and
15d-15(e) under the Exchange Act). Based on that evaluation, our
Chief Executive Officer and Chief Financial Officer concluded that
our disclosure controls and procedures were effective as of
June 30, 2022.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal control over financial
reporting (as defined in Rule 13a-15(f) and 15d-15(f) under the
Exchange Act) during the three months ended June 30, 2022 that
have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
The Company currently is not aware of any legal proceedings or
claims that management believes will have, individually or in the
aggregate, a material adverse effect on the Company’s business,
financial condition, results of operations, or cash
flows.
Item 1A. Risk Factors
Our risk factors are disclosed in Part I, Item 1A of our Annual
Report. There have been no material changes during the six months
ended June 30, 2022 from or updates to the risk factors
discussed in Part I, Item 1A,
Risk Factors
of our Annual Report.
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
None.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
None.
Item 5. Other Information
None.
Item 6. Exhibits
The following exhibits are filed as part of, or incorporated by
reference into, this Quarterly Report on Form 10-Q.
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Exhibit
Number
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Description |
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31.1* |
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31.2* |
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|
32.1** |
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32.2** |
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|
101* |
|
The following materials from Humacyte, Inc.’s Quarterly Report on
Form 10-Q for the quarter ended June 30, 2022, formatted in
Inline XBRL (Inline eXtensible Business Reporting Language): (i)
Condensed Consolidated Balance Sheets (unaudited), (ii) Condensed
Consolidated Statements of Operations and Comprehensive Income
(Loss) (unaudited), (iii) Condensed Consolidated Statements of
Changes in Redeemable Convertible Preferred Stock and Stockholders’
Equity (Deficit) (unaudited), (iv) Condensed Consolidated
Statements of Cash Flows (unaudited), (v) Notes to Condensed
Consolidated Financial Statements (unaudited), and (vi) Cover
Page.
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|
104 |
|
Cover Page Interactive Data File (formatted as Inline XBRL and
contained in Exhibit 101). |
* Filed herewith.
** This exhibit is being furnished rather than filed, and shall not
be deemed incorporated by reference into any filing, in accordance
with Item 601 of Regulation S-K.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of
1934, the registrant has duly caused this report to be signed on
its behalf by the undersigned hereunto duly authorized on this 12th
day of August, 2022.
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HUMACYTE, INC. |
Date: August 12, 2022
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By: |
/s/ Laura E. Niklason, M.D., Ph.D. |
|
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Name: |
Laura E. Niklason, M.D., Ph.D. |
|
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Title: |
President and Chief Executive Officer |
|
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|
|
By: |
/s/ Dale A. Sander |
|
|
Name: |
Dale A. Sander |
|
|
Title: |
Chief Financial Officer, Chief Corporate Development Officer and
Treasurer |
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