huma-20240630

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, 2024

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)

___________________________________________________________________________________________________


Delaware		85-1763759
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

2525 East North Carolina Highway 54
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:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.0001 per share

HUMA

The Nasdaq Stock Market LLC

Redeemable Warrants, each whole warrant exercisable for one share of Common Stock at an exercise price of $11.50

HUMAW

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.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

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, 2024, 119,351,122 shares of common stock, par value $0.0001, were issued and outstanding.

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Humacyte, Inc.

Quarterly Report on Form 10-Q

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		Page No.
	PART I – FINANCIAL INFORMATION

Item 1.	Financial Statements	5

	Condensed Consolidated Balance Sheets (unaudited)	5

	Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited)	6

	Condensed Consolidated Statements of Changes in Stockholders’ Equity (unaudited)	7

	Condensed Consolidated Statements of Cash Flows (unaudited)	8

	Notes to Condensed Consolidated Financial Statements (unaudited)	9

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	32

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	44

Item 4.	Controls and Procedures	44

	PART II – OTHER INFORMATION

Item 1.	Legal Proceedings	45

Item 1A.	Risk Factors	45

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	45

Item 3.	Defaults Upon Senior Securities	45

Item 4.	Mine Safety Disclosures	45

Item 5.	Other Information	46

Item 6.	Exhibits	47

SIGNATURES		48

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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:

•the outcome of the United States (“U.S.”) Food and Drug Administration (“FDA”) review of our Biologics License Application (“BLA”) seeking approval of our bioengineered human acellular vessels (Acellular Tissue Engineered Vessel or “ATEVTM”, formerly referred to as the “Human Acellular Vessel” or “HAV”) in urgent arterial repair following extremity vascular trauma when synthetic graft is not indicated and autologous vein graft is not feasible;

•our plans and ability to execute product development, process development and preclinical development efforts successfully and on our anticipated timelines;

•our plans, anticipated timeline and ability to file applications for, and obtain marketing approvals from, the U.S. FDA and other regulatory authorities, including the European Medicines Agency, for our ATEV 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 V007 and V012 Phase 3 clinical trials;

•the outcome of our ongoing discussions with the FDA concerning the design of our clinical trials;

•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 ATEVs;

•our plans and ability to commercialize our ATEVs and other product candidates, if approved by regulatory authorities;

•the degree of market acceptance of ATEVs, if approved by regulatory authorities, and the availability of third-party coverage and reimbursement;

•our ability to manufacture ATEVs and other product candidates in sufficient quantities to satisfy our clinical trial and commercial needs, if approved by regulatory authorities;

•our expectations regarding our strategic partnership with Fresenius Medical Care Holdings, Inc. (“Fresenius Medical Care”) to sell, market and distribute our 6 millimeter ATEV for certain specified indications and in specified markets, if approved by regulatory authorities;

•the expected size of the target populations for our product candidates;

•the anticipated benefits of our ATEVs relative to existing alternatives;

•our assessment of the competitive landscape;

•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;

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•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 estimates regarding how long our existing cash and cash equivalents will be sufficient to fund our anticipated operating expenses, capital expenditures and debt service obligations;

•our ability to implement and maintain effective internal controls; and

•the impact of the overall global economy and increasing interest rates and inflation on our business.

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 statements are based on information current as of the date of this Quarterly Report and speak only as of the date on which such statements are 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, 2023, which we filed with the SEC on March 28, 2024. 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.

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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, 2024		December 31, 2023
ASSETS
Current assets
Cash and cash equivalents	$	93,563	$	80,448
Prepaid expenses and other current assets	2,547		2,830


Total current assets	96,110		83,278

Property and equipment, net	24,820		26,791
Finance lease right-of-use assets, net	16,536		17,313
Other long-term assets	815		841
Total assets	$	138,281	$	128,223

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	6,005	$	6,490
Accrued expenses	8,950		9,340
Finance lease obligation, current portion	2,746		2,560
Operating lease obligation, current portion	56		53

Total current liabilities	17,757		18,443

Contingent Earnout Liability	68,080		37,916
Revenue interest liability	60,078		38,600
Finance lease obligation, net of current portion	15,123		16,293
Contingent derivative liability	4,266		2,636
Other long-term liabilities	1,264		789



Total liabilities	166,568		114,677

Commitments and contingencies (Note 11)

Stockholders’ equity
Preferred stock, $0.0001 par value; 20,000,000 shares designated as of June 30, 2024 and December 31, 2023; 0 shares issued and outstanding as of June 30, 2024 and December 31, 2023	—		—
Common stock, $0.0001 par value; 250,000,000 shares authorized as of June 30, 2024 and December 31, 2023; 119,347,688 and 103,673,728 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively	12		10
Additional paid-in capital	597,574		550,850
Accumulated deficit	(625,873)		(537,314)
Total stockholders’ equity	(28,287)		13,546
Total liabilities and stockholders’ equity	$	138,281	$	128,223

The accompanying notes are an integral part of these financial statements.

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Humacyte, Inc.

Condensed Consolidated Statements of Operations and Comprehensive 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,
	2024		2023		2024		2023

Revenue	$	—	$	—	$	—	$	—

Operating expenses:
Research and development	23,753		20,540		45,017		37,818
General and administrative	5,746		6,191		11,060		11,425
Total operating expenses	29,499		26,731		56,077		49,243
Loss from operations	(29,499)		(26,731)		(56,077)		(49,243)

Other income (expense), net:
Interest income	1,310		1,479		2,341		2,954
Change in fair value of Contingent Earnout Liability	(25,571)		3,627		(30,164)		(10,564)
Interest expense	(2,515)		(1,710)		(4,331)		(3,409)
Change in fair value of derivative liabilities	(388)		(57)		(328)		(99)
Employee retention credit	—		3,107		—		3,107
Loss on extinguishment of debt	—		(2,421)		—		(2,421)
Total other income (expense), net	(27,164)		4,025		(32,482)		(10,432)
Net loss and comprehensive loss	$	(56,663)	$	(22,706)	$	(88,559)	$	(59,675)

Net loss per share attributable to common stockholders, basic and diluted	$	(0.48)	$	(0.22)	$	(0.78)	$	(0.58)
Weighted-average shares outstanding used in computing net loss per share attributable to common stockholders, basic and diluted	119,174,681		103,361,501		113,710,344		103,312,785

The accompanying notes are an integral part of these financial statements.

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Humacyte, Inc.

Condensed Consolidated Statements of Changes in Stockholders’ Equity

(unaudited)

(in thousands except for share amounts)


	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Total Stockholders’ Equity
	Shares	Amount
Balance as of December 31, 2023	103,673,728	$	10	$	550,850	$	(537,314)	$	13,546
Issuance of stock in public offering, net of issuance costs	15,410,000	2		43,044		—		43,046
Proceeds from the exercise of stock options	625	—		2		—		2
Stock-based compensation	—	—		1,454		—		1,454
Net loss	—	—		—		(31,896)		(31,896)
Balance as of March 31, 2024	119,084,353	$	12	$	595,350	$	(569,210)	$	26,152
Proceeds from the exercise of stock options	263,335	—		787		—		787
Stock-based compensation	—	—		1,437		—		1,437
Net loss	—	—		—		(56,663)		(56,663)
Balance as of June 30, 2024	119,347,688	$	12	$	597,574	$	(625,873)	$	(28,287)


	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Total Stockholders’ Equity
	Shares	Amount
Balance as of December 31, 2022	103,229,013	$	10	$	543,456	$	(426,538)	$	116,928
Proceeds from the exercise of stock options	100,158	—		119		—		119
Stock-based compensation	—	—		1,809		—		1,809
Net loss	—	—		—		(36,969)		(36,969)
Balance as of March 31, 2023	103,329,171	$	10	$	545,384	$	(463,507)	$	81,887
Proceeds from the exercise of stock options

SEC Form 10-Q filed by Humacyte Inc.