SEC Filing | Aldeyra Therapeutics, Inc.

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10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2022

☐ 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: 001-36332

ALDEYRA THERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)


Delaware		20-1968197
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

131 Hartwell Avenue, Suite 320
Lexington, MA		02421
(Address of principal executive offices)		(Zip Code)

(781) 761-4904

(Registrant’s telephone number, including area code)

Securities registered pursuant to 12(b) of the Act:


Title of each class	Trading Symbol(s)	Name of exchange on which registered
Common Stock, $0.001 par value per share	ALDX	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 ☒ No ☐

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 ☒ No ☐

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 the “large accelerated filer,” “accelerated filer,” “non-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. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November 8, 2022 , there were 58,560,078 shares of the registrant’s common stock issued and outstanding.

Aldeyra Therapeutics, Inc.

Quarterly Report on Form 10-Q

For the Quarter Ended September 30, 2022

INDEX


		Page
PART I – FINANCIAL INFORMATION
ITEM 1.	Condensed Consolidated Financial Statements:	3
	Consolidated Balance Sheets at September 30, 2022 (Unaudited) and December 31, 2021	3
	Consolidated Statements of Operations for the three and nine months ended September 30, 2022 and 2021 (Unaudited)	4
	Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2022 and 2021 (Unaudited)	5
	Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2022 and 2021 (Unaudited)	6
	Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021 (Unaudited)	8
	Notes to Condensed Consolidated Financial Statements	9
ITEM 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
ITEM 3.	Quantitative and Qualitative Disclosures about Market Risk	25
ITEM 4.	Controls and Procedures	25
PART II – OTHER INFORMATION
ITEM 1.	Legal Proceedings	27
ITEM 1A.	Risk Factors	27
ITEM 2.	Unregistered Sales of Equity Securities and Use of Proceeds	69
ITEM 3.	Defaults Upon Senior Securities	69
ITEM 4.	Mine Safety Disclosures	69
ITEM 5.	Other Information	69
ITEM 6.	Exhibits	70
Signatures		71

Part I – FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS


	September 30,
	2022			December 31,
	(unaudited)			2021
ASSETS
Current assets:
Cash and cash equivalents	$	107,150,541		$	104,790,989
Cash equivalent - reverse repurchase agreements		21,500,000			125,000,000
Marketable securities		56,678,860			—
Prepaid expenses and other current assets		4,153,721			2,961,781
Total current assets		189,483,122			232,752,770
Right-of-use assets		181,943			351,863
Fixed assets, net		26,660			32,487
Total assets	$	189,691,725		$	233,137,120

LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable	$	1,306,926		$	1,019,702
Accrued expenses		10,254,451			10,523,353
Current portion of long-term debt		12,449,058			—
Current portion of operating lease liabilities		184,599			229,607
Total current liabilities		24,195,034			11,772,662
Operating lease liabilities, long-term		—			125,232
Long-term debt, net of current portion		3,303,042			15,503,703
Total liabilities		27,498,076			27,401,597
Commitments and contingencies (Notes 13, 14, and 15)
Stockholders' equity:
Preferred stock, $0.001 par value, 15,000,000 shares authorized, none issued and outstanding		—			—
Common stock, $0.001 par value; 150,000,000 authorized and 58,560,078 and 58,081,215 shares issued and outstanding, respectively		58,560			58,081
Additional paid-in capital		506,235,298			500,369,444
Accumulated other comprehensive loss		(285,733	)		—
Accumulated deficit		(343,814,476	)		(294,692,002	)
Total stockholders’ equity		162,193,649			205,735,523
Total liabilities and stockholders’ equity	$	189,691,725		$	233,137,120

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

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Operating expenses:
Research and development	$	11,539,620		$	12,894,344		$	38,344,594		$	32,095,132
General and administrative		3,244,936			2,546,807			10,638,602			8,720,161
Loss from operations		(14,784,556	)		(15,441,151	)		(48,983,196	)		(40,815,293	)

Other income (expense):
Interest income		648,242			59,306			1,094,001			122,732
Interest expense		(416,917	)		(413,110	)		(1,233,279	)		(1,329,166	)
Total other income (expense), net		231,325			(353,804	)		(139,278	)		(1,206,434	)
Net loss	$	(14,553,231	)	$	(15,794,955	)	$	(49,122,474	)	$	(42,021,727	)
Net loss per share - basic and diluted	$	(0.25	)	$	(0.27	)	$	(0.84	)	$	(0.80	)
Weighted average common shares outstanding - basic and diluted		58,457,863			58,019,099			58,352,991			52,688,846

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

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)


	Three Months Ended September 30,						Nine Months Ended September 30,
	2022			2021			2022			2021
Net loss	$	(14,553,231	)	$	(15,794,955	)	$	(49,122,474	)	$	(42,021,727	)
Other comprehensive loss:
Unrealized gain (loss) on marketable securities, net of tax		30			—			(285,733	)		—
Total other comprehensive gain (loss)	$	30		$	—		$	(285,733	)	$	—
Comprehensive loss	$	(14,553,201	)	$	(15,794,955	)	$	(49,408,207	)	$	(42,021,727	)

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

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)


	Stockholders' Equity
	Common Stock							Accumulated
	Shares		Amount		Additional Paid-in Capital			Other Comprehensive Income/(Loss), net of tax			Accumulated Deficit			Total Stockholders' Equity
Balance, December 31, 2021		58,081,215	$	58,081	$	500,369,444		$	—		$	(294,692,002	)	$	205,735,523
Stock-based compensation		—		—		4,646,241			—			—			4,646,241
Release of restrictions on Helio founders’ shares		10,890		11		(11	)		—			—			—
Issuance of common stock, exercise of stock options		236,962		237		1,123,190			—			—			1,123,427
Issuance of common stock, employee stock purchase plan		28,485		29		96,636			—			—			96,665
Issuance of common stock, vested restricted stock units		202,526		202		(202	)		—			—			—
Other comprehensive loss									(285,733	)					(285,733	)
Net loss												(49,122,474	)		(49,122,474	)
Balance, September 30, 2022		58,560,078	$	58,560	$	506,235,298		$	(285,733	)	$	(343,814,476	)	$	162,193,649

Balance, December 31, 2020		38,667,491	$	38,667	$	296,385,619		$	—		$	(236,915,728	)	$	59,508,558
Stock-based compensation		—		—		5,186,689			—			—			5,186,689
Release of restrictions on Helio founders’ shares		106,182		106		(106	)		—			—			—
Issuance of common stock in connection with Helio Vision, Inc. acquisition milestone		246,562		247		2,499,744			—			—			2,499,991
Issuance of common stock, net of issuance costs		18,091,947		18,092		189,793,519			—			—			189,811,611
Issuance of common stock, exercise of stock options		634,214		634		4,622,617			—			—			4,623,251
Issuance of common stock, employee stock purchase plan		12,092		12		61,517			—			—			61,529
Issuance of common stock, vested restricted stock units		286,944		287		(287	)		—			—			—
Other comprehensive loss		—		—		—			—			—			—
Net loss		—		—		—			—			(42,021,727	)		(42,021,727	)
Balance, September 30, 2021		58,045,432	$	58,045	$	498,549,312		$	—		$	(278,937,455	)	$	219,669,902

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)


	Stockholders' Equity
	Common Voting Stock							Accumulated Other
	Shares		Amount		Additional Paid-in Capital			Comprehensive Income/(Loss), net of tax			Accumulated Deficit			Total Stockholders' Equity
Balance, June 30, 2022		58,301,491	$	58,301	$	503,517,715		$	(285,763	)	$	(329,261,245	)	$	174,029,008
Stock-based compensation		—		—		1,521,074			—			—			1,521,074
Issuance of common stock, exercise of stock options		236,962		237		1,123,190			—			—			1,123,427
Issuance of common stock, employee stock purchase plan		21,625		22		73,319			—			—			73,341
Other comprehensive income		—		—		—			30			—			30
Net loss		—		—		—			—			(14,553,231	)		(14,553,231	)
Balance, September 30, 2022		58,560,078	$	58,560	$	506,235,298		$	(285,733	)	$	(343,814,476	)	$	162,193,649

Balance, June 30, 2021		57,997,345	$	57,997	$	496,764,448		$	—		$	(263,142,500	)	$	233,679,945
Stock-based compensation		—		—		1,721,134			—			—			1,721,134
Release of restrictions on Helio founders’ shares		35,784		36		(36	)		—			—			—
Issuance of common stock, net of issuance costs		2,997		3		12,121			—			—			12,124
Issuance of common stock, exercise of stock options		9,306		9		51,645			—			—			51,654
Other comprehensive income		—		—		—			—			—			—
Net loss		—		—		—			—			(15,794,955	)		(15,794,955	)
Balance, September 30, 2021		58,045,432	$	58,045	$	498,549,312		$	—		$	(278,937,455	)	$	219,669,902

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)


	Nine Months Ended September 30,
	2022			2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(49,122,474	)	$	(42,021,727	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation		5,467,684			6,123,554
Non-cash interest expense		248,397			326,672
Net amortization of premium on debt securities available for sale		(26,380	)		—
Depreciation and amortization expense		192,064			202,909
Change in operating assets and liabilities:
Prepaid expenses and other current assets		(1,191,940	)