10-Q
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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

or

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

 

2


 

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.

3


 

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.

4


 

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.

5


 

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

 

 

 

 

6


 

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

 

 

7


 

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

)

 

 

(202,304