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 June 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 August 2, 2022 , there were 58,323,116 shares of the registrant’s common stock issued and outstanding.

 

 

 

 


 

Aldeyra Therapeutics, Inc.

Quarterly Report on Form 10-Q

For the Quarter Ended June 30, 2022

INDEX

 

 

Page

PART I – FINANCIAL INFORMATION

ITEM 1.

Condensed Consolidated Financial Statements:

3

 

Consolidated Balance Sheets at June 30, 2022 (Unaudited) and December 31, 2021

3

 

Consolidated Statements of Operations for the three and six months ended June 30, 2022 and 2021 (Unaudited)

4

 

Consolidated Statements of Comprehensive Loss for the three and six months ended June 30, 2022 and 2021 (Unaudited)

5

 

Consolidated Statements of Stockholders’ Equity for the three and six months ended June 30, 2022 and 2021 (Unaudited)

6

 

Consolidated Statements of Cash Flows for the six months ended June 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

17

ITEM 3.

Quantitative and Qualitative Disclosures about Market Risk

24

ITEM 4.

Controls and Procedures

24

PART II – OTHER INFORMATION

 

ITEM 1.

Legal Proceedings

25

ITEM 1A.

Risk Factors

25

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

67

ITEM 3.

Defaults Upon Senior Securities

67

ITEM 4.

Mine Safety Disclosures

67

ITEM 5.

Other Information

67

ITEM 6.

Exhibits

67

Signatures

68

 

2


 

Part I – FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

 

 

 

June 30,

 

 

 

 

 

 

2022

 

 

December 31,

 

 

 

(unaudited)

 

 

2021

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

42,012,015

 

 

$

104,790,989

 

Cash equivalent - reverse repurchase agreements

 

 

79,000,000

 

 

 

125,000,000

 

Marketable securities

 

 

75,677,040

 

 

 

 

Prepaid expenses and other current assets

 

 

4,052,355

 

 

 

2,961,781

 

Total current assets

 

 

200,741,410

 

 

 

232,752,770

 

Right-of-use assets

 

 

239,873

 

 

 

351,863

 

Fixed assets, net

 

 

34,041

 

 

 

32,487

 

Total assets

 

$

201,015,324

 

 

$

233,137,120

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

264,225

 

 

$

1,019,702

 

Accrued expenses

 

 

10,810,155

 

 

 

10,523,353

 

Current portion of long-term debt

 

 

4,925,765

 

 

 

 

Current portion of operating lease liabilities

 

 

242,636

 

 

 

229,607

 

Total current liabilities

 

 

16,242,781

 

 

 

11,772,662

 

Operating lease liabilities, long-term

 

 

 

 

 

125,232

 

Long-term debt, net of current portion

 

 

10,743,535

 

 

 

15,503,703

 

Total liabilities

 

 

26,986,316

 

 

 

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 58,301,491
   and
58,081,215 shares issued and outstanding, respectively

 

 

58,301

 

 

 

58,081

 

Additional paid-in capital

 

 

503,517,715

 

 

 

500,369,444

 

Accumulated other comprehensive loss

 

 

(285,763

)

 

 

 

Accumulated deficit

 

 

(329,261,245

)

 

 

(294,692,002

)

Total stockholders’ equity

 

 

174,029,008

 

 

 

205,735,523

 

Total liabilities and stockholders’ equity

 

$

201,015,324

 

 

$

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

14,570,654

 

 

$

11,474,446

 

 

$

26,804,975

 

 

$

19,200,788

 

General and administrative

 

 

3,144,280

 

 

 

3,068,652

 

 

 

7,393,667

 

 

 

6,173,355

 

Loss from operations

 

 

(17,714,934

)

 

 

(14,543,098

)

 

 

(34,198,642

)

 

 

(25,374,143

)

 

 

 

 

 

 

 

 

 

 

 

 

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

344,378

 

 

 

39,665

 

 

 

445,760

 

 

 

63,427

 

Interest expense

 

 

(410,395

)

 

 

(433,477

)

 

 

(816,361

)

 

 

(916,056

)

Total other income (expense), net

 

 

(66,017

)

 

 

(393,812

)

 

 

(370,601

)

 

 

(852,629

)

Net loss

 

$

(17,780,951

)

 

$

(14,936,910

)

 

$

(34,569,243

)

 

$

(26,226,772

)

Net loss per share - basic and diluted

 

$

(0.30

)

 

$

(0.28

)

 

$

(0.59

)

 

$

(0.52

)

Weighted average common shares outstanding - basic and diluted

 

 

58,301,491

 

 

 

54,280,393

 

 

 

58,299,686

 

 

 

49,979,545

 

 

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 June 30,

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Net loss

 

$

(17,780,951

)

 

$

(14,936,910

)

 

$

(34,569,243

)

 

$

(26,226,772

)

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized loss on marketable securities, net of tax

 

 

(224,086

)

 

 

 

 

 

(285,763

)

 

 

 

Total other comprehensive loss

 

$

(224,086

)

 

$

 

 

$

(285,763

)

 

$

 

Comprehensive loss

 

$

(18,005,037

)

 

$

(14,936,910

)

 

$

(34,855,006

)

 

$

(26,226,772

)

 

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

 

 

 

 

 

 

 

 

3,125,167

 

 

 

 

 

 

 

 

 

3,125,167

 

Release of restrictions on Helio
   founders’ shares

 

 

10,890

 

 

 

11

 

 

 

(11

)

 

 

 

 

 

 

 

 

 

Issuance of common stock, employee
   stock purchase plan

 

 

6,860

 

 

 

7

 

 

 

23,317

 

 

 

 

 

 

 

 

 

23,324

 

Issuance of common stock, vested
   restricted stock units

 

 

202,526

 

 

 

202

 

 

 

(202

)

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(285,763

)

 

 

 

 

 

(285,763

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(34,569,243

)

 

 

(34,569,243

)

Balance, June 30, 2022

 

 

58,301,491

 

 

$

58,301

 

 

$

503,517,715

 

 

$

(285,763

)

 

$

(329,261,245

)

 

$

174,029,008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2020

 

 

38,667,491

 

 

$

38,667

 

 

$

296,385,619

 

 

$

 

 

$

(236,915,728

)

 

$

59,508,558

 

Stock-based compensation

 

 

 

 

 

 

 

 

3,465,555

 

 

 

 

 

 

 

 

 

3,465,555

 

Release of restrictions on Helio
   founders’ shares

 

 

70,398

 

 

 

70

 

 

 

(70

)

 

 

 

 

 

 

 

 

 

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

 

 

631,217

 

 

 

631

 

 

 

4,610,496

 

 

 

 

 

 

 

 

 

4,611,127

 

Issuance of common stock, employee
   stock purchase plan

 

 

2,786

 

 

 

3

 

 

 

9,872

 

 

 

 

 

 

 

 

 

9,875

 

Issuance of common stock, vested
   restricted stock units

 

 

286,944

 

 

 

287

 

 

 

(287

)

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26,226,772

)

 

 

(26,226,772

)

Balance, June 30, 2021

 

 

57,997,345

 

 

$

57,997

 

 

$

496,764,448

 

 

$

 

 

$

(263,142,500

)

 

$

233,679,945

 

 

 

 

 

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, March 31, 2022

 

 

58,301,491

 

 

$

58,301

 

 

$

502,172,392

 

 

$

(61,677

)

 

$

(311,480,294

)

 

$

190,688,722

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,345,323

 

 

 

 

 

 

 

 

 

1,345,323

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(224,086

)

 

 

 

 

 

(224,086

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,780,951

)

 

 

(17,780,951

)

Balance, June 30, 2022

 

 

58,301,491

 

 

$

58,301

 

 

$

503,517,715

 

 

$

(285,763

)

 

$

(329,261,245

)

 

$

174,029,008

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, March 31, 2021

 

 

47,651,035

 

 

$

47,651

 

 

$

374,232,411

 

 

$

 

 

$

(248,205,590

)

 

$

126,074,472

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,173,385

 

 

 

 

 

 

 

 

 

2,173,385

 

Release of restrictions on Helio
   founders’ shares

 

 

35,393

 

 

 

35

 

 

 

(35

)

 

 

 

 

 

 

 

 

 

Issuance of common stock, net of
   issuance costs

 

 

10,223,526

 

 

 

10,224

 

 

 

119,751,937

 

 

 

 

 

 

 

 

 

119,762,161

 

Issuance of common stock,
exercise of stock options

 

 

87,391

 

 

 

87

 

 

 

606,750

 

 

 

 

 

 

 

 

 

606,837

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(14,936,910

)

 

 

(14,936,910

)

Balance, June 30, 2021

 

 

57,997,345

 

 

$

57,997

 

 

$

496,764,448

 

 

$

 

 

$

(263,142,500

)

 

$

233,679,945

 

 

7


 

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

 

 

 

Six Months Ended June 30,

 

 

 

2022

 

 

2021

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

Net loss

 

$

(34,569,243

)

 

$

(26,226,772

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation

 

 

3,230,913

 

 

 

4,705,218

 

Non-cash interest expense

 

 

165,597

 

 

 

243,873

 

Net amortization of premium on debt securities available for sale

 

 

(8,614

)

 

 

 

Depreciation and amortization expense

 

 

126,753

 

 

 

134,557

 

Change in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(1,090,574

)

 

 

(1,254,761

)

Accounts payable

 

 

(755,477

)

 

 

712,823

 

Accrued expenses and other liabilities

 

 

68,853

 

 

 

(859,046

)

Net cash used in operating activities

 

 

(32,831,792

)

 

 

(22,544,108

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

Acquisitions of fixed assets

 

 

(16,317

)

 

 

(7,806

)

Purchases of marketable securities

 

 

(87,954,189

)

 

 

 

Sales and maturities of marketable securities

 

 

12,000,000

 

 

 

 

Net cash used in investing activities

 

 

(75,970,506

)

 

 

(7,806

)

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

 

 

 

189,811,611

 

Proceeds from exercise of stock options

 

 

 

 

 

4,611,127

 

Proceeds from employee stock purchase plan

 

 

23,324

 

 

 

9,875

 

Net cash provided by financing activities

 

 

23,324

 

 

 

194,432,613

 

NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS

 

 

(108,778,974

)

 

 

171,880,699

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

229,790,989

 

 

 

77,858,311

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

121,012,015

 

 

$

249,739,010

 

 

 

 

 

 

 

 

SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION:

 

 

 

 

 

 

Cash paid during the period for interest

 

$

652,167

 

 

$

681,333

 

 

 

 

 

 

 

 

SUPPLEMENTAL INFORMATION AND DISCLOSURES OF NONCASH ACTIVITIES:

 

 

 

 

 

 

Offering costs not yet paid

 

$

 

 

$

66,000

 

Common stock issued in connection with Helio Vision, Inc. acquisition milestone

 

$

 

 

$

2,499,991

 

 

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

8