aldx-10q_20200930.htm
false 2020 Q3 0001341235 --12-31 2021-05-01 2022-05-01 2020 P3Y P7Y5M26D P6Y4M17D 0001341235 2020-01-01 2020-09-30 xbrli:shares 0001341235 2020-11-03 iso4217:USD 0001341235 2020-09-30 0001341235 2019-12-31 iso4217:USD xbrli:shares 0001341235 2020-07-01 2020-09-30 0001341235 2019-07-01 2019-09-30 0001341235 2019-01-01 2019-09-30 0001341235 us-gaap:CommonStockMember 2019-12-31 0001341235 us-gaap:AdditionalPaidInCapitalMember 2019-12-31 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-12-31 0001341235 us-gaap:RetainedEarningsMember 2019-12-31 0001341235 us-gaap:AdditionalPaidInCapitalMember 2020-01-01 2020-09-30 0001341235 us-gaap:CommonStockMember 2020-01-01 2020-09-30 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-01-01 2020-09-30 0001341235 us-gaap:RetainedEarningsMember 2020-01-01 2020-09-30 0001341235 us-gaap:CommonStockMember 2020-09-30 0001341235 us-gaap:AdditionalPaidInCapitalMember 2020-09-30 0001341235 us-gaap:RetainedEarningsMember 2020-09-30 0001341235 us-gaap:CommonStockMember 2018-12-31 0001341235 us-gaap:AdditionalPaidInCapitalMember 2018-12-31 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2018-12-31 0001341235 us-gaap:RetainedEarningsMember 2018-12-31 0001341235 2018-12-31 0001341235 us-gaap:AdditionalPaidInCapitalMember 2019-01-01 2019-09-30 0001341235 us-gaap:CommonStockMember aldx:HelioVisionIncMember aldx:FoundersMember 2019-01-01 2019-09-30 0001341235 us-gaap:AdditionalPaidInCapitalMember aldx:HelioVisionIncMember aldx:FoundersMember 2019-01-01 2019-09-30 0001341235 aldx:HelioVisionIncMember aldx:FoundersMember 2019-01-01 2019-09-30 0001341235 us-gaap:CommonStockMember 2019-01-01 2019-09-30 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-01-01 2019-09-30 0001341235 us-gaap:RetainedEarningsMember 2019-01-01 2019-09-30 0001341235 us-gaap:CommonStockMember 2019-09-30 0001341235 us-gaap:AdditionalPaidInCapitalMember 2019-09-30 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-09-30 0001341235 us-gaap:RetainedEarningsMember 2019-09-30 0001341235 2019-09-30 0001341235 us-gaap:CommonStockMember 2020-06-30 0001341235 us-gaap:AdditionalPaidInCapitalMember 2020-06-30 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-06-30 0001341235 us-gaap:RetainedEarningsMember 2020-06-30 0001341235 2020-06-30 0001341235 us-gaap:AdditionalPaidInCapitalMember 2020-07-01 2020-09-30 0001341235 us-gaap:CommonStockMember 2020-07-01 2020-09-30 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2020-07-01 2020-09-30 0001341235 us-gaap:RetainedEarningsMember 2020-07-01 2020-09-30 0001341235 us-gaap:CommonStockMember 2019-06-30 0001341235 us-gaap:AdditionalPaidInCapitalMember 2019-06-30 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-06-30 0001341235 us-gaap:RetainedEarningsMember 2019-06-30 0001341235 2019-06-30 0001341235 us-gaap:AdditionalPaidInCapitalMember 2019-07-01 2019-09-30 0001341235 us-gaap:CommonStockMember 2019-07-01 2019-09-30 0001341235 us-gaap:AccumulatedOtherComprehensiveIncomeMember 2019-07-01 2019-09-30 0001341235 us-gaap:RetainedEarningsMember 2019-07-01 2019-09-30 0001341235 aldx:HelioVisionIncMember 2019-01-01 2019-09-30 0001341235 aldx:HelioVisionIncMember 2020-01-01 2020-09-30 0001341235 aldx:HelioVisionIncMember 2019-01-28 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:FoundersMember 2019-01-28 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:NonFoundersMember 2019-01-28 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:FoundersMember aldx:ServiceBasedAwardsMember 2019-01-28 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:FoundersMember us-gaap:RestrictedStockMember 2019-01-28 2019-01-28 xbrli:pure 0001341235 aldx:HelioVisionIncMember aldx:CommonStockTwentyFourMonthsFollowingClosingDateMember 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:CommonStockAfterFDAApprovalPriorToTenthAnniversaryMember 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:CommonStockAfterFDAApprovalPriorToTwelfthAnniversaryMember 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:CommonStockAfterFDAApprovalPriorToTwelfthAnniversaryMember srt:MaximumMember 2019-01-28 2019-01-28 0001341235 aldx:HelioVisionIncMember aldx:TaxGrossUpPaymentChangeOfControlOrDivestureMember srt:MaximumMember 2019-01-28 0001341235 aldx:HelioVisionIncMember 2019-01-01 2019-03-31 0001341235 us-gaap:EmployeeStockOptionMember 2020-07-01 2020-09-30 0001341235 us-gaap:EmployeeStockOptionMember 2019-07-01 2019-09-30 0001341235 us-gaap:RestrictedStockUnitsRSUMember 2020-07-01 2020-09-30 0001341235 us-gaap:RestrictedStockUnitsRSUMember 2019-07-01 2019-09-30 0001341235 aldx:NonvestedFounderSharesMember 2020-07-01 2020-09-30 0001341235 aldx:NonvestedFounderSharesMember 2019-07-01 2019-09-30 0001341235 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-09-30 0001341235 us-gaap:EmployeeStockOptionMember 2019-01-01 2019-09-30 0001341235 us-gaap:RestrictedStockUnitsRSUMember 2020-01-01 2020-09-30 0001341235 us-gaap:RestrictedStockUnitsRSUMember 2019-01-01 2019-09-30 0001341235 aldx:NonvestedFounderSharesMember 2020-01-01 2020-09-30 0001341235 aldx:NonvestedFounderSharesMember 2019-01-01 2019-09-30 0001341235 us-gaap:RestrictedStockMember 2020-09-30 0001341235 us-gaap:USGovernmentAgenciesDebtSecuritiesMember 2019-12-31 0001341235 us-gaap:AvailableforsaleSecuritiesMember 2019-12-31 0001341235 us-gaap:CashMember 2020-09-30 0001341235 us-gaap:MoneyMarketFundsMember 2020-09-30 0001341235 aldx:ReverseRepurchaseAgreementsMember 2020-09-30 0001341235 us-gaap:CashEquivalentsMember 2020-09-30 0001341235 us-gaap:CashMember 2019-12-31 0001341235 us-gaap:MoneyMarketFundsMember 2019-12-31 0001341235 aldx:ReverseRepurchaseAgreementsMember 2019-12-31 0001341235 us-gaap:CashEquivalentsMember 2019-12-31 0001341235 aldx:HerculesCreditFacilityMember 2020-09-30 0001341235 aldx:HerculesCreditFacilityMember aldx:TermLoanAdvanceOneMember 2020-09-30 0001341235 aldx:HerculesCreditFacilityMember aldx:TermLoanAdvanceTwoMember 2020-09-30 0001341235 aldx:HerculesCreditFacilityMember aldx:TermLoanAdvanceThreeMember 2020-09-30 0001341235 aldx:HerculesCreditFacilityMember aldx:TermLoanAdvanceFourMember 2020-09-30 0001341235 aldx:HerculesCreditFacilityMember aldx:TermLoanAdvanceFiveMember 2020-09-30 0001341235 us-gaap:PrimeRateMember 2020-01-01 2020-09-30 0001341235 srt:MaximumMember 2020-01-01 2020-09-30 0001341235 srt:MinimumMember 2020-01-01 2020-09-30 0001341235 srt:MaximumMember aldx:HerculesCreditFacilityMember 2020-01-01 2020-09-30 0001341235 aldx:JefferiesLimitedLiabilityCompanyMember srt:MaximumMember aldx:JefferiesSalesAgreementMember 2018-12-01 2018-12-31 0001341235 aldx:JefferiesLimitedLiabilityCompanyMember aldx:JefferiesSalesAgreementMember 2020-01-01 2020-09-30 0001341235 aldx:StateAndFederalMember 2020-01-01 2020-09-30 aldx:NumberofPlan 0001341235 aldx:EquityIncentivePlanMember 2020-09-30 0001341235 aldx:EquityIncentivePlanMember 2020-01-01 2020-09-30 0001341235 us-gaap:ResearchAndDevelopmentExpenseMember 2020-07-01 2020-09-30 0001341235 us-gaap:ResearchAndDevelopmentExpenseMember 2019-07-01 2019-09-30 0001341235 us-gaap:ResearchAndDevelopmentExpenseMember 2020-01-01 2020-09-30 0001341235 us-gaap:ResearchAndDevelopmentExpenseMember 2019-01-01 2019-09-30 0001341235 us-gaap:GeneralAndAdministrativeExpenseMember 2020-07-01 2020-09-30 0001341235 us-gaap:GeneralAndAdministrativeExpenseMember 2019-07-01 2019-09-30 0001341235 us-gaap:GeneralAndAdministrativeExpenseMember 2020-01-01 2020-09-30 0001341235 us-gaap:GeneralAndAdministrativeExpenseMember 2019-01-01 2019-09-30 0001341235 us-gaap:EmployeeStockOptionMember 2020-09-30 0001341235 us-gaap:EmployeeStockOptionMember 2020-01-01 2020-09-30 0001341235 us-gaap:RestrictedStockUnitsRSUMember 2019-12-31 0001341235 us-gaap:RestrictedStockUnitsRSUMember 2020-01-01 2020-09-30 0001341235 us-gaap:RestrictedStockUnitsRSUMember 2020-09-30 0001341235 aldx:TwoThousandSixteenEmployeeStockPurchasePlanMember 2020-09-30 0001341235 aldx:TwoThousandSixteenEmployeeStockPurchasePlanMember 2020-01-01 2020-09-30 0001341235 aldx:TwoThousandSixteenEmployeeStockPurchasePlanMember 2019-01-01 2019-09-30 0001341235 us-gaap:SubsequentEventMember 2020-10-01 2020-10-31

 

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, 2020

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)

 

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  

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

 

Title of Class

Trading Symbol

Name of exchange on which registered

Common Stock, $0.001 par value per share

ALDX

The Nasdaq Stock Market LLC

 

As of November 3, 2020, there were 38,820,347 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, 2020

INDEX

 

 

Page

PART I – FINANCIAL INFORMATION

ITEM 1.

Condensed Consolidated Financial Statements:

3

 

Consolidated Balance Sheets at September 30, 2020 (Unaudited) and December 31, 2019

3

 

Consolidated Statements of Operations for the three and nine months ended September 30, 2020 and 2019 (Unaudited)

4

 

Consolidated Statements of Comprehensive Loss for the three and nine months ended September 30, 2020 and 2019 (Unaudited)

5

 

Consolidated Statements of Stockholders’ Equity for the three and nine months ended September 30, 2020 and 2019 (Unaudited)

6

 

Consolidated Statements of Cash Flows for the nine months ended September 30, 2020 and 2019 (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

26

ITEM 4.

Controls and Procedures

26

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

65

ITEM 3.

Defaults Upon Senior Securities

65

ITEM 4.

Mine Safety Disclosures

65

ITEM 5.

Other Information

65

ITEM 6.

Exhibits

65

Signatures

66

 

2


 

Part I – FINANCIAL INFORMATION

Item 1.

Condensed Consolidated Financial Statements

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED BALANCE SHEETS

 

 

 

September 30,

 

 

 

 

 

 

 

2020

 

 

December 31,

 

 

 

(unaudited)

 

 

2019

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

71,175,507

 

 

$

16,425,830

 

Cash equivalent - reverse repurchase agreements

 

 

15,000,000

 

 

 

28,000,000

 

Marketable securities

 

 

 

 

 

28,938,545

 

Prepaid expenses and other current assets

 

 

2,017,273

 

 

 

1,804,450

 

Total current assets

 

 

88,192,780

 

 

 

75,168,825

 

Right-of-use assets

 

 

52,195

 

 

 

201,007

 

Fixed assets, net

 

 

79,455

 

 

 

148,449

 

Total assets

 

$

88,324,430

 

 

$

75,518,281

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

123,900

 

 

$

808,302

 

Accrued expenses

 

 

4,018,635

 

 

 

11,873,122

 

 

Current portion of credit facility

 

 

2,259,417

 

 

 

 

Current portion of operating lease liabilities

 

 

58,720

 

 

 

226,328

 

Total current liabilities

 

 

6,460,672

 

 

 

12,907,752

 

Long-term debt

 

 

12,693,311

 

 

 

14,528,212

 

Total liabilities

 

 

19,153,983

 

 

 

27,435,964

 

Commitments and contingencies (Notes 13 and 14)

 

 

 

 

 

 

 

 

Stockholders' equity:

 

 

 

 

 

 

 

 

Common stock, voting, $0.001 par value; 150,000,000 authorized and 38,631,709

   and 28,656,832 shares issued and outstanding, respectively

 

 

38,632

 

 

 

28,657

 

Additional paid-in capital

 

 

294,755,363

 

 

 

247,409,793

 

Accumulated other comprehensive income

 

 

 

 

 

5,866

 

Accumulated deficit

 

 

(225,623,548

)

 

 

(199,361,999

)

Total stockholders’ equity

 

 

69,170,447

 

 

 

48,082,317

 

Total liabilities and stockholders’ equity

 

$

88,324,430

 

 

$

75,518,281

 

 

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,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

6,133,580

 

 

$

16,223,972

 

 

$

17,653,058

 

 

$

34,737,420

 

Acquired in-process research and development

 

 

 

 

 

(47,102

)

 

 

 

 

 

6,500,602

 

General and administrative

 

 

2,255,617

 

 

 

2,839,319

 

 

 

7,480,461

 

 

 

8,940,771

 

Loss from operations

 

 

(8,389,197

)

 

 

(19,016,189

)

 

 

(25,133,519

)

 

 

(50,178,793

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

5,215

 

 

 

330,329

 

 

 

287,025

 

 

 

1,262,378

 

Interest expense

 

 

(489,191

)

 

 

(29,154

)

 

 

(1,415,055

)

 

 

(59,766

)

Total other income (expense), net

 

 

(483,976

)

 

 

301,175

 

 

 

(1,128,030

)

 

 

1,202,612

 

Loss before income taxes

 

 

(8,873,173

)

 

 

(18,715,014

)

 

 

(26,261,549

)

 

 

(48,976,181

)

Income tax benefit

 

 

 

 

 

 

 

 

 

 

 

1,309,973

 

Net loss

 

$

(8,873,173

)

 

$

(18,715,014

)

 

$

(26,261,549

)

 

$

(47,666,208

)

Net loss per share - basic and diluted

 

$

(0.23

)

 

$

(0.69

)

 

$

(0.81

)

 

$

(1.77

)

Weighted average common shares outstanding - basic and

   diluted

 

 

37,796,946

 

 

 

27,111,600

 

 

 

32,395,217

 

 

 

26,928,725

 

 

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,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Net loss

$

(8,873,173

)

 

$

(18,715,014

)

 

$

(26,261,549

)

 

$

(47,666,208

)

Other comprehensive (loss) income:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain (loss) on marketable securities, net of tax

 

(4,754

)

 

 

(7,687

)

 

 

(5,866

)

 

 

14,990

 

Total other comprehensive (loss) income

$

(4,754

)

 

$

(7,687

)

 

$

(5,866

)

 

$

14,990

 

Comprehensive loss

$

(8,877,927

)

 

$

(18,722,701

)

 

$

(26,267,415

)

 

$

(47,651,218

)

 

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 Voting Stock

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

Shares

 

 

Amount

 

 

Additional

Paid-in Capital

 

 

Other

Comprehensive

Income/(Loss),

net of tax

 

 

Accumulated

Deficit

 

 

Total

Stockholders'

Equity

 

Balance, December 31, 2019

 

 

28,656,832

 

 

$

28,657

 

 

$

247,409,793

 

 

$

5,866

 

 

$

(199,361,999

)

 

$

48,082,317

 

Stock-based compensation

 

 

 

 

 

 

 

 

5,453,520

 

 

 

 

 

 

 

 

 

5,453,520

 

Release of restrictions on Helio

   founders’ shares

 

 

237,834

 

 

 

238

 

 

 

(238

)

 

 

 

 

 

 

 

 

 

Issuance of common stock, net of

   issuance costs

 

 

9,351,749

 

 

 

9,352

 

 

 

40,707,191

 

 

 

 

 

 

 

 

 

40,716,543

 

Issuance of common stock, exercise

   of stock options

 

 

219,244

 

 

 

219

 

 

 

1,058,297

 

 

 

 

 

 

 

 

 

1,058,516

 

Issuance of common stock, employee

   stock purchase plan

 

 

30,254

 

 

 

30

 

 

 

126,936

 

 

 

 

 

 

 

 

 

126,966

 

Issuance of common stock, vested

   restricted stock awards

 

 

135,796

 

 

 

136

 

 

 

(136

)

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(5,866

)

 

 

 

 

 

(5,866

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(26,261,549

)

 

 

(26,261,549

)

Balance, September 30, 2020

 

 

38,631,709

 

 

$

38,632

 

 

$

294,755,363

 

 

$

 

 

$

(225,623,548

)

 

$

69,170,447

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2018

 

 

26,244,435

 

 

$

26,244

 

 

$

225,136,127

 

 

$

(9,224

)

 

$

(138,535,168

)

 

$

86,617,979

 

Stock-based compensation

 

 

 

 

 

 

 

 

6,133,990

 

 

 

 

 

 

 

 

 

6,133,990

 

Issuance of common stock,

   acquisition of Helio Vision, Inc.

 

 

724,518

 

 

 

724

 

 

 

4,862,007

 

 

 

 

 

 

 

 

 

4,862,731

 

Issuance of common stock, net of

   issuance costs

 

 

83,557

 

 

 

84

 

 

 

720,880

 

 

 

 

 

 

 

 

 

720,964

 

Issuance of common stock, employee

   stock purchase plan

 

 

34,253

 

 

 

35

 

 

 

194,813

 

 

 

 

 

 

 

 

 

194,848

 

Issuance of common stock, vested

   restricted stock awards

 

 

65,012

 

 

 

65

 

 

 

(65

)

 

 

 

 

 

 

 

 

 

Other comprehensive income

 

 

 

 

 

 

 

 

 

 

 

14,990

 

 

 

 

 

 

14,990

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(47,666,208

)

 

 

(47,666,208

)

Balance, September 30, 2019

 

 

27,151,775

 

 

$

27,152

 

 

$

237,047,752

 

 

$

5,766

 

 

$

(186,201,376

)

 

$

50,879,294

 

 

 

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, 2020

 

 

32,997,346

 

 

$

32,997

 

 

$

269,502,290

 

 

$

4,754

 

 

$

(216,750,375

)

 

$

52,789,666

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,757,479

 

 

 

 

 

 

 

 

 

1,757,479

 

Release of restrictions on Helio

   founders’ shares

 

 

35,783

 

 

 

36

 

 

 

(36

)

 

 

 

 

 

 

 

 

 

Issuance of common stock, net of

   issuance costs

 

 

5,377,681

 

 

 

5,378

 

 

 

22,440,677

 

 

 

 

 

 

 

 

 

22,446,055

 

Issuance of common stock, exercise

   of stock options

 

 

204,796

 

 

 

205

 

 

 

997,892

 

 

 

 

 

 

 

 

 

998,097

 

Issuance of common stock, employee

   stock purchase plan

 

 

16,103

 

 

 

16

 

 

 

57,061

 

 

 

 

 

 

 

 

 

57,077

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(4,754

)

 

 

 

 

 

(4,754

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(8,873,173

)

 

 

(8,873,173

)

Balance, September 30, 2020

 

 

38,631,709

 

 

$

38,632

 

 

$

294,755,363

 

 

$

 

 

$

(225,623,548

)

 

$

69,170,447

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, June 30, 2019

 

 

26,986,936

 

 

$

26,987

 

 

$

234,779,291

 

 

$

13,453

 

 

$

(167,486,361

)

 

$

67,333,370

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,152,938

 

 

 

 

 

 

 

 

 

2,152,938

 

Issuance of common stock,

   acquisition of Helio Vision, Inc.

 

 

142,155

 

 

 

142

 

 

 

(142

)

 

 

 

 

 

 

 

 

 

Issuance of common stock, employee

   stock purchase plan

 

 

22,684

 

 

 

23

 

 

 

115,665

 

 

 

 

 

 

 

 

 

115,688

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

(7,687

)

 

 

 

 

 

(7,687

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(18,715,015

)

 

 

(18,715,015

)

Balance, September 30, 2019

 

 

27,151,775

 

 

$

27,152

 

 

$

237,047,752

 

 

$

5,766

 

 

$

(186,201,376

)

 

$

50,879,294

 

 

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

7


 

ALDEYRA THERAPEUTICS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

 

 

 

Nine Months Ended September 30,

 

 

 

2020

 

 

2019

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss

 

$

(26,261,549

)

 

$

(47,666,208

)

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

 

 

 

 

 

 

 

 

Acquired in-process research and development

 

 

 

 

 

6,500,602

 

Deferred taxes

 

 

 

 

 

(1,309,973

)

Stock-based compensation

 

 

5,453,520

 

 

 

6,133,990

 

Non-cash interest expense

 

 

424,516

 

 

 

59,766

 

Accretion on debt securities available for sale, net

 

 

(91,231

)

 

 

(474,771

)

Depreciation and amortization expense

 

 

217,806

 

 

 

72,284

 

Change in assets and liabilities:

 

 

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

(212,823

)

 

 

404,264

 

Accounts payable

 

 

(684,402

)

 

 

(3,082,081

)

Accrued expenses

 

 

(8,022,095

)

 

 

5,604,224

 

Net cash used in operating activities

 

 

(29,176,258

)

 

 

(33,757,903

)

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Acquisitions of fixed assets

 

 

 

 

 

(9,529

)

Cash acquired in Helio asset acquisition

 

 

 

 

 

632,090

 

Purchases of marketable securities

 

 

(5,776,090

)

 

 

(36,860,554

)

Sales and maturities of marketable securities

 

 

34,800,000

 

 

 

59,000,000

 

Net cash provided by investing activities

 

 

29,023,910

 

 

 

22,762,007

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

40,716,543

 

 

 

720,964

 

Proceeds from exercise of stock options

 

 

1,058,516

 

 

 

 

Proceeds from employee stock purchase plan

 

 

126,966

 

 

 

194,849

 

Proceeds from long-term debt

 

 

 

 

 

14,450,000

 

Debt issuance costs paid in cash

 

 

 

 

 

(123,186

)

Net cash provided by financing activities

 

 

41,902,025

 

 

 

15,242,627

 

NET INCREASE IN CASH AND CASH EQUIVALENTS

 

 

41,749,677

 

 

 

4,246,731

 

CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD

 

 

44,425,830

 

 

 

47,357,472

 

CASH AND CASH EQUIVALENTS, END OF PERIOD

 

$

86,175,507

 

 

$

51,604,203

 

 

 

 

 

 

 

 

 

 

SUPPLEMENTAL INFORMATION AND DISCLOSURES OF NONCASH ACTIVITIES:

 

 

 

 

 

 

 

 

Helio acquisition:

 

 

 

 

 

 

 

 

Assets acquired

 

$

 

 

$

75,632

 

Liabilities acquired

 

$

 

 

$

637,994

 

Fair value of securities issued

 

$

 

 

$

4,862,731

 

Right-of-use assets acquired through operating leases

 

$

 

 

$

386,060

 

Cash paid during the period for interest

 

$

1,042,708

 

 

$

 

 

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

 

8


 

ALDEYRA THERAPEUTICS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)

1.

NATURE OF BUSINESS

Aldeyra Therapeutics, Inc., together with its wholly-owned subsidiaries (the “Company” or “Aldeyra”), a Delaware corporation, is a clinical-stage biotechnology company focused on the development of novel therapies with the potential to improve the lives of patients with immune-mediated diseases.

The Company’s principal activities to date include raising capital and research and development activities.

2.

BASIS OF PRESENTATION

The accompanying interim condensed consolidated financial statements and related disclosures are unaudited and have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) for interim financial information and the instructions to Form 10-Q and Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s audited consolidated financial statements and related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, which was filed with the Securities and Exchange Commission on March 12, 2020 (the “2019 Form 10-K”).

The financial information as of September 30, 2020, and the three and nine months ended September 30, 2020 and 2019, respectively, is unaudited. In the opinion of management all adjustments, consisting only of normal recurring adjustments considered necessary for the fair presentation of financial position, results of operations, and cash flows at the dates and for the periods presented, have been included. The balance sheet data as of December 31, 2019 was derived from audited consolidated financial statements. The results of the Company’s operations for any interim periods are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year.

 

Based on its current operating plan, and not including additional access to capital that may become available under the Company’s credit facility, the Company believes that its cash, cash equivalents, and marketable securities as of September 30, 2020, will be sufficient to fund currently anticipated operating expenses through the end of 2022, including potential new drug application (NDA) submissions for reproxalap in dry eye disease and allergic conjunctivitis, assuming positive clinical trial results and regulatory review; the Phase 2 clinical trials of ADX-629 in COVID-19, atopic asthma, and psoriasis; and the continuation of Part 1 of the adaptive Phase 3 GUARD trial in proliferative vitreoretinopathy, contingent on patient enrollment. As a result of the COVID-19 pandemic, clinical site availability, staffing, and patient recruitment have been negatively affected and the timelines to complete the Company’s clinical trials may be delayed. The Company’s assessment of its liquidity and capital resources includes an estimate of the financial impacts of these changes.  The Company will need to secure additional funding in the future, from one or more equity or debt financings, collaborations, or other sources, in order to carry out all of the Company’s planned research and development activities and regulatory activities; commercialize product candidates; or conduct any substantial, additional development requirements requested by the FDA. Additional funding may not be available to the Company on acceptable terms, or at all. If the Company is unable to secure additional capital, it will be required to significantly decrease the amount of planned expenditures and may be required to cease operations.  In addition, the disruption in the capital markets caused by the COVID-19 outbreak could make any financing more challenging, and there can be no assurance that Aldeyra will be able to obtain such financing on commercially reasonable terms or at all.

Curtailment of operations would cause significant delays in the Company’s efforts to develop and introduce its products to market, which is critical to the realization of its business plan and the future operations of the Company.

9


 

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions, including fair value estimates for investments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of expenses during the reporting periods. The Company’s management evaluates its estimates and assumptions on an ongoing basis. Management’s most significant estimates in the Company’s consolidated financial statements include, but are not limited to, estimates related to clinical trial accruals, estimates related to prepaid and accrued research and development costs, acquired in-process research and development (“IPR&D”) expense, contingent liabilities, and accounting for income taxes and related valuation allowance. Although these estimates and assumptions are based on the Company’s knowledge of current events and actions it may undertake in the future, actual results may ultimately materially differ from these estimates and assumptions.

Summary of Significant Accounting Policies

There were no changes to significant accounting policies during the nine months ended September 30, 2020, as compared to the those identified in the 2019 Form 10-K.

Recent Accounting Pronouncements

In June 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments (“ASU 2016-13”). ASU 2016-13 requires that credit losses be reported as an allowance using an expected losses model, representing the entity’s current estimate of credit losses expected to be incurred. The accounting guidance currently in effect is based on an incurred loss model. For available-for-sale debt securities with unrealized losses, this standard now requires allowances to be recorded instead of reducing the amortized cost of the investment. The amendments under ASU 2016-13 are effective for interim and annual fiscal periods beginning after December 15, 2022. The Company is continuing to evaluate the impact of ASU 2016-13 but does not expect the adoption of this ASU to have a material impact on its consolidated financial statements.

3.

Helio Vision Acquisition

On January 28, 2019 (the “Closing Date”), the Company acquired Helio Vision, Inc. (“Helio”). As a result of the acquisition, the Company initially issued an aggregate of 1,160,444 shares of common stock to the former securityholders and an advisor of Helio. The founders of Helio were issued 568,627 shares and non-founders were issued 591,817 shares. The Helio founders’ shares are subject to vesting based on continued service to the Company over three years from the Closing Date, of which, 67% are vested as of September 30, 2020. The Company recognizes the expense associated with the founders’ restricted shares as research and development compensation expense on a straight-line basis as the shares vest over the three-year period.  

The Company, subject to the conditions of the acquisition agreement, is contingently obligated to make additional payments to the former securityholders of Helio as follows: (a) $2.5 million of common stock on the date that is 24 months following the Closing Date (assuming certain technical milestones are met); (b) $10.0 million of common stock following approval by the FDA of a new drug approval application for the prevention and/or treatment of proliferative vitreoretinopathy or a substantially similar label prior to the 10th anniversary of the Closing Date; and (c) $2.5 million of common stock following FDA approval of a new drug application for an indication (other than proliferative vitreoretinopathy) prior to the 12th anniversary of the Closing Date (the shares of common stock issuable pursuant to the preceding clauses (a) – (c) are referred to herein as the “Milestone Shares”), provided that in no event shall the Company be obligated to issue more than an aggregate of 5,248,885 shares of common stock. Additionally, in the event of certain change of control or divestitures by the Company, certain former convertible noteholders