UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form
(Mark One)
For the quarterly period ended
or
For the transition period from to
Commission File Number:
(Exact name of registrant as specified in its charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip Code) |
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(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.
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).
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 |
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Accelerated filer |
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Smaller reporting company |
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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 |
As of October 26, 2021, there were
Aldeyra Therapeutics, Inc.
Quarterly Report on Form 10-Q
For the Quarter Ended September 30, 2021
INDEX
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PART I – FINANCIAL INFORMATION |
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ITEM 1. |
3 |
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Consolidated Balance Sheets at September 30, 2021 (Unaudited) and December 31, 2020 |
3 |
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4 |
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5 |
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6 |
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8 |
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9 |
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ITEM 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
18 |
ITEM 3. |
26 |
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ITEM 4. |
26 |
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PART II – OTHER INFORMATION |
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ITEM 1. |
27 |
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ITEM 1A. |
27 |
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ITEM 2. |
64 |
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ITEM 3. |
64 |
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ITEM 4. |
64 |
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ITEM 5. |
64 |
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ITEM 6. |
64 |
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65 |
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2
Part I – FINANCIAL INFORMATION
Item 1. Condensed Consolidated Financial Statements
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED BALANCE SHEETS
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September 30, |
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2021 |
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December 31, |
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(unaudited) |
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2020 |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
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$ |
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Cash equivalent - reverse repurchase agreements |
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Prepaid expenses and other current assets |
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Total current assets |
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Right-of-use assets |
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Fixed assets, net |
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Total assets |
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$ |
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$ |
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LIABILITIES AND STOCKHOLDERS' EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
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$ |
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Accrued expenses |
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Current portion of credit facility |
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Current portion of operating lease liabilities |
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Total current liabilities |
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Operating lease liabilities, long-term |
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Long-term debt |
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Total liabilities |
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Stockholders' equity: |
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Common stock, voting, $ |
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Additional paid-in capital |
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Accumulated other comprehensive income |
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Accumulated deficit |
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( |
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( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity |
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$ |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Operating expenses: |
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Research and development |
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$ |
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$ |
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$ |
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$ |
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General and administrative |
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Loss from operations |
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( |
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( |
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( |
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( |
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Other income (expense): |
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Interest income |
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Interest expense |
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( |
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( |
) |
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( |
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( |
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Total other income (expense), net |
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( |
) |
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( |
) |
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( |
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( |
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Net loss |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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Net loss per share - basic and diluted |
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$ |
( |
) |
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$ |
( |
) |
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$ |
( |
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$ |
( |
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Weighted average common shares outstanding - basic and diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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2021 |
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2020 |
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2021 |
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2020 |
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Net loss |
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$ |
( |
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$ |
( |
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$ |
( |
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$ |
( |
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Other comprehensive loss: |
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Unrealized loss on marketable securities, net of tax |
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( |
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( |
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Total other comprehensive loss |
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$ |
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$ |
( |
) |
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$ |
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$ |
( |
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Comprehensive loss |
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$ |
( |
) |
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$ |
( |
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$ |
( |
) |
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$ |
( |
) |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)
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Stockholders' Equity |
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Common Voting Stock |
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Accumulated |
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Shares |
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Amount |
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Additional |
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Accumulated |
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Total |
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Balance, December 31, 2020 |
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$ |
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$ |
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$ |
— |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Release of restrictions on Helio |
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( |
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— |
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— |
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— |
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Issuance of common stock in connection |
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— |
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— |
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Issuance of common stock, net of |
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— |
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— |
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Issuance of common stock, exercise |
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— |
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— |
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Issuance of common stock, employee |
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— |
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— |
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Issuance of common stock, vested |
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( |
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— |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
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( |
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Balance, September 30, 2021 |
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$ |
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$ |
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$ |
— |
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$ |
( |
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$ |
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Balance, December 31, 2019 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Release of restrictions on Helio |
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( |
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— |
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— |
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— |
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Issuance of common stock, net of |
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— |
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— |
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Issuance of common stock, |
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— |
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— |
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Issuance of common stock, employee |
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— |
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— |
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Issuance of common stock, vested |
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( |
) |
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— |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance, September 30, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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6
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (Unaudited)
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Stockholders' Equity |
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Common Voting Stock |
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Accumulated |
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Shares |
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Amount |
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Additional |
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Comprehensive |
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Accumulated |
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Total |
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Balance, June 30, 2021 |
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$ |
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$ |
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— |
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$ |
( |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Release of restrictions on Helio |
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( |
) |
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— |
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— |
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— |
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Issuance of common stock, exercise |
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— |
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— |
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Issuance of common stock, employee |
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— |
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— |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance, September 30, 2021 |
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$ |
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$ |
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$ |
— |
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$ |
( |
) |
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$ |
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Balance, June 30, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
) |
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$ |
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Stock-based compensation |
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— |
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— |
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— |
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— |
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Release of restrictions on Helio |
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( |
) |
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— |
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— |
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— |
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Issuance of common stock, net of |
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— |
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— |
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Issuance of common stock, exercise |
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— |
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— |
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Issuance of common stock, vested |
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— |
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— |
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Other comprehensive loss |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Net loss |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Balance, September 30, 2020 |
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$ |
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$ |
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$ |
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$ |
( |
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$ |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
ALDEYRA THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)
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Nine Months Ended September 30, |
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2021 |
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2020 |
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CASH FLOWS FROM OPERATING ACTIVITIES: |
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Net loss |
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$ |
( |
) |
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$ |
( |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Stock-based compensation |
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Non-cash interest expense |
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Net amortization of premium on debt securities available for sale |
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( |
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Depreciation and amortization expense |
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Change in assets and liabilities: |
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Prepaid expenses and other current assets |
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( |
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( |
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Accounts payable |
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( |
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Accrued expenses and other liabilities |
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( |
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Net cash used in operating activities |
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( |
) |
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( |
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CASH FLOWS FROM INVESTING ACTIVITIES: |
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Acquisitions of fixed assets |
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( |
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Purchases of marketable securities |
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( |
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Sales and maturities of marketable securities |
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Net cash (used in) provided by investing activities |
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( |
) |
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CASH FLOWS FROM FINANCING ACTIVITIES: |
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Proceeds from issuance of common stock, net of issuance costs |
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Proceeds from exercise of stock options |
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Proceeds from employee stock purchase plan |
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Net cash provided by financing activities |
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NET INCREASE IN CASH AND CASH EQUIVALENTS |
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CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
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CASH AND CASH EQUIVALENTS, END OF PERIOD |
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$ |
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$ |
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SUPPLEMENTAL DISCLOSURES OF CASH FLOW INFORMATION: |
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Cash paid during the period for interest |
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$ |
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$ |
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SUPPLEMENTAL INFORMATION AND DISCLOSURES OF NONCASH ACTIVITIES: |
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Common stock issued in connection with Helio Vision, Inc. acquisition milestone |
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$ |
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$ |
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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 devoted to developing and commercializing next-generation medicines to improve the lives of patients with immune-mediated diseases.
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, 2020, which was filed with the Securities and Exchange Commission on March 11, 2021 (the “2020 Form 10-K”).
The financial information as of September 30, 2021, and the three and nine months ended September 30, 2021 and 2020, 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, 2020 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, the Company believes that its cash and cash equivalents, as of September 30, 2021, will be sufficient to fund currently projected operating expenses through the end of 2023, including potential new drug application (“NDA”) submissions; initial commercialization of reproxalap, if approved; and continued early and late-stage development of our product candidates in ocular and systemic immune-mediated diseases. 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 Food and Drug Administration ("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.
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.
Use of Estimates
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Summary of Significant Accounting Policies
There were no changes to significant accounting policies during the nine months ended September 30, 2021, as compared to the those identified in the 2020 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