Check the appropriate box below if the Form 8-K filing is
intended to simultaneously satisfy the filing obligation of the
registrant under any of the following provisions:
Indicate by check mark whether the registrant is an emerging growth
company as defined in Rule 405 of the Securities Act of 1933
(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange
Act of 1934 (§240.12b-2 of this chapter).
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.
☐
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Item 1.01.
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Entry into a
Material Definitive Agreement.
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On December 22, 2022, Aldeyra Therapeutics, Inc. (“Aldeyra” or the
“Company”) entered into the Second Amendment (the “Second
Amendment”) to Loan and Security Agreement, which is effective as
of December 31, 2022 (the “Effective Date”) and amended that
certain Loan and Security Agreement, dated as of March 25, 2019, by
and among the Company, Helio Vision, LLC, the several banks and
other financial institutions or entities from time to time parties
thereto (the “Lenders”) and Hercules Capital, Inc., in its capacity
as administrative agent and collateral agent for itself and the
Lenders (the “Original Loan Agreement” and as previously amended
and as amended by the Second Amendment, the “Loan
Agreement”).
The Second Amendment makes certain changes to the Loan Agreement,
including, among other things, (i) extending the expiration of the
period in which interest-only payments on borrowings under the Loan
Agreement are made from May 1, 2023 to May 1, 2024; (ii) extending
the Term Loan Maturity Date (as defined in the Loan Agreement) from
October 1, 2023 to October 1, 2024; (iii) extending the
availability of the fourth term loan tranche commitment of $20
million from May 1, 2023 to May 1, 2024; and (iv) amending the
Prepayment Charge (as defined in the Loan Agreement) to equal 0.75%
of the amount prepaid during the 12-month period following the
Effective Date, and 0% thereafter. In addition, a supplemental end
of term charge of $292,500 shall be due on the earlier of (A) Term
Loan Maturity Date, as amended, or (B) repayment of the outstanding
Advances. The existing end of term charge of $1,042,500 remains due
on the earlier of (A) October 1, 2023 or (B) repayment of the
outstanding Advances. The ability to draw the fourth term loan
tranche commitment remains conditioned on approval by the Lenders’
investment committee.
The foregoing summary of the Original Loan Agreement and the Second
Amendment does not purport to be complete and is qualified in its
entirety by the complete text of the Original Loan Agreement and
the Second Amendment, which are filed as Exhibit 10.1 and 10.2,
respectively, to this Current Report on Form 8-K and are
incorporated herein by reference.
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Item 2.03.
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Creation of a
Direct Financial Obligation or an Obligation under an Off-Balance
Sheet Arrangement of a Registrant.
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The information provided in Item 1.01 of this Current Report on
Form 8-K is incorporated herein by reference.
Based on its current operating plans, as a result of the Second
Amendment disclosed in Item 1.01 above, Aldeyra believes that its
existing cash, cash equivalents, and marketable securities will now
be sufficient to fund the Company into the second half of 2024. The
current operating plan and use of funds includes initial
commercialization and launch plans for reproxalap and ADX-2191, if
approved; and continued early and late-stage development of the
Aldeyra’s product candidates in ocular and systemic immune-mediated
diseases.
Various
statements contained in this Current Report on
Form 8-K are “forward-looking statements”
under the securities laws, including, but not limited to,
statements regarding Aldeyra’s operating plans and expectations
regarding the sufficiency and uses of its existing cash, cash
equivalents, and marketable securities . In some cases, you can
identify forward looking statements by terms such
as, but not limited to, “may,” “might,” “will,” “objective,”
“intend,” “should,” “could,” “can,” “would,” “expect,” “believe,”
“anticipate,” “project,” “on track,” “scheduled,” “target,”
“design,” “estimate,” “predict,” “potential,” “aim,” “plan” or the
negative of these terms, and similar expressions intended to
identify forward-looking statements.
Such forward-looking statements are based upon
current expectations that involve risks, changes in circumstances,
assumptions, and uncertainties.
Important factors that could cause actual results to differ
materially from those reflected in Aldeyra's forward-looking statements include, among
others, the timing of enrollment, commencement and completion of
Aldeyra's clinical trials, the timing and success of preclinical
studies and clinical trials conducted by Aldeyra and its
development partners; delay in or failure to obtain regulatory
approval of Aldeyra's product candidates, including as a result of
the FDA not accepting Aldeyra’s regulatory filings, requiring
additional clinical trials or data prior to review or approval of
such filings; the ability to maintain regulatory approval of
Aldeyra's product candidates, and the labeling for any approved
products; the risk that prior results, such as signals of safety,
activity, or durability of effect, observed from preclinical or
clinical trials, will not be replicated or will not continue in
ongoing or future studies or clinical trials involving Aldeyra's
product candidates; the scope, progress, expansion, and costs of
developing and commercializing Aldeyra's product candidates; the
current and potential future impact of the COVID-19 pandemic on
Aldeyra’s business, results of operations, and financial position;
uncertainty as to Aldeyra’s ability to commercialize (alone or with
others) and obtain reimbursement for Aldeyra's product candidates
following regulatory approval, if any; the size and growth of the
potential markets and pricing for Aldeyra's product candidates and
the ability to serve those markets; Aldeyra's expectations
regarding Aldeyra's expenses and revenue, the sufficiency or use of
Aldeyra's cash resources and needs for additional financing; the
rate and degree of market acceptance of any of Aldeyra's product
candidates; Aldeyra's expectations regarding competition; Aldeyra's
anticipated growth strategies; Aldeyra's ability to attract or
retain key personnel; Aldeyra’s limited sales and marketing
infrastructure; Aldeyra's ability to establish and maintain
development partnerships; Aldeyra’s ability to successfully
integrate acquisitions into its business; Aldeyra's expectations
regarding federal, state, and foreign regulatory requirements;
political, economic, legal, social, and health risks, including the
COVID-19 pandemic and subsequent public health measures, and war or
other military actions, that may affect Aldeyra’s business or the
global economy; regulatory developments in the United States and
foreign countries; Aldeyra's ability to obtain and maintain
intellectual property protection for its product candidates; the
anticipated trends and challenges in Aldeyra's business and the
market in which it operates; and other factors that are described
in the "Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of
Aldeyra's Annual Report on Form 10-K for the year ended December
31, 2021, and Aldeyra’s Quarterly Report on Form 10-Q for the
quarter ended September 30, 2022, which are on file with the
Securities and Exchange Commission (SEC) and available on the SEC's
website at https://www.sec.gov/. In addition to the risks described
above and in Aldeyra’s other filings with the SEC, other unknown or
unpredictable factors also could affect Aldeyra’s results.
No forward-looking statements can be
guaranteed and actual results may differ materially from such
statements. The information conveyed this Current Report on Form
8-K is provided only as of the date hereof, and Aldeyra undertakes
no obligation to update any forward-looking statements included
herein on account of new information, future events, or otherwise,
except as required by law.
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Item 9.01.
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Financial
Statements and Exhibits.
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(d) Exhibits
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Exhibit
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Description
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104
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Cover Page Interactive Data File
(embedded within the Inline XBRL document)
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