Applied Therapeutics, Inc. (NASDAQ: APLT) (the “Company”), a
clinical-stage biopharmaceutical company developing a pipeline of
novel drug candidates against validated molecular targets in
indications of high unmet medical need, today announced it has
entered into a definitive securities purchase agreement, dated as
of April 23 2023, for the sale of 9,735,731 shares of the Company’s
common stock, par value $0.0001 per share at a purchase price of
$0.946 per share (the “Shares”) and 22,000,000 pre-funded warrants
to purchase common stock at a purchase price of $0.945, which equal
the purchase price per share of common stock less the $0.001 per
share exercise price of each pre-funded warrant (the “Pre-Funded
Warrants” and together with the Shares the “Securities”), in a
private placement (the “Private Placement”). The Private Placement
was led by new investor Venrock Healthcare Capital Partners and is
expected to result in gross proceeds to the Company of
approximately $30 million, before deducting placement agent
commissions and other offering expenses.
The Private Placement is expected to close on or about
April 26, 2023, subject to the satisfaction of customary
closing conditions. Additional details regarding the
Private Placement will be included in a Form 8-K to be filed by the
Company with the Securities and Exchange Commission (“SEC”).
The Company intends to use the net proceeds to fund research and
development and registration of its pipeline candidates, and for
working capital and general corporate purposes. The capital raised
in the Private Placement, in addition to current cash and potential
milestones expected from the Advanz European licensing
partnership, are expected to fund the business through the
middle of 2024.
SVB Securities and UBS Investment Bank acted as placement agents
in the transaction (the “Placement Agents”). Skadden, Arps, Slate,
Meagher & Flom LLP acted as legal counsel for the Company.
The Securities being sold in the Private Placement have not been
registered under the Securities Act of 1933, as amended, or state
securities laws and may not be offered or sold in the United States
absent registration with the SEC or an applicable exemption from
such registration requirements. The Company has agreed
to file a registration statement with the SEC covering the resale
of the Shares and the shares underlying the Pre-Funded Warrants
issuable in connection with the Private Placement.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy these securities, nor shall there
be any sale of these securities in any jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
jurisdiction.
About Applied TherapeuticsApplied Therapeutics
is a clinical-stage biopharmaceutical company developing a pipeline
of novel drug candidates against validated molecular targets in
indications of high unmet medical need. The Company’s lead drug
candidate, AT-007 (govorestat), is a novel central nervous system
penetrant Aldose Reductase Inhibitor (ARI) for the treatment of CNS
rare metabolic diseases, including Galactosemia, SORD Deficiency,
and PMM2-CDG. The Company is also developing AT-001, a novel potent
ARI, for the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal
fibrosis of the heart. The preclinical pipeline also includes
AT-003, an ARI designed to cross through the back of the eye when
dosed orally, for the treatment of Diabetic Retinopathy.
To learn more, please visit www.appliedtherapeutics.com and
follow the company on Twitter @Applied_Tx.
Forward-Looking StatementsCertain statements in
this press release including, without limitation, with respect to
the completion of the offering and the intended use of proceeds,
are forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and the Federal securities
laws. Statements, that are not statements of historical fact,
regarding the strategy, future operations, prospects, plans and
objectives of management, including words such as “may,” “will,”
“expect,” “anticipate,” “plan,” “intend,” and similar expressions
(as well as other words or expressions referencing future events,
conditions or circumstances) are forward-looking statements. The
Company cautions readers that these statements are subject to a
number of known and unknown risks, uncertainties and other factors,
many of which are beyond the Company’s ability to control or
predict, and any forward-looking statements in this release are not
a guarantee of future performance and actual results to differ
materially from those expressed or implied by the forward-looking
statements.
Such risks and uncertainties include, without limitation, (i)
our plans to develop, market and commercialize our product
candidates, (ii) the initiation, timing, progress and results of
our current and future preclinical studies and clinical trials and
our research and development programs, (iii) our ability to take
advantage of expedited regulatory pathways for any of our product
candidates, (iv) our estimates regarding expenses, future revenue,
capital requirements and needs for additional financing, (v) our
ability to successfully acquire or license additional product
candidates on reasonable terms and advance product candidates into,
and successfully complete, clinical studies, (vi) our ability to
maintain and establish collaborations or obtain additional funding,
(vii) our ability to obtain and timing of regulatory approval of
our current and future product candidates, (viii) the anticipated
indications for our product candidates, if approved, (ix) our
expectations regarding the potential market size and the rate and
degree of market acceptance of such product candidates, (x) our
ability to fund our working capital requirements and expectations
regarding the sufficiency of our capital resources, (xi) the
implementation of our business model and strategic plans for our
business and product candidates, (xii) our intellectual property
position and the duration of our patent rights, (xiii) developments
or disputes concerning our intellectual property or other
proprietary rights, (xiv) our expectations regarding government and
third-party payor coverage and reimbursement, (xv) our ability to
compete in the markets we serve, (xvi) the impact of government
laws and regulations and liabilities thereunder, (xvii)
developments relating to our competitors and our industry, (xvii)
our ability to achieve the anticipated benefits from the agreements
entered into in connection with our partnership with Advanz Pharma
and (xiv) other factors that may impact our financial results. In
light of the significant uncertainties in these forward-looking
statements, you should not rely upon forward-looking statements as
predictions of future events. Although we believe that we have a
reasonable basis for each forward-looking statement contained in
this press release, we cannot guarantee that the future results,
levels of activity, performance or events and circumstances
reflected in the forward-looking statements will be achieved or
occur at all. Factors that may cause actual results to differ from
those expressed or implied in the forward-looking statements in
this press release are discussed in our filings with the U.S.
Securities and Exchange Commission, including the “Risk Factors”
contained therein. Except as otherwise required by law, we disclaim
any intention or obligation to update or revise any forward-looking
statements, which speak only as of the date they were made, whether
as a result of new information, future events or circumstances or
otherwise.
Contacts
Investors: Maeve Conneighton(212) 600-1902
orappliedtherapeutics@argotpartners.com
Media: media@appliedtherapeutics.com
Applied Therapeutics, Inc.
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