Applied Therapeutics, Inc. (Nasdaq: APLT), 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 that it has entered into a
securities purchase agreement for a private placement of $100
million of equity.
The Company entered into a definitive securities
purchase agreement, dated as of February 27, 2024, for the sale of
12,285,714 shares of the Company’s common stock, par value $0.0001
per share at a purchase price of $7.00 per share (the “Shares”) and
2,000,000 pre-funded warrants to purchase common stock at a
purchase price of $6.999, which is equal to 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 is expected to result
in gross proceeds to the Company of approximately $100 million,
before deducting placement agent commissions and other offering
expenses.
The financing consisted of participation from
new and existing investors, including Perceptive Advisors, Janus
Henderson Investors, Venrock Healthcare Capital Partners, Adage
Capital Partners, Frazier Life Sciences, Logos Capital, Vestal
Point Capital, and Rock Springs Capital.
The Private Placement is expected to close on or
about March 1, 2024, 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 commercial activities for govorestat (AT-007) and to further
develop other 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 its Advanz European licensing partnership, are
expected to fund the business into 2026.
Leerink Partners, RBC Capital Markets, Baird,
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.
Company Update
The Company also provided an update on its cash
balance and share count. As of February 23, 2024, the Company had
$43.6 million in cash and cash equivalents, 90,101,117 shares of
common stock issued and outstanding, 49,301,676 exercisable
warrants, including 19,225,000 common warrants, 29,951,058
pre-funded warrants and 125,618 pre-IPO warrants, 4,695,619 options
to purchase common stock outstanding and 6,918,422 restricted stock
units.
About Applied
Therapeutics
Applied 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, 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
Statements
This press release contains
“forward-looking statements” that involve substantial risks and
uncertainties for purposes of the safe harbor provided by the
Private Securities Litigation Reform Act of 1995. Any statements,
other than statements of historical fact, included in this press
release regarding the strategy, future operations, prospects, plans
and objectives of management, including words such as “may,”
“will,” “expect,” “anticipate,” “plan,” “intend,” “predicts” and
similar expressions (as well as other words or expressions
referencing future events, conditions or circumstances) are
forward-looking statements. These include, without limitation,
statements regarding the likelihood that the NDA submission will be
approved. These include, without limitation, statements regarding
the likelihood that the NDA submission will be approved.
Forward-looking statements in this release involve substantial
risks and uncertainties that could cause actual results to differ
materially from those expressed or implied by the forward-looking
statements, and we, therefore cannot assure you that our plans,
intentions, expectations or strategies will be attained or
achieved.
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, (xviii) 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
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