Applied Therapeutics Reports Fourth Quarter and Year-end 2019 Financial Results
13 Marzo 2020 - 12:00PM
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 reported financial results for the
fourth quarter and full year ended December 31, 2019.
“This past year was a transformative time for
Applied Therapeutics. In addition to our transition to a public
company, we completed two additional financings, and made
significant progress in our clinical development programs in
Diabetic Cardiomyopathy and Galactosemia – both devastating
diseases with no treatment options available,” said Shoshana
Shendelman, Ph.D., Founder, CEO and Chair of the Board
of Applied Therapeutics. “With positive results from our
pivotal Phase 2 ACTION-Galactosemia study in hand, we plan to move
quickly towards regulatory filing, while preparing for Galactosemia
commercial launch and growing our organization. On our Diabetic
Cardiomyopathy program, we remain on track to fully enroll our
Phase 3 registrational study this year, as we continue to advance
this potential blockbuster opportunity. Throughout 2020 we’ll
continue to move additional candidates into the clinic, while
expanding our pipeline – delivering on our core strategy of
applying technological advances to high unmet need
indications.”
Recent Highlights
- Closed $143.4 Million
Underwritten Public Offering. In January 2020, we
completed an underwritten public offering of common stock at a
price to the public of $45.50 per share, resulting in
gross proceeds of approximately $143.4 million.
- Announced Positive Topline
Results of Pivotal Phase 2 ACTION-Galactosemia Study. In
January 2020, we announced positive topline results from the
Pivotal Phase 2 portion of the ACTION-Galactosemia study of AT-007,
a central nervous system (CNS) penetrant Aldose Reductase inhibitor
(ARI), in adult Galactosemia patients. AT-007 treatment resulted in
a statistically significant and robust reduction in plasma
galactitol vs placebo in adult Galactosemia patients, and AT-007
was well tolerated, with no drug-related adverse events noted. We
plan to utilize recent FDA guidance permitting biomarker-based
development in low prevalence, slowly progressing rare metabolic
diseases, such as Galactosemia, and expect to file for regulatory
approval in the second half of 2020. We plan to present the full
data from the ACTION-Galactosemia trial at the Society for
Inherited Metabolic Disorders Annual Meeting, being held April
26 – 29 in Austin, Texas.
- Presented Pre-Clinical Data
Highlighting AT-001 for Treatment of Diabetic Cardiomyopathy at the
World Congress on Insulin Resistance, Diabetes & Cardiovascular
Disease (WCIRDC). In December 2019, we presented
pre-clinical data on AT-001, a novel, potent and selective Aldose
Reductase inhibitor (ARI) in Phase 3 clinical development for
Diabetic Cardiomyopathy at WCIRDC in Los Angeles, California. The
data showed a head to head comparison of AT-001 vs a
first-generation ARI and highlights the improvements over these
prior ARIs.
- Presented Study Design and
Rationale for the ARISE-HF Pivotal Study of AT-001 for Treatment of
Diabetic Cardiomyopathy at the 16th Annual Global Cardiovascular
Clinical Trialist’s Forum (CVCT). In December 2019, we
presented the study design and rationale for our ongoing ARISE-HF
study at CVCT in Washington, D.C. ARISE-HF is a Phase 3 pivotal
study examining effects of AT-001 on functional capacity (as
measured by peak V02) in patients with Diabetic Cardiomyopathy at
high risk of progression. We expect to announce topline data from
the ARISE-HF trial in 2021.
- Presented Clinical Data
Highlighting AT-001 for the Treatment of Diabetic Cardiomyopathy at
the American Heart Association (AHA) Scientific Sessions
2019. In November 2019, we presented clinical data on
AT-001 at AHA 2019 in Philadelphia, Pennsylvania. The data
presented support our clinical rationale for development of AT-001
in Diabetic Cardiomyopathy by showing a reduction in NTproBNP, an
important cardiac stress biomarker shown to correlate with long
term heart failure outcomes and a strong preliminary indicator of
efficacy in this patient population.
Financial Results
- Cash and cash equivalents
and short-term investments totaled $38.9 million as of
December 31, 2019, compared with $18.8 million at December 31,
2018. This does not include approximately $143.4 million in gross
process we received from an underwritten public offering of common
stock in January 2020.
- Research and development
expenses for the year-ended December 31, 2019 were $32.4
million, compared to $11.5 million for the year ended December 31,
2018. The increase of approximately $20.9 million was primarily
related to increased activity on our clinical trials, including an
increase in clinical and pre‑clinical expenses of
$12.4 million and drug manufacturing and formulation expenses
of $4.1 million, an increase in personnel expenses of
$4.6 million that is allocated to research and development,
offset by a decrease in regulatory and other expenses of $0.2
million.
- General and administrative
expenses were $13.2 million for the year ended December
31, 2019, compared to $2.0 million for the year ended December 31,
2018. The increase of approximately $11.2 million was primarily
related to the increase of personnel expenses of $4.4 million
due to the portion of the chief executive officer’s salary that is
allocated to general and administrative and the hiring of other
personnel, including the chief financial officer, and an increase
in professional and legal fees of $3.5 million due to the
closing of multiple financings and increased IP work, and an
increase in other expenses of $3.2 million, primarily due to
recruiting efforts for the chief medical officer and rent.
- Net loss for year
ended December 31, 2019 was $45.5 million, or $3.55 per basic and
diluted common share, compared to a net loss of $16.5 million, or
$3.01 per basic and diluted common share, for the year ended
December 31, 2018.
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,
is a novel central nervous system penetrant aldose reductase
inhibitor (ARI) for the treatment of Galactosemia, a rare pediatric
metabolic disease. The Company initiated a Phase 1/2 clinical trial
in June 2019 and read out positive top-line biomarker data in adult
Galactosemia patients in January of 2020. The Company is also
developing AT-001, a novel potent ARI that is being developed for
the treatment of Diabetic Cardiomyopathy, or DbCM, a fatal fibrosis
of the heart. The Company initiated a Phase 3 registrational study
in DbCM in September 2019. 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, expected
to advance into a Phase 1 study in 2020, as well as novel dual PI3k
inhibitors in preclinical development for orphan oncology
indications.
Forward-Looking StatementsThis
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 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. These include, without limitation,
statements regarding (i) our plan to move quickly towards
regulatory filing following our pivotal Phase 2 ACTION-Galactosemia
study, while preparing for Galactosemia commercial launch and
growing our organization, (ii) the timing of the initiation and
completion of our clinical trials, (iii) the likelihood that data
from our clinical trials will support future development of our
product candidates, and (iv) the likelihood of obtaining regulatory
approval of our product candidates and qualifying for any special
designations, such as orphan drug designation. 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 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, (vi) our ability to maintain and establish
collaborations or obtain additional funding, (vii) our ability to
obtain regulatory approval of our current and future product
candidates, (viii) our expectations regarding the potential market
size and the rate and degree of market acceptance of such product
candidates, (ix) our ability to fund our working capital
requirements and expectations regarding the sufficiency of our
capital resources, (x) the implementation of our business model and
strategic plans for our business and product candidates, (xi) our
intellectual property position and the duration of our patent
rights, (xii) developments or disputes concerning our intellectual
property or other proprietary rights, (xiii) our expectations
regarding government and third-party payor coverage and
reimbursement, (xiv) our ability to compete in the markets we
serve, (xv) the impact of government laws and regulations and
liabilities thereunder, (xvi) developments relating to our
competitors and our industry and (xvii) 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:Trammy Lai(917) 297-5956
ormedia@appliedtherapeutics.com
|
Applied Therapeutics, Inc. |
Statement of Operations |
|
|
|
Year Ended December 31, |
|
|
2019 |
|
2018 |
OPERATING EXPENSES: |
|
|
|
|
|
|
Research and development |
|
$ |
32,350 |
|
|
$ |
11,471 |
|
General and administrative |
|
|
13,232 |
|
|
|
2,047 |
|
Total operating expenses |
|
|
45,582 |
|
|
|
13,518 |
|
LOSS FROM OPERATIONS |
|
|
(45,582 |
) |
|
|
(13,518 |
) |
OTHER INCOME (EXPENSE), NET: |
|
|
|
|
|
|
Interest income (expense), net |
|
|
93 |
|
|
|
(1,642 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
(221 |
) |
Other income (expense) |
|
|
(24 |
) |
|
|
(1,140 |
) |
Total other income (expense), net |
|
|
69 |
|
|
|
(3,003 |
) |
Net loss |
|
$ |
(45,513 |
) |
|
$ |
(16,521 |
) |
Net loss attributable to common stockholders—basic and diluted |
|
$ |
(45,513 |
) |
|
$ |
(16,521 |
) |
Net loss per share attributable to common stockholders—basic and
diluted |
|
$ |
(3.55 |
) |
|
$ |
(3.01 |
) |
Weighted-average common stock outstanding—basic and diluted |
|
|
12,831,221 |
|
|
|
5,483,149 |
|
Applied Therapeutics, Inc. |
Balance Sheet |
|
|
|
As of December 31, |
|
As of December 31, |
|
|
2019 |
|
2018 |
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
18,850 |
|
|
$ |
18,748 |
|
Prepaid expenses and other current assets |
|
|
7,301 |
|
|
|
1,498 |
|
Investments |
|
|
20,004 |
|
|
|
— |
|
Total current assets |
|
|
46,155 |
|
|
|
20,246 |
|
Operating lease right-of-use asset |
|
|
2,035 |
|
|
|
— |
|
Security deposits and leasehold improvements |
|
|
199 |
|
|
|
— |
|
TOTAL ASSETS |
|
$ |
48,389 |
|
|
$ |
20,246 |
|
LIABILITIES AND STOCKHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
|
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Current portion of operating lease liabilities |
|
|
356 |
|
|
|
— |
|
Accounts payable |
|
|
8,793 |
|
|
|
3,015 |
|
Accrued expenses and other current liabilities |
|
|
4,950 |
|
|
|
1,413 |
|
Total current liabilities |
|
|
14,099 |
|
|
|
4,428 |
|
CURRENT LIABILITIES: |
|
|
|
|
|
|
Noncurrent portion of operating lease liabilities |
|
|
1,683 |
|
|
|
— |
|
Total liabilities |
|
|
15,782 |
|
|
|
4,428 |
|
Series A convertible preferred stock, $0.0001 par value; 0
shares and 3,093,898 shares authorized at December 31, 2019
and December 31, 2018, respectively; 0 shares and
3,093,898 shares issued and outstanding at December 31, 2019
and December 31, 2018, respectively; liquidation
preference of $0 and $7,000 at December 31, 2019 and
December 31, 2018, respectively |
|
|
— |
|
|
|
6,254 |
|
Series B convertible preferred stock, $0.0001 par value; 0
shares and 7,790,052 shares authorized as of December 31, 2019
and December 31, 2018, respectively; 0 shares
and 4,001,848 shares issued and outstanding as of December
31, 2019 and December 31, 2018, respectively;
liquidation preference of $0 and $29,964 as of December
31, 2019 and December 31, 2018, respectively |
|
|
— |
|
|
|
29,156 |
|
STOCKHOLDERS’ EQUITY (DEFICIT): |
|
|
|
|
|
|
Common stock, $0.0001 par value; 100,000,000 and 20,441,982 shares
authorized as of December 31, 2019 and
December 31, 2018, respectively; 18,531,560 shares and
5,513,531 shares issued and outstanding as of December
31, 2019 and December 31, 2018, respectively |
|
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
|
99,378 |
|
|
|
1,665 |
|
Accumulated other comprehensive loss |
|
|
(2 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(66,770 |
) |
|
|
(21,257 |
) |
Total stockholders' equity (deficit) |
|
|
32,607 |
|
|
|
(19,592 |
) |
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’
EQUITY (DEFICIT) |
|
$ |
48,389 |
|
|
$ |
20,246 |
|
|
|
|
|
|
|
|
|
|
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