Full Press Release Details
Therapeutics Reports Fourth Quarter and Year-end 2019 Financial Results
YORK, March 13, 2020 - 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.
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."
Applied Therapeutics
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
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.
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
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 |
| 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' | $ | 48,389 | $ | 20,246 |