Applied Therapeutics Reports First Quarter 2019 Financial Results
-Strengthened Financial Position with Recent Initial Public Offering-
- Phase 1/2 Trial AT-007 in Adults with Galactosemia Expected to Start This Month -
- Pivotal Phase 2/3 Trial for AT-001 in Diabetic Cardiomyopathy Expected to Start Later This Year -
“Since the launch of
Recent Highlights
- Received FDA Orphan Drug Designation for AT-007 in Galactosemia. In
May 2019 , we received orphan drug designation for AT-007 in Galactosemia. The designation allows Applied Therapeutics to qualify for a number of incentives, including: seven years of market exclusivity upon regulatory approval, if received; exemption from FDA application fees for Galactosemia; and tax credits for qualified clinical trials. - Presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the
American Diabetes Association (ADA) 79th Annual Scientific Sessions inSan Francisco . InJune 2019 , we presented Phase 1/2 Data Highlighting Safety and Efficacy for AT-001 in DbCM at the ADA Annual Scientific Sessions. The data, presented as part of the Late Breaking session, demonstrated that AT-001 was well tolerated at all dose levels, and target engagement was confirmed by potent aldose reductase (AR) inhibition as evidenced by significant reductions in sorbitol, a pharmacodynamic biomarker of AR activity. AT-001 also improved selectivity and affinity for AR and resulted in potent AR inhibition.
- Presented Phase 1/2 Data Highlighting Safety and Proof of Biological Activity for AT-001 in DbCM at
The European Society for Cardiology (ESC) 6th WorldCongress inAthens, Greece . InMay 2019 , we presented two posters at ESC, the first of which was presented in the Late Breaking session and highlighted key data from a recently completed Phase 1/2 study in approximately 120 type 2 diabetic patients demonstrating the safety and proof of biological activity for AT-001 in DbCM. Supporting preclinical data from an animal model of DbCM was also presented, demonstrating that AT-001 prevents or reduces cardiac damage in a relevant disease model. - Completed Initial Public Offering. In
May 2019 , we completed our IPO, generating approximately$34.0 million in net proceeds, after deducting underwriting discounts and commissions and estimated offering expenses payable by us. - Announced Appointment of
Mark Vignola , PhD, as Chief Financial Officer. InApril 2019 , we announced the appointment ofMark Vignola , PhD, as Chief Financial Officer. Dr. Vignola served most recently as Head of Corporate Development & Investor Relations atIntercept Pharmaceuticals .
Financial Results
- Cash and cash equivalents totaled
$14.7 million as ofMarch 31, 2019 , compared with$18.7 million atDecember 31 , 2018. Subsequent to the close of the quarter, we completed an initial public offering resulting in net proceeds of approximately$34.0 million . - Research and development expenses for the three months ended March 31, 2019 were
$6.9 million , compared to$1.5 million for the three months ended March 31, 2018. The increase of approximately$5.4 million was primarily related to the progressing of our clinical trials through development, including an increase in clinical and pre‑clinical expenses of$4.1 million and drug manufacturing and formulation expenses of$0.7 million , and personnel expenses of$0.7 million due to the hiring of research and development personnel, including the Chief Medical Officer inAugust 2018 .
- General and administrative expenses were
$1.9 million for the three months ended March 31, 2019, compared to$0.4 million for the three months ended March 31, 2018. The increase of approximately$1.4 million was primarily related to professional fees of$0.7 million due to increased legal and consulting fees, personnel expenses of$0.4 million due to the hiring of other personnel, including the interim Chief Financial Officer and the Controller, and other expenses of$0.3 million , primarily due to public relations efforts, travel expenses and rent.
- Net loss for the first quarter of 2019 was
$8.7 million , or$1.58 per basic and diluted common share, compared to a net loss of$2.3 million , or$.43 per basic and diluted common share, for the first quarter of 2018.
About
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 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 the (i) our cash runway and acceleration of our clinical development plan, (ii) the likelihood data will support future development of our product candidates, (iii) qualification for exemptions resulting from the receipt of orphan drug designation and (iii) the expected timing of the initiation of our clinical trials. 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, the uncertainties inherent in the initiation, execution and completion of clinical trials, in the timing of availability of trial data, in the results of the clinical trials, in the actions of regulatory agencies, in the commercialization and acceptance of new therapies. 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
Investors:
(212) 600-1902 or
appliedtherapeutics@argotpartners.com
Media:
Applied Therapeutics, Inc. | |||||||||||||
Condensed Statements of Operations | |||||||||||||
(in thousands, except share and per share data) | |||||||||||||
(Unaudited) | Three Months Ended March 31, | ||||||||||||
2019 | 2018 | ||||||||||||
OPERATING EXPENSES: | |||||||||||||
Research and development | $ | 6,874 | $ | 1,448 | |||||||||
General and administrative | 1,855 | $ | 420 | ||||||||||
Total operating expenses | 8,729 | $ | 1,868 | ||||||||||
LOSS FROM OPERATIONS | (8,729 | ) | $ | (1,868 | ) | ||||||||
OTHER INCOME (EXPENSE), NET: | |||||||||||||
Interest income (expense), net | (1 | ) | $ | (281 | ) | ||||||||
Other expense | - | $ | (186 | ) | |||||||||
Total other income (expense), net | (1 | ) | $ | (467 | ) | ||||||||
Net loss | $ | (8,730 | ) | $ | (2,335 | ) | |||||||
Net loss attributable to common stockholders—basic and diluted |
$ | (8,730 | ) | $ | (2,335 | ) | |||||||
Net loss per share attributable to common stockholders—basic and diluted |
$ | (1.58 | ) | $ | (0.43 | ) | |||||||
Weighted-average common stock outstanding—basic and diluted | 5,513,531 | 5,458,450 | |||||||||||
Applied Therapeutics, Inc. | ||||||||||||
Condensed Balance Sheets | ||||||||||||
(in thousands, except share and per share data) | ||||||||||||
As of March 31, | As of December 31, | |||||||||||
2019 | 2018 | |||||||||||
(Unaudited) | ||||||||||||
ASSETS | ||||||||||||
CURRENT ASSETS: | ||||||||||||
Cash and cash equivalents | $ | 14,686 | $ | 18,748 | ||||||||
Prepaid expenses and other current assets | 2,186 | 1,498 | ||||||||||
Total current assets | 16,872 | 20,246 | ||||||||||
TOTAL ASSETS | $ | 16,872 | $ | 20,246 | ||||||||
LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT | ||||||||||||
CURRENT LIABILITIES: | ||||||||||||
Accounts payable | 2,649 | 3,015 | ||||||||||
Accrued expenses and other current liabilities | 3,679 | 1,413 | ||||||||||
Total current liabilities | 6,328 | 4,428 | ||||||||||
Total liabilities | 6,328 | 4,428 | ||||||||||
Series A convertible preferred stock, $0.0001 par value; 3,093,898 shares | ||||||||||||
authorized at March 31, 2019 and December 31, 2018; | ||||||||||||
3,093,898 shares issued and outstanding at March 31, 2019 | ||||||||||||
and December 31, 2018; liquidation preference | ||||||||||||
of $7,000 at March 31, 2019 and December 31, 2018; | 6,254 | 6,254 | ||||||||||
Series B convertible preferred stock, $0.0001 par value; 7,790,052 | ||||||||||||
shares authorized as of March 31, 2019 and December 31, 2018; | ||||||||||||
4,444,773 and 4,001,848 shares issued and outstanding as of | ||||||||||||
March 31, 2019 and December 31, 2018, respectively; | ||||||||||||
liquidation preference of $33,281 and $29,964 as of | ||||||||||||
March 31, 2019 and December 31, 2018, respectively; | 32,207 | 29,156 | ||||||||||
STOCKHOLDERS’ DEFICIT: | ||||||||||||
Common stock, $0.0001 par value; 20,441,982 shares authorized as of | ||||||||||||
March 31, 2019 and December 31, 2018; 5,513,531 shares issued | ||||||||||||
and outstanding as of March 31, 2019 and December 31, 2018 | - | - | ||||||||||
Additional paid-in capital | 2,070 | 1,665 | ||||||||||
Accumulated deficit | (29,987 | ) | (21,257 | ) | ||||||||
Total stockholders' deficit | (27,917 | ) | (19,592 | ) | ||||||||
TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT | $ | 16,872 | $ | 20,246 |
Source: Applied Therapeutics