Full Press Release Details
Applied Therapeutics Reports Third Quarter 2019 Financial Results
NEW YORK, November 13, 2019 - Applied Therapeutics, Inc. (Nasdaq: APLT), a clinical-stage biopharmaceutical company developing novel drug candidates in indications of high unmet medical need, today reported financial results for the third quarter ended September 30, 2019.
The third quarter was a critical period of progress at Applied, and we are extremely pleased to have met all of our objectives, said Shoshana Shendelman, PhD, Founder, Chief Executive Officer and Chair of the Board of Applied Therapeutics. We are now in the final phase of development on both of our lead programs, having initiated our Phase 3 registrational study of AT-001 in Diabetic Cardiomyopathy (ARISE-HF) and transitioned into the Phase 2 portion of our Galactosemia trial (ACTION-Galactosemia) in the third quarter. We continue to maintain our momentum and remain on track to report pivotal data on our Galactosemia program by year end. Recently, we had an opportunity to broaden our shareholder base and strengthen the balance sheet through a private placement, providing us with additional cash runway as we move beyond development and into commercialization of our lead assets.
About Applied Therapeutics Inc.
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, AT-001, is a novel aldose reductase inhibitor (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. Applied Therapeutics is also developing AT-007, a central nervous system penetrant ARI, for the treatment of Galactosemia, a rare pediatric metabolic disease, and initiated a Phase 1/2 clinical trial in June 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.
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 (i) the design, scope and results of our clinical trials, (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, (iv) the likelihood of obtaining regulatory approval of our product candidates and qualifying for any special designations, such as orphan drug designation, (v) our cash runway and the timing of our clinical development plan. 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 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.
Applied Therapeutics, Inc.
Statement of Operations
| Three Months Ended | Nine Months Ended | |||||||||||
| September 30, | September 30, | |||||||||||
| 2019 | 2018 | 2019 | 2018 | |||||||||
| OPERATING EXPENSES: | ||||||||||||
| Research and development | $ | 7,453 | $ | 2,726 | $ | 18,582 | $ | 6,111 | ||||
| General and administrative | 3,294 | 598 | 9,331 | 1,418 | ||||||||
| Total operating expenses | 10,747 | 3,324 | 27,913 | 7,529 | ||||||||
| LOSS FROM OPERATIONS | (10,747) | (3,324) | (27,913) | (7,529) | ||||||||
| OTHER INCOME (EXPENSE), NET: | ||||||||||||
| Interest income (expense), net | 34 | (584) | 33 | (1,400) | ||||||||
| Other expense | (373) | (873) | ||||||||||
| Total other income (expense), net | 34 | (957) | 33 | (2,273) | ||||||||
| Net loss | $ | (10,713) | $ | (4,281) | $ | (27,880) | $ | (9,802) | ||||
| Net loss attributable to common stockholders basic and diluted | $ | (10,713) | $ | (4,281) | $ | (27,880) | $ | (9,802) | ||||
| Net loss per share attributable to common stockholders basic and diluted | $ | (0.63) | $ | (0.78) | $ | (1.98) | $ | (1.79) | ||||
| Weighted-average common stock outstanding basic and diluted | 17,095,870 | 5,497,871 | 14,085,579 | 5,473,414 |
Applied Therapeutics, Inc.
| As of | As of | |||||
| September 30, | December 31, | |||||
| 2019 | 2018 | |||||
| (Unaudited) | ||||||
| ASSETS | ||||||
| CURRENT ASSETS: | ||||||
| Cash and cash equivalents | $ | 13,065 | $ | 18,748 | ||
| Prepaid expenses and other current assets | 4,080 | 1,498 | ||||
| Investments | 19,889 | |||||
| Total current assets | 37,034 | 20,246 | ||||
| Other assets | 230 | |||||
| TOTAL ASSETS | $ | 37,264 | $ | 20,246 | ||
| LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) | ||||||
| CURRENT LIABILITIES: | ||||||
| Accounts payable | 1,688 | 3,015 | ||||
| Accrued expenses and other current liabilities | 4,829 | 1,413 | ||||
| Total current liabilities | 6,517 | 4,428 | ||||
| Total liabilities | 6,517 | 4,428 | ||||
| Series A convertible preferred stock, $0.0001 par value; 0 shares and 3,093,898 shares authorized at September 30, 2019 and December 31, 2018, respectively; 0 shares and 3,093,898 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively; liquidation preference of $0 and $7,000 at September 30, 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 September 30, 2019 and December 31, 2018, respectively; 0 shares and 4,001,848 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively; liquidation preference of $0 and $29,964 as of September 30, 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 September 30, 2019 and December 31, 2018, respectively; 17,134,190 shares and 5,513,531 shares issued and outstanding as of September 30, 2019 and December 31, 2018, respectively | 1 | |||||
| Additional paid-in capital | 79,872 | 1,665 | ||||
| Accumulated other comprehensive loss | 11 | |||||
| Accumulated deficit | (49,137) | (21,257) | ||||
| Total stockholders' equity (deficit) | 30,747 | (19,592) | ||||
| TOTAL LIABILITIES, CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (DEFICIT) | $ | 37,264 | $ | 20,246 |