Full Press Release Details
Applied Therapeutics Reports Third Quarter 2023
Regulatory submissions on track for govorestat
(AT-007) for the treatment of Classic Galactosemia to US FDA and EMA in 4Q 2023
Two Upcoming Phase 3 Trial Readouts, with ARISE-HF
Trial of AT-001 (caficrestat) in Diabetic Cardiomyopathy on track for data readout in 4Q 2023 and INSPIRE Trial of AT-007 trial in Sorbitol
Dehydrogenase (SORD) Deficiency in 1Q 2024
NEW YORK, November 9, 2023 - 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 third quarter ended September 30,
"We have continued to make progress across our late-stage pipeline
and have several key regulatory and clinical inflection points expected later this quarter and in early 2024," said Shoshana Shendelman,
PhD, Founder, Chief Executive Officer, and Chair of the Board. "We are working expeditiously to submit our regulatory filings for
govorestat (AT-007) for the treatment of Classic Galactosemia in both the U.S. and in Europe and look forward to providing updates as
those submissions occur. In tandem, we are soon approaching Phase 3 readouts for our ARISE-HF Trial of AT-001 (caficrestat) in Diabetic
Cardiomyopathy (DbCM) and our INSPIRE Trial of AT-007 trial in Sorbitol Dehydrogenase (SORD) Deficiency, which are expected in 4Q23 and
in 1Q24, respectively."
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," 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 timing of data
readouts for our ARISE-HF and INSPIRE trials, (ii) the timing of our plans to submit an NDA and MAA for approval. 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, (xvii) 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
Applied Therapeutics, Inc.
Condensed Balance Sheets
(in thousands, except share and per share data)
| As of | As of | |||||||
| September 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | ||||||||
| ASSETS | ||||||||
| CURRENT ASSETS: | ||||||||
| Cash and cash equivalents | $ | 37,457 | $ | 16,657 | ||||
| Investments | - | 13,923 | ||||||
| Prepaid expenses and other current assets | 7,031 | 6,728 | ||||||
| Total current assets | 44,488 | 37,308 | ||||||
| Operating lease right-of-use asset | 510 | 857 | ||||||
| Security deposits and leasehold improvements | 197 | 198 | ||||||
| TOTAL ASSETS | $ | 45,195 | $ | 38,363 | ||||
| LIABILITIES AND STOCKHOLDERS' (DEFICIT)/EQUITY | ||||||||
| CURRENT LIABILITIES: | ||||||||
| Current portion of operating lease liabilities | $ | 491 | $ | 477 | ||||
| Accounts payable | 6,005 | 4,534 | ||||||
| Accrued expenses and other current liabilities | 12,245 | 14,756 | ||||||
| Warrant liabilities | 36,763 | 13,657 | ||||||
| Total current liabilities | 55,504 | 33,424 | ||||||
| NONCURRENT LIABILITIES: | ||||||||
| Noncurrent portion of operating lease liabilities | 44 | 414 | ||||||
| Clinical holdback - long-term portion | 691 | 464 | ||||||
| Total noncurrent liabilities | 735 | 878 | ||||||
| Total liabilities | 56,239 | 34,302 | ||||||
| STOCKHOLDERS' (DEFICIT)/EQUITY: | ||||||||
| Common stock, $0.0001 par value; 200,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 77,133,516 shares issued and outstanding as of September 30, 2023 and 48,063,358 shares issued and outstanding as of December 31, 2022 | 7 | 5 | ||||||
| Preferred stock, par value $0.0001; 10,000,000 shares authorized as of September 30, 2023 and December 31, 2022; 0 shares issued and outstanding as of September 30, 2023 and December 31, 2022 | - | - | ||||||
| Additional paid-in capital | 419,856 | 352,828 | ||||||
| Accumulated other comprehensive gain | - | 51 | ||||||
| Accumulated deficit | (430,907 | ) | (348,823 | ) | ||||
| Total stockholders' (deficit)/equity | (11,044 | ) | 4,061 | |||||
| TOTAL LIABILITIES AND STOCKHOLDERS' (DEFICIT)/EQUITY | $ | 45,195 | $ | 38,363 |
Applied Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| REVENUE: | ||||||||||||||||
| License Revenue | $ | - | $ | - | $ | 10,660 | $ | - | ||||||||
| Total Revenue | - | - | 10,660 | - | ||||||||||||
| OPERATING EXPENSES: | ||||||||||||||||
| Research and development | $ | 10,785 | $ | 13,116 | $ | 38,602 | $ | 43,542 | ||||||||
| General and administrative | 4,710 | 6,240 | 15,585 | 20,436 | ||||||||||||
| Total operating expenses | 15,495 | 19,356 | 54,187 | 63,978 | ||||||||||||
| LOSS FROM OPERATIONS | (15,495 | ) | (19,356 | ) | (43,527 | ) | (63,978 | ) | ||||||||
| OTHER INCOME (EXPENSE), NET: | ||||||||||||||||
| Interest income | 392 | 227 | 1,020 | 414 | ||||||||||||
| Change in fair value of warrant liabilities | (27,277 | ) | 36 | (39,611 | ) | (4,321 | ) | |||||||||
| Other income (expense): | 10 | (8 | ) | 34 | (194 | ) | ||||||||||
| Total other income (expense), net | (26,875 | ) | 255 | (38,557 | ) | (4,101 | ) | |||||||||
| Net loss | $ | (42,370 | ) | $ | (19,101 | ) | $ | (82,084 | ) | $ | (68,079 | ) | ||||
| Net loss attributable to common stockholders-basic and diluted | $ | (42,370 | ) | $ | (19,101 | ) | $ | (82,084 | ) | $ | (68,079 | ) | ||||
| Net loss per share attributable to common stockholders-basic and diluted | $ | (0.47 | ) | $ | (0.40 | ) | $ | (1.09 | ) | $ | (2.02 | ) | ||||
| Weighted-average common stock outstanding-basic and diluted | 90,669,969 | 48,000,183 | 75,482,234 | 33,785,386 |