On May 11, 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,reported financial results for the first quarter ended March 31, 2023 (Press release, Applied Therapeutics, MAY 11, 2023, View Source [SID1234631485]).
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"We are committed to bringing transformative therapies to patients with debilitating diseases and no treatment options, including Galactosemia, SORD Deficiency and Diabetic Cardiomyopathy," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "We look forward to discussing our recent Galactosemia data with regulatory agencies and potentially moving towards approval of govorestat for Galactosemia later this year. We are also excited about our upcoming data readouts in SORD Deficiency and Diabetic Cardiomyopathy. Our recent financing helps to strengthen the balance sheet to support advancement of our clinical programs towards commercialization."
Recent Highlights
· Announced Long-term Clinical Benefit of Govorestat (AT-007) in the Phase 3 ACTION-Galactosemia Kids Trial. In April 2023, the Company announced consistent long-term clinical benefit from the ACTION-Galactosemia Kids Phase 3 study of govorestat. Treatment with govorestat demonstrated consistent and sustained clinical benefit on activities of daily living, behavioral symptoms, cognition, adaptive behavior and tremor. Consistent with prior reported data, improvement in galactitol levels was sustained throughout the trial with no impact on Gal-1p or galactose, further establishing the causal role of galactitol in disease pathogenesis. The Company believes that there is compelling evidence of clinical efficacy and plans to request a pre-NDA meeting, with a potential NDA submission in the second half of 2023. The Company also plans to submit an MAA in mid-2023 for potential European approval.
· Closed $30 Million Private Placement of Equity, Strengthening the Company’s Balance Sheet. In April 2023, the Company announced the sale of shares of the Company’s common stock and pre-funded warrants to purchase common stock in a private placement led by Venrock, resulting in approximately $30 million of gross proceeds, before deducting placement agent commissions and other offering expenses, to the Company. The Company believes that the capital raised in the private placement, in addition to current cash and potential milestones expected from the Advanz European licensing partnership, is expected to fund the business through the middle of 2024.
Financial Results
· Cash and cash equivalents and short-term investments totaled $22.9 million as of March 31, 2023, compared with $30.6 million at December 31, 2022. The Company raised an additional $30 million of gross proceeds, before deducting placement agent commissions and other offering expenses, through a private placement in April 2023.
· Research and development expenses for the three months ended March 31, 2023 were $15.9 million, compared to $15.0 million for the three months ended March 31, 2022. The increase of approximately $0.9 million was primarily related to an increase in clinical and pre-clinical expense of $0.3 million, primarily due to the progression of the SORD Phase 3 registrational study; an increase in drug manufacturing and formulation costs of $1.0 million primarily related to purchase of raw materials in the three months ended March 31, 2023; a decrease in personnel expenses of $0.2 million due to the decrease in headcount; an increase in stock-based compensation of $6,000 due to new restricted stock grants; and a decrease in regulatory and other expenses of $0.2 million.
· General and administrative expenses were $5.6 million for the three months ended March 31, 2023, compared to $8.1 million for the three months ended March 31, 2022. The decrease of approximately $2.5 million was primarily related to a decrease in legal and professional fees of $0.1 million due to lower external legal fees; a decrease in commercial expenses of $1.1 million related to a decrease in spend for commercial operations; a decrease in personnel expenses of $0.5 million related to a decrease in headcount; a decrease in stock-based compensation of $29,000 relating to options being forfeited during the current period as well as decrease in headcount; a decrease in insurance expenses of $0.3 million related to decreased insurance costs; and a decrease in other expenses of $0.3 million relating to decreased costs of other office expenses.
· Net loss for the first quarter of 2023 was $10.1 million, or $0.18 per basic and diluted common share, compared to a net loss of $23.1 million, or $0.88 per basic and diluted common share, for the first quarter 2022.