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Applied Therapeutics Inc (APLT) Reports Q3 2023 Financial Results Amidst Upcoming Clinical ...

  • Applied Therapeutics Inc (NASDAQ:APLT) announces Q3 2023 financial results and upcoming regulatory submissions for govorestat (AT-007).

  • Phase 3 trial readouts for ARISE-HF Trial of AT-001 and INSPIRE Trial of AT-007 expected in 4Q 2023 and 1Q 2024, respectively.

  • Company reports a net loss of $42.37 million for the quarter, with research and development expenses accounting for a significant portion.

  • APLT's cash and cash equivalents stood at $37.457 million as of September 30, 2023.

On November 9, 2023, Applied Therapeutics Inc (NASDAQ:APLT), a clinical-stage biopharmaceutical company, reported its financial results for the third quarter ended September 30, 2023. The company is actively preparing for regulatory submissions for govorestat (AT-007) in the treatment of Classic Galactosemia to the US FDA and EMA in the fourth quarter of 2023. Additionally, APLT is anticipating the results of two Phase 3 trials, ARISE-HF and INSPIRE, which are expected to be released in the fourth quarter of 2023 and the first quarter of 2024, respectively.

Financial Performance Overview

During the third quarter, APLT reported a net loss of $42.37 million, or $0.47 per share, compared to a net loss of $19.101 million, or $0.40 per share, in the same period last year. The increase in net loss was primarily due to a significant change in the fair value of warrant liabilities, which amounted to a loss of $27.277 million. Research and development expenses were $10.785 million, a decrease from $13.116 million in the third quarter of 2022, reflecting the company's continued investment in its pipeline. General and administrative expenses also decreased to $4.710 million from $6.240 million year-over-year.

Balance Sheet and Cash Flow

APLT's balance sheet showed cash and cash equivalents of $37.457 million as of September 30, 2023, an increase from $16.657 million as of December 31, 2022. The total assets were reported at $45.195 million, while total liabilities stood at $56.239 million, resulting in a stockholders' deficit of $11.044 million. The company's accumulated deficit increased to $430.907 million, up from $348.823 million at the end of the previous year.

Management Commentary

Dr. Shoshana Shendelman, Founder, CEO, and Chair of the Board of Applied Therapeutics, commented on the company's progress, stating:

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. 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.

Looking Ahead

Applied Therapeutics continues to focus on advancing its pipeline of novel drug candidates. The upcoming regulatory submissions and trial readouts are critical milestones that could significantly impact the company's trajectory. Investors and stakeholders will be closely monitoring these developments as they unfold.

For more detailed information on Applied Therapeutics Inc's financial results and future prospects, please visit GuruFocus.com.

Explore the complete 8-K earnings release (here) from Applied Therapeutics Inc for further details.

This article first appeared on GuruFocus.

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