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Applied Therapeutics' (APLT) Action-packed Journey From $10 To $40 In 4 Months

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Shares of Applied Therapeutics Inc. (APLT) touched an all-time high of $40.14 in intraday trading on Wednesday, a gain of over 50% from the previous day's close, thanks to the Company's positive phase II Galactosemia study results.

We had alerted our premium subscribers to APLT on September 3, 2019, when it was trading around $10. (Report titled "ACTION At Work…"). Had you bought the stock then, you would have made a gain of over 200% based on yesterday's closing price.

Before we get into the details of the study, here's what Galactosemia means…

Galactosemia is a devastating rare pediatric metabolic disease that affects how the body processes a simple sugar called galactose, and for which there is no known cure or approved treatment available. Galactose is found in foods, but the human body also naturally produces galactose on its own, so dietary restriction can't prevent the complications of this disease.

It is estimated that the U.S. Galactosemia population is approximately 2,800 patients. Galactosemia causes life-threatening complications within a few days of birth if it is not promptly treated. Symptoms include feeding difficulties, lethargy, failure to thrive, jaundice, liver damage, and abnormal bleeding. Serious complications can include sepsis and shock. Children affected also have an increased risk of delayed development, cataract, speech difficulties, intellectual disability, and premature ovarian insufficiency.

Applied Therapeutics' investigational drug for Galactosemia is AT-007, which is under a phase I/II study, dubbed ACTION-Galactosemia.

In August 2019, the Company announced data from the healthy volunteer portion of the ACTION-Galactosemia study, demonstrating that AT-007 was well tolerated, with no drug-related adverse events or dose-limiting toxicities.

The results reported Wednesday (Jan.8, 2020) were from the phase II portion of the study, and it demonstrated that AT-007 treatment resulted in a statistically significant and robust reduction in plasma galactitol vs placebo in adult Galactosemia patients. Galactitol is an aberrant toxic metabolite of galactose, formed by the enzyme aldose reductase in Galactosemia patients.

The Company expects to file for regulatory approval of AT-007 for Galactosemia in the second half of 2020.

The Company's lead drug candidate is AT-001 that is being developed for the treatment of Diabetic Cardiomyopathy, a rapidly progressing degenerative disorder of the heart muscle in people with diabetes.

In September 2019, Applied Therapeutics initiated a phase III registrational trial for AT-001 in Diabetic Cardiomyopathy, dubbed ARISE-HF. This study is expected to enroll approximately 675 patients.

Balance Sheet:

Net loss for the third quarter ended September 30, 2019, was $10.7 million or $0.63 per share compared to a net loss of $4.3 million or $0.78 per share for the third quarter of 2018. No revenues have been generated to date.

The Company ended the third quarter of 2019 with cash, cash equivalents and short-term investments of $33.0 million and raised gross proceeds of approximately $20 million in a private placement last November.

Applied Therapeutics went public on the Nasdaq Global Market on May 14, 2019, offering its shares at a price of $10.00 each. The IPO was a damp squib - with the stock opening at $8.40 and closing a tad higher at $9.40. A lot has changed since then and the shares were trading in the range of $11 to $29 until January 7, 2020.

APLT touched an all-time high of $40.14 in intraday trading yesterday (Jan.8, 2020) before closing at $35.18, up 34.48%.

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