Applied Therapeutics Stock Price, News & Analysis

Applied Therapeutics, a clinical-stage biopharmaceutical company, has announced a definitive securities purchase agreement for the private placement of 9,735,731 shares of common stock at $0.946 each and 22,000,000 pre-funded warrants at $0.945, with gross proceeds expected to total approximately $30 million. This transaction is led by Venrock Healthcare Capital Partners and is set to close around April 26, 2023. The funds will be allocated to research and development, pipeline candidate registration, and general corporate purposes, extending the company's operational runway through mid-2024. The securities are not registered under the Securities Act and will require a registration statement for resale.

Applied Therapeutics (Nasdaq: APLT) announced positive results from the ACTION-Galactosemia Kids trial for govorestat, a treatment for Galactosemia. The trial demonstrated long-term clinical benefits in improving daily activities, behavior, cognition, and motor skills compared to placebo. Although not statistically significant on the primary endpoint, systematic improvements were observed. The company plans to request a pre-NDA meeting with the FDA and submit a Marketing Authorization Application with the EMA in mid-2023. Approximately 3,000 patients in the US and 4,000 in the EU suffer from Galactosemia, indicating a significant market need.

Applied Therapeutics reported progress in three Phase 3 trials, focusing on crucial unmet medical needs. Notably, the company announced positive interim results from the Phase 3 INSPIRE trial, showing a 52% reduction in sorbitol levels with AT-007 in patients with SORD Deficiency. The company also partnered with Advanz Pharma for commercialization in Europe, with potential milestone payments exceeding €130 million. Financially, cash reserves dropped to $30.6 million, while net loss improved to $82.5 million, or $2.18 per share, down from $105.6 million. Overall, the company is positioned for upcoming data readouts in 2023.

Applied Therapeutics, a clinical-stage biopharmaceutical company (Nasdaq: APLT), will participate in the Neuromuscular & Bone Panel at the Cowen 43rd Annual Health Care Conference on March 8, 2023, at 2:10 p.m. ET in Boston. This participation highlights the company’s ongoing commitment to addressing high unmet medical needs.

The event will be accessible via webcast on their Investor Relations page, with a replay available afterward. Applied Therapeutics is advancing novel drug candidates, including AT-007 for CNS rare metabolic diseases and AT-001 for Diabetic Cardiomyopathy.

Applied Therapeutics announced positive results from the ongoing Phase 3 INSPIRE trial for AT-007 in patients with SORD Deficiency. The trial is assessing the drug's effect on sorbitol reduction and clinical outcomes among approximately 50 patients aged 16-55 in the US and Europe. AT-007 demonstrated a significant mean sorbitol reduction of 52% (approximately 16,000 ng/ml) over 90 days compared to placebo (p<0.001). The company is collaborating with the FDA to determine the regulatory pathway for a New Drug Application (NDA). Continued monitoring will assess clinical outcome measures over 12 to 24 months.

Applied Therapeutics (Nasdaq: APLT) will present virtually at the SVB Securities Global Biopharma Conference on February 16, 2023, at 2:20 p.m. ET. Interested parties can access the webcast via the Events page on the company's investor relations website, with a replay available afterward.

The company focuses on developing novel drug candidates targeting high unmet medical needs. Its lead candidate, AT-007, aims to treat CNS rare metabolic diseases, while AT-001 targets Diabetic Cardiomyopathy. Preclinical development includes AT-003 for Diabetic Retinopathy.

Applied Therapeutics (APLT) has partnered with Advanz Pharma to commercialize AT-007 in Europe for Galactosemia and SORD Deficiency. The deal includes milestone payments exceeding €130 million and a 20% royalty on future net sales. This partnership is expected to enhance Applied Therapeutics' capital position and extends its cash runway through critical milestones. Advanz will oversee the packaging and distribution, while Applied Therapeutics remains responsible for development and manufacturing.