Applied Therapeutics, Inc. - APLT STOCK NEWS

Applied Therapeutics (NASDAQ: APLT) announced a public offering of 20 million shares of common stock and 10 million pre-funded warrants, aiming to raise approximately $30 million. Each share of common stock is priced at $1.00, while the pre-funded warrants are priced at $0.9999. Proceeds will be allocated for general corporate purposes, including R&D and clinical trials. The offering is set to close on June 27, 2022, pending customary conditions. The company is focusing on developing drug candidates for significant unmet medical needs, particularly in CNS rare metabolic diseases.

Applied Therapeutics (NASDAQ: APLT) announced a public offering of its common stock and pre-funded warrants, along with accompanying warrants. The company intends to use the net proceeds for general corporate purposes, including research and development costs and capital expenditures. SVB Securities is managing the offering, which is subject to market conditions. A registration statement has been filed for the offering, and no assurances can be made about its completion or final terms.

Applied Therapeutics (Nasdaq: APLT) announced that the European Medicines Agency (EMA) has granted orphan medicinal product designation for its drug AT-007 (gavorestat) to treat Galactosemia. This designation recognizes the significant medical need and potential of AT-007 to reduce toxic galactitol levels in patients. The company plans to meet with the EMA in Q3 to discuss a potential submission for conditional approval. The orphan status provides various incentives, including a decade of market exclusivity upon approval.

Applied Therapeutics, Inc. (Nasdaq: APLT) is participating in a fireside chat at the UBS Global Healthcare Conference on March 25, 2022, at 10:45 a.m. ET, in New York. The event can be accessed via webcast on their Investor Relations page, with a replay available post-event. The company specializes in developing novel biopharmaceutical candidates targeting significant unmet medical needs, including CNS rare metabolic diseases and diabetic cardiomyopathy. Their leading drug candidates include AT-007 and AT-001, among others.

Applied Therapeutics (APLT) reported progress in three Phase 3 trials in areas of high unmet medical need, with multiple clinical milestones anticipated in 2022. The company achieved alignment with the FDA regarding its Galactosemia program, which requires clinical outcomes data for NDA submission. Financially, as of March 31, 2022, cash and equivalents totaled $55.7 million, down from $80.8 million at year-end. Research and development expenses rose to $15 million, while general and administrative expenses decreased to $8.1 million. The net loss for Q1 2022 was $23.1 million, or $0.88 per share.

Applied Therapeutics, Inc. (Nasdaq: APLT) announced findings at the 2022 Annual Meeting of the Peripheral Nerve Society regarding SORD Deficiency. Data revealed that high levels of sorbitol correlate with disease severity. In a pilot study, treatment with AT-007 significantly reduced sorbitol levels, which are linked to mitochondrial dysfunction and neuronal loss. The findings indicate AT-007 could prevent disease progression by inhibiting sorbitol production. This research highlights the potential of AT-007, a novel Aldose Reductase inhibitor, in treating SORD Deficiency.

Applied Therapeutics (Nasdaq: APLT) announced poster presentations at the 43rd Annual Meeting of the Society for Inherited Metabolic Disorders, held April 10-13, 2022, in Orlando, Florida. The presentations highlighted baseline data from the ACTION-Galactosemia Kids study, revealing significant disease burdens in pediatric patients with Galactosemia, including neurological issues due to elevated galactitol levels. The drug candidate AT-007, designed for treating Galactosemia, is undergoing a Phase 3 clinical trial, showcasing its potential in reducing toxic levels and disease complications.

Applied Therapeutics (Nasdaq: APLT) announced the acceptance of their abstract #OP005 for an oral presentation at the 2022 Annual Clinical Genetics Meeting, scheduled for March 22-26 in Nashville. This presentation will focus on the efficacy of AT-007 in reducing toxic galactitol levels in pediatric patients with Classic Galactosemia. Dr. Riccardo Perfetti highlighted the significant correlation between galactitol levels and CNS deficit severity in patients. Approximately 3,000 individuals are affected by Galactosemia in the U.S., emphasizing the importance of ongoing clinical research and development.

Applied Therapeutics, Inc. (Nasdaq: APLT) reported its fourth-quarter and full-year financial results for 2021, showing a net loss of $105.6 million, or $4.12 per share, up from a loss of $94.0 million in 2020. The company is focused on three ongoing Phase 3 trials in Galactosemia, SORD Deficiency, and Diabetic Cardiomyopathy. A regulatory update indicates the FDA may require clinical outcomes data for the Galactosemia program before NDA submission. Cash reserves are reported at $80.8 million, down from $96.8 million in 2020, while R&D expenses increased to $62.6 million.