| Over a week ago | ||||
Applied Therapeutics… Applied Therapeutics announced the pricing of its underwritten public offering of 20.0M shares of its common stock, par value $0.0001 per share, 10.0M pre-funded warrants to purchase common stock in lieu of common stock to certain investors, and accompanying warrants to purchase up to 30.0M shares of its common stock. Each share of common stock and accompanying common warrant are being offered at a combined public offering price of $1.00, less underwriting discounts and commissions, and each pre-funded warrant and accompanying common warrant are being offered at a combined public offering price of $0.9999, less underwriting discounts and commissions. The pre-funded warrants have an exercise price of $0.0001 per share and the common warrants have an exercise price of $1.00 per share. The pre-funded warrants and the common warrants are immediately exercisable and will expire five years from the date of issuance. The gross proceeds to the Company from the offering, before deducting the underwriting discounts and commissions and offering expenses payable by the Company, are expected to be $30M. SVB Securities is acting as the sole book-running manager for the offering. The offering is expected to close on June 27, 2022. | ||||
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Applied Therapeutics… Applied Therapeutics announced that it plans to make a public offering of shares of its common stock, or pre-funded warrants to purchase common stock in lieu of common stock to certain investors, and accompanying warrants to purchase shares of its common stock, in an underwritten registered public offering. The company intends to use the net proceeds from this offering for general corporate purposes. General corporate purposes may include research and development costs, including the conduct of clinical trials and process development and manufacturing of the company's product candidates, expansion of the company's research and development capabilities, working capital and capital expenditures. SVB Securities is acting as the sole book-running manager for the offering. | ||||
| Over a month ago | ||||
Applied Therapeutics… Applied Therapeutics announced designation of AT-007 as an orphan medicinal product by the European Medicines Agency, EMA, for treatment of Galactosemia. "We are pleased that the EMA has recognized the high unmet medical need in Galactosemia, the role of galactitol as the toxic metabolite responsible for long-term complications in Galactosemia, and the potential benefit of AT-007 treatment in reducing toxic galactitol levels," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "Orphan designation for AT-007 marks an important step towards advancing our regulatory initiatives in Europe. We plan to meet with the EMA in the third quarter to discuss a potential MAA submission in Europe for conditional approval based on available biomarker data or for full approval based on expected clinical outcomes data." | ||||
Cash and cash equivalents… Cash and cash equivalents and short-term investments totaled $55.7M as of March 31, 2022, compared with $80.8M at December 31, 2021. "We made significant progress in the first quarter across all three of our Phase 3 programs," said CEO Shoshana Shendelman. "We are pleased to have reached alignment with the FDA on Galactosemia, and are excited about the expected milestones in the year ahead." | ||||
Truist analyst Robyn… Truist analyst Robyn Karnauskas lowered the firm's price target on Applied Therapeutics to $6 from $85 and keeps a Buy rating on the shares as part of a broader research note on Biotech. The analyst is adjusting her model as AT007 for pediatric galactosemia patients was pushed back to launch in 2024 from 2022 given the need for hard outcomes data and also taking out assumed revenue for adult patient population given that the ongoing pivotal trial is only in pediatric population. | ||||
| Over a quarter ago | ||||
Barclays analyst Carter… Barclays analyst Carter Gould lowered the firm's price target on Applied Therapeutics to $2.50 from $7 and keeps an Equal Weight rating on the shares. Applied recently announced Q4 results, notably disclosing a going concern risk given the company's cash position and historical burn rate, Gould tells investors in a research note. The analyst says that even with a lower burn going forward, the company's cash position will remain an overhang until addressed. | ||||
Cash and cash equivalents… Cash and cash equivalents and short-term investments totaled $80.8 million as of December 31, 2021, compared with $96.8 million at December 31, 2020. "We remain committed to bringing new treatments to patients in areas of high unmet need," said Shoshana Shendelman, PhD, Founder and CEO of Applied Therapeutics. "With three ongoing Phase 3 studies across Galactosemia, Sorbitol Dehydrogenase Deficiency and Diabetic Cardiomyopathy, we are advancing treatments forward, and expect multiple catalysts and opportunities for value creation in 2022 and 2023." | ||||
Applied Therapeutics is… Applied Therapeutics is recognizing the 15th Annual Rare Disease Day to help elevate awareness of rare diseases and call attention to the unique challenges facing people with rare diseases. Applied Therapeutics is proud to support Rare Disease Day events across the U.S., including participating in the 5th Annual GLOW for Galactosemia Event in Knoxville, Tennessee, and virtually supporting GLOW teams across the country as they raise awareness of Galactosemia, a rare genetic metabolic disease resulting in an inability to metabolize the sugar galactose, which is found in foods and is also synthesized by the body. The company is collaborating with advocacy partners on a wide range of Galactosemia initiatives throughout the year, including Race 4 Jase and Fore Joey's Cause. Applied Therapeutics is also partnering with the Charcot-Marie-Tooth Foundation and the Hereditary Neuropathy Foundation to raise awareness of SORD Deficiency, a rare disease which results in a progressive, debilitating hereditary neuropathy. | ||||
Healthcare Analyst… Healthcare Analyst Karnauskas holds a conference call to discuss SORD deficiency with an expert on January 7 at 10 am hosted by Truist. | ||||
