ARS Pharmaceuticals, Inc. has recently released its 10-Q report, detailing its financial performance and operational activities. The company, founded in 2015 and headquartered in San Diego, California, is a biopharmaceutical firm focused on developing treatments for severe allergic reactions. Its primary product, neffy, is a needle-free and low-dose intranasal epinephrine nasal spray for the emergency treatment of Type I allergic reactions, including anaphylaxis. ARS Pharmaceuticals serves healthcare professionals, patients, and caregivers.
According to the 10-Q report, ARS Pharmaceuticals initiated the commercial launch of neffy in the United States in September 2024, following the FDA's approval of neffy 2 mg for the treatment of type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater. The company also filed a supplemental New Drug Application for neffy 1 mg dose for the treatment of type I allergic reactions, including anaphylaxis, in adults and children who weigh 15 to 30 kg, which is currently under priority review by the FDA.
ARS Pharmaceuticals reported net losses of $41.9 million and $47.2 million for the nine months ended September 30, 2024, and 2023, respectively. As of September 30, 2024, the company had an accumulated deficit of $173.2 million. To fund its operations, the company has raised $262.3 million in cash, cash equivalents, and short-term investments since its inception in 2015.
Additionally, ARS Pharmaceuticals entered into a collaboration, license, and distribution agreement with ALK-Abelló A/S in November 2024. Under this agreement, ALK will make an upfront payment of $145.0 million to ARS Pharmaceuticals, with potential regulatory and commercialization milestones of up to $20.0 million and sales-based milestones of up to $300.0 million. The company is also entitled to receive tiered royalty payments on net sales in the mid* to high-teens, subject to certain standard reductions and offsets.
The 10-Q report also mentioned ARS Pharmaceuticals' plans to expand its regulatory filings for neffy in Canada, the United Kingdom, China, Japan, and Australia by the end of 2024. Furthermore, the company reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients and anticipates initiating a Phase 2b clinical trial in the outpatient urticaria setting in early 2025.
Following these announcements, the company's shares moved -7.9%, and are now trading at a price of $15.3. For the full picture, make sure to review ARS Pharmaceuticals's 10-Q report.
