ARS Pharmaceuticals Updates on neffy Regulatory Progress and Q1 2024 Financial Results

ARS Pharmaceuticals, Inc. has provided updates regarding its business and financial performance for the first quarter of 2024. The company is focused on the development and commercialization of neffy® (epinephrine nasal spray), an innovative solution designed to manage severe allergic reactions such as anaphylaxis. Key highlights and developments are outlined below.

ARS Pharmaceuticals has completed all necessary studies for neffy and responded to the FDA's Complete Response Letter (CRL), which addressed additional requests including data from a repeat dose pharmacokinetic/pharmacodynamic (PK/PD) study under nasal allergen challenge conditions. The company also conducted updated testing that detected no measurable nitrosamine levels, following FDA’s draft guidance. With the submission of their response on April 2, 2024, ARS anticipates the FDA review to conclude by early October 2024. Assuming the approval is granted by the expected PDUFA date, ARS plans to launch neffy in the U.S. in the second half of 2024.

On the global front, ARS submitted a Day 180 response to the EMA’s Committee for Medicinal Products for Human Use (CHMP) for neffy’s Marketing Authorization Application (MAA) on April 30. The company expects a decision from CHMP in the second quarter of 2024. Additionally, ARS has partnered with CSL Seqirus to facilitate the regulatory approval and commercialization of neffy in Australia and New Zealand. This arrangement includes upfront and milestone payments potentially totaling up to $5 million.

Moreover, ARS Pharmaceuticals is preparing to initiate an outpatient study of neffy for urticaria (hives) in the latter half of 2024. This Phase 2b trial is aimed at patients who frequently experience acute flares despite being treated with antihistamines. A pivotal efficacy study may follow in 2025.

Financially, ARS Pharmaceuticals reported a cash position of $223.6 million as of March 31, 2024, which is projected to support their operations for at least three years. Research and development expenses for the first quarter were $5.2 million, a decrease from $6.6 million in the same period last year, primarily due to reduced device development costs. General and administrative expenses also decreased to $8.0 million from $12.2 million, reflecting a pause in pre-commercial launch activities. The net loss for the quarter was $10.3 million, down from $15.0 million in the first quarter of 2023.

Type I severe allergic reactions, including anaphylaxis, are critical medical conditions requiring immediate treatment with epinephrine, the only FDA-approved medication for such reactions. Despite the effectiveness of epinephrine autoinjectors, limitations like fear of needles and portability issues result in many patients delaying or avoiding treatment during emergencies. With approximately 40 million individuals in the U.S. experiencing Type I severe allergic reactions and only a fraction carrying epinephrine autoinjectors, the needle-free neffy offers a promising alternative.

Urticaria, characterized by itchy hives and angioedema, affects about 5 million people annually in the U.S., with chronic cases often unresponsive to first-line antihistamine therapy. There are currently no approved community use treatments for acute flares in chronic urticaria patients. neffy is being investigated as a potential treatment to provide episodic relief and improve the quality of life for these patients, potentially reducing the need for emergency room visits or chronic use of systemic biologics.

ARS Pharmaceuticals remains committed to advancing neffy to provide a safe, effective, and easily accessible solution for managing severe allergic reactions and urticaria, aiming to enhance the quality of life for patients worldwide.