ARS Pharmaceuticals (SPRY) Guggenheim Securities Inaugural Healthcare Innovation Conference summary

Company background and technology

• Founded eight years ago by a team experienced in nasal spray products, including Narcan and Valtoco.

• Licensed Intravail technology for epinephrine, enabling rapid, painless nasal absorption.

• Secured funding from Deerfield Management, SR One, RA Capital, Baker Bros., and a reverse merger with Silverback Therapeutics, resulting in a strong cash position.

• Recently received $145 million from a European licensing agreement with ALK for neffy.

Market landscape and product differentiation

• U.S. allergy market exceeds $1 billion, dominated by generic auto-injectors; 20 million patients have severe disease.

• 3.2 million have prescriptions, but 80% do not carry or use auto-injectors; 3.3 million prescribed but do not fill.

• Neffy targets switchers, non-fillers, and 13.5 million undiagnosed or untreated patients through CME, DTC, and advocacy campaigns.

• Nasal delivery offers psychological and practical advantages, reducing hesitancy and improving outcomes.

• New labeling aligns with updated guidelines: emergency care only if symptoms persist after dosing.

Clinical and regulatory updates

• Neffy approved in both U.S. and Europe in August; designed to be as effective as or better than IM injection, but not exceeding EpiPen exposure.

• Demonstrates faster, more sustained pharmacodynamic response than IM injection, with improved stability and 30-month shelf life.

• Stable at high temperatures, with label allowing excursions up to 122°F.

• sNDA for 1 mg dose (for 15–30 kg children) accepted by FDA with priority review; PDUFA date March 6.