SPRY — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-05-15

• Our U.S. commercial launch is building momentum, and our launch data shows meaningful physician and patient demand. More than 28,000 healthcare providers have prescribed neffy to date, with approximately half being repeat prescribers. Approximately 120,000 patients are using neffy in the U.S. as of …

• In August 2024, the FDA approved neffy 2 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater, with neffy 1 mg subsequently approved in March 2025 for patients who are four years of age and older who weigh 15 kg to less…

• Our launch strategy is also supported by: active participation since November 2024 of approximately 3,400 healthcare professionals in our neffy experience program that allows healthcare professionals to use neffy firsthand as rescue therapy for anaphylaxis during in-clinic allergen challenge as well…

• In August 2024, the EC granted marketing authorization in the EU for EURneffy 2 mg (the trade name for neffy 2 mg in the EU and UK), for the emergency treatment of allergic reactions, including anaphylaxis, in adults and children who are four years of age and older who weigh 30 kg or greater. In Mar…

• Real-world data supports that neffy delivers similar response rates as injections for the emergency treatment of Type I allergic reactions. In September 2025, we reported survey results of anaphylaxis treatment outcomes in the neffy experience program, which provides 1 mg and 2 mg doses of neffy to …

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• The use of needles in epinephrine autoinjectors can result in patient and caregiver injury as well as hesitation and delays in administration due principally to apprehension and pain of needles, allowing the allergic reaction to progress in severity leading to symptoms that seriously impact patient …

• We believe neffy’s and our intranasal epinephrine technology product candidates’ design, particularly the compact size and “no needle, no injection” delivery, eliminates needle-related apprehension and pain, improves portability and ease of use, is highly reliable, and will increase prescriptions fo…

• Data from our studies of neffy and our intranasal epinephrine technology product candidates demonstrated nasally delivered epinephrine reached blood levels comparable to those of already approved epinephrine injectable products across single dosing, repeat dosing, self-administration or allergen cha…

• On August 9, 2024, the FDA approved neffy 2 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater. As a result, we initiated commercial launch of neffy 2 mg in the United States, with product becoming available for shipm…

• Our launch strategy for neffy in the United States involves direct outreach to high-volume prescribers of epinephrine accounting for approximately 55% of prescriptions in the last year through an efficient sales force. As of September 30, 2025, our sales force is comprised of approximately 107 ARS P…

Text added vs the prior filing · source: 10-Q · 2026-05-15

• We maintain a low-risk, short-term investment portfolio consisting solely of U.S. Treasury securities and hold highly liquid cash equivalents in money market mutual funds, which are subject to interest rate risk. Due to the short-term nature of our holdings, changes in market interest rates are not …

• Our Term Loans bear interest based on an applicable margin and the greater of (i) the three-month forward-looking term SOFR or (ii) 3.00%. Because the SOFR is variable, interest expense may fluctuate with changes in market rates. A hypothetical 100 basis point change in SOFR would not have a materia…

• Our operations are primarily denominated in U.S. dollars, including revenue earned under our collaboration and supply agreements. We transact with a limited number of vendors in foreign currencies that may result in foreign currency transaction gains or losses. As of March 31, 2026, we have not incu…

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• Not required for a “smaller reporting company” as defined under Item 10(f)(1) of Regulation S-K of the Securities Act.

Text added vs the prior filing · source: 10-Q · 2026-05-15

• In the United States, once an NDA is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” or the Orange Book. The FDA may not finally approve an ANDA for a generic product or a Section 505…

• In support of an ANDA, a generic manufacturer generally must show that its product has the same active ingredient(s), dosage form, strength, route of administration, and adequate labeling as the reference listed drug and that the generic version is bioequivalent to the reference listed drug, meaning…

• Upon receiving a marketing authorization in the EU from the European Commission, innovative medicinal products are generally entitled to receive eight years of data exclusivity and 10 years of market exclusivity. Data exclusivity, if granted, prevents regulatory authorities in the EU from referencin…

• In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage o…

• The FDA and other regulatory agencies actively enforce the laws and regulations relating to the promotion of our products.

Text removed vs the prior filing · source: 10-Q · 2025-11-10

• In the United States, once an NDA is approved, the product covered thereby becomes a “reference listed drug” in the FDA’s publication, “Approved Drug Products with Therapeutic Equivalence Evaluations,” or the Orange Book. The FDA may not finally approve an ANDA for a generic product or a Section 505…

• Upon receiving a marketing authorization in the EU from the European Commission, innovative medicinal products are generally entitled to receive eight years of data exclusivity and 10 years of market exclusivity. Data exclusivity, if granted, prevents regulatory authorities in the EU from referencin…

• We received Fast Track designation for neffy in the United States and may in the future pursue Fast Track designation for other product candidates that we may develop, but we might not receive such future designations, and Fast Track designations may not lead to a faster development or regulatory re…

• If the FDA determines that a product candidate is intended for the treatment of a serious or life-threatening condition and preclinical or clinical data demonstrate the potential to address an unmet medical need for this condition, the FDA may grant a product candidate Fast Track designation. Fast T…

• In addition to experiencing a security incident, third parties may gather, collect, or infer sensitive information about us from public sources, data brokers, or other means that reveals competitively sensitive details about our organization and could be used to undermine our competitive advantage o…