SPRY — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• We believe there is a multi-billion dollar market opportunity for neffy in the United States. Approximately 40.0 million people in the U.S. have experienced a type I allergic reaction based on epidemiology. Of this group, approximately 21.0 million people are reported to have been diagnosed and expe…

• 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 commercialization strategy for neffy in the United States is focused on direct engagement with high-value prescribers of epinephrine, which account for approximately 44% of the total U.S. market opportunity, to drive market share growth. We believe growth in this market can be achieved through r…

• Our U.S. commercial launch is building momentum, and our launch data show meaningful physician and patient demand. More than 35,000 healthcare providers have prescribed neffy to date, with approximately 40% being repeat prescribers. Over 16,000 of these prescribers were unique additions in the secon…

• In parallel, we have secured broad insurance coverage and will continue to engage with U.S. payers, both commercial and Medicaid, with a goal of furthering expanding coverage. Currently, we have secured approximately 90% overall commercial coverage, inclusive of plans that may still require prior au…

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

• We believe neffy’s “no needle, no injection” approach addresses a significant unmet need in the use of epinephrine. There are approximately 40 million people in the U.S. who experience Type I allergic reactions. Of this group, approximately 20 million people are reported to have been diagnosed and e…

• 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…

Text added vs the prior filing · source: 10-Q · 2026-08-13

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

Text removed 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 added vs the prior filing · source: 10-Q · 2026-08-13

• Our operations have consumed significant amounts of cash since inception. Based upon our current operating plan, we believe that our cash, cash equivalents, short-term investments, revenues from product sales, cash proceeds from collaboration and out-licensing agreements, and additional borrowings o…

• Securities-related class action litigation could divert our resources and management's attention and harm our business.*

• Securities-related class action lawsuits and/or derivative lawsuits have often been brought against companies, including biotechnology and biopharmaceutical companies, that experience volatility in the market price of their securities. Such lawsuits and any other related lawsuits are subject to inhe…

• If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after any applicable legal restrictions on resale lapse or otherwise, the trading price of our common stock could decline. Furthermore, our former executive officers cont…

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

• Our operations have consumed significant amounts of cash since inception. Based upon our current operating plan, we believe that our cash and cash equivalents will fund our operating and capital expenses for at least three years. We expect to incur significant expenses related to commercialization, …

• If our existing stockholders sell, or indicate an intention to sell, substantial amounts of our common stock in the public market after any applicable legal restrictions on resale lapse, the trading price of our common stock could decline. We are not able to predict the effect that sales may have on…