ARS Pharmaceuticals, Inc.

Previous wording

We are a biopharmaceutical company focused on the commercialization and development ofneffy(currently identified in the European Union (“EU”) by the tradename EURneffy) for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions, including anaphylaxis. neffyis the first and only U.S. Food and Drug Administration (“FDA”) and European Commission-approved needle-free epinephrine product, and the first new delivery method for epinephrine in more than 35 years. neffyis a proprietary composition of epinephrine with an innovative absorption enhancer called Intravail, which allows neffyto safely provide intranasal delivery of epinephrine at a low dose within the exposures of approved injectable products across a range of dosing conditions (including repeat dosing and allergen challenge). We believe the market opportunity forneffy in the United States alone is significant. At the current list price for a two-pack ofneffyand our target total gross-to-net yield, the estimated 6.5 million patients currently prescribed an epinephrine autoinjector in the United States represents an initial addressable market opportunity of approximately $3 billion in annual net sales, while the remaining 13.5 million diagnosed patients that have not been prescribed an epinephrine product represent an additional addressable market opportunity of approximately $7 billion in annual net sales.

Current wording

We are a biopharmaceutical company focused on the commercialization and development ofneffy(currently identified in the European Union (“EU”) by the tradename EURneffy) for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions, including anaphylaxis. neffyis the first and only U.S. Food and Drug Administration (“FDA”) and European Commission-approved needle-free epinephrine product, and the first new delivery method for epinephrine in more than 35 years. neffyis a proprietary composition of epinephrine with an innovative absorption enhancer called Intravail, which allows neffyto safely provide intranasal delivery of epinephrine at a low dose within the exposures of approved injectable products across a range of dosing conditions (including repeat dosing and allergen challenge). We believe the market opportunity forneffy in the United States alone is significant. At the current list price for a two-pack ofneffyand our target total gross-to-net yield, the estimated 6.5 million patients currently prescribed an epinephrine autoinjector in the United States represents an initial addressable market opportunity of approximately $3.5 billion in annual net sales, while the remaining 13.5 million diagnosed patients that have not been prescribed an epinephrine product represent an additional addressable market opportunity of approximately $7.0 billion in annual net sales.

Previous wording

We believe neffy’s “no needle, no injection” approach addresses a significant unmet need in the use of epinephrine, which, except forneffy, is currently approved only in injectable formulations for the emergency treatment of Type I allergic reactions. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, approximately 20 million people have been diagnosed and experienced severe Type I allergic reactions that may lead to anaphylaxis, and approximately 6.5 million were prescribed an epinephrine autoinjector. However (in 2023, for example), only 3.2 million filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector with them due to the many drawbacks of these devices.

Current wording

We believe neffy’s “no needle, no injection” approach addresses a significant unmet need in the use of epinephrine, which, except forneffy, is currently approved only in injectable formulations for the emergency treatment of Type I allergic reactions. There are approximately 40 million people in the United States who experience Type I allergic reactions. Of this group, approximately 20 million people have been diagnosed and experienced severe Type I allergic reactions that may lead to anaphylaxis, and approximately 6.5 million patients were prescribed an epinephrine autoinjector. However (in 2023, for example), only 3.2 million patients filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector with them due to the many drawbacks of these devices. Those estimated 3.2 million patients who currently fill their active epinephrine autoinjector prescription represent approximately $2.0 billion in annual U.S. net sales atneffy’s target total gross-to-net yield based on trailing 12-month epinephrine device unit volume as of September 2025.

Previous wording

These drawbacks include the use of needles, which 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 quality of life, to potential need for emergency services and/or hospitalizations, and to life-threatening symptoms or events. In particular, intra-muscular injections are subject to dosing errors and risk of accidental blood vessel injections, which can cause a significant spike in the intravascular delivery of epinephrine potentially leading to serious cardiovascular complications or events. In aggregate, we estimate that up to 90% of patients prescribed an epinephrine device are not achieving an optimal treatment outcome today.

Current wording

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 quality of life, to potential need for emergency services and/or hospitalizations, and to life-threatening symptoms or events. Moreover, intra-muscular injections are subject to dosing errors and risk of accidental blood vessel injections, which can cause a significant spike in the intravascular delivery of epinephrine potentially leading to serious cardiovascular complications or events. In aggregate, we estimate that up to 90% of patients prescribed an epinephrine device are not achieving an optimal treatment outcome today.

Previous wording

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 ofneffy 2 mg in the United States, with product becoming available for shipment on September 23, 2024. This commercialization effort currently includes a direct sales force of approximately 108 individuals targeting high-volume epinephrine prescribers that is supported by branded direct-to-consumer marketing, disease awareness campaigns with advocacy groups and non-personal promotion including continuing medical education programs in collaboration with allergist societies, speaker bureaus, peer-to-peer programs and participation in regional and national medical conferences. On March 5, 2025, the FDA approved neffy 1 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in patients who are four years of age and older and weigh 15 kg to less than 30 kg. As a result, we initiated commercial launch ofneffy 1 mg in the United States, with product becoming available on May 7, 2025.

Current wording

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 ofneffy 2 mg in the United States, with product becoming available for shipment on September 23, 2024. This commercialization effort currently includes a direct sales force of approximately 107 individuals targeting high-volume epinephrine prescribers that is supported by branded direct-to-consumer marketing, disease awareness campaigns with advocacy groups and non-personal promotion including medical education programs in collaboration with allergist societies, speaker bureaus, peer-to-peer programs and participation in regional and national medical conferences. On March 5, 2025, the FDA approved neffy 1 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in patients who are four years of age and older and weigh 15 kg to less than 30 kg. As a result, we initiated commercial launch ofneffy 1 mg in the United States, with product becoming available on May 7, 2025.

Previous wording

Our launch strategy forneffyin 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 June 30, 2025, our sales force is comprised of approximately 108 ARS Pharma employees, who serve as sales reps, area sales managers, and national sales directors that began field operations as early as October 2024, as well as 10 virtual sales reps, and approximately 60 sales reps via our co-promotion partner, ALK-Abelló, Inc. (“ALK U.S.”, an affiliate of ALK-Abelló A/S (“ALK”)), who began field operations in early June 2025 and will target up to 9,000 specified pediatricians and other prescribers in the U.S. Our launch strategy is also supported by: active participation since November 2024 of approximately 2,800 healthcare professionals in ourneffy experience program that allows healthcare professionals to useneffy firsthand as rescue therapy for anaphylaxis during in-clinic allergen challenge; extensive non-personal promotion including continuing medical education programs in collaboration with allergist societies, speaker bureaus, peer-to-peer programs and participation in regional and national medical conferences; engagement and contracting with payors to obtain timely coverage with favorable gross-to-net discounting; ourneffyconnect program that provides support to physicians and patients including our $25 co-pay savings card, $199 cash price and patient assistance programs; a telemedicine service to conveniently obtain a prescription online; partnerships with patient advocacy organizations including disease awareness campaigns in 2025; and multi-channel branded direct to consumer advertising including connected television, linear television, point of care, endemic and programmatic display, social media, and paid search that initiated on May 15, 2025. We also initiated a U.S. post-marketing registry-based study forneffyfor the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics in the second quarter of 2025.

Current wording

Our launch strategy forneffyin 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 Pharma employees, who serve as sales reps, area sales managers, and national sales directors that began field operations as early as October 2024, as well as 10 virtual sales reps, and approximately 70 sales reps via our co-promotion partner, ALK-Abelló, Inc. (“ALK U.S.”, an affiliate of ALK-Abelló A/S (“ALK”)), who began field operations in early June 2025 and will target up to 9,000 specified pediatricians and other prescribers in the U.S. Our launch strategy is also supported by: active participation since November 2024 of approximately 2,800 healthcare professionals in ourneffy experience program that allows healthcare professionals to useneffy firsthand as rescue therapy for anaphylaxis during in-clinic allergen challenge as well as for the ongoing collection of real-world evidence that supports neffy’s clinical equivalence to injection; extensive non-personal promotion including medical education programs in collaboration with allergist societies, speaker bureaus, peer-to-peer programs and participation in regional and national medical conferences; engagement and contracting with payors to obtain timely coverage with favorable gross-to-net discounting; ourneffyconnect program that provides support to physicians and patients including our $25 co-pay savings card, $199 cash price and patient assistance programs; ourneffy inSchools programs, where more than 6,500 schools to date have opted into receiving two cartons ofneffy at no cost with accompanying school nurse education about neffy; partnerships with patient advocacy organizations including disease awareness campaigns; and multi-channel branded direct to consumer advertising including connected television, point of care, endemic and programmatic display, social media, and paid search that initiated on mid-May 2025, as well as linear television advertising that started in late June 2025. To reduce the time burden of an in-person healthcare provider visit, we also launched a new commercial initiative in November 2025 called “Getneffyon Us” that offers patients a free visit with a virtual prescriber, along with a $0 co-pay for eligible patients with commercial insurance. We also initiated a U.S. post-marketing registry-based study forneffyfor the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics in the second quarter of 2025, which is ongoing.

Previous wording

On August 22, 2024, the EC granted marketing authorization in the EU for EURneffy(the trade name forneffy 2 mg in the EU), for the emergency treatment of allergic reactions (anaphylaxis), in adults and children who weigh 30 kg or greater. The 1 mg dose of EURneffy for children who weigh 15 to 30 kg is currently under review by the European Medicines Agency (“EMA”), and a regulatory decision is expected in the first half of 2026. Through our collaboration with ALK (discussed below), EURneffy was launched in Germany in June 2025. We received approval of EURneffy in the United Kingdom (“U.K.”) in July 2025 for the emergency treatment of allergic reactions (anaphylaxis), in adults and children who weigh 30 kg or greater, and commercial launch in the U.K. is expected late in the second half of 2025. Regulatory review ofneffyis ongoing in Canada, China, Japan, and Australia with filings submitted by our partners, or by ARS Pharma on behalf of our partners, during the fourth quarter of 2024. neffyhas been approved or is under regulatory review in countries representing approximately 98% of the current global epinephrine autoinjector sales. Regulatory decisions are anticipated by year-end 2025 in Japan, Canada and Australia, with commercial rollouts planned for the first half of 2026. A regulatory decision is also anticipated in the first half of 2026 in China.

Current wording

On August 22, 2024, the European Commission granted marketing authorization in the EU for EURneffy(the trade name forneffy 2 mg in the EU), for the emergency treatment of allergic reactions (anaphylaxis), in adults and children who weigh 30 kg or greater. The 1 mg dose of EURneffy for children who weigh 15 to 30 kg is currently under review by the European Medicines Agency (“EMA”), and a regulatory decision is expected in the first half of 2026. Through our collaboration with ALK (discussed below), EURneffy was launched in Germany in June 2025 and in the United Kingdom (“U.K.”) in October 2025. We received approval ofneffy 2 mg and 1 mg doses in Japan in September 2025, with commercial launch by Alfresa, our partner in Japan, expected to start in the fourth quarter of 2025. Regulatory review ofneffyis ongoing in Canada and China with filings submitted by our partners, or by ARS Pharma on behalf of our partners, during the fourth quarter of 2024. neffyhas been approved or is under regulatory review in countries representing approximately 98% of the current global epinephrine autoinjector sales. Regulatory decisions are anticipated in the first quarter of 2026 in Canada, with launch expected to start in the first half of 2026, and in the first half of 2026 in China.

Previous wording

We reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients at the American Academy of Allergy and Immunology medical conference in February 2024. In the second quarter of 2025, we initiated a Phase 2b randomized, placebo-controlled outpatient clinical trial involving chronic spontaneous urticaria patients, on chronic treatment regimens, who still experience flares or exacerbations. Topline data from this clinical trial is anticipated in the first half of 2026, followed by the potential initiation of a single pivotal efficacy study in 2026.

Current wording

We reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients at the American Academy of Allergy and Immunology medical conference in February 2024. In the second quarter of 2025, we initiated a Phase 2b randomized, placebo-controlled outpatient clinical trial involving chronic spontaneous urticaria patients, on chronic treatment regimens, who still experience flares or exacerbations. Topline data from this clinical trial is anticipated in mid-2026, followed by the potential initiation of a single pivotal efficacy study.

Previous wording

Since our inception in 2015 as ARS Pharmaceuticals, Inc., we have devoted substantially all of our efforts to developing intellectual property, conducting product development and clinical trials, organizing and staffing, business planning, raising capital, building infrastructure, pre-commercial and commercial activities, and providing general and administrative support for these operations. We began commercial operations in September 2024 and therefore have had limited net product sales. We have funded our operations primarily with proceeds from the Merger (see Note 1 – Nature of Business to the notes to the condensed consolidated financial statements included in this report), private placement of convertible preferred stock, issuance of common stock, licensing, supply and distribution arrangements with our commercialization partners, bank debt, and limited net product sales. As of June 30, 2025, we had cash, cash equivalents, and short-term investments of $240.1 million.

Current wording

Since our inception in 2015 as ARS Pharmaceuticals, Inc., we have devoted substantially all of our efforts to developing intellectual property, conducting product development and clinical trials, organizing and staffing, business planning, raising capital, building infrastructure, pre-commercial and commercial activities, and providing general and administrative support for these operations. We have funded our operations primarily with proceeds from the Merger (see Note 1 – Nature of Business to the notes to the condensed consolidated financial statements included in this report), private placement of convertible preferred stock, issuance of common stock, licensing, supply and distribution arrangements with our commercialization partners, debt, and net product sales. As of September 30, 2025, we had cash, cash equivalents, and short-term investments of $288.2 million.

Previous wording

We have incurred net losses from operations in most years since our inception. Our net loss from operations for the six months ended June 30, 2025 and 2024 was $47.6 million and $15.3 million, respectively. As of June 30, 2025, we had an accumulated deficit of $202.1 million. Until we consistently generate positive net income, if ever, our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, our expenditures on other development activities, the cost for regulatory filings, expenses for commercial activities to establish, maintain and enhance sales, marketing and distribution capabilities forneffy, the timing and volume of our product sales, and our ability to earn potential regulatory and commercial milestones under our license and collaboration arrangements.

Current wording

We have incurred net losses in most years since our inception. Net losses for the nine months ended September 30, 2025 and 2024 were $130.0 million and $41.9 million, respectively. As of September 30, 2025, we had an accumulated deficit of $253.3 million. Until we consistently generate positive net income, if ever, our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical trials, our expenditures on other development activities, the cost for regulatory filings, expenses for commercial activities to establish, maintain and enhance sales, marketing and distribution capabilities forneffy, the timing and volume of our product sales, and our ability to earn potential regulatory and commercial milestones under our license and collaboration arrangements.

Previous wording

Until such time, if ever, that we can generate substantial product revenue, we may finance our operations through our existing cash, cash equivalents, short-term investments, equity offerings, debt financings and other capital sources which may include collaborations, strategic alliances, marketing, distribution or licensing arrangements or other arrangements with third parties. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. In addition, any future debt agreements may limit our ability to enter into certain debt financings without the consent of the lenders thereunder. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and may require us to delay or reduce our marketing and sales efforts, or delay, reduce or terminate our research and development programs or other operations, or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

Current wording

Until such time, if ever, that we can generate substantial product revenue, we may finance our operations through our existing cash, cash equivalents, short-term investments, equity offerings, debt financings and other capital sources which may include collaborations, strategic alliances, marketing, distribution or licensing arrangements or other arrangements with third parties. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. In addition, any future debt agreements may limit our ability to enter into certain debt financings without the consent of the lenders thereunder. On September 29, 2025 we entered into a Credit Agreement (the “Credit Agreement”) with RA Capital Agency Services, LLC (as the “Administrative Agent”) and affiliates of OMERS Administration Corporation and RA Capital Management, L.P. as lenders (the “Lenders”), which provides for an aggregate principal amount of up to $250.0 million of term loans from the Lenders to us (the “Credit Facility”). Subject to limited exceptions, we are prohibited from incurring additional indebtedness and entering into certain strategic and licensing transactions without the prior written consent of the Lenders pursuant to the Credit Agreement. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and may require us to delay or reduce our marketing and sales efforts, or delay, reduce or terminate our research and development programs or other operations, or grant rights to develop and market products or product candidates that we would otherwise prefer to develop and market ourselves.

Previous wording

In May 2025, the Company and ALK U.S. entered into a co-promotion agreement (the “ALK Co-Promotion Agreement”) to co-promote neffy to up to 9,000 specified pediatricians and other prescribers in the U.S. Accordingly, we granted ALK U.S. a non-exclusive, royalty-free license to use theneffy trademarks and copyrights and the ARS house marks in the U.S. solely in connection with promoting neffy pursuant to the terms of the ALK Co-Promotion Agreement.

Current wording

In May 2025, the Company and ALK U.S. entered into a co-promotion agreement, which was subsequently amended in October 2025 (the “ALK Co-Promotion Agreement”), to co-promote neffy to up to 9,000 specified pediatricians and other prescribers in the U.S. Accordingly, we granted ALK U.S. a non-exclusive, royalty-free license to use theneffy trademarks and copyrights and the ARS house marks in the U.S. solely in connection with promoting neffy pursuant to the terms of the ALK Co-Promotion Agreement.

Previous wording

Under the ALK Co-Promotion Agreement, ALK U.S. was obligated to start its promotion activities in May 2025 and meet specified ramp-up milestones and minimum detail requirements, using sales representatives that meet specific qualifications. In addition, during the term of the ALK Co-Promotion Agreement and for 180 days thereafter, ALK U.S. will not market, sell or manufacture any injection product containing epinephrine in the U.S.

Current wording

Under the ALK Co-Promotion Agreement, ALK U.S. commenced its promotion activities in May 2025 and is obligated to meet specified ramp-up milestones and minimum detail requirements using sales representatives that meet specific qualifications. In addition, during the term of the ALK Co-Promotion Agreement and for 180 days thereafter, ALK U.S. will not market, sell or manufacture any injection product containing epinephrine in the U.S.

Previous wording

We have recognized limited net product sales in the United States since the commercial launch ofneffy in September 2024. We have signed collaboration and license agreements forneffyfor all geographies outside of the United States. The terms of these agreements may include payment to us of one or more of the following: non-refundable, upfront license fees; clinical, regulatory, and/or commercial milestone payments; clinical development fees; and royalties or a transfer price on net sales of licensed products ifneffy receives marketing approval in these regions. We expect product revenues to fluctuate in future periods as we continue with the commercial launch ofneffy. We expect revenues under collaboration agreements to fluctuate in future periods based on our ability to meet various regulatory milestones, and contingent on successfully obtaining regulatory approval forneffyin the licensed regions, commercial milestones, royalties or transfer price earned from our partner’s net sales and the supply of commercial product as set forth in the agreements described earlier.

Current wording

We have recognized net product sales in the United States since the commercial launch ofneffy in September 2024. We have signed collaboration and license agreements forneffyfor all geographies outside of the United States. The terms of these agreements may include payment to us of one or more of the following: non-refundable, upfront license fees; clinical, regulatory, and/or commercial milestone payments; clinical development fees; and royalties or a transfer price on net sales of licensed products ifneffy receives marketing approval in these regions. We expect product revenues to fluctuate in future periods as we continue with the commercial launch ofneffy. We expect revenues under collaboration agreements to fluctuate in future periods based on our ability to meet various regulatory milestones, and contingent on successfully obtaining regulatory approval forneffyin the licensed regions, commercial milestones, royalties or transfer price earned from our partner’s net sales and the supply of commercial product as set forth in the agreements described earlier.

Previous wording

Cost of goods sold consists primarily of direct and indirect costs related to the manufacture ofneffyfor commercial sale, including salaries and related expenses for personnel, stock-based compensation, third-party manufacturing costs, raw material and component costs, excess or obsolete inventory adjustment charges, inventory write offs, packaging services, freight, storage costs, distribution fees, amortization of capitalized in-licensed costs, and royalties on product sales. Prior to the FDA approval ofneffyin August 2024, costs incurred for the manufacture ofneffy were recorded as research and development expenses, which resulted in zero-cost inventory. As a result, the cost of goods sold related toneffy will initially reflect a lower average per unit cost of materials, as previously expensed zero-cost inventory is utilized for commercial production and sold to customers. We expect the cost of goods sold forneffyto increase in relation to product revenues as we deplete this inventory. As of June 30, 2025, we had $9.8 million in zero-cost inventory remaining and based on our current forecast, we expect zero-cost inventory to be depleted by mid-2026.

Current wording

Cost of goods sold consists primarily of direct and indirect costs to manufacture neffyfor commercial sale, including salaries and related expenses for personnel, stock-based compensation, third-party manufacturing costs, raw material and component costs, excess or obsolete inventory adjustment charges, inventory write offs, packaging services, freight, storage costs, distribution fees, amortization of capitalized in-licensed costs, and royalties on product sales. Prior to the FDA approval ofneffyin August 2024, certain inventory components were purchased to manufacture neffyand recorded as research and development expenses, resulting in zero-cost inventory components. As a result, the cost of goods sold related toneffy will initially reflect a lower average per unit cost of materials, as previously expensed inventory components are consumed in commercial production and sold to customers.

Previous wording

costs related to manufacturing neffyand our intranasal epinephrine technology product candidates for clinical trials and process validation studies, including fees paid to third-party manufacturers;

Current wording

costs related to manufacturing neffyand our intranasal epinephrine technology product candidates for clinical trials and process validation studies, including fees paid to contract manufacturing organizations (“CMOs”) and other third-party manufacturers;

Previous wording

We expect our research and development expenses to remain relatively consistent in 2025 based on our planned clinical development and manufacturing activities. We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future clinical trials and the manufacturing costs ofneffyand our intranasal epinephrine technology product candidates due to the inherently unpredictable nature of clinical development and manufacturing activities. Clinical development and manufacturing timelines, the probability of success and development costs can differ materially from expectations. In addition, we cannot forecast to what degree our licensing, supply and distribution arrangements would affect our development plans and capital requirements.

Current wording

We cannot determine with certainty the timing of initiation, the duration or the completion costs of current or future clinical trials and the manufacturing costs ofneffyand our intranasal epinephrine technology product candidates due to the inherently unpredictable nature of clinical development and manufacturing activities. Clinical development and manufacturing timelines, the probability of success and development costs can differ materially from expectations. In addition, we cannot forecast to what degree our licensing, supply and distribution arrangements would affect our development plans and capital requirements.

Previous wording

We expect our selling, general and administrative expenses to increase substantially in 2025. The increase in expenses is due to our sales force which was established in the third quarter of 2024, the development and commencement of our marketing campaigns and initiatives, the ALK Co-Promotion Agreement, the hiring of additional sales and marketing personnel to support full commercialization activities, and the addition of infrastructure and programs to support commercialization activities. We expect to continue to incur audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, board of director fees, investor relations costs associated with operating as a public company, patent costs and defense, and general and administrative personnel.

Current wording

Selling, general and administrative expenses have increased since the third quarter of 2024 due to the establishment of our sales force, the development and commencement of our marketing campaigns and initiatives, the ALK Co-Promotion Agreement, the hiring of additional sales and marketing personnel to support full commercialization activities, and the addition of infrastructure and programs to support commercialization activities. We expect to continue to incur audit, legal, regulatory and tax-related services associated with maintaining compliance with exchange listing and SEC requirements, director and officer insurance premiums, board of director fees, investor relations costs associated with operating as a public company, patent costs and defense, and general and administrative personnel.

Previous wording

Other income, net consists primarily of interest income from our cash, cash equivalents, and short-term investments, and net amortization and accretion associated with our short-term investments.

Current wording

Other income, net consists primarily of interest income from our cash, cash equivalents, and short-term investments, interest expense on our outstanding debt, and net amortization and accretion associated with our short-term investments.

Previous wording

Revenues. Revenue for the six months ended June 30, 2025 was $23.7 million, as compared to $0.5 million for the six months ended June 30, 2024. Revenue for the six months ended June 30, 2025 includes $20.6 million in net product revenues for sales ofneffy,$2.8 million in revenue for the achievement of the milestone for the first commercial sale of EURneffyand for the performance of development and regulatory services performance obligations under the ALK Collaboration Agreement, and $0.3 million in revenue under supply agreements. Revenue for the six months ended June 30, 2024 includes the recognition of revenue for the delivery of the license forneffyin the Seqirus Territory in combination with the transfer of know-how under our license and distribution agreement with Seqirus.

Current wording

Revenues. Revenue for the three months ended September 30, 2025 was $32.5 million, as compared to $2.1 million for the three months ended September 30, 2024. Revenue for the three months ended September 30, 2025 includes $31.3 million in net product revenues for sales ofneffy in the United States, $1.1 million in revenue under supply agreements with partners, and less than $0.1 million in revenue for the performance of development and regulatory services performance obligations under the ALK Collaboration Agreement. Revenue for the three months ended September 30, 2024 includes $0.6 million in net product revenues for sales ofneffy and $1.5 million in revenue for the first milestone event under the Seqirus Agreement.

Previous wording

Cost of Goods Sold. Cost of goods sold for the three months ended June 30, 2025 was $5.0 million, as compared to zero for the three months ended June 30, 2024. Prior to August 2024, costs incurred to manufacture neffy were recorded as research and development expenses, and product sales subsequent to August 2024 primarily utilized zero-cost inventory. Cost of goods sold consisted primarily of product costs, the establishment of an inventory reserve, and royalties.

Current wording

Cost of Goods Sold. Cost of goods sold for the three months ended September 30, 2025 was $8.2 million, as compared to $0.1 million for the three months ended September 30, 2024. Prior to August 2024, costs incurred to manufacture neffy were recorded as research and development expenses, and product sales subsequent to August 2024 partially utilized zero-cost inventory components. Cost of goods sold consisted primarily of product costs and royalties in both periods.

Previous wording

Research and Development Expenses. Research and development expenses for the six months ended June 30, 2025 was $7.0 million, as compared to $12.1 million for the six months ended June 30, 2024. The decrease of $5.1 million was primarily due to decreases in IPR&D expense of $2.1 million, clinical trial costs of $1.7 million, personnel-related expenses of $0.7 million, stock-based compensation expense of $0.5 million, and other research and development expenses of $0.4 million, partially offset by an increase in outside services of $0.3 million.

Current wording

Research and Development Expenses. Research and development expenses for the three months ended September 30, 2025 was $2.8 million, as compared to $4.4 million for the three months ended September 30, 2024. The decrease of $1.7 million was primarily due to decreases in product development-related expense of $1.5 million, outside services of $0.4 million, and other research and development expenses of $0.2 million, partially offset by an increase in clinical trial costs of $0.4 million.

Previous wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the six months ended June 30, 2025 was $95.4 million, as compared to $16.9 million for the six months ended June 30, 2024. The increase of $78.5 million was primarily due to increases in marketing-related expenses of $45.7 million, personnel-related expenses of $18.0 million, stock-based compensation expense of $4.5 million, outside services and consulting fees of $2.8 million, travel and meals expense of $2.7 million incurred by our sales personnel, conference and seminar expense of $1.8 million, legal fees of $1.3 million, audit, tax and valuation fees of $1.0 million, and other general operating costs of $0.7 million.

Current wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended September 30, 2025 was $74.8 million, as compared to $19.3 million for the three months ended September 30, 2024. The increase of $55.5 million was primarily due to increases in marketing-related expenses of $41.6 million, personnel-related expenses of $7.9 million, stock-based compensation expense of $2.2 million, outside services of $1.5 million, travel and meals expense of $1.1 million incurred by our sales personnel, and other general operating costs of $1.2 million.

Previous wording

Other Income, Net. Other income, net for the three months ended June 30, 2025 was $2.7 million, as compared to $2.8 million for the three months ended June 30, 2024. The decrease of $0.1 million was primarily due to a decrease in net accretion of discounts on short-term investments of $0.5 million, partially offset by an increase in interest income of $0.4 million from our cash, cash equivalents, and short-term investments.

Current wording

Other Income, Net. Other income, net for the three months ended September 30, 2025 was $2.0 million, as compared to $2.6 million for the three months ended September 30, 2024. The decrease of $0.6 million was primarily due to a decrease in net accretion of discounts on short-term investments of $0.9 million, partially offset by an increase in interest income of $0.3 million from our cash, cash equivalents, and short-term investments.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024 (in thousands, except percentages):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024 (in thousands, except percentages):

Previous wording

Revenues. Revenue for the three months ended June 30, 2025 was $15.7 million, as compared to $0.5 million for the three months ended June 30, 2024. Revenue for the three months ended June 30, 2025 includes $12.8 million in net product revenues for sales ofneffy,$2.6 million in revenue for the achievement of the milestone for the first commercial sale of EURneffy and for the performance of development and regulatory services performance obligations under the ALK Collaboration Agreement, and $0.3 million in revenue under supply agreements. Revenue for the three months ended June 30, 2024 includes the recognition of revenue for the delivery of the license forneffyin the Seqirus Territory in combination with the transfer of know-how under our license and distribution agreement with Seqirus.

Current wording

Revenues. Revenue for the nine months ended September 30, 2025 was $56.2 million, as compared to $2.6 million for the nine months ended September 30, 2024. Revenue for the nine months ended September 30, 2025 includes $51.9 million in net product revenues for sales ofneffyin the United States, $2.9 million in revenue for the achievement of the milestone for the first commercial sale of EURneffyand for the performance of development and regulatory services performance obligations under the ALK Collaboration Agreement, and $1.5 million in revenue under supply agreements with partners. Revenue for the nine months ended September 30, 2024 includes $0.6 million in net product revenue for sales ofneffy and $2.0 million in revenues under the Seqirus Agreement. The revenues under the Seqirus Agreement consists of $1.5 million for the first event milestone and $0.5 million for the delivery of the license forneffyin the Seqirus Territory in combination with the transfer of know-how.

Previous wording

Cost of Goods Sold. Cost of goods sold for the six months ended June 30, 2025 was $6.1 million, as compared to zero for the six months ended June 30, 2024. Prior to August 2024, costs incurred to manufacture neffy were recorded as research and development expenses, and product sales subsequent to August 2024 primarily utilized zero-cost inventory. Cost of goods sold consisted primarily of product costs, the establishment of an inventory reserve, and royalties.

Current wording

Cost of Goods Sold. Cost of goods sold for the nine months ended September 30, 2025 was $14.3 million, as compared to $0.1 million for the nine months ended September 30, 2024. Prior to August 2024, costs incurred to manufacture neffy were recorded as research and development expenses, and product sales subsequent to August 2024 partially utilized zero-cost inventory components. Cost of goods sold consisted primarily of product costs and royalties, and during the nine months ended September 30, 2025, the establishment of an inventory reserve.

Previous wording

Research and Development Expenses. Research and development expenses for the three months ended June 30, 2025 was $4.0 million, as compared to $6.9 million for the three months ended June 30, 2024. The decrease of $2.9 million was primarily due to decreases in in-process research and development (“IPR&D”) expense of $2.1 million, personnel-related expenses of $0.3 million, stock-based compensation expense of $0.3 million, and other research and development expenses of $0.2 million.

Current wording

Research and Development Expenses. Research and development expenses for the nine months ended September 30, 2025 was $9.7 million, as compared to $16.6 million for the nine months ended September 30, 2024. The decrease of $6.8 million was primarily due to decreases in IPR&D expense of $2.1 million from the achievement of the EMA regulatory milestone under the Recordati Termination Agreement during the nine months ended September 30, 2024, product-development related expense of $1.6 million, clinical trial costs of $1.3 million, personnel-related expenses of $0.9 million, stock-based compensation expense of $0.6 million, and other research and development expenses of $0.3 million.

Previous wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended June 30, 2025 was $54.3 million, as compared to $8.9 million for the three months ended June 30, 2024. The increase of $45.4 million was primarily due to increases in marketing-related expenses of $28.2 million, personnel-related expenses of $9.0 million, stock-based compensation expense of $2.3 million, outside services and consulting fees of $1.8 million, travel and meals expense of $1.3 million incurred by our sales personnel, conference and seminar expense of $1.2 million, legal fees of $0.9 million, audit, tax and valuation fees of $0.3 million, and other general operating costs of $0.4 million.

Current wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the nine months ended September 30, 2025 was $170.2 million, as compared to $36.2 million for the nine months ended September 30, 2024. The increase of $134.0 million was primarily due to increases in marketing-related expenses of $87.3 million, personnel-related expenses of $25.9 million, stock-based compensation expense of $6.7 million, outside services of $4.0 million, travel and meals expense of $3.8 million incurred by our sales personnel, conference and seminar expense of $2.2 million, audit, tax and valuation fees of $1.5 million, legal fees of $1.3 million, and other general operating costs of $1.3 million.

Previous wording

Other Income, Net. Other income, net for the six months ended June 30, 2025 was $6.0 million, as compared to $5.7 million for the six months ended June 30, 2024. The increase of $0.2 million was primarily due to an increase in interest income from our cash, cash equivalents, and short-term investments of $0.7 million, partially offset by a decrease in net accretion of discounts on short-term investments of $0.5 million.

Current wording

Other Income, Net. Other income, net for the nine months ended September 30, 2025 was $8.0 million, as compared to $8.3 million for the nine months ended September 30, 2024. The decrease of $0.3 million was primarily due to a decrease in net accretion of discounts on short-term investments of $1.3 million, partially offset by an increase in interest income from our cash, cash equivalents, and short-term investments of $1.0 million.

Previous wording

Since our inception, we have incurred significant operating losses and negative cash flows from our operations. We have recognized limited net product sales since the commercial launch ofneffyin September 2024. We have funded our operations to date primarily with proceeds from the Merger, private placement of convertible preferred stock, issuance of common stock, licensing, supply and distribution arrangements with our commercialization partners, bank debt, and limited net product sales. As of June 30, 2025, we had cash, cash equivalents, and short-term investments of $240.1 million.

Current wording

Since our inception, we have incurred significant operating losses and negative cash flows from our operations. We have recognized limited net product sales since the commercial launch ofneffyin September 2024. We have funded our operations to date primarily with proceeds from the Merger, private placement of convertible preferred stock, issuance of common stock, licensing, supply and distribution arrangements with our commercialization partners, debt, and net product sales. As of September 30, 2025, we had cash, cash equivalents, and short-term investments of $288.2 million.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2025 and 2024 (in thousands):

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2025 and 2024 (in thousands):

Previous wording

During the six months ended June 30, 2025, net cash used in operating activities was $80.3 million. This consisted primarily of a net loss of $78.8 million, an increase in our operating assets and operating liabilities of $28.3 million and $16.8 million, respectively, and non-cash charges of $10.0 million. The increase in our operating assets was due to increases in accounts receivable of $14.4 million, inventories of $13.2 million, and prepaid expenses and other assets of $0.7 million. The increase in our operating liabilities was primarily attributable to an increase in accounts payable and accrued expenses of $17.0 million, partially offset by a decrease in contract liability of $0.2 million. The non-cash charges consisted primarily of non-cash stock-based compensation of $10.7 million, establishment of an inventory reserve of $2.2 million, and depreciation and amortization expense of $0.6 million, partially offset by $3.4 million in net accretion of discounts on short-term investments.

Current wording

During the nine months ended September 30, 2025, net cash used in operating activities was $127.4 million. This consisted primarily of a net loss of $130.0 million, an increase in our operating assets and operating liabilities of $40.3 million and $27.7 million, respectively, and non-cash charges of $15.1 million. The increase in our operating assets was due to increases in accounts receivable of $28.4 million and inventories of $12.3 million, partially offset by a decrease in prepaid expenses and other assets of $0.4 million. The increase in our operating liabilities was primarily attributable to an increase in accounts payable and accrued expenses of $27.9 million, partially offset by a decrease in contract liability of $0.3 million. The non-cash charges consisted primarily of non-cash stock-based compensation of $16.4 million, establishment of an inventory reserve of $2.2 million, and depreciation and amortization expense of $1.0 million, partially offset by $4.5 million in net accretion of discounts on short-term investments.

Previous wording

During the six months ended June 30, 2024, net cash used in operating activities was $14.0 million. This consisted primarily of a net loss of $22.8 million, an increase in our operating liabilities of $4.4 million, a decrease in our operating assets of $1.6 million, and non-cash charges of $2.8 million. The increase in our operating liabilities was primarily due to an increase in accounts payable and accrued liabilities of $4.4 million. The decrease in our operating assets was primarily due to a decrease in prepaid and other assets of $1.6 million. The non-cash charges consisted of non-cash stock-based compensation of $6.7 million, partially offset by $3.9 million in net accretion of discounts on short-term investments.

Current wording

During the nine months ended September 30, 2024, net cash used in operating activities was $28.5 million. This consisted primarily of a net loss of $41.9 million, an increase in our operating liabilities of $8.7 million, a decrease in our operating assets of $0.1 million, and non-cash charges of $4.6 million. The increase in our operating liabilities was primarily due to an increase in accounts payable and accrued liabilities of $8.7 million. The decrease in our operating assets was primarily due to a decrease in prepaid and other assets of $1.1 million, partially offset by an increase in accounts receivable of $0.8 million and an increase in inventories of $0.2 million. The non-cash charges consisted of non-cash stock-based compensation of $10.3 million, partially offset by $5.7 million in net accretion of discounts on short-term investments.

Previous wording

During the six months ended June 30, 2025, the cash and cash equivalents provided by investing activities was $77.6 million. This consisted of maturities of short-term investments of $143.5 million, partially offset by purchases of short-term investments of $65.7 million and purchases of property and equipment of $0.1 million. During the six months ended June 30, 2024, the cash and cash equivalents used in investing activities was $21.2 million. This consisted primarily of purchases of short-term investments of $151.0 million, maturities of short-term investments of $130.0 million, and purchases of property and equipment of $0.1 million.

Current wording

During the nine months ended September 30, 2025, the cash and cash equivalents provided by investing activities was $32.7 million. This consisted of maturities of short-term investments of $232.0 million, partially offset by purchases of short-term investments of $193.1 million, payments of milestone obligations under license agreements of $5.9 million, and purchases of property and equipment of $0.3 million. During the nine months ended September 30, 2024, the cash and cash equivalents used in investing activities was $4.3 million. This consisted primarily of purchases of short-term investments of $192.6 million, maturities of short-term investments of $191.0 million, payments of milestone obligations under license agreements of $2.5 million, and purchases of property and equipment of $0.3 million.

Previous wording

During the six months ended June 30, 2025, the $3.4 million of cash and cash equivalents provided by financing activities was attributable to proceeds from stock option exercises and issuance of common stock under the employee stock purchase plan. During the six months ended June 30, 2024, the cash and cash equivalents provided by financing activities was $0.8 million, which consisted of proceeds from stock option exercises and issuance of common stock under the employee stock purchase plan.

Current wording

During the nine months ended September 30, 2025, the $103.5 million of cash and cash equivalents provided by financing activities was attributable to net proceeds from the term loan under the Credit Agreement of $97.8 million, proceeds from stock option exercises and issuance of common stock under the employee stock purchase plan of $3.9 million, and proceeds from milestone obligations met under license agreements of $2.6 million, partially offset by payments of term loan issuance costs of $0.8 million. During the nine months ended September 30, 2024, the cash and cash equivalents provided by financing activities was $1.5 million, which consisted of proceeds from stock option exercises and issuance of common stock under the employee stock purchase plan.

Previous wording

Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through a combination of our existing cash, cash equivalents, short-term investments, equity offerings, debt financings and other capital sources which may include collaborations, strategic alliances, marketing, distribution or licensing arrangements or other arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, our current or future debt agreements may limit our ability to incur additional debt. If we raise funds through additional collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, development programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock.

Current wording

Until such time, if ever, as we can generate substantial product revenues to support our cost structure, we expect to finance our cash needs through a combination of our existing cash, cash equivalents, short-term investments, equity offerings, debt financings and other capital sources which may include collaborations, strategic alliances, marketing, distribution or licensing arrangements or other arrangements with third parties. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our stockholders will be or could be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders. Debt financing and equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. In addition, our current or future debt agreements may limit our ability to incur additional debt. Subject to limited exceptions, we are prohibited from incurring additional indebtedness and entering into certain strategic and licensing transactions without the prior written consent of the Lenders pursuant to the Credit Agreement. If we raise funds through additional collaborations, or other similar arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, development programs or product candidates or grant licenses on terms that may not be favorable to us and/or may reduce the value of our common stock.

Previous wording

The total amount of unconditional purchase obligations related to the supply of raw materials is $57.6 million as of June 30, 2025. Our estimated remaining payment obligations by year are as follows: 2025 ($0.9 million), 2026 ($10.5 million), 2027 ($11.8 million), 2028 ($13.8 million), and $2.9 million per year thereafter through 2035.

Current wording

The total amount of unconditional purchase obligations related to the supply of raw materials is $56.9 million as of September 30, 2025. Our estimated remaining payment obligations by year are as follows: 2025 ($0.2 million), 2026 ($10.4 million), 2027 ($11.8 million), 2028 ($13.8 million), and $2.9 million per year thereafter through 2035.

Previous wording

The total amount of unconditional purchase obligations related to hosted software license subscription fees is $2.5 million as of June 30, 2025. Our estimated remaining payment obligations by year are as follows: 2025 ($0.6 million), 2026 ($1.5 million), and 2027 ($0.4 million).

Current wording

The total amount of unconditional purchase obligations related to hosted software license subscription fees is $2.2 million as of September 30, 2025. Our estimated remaining payment obligations by year are as follows: 2025 ($0.3 million), 2026 ($1.5 million), and 2027 ($0.4 million).

Previous wording

In August 2024, we entered into a corporate sponsorship agreement with Food Allergy Research and Education, Inc., which was subsequently amended in May 2025, pursuant to which we have payment obligations of $14.0 million over a 43-month period. Our remaining payment obligations as of June 30, 2025 are $10.0 million. Our estimated remaining payment obligations by year are as follows: 2025 ($4.0 million), 2026 ($5.0 million), and 2027 ($1.0 million).

Current wording

In August 2024, we entered into a corporate sponsorship agreement with Food Allergy Research and Education, Inc., which was subsequently amended in May 2025, pursuant to which we have payment obligations of $14.0 million over a 43-month period. Our remaining payment obligations as of September 30, 2025 are $7.0 million. Our estimated remaining payment obligations by year are as follows: 2025 ($1.0 million), 2026 ($5.0 million), and 2027 ($1.0 million).

Previous wording

In February 2023, we entered into a termination agreement (the “Recordati Termination Agreement”) with Recordati Ireland, Ltd. (“Recordati”) to reacquire the rights toneffyin Europe and certain European Free Trade Association, Russia/the Commonwealth of Independent States, Middle East and African countries (the “Recordati Territory”). Pursuant to which, we are obligated to make milestone payments to Recordati that are contingent upon our achievement of certain regulatory and commercial milestones. Our remaining milestone payment obligations to Recordati have been reduced to €5.0 million (approximately $5.9 million in U.S. dollars) as of June 30, 2025. Under the Recordati Termination Agreement, we are also required to make royalty payments to Recordati of up to €5.0 million (approximately $5.9 million in U.S. dollars) in the aggregate from sales of Recordati Licensed Product(s) in the Recordati Territory. Future royalty payment amounts are indeterminate since they depend on future revenues, which are uncertain.

Current wording

In February 2023, we entered into a termination agreement (the “Recordati Termination Agreement”) with Recordati Ireland, Ltd. (“Recordati”) to reacquire the rights toneffyin Europe and certain European Free Trade Association, Russia/the Commonwealth of Independent States, Middle East and African countries (the “Recordati Territory”). Under the Recordati Termination Agreement, we are required to make royalty payments to Recordati of up to €5.0 million in the aggregate from sales of Recordati Licensed Product(s) in the Recordati Territory, of which up to €4.8 million (approximately $5.7 million in U.S. dollars) remain. Future royalty payment amounts are indeterminate since they depend on future revenues, which are uncertain.