ARS Pharmaceuticals, Inc.

Previous wording

We are a biopharmaceutical company focused on the commercialization ofneffy® (also identified in the European Union (“EU”) and United Kingdom (“UK”) by the trade name EURneffyand in China by the trade name优敏速) needle-free intranasal delivery of epinephrine for emergency treatment of Type I allergic reactions, including anaphylaxis. neffyis the first and only needle-free epinephrine product approved by the U.S. Food and Drug Administration (“FDA”) and the European Commission, and also has approvals in the UK, Japan, Australia, China, and Canada. It is 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).

Current wording

We are a biopharmaceutical company focused on the commercialization ofneffy® (also identified in the European Union (“EU”) and United Kingdom (“UK”) by the trade name EURneffyand in China by the trade name优敏速) for the needle-free intranasal delivery of epinephrine for emergency treatment of Type I allergic reactions, including anaphylaxis. neffyis the first and only needle-free epinephrine product approved by the U.S. Food and Drug Administration (“FDA”) and the European Commission, and also has approvals in other major markets including the UK, Japan, Australia, China, and Canada. It is 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).

Previous wording

Our commercialization strategy forneffyin 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 repeated interactions with prescribers regarding the treatment and prevention of Type 1 allergic reactions, including anaphylaxis, and the delayed or avoided administration of injectable epinephrine, and through efforts to convert established prescribing habits with injectable epinephrine products.

Current wording

Our commercialization strategy forneffyin the United States is focused on achieving market share growth through targeted provider engagement, increasing our share in the existing U.S. epinephrine market of approximately five million prescriptions annually, and laying the groundwork to expand into the broader market over time. We believe growth in the existing market can be achieved through account-based sales targeting of high-value prescribers of epinephrine, which account for approximately 44% of the total U.S. market opportunity, as well as the nurses and office staff who often manage the prescription process through fulfillment. Our engagement addresses the well-established limitations of injectable epinephrine in the treatment and prevention of Type I allergic reactions, including anaphylaxis, such as low rates of device carry and the delay or avoidance of administration, with the aim of converting established prescribing habits from injectable epinephrine products toneffy.

Previous wording

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 neffyto date, with approximately 40% being repeat prescribers. Over 16,000 of these prescribers were unique additions in the second quarter of 2026, representing a nearly threefold increase over the same period in 2025. Approximately 167,000 patients in the U.S. have been prescribed neffyas of the end of the second quarter of 2026, with about 41,200 added during the second quarter of 2026. This demand has contributed to a doubling of U.S. epinephrine market share in the second quarter of 2026 compared to the same period in 2025, with total market share increasing to 5% from 2.5% and market share in field-targeted accounts increasing to 8% from 4%.

Current wording

Our U.S. commercial launch is building momentum, and data shows meaningful physician demand. More than 44,000 healthcare providers have prescribed neffyto date. Over 19,000 of these prescribers were unique additions in the third quarter of 2026, representing an increase of approximately 49% over the same period in 2025. This demand has contributed to a total market share byneffyof 5%, up from 4% in the third quarter of 2025. Among field-targeted accounts, the leading indicator of demand, neffy market share reached approximately 9%, up from 6% a year ago, compared with 2% in non-targeted accounts.

Previous wording

Our U.S. launch strategy is also supported by: active participation of approximately 4,400 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, including certain pharmacy benefit managers, where the approval processes are actively ongoing for addition ofneffyto their formularies without prior authorization; our artificial intelligence solution to support healthcare providers by automating the checking and writing of prior authorizations; ourneffyconnect program that provides support to physicians and patients including our $25 co-pay savings card, $199 cash price available through all channels including retail via a denial-conversion system, and patient assistance programs; ourneffy inSchools programs, where more than 14,000 schools to date have opted into receiving two cartons ofneffy at no cost with accompanying school nurse education about neffy; multi-channel branded direct to consumer advertising including connected television, point of care, endemic and programmatic display, social media, and paid search, as well as linear television advertising; and partnerships with patient advocacy organizations including disease awareness campaigns. To reduce the time burden of an in-person healthcare provider visit, our “Getneffyon Us” program that offers patients a free visit through our virtual prescriber website, getneffy.com, along with a $0 co-pay for eligible patients with commercial insurance. We also have an ongoing U.S. post-marketing registry-based study forneffyfor the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics.

Current wording

Our U.S. commercialization strategy is also supported by a comprehensive program that includes: ourneffy experience program, allowing healthcare professionals to useneffy firsthand as rescue therapy for anaphylaxis during in-clinic allergen challenge; 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, including certain pharmacy benefit managers, where the approval processes are actively ongoing for addition ofneffyto their formularies without prior authorization; our artificial intelligence solution to support healthcare providers by automating the checking and writing of prior authorizations; as well as other programs intended to enable access toneffyby patients. We also have an ongoing U.S. post-marketing registry-based study forneffyfor the treatment of anaphylaxis in oral food challenge or allergen immunotherapy clinics.

Previous wording

In August 2024, the EC granted marketing authorization in the EU for EURneffy 2 mg (the trade name forneffy 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 March 2026, the EMA granted marketing authorization in the EU for EURneffy 1 mg for children who are four years of age and older who weigh 15 kg to less than 30 kg. Through our collaboration with ALK, EURneffy 2 mg was launched in Europe, beginning with Germany in June 2025, followed by the UK in October 2025. We received approval ofneffy 2 mg and 1 mg in Japan in September 2025, andneffy was launched in February 2026 by our collaboration partner, Alfresa. We also received approval ofneffy 2 mg and 1 mg in Australia in December 2025, andneffy was launched in February 2026 by our collaboration partner, Seqirus. In December 2025, we received approval in China of优敏速 (the trade name forneffy 2 mg in China), and优敏速 was launched by our collaboration partner, Pediatrix, in May 2026. In April 2026, we received approval in Canada ofneffy 2 mg, with commercial launch by our collaboration partner, ALK, expected later in 2026. neffyhas already been approved or is under regulatory review in countries representing approximately 98% of the current global epinephrine autoinjector sales market.

Current wording

In August 2024, the EC granted marketing authorization in the EU for EURneffy 2 mg (the trade name forneffy 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 March 2026, the European Medicines Agency (“EMA”) granted marketing authorization in the EU for EURneffy 1 mg for children who are four years of age and older who weigh 15 kg to less than 30 kg. Through our collaboration with ALK, EURneffy 2 mg was launched in Europe, beginning with Germany in June 2025, followed by the UK in October 2025. We received approval ofneffy 2 mg and 1 mg in Japan in September 2025, andneffy was launched in February 2026 by our collaboration partner, Alfresa. We also received approval ofneffy 2 mg and 1 mg in Australia in December 2025, andneffy was launched in February 2026 by our collaboration partner, Seqirus. In December 2025, we received approval in China of优敏速 (the trade name forneffy 2 mg in China), and优敏速 was launched by our collaboration partner, Pediatrix, in May 2026. In April 2026, we received approval in Canada ofneffy 2 mg, and it was launched by our collaboration partner, ALK, in August 2026. neffyhas already been approved in countries representing approximately 98% of the current global epinephrine autoinjector sales market.

Previous wording

Since our inception in 2015 as ARS Pharmaceuticals, Inc., we have devoted substantially all of our efforts to commercialization activities forneffy in the U.S., pre-commercial activities, conducting product development and clinical trials, developing and protecting intellectual property, organizing and staffing the Company, business planning, raising capital, building infrastructure, and providing general and administrative support for these operations. We have funded our operations primarily with proceeds from net product sales, debt, licensing, supply and distribution arrangements with our commercialization partners, issuance of common stock, the merger with Silverback Therapeutics, Inc. (“Silverback”) in November 2022 (the “Merger”), and the private placement of convertible preferred stock. As of June 30, 2026, we had cash, cash equivalents, and short-term investments of $143.8 million.

Current wording

Since our inception in 2015 as ARS Pharmaceuticals, Inc., we have devoted substantially all of our efforts to commercialization activities forneffy in the U.S., pre-commercial activities, conducting product development and clinical trials, developing and protecting intellectual property, organizing and staffing the Company, business planning, raising capital, building infrastructure, and providing general and administrative support for these operations. We have funded our operations primarily with proceeds from net product sales, debt, licensing, supply and distribution arrangements with our commercialization partners, issuance of common stock, the merger with Silverback Therapeutics, Inc. (“Silverback”) in November 2022 (the “Merger”), and the private placement of convertible preferred stock. As of September 30, 2026, we had cash, cash equivalents, and short-term investments of $138.4 million.

Previous wording

We have incurred net losses in most years since our inception. Net loss for the six months ended June 30, 2026 and 2025 was $123.0 million and $78.8 million, respectively. As of June 30, 2026, we had an accumulated deficit of $417.6 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 royalties and regulatory and commercial milestones under our license and collaboration arrangements.

Current wording

We have incurred net losses in most years since our inception. Net loss for the nine months ended September 30, 2026 and 2025 was $158.5 million and $130.0 million, respectively. As of September 30, 2026, we had an accumulated deficit of $453.1 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 royalties and regulatory and commercial milestones under our license and collaboration arrangements.

Previous wording

As of June 30, 2026, we had $3.1 million in zero-cost inventory components remaining, and no zero-cost inventory components were determined to be obsolete. Based on our current forecast, we expect zero-cost inventory components to be substantially consumed in commercial production by the second half of 2026. The time over which the zero-cost inventory components are included in cost of goods sold will depend on several factors, but primarily the timing of future neffy sales.

Current wording

As of September 30, 2026, we held no zero-cost inventory components.

Previous wording

Our external research and development expenses forneffy and our intranasal epinephrine technology product candidates consist primarily of fees, materials and other costs paid to CROs, CMOs, consultant and contractors. Our clinical, regulatory, manufacturing, and non-clinical development costs for the periods presented below reflect an allocation of expenses associated with personnel costs, stock-based compensation expense, and indirect costs incurred in support of overall research and development, such as facilities-related costs.

Current wording

Our external research and development expenses forneffy and our intranasal epinephrine technology product candidates consist primarily of fees, materials and other costs paid to CROs, CMOs, consultants and contractors. Our clinical, regulatory, manufacturing, and non-clinical development costs for the periods presented below reflect an allocation of expenses associated with personnel costs, stock-based compensation expense, and indirect costs incurred in support of overall research and development, such as facilities-related costs.

Previous wording

Selling, general and administrative expenses have increased due to the establishment of our sales force, the development and commencement of our marketing campaigns and initiatives, the co-promotion agreement between us and ALK-Abelló, Inc., which was entered into in May 2025 and subsequently amended in October 2025 and March 2026 (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. While broad consumer advertising has supported our commercialization efforts to date, we are also taking action to align resources with our strategic priorities and support more focused marketing. 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 commercial launch ofneffydue to the establishment of our sales force, the development and commencement of our marketing campaigns and initiatives, the co-promotion agreement between us and ALK-Abelló, Inc., which was entered into in May 2025 and subsequently amended in October 2025 and March 2026, with the parties entering into a related side letter in August 2026 (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. While broad consumer advertising has supported our commercialization efforts to date, we are also taking action to align resources with our strategic priorities and support more focused marketing. 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

Revenues. Revenue for the three months ended June 30, 2026 was $33.7 million, as compared to $15.7 million for the three months ended June 30, 2025. Revenue for the three months ended June 30, 2026 includes $26.2 million in net product revenues for sales ofneffyin the United States, $7.4 million in revenue under supply agreements with partners, and less than $0.1 million in revenue for the performance of development and regulatory services under the collaboration, license and distribution agreement we entered into with ALK-Abelló A/S (the “ALK Collaboration Agreement”). 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. The increase in revenue was primarily driven by higher net product revenues resulting from increased unit sales volumes ofneffyin the United States.

Current wording

Revenues. Revenue for the three months ended September 30, 2026 was $37.7 million, as compared to $32.5 million for the three months ended September 30, 2025. Revenue for the three months ended September 30, 2026 includes $33.4 million in net product revenues for sales ofneffyin the United States, $2.6 million in revenue under supply agreements with partners, and $1.7 million in revenue for the performance of development and regulatory services and achievement of a commercial milestone under our collaboration agreements with ALK-Abelló A/S (the “ALK Collaboration Agreement”) and Seqirus Pty Ltd. (the “Seqirus Agreement”). Revenue for the three months ended September 30, 2025 includes $31.3 million in net product revenues for sales ofneffyin 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. The increase in revenue was primarily driven by higher global unit sales volumes ofneffy.

Previous wording

Cost of Goods Sold. Cost of goods sold for the three months ended June 30, 2026 was $12.8 million, as compared to $5.0 million for the three months ended June 30, 2025. The increase of $7.9 million was primarily driven by direct and indirect product costs incurred in connection with U.S. product sales and the commercial launches ofneffyin the U.K., EU, Japan, Australia, and China following regulatory approval in each market. Our global expansion also resulted in a corresponding increase in royalty expense on worldwide net product revenue.

Current wording

Cost of Goods Sold. Cost of goods sold for the three months ended September 30, 2026 was $10.1 million, as compared to $8.2 million for the three months ended September 30, 2025. The increase of $1.9 million was primarily driven by direct and indirect product costs incurred in connection with U.S. product sales and the commercial launches ofneffyin the U.K., EU, Japan, Australia, and China following regulatory approval in each market. Our global expansion also resulted in a corresponding increase in royalty expense on worldwide net product revenue.

Previous wording

Other (Expense) Income, Net. Other expense, net for the three months ended June 30, 2026 was $0.9 million, as compared to other income, net of $2.7 million for the three months ended June 30, 2025. The change of $3.6 million was primarily due to interest expense related to our Credit Agreement of $2.5 million and decreases in net accretion of discounts on short-term investments of $0.8 million and interest income of $0.3 million from our cash, cash equivalents, and short-term investments.

Current wording

Other (Expense) Income, Net. Other expense, net for the three months ended September 30, 2026 was $1.4 million, as compared to other income, net of $2.0 million for the three months ended September 30, 2025. The change of $3.5 million was primarily due to an increase in interest expense related to our Credit Agreement of $2.5 million and decreases in net accretion of discounts on short-term investments of $0.7 million and 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, 2026 and 2025 (in thousands, except percentages):

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2026 and 2025 (in thousands, except percentages):

Previous wording

Revenues. Revenue for the six months ended June 30, 2026 was $56.3 million, as compared to $23.7 million for the six months ended June 30, 2025. Revenue for the six months ended June 30, 2026 includes $43.7 million in net product revenues for sales ofneffyin the United States, $10.1 million in revenue under supply agreements with partners, and $2.5 million in revenue for the achievement of the regulatory milestone and performance of development and regulatory services under the ALK Collaboration Agreement. 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. The increase in revenue was primarily driven by higher net product revenues resulting from increased unit sales volumes ofneffyin the United States.

Current wording

Revenues. Revenue for the nine months ended September 30, 2026 was $94.0 million, as compared to $56.2 million for the nine months ended September 30, 2025. Revenue for the nine months ended September 30, 2026 includes $77.1 million in net product revenues for sales ofneffyin the United States, $12.8 million in revenue under supply agreements with partners, and $4.2 million in revenue for the achievement of the regulatory and commercial milestones and performance of development and regulatory services under the ALK Collaboration Agreement and the Seqirus Agreement. Revenue for the nine months ended September 30, 2025 includes $51.9 million in net product revenues for sales ofneffy,$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. The increase in revenue was primarily driven by higher global unit sales volumes ofneffy.

Previous wording

Cost of Goods Sold. Cost of goods sold for the six months ended June 30, 2026 was $19.1 million, as compared to $6.1 million for the six months ended June 30, 2025. The increase of $13.1 million was primarily driven by direct and indirect product costs incurred in connection with U.S. product sales and the commercial launches ofneffyin the U.K., EU, Japan, Australia, and China following regulatory approval in each market. Our global expansion also resulted in a corresponding increase in royalty expense on worldwide net product revenue.

Current wording

Cost of Goods Sold. Cost of goods sold for the nine months ended September 30, 2026 was $29.2 million, as compared to $14.3 million for the nine months ended September 30, 2025. The increase of $15.0 million was primarily driven by direct and indirect product costs incurred in connection with U.S. product sales and the commercial launches ofneffyin the U.K., EU, Japan, Australia, and China following regulatory approval in each market. Our global expansion also resulted in a corresponding increase in royalty expense on worldwide net product revenue.

Previous wording

Research and Development Expenses. Research and development expenses for the six months ended June 30, 2026 were $9.0 million, as compared to $7.0 million for the six months ended June 30, 2025. The increase of $2.0 million was primarily due to increases in clinical trial costs of $1.0 million, personnel-related expenses, including stock-based compensation expense, of $0.9 million, and consulting fees of $0.5 million, partially offset by a decrease in other research and development expenses of $0.4 million.

Current wording

Research and Development Expenses. Research and development expenses for the nine months ended September 30, 2026 were $27.3 million, as compared to $9.7 million for the nine months ended September 30, 2025. The increase of $17.6 million was primarily due to costs related to in-licensing of technology of $12.5 million, increases in stock-based compensation and other personnel-related expenses of $2.8 million, of which, $1.7 million related to accelerated vesting of previously unvested equity awards upon the termination of a former executive officer, clinical trial costs of $1.2 million, consulting fees of $0.5 million, and other research and development expenses of $0.6 million.

Previous wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended June 30, 2026 were $77.6 million, as compared to $54.3 million for the three months ended June 30, 2025. The increase of $23.3 million was primarily due to increases in marketing-related expenses of $9.9 million, stock-based compensation expense of $6.8 million, of which $5.3 million relates to accelerated vesting of previously unvested equity awards upon the termination of a former executive officer, personnel-related expense of $3.3 million, legal fees of $2.0 million, outside services of $1.6 million, and other general operating costs of $0.8 million, partially offset by a decrease in conference and seminar expense of $1.1 million.

Current wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the nine months ended September 30, 2026 were $193.3 million, as compared to $170.2 million for the nine months ended September 30, 2025. The increase of $23.1 million was primarily due to increases in stock-based compensation expense of $9.6 million, of which $6.8 million relates to accelerated vesting of previously unvested equity awards upon the termination of former executive officers, personnel-related expense of $6.8 million, legal fees of $5.7 million, outside services of $3.1 million, and other general operating costs of $1.2 million, partially offset by decreases in marketing-related expenses of $1.7 million, conference and seminar expenses of $1.2 million, and audit, tax, and valuation fees of $0.7 million.

Previous wording

Other (Expense) Income, Net. Other expense, net for the six months ended June 30, 2026 was $1.3 million, as compared to other income, net of $6.0 million for the six months ended June 30, 2025. The change of $7.3 million was primarily due to interest expense related to our Credit Agreement of $4.9 million and decreases in net accretion of discounts on short-term investments of $1.9 million and interest income of $0.5 million from our cash, cash equivalents, and short-term investments.

Current wording

Other (Expense) Income, Net. Other expense, net for the nine months ended September 30, 2026 was $2.8 million, as compared to other income, net of $8.0 million for the nine months ended September 30, 2025. The change of $10.8 million was primarily due to interest expense related to our Credit Agreement of $7.4 million and decreases in net accretion of discounts on short-term investments of $2.6 million and interest income of $0.8 million from our cash, cash equivalents, and short-term investments.

Previous wording

Since our inception, we have incurred significant operating losses and negative cash flows from our operations. We have funded our operations to date primarily with proceeds from net product sales, debt, licensing, supply and distribution arrangements, issuance of common stock, the Merger with Silverback, and private placement of convertible preferred stock. As of June 30, 2026, we had cash, cash equivalents, and short-term investments of $143.8 million.

Current wording

Since our inception, we have incurred significant operating losses and negative cash flows from our operations. We have funded our operations to date primarily with proceeds from net product sales, debt, licensing, supply and distribution arrangements, issuance of common stock, the Merger with Silverback, and private placement of convertible preferred stock. As of September 30, 2026, we had cash, cash equivalents, and short-term investments of $138.4 million.

Previous wording

The following table summarizes our cash flows for the six months ended June 30, 2026 and 2025 (in thousands):

Current wording

The following table summarizes our cash flows for the nine months ended September 30, 2026 and 2025 (in thousands):

Previous wording

During the six months ended June 30, 2026, net cash used in operating activities was $105.9 million. This consisted primarily of a net loss of $123.0 million, an increase in our operating assets and operating liabilities of $25.0 million and $20.8 million, respectively, and non-cash charges of $21.3 million. The increase in our operating assets was primarily attributable to increases in accounts receivable of $21.5 million and prepaid expenses and other assets of $3.2 million. The increase in our operating liabilities was primarily attributable to an increase in accounts payable and accrued expenses of $20.8 million. The non-cash charges consisted primarily of non-cash stock-based compensation of $19.8 million, other non-cash items of $2.3 million, and depreciation and amortization expense of $0.8 million, partially offset by $1.6 million in net accretion of discounts on short-term investments. While cash used in operating activities reflects our ongoing investment in the commercialization ofneffy, we remain focused on allocating resources efficiently and managing operating expenditures in support of our strategic priorities.

Current wording

During the nine months ended September 30, 2026, net cash used in operating activities was $139.6 million. This consisted primarily of a net loss of $158.5 million, an increase in our operating assets and operating liabilities of $32.5 million and $21.8 million, respectively, and non-cash charges of $29.6 million. The increase in our operating assets was attributable to increases in accounts receivable of $27.4 million and prepaid expenses and other assets of $2.6 million, and inventories of $2.6 million. The increase in our operating liabilities was primarily attributable to an increase in accounts payable and accrued expenses of $22.1 million. The non-cash charges consisted primarily of non-cash stock-based compensation of $27.9 million, other non-cash items of $2.5 million, and depreciation and amortization expense of $1.2 million, partially offset by $2.1 million in net accretion of discounts on short-term investments. While cash used in operating activities reflects our ongoing investment in the commercialization ofneffy, we remain focused on allocating resources efficiently and managing operating expenditures in support of our strategic priorities.

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, 2026, cash and cash equivalents provided by investing activities was $69.4 million. This consisted of proceeds from maturities and sales of short-term investments of $104.0 million, partially offset by purchases of short-term investments of $34.6 million. 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.

Current wording

During the nine months ended September 30, 2026, cash and cash equivalents provided by investing activities was $92.8 million. This consisted of proceeds from maturities and sales of short-term investments of $160.5 million, partially offset by purchases of short-term investments of $67.7 million. 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.

Previous wording

During the six months ended June 30, 2026, the $3.4 million of cash and cash equivalents provided by financing activities was attributable to proceeds from milestone obligations met and royalties earned under license agreements of $2.5 million and proceeds from stock option exercises and issuance of common stock under the employee stock purchase plan of $0.8 million. 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.

Current wording

During the nine months ended September 30, 2026, the $31.1 million of cash and cash equivalents provided by financing activities was attributable to net proceeds from the funding of the Term B Loan under the Credit Agreement of $25.0 million, proceeds from exercises and issuance of common stock under the employee stock purchase plan of $3.4 million and proceeds from milestone obligations met and royalties earned under license agreements of $2.7 million. 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 funding of the Term A 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.

Previous wording

On September 29, 2025 (the “Closing Date”), we entered into the Credit Agreement with the Administrative Agent and the Lenders, which provides for an aggregate principal amount up to $250.0 million of term loans (the “Term Loans”) from the Lenders to us, including an initial tranche of $100.0 million under Term A Loan funded on the Closing Date, $25.0 million under Term B Loan that will be made available during the period commencing on the six-month anniversary of the Closing Date and ending no later than the one-year anniversary of the Closing Date, up to $25.0 million under Term C Loan will be made available at our election during the period commencing on and including the Closing Date and ending no later than the two-year anniversary of the Closing Date, subject to the satisfaction of a certain revenue requirement, and up to $100.0 million under Term D Loan, subject to the consent of the Lenders. The Term Loans will mature on the five-year anniversary of the Closing Date. The Credit Facility enhances our liquidity position and provides additional financial flexibility, subject to the satisfaction of certain customary conditions for future tranches and revenue-based requirements for the third tranche.

Current wording

On September 29, 2025 (the “Closing Date”), we entered into the Credit Agreement, as amended in July 2026, with the Administrative Agent and the Lenders, which provides for an aggregate principal amount up to $250.0 million of term loans (the “Term Loans”) from the Lenders to us, including an initial tranche of $100.0 million under Term A Loan funded on the Closing Date, $25.0 million under Term B Loan funded on September 25, 2026, up to $25.0 million under Term C Loan will be made available at our election during the period commencing on and including the Closing Date and ending no later than the two-year anniversary of the Closing Date, subject to the satisfaction of a certain revenue requirement, and up to $100.0 million under Term D Loan, subject to the consent of the Lenders. The Term Loans will mature on the five-year anniversary of the Closing Date. The Credit Facility enhances our liquidity position and provides additional financial flexibility, subject to the satisfaction of certain customary conditions for future tranches and revenue-based requirements for the Term C Loan.

Previous wording

Based on our current operating plan, we believe that our existing cash, cash equivalents, short-term investments, revenues from product sales, cash proceeds from collaboration and out-licensing agreements, and additional borrowings on our Term Loans will be sufficient to meet our anticipated cash requirements until we achieve cash-flow break-even. In particular, we expect these resources will allow us to fund commercial manufacturing and sales and marketing activities, general operating activities and working capital requirements, and proof of concept clinical trials ofneffyfor additional indications. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain.

Current wording

Based on our current operating plan, we believe that our existing cash, cash equivalents, short-term investments, revenues from product sales, cash proceeds from collaboration and out-licensing agreements, and additional borrowings on our Term Loans will be sufficient to meet our anticipated cash requirements until we achieve cash flow breakeven. In particular, we expect these resources will allow us to fund commercial manufacturing and sales and marketing activities, general operating activities and working capital requirements, and proof of concept clinical trials ofneffyfor additional indications. However, our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement that involves risks and uncertainties, and actual results could vary materially. We have based this estimate on assumptions that may prove to be wrong, and we could deplete our capital resources sooner than we expect. Additionally, the process of testing product candidates in clinical trials is costly, and the timing of progress and expenses in these trials is uncertain.

Previous wording

the timing and amount of any milestone and royalty payments under the ALK Collaboration Agreement, ALK Co-Promotion Agreement, collaboration and distribution agreement with Pediatrix Therapeutics, Inc., license agreement with Aegis Therapeutics, LLC, collaboration and license agreement with Alfresa Pharma Corporation, termination agreement with Recordati Ireland, Ltd., license and distribution agreement with Seqirus Pty Ltd., and license agreement with a licensor;

Current wording

the timing and amount of any milestone and royalty payments under collaboration, license, distribution, and related agreements;

Previous wording

our headcount growth and associated costs as we expand our employee headcount and building and maintaining a commercial infrastructure;

Current wording

our headcount growth and associated costs as we expand our employee headcount and build and maintain a commercial infrastructure;

Previous wording

The remaining unconditional purchase obligations related to the supply of raw materials totaled $55.6 million as of June 30, 2026. Our remaining obligations by year are as follows: 2026 ($9.4 million), 2027 ($11.8 million), 2028 ($13.8 million), and $2.9 million per year thereafter through 2035.

Current wording

The remaining unconditional purchase obligations related to the supply of raw materials totaled $55.6 million as of September 30, 2026. Our remaining obligations by year are as follows: 2026 ($9.4 million), 2027 ($11.8 million), 2028 ($13.8 million), and $2.9 million per year thereafter through 2035. Subsequent to period end, the Company entered into an amendment to certain arrangements related to the supply of raw materials, reducing our remaining unconditional purchase obligations by $23.9 million.

Previous wording

Under the ALK Co-Promotion Agreement, the remaining obligation totaled $28.3 million as of June 30, 2026. Our remaining obligations by year are as follows: 2026 ($4.3 million), 2027 ($14.6 million), 2028 ($5.8 million), and 2029 ($3.6 million). In addition to the base fee, ALK U.S will be eligible to receive performance-based payments from us. Future performance-based payment amounts are indeterminate since they depend on future revenues, which are uncertain.

Current wording

Under the ALK Co-Promotion Agreement, the remaining obligation totaled $18.2 million as of September 30, 2026. Our remaining obligations by year are as follows: 2026 ($4.4 million), 2027 ($10.7 million), 2028 ($1.8 million), and 2029 ($1.3 million). In addition to the base fee, ALK U.S. will be eligible to receive performance-based payments from us. Future performance-based payment amounts are indeterminate since they depend on future revenues, which are uncertain.

Previous wording

Under the Credit Agreement, the outstanding principal of $100.0 million as of June 30, 2026 is due upon maturity on September 29, 2030. Estimated interest payments are calculated based on the outstanding principal, the applicable interest rate and expected timing of scheduled payments as of June 30, 2026. As of June 30, 2026, based on the interest rate in effect at such date, estimated remaining interest payments are $39.8 million, and our estimated remaining interest payments by year are as follows: 2026 ($4.7 million), 2027 ($9.4 million), 2028 ($9.4 million), 2029 ($9.4 million), and 2030 ($6.9 million).

Current wording

Under the Credit Agreement, the outstanding principal of $125.0 million as of September 30, 2026 is due upon maturity on September 29, 2030. Estimated interest payments are calculated based on the outstanding principal, the applicable interest rate and expected timing of scheduled payments as of September 30, 2026. As of September 30, 2026, based on the interest rate in effect at such date, estimated remaining interest payments are $48.5 million, and our estimated remaining interest payments by year are as follows: 2026 ($3.1 million), 2027 ($12.1 million), 2028 ($12.2 million), 2029 ($12.1 million), and 2030 ($9.0 million).

Previous wording

Under the Aegis Agreement, remaining payment obligations to OrbiMed are contingent upon our achievement of certain commercial milestones and totaled $9.0 million as of June 30, 2026. We are also required to make royalty payments to OrbiMed based on a mid-single-digit percentage of net product sales. Future royalty payment amounts are indeterminate since they depend on future revenues, which are uncertain.

Current wording

Under the Aegis Agreement, remaining payment obligations are contingent upon our achievement of certain commercial milestones and totaled $9.0 million as of September 30, 2026. We are also required to make royalty payments to OrbiMed based on a mid-single-digit percentage of net product sales. Future royalty payment amounts are indeterminate since they depend on future revenues, which are uncertain.

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”). 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 ofneffyin the Recordati Territory, of which up to €4.4 million (approximately $5.0 million in U.S. dollars) remain outstanding as of June 30, 2026. 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 ofneffyin the Recordati Territory, of which up to €4.1 million (approximately $4.7 million in U.S. dollars) remain as of September 30, 2026. Future royalty payment amounts are indeterminate since they depend on future revenues, which are uncertain.

Previous wording

In July 2026, we entered into a license agreement (the “License Agreement”) pursuant to which we obtained exclusive worldwide rights to certain intellectual property. Under the License Agreement, we paid an upfront payment of $12.5 million. We may also be required to make future milestone payments. In addition, we may be required to pay tiered royalties on net sales of licensed products, subject to certain reductions, as specified in the License Agreement. Future milestone and royalty payments are contingent upon the occurrence of specified contractual events and, accordingly, the timing and amount of such payments are uncertain.

Current wording

In July 2026, we entered into a license agreement with a strategic partner, pursuant to which we obtained exclusive worldwide rights to certain intellectual property. We may also be required to make future milestone payments. In addition, we may be required to pay tiered royalties on net sales of licensed products, subject to certain reductions, as specified in the license agreement. Future milestone and royalty payments are contingent upon the occurrence of specified contractual events and, accordingly, the timing and amount of such payments are uncertain.

Previous wording

During the six months ended June 30, 2026, there were no material changes to our critical accounting policies or estimates. Our critical accounting policies and estimates are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates” in our Annual Report on Form 10-K filed with the SEC on March 9, 2026 and under the heading “Use of Estimates” in Note 2 – Summary of Significant Accounting Policies to our unaudited condensed consolidated financial statements appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q.

Current wording

During the nine months ended September 30, 2026, there were no material changes to our critical accounting policies or estimates. Our critical accounting policies and estimates are described under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical Accounting Estimates” in our Annual Report on Form 10-K filed with the SEC on March 9, 2026 and under the heading “Use of Estimates” in Note 2 – Summary of Significant Accounting Policies to our unaudited condensed consolidated financial statements appearing in Part I, Item 1 of this Quarterly Report on Form 10-Q.