ARS Pharmaceuticals, Inc.

Previous wording

We are a biopharmaceutical company focused on the commercialization and development ofneffy(currently 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 needle-free intranasal delivery of epinephrine for 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 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). We believe the market opportunity forneffyin the United States is significant. At the current list price forneffyand 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.

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) 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).

Previous wording

In August 2024, the FDA approved neffy 2 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater, with neffy 1 mg subsequently approved in March 2025 for patients who are four years of age and older who weigh 15 kg to less than 30 kg. In March 2026, the FDA approved updating theneffy 1 mg label to remove the age criteria so all children and adults who weigh 15 kg or more can utilize neffy 1 mg. 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 March 31, 2026, our sales force is comprised of approximately 106 ARS Pharma employees, who serve as sales reps, key account managers, area sales managers, and national sales directors, as well as 10 virtual sales reps, and approximately 80 sales reps via our co-promotion partner, ALK U.S., who began field operations in June 2025 and will target over 10,000 specified pediatricians and other prescribers in the U.S. We completed our sales force expansion in early May 2026, expanding our internal sales force to 148 ARS Pharma employees.

Current wording

In August 2024, the FDA approved neffy 2 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater, with neffy 1 mg subsequently approved in March 2025 for patients who are four years of age and older who weigh 15 kg to less than 30 kg. In March 2026, the FDA approved updating theneffy 1 mg label to remove the age criteria so all children and adults who weigh 15 kg or more can utilize neffy 1 mg.

Previous wording

Our U.S. commercial launch is building momentum, and our launch data shows meaningful physician and patient demand. More than 28,000 healthcare providers have prescribed neffy to date, with approximately half being repeat prescribers. Approximately 120,000 patients are using neffy in the U.S. as of the end of the first quarter of 2026, with about 29,500 added during the first quarter of 2026. With increasing demand, we’re securing broad insurance coverage, which we believe is a critical factor for accelerating adoption in the high patient volume epinephrine market. Currently, we have approximately 90% overall commercial coverage, inclusive of plans that may still require prior authorization, approximately 57% coverage with commercial insurance without prior authorization, and 9 of 50 Medicaid states covering neffy without prior authorization, including Florida. Florida, a bellwether Medicaid state, has added neffy to its unrestricted formulary effective July 1, 2026, with many additional states progressing towards placing neffy on their preferred drug list.

Current wording

In parallel, we have secured broad insurance coverage and will continue to engage with U.S. payers, both commercial and Medicaid, with a goal of furthering expanding coverage. Currently, we have secured approximately 90% overall commercial coverage, inclusive of plans that may still require prior authorization, approximately 57% commercial coverage without prior authorization, and 9 of 50 Medicaid states cover neffy without prior authorization, including Florida, a bellwether Medicaid state that added neffy to its unrestricted formulary effective July 1, 2026. We understand that many additional states are progressing towards placing neffy on their preferred drug list.

Previous wording

Our launch strategy is also supported by: active participation since November 2024 of approximately 3,400 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 CVS Caremark, where the approval process is actively ongoing for addition ofneffyto CVS’ commercial 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 10,000 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, as well as linear television advertising. 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 on our virtual prescriber website, getneffy.com, 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.

Current 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.

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), with commercial launch by our collaboration partner, Pediatrix, expected to start in the first half of 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 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.

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. The interim analysis population is fully enrolled as of May 2026, and interim data from this clinical trial is anticipated in the fourth quarter of 2026, followed by the potential initiation of a single Phase 3 pivotal efficacy study in mid-2027.

Current wording

In addition to ourneffy base business, we are evaluating our intranasal epinephrine technology known as ARS-2, as a potential needle-free, on-demand rescue treatment option for acute flares in chronic spontaneous urticaria (“CSU”). At the 2024 American Academy of Allergy, Asthma and Immunology Annual Meeting, we reported positive topline results from a Phase 2 inpatient trial in 18 treatment-refractory CSU patients that demonstrated statistically significant and clinically meaningful improvements in pruritus (itchy skin), hives, body surface area and erythema from baseline as early as five minutes after dosing. In the second quarter of 2025, we initiated a Phase 2b randomized, placebo-controlled outpatient clinical trial in CSU patients, on chronic treatment regimens, who still experience flares or exacerbations. The interim analysis population was fully enrolled as of May 2026. The timing of data collection in our Phase 2b trial is dependent on patients experiencing and documenting multiple qualifying flare episodes treated with placebo and varying doses of intranasal epinephrine. We currently expect to report interim Phase 2b data in the first quarter of 2027.

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 have funded our operations primarily with proceeds from the merger with Silverback Therapeutics, Inc. (“Silverback”) in November 2022 (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 March 31, 2026, we had cash, cash equivalents, and short-term investments of $201.0 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 June 30, 2026, we had cash, cash equivalents, and short-term investments of $143.8 million.

Previous wording

We have incurred net losses in most years since our inception. Net loss for the three months ended March 31, 2026 and 2025 was $60.6 million and $33.9 million, respectively. As of March 31, 2026, we had an accumulated deficit of $355.2 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 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.

Previous wording

As of March 31, 2026, we had $5.3 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 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.

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. 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 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.

Previous wording

Revenues. Revenue for the three months ended March 31, 2026 was $22.7 million, as compared to $8.0 million for the three months ended March 31, 2025. Revenue for the three months ended March 31, 2026 includes $17.5 million in net product revenues for sales ofneffyin the United States, $2.5 million in revenue for the achievement of the regulatory milestone and performance of development and regulatory services under the collaboration, license and distribution agreement we entered into with ALK-Abelló A/S in November 2024 (the “ALK Collaboration Agreement”), and $2.7 million in revenue under supply agreements with partners. Revenue for the three months ended March 31, 2025 includes $7.8 million in net product revenues for sales ofneffyand $0.2 million in revenue for the performance of development and regulatory services under the ALK Collaboration Agreement.

Current 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.

Previous wording

Cost of Goods Sold. Cost of goods sold for the three months ended March 31, 2026 was $6.3 million, as compared to $1.1 million for the three months ended March 31, 2025. The increase of $5.2 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, and Australia 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 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.

Previous wording

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended March 31, 2026 was $72.2 million, as compared to $41.1 million for the three months ended March 31, 2025. The increase of $31.1 million was primarily due to increases in marketing-related expenses of $26.4 million, stock-based compensation expense of $1.9 million, legal fees of $0.9 million, outside services of $0.9 million, conference and seminar expense of $0.6 million, and other general operating costs of $0.4 million.

Current 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.

Previous wording

Other (Expense) Income, Net. Other expense, net for the three months ended March 31, 2026 was $0.5 million, as compared to other income, net of $3.2 million for the three months ended March 31, 2025. The change of $3.7 million was primarily due to interest expense related to our Credit Agreement of $2.4 million and decreases in net accretion of discounts on short-term investments of $1.1 million and interest income of $0.2 million from our cash, cash equivalents, and short-term investments.

Current 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.

Previous wording

Research and Development Expenses. Research and development expenses for the three months ended March 31, 2026 was $4.3 million, as compared to $3.0 million for the three months ended March 31, 2025. The increase of $1.4 million was primarily due to increases in product-development related expense of $0.5 million, personnel-related expenses, including stock-based compensation expense, of $0.5 million, and other research and development expenses of $0.4 million.

Current 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.

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 the Merger with Silverback, 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 March 31, 2026, we had cash, cash equivalents, and short-term investments of $201.0 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 June 30, 2026, we had cash, cash equivalents, and short-term investments of $143.8 million.

Previous wording

The following table summarizes our cash flows for the three months ended March 31, 2026 and 2025 (in thousands):

Current wording

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

Previous wording

During the three months ended March 31, 2026, net cash used in operating activities was $44.9 million. This consisted primarily of a net loss of $60.6 million, an increase in our operating assets and operating liabilities of $1.7 million and $10.3 million, respectively, and non-cash charges of $7.1 million. The increase in our operating assets was primarily attributable to increases in accounts receivable of $0.8 million and prepaid expenses and other assets of $0.5 million. The increase in our operating liabilities was primarily attributable to an increase in accounts payable and accrued expenses of $10.3 million. The non-cash charges consisted primarily of non-cash stock-based compensation of $7.4 million, partially offset by $1.0 million in net accretion of discounts on short-term investments.

Current 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.

Previous wording

During the three months ended March 31, 2025, net cash used in operating activities was $40.7 million. This consisted primarily of a net loss of $33.9 million, an increase in our operating assets of $14.4 million, an increase in our operating liabilities of $4.0 million, and non-cash charges of $3.6 million. The increase in our operating assets was due to increases in inventories of $8.4 million, prepaid expenses and other assets of $4.8 million, and accounts receivable of $1.1 million. The increase in our operating liabilities was due to an increase in accounts payable and accrued expenses of $4.2 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 $5.3 million and depreciation and amortization expense of $0.3 million, partially offset by $2.0 million in net accretion of discounts on short-term investments.

Current 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.

Previous wording

During the three months ended March 31, 2026, cash and cash equivalents provided by investing activities was $27.8 million. This consisted primarily of maturities of short-term investments of $42.5 million, partially offset by purchases of short-term investments of $14.7 million. During the three months ended March 31, 2025, cash and cash equivalents provided by investing activities was $29.1 million. This consisted of maturities of short-term investments of $63.5 million, partially offset by purchases of short-term investments of $34.3 million and purchases of property and equipment of $0.1 million.

Current 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.

Previous wording

During the three months ended March 31, 2026, the $0.2 million of cash and cash equivalents provided by financing activities was attributable to proceeds from stock option exercises and proceeds from royalties earned under license agreements. During the three months ended March 31, 2025, the $0.7 million of cash and cash equivalents provided by financing activities was attributable to proceeds from stock option exercises.

Current 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.

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 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 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.

Previous wording

Based on our current operating plan, we believe that our existing cash, cash equivalents, short-term investments, revenues from product sales, and cash proceeds from collaboration and out-licensing agreements 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 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.

Previous wording

the timing and amount of any milestone and royalty payments under the ALK Collaboration Agreement, ALK Co-Promotion Agreement, Pediatrix Agreement, Aegis Agreement, Alfresa Agreement, Recordati Termination Agreement, and the Seqirus Agreement;

Current 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;

Previous wording

The remaining unconditional purchase obligations related to the supply of raw materials totaled $55.3 million as of March 31, 2026. Our remaining obligations by year are as follows: 2026 ($9.1 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 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.

Previous wording

Under the ALK Co-Promotion Agreement, the remaining obligation totaled $28.3 million as of March 31, 2026. Our remaining obligations by year are as follows: 2026 ($4.4 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 $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.

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. Our remaining obligations under this agreement totaled $5.0 million as of March 31, 2026. Our remaining obligations by year are as follows: 2026 ($4.0 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. Our remaining obligations under this agreement totaled $3.0 million as of June 30, 2026. Our remaining obligations by year are as follows: 2026 ($2.0 million) and 2027 ($1.0 million).

Previous wording

Under the Credit Agreement, the outstanding principal of $100.0 million as of March 31, 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 March 31, 2026. As of March 31, 2026, based on the interest rate in effect at such date, estimated remaining interest payments are $41.9 million, and our estimated remaining interest payments by year are as follows: 2026 ($7.0 million), 2027 ($9.3 million), 2028 ($9.3 million), 2029 ($9.3 million), and 2030 ($6.9 million).

Current 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).

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 €4.6 million (approximately $5.2 million in U.S. dollars) remain outstanding as of March 31, 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 €4.4 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.

Previous wording

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue, accrued expenses, stock-based compensation, and valuation allowances for deferred tax assets. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Current wording

Our management’s discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and the disclosure of contingent assets and liabilities in our financial statements. On an ongoing basis, we evaluate our estimates and judgments, including those related to revenue recognized under collaboration agreements and accruals for variable consideration of product revenue. We base our estimates on historical experience, known trends and events, and various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Previous wording

During the three months ended March 31, 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 Policies and Significant Judgments and Estimates” in our Annual Report on Form 10-K filed with the SEC on March 9, 2026 and 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 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.