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Item 1. Business

2026-03-09 compared with 2025-03-20 · 354 added, 406 removed, 694 unchanged (52% of the section changed)

As used in this Annual Report, unless the context indicates or otherwise requires, “ARS,” “ARS Pharma,” the “company,” “we,” “us,” “our,” and other similar terms refer to ARS Pharmaceuticals, Inc., a Delaware corporation and its consolidated subsidiaries.

neffy is a trademark of ours that we use in this Annual Report.

neffy and EURneffy are trademarks of ours that we use in this Annual Report.

This Annual Report also includes trademarks, trade names, and service marks that are the property of other organizations.

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Company Summary

We are a biopharmaceutical company focused on the commercialization and development of neffy (previously referred to as ARS-1 and currently identified in the EU by the trade name EURneffy ) for the needle-free intranasal delivery of epinephrine for the emergency treatment of Type I allergic reactions, including anaphylaxis.

neffy is the first and only FDA and European Commission (“EC”)-approved needle-free epinephrine product, and the first new delivery method for epinephrine in more than 35 years.

We are a biopharmaceutical company focused on the commercialization and development of neffy (currently identified in the European Union (“EU”) and United Kingdom (“U.K.”) by the trade name EURneffy and 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.

neffy is the first and only FDA and European Commission (“EC”)-approved needle-free epinephrine product, and also has approvals in the U.K., Japan, Australia, and China.

It is the first new delivery method for epinephrine in more than 35 years.

neffy is a proprietary composition of epinephrine with an innovative absorption enhancer called Intravail, which allows neffy to 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 neffy ’s “no needle, no injection” approach addresses a significant unmet need in the use of epinephrine, which, except for neffy , is currently approved only in injectable formulations for the emergency treatment of Type I allergic reactions.

There are approximately 40 million people in the United States who experience Type I allergic reactions.

Of this group, approximately 20 million people are reported in the last 3 years of claims data to have been diagnosed and experienced severe Type I allergic reactions that may lead to anaphylaxis, and approximately 6.5 million were prescribed an epinephrine autoinjector.

However (in 2023, for example), only 3.2 million filled their active epinephrine autoinjector prescription, and of those, only half consistently carry their prescribed autoinjector with them due to the many drawbacks of these devices.

We believe the market opportunity for neffy in the United States is significant.

At the current list price for neffy and our target total gross-to-net yield, the estimated 6.5 million patients prescribed an epinephrine autoinjector in the United States represents an initial addressable market opportunity of approximately $3 billion in annual net sales with an additional 13.5 million diagnosed patients that have not been prescribed an epinephrine autoinjector.

The drawbacks of approved epinephrine devices, with the exception of neffy and our intranasal epinephrine technology product candidates, include the use of needles, which can result in patient and caregiver injury as well as hesitation and delays in administration due principally to apprehension and pain of needles, allowing the allergic reaction to progress in severity leading to symptoms that seriously impact patient quality of life, to potential need for emergency services and/or hospitalizations, and to life-threatening symptoms or events.

In particular, intra-muscular injections also subject to dosing errors and risk of accidental blood vessel injections, which can cause a significant spike in the intravascular delivery of epinephrine potentially leading to serious cardiovascular complications or events.

We believe neffy’s and our intranasal epinephrine technology product candidates’ design, particularly the compact size and “no needle, no injection” delivery, eliminates needle-related apprehension and pain, improves portability and ease of use, is highly reliable, and will increase prescriptions for epinephrine, making it more likely that patients and caregivers will administer epinephrine sooner, achieve more rapid symptom relief, and prevent the allergic reaction from progressing to a level of severity that could lead to hospitalization or even death.

Data from our studies of neffy and our intranasal epinephrine technology product candidates demonstrated nasally delivered epinephrine reached blood levels comparable to those of already approved epinephrine injectable products across single dosing, repeat dosing, self-administration or allergen challenge conditions, and produced clinically significant pharmacodynamic responses that were greater than or comparable to reference injection products.

Pharmacodynamic response is a surrogate for efficacy and was observed approximately one minute after dosing with neffy and our intranasal epinephrine technology product candidates Pharmacodynamic response as a surrogate for efficacy was considered the primary basis for approval in the European Union with the EMA approval of neffy 2 mg.

On August 9, 2024, the FDA approved neffy 2 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater.

As a result, we initiated commercial launch of neffy 2 mg in the United States, with product becoming available for shipment on September 23, 2024.

This commercialization effort currently includes a direct sales force of 118 individuals targeting high-volume epinephrine prescribers that is supported by branded direct-to-consumer marketing, disease awareness campaigns with advocacy groups and non-personal promotion such as non-personal promotion including continuing medical education programs in collaboration with allergist societies, speaker bureaus, peer-to-peer programs and participation in regional and national medical conferences.

On March 5, 2025, the FDA approved the supplemental NDA for neffy 1 mg dose for the emergency treatment of Type I allergic reactions, including anaphylaxis, in patients who are four years of age and older and weigh 15 kg to less than 30 kg.

Commercial Launch Initiated on September 23, 2024

On August 22, 2024, the EC granted marketing authorization in the EU for EURneffy (the trade name for neffy 2 mg in the European Union and United Kingdom), for the emergency treatment of allergic reactions (anaphylaxis), in adults and children who weigh 30 kg or greater.

Through our collaboration with ALK (discussed below), we anticipate that EURneffy will be made available to patients in certain EU member states in 2025.

Regulatory review of neffy is ongoing in Canada, the United Kingdom, China, Japan, and Australia.

ARS has filed in Canada in January 2025 and the United Kingdom in December 2024 on behalf of ALK, while Pediatrix, Alfresa and CSL have filed in China, Japan and Australia during the fourth quarter of 2024, respectively.

Regulatory decisions are anticipated by mid-2025 in the U.K., the second-half of 2025 in Japan, year-end 2025 in Canada, and in the first-half of 2026 in China and Australia.

We believe neffy ’s “no needle, no injection” approach addresses a significant unmet need in the use of epinephrine.

There are approximately 40 million people in the U.S.

who experience Type I allergic reactions.

Of this group, approximately 20 million people are reported to have been diagnosed and experienced severe Type I allergic reactions that may lead to anaphylaxis, and approximately 6.5 million of those were prescribed an epinephrine autoinjector.

However, in recent years, only an estimated one-half of those consistently fill their prescribed autoinjector with them.

We believe the market opportunity for neffy in the U.S.

is significant.

Those estimated 3.2 million patients who currently fill their active epinephrine autoinjector prescription would represent approximately $1.8 billion in annual U.S.

net sales at neffy ’s estimated gross-to-net yield based on epinephrine device unit volume in 2025.

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 and weigh 15 kg to less than 30 kg.

Our commercialization efforts for neffy currently include a direct sales force of 106 individuals targeting high-volume prescribers, an additional co-promotion U.S.

sales force of approximately 70 individuals with our partner, ALK-Abelló, Inc.

(“ALK U.S.”, an affiliate of ALK-Abelló A/S (“ALK”)), targeting pediatricians that launched in May 2025, as well as our getneffy.com virtual prescriber website formally launched in November 2025 to minimize physician and patient burden.

Our sales force and virtual prescriber options are supported by branded direct-to-consumer marketing through streaming platforms, traditional broadcast and cable television, consumer-facing digital channels, non-personal promotion with healthcare providers, and disease awareness campaigns with advocacy groups.

commercial launch is building momentum, and our launch data shows meaningful physician and patient demand.

As of February 2026, more than 22,500 physicians have prescribed neffy since launch.

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 93% overall commercial coverage, inclusive of plans that may still require prior authorization, approximately 57% coverage with commercial insurance without prior authorization, and 8 of 50 Medicaid states covering neffy without prior authorization.

The EC has granted marketing authorization in the EU for EURneffy 2 mg (the trade name for neffy 2 mg in the EU and U.K.), for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater and on January 29, 2026, the Committee for Medicinal Products for Human Use (“CHMP”) of the EMA adopted a positive opinion, recommending marketing authorization in the EU for EURneffy 1 mg for children who are four years of age and older and 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 U.K.

in October 2025.

We received approval of neffy 2 mg and 1 mg in Japan in September 2025, which is expected to launch in the first quarter of 2026 by our collaboration partner, Alfresa.

We also received approval of neffy 2 mg and 1 mg doses in Australia in December 2025, with commercial launch by our collaboration partner, Seqirus, initiated in February 2026.

In December 2025, we received approval in China of 优敏速 (the trade name for neffy 2 mg in China), with commercial launch by our collaboration partner, Pediatrix, expected to start in the first half of 2026.

neffy 2 mg is under review by Health Canada, with a regulatory decision expected in the second quarter of 2026 and if approved, commercial launch by our collaboration partner, ALK, expected to start later in 2026.

neffy has already been approved or is under regulatory review in countries representing approximately 98% of the current global epinephrine autoinjector sales.

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, and anticipate initiating a Phase 2b randomized, placebo controlled outpatient clinical trial in chronic spontaneous urticaria patients on a chronic antihistamine treatment regimen who still experience flares or exacerbations.

This Phase 2b study is anticipated to be initiated in the second quarter of 2025, with topline data anticipated in early 2026, followed by the potential initiation of a single pivotal efficacy study in 2026.

For more information regarding our partners and collaboration agreements, see “ Business—Our Collaboration and Licensing Agreements.

Real-world data supports that neffy delivers similar response rates as injections for the emergency treatment of Type I allergic reactions.

In September 2025, we reported survey results of anaphylaxis treatment outcomes in the neffy experience program, which provides 1 mg and 2 mg doses of neffy to allergists for in-office use if patients experience an anaphylactic event during oral food challenges or allergen immunotherapy.

These results showed that approximately 90% of patients experiencing anaphylaxis symptoms were effectively treated with a single dose of neffy , which is consistent with that historically reported for epinephrine injection.

The results were presented as an oral presentation at the American College of Allergy, Asthma and Immunology (“ACAAI”) meeting in early November 2025 and was also published in the Annals of Allergy, Asthma and Immunology, the official peer-reviewed journal of the ACAAI, in December 2025.

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.

Interim data from this clinical trial is anticipated in the second half of 2026, followed by the potential initiation of a single pivotal efficacy study in mid-2027.

We estimate that there are approximately 1.5 million diagnosed chronic urticaria patients in the U.S., of whom approximately half are not well-controlled by antihistamines and continue to experience multiple acute flares a year, and therefore would be prescribed multiple epinephrine nasal spray devices if approved.

The chronic urticaria indication represents an addressable market opportunity of more than $2.0 billion annually based on neffy ’s current net pricing.

We currently own, co-own and exclusively license a robust global intellectual property portfolio including issued composition of matter and method patents relating to neffy and our intranasal epinephrine technology product candidates that are not expected to expire until 2038.

Epinephrine and Allergic Reactions Background

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These intra-muscular auto-injection devices have several limitations that include:

lack ease of portability with only 50% of patients filling prescriptions carrying the device;

reluctance to use the device with approximately 25% to 60% of patients carrying the device refusing to administer;

• they lack convenience of portability, with only 50% of patients who fill their prescriptions carrying the device;

• patients are reluctant to use the device, with approximately 25% to 60% of patients who carry the device refusing to administer;

• apprehension stemming from the use of a needle that leads to approximately 40% to 60% of patients delaying administration by up to 18 minutes even if they are carrying the device;

• a high rate of dosing errors, with meta-analyses reporting 23% of patients still failing to dose correctly even after training;

safety concerns including lacerations, caregiver self-injection and frequent potentially cardiotoxic blood vessel injections, which occurred in approximately 14% of EpiPen subjects in our patient self-administration studies.

As a result, many of the approximately 40 million patients at risk of severe Type I allergic reactions do not receive or fill prescriptions for intra-muscular injectables.

Of 3.2 million patients that do fill their prescriptions, approximately half do not carry the intra-muscular injectable products with them on a regular basis, while many of the other half delay or hesitate treatment during a severe Type I allergic reaction.

This may contribute to treatment postponement, prolonging troublesome symptoms, reducing quality of life and increasing the risk of complications or even death.

In addition to the 3.2 million patients who currently fill their prescriptions for an epinephrine injectable device, we estimate that approximately 3.3 million patients received a prescription, but either did not fill or renew it.

We believe the advantages of neffy, will be attractive to this group and lead to an increase in the number of patients filling their prescription as further described below.

These patients are additive to the 3.2 million patients that do fill a prescription per year, for an estimated total initial addressable market of 6.5 million, representing approximately $3 billion in annual net sales based on neffy ’s current list price and target total gross-to-net yield to ARS Pharma.

In addition, there are an estimated 13.5 million unique patients who are diagnosed, but never received an epinephrine prescription.

neffy 2 mg is approved by the FDA and EC for the emergency treatment of Type I allergic reactions, including anaphylaxis, for adults and children who weigh 30 kg or greater;

neffy 1 mg is approved by the FDA for the emergency treatment of Type I allergic reactions, including anaphylaxis, for patients who are four years of age and older and weigh 15 kg to less than 30 kg .

• safety concerns including lacerations, caregiver self-injection and frequent potentially cardiotoxic blood vessel injections.

neffy 2 mg is approved in the U.S, E.U., U.K., Japan, Australia, and China for the emergency treatment of Type I allergic reactions, including anaphylaxis, for adults and children who weigh 30 kg or greater;

neffy 1 mg is approved in the U.S., Australia, and China for the emergency treatment of Type I allergic reactions, including anaphylaxis, for patients who are four years of age and older and weigh 15 kg to less than 30 kg.

neffy and our intranasal epinephrine technology product candidates are designed to address the shortcomings of intra-muscular injectable devices.

neffy and our intranasal epinephrine technology product candidates are a convenient “no needle, no injection,” solution designed to be easier to carry, more reliable and easier to administer, without the aversion, safety concerns and fear and pain of needles associated with intra-muscular injectables.

Based on the factors set forth below, we believe that neffy and our intranasal epinephrine technology product candidates can transform the paradigm of epinephrine delivery from cumbersome, unreliable, intra-muscular injectable devices to an intranasal delivery method that makes patients more likely to administer epinephrine sooner, thus achieving more rapid symptom relief and preventing symptoms from becoming serious or life-threatening.

Based on the factors set forth below, we believe that neffy and our intranasal epinephrine technology product candidates can transform the paradigm of epinephrine delivery by achieving more rapid symptom relief and preventing symptoms from becoming serious or life-threatening.

• Needle-free, easy-to-use, pocket-sized and highly reliable nasal spray.

neffy and our intranasal epinephrine technology product candidates are easier to carry than approved intra-muscular injectables because it is pocket-sized, increasing the likelihood that the device is available for use in an emergency.

Our registrational self-administration study (EPI-17) with 2.0 mg neffy demonstrated that adult patients had zero critical dosing errors, and 100% of untrained adults and untrained children were able to successfully self-administer our intranasal epinephrine technology in our human factors validation study using the intended commercial instructions for use and quick reference guide.

Unlike autoinjector delivery that has patients and caregivers hold an injection in place for three seconds, neffy and our intranasal epinephrine technology product candidates delivery requires no holding time with epinephrine being delivered nearly instantaneously into the systemic circulation via the nose after device activation.

Dosing neffy and our intranasal epinephrine technology product candidates cannot be obstructed by common anaphylaxis co-morbidities such as vomiting or angioedema of the lips, face, mouth or tongue.

No inhalation or breathing is needed during administration of neffy or our intranasal epinephrine technology product candidates.

neffy and our intranasal epinephrine technology product candidates are easier to carry than approved intra-muscular injectables because they are pocket-sized, increasing the likelihood that the device is available for use in an emergency.

The device is also highly reliable and easy to use.

100% of untrained adults and untrained children were able to successfully self-administer our intranasal epinephrine technology in our human factors validation study using the intended commercial instructions for use and quick reference guide.

• No risk of needle-related injuries .

neffy and our intranasal epinephrine technology product candidates have no risk of needle-related injuries including injection into a blood vessel, lacerations, or caregiver self-injection since the sprayer device does not have a needle.

Accidental injections to the hands or fingers of a caregiver or a child occur more than 3,500 times a year in the United States with epinephrine injection devices.

Accidental injections to the hands or fingers of a caregiver or a child occur more than 3,500 times a year in the U.S.

with epinephrine injection devices.

• Less hesitation to dose epinephrine.

Early administration of epinephrine can reduce the severity, risk of hospitalization and mortality associated with severe Type I allergic reactions.

In patient surveys we have conducted, patients indicated a relief from fear of injection and an expectation to utilize neffy without delay in a manner more consistent with recommended guidelines due to neffy and our intranasal epinephrine technology product candidates being a nasal spray.

In patient surveys, patients indicated a relief from fear of injection and an expectation to utilize neffy without delay in a manner more consistent with recommended guidelines because it’s administered intranasally.

• Low potent dose of epinephrine .

Delivery of higher exposures of epinephrine increases the risk of overexposure and potential adverse events including gastrointestinal (GI) symptoms due to swallowing of the excess epinephrine that is not absorbed.

neffy and our intranasal epinephrine technology product candidates have high bioavailability matching the approved doses of injection at a low dose of 2.0 or 1.0 mg intranasally.

Higher exposures of epinephrine increase the risk of overexposure and potential adverse events including gastrointestinal (“GI”) symptoms due to swallowing excess epinephrine that is not absorbed, if delivered orally.

neffy and our intranasal epinephrine technology product candidates have high bioavailability matching the approved doses of injection at a low dose of 2 mg or 1 mg intranasally.

Even in the unlikely situation where epinephrine would be 100% bioavailable after administration of neffy or our intranasal epinephrine technology product candidates, the resulting exposure is expected to be tolerable.

Due to its low dose of epinephrine and high bioavailability, neffy and our intranasal epinephrine technology product candidates have minimal to no GI symptoms.

GI symptoms such as vomiting occur in approximately 20% of anaphylaxis events and the presence of such GI events due to administration of higher dose epinephrine products could confound the evaluation of anaphylaxis treatment response and monitoring.

Increased stability over existing treatment options .

neffy 2 mg has a shelf-life of 30 months at room temperature, as opposed to the reported shelf-life range of approved injection products from the date of product manufacture of 18 to 24 months, and volume-weighted average shelf-life of between 22 and 23 months.

Furthermore, neffy 2 mg has improved stability and shelf-life at high-temperature compared to existing products in the market (testing met specifications in conditions up to 3 months at 50 o C or 122 o F), which allows neffy to retain potency even if accidentally left in a high temperature environment.

Combination of previously validated product components .

neffy consists of a unique combination of three validated products, which we believe will significantly reduce neffy’s commercial development risks:

epinephrine, which has been approved by regulators and accepted by the physician community as the only effective option to treat Type I allergic reactions;

the intranasal device, which has been commercially proven with millions of sprayers sold to date across four FDA-approved products, including NARCAN for opioid overdose (marketed by Emergent BioSolutions);

and Intravail, an innovative absorption enhancer that has been previously included in the formulations of FDA approved products, such as VALTOCO and TOSYMRA nasal spray.

We believe the cost of goods for neffy will allow us to achieve gross profit margins similar to branded oral small molecule products at our current list price for neffy and our expected total gross-to-net yield.

Potential for high demand and attractive product uptake conditions.

We have conducted extensive market research with physicians, patients, parents and other caregivers that shows neffy clinical product profile that is highly desirable and addresses key unmet needs.

We believe we can successfully commercialize neffy by targeting high-prescribing allergists, pediatricians and primary care physicians who we believe will prescribe neffy as it would be a very attractive treatment option within the patient community.

In addition, our market research indicates that insurance plans (payors) perceive neffy as a differentiated product candidate, which has been validated by successful contracting with payers at a total gross-to-net yield which is in line with other innovator branded products.

We anticipate approximately 52% of commercially insured patients will have unrestricted access to neffy as of April 1, 2025.

We currently own or exclusively license a robust global intellectual property portfolio including issued composition of matter and method patents relating to neffy and our intranasal epinephrine technology product candidates that are not expected to expire until 2039 before consideration of any potential patent term adjustment.

• Increased stability over other existing treatment options .

neffy 2 mg has a shelf-life of 30 months at room temperature, while neffy 1 mg has a shelf-life of 24 months at room temperature, as opposed to the reported shelf-life range of approved injection products from the date of product manufacture of 18 to 24 months.

Furthermore, neffy has improved stability and shelf-life at high-temperature compared to existing products in the market (testing met specifications in conditions up to 3 months at 50 o C or 122 o F), which allows neffy to retain potency even if accidentally left in a high temperature environment.

Our Management Team, Financing History and Investors

We were created to innovate, develop and commercialize neffy , a novel, potentially first-in-class treatment that addresses Type I allergy patients’ desire and need for a no needle, no injection, easy-to-use, portable and reliable solution for delivering epinephrine.

To achieve this goal, we have assembled a management team with extensive experience in the development and commercialization of drugs, such as recently approved nasal sprays NARCAN (naloxone nasal spray) and VALTOCO (diazepam nasal spray).

We were created to innovate, develop and commercialize neffy , a novel, first-in-class treatment that addresses Type I allergy patients’ desire and need for a no needle, no injection, easy-to-use, portable and reliable solution for delivering epinephrine.

To achieve this goal, we have assembled a management team with extensive experience in the development and commercialization of drugs, such as approved nasal sprays NARCAN (naloxone nasal spray) and VALTOCO (diazepam nasal spray).

Our company was founded by Richard Lowenthal, M.S., MSEL, Robert Bell, Ph.D.

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Lowenthal, our Co-Founder, President, Chief Executive Officer, and one of our directors, has more than 25 years of biotechnology and pharmaceutical development experience including leading the regulatory approvals of VALTOCO (diazepam nasal spray) and NARCAN (naloxone nasal spray).

Bell, our Co-Founder and Chief Scientific Officer, has more than 25 years of product development experience including leading R&D at Barr Laboratories, Somerset Pharmaceuticals and UDL Laboratories.

Bell, our Co-Founder and Chief Scientific Officer, has more than 25 years of product development experience including leading research and development at Barr Laboratories, Inc., Somerset Pharmaceuticals, Inc.

and UDL Laboratories, Inc.

Tanimoto, our Co-Founder and Chief Medical Officer, has more than 20 years of pharmaceutical experience in clinical drug development including supporting the approval of multiple nasal spray products such as VALTOCO and NARCAN.

Shah, our Chairman, has more than 30 years of experience founding and leading biopharmaceutical companies and healthcare investment decisions including his role as Chairman and Chief Executive Officer of Design Therapeutics, former Chairman of Synthorx (now part of Sanofi) and former Chief Executive Officer of Auspex Pharmaceuticals (now part of Teva Pharmaceuticals).

Our commercial team is led by Eric Karas, Chief Commercial Officer, who has more than 25 years of sales, marketing, market access and strategic planning experience across multiple specialty products, including leading commercial initiatives for NARCAN nasal spray at Emergent BioSolutions and Adapt Pharmaceutical (now part of Emergent BioSolutions).

(now part of Sanofi S.A.) and former Chief Executive Officer of Auspex Pharmaceuticals, Inc.

(now part of Teva Pharmaceutical Industries Ltd.).

and Adapt Pharma Operations Limited (now part of Emergent BioSolutions, Inc.).

The other key members of the ARS team bring extensive finance, business development and commercial operations experience and include Kathleen Scott, Chief Financial Officer;

Justin Chakma, Chief Business Officer;

Brian Dorsey, Chief Operating Officer and Alex Fitzpatrick, Chief Legal Officer.

Since our inception, we have raised $518.9 million in proceeds, including equity financing from a syndicate of leading life sciences investors that include, among others, RA Capital, SR One and Deerfield, from our licensing and collaboration agreements and from our reverse merger with Silverback Therapeutics, Inc.

We have entered into licensing and collaboration agreements for neffy with Alfresa Pharma for Japanese rights, Pediatrix Therapeutics (founded by F-Prime Capital, Eight Roads and Creacion Ventures) for Chinese rights and CSL Seqirus for Australia and New Zealand rights.

We have also entered into a licensing and collaboration agreement with ALK for territories outside the United States and the territories covered by the Alfresa, Pediatrix and CSL agreements;

these territories include Canada, the United Kingdom, European Union and other countries.

Our strategy is focused on commercializing and developing neffy as the first and only approved intranasal treatment for the approximately 20 million patients in the United States under the active care of physicians between 2020-2022 who have been diagnosed with severe Type I allergic reactions and are at risk of anaphylaxis, for patients in geographic regions outside of the United States and for patients in other allergy indications.

Brian Dorsey, Chief Operating Officer;

and Alex Fitzpatrick, Chief Legal Officer.

We have funded our operations to date primarily with proceeds from our equity financing from a syndicate of leading life sciences investors that include, among others, RA Capital, SR One and Deerfield, debt financing with affiliates of RA Capital and OMERS Administration Corporation, licensing and collaboration agreements, product sales, and the reverse merger with Silverback Therapeutics.

We have entered into licensing and collaboration agreements for neffy with Alfresa Pharma Corporation (“Alfresa”) for rights in Japan, Pediatrix Therapeutics, Inc.

(“Pediatrix”) — founded by F-Prime Capital, Eight Roads and Creacion Ventures — for rights in China, and Seqirus Pty Ltd.

(“Seqirus”) for rights in Australia and New Zealand.

We have also entered into a licensing and collaboration agreement with ALK for territories outside the U.S.

and the territories covered by the Alfresa, Pediatrix and Seqirus agreements;

these territories include Canada, the U.K, E.U., and other countries.

Our mission is to develop innovative, patient-friendly and easy-to-use treatments that empower people with allergies and their caregivers to treat at the first sign of symptoms.

Our strategy is focused on commercializing and developing neffy as the first and only approved intranasal treatment for patients diagnosed with severe Type I allergic reactions and are at risk of anaphylaxis and for patients in other allergy indications.

Key elements of our strategy include:

• Continue to educate healthcare providers about neffy.

We began our commercialization efforts in the United States during the fourth quarter of 2024 by deploying a combination of direct promotion through a current sales force of 118 individuals comprising sales reps, virtual sales consultants and area sales managers, and non-personal promotion efforts, which are intended to reach, at a minimum, healthcare professionals that account for 40 to 45% of the current epinephrine prescriptions.

Our commercial infrastructure includes a national sales force of 106 individuals comprising sales reps, area sales managers, and nation sales directors, as well as 10 virtual sales reps and approximately 70 sales reps via our co-promotion partner, ALK U.S., which are collectively intended to reach, at a minimum, healthcare professionals that account for 50 to 55% of the current epinephrine prescriptions in the U.S.

Our promotion targets high-prescribing allergists, pediatricians and primary care physicians through both traditional and non-traditional professional channels.

As of March 2025, approximately 2,500 healthcare professionals have enrolled in our neffy experience program that allows healthcare professionals to use neffy firsthand as rescue therapy for anaphylaxis during in-clinic allergen challenge, and obtain direct clinical experience using neffy .

We anticipate that our promotional reach will eventually exceed greater than 80% of the current epinephrine prescriptions in the United States through a combination of sales force expansion by early 2026 and non-personal promotion that includes continuing medical education programs in collaboration with allergist societies, speaker bureaus, peer-to-peer programs and participation in regional and national medical conferences.

Continue to obtain payer coverage and grow sales of neffy.

Quickly attaining broad market access for severe allergy patients is a key element to ensuring a seamless patient experience to acquiring neffy and rapidly growing neffy sales.

We have successfully contracted with key payers including Express Scripts, the second largest pharmacy benefit manager in the United States.

We believe payers recognize the value and innovation of neffy for Type I allergic patients, including potential cost-savings to the healthcare system due to greater carriage and early use of epinephrine devices.

We are on track to achieve access to commercial lives under contract of 60% or greater by the end of the first quarter of 2025, and 80% by the early part of the third quarter of 2025.

With our payer contracting strategy, a $25 or less co-pay savings card, a $199 cash price, and patient assistance programs, we anticipate that the out-of-pocket cost for acquiring neffy to patients may be less than or similar to that of generic epinephrine autoinjectors, thereby minimizing cost barriers to acquiring neffy .

Accelerate direct to consumer marketing efforts of neffy.

As of February 2026, approximately 3,400 healthcare professionals have enrolled in our neffy experience program that allows healthcare professionals to use neffy firsthand as rescue therapy for anaphylaxis during in-clinic allergen challenges, allergen immunotherapy, as well as on-going collection of real-world evidence that supports neffy’s clinical equivalence to injection.

We are also disseminating survey results from the neffy experience program that were published in a major peer-reviewed allergy journal, and showed that neffy demonstrated similar treatment response rates as those reported historically with injection in more than 680 treated patients.

We anticipate that our promotional reach will eventually exceed greater than 80% of the current epinephrine prescriptions in the U.S.

through a combination of continued sales force expansion and non-personal promotion that includes continuing medical education programs in collaboration with allergist societies, speaker bureaus, peer-to-peer programs and participation in regional and national medical conferences.

• Continue to obtain payor coverage and grow sales of neffy .

We have attained approximately 57% unrestricted commercial coverage (i.e.

without prior authorization formwork) at a gross-to-net similar to other innovator products, and with 8 state Medicaid programs also covering neffy without prior authorization.

We believe payors recognize the value and innovation of neffy for Type I allergic patients, including potential cost-savings to the healthcare system due to greater carriage and early use of epinephrine devices.

With our payor contracting strategy, $0 co-pay for commercially eligible patients, a $199 cash price, and patient assistance programs, we anticipate that the out-of-pocket cost for acquiring neffy to patients may be less than, or equivalent to, generic epinephrine autoinjectors, thereby minimizing cost barriers to acquiring neffy .

• Continue to accelerate direct-to-consumer marketing efforts of neffy.

We believe that the epinephrine market has been a historically promotionally sensitive product category, and that the favorable product attributes of neffy are attractive to consumers.

Using direct-to-consumer omnichannel strategies to drive awareness and patients asking for neffy , we believe we can quickly and efficiently reach a majority of the approximately 3.2 million patients in the United States who filled a prescription for an epinephrine intra-muscular injectable device in 2023, as well as the 3.3 million patients who have received a prescription, but either refused or discontinued treatment.

Using direct-to-consumer omnichannel strategies to drive awareness and patients asking for neffy , we believe we can reach a majority of the approximately 3.2 million patients in the United States who filled a prescription for an epinephrine intra-muscular injectable device in 2023, as well as the 3.3 million patients who have received a prescription, but refused or discontinued treatment.

These 6.5 million patients are primarily treated by the same high-prescribing allergists and pediatricians that our sales force is targeting.

We believe that our direct-to-consumer marketing strategy will also activate the 13.5 million patients who are diagnosed and under the care of physicians (primarily non-allergists), but who have not been prescribed an epinephrine intramuscular injectable between 2020-2022.

Commercialize neffy outside of the United States with our partners .

We believe that there is significant commercial potential for neffy in markets outside of the United States.

The EC granted marketing authorization in the EU for EURneffy (the trade name for neffy 2 mg in the EU), for the emergency treatment of allergic reactions (anaphylaxis), in adults and children who weigh 30 kg or greater.

Through our collaboration with ALK, we anticipate that neffy will be made available to patients in certain EU member states, the United Kingdom and Canada.

ALK anticipates peak sales for neffy of approximately $425 million USD in Canada, the United Kingdom and European Union.

Regulatory review of neffy is ongoing in Canada, the United Kingdom, China, Japan, and Australia with filings for marketing approval submitted in the fourth quarter of 2024 or January 2025.

Regulatory decisions are anticipated by mid-2025 in the U.K., the second-half of 2025 in Japan, year-end 2025 in Canada, and in the first-half of 2026 in China and Australia.

We believe that our direct-to-consumer marketing strategy will also activate a portion of the 13.5 million patients who are diagnosed and under the care of physicians (primarily non-allergists), but who have not been prescribed an epinephrine intramuscular injectable between 2020 and 2022.

We also formally launched and began direct-to-consumer advertising of our getneffy.com virtual prescriber website in November 2025, which offers patients the option to obtain a neffy prescription the same day with a free visit via a virtual healthcare provider to eliminate the time-burden of an in-person visit.

Our launch strategy is also supported by our neffyconnect program that provides support to physicians and patients, including our $25 co-pay savings card, $199 cash price and patient assistance programs;

our neffy inSchools programs, where more than 9,000 schools to date have opted into receiving two cartons of neffy at no cost with accompanying school nurse education about neffy ;

partnerships with patient advocacy organizations including disease awareness campaigns;

and multi-channel branded direct to consumer advertising including connected television, point of care, endemic and programmatic display, social media, and paid search that initiated in May 2025, as well as linear television advertising that started in June 2025.

• Commercialize neffy outside of the U.S.

with our partners.

The EC granted marketing authorization in the EU for EURneffy 2 mg (the trade name for neffy in the EU and U.K.), for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater.

On January 29, 2026, the CHMP of the EMA adopted a positive opinion, recommending marketing authorization in the EU for neffy 1 mg for patients who are four years of age and older and weigh 15 kg to less than 30 kg.

Through our collaboration with ALK, EURneffy 2 mg has successfully launched in Europe and the U.K.

ALK anticipates peak sales for neffy of approximately $425 million USD in Canada, the EU and U.K.

We also received approval of neffy 2 mg and 1 mg doses in Japan in September 2025, which is expected to launch in the first quarter of 2026.

In addition, we received approval of neffy 2 mg and 1 mg doses in Australia in October 2025, which launched in February 2026.

In December 2025, we received approval in China of 优敏速 (the trade name for neffy 2 mg in China), with commercial launch expected to start in the first half of 2026.

We anticipate a regulatory decision for neffy 2 mg in Canada in the second quarter of 2026 and if approved, with commercial launch expected to start later in 2026.

• Conduct additional studies of neffy and our intranasal epinephrine technology product candidates to address additional Type I allergic reactions.

There remains a significant unmet need for treatments for allergies that can produce Type I reactions.

For other conditions that can produce Type I reactions, there remains a significant unmet need.

We are conducting clinical studies to support the expansion of labeling for neffy and our intranasal epinephrine technology product candidates to outpatient epinephrine use in other Type I allergy conditions such as urticaria for which epinephrine intra-muscular injectables are not approved.

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, and anticipate initiating a Phase 2b randomized placebo-controlled outpatient clinical trial in chronic spontaneous urticaria patients who are on a chronic antihistamine regimen, but still experience flares, in the second quarter of 2025, with topline data anticipated in early 2026.

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.

Interim data from this clinical trial is anticipated in the second half of 2026, followed by the potential initiation of a single pivotal efficacy study in mid-2027.

Overview of Type I Allergic Reactions and Current Challenges

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The immune system plays an important role in monitoring and protecting the body against microbial threats.

However, this system can lead to overstated immune and inflammatory responses that results in adverse outcomes known as hypersensitivity reactions.

However, this system can lead to overstated immune and inflammatory responses that result in adverse outcomes known as hypersensitivity reactions.

Type I allergic reactions are potentially life-threatening hypersensitivity reactions that can occur within minutes following exposure to an allergen and need to be treated immediately to relieve troublesome symptoms, mitigate severity and avoid a potentially fatal event.

These severe reactions are caused by exposure to a specific allergen, typically foods (most commonly, nuts, eggs, shellfish), drugs and venoms and are mediated by immunoglobulin E IgE antibodies that bind to mast cells causing the release of histamines.

These severe reactions are caused by exposure to a specific allergen, typically stinging and biting insects, allergy injections, food, medicines, exercise or other unknown causes, and are mediated by immunoglobulin E IgE antibodies that bind to mast cells causing the release of histamines.

The histamines induce smooth muscle contraction in the airways and a wheal and flare response in the skin producing swelling and inflammation.

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Pete Smith (Medical Media Kits) and Mary Johnson

Analysis of symptom frequency during anaphylaxis in the United States (n = 4,805 events)

Role of Epinephrine in Treating Type I Allergic Reactions

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When properly used, these devices can allow for the early administration of epinephrine to stop or reduce the intensity of the systemic allergic reaction before refractory anaphylaxis develops.

Even a few minutes delay in the administration of epinephrine can lead to the need for emergency services and/or hospitalizations, comorbidities and life-threatening symptoms or events, while also prolonging the significant negative impact on patient quality of life by delaying symptom relief.

EpiPen epinephrine autoinjector was first approved by the FDA for the emergency treatment of Type I hypersensitivity reactions, including anaphylaxis, in December 1987.

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In June 2017, the FDA approved Symjepi epinephrine injection, which is a pre-filled syringe for the same indication.

These injection devices were approved by the FDA without PK data based on an assumption that injections and devices were all effectively the same as the reference listed drug of intra-muscular injection with a needle and syringe.

These injection devices were approved by the FDA without pharmacokinetic (“PK”) data based on an assumption that injections and devices were all effectively the same as the reference listed drug of intra-muscular injection with a needle and syringe.

Intra-muscular injection with a needle and syringe is considered the gold standard and is almost exclusively used in non-community use clinical settings.

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A single dose with either an intra-muscular injection with needle and syringe or an auto-injector device results in resolution of allergic reaction for approximately 90% of cases within 5 to 15 minutes.

Epinephrine works due to its agonistic effects on the body’s adrenergic receptors (alpha and beta receptors).

By activating alpha-1 receptors, epinephrine prevents and relieves airway edema, hypotension and shock.

By activating beta-1 receptors, epinephrine increases the rate and force of cardiac contractions.

Lastly, epinephrine’s effect on beta-2 receptors leads to bronchodilation and decreased allergy causing mediator release by mast cells.

Alpha-1 receptors responsible for systolic blood pressure increases are the least sensitive to epinephrine, followed by beta-1 receptors that are responsible for heart rate increases, while beta-2 receptors responsible for stopping mast cell degranulation and the allergic reactions are the most sensitive to epinephrine.

Treatment guidelines recommend that epinephrine be administered immediately at the first sign of a severe allergic reaction.

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The sooner epinephrine is administered following allergen exposure, the less severe the systemic allergic reaction may become, and the less likely it will develop into an anaphylaxis event.

As shown in the graphic above, delayed treatment is a statistically significant risk factor for multiple negative clinical outcomes for patients.

A short delay of even a few minutes in the recognition and treatment of anaphylaxis can lead to more serious symptoms, including potential hypoxia or death.

Additionally, accompanying symptoms of even non-life-threatening allergic reactions can adversely impact health-related quality of life and can lead to loss of productivity, negatively impact social life, as well as lead to depression and anxiety and feelings of fear, frustration, worry and lack of control.

A second dose of epinephrine is required for adequate treatment in about 10% of cases, irrespective of whether epinephrine was dosed using an auto-injector such as EpiPen or needle and syringe.

A second dose of epinephrine is required for adequate treatment in about 10% of cases, irrespective of whether epinephrine was dosed using an auto-injector such as EpiPen or needle and syringe, or the only approved nasal spray, neffy .

While antihistamines such as diphenhydramine, also known as Benadryl (marketed by Johnson & Johnson), can sometimes relieve the dermatological symptoms and pruritus associated with severe Type I allergic reactions, treatment guidelines state that antihistamines should never be administered instead of epinephrine because they do not reverse the cardiovascular symptoms such as hypotension and shock, or respiratory distress.

Instead, antihistamines can potentially mask symptoms and allow the disease to continue to progress silently.

In the United States, dosing recommendations for epinephrine use by intra-muscular injection are from 0.1 mg to 0.5 mg depending on weight with repeat dosing administered as needed to control a severe allergic reaction.

In the United States, dosing recommendations for epinephrine use by intra-muscular injection are from 0.1 mg to 0.5 mg depending on the patient’s weight with repeat dosing administered as needed to control a severe allergic reaction.

0.1 mg, 0.15 mg and 0.3 mg are the approved doses for the epinephrine auto-injectors.

Approximately 77% of epinephrine auto-injectors prescribed in the United States in 2023 for outpatient use are the 0.3 mg dose level for persons greater than 30 kg in weight, approximately 22% contain doses of 0.15 mg for persons between 15 to 30 kg and 1% contain 0.1 mg doses for persons less than 15 kg.

Approximately 77% of epinephrine auto-injectors prescribed in the U.S.

in 2023 for outpatient use were the 0.3 mg dose level for persons greater than 30 kg in weight, approximately 22% contain doses of 0.15 mg for persons between 15 kg to 30 kg and 1% contained 0.1 mg doses for persons less than 15 kg.

A low dose of epinephrine is important for safety as overexposure to epinephrine can lead to adverse events.

Limitations of Existing Injectable Epinephrine Products

Epinephrine intra-muscular injectables have been proven to be highly effective if they are administered timely and effectively, and work as intended, but the limitations of these products include painful application, inconvenient size and a complicated mechanism of administration.

Epinephrine intra-muscular injectables have been proven to be highly effective if they are administered timely and effectively, but the limitations of these products include painful application, inconvenient size and a complicated mechanism of administration.

These limitations discourage patients and caregivers from carrying these devices and administering epinephrine in a timely manner.

Both patient adoption and use of intra-muscular injection devices has been limited among eligible patients with severe Type I allergic reactions at risk of anaphylaxis.

Of the approximately 20 million people in the United States under the active care of physicians between 2020-2022 who have been diagnosed with Type I severe allergic reactions, only 3.2 million had an active and filled epinephrine autoinjector prescription in 2022, and 3.3 million received, but did not fill an epinephrine autoinjector prescription during 2020-2022.

The remaining 13.5 million patients that have been diagnosed with a Type I severe allergic reaction between 2020-2022 did not receive an epinephrine prescription from their physician, and are managed almost entirely by non-allergist physicians who we believe are not well-educated about the management of Type I severe allergic reactions.

Both patient adoption and use of intra-muscular injection devices have been limited among eligible patients with severe Type I allergic reactions at risk of anaphylaxis.

In studies published in peer-reviewed journals, only 23% to 48% of patients self-administered with an auto-injector during a severe Type I allergic reaction, likely due to less than half of patients actually carrying their prescribed injection device, and only half administering even if the device was available.

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In a meta-analysis of 32 studies evaluating epinephrine injectable administration techniques, 23% to 35% of participants failed to achieve the correct administration technique following training.

Further, there is variability in respect to whether auto-injector devices are able to reliably deliver a sufficient dose of epinephrine.

Further, there is variability with respect to whether auto-injector devices are able to reliably deliver a sufficient dose of epinephrine.

The FDA has reported that EpiPen device failures lead to multiple deaths and dozens of hospitalizations annually.

The injection needle can be painful and dangerous not just due to the risk of skin lacerations and the possibility of the needle hitting a patient’s bone during administration, but also the risk of serious, sudden cardiovascular events resulting from accidental blood vessel injection.

In our clinical studies, we observed instances of potential accidental blood vessel injection in approximately 14% of patients dosing themselves with EpiPen.

In comparison, neffy is perceived by patients and parents as a potentially “game changing” device that can improve the management of severe Type I allergic reactions by addressing the current limitations of epinephrine intra-muscular injectable devices.

neffy can improve the management of severe Type I allergic reactions by addressing the current limitations of epinephrine intra-muscular injectable devices.

Clinical Development of neffy and our Intranasal Epinephrine Technology

Our intranasal technology, including neffy , is designed to provide injection-like absorption of epinephrine at a 2.0 or 1.0 mg dose comparable to 0.3 mg or 0.15 mg injection, in a small, easy-to-carry, easy-to-use, rapidly administered and reliable nasal spray.

Our intranasal technology, including neffy , is designed to provide injection-like absorption of epinephrine at a 2.0 mg or 1.0 mg dose comparable to 0.3 mg or 0.15 mg injection, in a small, easy-to-carry, easy-to-use, rapidly administered and reliable nasal spray.

On August 9, 2024, the FDA approved neffy 2 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater.

As a result, we initiated the commercial launch of neffy 2 mg in the United States, with product becoming available for shipment on September 23, 2024.

As a result, we initiated the commercial launch of neffy 2 mg in the United States, with product becoming available in September 2024.

On March 5, 2025, the FDA approved neffy 1 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in patients who are four years of age and older and weigh 15 kg to less than 30 kg.

We initiated commercial launch of neffy 1 mg in the U.S., with product becoming available on May 7, 2025.

Based on our clinical studies completed to date and FDA labeling, we believe neffy ’s “no needle, no injection” clinical profile supports differentiation over intra-muscular injections for the emergency treatment of Type I allergic reactions, including anaphylaxis.

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Repeat doses of 2.0 mg neffy compared to repeat doses of approved 0.3 mg injection products

The hemodynamic response, measured by systolic blood pressure and heart rate, was observed even 1 minute after administration of neffy , and was comparable to some injection products including EpiPen, and was greater than 0.3 mg intra-muscular needle-with-syringe.

The hemodynamic response, measured by systolic blood pressure and heart rate, was observed as soon as 1 minute after administration of neffy , and was comparable to some injection products including EpiPen, and was greater than 0.3 mg intra-muscular needle-with-syringe.

These hemodynamic responses were within normal physiologic ranges that are typically experienced during exercise or climbing stairs.

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Since neffy is given without a needle, there was also no needle-related injuries or accidental blood vessel injections.

In contrast, for patients self-administering devices, which involved 132 subjects dosed with EpiPen, approximately 14% of subjects dosed with EpiPen (auto-injector) experienced a potential blood vessel injection leading to a rapid bolus dose of epinephrine, which could lead to serious side effects including cardiovascular events and cerebral hemorrhage according to the FDA EpiPen label.

No subjects dosed with neffy experienced a blood vessel injection since it is not possible via the nasal route of administration.

Furthermore, our registrational self-administration study of 2.0 mg neffy by adults with severe Type I allergies (EPI-17) showed no critical dosing errors with neffy as evaluated by human factors professionals.

Furthermore, our registrational self-administration study of 2.0 mg neffy by adults with severe Type I allergies showed no critical dosing errors with neffy as evaluated by human factors professionals.

Furthermore, neffy also showed zero dosing errors in two human factor validation studies involving 150 subjects when used by trained adults or trained children across multiple demographic groups, as well as when used by passers-byers with no prior experience or training with an epinephrine device.

Following FDA approval, we collected survey data through our neffy experience program to evaluate the clinical performance of neffy in patients experiencing anaphylaxis symptoms during oral food challenges and allergen immunotherapy.

Nearly 90% (88.7%) of 680 patients experiencing anaphylaxis symptoms during oral food challenge and allergen immunotherapy were successfully treated with a single dose of neffy by a healthcare provider.

Meta-analyses report a similar proportion of patients, 88.9%, being successfully treated with a single dose of epinephrine intramuscular injection or auto-injector by a healthcare provider for food-induced anaphylaxis.

This highly similar treatment success rate supports that the real-world clinical effectiveness of neffy in anaphylaxis is consistent with epinephrine injection.

Key features of neffy demonstrated in our clinical, human factors or stability studies include:

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Comparable PKs to epinephrine

C max , t max and AUCs were within the range of approved intra-muscular injection products with a low intranasal dose of 2.0 mg neffy (people >30 kg in weight) and 1.0 mg neffy

(people 15 kg – 30 kg weight).

C max , t max and AUCs were within the range of approved intra-muscular injection products with a low intranasal dose of 2.0 mg neffy (people > 30 kg in weight) and 1.0 mg neffy (people 15 kg – 30 kg weight).

Exposures with repeat doses of neffy were greater than IM to ensure efficacy, and comparable to EpiPen to ensure safety.

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Minimal to no gastrointestinal side effects with 1.0 or 2.0 mg neffy such as vomiting, diarrhea or abdominal pain that can occur if excess non-absorbed epinephrine is swallowed, confounding clinical monitoring since those same gastrointestinal side effects are symptoms of anaphylaxis during approximately 20% of events.

Robust PDs within a range comparable to injection products with no risk of accidental blood vessel injections

Robust pharmacodynamics (“PD”) within a range comparable to injection products with no risk of accidental blood vessel injections

PD responses including systolic blood pressure and heart rate were within normal physiologic changes and comparable to auto-injector products, with maximum changes less than EpiPen.

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Needle containing intra-muscular injection products are known to be painful and cause reluctance to dose.

No critical dosing errors during self-administration with 2.0 mg neffy by Type I allergy adult subjects (EPI-17).

No critical dosing errors during self-administration with 2.0 mg neffy by Type I allergy adult subjects.

Zero percent error rate in human factor validation studies with intended commercial instructions for use and quick reference guide, when used by untrained adults or untrained children.

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In addition, at high temperatures, neffy remains within specifications even when exposed to temperatures of 50 o C (122 o F) for at least three months, or temperatures of 40 o C (104 o F) for at least six months.

Regulatory Review of neffy by the FDA

Following the acceptance of our new drug application (“NDA”) in October 2022 for review by the FDA, on May 11, 2023, the FDA held a virtual meeting of the PADAC.

At that meeting, on the question of whether the data from our neffy PK/PD results support a favorable benefit-risk assessment in adults for the emergency treatment of Type I allergic reactions including anaphylaxis, the PADAC voted 16 (yes) and 6 (no).

On the question of whether the neffy PK/PD results support a favorable benefit-risk assessment in children weighing 30 kg or greater for the emergency treatment of Type I allergic reactions including anaphylaxis, the PADAC voted 17 (yes) and 5 (no).

On September 19, 2023, the FDA issued a complete response letter (“CRL”) for our NDA requesting completion of a PK/PD study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis.

This request came after the favorable benefit-risk assessment of the PADAC to approve neffy without need for additional studies.

In addition, the FDA and ARS Pharma had previously aligned in August 2023 on final physician’s labeling and a post-marketing requirement to conduct this study as informative for labeling.

We reported topline results in February 2024 from this additional repeat dose study requested by the FDA.

In this study, repeat doses of neffy under allergen-induced allergic rhinitis conditions demonstrated a PK and PD profile comparable to or better than repeat doses of intra-muscular injection.

The results are shown below:

As part of the CRL, the FDA also requested additional information on nitrosamine impurities to be tested for based on new draft guidance issued in August 2023 after the neffy NDA submission.

We completed this updated testing, and no measurable levels of nitrosamine impurities were detectable.

We submitted our response to the FDA CRL in April 2024.

On August 9, 2024, the FDA approved neffy 2 mg for the emergency treatment of Type I allergic reactions, including anaphylaxis, in adults and children who weigh 30 kg or greater.

As a result, we initiated commercial launch of neffy 2 mg in the United States, with product becoming available for shipment on September 23, 2024.

Planned Clinical Trials in Additional Indications

Planned Clinical Trials in Chronic Spontaneous Urticaria

Epinephrine has been used empirically by physicians and included in treatment guidelines for multiple allergy conditions that do not fall under the emergency treatment of Type I allergic reactions indication that epinephrine auto-injectors are labelled for.

The needle-free, portable, easy-to-use and potentially safer clinical profile of our intranasal epinephrine technology product candidates supported by PK and PD data could enable the broader adoption of epinephrine in the outpatient setting for these other indications.

We reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients, and anticipate initiating a Phase 2b randomized placebo-controlled clinical trial in the outpatient urticaria setting in the second quarter of 2025, with topline data anticipated in early 2026, followed potentially by a single pivotal registration study in 2026.

Development outside the United States

On August 22, 2024, the EC granted marketing authorization in the EU for EURneffy (the trade name for neffy 2 mg in the EU), for the emergency treatment of allergic reactions (anaphylaxis), in adults and children who weigh 30 kg or greater.

Through our collaboration with ALK, we anticipate that EURneffy will be made available to patients in certain EU member states in 2025.

In the first quarter of 2025 we submitted a post-approval variation to EMA for the 1.0 mg neffy for patients who weigh 15 kg to less than 30 kg in the first quarter of 2025.

Using the same clinical studies that supported neffy approval by FDA and EC, we have also filed for regulatory approval of neffy in Canada and the United Kingdom on behalf of our partner ALK.

Our partners in Japan, China and Australia filed for regulatory approval of neffy in their respective regions in the fourth quarter of 2024.

Regulatory decisions are expected in UK by mid-2025, Canada and Japan by year-end 2025, and China and Australia in the first half of 2026.

Development in Chronic Spontaneous Urticaria

There are approximately 1 million patients in the U.S.

diagnosed with chronic spontaneous urticaria and treated with antihistamines or biologic treatments, such as Xolair, that still experience frequent flares, which is an indication for which epinephrine has never been formally developed as a prescription product, despite being used in-hospital to resolve such acute symptoms.

Such patients experience multiple episodes each year, and we believe they would likely use multiple doses of our intranasal epinephrine technology product candidate each year to resolve their symptoms.

Therefore, the market opportunity for treating flares in chronic spontaneous urticaria patients could be as large as the Type I allergy including anaphylaxis indication.

Assuming that one sprayer device is used monthly to treat such flares in chronic spontaneous urticaria, we estimate that the market opportunity in the United States alone is greater than $2 billion in net sales in this indication, assuming a similar price and gross-to-net realizations as neffy , if approved.

Although both patients treated with either antihistamines or biologic treatments, such as Xolair, can experience frequent flares that may be suitable for treatment with our intranasal epinephrine technology product candidates, our development strategy has focused first on patients treated with only antihistamines.

Our intranasal epinephrine technology product candidates may offer significant pharmacoeconomic value to payors by reducing the likelihood of step-up therapy to a much more expensive biologic treatment.

We reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients.

Interim data from this clinical trial is anticipated in the second half of 2026, followed by the potential initiation of a single pivotal efficacy study in mid-2027.

Commercialization Opportunity and Commercialization Plan

Type I Allergy Market Overview

neffy is a needle-free, low-dose intranasal epinephrine nasal spray approved for use as a rescue medication for people with Type I severe allergic reactions including anaphylaxis.

neffy was designed to provide injection-like absorption of epinephrine, in a small, easy-to-carry, easy-to-use, rapidly administered, and reliable nasal spray device.

All systemic allergic reactions have the potential of progressing to anaphylaxis and becoming life-threatening.

These reactions can be unpredictable and progress quickly to develop severe symptoms within a few minutes after exposure and can progress to a life-threatening event if not treated immediately.

Patient and caregiver preparedness to act quickly and confidently during a severe allergic reaction is imperative.

Hesitation can lead to worse clinical outcomes and can be fatal.

Epinephrine is the first-line treatment for the emergency treatment of Type I allergic reactions including anaphylaxis.

Epinephrine needs to be given as soon as symptoms occur because it is the only medication proven to stop a potentially life-threatening allergic reaction.

Needle-free and easy-to-use neffy may allow for improved patient and caregiver preparedness to give epinephrine quickly, confidently, and without hesitation that is caused by fear of the needle.

Intended for use at the first signs of an allergic response, neffy is designed to provide patients and their families with a new option to rapidly resolve symptoms and prevent progression to severe anaphylaxis.

We believe our first-in-class nasal spray may transform the way we think about and use life-saving epinephrine.

Existing U.S.

Market Opportunity

We estimate approximately 40 million people in the United States have experienced Type I allergic reactions.

Of this group, approximately 20 million people have been diagnosed and experienced severe Type I allergic reactions that may lead to anaphylaxis, but only about 3.2 million of them filled a prescription in 2022 for an epinephrine intra-muscular injectable device, including auto-injectors, equating to approximately 5 million two-pack units.

Of those 3.2 million people, roughly half don’t carry these devices due to many drawbacks that can result in patient and caregiver injury, hesitation, and delays in administration principally because of apprehension and pain of needles.

In turn, the failure or delay of epinephrine delivery can allow the allergic reaction to progress in severity causing life-threatening symptoms or events that potentially require emergency services and/or hospitalization.

We believe neffy could address the needs of the approximately 3.2 million patients in the United States who currently fill intra-muscular injectable prescriptions, the approximately 3.3 million former injectable patients in the United States that either refused to fill, or did not renew an intra-muscular injectable device prescription, and the more than 13.5 million eligible Type I allergy patients in the United States who are at risk of severe allergic reactions that are not prescribed an epinephrine product.

Based on the current list price of neffy and our target total gross-to-net yield, we estimate that the initial addressable market opportunity of 6.5 million patients who have been prescribed epinephrine during 2020-2022 is approximately $3 billion in annual net sales for neffy .

We estimate the addressable market opportunity for the 13.5 million patients who have been diagnosed during 2020-2022, but were not prescribing epinephrine, is approximately $7 billion in annual net sales for neffy .

We have conducted multiple market research studies with caregivers, generally parents, and patients with severe Type I allergic reactions in the United States to evaluate potential market perceptions of neffy and currently available epinephrine delivery devices.

Based on quantitative market research studies including a total of 480 patients and 185 allergists, pediatricians and primary care physicians, approximately 88% of patients with a current epinephrine auto-injector prescription stated that they would prefer neffy .

Furthermore, 99% of the physicians surveyed stated they would prescribe if their patient asked for neffy , indicating that neffy prescriptions would likely be highly driven by patient preference and awareness of neffy .

In our market research, parents and people with current or prior epinephrine auto-injector prescriptions were asked if and when they would adopt a new nasal spray device product such as neffy .

75% of patients indicated they would adopt neffy within one year of approval

81% of patients indicated they would use neffy sooner than their current auto-injector device,

72% of patients indicated that they would use neffy first instead of an over-the-counter antihistamine

88% reported they would be more willing to use neffy in public.

We believe neffy could address the needs of the approximately 3.2 million patients in the U.S.

who currently fill intra-muscular injectable prescriptions, the approximately 3.3 million people in the U.S.

that either refused to fill, or did not renew an intra-muscular injectable device prescription, and the more than 13.5 million eligible Type I allergy patients in the United States who are at risk of severe allergic reactions that are not prescribed an epinephrine product.

Based on the current list price of neffy and our target total gross-to-net yield, we estimate that the initial addressable potential market opportunity of 6.5 million patients who have been prescribed epinephrine during 2020-2022 is approximately $3.5 billion in annual net sales for neffy .

Key potential growth levers for neffy within the existing epinephrine market for the emergency treatment of Type I allergic reactions, which currently consists of only intra-muscular injectable products include:

• Consistent base market growth observed with the epinephrine intra-muscular injectable products.

From 2010 to 2023, the number of epinephrine intra-muscular injectable devices sold in the United States has increased by approximately 6.5% annually based on IQVIA unit sales data, primarily due to the increasing size of the overall population affected by severe Type I allergies, led by food-based allergies.

From 2010 to 2023, the number of epinephrine intra-muscular injectable devices sold in the U.S.

has increased by approximately 6.5% annually based on IQVIA unit sales data, primarily due to the increasing size of the overall population affected by severe Type I allergies, led by food-based allergies.

• Potential promotional lift due to new marketing and education efforts by a branded product such as neffy .

The existing market for epinephrine intra-muscular injectable products is characterized by being highly promotionally sensitive, particularly from a consumer perspective, and our market research has indicated that neffy ’s user-friendly product profile has the potential to resonate significantly with consumers.

We estimate that branded marketing of EpiPen prior to generic entry contributed a promotional lift of 31% over base epinephrine intra-muscular injectable market trends.

We plan to reach and support patients directly through efficient direct-to-consumer advertising after educating professional physician practices and securing appropriate payor coverage for neffy .

Targeting the approximately 3.3 million former patients that either do not fill their epinephrine intra-muscular injectables prescriptions or whose prescriptions have recently lapsed .

The exodus of patients who have received prescriptions from the market has been attributed to a number of factors, including reduced promotional activities in recent years, limited adherence program effectiveness (lapsed prescriptions) and patient adversity to currently marketed products (i.e., fear of needles and concerns regarding poor reliability).

In our market research of 88 former patients who refused to fill or renew a prescription, approximately 89% indicated a willingness to return to the market and request neffy .

We hope to engage with these patients through programs to encourage appropriate epinephrine use with neffy and increase consistency of epinephrine acquisition to help manage their condition.

The existing market for epinephrine intra-muscular injectable products is characterized by being highly promotionally sensitive, particularly from a consumer perspective.

We estimate that branded marketing of EpiPen prior to generic entry contributed a promotional lift in sales of 31% over organic epinephrine intra-muscular injectable market growth trends.

Our market research has indicated that neffy’s user-friendly product profile has the potential to resonate significantly with consumers, and we are investing significantly into direct-to-consumer advertising to patients.

• Improving refill rates by patients.

Based on IQVIA longitudinal claims data, only 31% to 39% of patients refilled their epinephrine intra-muscular injectable product prescription after 12 to 24 months from the initial prescription.

In contrast, September 2025 survey we conducted of actual neffy users indicated that 95% were likely to refill neffy , which we believe indicates significant potential for market expansion through improved persistency and retention as neffy product expires and is re-filled by patients.

• Increased per patient device acquisition by patients and parents.

In our market research of 350 patients with an active intra-muscular injectable prescription, approximately 70% to 80% of patients reported an intention to acquire additional devices compared to their current injectable device if neffy is approved by the FDA.

In our market research conducted prior to FDA approval of neffy of 350 patients with an active intra-muscular injectable prescription, approximately 70% to 80% of patients reported an intention to acquire additional devices over time compared to their current injectable device.

Currently, we estimate only between 20% to 30% of patients obtain more than one pack (containing two devices) per year today.

US Market Expansion Opportunity

Market Expansion Opportunity

While we believe the existing epinephrine intra-muscular injectables market is a large commercial opportunity for neffy with multiple independent opportunities for further growth, IQVIA claims data indicates that many diagnosed, identifiable eligible patients do not receive prescriptions for intra-muscular injectables.

Outside of the 6.5 million patients who were recently prescribed an epinephrine injectable device, there are approximately 13.5 million patients who are under the care of physicians per IQVIA claims data, but have not been prescribed an epinephrine intra-muscular injectable device, as well as another approximately 20 million patients not currently under the care of physicians.

Over time, targeting the approximately 13.5 million identified and diagnosed in-office patients in IQVIA claims data with Type I allergic reactions that are eligible but have not been prescribed epinephrine device between 2020-2022.

In our market research, physicians indicated they would prescribe neffy to 75 to 85% of the patients who were eligible, but do not currently receive an intra-muscular injectable prescription.

Development in new allergy indications.

There are approximately 1 million patients in the United States diagnosed with chronic spontaneous urticaria and treated with antihistamines or biologic treatments, such as Xolair, that still experience frequent flares, which is an indication for which epinephrine has never been formally developed as a prescription product, despite being used in-hospital to resolve such acute symptoms.

Therefore, the market opportunity for treating flares in chronic spontaneous urticaria patients may be as meaningful as the Type I allergy including anaphylaxis indication.

Although both patients treated with either antihistamines or biologic treatments, such as Xolair, can experience frequent flares that may be suitable for treatment with our intranasal epinephrine technology product candidates , our development strategy has focused first on patients treated with only antihistamines.

Our intranasal epinephrine technology product candidates may offer significant pharmacoeconomic value to payers by reducing the likelihood of step-up therapy to a much more expensive biologic treatment.

We reported positive topline results demonstrating statistically significant and clinically meaningful improvements in treatment-refractory chronic urticaria patients in February 2024, and anticipate initiating a Phase 2b randomized placebo-controlled outpatient clinical trial in chronic spontaneous urticaria patients on a chronic antihistamine regimen, but who still experience flares, in the second quarter of 2025, with topline data anticipated in early 2026.

Ex-US Market Opportunity

Outside of the United States, we estimate that there are an additional 15 million patients in Europe, and over 30 million patients in Asia including China and Japan, that experience Type I allergic reactions that are clinically appropriate for being prescribed neffy .

• In addition to the 3.2 million patients per year who fill their prescription for an epinephrine injectable device, there are approximately 3.3 million people who do not fill their epinephrine intra-muscular injectable prescription, or whose prescription has recently lapsed.

In addition, there are 13.5 million patients who are under the care of physicians for potential severe allergic reactions per IQVIA claims data, but have not been prescribed an epinephrine intra-muscular injectable device.

• The poor refill rates of epinephrine autoinjectors have been attributed to a number of factors, including reduced promotional activities in recent years, limited adherence program effectiveness (lapsed prescriptions) and patient adversity to currently marketed products (i.e., fear of needles and concerns regarding poor reliability).

• Our September 2025 survey of actual neffy patients indicates that approximately 26% of patients are from market expansion segments that have either lapsed or never filled, which we believe supports that neffy is already expanding the market.

Market Opportunity

• Outside of the United States, we estimate that there are an additional 15 million patients in Europe, and 30 million patients in Asia including China and Japan, that experience Type I allergic reactions that are clinically appropriate for being prescribed neffy .

• We believe education around Type I allergic reactions and marketing of intra-muscular injectables has been limited in these regions, and that promotion and the availability of neffy would significantly expand the market.

Market research conducted in Europe with 120 patients who have an epinephrine auto-injector prescription indicated that 98% would prefer neffy , and that they would acquire approximately twice as many neffy devices compared to their current injectable device.

To target these opportunities outside of the United States, we have entered into licensing, collaboration and partnership agreements, including with Alfresa Pharma for Japanese rights to neffy and Pediatrix Therapeutics (founded by F-Prime Capital, Eight Roads and Creacion Ventures) for Chinese rights to neffy , CSL for Australian and New Zealand rights to neffy , and ALK for, among other things, rights to neffy in all other territories outside of the United States.

ALK anticipates peak sales in excess of $425 million for its licensed regions alone, principally comprising Canada, the United Kingdom and the European Union.

Commercial Strategy

• To target these opportunities outside of the U.S., we have entered into licensing, collaboration and partnership agreements, including with Alfresa for rights to neffy in Japan, Pediatrix for rights to neffy in China, Seqirus for rights to neffy in Australian and New Zealand, and ALK for, among other things, rights to neffy in all other territories outside of the U.S.

• ALK anticipates peak sales in excess of $425.0 million for its licensed regions alone, principally comprising Canada, the EU and the U.K.

Sales and Marketing

We believe that the epinephrine market is a highly consumer driven market .

We expect this to be especially true for neffy , given that 99% of the physicians surveyed in our quantitative market research studies indicated that they would prescribe neffy if asked by a patient and approximately 70% of physicians would recommend neffy .

As a result, we believe that driving consumer awareness, so that patients and parents ask their healthcare provider for neffy , while minimizing both access and educational barriers to acceptance is essential.

Our go-to-market strategy for neffy includes the following key elements:

We have initiated the commercialization of neffy in the United States with a combination of direct promotion, virtual sales consultants, and non-personal promotion intended to reach, at a minimum, the healthcare professionals that account for 40 to 45% of the current epinephrine prescriptions.

Our launch has focused on the highest potential practicing allergists, pediatricians, and primary care physicians.

In our market research, approximately 80% of patients see their treating physicians at least every six months, and 98% at least once a year.

We have optimized our field representatives based on research on current market dynamics, geo-targeting and assessment of current professional-industry interaction preferences initially to reach these professionals.

As of January 2025, about three months after launch, approximately 50% of the prioritized 4,000 top decile healthcare providers (deciles 8 to 10) have already prescribed neffy .

Our current sales force of 118 individuals includes sales reps, virtual sales consultants and area sales managers, and we anticipate potentially expanding our sales force to over 200 individuals by early 2026.

We expect significant reach of approximately 80% of epinephrine prescriptions to be achieved based on expanded use of non-personal promotional tactics to reach healthcare professionals and focus on the sequential activation of patient demand through direct-to-consumer tactics that will help also drive physician awareness due to overlapping exposure.

We intend to secure affordable market access for all consumers by optimizing contracting, co-pay support and distribution of neffy .

To ensure access and affordability for neffy , we have engaged and successfully contracted with insurers and payers to convey the clinical rationale and value proposition of neffy .

We are on track to achieve commercial coverage of 60% or greater by the end of the first quarter of 2025, and commercial coverage of 80% or greater by the early part of the third quarter of 2025.

The second largest pharmacy benefit manager in the United States, ExpressScripts, added neffy to its national commercial formularies at Tier 2 preferred, which is the lowest possible tier for a branded innovator product, only 9 weeks after product availability on September 23, 2024.

With our contracting strategy, a $25 or less co-pay savings card, a $199 cash price, and patient assistance programs, we anticipate that the out-of-pocket cost to patients for acquiring neffy may be less than or similar to that of generic epinephrine autoinjectors.

Prior to our anticipated inclusion on formularies by a vast majority of payers later in 2025, our neffyconnect program provides patients, caregivers, and healthcare professionals (HCPs) with information about patient support programs, such as medication fulfillment services and financial support to guide their treatment journey, including navigating insurance requirements and potential barriers to access.

In particular, the program has been facilitating prior authorization formwork required by payers today that do not currently include neffy in their formulary, with a majority of prior authorizations submitted by healthcare providers currently being approved on the first pass.

We believe our comprehensive market access strategy can ensure access and affordability for all patients that may be interested in neffy .

We intend to leverage an omnichannel strategy including direct-to-patient and parent tactics, social and traditional media, digital presence, and additional public relations including partnerships with patient advocacy organizations as well as influencers to drive awareness, for patients to ask for neffy , and communicate our value proposition .

The pent-up patient demand that we believe is ready to be activated by neffy is reflected in our market research where 87% of patients indicated a high likelihood to proactively visit their physician in-person and ask about getting a new prescription for neffy (43% of patients indicating a 10 out of 10 likelihood, and 44% of patients indicating a 7-9 out of 10 likelihood).

Our research also showed that physicians would recommend neffy to approximately 70% of their patients.

In addition, the severe Type I allergy market has historically been highly promotionally sensitive, and in recent years, there has been limited investment in education or promotion, which we believe provides an opportunity for significant promotional lift from our planned marketing efforts.

To activate this pent-up patient demand for neffy , we intend to launch an extensive branded direct-to-consumer marketing campaign to raise awareness of neffy , and motivate action, including television, radio, print, digital and social media in the second quarter of 2025 following attainment of our commercial payer coverage goals in mid-2025 and availability of the 1 mg neffy dose, for patients who are four years of age and older and weigh 15 kg to less than 30 kg, in the second quarter of 2025.

This neffy direct-to-consumer marketing campaign will also coincide with the “back to school” increased seasonal volume of epinephrine prescriptions during the summer that is driven by the pediatric population, which is approximately half of the epinephrine injection market today.

We intend to establish neffy as the dominant and most recognized brand in the category.

We believe neffy ’s potential brand recognition and user-friendly profile can be an important driver of growth and source of competitive differentiation, especially as the first “no needle, no injection” solution for severe Type I allergic reactions.

We have designed neffy to offer healthcare professionals, patients and caregivers a simple, injection-free, portable, highly reliable and user-friendly alternative that facilitates early administration of epinephrine to provide rapid symptom relief and to stop the allergic reaction from progressing to more serious events.

We believe the attractiveness and meaningful differentiation of neffy across both physicians and payors will stimulate a high patient and parent desire to switch to or return to managing their condition with neffy .

We intend to expand the market beyond the 3.2 million patients currently filling epinephrine injection device prescriptions.

We believe that the severe Type I allergy market is currently significantly underpenetrated due to the lack of, and limitations in, current treatment options.

We believe the availability of neffy could drive increased device uptake among the existing 3.2 million patients currently filling epinephrine injection device prescriptions, adoption by the approximately 3.3 million patients that receive, but do not fill their prescription, and the 13.5 million patients diagnosed and managed by physicians who do not currently have an epinephrine auto-injector, especially those incorrectly using antihistamines as a substitute.

Other launches of intranasal products for emergency use into previously injection-only markets such as NARCAN (marketed by Emergent BioSolutions), VALTOCO (marketed by Neurelis), NAYZILAM (marketed by UCB) and BAQSIMI (marketed by Eli Lilly) have rapidly captured a significant percentage of the existing market, and also expanded their respective markets.

Both products use the same device that we have chosen for neffy .

We believe that NARCAN’s widespread use clearly demonstrates market uptake in response to the advantages of an intranasal product via proven device over injection, considering in particular that NARCAN is used in life threatening rescue situations where reliable administration is required for confident administration, similar to severe Type I allergic reactions.

Beyond just reliability, we believe that an intranasal product has unique advantages for treating a severe Type I allergic reaction due to patient and parent fear and avoidance of injection and because time is of the essence.

This perspective is distinct from other diseases with chronic use of injection products, administration by a trained professional is required, or where the injection is more manageable and tolerated.

In our market research, respondents have described neffy as “game-changing” and we believe neffy can make a significant difference in patient lives and outcomes.

We have established a distribution channel in the United States for the commercialization of neffy .

We are selling neffy to wholesalers, who, in turn, sell neffy to retailers and other customers.

We are using a third-party logistics provider for key services related to logistics, warehousing and inventory management, distribution, contract administration, order management and chargeback processing and accounts receivable management.

neffy is also available through telemedicine.

To target markets outside of the United States, we have entered into strategic partnerships with several pharmaceutical companies to obtain regulatory approval and market neffy .

These include Alfresa Pharma for Japan, Pediatrix Therapeutics for China, CSL for Australia and New Zealand, and ALK for all other regions outside of the United States including Canada, the United Kingdom and the European Union.

The EC has granted marketing authorization for EURneffy (the trade name for neffy 2 mg in the European Union), and regulatory filings are actively under review in Canada, the United Kingdom, Japan, China and Australia and New Zealand, with additional filings anticipated in other countries.

Regulatory decisions are expected in UK by mid-2025, Canada and Japan by year-end 2025, and China and Australia in the first half of 2026.

We have established robust marketing, sales, and distribution capabilities to support the launch of neffy in the U.S.

through an experienced national sales force targeting healthcare providers.

We believe we can successfully commercialize neffy in the U.S.

with a focused sales force targeting high prescribers of epinephrine, particularly allergists and pediatricians.

Our strategy is to target approximately 20,000 core high volume prescribers that represent between 50 to 55% of all epinephrine prescriptions.

Our current sales force of 106 individuals is comprised of sales reps, area sales managers, and national sales directors, plus we have an additional 10 virtual sales reps and approximately 70 sales reps via our co-promotion partner, ALK U.S.

We plan to expand our sales force to approximately 150 individuals beginning in the second quarter of 2026.

In the U.S., we sell primarily to pharmaceutical wholesale distributors, which are the principal means of distributing our products to healthcare providers.

Our ongoing neffy experience program also allows healthcare professionals to use neffy firsthand as rescue therapy for anaphylaxis during in-clinic allergen challenge, and obtain direct clinical experience using neffy .

neffy market share among participants in the neffy experience program is more than three-fold higher than the typical healthcare provider.

We also market through direct-to-consumer channels, including across streaming platforms, traditional broadcast and cable television, and consumer-facing digital channels including Facebook, Instagram, waiting room TVs in doctors’ offices, and digital banner ads.

Since launch, the campaign has reached millions of allergy patients and is driving strong patient awareness, increasing prescription requests, and motivating patients to explore a non-injectable treatment option.

In November 2025, we also launched and began direct-to-consumer advertising of our getneffy.com website, which offers patients the option to obtain a neffy prescription the same day with a free visit with a virtual healthcare provider, eliminating the time-burden of an in-person visit.

Patients may receive neffy with a $0 co-pay, if eligible with commercial insurance.

Our industry is highly competitive and subject to rapid technological changes.

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We are aware of several companies developing higher dose spray candidates including Bryn Pharma, Hikma Pharmaceuticals, Inc.

(previously INSYS Therapeutics, Inc.), Nasus Pharma, Orexo AB, Insignis Therapeutics and Belhaven BioPharma.

Aquestive Therapeutics is developing a sublingual candidate based on a prodrug of epinephrine.

(previously INSYS Therapeutics, Inc.), Nasus Pharma Ltd., Orexo AB, Insignis Therapeutics, Inc.

and Belhaven BioPharma.

Aquestive Therapeutics, Inc.

is developing a sublingual candidate based on a prodrug of epinephrine, which recently received a Complete Response Letter (“CRL”) from the FDA due to concerns with their application.

Manufacturing and Supply

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Epinephrine is the API used in neffy .

We intend to use Cambrex Profarmco (“Cambrex”) as one of our commercial sources for epinephrine API.

We use Cambrex Profarmco (“Cambrex”) as one of our commercial sources for epinephrine API.

Cambrex holds a U.S.

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We have entered into a commercial supply agreement with Cambrex, and while we believe that Cambrex has sufficient capacity to satisfy our long-term requirements, there are several sources of API available.

Dodecyl maltoside or Intravail is purchased through our license agreement with Aegis Therapeutics, LLC from two manufacturers, Dr.

Dodecyl maltoside or Intravail is purchased through our license agreement with Aegis Therapeutics, LLC (“Aegis”) from two manufacturers, Dr.

Reddy Laboratories and Inalco, which are based in India and Italy, respectively.

The unit dose sprayer device used to delivery drug product in neffy is produced by Aptar Pharma (“Aptar”) and Silgan Dispensing Systems (“Silgan”).

Aptar produces devices in France and the United States, while Silgan produces devices in Germany, and both have sufficient capacity to satisfy our long-term requirements.

Aptar produces devices in France and the U.S., while Silgan produces devices in Germany, and both have sufficient capacity to satisfy our long-term requirements.

The patent for the Aptar unit dose nasal spray device expired in early 2020.

Manufacturing drug product for neffy and our intranasal epinephrine technology product candidates is conducted by Renaissance Pharmaceuticals, Inc.

(“Renaissance Pharma”), which has been actively involved in supporting the manufacture of neffy and our intranasal epinephrine technology product candidates.

We intend to use its facility in Lakewood, New Jersey as our primary source for drug product manufacturing and final packaging.

We have entered into a commercial supply agreement with Renaissance Pharma, and believe they have sufficient capacity to satisfy our long-term requirements, although we are evaluating alternating sourcing options.

Manufacturing drug product for neffy and our intranasal epinephrine technology product candidates is conducted by Renaissance Lakewood, LLC (“Renaissance”), which has been actively involved in supporting the manufacture of neffy and our intranasal epinephrine technology product candidates.

We use its facility in Lakewood, New Jersey as our primary source for drug product manufacturing and final packaging.

We have entered into a commercial supply agreement with Renaissance, and believe they have sufficient capacity to satisfy our long-term requirements, although we are evaluating alternative sourcing options.

Our registration stability studies demonstrate that neffy is stable at room temperature for up to 30 months, based on stability data meeting specifications with the 2 mg dose of neffy for 30 months and the 1 mg dose of neffy for 24 months.

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We have also conducted studies indicating that neffy is also stable at temperature excursions including 40 o C for up to six months, and at 50 o C for up to three months, without labeling permitting excursions up to such temperature, or neffy not requiring any special storage conditions.

Manufacturing Agreement with Renaissance

In September 2020, we entered into a manufacturing agreement with Renaissance Lakewood, LLC (“Renaissance”), which was subsequently amended in July 2023, September 2024 and July 2025 (the “Renaissance Agreement”).

Pursuant to the agreement, Renaissance agreed to manufacture for, and provide to us, neffy nasal unit dose sprays (“Renaissance Products”).

We are obligated to provide Renaissance with certain supplies to manufacture the Renaissance Products and to purchase from Renaissance a mid-double-digit percentage of our annual aggregate Renaissance Product requirements in the EU, and a high-double-digit percentage of our annual aggregate Renaissance Product requirements in the U.S.

The agreement contains conventional commercial pharmaceutical manufacturing provisions including certain minimum purchase amounts to be determined in the future based on forecast needs and minimum batch size projections.

We may also request Renaissance to perform certain services related to the Renaissance Product, for which we will pay reasonable compensation to Renaissance.

The initial term of the Renaissance Agreement commenced on September 17, 2024 and will terminate on (a) December 31, 2029 for Renaissance Product designated for commercial sale in the U.S.

Initial Term”), and (b) December 31, 2030 for Renaissance Product designated for commercial sale in the EU (“EU Initial Term”), in each case unless earlier terminated by one of the parties.

Initial Term and EU Initial Term automatically renew for successive two-year terms (“Renewal Term”).

Either party may elect not to renew the U.S.

Renewal Term and/or the EU Renewal Term by providing the requisite prior notice to the other party.

Either party may terminate the agreement (1) for uncured material breach of the other party, (2) upon notice for insolvency-related events of the other party that are not discharged within a defined time period, (3) on a product-by-product basis if the manufacture, distribution or sale would materially contravene any applicable law, (4) by providing the requisite notice if (a) the authorization and approval to distribute or sell Renaissance Product in the U.S.

is not granted on or before a specified date, (b) the authorization and approval representing more than a certain number of units of Renaissance Product sold in the U.S.

during the last calendar year is withdrawn by the FDA, or (c) we decided in our sole discretion to cease commercializing the Renaissance Product in the U.S., (5) in the case of a force majeure event that continues for six months or more, or (6) a violation by the other party of trade control or anti-corruption laws.

Intellectual Property

We strive to protect our intranasal epinephrine product candidates by seeking, maintaining, and defending our patent rights in the United States and internationally.

We strive to protect our intranasal epinephrine product candidates by seeking, maintaining, and defending our patent rights in the U.S.

and internationally.

Our policy is to pursue, maintain and defend patent rights in strategic areas, whether developed internally or licensed from third parties, and to protect the technology, inventions and improvements that are commercially important to the development of our business.

We also rely on trade secrets that may be important to the development of our business.

We co-own or exclusively license the patents and patent applications relating to our intranasal epinephrine product candidates.

As of December 31, 2024, our patent portfolio consisted of issued patents and pending patent applications that we co-own or exclusively license from Aegis Therapeutics LLC in the United States and other countries throughout the world.

In total, as of that date, our patent portfolio consisted of seven issued U.S.

patents, granted patents in each of Australia, Canada, China, Hong Kong, Israel, Japan, Mexico, Singapore, South Korea, Europe, the United Kingdom, two pending U.S.

non-provisional patent applications, a pending U.S.

provisional patent application, and over fifteen pending foreign patent applications directed to intranasal epinephrine formulations and methods of their use, among other things.

We own, co-own or exclusively license the patents and patent applications relating to our intranasal epinephrine product candidates.

As of December 31, 2025, our patent portfolio consisted of issued patents and pending patent applications that we own, co-own or exclusively license from Aegis in the U.S.

and other countries throughout the world.

In total, as of that date, our patent portfolio consisted of eight issued U.S.

patents, granted patents in each of Australia, Canada, China, Hong Kong, Israel, Japan, Mexico, Singapore, South Korea, and over thirty member states of the European Patent Organization, including the U.K., directed to neffy and its uses, among other things, three pending U.S.

patent applications, one pending international patent application and sixteen pending foreign patent applications, directed to neffy and its uses, among other things, and a pending U.S.

provisional patent application directed to intranasal epinephrine formulations and methods of their use, among other things.

These issued patents and pending patent applications provide patent protection for neffy and are expected to expire as early as 2038, absent any patent term adjustments.

In addition to patent protection, we also rely on trademarks, trade secrets, know how, and other proprietary information to develop and maintain our competitive position.

We seek trademark protection in the United States and in certain other jurisdictions where available and when we deem appropriate.

We currently have registrations and pending applications for our “ neffy ” mark in the United States as well as in certain foreign jurisdictions.

We seek trademark protection in the U.S.

and in certain other jurisdictions where available and when we deem appropriate.

We currently have registrations and pending applications for our “ neffy ” mark in the U.S.

as well as in certain foreign jurisdictions and for our “ EURneffy ” mark in the EU, U.K., and other foreign jurisdictions.

Our commercial success will depend in part on obtaining and maintaining patent protection and trade secret protection of our current and future product candidates and the methods used to develop and manufacture them, as well as successfully defending these patents against third-party challenges.

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Our breach of any license agreements or our failure to obtain a license to proprietary rights required to develop or commercialize our future products may have a material adverse impact on us.

If third parties prepare and file patent applications in the United States that also claim technology to which we have rights, we may have to participate in interference or derivation proceedings in the U.S.

If third parties prepare and file patent applications in the U.S.

that also claim technology to which we have rights, we may have to participate in interference or derivation proceedings in the U.S.

Patent and Trademark Office (the “USPTO”) to determine priority of invention.

For more information, see “ Risk Factors—Risks Related to Our Intellectual Property.

For more information regarding the risks related to our intellectual property, see “ Risk Factors—Risks Related to Our Intellectual Property.

Our Collaboration and Licensing Agreements

License Agreement with Aegis

In June 2018, we entered into a license agreement with Aegis Therapeutics, LLC (“Aegis”), which was amended in July 2020 and January 2021.

Pursuant to the agreement, Aegis granted us an exclusive, worldwide, sublicensable license under patents and know-how relating to the INTRAVAIL drug delivery technology to research, develop, make (subject to Aegis supplying the INTRAVAIL drug delivery technology to us under a supply agreement), use, sell, offer for sale, import, and otherwise commercialize products incorporating epinephrine compounds (“Aegis Licensed Compounds”), including the neffy nasal spray.

During the term of the agreement, we are required to use commercially reasonable efforts to obtain regulatory approval for products containing one or more Aegis Licensed Compounds and using the excipient (including INTRAVAIL) (“Aegis Licensed Products”) and to thereafter maximize sales of the Aegis Licensed Products, and Aegis may not directly or indirectly exploit an Aegis Licensed Product or Aegis Licensed Compound or derivatives thereof without our consent.

Under the agreement, Aegis received an upfront license fee of $50,000 and is entitled to receive development milestone payments of up to $3.95 million in aggregate and commercialization milestone payments up to $16.0 million in the aggregate for each Aegis Licensed Product.

We made a $0.5 million milestone payment to Aegis upon the achievement of a regulatory milestone during 2019, a $1.0 million payment to Aegis upon the FDA’s acceptance of our U.S.

NDA filing, which occurred in the third quarter of 2022, a $2.5 million milestone payment to Aegis for achieving FDA approval of neffy 2.0 mg in September 2024, and a $5.0 million milestone payment to Aegis for the first commercial sale of neffy 2.0 mg in October 2024.

In June 2018, we entered into a license agreement (the “Aegis Agreement”) with Aegis Therapeutics, LLC (“Aegis”), which was amended in July 2020 and January 2021.

Pursuant to the Aegis Agreement, Aegis granted us an exclusive, worldwide, sublicensable license under patents and know-how relating to the Intravail drug delivery technology to research, develop, make (subject to Aegis supplying the Intravail drug delivery technology to us under a supply agreement), use, sell, offer for sale, import, and otherwise commercialize products incorporating epinephrine compounds (“Aegis Licensed Compounds”), including the neffy nasal spray.

During the term of the Aegis Agreement, we are required to use commercially reasonable efforts to obtain regulatory approval for products containing one or more Aegis Licensed Compounds and using the excipient (including Intravail) (“Aegis Licensed Products”) and to thereafter maximize sales of the Aegis Licensed Products.

Aegis may not directly or indirectly exploit an Aegis Licensed Product or Aegis Licensed Compound or derivatives thereof without our consent.

Under the Aegis Agreement, Aegis received an upfront license fee of $50,000 in 2018 and is entitled to receive development milestone payments of up to $3.95 million in the aggregate and commercialization milestone payments up to $16.0 million in the aggregate for each Aegis Licensed Product.

We made a $0.5 million milestone payment to Aegis upon the achievement of a regulatory milestone in 2019, a $1.0 million payment to Aegis upon the FDA’s acceptance of our U.S.

NDA filing in 2022, a $2.5 million milestone payment to Aegis for achieving FDA approval of neffy 2 mg in September 2024, $5.0 million milestone payment to Aegis for the first commercial sale of neffy 2 mg in October 2024, and a $2.0 million milestone payment to Aegis for achieving a certain annual net sales of neffy 2 mg in September 2025.

Additionally, Aegis is entitled to receive a low- to mid-single-digit percentage royalty, subject to reductions under certain conditions including due to generic competition or below threshold levels of profitability in specific countries around the world, on net sales of all Aegis Licensed Products during the applicable royalty term, which commences on the first commercial sale of a Aegis Licensed Product in a country and ends upon the later of the expiration of all licensed patents covering such Aegis Licensed Product in such country or 15 years after the date of the first commercial sale of the Aegis Licensed Product in such country (“Aegis Royalty Term”).

The agreement will continue until the expiration of the last-to-expire Aegis Royalty Term, unless sooner terminated.

We have the right to terminate the agreement at any time after a specified notice period to Aegis.

Either party may terminate the agreement for uncured material breach of the other party, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period.

The Aegis Agreement will continue until the expiration of the last-to-expire Aegis Royalty Term, unless sooner terminated.

We have the right to terminate the Aegis Agreement at any time after a specified notice period to Aegis.

Either party may terminate the Aegis Agreement for uncured material breach of the other party, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period.

Collaboration and License Agreement with Alfresa

In April 2020, we entered into a collaboration and license agreement with Alfresa Pharma Corporation (“Alfresa”).

Pursuant to the agreement, we granted Alfresa (i) an exclusive, sublicensable license under our patents relating to neffy to develop, use and import epinephrine compositions (“Alfresa Licensed Compositions”) and related products (“Alfresa Licensed Products”) in Japan (the “Alfresa Territory”) and to promote, distribute, offer for sale and sell Alfresa Licensed Products in the Alfresa Territory, and (ii) a non-exclusive, sublicensable license to manufacture and commercialize Alfresa Licensed Products under the license described in clause (i), under our technology to make and have made Alfresa Licensed Compositions and Alfresa Licensed Products in and outside the Alfresa Territory solely for the purpose of exercising the license described in clause (i) in the Alfresa Territory.

In April 2020, we entered into a collaboration and license agreement (the “Alfresa Agreement”) with Alfresa Pharma Corporation (“Alfresa”).

Pursuant to the Alfresa Agreement, we granted Alfresa (i) an exclusive, sublicensable license under our patents relating to neffy to develop, use and import epinephrine compositions (“Alfresa Licensed Compositions”) and related products (“Alfresa Licensed Products”) in Japan (the “Alfresa Territory”) and to promote, distribute, offer for sale and sell Alfresa Licensed Products in the Alfresa Territory, and (ii) a non-exclusive, sublicensable license to manufacture and commercialize Alfresa Licensed Products under the license described in clause (i), under our technology to make and have made Alfresa Licensed Compositions and Alfresa Licensed Products in and outside the Alfresa Territory solely for the purpose of exercising the license described in clause (i) in the Alfresa Territory.

We expressly reserved all rights to practice and grant licenses under our technology outside the scope of the licenses granted to Alfresa, including the right to manufacture Alfresa Licensed Compositions and Alfresa Licensed Products in the Alfresa Territory.

During the term of the agreement, (1) we and Alfresa are obligated to use commercially reasonable efforts to develop a Alfresa Licensed Product throughout the Alfresa Territory, and (2) Alfresa is obligated to use commercially reasonable efforts to (A) seek pricing and reimbursement approval, (B) seek and maintain regulatory approval for the Alfresa Licensed Products through the Alfresa Territory, and (C) market, promote and otherwise commercialize Alfresa Licensed Products in the field throughout the Alfresa Territory.

Under the agreement, we received a one-time upfront payment of $2.0 million, earned $5.0 million upon the achievement of a clinical milestone during 2021, and earned $6.0 million upon the completion of a regulatory milestone in Japan.

We are eligible to receive a final regulatory milestone of $2.0 million.

Further, we are eligible to receive a negotiable transfer price expected to be in the low-double-digit percentage on net sales subject to the regulatory approval to commercialize neffy in Japan.

We share the cost of any additional clinical studies required for approval of neffy in Japan.

Additionally, Alfresa is obligated to either (i) enter into a commercial supply agreement with us pursuant to which we will supply drug product for commercial sale at an agreed upon transfer price, or (ii) if Alfresa elects to manufacture its own supply of drug product, pay us a royalty payment on the net sales of drug product in the Alfresa Territory in an amount equal to monetary value we would receive by supplying drug product to Alfresa at the transfer price.

The agreement will continue until the later of (i) expiration of the last-to-expire valid claim of our patents or joint patent with Alfresa covering the composition, method of manufacture or method of use in the field of any Alfresa Licensed Product in the Alfresa Territory, and (ii) 10 years after the first commercial sale of any Alfresa Licensed Product in the Alfresa Territory.

Alfresa has the right to terminate the agreement (1) at any time after a specified notice period to us, or (2) upon notice to us if a binding decision is rendered invalidating any of our patents.

During the term of the Alfresa Agreement, (1) we and Alfresa are obligated to use commercially reasonable efforts to develop a Alfresa Licensed Product throughout the Alfresa Territory, and (2) Alfresa is obligated to use commercially reasonable efforts to (A) seek pricing and reimbursement approval, (B) seek and maintain regulatory approval for the Alfresa Licensed Products through the Alfresa Territory, and (C) market, promote and otherwise commercialize Alfresa Licensed Products in the field throughout the Alfresa Territory.

Under the Alfresa Agreement, we received a one-time upfront payment of $2.0 million in 2020, earned $5.0 million upon the achievement of a clinical milestone in 2021, earned $6.0 million upon the completion of a regulatory milestone in Japan in November 2024, and earned $2.0 million upon the achievement of a commercial milestone in Japan in November 2025.

We shared the cost of any additional clinical studies required for approval of neffy in Japan.

The Alfresa Agreement will continue until the later of (i) expiration of the last-to-expire valid claim of our patents or joint patent with Alfresa covering the composition, method of manufacture or method of use in the field of any Alfresa Licensed Product in the Alfresa Territory, and (ii) 10 years after the first commercial sale of any Alfresa Licensed Product in the Alfresa Territory.

Alfresa has the right to terminate the Alfresa Agreement (1) at any time after a specified notice period to us, or (2) upon notice to us if a binding decision is rendered invalidating any of our patents.

Either party may terminate the Alfresa Agreement for uncured material breach of the other party, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period.

In December 2025, in connection with the Alfresa Agreement, ARS and Alfresa also entered into a commercial supply agreement (the “Alfresa Supply Agreement”), under which we will supply Alfresa’s requirements (and Alfresa will purchase from ARS its requirements) for a transfer price in the low-double-digit percentage on net sales of neffy in Japan.

The Alfresa Supply Agreement is coterminous with our Alfresa Agreement.

Pursuant to the Alfresa Agreement, at any time, Alfresa may elect to manufacture its own supply of drug product.

In the event Alfresa elects to do so, Alfresa is obligated to pay us a royalty payment on the net sales of drug product in the Alfresa Territory in an amount equal to monetary value we would receive by supplying drug product to Alfresa at the transfer price.

Collaboration and Distribution Agreement with Pediatrix

In March 2021, we entered into a collaboration and distribution agreement with Pediatrix Therapeutics (“Pediatrix”).

Pursuant to the agreement, we granted Pediatrix (i) an exclusive, royalty-bearing, sublicensable license under our patents relating to neffy to develop, use, register and import epinephrine compositions (“Pediatrix Licensed Compositions”) and related products (“Pediatrix Licensed Products”) in China, Macau, Hong Kong and Taiwan (the “Pediatrix Territory”) and to promote, offer for sale and sell Pediatrix Licensed Products in the Pediatrix Territory;

In March 2021, we entered into a collaboration and distribution agreement (the “Pediatrix Agreement”) with Pediatrix Therapeutics (“Pediatrix”).

Pursuant to the Pediatrix Agreement, we granted Pediatrix (i) an exclusive, royalty-bearing, sublicensable license under our patents relating to neffy to develop, use, register and import epinephrine compositions (“Pediatrix Licensed Compositions”) and related products (“Pediatrix Licensed Products”) in China, Macau, Hong Kong and Taiwan (the “Pediatrix Territory”) and to promote, offer for sale and sell Pediatrix Licensed Products in the Pediatrix Territory;

and (ii) an exclusive, royalty-bearing, sublicensable license to manufacture Pediatrix Licensed Compositions and Pediatrix Licensed Products solely for the purpose of exercising the license described in clause (i) in the Pediatrix Territory.

We expressly reserved all rights to practice and grant licenses under our technology outside the scope of the licenses granted to Pediatrix.

During the term of the agreement, Pediatrix is obligated to use commercially reasonable efforts to (1) develop the Pediatrix Licensed Products throughout the Pediatrix Territory, (2) prepare, obtain, maintain and renew all necessary regulatory approvals for the Pediatrix Licensed Products in the Pediatrix Territory, and (3) market, promote and otherwise commercialize the Pediatrix Licensed Products throughout the Pediatrix Territory.

Under the agreement, we received a one-time upfront payment of $3.0 million and are eligible to receive a regulatory milestone payment of $4.0 million and net sales milestone payments of up to $80.0 million in the aggregate.

During the term of the Pediatrix Agreement, Pediatrix is obligated to use commercially reasonable efforts to (1) develop the Pediatrix Licensed Products throughout the Pediatrix Territory, (2) prepare, obtain, maintain and renew all necessary regulatory approvals for the Pediatrix Licensed Products in the Pediatrix Territory, and (3) market, promote and otherwise commercialize the Pediatrix Licensed Products throughout the Pediatrix Territory.

Under the Pediatrix Agreement, we received a one-time upfront payment of $3.0 million in 2021 and earned a regulatory milestone payment of $4.0 million in December 2025, and are eligible to receive net sales milestone payments of up to $80.0 million in the aggregate.

We will receive a per unit supply price for any sale of commercial supply to Pediatrix.

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or (iii) ten years after the first commercial sale of such Pediatrix Licensed Product in such region (the “Pediatrix Royalty Term”).

The agreement will continue until the expiration of the last-to-expire Pediatrix Royalty Term.

Pediatrix has the right to terminate the agreement at any time after a specified notice period to us.

Manufacturing Agreement with Renaissance

In September 2020, we entered into a manufacturing agreement with Renaissance Lakewood, LLC (“Renaissance”), which was subsequently amended in July 2023 and September 2024 (the “Renaissance Agreement”).

Pursuant to the agreement, Renaissance agreed to manufacture for, and provide to us, neffy nasal unit dose sprays (“Renaissance Products”).

We may also request Renaissance to perform certain services related to the Renaissance Product, for which we will pay reasonable compensation to Renaissance.

The initial term of the Renaissance Agreement commenced on September 17, 2024 and will terminate (a) for Renaissance Product designated for commercial sale in the U.S., on December 31 immediately following the fifth anniversary of the initial U.S.

launch date (“U.S.

Initial Term”), and (b) for Renaissance Product designated for commercial sale in the EU, on December 31 immediately following the fifth anniversary of the initial EU launch date (“EU Initial Term”), in each case unless earlier terminated by one of the parties.

Initial Term and EU Initial Term automatically renew for successive two-year terms (“Renewal Term”).

Either party may elect not to renew the U.S.

Renewal Term and/or the EU Renewal Term by providing the requisite prior notice to the other party.

is not granted on or before a specified date, (b) the authorization and approval representing more than a certain number of units of Renaissance Product sold in the U.S.

Supply Agreement with Ompi

In October 2024, we entered into a supply agreement (the “Ompi Agreement”) with Nuova Ompi S.r.l.

(the “Ompi”), pursuant to which Ompi has agreed to supply glass microvials to support our manufacture and commercialization of neffy .

Under the Ompi Agreement, we have committed to purchase, and Ompi has committed to supply, specified annual minimum quantities of glass microvials, which may be increased with prior notice by us or through the rolling forecast process, subject to a specified annual cap.

Ompi is obligated to establish the relevant manufacturing force, assets and capabilities needed to comply with its supply obligations.

In December 2024, as partial consideration for the supply arrangement, we made an upfront payment of €3.0 million (approximately $3.2 million in U.S.

dollars) to Ompi.

The supply price for the glass microvials is specified in the Ompi Agreement, subject to an annual adjustment that is capped at a specified percentage except in the case of material and extraordinary increase in Ompi’s cost of manufacturing the glass microvials.

The Ompi Agreement will expire on December 31, 2035, and may be terminated (i) upon the parties’ mutual written consent, (ii) by the Company for any reasonable business reasons (in which case the termination will become effective at the end of the following calendar year), or (iii) by the non-breaching party if the other party is in material breach of the Ompi Agreement and fails to cure such breach within 90 days after receipt of notice thereof from the non-breaching party.

Collaboration, License and Distribution Agreement with ALK

ALK Agreement

In November 2024, we entered into a collaboration, license and distribution agreement (the “ALK Agreement”) with ALK-Abelló A/S (“ALK”).

Pursuant to the ALK Agreement, we granted to ALK a worldwide (other than the United States, Japan, mainland China, Hong Kong, Taiwan, Macau, Australia and New Zealand) (“ALK Territory”), exclusive license under certain of our patents and know-how to develop, manufacture and commercialize products containing epinephrine administered intranasally, including EURneffy (the tradename for neffy 2 mg in the European Union) (epinephrine nasal spray) (“Products”), for all human uses, including the immediate or emergency treatment of allergic reactions (including Type I) and anaphylaxis and urticaria, and other future indications as agreed by the parties.

If we develop any new intranasally administered product that contains epinephrine and files a new drug application in the United States for such product (“New Product”), upon ALK’s request such New Product will be included as a Product under the ALK Agreement, subject to ALK bearing the costs of development of such New Product for its licensed territory.

Under the ALK Agreement, we are obligated to transfer to ALK the existing marketing authorizations for the Products in ALK’s territory.

We are also required to conduct certain development and regulatory activities for Products in support of obtaining further regulatory approval of Products in ALK’s territory, and will transfer such regulatory approvals to ALK.

ALK is obligated to use commercially reasonable efforts to obtain and maintain regulatory approval for Products through the European Commission and within specified countries within ALK’s territory.

Following such approval for a Product in each indication within specified countries within ALK’s territory, ALK is obligated to use commercially reasonable efforts to commercialize such Product in such indication in such countries and to achieve first commercial sale of a Product in certain countries in accordance with a timeline specified in the ALK Agreement.

Under the ALK Agreement, ALK made an upfront payment to us of $145.0 million in November 2024.

The Pediatrix Agreement will continue until the expiration of the last-to-expire Pediatrix Royalty Term.

Pediatrix has the right to terminate the Pediatrix Agreement at any time after a specified notice period to us.

Either party may terminate the Pediatrix Agreement for uncured material breach of the other party, or upon notice for insolvency-related events of the other party that are not discharged within a defined time period.

Seqirus Agreement

In March 2024, we entered into a license and distribution agreement (the “Seqirus Agreement”) with Seqirus Pty Ltd.

(“Seqirus”), which was amended in December 2025, for the exclusive license to commercialize neffy in Australia and New Zealand (the “Seqirus Territory”).

Under the Seqirus Agreement, we are responsible for the transfer of know-how, which includes regulatory materials, regulatory data, and commercialization data, and also for the manufacturing of product for commercial supply which is available to Seqirus at a negotiated price.

Seqirus is solely responsible for all regulatory and commercialization activities in the Seqirus Territory.

Either party may terminate the Seqirus Agreement for certain breaches.

Unless terminated earlier by either or both parties, the initial term of the Seqirus Agreement is 15 years from the first commercial sale of neffy in the Seqirus Territory.

The Seqirus Agreement will automatically renew for two-year periods unless either party gives a notice to terminate at least 12 months prior to the end of the initial or any renewal term.

Under the Seqirus Agreement, we received an upfront payment of $0.5 million in May 2024, earned a regulatory milestone payment of $1.5 million in August 2024, and earned a regulatory milestone payment of $0.6 million in December 2025.

In addition, we are eligible to receive up to $2.3 million of milestone payments upon achievement of certain event milestones.

Subject to regulatory approval in Australia and New Zealand, we will also receive a per unit supply price for the sale of commercial supply to Seqirus.

ALK Collaboration Agreement

In November 2024, we entered into a collaboration, license and distribution agreement (the “ALK Collaboration Agreement”) with ALK.

Pursuant to the ALK Collaboration Agreement, we granted to ALK a worldwide (other than the United States, Japan, mainland China, Hong Kong, Taiwan, Macau, Australia and New Zealand) (“ALK Territory”), exclusive license under certain of our patents and know-how to develop, manufacture and commercialize products containing epinephrine administered intranasally, including EURneffy (the tradename for neffy 2 mg in the European Union) (epinephrine nasal spray) (“Products”), for all human uses, including the immediate or emergency treatment of allergic reactions (including Type I) and anaphylaxis and urticaria, and other future indications as agreed by the parties.

If we develop any new intranasally administered product that contains epinephrine and files a new drug application in the United States for such product (“New Product”), upon ALK’s request such New Product will be included as a Product under the ALK Collaboration Agreement, subject to ALK bearing the costs of development of such New Product for its licensed territory.

Under the ALK Collaboration Agreement, we are obligated to transfer to ALK the existing marketing authorizations for the Products in the ALK Territory.

We are also required to conduct certain development and regulatory activities for Products in support of obtaining further regulatory approval of Products in the ALK Territory, and will transfer such regulatory approvals to ALK.

Following such approval for a Product in each indication within specified countries within the ALK Territory, ALK is obligated to use commercially reasonable efforts to commercialize such Product in such indication in such countries and to achieve first commercial sale of a Product in certain countries in accordance with a timeline specified in the ALK Collaboration Agreement.

Under the ALK Collaboration Agreement, ALK made an upfront payment to us of $145.0 million in November 2024 and earned a commercial milestone payment of $5.0 million for the first commercial sale of neffy in June 2025.

We are eligible to receive regulatory and development milestones of up to $15.0 million and commercial sales-based milestones of up to $300.0 million, provided that $55.0 million of such sales-based milestones are contingent upon us obtaining regulatory approval for the Product in Canada by a specified time.

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The contract will expire upon the expiration of the last to expire royalty term for all Products in the ALK Territory, unless terminated earlier.

Either we or ALK may terminate the ALK Agreement in the case of the other party’s insolvency or in the event of an uncured material breach of the other party, except that we may not terminate the ALK Agreement for ALK’s material breach of its commercial diligence obligations.

ALK may terminate the ALK Agreement for convenience upon prior written notice or for a safety or regulatory concern.

We may terminate the ALK Agreement in the event ALK makes certain challenges to certain of our patents.

Prior to a change of control and outside of a set period of time after which we commence change of control negotiations, we may terminate the ALK Agreement with respect to all countries in the European Economic Area (“EEA”) upon prior written notice to ALK and payment of a termination fee that is the higher of an agreed mid-nine digit amount and the fair market value of the Products business in the EEA at the time of such termination.

We may also terminate the ALK Agreement if ALK commercializes a non-injectable epinephrine product or manufactures such a product in the United States.

Either we or ALK may terminate the ALK Collaboration Agreement in the case of the other party’s insolvency or in the event of an uncured material breach of the other party, except that we may not terminate the ALK Collaboration Agreement for ALK’s material breach of its commercial diligence obligations.

ALK may terminate the ALK Collaboration Agreement for convenience upon prior written notice or for a safety or regulatory concern.

We may terminate the ALK Collaboration Agreement in the event ALK makes certain challenges to certain of our patents.

Prior to a change of control and outside of a set period of time after which we commence change of control negotiations, we may terminate the ALK Collaboration Agreement with respect to all countries in the European Economic Area (“EEA”) upon prior written notice to ALK and payment of a termination fee that is the higher of an agreed mid-nine digit amount and the fair market value of the Products business in the EEA at the time of such termination.

We may also terminate the ALK Collaboration Agreement if ALK commercializes a non-injectable epinephrine product or manufactures such a product in the United States.

ALK Supply Agreement

On November 9, 2024, in connection with the ALK Collaboration Agreement, ARS and ALK also entered into a commercial supply agreement (the “Supply Agreement”), under which ARS will supply ALK’s requirements (and ALK will purchase from ARS its requirements) of Products for five years for a specified supply price, after which ALK may elect to transition to itself or its contract manufacturer the manufacture and supply of Products.

Either we or ALK may terminate the Supply Agreement in the event of an uncured material breach of the other party.

On November 9, 2024, in connection with the ALK Collaboration Agreement, ARS and ALK also entered into a commercial supply agreement (the “ALK Supply Agreement”), under which ARS will supply ALK’s requirements (and ALK will purchase from ARS its requirements) of Products for five years for a specified supply price, after which ALK may elect to transition to itself or its contract manufacturer the manufacture and supply of Products.

Either we or ALK may terminate the ALK Supply Agreement in the event of an uncured material breach of the other party.

ALK Co-Promotion Agreement

In May 2025, we entered into a co-promotion agreement with ALK U.S., which was subsequently amended in October 2025 and March 2026 (as amended, the “ALK Co-Promotion Agreement”), to co-promote neffy to up to 9,000 specified pediatricians and other prescribers in the U.S.

Under the ALK Co-Promotion Agreement, we granted ALK U.S.

a non-exclusive, royalty-free license to use the neffy trademarks and copyrights and the ARS house marks in the U.S.

solely in connection with promoting neffy pursuant to the terms of the ALK Co-Promotion Agreement.

commenced its promotion activities in May 2025 and is obligated to meet specified ramp-up milestones and minimum detail requirements using qualified sales representatives.

In addition, during the term of the ALK Co-Promotion Agreement and for 180 days thereafter, ALK U.S.

will not market, sell or manufacture any injection product containing epinephrine in the U.S.

We record all sales of neffy in the U.S.

and, subject to the terms of the ALK Co-Promotion Agreement, continue to have sole responsibility for all U.S.

commercialization activities, including marketing, medical affairs, market access, production, distribution, pharmacovigilance, quality and safety.

We will pay ALK U.S.

a base fee to compensate ALK U.S.

for its promotion activities.

Payments for the first year of the partnership will be deferred and paid in the second year of the partnership.

In addition to the base fee, ALK U.S.

will be eligible to receive performance-based bonus payments from us starting in May 2026 equal to 30% of the portion of neffy net sales generated from the ALK U.S.-targeted prescribers in excess of a specified initial market share threshold in year two or a 50% market share threshold during years three and four of the partnership.

The ALK Co-Promotion Agreement expires in May 2029.

Either party may terminate the ALK Co-Promotion Agreement in the event of an uncured material breach of the other party or for either party’s change of control.

We may terminate the ALK Co-Promotion Agreement in the case of ALK U.S.’s insolvency, if ALK U.S.

fails to meet specified ramp-up timelines, or if ALK U.S.

markets, sells or commercializes any non-injection product containing epinephrine in the U.S.

We may terminate the ALK Co-Promotion Agreement if minimum detail requirements are not met for a consecutive three-month period.

After the first year, we may terminate the ALK Co-Promotion Agreement for any reason or no reason for a fee (as described below).

After the first year, ALK U.S.

may terminate the ALK Co-Promotion Agreement for any reason or no reason, and we may terminate the ALK Co-Promotion Agreement in the event ALK U.S.

restructures its sales force.

Upon termination of the ALK Co-Promotion Agreement by us for convenience, so long as ALK U.S.

has met specified performance thresholds during the term, we are obligated to pay ALK U.S.

a specified mid-to-low double-digit percentage of the portion of neffy net sales generated from the ALK U.S.-targeted prescribers in excess of a specified mid-quartile market share threshold that increases over time up to 50% for a specified period after termination, which period decreases in duration the later that the termination occurs.

Upon termination of the ALK Co-Promotion Agreement by us in connection with a change of control of the Company, we are obligated to pay ALK U.S.

a one-time mid-seven digit to low eight-digit termination fee in an amount that increases the later that the termination occurs.

Government Regulation and Product Approval

As a pharmaceutical company that operates in the United States, we are subject to extensive regulation.

Government authorities in the United States (at the federal, state and local level) and in other countries extensively regulate, among other things, the research, development, testing, manufacturing, quality control, approval, labeling, packaging, storage, record-keeping, promotion, advertising, distribution, post-approval monitoring and reporting, marketing and export and import of drug products such as those we are developing.

Product candidates that we develop must be approved by the FDA, before they may be legally marketed in the United States and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries.

Generally, our activities in other countries will be subject to regulation that is similar in nature and scope as that imposed in the United States, although there can be important differences.

As a pharmaceutical company that operates in the U.S., we are subject to extensive regulation.

Product candidates that we develop must be approved by the FDA, before they may be legally marketed in the U.S.

and by the appropriate foreign regulatory agency before they may be legally marketed in foreign countries.

Generally, our activities in other countries will be subject to regulation that is similar in nature and scope as that imposed in the U.S., although there can be important differences.

Additionally, some significant aspects of regulation in Europe are addressed in a centralized way, but country-specific regulation remains essential in many respects.

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The determination of which center will be the lead center is based on the “primary mode of action” of the combination product.

Thus, if the primary mode of action of a drug-device combination product is attributable to the drug product, the FDA center responsible for premarket review of the drug product would have primary jurisdiction for the combination product.

A combination product with a primary mode of action attributable to the drug component, such as neffy and our intranasal epinephrine technology product candidates, generally would be reviewed and approved pursuant to the drug approval processes set forth in the FDCA.

In reviewing the NDA for such a product, however, FDA reviewers would consult with their counterparts in the device center to ensure that the device component of the combination product – the sprayer - met applicable requirements regarding safety, effectiveness, durability and performance.

In addition, under FDA regulations, combination products such as neffy and our intranasal epinephrine technology product candidates are subject to cGMP requirements applicable to both drugs and devices, including the Quality System Regulations applicable to medical devices.

In reviewing the New Drug Application (“NDA”) for such a product, however, FDA reviewers would consult with their counterparts in the device center to ensure that the device component of the combination product – the sprayer - met applicable requirements regarding safety, effectiveness, durability and performance.

In addition, under FDA regulations, combination products such as neffy and our intranasal epinephrine technology product candidates are subject to current Good Manufacturing Practice (“cGMP”) requirements applicable to both drugs and devices, including the Quality Management System Regulations applicable to medical devices.

Drug Development Process

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The sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

An IND is a request for authorization from the FDA to administer an investigational drug product to humans.

The central focus of an IND submission is on the general investigational plan and the protocol(s) for human trials.

Some preclinical testing may continue even after the IND is submitted.

The IND automatically becomes effective 30 days after receipt by the FDA, unless the FDA raises concerns or questions regarding the proposed clinical trials and places the IND on clinical hold within that 30-day time period.

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Clinical trials involve the administration of the product candidate to healthy volunteers or patients under the supervision of qualified investigators, generally physicians not employed by or under the trial sponsor’s control, in accordance with GCPs, which include the requirement that all research subjects provide their informed consent for their participation in any clinical trial.

Clinical trials are conducted under protocols detailing, among other things, the objectives of the clinical trial, dosing procedures, subject selection and exclusion criteria and the parameters to be used to monitor subject safety and assess efficacy.

Each protocol, and any subsequent amendments to the protocol, must be submitted to the FDA as part of the IND.

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In certain instances, FDA may mandate the performance of Phase 4 trials.

In certain instances, the FDA may mandate the performance of Phase 4 clinical trials as a condition of approval of an NDA.

During the development of a new drug, sponsors are given opportunities to meet with the FDA at certain points.

These points may be prior to submission of an IND, at the end of Phase 2, and before an NDA is submitted.

Meetings at other times may be requested.

These meetings can provide an opportunity for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to reach agreement on the next phase of development.

Sponsors typically use the meetings at the end of the Phase 2 trial to discuss Phase 2 clinical results and present plans for the pivotal Phase 3 clinical trials that they believe will support approval of the new drug.

Progress reports detailing the results of the clinical trials must be submitted at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected AEs or any finding from tests in laboratory animals that suggests a significant risk for human subjects.

Phase 1, Phase 2 and Phase 3 clinical trials may not be completed successfully within any specified period, if at all.

The FDA, the IRB, or the sponsor may suspend or terminate a clinical trial at any time on various grounds, including a finding that the research subjects or patients are being exposed to an unacceptable health risk.

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Assuming successful completion of all required testing in accordance with all applicable regulatory requirements, the results of product development, preclinical studies and clinical trials, along with descriptions of the manufacturing process, analytical tests conducted on the chemistry of the drug, proposed labeling and other relevant information are submitted to the FDA as part of an NDA requesting approval to market the product.

Data may come from company-sponsored clinical trials intended to test the safety and effectiveness of a use of a product, or from a number of alternative sources, including studies initiated by investigators.

To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety and effectiveness of the investigational drug product to the satisfaction of the FDA.

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Under the PDUFA guidelines that are currently in effect, the FDA has a goal of ten months from the date of “filing” of a standard NDA for a new molecular entity to review and act on the submission.

This review typically takes twelve months from the date the NDA is submitted to FDA because the FDA has approximately two months to make a “filing” decision after it the application is submitted The FDA does not always meet its PDUFA goal dates for standard and priority NDAs, and the review process is often significantly extended by FDA requests for additional information or clarification.

The FDA does not always meet its PDUFA goal dates for standard and priority NDAs, and the review process is often significantly extended by FDA requests for additional information or clarification.

After the NDA submission is accepted for filing, the FDA reviews the NDA to determine, among other things, whether the proposed product is safe and effective for its intended use and whether the product is being manufactured in accordance with cGMP to assure and preserve the product’s identity, strength, quality and purity.

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Further, the FDA may require that certain contraindications, warnings or precautions be included in the product labeling or may condition the approval of the NDA on other changes to the proposed labeling, development of adequate controls and specifications, or a commitment to conduct one or more post-market studies or clinical trials.

For example, the FDA may require Phase 4 testing, which involves clinical trials designed to further assess a drug safety and effectiveness, and may require testing and surveillance programs to monitor the safety of approved products that have been commercialized.

The FDA may also determine that a risk evaluation and mitigation strategy (“REMS”) is necessary to assure the safe use of the drug.

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A REMS could include medication guides, physician communication plans, or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization tools.

Fast Track Designation

The FDA has a number of programs intended to expedite the development or review of products that meet certain criteria.

For example, the FDA has a fast track designation program that is intended to expedite or facilitate the process for reviewing new drug products that meet certain criteria.

Specifically, new drugs are eligible for fast track designation if they are intended to treat a serious or life-threatening disease or condition and demonstrate the potential to address unmet medical needs for the disease or condition.

Fast track designation applies to the combination of the product and the specific indication for which it is being studied.

The sponsor of a fast track product has opportunities for more frequent interactions with the applicable FDA review team during product development and, once an NDA is submitted, the product candidate may be eligible for priority review.

With regard to a fast track product, the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted, if the sponsor provides a schedule for the submission of the sections of the NDA, the FDA agrees to accept sections of the NDA and determines that the schedule is acceptable, and the sponsor pays any required user fees upon submission of the first section of the NDA.

Any product submitted to the FDA for approval, including a product with a fast track designation, may also be eligible for other types of FDA programs intended to expedite development and review, such as priority.

A product is eligible for priority review if it is designed to treat a serious condition, and if approved, would provide a significant improvement in the treatment, diagnosis or prevention of a serious condition compared to marketed products.

The FDA will attempt to direct additional resources to the evaluation of an application for a new drug designated for priority review in an effort to facilitate the review.

The FDA endeavors to review applications with priority review designations within six months of the filing date as compared to ten months for review of new molecular entity NDAs under its current PDUFA review goals.

Fast track designation and priority review do not change the standards for approval but may expedite the development or approval process.

Even if a product qualifies for one of these programs, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review or approval will not be shortened.

In addition, such designations or shortened review periods may not provide a material commercial advantage.

Post-Approval Requirements

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Moreover, as a condition of participating in, and having products covered under, certain federal healthcare programs, such as Medicare and Medicaid, we are subject to federal laws and regulations that require pharmaceutical manufacturers to calculate and report certain price reporting metrics to the government, such as Medicaid Average Manufacturer Price (“AMP”), and Best Price, Medicare Average Sales Price, the 340B Ceiling Price, and Non-Federal AMP reported to the Department of Veteran Affairs, and with respect to Medicaid, pay statutory rebates on utilization of manufacturers’ products by Medicaid beneficiaries.

In addition, the U.S.

Department of Health and Human Services (“HHS”) imposes rebates on many Medicare Part B and Medicare Part D products to penalize price increases that outpace inflation on an annual basis.

In addition, HHS has been empowered to negotiate the price of certain single-source drugs that have been on the market for at least seven (7) years covered under Medicare as part of the Medicare Drug Price Negotiation Program.

Each year up to twenty (20) products will be selected by HHS for the Medicare Drug Price Negotiation Program.

Products subject to the Medicare Drug Price Negotiation Program are expected to experience a significant reduction in reimbursement from the Medicare program on a per unit basis.

If coverage and adequate reimbursement are not available, or are available only to limited levels, we may not be able to successfully commercialize neffy and any product candidates for which we receive approval.

In international markets, reimbursement and healthcare payment systems vary significantly by country, and many countries have instituted price ceilings on specific products and therapies.

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For example, implementation of the ACA substantially changed the way healthcare is financed by both governmental and private insurers in the United States and significantly affected the pharmaceutical industry.

The ACA, among other things, increased the minimum level of Medicaid rebates payable by manufacturers of brand name drugs;

required collection of rebates for drugs paid by Medicaid managed care organizations;

required manufacturers to participate in a coverage gap discount program, under which they must agree to offer point-of-sale discounts (increased to 70 percent, effective as of January 1, 2019) off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;

imposed a non-deductible annual fee on pharmaceutical manufacturers or importers who sell certain “branded prescription drugs” to specified federal government programs, implemented a new methodology by which rebates owed by manufacturers under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted, or injected expanded the types of entities eligible for the 340B drug discount program;

expanded eligibility criteria for Medicaid programs;

created a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research;

and established a Center for Medicare Innovation at CMS to test innovative payment and service delivery models to lower Medicare and Medicaid spending, potentially including prescription drug spending.

Since its enactment, there have been amendments and judicial, administrative, executive, and Congressional legislative challenges to certain aspects of the ACA.

For example, on August 16, 2022, the Inflation Reduction Act of 2022 (“IRA”) was signed into law, which among other things, extends enhanced subsidies for individuals purchasing health insurance coverage in ACA marketplaces through plan year 2025.

The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and creating a new manufacturer discount program.

It is unclear how such challenges and the healthcare reform measures of the second Trump administration will impact the ACA.

For example, on July 4, 2025, the One Big Beautiful Bill Act (“OBBBA”) was signed into law, which narrowed access to ACA marketplace exchange enrollment and declined to extend the ACA enhanced advanced premium tax credits that expired at the end of 2025, which, among other provisions in the law, are anticipated to reduce the number of Americans with health insurance.

The OBBBA also is expected to reduce Medicaid spending and enrollment by implementing work requirements for some beneficiaries, capping state-directed payments, reducing federal funding, and limiting provider taxes used to fund the program.

Congress is considering proposed legislation intended to further reduce healthcare costs with alternatives to replace the expired ACA subsidies.

It is unclear how such challenges and the healthcare reform measures of the current administration will impact the ACA and our business.

Other legislative changes have been proposed and adopted since the ACA was enacted, including aggregate reductions of Medicare payments to providers of 2% per fiscal year pursuant to the Budget Control Act of 2011 which went into effect on April 1, 2013, and due to subsequent legislative amendments, will remain in effect until 2032, unless additional Congressional action is taken.

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Presidential executive orders, congressional inquiries, and proposed and enacted legislation designed, among other things, to bring more transparency to product pricing, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for pharmaceutical products.

For example, the IRA, among other things, (i) directs the U.S.

Department of Health and Human Services (“HHS”) to negotiate the price of certain high-expenditure, single-source drugs that have been on the market for at least 7 years covered under Medicare (the “Medicare Drug Price Negotiation Program”), and subject drug manufacturers to civil monetary penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price” for such drugs under the law, and (ii) imposes rebates with respect to certain drugs covered under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation.

The IRA permits HHS to implement many of these provisions through guidance, as opposed to regulation, for the initial years.

These provisions began to take effect progressively starting in fiscal year 2023.

On August 15, 2024, HHS announced the agreed-upon price of the first ten drugs that were subject to price negotiations, although the Medicare Drug Price Negotiation Program is currently subject to legal challenges.

On January 17, 2025, HHS selected fifteen additional products covered under Part D for price negotiation in 2025.

Each year thereafter more Part B and Part D products will become subject to the Medicare Drug Price Negotiation Program.

Further, on December 7, 2023, an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act was announced.

On December 8, 2023, the National Institute of Standards and Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.

While march-in rights have not previously been exercised, it is uncertain if that will continue under the new framework.

In addition, the American Taxpayer Relief Act of 2021, effective January 1, 2024, would eliminate the statutory cap on rebate amounts owed by drug manufacturers under the Medicaid Drug Rebate Program (“MDRP”), which is currently capped at 100% of the AMP for a covered outpatient drug.

For example, the American Taxpayer Relief Act of 2021, effective January 1, 2024, eliminated the statutory cap on rebate amounts owed by drug manufacturers under the Medicaid Drug Rebate Program (“MDRP”), previously capped at 100% of the AMP for a covered outpatient drug.

The current administration is pursuing policies to reduce regulations and expenditures across government agencies including at HHS, the FDA, CMS and related agencies.

These actions, presently directed by executive orders or memoranda from the Office of Management and Budget, may propose policy changes that create additional uncertainty for our business.

For example, the current administration has announced agreements with pharmaceutical companies that require the drug manufacturers to offer, through a direct-to-consumer platform, U.S.

patients and Medicaid programs prescription drug Most-Favored Nation pricing equal to or lower than those paid in other developed nations, with additional mandates for direct-to-patient discounts and repatriation of foreign revenues.

Other recent actions, for example, include (1) directing agencies to reduce agency workforce and cut programs;

(2) directing HHS and other agencies to lower prescription drug costs through a variety of initiatives, including by improving upon the Medicare Drug Price Negotiation Program and establishing Most-Favored-Nation pricing for pharmaceutical products;

(3) imposing tariffs on imported pharmaceutical products;

and (4) as part of the Make America Healthy Again Commission’s Strategy Report released in September 2025, working across government agencies to increase enforcement on direct-to-consumer pharmaceutical advertising.

Additionally, the current administration recently called on Congress to enact “The Great Healthcare Plan,” to codify and expand Most-Favored Nation pricing, lower government subsidies to private insurance companies, increase healthcare price transparency, expand pharmaceutical drugs available for over-the-counter purchase, and enact restrictions on pharmacy benefit manager payment methodologies, among other things.

These actions and policies may significantly reduce U.S.

drug prices, potentially impacting manufacturers’ global pricing strategies and profitability, while increasing their operational costs and compliance risks.

In June 2024, in Loper Bright Enterprises v.

Raimondo, the U.S.

Supreme Court greatly reduced judicial deference to regulatory agencies, which could increase successful legal challenges to federal regulations affecting our operations.

Congress may introduce and ultimately pass health care related legislation that could impact the drug approval process and make changes to the Medicare Drug Price Negotiation Program.

Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures and, in some cases, mechanisms to encourage importation from other countries and bulk purchasing.

For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (“SIP”) proposal to import certain drugs from Canada for specific state healthcare programs.

It is unclear how this program will be implemented, including which drugs will be chosen, and whether it will be subject to legal challenges in the United States or Canada.

Other states have also submitted SIP proposals that are pending review by the FDA.

Any such approved importation plans, when implemented, may result in lower drug prices for products covered by those programs.

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For products with a new active substance indicated for the treatment of other diseases and products that are highly innovative or for which a centralized process is in the interest of patients, authorization through the centralized procedure is optional on related approval.

Under the centralized procedure, the EMA’s Committee for Medicinal Products for Human Use(“CHMP”), conducts the initial assessment of a product.

Under the centralized procedure, the CHMP of the EMA conducts the initial assessment of a product.

The CHMP is also responsible for several post-authorization and maintenance activities, such as the assessment of modifications or extensions to an existing MA.

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If we or our potential collaborators fail to comply with applicable foreign regulatory requirements, we may be subject to, among other things, fines, suspension, variation or withdrawal of regulatory approvals, product recalls, seizure of products, operating restrictions and criminal prosecution.

As of December 31, 2025, we had 158 full-time employees and 5 part-time employees.

Of these employees, 4 held Ph.D.

None of our employees are represented by labor unions or covered by collective bargaining agreements.

We consider our relationship with our employees to be good.

Corporate Information

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Our corporate headquarters are located at 11682 El Camino Real, Suite 300, San Diego, California 92130, and our telephone number is (858) 771-9307.

Our corporate website address is www.ars-pharma.com.

Our corporate website address is ars-pharma.com .

Information contained on, or accessible through, our website shall not be deemed incorporated into and is not a part of this Annual Report on Form 10-K.

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We have included our website in this Annual Report on Form 10-K solely as an inactive textual reference.

As of December 31, 2024, we had 155 full-time employees and 5 part-time employees.

Of these employees, three held Ph.D.

None of our employees are represented by labor unions or covered by collective bargaining agreements.

We consider our relationship with our employees to be good.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business