ARS PHARMACEUTICALS, INC.
The event included presentations by members of the ARS Pharma management team and by two distinguished allergists, Dr.
'During our neffy Investor Day, we highlighted the substantial unmet need faced by patients suffering from severe allergies, and how current epinephrine treatments, while effective, have limitations - largely stemming from needle-related risks and portability issues,' said
Dr.
About Type I Allergic Reactions including Anaphylaxis
Type I severe allergic reactions are serious and potentially life-threatening events that can occur within minutes of exposure to an allergen and require immediate treatment with epinephrine, the only FDA-approved medication for these reactions. While epinephrine autoinjectors have been shown to be highly effective, there are well published limitations that result in many patients and caregivers delaying or not administering treatment in an emergency situation. These limitations include fear of the needle, lack of portability, needle-related safety concerns, lack of reliability, and complexity of the devices. There are approximately 40 million people in
About Urticaria
Urticaria is a skin disorder that causes itchy hives and/or angioedema. Approximately 50% of chronic urticaria cases are non-responsive to first-line antihistamine therapy. These non-responsive patients on stable therapy regimens can experience exacerbations or flares several times a year among acute cases, and even several times a week, including up to three or four emergency room visits, among chronic urticaria cases.
About
ARS Pharma is a biopharmaceutical company dedicated to empowering at-risk patients and caregivers to better protect themselves from severe allergic reactions that could lead to anaphylaxis. The Company is developing neffy (also referred to as ARS-1), an intranasal epinephrine product in clinical development for patients and their caregivers with Type I allergic reactions including food, medications and insect bites that could lead to life-threatening anaphylaxis.
Forward-Looking Statements
Statements in this press release that are not purely historical in nature are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the potential market, demand and expansion opportunities for neffy; potential benefits and favorable attributes of neffy, if approved, including the likelihood that allergy patients, especially children, as well as caregivers, will choose to carry and dose neffy compared to needle-bearing options; ARS Pharma's plan to file its NDA early in the second quarter of 2024, with an anticipated Prescription Drug User Fee Act ('PDUFA') action date and launch of neffy, if approved, in the second half of 2024; the timing of the EMA's decision of ARS Pharma's MAA; the timing of additional submissions to other foreign regulatory authorities; ARS pharma's plans to initiate an outpatient urticaria study later in 2024, potentially followed by initiation of a single pivotal efficacy study and other statements that are not historical fact. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Words such as 'anticipate,' 'expects,' 'plans,' 'potential,' 'will,' and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon ARS Pharma's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, the ability to obtain and maintain regulatory approval for neffy; even though the FDA has stated that completion of the repeat-dose study under allergen-induced allergic rhinitis conditions for neffy will sufficiently address the agency's outstanding questions, there is no guarantee that new issues will not be identified which could delay or prevent the approval of neffy; whether the FDA will view the results from ARS Pharma's repeat-dose study under allergen-induced allergic rhinitis conditions for neffy as successful and sufficient to support approval; the PDUFA target action date may be further delayed due to various factors outside ARS Pharma's control; results from clinical trials may not be indicative of results that may be observed in the future; potential safety and other complications from neffy; the labelling for neffy, if approved; the scope, progress and expansion of developing and commercializing neffy; potential for payers to delay, limit, or deny coverage for neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis-a-vis intramuscular injectable products; ARS Pharma's ability to protect its intellectual property position; uncertainties related to capital requirements and the impact of government laws and regulations. Additional risks and uncertainties that could cause actual outcomes and results to differ materially from those contemplated by the forward-looking statements are included under the caption 'Risk Factors' in ARS Pharma's Quarterly Report on Form 10-Q for the quarter ended
The forward-looking statements included in this press release are made only as of the date hereof. ARS Pharma assumes no obligation and does not intend to update these forward-looking statements, except as required by law.
Contact:
Email: justinc@ars-pharma.com
Email: Laura.oneill@finnpartners.com
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