ARS Pharmaceuticals Reports Third Quarter 2023 Financial Results and Provides Business Updates
Company is on track with ongoing repeat-dose study under allergen-induced allergic rhinitis conditions requested by
Resubmission of New Drug Application (NDA) for neffy® anticipated in H1 2024
Ended third quarter with
“While we remain disappointed in the FDA’s decision to change the repeat-dose rhinitis study from a post-marketing requirement to a pre-approval requirement, we are moving quickly to complete the study and meet the urgent medical need for people with severe allergic reactions. We continue to expect resubmission of our New Drug Application for neffy in the first half of next year, with a
- In September, ARS Pharma announced that the FDA issued a Complete Response Letter (CRL) regarding its NDA for neffy. In the CRL, the FDA requested completion of a pharmacokinetic/pharmacodynamic study assessing repeat doses of neffy compared to repeat doses of an epinephrine injection product under allergen-induced allergic rhinitis conditions to support approval.
- No member of the
May 2023 FDA Advisory Committee(PADAC), that concluded a favorable benefit-risk profile of neffy (16:6 for adults and 17:5 for children), requested a repeat dose study during allergen-induced allergic rhinitis, and ARS Pharma aligned with FDA in August 2023that such a study could be completed as a post-marketing requirement.
- ARS Pharma expects to report its findings from this study in the first quarter of 2024. With this study being previously planned as a post-marketing requirement, ARS Pharma was able to quickly ramp up following the CRL.
- The company anticipates a resubmission of its NDA in the first half of 2024, positioning ARS Pharma for an anticipated FDA action date and potential launch in the second half of 2024.
- No member of the
- In October, ARS Pharma announced its participation in a Type A meeting with the FDA to understand the agency’s view related to the CRL, and to confirm next steps to support an NDA resubmission seeking approval of neffy.
- At this Type A meeting, the FDA confirmed that the previously agreed upon design for the repeat-dose study to evaluate the similarity of twice dosing injection and twice dosing neffy under allergen-induced allergic rhinitis will generate the necessary data to answer its outstanding questions regarding neffy.
- The neffy NDA re-submission will be classified as Class 2, with an action expected within six months of submission.
Additional Business Updates and Anticipated Milestones
- Marketing authorization application (MAA) for neffy is under review by the
European Medicines Agency(EMA) with a decision now expected in the second quarter of 2024. Submissions to other regulatory authorities in additional countries are planned for 2024.
- In October, ARS Pharma announced that results from the single and repeat dose clinical study of neffy were published in the
Journal of Allergy and Clinical Immunology(JACI). The clinical study evaluated single and repeat doses of neffy compared to single and repeat doses of approved injection products in healthy subjects.
- In November, ARS Pharma will present positive results during the 2023
American College of Allergy, Asthma and Immunology(ACAAI) meeting supporting that neffy is expected to be a safe and effective treatment option in sub-populations including upper respiratory tract infection, pediatrics ≥30 kg and patients with varying body mass index (BMI) or body weight.
- Following the neffy program delay, ARS Pharma implemented a plan to prioritize resources on clinical and regulatory activities while maintaining core commercial readiness status ahead of the anticipated FDA approval of neffy in H2 2024.
Third Quarter 2023 Financial Results
- Cash Position: Cash, cash equivalents and short-term investments were
$241.9 millionas of September 30, 2023, which ARS Pharma believes is sufficient to fund its current operating plan for at least three years.
- R&D Expenses: Research and development (R&D) expenses were
$3.0 millionfor the quarter ended September 30, 2023.
- G&A Expenses: General and administrative (G&A) expenses were
$15.0 millionfor the quarter ended September 30, 2023.
- Net Loss: Net loss was
$14.9 millionfor the quarter ended September 30, 2023.
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
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. For more information, visit www.ars-pharma.com.
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, ARS Pharma’s plan to complete the repeat-dose study under allergen-induced allergic rhinitis conditions and file its NDA re-submission to the FDA in the first half of 2024, with an anticipated launch of neffy, if approved, in the second half of 2024; ARS Pharma’s expectation to report topline data from its repeat-dose study in the first quarter of 2024; ARS Pharma’s projected cash runway; ARS Pharma’s belief that it is well capitalized to support the launch of neffy in the
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.
ARS Pharma Investor Contacts:
ARS Pharma Media Contact:
Condensed Consolidated Balance Sheets
(in thousands, except share and par value data)
|Cash and cash equivalents||$||60,532||$||210,518|
|Prepaid expenses and other current assets||2,564||3,319|
|Total current assets||244,466||277,700|
|Fixed assets, net||617||329|
|Liabilities, convertible preferred stock and stockholders’ equity|
|Accounts payable and accrued liabilities (including related party amounts of
|Lease liability, current||235||230|
|Contract liability, current||—||283|
|Total current liabilities||11,180||5,444|
|Lease liability, net of current portion||92||251|
|Contract liability, net of current portion||—||2,854|
|Commitments and contingencies|
|Additional paid-in capital||361,571||349,408|
|Accumulated other comprehensive (loss) gain, net||(161||)||407|
|Total stockholders’ equity||237,284||272,886|
|Total liabilities, convertible preferred stock and stockholders’ equity||$||248,556||$||281,435|
Condensed Consolidated Statements of Operations and Comprehensive Loss
(in thousands, except share and per share data)
|Three Months Ended
||Nine Months Ended
|Revenue under collaboration agreements||$||—||$||189||$||30||$||1,316|
|Research and development (including related party amounts of
|General and administrative (including related party amounts of
|Total operating expenses||17,978||6,819||57,324||21,389|
|Loss from operations||(17,978||)||(6,630||)||(57,294||)||(20,073||)|
|Other income (expense), net||3,112||47||10,097||(180||)|
|Change in unrealized gains and losses on available-for-sale securities||19||—||(568||)||—|
|Net loss per share, basic and diluted||$||(0.16||)||$||(0.21||)||$||(0.50||)||$||(0.66||)|
|Weighted-average shares outstanding used in computing net loss per share, basic and diluted||95,576,627||30,755,123||94,910,012||30,578,516|
ARS Pharmaceuticals, Inc.