ARS Pharmaceuticals reports FY23 EPS (57c), consensus (14c)

Reports FY23 cash, cash equivalents and short-term investments were $228.4M as of December 31which ARS Pharma believes is sufficient to fund its current operating plan for at least three years.”We started the year by turning the page and quickly addressing the two deficiencies identified in the FDA’s CRL for neffy late last year and are now working to finalize our response to the CRL, which we expect to submit in early Q2 2024. We want to deliver this needle-free, safe, effective, and easy to carry epinephrine solution to patients in need as quickly as possible. To do so, we remain well capitalized with anticipated cash and equivalents greater than $200 million at the time of the anticipated FDA approval of neffy, expected in the second half of 2024,” said Richard Lowenthal, Co-founder, President and CEO of ARS Pharma. Mr. Lowenthal further stated, “At the recent American Academy of Allergy, Asthma & Immunology annual meeting in February 2024, six posters and oral presentations on neffy were presented, including efficacy data showing a 100% response rate with a single dose of neffy in the 15 enrolled pediatric subjects experiencing anaphylaxis symptoms following oral food challenge, further increasing our confidence in neffy’s commercial ramp and potential. At AAAAI, we also presented positive topline data from our Phase 2 inpatient, randomized, controlled study of neffy in patients with refractory chronic spontaneous urticaria. neffy met all primary endpoints and showed rapid symptom control, supporting advancement to an outpatient study in chronic spontaneous urticaria patients who experience acute exacerbations of symptoms, which we plan to initiate later in 2024, followed by a potential pivotal study in 2025.”