Full Press Release Details
THE FIRST NO-NEEDLE, NO-INJECTION
SOLUTION for Type I Allergic Reactions Q2 2023 Exhibit 99.1
Forward-looking statements This
presentation contains forward-looking statements which include, but are not limited to, statements regarding the design and potential benefits of neffy; the anticipated Prescription Drug User Fee Act (PDUFA) date for neffy; the timing of regulatory
approval for and the commercial launch of neffy, if approved; ARS Pharma's commercialization strategy; the potential market opportunity for neffy; the projected growth thereof and neffy's ability to capture and grow that market; ARS
Pharma's expected competitive position; ARS Pharma's potential to become the standard in treatment and transform the treatment of allergic reactions; the likelihood of neffy attaining favorable coverage; the expected intellectual
property protection for neffy; and any statements of assumptions underlying any of the foregoing. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. ARS
Pharma's expectations and beliefs regarding these matters may not materialize. Actual outcomes and results may differ materially from those contemplated by these forward-looking statements as a result of uncertainties, risks, and changes in
circumstances, including but not limited to risks and uncertainties related to: the ability to obtain and maintain regulatory approval for neffy; results from clinical trials may not be indicative of results that may be observed in the future; the
FDA advisory committee's decision should not be relied on as an indication that neffy will ultimately be approved; the FDA is not bound by decision of its advisory committee or any of its recommendations and there are a number of
instances where the FDA has voted against the recommendations of advisory committees; potential safety and other complications from neffy; the labelling for neffy, if approved; the scope, progress and expansion of developing and commercializing
neffy; the size and growth of the market therefor and the rate and degree of market acceptance thereof vis- -vis intramuscular injectable products; the ARS Pharma's ability to protect its intellectual property position; the impact of
health epidemics or pandemics on ARS Pharma's business and the actions ARS Pharma may take in response thereto; 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 the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with
the Securities and Exchange Commission ("SEC") on May 15, 2023. This and other documents ARS files with the SEC can also be accessed on ARS's web page at ir.ars-pharma.com by clicking on the link
"Financials & Filings." The forward-looking statements included in this presentation are made only as of the date hereof. ARS Pharma does not assume any obligation and does not intend to update these forward-looking statements,
except as required by law.
Potential to Transform the Treatment of
Type I Allergic Reactions neffy : first "no needle, no injection" solution for Type I allergic reactions to address an unmet market need Registration program demonstrates comparable PK and PD, without risk of needle-related safety
concerns, fear and hesitation Rapid and statistically significant response on PD surrogates for efficacy (SBP, HR) observed even 1 minute after dosing with neffy vs. injection Significant opportunity to disrupt current epinephrine injectables market
Mid-2023 PDUFA anticipated; FDA AdCom supports favorable benefit-risk assessment of neffy Potential multi-billion-dollar market driven by HCP and consumer preference and adoption NCE-like IP exclusivity potential until at least 2038 $264.5
million in cash and securities as of 3/31/2023
Proven leadership team with track
record developing and commercializing intranasal and consumer-driven medicines Richard Lowenthal, M.S. Chief Executive Officer, Co-Founder Led FDA approvals for multiple nasal spray products 25+ years of experience Robert Bell, Ph.D. Chief
Scientific Officer, Co-Founder 30+ years of senior R&D leadership experience including Barr and Somerset Sarina Tanimoto, M.D. Chief Medical Officer, Co-Founder Led FDA approvals for multiple nasal spray products 20+ years of experience Eric
Karas Chief Commercial Officer Led Narcan commercial ops at Emergent/Adapt, and Auxilium specialty 25+ years of experience Harris Kaplan EVP, Commercial Strategy 40+ years of commercial strategy across more than 125 product launches Dan
Relovsky SVP, Marketing 30+ years of marketing, sales and operational experience across specialty and consumer markets Brian Dorsey Chief Operating Officer 25+ years of R&D experience as including multiple head of R&D roles including Pernix,
Apricus and Somaxon Kathy Scott Chief Financial Officer 30+ years of finance experience with multiple CFO roles including Neurana, Recros and Oncternal Justin Chakma Chief Business Officer 10+ years of M&A, licensing, financing and strategy
experience including Celgene, Receptos and Auspex Alex Fitzpatrick Chief Legal Officer 30+ years of legal experience with multiple GC roles including Evofem, Kyriba, Verenium, Blackbaud
Top-tier board of directors Pratik
Shah, Ph.D. Chairman of Board of Directors Executive Chairman at Design, Former Chairman of Synthorx (acq. $2.5B), Former CEO at Auspex (acq. $3.5B) Peter Kolchinsky, Ph.D. Managing Partner and Founder at RA Capital Rajeev Dadoo, Ph.D. Managing
Partner at SR One Richard Lowenthal, M.S. Chief Executive Officer, Co-Founder Led FDA approvals for multiple nasal spray products 25+ years of experience Brent Saunders Chairman at The Beauty Health Co., Former CEO of Allergan (acq. $63B), Actavis,
Forest Labs, and Bausch + Lomb (acq. $8.7B) Michael Kelly Former President, US Operations at Adapt (acq. $735M), CEO at Covis (acq. $1.2B), founder at Azur Jonathan Leff Partner at Deerfield Management Chairman of Deerfield Institute Philip
Schneider Former CFO at IDEC, former Board member at Arena (acq. $6.7B), Auspex (acq. $3.5B), GenProbe (acq. $3.7B) Laura Shawver, Ph.D. CEO at Capstan, former CEO at Silverback, Synthorx (acq. $2.5B) Peter Thompson, M.D. Private Equity Partner at
Orbimed Saqib Islam, J.D. CEO of Springworks, former CBO at Moderna and EVP at Alexion
Type I allergic reactions: a
life-threatening hypersensitivity reaction Carrillo-Martin et al. J Allergy Clin Immunol Pract (2020), BlueCross BlueShield of America. Childhood Allergies in America (2018) Images Reproduced with permission from Allergy & Anaphylaxis Australia
Caused by exposure to a specific allergen, most commonly food, venom, drugs ~25 to 40 million people in US with systemic Type I allergic reaction to allergens (e.g., 2+ organ systems involved) 10+ million people with other Type I allergy indications
(e.g. urticaria flares, asthma exacerbations) Significant co-morbidities and symptomatic impact on patient quality of life More than half a million1 ER visits each year due to systemic Type I allergic reactions, costing an average of $1600+ per
Epinephrine recognized as the only
first-line therapy by allergy society treatment guidelines1, but Epinephrine is effective, but significant device limitations exist Anaphylaxis - a 2020 practice parameter update, systematic review and Grading Recommendations,
Assessment, Development and Evaluation (GRADE) analysis Apprehension to dose due to needle Lack of portability Reluctance to use in public Safety concerns: lacerations, caregiver self-injection, blood vessel hits Lack of reliability Not user
friendly 7 fatalities and 35 hospitalizations reported due to failures
Early intervention with epinephrine is
critical in a Type I allergic reaction FIRST 15 MINUTES TYPE I SEVERE ALLERGIC REACTION ANTIGEN EXPOSURE 1. Emergency treatment of anaphylactic reactions: guidelines for healthcare providers. Resuscitation Council (UK); 2016, 2. JF Philips et al.
Allergy Asthma Proc (2011), 3. JT Fleming et al. J Allergy Clin Immunol Pract (2014), 4. E. Andrew et al. Prehospital Emergency Care (2018), 5. Data on file from ARS market research SERIOUS PATIENT DISCOMFORT HIGHER RISK OF HOSPITALIZATION AND
DISEASE PROGRESSION2,3,4 30 MINUTES ANAPHYLAXIS 15 TO 30 MINUTES LIKELIHOOD OF LIFE-THREATENING REACTION Sudden drop in blood pressure leads to anaphylactic shock and cardiovascular failure Airways narrow blocking breathing, leading to loss of
consciousness Possible death Time to respiratory arrest or shock1 FOOD: 30-35 minutes INSECT STINGS: 10-15 minutes DRUGS: <10 minutes Hypotension, dizziness, faintness Rhinitis, watery red eyes Rashes, itching (urticaria) Rapid
swelling (angioedema) including lips, tongue, throat Bronchospasm, difficulty breathing, wheezing Abdominal and chest pain, vomiting Up to 18 minutes average wait to dose epinephrine5 among the ~50% who have injection available and are willing to
inject themselves REACTION PROGRESSION
FAILURE OF TREATMENT 23 - 35%4 fail to
dose correctly Limitations of injection lead to hesitation and decreased or ineffective usage neffy may address these limitations to transform the treatment paradigm Rapid administration without a needle No risk of needle-related injuries;
lacerations2 or cardiotoxic blood vessel injections Less hesitation to dose NO NEEDLE NO INJECTION SMALL Fits in your pocket; can carry more than 1 ~10% of cases require multiple doses of epinephrine1 EASIER AND MORE CONSISTENT DOSING 0% critical
dosing errors in registration self-administration study Low 2 mg dose of epinephrine achieves comparable PK without overexposure risk RELIABLE 99.999% delivery of effective dose in reliability testing; no inhalation required Stability data up to 24
months, including at high temperature for up to 3 months DELAY IN TREATMENT ~40 - 60%2 of patients delay NO TREATMENT AVAILABLE ~50% of patients carry1 (<20% carry two) REFUSAL OF TREATMENT ~25% - 50%1, 3, 5 do not administer 3 4 2 1 neffy
SOLUTIONS PROBLEM Only 10% - 20% of Rx filled or used as indicated6 Warren et al. Ann Allergy Asthma Immunol (2018), Data on file from ARS market research, Brooks et al. Ann Allergy Asthma Immunol (2017), El Turki et al. Emerg Med J (2017), Asthma
and Allergy Foundation of America Patient Survey Report (2019), Company estimates based on prior references (1) through (5) and IQVIA data Demonstrated PK/PD comparable to injection with PD response observed 1 min after dosing 3 4 2 1
neffy Designed for Needle-free,
Approved injection products have a
range of PK profiles, but are all deemed efficacious (no known difference across products) 0.3 mg IM (needle & syringe) is considered to be the gold standard, and autoinjectors were approved based on literature support from 0.3 mg IM for
efficacy and safety1, 2 Autoinjectors are a variable mix of IV, SC or IM dosing depending on technique All approved products have indistinguishable clinical effect and time to observed clinical benefit All products approved without any PK or PD data
required Treatment Source N Mean Study Cmax (pg/mL) Median or Mean Study Tmax (min) Study Tmax Range (min) EpiPen 0.3 mg Literature and ARS 507 288 - 869 5 - 40 1 - 240 IM 0.3 mg Literature and ARS 381 209 - 489 30 to 60 3
- 360 Auvi-Q 0.3 mg Literature 67 486 20 5 - 60 Symjepi 0.3 mg ARS data 88 337 - 438 30 4 - 240 SC 0.3 mg ARS 36 246 45 4 - 180 Total Range 209 to 869 5 to 60 1 to 360
Differences in PK (including tmax -
time to max concentration) do not translate to any meaningful difference in efficacy among injection products Analysis of 12 studies with 100% autoinjector ( 80% EpiPen) or 100% IM-needle-and-syringe use in community or emergency room or
hospital setting, respectively1 Differences in PK profile across products do not impact efficacy based on need for repeat dosing to resolve symptoms Cases in emergency room or hospital settings are typically more severe or advanced (where IM is
administered) than those in a community setting, but still no difference in efficacy is observed with IM vs. auto-injector Autoinjector reactions n = 799a IM Needle-in-Syringe reactions n = 570 Treated Reactions Requiring Second Epinephrine Dose (%)
~90% resolution on first dose a. 79.6% of the autoinjector treated reactions are specifically identified occurring with EpiPen
Systolic blood pressure and heart
rate are surrogates for efficacy, and most important to clinicians given the high variability of PK Adrenergic Receptor Pharmacological Effect of Epinephrine Clinical Effect of Epinephrine 1 Increases systolic blood pressure Causes blood vessel
constriction Decreases mucosal edema Relieves hypotension and shock Relieves upper airway obstruction 1 Increases blood pressure and heart rate Relieves hypotension and shock 2 Relaxation of bronchial smooth muscles Vasodilation in
skeletal vasculature Inhibits inflammatory mediator release from mast cells and basophils Increase in bronchial airflow Increases blood flow to skeletal muscle Reverses pathological histamine cascade PD responses show that neffy activates the
receptors that reverse anaphylaxis symptoms
neffy clinical program under NDA
review; FDA Advisory Committee voted that data supports favorable benefit-risk for allergic reactions (type I) Target PDUFA action date anticipated in mid-2023 FDA Advisory Committee / PADAC (May 11) voted 16:6 and 17:5 in favor of adults and
children <18 years of age and 30 kg that available data support a favorable benefit-risk assessment FDA confirmed three primary registration studies required for neffy approval EPI-17: Self-administration in Type I allergy patients (n=42)
EPI-15: Single dose and twice dosing in healthy volunteers (n=42) EPI-16: Nasal challenge in allergic rhinitis patients (n=36) neffy meets the endpoints discussed with FDA in completed clinical studies* Criteria is comparability to epinephrine
injection products: PD (SBP, HR approved products) and PK bracketed (exposures IM/SC for efficacy, < EpiPen for safety) IM needle & syringe is the gold standard and reference-listed drug Primary outcomes for all trials: PD (SBP, HR)
and PK (bioavailability) EPI-10 pediatric trial interim data included in NDA submission, FDA requested Data in subjects aged 4 to 18 (single-arm, non-comparative expected in 2022) to support pediatric labeling
Notable PD response observed with
neffy even at 1 minute after dosing, and comparable to or significantly higher than 0.3 mg IM injection Mean Change HR (BPM) Time (Minutes) Heart Rate Response Mean Change SBP (mmHg) Time (Minutes) Systolic Blood Pressure Response First PD 1 minute
First PD 1 minute neffy 2 mg IM 0.3 mg neffy 2 mg IM 0.3 mg ** Significance level: ** p <0.01, *** p <0.001 **** p <0.0001 **** **** *** ** **** **** **** Epi 53 pg/mL (2 min PK) Epi 53 pg/mL (2 min PK)
PD response is comparable to EpiPen
on single dose, with significantly higher response on second dose neffy 2 mg n = 78 EpiPen 0.3 mg n = 77 IM 0.3 mg n = 178 p < 0.0001 p = 0.0787 (ns) Emax (mmHg) 2 mg x 2 neffy (L/R) n = 39 0.3 mg EpiPen n = 78 0.3 mg IM n = 70 p = 0.947 (ns) p =
0.01 Emax (mmHg) p < 0.0001 2 mg x 2 neffy (R/R) n = 39 Single Dose SBP Response Twice Dose SBP Response
neffy meets PK endpoints agreed with
FDA in 3 primary studies* Integrated PK data summary for neffy and comparators Plasma Epinephrine Cmax (pg/mL) Median tmax (minutes) Mean Early Partial AUCs 0.3 mg IM (n = 178) 2 mg neffy HCP-admin (n = 78) 0.3 mg EpiPen (n = 77) 0.5 mg IM (n = 123)
2 mg neffy Self-admin (n = 42) 10 45 45 20.5 30 Treatment pAUC (0-20) pAUC (0-45) 0.3 mg IM (n=178) 2,090 (86) 6,290 (61) 2 mg neffy (n=78) HCP-admin 3,610 (84) 11,000 (76) 2 mg neffy (n=42) Self-admin 3,128 (79) 11,006 (63) 0.3 mg EpiPen (n=77)
5,640 (73) 12,000 (53) Treatment AUC0-t 0.5 mg IM (n=123) 2 mg neffy (n=36) 0.3 mg IM (n=178) 43,700 (34) 37,700 (64) 27,900 (39) Mean early partial AUCs bracketed by approved products Overall mean AUC(0-t) bracketed by approved products 0.3 mg IM
(n = 178) 2 mg neffy HCP-admin (n = 78) 0.3 mg EpiPen (n = 77) 0.5 mg IM (n = 123) 2 mg neffy Self-admin (n = 42) Lowest Cmax of approved product Highest Cmax of approved product Lowest Tmax of approved product Highest Tmax of approved product Cmax
bracketed by approved products Tmax bracketed by approved products Mean values denoted by bolded numbers All data from ARS clinical studies % CV shown in parentheses in tables above
neffy PK is Bracketed by EpiPen
Studies (high variability) Treatment Study Reference N Mean Study Cmax (pg/mL) Median Study Tmax (min) EpiPen (0.3 mg) AQST-109 EPIPHAST II Results (2022) 22 869 22 ARS EPI-JP01 Data (2020) 30 676 10 ARS EPI-15 (2022) 35 612 8 Tal et al. EAACI
(2022) 12 550 9 ARS EPI-11b Data (2021) 9 537 6 Edwards et al. NDA #201739 (2012) 67 520 10.2 Chen et al. AAAAI (2019) 11 511 5 ARS EPI-12 Data (2021) 36 493 8 ARS EPI-13 Data (2022) 39 490 6 neffy (2.0 mg) ARS EPI-16 data (2022) 36 491 20 ARS
integrated analysis (2022) EPI-15/16 78 485 20.5 ARS EPI-15 data (2022) 42 481 30 ARS EPI-17 data (2022) 42 421 30 EpiPen (0.3 mg) Worm et al. Clin Transl Allergy (2020) 12 390 to 530 9 to 30 Turner et al. Clin Exp Allergy (2021) 37 386 40 Amphastar
US2021/030502 (2021) 56 364 - 458 7-15 ARS EPI-07 Data (2019) 35 375 24 Dworaczyk et al. AAAAI (2020) 55 308 to 440 10-16 Oppenheimer et al. AAAAI (2022) 10 341 22 ARS EPI-01 Data (2018) 12 333 20 Aquestive R&D Day (2021) 9 300 104 Dworaczyk et
al. AAAAI (2021) 25 288 10
Dosing neffy immediately following
nasal allergen challenge (worst-case conditions) shows no clinically meaningful impact on PK or PD ~2 to 11% of patients experience nasal symptoms during an allergic reaction1 Congestion accelerates absorption, and rhinorrhea accelerates drainage
neffy during moderate to severe congestion and rhinorrhea following nasal allergen challenge in allergic rhinitis patients has significantly higher exposures than IM during early time points when treatment response is observed If no response is