Full Press Release Details
Allergic Reactions Q1 2023 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; 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 - Risks
Related to ARS Pharma" heading of the company's definitive proxy statement on DEFM14A filed with the Securities and Exchange Commission on October 6, 2022, available at www.sec.gov. These documents can be accessed on ARS Pharma's
web page at www.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. 2
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 Significant opportunity to disrupt current epinephrine injectables market NDA accepted by FDA; mid-2023 PDUFA date anticipated Potential multi-billion-dollar market driven by HCP and consumer preference
and adoption NCE-like IP exclusivity potential until at least 2038 ~$275 million in cash and securities as of 12/31/2022 3
Proven leadership team with track record developing and commercializing
intranasal and consumer-driven medicines Sarina Tanimoto, M.D. Richard Lowenthal, M.S. Eric Karas Chief Medical Officer, Co-Founder Chief Executive Officer, Co-Founder Chief Commercial Officer Led FDA approvals for Led FDA approvals for Led
Narcan commercial ops at multiple nasal spray products multiple nasal spray products Emergent/Adapt, and Auxilium specialty 20+ years of experience 25+ years of experience 25+ years of experience Harris Kaplan Dan Relovsky Brian Dorsey EVP,
Commercial Strategy SVP, Marketing Chief Operating Officer 40+ years of commercial strategy 30+ years of marketing, sales and 25+ years of R&D experience as across more than 125 product operational experience across including multiple head of
R&D roles launches specialty and consumer markets including Pernix, Apricus and Somaxon Kathy Scott Alex Fitzpatrick Justin Chakma Robert Bell, Ph.D. Chief Financial Officer Chief Legal Officer Chief Business Officer Chief Scientific Officer,
30+ years of finance 30+ years of legal 10+ years of M&A, Co-Founder experience with multiple experience with multiple licensing, financing and 30+ years of senior R&D CFO roles including GC roles including strategy experience leadership
experience Neurana, Recros and Evofem, Kyriba, including Celgene, including Barr and Oncternal Verenium, Blackbaud Receptos and Auspex Somerset 4
Top-tier board of directors Peter Kolchinsky, Ph.D. Rajeev Dadoo, Ph.D.
Managing Partner and Founder Managing Partner at SR One at RA Capital Pratik Shah, Ph.D. Chairman of Board of Directors Executive Chairman at Design, Former Chairman of Synthorx (acq. $2.5B), Former CEO at Brent Saunders Michael Kelly Auspex (acq.
$3.5B) Chairman at The Beauty Health Co., Former President, US Operations at Former CEO of Allergan (acq. $63B), Adapt (acq. $735M), CEO at Covis Actavis, Forest Labs, and Bausch + (acq. $1.2B), founder at Azur Lomb (acq. $8.7B) Richard Lowenthal,
M.S. Chief Executive Officer, Co-Founder Led FDA approvals for multiple nasal spray products Jonathan Leff Philip Schneider 25+ years of experience Partner at Deerfield Management Former CFO at IDEC, former Board Chairman of Deerfield Institute
member at Arena (acq. $6.7B), Auspex (acq. $3.5B), GenProbe (acq. $3.7B) Saqib Islam, J.D. Peter Thompson, M.D. Laura Shawver, Ph.D. CEO of Springworks, former CBO at Private Equity Partner at Orbimed CEO at Capstan, former CEO at Moderna and EVP at
Alexion Silverback, Synthorx (acq. $2.5B) 5
Type I allergic reactions: a life-threatening hypersensitivity reaction
Caused by exposure to a ~25 to 40 million people in US specific allergen, with systemic Type I allergic most commonly food, reaction to allergens venom, drugs (e.g., 2+ organ systems involved) 10+ million people with other Type I allergy indications
(e.g. urticaria flares, asthma exacerbations) 1 Significant More than half a million ER co-morbidities and visits each year due to systemic symptomatic impact Type I allergic reactions, costing 2 on patient quality of life an average of $1600+ per
visit Sources: (1) Carrillo-Martin et al. J Allergy Clin Immunol Pract (2020), (2) BlueCross BlueShield of America. Childhood Allergies in America (2018) 6 Images Reproduced with permission from Allergy & Anaphylaxis Australia
Epinephrine is effective, but significant device limitations exist
Epinephrine recognized as the only first-line therapy by 1 allergy society treatment guidelines , but Safety concerns: lacerations, Apprehension to dose due to caregiver self-injection, blood needle vessel hits Lack of portability Lack of
reliability Reluctance to use in public Not user friendly 1 Sources: Anaphylaxis - a 2020 practice parameter update, systematic review and Grading Recommendations, Assessment, Development and Evaluation (GRADE) analysis 7
Early intervention with epinephrine is critical in a Type I allergic
reaction REACTION 2,3,4 SERIOUS PATIENT DISCOMFORT HIGHER RISK OF HOSPITALIZATION AND DISEASE PROGRESSION PROGRESSION 5 MINUTES 15 MINUTES 30 MINUTES TYPE I SEVERE LIKELIHOOD OF ANAPHYLAXIS ALLERGIC REACTION LIFE-THREATENING REACTION ANTIGEN
EXPOSURE Hypotension, dizziness, Time to respiratory arrest or Sudden drop in blood 1 faintness shock pressure leads to anaphylactic shock and Rhinitis, watery red eyes FOOD: 30-35 minutes cardiovascular failure
Rashes, itching (urticaria) INSECT STINGS: 10-15 Airways narrow blocking minutes Rapid swelling (angioedema) breathing, leading to loss including lips, tongue, throat DRUGS: <10 minutes of
consciousness Bronchospasm, difficulty Possible death breathing, wheezing Abdominal and chest pain, vomiting 5 Up to 18 minutes average wait to dose epinephrine among the ~50% who have injection available and are willing to
inject themselves 1 2 3 Sources: Emergency treatment of anaphylactic reactions: guidelines for healthcare providers. Resuscitation Council (UK); 2016, JF Philips et al. Allergy Asthma Proc (2011), JT 8 4 5 Fleming et al. J Allergy Clin Immunol Pract
(2014), E. Andrew et al. Prehospital Emergency Care (2018), Data on file from ARS market research
Limitations of injection lead to hesitation and decreased or ineffective
usage neffy may address these limitations to transform the treatment paradigm 1 2 3 4 PROBLEM NO TREATMENT REFUSAL OF FAILURE OF DELAY IN Only 10% - AVAILABLE TREATMENT TREATMENT TREATMENT 20% of Rx 1, 3, 5 2 4 ~50% of ~25% - 50% ~40 - 60% of 23 -
35% fail to filled or used 1 patients carry do not administer patients delay dose correctly 6 as indicated 1 2 3 4 neffy NO NEEDLE EASIER AND MORE RELIABLE SMALL SOLUTIONS NO INJECTION CONSISTENT DOSING 99.999% delivery of effective
Fits in your pocket; dose in reliability testing; Rapid administration 0% critical dosing errors can carry more than 1 no inhalation required without a needle in registration ~10% of cases self-administration study
Same shelf-life as EpiPen, but No risk of needle-related require multiple 2 also stable at high temperatures injuries; lacerations or Low 2 mg dose of doses of 1 cardiotoxic blood vessel epinephrine achieves epinephrine
injections comparable PK without overexposure risk Less hesitation to dose Demonstrated PK and PD comparable to injection Sources: (1) Warren et al. Ann Allergy Asthma Immunol (2018), (2) Data on file from ARS market research, (3) Brooks et
al. Ann Allergy Asthma Immunol (2017), (4) El Turki et al. 9 Emerg Med J (2017), (5) Asthma and Allergy Foundation of America Patient Survey Report (2019), (6) Company estimates based on prior references (1) through (5) and IQVIA data
Approved injection products have a range of PK profiles, but are all
deemed efficacious (no known difference across products) Median or Study FDA stated neffy should be Mean Study Mean T max TREATMENT Source N C bracketed by PK of approved products max Study T range (pg/mL) max (min) (min) 0.3 mg IM
(needle & syringe) is the reference- Literature 200 209 - 489 30 to 60 3 - 120 Epinephrine listed drug (RLD) and considered to be the gold 0.3 mg IM standard as autoinjectors are a variable mix of ARS 181 244 - 339 45 4 -
360 IV, SC or IM dosing depending on technique Symjepi 0.3 mg ARS 88 337 - 438 22 to 30 4 - 240 All approved products have indistinguishable clinical effect and time to observed clinical Auvi-Q 0.3 mg* Literature 67 486 20 5
- 60 benefit: ~90% resolution on first dose within the first 5 to 15 minutes observed for both IM and Literature 311 288 - 869 5 - 40 1 - 120 autoinjectors in literature and practice EpiPen 0.3 mg ARS 196 333 - 753 6
- 24 2 - 240 All products approved based on only PK, despite significant PK differences - (i.e. not Total Range 209 to 869 5 to 60 1 to 360 bioequivalent to each other) PD is supportive *Baseline corrected
neffy clinical program supports NDA filed and accepted by FDA FDA
confirmed three primary registration studies required for neffy approval EPI-15: Single dose and twice EPI-17: Self-administration in EPI-16: Nasal challenge in dosing in healthy volunteers (n=42) allergic rhinitis patients (n=36) Type I allergy
patients (n=42) IM needle & syringe is the gold standard and reference-listed drug Primary outcomes for all trials: PK (bioavailability) and PD (SBP, HR) EPI-10 pediatric trial interim data included in NDA submission, FDA requested neffy meets
the endpoints discussed with FDA in completed clinical studies* Criteria (C , t , early partial AUCs) is comparability to epinephrine injection products max max (bracketed by approved products) NDA submission accepted by FDA in Q4 2022; Target PDUFA
action date anticipated in mid-2023 Data in subjects aged 4 to 18 (single-arm, non-comparative expected in 2022) to support pediatric labeling 11 *Pending review by the FDA
neffy meets FDA-confirmed endpoints in 3 primary studies* Integrated PK
data summary for neffy and comparators Plasma Epinephrine C (pg/mL) Median t (minutes) Mean Early Partial AUCs max max 100 Mean early partial AUCs bracketed by approved products Cmax bracketed Tmax bracketed by approved pAUC pAUC by approved
Treatment products (0-20) (0-45) products 75 Mean values 1000 0.3 mg IM (n=178) 2,090 (86) 6,290 (61) denoted by bolded numbers 2 mg neffy (n=78) 3,610 (84) 11,000 (76) HCP-admin 2 mg neffy (n=42) 3,128 (79) 11,006 (63) Self-admin 50 Highest Tmax
Highest Cmax 581 45 0.3 mg EpiPen (n=77) 5,640 (73) 12,000 (53) of approved of approved 45 product 500 product 485 Overall mean AUC(0-t) 421 399 30 bracketed by approved products 25 Lowest Cmax 277 20.5 of approved Treatment AUC 0-t Lowest Tmax
product of approved 0.5 mg IM (n=123) 43,700 (34) 10 product 2 mg neffy (n=36) 37,700 (64) 0 0 0.3 mg 0.5 mg 2 mg 2 mg 0.3 mg 0.3 mg 0.5 mg 2 mg 2 mg 0.3 mg 0.3 mg IM (n=178) 27,900 (39) EpiPen IM neffy neffy IM EpiPen IM neffy neffy IM % CV shown
in parentheses in tables above (n = 77) (n = 123) Self-admin HCP-admin (n = 178) (n = 77) (n = 123) Self-admin HCP-admin (n = 178) (n = 42) (n = 78) (n = 42) (n = 78) All data from ARS clinical studies 12 *Pending review by the FDA
neffy well-tolerated across 600+ individuals dosed in clinical program
Risk of blood vessel injection during self- administration that could lead to adverse events Well-tolerated at all single-doses (0.5 mg to 2 mg) and repeat doses up to 4 mg within 10 minutes 13.8% Mostly grade 1 events and comparable
to injection products Low Pain Scores: recorded by VAS (100mm scale) with mean scores between 5 and 8 out of a score of 100 across studies No irritation based on formal scoring in all studies No serious treatment-related
adverse events 2% No risk of needle-related injuries or blood vessel 0% injections Symjepi EpiPen All data from ARS clinical studies 13 Event Frequency
neffy market exclusivity potential until at least 2038
Issued composition of matter patent (US10,576,156) on Intravail + epinephrine Extensive studies in provides foundational exclusivity blocking any generic products. Method of treatment patents (US11,173,209; US11,191,838) block other alkyl
glycosides. the lab and clinic completed to develop Issued method of treatment patent (US10,682,414) blocks any intranasal a proprietary product epinephrine product using a different technology using a low dose (<2.5 mg) with expected
NCE- PCT patent granted in Europe (EP19751807), UK (GB2583051), Japan like exclusivity (JP6941224), Canada (3088909), Australia (AUS2019217643), Korea (10- 2375232), China (2019800010042), with same claims as the US 2023 2038 EXPECTED FIRST
PATENT ADDITIONAL LAUNCH EXPIRATION PROTECTION (without patent term extension) 14
Commercial Opportunity and Strategy 15
Significant existing US market opportunity for neffy penetration 1
CURRENT ~$1 BILLION ANNUAL EPINEPHRINE MARKET IS THE IMMEDIATE OPPORTUNITY MULTIPLE LEVERS OF CURRENT MARKET GROWTH ~16M Consistent market growth diagnosed and HCP- +5% y/y in the last ~15 years managed patients with severe type I allergic
Promotional responsiveness reactions (claims data) Up to 40M +31% historic lift from Mylan total type I allergy No meaningful promotion today patients (epidemiology) ~3.3M More devices per patient ~2.5M Patients have Former patients Potential for
twice as many neffy injectable today discontinued or devices annually vs. injectables (~10 million did not fill Rx in 3 devices) last 3 years 1 SEC filings, IQVIA data and ARS payer research data on file 16 2 3 ARS market research data on file (n =
75 physicians, n = 150 patients), IQVIA extended unit data
Physicians supportive of adopting neffy into practice 8.5 out of 10
rating viewed as a major advance in therapy 10 = MAJOR ADVANCE / 1 = NOT AN ADVANCE AT ALL n = 75 Physicians Would prescribe neffy 100% if their patients asked for it No difference in uptake of neffy by physician specialty 17
neffy addresses the unmet need and is better aligned with what
healthcare providers, patients and parents want OF PATIENTS EXPECTED TO ~80% SWITCH TO neffy n = 150 Current Users OF NON-FILLING PATIENTS STATED THEY WOULD ASK THEIR 75% PHYSICIAN ABOUT neffy RX n = 100 Non-fillers 65% to 72% 69% OF THE TIME, OF
PEOPLE PEOPLE WHO WOULD USE neffy SOONER THAN CURRENT USE AN OTC WOULD USE neffy FIRST AUTOINJECTOR 18
Caregivers are enthusiastic about neffy and its benefits Time from
Onset of Symptoms to Epinephrine Administration Current neffy I want this. Is it 9.3 This is fantastic. available yet? Let me 8.8 Much easier than know when it is, I will 8.3 jabbing the thigh. literally call the doctor from my car. - Father
- Mother 5.1 4.9 4.7 We are talking about I don't have a co-pay, someone's life and but I'd get this for my lifestyle here. Great daughters even if I improvement. have to pay $50. Total Caregivers Patients - Mother
- Mother N=200 N=100 N=100 Source: ARS Consumer Quant Research, 2022 Guidelines recommend immediate treatment with epinephrine. Earlier administration is associated with improved clinical outcomes and decreased likelihood of hospitalizations.
19 Avg # of Minutes Before Using Device " " " "
By Addressing Needle Injector Deficiencies neffy can Become the
Standard in Treatment Propensity of Current SAR Patients neffy Patient Research Shows Prescribed a Needle Injector 45% 47% 1 Don't Use Properly 42% 3 3 More Likely to Fill Rx Faster Treatment Time 2 50% Don't Keep On Hand 100% 86%
4 3 Would Keep On Hand Used Device Correctly 3 Delay Treatment 60% (1) ARS Consumer Quant Research, 2022, (2) Warren et al. Ann Allergy Asthma Immunol (2018), (3) Data on file from ARS market research, (4) ARS human factors studies 20
Payer research supports positive reimbursement environment Key findings
from discussions with ~50 decision-makers within the major payers and PBMs: Category is generally not restricted, unlike biologics and orphan disease drugs with high WACs Payers view neffy as a valuable and differentiated treatment
option High likelihood of attaining favorable coverage (Tier 2 or 3) for ~80% of lives "Nasal delivery will overcome some negative perceived "This is a game-changer; it "There is no value in factors of an injection."