UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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| Item 7.01. | Regulation FD Disclosure |
On December 6, 2022, ARS Pharmaceuticals, Inc. (the “Company”) updated its corporate slide presentation for use in meetings with investors, analysts and others. The presentation is available through the Company’s website and a copy is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein.
The information under this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.
| Item 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit |
Description | |
| 99.1 | Company Presentation dated December 6, 2022 | |
| 104 | Cover Page of Interactive Data File (embedded within the Inline XBRL document). | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: December 6, 2022 | ARS Pharmaceuticals, Inc. | |||||
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By: | /s/ Richard Lowenthal, M.S., MSEL | ||||
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Name: | Richard Lowenthal, M.S., MSEL | ||||
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Title: | President and Chief Executive Officer | ||||
THE FIRST NO-NEEDLE, NO-INJECTION SOLUTION for Type I Allergic Reactions December 6, 2022 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; ARS Pharmaceuticals Inc.’s (“ARS Pharma”) plans to submit an sNDA to the FDA for neffy, the timing thereof and optimism regarding the support therefor; 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; 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-à-vis intramuscular injectable products; the ARS Pharma’s ability to protect its intellectual property position; the impact of health epidemics, including the COVID-19 pandemic, 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” and elsewhere in ARS Pharma’s most recent filings with the U.S. Securities and Exchange Commission (“SEC”), including its Quarterly Report on Form 10-Q for the quarter ended September 30, 2022 and any subsequent reports on Form 10-K, Form 10-Q or Form 8-K filed with the SEC from time to time and 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. CONFIDENTIAL
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 Over ~$280 million in cash and securities
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, Sales & 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 Sources: (1) Carrillo-Martin et al. J Allergy Clin Immunol Pract (2020), (2) 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 visit2
Epinephrine recognized as the only first-line therapy by allergy society treatment guidelines1, but… Epinephrine is effective, but significant device limitations exist Sources: 1Anaphylaxis – 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 5 MINUTES TYPE I SEVERE ALLERGIC REACTION ANTIGEN EXPOSURE Sources: 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 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 CONSISENT DOSING 0% critical dosing errors in registration self-administration study Low dose of epinephrine achieves comparable PK without overexposure risk RELIABLE 99.999% delivery of effective dose in reliability testing; no inhalation required Same shelf-life as EpiPen, but also stable at high temperatures DELAY IN TREATMENT ~40 - 60%2 of patients delay NO TREATMENT AVAILABLE ~50% of patients carry1 REFUSAL OF TREATMENT ~25% - 50%1, 3, 5 do not administer 3 4 2 1 neffy SOLUTIONS PROBLEM 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. Emerg Med J (2017), (5) Asthma and Allergy Foundation of America Patient Survey Report (2019) Demonstrated PK and PD comparable to injection 3 4 2 1
neffy clinical program supports NDA filed and accepted by FDA NDA submission accepted by FDA in Q4 2022; Target PDUFA action date anticipated in mid-2023 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 (Cmax, tmax, early partial AUCs) is comparability to epinephrine injection products (bracketed by approved products) 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 Data in subjects aged 4 to 18 (single-arm, non-comparative expected in 2022) to support pediatric labeling *Pending review by the FDA
Approved injection products have a range of PK profiles, but are all deemed efficacious (no known difference across products) TREATMENT N Mean Study Cmax (pg/mL) Median or Mean Study Tmax (min) Study Tmax range (min) Epinephrine 0.3 mg IM (ARS Data) 181 244 – 339 45 4 – 360 Symjepi 0.3 mg (ARS Data) 36 438 30 4 – 90 EpiPen 0.3 mg (ARS Data) 113 375 – 753 6 – 24 2 – 154 EpiPen 0.3 mg (Literature) 296 308 – 649* 5 – 30 1 - 120 Auvi-Q 0.3 mg* (Literature) 67 486 20 5 – 60 Total Range 244 to 753 5 to 45 1 to 360 FDA stated neffy should be bracketed by PK of approved products 0.3 mg IM (needle & syringe) is the reference-listed drug (RLD) and considered to be the gold standard as 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: ~90% resolution on first dose within the first 5 to 15 minutes observed for both IM and autoinjectors in literature and practice All products approved based on only PK, despite significant PK differences – (i.e. not bioequivalent to each other) PD is supportive *Baseline corrected
neffy meets FDA-confirmed endpoints 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 *Pending review by the FDA % CV shown in parentheses in tables above
neffy well-tolerated across 500+ individuals dosed in clinical program Well-tolerated at all single-doses (0.5 mg to 2 mg) and repeat doses up to 4 mg within 10 minutes 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 No risk of needle-related injuries or blood vessel injections Event Frequency EpiPen Symjepi Risk of blood vessel injection during self-administration that could lead to adverse events All data from ARS clinical studies
neffy market exclusivity potential until at least 2038 Issued composition of matter patent (US10,576,156) on Intravail® + epinephrine provides foundational exclusivity blocking any generic products. Method of treatment patents (US11,173,209; US11,191,838) block other alkyl glycosides. Issued method of treatment patent (US10,682,414) blocks any intranasal epinephrine product using a different technology using a low dose (<2.5 mg) PCT patent granted in Europe (EP19751807), UK (GB2583051), Japan (JP6941224), Australia (AUS2019217643) and Korea (10-2375232) with same composition of matter and method of treatment claims as the US Extensive studies in the lab and clinic completed to develop a proprietary product with expected NCE-like exclusivity EXPECTED LAUNCH FIRST PATENT EXPIRATION (without patent term extension) ADDITIONAL PROTECTION 2022 2023 2038
Commercial Opportunity and Strategy
MULTIPLE LEVERS OF CURRENT MARKET GROWTH Significant existing US market opportunity for neffy penetration CURRENT ~$1 BILLION1 ANNUAL EPINEPHRINE MARKET IS THE IMMEDIATE OPPORTUNITY 1 SEC filings, IQVIA data and ARS payer research data on file 2 ARS market research data on file (n = 75 physicians, n = 150 patients), 3 IQVIA extended unit data ~3.3M Patients have injectable today (~10 million devices)3 ~16M diagnosed patients with severe type I allergic reactions (claims data) Consistent market growth +5% y/y in the last ~15 years Promotional responsiveness +31% historic lift from Mylan No meaningful promotion today More devices per patient Potential for twice as many neffy devices annually vs. injectables ~2.5M Former patients discontinued or did not fill Rx in last 3 years Up to 40M total type I allergy patients (epidemiology)
Physicians supportive of adopting neffy into practice Would prescribe neffy if their patients asked for it 100% 10 = MAJOR ADVANCE / 1 = NOT AN ADVANCE AT ALL 8.5 out of 10 rating viewed as a major advance in therapy n = 75 Physicians No difference in uptake of neffy by physician specialty
neffy addresses the unmet need and is better aligned with what healthcare providers, patients and parents want 65% to 72% OF THE TIME, PEOPLE WHO USE AN OTC WOULD USE neffy FIRST 69% OF PEOPLE WOULD USE neffy SOONER THAN CURRENT AUTOINJECTOR OF NON-FILLING PATIENTS STATED THEY WOULD ASK THEIR PHYSICIAN ABOUT neffy RX 75% n = 150 Current Users OF PATIENTS EXPECTED TO SWITCH TO neffy ~80% n = 100 Non-fillers
Caregivers are enthusiastic about neffy and its benefits Source: ARS Consumer Quant Research, 2022 Q29/68. How long would you estimate it took from the time the symptoms started before you used your device? Q75. The last time you/your child had an allergic reaction, you said you used your/your child’s device within XX minutes. If you had had this epinephrine nasal spray device instead of your/your child’s current device, how quickly do you believe you would have used it after your/your child’s initial symptoms of the reaction? Q76. On a scale of 1-10, how much impact would each of the following have to motivate you to use this epinephrine nasal spray device sooner than your/your child’s current device? Q77. On a scale of 1-10, how likely would each of the following be if you were to have this new epinephrine nasal spray device instead of your/your child’s current device? This is fantastic. Much easier than jabbing the thigh. – Father We are talking about someone’s life and lifestyle here. Great improvement. – Mother I don’t have a co-pay, but I’d get this for my daughters even if I have to pay $50. – Mother I want this. Is it available yet? Let me know when it is, I will literally call the doctor from my car. – Mother “ “ “ “
Propensity of Current SAR Patients Prescribed a Needle Injector CONFIDENTIAL 50% Don’t Keep On Hand2 42% Don’t Use Properly1 By Addressing Needle Injector Deficiencies neffy can Become the Standard in Treatment 60% Delay Treatment3 86% Would Keep On Hand3 neffy Patient Research Shows… 100% Used Device Correctly4 (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 45% Faster Treatment Time3 47% More Likely to Fill Rx3
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 “This is a game-changer; it really addresses the unmet needs we currently have in this space, specifically the safety and tolerability issues.” – Payer “If this is priced properly, this could be a ‘state-of-the-art therapy’ for patients.” – PBM “Nasal delivery will overcome some negative perceived factors of an injection.” – Payer “There is no value in delaying access to a product like this and nothing to prior authorize (PA). We can’t PA if the patient needs it.” – PBM
Commercial strategy and imperatives Ensure broad and rapid neffy coverage as well as affordable access for patients Change HCP habits and switch prescribing from needle to neffy Drive neffy awareness and new patient growth (into and back into) the market 3 1 2 From needle to neffy: Convert the existing market Bring back patients that are lapsed Bring in patients who should be carrying epinephrine now, but do not carry
CONFIDENTIAL Drive neffy awareness and new patient growth (into and back into) the market Ensure broad and rapid neffy coverage as well as affordable access for patients Strategic Imperatives and CSFs: From Needle to neffy Change HCP habits and switch prescribing from needle to neffy 1 2 3 Payers recognize the value proposition of neffy Patients can access neffy Prescriptions are filled seamlessly HCP awareness at launch Confidence in neffy and intranasal delivery Allergists and KOL endorsement Consumer awareness of neffy Patient understanding of effectiveness and safety Patients will ask for neffy proactively CRITICAL SUCCESS FACTORS STRATEGIC IMPERATIVES
Integrated HCP Promotional Approach*: Drive Awareness and Reach 45%+ Current Epinephrine Prescribers within Initial Launch Period Specialty Salesforce CSO Representatives Virtual Salesforce Non-Personal Promotion FTEs ~125 FTEs 40 - 50 15 N/A HCP Reach Greater than 7,500 ~3,000 Top 2,500 Top 12,000 *Opportunistic expansion over time of sales force based on performance to maximize HCP reach with optimization HCP promotion will be supported by DTC promotion to enhance eventual effective reach into epinephrine Rx market
neffy is positioned potentially to transform the treatment of serious allergic reactions Less Hesitation to Dose Effective Compact Safe Easy to Use No Needle PK superior to IM (Reference listed drug & gold standard) offers therapeutic exposures and makes it easy to switch No meaningful side effects No needle-related injuries possible No serious safety risks associated with injection devices (needle) No blood vessel injections, no lacerations, no bone injections No needle, no fear, no wait Easier to use and more reliable delivery than with autoinjectors (less chance of failed dosing) Always available with child, parent and caregiver 100% of adults (N=105) successfully dosed in human factors studies