THE FIRST NO-NEEDLE,NO-INJECTION SOLUTION
for Type I 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-à-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.comby 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-dollarmarket driven by HCP and consumer preference and adoption
- NCE-likeIP 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
Richard Lowenthal, M.S.
Chief Executive Officer, Co-Founder Led FDA approvals for
multiple nasal spray products 25+ years of experience
Harris Kaplan
EVP, Commercial Strategy
40+ years of commercial strategy across more than 125 product launches
Sarina Tanimoto, M.D.
Chief Medical Officer, Co-Founder Led FDA approvals for
multiple nasal spray products 20+ years of experience
Dan Relovsky
SVP, Marketing
30+ years of marketing, sales and operational experience across specialty and consumer markets
Eric Karas
Chief Commercial Officer
Led Narcan® commercial ops at Emergent/Adapt, and Auxilium specialty 25+ years of experience
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 | 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
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)
Richard Lowenthal, M.S.
Chief Executive Officer, Co-Founder
Led FDA approvals for
multiple nasal spray products 25+ years of experience
Laura Shawver, Ph.D.
CEO at Capstan, former CEO at
Silverback, Synthorx (acq. $2.5B)
5
Peter Kolchinsky, Ph.D.
Managing Partner and Founder
at RA Capital
Brent Saunders
Chairman at The Beauty Health Co., Former CEO of Allergan (acq. $63B), Actavis, Forest Labs, and Bausch + Lomb (acq. $8.7B)
Jonathan Leff
Partner at Deerfield Management Chairman of Deerfield Institute
Peter Thompson, M.D.
Private Equity Partner at Orbimed
Rajeev Dadoo, Ph.D.
Managing Partner at SR One
Michael Kelly
Former President, US Operations at Adapt (acq. $735M), CEO at Covis (acq. $1.2B), founder at Azur
Philip Schneider
Former CFO at IDEC, former Board member at Arena (acq. $6.7B), Auspex (acq. $3.5B), GenProbe (acq. $3.7B)
Saqib Islam, J.D.
CEO of Springworks, former CBO at Moderna and EVP at Alexion
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Disclaimer
ARS Pharmaceuticals Inc. published this content on 14 February 2023 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 March 2023 12:03:02 UTC.