Slide 1: The First No-Needle, No-Injection Solution for Type I Allergic Reactions
THE FIRST NO-NEEDLE, NO-INJECTION SOLUTION for Type I Allergic Reactions Q1 2023 Exhibit 99.1
Slide 2: Forward looking statements
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 th
Slide 3: Potential to Transform the Treatment of Type I Allergic Reactions
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
Slide 4: Proven leadership team with track record developing and commercializing intranasal medicines
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-Fou
Slide 5: Top-tier board of directors
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 Ri
Slide 6: Type I allergic reactions: a life-threatening hypersensitivity reaction
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
Slide 7: Epinephrine is effective, but significant device limitations exist
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
Slide 8: Early intervention with epinephrine is critical in a Type I allergic reaction
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
Slide 9: neffy may address limitations of injection to transform the treatment paradigm
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 cardi
Slide 10: Approved injection products have a range of PK profiles, but are all deemed efficacious
Approved injection products have a range of PK profiles, but are all deemed efficacious (no known difference across products) 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 auto
Slide 11: neffy clinical program supports NDA filed and accepted by FDA
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:
Slide 12: neffy meets FDA-confirmed endpoints in primary studies
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-ad
Slide 13: neffy well-tolerated across 600+ individuals dosed in clinical program
neffy well-tolerated across 600+ 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
Slide 14: neffy market exclusivity potential until at least 2038
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
Slide 15: Commercial Opportunity and Strategy
Commercial Opportunity and Strategy
Slide 16: Multiple levers of current market growth
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
Slide 17: Physicians supportive of adopting neffy into practice
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
Slide 18: neffy addresses the unmet need and is better aligned with what HCPs, patients and parents want
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 PHYSIC
Slide 19: Caregivers are enthusiastic about neffy and its benefits
Caregivers are enthusiastic about neffy and its benefits Source: ARS Consumer Quant Research, 2022 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 daught
Slide 20: By addressing needle injector deficiencies neffy can become the standard in treatment
Propensity of Current SAR Patients Prescribed a Needle Injector 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
Slide 21: Payer research supports positive reimbursement environment
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 treatm
Slide 22: Commercial strategy and imperatives
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 exist
Slide 23: Strategic imperatives and critical success factors
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 v
Slide 24: Integrated HCP promotion to drive awareness and reach
Integrated HCP Promotion to Drive Awareness and Reach with Current Epinephrine Prescribers Representing >40% of Prescriptions* Specialty Salesforce Virtual Salesforce Non-Personal Promotion FTEs ~125 FTEs 40 - 50 Top 50,000 Decile 5 to 10 HCP Reach ~ 15,000 HCPs ~3,000 Top 12,000 HCP promotion will
Slide 25: neffy is positioned potentially to transform the treatment of serious allergic reactions
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
Slide 26: Many patients/caregivers do not administer treatment or delay use during reaction
Many patients/caregivers do not administer treatment or delay use during reaction Did not fill or re-fill their Rx in last 3 years1 ~50% do not carry2 Patients (millions) Rx’ed Epinephrine in Last 3 Years1 40-60% delay 9 to 18 min6 25-50% refuse to inject and go to ER2-5 23-35% fail to dose correctl