Pharvaris N.v. · NASDAQ:PHVS
Pharvaris — Investor Day (October 2024)
32 slides from Pharvaris's investor day presentation, Oct 23, 2024
Slide 1: Virtual Investor Day
Virtual Investor Day Pioneering science for patient choice October 23, 2024 1 ©2024
Slide 2: Disclaimer
Disclaimer This Presentation contains certain “forward‐looking statements” within the meaning of the federal securities laws that involve substantial risks and uncertainties. All statements contained in this Presentation that do not relate to matters of historical fact should be considered forward-l
Slide 3: Agenda
Agenda Michael Manning, M.D., Allergy, Asthma & Immunology, Scottsdale, AZ Raffi Tachdjian, M.D., MPH, David Geffen School of Medicine, UCLA Berndt Modig, CEO Pharvaris Peng Lu, M.D., Ph.D., CMO Pharvaris Wim Souverijns, Ph.D., CCO Pharvaris 3 ©2024 CONFIDENTIAL
Slide 4: Agenda
Agenda Michael Manning, M.D., Allergy, Asthma & Immunology, Scottsdale, AZ Raffi Tachdjian, M.D., MPH, David Geffen School of Medicine, UCLA Berndt Modig, CEO Pharvaris Peng Lu, M.D., Ph.D., CMO Pharvaris Wim Souverijns, Ph.D., CCO Pharvaris 4 ©2024 CONFIDENTIAL
Slide 5: Agenda
Agenda Michael Manning, M.D., Allergy, Asthma & Immunology, Scottsdale, AZ Raffi Tachdjian, M.D., MPH, David Geffen School of Medicine, UCLA Berndt Modig, CEO Pharvaris Peng Lu, M.D., Ph.D., CMO Pharvaris Wim Souverijns, Ph.D., CCO Pharvaris 5 ©2024 CONFIDENTIAL
Slide 6: Agenda
Agenda Michael Manning, M.D., Allergy, Asthma & Immunology, Scottsdale, AZ Raffi Tachdjian, M.D., MPH, David Geffen School of Medicine, UCLA Berndt Modig, CEO Pharvaris Peng Lu, M.D., Ph.D., CMO Pharvaris Wim Souverijns, Ph.D., CCO Pharvaris 6 ©2024 CONFIDENTIAL
Slide 7: Deucrictibant has the potential to become a preferred therapy for people living with HAE
Deucrictibant has the potential to become a preferred therapy for people living with HAE DEUCRICTIBANT DEUCRICTIBANT extended-release (XR) tablet immediate-release (IR) capsule sustained absorption1 rapid absorption3 Maintains sustained therapeutic exposure over 24 deucrictibant Rapidly reaches ther
Slide 8: Agenda
Agenda Michael Manning, M.D., Allergy, Asthma & Immunology, Scottsdale, AZ Raffi Tachdjian, M.D., MPH, David Geffen School of Medicine, UCLA Berndt Modig, CEO Pharvaris Peng Lu, M.D., Ph.D., CMO Pharvaris Wim Souverijns, Ph.D., CCO Pharvaris 8 ©2024 CONFIDENTIAL
Slide 9: Deucrictibant's differentiated profile for LTP and ODT
Deucrictibant’s differentiated profile for LTP and ODT LTP ODT Oral LTP or ODT Deucrictibant is the only HAE therapy1 in development that allows Formulations for oral administration in both prophylaxis and on-demand2 Specific formulations allow for once-daily dosing3 (XR for LTP) or Single Oral Pill
Slide 10: RAPIDe-3 study enrolling: global Phase 3 study of on-demand treatment of HAE
HAE RAPIDe-31 study enrolling: A global Phase 3 study of on-demand treatment of angioedema attacks in people with HAE-1/2 ▪ Target enrollment of approximately 120 adolescents Double-blind crossover treatment and adults (between 12 and 75 years old) with two qualifying attacks ▪ Endpoints • Onset of
Slide 11: Clinical trial endpoints span the entire attack timecourse
Clinical trial endpoints span the entire attack timecourse Symptom Symptom evolution towards relief and resolution progression End of progression Clinical manifestations Onset of symptom relief Substantial symptom relief Treatment with deucrictibant IR Complete symptom resolution Onset of HAE attack
Slide 12: PGI-C "a little better" is the RAPIDe-3 primary endpoint
PGI-C “a little better” is the RAPIDe-3 primary endpoint Propensity score-matched analysis RAPIDe-2 long-term extension data2 findings1 100 Proportion of attacks (%) 80 60 40 RAPIDe-2 study cohort (deucrictibant IR capsule) KM estimate: 1.07 (0.98, 1.89) 20 Mixed-methods study cohort (SOC) 0 KM esti
Slide 13: Median attack resolution time 11.5 hours: 85.8% of attacks completely resolved within 24 hours
Median attack resolution time 11.5 hours: 85.8% of attacks completely resolved within 24 hours (90.2% of which with one only dose)1 complete resolution by PGI-S Proportion of attacks with (%) Median time to complete attack resolution: 11.5 hours (95% CI: 11.0, 13.0) 85.8% (224/261*) of attacks achie
Slide 14: Deucrictibant's differentiated profile for LTP and ODT
Deucrictibant’s differentiated profile for LTP and ODT LTP ODT Oral LTP or ODT Deucrictibant is the only HAE therapy1 in development that allows Formulations for oral administration in both prophylaxis and on-demand2 Specific formulations allow for once-daily dosing3 (XR for LTP) or Single Oral Pill
Slide 15: Continuing deucrictibant treatment sustained the early-onset attack reduction for over one and a half years
Continuing deucrictibant treatment sustained the early-onset attack reduction for over one and a half years RCT OLE 2.50 84.5% reduction; P=0.0008 79.3% reduction; P=0.0009 1.94 2.00 Attack ratea (LS mean) 1.50 In the open-label extension up to 18 months: 1.00 ▪ 93% attack rate reduction from baseli
Slide 16: Commercial XR formulation maintains exposure above therapeutic level for at least 24 hours
Commercial XR formulation maintains exposure above therapeutic level for at least 24 hours ▪ Extended-release matrix controls release and absorption of compound in small intestine as well as in colon ▪ Supports once-daily dosing while maintaining exposure more consistently versus twice-daily IR (use
Slide 17: CHAPTER-3 study: A global Phase 3 study of prophylactic treatment of angioedema attacks in people with HAE
CHAPTER-3 study: A global Phase 3 study of prophylactic treatment of angioedema attacks in people with HAE ▪ Target enrollment of approximately 81 adolescents and adults living with HAE; 2:1 randomization ▪ Initiating by year-end 2024 ▪ Study objectives • Evaluation and characterization of investiga
Slide 18: Deucrictibant proof-of-concept in acquired angioedema due to C1-INH deficiency (AAE-C1INH)
Deucrictibant proof-of-concept in acquired angioedema due to C1- INH deficiency (AAE-C1INH)1,2 ▪ Estimated prevalence of 1:100,000 to 1:500,000 • ~ 10% of HAE type 1/2 ▪ Currently, no therapies approved for AAE ▪ Investigator-initiated trial (IIT) by the Amsterdam UMC POP-AID ONCE-AID Part 1: On-dem
Slide 19: Deucrictibant XR tablet for the prevention of acquired angioedema (AAE-C1INH) attacks
Deucrictibant XR tablet for the prevention of acquired angioedema (AAE-C1INH) attacks1,2 Attacks per month Patient 1 Patient 2 Patient 3 Patient 4 Baseline 1.2 1.2 0.9 2.2 Placebo 2.0 0.6 1.0 N/A Deucrictibant 0 0 0 0.1 Attacks before and during deucrictibant XR treatment Notes: the baseline attack
Slide 20: Wholly-owned pipeline focused on bradykinin B2 receptor mechanism
Wholly-owned pipeline focused on bradykinin B2 receptor mechanism MOLECULE FORMULATION INDICATION PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGISTRATION Next Milestone HAE Complete Enrollment On-Demand LTE Immediate-Release Capsule deucrictibant HAE OLE Prophylaxis Extended-Release Tablet Initiation PHAXX
Slide 21: Agenda
Agenda Michael Manning, M.D., Allergy, Asthma & Immunology, Scottsdale, AZ Raffi Tachdjian, M.D., MPH, David Geffen School of Medicine, UCLA Berndt Modig, CEO Pharvaris Peng Lu, M.D., Ph.D., CMO Pharvaris Wim Souverijns, Ph.D., CCO Pharvaris 21 ©2024 CONFIDENTIAL
Slide 22: Our strategy is to become a market leader in HAE
Our strategy is to become a market leader in HAE Rooted in a deep commitment to Leverage engage with the HAE community portfolio with B2R antagonism MoA Become 4 preferred LTP LTP Win the oral LTP 3 Become standard market ODT of care in ODT 2 1 Both Notes: Aspirational, to be confirmed with Phase 3
Slide 23: In the U.S., significant growth in the LTP and ODT market is expected over the next decade
In the U.S., significant growth in the long-term prophylaxis (LTP) and on-demand therapy (ODT) market is expected over the next decade1 Value of prophylaxis1-3 Value of on-demand1-3 $4,000m ODT ODT 6% CAGR >$1,200m 23% Icatibant Gx >2% CAGR 31% Orladeyo Ruconest $850m Cinryze $1,869m Kalbitor ~40% s
Slide 24: Despite treatment satisfaction, the U.S. HAE market is dynamic, with people actively seeking a better product
Despite treatment satisfaction, the U.S. HAE market is dynamic, with people actively seeking a better1 product People actively switch therapies2,3: first-to-market is Across ~7,000 people with HAE, there were over no guarantee for long-term market leadership >1,500 unique counts of treatment initiat
Slide 25: For both patients on prophylaxis or on-demand therapy, switching treatment is moderately easy for HCPs
For both patients on prophylaxis or on-demand therapy, switching treatment is moderately easy for HCPs1 Switching barriers Ease of switching Tx* (% selected; 1=not easy at all to 10=very easy) Base: Total U.S. HCPs (N=88)1. [1-3] [4-7] [8-10] Mean /10 ODT Change in brand of ACUTE therapy 11% 65% 24%
Slide 26: Efficacy is prime for HCPs, but patient preference drives choice for oral administration
Efficacy is prime for HCPs, but patient preference drives choice for oral administration1 HCPs top reasons for selecting a therapy (current users, n = 216) Efficacy 44% ▪ Efficacy remains the first driver for Convenience of dosing frequency 30% HCP preference Convenience of administration 28% ▪ Dosi
Slide 27: But people with HAE are not willing to trade off efficacy for the convenience of an oral therapy
But people with HAE are not willing to trade off efficacy for the convenience of an oral therapy1 Efficacy vs. Convenience trade-off Base: Total U.S. Patients (N=94); excluding those not on prophylaxis and unlikely to start (N=87)1. Strongly agree (L) Somewhat Agree (L) Agree with Neither more Somew
Slide 28: Despite high compliance on novel therapies, breakthrough attacks are still common
Despite high compliance on novel therapies, including Orladeyo®, breakthrough attacks are still common with nearly 3 attacks per year1 Base: Total U.S. HCPs (N=88)1. Total TAKHZYRO® CINRYZE® ORLADEYO® HAEGARDA® DANOCRINE® Base: current users 216 83 22 55 46 *10 Compliance High 65% 64% 50% 71% 70% 60
Slide 29: People living with HAE are seeking a life not defined by their condition nor burdened by its management
People living with HAE are seeking a life not defined by their condition nor burdened by its management1 Efficacy is a prime driver… but safety and tolerability cause exploration of alternatives… …while convenience is a key driver for overall preference2 People living with HAE actively switch betwee
Slide 30: Pharvaris aspires to leverage its foundational B2R expertise to develop therapies beyond HAE
Pharvaris aspires to leverage its foundational B2R expertise to develop therapies for conditions beyond HAE Rare allergy & immunology conditions (commercial) BK-mediated diseases (R&D) BK-mediated angioedema: nC1, AAE HAE Type 1/2 : 30 ©2024 This presentation includes data for an investigational pro
Slide 31: Agenda
Agenda Michael Manning, M.D., Allergy, Asthma & Immunology, Scottsdale, AZ Raffi Tachdjian, M.D., MPH, David Geffen School of Medicine, UCLA Berndt Modig, CEO Pharvaris Peng Lu, M.D., Ph.D., CMO Pharvaris Wim Souverijns, Ph.D., CCO Pharvaris 31 ©2024 CONFIDENTIAL
Slide 32: Pioneering science for patient choice for hereditary angioedema (HAE)
Pioneering science for patient choice for hereditary angioedema (HAE) TWO LATE-STAGE PROGRAMS • Deucrictibant is an orally available small molecule targeting the validated bradykinin B2 receptor4 • Results from randomized Phase 2 trials 5,6 and their ongoing extensions7,8 demonstrate a DEUCRICTIBANT