Slide 1: Corporate Presentation December 2023
Corporate Presentation December 2023 Pioneering science for patient choice Exhibit 99.1
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: HAE: A rare, life-long genetic condition with significant burden
HAE: A rare, life-long genetic condition with significant burden from unpredictable, debilitating, and potentially lethal attacks of swelling Source: Nordenfelt et al, Acta Derm. Venereol 2016: 96: 540-545; Busse 2020 J Allergy Clin Immunol Pract; Bork et al 2021 J Allergy Clin Immunol Unpredictable
Slide 4: Significant global unmet need affecting people living with HAE
Significant global unmet need affecting potentially up to 100,000 people living with HAE Source: Proprietary company research 2022; Maurer et al. Consensus on diagnosis and management of Hereditary Angioedema in the Middle East: A Delphi initiative. World Allergy Organization Journal (2023);16:1-2;
Slide 5: People living with HAE actively switch products, seeking improvement
Source: Proprietary company research 2022 People living with HAE actively switch products, seeking improvement in efficacy, safety/tolerability, and convenience Efficacy is patients’ prime concern … … but safety & tolerability are pushing patients to explore alternatives … … while convenience has be
Slide 6: People living with HAE use approved therapeutics for treatment or prevention
People living with HAE use approved therapeutics for treatment (‘on demand’) or prevention of attacks (‘prophylaxis’) Estimated $2.7B global HAE sales in 2022 Estimated 15% CAGR 2021-2028 SC oral IV No new on-demand therapies introduced since 2014 Three new prophylactic products approved since 2017:
Slide 7: The swelling of an HAE attack is caused by excess levels of bradykinin
The swelling of an HAE attack is caused by excess levels of bradykinin Source: Busse 2020 J Allergy Clin Immunol Pract; Bork et al 2021 J Allergy Clin Immunol; Notes: HMWK: high-molecular-weight kininogen; cHMWK: cleaved high-molecular-weight kininogen; FXII(a): Factor XII(a); ACE(i): angiotensin-co
Slide 8: Bradykinin-mediated disease also includes acquired angioedema beyond HAE
Bradykinin-mediated disease also includes acquired angioedema beyond HAE No products approved for treatment of bradykinin-dependent acquired angioedema Therapies approved broadly for HAE are used for treatment An independent investigator-initiated trial (IIT) in AAE-C1-INH with PHVS416 has been cond
Slide 9: Pharvaris has discovered the first orally bioavailable bradykinin B2 receptor antagonist
Pharvaris has discovered the first orally bioavailable bradykinin B2 receptor antagonist Surce: Lesage et al, Frontiers in Pharmacology 2020, doi: 10.3389/fphar.2020.00916; ; Lesage et al, Int. Immunopharmacology 2022, doi.org/10.1016/j.intimp.2022.108523; https://ir.pharvaris.com/static-files/0361c
Slide 10: Product Strategy
Product Strategy PHARVARiS ©2023
Slide 11: Our strategy: Managing HAE with two oral products with the same active ingredient
Our strategy: Managing HAE with two oral products with the same active ingredient for on-demand and prophylactic treatment Deucrictibant has the potential to become the preferred therapy for people living with HAE to manage their condition *Aspirational; to be confirmed with clinical data Deucrictib
Slide 12: Regulatory update
Regulatory update In August 2022, the U.S. Food & Drug Administration (FDA) placed a hold on clinical trials of deucrictibant in the U.S. based on its review of nonclinical data The agency requested that Pharvaris conduct an additional long-term rodent toxicology study and update the Investigator’s
Slide 13: Wholly-owned pipeline focused on bradykinin B2 receptor mechanism
Wholly-owned pipeline focused on bradykinin B2 receptor mechanism * The FDA has placed a hold on clinical trials of deucrictibant for long-term prophylaxis in the U.S.; see slide 12 for an update on our clinical program
Slide 14: On-Demand: Deucrictibant immediate-release capsules (PHVS416)
On-Demand Deucrictibant immediate-release capsules (PHVS416) [deucrictibant]
Slide 15: Only injectable options: Significant unmet need in on-demand treatment
Only injectable options: Significant unmet need in the on-demand treatment of HAE attacks Source: Proprietary Pharvaris research, 2022 (representative sample of patients, n = 103, and doctors, n = 100) Treatment today means painful injections … … and often one dose does not suffice … … while finding
Slide 16: Not all attacks are treated: reasons for not treating most recent attack
Not all attacks are treated: Physicians and patients report reasons for not treating most recent attack Source: Mendivil et al., ACAAI 2023; https://ir.pharvaris.com/static-files/1b7e2270-34fd-411c-8f64-a0da8b2a65ec Attack was mild Not prescribed ODT Too long to resolve attack Not carrying medicatio
Slide 17: People living with HAE are hoping for better on-demand therapies
People living with HAE are hoping for better on-demand therapies that offer rapid symptom relief with one single, oral dose Source: Proprietary Pharvaris research, 2022 (representative sample of patients, n = 103, and doctors, n = 100) Effectively targeting the bradykinin receptor with a small molec
Slide 18: HAE RAPIDe-1 study: Phase 2 study of on-demand treatment
HAE RAPIDe-1 study: Phase 2 study of on-demand treatment of angioedema attacks in patients with Type I or II HAE Source: www.hae-rapide.com; https://clinicaltrials.gov/ct2/show/NCT04618211; https://hae-rapide.us/; https://www.clinicaltrialsregister.eu/ctr-search/search?query=2020-003445-11 Screening
Slide 19: Positive top-line Phase 2 data from RAPIDe-1 study of PHVS416
Positive top-line Phase 2 data from RAPIDe-1 study of PHVS416 for the on-demand treatment of HAE attacks A total of 74 patients from 13 countries were enrolled to the study, 62 of them had 147 attacks that were treated with blinded study drug and included in efficacy evaluation The primary endpoint
Slide 20: Rapid absorption with mean plasma levels exceeding EC85 within 30 min
Rapid absorption with mean plasma levels exceeding EC85 (13.8 ng/mL) within 30 min Mean plasma levels maintained >EC85 for approximately 8 h at 10 mg or 20 mg >10 h at 30 mg dose EC85 levels established using bradykinin challenge, a human surrogate endpoint study in healthy volunteers PK analysis in
Slide 21: Primary endpoint: Deucrictibant IR significantly reduces attack symptoms by VAS-3 at 4h
Primary endpoint: Deucrictibant IR significantly reduces attack symptoms by VAS-3 at 4h †Nominal p-value; VAS assessed every 30 minutes up to 4 hours post-treatment, then at 5, 6, 8, 24, 48 hours; N = The number of attacks in the mITT Analysis Set. Attacks in mITT Analysis Set refer to attacks treat
Slide 22: Deucrictibant IR significantly shortened time to onset of symptom relief
Deucrictibant IR significantly shortened time to onset of symptom relief (30% reduction in VAS-3) Nominal p-value; N = The number of attacks in the mITT Analysis Set. Median time based on Kaplan-Meier estimates. p-values based on a marginal Cox proportional hazards model. The combined PHVS416 result
Slide 23: Post-hoc analysis: end of progression by VAS-3 within 25 to 26 min
In a post-hoc analysis, patients on deucrictibant achieved end of progression by VAS-3 within 25 to 26 min versus 20 h for placebo Source: Maurer et al., ACAAI 2023; https://ir.pharvaris.com/static-files/0bae214b-7ff8-49ec-8340-1bb60a5935b9
Slide 24: TOS PRO captures change in five symptom complexes of HAE attacks
At each timepoint, the change in attack symptom from pre-treatment is reported by patient TOS PRO captures change in five symptom complexes of HAE attacks TOS Patient Reported Outcome (PRO) A lot better or resolved A little better Same A little worse A lot worse PRO – how do you feel now compared to
Slide 25: TOS endpoint shows early response to treatment: Significant at 4h
TOS endpoint shows early response to treatment: Significant at 4h Source: Vernon M, Rentz AM, Wyrwich KW, et al. Qual Life Res.2009; † Nominal p-value; N = The number of attacks in the mITT Analysis Set. TOS = Treatment Outcome Score. Figure is based on descriptive summary of mean and SEM. The least
Slide 26: Deucrictibant IR significantly reduces time to almost complete or complete symptom relief
Deucrictibant IR significantly reduces time to almost complete or complete symptom relief (all individual VAS ≤10) †Nominal p-value; N = The number of attacks in the mITT Analysis Set. Median time based on Kaplan-Meier estimates. p-values based on a marginal Cox proportional hazards model. The combi
Slide 27: Patients treating with deucrictibant IR used substantially less rescue medication
Patients treating with deucrictibant IR used substantially less rescue medication N = The number of attacks in the mITT Analysis Set
Slide 28: Deucrictibant IR was well tolerated at all doses
Deucrictibant IR was well tolerated at all doses N= The number of subjects (Part I) and number of attacks (Part II) in the Safety Analysis Set. The Safety Analysis Set includes all randomized patients who received any dose of study drug. Treatment-related AEs within 48 h post-treatment are included
Slide 29: Oral acute therapy would increase likelihood patients treat more attacks, earlier
Both doctors and patients consider an oral acute therapy would increase likelihood that patients would treat more attacks, earlier Source: Proprietary Pharvaris research, 2022 (representative sample of patients, n = 103, and doctors, n = 100) Doctors (n=100) Patients (n=103) Anticipated impact of OR
Slide 30: Long Term Prophylaxis: Deucrictibant extended-release tablets (PHVS719)
Long Term Prophylaxis Deucrictibant extended-release tablets (PHVS719) [deucrictibant]
Slide 31: People living with HAE are seeking highly effective, well-tolerated prophylactic therapies
People living with HAE are seeking highly effective, well-tolerated, and less burdensome prophylactic therapies Source: Proprietary Pharvaris research, 2022 (representative sample of patients, n = 103, and doctors, n = 100) Injectable-like efficacy Easy, painless administration Well-tolerated Effect
Slide 32: HAE CHAPTER-1 study has completed: Study design
HAE CHAPTER-1 study has completed: Study design CONFIDENTIAL Double-blind, placebo-controlled Phase 2 study assessing safety and efficacy of deucrictibant in preventing HAE attacks in patients with HAE type 1 or type 2 34 participants enrolled in North America and Europe R = randomization; *deucrict
Slide 33: Positive top-line Phase 2 data from the CHAPTER-1 study
Positive top-line Phase 2 data from the CHAPTER-1 study of deucrictibant for the prophylactic treatment of HAE attacks
Slide 34: Phase 1 pharmacokinetics offered options to use deucrictibant IR in prophylaxis
Phase 1 pharmacokinetics offered options to use deucrictibant IR as proof-of-concept in prophylactic development Source: https://ir.pharvaris.com/static-files/0361cd85-6000-490b-932b-d305e1f3ca1b; https://ir.pharvaris.com/static-files/81a9499d-0769-4b89-8ecd-8ace5ca521d3 EC85 Food effect on single d
Slide 35: Deucrictibant XR single-dose PK study demonstrates QD potential
Deucrictibant XR single-dose PK study demonstrates QD potential; target for Phase 3 dosage form Deucrictibant IR capsule (2x10mg), fasted Deucrictibant XR tablet (40 mg), fasted EC85 Deucrictibant XR tablet (40 mg), fed Deucrictibant IR and XR well tolerated No SAEs or severe TEAEs Deucrictibant IR
Slide 36: Our strategy: Managing HAE with two oral products with the same active ingredient
Our strategy: Managing HAE with two oral products with the same active ingredient for on-demand and prophylactic treatment *Aspirational; to be confirmed with clinical data Deucrictibant (PHVS416) Immediate-release capsule rapid absorption Deucrictibant (PHVS719) Extended-release tablet sustained ab
Slide 37: Corporate summary and milestones
Corporate summary and milestones HAE On-Demand (type 1 and type 2) HAE Prophylaxis (type 1 and type 2) PHVS416 deucrictibant immediate-release capsule RAPIDe-1 Ph2 top-line data meets all primary and key secondary endpoints Phase 3 initiation CHAPTER-1 Ph2 top-line data meets the primary endpoint Ph
Slide 38: Aspiring to free people from HAE or other bradykinin-mediated diseases
Aspiring to free people from HAE or other bradykinin-mediated diseases
Slide 39: Slide 39
Slide 40: Alternative endpoints to measure symptom relief in an HAE attack
The relationship between alternative endpoints to measure symptom relief in an HAE attack was assessed in a mixed-methods study Source: Mendivil et al., UCARE 2023 Overall probability of attacks achieving symptom relief 1.00 0.75 0.50 0.25 0.00 0 2 4 6 8 12 48 24 Hours post-treatment Symptom relief: