Avalyn Pharma Inc. · NASDAQ:AVLN
Avalyn Pharma — Investor Presentation (September 2026)
37 slides from Avalyn Pharma's investor presentation, September 2026
Slide 1: Reimagining the Future of Rare Lung Disease Treatment
Reimagining the Future of Rare Lung Disease Treatment Corporate Overview Nasdaq: AVLN September 2026
Slide 2: Disclaimer
Disclaimer Disclaimer This presentation includes forward looking statements, including statements related to our product candidates, preclinical and/or clinical trial timelines and projected data announcements, as well as statements related to patient populations and total addressable markets . All
Slide 3: Our Approach Reimagines the Future of Rare Lung Disease Treatment
Our Approach Reimagines the Future of Rare Lung Disease Treatment Clinical-stage portfolio of inhaled therapies targeting multi-billion dollar total addressable market Multiple clinical catalysts expected in 2026 and beyond Well-capitalized with $345M raised in upsized IPO (Nasdaq: AVLN) in April 20
Slide 4: Pulmonary Fibrosis: Deadly Disease with Limited Approved Agents
Pulmonary Fibrosis: Deadly Disease with Limited Approved Agents 3-5 year survival rate – worse than ~70% of IPF patients are not on most forms of cancer1-4 therapy5 Lung Cancer 18% ~30% treated Pirfenidone with oral medicines8 IPF 45% ~70% Ovarian Cancer 47% Untreated IPF Nintedanib Pulmonary Arteri
Slide 5: Inhaled Delivery Has Potential to Improve Efficacy and Tolerability of Approved Oral Agents
Inhaled Delivery Has Potential to Improve Efficacy and Tolerability of Approved Oral Agents AVALYN’S TREATMENT THESIS Increases lung exposure Decreases systemic Dramatic improvement to even at >10x lower dose than oral exposure existing product profiles 5
Slide 6: Clinical Stage Portfolio with Potential to Transform Treatment of Pulmonary Fibrosis
Clinical Stage Portfolio with Potential to Transform Treatment of Pulmonary Fibrosis Inhaled pirfenidone: Enrollment completed in global Phase 2b MIST study in PPF; data expected 2H27 AP01 • >150 patients with pulmonary fibrosis studied in Phase 1 and open label extension studies – Substantially bet
Slide 7: We Believe Avalyn is Positioned to Evolve the Treatment Algorithm in PF
We Believe Avalyn is Positioned to Evolve the Treatment Algorithm in PF Asthma and COPD treatments now include many combinations GENERATION 1 GENERATION 2 GENERATION 3 GENERATION 4 Oral Molecules Inhaled Molecules Dual FDCs Triple FDCs Rapid evolution of PF treatment options GENERATION 1 GENERATION
Slide 8: IPF and PPF Are Two Key Types of Interstitial Lung Disease
IPF and PPF Are Two Key Types of Interstitial Lung Disease INTERSTITIAL LUNG DISEASE ~650K US patients 1 >200 types1 of interstitial lung diseases (ILDs) Autoimmune- related IDIOPATHIC e.g., RA-ILD PULMONARY ILD-associated inflammation FIBROSIS can lead to fibrosis, damaging Idiopathic interstitial
Slide 9: Pulmonary Fibrosis Represents a Large Market Opportunity in the US
Pulmonary Fibrosis Represents a Large Market Opportunity in the US US Market Prevalence ~650,000 patients with ILDs1 ~120,000 IPF ~180,000 PPF >$4B patients2 patients3 Ofev® global revenue in 2025 Approved Oral Medicines Annual Brand Pricing > $150k / yr ~$2B Jascayd® annualized run Implied US Marke
Slide 10: Avalyn's Anticipated Near-Term Value Inflection Points
Avalyn’s Anticipated Near-Term Value Inflection Points Program 1H26 2H26 1H27 2H27 Anticipated Milestones Ph2b trial enrollment MIST Phase 2b completed mid 2026 AP01 MIST Phase 2b Enrollment (Inhaled pirfenidone) Study Readout Completed • Ph2b top line data expected 2H27 First patient dosed in A
Slide 11: Optimized Drug/Device Combination for Treatment of PF
Optimized Drug/Device Combination for Treatment of PF Handheld nebulized formulation delivered by proprietary, patented, 510(k) cleared PARI eFlow® device. Device would be included in FDA label. The same device configuration is used in other commercial products, including Insmed’s Arikayce® and Gile
Slide 12: AP01: Inhaled Pirfenidone
AP01: Inhaled Pirfenidone
Slide 13: Inhaled Pirfenidone (AP01): Phase 1b ATLAS Trial
Inhaled Pirfenidone (AP01): Phase 1b ATLAS Trial Open-Label Extension (OLE) / Compassionate Use Trials Include IPF and PPF COMPLETED ATLAS Trial in IPF Patients Cohort 1: 100mg BID (n=45) Cohort 2: 50mg QD (n=46) Study complete Data published in Thorax in March 20231 Rolled over to OLE on 100 mg
Slide 14: AP01 Showed Improved Tolerability in ATLAS
AP01 Showed Improved Tolerability in ATLAS 40% Top 10 AEs for Oral Pirfenidone Corresponding AEs from AP01 40% (Esbriet®) (ATLAS study) 35% • Gastrointestinal and skin 35% AEs are common reasons 30% 30% for discontinuing oral pirfenidone Incidence of AEs Incidence of AEs 25% 25% 20% 20% 15% 15% • Co
Slide 15: AP01 100mg Achieved Near Stabilization in ATLAS
AP01 100mg Achieved Near Stabilization in ATLAS Exhibiting Significant Dose-Dependent Improvement in Lung Function Lung function (FVC) with AP01 100 mg BID vs. 50 mg QD dosing in 48-week ATLAS trial1 4% 50mg QD slope 100mg BID slope Historical data of oral Change from Baseline in FVC % Predicted pir
Slide 16: Oral Data Suggests Avalyn's Inhaled Pirfenidone (AP01) Achieves Favorable FVC Change
Oral Data Suggests Avalyn’s Inhaled Pirfenidone (AP01) Achieves Favorable FVC Change Avalyn AP01 Oral pirfenidone (Esbriet®) Oral nintedanib (Ofev®) Oral nerandomilast (Jascayd®) IPF Indication IPF IPF IPF IPF IPF PPF IPF PPF ATLAS1 Trial CAPACITY-12 CAPACITY-22 ASCEND3 INPULSIS-14 INPULSIS-24 INBUI
Slide 17: AP01 Activity in AP01-Naïve Use Cohorts Similar to IPF Patients in ATLAS
AP01 Activity in AP01-Naïve Use Cohorts Similar to IPF Patients in ATLAS over 48 weeks Cohort 1: IPF Patients Cohort 3: IPF Patients – Cohort 4: PPF Patients - from ATLAS1,2 AP01-Naïve2 AP01-Naïve2 FVC % Predicted Change from Baseline 25 20 15 10 5 0 -5 -10 -15 -20 -25 -30 -35 0 12 24 36 48 0 12 24
Slide 18: Treatment with AP01 Showed Favorable Tolerability and Trend Toward Stabilization
Treatment with 100 mg BID AP01 Showed Favorable Tolerability Profile and Trend Toward Disease Stabilization For Up To Four Years Cohort 1: ATLAS IPF Patients Rolled Over Into OLE Cohort 4: AP01-Naïve PPF Patients 30 25 FVC % Predicted Change from Baseline FVC % Predicted Change from Baseline 20 20 1
Slide 19: ATLAS Showed Promising Potential for Disease Modification
ATLAS Showed Promising Potential for Disease Modification: Imaging Correlated with FVC Data Axial HRCT Images • >70% of patients in ATLAS showed stabilization or reversal of fibrosis on 100 mg BID1,2 BASELINE • Signals of disease course reversal seen, especially with early intervention • Routine ima
Slide 20: Stabilization or Reversal of Fibrosis Seen in Majority of Patients on 100mg BID
Stabilization or Reversal of Fibrosis Seen in Majority of Patients on 100mg BID Dose, with Correlation between Lung Function, Fibrosis, and QoL 100% 1,000 50mg QD: r = -0.24; 95% CI = (-0.52, 0.09) 16% Change from Baseline in FVC (mL) at 48 Weeks 100mg BID: r = -0.72; 95% CI = (-0.86, -0.47) 750 80%
Slide 21: Modeling of AP01 predicts aerosol distribution throughout the lung
Modeling of AP01 (nebulized pirfenidone) predicts aerosol distribution throughout the lung AP01 Preferentially Deposits in Significant AP01 Distribution is Achieved AP01 is Distributed Throughout Lung the Peripheral Region in the Alveolar Tissue Even in Severe Disease Figure 5. Deposited API mass p
Slide 22: AP01 is predicted to permeate throughout lung tissue in both healthy and diseased tissue
AP01 is predicted to permeate throughout lung tissue in both healthy and diseased tissue SCAN ME TODO: Update TODO: Update Healthy Mild IPF Severe IPF Figure 4. Transport and deposition of aerosol mass of three cases, visualized in single breath and in slow motion* *Variation in lung sizes attribute
Slide 23: Phase 2b PPF MIST Study is Designed to Support Registration
Phase 2b PPF MIST Study is Designed to Support Registration Primary Endpoint Inhaled Pirfenidone | 100 mg BID Randomization (2:1:2) (n: 159) • Forced vital capacity Patient Population Secondary Endpoints Inhaled Pirfenidone | 50 mg BID SAIL Key Criteria (n: 80) (OLE) • QoL • PPF patients with recent
Slide 24: AP01 Program Supported By Over 4 Years of Long-Term Data
AP01 Program Supported By Over 4 Years of Long-Term Data ATLAS Phase 1b ATLAS Open Label ATLAS 50 mg QD or 100mg BID (n=91) Extension Study Complete COMPLETED IPF patients • Over 4 years of open label extension data • Some patients from ATLAS on OLE ATLAS Rollover to OLE AP01-naïve* cohorts AP01 for
Slide 25: AP02: Inhaled Nintedanib
AP02: Inhaled Nintedanib
Slide 26: AP02: Inhaled Nintedanib for the Treatment of IPF Patients
AP02: Inhaled Nintedanib for the Treatment of IPF Patients ✓ Nonclinical program completed ✓ Phase 1 SAD / MAD trials in healthy volunteers & IPF patients completed demonstrating: − 92 healthy volunteers and 6 patients with IPF have participated in Phase 1 studies to date − PK comparable between IPF
Slide 27: First AP02 Phase 1 SAD Study (2023) Results Supported Dose Escalation
First AP02 Phase 1 SAD Study (2023) Results Supported Dose Escalation Lung Exposure SAD Cohorts IPF Cohort Cohorts Cohorts 1-3 4-5 6 NHVs NHVs IPF Subject N=24 N=8 N=6 6 active, 2 PBO per cohort 4 per cohort Phase 1 150 mg oral Dose (Single) 0.5, 1.0, 2.0 mg AP02 2.0 mg AP02 2.0 mg AP02 Study Design
Slide 28: Second AP02 Phase 1 SAD / MAD Study Design Included Epithelial Lining Fluid Samples
Second AP02 Phase 1 SAD / MAD Study Design Included Epithelial Lining Fluid Samples Phase 1 Part A: Healthy Volunteer SAD Phase 1 Part B: Healthy Volunteer MAD (7 days) Cohort 1 2.0 mg QD Cohort 2 Cohort 6 4.0 mg QD 2.0 mg BID Cohort 3 Cohort 7 8.0 mg QD 4.0 mg BID Cohort 4: Lung Exposure Cohort 8 4
Slide 29: AP02 Significantly Improved Nintedanib Lung Exposure
AP02 Significantly Improved Nintedanib Lung Exposure Nintedanib Concentration in Epithelial Lining Fluid (ELF) 10,000 1,000 Inhaled at 4mg* vs oral 150 mg Mean Concentration (ng/mL) Cmax 100 +27x (2,720 ng/mL vs 99 ng/mL) 10 AUC0-24h 1 Oral 150 mg 4 mg AP02 +27x (20,900 ng*h/mL vs 779 ng*h/mL) 0.1 0
Slide 30: Inhaled Delivery of AP02 Avoided Systemic Exposure with No TEAEs at 4mg BID
Inhaled Delivery of AP02 Avoided Systemic Exposure with No TEAEs at 4mg BID Inhalation Results in Generally Well Tolerated Lower Plasma Exposure vs Oral Inhaled at 4mg vs oral 150 mg No drug-related AEs at 4 mg BID Cmax AUC0-24h No bronchospasm or cough -17x -26x (1.94 ng/mL vs 31.95 ng/mL) (14.1 ng
Slide 31: Inhaled AP02 Concentration Exceeded IC50 For Key Markers of Fibrosis
Inhaled AP02 Concentration Exceeded IC50 For Key Markers of Fibrosis Nintedanib concentrations in ELF were compared to the Select nintedanib in vitro PCLS IC50 and in vitro tyrosine kinase IC50 values kinase inhibition profile1 10,000 Kinase IC50 (ng/mL) VEGFR-1 18 1,000 VEGFR-2 11 Concentration (ng
Slide 32: Now Enrolling: AP02 Phase 2 AURA IPF Study Design
Now Enrolling: AP02 Phase 2 AURA IPF Study Design A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Trial Evaluating the Safety and Efficacy of AP02 in IPF AP02 4 mg BID (n=60) Randomization Primary Endpoint Screening (3:2:3) Period AP02 2 mg BID (n=40) • Change from baseline Patient Populatio
Slide 33: AP03: Fixed Dose Combination
AP03: Fixed Dose Combination
Slide 34: AP03 Fixed Dose Combination: Advancing Toward Phase 1 Readiness
AP03 Fixed Dose Combination: Advancing Toward Phase 1 Readiness ✓ CMC fixed dose formulation identified that supports full dose range potential ✓ CMC engineering batches manufactured ✓ Completed IPF patient-derived Precision Cut Lung Slice (PCLS) pharmacology studies to help ✓ Clinical supply manufa
Slide 35: AP03 Informed by Third Party INJOURNEY Trial Showing Improved Efficacy with Tolerability Challenges
AP03 Informed by Third Party INJOURNEY Trial That Showed Improved Efficacy in Combination with Significant Tolerability Challenges Increased Efficacy Benefit with Combination at 12Wks Worse Tolerability with Combination of Oral Agents 10 45% 40% Pirfenidone + Nintedanib 0 Nintedanib only Slope: +3.6
Slide 36: For patients like Peter…
For patients like Peter… He was first treated in our ATLAS study in 2020 and remains on treatment in our open-label extension today, over five years later. 36
Slide 37: Avalyn Strategy: Innovation With The Goal Of Improving Patient Outcomes In Rare Lung Diseases
Avalyn Strategy: Innovation With The Goal Of Improving Patient Outcomes In Rare Lung Diseases ✓ ✓ ✓ New formulation of Device selection Large patient base approved medicines that offers medical with high unmet with derisked and commercial need mechanism of action advantages Multiple near-term clinic
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