Aura Biosciences, Inc. · NASDAQ:AURA
Aura Biosciences — Investor Presentation (November 2023)
42 slides from Aura Biosciences's investor presentation, Nov 6, 2023
Slide 1: Corporate Presentation November 2023
Exhibit 99.2 Corporate Presentation November 2023
Slide 2: Legal Disclosure
Legal Disclosure This presentation contains forward-looking statements, all of which are qualified in their entirety by this cautionary statement. Many of the forward-looking statements contained herein can be identified by the use of forward-looking words such as may , anticipate , believe , could'
Slide 3: Aura Biosciences Highlights
Aura Biosciences Highlights Virus-Like Drug Conjugates - Novel class of drugs to treat solid tumors - Dual Mechanism of Action: targeted cytotoxicity and immune activation (VDCs) - Special Protocol Assessment (SPA) Agreement with FDA: - Global Ph 3 study design and analysis supports regulatory submi
Slide 4: Pipeline Targeting Life-Threatening Cancers with High Unmet Needs
Pipeline Targeting Life-Threatening Cancers with High Unmet Needs Planned Milestones Program Preclinical Phase 1 Phase 2 Phase 3 OCULAR ONCOLOGY Primary Choroidal Melanoma YE 2023 – FPI Ph 3 trial (Suprachoroidal administration) Choroidal Metastasis YE 2024 – Ph 2 data (Multiple primary cancers with
Slide 5: Targeted Oncology Platform: Virus-Like Drug Conjugates (VDCs)
Targeted Oncology Platform: Virus-Like Drug Conjugates (VDCs) Potential Treatment of Virus-Like Particle Conjugated Selective Binding to Tumor Associated HSPGs* to a Cytotoxic Payload Multiple Solid Tumors Cx Virus-Like Drug Virus-Like Particle Cytotoxic Drug Conjugate (VDC) (VLP) Potential Key Diff
Slide 6: Bel-sar is a VDC with a Novel Dual Mechanism of Action
Bel-sar is a VDC with a Novel Dual Mechanism of Action Reactive oxygen species disrupts cell membrane and organelles Light Activatable Drug Bel-sar Bel-sar is a novel VDC that consists of VLP conjugated to ~200 molecules of light activatable drug Potential Key Differentiation: Agnostic to Genetic Mu
Slide 7: Ocular Oncology Bel-sar Franchise
Ocular Oncology Bel-sar Franchise INN: belzupacap sarotalocan Target Indications: • Early-Stage Choroidal Melanoma • Choroidal Metastasis • Other Ocular Cancers 7
Slide 8: Primary Choroidal Melanoma—High Unmet Medical Need
Primary Choroidal Melanoma—High Unmet Medical Need Most common primary Uvea: Choroid, Ciliary Body and Iris 2 intraocular cancer in adults Choroid is 90% 1 of the uvea choroid Impacts ~11,000 3 50% of patients patients in US/Europe per year develop metastasis within 15 years (metastatic uveal ~80% p
Slide 9: Radiotherapy is the Standard of Care for Early-Stage Disease
Radiotherapy is the Standard of Care for Early-Stage Disease Plaque Brachytherapy for Choroidal Melanoma Requires Invasive Surgery with Irreversible Complications and Does Not Prevent Metastasis 2 (A) Schematic drawing showing a Collaborative Ocular Melanoma Study (COMS) style plaque Surgical treatm
Slide 10: Up to 87% of Patients Will be Blinded when Treated with Radiotherapy
Up to 87% of Patients Will be Blinded when Treated with Radiotherapy Contrast Sensitivity Diminishes Significantly within Proportion of Patients Legally Blind (BCVA the First Year after Brachytherapy and Continues to Proportion of patients legally blin 1, d 2 (BCVA ≤20/200) after Brachytherapy 2 Det
Slide 11: Benefit/Risk of Radiotherapy Drives "Watch and Wait" in Early-Stage Disease
Benefit/Risk of Radiotherapy Drives “Watch and Wait” in Patients with Early-Stage Disease Early Stage Late Stage Metastatic Disease 2 Indeterminate Lesions and Small PCM Medium/large PCM (~2,000) 1 1 (~8,000) (~2,300) Watch and Wait/Brachytherapy Systemic Chemotherapy Brachytherapy: Vision Loss/Blin
Slide 12: Bel-sar has the Potential to be the First Approved Therapy in Primary Choroidal Melanoma
Bel-sar has the Potential to be the First Approved Therapy in Primary Choroidal Melanoma Bel-sar is Delivered by Simple Light Activation with Standard Goals of Treatment Suprachoroidal Injection Ophthalmic Laser Local tumor control suprachoroidal Preservation of vision No radiation-related morbidity
Slide 13: Ocular Oncology Franchise Represents a Multi-Billion Dollar Addressable Market Opportunity
Ocular Oncology Franchise Represents a Multi-Billion Dollar Addressable Market Opportunity ~66,000 patients/year 11,000 patients/year Ocular Oncology Franchise total addressable market (US/EU) Choroidal Melanoma patients diagnosed each year (US/EU) 3 1 ~35,000 patients/year 11,000 patients/year Curr
Slide 14: Potential Future Patient Treatment Journey
Potential Future Patient Treatment Journey Early Stage Late Stage Metastatic Disease 2 Indeterminate Lesions and Small PCM Medium/large PCM (~2,000) 1 1 (~8,000) (~2,300) Chemotherapy Brachytherapy: Vision Loss/Blindness (KIMMTRAK) First Line Treatment Treatment with Bel-sar Bel-Sar has the Potentia
Slide 15: Bel-sar has Demonstrated a Favorable Profile for Treatment of Early-Stage Disease
Bel-sar has Demonstrated a Favorable Profile for the Treatment of Early-Stage Disease Darovasertib + Crizotinib 1 KIMMTRAK Bel-Sar 2 Combination Adverse Event or Adverse Reactions Any Grade Any Grade Any Grade* Cytokine release syndrome 89% Not Disclosed 0% Rash 83% Not Disclosed 0% Pyrexia 76% Not
Slide 16: Choroidal Melanoma Ph 2 Data
Choroidal Melanoma Ph 2 Data 16
Slide 17: Ph 2 Trial – Dose Escalation and Expansion with Suprachoroidal Administration
Ph 2 Trial – Dose Escalation and Expansion with Suprachoroidal Administration Patient Population Representative of Early-Stage Disease: Indeterminate Lesions and Small Choroidal Melanoma Trial Design – Enrollment Complete (n=22) Endpoint Endpoint Definitions Growth in Tumor Height 9 doses- 80 μg 6-9
Slide 18: High Tumor Control Rates Observed – Durable at 12 Months Follow Up
High Tumor Control Rates Observed – Durable at 12 Months Follow Up Dose Response: >90% Completed 12 Months Subtherapeutic vs Therapeutic Regimen Total Patients Tumor Control Dose/Regimen (n) Rate 100% Subtherapeutic Regimens 80% 80% Single dose up to 2 cycles 10 20% (2/10) 60% Therapeutic Regimen 3
Slide 19: High Tumor Control Rates Observed in Ph 3 Population Treated with Therapeutic Regimen
High Tumor Control Rates Observed in Ph 3 Population Treated with Therapeutic Regimen Subtherapeutic Regimens (n=10) Active Growth and 3 Cycle Regimens (n=10) Change from Baseline in Tumor Thickness Over 12 Months Change from Baseline in Tumor Thickness Over 12 Months 2.00 1.75 1.50 1.25 1.00 0.75 0
Slide 20: Ph 2 Interim Data Demonstrated a Negative Growth Rate Post-Treatment
Ph 2 Interim Data Demonstrated a Negative Growth Rate Post- Treatment Successful Treatment with 3 Cycle Regimen in Ph 3 Eligible Tumors with Active Growth Change in Tumor Growth (mm/yr) (n=8) P < 0.0001 + 0.383 - 0.001 August 3, 2023, data on file Aura Biosciences Tumor thickness growth rates/ slope
Slide 21: 90% Visual Acuity Preservation Despite High Risk for Vision Loss
90% Visual Acuity Preservation Despite 80% of These Patients Being at High Risk for Vision Loss >90% Patients Completed 12 months . Total Vision Vision Patients Failures Preservation Median Change in BCVA in Ph3 Eligible Populations (n) (n) Rate Patients with Therapeutic Regimen (n=10) All Dose Coho
Slide 22: Ph 2 Safety Data Supports Potential to be First Line Treatment
Ph 2 Safety Data Supports Potential to be First Line Treatment in Early-Stage Disease + Adverse Event Radiotherapy* Bel-Sar Ongoing Ph 2 Safety Outcomes with SC Administration + Surgeries secondary to AEs (e.g., Cataracts) 40%+ 0% All Treated Subjects (n=22) Radiation Retinopathy 40%+ 0% Grade III T
Slide 23: Randomized Controlled Global Ph 3 Trial
Randomized Controlled Global Ph 3 Trial 23
Slide 24: SPA Agreement with FDA Supports Global Ph 3 Trial Design
SPA Agreement with FDA Supports Global Ph 3 Trial Design Fast Track and Orphan Designations SPA Agreement 80 µg bel-sar treatment arm (n=40) 15 Month Primary Efficacy Analysis Randomize 40 µg bel-sar treatment arm (n=20) (2:1:2) Sham control arm (n=40) Enrollment (N=~100) Primary Endpoint First Key
Slide 25: Kaplan-Meier Analysis Simulation of Key Primary & Secondary Endpoint with Ph 2 Data
Kaplan-Meier Analysis Simulation of Key Primary & Secondary Endpoint with Ph 2 Data Time to Tumor Progression Time to Composite Endpoint Log-rank test Log-rank test p=0.0012 p=0.0023 Subtherapeutic up to 2 cycles (n=10) Subtherapeutic up to 2 cycles (n=10) 3 cycles (n=10) 3 cycles (n=10) Days Days N
Slide 26: Clinical Endpoints to Support Potential Approval in Alignment with Regulatory Agencies
Clinical Endpoints to Support Potential Approval in Alignment with Regulatory Agencies Endpoint Endpoint Assumptions Endpoint Definitions Bel-sar: 35% Tumor Progression Growth in Tumor Height ≥0.5mm or Tumor Progression Sham: 80% Tumor Progression ≥1.5 mm in Largest Basal Diameter Bel-sar: 15% VA Lo
Slide 27: Choroidal Metastasis
Choroidal Metastasis ” aura
Slide 28: Choroidal Metastasis is a High Unmet Medical Need
Choroidal Metastasis is a High Unmet Medical Need Standard of Care is Daily Radiotherapy Originate from Multiple for 4 Weeks Primary Cancers Breast Skin (e.g., Breast and Lung) 40-53% 2% 20,000/year eyes Lung diagnosed in US Kidney 20-29% 2% 88% with choroidal location GI Prostate 72% unilateral and
Slide 29: Choroidal Metastasis – Ph 2 Trial Design
Choroidal Metastasis – Ph 2 Trial Design Study Design (n=12*) Cohort 1a Cohort 2a Cohort 3a Cohort 3b N=3 patients N=3 patients N=3 patients N=3 patients 80µg x 2L 140µg x 2L 200µg x 2L 200µg x 2L 1 cycle 1 cycle 1 cycle 2 cycles Study Objectives Study Population • Safety/DLT • Patients with unilate
Slide 30: Urologic Oncology Bel-sar
Urologic Oncology Bel-sar INN: belzupacap sarotalocan Target Indications: Bladder Cancer 30
Slide 31: Bladder Cancer is a High Unmet Medical Need
Bladder Cancer is a High Unmet Medical Need 61,000 20,000 ~500,000 1 1 2 New cases/year in the US New cases/year in the US New cases/ year globally Muscle Invasive Bladder Cancer Non-Muscle Invasive Bladder Cancer Unmet Need Unmet Need Recurrence, multiple TURBT surgeries, Progression of Disease, Lo
Slide 32: Bel-Sar has the Potential to be Front Line in Conjunction with TURBT
Bel-Sar has the Potential to be Front Line in Conjunction with TURBT Adjuvant Urologist Therapy Intravesical Presents with Diagnosis and Cystectomy BCG Refractory BCG >6 tx TURBT gene therapy Blood in urine Treatment Plan (Adstiladrin) Systemic INTRAVESICAL recurrence Immunotherapy CHEMOTHERAPY (Key
Slide 33: Bel-Sar has a Unique MoA Designed for the Local Treatment
Bel-Sar has a Unique MoA Designed for the Local Treatment Local Administration and Light Activation with Standard Cystoscope Treatment Aligned with Current Urologic Oncology Practice Bladder injections are Lasers are commonly used common and simple to by urologists perform (e.g., Botox) Precedent fo
Slide 34: Ph 1 Trial Designed to Evaluate Safety, Feasibility and MoA
Ph 1 Trial Designed to Evaluate Safety, Feasibility and MoA Study Objectives Study Design and Objectives (n=19) • Safety/DLT • Feasibility of technique Completed Part 1 (n=5) • Focal distribution of bel-sar No treatment-related Bel-sar Alone • Focal necrosis adverse events, serious adverse events or
Slide 35: Clinical Complete Response with Immune Activation after Single Dose Confirmed by Histopathology
Clinical Complete Response with Immune Activation after Single Dose Confirmed by Histopathology Ph 1- Preliminary Data Light Activated Cohort (n=1) TURBT DAY 1 Biopsy Biopsy Day 1 Day 1 Day 2 Day 3-7 Day 9 Day 2 Day 9 Day 1 Urologist performs Light Urologist performs TURBT in area where Diagnostic b
Slide 36: Pre-Treatment Biopsy (Day 1) shows Papillary Urothelial Carcinoma
Pre-Treatment Biopsy (Day 1) shows Papillary Urothelial Carcinoma H&E Stain Papillary urothelial carcinoma Example of papillary carcinoma (Ta) Pre-injection bladder biopsy demonstrating low-grade papillary urothelial carcinoma; non-invasive. 36
Slide 37: Clinical Complete Response Confirmed by Histopathology after Single Dose of Bel-sar
Clinical Complete Response Confirmed by Histopathology after Single Dose of Bel-sar Disappearance of all cancer cells after treatment and immune activation Immune infiltrate necrosis Post-treatment TURBT demonstrating necrosis, inflammatory infiltrate, and no residual carcinoma. Circled region shows
Slide 38: Durable CRs with Single Administration of Bel-sar in Bladder Cancer Model
Durable CRs with Single Administration of Bel-sar in Bladder Cancer Model Treatment of Tumor Caused Anti-Tumor Immune Response and Prevented Tumor Growth After Re-Challenge Tumor Regression Survival Survival After Re-challenge 100 100 1600 Control 1400 anti-PD-1 80 80 AU-011 1200 anti-PD-1 + AU-011
Slide 39: Strategy & Key Milestones
Strategy & Key Milestones i * aura
Slide 40: Aura Biosciences Investment Highlights
Aura Biosciences Investment Highlights • Primary Choroidal Melanoma • SPA Agreement with FDA supports regulatory submission • Ph 2 data supports assumptions for Ph 3 study (powered at 95%) Key Highlights • Global Ph 3 trial ongoing with many sites activated in the US • Bladder Cancer (NMIBC/MIBC) •
Slide 41: Slide 41
Slide 42: Bel-Sar Has Shown Long Term Durable Response with Visual Acuity Preservation
Bel-Sar Has Shown Long Term Durable Response with Visual Acuity Preservation in Phase 3 Eligible Patient Base Line Characteristics Base Line Characteristics Phase 3 Eligible Subject Documented Tumor Growth Yes Tumor Size at Baseline AU-011 Treatment Cycles Tumor Height 1.03 mm Largest Basal Diameter
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