Aura Biosciences, Inc. · NASDAQ:AURA
Aura Biosciences — Investor Presentation (October 2022)
46 slides from Aura Biosciences's investor presentation, Oct 3, 2022
Slide 1: October 2022 Corporate Presentation
Exhibit 99.2 October 2022 Corporate Presentation
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: Novel Oncology Platform Using Virus-Like Drug Conjugates (VDCs)
Novel Oncology Platform Using Virus-Like Drug Conjugates (VDCs) - Multi-billion dollar market opportunity Ocular Oncology Franchise - Standard of care is invasive and may lead to blindness and eye loss - Completed Phase 1b/2 trial: Positive data in key clinical endpoints Foundational Value - FDA/EMA
Slide 4: Pipeline Targeting Life-Threatening Cancers with High Unmet Needs
Pipeline Targeting Life-Threatening Cancers with High Unmet Needs Program Preclinical Phase 1 Phase 2 Pivotal Milestones OCULAR ONCOLOGY ü 2022 – Phase 2a safety and efficacy data Primary Choroidal Melanoma Q4 2022 – Initiate Phase 2b (pivotal trial) (Ph 1b/2 Intravitreal and Ph2 Suprachoroidal) Cho
Slide 5: Experienced Team
Experienced David Johnson Elisabet de los Pinos, PhD Cadmus Rich, MD Julie Feder Mark De Rosch, PhD Executive Board Chair Founder & Chief Medical Officer, Chief Operating Officer Chief Financial Officer Chief Executive Officer Head of R&D Team and CEO (acq Merck) Board CEO (acq AstraZeneca) 20+ 20+
Slide 6: Targeted Oncology Platform - Virus-Like Drug Conjugates (VDCs)
Targeted Oncology Platform - Virus-Like Drug Conjugates (VDCs) Virus-Like Particles Conjugated Selective Binding to Potential Treatment of Multiple Solid Tumors to a Cytotoxic Payload Tumor Associated HSPGs Cx Virus-Like Drug Virus-Like Particle Cytotoxic Drug Conjugate (VDC) (VLP) Potential Key Dif
Slide 7: Bel-Sar (AU-011) Is a VDC with a Novel Dual Mechanism of Action
Bel-Sar (AU-011) Is a VDC with a Novel Dual Mechanism of Action Light Activated Drug Bel-Sar Bel-Sar is a novel VDC that consists of VLP conjugated to ~200 molecules of light activated drug Potential Key Differentiation: Physical ablation is agnostic to genetic mutations and may reduce risk of devel
Slide 8: Ocular Oncology AU-011 Franchise
Ocular Oncology AU-011 Franchise INN: belzupacap sarotalocan Target Indications: • Early-Stage Choroidal Melanoma • Choroidal Metastasis • Other Ocular Cancers 8
Slide 9: Choroidal Melanoma – High Unmet Medical Need with No Drugs Approved
Choroidal Melanoma – High Unmet Medical Need with No Drugs Approved The choroid is the part of the uvea that is behind the retina Standard of Care is Radiotherapy or Enucleation Melanocytic Most common primary Lesion intraocular cancer in adults Impacts 11,000 patients in US/Europe per year Melanoma
Slide 10: 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 Intravitreal Light Activation with Standard or Suprachoroidal Injection Goals of Treatment Ophthalmic Laser Local tumor control intravitreal Preservation of vision No radioactive c
Slide 11: Ocular Oncology Franchise Represents a Multi-Billion Dollar Commercial Opportunity
Ocular Oncology Franchise Represents a Multi-Billion Dollar Commercial Opportunity 11,000 33,500 Ocular Oncology Franchise total addressable market Choroidal Melanoma patients diagnosed each year (US/EU) 2,000 patients/year Current radiotherapy 11,000 patients/year ~80% Cancers of the Ocular Surface
Slide 12: Clinical Program Ocular Oncology AU-011 Franchise
Clinical program Ocular Oncology AU-011 Franchise INN: belzupacap sarotalocan Initial Target Indication: Early-Stage Choroidal Melanoma 12
Slide 13: Current Standard of Care is Invasive with Significant Co-Morbidities
Current Standard of Care is Invasive with Significant Co-Morbidities Standard of Care is Radiotherapy or Enucleation Standard of Care Often Results in Irreversible Vision Loss — Does Not Reduce Rate of Developing Metastasis 13
Slide 14: Goal for Bel-Sar: Eliminate Malignant Cells in the Choroid and Preserve Vision
Goal for Bel-Sar: Eliminate Malignant Cells in the Choroid and Preserve Vision 3mm 3mm 3mm Fibrotic Scar Melanoma Unaffected cells Benign nevus cells nevus cells Baseline Measurement Treatment Post-treatment Measurement (Unchanged Tumor Height) Many early-stage melanomas have Bel-Sar targets only th
Slide 15: Study Design and Clinical Endpoints in Phase 1b/2 IVT Trial
Study Design and Clinical Endpoints in Phase 1b/2 IVT Trial Dose escalation and expansion study with up to two cycles of therapy Evaluated safety and efficacy over 12 months Additional follow up in registry trial for 4 years to evaluate vision, tumor control and onset of metastases Endpoint Definiti
Slide 16: Phase 1b/2 – Key Patient Populations and Objectives
Phase 1b/2 – Key Patient Populations and Objectives Primary Objective: Safety All Patients Enrolled with Clinical Diagnosis of Choroidal Melanoma or Indeterminate Lesions £ Drug or treatment related adverse events Efficacy Evaluation (AEs) / serious adverse events (SAEs) Safety Evaluation Therapeuti
Slide 17: Phase 1b/2 – Two Cycles of Therapy is a Therapeutic Regimen
Phase 1b/2 – Two Cycles of Therapy is a Therapeutic Regimen Tumor Control Rates 12 months Tumor Control - Highest Treatment Regimen (Cohorts 10 - 12) vs Lower Regimens (Cohorts 1 - 9) Tumor Control Rate Total Patients Populations (n) (at 12 months) 100.0% Highest/Therapeutic All Doses/Regimens Dose/
Slide 18: Phase 1b/2 – Tumor Control Achieved with Therapeutic Regimen
Phase 1b/2 – Tumor Control Achieved with Therapeutic Regimen All Patients with Active Growth Tumor Control Rate at 12 months Treated with 2 Cycles (n=14) Tumor Control Rate Total Patients Populations (n) (at 12 months) Therapeutic Dose/Regimen (2 Cycles) All Patients Treated with 2 Cycles 20 70% (14
Slide 19: Phase 1b/2 – Statistically Significant Growth Rate Reduction
Phase 1b/2 – Statistically Significant Growth Rate Reduction Change in Tumor Growth Change in Tumor Growth (mm/yr) Follow up 12 months AU-011 Total Historical Growth Rate Growth Rate Patients Growth Rate Reduction p-value Population (mm/yr) (mm/yr) (mm/yr) n 12 months * Active Growth/Therapeutic Reg
Slide 20: Phase 1b/2 – Visual Acuity was Preserved in Majority of Patients
Phase 1b/2 – Visual Acuity was Preserved in Majority of Patients Vision Preservation Rates Follow up 12 months Vision Preservation £ Vision loss was transient but recovered in Rate Total Patients Failure: Long term most patients after inflammation or Populations (n) loss ≥15 letters transient AEs re
Slide 21: Phase 1b/2 – Demonstrated Favorable Safety Profile
Phase 1b/2 – Demonstrated Favorable Safety Profile Majority of AEs Were Transient and Resolved Without Clinical Sequelae AU-011 Treatment Related AEs Adverse Event Radiotherapy* Bel-Sar Grade I/II Grade III ≥15% Subjects (n=56) Final Surgeries secondary to AEs (e.g., Cataracts) 40%+ ~13% Vitreous In
Slide 22: Summary of Ph 1b/2 (IVT) Clinical Results
Summary of Ph 1b/2 (IVT) Clinical Results AU-011 was well tolerated with the majority of AEs transient and managed with Safety the standard of care Visual acuity preservation rate of 71-86% even in subjects with tumors close to Visual Acuity the fovea or optic disk Tumor Control rate of 64%-70% in s
Slide 23: Retrospective Matched Case-Control Study
Retrospective Matched Case-Control Study 23
Slide 24: Retrospective MCC Study to Evaluate Visual Acuity Outcomes of Bel-Sar vs. Radiotherapy
Retrospective MCC Study to Evaluate Visual Acuity Outcomes of Bel-Sar vs. Radiotherapy • Matching criteria: baseline tumor thickness, LBD, distance to fovea/ optic disk, visual acuity (all 4 must match) • Matching performed by Independent Statistician (n=43 AU-011 and n=150 plaque matched case contr
Slide 25: rMCC Results – Visual Preservation with Bel-Sar vs. Radiotherapy
rMCC Results –Visual Preservation with Bel-Sar vs. Radiotherapy Statistically Significant (Year 2 Data) logMAR Visual Acuity Results – Bel-Sar vs Plaque Change in logMAR logMAR Bel-Sar Plaque Year Year Bel-Sar Plaque p-value Bel-Sar Plaque p-value Year 1 Year 1 0.182 0.216 0.6952 0.283 0.369 0.3415
Slide 26: rMCC Results – Analyses of Lines of Vision Loss
rMCC Results – Analyses of 3 & 6 Lines of Vision Loss Demonstrated Superiority of Bel-Sar vs Radiotherapy Loss of >3 and >6 Lines of logMAR Vision Loss of LogMAR ≥ 03 Loss of logMAR ≥0.6 (3 lines) (6 lines) Bel-Sar Plaque Year Year Bel-Sar Plaque Bel-Sar Plaque p-value p-value (%) (%) (%) (%) Year 1
Slide 27: Results Demonstrated Bel-Sar Preserves Visual Acuity at 2 Years
Results Demonstrated Bel-Sar Preserves Visual Acuity at 1 & 2 Years • Objective to compare 2 Year Bel-Sar vision value to yearly plaque values for 5 years • Statistical significance starting in Year 2 @ p<0.05 level • Primary endpoint – Change from baseline in logMAR vision at 5 years • Statisticall
Slide 28: Phase 2 Suprachoroidal Study
Phase 2 Suprachoroidal Study 28
Slide 29: Evaluating Suprachoroidal Administration to Determine Optimal Route for Pivotal Trial
Evaluating Suprachoroidal Administration to Determine Optimal Administration Route for Pivotal Trial Ph2 SC Trial Design: Dose Escalation Phase Patient Population Representative of Early- Single Dose Cohorts – Completed Stage Disease (IL/CM) 20 μg 40 μg 40 μg x 1 Laser x 1 Laser x 2 Lasers suprachor
Slide 30: Phase 2 Suprachoroidal Trial – Tumor Control Rates Demonstrated Dose Response
Phase 2 Suprachoroidal Trial– Tumor Control Rates at 6 Months of Follow Up Demonstrated Dose Response 3 Cycle Regimes vs. Lower Regimens Average 6 Months of Follow Up Average 6 Months Follow Up Total Average Patients Tumor Control Follow-up Populations (n) Rate (months) All Doses/Regimens All Treate
Slide 31: Phase 2 Suprachoroidal Trial – Early Analysis of Tumor Control with 2-3 Cycle Regimens
Phase 2 Suprachoroidal Trial – Early Analysis of Tumor Control with 2-3 Cycle Regimens Therapeutic Regimen (3 cycles) Tumor Control Rate Total Tumor Control Average Follow Patients Populations Rate (%,n) up (months) (n) Active Growth and Highest dose/Regimen* 3 Cycles (9 treatments) 9 88.9% (8/9) 6
Slide 32: Phase 2 Suprachoroidal Trial – Early Analysis of Tumor Growth Rate
Phase 2 Suprachoroidal Trial – Early Analysis of Tumor Growth Rate with 3 Cycles of Therapy Change in Tumor Growth (mm/yr) Change in Tumor Growth 3 Cycle Regimens (n=9) Total Average Historical AU-011 Growth Rate Patients Follow up Population Growth Rate Growth Rate Reduction p-value (mm/yr) (mm/yr)
Slide 33: Phase 2 Suprachoroidal Trial – Early Analysis of Visual Acuity
Phase 2 Suprachoroidal Trial – Early Analysis of Visual Acuity Showed Preservation Rate of 89% at the Highest Dose Regimen Vision Preservation Rates Average Total Vision Vision Mean Change Follow-up Patients Failures** Preservation from Baseline at Populations (n) (n) Rate Last Visit (letters) (mont
Slide 34: Ongoing Safety Evaluation Continues to Be Favorable
Ongoing Safety Evaluation Continues to Be Favorable with No Related SAEs/DLTs Observed to Date § Majority of AEs were transient and resolved Grade Grade Grade All Treated Subjects (n=20) without clinical sequelae Total Drug/Laser Related Adverse Events ≥10% Subjects I II III § No DLTs Anterior Chamb
Slide 35: Suprachoroidal Delivery Provides Additional Safety and Efficacy
Suprachoroidal Delivery Provides Additional Safety and Efficacy to Support Potential Treatment of Early-Stage Disease (IL/CM) Mild to moderate AEs overall and no related SAEs/DLTs observed to date Safety Visual acuity preservation rate of 87-90% even in subjects with tumors close to Visual Acuity th
Slide 36: Choroidal Metastasis
Choroidal Metastasis * aura
Slide 37: Choroidal Metastasis are a High Unmet Medical Need
Choroidal Metastasis are a High Unmet Medical Need Standard of Care is Radiotherapy Originate from Multiple Primary Cancers Breast Skin 40-53% 2% 20,000/year eyes Lung diagnosed in US Kidney 20-29% 2% 88% with choroidal location GI Prostate 72% unilateral and solitary 4% 2% Blindness, Eye Loss, and
Slide 38: ARVO – Bel-Sar Dose-Dependent Activity for Cancer Types Known to Metastasize to the Choroid
ARVO – Bel-Sar has Demonstrated Dose-Dependent Activity for Cancer Types Known to Metastasize to the Choroid Breast Cancer In-Vivo (Syngeneic Mouse Model, EMT-6) Reduced Tumor Growth Prolonged Survival 3 Tumor cells were implanted subcutaneously. AU-011 treatment was initiated when tumors reached ap
Slide 39: Oncology Franchise AU-011: Non-Muscle Invasive Bladder Cancer
Oncology Franchise AU-011 INN: belzupacap sarotalocan Target Indications: Non-Muscle Invasive Bladder Cancer 39
Slide 40: NMIBC is a High Unmet Need With No Approved Targeted Therapies
NMIBC is a High Unmet Need With No Approved Targeted Therapies 573,000 81,000 New cases/year globally New cases/year in the US Risk Stratification Treatment Guidelines Problem Cross section of the bladder wall and staging of bladder cancer Surveillance or Low Risk (40%) Recurrence after TURBT TURBT
Slide 41: Pre-clinical Activity Supports Initiation of Clinical Trials in NMIBC
Pre-clinical Activity Supports Initiation of Clinical Trials in NMIBC Treatment of Tumor Caused Anti-Tumor Immune Response and Prevented Tumor Growth After Re-Challenge Tumor Growth Survival Survival After Re-challenge 100 100 1600 Control 1400 anti-PD-1 80 80 AU-011 1200 anti-PD-1 + AU-011 1000 60
Slide 42: Phase 1 Trial Design: Intra-mural Administration in NMIBC
Phase 1 has the Possibility to Demonstrate Bel-Sar’s MoA in Intermediate and High-Risk Patients Intra-mural Administration Trial Design Bel-Sar will be administered in the lamina propria close to the base of the tumor Clinical Trial will Explore Bel-Sar Distribution, Local Necrosis and Evidence of I
Slide 43: Treatment of Primary and Distant Tumors is Enhanced by Bel-Sar with Immune Checkpoint Inhibitors
Treatment of Primary and Distant Tumors is Enhanced by Bel-Sar with Immune Checkpoint Inhibitors Primary Tumor Distant Tumors Bel-Sar is Synergistic with Immune Checkpoint Inhibitors and has Improved Primary and Distant Lesion Efficacy when Combined With PD-L1 and LAG-3 Antibodies Huis in‘t Veld, et
Slide 44: Drug Portfolio Strategy & Key Milestones
Drug portfolio Strategy & Key Milestones 44
Slide 45: Novel Oncology Platform Using Virus-Like Drug Conjugates (VDCs)
Novel Oncology Platform Using Virus-Like Drug Conjugates (VDCs) - Multi-billion dollar market opportunity Ocular Oncology Franchise - Standard of care is invasive and may lead to blindness and eye loss - Completed Phase 1b/2 trial: Positive data in key clinical endpoints Foundational Value - FDA/EMA
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