Aura Biosciences, Inc. · NASDAQ:AURA
Aura Biosciences — Investor Presentation (September 2024)
33 slides from Aura Biosciences's investor presentation, Sep 12, 2024
Slide 1: Innovating the future of cancer care to cure patients and preserve organ function
Exhibit 99.2 September 2024 Innovating the future of cancer care to cure patients and preserve organ function
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: Well positioned with multiple near-term clinical catalysts
Well positioned with multiple near-term clinical catalysts Precision therapy Late-stage clinical Large market opportunity Key upcoming platform development in areas of unmet need catalysts Developing a novel class of Phase 3 in primary uveal Ocular oncology Multiple clinical data 1–7 drugs called vi
Slide 4: Clinical pipeline across multiple solid tumor indications
Clinical pipeline across multiple solid tumor indications Program Preclinical Phase 1 Phase 2 Phase 3 Planned milestones Ocular oncology 2024 – Phase 3 enrollment Primary uveal melanoma ongoing Metastases to the choroid 2024 – Phase 2 initiation Multiple primary cancers with metastasis YE 2024 – Ini
Slide 5: Bel-sar is a potential first-in-class therapy for multiple solid tumors
Bel-sar is a potential first-in-class therapy for multiple solid tumors
Slide 6: Virus-like drug conjugates (VDCs) are a novel technology platform
Virus-like drug conjugates (VDCs) are a novel technology platform Virus-like particle (VLP) Light-activatable molecules Bel-sar (AU-011) is a VDC designed with dual specificity to reduce potential for off-target effects: • Non-replicating viral capsid • VLP conjugated to ~200 (no genetic material) m
Slide 7: Bel-sar has a novel dual mechanism of action
Bel-sar has a novel dual mechanism of action Reactive oxygen species disrupts cell membrane and organelles Disruption of tumor cell membrane and pro-immunogenic cell death by necrosis T cell activation and immune-mediated tumor cell killing Potential key differentiation: • Genetic mutation-agnostic
Slide 8: Ocular Oncology
Ocular Oncology Bel-sar target indications: Primary uveal melanoma | Metastases to the choroid | Ocular surface cancers
Slide 9: Ocular oncology franchise total addressable market
~66,000 patients/year Bel-sar opportunities Ocular oncology franchise total addressable market (US/EU) in ocular oncology represent a multi- a,1–5 6 ~35,000/yr ~11,000/yr billion-dollar Ocular surface cancers Primary uveal melanoma addressable market • With only ~100 ocular oncologists in the US/EU,
Slide 10: Bel-sar is in phase 3 for primary uveal melanoma
Choroid is 90% 1 of the uvea Bel-sar is in phase 3 for primary uveal Most common primary 2,3 melanoma, the most intraocular cancer in adults 3 ~11,000/yr common primary Choroidal melanoma intraocular cancer ~80% of patients diagnosed 3 with early-stage disease in adults Iris • Primary uveal melanoma
Slide 11: Current treatment paradigm for primary uveal melanoma
Current treatment paradigm for primary uveal melanoma Small Medium Large Metastatic SIZE 1 2.5 – 3 >10 (mm): Indeterminate lesions Small melanomas Risk Factors Growth Small CM Enuc. Observation Systemic chemotherapy Radiotherapy Radiotherapy (KIMMTRAK®) Local – Early Local – Late Metastatic (~8,000)
Slide 12: High morbidity associated with current standard of care
High morbidity associated with current standard of care 3–6 Radiotherapy Up to 87% of primary uveal melanoma patients become legally blind 1,2 Adverse Event over time in the eye treated with radiotherapy Surgeries secondary to AEs 40%+ (e.g., cataracts) Proportion of patients legally blind (BCVA Rad
Slide 13: Bel-sar has the potential to be the first approved vision-preserving therapy
Treatment Goals Bel-sar has the potential to be the Reduce metastasis Local tumor Vision No radiation- Improve safety risk with early control preservation related morbidity and quality of life first approved vision- treatment preserving therapy in In-office procedure primary uveal melanoma Delivery
Slide 14: Phase 2 trial of bel-sar for choroidal melanoma
Phase 2 trial of bel-sar for choroidal melanoma: Open-label, dose-escalation with suprachoroidal administration Trial design – 22 participants enrolled Patient population representative of early-stage disease: Small choroidal melanoma and indeterminate lesions Subtherapeutic regimens Therapeutic reg
Slide 15: Baseline characteristics of study participants
All patients (n=22) Female (%) 54.5 White, not Hispanic or Latino (%) 100 Subretinal fluid at screening (%) 100 Baseline Orange pigment at screening (%) 86.4 characteristics 86.4 Documented growth prior to screening (%) (100% of therapeutic group) Mean age at screening (years, ± SD) 59.2 (±16.5) All
Slide 16: High tumor control rates with therapeutic regimen
High tumor control rates with therapeutic regimen in phase 3-eligible patients with active growth Phase 3-eligible 100% participants 80% 80% Tumor control Dose/ Regimen n rate, % High local complete response rate at 12 60% Subtherapeutic regimen months follow-up ≤2 cycles 10 20% (2/10) 40% a 80% tum
Slide 17: Rate of tumor growth with bel-sar treatment
Rate of tumor growth with bel-sar treatment P < 0.0001 In phase 3-eligible 1.0 0.5 Untreated patients, the 3-cycle projected growth rate 0.351 regimen resulted in 0.4 0.5 cessation of growth Pre-treatment 0.3 among responders (N=8) actual growth rate 0.0 0.2 Post-treatment 0.1 0.011 actual growth ra
Slide 18: Median change in BCVA with therapeutic regimen
Median change in BCVA in phase 3-eligible participants with therapeutic regimen a (N=10) Visual acuity was 5 preserved in 90% of 0 • Vision preservation in phase 3-eligible 9/10 participants • Loss of 18 letters in one patients receiving a -5 patient with progression of -5 preexisting juxtafoveal fl
Slide 19: Phase 2 safety outcomes
Phase 2 safety outcomes (bel-sar/laser-related) All treated participants (n=22)* Drug/laser-related Grade I Grade II Grade III-V Total adverse events Bel-sar treatment Anterior chamber inflammation** 4 (18.2%) 0 0 4 (18.2%) had a favorable Anterior chamber cell** 2 (9.1%) 0 0 2 (9.1%) safety profile
Slide 20: Global phase 3 CoMpass trial now enrolling
Bel-sar for small choroidal melanoma or indeterminate lesions: Global phase 3 CoMpass trial now enrolling Target enrollment ~100 participants globally Anticipated sites in North America, Europe, Middle East and Asia-Pacific Regions Primary endpoint 80 µg bel-sar treatment arm Time to tumor progressi
Slide 21: Phase 2 final data represented using planned phase 3 endpoints
j 11 1 .0 ..0 0 + C + C ens ens o o red red Time to tumor 00 0 .8 ..8 8 progression 00 0 .6 ..6 6 P = 0.0005 Change from baseline in thickness ≥0.5 mm; or in LBD ≥1.5 mm 0.4 0 0..4 4 confirmed by at least one repeat Phase 2 final data assessment 00 0 .2 ..2 2 represented using 00 0 .0 ..0 0 planned
Slide 22: Phase 2 data support phase 3 assumptions
Phase 2 data support phase 3 assumptions Robustness analysis of tumor control rates 100% Overall rate P < 0.05 P < 0.005 in phase 2 80% 2x “worse” than phase 2 60% 2x “worse” Actual data 94% Actual data 93% than phase 2 (Δ60) >99% power (Δ60) >99% power power (Δ30) power (Δ20) 40% Overall rate Actua
Slide 23: Ocular oncology franchise total addressable market
~66,000 patients/year Bel-sar opportunities Ocular oncology franchise total addressable market (US/EU) in ocular oncology represent a multi- a,1–5 6 ~35,000/yr ~11,000/yr billion-dollar Ocular surface cancers Primary uveal melanoma addressable market • With only ~100 ocular oncologists in the US/EU,
Slide 24: Metastases to the choroid: Phase 2 trial expected to begin in 2024
Metastases to the choroid: Phase 2 trial expected to begin in 2024 Planned Study Design (n=12*) Cohort 1 Cohort 2 Cohort 3 Cohort 4 (N=3) (N=3) (N=3) (N=3) 80µg 160µg 200µg 200µg 1 cycle 1 cycle 1 cycle 2 cycles • Patients with unilateral, unifocal • Safety/dose-limiting toxicity metastases to the c
Slide 25: Urologic Oncology
Urologic Oncology Bel-sar target indications: Non-muscle-invasive bladder cancer | Muscle-invasive bladder cancer
Slide 26: Bladder cancer is a global high unmet medical need
Bladder cancer is a global high unmet medical need Non-Muscle Invasive Bladder Cancer Muscle Invasive Bladder Cancer ~500,000 1 New cases/ year globally >200,000 NMIBC 1 New cases/year US, Europe & Asia >60,000 MIBC Unmet Need Unmet Need 1 New cases/year US, Europe & Asia Recurrence, multiple TURBT
Slide 27: Current treatment paradigm for bladder cancer
Current treatment paradigm for bladder cancer Low grade – Low & intermediate risk High risk papillary disease CIS – BCG unresponsive Progression Adjuvant therapy Adjuvant therapy Adjuvant therapy Intravesical gene therapy (Adstiladrin®) BCG >6 tx TURBT BCG >6 tx TURBT Systemic immunotherapy (Keytrud
Slide 28: Bel-sar treatment goals in bladder cancer
Treatment Goals Focal treatment Stimulate anti- Improvement in Reduce risk Avoid TURBT / with direct tumor tumor specific safety and quality of recurrence operating room cell killing T cell response of life Bel-sar has the In-office procedure potential to be a front-line therapy Bel-sar can potentia
Slide 29: Bel-sar's local administration aligned with current urologic oncology practice
Bel-sar’s local administration aligned with current urologic oncology practice Bel-sar as potential No virus replication or viral shedding front-line therapy in NMIBC may be Lasers and bladder injections (e.g. botox) are commonly used optimized for in office- based procedure Goals of treatment with
Slide 30: Phase 1 trial for NMIBC and MIBC patients
21 participants TURBT and cystectomy patients Phase 1 trial for NMIBC and MIBC patients bladder cancer Part 1 (n=5) Part 2 (n=16) designed to evaluate Bel-sar alone Bel-sar + focal light activation safety, feasibility, NMIBC MIBC and MoA n=10 n=6 Completed No treatment-related AEs, SAEs, or dose-lim
Slide 31: Phase 1 preliminary data: Light-activated cohort
Phase 1 preliminary data: Light-activated cohort (n=1) Clinical complete TURBT response with immune activation after single dose confirmed Pathology by histopathology Day 1 Day 2 Day 3–7 Day 9 • Diagnostic pathology shows • Urologist performs light • Urologist performs TURBT in non-invasive, low gra
Slide 32: Clinical complete response with immune activation after single dose
Clinical complete response with immune activation after single dose confirmed by histopathology (part 2; first patient) Evidence of complete response by absence of tumor cells, as well as immune activation, Immune infiltrate after single dose treatment in first patient Example of papillary carcinoma
Slide 33: Company highlights
Company highlights Corporate Ocular Oncology Therapeutic Area • Strong cash position – expected to fund Primary uveal melanoma operations into 2H 2026 • Global phase 3 CoMpass trial actively • Experienced leadership team across functions enrolling • Special Protocol Assessment (SPA) agreement with F
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