Aura Biosciences, Inc. · NASDAQ:AURA
Aura Biosciences — Investor Presentation (August 2025)
54 slides from Aura Biosciences's investor presentation, Aug 13, 2025
Slide 1: Innovating the future of cancer care to cure patients and preserve organ function
Innovating the future of cancer care to cure patients and preserve organ function August 2025 Exhibit 99.2
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", "co
Slide 3: Well positioned for continued clinical program execution
1. Yu G-P et al. Am J Ophthalmol. 2003;135(6):800-6. 2. Triay E et al. Br J Ophthalmol. 2009;93(11):1524-8. 3. Newton R et al. Lancet. 1996;347(9013):1450-1. 4. Dalvin LA. Br J Ophthalmol. 2018;102(12):1728-1734. 5. Sun EC et al. Cancer Epidemiol Biomarkers Prev. 1997;6(2):73-7. 6. Epidemiology anal
Slide 4: Clinical pipeline across multiple solid tumor indications
a.Virus-like drug conjugates (VDCs) bind to a subset of modified tumor associated glycosaminoglycans (GAGs) that are part of the heparan sulphate chain of heparan sulfate proteoglycans (HSPGs).1 1. Kines RC, and Schiller JT. Viruses. 2022;14(8):1656. mHSPG, modified heparan sulphate proteoglycan. Cl
Slide 5: Virus-like drug conjugates have the potential to transform early cancer treatment
DLT, dose-limiting toxicity; SAE, serious adverse event; VLP, virus-like particle. Virus-like drug conjugates have the potential to transform early cancer treatment 5 Positive clinical data in multiple early-stage local cancers Choroidal melanoma: Positive phase 2 end of study data; phase 3 ongoing
Slide 6: AU-011 has a novel dual mechanism of action
AU-011 has a novel dual mechanism of action Disruption of the tumor cell membrane and pro-immunogenic cell death by necrosis leads to T cell activation and immune-mediated tumor cell killing Kines RC, et al. Int J Cancer. 2016;138(4):901–11. Kines RC, et al. Mol Cancer Ther. 2018;17(2):565–74. Kines
Slide 7: Bel-sar's platform technology potentially applicable across multiple cancers
Bel-sar, belzupacap sarotalocan; CR, clinical complete response; CNS, central nervous system; GI, gastrointestinal; MIBC, muscle-invasive bladder cancer. The effectiveness and safety of bel-sar have not been established or clinically evaluated in tumors outside the ocular or bladder setting, and bel
Slide 8: Ocular Oncology
Ocular Oncology Bel-sar target indications: Early choroidal melanoma | Metastases to the choroid | Ocular surface cancers
Slide 9: Bel-sar opportunities in ocular oncology represent a multi-billion-dollar addressable market
Bel-sar opportunities in ocular oncology represent a multi-billion-dollar addressable market With only ~100 ocular oncologists in the US/EU, a global launch may be accomplished with a small (<20) field-based team aIncludes conjunctival melanoma, primary acquired melanosis, squamous cell carcinoma an
Slide 10: Early choroidal melanoma is a high unmet medical need
Bel-sar is in phase 3 for early choroidal melanoma, the most common primary intraocular cancer in adults Early choroidal melanoma is a high unmet medical need With no currently approved vision-preserving therapies, the current standard-of-care is radiotherapy – treatment that leads to legal blindnes
Slide 11: Current treatment paradigm for choroidal melanoma
aEach figure represents ~250 persons. 1. Shields CL et al. Choroidal and ciliary body melanoma. Available at: https://eyewiki.aao.org/Choroidal_and_Ciliary_Body_Melanoma Accessed September 9, 2024. 2. Singh AD, et al. Ophthalmology. 2005;112(10):1784–89. 3. Epidemiology analysis for choroidal melano
Slide 12: Current standard of care associated with high morbidity
a75-80% of patients diagnosed with early-stage disease7. 2/3 of patients present with symptoms, 1/3 of patients diagnosed during routine exam.8 1. Kaliki S, Shields CL. Eye. 2017;31(2):241–257. 2. Jarczak J et al. Medicina (Kaunas). 2023;59(6):1131. 3. Tsui I, et al. Open Ophthalmol J. 2015;9:131–5.
Slide 13: Bel-sar potential first approved vision-preserving therapy in early choroidal melanoma
Bel-sar has the potential to be the first approved vision-preserving therapy in early choroidal melanoma Bel-sar (AU-011) is an investigational product candidate. The effectiveness and safety of bel-sar have not been established, and bel-sar is not approved for use in any jurisdiction. No radiation-
Slide 14: Global phase 3 CoMpass trial now enrolling
Received fast track and orphan drug designations An SPA agreement indicates concurrence by the FDA that the design of the trial can adequately support a regulatory submission aEarly choroidal melanoma, small choroidal melanoma or indeterminite lesions. ETDRS, Early Treatment Diabetic Retinopathy Stu
Slide 15: High local complete response rate at 12 months follow-up
High local complete response rate at 12 months follow-up 80% tumor control ratea at 12 months among the 10 phase 3-eligible patients in the 3-cycle cohorts aLocal complete response, or CR, in early-stage choroidal melanoma is described as tumor control and complete arrest of tumor growth by ocular o
Slide 16: Visual acuity preserved in phase 3-eligible patients
Vision loss threshold (−15 letters) Populations Patients (n) Vision failuresb (n) Vision preservation rate (%) All dose cohorts All treated patients 22 1 95% Subtherapeutic ≤2 cycles 10 0 100% Therapeutic 3 cycles and phase 3-eligiblea 10 1 90% BCVA change from baseline (ETDRS letter score) Median c
Slide 17: Phase 2 end of study data using phase 3 endpoints
Phase 2 end of study data represented using phase 3 endpoints Kaplan-Meier analysis simulation of time-to-event Study duration 12 months. Participants either had an event or were censored at the last visit; some had their Week 52 visit after 365 days. Any events at the final visit are assigned to th
Slide 18: Bel-sar has a significant commercial opportunity in ocular oncology
aIncludes conjunctival melanoma, primary acquired melanosis, squamous cell carcinoma and ocular surface squamous neoplasia.2-6 1. Epidemiology analysis for choroidal melanoma and choroidal metastasis by ClearView Healthcare Partners and Putnam. 2. Yu G-P et al. Am J Ophthalmol. 2003;135(6):800-6. 3.
Slide 19: Metastases to the choroid
US/EU incidence. 1. Epidemiology analysis for choroidal melanoma and choroidal metastasis by ClearView Healthcare Partners and Putnam. 2. IARC Cancer Today. GLOBOCAN 2022 (version 1.1). Available at: Cancer Today. Accessed May 6, 2025. 3. Mathis T et al. Prog Ret Eye Res. 2019;68:144-176. Bel-sar (A
Slide 20: Metastases to the choroid: study expanded to any systemic carcinoma
Multiple sites activated Primary endpoint at one-month post-treatment; possibility to see tumor shrinkage and vision preservation/improvement a3+3 Design. Each cohort to have a minimum of 3 and a maximum of 6 patients. bSimplified schema of study design. Metastases to the choroid: Study expanded to
Slide 21: Cancers of the Ocular Surface: high unmet need
1. Yu G-P et al. Am J Ophthalmol. 2003;135(6):800-6. 2. Triay E et al. Br J Ophthalmol. 2009;93(11):1524-8. 3. Newton R et al. Lancet. 1996;347(9013):1450-1. 4. Dalvin LA. Br J Ophthalmol. 2018;102(12):1728-1734. 5. Sun EC et al. Cancer Epidemiol Biomarkers Prev. 1997;6(2):73-7. 6. Vora et al. Surv
Slide 22: Planned proof-of-concept phase 1 study for ocular surface tumors
IMAGE: Measure tumor BIOPSY: Main tumor Adjacent flat tumor Planned proof-of-concept phase 1 study of bel-sar for ocular surface tumors Day 1 Day 8 TREATMENT #2: Inject bel-sar intratumorally Light activate only over main tumor Day 15 IMAGE: Measure tumor SOC EXCISION: Main tumor Map Biopsies near p
Slide 23: Urologic Oncology
Urologic Oncology Bel-sar target indications: Intermediate-risk NMIBC | High-risk NMIBC
Slide 24: Bladder cancer: high unmet medical need for organ-sparing therapies
1. GLOBOCAN 2022. Bladder. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf. [Accessed October 1, 2024]. 2. Sung H, et al. CA Cancer J Clin. 2021;71(3):209–49. 3. Burger M, et al. Eur Urol. 2013;63(2):234–41. 4. Flaig TW, et al. J Natl Compr Canc Net
Slide 25: Current treatment paradigm based on upfront resection leads to recurrence
~80,000 ~20,000 Low grade – low & intermediate risk High-risk papillary disease High-risk CIS – BCG unresponsive BCG Intravesical chemotherapy ~4,000 TURBT recurrence Intravesical gene therapy Systemic immunotherapy TURBT recurrence Adjuvant therapy Adjuvant therapy Intravesical immunotherapy BCG In
Slide 26: Bel-sar has an innovative dual MoA
Bel-sar has an innovative dual MoA Long-term anti-tumor immune memory has the potential to provide immune surveillance, urothelial field effect, and prevent recurrence Robust targeted cytotoxicity designed to rapidly destroy cancer cells 1 2 Focal administration treats the tumor, not the entire urot
Slide 27: VDCs have potential advantages over oncolytic viruses
Virus-like drug conjugates (VDCs) have potential advantages over oncolytic viruses CMI, cell-mediated immunity. Broader and more specific tropism for binding over normal tissue No viral genes expressed to compete with tumor antigens for induction of CMI Killing mechanism promotes induction of CMI to
Slide 28: New formulation of bel-sar for use in bladder cancer
New formulation of bel-sar for use in bladder cancer BSL, biosafety level. AU-012 Stable at 2–8°C with simple refrigeration Convenient administration in urologist office anticipated No need for cold chain (–70°C) No need for biosafety (BSL-2) No need for general anesthesia <20-minute procedure No sp
Slide 29: Bel-sar may shift paradigm from resection-based to immune-ablative treatment
A, adjuvant treatment; APC, antigen-presenting cell; B, bel-sar; M, month; NIR, near-infrared. Bel-sar may shift the treatment paradigm from resection-based to immune-ablative front-line treatment Opportunity for direct tumor cell killing + long-term anti-tumor immunity B A A A T A A A A A A A A A A
Slide 30: Phase 1 NMIBC trial design
Clinicaltrials.gov identifier: NCT05483868; AU-011-102. Phase 1: Bel-sar administered before scheduled biopsy and standard of care (SoC) TURBT Day 1 Cystoscopy + biopsy bel-sar injection Day 2 Cystoscopy Laser light activation Day 9 ± 1 (Cohort A) Day 14+7 (Cohort B+C) Day 56 ± 7 End of follow-up Pa
Slide 31: Cohort A-C safety data
Cohort A-C: Single-dose drug with light activation Safety data No serious adverse events No dose limiting toxicities ACompiled safety data includes all completed light-activated cohorts (A, B, and C), including two patients treated but not efficacy evaluable. TEAE, treatment-emergent adverse event.
Slide 32: Clinical complete response efficacy data in NMIBC
aFor purposes of this analysis, Clinical complete response defined as absence of tumor cells on histopathologic evaluation. bBladder urothelial field effect: absence of tumor cells in non-target lesions. cPreviously treated tumor demonstrated high-grade disease but pathology at time of treatment rev
Slide 33: Efficacy data: Ta high-risk NMIBC
aClinical complete response defined as absence of tumor cells on histopathologic evaluation. bBladder urothelial field effect: absence of tumor cells in non-target lesions. cImmune response is defined by immunocyte infiltration on post-treatment histopathology. dTwo tumors in target tumor field with
Slide 34: Patient A3 case
Cohort A: Single-dose drug with light activation Patient A3 72-year-old Hispanic male Screening diagnosis: (2024) Multiple Ta low-grade (<3 cm) No CIS Screening AUA risk classification: Intermediate Initial diagnosis: (2019) Ta high-grade <3 cm No CIS Intermediate risk Prior TURBT: 2019, 2020 (x2),
Slide 35: Multiplex immunofluorescence: mature tertiary lymphoid structures in treated lesion
Multiplex Immunofluorescence: Patient A3 (Intermediate-Risk NMIBC) TLS Not Present in Lesion Prior to Treatment Mature Tertiary Lymphoid Structures (TLS) in Target (Treated) Lesion: Active Immunosurveillance After Bel-sar Treatment CD3: T cells CD20: B cells CD23: Follicular Dendritic Cells (FDC) (F
Slide 36: Early tertiary lymphoid structures in non-target lesion
Early Tertiary Lymphoid Structures (TLS) in Distant Non-Target (Non-Treated) Lesion: Urothelial Immune Field Effect After Bel-sar Treatment Multiplex Immunofluorescence: Patient A3 (Intermediate-Risk NMIBC) CD3: T cells CD20: B cells CD23: Follicular Dendritic Cells (FDC) (Found in B cell follicles,
Slide 37: Advancing bel-sar in NMIBC: phase 1b/2 trial overview
Clinicaltrials.gov identifier: NCT05483868; AU-011-102. Advancing bel-sar in NMIBC: Phase 1b/2 trial overview ~26 patients with NMIBC Intermediate-risk High-risk Potential use across disease spectrum Immune-ablative Multimodal neoadjuvant (bel-sar followed by TURBT) Two front-line treatment approach
Slide 38: Company highlights
1. ClearView & Putnam & Assoc. Epidemiology Analysis Choroidal Melanoma and Choroidal Metastasis. Bel-sar (AU-011) is an investigational product candidate. The effectiveness and safety of bel-sar have not been established, and bel-sar is not approved for use in any jurisdiction. Company highlights C
Slide 39: Appendix: VDC Platform
Appendix VDC Platform & aura
Slide 40: VDCs have potential advantages over antibody-drug conjugates
Virus-like drug conjugates (VDCs) have potential advantages over antibody-drug conjugates (ADCs) High tumor cell killing with preservation of organs and function Antibody-drug conjugate Bel-sar DAR (drug-antibody/VLP ratio) 2–8 200–500 Binding Bivalent Multivalent Tumor Tropism Narrow Broad Delivery
Slide 41: Appendix: Ocular Oncology
Appendix Ocular Oncology & aura
Slide 42: Phase 2 trial of bel-sar for choroidal melanoma
Goal: To determine safety, optimal dose and therapeutic regimen with suprachoroidal administration One cycle = Doses on days 1, 8, and 15. a12 patients enrolled, 1 patient who discontinued after 1 cycle due to unrelated SAEs is not included in data analysis (n=11). bCohort 2: 2 participants were pla
Slide 43: Baseline characteristics
Baseline characteristics All study participants aHigh risk for vision loss defined as tumor edge within either 3 mm of foveal center or 3 mm of optic disc edge. Data on file, Aura Biosciences. All patients (n=22) Female (%) 54.5 White, not Hispanic or Latino (%) 100 Subretinal fluid at screening (%)
Slide 44: High local complete response rate at 12 months
High local complete response rate at 12 months follow-up 80% tumor control ratea at 12 months among the 10 phase 3-eligible patients in the 3-cycle cohorts aLocal complete response, or CR, in early-stage choroidal melanoma is described as tumor control and complete arrest of tumor growth by ocular o
Slide 45: Rate of tumor growth with bel-sar treatment
Rate of tumor growth ± SE, mm/yr P < 0.0001 Rate of tumor growth with bel-sar treatment In phase 3-eligible patients, the 3-cycle regimen resulted in cessation of growth among responders (N=8) Tumor thickness growth rates/slopes estimated using Mixed Models for Repeat Measures (MMRM); random interce
Slide 46: Visual acuity preservation
Vision loss threshold (−15 letters) Populations Patients (n) Vision failuresb (n) Vision preservation rate (%) All dose cohorts All treated patients 22 1 95% Subtherapeutic ≤2 cycles 10 0 100% Therapeutic 3 cycles and phase 3-eligiblea 10 1 90% BCVA change from baseline (ETDRS letter score) Median c
Slide 47: Bel-sar treatment had a favorable safety profile
Bel-sar treatment had a favorable safety profile No posterior inflammation No treatment-related SAEs No grade 3–5 treatment-related AEs * Table presents participants with AEs related to bel-sar or laser by severity and overall; participants with >1 AE are counted in the highest severity group. Clini
Slide 48: Phase 2 data support phase 3 assumptions
ClinicalTrials.gov Identifier: NCT06007690; AU-011-301. Phase 2 data support phase 3 assumptions Phase 3 trial design P < 0.005 93% power (Δ20) Actual data (Δ60) >99% power P < 0.05 Robustness analysis of tumor control rates Overall rate in phase 2 2x “worse” than phase 2 2x “worse” than phase 2 Act
Slide 49: Appendix: Urologic Oncology
Appendix Urologic Oncology & aura
Slide 50: Paradigm-shifting treatment approach
Paradigm-shifting treatment approach Treat the tumor first to generate cell-mediated immunity (CMI) Neoadjuvant/multimodal (+ TURBT) Treat tumor with bel-sar first ahead of TURBT Immune-ablative (-TURBT) Treat tumor with bel-sar first and avoid the need for TURBT Value proposition: Prevent recurrenc
Slide 51: Bel-sar as standalone immune-ablative treatment or neoadjuvant to TURBT
Bel-sar has potential as a standalone immune-ablative treatment or as a neoadjuvant to TURBT Immune-ablative approach could eliminate the need for TURBT, or be used prior to resection to improve treatment outcomes HR, high-risk; IR, intermediate risk; LR, low-risk. Immune-ablative treatment without
Slide 52: Advancing bel-sar in NMIBC: phase 1b/2 study design
Dose per tumor, per treatment. Up to three tumors treated per visit. a+2-day window for injection in 2nd treatment cycle. D, day; W, week. Clinicaltrials.gov identifier: NCT05483868; AU-011-102. Advancing bel-sar in NMIBC: Phase 1b/2 study design 52 Immune-ablative Cycle 1 Cycle 2 8W Response assess
Slide 53: Single systemic bel-sar treatment in TC-1 murine tumor model
A single systemic treatment of bel-sar resulted in long-term tumor-free survival and induction of anti-tumor responses in TC-1 murine tumor model Long-term tumor-free survival and protection from tumor re-challenge CD4+ and CD8+ T-cells are required both at the time of treatment and at the time of r
Slide 54: CD4+ and CD8+ T-cells key to durability of response
Kines RC, et al. Cancer Immunol Res. 2021;9(6):693–706. CD4+ and CD8+ T-cells are key to the long-term durability of response and protection of rechallenge with bel-sar +1 9 11 Day: 0 100 Implant TC-1 tumor cells Tumor volume: 50mm3 7 10 13 20 Day: -100 0 Implant TC-1 tumor cells Rechallenge with TC
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