Core Insights - Aura Biosciences is advancing its clinical programs, particularly the Phase 3 CoMpass trial for early choroidal melanoma and the Phase 1b/2 trial for non-muscle invasive bladder cancer (NMIBC) [2][3][11] - The company successfully completed a $75 million equity financing, strengthening its balance sheet and ensuring operational funding into the first half of 2027 [1][17] - The ongoing CoMpass trial is the first registration-enabling study for early choroidal melanoma, with over 240 patients pre-screened for enrollment [3][4] Clinical Programs - The CoMpass trial is a global, randomized study evaluating bel-sar treatment against a sham control, targeting approximately 100 patients with documented tumor growth [3] - The trial is expected to complete enrollment by the end of 2025, highlighting the need for vision-preserving therapies [4] - Bel-sar is also being developed for metastases to the choroid and cancers of the ocular surface, with a combined annual incidence of over 60,000 patients in the U.S. and Europe [6][10] Financial Performance - As of June 30, 2025, the company reported cash and cash equivalents totaling $177.3 million, sufficient to fund operations into the first half of 2027 [17] - Research and development expenses increased to $22.9 million in Q2 2025 from $16.9 million in Q2 2024, driven by clinical trial costs [17] - The net loss for Q2 2025 was $27.0 million, compared to $20.3 million in Q2 2024, reflecting ongoing investment in clinical development [17][20] Future Developments - The company is initiating a Phase 2 trial for bel-sar in metastases to the choroid, expanding inclusion criteria to include various solid tumors [7] - Initial data from the Phase 2 trial is expected in 2025, while a Phase 1 clinical trial for cancers of the ocular surface is planned for 2026 [10][11] - A patent application has been filed for a new formulation of bel-sar for bladder cancer, potentially extending patent coverage to 2046 [12]

Company Overview - Aura Biosciences is developing virus-like drug conjugates (VDCs) targeting multiple solid tumor indications, including ocular and bladder cancers[7] - The company highlights a multi-billion dollar addressable market opportunity in early-stage choroidal melanoma (CM) and other ocular tumors[7] - Aura Biosciences expects to fund operations into 2025[7, 95] Ocular Oncology Program - Approximately 80% of choroidal melanoma patients are diagnosed with early-stage disease[21, 32] - Interim Phase 2 data showed that with 3 cycle regimens, the tumor control rate was 88.9% (8/9 patients)[44] - In the Phase 2 trial, vision preservation rate was 90% across all dose cohorts (20 patients)[52] Non-Muscle Invasive Bladder Cancer (NMIBC) Program - The company is targeting Non-Muscle Invasive Bladder Cancer, which affects over 200,000 patients per year globally[78] - Approximately 40% of intermediate-risk NMIBC patients experience failure of BCG/Chemo treatment[80] - Preclinical data demonstrates durable complete responses (CRs) with a single administration of Bel-sar in a bladder cancer model[82] Upcoming Milestones - The company plans to dose the first patient in the Phase 3 trial for primary choroidal melanoma in the first half of 2023[8, 95] - Phase 2 data for suprachoroidal administration in primary choroidal melanoma is expected in the second half of 2023[8, 95] - The company plans to initiate a Phase 2 trial in choroidal metastasis in the second half of 2023[8, 95]

Summary of Aura Biosciences (AURA) FY Conference Call Company Overview - Aura Biosciences is focused on ocular oncology, with a late-stage asset in Phase III clinical development for ocular melanoma, which is identified as the key value driver for the company [2][3] - The company has multiple clinical data readouts expected in the ocular oncology therapeutic area, including the COMPASS study, which is anticipated to complete enrollment this year and provide top-line data potentially in late 2026 or early 2027 [3][4] Key Opportunities - The ocular melanoma market has an estimated potential of 66,000 patients, with three synergistic indications that allow for orphan pricing and rare disease opportunities [4] - The bladder cancer program has recently initiated a Phase II study, with a new formulation designed to differentiate between ocular and bladder cancer treatments [5] Clinical Trial Insights - The bladder cancer Phase I trial is designed as a "window of opportunity" study, allowing for quick assessment of feasibility and early efficacy signals, although it does not measure durability of response [6][7] - Initial data from the bladder cancer study showed a remarkable complete response rate of approximately 80% in the intermediate-risk population with a single dose [8] - Biomarker data indicated strong immune activation, suggesting potential for long-term adaptive immunity [9][10] Safety and Efficacy - The treatment has shown a favorable safety profile, with only grade one adverse events reported, indicating a well-tolerated drug that can be administered quickly in an office setting without general anesthesia [11][12] - The ongoing Phase I/II trial aims to evaluate durability of response, with initial data expected by the end of 2025 and comprehensive data by the end of 2026 [17][18] Market Potential - The bladder cancer market is estimated to have around 80,000 patients in the U.S. for intermediate-risk cases, with a significant opportunity for a safe drug that can be administered in an office setting [23] - The company also sees potential in the high-risk bladder cancer market, addressing the unmet need for durability of response [24] Choroidal Melanoma Insights - The Phase II data for choroidal melanoma showed 80% tumor control and 90% visual acuity preservation at twelve months, indicating a strong safety and efficacy profile [25][26] - The pivotal trial design includes a randomized, sham-controlled study, which has received SPA agreement from the FDA, enhancing the likelihood of approval [27][29] Pricing Strategy - Aura Biosciences is considering orphan disease pricing, with benchmarks from successful drugs in the ultra-rare space, potentially leading to a multibillion-dollar franchise [43][44] - The company aims to position its drug as a safe alternative that prevents blindness, which carries a high value proposition for pricing discussions with payers [45] Future Directions - The ongoing Phase II study for choroidal metastases is expected to provide proof of concept data by the end of the year, with a broader inclusion criteria to enhance the study's applicability [49][50] - The company is optimistic about the potential of its drug beyond ocular oncology, indicating a broader market opportunity across various tumor types [51] Conclusion - Aura Biosciences is strategically positioned in the ocular oncology market with promising clinical data and a robust pipeline, focusing on safety, efficacy, and market potential to create shareholder value in the coming years [42]

Financial Data and Key Metrics Changes - The company raised $75 million recently, extending its runway into the first half of 2027, indicating strong market demand and investor support [37]. Business Line Data and Key Metrics Changes - The company is focusing on its viral drug conjugate platform, particularly Belsar, which is designed for early-stage cancer treatment, showing promising results in ocular oncology and bladder cancer [3][20]. - In the Phase II trial for choroidal melanoma, 80% of patients treated with Belsar showed complete cessation of tumor growth, and 90% preserved vision, highlighting the efficacy of the treatment [13][16]. Market Data and Key Metrics Changes - The ocular oncology market presents a significant opportunity, with over 65,000 patients across three main indications having never received therapeutic intervention [6][9]. - The company is also exploring bladder cancer treatment, with Phase I data showing complete responses in 4 out of 5 treated lesions, indicating strong immune responses [22]. Company Strategy and Development Direction - The company aims to build a franchise in ocular oncology, leveraging its tumor-agnostic platform to transform treatment paradigms for early-stage tumors [6][10]. - There is a strategic focus on expanding into gastrointestinal cancers and other solid tumors, with plans for future partnerships to enhance development [34][36]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the Phase III program for Belsar, with a primary endpoint of time to tumor progression, and anticipates good tumor control compared to sham treatments [15][17]. - The company is committed to a focused approach on its four deliverables of data across its indications, emphasizing the importance of derisking the program before seeking partnerships [38][39]. Other Important Information - The company has a Special Protocol Assessment (SPA) agreement with the FDA for its Phase III trial, which is currently enrolling patients in 18 countries [15]. - The treatment workflow for Belsar is designed to be convenient for both patients and physicians, potentially expanding the funnel of treating physicians over time [19][30]. Q&A Session Summary Question: How does Belsar's delivery system and safety profile shift the treatment paradigm? - Management highlighted that Belsar offers a positive safety profile with minimal adverse events, allowing for earlier intervention and preservation of vision compared to traditional radiotherapy [12]. Question: What does success look like in the Phase III trial? - The primary endpoint is time to tumor progression, with hopes to achieve similar or better results than the Phase II trial, where significant tumor control was observed [14][16]. Question: How does Belsar fit into the treatment workflow for retinal specialists? - Management indicated that Belsar can be administered in a routine clinical setting, allowing for easier integration into existing practices and potentially increasing the number of treating physicians [18][19]. Question: What are the unique aspects of Belsar compared to other treatments? - The company emphasized that Belsar's mechanism allows for immediate immune response due to tumor-specific antigen release, differentiating it from traditional therapies that require tumor removal first [29][30]. Question: What can investors expect in the next 6 to 12 months? - Investors can anticipate data releases across all four indications, with a focus on ocular oncology and bladder cancer, and potential NDA filings as the company progresses [37][38].

Core Viewpoint - Aura Biosciences, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $75 million to support its clinical programs and general corporate purposes [2][3]. Group 1: Offering Details - The public offering consists of 11,735,565 shares of common stock and warrants to purchase 2,933,891 shares of common stock, along with pre-funded warrants for up to 3,571,435 shares at an exercise price of $0.00001 [1]. - The combined offering price for each share of common stock and accompanying warrant is set at $4.90, while the pre-funded warrant and accompanying warrant are priced at $4.89999 [1]. - The offering is expected to close on or about May 16, 2025, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance clinical programs in early-stage choroidal melanoma, metastases to the choroid, cancers of the ocular surface, and non-muscle invasive bladder cancer [3]. Group 3: Company Overview - Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors, with a mission to transform the lives of patients [7]. - The company's lead candidate, bel-sar (AU-011), is in late-stage development for primary choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [7]. Group 4: Management and Underwriters - Leerink Partners and Evercore ISI are acting as joint bookrunning managers for the offering, with LifeSci Capital also serving as a bookrunning manager [4]. - Citizens Capital Markets and Scotiabank are co-managers for the offering [4]. Group 5: Regulatory Information - A shelf registration statement for the offering was filed with the SEC on March 27, 2024, and was declared effective on April 5, 2024 [5]. - A preliminary prospectus supplement was filed with the SEC on May 15, 2025, and will be available on the SEC's website [5].

Company Overview - Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors aimed at preserving organ function [5] - The company's lead candidate, bel-sar (AU-011), is in late-stage development for primary choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [5] Public Offering Announcement - Aura announced the launch of an underwritten public offering of shares of its common stock, including pre-funded warrants and accompanying warrants [1] - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] Management and Underwriters - Leerink Partners and Evercore ISI are acting as joint bookrunning managers for the offering, with LifeSci Capital also serving as a bookrunning manager [2] - Citizens Capital Markets and Scotiabank are co-managers for the offering [2] Regulatory Compliance - The offering is made pursuant to a shelf registration statement filed with the SEC on March 27, 2024, and declared effective on April 5, 2024 [3] - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website [3] Investor Relations - For inquiries, investors can contact Alex Dasalla, Head of Investor Relations and Corporate Communications at Aura [7]

Clinical Development - The lead candidate bel-sar is in late-stage clinical development for primary choroidal melanoma and other solid tumors, with enrollment for the Phase 3 trial expected to complete by the end of 2025 [88]. - In a Phase 2 study, bel-sar achieved an 80% tumor control rate among Phase 3-eligible patients, with a post-treatment average growth rate of 0.011 mm/yr compared to 0.351 mm/yr prior to study entry (p<0.0001) and 90% visual acuity preservation [89]. - The ongoing Phase 1b/2 trial for non-muscle invasive bladder cancer (NMIBC) will evaluate bel-sar in approximately 26 patients, with initial data expected by year-end 2025 [93]. - The company plans to initiate a Phase 1 trial in cancers of the ocular surface in 2025, targeting an incidence rate of 35,000 patients per year in the U.S. and Europe [90]. Financial Performance - As of March 31, 2025, the company reported net losses of $27.5 million and an accumulated deficit of $401.7 million [95]. - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future [99]. - Research and development expenses are expected to increase as the company continues clinical development for bel-sar and other product candidates [102]. - Research and development expenses increased to $23.3 million for the three months ended March 31, 2025, up from $17.1 million in the same period of 2024, primarily due to ongoing clinical and CRO costs associated with the global Phase 3 trial of bel-sar [109]. - General and administrative expenses rose to $5.7 million for the three months ended March 31, 2025, compared to $5.3 million in the same period of 2024, driven by higher personnel expenses [110]. - Total operating expenses for the three months ended March 31, 2025, were $29.0 million, an increase of $6.7 million from $22.3 million in the same period of 2024 [108]. - The net loss for the three months ended March 31, 2025, was $27.5 million, compared to a net loss of $19.7 million for the same period in 2024, reflecting an increase of $7.8 million [108]. Cash and Funding - The company has raised approximately $420.0 million since inception, with $99.0 million raised from the 2023 Follow-On Offering at $9.00 per share [94]. - The company had cash and cash equivalents of $128.0 million as of March 31, 2025, which is expected to fund operations into the second half of 2026 [98]. - Cash, cash equivalents, and marketable securities as of March 31, 2025, totaled $128.0 million, expected to fund operations into the second half of 2026 [118]. - Net cash used in operating activities was $23.4 million for the three months ended March 31, 2025, compared to $24.5 million for the same period in 2024 [112]. - Net cash provided by investing activities was $29.8 million for the three months ended March 31, 2025, significantly higher than $9.4 million in the same period of 2024 [115]. - The company raised approximately $420.0 million in gross proceeds through the sale of equity and convertible preferred stock up to March 31, 2025 [111]. Operating Expenses and Commitments - The company has incurred significant operating losses since 2009 and anticipates needing substantial additional funding to support ongoing operations and growth strategies [96]. - Operating lease commitments total $26.836 million, with $3.331 million due within 1 year, $10.6 million due in 1 to 3 years, and $7.598 million due in 3 to 5 years [123]. - The company has no long-term debt or finance leases, and contracts with service providers are generally cancelable [125]. - Payments due upon cancellation of contracts consist only of services provided or expenses incurred, with no material non-cancelable purchase commitments [125]. Regulatory and Accounting Matters - The company remains classified as an "emerging growth company" until it exceeds $1.235 billion in annual revenue or meets other specified criteria [129]. - The market value of the company's stock held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company" [130]. - The company has not experienced material changes to its critical accounting policies as of March 31, 2025 [126]. - No recent accounting pronouncements have had a material impact on the company's financial statements [127]. - The company has elected to use the extended transition period under the JOBS Act for compliance with new accounting standards [128]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company [132]. - The lease for office and laboratory space in Boston, MA, has an initial term of 10 years with a renewal option for an additional 7 years [124]. - The income tax provision for the year ended December 31, 2024, was recorded at $0.1 million, with accumulated net operating loss carryforwards of approximately $209.8 million [107]. - The company anticipates a substantial increase in expenses related to ongoing research and development activities and operating as a public company [117].

Financial Performance - Aura Biosciences reported a net loss of $27.5 million for Q1 2025, compared to a net loss of $19.7 million for Q1 2024, reflecting an increase of approximately 39% year-over-year [21]. - The comprehensive loss for Q1 2025 was $27.6 million, compared to $20.2 million in Q1 2024 [24]. - General and administrative expenses increased to $5.7 million in Q1 2025 from $5.3 million in Q1 2024, driven by higher personnel costs [21]. Research and Development - Research and development expenses rose to $23.3 million in Q1 2025 from $17.1 million in Q1 2024, primarily due to ongoing clinical trial costs [17]. - The ongoing Phase 1b/2 trial for NMIBC will evaluate bel-sar in approximately 26 patients, with initial efficacy data expected by year-end 2025 [12]. - The CoMpass trial for early-stage choroidal melanoma has enrolled over 220 patients in a pre-screening tool since June 2024, with completion expected by the end of 2025 [4]. - The company expects initial data from the Phase 2 trial for metastases to the choroid in 2025, with a focus on a basket study approach [7]. - Bel-sar is being explored for three ocular oncology indications, collectively affecting over 60,000 patients annually in the U.S. and Europe [6]. - The company has filed a patent application for a new formulation of bel-sar for bladder cancer, aimed at enhancing in-office urologist procedures [10]. Financial Position - As of March 31, 2025, the company had cash and cash equivalents totaling $128.0 million, sufficient to fund operations into the second half of 2026 [17]. - Total assets decreased from $182,503 million as of December 31, 2024, to $155,401 million as of March 31, 2025, representing a decline of approximately 14.85% [26]. - Total current assets decreased from $160,623 million to $134,517 million, a reduction of about 16.26% [26]. - Stockholders' equity decreased from $151,970 million to $127,966 million, reflecting a decline of approximately 15.77% [26]. - Cash and cash equivalents increased from $31,693 million to $38,226 million, an increase of about 20.04% [26]. - Total liabilities decreased from $30,533 million to $27,435 million, a decrease of approximately 10.14% [26]. - Total current liabilities decreased from $14,913 million to $12,163 million, a decrease of about 18.43% [26]. - Long-term operating lease liability slightly decreased from $15,620 million to $15,272 million, a reduction of about 2.23% [26]. - Additional paid-in capital increased from $525,934 million to $529,571 million, a growth of about 0.25% [26]. - Accumulated deficit increased from $(374,227) million to $(401,710) million, indicating a worsening of approximately 7.36% [26]. - Accumulated other comprehensive income decreased from $263 million to $105 million, a decline of approximately 60.00% [26].

Core Insights - Aura Biosciences, Inc. has initiated a multi-dose Phase 1b/2 trial of bel-sar for Non-Muscle-Invasive Bladder Cancer (NMIBC), with initial data expected by the end of 2025 [1][14] - The company has strengthened its leadership team by appointing Tony Gibney as Chief Financial and Business Officer [1][18] - Aura is making significant progress in its ocular and urologic oncology programs, particularly with the Phase 3 CoMpass trial for early-stage choroidal melanoma [2][3] Recent Pipeline Developments - The CoMpass trial is the first registration-enabling study for early-stage choroidal melanoma, actively enrolling patients globally [3][4] - Over 220 patients have been pre-screened for the CoMpass trial since June 2024, indicating a strong demand for vision-preserving therapies [4] - Bel-sar is also being explored for metastases to the choroid and cancers of the ocular surface, with a collective incidence of over 60,000 patients annually in the U.S. and Europe [6][10] Clinical Trials and Data - A Phase 2 trial for bel-sar in metastases to the choroid has been initiated, with plans to broaden inclusion criteria to include various solid tumors [7] - Positive results from a completed Phase 1 trial for NMIBC showed multiple clinical complete responses and a favorable safety profile [12] - The ongoing Phase 1b/2 trial for NMIBC will evaluate two approaches, with endpoints including complete response rates and recurrence-free survival [13][14] Financial Overview - As of March 31, 2025, Aura reported cash and cash equivalents totaling $128.0 million, sufficient to fund operations into the second half of 2026 [18] - Research and development expenses increased to $23.3 million in Q1 2025 from $17.1 million in Q1 2024, driven by clinical trial costs [19] - The net loss for Q1 2025 was $27.5 million, compared to $19.7 million in Q1 2024, reflecting increased operational expenses [24]

Summary of Aura Biosciences Conference Call Company Overview - **Company**: Aura Biosciences (AURA) - **Technology**: Novel virus-like drug conjugates with a dual mechanism of action for cancer treatment, focusing on local early-stage diseases with a good safety profile [3][60] Core Industry Insights Uveal Melanoma - **Lead Indication**: Primary uveal melanoma, a rare and life-threatening disease with an incidence of 11,000 patients annually in the U.S. [4][61] - **Market Opportunity**: Approximately 66,000 patients in ocular oncology with no approved drugs, primarily treated with surgery or radiotherapy [4][61] - **Current Treatment Limitations**: Existing treatments often lead to blindness; Aura's drug, Belzar, aims to preserve vision in over 90% of patients [8][64] Treatment Administration - **Administration Method**: Belzar is administered via a suprachoroidal injection, which is safer than intravitreal injections and can be done in an office setting without the need for hospitalization [12][68] - **Treatment Regimen**: Nine treatments over three months, with a focus on achieving a durable local cure [14][70] Clinical Development - **Current Phase**: Phase III clinical trials with SPA agreement, aiming for BLA submission [16][72] - **Efficacy Data**: 80% efficacy reported in previous trials, with a focus on patients with actively growing lesions to ensure quick differentiation from sham treatments [19][74] Bladder Cancer Insights - **Emerging Opportunity**: Similar to ocular oncology, bladder cancer presents a high incidence of pre-metastatic disease [31][82] - **Efficacy in Trials**: Initial trials showed 80% complete response rates with a single dose, with plans for further dose escalation [84][87] - **Mechanism of Action**: The treatment aims to prime the immune system for an anti-tumoral response, contrasting with traditional adjuvant treatments that may not effectively target residual tumors [85][86] Market Dynamics - **Competitive Landscape**: Aura operates in a white space with no direct competition for its lead indication, positioning itself for a successful market launch [5][61] - **Physician Adoption**: There may be initial resistance from urologists who are accustomed to surgical interventions; however, the economic incentives favor office-based treatments [42][91] Future Outlook - **Cash Position**: Aura has sufficient funding to support clinical programs into the second half of 2026 [56][56] - **Upcoming Milestones**: Key data milestones expected within the next six months, including bladder cancer durability data and ocular metastasis results [56][57] Additional Considerations - **Tumor Agnostic Potential**: The technology is designed to treat various solid tumors, expanding the potential market significantly beyond ocular and bladder cancers [52][53] - **Patient-Centric Approach**: The treatment strategy emphasizes patient safety and efficacy, aiming to provide options that do not compromise quality of life [42][92]