[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) This section covers unaudited financial statements, management's discussion, market risk, and internal controls [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents the unaudited condensed consolidated financial statements for Aura Biosciences, Inc. for the quarterly period ended June 30, 2025, reflecting increased cash from financing and widening net losses [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2025, shows total assets of $204.4 million, driven by a rise in cash to $107.4 million from a follow-on offering, with total liabilities slightly decreasing and stockholders' equity increasing Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash and cash equivalents | $107,367 | $31,693 | | Total Assets | $204,397 | $182,503 | | Total Liabilities | $29,768 | $30,533 | | Total Stockholders' Equity | $174,629 | $151,970 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended June 30, 2025, the company reported a net loss of $27.0 million, primarily due to higher research and development expenses, with the six-month net loss widening to $54.5 million Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2025 (in thousands) | Three Months Ended June 30, 2024 (in thousands) | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $22,882 | $16,879 | $46,225 | $33,932 | | General and administrative | $5,731 | $5,883 | $11,423 | $11,145 | | Total operating loss | $(28,613) | $(22,762) | $(57,648) | $(45,077) | | Net loss | $(27,019) | $(20,337) | $(54,502) | $(40,043) | | Net loss per share | $(0.47) | $(0.41) | $(1.01) | $(0.81) | [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders%27%20Equity) Total stockholders' equity increased to $174.6 million by June 30, 2025, primarily driven by $46.5 million in net proceeds from a follow-on offering, partially offset by a $54.5 million net loss - The company completed a follow-on offering, issuing **11,735,565 shares of common stock** and various warrants, resulting in net proceeds of approximately **$69.9 million** after costs[17](index=17&type=chunk)[44](index=44&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2025, net cash used in operating activities was $44.1 million, while investing activities provided $49.8 million and financing activities provided $70.0 million, leading to a net cash increase of $75.7 million Six-Month Cash Flow Summary (in thousands) | Metric | Six Months Ended June 30, 2025 (in thousands) | Six Months Ended June 30, 2024 (in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | $(44,129) | $(40,580) | | Net cash provided by investing activities | $49,790 | $29,237 | | Net cash provided by financing activities | $70,025 | $336 | | Net increase (decrease) in cash | $75,686 | $(11,007) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) The notes detail the company's focus on its lead candidate, bel-sar, its reliance on capital raises, the May 2025 follow-on offering, and management's assertion of sufficient funding for the next 12 months - Aura Biosciences is a clinical-stage biotechnology company focused on developing its lead candidate, **bel-sar**, a Virus-Like Drug Conjugate (VDC), for the treatment of solid tumors, with an initial focus on ocular and urologic oncology[23](index=23&type=chunk) - In May 2025, the company completed a follow-on offering, receiving approximately **$69.9 million** in net proceeds after deducting underwriting discounts and commissions[26](index=26&type=chunk)[44](index=44&type=chunk) - The company expects its cash, cash equivalents, and marketable securities will be sufficient to fund its operating expenses and capital expenditure requirements through at least **12 months** from the issuance of these financial statements[27](index=27&type=chunk) - As of June 30, 2025, there was **$16.7 million** of unrecognized compensation expense related to stock options and **$19.5 million** related to unvested restricted stock units, expected to be recognized over weighted-average periods of **2.89 and 3.07 years**, respectively[57](index=57&type=chunk)[58](index=58&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance and operational progress, highlighting increased R&D expenses for the bel-sar Phase 3 trial, a $54.5 million net loss, and $177.3 million in cash and marketable securities expected to fund operations into the first half of 2027 - The company's lead candidate, **bel-sar**, is in an ongoing global Phase 3 CoMpass trial for the first-line treatment of early choroidal melanoma, with enrollment potentially completing as early as the end of **2025**[93](index=93&type=chunk) - **Bel-sar** is also being developed for other indications, including a Phase 2 trial for metastases to the choroid and a Phase 1b/2 trial for non-muscle invasive bladder cancer (NMIBC)[95](index=95&type=chunk)[98](index=98&type=chunk) Comparison of Operating Results (Six Months Ended June 30, in thousands) | Metric | 2025 (in thousands) | 2024 (in thousands) | Change (in thousands) | | :--- | :--- | :--- | :--- | | Research and development | $46,225 | $33,932 | $12,293 | | General and administrative | $11,423 | $11,145 | $278 | | Total operating expenses | $57,648 | $45,077 | $12,571 | | Net loss | $(54,502) | $(40,043) | $(14,459) | - As of June 30, 2025, the company had cash, cash equivalents, and marketable securities of **$177.3 million**, which management believes will fund operations into the **first half of 2027**[105](index=105&type=chunk)[129](index=129&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=34&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company, as a smaller reporting entity, is not required to provide quantitative and qualitative disclosures regarding market risk - As a smaller reporting company, Aura Biosciences is not required to provide quantitative and qualitative disclosures about market risk[143](index=143&type=chunk) [Item 4. Controls and Procedures](index=34&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of June 30, 2025, with no material changes to internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[145](index=145&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[146](index=146&type=chunk) [PART II. OTHER INFORMATION](index=35&type=section&id=PART%20II.%20OTHER%20INFORMATION) This section outlines legal proceedings, risk factors, equity sales, and other required disclosures [Item 1. Legal Proceedings](index=35&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2025, the company is not involved in any legal proceedings that would reasonably be expected to have a material adverse effect on its business - As of June 30, 2025, the company is not involved in any material legal proceedings[148](index=148&type=chunk) [Item 1A. Risk Factors](index=35&type=section&id=Item%201A.%20Risk%20Factors) This section provides a comprehensive overview of material risks, including a history of significant net losses, heavy dependence on its sole product candidate bel-sar, the need for substantial additional capital, and complexities in regulatory approval and commercialization - The company has incurred significant net losses since inception, with an accumulated deficit of **$428.7 million** as of June 30, 2025, and anticipates continued losses for the foreseeable future[150](index=150&type=chunk) - The company's business is heavily dependent on the successful development, regulatory approval, and commercialization of its only product candidate, **bel-sar**[164](index=164&type=chunk) - Substantial additional capital will be required to finance operations. The company's existing cash is expected to fund operations into the **first half of 2027**, but it will not be sufficient to fund **bel-sar** through regulatory approval[154](index=154&type=chunk)[155](index=155&type=chunk) - The company relies on third parties, such as CROs and CDMOs, to conduct clinical trials and manufacture **bel-sar**, which increases risks related to performance, compliance, and supply chain disruptions[219](index=219&type=chunk)[223](index=223&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=87&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities occurred during the reporting period - There were no unregistered sales of equity securities during the quarter[364](index=364&type=chunk) [Item 3. Defaults Upon Senior Securities](index=87&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[367](index=367&type=chunk) [Item 4. Mine Safety Disclosures](index=87&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[368](index=368&type=chunk) [Item 5. Other Information](index=87&type=section&id=Item%205.%20Other%20Information) The company discloses that no directors or officers adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading arrangement during the quarter[369](index=369&type=chunk) [Item 6. Exhibits](index=88&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed with the Form 10-Q, including corporate governance documents, warrant forms, compensation policies, and required certifications - The report includes a list of filed exhibits, such as corporate governance documents, warrant forms, and required CEO/CFO certifications[370](index=370&type=chunk)

[Aura Biosciences Q2 2025 Report Overview](index=1&type=section&id=Aura%20Biosciences%20Q2%202025%20Report%20Overview) [Second Quarter 2025 Business Highlights](index=1&type=section&id=Second%20Quarter%202025%20Business%20Highlights) Aura Biosciences reported Q2 2025 results, highlighting clinical program execution, a **$75 million** equity financing, and extended cash runway into H1 2027 - Continued clinical program execution in **Phase 3 CoMpass trial** in early choroidal melanoma and **Phase 1b/2 trial** in NMIBC[1](index=1&type=chunk)[2](index=2&type=chunk) - Strengthened balance sheet with **$75 million** equity financing[1](index=1&type=chunk)[2](index=2&type=chunk) - Cash position expected to fund operations into the **first half of 2027**[1](index=1&type=chunk)[2](index=2&type=chunk) [Recent Pipeline Developments](index=1&type=section&id=Recent%20Pipeline%20Developments) [Early Choroidal Melanoma](index=1&type=section&id=Early%20Choroidal%20Melanoma) The global Phase 3 CoMpass trial for early choroidal melanoma is actively enrolling, with enrollment completion anticipated by end of 2025, supported by Orphan Drug and Fast Track designations - **Phase 3 CoMpass trial** is actively enrolling globally, with **over 240 patients** registered in pre-screening[3](index=3&type=chunk)[4](index=4&type=chunk) - Study enrollment may be completed as early as the **end of 2025**[4](index=4&type=chunk) - Received **Orphan Drug Designation** (FDA, EMA) and **Fast Track designation** (FDA); CoMpass trial is under a **Special Protocol Assessment agreement** with the FDA[5](index=5&type=chunk) [Additional Ocular Oncology Indications](index=2&type=section&id=Additional%20Ocular%20Oncology%20Indications) Bel-sar is being developed for metastases to the choroid and cancers of the ocular surface, addressing over **60,000** annual patients in the US and Europe - Bel-sar is in development for **metastases to the choroid** and **cancers of the ocular surface**[6](index=6&type=chunk) - These three ocular oncology indications have a collective annual incidence of **greater than 60,000 patients** in the United States and Europe[6](index=6&type=chunk) [Metastases to the Choroid](index=2&type=section&id=Metastases%20to%20the%20Choroid) A Phase 2 trial for metastases to the choroid has begun, broadening inclusion criteria to all solid tumors, with initial data expected in 2025 for **20,000** annual patients - Initiated a **Phase 2 clinical trial** in metastases to the choroid from breast and lung cancer, with sites activated[7](index=7&type=chunk) - Implementing a **protocol amendment** for the Phase 2 trial to broaden inclusion criteria beyond breast and lung cancer to include **all metastases from different solid tumors**[7](index=7&type=chunk) - Expects initial data from this trial **in 2025**. Affects **approximately 20,000 patients annually** in the US and Europe; received **FDA Fast Track designation**[7](index=7&type=chunk)[8](index=8&type=chunk) [Cancers of the Ocular Surface](index=2&type=section&id=Cancers%20of%20the%20Ocular%20Surface) Pre-clinical activities for cancers of the ocular surface are on track, with initial Phase 1 data anticipated in 2026 for **35,000** annual patients lacking approved therapies - **Pre-clinical activities** in cancers of the ocular surface remain on track[9](index=9&type=chunk) - Plans to have initial data from an early proof of concept **Phase 1 clinical trial** **in 2026**[9](index=9&type=chunk) - Affects **approximately 35,000 patients** in the United States and Europe annually and has **no approved therapies**[9](index=9&type=chunk) [Bladder Cancer](index=2&type=section&id=Bladder%20Cancer) The Phase 1b/2 trial for NMIBC is actively enrolling, evaluating bel-sar doses and cycles, with a new formulation patent application potentially extending coverage into **2046** - Ongoing **Phase 1b/2 trial** for NMIBC is actively enrolling, evaluating additional doses and cycles of bel-sar in **approximately 26 intermediate and high-risk NMIBC patients**[10](index=10&type=chunk) - Trial evaluates two approaches: an **immune ablative design** (two cycles without TURBT) and a **multimodal neoadjuvant design** (two cycles ahead of TURBT)[10](index=10&type=chunk) - Filed a **patent application** for a new formulation of bel-sar for use in urologic oncology, which if issued, would provide patent coverage **into 2046**, designed for convenient in-office procedures with enhanced storage[11](index=11&type=chunk) [Second Quarter 2025 Financial Results](index=3&type=section&id=Second%20Quarter%202025%20Financial%20Results) [Key Financial Highlights](index=3&type=section&id=Key%20Financial%20Highlights) Aura Biosciences reported increased R&D expenses, decreased G&A, and a higher net loss for Q2 2025, with cash projected to fund operations into H1 2027 Key Financial Data (Three Months Ended June 30) | Financial Metric | 2025 (Millions $) | 2024 (Millions $) | Change (YoY) | | :-------------------------------------------- | :---------------- | :---------------- | :----------- | | Cash & Cash Equivalents & Marketable Securities (as of June 30) | $177.3 | N/A | N/A | | Research and Development Expenses | $22.9 | $16.9 | +$6.0 (+35.5%) | | General and Administrative Expenses | $5.7 | $5.9 | -$0.2 (-3.4%) | | Net Loss | $(27.0) | $(20.3) | +$(6.7) (+33.0%) | - Cash and cash equivalents and marketable securities totaling **$177.3 million** as of **June 30, 2025**, expected to fund operations into the **first half of 2027**[16](index=16&type=chunk) - Research and development expenses **increased** primarily due to **ongoing clinical and CRO costs** associated with the progression of the **global Phase 3 trial** and **manufacturing/development costs** for bel-sar[16](index=16&type=chunk) - General and administrative expenses **decreased** primarily driven by **reduced professional fees**[16](index=16&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Q2 2025 saw a total operating loss of **$28.6 million** and net loss of **$27.0 million**, driven by increased R&D expenses and decreased interest income Condensed Consolidated Statements of Operations and Comprehensive Loss (Three Months Ended June 30, in thousands) | Operating Expenses | 2025 | 2024 | Change (YoY) | | :---------------------------------------------------------- | :-------- | :-------- | :----------- | | Research and development | $22,882 | $16,879 | +$6,003 (+35.6%) | | General and administrative | $5,731 | $5,883 | -$152 (-2.6%) | | Total operating expenses | $28,613 | $22,762 | +$5,851 (+25.7%) | | Total operating loss | $(28,613) | $(22,762) | -$(5,851) (-25.7%) | | Interest income | $1,678 | $2,451 | -$773 (-31.5%) | | Net loss | $(27,019) | $(20,337) | -$(6,682) (-32.9%) | | Net loss per common share—basic and diluted | $(0.47) | $(0.41) | -$(0.06) (-14.6%) | | Weighted average common stock outstanding | 58,015,718| 49,548,120| +8,467,598 (+17.1%) | Condensed Consolidated Statements of Operations and Comprehensive Loss (Six Months Ended June 30, in thousands) | Operating Expenses | 2025 | 2024 | Change (YoY) | | :---------------------------------------------------------- | :-------- | :-------- | :----------- | | Research and development | $46,225 | $33,932 | +$12,293 (+36.2%) | | General and administrative | $11,423 | $11,145 | +$278 (+2.5%) | | Total operating expenses | $57,648 | $45,077 | +$12,571 (+27.9%) | | Total operating loss | $(57,648) | $(45,077) | -$(12,571) (-27.9%) | | Interest income | $3,271 | $5,137 | -$1,866 (-36.3%) | | Net loss | $(54,502) | $(40,043) | -$(14,459) (-36.1%) | | Net loss per common share—basic and diluted | $(1.01) | $(0.81) | -$(0.20) (-24.7%) | | Weighted average common stock outstanding | 54,092,728| 49,500,032| +4,592,696 (+9.3%) | [Condensed Consolidated Balance Sheets](index=6&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2025, total assets increased to **$204.4 million**, driven by higher cash and cash equivalents, with total stockholders' equity reaching **$174.6 million** Condensed Consolidated Balance Sheets (in thousands) | Balance Sheet Item | June 30, 2025 | December 31, 2024 | Change (vs. Dec 31, 2024) | | :-------------------------------- | :------------ | :---------------- | :------------------------ | | Cash and cash equivalents | $107,367 | $31,693 | +$75,674 (+238.8%) | | Marketable securities | $69,944 | $119,401 | -$49,457 (-41.4%) | | Total current assets | $183,958 | $160,623 | +$23,335 (+14.5%) | | Total Assets | $204,397 | $182,503 | +$21,894 (+12.0%) | | Total Liabilities | $29,768 | $30,533 | -$765 (-2.5%) | | Total Stockholders' Equity | $174,629 | $151,970 | +$22,659 (+14.9%) | [About Aura Biosciences](index=3&type=section&id=About%20Aura%20Biosciences) [Company Profile and Mission](index=3&type=section&id=Company%20Profile%20and%20Mission) Aura Biosciences is a clinical-stage biotech developing precision therapies for solid tumors, with lead candidate bel-sar in late-stage development for ocular melanoma and early-stage for other indications - Aura Biosciences is a **clinical-stage biotechnology company** focused on developing **precision therapies for solid tumors** that aim to **preserve organ function**[13](index=13&type=chunk) - Lead candidate, **bel-sar (AU-011)**, is in **late-stage development** for **early choroidal melanoma** and in **early-stage development** in **other ocular oncology indications and bladder cancer**[13](index=13&type=chunk) - Mission is to grow as an **innovative global oncology company** that **positively transforms the lives of patients**[13](index=13&type=chunk) [Forward-Looking Statements](index=3&type=section&id=Forward-Looking%20Statements) [Disclaimer and Risk Factors](index=3&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains forward-looking statements on Aura's future expectations, plans, and prospects, including bel-sar's potential and clinical timings, with a disclaimer on inherent risks and uncertainties - Contains **forward-looking statements** regarding Aura's future expectations, plans and prospects, including **therapeutic potential of bel-sar**, **clinical trial initiations and timing**, **patient quality of life**, **market opportunities**, and **cash runway**[15](index=15&type=chunk) - **Forward-looking statements** involve **known and unknown risks, uncertainties and other factors**, many of which are **beyond Aura's control**, that could cause **actual results to differ materially**[17](index=17&type=chunk) - Risks include **uncertainties inherent in clinical trials**, **timing of data**, **regulatory approvals**, **sufficiency of cash resources**, and **ability to initiate, enroll, conduct or complete ongoing and planned clinical trials**[17](index=17&type=chunk) [Investor and Media Relations Contact](index=4&type=section&id=Investor%20and%20Media%20Relations%20Contact) [Contact Information](index=4&type=section&id=Contact%20Information) Contact information for investor and media relations is provided, with Alex Dasalla as Head of Investor Relations and Corporate Communications - Investor and Media Relations Contact: **Alex Dasalla**, **Head of Investor Relations and Corporate Communications**[18](index=18&type=chunk) - Email: **IR@aurabiosciences.com**[18](index=18&type=chunk)

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].