Core Insights - Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors aimed at preserving organ function [3] - The CEO, Elisabet de los Pinos, will participate in a fireside chat at the 8th Annual Evercore Healthcare Conference on December 2, 2025 [1] - The company's lead candidate, bel-sar (AU-011), is in late-stage development for early choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [3] Company Overview - Aura Biosciences is headquartered in Boston, MA, and aims to grow as an innovative global oncology company that positively transforms patients' lives [3] - The company provides a live webcast of events on its "Investors & Media" page, with replays available for 90 days [2] - Investor relations contact is Alex Dasalla, Head of Investor Relations and Corporate Communications [5]

Financial Performance - The company reported net losses of $80.6 million and $61.1 million for the nine months ended September 30, 2025 and 2024, respectively, with an accumulated deficit of $454.9 million as of September 30, 2025[103]. - The net loss for the three months ended September 30, 2025, was $26.1 million, compared to a net loss of $21.0 million for the same period in 2024, representing an increase in loss of $5.1 million[117]. - Net cash used in operating activities for the nine months ended September 30, 2025, was $64.3 million, compared to $55.9 million for the same period in 2024[125]. - Total operating expenses for the three months ended September 30, 2025, were $27.9 million, compared to $23.2 million for the same period in 2024, reflecting an increase of $4.7 million[117]. - Research and development expenses increased to $22.2 million for the three months ended September 30, 2025, from $17.0 million for the same period in 2024, primarily due to ongoing clinical and CRO costs associated with the Phase 3 trial of bel-sar[118]. - For the nine months ended September 30, 2025, research and development expenses totaled $68.4 million, up from $51.0 million for the same period in 2024, an increase of $17.4 million[121]. - General and administrative expenses decreased to $5.7 million for the three months ended September 30, 2025, from $6.2 million for the same period in 2024, primarily due to reduced professional fees[119]. - Total other income for the three months ended September 30, 2025, was $1.8 million, down from $2.2 million for the same period in 2024, a decrease of $431,000[117]. Funding and Capital Requirements - The company has raised approximately $495.4 million in gross proceeds since inception through private placements and stock offerings[102]. - The company raised approximately $495.4 million in gross proceeds through the sale of equity and convertible preferred stock and warrants as of September 30, 2025[124]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $74.4 million, primarily from the 2025 Follow-On Offering[130]. - The company may need to raise additional funds through equity or debt financing, which could lead to dilution for existing stockholders[135]. - The company’s future capital requirements will depend on various factors, including the costs and timing of clinical trials and regulatory approvals[134]. - The company’s ability to raise additional funds may be adversely impacted by global economic conditions and market volatility[137]. Clinical Trials and Research - The ongoing Phase 3 CoMpass trial for bel-sar is expected to complete enrollment by 2026, with top-line data readout anticipated in Q4 2027[95]. - 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[96]. - The company plans to initiate a Phase 2 trial for bel-sar in metastases to the choroid from breast and lung cancer, with early proof-of-concept data expected in 2026[97]. - The ongoing Phase 1b/2 trial for bel-sar in non-muscle invasive bladder cancer (NMIBC) will evaluate approximately 26 patients, with initial 3-month clinical data expected in mid-2026[100]. - The company anticipates significant increases in expenses and capital requirements as it advances clinical trials and seeks regulatory approvals[104]. - The company anticipates substantial increases in expenses related to ongoing research, development, and clinical trials for current and future product candidates[132]. Cash Position and Assets - As of September 30, 2025, the company had cash and cash equivalents of $161.9 million, expected to fund operations into the first half of 2027[107]. - As of September 30, 2025, the company had cash, cash equivalents, and marketable securities totaling $161.9 million, expected to fund operations into the first half of 2027[133]. Lease and Commitments - The company has operating lease commitments totaling $25.187 million, with $3.38 million due within one year[139]. - The company entered into a 10-year office and laboratory lease in Boston, MA, which commenced on August 1, 2022[140]. Regulatory and Reporting Status - The company is classified as a smaller reporting company, with a market value of stock held by non-affiliates below $700 million[146]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company[147]. - The company has no long-term debt or finance leases, and its contracts with service providers are generally cancelable[141].

Financial Position - As of September 30, 2025, the company had cash and cash equivalents and marketable securities totaling $161.9 million, sufficient to fund operations into the first half of 2027[18] - Total assets increased to $190,024 million as of September 30, 2025, up from $182,503 million at December 31, 2024, representing a growth of 4.2%[24] - Current assets rose to $170,120 million, compared to $160,623 million in the previous period, marking a 5.3% increase[24] - Cash and cash equivalents significantly increased to $47,553 million from $31,693 million, reflecting a growth of 49.9%[24] - Total liabilities increased to $33,357 million from $30,533 million, an increase of 9.2%[24] - Stockholders' equity grew to $156,667 million, up from $151,970 million, indicating a rise of 3.7%[24] - Additional paid-in capital increased to $611,457 million from $525,934 million, a substantial increase of 16.3%[24] - The accumulated deficit widened to $(454,859) million from $(374,227) million, indicating a deterioration in financial position[24] - Total current liabilities increased to $18,823 million from $14,913 million, a rise of 26.5%[24] - The company maintained restricted cash and deposits at $768 million, unchanged from the previous period[24] - Property and equipment, net decreased to $2,629 million from $3,215 million, a decline of 18.2%[24] Operational Performance - Research and development expenses increased to $22.2 million for Q3 2025, up from $17.0 million in Q3 2024, primarily due to ongoing clinical trial costs[18] - General and administrative expenses decreased to $5.7 million for Q3 2025 from $6.2 million in Q3 2024, driven by reduced professional fees[18] - The net loss for Q3 2025 was $26.1 million compared to $21.0 million for Q3 2024, reflecting an increase in operational costs[18] - The company reported a total operating loss of $27.9 million for Q3 2025, compared to $23.2 million for Q3 2024[22] Clinical Trials and Research - The ongoing Phase 3 CoMpass trial for early choroidal melanoma is expected to complete enrollment in 2026, with topline data readout anticipated in Q4 2027[5] - Approximately 90% of targeted clinical sites for the CoMpass trial are now activated, with over 400 patients entered into the patient identification tool since June 2024[4] - The Phase 1b/2 trial for NMIBC is on track, with initial data expected in mid-2026, reinforcing bel-sar's potential as a frontline therapy[10] - The company has dosed the first patient in a Phase 2 trial for metastases to the choroid, with early proof of concept data expected in 2026[11] - Bel-sar has the potential to become the first frontline vision-preserving therapy for early choroidal melanoma, addressing a significant unmet medical need[6]

Aura Provides Phase 3 CoMpass Trial Completion Guidance: 2026 Enrollment Completion and Q4 2027 Topline Data Readout for the 15-Month Primary Endpoint Immune Profiling Data Reveal Bel-sar’s Potential to Convert ‘Cold’ to ‘Hot’ Tumors, Supporting a Frontline Therapy Across the Bladder Cancer Spectrum; Phase 1b/2 Trial is on Track for Data Mid-2026 BOSTON, Nov. 13, 2025 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid t ...

Core Viewpoint - Aura Minerals Inc. is launching an Incentive Program allowing holders of Brazilian Depositary Receipts (BDRs) to convert them into common shares at a ratio of three BDRs to one common share, without incurring conversion fees during a specified period from October 6, 2025, to November 6, 2025 [1][3][4] Summary by Sections Incentive Program Details - The conversion ratio is set at three BDRs for one common share, and each BDR holder can submit only one conversion request during the Subsidy Period [2][3] - Aura will cover the conversion fees charged by Banco Bradesco for eligible shareholders [3] - Holders are responsible for instructing their brokers on the conversion process [4] Company Overview - Aura Minerals focuses on the development and operation of gold and base metal projects across the Americas, with five operating assets including gold mines in Honduras and Brazil, and a copper, gold, and silver mine in Mexico [6] - The company also has several projects in Guatemala, Colombia, and Brazil, including one under development and others in care and maintenance or exploration phases [6] Strategic Intent - The Incentive Program is part of Aura's strategy to consolidate and enhance the trading of its shares on Nasdaq, with no expected impact on the company's financial performance [4]

Core Insights - Western Exploration Inc. has filed an amended technical report for the Aura Gold-Silver Project, which includes a revised all-in sustaining cost for the "Base Case" from $1,152 to $1,172 per gold ounce, with no impact on capital costs or economic results [1][5]. Summary by Sections Technical Report Filing - The amended technical report, titled "Preliminary Economic Assessment of the Doby George Deposits and Updated Resource Estimate for the Gravel Creek Gold-Silver Deposits," was filed on SEDAR+ and is effective as of June 17, 2025 [2]. - This report supersedes all previous technical reports for the Aura Project, including the initial technical report dated June 17, 2025 [2]. Economic Assessment - The amended report confirms the economic assessment results from the initial technical report and the previous news releases, with no changes to the underlying inputs or economic outcomes [3][5]. - Key economic metrics for the Doby George 2025 PEA include: - Base Case Gold Price: $2,150 per ounce - Average Annual Operating Cash Flow: $63.3 million - Pre-Tax NCF: $132.4 million - Pre-Tax NPV5: $94.7 million - Pre-Tax IRR: 31.8% [4]. Project Costs - The project capital costs are detailed as follows: - Pre-Production Costs: $127.6 million - LOM Sustaining Costs: $10.5 million [6]. - Operating costs are summarized as: - Total LOM Operating Costs: $253.6 million - Per Tonne Processed: $22.24 [7]. Technical Information - The mineral resource estimate was prepared by qualified persons from RESPEC and KCA, ensuring compliance with NI 43-101 standards [8][9]. - The Aura Project includes three deposits: Doby George, Gravel Creek, and Wood Gulch, located approximately 120 kilometers north of Elko, Nevada [10].

Summary of Aura Biosciences FY Conference Call Company Overview - **Company**: Aura Biosciences - **Ticker**: AURA (NASDAQ) - **Industry**: Biotechnology, specifically focused on cancer treatment through virus-like drug conjugates Key Points and Arguments 1. **Clinical Development and Innovation** Aura is developing a novel class of drugs, specifically virus-like drug conjugates (VDCs), for cancer treatment, with a focus on ocular oncology and urologic oncology [2][3] 2. **Phase 3 Study for Early Choroidal Melanoma** The company is currently running a Phase 3 study for early choroidal melanoma, supported by a Special Protocol Assessment (SPA) agreement, which is crucial for registration [2][3][11] 3. **Market Opportunity** There are approximately 66,000 patients with ocular cancers currently lacking treatment options, presenting a significant market opportunity for Aura's VDCs [4][6] 4. **Mechanism of Action** The VDC, AU-011 (bel-sar), selectively targets cancer cells, activating a cytotoxic payload only upon exposure to infrared light, which minimizes damage to surrounding healthy tissues [5][10] 5. **Durability of Response** Data indicates an 80% tumor control rate with durability up to 12 months, showcasing the potential effectiveness of the treatment [11][14] 6. **Comparison to Current Treatments** Aura's treatment offers a non-invasive alternative to radiotherapy, which is currently the only option for early-stage choroidal melanoma, thus avoiding the associated risks of blindness and other comorbidities [10][11] 7. **Bladder Cancer Development** Aura is also developing treatments for bladder cancer, which is the ninth most common cancer globally, with a significant unmet medical need [16][18] 8. **Formulation Advantages** The bladder cancer formulation is stable at 2 to 8 degrees Celsius, eliminating the need for complex refrigeration, making it more accessible for urologists [18][19] 9. **Immune Response Mechanism** The treatment is designed to activate the immune system against tumor antigens, providing a first-line therapy option that could disrupt the current treatment paradigm [20][21] 10. **Commercial Launch Strategy** Aura plans to leverage a small number of ocular oncologists (approximately 100 in the U.S. and Europe) for a focused and efficient commercial launch [15][16] Additional Important Content - **Patient Enrollment and Study Design** The Phase 3 study will involve 100 patients, randomized to treatment and sham arms, with primary endpoints focused on tumor progression and visual acuity [12][14] - **Efficacy Data from Phase 2 Study** The Phase 2 study showed a significant difference in tumor progression events between high-dose and low-dose treatment groups, indicating strong efficacy [13][14] - **Potential for Broader Applications** The technology has the potential to expand beyond ocular and bladder cancers into other solid tumors, enhancing the company's market position [6][10] - **Financial Position** Aura has sufficient cash operations to support its clinical programs into the first half of 2027, indicating a stable financial outlook for ongoing research and development [3]

Core Insights - Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors that aim to preserve organ function [3] - The company will present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025, at 11:00 a.m. ET [1] - The lead candidate, bel-sar (AU-011), is in late-stage development for early choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [3] Company Overview - Aura Biosciences is headquartered in Boston, MA, and aims to grow as an innovative global oncology company that positively transforms the lives of patients [3] - The company provides a live webcast of its presentations, which will be archived for 90 days following the event [2]

[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)