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Incentive Program for the Conversion of BDRs into Shares
Globenewswire· 2025-10-02 11:00
ROAD TOWN, British Virgin Islands, Oct. 02, 2025 (GLOBE NEWSWIRE) -- Aura Minerals Inc. (NASDAQ: AUGO; B3: AURA33) (“Aura” ou “Companhia”) Announces to the holders of the Company’s Brazilian Depositary Receipts ("BDRs") the launch of the Incentive Program for the conversion of BDRs into common shares (“Incentive Program”), under which holders may request the conversion of their BDRs (“AURA33”) into the underlying common shares (“AUGO”) listed on Nasdaq (“common shares”), at a ratio of three to one, without ...
Western Exploration Files Amended NI 43-101 Technical Report for the AURA Gold Silver Project
Newsfile· 2025-10-01 21:00
Western Exploration Files Amended NI 43-101 Technical Report for the AURA Gold Silver ProjectThere is no impact to the capital costs or economic results. The only change is a slightly revised all-in sustaining cost for the "Base Case" from $1,152 to $1,172 per gold ounce.October 01, 2025 5:00 PM EDT | Source: Western Exploration Inc.Reno, Nevada--(Newsfile Corp. - October 1, 2025) - Western Exploration Inc. (TSXV: WEX) OTCQX: WEXPF) (the "Company" or "Western Exploration") announces that it ha ...
Aura Biosciences (NasdaqGM:AURA) FY Conference Transcript
2025-09-10 16:02
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]
Aura Biosciences to Participate in the H.C. Wainwright 27th Annual Global Investment Conference
Globenewswire· 2025-09-03 11:00
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]
Aura Biosciences(AURA) - 2025 Q2 - Quarterly Report
2025-08-13 11:16
[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(AURA) - 2025 Q2 - Quarterly Results
2025-08-13 11:05
[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)
Aura Biosciences Reports Second Quarter 2025 Financial Results and Business Highlights
Globenewswire· 2025-08-13 11:00
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]
Aura Biosciences (AURA) Earnings Call Presentation
2025-07-03 09:28
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]
Aura Biosciences (AURA) FY Conference Transcript
2025-05-27 15:00
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]
Aura Biosciences(AURA) - 2025 FY - Earnings Call Transcript
2025-05-20 19:00
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].