Aura Biosciences(AURA) - 2025 Q2 - Quarterly Results

Aura Biosciences Q2 2025 Report Overview Second Quarter 2025 Business Highlights 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][2] - Strengthened balance sheet with $75 million equity financing[1][2] - Cash position expected to fund operations into the first half of 2027[1][2] Recent Pipeline Developments Early Choroidal Melanoma 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][4] - Study enrollment may be completed as early as the end of 2025[4] - Received Orphan Drug Designation (FDA, EMA) and Fast Track designation (FDA); CoMpass trial is under a Special Protocol Assessment agreement with the FDA[5] Additional Ocular Oncology Indications 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] - These three ocular oncology indications have a collective annual incidence of greater than 60,000 patients in the United States and Europe[6] Metastases to the Choroid 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] - 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] - 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][8] Cancers of the Ocular Surface 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] - Plans to have initial data from an early proof of concept Phase 1 clinical trial in 2026[9] - Affects approximately 35,000 patients in the United States and Europe annually and has no approved therapies[9] Bladder Cancer 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] - Trial evaluates two approaches: an immune ablative design (two cycles without TURBT) and a multimodal neoadjuvant design (two cycles ahead of TURBT)[10] - 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] Second Quarter 2025 Financial Results Key Financial Highlights 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] - 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] - General and administrative expenses decreased primarily driven by reduced professional fees[16] Condensed Consolidated Statements of Operations and Comprehensive Loss 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 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 Company Profile and Mission 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] - 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] - Mission is to grow as an innovative global oncology company that positively transforms the lives of patients[13] Forward-Looking Statements Disclaimer and Risk Factors 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] - 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] - 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] Investor and Media Relations Contact Contact Information 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] - Email: IR@aurabiosciences.com[18]