Aura Biosciences(AURA) - 2023 Q4 - Annual Results

Fourth Quarter and Full Year 2023 Business Highlights and Financial Results Pipeline Developments Aura Biosciences advances its lead candidate, bel-sar, across multiple oncology indications, including ongoing Phase 3 trials for choroidal melanoma and Phase 1 for bladder cancer - The company is expanding its lead therapy, bel-sar, into bladder cancer and other solid tumor indications, targeting a multi-billion dollar market with significant unmet medical need[2] Choroidal Melanoma (CM) and Indeterminate Lesions (ILs) Phase 3 CoMpass trial for small CM and ILs actively enrolls, supported by positive Phase 2 data and FDA SPA agreement - The global Phase 3 CoMpass trial is actively enrolling patients for small choroidal melanoma (CM) and indeterminate lesions (ILs). The trial design has a Special Protocol Assessment (SPA) agreement from the FDA[1][3] - Positive Phase 2 data presented at AAO 2023 showed that patients receiving three cycles of therapy had an 80% tumor control rate and a 90% visual acuity preservation rate at 12 months follow-up[4] - The overall tolerability of bel-sar was favorable, with no dose-limiting toxicities, treatment-related serious adverse events (SAEs), or significant adverse events reported[5] - The company plans to initiate a Phase 2 trial in 2024 for choroidal metastasis (Cmets), the second potential ocular oncology indication for bel-sar, affecting over 20,000 patients annually in the US/EU[6] Bladder Cancer (NMIBC and MIBC) Phase 1 trial for NMIBC and MIBC is ongoing, with mid-2024 data expected and initial complete clinical response observed - The Phase 1 trial for NMIBC and MIBC is ongoing, with data expected in mid-2024. The company received Fast Track Designation from the FDA for NMIBC in June 2022[7] - The trial has completed enrollment for the cohort receiving bel-sar injection without light activation and has proceeded to the light activation cohorts after a safety review found no issues[8] - Preliminary data from the first patient in the light-activated cohort demonstrated a complete clinical response, with histopathology showing extensive necrosis and immune activation[9] Corporate Events Aura Biosciences completed a public offering in November 2023, raising $99.0 million in gross proceeds - Raised gross proceeds of $99.0 million in an underwritten public offering in November 2023, selling 11,000,000 shares at $9.00 per share[10] Financial Results Summary Aura Biosciences ended 2023 with $226.2 million cash, funding operations into mid-2026, and reported a $76.4 million net loss - As of December 31, 2023, the company had cash, cash equivalents, and marketable securities of $226.2 million, sufficient to fund operations into the second half of 2026[11] Financial Performance Comparison (in millions) | Metric | Q4 2023 | Q4 2022 | FY 2023 | FY 2022 | | :--- | :--- | :--- | :--- | :--- | | R&D Expenses | $20.3 | $13.2 | $65.2 | $42.2 | | G&A Expenses | $4.5 | $4.5 | $19.8 | $18.1 | | Net Loss | $22.1 | $16.6 | $76.4 | $58.8 | Financial Statements Consolidated financial statements detail the company's financial position and performance, including the Statement of Operations and Balance Sheets Consolidated Statement of Operations and Comprehensive Loss Aura Biosciences reported a total operating loss of $85.0 million and a net loss of $76.4 million for FY2023, with a net loss per share of $1.93 Statement of Operations (Year Ended Dec 31, in thousands) | Account | 2023 | 2022 | | :--- | :--- | :--- | | Research and development | $65,232 | $42,238 | | General and administrative | $19,759 | $18,057 | | Total operating loss | ($84,991) | ($60,295) | | Interest income | $8,588 | $1,864 | | Net loss | ($76,408) | ($58,763) | | Net loss per share | ($1.93) | ($1.96) | Consolidated Balance Sheets As of December 31, 2023, total assets increased to $255.1 million, driven by marketable securities, with stockholders' equity rising to $225.8 million Balance Sheet Highlights (As of Dec 31, in thousands) | Account | 2023 | 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $41,063 | $121,582 | | Marketable securities | $185,087 | $67,229 | | Total Assets | $255,075 | $223,935 | | Total Liabilities | $29,227 | $28,352 | | Total Stockholders' Equity | $225,848 | $195,583 |