[PART I. FINANCIAL INFORMATION](index=5&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) Unaudited H1 2024 financial statements report a **$40.0 million** net loss, decreased assets, and strong liquidity from equity financing [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Balance Sheet Highlights (in thousands) | Account | June 30, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash and cash equivalents | $30,075 | $41,063 | | Marketable securities | $157,341 | $185,087 | | **Total Assets** | **$218,282** | **$255,075** | | Total current liabilities | $10,548 | $12,357 | | **Total Liabilities** | **$26,828** | **$29,227** | | **Total Stockholders' Equity** | **$191,454** | **$225,848** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Results (in thousands, except per share data) | Metric | Three Months Ended June 30, 2024 | Three Months Ended June 30, 2023 | Six Months Ended June 30, 2024 | Six Months Ended June 30, 2023 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $16,879 | $15,120 | $33,932 | $29,524 | | General and administrative | $5,883 | $5,156 | $11,145 | $10,196 | | **Total operating loss** | **($22,762)** | **($20,276)** | **($45,077)** | **($39,720)** | | **Net loss** | **($20,337)** | **($18,299)** | **($40,043)** | **($35,765)** | | Net loss per share | ($0.41) | ($0.48) | ($0.81) | ($0.95) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary for Six Months Ended June 30 (in thousands) | Activity | 2024 | 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | ($40,580) | ($31,057) | | Net cash provided by (used in) investing activities | $29,237 | ($45,472) | | Net cash provided by financing activities | $336 | $2,679 | | **Net decrease in cash, cash equivalents and restricted cash** | **($11,007)** | **($73,850)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) - The company is a clinical-stage biotechnology firm focused on developing its lead candidate, bel-sar, for solid tumors, initially in ocular and urologic oncology, utilizing its proprietary Virus-Like Drug Conjugates (VDCs) platform[24](index=24&type=chunk) - As of the report date, the company expects its cash, cash equivalents, and marketable securities to be sufficient to fund operations and capital expenditures through at least the next 12 months[27](index=27&type=chunk) - In March 2024, the company filed a new **$350.0 million** shelf registration statement (Form S-3), which includes an ATM facility, though no shares were issued under the ATM in the first six months of 2024[26](index=26&type=chunk)[42](index=42&type=chunk) - As of June 30, 2024, there was **$17.7 million** of unrecognized compensation expense related to stock options and **$13.5 million** related to restricted stock units, expected to be recognized over weighted-average periods of 2.66 and 3.11 years, respectively[52](index=52&type=chunk)[53](index=53&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses bel-sar's clinical progress, reporting a **$40.0 million** net loss for H1 2024 due to increased expenses, while maintaining strong liquidity - The company is advancing its lead candidate, bel-sar, in a global Phase 3 CoMpass trial for early-stage choroidal melanoma, with an FDA Special Protocol Assessment (SPA) agreement in place[82](index=82&type=chunk)[84](index=84&type=chunk) - A Phase 2 trial for metastases to the choroid is planned to start in 2024, with initial data expected by year-end, while the ongoing Phase 1 trial in bladder cancer is enrolling patients in light-activated cohorts, with early data expected in October 2024[87](index=87&type=chunk)[92](index=92&type=chunk) Comparison of Operating Expenses for Six Months Ended June 30 (in thousands) | Expense Category | 2024 | 2023 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $33,932 | $29,524 | $4,408 | Higher personnel expenses due to company growth | | General & Administrative | $11,145 | $10,196 | $949 | Higher personnel and general corporate expenses | - As of June 30, 2024, the company had **$187.4 million** in cash, cash equivalents, and marketable securities, which management believes is sufficient to fund operations into the second half of 2026[99](index=99&type=chunk)[126](index=126&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, the company is exempt from providing quantitative and qualitative market risk disclosures - The company is a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and is not required to provide quantitative and qualitative disclosures about market risk[135](index=135&type=chunk) [Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were effective as of June 30, 2024, with no material changes to internal financial reporting controls - The CEO and CFO concluded that as of June 30, 2024, the company's disclosure controls and procedures were effective[137](index=137&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that have materially affected, or are reasonably likely to materially affect, these controls[138](index=138&type=chunk) [PART II. OTHER INFORMATION](index=33&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) As of June 30, 2024, the company is not involved in any material legal proceedings - The company is not currently involved in any material legal proceedings[139](index=139&type=chunk) [Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks related to its financial position, product development, third-party reliance, commercialization, and intellectual property [Risks Related to Financial Position and Capital Needs](index=33&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%2C%20and%20Additional%20Capital%20Needs) - The company has a history of significant net losses, with a **$40.0 million** loss for the six months ended June 30, 2024, and an accumulated deficit of **$327.4 million**, anticipating continued losses for the foreseeable future[141](index=141&type=chunk) - Substantial additional capital will be required to finance operations, and while existing cash is expected to fund operations into the second half of 2026, this estimate is based on assumptions that may prove wrong[145](index=145&type=chunk)[146](index=146&type=chunk) [Risks Related to Product Discovery and Development](index=39&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20our%20Product%20Candidates) - The company is heavily dependent on the success of its only product candidate, bel-sar, and failure to gain regulatory approval or achieve commercial viability would severely harm the business[157](index=157&type=chunk) - Bel-sar is a biologic-device combination product, requiring use of a microinjector and a laser, which adds complexity and risk to the regulatory approval process[172](index=172&type=chunk) - The company has an FDA Special Protocol Assessment (SPA) for its Phase 3 trial, but this does not guarantee a successful review or ultimate approval[208](index=208&type=chunk)[210](index=210&type=chunk) [Risks Related to Reliance on Third Parties](index=52&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) - The company relies on third-party CROs to conduct clinical trials and CDMOs for the manufacturing of bel-sar, which reduces control over these activities and introduces risks related to performance, compliance, and supply[212](index=212&type=chunk)[216](index=216&type=chunk) [Risks Related to Commercialization](index=54&type=section&id=Risks%20Related%20to%20Commercialization) - The company has no experience in marketing or sales and must build these capabilities or rely on partners, which is critical for generating revenue if bel-sar is approved[229](index=229&type=chunk) - The market opportunity for bel-sar may be smaller than estimated, and its success depends on acceptance by physicians, patients, and payors, as well as favorable pricing and reimbursement[226](index=226&type=chunk)[235](index=235&type=chunk) [Risks Related to Intellectual Property](index=60&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - Commercial success depends on obtaining and maintaining proprietary rights for its technology, where patents may be challenged, and the company may need to license IP from third parties on potentially unfavorable terms[245](index=245&type=chunk)[250](index=250&type=chunk) [Risks Related to Business and Industry](index=65&type=section&id=Risks%20Related%20to%20our%20Business%20and%20Industry) - The business is exposed to risks from cybersecurity incidents, which could compromise confidential information and disrupt development programs, while compliance with evolving data privacy laws (e.g., GDPR, CCPA) is complex and costly[283](index=283&type=chunk)[288](index=288&type=chunk) [Risks Related to Common Stock](index=74&type=section&id=Risks%20Related%20to%20Our%20Common%20Stock) - Principal stockholders and management own approximately **51%** of the common stock, allowing them to exert significant influence over corporate actions[315](index=315&type=chunk) - The company's ability to use its net operating loss (NOL) carryforwards of approximately **$174.4 million** (federal) may be limited by ownership changes under Section 382 of the Code[316](index=316&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=72&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities or issuer purchases during the period - There were no unregistered sales of equity securities or issuer purchases of equity securities in the quarter[354](index=354&type=chunk) [Defaults Upon Senior Securities](index=72&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is not applicable to the company - Not applicable[354](index=354&type=chunk) [Mine Safety Disclosures](index=73&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[355](index=355&type=chunk) [Other Information](index=73&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during the quarter ended June 30, 2024 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the quarter[355](index=355&type=chunk) [Exhibits](index=74&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including corporate governance documents and CEO/CFO certifications - Key exhibits filed include the Tenth Amended and Restated Certificate of Incorporation and an Amended and Restated Non-Employee Director Compensation Policy[358](index=358&type=chunk)

Exhibit 99.1 Aura Biosciences Reports Second Quarter 2024 Financial Results and Business Highlights Company to Present Early Non-muscle Invasive Bladder Cancer (NMIBC) Data from Ongoing Phase 1 Trial at a Urologic Oncology Investor Event in October 2024 Phase 2 End of Study Data Evaluating Suprachoroidal Administration of Bel-sar for the First-Line Treatment of Patients with Early-stage Choroidal Melanoma to be Presented at Retina Society Annual Meeting Strong Cash Position Expected to Fund Operations into ...

Shares of Aura Biosciences, Inc. (AURA) have gained 1.8% over the past four weeks to close the last trading session at $7.52, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $19.75 indicates a potential upside of 162.6%.The average comprises four short-term price targets ranging from a low of $19 to a high of $21, with a standard deviation of $0.96. While the lowest estimate ind ...

BOSTON, May 23, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ:AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat solid tumors designed to preserve the function of the organ with cancer, today announced that it will host a virtual KOL event on Wednesday, May 29, 2024 at 2:00 PM ET. To register, click here. The event will feature Carol Shields, MD (Wills Eye Hospital), Hakan Demirci, MD (University of Michigan), and Mandeep Sagoo, MB, PhD, FRCS (Ed), FRCOPTH ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-------------------------------------------------------------------------------------|---------------------------------------------| | | | | For the transition period from ____ ...

Exhibit 99.1 Aura Biosciences Reports First Quarter 2024 Financial Results and Business Highlights Continued Enrollment in Global Phase 3 CoMpass Trial in Small Choroidal Melanoma and Indeterminate Lesions Ongoing Phase 1 Trial in Bladder Cancer Enrolling; Early Data Expected Mid-2024 Strong Cash Position Expected to Fund Operations into Second Half of 2026 BOSTON, MA – May 9, 2024 – Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision immunotherapies to treat s ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-40971 AURA BIOSCIENCES, INC. (Exact name of Registrant as specified in its Charter) Delaware 32-0271970 (State or other jurisdiction ...

[Fourth Quarter and Full Year 2023 Business Highlights and Financial Results](index=1&type=section&id=Aura%20Biosciences%20Reports%20Fourth%20Quarter%20and%20Full%20Year%202023%20Financial%20Results%20and%20Business%20Highlights) [Pipeline Developments](index=1&type=section&id=Recent%20Pipeline%20Developments) 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](index=2&type=chunk) [Choroidal Melanoma (CM) and Indeterminate Lesions (ILs)](index=1&type=section&id=Choroidal%20Melanoma%20%28CM%29%20and%20Indeterminate%20Lesions%20%28ILs%29) 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](index=1&type=chunk)[3](index=3&type=chunk) - 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](index=4&type=chunk) - 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](index=5&type=chunk) - 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](index=6&type=chunk) [Bladder Cancer (NMIBC and MIBC)](index=2&type=section&id=Bladder%20Cancer%20%28NMIBC%20and%20MIBC%29) 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](index=7&type=chunk) - 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](index=8&type=chunk) - 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](index=9&type=chunk) [Corporate Events](index=3&type=section&id=Recent%20Corporate%20Events) 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](index=10&type=chunk) [Financial Results Summary](index=3&type=section&id=Full%20Year%20and%20Fourth%20Quarter%202023%20Financial%20Results) 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](index=11&type=chunk) 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](index=6&type=section&id=Financial%20Statements) 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](index=6&type=section&id=Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) 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](index=7&type=section&id=Consolidated%20Balance%20Sheets) 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** |

PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) Aura Biosciences reported a net loss of **$54.3 million** for the nine months ended September 30, 2023, driven by increased R&D expenses, with total assets of **$179.8 million** [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Condensed Consolidated Balance Sheet Highlights (in thousands) | Balance Sheet Item | Sep 30, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash and cash equivalents | $55,584 | $121,582 | | Marketable securities | $93,472 | $67,229 | | **Total Assets** | **$179,766** | **$223,935** | | Total Liabilities | $28,048 | $28,352 | | **Total Stockholders' Equity** | **$151,718** | **$195,583** | - The company's cash and cash equivalents decreased significantly from **$121.6 million** at the end of 2022 to **$55.6 million** as of September 30, 2023, while marketable securities increased. Total assets and stockholders' equity also decreased during the period[12](index=12&type=chunk) [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended Sep 30, 2023 | Three Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $15,428 | $11,293 | $44,952 | $29,079 | | General and administrative | $5,060 | $4,762 | $15,256 | $13,603 | | **Total operating loss** | **($20,488)** | **($16,055)** | **($60,208)** | **($42,682)** | | **Net loss** | **($18,512)** | **($15,901)** | **($54,277)** | **($42,204)** | | Net loss per share | ($0.48) | ($0.54) | ($1.43) | ($1.44) | - The net loss for the nine months ended September 30, 2023, increased to **$54.3 million** from **$42.2 million** in the prior-year period, primarily due to a significant rise in research and development expenses[16](index=16&type=chunk) [Condensed Consolidated Statements of Stockholders' Equity](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Stockholders'%20Equity) - Total stockholders' equity decreased from **$195.6 million** at December 31, 2022, to **$151.7 million** at September 30, 2023, primarily due to the **$54.3 million** net loss, partially offset by stock-based compensation and stock issuances[19](index=19&type=chunk)[20](index=20&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2023 | Nine Months Ended Sep 30, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($46,460) | ($36,588) | | Net cash used in investing activities | ($23,843) | ($50,993) | | Net cash provided by financing activities | $4,305 | $430 | | **Net decrease in cash, cash equivalents and restricted cash** | **($65,998)** | **($87,151)** | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail Aura Biosciences' clinical-stage biotechnology focus on cancer treatment with bel-sar, sufficient cash for 12 months, key license agreements, and a **$92.6 million** November 2023 follow-on offering - Aura Biosciences is a clinical-stage biotechnology company developing its Virus-Like Drug Conjugates (VDCs) platform for cancer, with bel-sar as its lead candidate for choroidal melanoma and other cancers[26](index=26&type=chunk) - The company expects its cash, cash equivalents, and marketable securities to fund operating expenses and capital requirements for at least the next 12 months from the report's issuance date[31](index=31&type=chunk) - On November 9, 2023, the company completed a follow-on offering, raising approximately **$92.6 million** in net proceeds from selling 11,000,000 shares at **$9.00** per share[93](index=93&type=chunk) - Key license agreements for core technology are in place with LI-COR, Life Technologies, the National Institute of Health (NIH), and Clearside Biomedical, involving potential milestone and royalty payments[71](index=71&type=chunk)[72](index=72&type=chunk)[80](index=80&type=chunk)[84](index=84&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses bel-sar's clinical development, including Phase 2 completion and Phase 3 initiation, noting a **$54.3 million** net loss for the first nine months of 2023, with sufficient funds to operate into H2 2026 [Overview](index=21&type=section&id=Overview) - Aura is a clinical-stage biotechnology company developing bel-sar, a Virus-like Drug Conjugate (VDC), for first-line treatment of early-stage choroidal melanoma and other ocular and urologic cancers[97](index=97&type=chunk)[98](index=98&type=chunk) - Enrollment is complete in the Phase 2 trial for choroidal melanoma, showing an **80% tumor control rate** and **90% visual acuity preservation**, with a global Phase 3 trial expected to begin dosing in Q4 2023 following FDA agreement on a Special Protocol Assessment[98](index=98&type=chunk)[99](index=99&type=chunk)[100](index=100&type=chunk) - Bel-sar is also being developed for non-muscle invasive bladder cancer (NMIBC), with preliminary Phase 1 data from the first light-activated patient showing a clinical complete response[102](index=102&type=chunk) - The company has not generated revenue and incurred significant operating losses, with a net loss of **$54.3 million** for the nine months ended September 30, 2023, and an accumulated deficit of **$265.2 million**[103](index=103&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) Comparison of Operating Results (in thousands) | Period | Research & Development | General & Administrative | Net Loss | | :--- | :--- | :--- | :--- | | **Three Months Ended Sep 30, 2023** | $15,428 | $5,060 | ($18,512) | | **Three Months Ended Sep 30, 2022** | $11,293 | $4,762 | ($15,901) | | **Nine Months Ended Sep 30, 2023** | $44,952 | $15,256 | ($54,277) | | **Nine Months Ended Sep 30, 2022** | $29,079 | $13,603 | ($42,204) | - R&D expenses increased by **$15.9 million** for the nine months ended Sep 30, 2023, primarily due to higher clinical trial costs for Phase 2 and Phase 3 studies, and increased manufacturing and development costs for bel-sar[130](index=130&type=chunk) - General and administrative expenses increased by **$1.7 million** for the nine months ended Sep 30, 2023, mainly driven by higher personnel expenses and general corporate costs related to company growth[131](index=131&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=Liquidity%20and%20Capital%20Resources) - As of September 30, 2023, the company held **$149.1 million** in cash, cash equivalents, and marketable securities[109](index=109&type=chunk)[141](index=141&type=chunk) - Subsequent to quarter-end, on November 9, 2023, the company raised approximately **$92.6 million** in net proceeds from a follow-on public offering[133](index=133&type=chunk) - Management believes existing cash combined with the November 2023 offering proceeds will fund operations and capital expenditures into the second half of 2026[109](index=109&type=chunk)[141](index=141&type=chunk) Cash Flow Summary (Nine Months Ended Sep 30, in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($46,460) | ($36,588) | | Net cash used in investing activities | ($23,843) | ($50,993) | | Net cash provided by financing activities | $4,305 | $430 | [Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Aura Biosciences is exempt from providing quantitative and qualitative disclosures about market risk - The company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and is not required to provide the information under this item[151](index=151&type=chunk) [Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded the company's disclosure controls and procedures were effective as of September 30, 2023, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of September 30, 2023[153](index=153&type=chunk) - No changes in internal control over financial reporting occurred during the quarter that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[154](index=154&type=chunk) PART II. OTHER INFORMATION [Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) As of September 30, 2023, the company is not party to any material legal proceedings expected to adversely affect its business - The company reports that it is not currently a party to any claim or litigation that would be reasonably expected to have a material adverse effect on its business[156](index=156&type=chunk) [Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company outlines significant risks including financial losses, reliance on bel-sar's success, dependence on third parties for development and manufacturing, and challenges in market acceptance and intellectual property protection - The company has a history of significant net losses (**$54.3 million** for the nine months ended Sep 30, 2023) and anticipates continued losses for the foreseeable future[159](index=159&type=chunk) - The business is heavily dependent on the success of its only product candidate, bel-sar; failure to gain regulatory approval or achieve commercial viability would severely harm the company[178](index=178&type=chunk) - The company relies on third-party contract manufacturing organizations (CMOs) for the production of bel-sar, increasing risks related to supply sufficiency, cost, and regulatory compliance[244](index=244&type=chunk) - The company's ability to compete depends on adequately protecting its proprietary rights, which may not address all potential threats, relying on both owned and in-licensed intellectual property[276](index=276&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=75&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities, no use of IPO proceeds, and no issuer purchases during the period - There were no unregistered sales of equity securities during the reporting period[398](index=398&type=chunk) [Other Information](index=75&type=section&id=Item%205.%20Other%20Information) The company entered a Transition and Release Agreement with its former Chief Medical Officer, Dr. Cadmus Rich, effective November 7, 2023, detailing separation terms - On November 6, 2023, the company entered into a Transition and Release Agreement with its former Chief Medical Officer, Dr. Cadmus Rich, detailing his separation terms, including severance and continued benefits for nine months[399](index=399&type=chunk) [Exhibits](index=76&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including corporate governance documents, employment agreements, and SEC certifications - Exhibits filed include the employment offer letter for Jill Hopkins, transition and release agreements with Cadmus Rich, and certifications by the Principal Executive Officer and Principal Financial Officer[401](index=401&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition period from ________ ...