PART I. FINANCIAL INFORMATION [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents unaudited condensed consolidated financial statements for Q1 2022, showing a $12.8 million net loss and increased operating expenses [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2022, total assets were $146.4 million, down from $160.0 million, primarily due to reduced cash and cash equivalents Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $108,382 | $149,063 | | Marketable securities | $24,899 | $0 | | **Total Assets** | **$146,422** | **$160,030** | | Total Liabilities | $7,715 | $5,336 | | **Total Stockholders' Equity** | **$141,086** | **$152,315** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For Q1 2022, the company reported a $12.8 million net loss, a significant increase from $5.9 million in Q1 2021, driven by higher R&D and G&A expenses Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $8,276 | $4,185 | | General and administrative | $4,535 | $1,742 | | **Total operating expenses** | **$12,811** | **$5,927** | | **Net loss** | **$(12,835)** | **$(5,927)** | | Net loss per share | $(0.44) | $(20.62) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Q1 2022 saw $15.2 million cash used in operations and $25.5 million in investing activities, contrasting with Q1 2021's $87.5 million financing inflow Cash Flow Summary (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(15,200) | $(5,137) | | Net cash used in investing activities | $(25,498) | $(71) | | Net cash provided by financing activities | $17 | $87,489 | [Notes to Unaudited Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's clinical-stage biotech focus, $133.3 million in funds sufficient for 12 months, and key license agreements - Aura Biosciences is a clinical-stage biotechnology company developing its Virus-Like Drug Conjugates (VDCs) platform, with its first candidate, AU-011, targeting primary choroidal melanoma and other cancers[31](index=31&type=chunk) - As of March 31, 2022, the company had **$133.3 million** in cash, cash equivalents, and marketable securities, expected to be sufficient for at least 12 months from the financial statement issuance date[35](index=35&type=chunk)[36](index=36&type=chunk) Stock-Based Compensation Expense (in thousands) | Category | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $555 | $44 | | General and administrative | $1,039 | $141 | | **Total** | **$1,594** | **$185** | - The company has entered into multiple key license agreements for its core technology with entities including LI-COR, Life Technologies, National Institute of Health (NIH), and Clearside, involving potential future milestone and royalty payments[85](index=85&type=chunk)[86](index=86&type=chunk)[97](index=97&type=chunk) [Item 2. 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 Q1 2022's $12.8 million net loss, driven by R&D and G&A, and confirms $133.3 million cash funds operations into 2024 - The company is a clinical-stage biotech focused on its lead candidate AU-011 for choroidal melanoma, with plans to initiate a pivotal trial in the second half of 2022 and expand into other indications like non-muscle invasive bladder cancer (NMIBC)[109](index=109&type=chunk) - The company has incurred significant operating losses since inception and expects them to continue, with a **net loss of $12.8 million** for Q1 2022 and an accumulated deficit of **$165.0 million** as of March 31, 2022[111](index=111&type=chunk) - With **$133.3 million** in cash, cash equivalents, and marketable securities as of March 31, 2022, management believes it has sufficient capital to fund operations into 2024[116](index=116&type=chunk)[142](index=142&type=chunk) Comparison of Results of Operations (in thousands) | Line Item | Three Months Ended March 31, 2022 | Three Months Ended March 31, 2021 | | :--- | :--- | :--- | | Research and development | $8,276 | $4,185 | | General and administrative | $4,535 | $1,742 | | **Net loss** | **$(12,835)** | **$(5,927)** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Aura Biosciences is not required to provide information for this item - 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[154](index=154&type=chunk) [Item 4. Controls and Procedures](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of March 31, 2022, with no material changes to internal controls - Based on an evaluation as of the end of the period, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[156](index=156&type=chunk) - There were no changes in the company's internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, its internal control over financial reporting[157](index=157&type=chunk) PART II. OTHER INFORMATION [Item 1. Legal Proceedings](index=29&type=section&id=Item%201.%20Legal%20Proceedings) As of March 31, 2022, the company is not a party to any material legal proceedings - The company is not currently party to any claim or litigation that would be reasonably expected to have a material adverse effect on its business[159](index=159&type=chunk) [Item 1A. Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including financial losses, dependence on AU-011, reliance on third parties, and regulatory hurdles - **Financial Risk:** The company has a history of significant net losses (**$12.8 million** in Q1 2022) and expects to incur losses for the foreseeable future, requiring substantial additional capital[162](index=162&type=chunk) - **Product Dependency Risk:** The company's business is heavily dependent on the success of AU-011, its only product candidate to date[179](index=179&type=chunk) - **Third-Party Reliance Risk:** The company relies on third-party CMOs for manufacturing and CROs for clinical trials, which increases risks related to supply, quality control, and trial execution[237](index=237&type=chunk)[241](index=241&type=chunk) - **Regulatory and Commercialization Risk:** The company faces significant hurdles in obtaining regulatory approval for its novel biologic-device combination product and achieving market acceptance if approved[183](index=183&type=chunk)[193](index=193&type=chunk)[251](index=251&type=chunk) [Item 2. 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) No unregistered sales occurred; IPO net proceeds of $78.3 million remain consistent with planned use - The company completed its IPO on November 2, 2021, with net proceeds of approximately **$78.3 million** after deducting discounts, commissions, and expenses[400](index=400&type=chunk) - There has been no material change in the planned use of proceeds from the IPO as disclosed in the prospectus[402](index=402&type=chunk) [Item 3. Defaults Upon Senior Securities](index=75&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) Not applicable - Not applicable[403](index=403&type=chunk) [Item 4. Mine Safety Disclosures](index=75&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Not applicable - Not applicable[403](index=403&type=chunk) [Item 5. Other Information](index=75&type=section&id=Item%205.%20Other%20Information) None - None[403](index=403&type=chunk) [Item 6. Exhibits](index=76&type=section&id=Item%206.%20Exhibits) This section lists exhibits, including corporate governance documents and SOX certifications by key officers - The report includes certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002[405](index=405&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 September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-----------------------------------------------------------------------------------------|------------------------------------------| | | | | Commission File Number: | 001- ...