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 ________ ...

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, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | --- | --- | |-------------------------------------------------------------------------------------|------------------------------------------| | | | | For the transition period from _______ ...

Company Overview - Aura Biosciences is developing virus-like drug conjugates (VDCs) to target multiple solid tumor indications, including ocular and bladder cancers[6] - The company highlights a multi-billion-dollar addressable market opportunity with its novel platform to treat multiple solid tumors[6] - Aura Biosciences has a strong cash position with a cash runway to fund operations into 2025[6] Ocular Oncology Program - The company initiated activities for a global Phase 3 trial for Primary Choroidal Melanoma and plans to initiate a Phase 2 trial for Choroidal Metastasis in the second half of 2023[6] - In Primary Choroidal Melanoma, approximately 80% of patients are diagnosed with early-stage disease, representing a significant target population[17] - Current radiotherapy treatments leave approximately 70% of patients with major irreversible vision loss within 5-10 years[26] - Phase 2 interim data showed an 89% tumor control rate in the highest dose/regimen group (3 cycles)[39] and 100% tumor control rate in planned Phase 3 population[46] - Phase 2 interim analysis demonstrated visual acuity preservation in approximately 90% of patients[47] - Phase 2 interim data demonstrated a statistically significant tumor growth rate reduction with a p-value of <0.0001 in the planned Phase 3 population[53] - The company estimates a total addressable market of 33,500 for the Ocular Oncology Franchise, including 20,000 Choroidal Metastasis patients diagnosed each year in the US/EU[70, 71] Urologic Oncology Program - The company is enrolling patients in a Phase 1 trial in Non-Muscle Invasive Bladder Cancer (NMIBC), with initial data expected in the second half of 2023[84] - The company notes that NMIBC has a high incidence globally, affecting over 500,000 patients per year[84]

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, 2022 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 ...

PART I. [FINANCIAL INFORMATION](index=6&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) Aura Biosciences' unaudited consolidated financial statements as of September 30, 2022, present key financial positions, operations, and cash flows Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | Cash and cash equivalents | $61,110 | $149,063 | | Marketable securities | $50,409 | $0 | | **Total Assets** | **$143,147** | **$160,030** | | Total current liabilities | $9,964 | $7,355 | | Long-term operating lease liability | $18,129 | $360 | | **Total Liabilities** | **$28,093** | **$7,715** | | **Total Stockholders' Equity** | **$115,054** | **$152,315** | Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Research and development | $29,079 | $17,182 | | General and administrative | $13,603 | $6,441 | | **Total operating loss** | **($42,682)** | **($23,623)** | | **Net loss** | **($42,204)** | **($23,617)** | | **Net loss per share** | **($1.44)** | **($77.93)** | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Nine Months Ended Sep 30, 2022 | Nine Months Ended Sep 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | ($36,588) | ($20,324) | | Net cash used in investing activities | ($50,993) | ($1,306) | | Net cash provided by financing activities | $430 | $86,117 | - As of the report issuance date, the company expects its cash, cash equivalents, and marketable securities of **$111.5 million** to be sufficient to fund operating expenses and capital requirements through at least the next 12 months[28](index=28&type=chunk)[30](index=30&type=chunk) - On November 1, 2022, the company filed a shelf registration statement for up to **$250.0 million** and entered into an "at-the-market" (ATM) offering agreement for up to **$75.0 million** of its common stock[102](index=102&type=chunk) [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 condition, operational results, and belzupacap sarotalocan's clinical progress, highlighting expenses and liquidity [Overview](index=22&type=section&id=MD%26A%20Overview) Aura Biosciences, a clinical-stage biotech, advances belzupacap sarotalocan for ocular and urologic cancers, planning a global Phase 3 trial - The lead product candidate, belzupacap sarotalocan, has received **Orphan Drug Designation** and **Fast Track Designation** from the FDA for the treatment of uveal melanoma[106](index=106&type=chunk) - Interim six-month data from the Phase 2 trial of belzupacap sarotalocan with suprachoroidal (SC) administration showed a favorable safety profile, high levels of visual acuity preservation, and a statistically significant tumor growth rate reduction (**p = 0.0007**)[106](index=106&type=chunk) - The company is expanding into urologic oncology, having initiated a **Phase 1 trial** for non-muscle invasive bladder cancer (NMIBC) in September 2022, with initial data expected in 2023[107](index=107&type=chunk) [Results of Operations](index=26&type=section&id=MD%26A%20Results%20of%20Operations) This section compares Q3 and nine-month operating results, highlighting increased net losses due to higher R&D and G&A expenses Comparison of Operating Results (in thousands) | Period | R&D Expense | G&A Expense | Net Loss | | :--- | :--- | :--- | :--- | | **Q3 2022** | $11,293 | $4,762 | ($15,901) | | **Q3 2021** | $6,365 | $2,530 | ($8,838) | | **Nine Months 2022** | $29,079 | $13,603 | ($42,204) | | **Nine Months 2021** | $17,182 | $6,441 | ($23,617) | - The increase in R&D expenses was primarily due to ongoing preclinical costs, manufacturing and development costs for belzupacap sarotalocan, and higher personnel expenses from growing headcount[132](index=132&type=chunk)[138](index=138&type=chunk) - The increase in G&A expenses was driven by higher personnel costs and increased general corporate expenses related to operating as a public company[133](index=133&type=chunk)[139](index=139&type=chunk) [Liquidity and Capital Resources](index=27&type=section&id=MD%26A%20Liquidity%20and%20Capital%20Resources) Liquidity from equity sales, with **$111.5 million** cash as of September 30, 2022, funds operations into 2024, but substantial additional capital is needed - As of September 30, 2022, the company had cash, cash equivalents, and marketable securities totaling **$111.5 million**[114](index=114&type=chunk)[150](index=150&type=chunk) - The company believes its existing cash will be sufficient to fund operating expenses and capital expenditure requirements into **2024**, but this will not be enough to fund belzupacap sarotalocan through regulatory approval[150](index=150&type=chunk)[177](index=177&type=chunk) Material Cash Requirements (in thousands) | Commitment | Total | Less than 1 Year | 1 to 3 Years | 3 to 5 Years | More than 5 Years | | :--- | :--- | :--- | :--- | :--- | :--- | | Operating lease commitments | $34,718 | $3,089 | $6,458 | $6,851 | $18,320 | [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 not required to provide 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[161](index=161&type=chunk) [Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management, including CEO and CFO, concluded disclosure controls were effective as of September 30, 2022, with no material internal control changes - Management, including the CEO and CFO, concluded that as of September 30, 2022, the company's disclosure controls and procedures were effective[164](index=164&type=chunk) - No change in internal control over financial reporting occurred during the quarter that has materially affected, or is reasonably likely to materially affect, internal controls[165](index=165&type=chunk) PART II. [OTHER INFORMATION](index=32&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings.) As of September 30, 2022, the company is not party to any claim or litigation expected to have a material adverse effect on its business - As of September 30, 2022, the company does not believe it is party to any claim or litigation that would be reasonably expected to have a material adverse effect on its business[167](index=167&type=chunk) [Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors.) This section outlines material risks related to financial position, product development, third-party reliance, commercialization, intellectual property, and general business [Risks Related to Financial Position and Capital Needs](index=32&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%2C%20and%20Additional%20Capital%20Needs) This section details financial risks, including significant net losses, an accumulated deficit of **$194.3 million**, and the need for substantial additional capital - The company has incurred significant net losses since inception, with an accumulated deficit of **$194.3 million** as of September 30, 2022, and expects to incur increasing operating losses for the foreseeable future[170](index=170&type=chunk) - Substantial additional capital is required to finance operations. Existing cash is expected to fund operations into **2024** but is not sufficient to complete the development and commercialization of belzupacap sarotalocan[176](index=176&type=chunk)[177](index=177&type=chunk) [Risks Related to the Discovery and Development of our Product Candidates](index=36&type=section&id=Risks%20Related%20to%20the%20Discovery%20and%20Development%20of%20our%20Product%20Candidates) This section outlines product development risks, including dependence on belzupacap sarotalocan, regulatory uncertainty for combination products, and clinical trial failures - The company's business is heavily dependent on the successful development, regulatory approval, and commercialization of its only product candidate, **belzupacap sarotalocan**[190](index=190&type=chunk) - The company has not yet successfully initiated or completed any pivotal clinical trials or commercialized any products, making it difficult to evaluate future prospects[200](index=200&type=chunk) - Belzupacap sarotalocan is a **biologic-device combination product**, which may result in additional regulatory complexity and risks during the approval process[204](index=204&type=chunk) [Risks Related to Our Reliance on Third Parties](index=47&type=section&id=Risks%20Related%20to%20Our%20Reliance%20on%20Third%20Parties) This section details risks from reliance on third parties for clinical trials and manufacturing, including performance, compliance, and single-source supply disruptions - The company relies on third parties like **CROs** to conduct clinical trials, which reduces direct control over these activities but does not relieve the company of its regulatory responsibilities[247](index=247&type=chunk)[248](index=248&type=chunk) - The company relies on third-party **CMOs** for the manufacture of belzupacap sarotalocan and is currently reliant on a **single source** for each of its regulatory starting materials, drug substance, and drug product[252](index=252&type=chunk) [Risks Related to Commercialization](index=50&type=section&id=Risks%20Related%20to%20Commercialization) This section covers commercialization risks, including market acceptance, lack of sales infrastructure, intense competition, uncertain pricing, and healthcare law compliance - The company currently has no sales, marketing, or distribution capabilities and no experience in marketing products, which will require significant investment and resources to build[266](index=266&type=chunk) - The market opportunity for belzupacap sarotalocan may be smaller than estimated, which would adversely affect potential revenue and profitability[277](index=277&type=chunk) - The business is subject to numerous healthcare laws and regulations (e.g., **Anti-Kickback Statute**, **False Claims Act**, **HIPAA**), and non-compliance could lead to significant penalties[279](index=279&type=chunk)[281](index=281&type=chunk) [Risks Related to Intellectual Property](index=58&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) This section details intellectual property risks, including patent protection challenges, reliance on third-party licenses, and the difficulty of protecting trade secrets - The company's ability to compete depends on adequately protecting its proprietary rights, which is subject to challenges, potential invalidation, and the high cost of enforcement[299](index=299&type=chunk)[301](index=301&type=chunk) - The company relies on intellectual property licensed from third parties and could lose these rights if it fails to comply with its obligations under the license agreements[307](index=307&type=chunk) - The company relies on confidentiality agreements to protect trade secrets, such as the manufacturing process for the **IRDye 700DX® dye** used in its lead product, which may be breached or difficult to enforce[327](index=327&type=chunk) [General Risks](index=63&type=section&id=General%20Risks) This section outlines general business risks, including personnel, disruptions, cybersecurity, data privacy, stock volatility, dilution, ownership, and emerging growth company status - The company's executive officers, directors, and 5%+ stockholders beneficially own approximately **60.1%** of its outstanding common stock, enabling them to exert significant influence over corporate actions[378](index=378&type=chunk) - The company is an "**emerging growth company**" and a "**smaller reporting company**," which allows for reduced public reporting requirements but may make its stock less attractive to some investors[402](index=402&type=chunk) - Future sales of common stock, including through a new "**at-the-market**" (ATM) program, will be necessary for additional capital but could result in significant dilution to existing stockholders and cause the stock price to decline[393](index=393&type=chunk)[394](index=394&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=80&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) No unregistered equity sales occurred, and no material change in the planned use of **$78.3 million** net IPO proceeds from November 2021 - The company completed its IPO on November 2, 2021, receiving total net proceeds of approximately **$78.3 million** after the underwriters fully exercised their option[420](index=420&type=chunk) - There has been no material change in the planned use of proceeds from the IPO as disclosed in the original prospectus[422](index=422&type=chunk) [Defaults Upon Senior Securities](index=80&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities.) This item is not applicable to the company for the reporting period - Not applicable[422](index=422&type=chunk) [Mine Safety Disclosures](index=80&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company for the reporting period - Not applicable[422](index=422&type=chunk) [Other Information](index=80&type=section&id=Item%205.%20Other%20Information.) The company reported no other information for this item during the period - None[422](index=422&type=chunk) [Exhibits](index=81&type=section&id=Item%206.%20Exhibits.) This section lists exhibits filed with the Form 10-Q, including corporate documents and certifications from the Principal Executive and Financial Officers - The filing includes certifications from the Principal Executive Officer and Principal Financial Officer pursuant to Sections **302** and **906** of the Sarbanes-Oxley Act of 2002[425](index=425&type=chunk)