Core Insights - Aura Biosciences, Inc. has revealed early data from a Phase 1 trial of bel-sar (AU011) for non-muscle-invasive bladder cancer (NMIBC) [1] - The trial includes 13 patients, focusing on the safety and feasibility of bel-sar alone and with light activation [1][2] Trial Details - The primary endpoints are to evaluate the safety and feasibility of local administration of bel-sar alone (n=5) and with light activation (n=8) [1] - Secondary endpoints include assessing biological activity and immune-mediated changes in the tumor microenvironment [2] Clinical Outcomes - In the group receiving bel-sar with light activation (n=8), 4 out of 5 patients with low-grade disease showed a complete response with no tumor cells remaining [2] - Among patients with high-grade disease, 2 out of 3 demonstrated visual tumor shrinkage [2] - Clinical activity was detectable as soon as seven days after a single low dose of bel-sar with light activation [2] Immune Response - A notable aspect of this treatment is the rapid tumor response and marked CD8+ T-cell infiltration observed within days of treatment [3] - This rapid response may indicate potential for a durable effect [3] Safety Profile - As of the data cut-off on September 9, bel-sar was well-tolerated, with less than 10% of patients reporting Grade 1 adverse events and no Grade 2 or higher events [3] - No serious adverse events have been reported [3] Market Reaction - Following the announcement, AURA stock increased by 18.85%, trading at $12.23 in after-hours trading [4]

Core Insights - Aura Biosciences announced positive early data from a Phase 1 clinical trial of bel-sar (AU-011) for non-muscle invasive bladder cancer (NMIBC), showing clinical complete responses in 4 out of 5 patients with low-grade disease [1][2][4] - The trial demonstrated a favorable safety profile, with less than 10% of patients experiencing Grade 1 drug-related adverse events and no serious adverse events reported [1][4] - The company plans to expand the ongoing Phase 1 trial and prepare for a Phase 2 trial to further evaluate the clinical activity and durability of response of bel-sar [2][3] Trial Design - The ongoing Phase 1 trial (NCT05483868) is a two-part, open-label study assessing the safety and feasibility of bel-sar as a monotherapy, with participants followed for safety monitoring over a 56-day period [3] - Part 1 of the trial is complete, involving 5 patients receiving a single bel-sar dose without light activation, while Part 2 is ongoing with 10 patients [3] - The study includes patients with a history of recurrent bladder cancer who have undergone multiple treatments prior to enrollment [3] Safety Data - As of the September 9, 2024 data cut-off, bel-sar was well-tolerated, with no Grade 2 or higher drug-related adverse events reported [4] - No significant differences were observed between the light-activated and non-light activated cohorts in terms of safety [4] Biological Activity - Clinical activity was detectable as soon as 7 days after a single low dose of bel-sar with light activation, evidenced by histopathological evaluations [4][5] - Among patients with low-grade disease, 4 out of 5 exhibited a clinical complete response, while 2 out of 3 patients with high-grade disease showed visual tumor shrinkage [5] - Immune activation was noted in all patients, indicating a potential bladder urothelial field effect beyond the target tumor [5] Upcoming Events - Aura will host a Virtual Urologic Oncology Investor Event featuring key opinion leaders to discuss the early Phase 1 data on October 17, 2024 [6]

Small-cap stocks faced a challenging environment for the last several years as inflation and high interest rates dampened lending opportunities. These companies—which are often in the early stages of development and lack stability—rely heavily on debt to fuel their growth.Fortunately for the small-cap space, the Federal Reserve's September rate cut of 50 basis points is a welcome relief that should make borrowing more accessible. The fact that the Fed has signaled that additional rate cuts are likely in the ...

I covered Aura Biosciences, Inc. (NASDAQ: AURA ) last year, and just last week, the company presented convincing phase 2 data for lead asset bel-sar as a first-line treatment in early-stage choroidal melanoma. AURA hasAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investors r ...

Shares of Aura Biosciences (AURA) gained 7.9% on Sept. 12 after the company announced encouraging data from a phase II study evaluating its lead candidate, bel-sar (AU-011), to treat early-stage choroidal melanoma (CM) in the first-line setting. Bel-sar is a novel investigational agent designed with a dual mechanism of action that includes targeted cytotoxicity and immune activation.CM is a type of cancer occurring in the choroid, a layer of blood vessels and connective tissue between the sclera (white of t ...

Thursday, Aura Biosciences, Inc. AURA revealed Phase 2 end-of-study results evaluating bel-sar (AU-011) for the first-line treatment of early-stage choroidal melanoma (CM), a vision and ocular cancer.The Phase 2 results demonstrated that bel-sar achieved an 80% tumor control rate (n=8/10) among Phase 3-eligible patients who received the therapeutic regimen, with complete cessation of growth following treatment among responders (post-treatment average growth rate of 0.011 mm/yr among responders compared to 0 ...

Bel-sar Demonstrated 80% Tumor Control Rate, 90% Visual Acuity Preservation, and a Highly Favorable Safety Profile Aura to Host a Virtual Ocular Oncology Investor Event Featuring Key Opinion Leaders Today at 8:00 am ET BOSTON, Sept. 12, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today announced positive Phase 2 end of study results evaluating bel-sar (AU-011) for t ...

BOSTON, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that it will host a virtual urologic oncology investor event on Thursday, October 17, 2024, at 4:30 PM ET. Aura also announced that Dr. Sabine Brookman-May is joining Aura as its Senior Vice President, Clinical Development Urologic Oncology in October 2024. Virtual investor ...

BOSTON, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that members of its senior management team will participate in the following upcoming investor conferences: Morgan Stanley 22nd Annual Global Healthcare Conference on Wednesday, September 4, 2024. Members of Aura’s senior management team will participate in one-on-one invest ...

[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)