Company Overview - Aura Biosciences is developing virus-like drug conjugates (VDCs) targeting multiple solid tumor indications, including ocular and bladder cancers[7] - The company highlights a multi-billion dollar addressable market opportunity in early-stage choroidal melanoma (CM) and other ocular tumors[7] - Aura Biosciences expects to fund operations into 2025[7, 95] Ocular Oncology Program - Approximately 80% of choroidal melanoma patients are diagnosed with early-stage disease[21, 32] - Interim Phase 2 data showed that with 3 cycle regimens, the tumor control rate was 88.9% (8/9 patients)[44] - In the Phase 2 trial, vision preservation rate was 90% across all dose cohorts (20 patients)[52] Non-Muscle Invasive Bladder Cancer (NMIBC) Program - The company is targeting Non-Muscle Invasive Bladder Cancer, which affects over 200,000 patients per year globally[78] - Approximately 40% of intermediate-risk NMIBC patients experience failure of BCG/Chemo treatment[80] - Preclinical data demonstrates durable complete responses (CRs) with a single administration of Bel-sar in a bladder cancer model[82] Upcoming Milestones - The company plans to dose the first patient in the Phase 3 trial for primary choroidal melanoma in the first half of 2023[8, 95] - Phase 2 data for suprachoroidal administration in primary choroidal melanoma is expected in the second half of 2023[8, 95] - The company plans to initiate a Phase 2 trial in choroidal metastasis in the second half of 2023[8, 95]

Summary of Aura Biosciences (AURA) FY Conference Call Company Overview - Aura Biosciences is focused on ocular oncology, with a late-stage asset in Phase III clinical development for ocular melanoma, which is identified as the key value driver for the company [2][3] - The company has multiple clinical data readouts expected in the ocular oncology therapeutic area, including the COMPASS study, which is anticipated to complete enrollment this year and provide top-line data potentially in late 2026 or early 2027 [3][4] Key Opportunities - The ocular melanoma market has an estimated potential of 66,000 patients, with three synergistic indications that allow for orphan pricing and rare disease opportunities [4] - The bladder cancer program has recently initiated a Phase II study, with a new formulation designed to differentiate between ocular and bladder cancer treatments [5] Clinical Trial Insights - The bladder cancer Phase I trial is designed as a "window of opportunity" study, allowing for quick assessment of feasibility and early efficacy signals, although it does not measure durability of response [6][7] - Initial data from the bladder cancer study showed a remarkable complete response rate of approximately 80% in the intermediate-risk population with a single dose [8] - Biomarker data indicated strong immune activation, suggesting potential for long-term adaptive immunity [9][10] Safety and Efficacy - The treatment has shown a favorable safety profile, with only grade one adverse events reported, indicating a well-tolerated drug that can be administered quickly in an office setting without general anesthesia [11][12] - The ongoing Phase I/II trial aims to evaluate durability of response, with initial data expected by the end of 2025 and comprehensive data by the end of 2026 [17][18] Market Potential - The bladder cancer market is estimated to have around 80,000 patients in the U.S. for intermediate-risk cases, with a significant opportunity for a safe drug that can be administered in an office setting [23] - The company also sees potential in the high-risk bladder cancer market, addressing the unmet need for durability of response [24] Choroidal Melanoma Insights - The Phase II data for choroidal melanoma showed 80% tumor control and 90% visual acuity preservation at twelve months, indicating a strong safety and efficacy profile [25][26] - The pivotal trial design includes a randomized, sham-controlled study, which has received SPA agreement from the FDA, enhancing the likelihood of approval [27][29] Pricing Strategy - Aura Biosciences is considering orphan disease pricing, with benchmarks from successful drugs in the ultra-rare space, potentially leading to a multibillion-dollar franchise [43][44] - The company aims to position its drug as a safe alternative that prevents blindness, which carries a high value proposition for pricing discussions with payers [45] Future Directions - The ongoing Phase II study for choroidal metastases is expected to provide proof of concept data by the end of the year, with a broader inclusion criteria to enhance the study's applicability [49][50] - The company is optimistic about the potential of its drug beyond ocular oncology, indicating a broader market opportunity across various tumor types [51] Conclusion - Aura Biosciences is strategically positioned in the ocular oncology market with promising clinical data and a robust pipeline, focusing on safety, efficacy, and market potential to create shareholder value in the coming years [42]

Aura Biosciences (AURA) FY 2025 Conference May 20, 2025 02:00 PM ET Speaker0 Great. I'd like to welcome everybody back to our afternoon session of the H. C. Wainwright BioConnect Investor Conference at NASDAQ. My name is Andres Maldonado. I'm a covering analyst here at the firm. And I'd like to welcome our next presenters, Aura Biosciences. And today we're joined by Jill Hopkins, Chief Medical Officer, President of R and D as well and Tony Gibney, Chief Financial and Business Officer. Welcome on behalf of H ...

Core Viewpoint - Aura Biosciences, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $75 million to support its clinical programs and general corporate purposes [2][3]. Group 1: Offering Details - The public offering consists of 11,735,565 shares of common stock and warrants to purchase 2,933,891 shares of common stock, along with pre-funded warrants for up to 3,571,435 shares at an exercise price of $0.00001 [1]. - The combined offering price for each share of common stock and accompanying warrant is set at $4.90, while the pre-funded warrant and accompanying warrant are priced at $4.89999 [1]. - The offering is expected to close on or about May 16, 2025, subject to customary closing conditions [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to advance clinical programs in early-stage choroidal melanoma, metastases to the choroid, cancers of the ocular surface, and non-muscle invasive bladder cancer [3]. Group 3: Company Overview - Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors, with a mission to transform the lives of patients [7]. - The company's lead candidate, bel-sar (AU-011), is in late-stage development for primary choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [7]. Group 4: Management and Underwriters - Leerink Partners and Evercore ISI are acting as joint bookrunning managers for the offering, with LifeSci Capital also serving as a bookrunning manager [4]. - Citizens Capital Markets and Scotiabank are co-managers for the offering [4]. Group 5: Regulatory Information - A shelf registration statement for the offering was filed with the SEC on March 27, 2024, and was declared effective on April 5, 2024 [5]. - A preliminary prospectus supplement was filed with the SEC on May 15, 2025, and will be available on the SEC's website [5].

Company Overview - Aura Biosciences, Inc. is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors aimed at preserving organ function [5] - The company's lead candidate, bel-sar (AU-011), is in late-stage development for primary choroidal melanoma and early-stage development for other ocular oncology indications and bladder cancer [5] Public Offering Announcement - Aura announced the launch of an underwritten public offering of shares of its common stock, including pre-funded warrants and accompanying warrants [1] - The offering is subject to market conditions, and there is no assurance regarding its completion or the actual size and terms [1] Management and Underwriters - Leerink Partners and Evercore ISI are acting as joint bookrunning managers for the offering, with LifeSci Capital also serving as a bookrunning manager [2] - Citizens Capital Markets and Scotiabank are co-managers for the offering [2] Regulatory Compliance - The offering is made pursuant to a shelf registration statement filed with the SEC on March 27, 2024, and declared effective on April 5, 2024 [3] - A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC and made available on their website [3] Investor Relations - For inquiries, investors can contact Alex Dasalla, Head of Investor Relations and Corporate Communications at Aura [7]

Clinical Development - The lead candidate bel-sar is in late-stage clinical development for primary choroidal melanoma and other solid tumors, with enrollment for the Phase 3 trial expected to complete by the end of 2025 [88]. - In a Phase 2 study, bel-sar achieved an 80% tumor control rate among Phase 3-eligible patients, with a post-treatment average growth rate of 0.011 mm/yr compared to 0.351 mm/yr prior to study entry (p<0.0001) and 90% visual acuity preservation [89]. - The ongoing Phase 1b/2 trial for non-muscle invasive bladder cancer (NMIBC) will evaluate bel-sar in approximately 26 patients, with initial data expected by year-end 2025 [93]. - The company plans to initiate a Phase 1 trial in cancers of the ocular surface in 2025, targeting an incidence rate of 35,000 patients per year in the U.S. and Europe [90]. Financial Performance - As of March 31, 2025, the company reported net losses of $27.5 million and an accumulated deficit of $401.7 million [95]. - The company has not generated any revenue since inception and does not expect to do so in the foreseeable future [99]. - Research and development expenses are expected to increase as the company continues clinical development for bel-sar and other product candidates [102]. - Research and development expenses increased to $23.3 million for the three months ended March 31, 2025, up from $17.1 million in the same period of 2024, primarily due to ongoing clinical and CRO costs associated with the global Phase 3 trial of bel-sar [109]. - General and administrative expenses rose to $5.7 million for the three months ended March 31, 2025, compared to $5.3 million in the same period of 2024, driven by higher personnel expenses [110]. - Total operating expenses for the three months ended March 31, 2025, were $29.0 million, an increase of $6.7 million from $22.3 million in the same period of 2024 [108]. - The net loss for the three months ended March 31, 2025, was $27.5 million, compared to a net loss of $19.7 million for the same period in 2024, reflecting an increase of $7.8 million [108]. Cash and Funding - The company has raised approximately $420.0 million since inception, with $99.0 million raised from the 2023 Follow-On Offering at $9.00 per share [94]. - The company had cash and cash equivalents of $128.0 million as of March 31, 2025, which is expected to fund operations into the second half of 2026 [98]. - Cash, cash equivalents, and marketable securities as of March 31, 2025, totaled $128.0 million, expected to fund operations into the second half of 2026 [118]. - Net cash used in operating activities was $23.4 million for the three months ended March 31, 2025, compared to $24.5 million for the same period in 2024 [112]. - Net cash provided by investing activities was $29.8 million for the three months ended March 31, 2025, significantly higher than $9.4 million in the same period of 2024 [115]. - The company raised approximately $420.0 million in gross proceeds through the sale of equity and convertible preferred stock up to March 31, 2025 [111]. Operating Expenses and Commitments - The company has incurred significant operating losses since 2009 and anticipates needing substantial additional funding to support ongoing operations and growth strategies [96]. - Operating lease commitments total $26.836 million, with $3.331 million due within 1 year, $10.6 million due in 1 to 3 years, and $7.598 million due in 3 to 5 years [123]. - The company has no long-term debt or finance leases, and contracts with service providers are generally cancelable [125]. - Payments due upon cancellation of contracts consist only of services provided or expenses incurred, with no material non-cancelable purchase commitments [125]. Regulatory and Accounting Matters - The company remains classified as an "emerging growth company" until it exceeds $1.235 billion in annual revenue or meets other specified criteria [129]. - The market value of the company's stock held by non-affiliates is less than $700 million, qualifying it as a "smaller reporting company" [130]. - The company has not experienced material changes to its critical accounting policies as of March 31, 2025 [126]. - No recent accounting pronouncements have had a material impact on the company's financial statements [127]. - The company has elected to use the extended transition period under the JOBS Act for compliance with new accounting standards [128]. - The company is not required to provide quantitative and qualitative disclosures about market risk due to its status as a smaller reporting company [132]. - The lease for office and laboratory space in Boston, MA, has an initial term of 10 years with a renewal option for an additional 7 years [124]. - The income tax provision for the year ended December 31, 2024, was recorded at $0.1 million, with accumulated net operating loss carryforwards of approximately $209.8 million [107]. - The company anticipates a substantial increase in expenses related to ongoing research and development activities and operating as a public company [117].

Financial Performance - Aura Biosciences reported a net loss of $27.5 million for Q1 2025, compared to a net loss of $19.7 million for Q1 2024, reflecting an increase of approximately 39% year-over-year [21]. - The comprehensive loss for Q1 2025 was $27.6 million, compared to $20.2 million in Q1 2024 [24]. - General and administrative expenses increased to $5.7 million in Q1 2025 from $5.3 million in Q1 2024, driven by higher personnel costs [21]. Research and Development - Research and development expenses rose to $23.3 million in Q1 2025 from $17.1 million in Q1 2024, primarily due to ongoing clinical trial costs [17]. - The ongoing Phase 1b/2 trial for NMIBC will evaluate bel-sar in approximately 26 patients, with initial efficacy data expected by year-end 2025 [12]. - The CoMpass trial for early-stage choroidal melanoma has enrolled over 220 patients in a pre-screening tool since June 2024, with completion expected by the end of 2025 [4]. - The company expects initial data from the Phase 2 trial for metastases to the choroid in 2025, with a focus on a basket study approach [7]. - Bel-sar is being explored for three ocular oncology indications, collectively affecting over 60,000 patients annually in the U.S. and Europe [6]. - The company has filed a patent application for a new formulation of bel-sar for bladder cancer, aimed at enhancing in-office urologist procedures [10]. Financial Position - As of March 31, 2025, the company had cash and cash equivalents totaling $128.0 million, sufficient to fund operations into the second half of 2026 [17]. - Total assets decreased from $182,503 million as of December 31, 2024, to $155,401 million as of March 31, 2025, representing a decline of approximately 14.85% [26]. - Total current assets decreased from $160,623 million to $134,517 million, a reduction of about 16.26% [26]. - Stockholders' equity decreased from $151,970 million to $127,966 million, reflecting a decline of approximately 15.77% [26]. - Cash and cash equivalents increased from $31,693 million to $38,226 million, an increase of about 20.04% [26]. - Total liabilities decreased from $30,533 million to $27,435 million, a decrease of approximately 10.14% [26]. - Total current liabilities decreased from $14,913 million to $12,163 million, a decrease of about 18.43% [26]. - Long-term operating lease liability slightly decreased from $15,620 million to $15,272 million, a reduction of about 2.23% [26]. - Additional paid-in capital increased from $525,934 million to $529,571 million, a growth of about 0.25% [26]. - Accumulated deficit increased from $(374,227) million to $(401,710) million, indicating a worsening of approximately 7.36% [26]. - Accumulated other comprehensive income decreased from $263 million to $105 million, a decline of approximately 60.00% [26].

Core Insights - Aura Biosciences, Inc. has initiated a multi-dose Phase 1b/2 trial of bel-sar for Non-Muscle-Invasive Bladder Cancer (NMIBC), with initial data expected by the end of 2025 [1][14] - The company has strengthened its leadership team by appointing Tony Gibney as Chief Financial and Business Officer [1][18] - Aura is making significant progress in its ocular and urologic oncology programs, particularly with the Phase 3 CoMpass trial for early-stage choroidal melanoma [2][3] Recent Pipeline Developments - The CoMpass trial is the first registration-enabling study for early-stage choroidal melanoma, actively enrolling patients globally [3][4] - Over 220 patients have been pre-screened for the CoMpass trial since June 2024, indicating a strong demand for vision-preserving therapies [4] - Bel-sar is also being explored for metastases to the choroid and cancers of the ocular surface, with a collective incidence of over 60,000 patients annually in the U.S. and Europe [6][10] Clinical Trials and Data - A Phase 2 trial for bel-sar in metastases to the choroid has been initiated, with plans to broaden inclusion criteria to include various solid tumors [7] - Positive results from a completed Phase 1 trial for NMIBC showed multiple clinical complete responses and a favorable safety profile [12] - The ongoing Phase 1b/2 trial for NMIBC will evaluate two approaches, with endpoints including complete response rates and recurrence-free survival [13][14] Financial Overview - As of March 31, 2025, Aura reported cash and cash equivalents totaling $128.0 million, sufficient to fund operations into the second half of 2026 [18] - Research and development expenses increased to $23.3 million in Q1 2025 from $17.1 million in Q1 2024, driven by clinical trial costs [19] - The net loss for Q1 2025 was $27.5 million, compared to $19.7 million in Q1 2024, reflecting increased operational expenses [24]

Summary of Aura Biosciences Conference Call Company Overview - **Company**: Aura Biosciences (AURA) - **Technology**: Novel virus-like drug conjugates with a dual mechanism of action for cancer treatment, focusing on local early-stage diseases with a good safety profile [3][60] Core Industry Insights Uveal Melanoma - **Lead Indication**: Primary uveal melanoma, a rare and life-threatening disease with an incidence of 11,000 patients annually in the U.S. [4][61] - **Market Opportunity**: Approximately 66,000 patients in ocular oncology with no approved drugs, primarily treated with surgery or radiotherapy [4][61] - **Current Treatment Limitations**: Existing treatments often lead to blindness; Aura's drug, Belzar, aims to preserve vision in over 90% of patients [8][64] Treatment Administration - **Administration Method**: Belzar is administered via a suprachoroidal injection, which is safer than intravitreal injections and can be done in an office setting without the need for hospitalization [12][68] - **Treatment Regimen**: Nine treatments over three months, with a focus on achieving a durable local cure [14][70] Clinical Development - **Current Phase**: Phase III clinical trials with SPA agreement, aiming for BLA submission [16][72] - **Efficacy Data**: 80% efficacy reported in previous trials, with a focus on patients with actively growing lesions to ensure quick differentiation from sham treatments [19][74] Bladder Cancer Insights - **Emerging Opportunity**: Similar to ocular oncology, bladder cancer presents a high incidence of pre-metastatic disease [31][82] - **Efficacy in Trials**: Initial trials showed 80% complete response rates with a single dose, with plans for further dose escalation [84][87] - **Mechanism of Action**: The treatment aims to prime the immune system for an anti-tumoral response, contrasting with traditional adjuvant treatments that may not effectively target residual tumors [85][86] Market Dynamics - **Competitive Landscape**: Aura operates in a white space with no direct competition for its lead indication, positioning itself for a successful market launch [5][61] - **Physician Adoption**: There may be initial resistance from urologists who are accustomed to surgical interventions; however, the economic incentives favor office-based treatments [42][91] Future Outlook - **Cash Position**: Aura has sufficient funding to support clinical programs into the second half of 2026 [56][56] - **Upcoming Milestones**: Key data milestones expected within the next six months, including bladder cancer durability data and ocular metastasis results [56][57] Additional Considerations - **Tumor Agnostic Potential**: The technology is designed to treat various solid tumors, expanding the potential market significantly beyond ocular and bladder cancers [52][53] - **Patient-Centric Approach**: The treatment strategy emphasizes patient safety and efficacy, aiming to provide options that do not compromise quality of life [42][92]

BOSTON, April 02, 2025 (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 the appointment of Teresa Bitetti, President of the Global Oncology Business Unit at Takeda, to the Company's Board of Directors, effective March 31, 2025. "I am pleased to welcome Teresa to our Board of Directors," said Elisabet de los Pinos, Chief Executive Officer of Aura Biosciences. "S ...