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 ...

Financial Performance and Capital Needs - The company incurred net losses of $86.9 million and $76.4 million for the years ended December 31, 2024 and 2023, respectively, with an accumulated deficit of $374.2 million as of December 31, 2024[205]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future[205]. - The company will require substantial additional capital to finance operations, particularly for the development and commercialization of bel-sar, and may need to raise additional funds sooner than planned[210]. - Existing cash and cash equivalents are expected to fund operations into the second half of 2026, but will not be sufficient to fund bel-sar through regulatory approval[211]. - The company has federal gross operating loss carryforwards of approximately $209.8 million, state gross operating loss carryforwards of $183.6 million, and foreign gross operating loss carryforwards of $0.7 million as of December 31, 2024[386]. - The company has never declared or paid cash dividends on its capital stock, intending to retain future earnings to finance business growth[387]. Product Development and Regulatory Approval - Significant research and development expenses are anticipated to increase as the company continues clinical development for bel-sar and other product candidates[205]. - The company is heavily dependent on the success of bel-sar, its only product candidate to date, and its business relies on its successful development and commercialization[221]. - The ability to generate revenue and achieve profitability depends on successful completion of clinical development and obtaining marketing approvals for bel-sar and future product candidates[218]. - The company faces risks related to the regulatory approval process, which could delay or prevent the commercialization of bel-sar[222]. - The company has not yet received regulatory approval for any of its product candidates, which significantly impacts its ability to generate revenue[225]. - The process of obtaining regulatory approvals is expensive and may take many years, with potential delays due to additional clinical trials or changes in regulations[226]. - The company is currently conducting a global Phase 3 trial for bel-sar, but has not yet completed pivotal clinical trials necessary for marketing approval[232]. - The FDA may require an Advisory Committee to evaluate the safety and efficacy data, which could further delay the approval process[229]. - The company plans to submit a single Biologics License Application (BLA) for bel-sar in combination with the SCS Microinjector and laser[235]. - The lengthy and unpredictable nature of the drug approval process poses significant risks to the company's business and operational prospects[227]. Clinical Trials and Market Risks - The company faces challenges in recruiting sufficient patients for clinical trials, which could delay regulatory approvals[237]. - Changes in manufacturing methods or formulations during development may lead to increased costs and delays in clinical trials[236]. - The acceptance of data from foreign clinical trials by the FDA is subject to specific conditions, and failure to meet these could necessitate additional costly trials[240]. - Regulatory approval in one jurisdiction does not guarantee approval in others, which could negatively impact market potential[241]. - The marketing approval process in other countries may involve additional testing and could lead to significant delays[243]. - The company may face significant delays and costs in obtaining foreign regulatory approvals, impacting market introduction[244]. - Adverse events or side effects from product candidates could delay or prevent marketing approval, impacting commercialization[250]. - The number of patients required for clinical trials may be larger than anticipated, leading to slower enrollment and potential dropout rates[256]. - The company may face delays in clinical trials due to regulatory suspensions or terminations, which could impact the approval of product candidates[257]. Competition and Market Acceptance - Market acceptance of bel-sar and future product candidates is uncertain, which could limit revenue generation and delay profitability[291]. - Significant resources may be required to educate the medical community on the benefits of bel-sar, and failure to achieve market acceptance could hinder profitability[292]. - The company faces intense competition in the biopharmaceutical industry, with potential competitors having greater financial and technical resources[298]. - The total addressable market for the product candidate bel-sar may be smaller than estimated, adversely affecting revenue and profitability[301]. - The acceptance of the company's product candidates may be inhibited by price competition and reluctance from physicians to switch from existing treatments[299]. Intellectual Property and Legal Risks - The ability to protect proprietary rights is crucial for commercial success, as competition may arise from third parties if patents are not adequately maintained[310]. - Patent protection for products like bel-sar is uncertain due to potential challenges from third parties and the complexity of patent laws[312]. - The company may face significant expenses related to maintaining its patent portfolio, including maintenance fees and renewal costs[313]. - Legal actions to enforce patent rights can be costly and may divert management resources, impacting overall business operations[314]. - The company may need to license intellectual property from third parties, which may not be available on commercially reasonable terms[315]. - The company faces risks from potential patent infringement claims by third parties, which could lead to substantial costs and delays in product development[328]. Management and Operational Risks - The company is highly dependent on key management and scientific personnel, and losing them could impair its business strategy and competitiveness[341]. - The competitive hiring environment in the Boston area poses challenges for the company in attracting and retaining qualified personnel[342]. - The company anticipates significant growth in employee numbers and operational scope, particularly in sales, marketing, finance, and accounting[378]. - The company may face increased operating expenses and cash requirements due to anticipated growth[379]. Cybersecurity and Compliance Risks - Significant disruptions to information technology systems or cybersecurity incidents could lead to material disruptions in product development programs, potentially increasing costs and delaying regulatory approvals[352]. - Cybersecurity incidents may result in unauthorized access to confidential information, leading to financial, legal, and reputational harm to the company[352]. - The company faces stringent and evolving privacy and information security laws, which could increase compliance costs and impact operational results[356]. - The company must navigate complex regulatory environments across different jurisdictions, which may complicate compliance and increase operational costs[361]. Financial Market and Economic Risks - The trading market for the company's common stock may decline if analysts publish unfavorable research or cease coverage[384]. - The company anticipates fluctuations in quarterly operating results, which may affect stock price and investor expectations[389]. - Access to funding sources and credit arrangements may be significantly impaired due to liquidity constraints or disruptions in the financial services industry[402]. - Any decline in available funding could adversely impact the company's ability to meet operating expenses and financial obligations[403].

Financial Performance - Aura Biosciences reported a net loss of $86.9 million for the full year ended December 31, 2024, compared to a net loss of $76.4 million in 2023, representing a 13.5% increase in losses[22] - Total current assets decreased from $231,794 million in 2023 to $160,623 million in 2024, a decline of approximately 30.7%[24] - Cash and cash equivalents dropped from $41,063 million in 2023 to $31,693 million in 2024, representing a decrease of about 22.8%[24] - Total liabilities increased slightly from $29,227 million in 2023 to $30,533 million in 2024, an increase of approximately 4.5%[24] - Stockholders' equity decreased significantly from $225,848 million in 2023 to $151,970 million in 2024, a decline of around 32.6%[24] - The accumulated deficit widened from $287,308 million in 2023 to $374,227 million in 2024, indicating a deterioration in financial health[24] - Additional paid-in capital increased from $512,617 million in 2023 to $525,934 million in 2024, reflecting a growth of about 2.6%[24] - Total assets decreased from $255,075 million in 2023 to $182,503 million in 2024, a reduction of approximately 28.5%[24] - Current liabilities rose from $12,357 million in 2023 to $14,913 million in 2024, an increase of about 20.6%[24] - Long-term operating lease liability decreased from $16,870 million in 2023 to $15,620 million in 2024, a decline of approximately 7.4%[24] - Right-of-use assets for operating lease decreased from $18,854 million in 2023 to $17,379 million in 2024, a reduction of about 7.8%[24] Research and Development - Research and development expenses increased to $73.3 million for the full year 2024, up from $65.2 million in 2023, reflecting ongoing clinical trial costs[22] - The Phase 3 CoMpass trial for early-stage choroidal melanoma is actively enrolling, with over 175 patients registered in pre-screening since June 2024[6] - Positive data from the Phase 1 trial in non-muscle invasive bladder cancer (NMIBC) demonstrated clinical complete responses and robust cell-mediated immunity across the disease spectrum[11] - The company has initiated a Phase 2 clinical trial for metastases to the choroid, with initial data expected in 2025[8] Regulatory and Market Position - The company received Orphan Drug Designation and Fast Track designation from the FDA for early-stage choroidal melanoma, indicating significant regulatory support[4] - The collective incidence of ocular oncology indications being targeted by bel-sar exceeds 60,000 patients annually in the U.S. and Europe[7] - The company anticipates that bel-sar could transform treatment paradigms for multiple rare oncology indications, starting with ocular cancers[3] General and Administrative Expenses - General and administrative expenses rose to $22.8 million for the full year 2024, compared to $19.8 million in 2023, driven by personnel and corporate expenses[22]

Core Insights - Aura Biosciences, Inc. reported positive Phase 1 trial data for bel-sar in non-muscle invasive bladder cancer (NMIBC), indicating its potential as a front-line treatment option [1][9] - The company is actively enrolling patients in the Phase 3 CoMpass trial for early-stage choroidal melanoma, which is the first registration-enabling study for this indication [4][5] - Aura's cash position is projected to support operations into the second half of 2026, with total cash and cash equivalents amounting to $151.1 million as of December 31, 2024 [12][19] Clinical Pipeline Developments - The Phase 2 trial for metastases to the choroid has been initiated, addressing a significant unmet medical need with no approved therapies [3][6] - The CoMpass trial aims to enroll approximately 100 patients with documented tumor growth, with over 175 patients registered in pre-screening since June 2024 [5][4] - Bel-sar is also being explored for additional ocular oncology indications, including cancers of the ocular surface, which collectively affect over 60,000 patients annually in the U.S. and Europe [6][8] Financial Performance - Research and development expenses increased to $22.3 million for Q4 2024, up from $20.3 million in Q4 2023, primarily due to ongoing clinical trial costs [12][19] - General and administrative expenses rose to $5.5 million for Q4 2024, compared to $4.5 million in Q4 2023, driven by personnel and corporate expenses [12][19] - The net loss for the full year 2024 was $86.9 million, compared to $76.4 million in 2023, reflecting increased operational costs [12][19]

Core Insights - Aura Biosciences announced positive data from a Phase 1 trial of bel-sar (AU-011) for patients with non-muscle invasive bladder cancer (NMIBC), indicating potential for a paradigm shift in treatment approaches [1][3] - The trial demonstrated clinical complete responses in patients with intermediate and high-risk NMIBC, with a favorable safety profile [1][4] Trial Design and Results - The trial included 15 patients, assessing safety and feasibility of bel-sar alone and with light activation, focusing on tumor necrosis and immune changes [2] - In the light-activated group, 4 out of 5 intermediate-risk patients showed clinical complete responses, while 1 out of 5 high-risk patients also responded positively [2][5] - Immune profiling indicated significant infiltration of cytotoxic T-cells and the formation of tertiary lymphoid structures, suggesting a robust anti-tumor immune response [6] Safety Profile - Bel-sar was well-tolerated, with drug-related Grade 1 adverse events reported in less than 10% of patients, and no serious adverse events noted [4] Future Development Plans - Aura will host a virtual investor event to discuss the Phase 1b/2 trial and future development plans for bel-sar [7][8] - The company aims to outline the potential of bel-sar as a new front-line treatment option for NMIBC, which could expand treatment options and improve patient outcomes [3][10]

Core Insights - Aura Biosciences, Inc. is set to present additional Phase 1 data on bel-sar (AU-011) for non-muscle invasive bladder cancer (NMIBC) at the 40th Annual European Association of Urology (EAU) Congress in Madrid, Spain from March 21-24, 2025 [1] - The company will also host a virtual urologic oncology investor event on March 24, 2025, featuring key opinion leaders discussing ongoing clinical trials and future development plans [5][6] Presentation Details - The late-breaker presentation titled "Safety and efficacy of Bel-sar (AU-011), a Virus-like-Drug-Conjugate (VDC), in patients with Non-Muscle Invasive Bladder Cancer (NMIBC)" will be presented by Dr. Seth Lerner on March 22, 2025 [2] - The EAU Research Forum will feature a presentation on "Virus-like Drug Conjugates (VDC), a paradigm shifting approach for the treatment of bladder cancer" on March 23, 2025 [3][4] Investor Event - The virtual investor event will include discussions on the ongoing Phase 1 trial of bel-sar, focusing on its safety and feasibility as a monotherapy prior to transurethral resection of bladder tumor (TURBT) [5] - The event will also provide updates on the bladder cancer program, including plans for a Phase 1b/2 trial expansion [6] Company Overview - Aura Biosciences is a clinical-stage biotechnology company focused on developing precision therapies for solid tumors, with its lead candidate bel-sar (AU-011) in late-stage development for primary choroidal melanoma and early-stage development in bladder cancer [12]

Core Insights - The report titled "Muscle Invasive Bladder cancer- Pipeline Insight, 2024" provides a comprehensive overview of the current landscape and growth prospects for muscle invasive bladder cancer treatments [1][2] - It includes detailed assessments of commercial and clinical aspects of pipeline products, including mechanisms of action, clinical studies, and product development activities [2][4] Pipeline Overview - The report highlights various drugs in different stages of clinical development, including Phase I, II, and III, as well as preclinical and discovery stages [4][11] - Emerging drugs such as TAR-200 and AU-011 are under development, with TAR-200 currently in Phase III trials and AU-011 in Phase I trials [5][6] Key Players - Major companies involved in the development of muscle invasive bladder cancer therapies include Aura Biosciences, Janssen Research & Development, LLC, Asieris Pharmaceuticals, and RemeGen Co., Ltd. [8][9] - Approximately 10+ key companies are actively developing therapies for muscle invasive bladder cancer, with Janssen Research & Development, LLC having candidates in the most advanced stage [9] Drug Development Activities - The report outlines various therapeutic candidates categorized by their development phases, including late-stage (Phase III), mid-stage (Phase II), and early-stage (Phase I) products [10][11] - It also discusses the types of drugs being developed, such as recombinant fusion proteins, small molecules, monoclonal antibodies, and gene therapies [10] Therapeutic Assessment - The report addresses key questions regarding the number of companies developing drugs, the stage of development for each drug, and recent trends in drug types and technologies [7] - It emphasizes the importance of collaborations, mergers, and acquisitions in the muscle invasive bladder cancer therapeutics landscape [7]

Financial Performance - Net loss for the three months ended September 30, 2024, was $21,042, compared to a net loss of $18,512 for the same period in 2023, reflecting a 8.2% increase in losses[7] - For the nine months ended September 30, 2024, the company reported a net loss of $61.085 million, compared to a net loss of $54.277 million for the same period in 2023, representing an increase in loss of approximately 12.5%[70] - The basic and diluted net loss per share for the nine months ended September 30, 2024, was $(1.23), compared to $(1.43) for the same period in 2023, indicating an improvement of approximately 13.9%[70] Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $23,232, an increase of 13.5% compared to $20,488 for the same period in 2023[7] - Research and development expenses for the nine months ended September 30, 2024, were $50,968, up 13.5% from $44,952 in the prior year[7] - The company reported a stock-based compensation expense of $8,785 for the nine months ended September 30, 2024, compared to $6,169 for the same period in 2023, marking a 42.5% increase[11] Cash Flow and Liquidity - Cash used in operating activities for the nine months ended September 30, 2024, was $55,853, compared to $46,460 for the same period in 2023, indicating a 20.2% increase in cash outflow[11] - Cash, cash equivalents, and restricted cash at the end of the period on September 30, 2024, totaled $26,175, down from $56,372 at the end of September 30, 2023[11] - As of September 30, 2024, cash and cash equivalents decreased to $25.4 million from $55.6 million in 2023, representing a decline of approximately 54%[12] Stock and Equity - Weighted average common stock outstanding for the three months ended September 30, 2024, was 49,663,532, compared to 38,185,197 for the same period in 2023, reflecting a 30.0% increase in shares outstanding[7] - The total stockholders' equity as of September 30, 2024, was $174,668, compared to $151,718 as of September 30, 2023, indicating a 15.1% increase[8] - The Company had 49,778,861 shares of common stock issued and outstanding as of September 30, 2024, compared to 49,350,788 shares at December 31, 2023[34] Marketable Securities - As of September 30, 2024, the Company had total marketable securities valued at $185.087 million, with no unrealized losses reported[32] - The total financial assets as of September 30, 2024, amounted to $173.9 million, with cash equivalents of $24.9 million and marketable securities of $148.9 million[23] Future Capital Needs - The company has sufficient cash and cash equivalents to fund its operating expenses for at least the next 12 months, but future viability depends on raising additional capital[18] - The company has filed a new shelf registration statement for an aggregate offering price of $350 million, superseding the previous registration[17] Lease Obligations - The Company has future minimum lease payments totaling $28.468 million as of September 30, 2024, with lease liabilities net of current portion amounting to $15.958 million[53] - The weighted-average remaining lease term for operating leases is 7.84 years, with a weighted-average discount rate of 10.71%[52] Research and Development - The company is developing Virus-Like Drug Conjugates (VDCs) targeting solid tumors, with a focus on ocular and urologic oncology[14] - The lead candidate, bel-sar, is currently in a global Phase 3 trial for treating small choroidal melanoma and is also being explored for bladder cancer[14] Taxation - The company recorded an income tax provision of $0.1 million for the nine months ended September 30, 2024, resulting in an effective tax rate of 0.1%[72] - As of September 30, 2024, the company had no unrecognized income tax benefits that would reduce its effective tax rate if recognized[74] - The company has recorded a full valuation allowance against its net deferred tax assets due to a history of losses, indicating uncertainty in realizing these assets[73] Miscellaneous - There were no subsequent events identified that require disclosure as of the date of filing of the unaudited condensed consolidated financial statements[75] - The company is classified as a smaller reporting company and is not required to provide certain market risk disclosures[131]

Financial Performance - The net loss for Q3 2024 was $21.0 million, an increase from $18.5 million in Q3 2023[23]. - Net loss for the three months ended September 30, 2024, was $21,042,000, compared to a net loss of $18,512,000 for the same period in 2023, representing a 27.3% increase in losses[27]. - Total comprehensive loss for the three months ended September 30, 2024, was $(20,252,000), compared to $(18,423,000) for the same period in 2023, an increase of 9.0%[27]. - Net loss per common share for the three months ended September 30, 2024, was $(0.42), an improvement from $(0.48) in the same period of 2023[27]. Cash and Assets - As of September 30, 2024, the company had cash and cash equivalents totaling $174.4 million, sufficient to fund operations into the second half of 2026[20]. - Cash and cash equivalents decreased to $25,407,000 as of September 30, 2024, down from $41,063,000 at the end of 2023, indicating a decline of 38.0%[28]. - Total assets decreased to $205,340,000 as of September 30, 2024, from $255,075,000 at the end of 2023, a reduction of 19.5%[28]. - Total liabilities increased to $30,672,000 as of September 30, 2024, compared to $29,227,000 at the end of 2023, reflecting a rise of 4.9%[28]. Operating Expenses - Total operating expenses for the three months ended September 30, 2024, were $23,232,000, an increase of 13.5% compared to $20,488,000 for the same period in 2023[27]. - General and administrative expenses rose to $6.2 million for Q3 2024, compared to $5.1 million in Q3 2023, driven by higher personnel and corporate expenses[22]. - Research and development expenses increased to $17.0 million for Q3 2024, up from $15.4 million in Q3 2023, primarily due to manufacturing and development costs for bel-sar[21]. - Research and development expenses rose to $17,036,000 for the three months ended September 30, 2024, up from $15,428,000, reflecting a 10.4% increase year-over-year[27]. Clinical Trials and Development - The Phase 2 trial of bel-sar in early-stage choroidal melanoma showed an 80% tumor control rate (8 out of 10 patients) and 90% visual acuity preservation at 12 months[8]. - The ongoing Phase 3 CoMpass trial aims to enroll 100 patients with documented growth, with pre-screening identifying over 100 patients since June 2024[6]. - The company plans to initiate a Phase 2 trial for bel-sar in metastases to the choroid, targeting approximately 20,000 patients annually in the U.S. and Europe[11]. - Bel-sar is also being explored for cancers of the ocular surface, affecting around 35,000 patients annually in the U.S. and Europe[12]. - The company is focusing on bladder cancer development, particularly low-grade, intermediate-risk NMIBC patients, with plans for trial expansion[16]. - The safety profile of bel-sar was favorable, with no serious adverse events reported in the ongoing trials[9]. Shareholder Information - Weighted average common stock outstanding for the three months ended September 30, 2024, was 49,663,532, compared to 38,185,197 for the same period in 2023, indicating a 30.0% increase in shares outstanding[27]. - Interest income for the three months ended September 30, 2024, was $2,258,000, up from $1,981,000, marking a 14.0% increase year-over-year[27].

Core Insights - Aura Biosciences, Inc. (NASDAQ: AURA) has achieved significant clinical success in advancing its pipeline over the past several months, reporting positive results from two studies involving its virus-like drug [1]. Company Overview - Aura Biosciences is focused on developing innovative therapies in the pharmaceutical sector, particularly utilizing virus-like drug technology [1]. Market Position - The company is part of the Biotech Analysis Central service, which provides in-depth analysis and insights into various pharmaceutical companies, indicating a competitive landscape in biotech investments [1].