On August 9, 2023 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported financial results for the second quarter ended June 30, 2023, and provided clinical development and operational highlights (Press release, Aura Biosciences, AUG 9, 2023, View Source [SID1234634050]).

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"As we build momentum across our portfolio, we are happy to welcome Drs. Bruce Brown and Anthony Daniels as our Therapeutic Area Heads in Urologic Oncology and Ocular Oncology, respectively, as well as Dr. Richard Mountfield as our new Senior Vice President of Regulatory Affairs and Quality. These key appointments are critical in supporting our corporate growth and expansion of our clinical programs in two important oncology therapeutic areas with high unmet medical needs for patients," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura.

Dr. de los Pinos added, "We are excited to announce that we have released our drug product manufactured using the commercial process to be used in the global Phase 3 trial and remain encouraged by the progress we have made with the start-up activities, with multiple sites ready to enroll patients in the United States. We remain focused on the execution of our clinical studies and plan to share 12-month data from the Phase 2 trial in choroidal melanoma in the second half of 2023."

Recent Pipeline Developments

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Global Start up Activities for the Phase 3 trial ongoing.
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The Phase 3 trial is designed as a superiority trial comparing belzupacap sarotalocan (bel-sar) versus sham. The trial is a global Phase 3, randomized, multi-center, masked study, and it is intended to enroll approximately 100 patients randomized 2:1:2 to receive high dose regimen of bel-sar, low dose regimen of bel-sar with suprachoroidal (SC) administration, or a sham control.
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The primary endpoint is time to tumor progression and the first key secondary endpoint is a composite time to event analysis that will compare the tumor control and visual acuity of the bel-sar high dose regimen to sham when the last patient completes their 12 months of follow up.

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Aura released the commercial process material for the global Phase 3 trial. The majority of sites are qualified globally, and multiple sites are ready to enroll patients in the United States.
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The first patient is expected to be dosed in the second half of 2023.

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Enrollment is complete in the Phase 2 trial evaluating SC administration of bel-sar for the first-line treatment of adult patients with early-stage choroidal melanoma (CM). Updated efficacy data with 12 months median follow up of patients treated with the therapeutic regimen intended to be used in the global Phase 3 trial is on track to be presented in the second half of 2023.

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The Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC) is currently ongoing, and Aura expects to report data in 2024. This represents an area of high unmet need with approximately 60,000 patients diagnosed in the United States every year. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in June 2022.

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The Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 19 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The primary endpoint of the Phase 1 trial is the incidence and severity of treatment-related adverse events, serious adverse events and/or the incidence of dose-limiting toxicities. The trial will provide histopathological evaluation after the local treatment to support bel-sar’s biological activity.

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Beyond early-stage CM, Aura continues to build its ocular oncology franchise. Aura’s goal is to initiate clinical development in choroidal metastasis, an indication with a high unmet medical need and no approved therapies, as the second ocular oncology indication. Aura is on track to initiate the Phase 2 trial in 2024.

Recent Corporate Events

Strengthened the clinical leadership team with the following key appointments:

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Dr. Bruce Brown joined Aura as Therapeutic Area Head Urologic Oncology. Dr. Brown is responsible for leading the bladder cancer program, including the current ongoing trial, as well as driving future strategy and development plans. Dr. Brown was previously VP, Clinical Development at Myovant Sciences. Dr. Brown is a board-certified urologist and joined the pharmaceutical industry after practicing urology for 17 years.

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Dr. Anthony Daniels is joining Aura as the Therapeutic Area Head Ocular Oncology. Dr. Daniels will be responsible for leading the ocular oncology program and driving future strategy. Dr. Daniels is a board-certified ophthalmologist who has treated ocular oncology patients for 15 years, and most recently was Chief of the Division of Ocular Oncology at Vanderbilt University Medical Center.

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Dr. Richard Mountfield joined Aura as SVP, Regulatory Affairs & Quality. Dr. Mountfield is responsible for overseeing regulatory affairs and quality activities for all programs. Dr. Mountfield was previously the SVP of Regulatory Affairs & Quality at Zenas BioPharma.

Second Quarter 2023 Financial Results

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As of June 30, 2023, Aura had cash and cash equivalents and marketable securities totaling $162.0 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into the second half of 2025.

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Research and development expenses increased to $15.1 million for the three months ended June 30, 2023 from $9.5 million for the three months ended June 30, 2022, primarily due to ongoing clinical costs associated with the progression of our Phase 2 study and CRO costs associated with the start of our Phase 3 global trial, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

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General and administrative expenses increased to $5.2 million for the three months ended June 30, 2023 from $4.3 million for the three months ended June 30, 2022. General and administrative expenses include $1.2 million and $0.8 million of stock-based compensation for the three months ended June 30, 2023 and 2022, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to growth of the Company.

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Net loss for the three months ended June 30, 2023 was $18.3 million compared to $13.5 million for the three months ended June 30, 2022.