Aura Biosciences Reports Third Quarter 2023 Financial Results and Provides Clinical Development and Operational Highlights

Received FDA Agreement Under Special Protocol Assessment (SPA) for the CoMpass Phase 3 Clinical Trial

Positive Clinical Efficacy Updates of Bel-sar for Early-Stage Choroidal Melanoma from the Ongoing Phase 2 Clinical Trial with Suprachoroidal Administration Presented at AAO 2023

Preliminary Data from Phase 1 Trial in Bladder Cancer – First Patient Utilizing a Single Dose of Bel-sar with Light Activation Demonstrated a Clinical Complete Response

Raised Gross Proceeds of $99.0 Million in an Underwritten Public Offering

BOSTON--(BUSINESS WIRE)-- 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, today reported financial results for the third quarter ended September 30, 2023, and provided clinical development and operational highlights.

“In the third quarter we made meaningful progress across our portfolio,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are encouraged by the agreement with the FDA under the SPA, as it reinforces the plan for our CoMpass trial and further supports our goal of having the first approved vision-preserving therapy for patients with early-stage choroidal melanoma. The Phase 2 data presented at AAO, with 90% of patients at twelve months follow-up, show results that are highly consistent with, and strongly support, the assumptions for the design of the CoMpass Phase 3 trial.”

Dr. de los Pinos added, “We are pleased with the preliminary data from our ongoing Phase 1 trial in bladder cancer, where the first patient who received a single dose of bel-sar with light activation demonstrated a clinical complete response evidenced by absence of cancer cells on histopathology, and we look forward to additional data from the program in mid-2024. With a strong balance sheet from our recent financing, we are well-positioned to execute our pipeline to meaningful clinical milestones.”

Recent Pipeline Developments

• The CoMpass trial is designed as a superiority trial comparing 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.
• The Company received written agreement from the FDA under an SPA for the overall design of the CoMpass trial. 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 15 months of follow up.
• The Company is planning to dose the first patient in Q4 2023.

Positive updated Phase 2 data evaluating SC administration of bel-sar for the first-line treatment of adult patients with early-stage CM was presented at AAO 2023.

• The results, with 90% of patients at twelve months of follow-up who received three cycles of therapy in Cohorts 5 and 6, and who match the criteria for the global Phase 3 trial, showed a tumor control rate of 80% (8/10) and the visual acuity preservation rate was 90% (9/10), with the majority of patients being at high-risk for vision loss with tumors close to the fovea or optic disk. For the 80% of patients that responded, data showed a statistically significant reduction in tumor growth rate (-0.382 mm/yr, p =