AURA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-11

• In August 2026, we announced interim data from the ongoing Phase 1b/2 dose-escalation study of bel-sar in non-muscle invasive bladder cancer (NMIBC), which demonstrated an encouraging early clinical profile. Among intermediate-risk patients treated with bel-sar alone (n=8) or with TURBT (n=8), 81% o…

• Bel-sar demonstrated a favorable safety profile, with all treatment-related adverse events limited to Grade 1 events, no dose-limiting toxicities, and no treatment-related serious adverse events. We believe these data provide encouraging early clinical proof-of-concept for intratumoral delivery of b…

• While these early data are encouraging, as part of our strategic refocus on ocular oncology, we are minimizing resource allocation toward the NMIBC program on a going forward basis. We remain committed to the care of patients and intends to complete data collection through the protocol-defined 12-mo…

• In August 2026, our Board of Directors approved a plan to streamline our operating plan and organizational structure to focus resources in ocular oncology, including a reduction in force of approximately 20% of our workforce.

• In August 2026, we also announced the appointments of Susan Abu-Absi as Chief Operating Officer, Erica Kratz as Chief Regulatory and Quality Officer, and Julie Person as Chief People Officer.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• Beyond ocular cancers, bel-sar is in clinical development in bladder cancer. Bladder cancer is the ninth most common cancer worldwide and the majority of cases are diagnosed early as non-muscle invasive bladder cancer, or NMIBC, with a prevalence of approximately 80,000 cases per year in the United …

• We were incorporated as a Delaware corporation in 2009 and our headquarters are located in Boston, Massachusetts. Since our inception, we have focused our efforts on identifying and developing potential product candidates, conducting preclinical studies and clinical trials, organizing and staffing o…

• We have incurred significant operating losses in every year since our inception in 2009 and have not generated any revenue. We expect to continue to incur significant expenses and operating losses for the foreseeable future. Our ability to generate product revenue sufficient to achieve profitability…

• Comparison of the Three Months Ended March 31, 2026 and 2025

• The following table summarizes our results of operations for the three months ended March 31, 2026 and 2025:

Text added vs the prior filing · source: 10-Q · 2026-08-11

• We have completed enrollment in our pivotal Phase 3 clinical trial, but we do not expect topline data until the second half of 2027, and we have not yet completed such trial nor commercialized any pharmaceutical products, which may make it difficult to evaluate our future prospects.

• Moreover, in August 2026, we approved a plan to streamline our operating plan and organizational structure to focus resources in ocular oncology, including a reduction in force of approximately 20% of our workforce. These reductions in our workforce may also make retention of our current personnel b…

• Further, we recently underwent a leadership transition, which may be viewed negatively by employees, investors and/or our strategic partners. Moreover, any attrition associated with this transition could significantly delay or prevent the achievement of product development and commercialization, and…

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• We have initiated but not yet completed a pivotal clinical trial nor have we commercialized any pharmaceutical products, which may make it difficult to evaluate our future prospects.

Text added vs the prior filing · source: 10-Q · 2026-08-11

• None of our directors or officers, as defined in Rule 16a-1(f) under the Securities Act, adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement, as defined in Item 408(c) of Regulation S-K, during the quarter ended June 30, 2026.

Text removed vs the prior filing · source: 10-Q · 2026-05-11

• As previously disclosed, on April 30, 2026, we and Matrix entered into a stock purchase agreement pursuant to which we agreed to repurchase, in a privately negotiated transaction, up to 6,922,870 shares of our common stock held by Matrix. On May 7, 2026, we completed the repurchase of all 6,922,870 …

• None of our directors or officers, as defined in Rule 16a-1(f) under the Securities Act, adopted or terminated a Rule 10b5-1 trading arrangement or a non-Rule 10b5-1 trading arrangement, as defined in Item 408(c) of Regulation S-K, during the quarter ended March 31, 2026.