On November 24, 2021 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 including ocular and urologic cancers, reported financial results for the third quarter ended September 30, 2021 (Press release, Aura Biosciences, NOV 24, 2021, View Source [SID1234596046]).

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"We recently completed a successful initial public offering, placing us in a solid financial position to advance our lead VDC, AU-011, through pivotal development for our first indication in the ocular oncology franchise," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "We are very encouraged with the final data from the Phase 1b/2 trial with intravitreal administration that was presented by Dr. Carol Shields at the AAO annual meeting last week, as well as the continued favorable safety and tolerability profile of the ongoing Phase 2 study with suprachoroidal administration. These data support our plan to move into the pivotal program in 2022 with the goal to develop the first targeted therapy for patients with indeterminate lesions and small choroidal melanoma.

Dr. Pinos continued: "We are also excited to work toward unlocking the broad oncology potential of the VDC platform and plan to initiate clinical development in non-muscle invasive bladder cancer during the second half of next year. Supporting the advancement of our programs, we have a robust balance sheet and a strong team, which we recently built out with several key additions to our management team and Board of Directors."

Recent Pipeline Developments

AU-011 is being developed for the first line treatment of indeterminate lesions and small choroidal melanoma, a life threatening and rare disease with no approved drugs. Data from two clinical trials were recently presented at the American Academy of Ophthalmology (AAO) 2021 Annual Meeting.
Final Phase 1b/2 Data with Intravitreal (IVT) Administration. Data from the completed Phase 1b/2 trial using IVT administration were presented by Dr. Carol Shields, Director, Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. The data demonstrated a statistically significant reduction in tumor growth rate (-0.483 mm/yr, p = 0.018), a 64% tumor control rate, and a visual acuity preservation rate of 71%, which is a dramatic improvement compared to the current standard of care with radiotherapy. These three endpoints have been agreed upon with FDA and will be used in the pivotal program.
Interim Phase 2 Safety Data with Suprachoroidal (SC) Administration. Preliminary results presented by Dr. Hakan Demirci, Professor of Ophthalmology at Kellogg Eye Center, University of Michigan, demonstrate a favorable safety and tolerability profile for AU-011 with SC administration. The data showed no treatment-related serious adverse events, dose limiting toxicities, or grade 3/4 adverse events. Aura plans to present 6-12 months safety and efficacy data from this trial in 2022.
Aura plans to select the route of administration and treatment regimen to initiate the pivotal program in the second half of 2022.
Leveraging the broad tumor targeting capabilities of the VDC platform, Aura is planning to pursue clinical development of AU-011 in non-muscle invasive bladder cancer (NMIBC).
NMIBC is an area of high unmet need with no approved targeted therapies. The AU-011 mechanism of action supports the opportunity for use as a first-line treatment either following initial diagnosis and/or Bacillus Calmette-Guerin, BCG, refractory disease. The data from preclinical Investigational New Drug (IND)-enabling studies of AU-011 demonstrated robust efficacy, supporting its clinical development as a single agent or in combination with checkpoint inhibitors. The planned Phase 1a trial will evaluate the safety and early proof of mechanism in the setting, exploring local necrosis and evidence of immune activation, and Aura expects to initiate the trial in the second half of 2022.
Recent Corporate Updates

Completed Initial Public Offering (IPO). In November 2021, Aura closed a successful IPO of 6,210,000 shares of its common stock, which included the full exercise of the underwriters’ option, at a public offering price of $14.00 per share. The aggregate gross proceeds to Aura from the IPO were approximately $86.9 million, before deducting underwriting discounts and commissions and other estimated offering expenses. Aura’s common stock commenced trading on the Nasdaq Global Market on October 29, 2021 under the ticker symbol "AURA".
Antony Mattessich Appointed to the Board of Directors in September 2021. Mr. Mattessich is currently the Chief Executive Officer at Ocular Therapeutix. Prior to Ocular Therapeutix, he was Managing Director of Mundipharma International, based in Cambridge, England. Prior to his time at Mundipharma, Mr. Mattessich ran the U.S. respiratory, dermatology and pediatrics group at Novartis.
Chris Primiano, J.D., Appointed Chief Business Officer in September 2021. Mr. Primiano joined Aura from Karyopharm Therapeutics Inc., where he most recently served as Executive Vice President, Chief Business Officer, General Counsel and Secretary. Mr. Primiano played an important role in transitioning Karyopharm Therapeutics Inc. from 40 employees in a preclinical and early clinical development setting to 400 employees, commercializing XPOVIO (selinexor) across multiple indications.
Third Quarter 2021 Financial Results

As of September 30, 2021, Aura had cash and cash equivalents totaling $81.8 million. Aura raised $86.9 million in gross proceeds from the IPO. Aura believes its current cash and cash equivalents are sufficient to fund the Company’s operations into 2024.
Research and development expenses increased to $6.4 million for the three months ended September 30, 2021 from $2.9 million for the three months ended September 30, 2020, primarily due to progression of clinical trials and ongoing manufacturing development costs for AU-011. In addition, research and development expenses related to personnel increased from growing headcount due to the progression of clinical trials.
General and administrative expenses increased to $2.5 million for the three months ended September 30, 2021 from $0.8 million for the three months ended September 30, 2020. General and administrative expenses include $0.4 million and $0.1 million of stock-based compensation for the three months ended September 30, 2021 and 2020, respectively. The increase was primarily related to an increase in personnel expenses due to an increase in headcount, as well as general increases in audit, legal, consulting and facilities expenses in anticipation of becoming a public company.
Net loss for the three months ended September 30, 2021, was $8.8 million, compared to $3.6 million for the three months ended September 30, 2020.