AURA Aura Biosciences Inc

Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function, today announced that it will host a virtual urologic oncology investor event on Thursday, October 17, 2024, at 4:30 PM ET. Aura also announced that Dr. Sabine Brookman-May is joining Aura as its Senior Vice President, Clinical Development Urologic Oncology in October 2024.

Virtual investor event on Thursday, October 17, 2024, to present early NMIBC data from ongoing Phase 1 trial

The event will feature key opinion leaders (KOLs) Max Kates, MD (Brady Urological Institute at Johns Hopkins), Joe Jacob, MD, MCR (SUNY Upstate), Neal Shore, MD, FACS (Carolina Urologic Research Center) and Gary Steinberg, MD, FACS (Rush University). The KOLs will discuss the early NMIBC data from Aura’s ongoing Phase 1 trial as well as the high unmet medical need and current treatment landscape in NMIBC. To register for the virtual event, click here.

The ongoing Phase 1 multi-center, open-label clinical trial is designed as a window of opportunity study to assess the safety and feasibility of local administration of a novel virus-like drug conjugate (bel-sar (AU-011)) as a monotherapy prior to standard of care. The study is designed to evaluate different approaches to optimize the feasibility of local administration and includes histopathological evaluation after a single dose to assess bel-sar’s biological activity and dual mechanism of action including the characterization of the immune response.

A live question and answer session will follow the formal presentation.

The live webcast of the event will be available on the “Investors & Media” page under the “Events & Presentations” section of Aura’s website at https://ir.aurabiosciences.com/events-and-presentations, where a replay of the webcast will be archived for 90 days following the presentation date.

Dr. Sabine Brookman-May to join Aura as its Senior Vice President, Clinical Development Urologic Oncology

“We are excited to expand our leadership team with the appointment of Dr. Sabine Brookman-May who brings years of experience leading bladder cancer development globally with a multidisciplinary approach to clinical research,” said Elisabet de los Pinos, Ph.D, Chief Executive Officer of Aura. “Dr. Brookman-May’s appointment comes at an important time for Aura’s bladder cancer program, as we develop the strategic clinical development plan for bel-sar in bladder cancer and more broadly in oncology.”

“I look forward to joining Aura and believe that virus-like drug conjugates are one of the most exciting novel class of drugs that are currently being developed in NMIBC with the potential to transform the treatment paradigm for patients with bladder cancer,” said Dr. Brookman-May. “I believe Aura has a unique opportunity with bel-sar’s highly differentiated dual mechanism of action to potentially become a new standard of care for patients living with this disease. I look forward to leading Aura’s urologic oncology therapeutic area.”

Dr. Brookman-May brings over 20 years of multidisciplinary experience in urology, spanning clinical care, academia, industry and entrepreneurial innovation. Dr. Brookman-May has served as Vice President, Global R&D, Bladder Cancer Development Head at Janssen Research and Development with responsibility for strategic and clinical oversight of its portfolio of bladder cancer programs. Prior to this position, Dr. Brookman-May also served in several research and clinical positions at Janssen of increasing complexity and responsibility since 2012. In addition, Dr. Brookman-May holds an academic appointment as a professor in the Department of Urology at Ludwig-Maximilians University Munich. She is a board-certified urologist with certificates in both medical tumor treatment and sports medicine, and has published more than 200 peer-reviewed papers in the field of urologic oncology.

About Max Kates, MD

Max Kates, MD is an Associate Professor of Urology and Oncology in the Brady Urological Institute at Johns Hopkins. He directs the Division of Urologic Oncology for the Brady Urological Institute and is a clinical director of the bladder cancer multidisciplinary clinic. Dr. Kates completed his undergraduate degree at Wesleyan University in Connecticut before pursuing his medical degree at Mount Sinai School of Medicine in New York. He then went on to train at Johns Hopkins for his urologic residency and Society of Urologic Oncology (SUO) fellowship. Dr. Kates has expertise in all areas of urologic oncology, with a particular clinical emphasis on prostate and bladder cancer and research interest in novel treatments for cancers of the urinary tract. Dr. Kates has authored more than 135 journal articles in the fields of bladder, prostate, and kidney cancer. He currently has a provisional patent for a novel intravesical chemotherapy developed with nano-engineer collaborators. Additionally, Dr. Kates has made important discoveries into the mechanism of action of intravesical BCG, the most common treatment for bladder cancer and is the principal investigator on multiple trials.

About Joe Jacob, MD, MCR

Joe Jacob, MD, MCR received his medical degree from Ohio State University College of Medicine and completed urology residency and urologic oncology fellowship at Indiana University. In addition, he holds a Master’s in Clinical Research from Indiana University. He is currently an associate professor at SUNY Upstate, where he is both Director of Urologic Oncology and of the bladder cancer program. His published research includes work in genomic profiling of genitourinary tumors as well as assessments of immuno-oncologic biomarkers. Dr. Jacob has conducted numerous clinical trials both as a principal investigator (PI) and is an active global PI. He is currently a member of the Bladder Clinical Trials Committee for the Society of Urologic Oncology.

About Neal Shore, MD, FACS

Neal Shore, MD, FACS graduated from Duke University and Duke University Medical School. He completed his general surgery/urology residency at New York Hospital-Cornell Medical Center/Memorial Sloan Ketering Cancer Center. He serves as the Medical Director for the Carolina Urologic Research Center. Dr. Shore has conducted more than 400 clinical trials, focusing mainly on genitourinary oncology, and has authored more than 350 peer-reviewed publications and numerous book chapters. He serves on the Society for Immunotherapy of Cancer (SITC) Guidelines Committee for Bladder Cancer, as well as the boards of the Bladder Cancer Advocacy Network, the APCCC Scientific Steering Committee, Maple Tree Cancer Alliance, Alessa Therapeutics, Photocure, and the Duke Global Health Institute. He is the Chair of both the Prostate Cancer Academy and the Bladder/Kidney Cancer Academy, and the co-chair of the annual AUA International Prostate Forum. He has served/serves on the editorial boards of Reviews in Urology, Urology Times, Chemotherapy Advisor, OncLive, PLOS ONE, Urology Practice, JUOP and World Journal of Urology. He is the Editor of Reviews in Urology and serves as an Editor of Everyday Urology-Oncology. He is a Fellow of the American College of Surgeons.

About Gary Steinberg, MD, FACS

Gary Steinberg, MD, FACS received his medical degree from the University of Chicago Pritzker School of Medicine and completed urology residency and urologic oncology fellowship at The Brady Urological Institute- Johns Hopkins University. He is a professor in the Department of Urology at Rush University in Chicago. Dr. Steinberg is a national authority in the surgical treatment of bladder cancer and continent urinary tract reconstruction and is a recognized expert in translational bladder cancer research as well as innovative clinical trials. A prolific researcher, Dr. Steinberg has made significant contributions to our understanding of both non-muscle invasive and invasive bladder cancer and serves as the principal investigator on numerous clinical trials, working to identify new novel therapies as well as molecular biomarkers to detect the disease. Dr. Steinberg has authored or coauthored more than 200 articles as well as nearly two dozen chapters for medical textbooks. Currently, he serves on the editorial board of multiple urologic oncology journals and is the immediate past chairperson of the scientific advisory board of the Bladder Cancer Advocacy Network.

About Aura Biosciences

Aura Biosciences is a clinical-stage biotechnology company developing precision therapies to treat a range of solid tumors designed to preserve organ function. Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma, and other ocular oncology indications as well as in early-stage clinical development in bladder cancer. We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in an ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early-stage choroidal melanoma. Bel-sar is also being evaluated in additional solid cancers, including bladder cancer. Our mission is to develop vision and organ-sparing therapies to improve patient outcomes in cancer. Aura is headquartered in Boston, MA. For more information, visit aurabiosciences.com. Visit us @AuraBiosciences and on LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, and other federal securities laws. Any statements that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “may,” “will,” “could,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “projects,” “seeks,” “endeavor,” “potential,” “continue” or the negative of such words or other similar expressions that can be used to identify forward-looking statements. These forward-looking statements include express or implied statements regarding Aura’s future expectations, plans and prospects, including, without limitation, statements regarding the therapeutic potential of bel-sar for the treatment of cancers including bladder cancer; statements regarding the Company’s expectations for the Phase 1 trial of bel-sar for bladder cancer; statements regarding the timing of the Company’s plans to present data with respect to its Phase 1 clinical trial of bel-sar for the treatment of bladder cancer; statements regarding the Company’s expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; statements regarding the Company’s beliefs and expectations for the high unmet medical need for an effective local treatment in urologic oncology; statements regarding the Company’s expectations for the estimated patient populations and related market opportunities for bel-sar; and statements regarding the timing of the announcement of early NMIBC data from Aura’s ongoing Phase 1 trial of bel-sar.

The forward-looking statements in this press release are neither promises nor guarantees, and investors should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond Aura’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements, including, without limitation, uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; the expected timing for submissions for regulatory approval or review by governmental authorities; the risk that the results of Aura’s preclinical and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that interim data from ongoing clinical trials may not be predictive of final data from completed clinical trials; the risk that governmental authorities may disagree with Aura’s clinical trial designs, even where Aura has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 special protocol assessment agreement with the U.S. Food and Drug Administration; whether Aura will receive regulatory approvals to conduct trials or to market products; whether Aura’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; Aura’s ongoing and planned preclinical activities; and Aura’s ability to initiate, enroll, conduct or complete ongoing and planned clinical trials. These risks, uncertainties and other factors include those risks and uncertainties described under the heading “Risk Factors” in Aura’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in subsequent filings made by Aura with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Aura disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Aura’s current expectations and speak only as of the date hereof and no representations or warranties (express or implied) are made about the accuracy of any such forward-looking statements.

Investor and Media Contact:

Alex DasallaHead of Investor Relations and Corporate CommunicationsIR@aurabiosciences.com