AURA Aura Biosciences Inc.

22.62
+2.63  (+13%)
Previous Close 19.99
Open 19.24
52 Week Low 14
52 Week High 26.16
Market Cap $642,625,446
Shares 28,409,613
Float 28,138,529
Enterprise Value $476,973,163
Volume 84,954
Av. Daily Volume 103,599
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Upcoming Catalysts

Drug Stage Catalyst Date
AU-011
Non-muscular invasive bladder cancer (NMIBC)
Phase 1a
Phase 1a
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Drug Pipeline

Drug Stage Notes
AU-011 (IVT administration)
Indeterminate lesions (ILs) and choroidal melanoma (CM)
Phase 1/2
Phase 1/2
Phase 1b/2 12-month safety and efficacy data noted a statistically significant reduction in the tumor growth rate, a 64% tumor control rate, and visual acuity preservation rate of 71%, noted November 15, 2021.
AU-011
Primary choroidal melanoma
Phase 2
Phase 2
Phase 2 safety data reported that there have been no related SAE, dose limiting toxicities, or grade 3 adverse events observed during the trial and that dose administration may improve the therapeutic index and optimize treatment parameters, noted November 10, 2021.

Latest News

  1. Presented Final Data from Phase 1b/2 Trial of AU-011 in Choroidal Melanoma at the American Academy of Ophthalmology's Annual Meeting

    Completed Initial Public Offering to Fund Pivotal Program for AU-011 in Choroidal Melanoma and Earlier Stage Oncology Pipeline

    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, today announced financial results for the third quarter ended September 30, 2021.

    "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…

    Presented Final Data from Phase 1b/2 Trial of AU-011 in Choroidal Melanoma at the American Academy of Ophthalmology's Annual Meeting

    Completed Initial Public Offering to Fund Pivotal Program for AU-011 in Choroidal Melanoma and Earlier Stage Oncology Pipeline

    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, today announced financial results for the third quarter ended September 30, 2021.

    "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.

    About Aura Biosciences

    Aura Biosciences, Inc. is 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. Aura's technology utilizes VDCs to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, life-threatening eye cancers, the majority of which have no approved drugs available for treatment. Aura's lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of indeterminate lesions and small choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care radioactive treatment leaves patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating a statistically significant growth rate reduction in patients with prior active growth and high levels of tumor control with visual acuity preservation in a majority of patients. We believe these data provide the potential to introduce a new standard of care in choroidal melanoma and treat patients with early-identified lesions for whom no treatments are currently available. Future clinical development for AU-011 is planned throughout ocular oncology, including in choroidal metastases where Aura expects to file an IND during the second half of 2022. The unique mechanism of action of Aura's HSPG-targeting VDCs also enables development of AU-011 as a platform broadly across multiple solid tumors; the first clinical trial of AU-011 outside ocular oncology is planned for the second half of 2022 in non-muscle invasive bladder cancer, a high unmet medical need where patients have poor treatment options and tumor progression leads to cystectomy (bladder removal) and a high risk of metastases. Future pipeline growth is expected to include additional drug conjugates for broad oncology applications. Aura is headquartered in Cambridge, MA.

    Forward Looking Statement

    This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 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 expectations and plans for presenting clinical data, including of Phase 2 safety and efficacy data of AU-011 in SC administration, projections regarding Aura's long-term growth, including having a cash runway into 2024, the anticipated timing of Aura's clinical trials and regulatory filings, including for initiation of a pivotal program of AU-011 in indeterminate lesions and choroidal melanoma and of a Phase 1a trial of AU-011 in non-muscle invasive bladder cancer, the development of Aura's product candidates and advancement of Aura's clinical programs.

    The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; whether interim results from a clinical trial, including the Phase 2 SC administration trial, will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials, including regarding AU-011's ability to offer vision preserving therapy for the first line treatment of choroidal melanoma; the expected timing of the expansion phase of the Phase 2 SC administration trial; the expected timing for submissions for regulatory approval or review by governmental authorities; 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; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura's business, operations, strategy, goals and anticipated timelines; Aura's ongoing and planned pre-clinical activities; Aura's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Aura's timelines for regulatory submissions; and Aura's financial position. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" set forth in Aura's filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Aura believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Aura nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Aura undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

     

    Aura Biosciences, Inc.

    Condensed Statement of Operations

    (in thousands, except share and per share amounts)

     
     

     

     

    Three Months Ended

    September 30,

     

     

    Nine Months Ended

    September 30,

     

     

     

    2021

     

     

    2020

     

     

    2021

     

     

    2020

     

    Operating Expenses:

     

     

     

     

     

     

     

     

     

     

     

     

    Research and development

     

    $

    6,365

     

     

    $

    2,850

     

     

    $

    17,182

     

     

    $

    14,499

     

    General and administrative

     

     

    2,530

     

     

     

    781

     

     

     

    6,441

     

     

     

    2,798

     

    Total operating expenses

     

     

    8,895

     

     

     

    3,631

     

     

     

    23,623

     

     

     

    17,297

     

    Total operating loss

     

     

    8,895

     

     

     

    3,631

     

     

     

    23,623

     

     

     

    17,297

     

    Other income (expense):

     

     

     

     

     

     

     

     

     

     

     

     

    Change in fair value of warrant liability

     

     

    -

     

     

     

    -

     

     

     

    1

     

     

     

    -

     

    Change in fair value of derivative liability

     

     

    52

     

     

     

    -

     

     

     

    -

     

     

     

    -

     

    Interest income (expense), including amortization

    of discount

     

     

    5

     

     

     

    -

     

     

     

    8

     

     

     

    (2)

     

    Loss from disposal of assets

     

     

    -

     

     

     

    -

     

     

     

    (3)

     

     

     

    -

     

    Total other income (expense)

     

     

    57

     

     

     

    -

     

     

     

    6

     

     

     

    (2)

     

    Net loss and comprehensive loss

     

    $

    (8,838)

     

     

    $

    (3,631)

     

     

    $

    (23,617)

     

     

    $

    (17,299)

     

    Net loss attributable to common stockholders—

    basic and diluted

     

    $

    (12,506)

     

     

    $

    (5,579)

     

     

    $

    (33,244)

     

     

    $

    (23,101)

     

    Net loss per share attributable to common stockholders—

    basic and diluted

     

     

    (28.33)

     

     

     

    (14.81)

     

     

     

    (77.93)

     

     

     

    (63.69)

     

    Weighted average common stock outstanding—

    basic and diluted

     

     

    441,448

     

     

     

    376,738

     

     

     

    426,604

     

     

     

    362,735

     

     
     

    Aura Biosciences, Inc.

    Condensed Balance Sheets

    (in thousands, except share and per share amounts)

     
     

     

     

    As of

     

     

     

    September 30, 2021

     

     

    December 31, 2020

     

    Assets

     

     

     

     

     

     

    Current assets:

     

     

     

     

     

     

    Cash and cash equivalents

     

    $

    81,829

     

     

    $

    17,393

     

    Restricted cash and deposits

     

     

    20

     

     

     

    19

     

    Prepaid expenses and other current assets

     

     

    1,609

     

     

     

    1,043

     

    Total current assets

     

     

    83,458

     

     

     

    18,455

     

    Restricted cash and deposits, net of current portion

     

     

    125

     

     

     

    75

     

    Right of use assets - operating lease

     

     

    1,096

     

     

     

    -

     

    Property and equipment, net

     

     

    4,442

     

     

     

    3,574

     

    Deferred offering costs

     

     

    1,583

     

     

     

    -

     

    Total Assets

     

    $

    90,704

     

     

    $

    22,104

     

    Liabilities, Convertible Preferred Stock, and Stockholders' Deficit

     

     

     

     

     

     

    Current liabilities:

     

     

     

     

     

     

    Accounts payable

     

     

    1,736

     

     

     

    611

     

    Current portion of operating lease liabilities

     

     

    607

     

     

     

    -

     

    Accrued expenses and other current liabilities

     

     

    3,488

     

     

     

    2,050

     

    Total current liabilities

     

     

    5,831

     

     

     

    2,661

     

    Deferred rent

     

     

    -

     

     

     

    8

     

    Operating lease liabilities, net of current portion

     

     

    513

     

     

     

    -

     

    Warrant liability

     

     

    71

     

     

     

    72

     

    Total Liabilities

     

     

    6,415

     

     

     

    2,741

     

    Commitments and Contingencies (Note 12)

     

     

     

     

     

     

    Series A convertible preferred stock, $0.00001 par value, 1,701,141 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $3,403 at September 30, 2021 and December 31, 2020, respectively

     

     

    3,368

     

     

     

    3,368

     

    Series A-1 convertible preferred stock, $0.00001 par value, 3,298,732 shares authorized, issued, and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $8,196 at September 30, 2021 and December 31, 2020, respectively

     

     

    7,837

     

     

     

    7,837

     

    Series A-2 convertible preferred stock, $0.00001 par value, 4,325,021 shares authorized, and 4,324,998 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $5,373 at September 30, 2021 and December 31, 2020, respectively

     

     

    5,373

     

     

     

    5,373

     

    Series B convertible preferred stock, $0.00001 par value, 22,705,646 shares authorized, and 22,531,819 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $38,894 and $37,429 at September 30, 2021 and December 31, 2020, respectively

     

     

    20,806

     

     

     

    20,806

     

    Series C-1 convertible preferred stock, $0.00001 par value, 58,109,711 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $37,736 and $36,150 at September 30, 2021 and December 31, 2020, respectively

     

     

    29,353

     

     

     

    29,353

     

    Series C-2 convertible preferred stock, $0.00001 par value, 33,218,192 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $15,332 and $14,697 at September 30, 2021 and December 31, 2020, respectively

     

     

    11,746

     

     

     

    11,746

     

    Series D-1 convertible preferred stock, $0.00001 par value, 57,878,742 shares authorized, issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $46,003 and $43,908 at September 30, 2021 and December 31, 2020, respectively

     

     

    39,686

     

     

     

    39,686

     

    Series D-2 convertible preferred stock, $0.00001 par value, 24,598,481 shares authorized, and 24,598,481 and 14,469,710 issued and outstanding at September 30, 2021 and December 31, 2020, respectively, and a liquidation preference of $17,982 and $10,176 at September 30, 2021 and December 31, 2020, respectively

     

     

    16,889

     

     

     

    9,907

     

    Series E convertible preferred stock, $0.00001 par value, 102,671,041 shares authorized, issued and outstanding at September 30, 2021, and a liquidation preference of $83,525 at September 30, 2021; no shares authorized, issued or outstanding at December 31, 2020, respectively

     

     

    80,246

     

     

     

    -

     

    Stockholders' Deficit:

     

     

     

     

     

     

    Common stock, $0.00001 par value, 470,183,383 and 232,697,999 authorized at September 30, 2021 and December 31, 2020, and 442,717 and 381,123 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

     

     

    -

     

     

     

    -

     

    Additional paid-in capital

     

     

    9,488

     

     

     

    8,173

     

    Accumulated deficit

     

     

    (140,503)

     

     

     

    (116,886)

     

    Total Stockholders' Deficit

     

     

    (131,015)

     

     

     

    (108,713)

     

    Total Liabilities, Convertible Preferred Stock, and Stockholders' Deficit

     

    $

    90,704

     

     

    $

    22,104

     

     

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  2. 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, today announced that Elisabet de los Pinos, Chief Executive Officer of Aura, will participate in a fireside chat at the 4th Annual Evercore ISI HealthCONx conference taking place on Tuesday, November 30, 2021 at 2:15 p.m. Eastern Time.

    A live webcast of the fireside chat will be available on the "Investors & Media" page under the "Events & Presentations" section of the Company'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…

    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, today announced that Elisabet de los Pinos, Chief Executive Officer of Aura, will participate in a fireside chat at the 4th Annual Evercore ISI HealthCONx conference taking place on Tuesday, November 30, 2021 at 2:15 p.m. Eastern Time.

    A live webcast of the fireside chat will be available on the "Investors & Media" page under the "Events & Presentations" section of the Company'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.

    About Aura Biosciences

    Aura Biosciences, Inc. is 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. Aura's technology utilizes VDCs to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The company has the goal of developing this technology in multiple cancer indications with an initial focus in ocular oncology, life-threatening eye cancers, the majority of which have no approved drugs available for treatment. Aura's lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of indeterminate lesions and small choroidal melanoma, a vision- and life-threatening form of eye cancer where standard of care radioactive treatment leaves patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating a statistically significant growth rate reduction in patients with prior active growth and high levels of tumor control with visual acuity preservation in a majority of patients.  We believe these data provide the potential to introduce a new standard of care in choroidal melanoma and treat patients with early-identified lesions for whom no treatments are currently available. Future clinical development for AU-011 is planned throughout ocular oncology, including in choroidal metastases where Aura expects to file an IND during the second half of 2022. The unique mechanism of action of Aura's HSPG-targeting VDCs also enables development of AU-011 as a platform broadly across multiple solid tumors; the first clinical trial of AU-011 outside ocular oncology is planned for the second half of 2022 in non-muscle invasive bladder cancer, a high unmet medical need where patients have poor treatment options and tumor progression leads to cystectomy (bladder removal) and a high risk of metastases.  Future pipeline growth is expected to include additional drug conjugates for broad oncology applications. Aura is headquartered in Cambridge, MA.

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  3. Presentations Include Final Safety and Efficacy Data from the Phase 1b/2 Trial using Intravitreal Administration and Updated Safety Data from the Phase 2 Trial using Suprachoroidal Administration

    Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of data evaluating its first VDC, AU-011, in indeterminate lesions (ILs) and choroidal melanoma (CM), including final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration, as well as updated safety results from the Phase 2 trial using suprachoroidal (SC) administration. The results are presented as part of the American Academy…

    Presentations Include Final Safety and Efficacy Data from the Phase 1b/2 Trial using Intravitreal Administration and Updated Safety Data from the Phase 2 Trial using Suprachoroidal Administration

    Aura Biosciences, a clinical-stage oncology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, today announced the presentation of data evaluating its first VDC, AU-011, in indeterminate lesions (ILs) and choroidal melanoma (CM), including final safety and efficacy data from the Phase 1b/2 trial using intravitreal (IVT) administration, as well as updated safety results from the Phase 2 trial using suprachoroidal (SC) administration. The results are presented as part of the American Academy of Ophthalmology (AAO) 2021 Annual Meeting.

    "The final safety and efficacy data from the Phase 1b/2 trial using intravitreal administration presented today, along with the data from the Phase 2 trial using suprachoroidal administration, provide a high level of confidence for further clinical development in patients with indeterminate lesions or choroidal melanoma," said Carol Shields, MD, Chief of the Ocular Oncology Service at Wills Eye Hospital and Professor of Ophthalmology at Thomas Jefferson University. "I believe AU-011 may offer patients a safe, effective first-line therapy for early-stage disease that preserves vision, a critical component in patients' quality of life often neglected with today's current treatment options."

    Final 12-Month Safety and Efficacy Data from Phase 1b/2 Trial with IVT administration

    The Phase 1b/2 trial (NCT03052127) evaluated the safety and efficacy of AU-011 using IVT administration for the treatment of ILs and CM. A total of 56 patients were enrolled in the Ph1b/2 trial including the single and multiple dose escalation cohorts and received up to two cycles of therapy (therapeutic regimen). As part of an enrichment strategy agreed with FDA, patients with small tumors with active growth were enrolled in the Phase 2 part of the study (expansion cohort). This group of patients (n=14) received the therapeutic regimen and were evaluated for the tumor growth rate, tumor control, and visual acuity preservation as the efficacy endpoints. These endpoints have been agreed with FDA and are planned to be used in the pivotal program. The results at 12 months showed a statistically significant reduction in the tumor growth rate (-0.483 mm/yr, p = 0.018) compared to each patient's documented growth rate at study entry, and a 64% (9/14) tumor control rate. In addition, the visual acuity preservation rate was 71%, which is unprecedented compared to the current standard of care with radiotherapy. Overall, AU-011 demonstrated a favorable safety and tolerability profile. The majority of adverse events (AEs), which included intraocular inflammation and increased intraocular pressure, were transient and resolved without clinical sequelae. A large number of patients (43/56) had tumors close to the fovea and optic disk and only two patients with juxta-foveal tumors had a treatment related serious adverse event (SAE) of vision loss. No other treatment related SAEs were observed in the trial. These safety and efficacy results indicate that AU-011 may offer a targeted vision preserving therapy for the first line treatment of CM.

    Safety Data from Phase 2 Trial with SC Administration

    This Phase 2 trial (NCT04417530) includes an open-label, dose escalation phase assessing the safety and efficacy of AU-011 via SC administration in patients with ILs and CM and plans to enroll up to 22 patients. In this preliminary safety data review of the initial dose escalation cohorts (n=14), no treatment related SAEs, dose limiting toxicities (DLTs), or grade 3/4 AEs were reported. Preliminary results indicate a positive safety and tolerability profile for AU-011 via SC administration.

    Details for the AAO 2021 Presentations are as follows:

    Title: A Phase 1b/2 Trial of AU-011, a First in Class Targeted Therapy for the Treatment of Choroidal Melanoma via Intravitreal Administration

    Presenter: Carol L. Shields, Wills Eye Hospital

    Session: OP10 Ocular Pathology and Oculoplastics Original Paper Session

    Date and time: Monday, November 15 from 9:45 – 9:52 AM CT

    Location: 255-257

    Title: A Phase 2 Trial of a First in Class Targeted Therapy for Choroidal Melanoma via Suprachoroidal (SC) Administration

    Presenter: Hakan Demirci, Kellogg Eye Center

    Session: PD08 Ocular Pathology and Oculoplastics Poster Discussion

    Date and time: Available on demand beginning Friday, November 12, 2021, at 7:30am PT

    Location: Virtually on demand

    The presentations can be accessed by visiting the "Scientific Presentations" section of "VDC Platform" page of the Aura Biosciences website.

    About Choroidal Melanoma

    Choroidal melanoma is a rare and aggressive type of eye cancer. Choroidal melanoma is the most common primary intraocular tumor in adults and develops in the uveal tract of the eye. No targeted therapies are available at present, and current radiotherapy treatments can be associated with severe visual loss and other long-term sequelae such as dry eye, glaucoma, cataracts, and radiation retinopathy. The most common current treatment is plaque radiotherapy, which involves surgical placement of a radiation device on the exterior of the eye over the tumor. The alternative is enucleation, or total surgical removal of the eye. Choroidal melanoma metastasizes in approximately 50 percent of cases with liver involvement in 80-90% of cases and, unfortunately, metastatic disease is universally fatal. There is a very high unmet need for a new vision sparing targeted therapy that could enable early treatment intervention for this life-threatening rare disease given the mortality rate in metastatic disease, lack of approved therapies, and the comorbidities of radioactive treatment options.

    About AU-011

    AU-011 is a first-in-class virus-like drug conjugate (VDC) therapy in clinical development for the first line treatment of choroidal melanoma. The virus-like component of the VDC selectively binds unique heparin sulphate proteoglycans (HSPGs), which are modified and overexpressed on the tumor cell surface of malignant cells in the choroid and AU-011 delivers a potent cytotoxic drug that is activated with infrared light. Upon activation with an ophthalmic laser, the cytotoxic drug rapidly and specifically disrupts the cell membrane of malignant cells with a pro-immunogenic cell death that can activate the immune system generating long term anti-tumor immunity. The unique specificity of tumor binding by the VDC enables the preservation of key eye structures, which may allow for the potential of preserving patients' vision and reducing other long-term complications of radiation treatment. AU-011 can be delivered using equipment commonly found in an ophthalmologist's office and does not require a surgical procedure, pointing to a potentially less invasive, more convenient therapy for patients and physicians. AU-011 for the treatment of choroidal melanoma is currently in Phase 2 clinical development and the company plans to expand the clinical program into choroidal metastasis.

    About Suprachoroidal Administration

    The suprachoroidal space (SCS®) injection treatment approach offers unprecedented access to the back of the eye where sight-threatening disease often occurs. Aura believes that delivering AU-011 into SCS within the eye, has the potential to offer certain advantages, including higher bioavailability at the tumor site and reduced exposure of non-targeted tissues, which may lead to an improved therapeutic index for AU-011. Collectively, these features could allow for the treatment of a wider range of tumor sizes, and, therefore, a larger number of patients may be treatable. The Company is partnered with Clearside Biomedical for use of Clearside's SCS Microinjector® for administration of AU-011 into the SCS.

    About Aura Biosciences

    Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute. The company has the goal of developing this technology in multiple cancer indications with an initial focus on primary choroidal melanoma, a rare disease for which there are no approved drugs. Aura's lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of primary choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura's technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.

    Forward Looking Statement

    This press release may contain forward-looking statements and information within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Aura's future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting clinical data, projections regarding our long-term growth, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our clinical programs, as well as other statements containing 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. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical trials and in the availability and timing of data from ongoing clinical trials; whether interim results from a clinical trial, including the Phase 2 SC administration trial, will be predictive of the final results of the trial; whether results from pre-clinical studies or earlier clinical studies will be predictive of the results of future trials, including regarding AU-011's ability to offer vision preserving therapy for the first line treatment of choroidal melanoma; the expected timing of the expansion phase of the Phase 2 SC administration trial; the expected timing for submissions for regulatory approval or review by governmental authorities; 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; risks, assumptions and uncertainties regarding the impact of the continuing COVID-19 pandemic on Aura's business, operations, strategy, goals and anticipated timelines, Aura's ongoing and planned pre-clinical activities, Aura's ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Aura's timelines for regulatory submissions and Aura's financial position. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" set forth in Aura's filings with the Securities and Exchange Commission. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances discussed in this press release may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although Aura believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward-looking statements will be achieved or occur. Moreover, except as required by law, neither Aura nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made. Aura undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law.

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  4. Aura Biosciences, Inc. ("Aura"), a clinical-stage oncology company developing a novel class of virus-like drug conjugate therapies for multiple oncology indications, today announced the pricing of its initial public offering of 5,400,000 shares of common stock at a public offering price of $14.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Aura, are expected to be $75.6 million. All of the shares are being offered by Aura. In addition, Aura has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.

    The shares are expected…

    Aura Biosciences, Inc. ("Aura"), a clinical-stage oncology company developing a novel class of virus-like drug conjugate therapies for multiple oncology indications, today announced the pricing of its initial public offering of 5,400,000 shares of common stock at a public offering price of $14.00 per share. The gross proceeds of the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Aura, are expected to be $75.6 million. All of the shares are being offered by Aura. In addition, Aura has granted the underwriters a 30-day option to purchase up to an additional 810,000 shares of common stock at the initial public offering price less underwriting discounts and commissions.

    The shares are expected to begin trading on the Nasdaq Global Market on October 29, 2021 under the ticker symbol "AURA." The offering is expected to close on November 2, 2021, subject to the satisfaction of customary closing conditions.

    Cowen, SVB Leerink and Evercore ISI are acting as joint book-running managers for the offering, and BTIG is acting as lead manager for the offering.

    The registration statements relating to these securities became effective on October 28, 2021. The offering will be made only by means of a prospectus, copies of which may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by telephone at (833) 297-2926, or by email at ; SVB Leerink LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at ; or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055; by telephone at (888) 474-0200, or by email at .

    This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Aura Biosciences

    Aura Biosciences, Inc. is a clinical-stage oncology company developing a novel technology platform based on virus-like drug conjugates (VDCs) to target and destroy cancer cells selectively while activating the immune system to create long lasting anti-tumor immunity. The VDC technology platform is based on the discoveries of NIH Distinguished Investigator Dr. John Schiller of the Center for Cancer Research at the National Cancer Institute. The company has the goal of developing this technology in multiple cancer indications with an initial focus on primary choroidal melanoma, a rare disease for which there are no approved drugs. Aura's lead product candidate belzupacap sarotalocan (AU-011) is currently in Phase 2 development for the first line treatment of primary choroidal melanoma, a vision and life-threatening form of eye cancer where standard of care radioactive treatments leave patients with major vision loss and severe comorbidities. AU-011 was well tolerated in a Phase 1b/2 trial, demonstrating high rates of tumor control and vision preservation. Future pipeline applications for Aura's technology include additional ocular oncology indications like choroidal metastases and solid tumor indications like non-muscle invasive bladder cancer. Aura is headquartered in Cambridge, MA.

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