UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
Securities registered pursuant to Section 12(b) of the Act:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item 2.02 Results of Operations and Financial Condition.
On August 8, 2024, Aura Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2024. A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 2.02, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 8.01 Other Events.
On August 8, 2024, the Company updated its corporate presentation for use in meetings with investors, analysts, and others. A copy of the corporate presentation is filed as Exhibit 99.2 for purposes of Section 18 of the Exchange Act.
Forward Looking Statements
Statements contained under this Item 8.01 regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements about the initiation, timing, progress, results, and cost of the Company’s research and development programs and the Company’s current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and the Company’s research and development programs; the Company’s ability to successfully manufacture its drug substances and product candidates for preclinical use, for clinical trials and on a larger scale for commercial use, if approved; the ability and willingness of the Company’s third-party strategic collaborators to continue research and development activities relating to the Company’s development candidates and product candidates; the Company’s ability to commercialize its products, if approved; the Company’s ability to obtain funding for its operations necessary to complete further development and commercialization of its product candidates; the Company’s ability to obtain and maintain regulatory approval of its product candidates; the size and growth potential of the markets for the Company’s product candidates, and the Company’s ability to serve those markets; the Company’s financial performance; the Company’s expected cash runway into the second half of 2026; and the implementation of the Company’s business model, including strategic plans for its business and product candidates.
Any forward-looking statements 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 the Company’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 the Company’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 the Company’s clinical trial designs even where the Company has obtained agreement with governmental authorities on the design of such trials, such as the Phase 3 Special Protocol agreement with the United States Food and Drug Administration; whether the Company will receive regulatory approvals to conduct trials or to market products; whether the Company’s cash resources will be sufficient to fund its foreseeable and unforeseeable operating expenses and capital expenditure requirements; the Company’s ongoing and planned preclinical activities; and the Company’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 the Company’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 the Company with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, the Company disclaims any intention or responsibility for updating or revising any forward-looking statements contained under this Item 8.01 in the event of new information, future developments or otherwise. These forward-looking statements are based on the Company’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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. |
Description |
99.1 |
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99.2 |
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104 |
Cover Page Interactive Data File (embedded within the Inline XBRL document). |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Aura Biosciences, Inc. |
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Date: |
August 8, 2024 |
By: |
/s/ Julie Feder |
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Julie Feder |
Exhibit 99.1
Aura Biosciences Reports Second Quarter 2024 Financial Results and Business Highlights
Company to Present Early Non-muscle Invasive Bladder Cancer (NMIBC) Data from Ongoing Phase 1 Trial at a Urologic Oncology Investor Event in October 2024
Phase 2 End of Study Data Evaluating Suprachoroidal Administration of Bel-sar for the First-Line Treatment of Patients with Early-stage Choroidal Melanoma to be Presented at Retina Society Annual Meeting
Strong Cash Position Expected to Fund Operations into Second Half of 2026
BOSTON, MA – August 8, 2024 – 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 reported financial results for the second quarter ended June 30, 2024, and provided recent business highlights.
“We are excited by the progress we made in the second quarter across all our clinical programs and in particular in our bladder cancer clinical trial. We look forward to our upcoming urologic oncology virtual event in October, where we plan to share early data in NMIBC,” said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. “We are well-capitalized and remain focused on the execution of our ongoing clinical trials in ocular and urologic oncology, two areas where novel treatment options are needed that can provide effective local treatment while preserving organ function.”
Recent Pipeline Developments
Bladder Cancer
A Phase 1 trial of bel-sar for the treatment of bladder cancer is currently ongoing. The company plans to host a virtual urologic oncology investor event featuring key opinion leaders (KOLs) in October 2024. Early NMIBC data from the ongoing Phase 1 trial is expected to be presented at this event.
The ongoing Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 21 adult patients. The trial is designed to assess the safety and feasibility of bel-sar as a monotherapy. The trial includes histopathological evaluation after local treatment to assess bel-sar’s biological activity, including the evaluation of focal necrosis and immune activation after a single dose of treatment.
Primary Uveal Melanoma
Phase 2 end of study data in small choroidal melanoma and indeterminate lesions will be presented at the Retina Society Annual Meeting taking place September 11-15, 2024, in Lisbon, Portugal.
Enrollment continues in global Phase 3 CoMpass trial for the treatment of small choroidal melanoma and indeterminate lesions.
Additional Ocular Oncology Indications:
In addition to primary uveal melanoma, bel-sar is being explored for metastases to the choroid and cancers of the ocular surface. These three ocular oncology indications have a collective incidence of greater than 60,000 patients annually in the United States and Europe.
Metastases to the Choroid
The Company plans to initiate clinical development in metastases to the choroid, an indication with a high unmet medical need and no approved therapies. Metastases to the choroid is the second potential ocular oncology indication for bel-sar, affecting approximately 20,000 patients in the United States and Europe annually. The Company received Fast Track designation from the FDA’s Division of Oncology for the treatment of metastases to the choroid. The Company is on track to initiate a Phase 2 trial in 2024.
Cancers of the Ocular Surface
Cancers of the ocular surface is the Company’s third potential ocular oncology indication affecting approximately 35,000 patients in the United States and Europe annually. The Company continues to advance its preclinical work designed to be IND-enabling in cancers of the ocular surface.
Recent Corporate Events
Second Quarter 2024 Financial Results
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 primary uveal melanoma, bladder cancer, metastases to the choroid and cancers of the ocular surface; statements regarding the orphan and Fast Track designations held by the Company; statements regarding the Company’s expectations for the Phase 2 and Phase 3 clinical trials of bel-sar for small choroidal melanoma and indeterminate lesions, the Phase 2 clinical trial of bel-sar for metastases to the choroid, the Phase 1 trial of bel-sar for bladder cancer and the preclinical development of bel-sar in cancers of the ocular surface; statements regarding the timing of the Company’s plans to present data with respect to its Phase 2 clinical trial of bel-sar for the treatment of early-stage choroidal melanoma and 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; statements regarding the Company’s beliefs and expectations for the urgent need for an effective local treatment in ocular and urologic oncology to preserve organ function; statements regarding the Company’s expectations for the estimated patient populations and related market opportunities for bel-sar; and statements regarding the Company’s expected cash runway.
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 SPA agreement with the FDA; 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 Dasalla
Head of Investor Relations and Corporate Communications
IR@aurabiosciences.com
Aura Biosciences, Inc.
Condensed Consolidated Statement of Operations and Comprehensive Loss
(Unaudited)
(in thousands, except share and per share amounts)
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Three Months Ended |
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Six Months Ended |
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2024 |
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2023 |
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2024 |
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2023 |
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Operating Expenses: |
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Research and development |
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$ |
16,879 |
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$ |
15,120 |
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$ |
33,932 |
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$ |
29,524 |
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General and administrative |
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5,883 |
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5,156 |
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11,145 |
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10,196 |
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Total operating expenses |
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22,762 |
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20,276 |
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45,077 |
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39,720 |
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Total operating loss |
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(22,762 |
) |
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(20,276 |
) |
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(45,077 |
) |
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(39,720 |
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Other income (expense): |
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Interest income, including amortization and accretion income |
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2,451 |
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2,009 |
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5,137 |
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4,000 |
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Other income (expense) |
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(26 |
) |
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(32 |
) |
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(57 |
) |
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(45 |
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Total other income |
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2,425 |
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1,977 |
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5,080 |
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3,955 |
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Loss before income taxes |
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(20,337 |
) |
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(18,299 |
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(39,997 |
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(35,765 |
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Income tax benefit (provision), net |
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— |
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— |
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(46 |
) |
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— |
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Net loss |
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$ |
(20,337 |
) |
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$ |
(18,299 |
) |
$ |
(40,043 |
) |
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$ |
(35,765 |
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Net loss per common share—basic and diluted |
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$ |
(0.41 |
) |
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$ |
(0.48 |
) |
$ |
(0.81 |
) |
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$ |
(0.95 |
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Weighted average common stock outstanding—basic and diluted |
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49,548,120 |
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37,855,533 |
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49,500,032 |
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37,820,104 |
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Comprehensive loss: |
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Net loss |
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$ |
(20,337 |
) |
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$ |
(18,299 |
) |
$ |
(40,043 |
) |
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$ |
(35,765 |
) |
Other comprehensive items: |
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Unrealized gain (loss) on marketable securities |
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(201 |
) |
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(178 |
) |
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(722 |
) |
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(151 |
) |
Total other comprehensive income (loss) |
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(201 |
) |
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(178 |
) |
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(722 |
) |
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(151 |
) |
Total comprehensive loss |
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$ |
(20,538 |
) |
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$ |
(18,477 |
) |
$ |
(40,765 |
) |
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$ |
(35,916 |
) |
Aura Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
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June 30, 2024 |
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December 31, 2023 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
30,075 |
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$ |
41,063 |
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Marketable securities |
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157,341 |
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185,087 |
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Restricted cash and deposits |
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— |
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19 |
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Prepaid expenses and other current assets |
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8,180 |
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5,625 |
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Total current assets |
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195,596 |
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231,794 |
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Restricted cash and deposits, net of current portion |
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768 |
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768 |
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Right of use assets - operating lease |
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18,141 |
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18,854 |
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Other long-term assets |
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443 |
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509 |
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Property and equipment, net |
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3,334 |
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3,150 |
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Total Assets |
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$ |
218,282 |
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$ |
255,075 |
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Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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1,459 |
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1,787 |
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Short-term operating lease liability |
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2,754 |
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2,687 |
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Accrued expenses and other current liabilities |
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6,335 |
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7,883 |
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Total current liabilities |
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10,548 |
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12,357 |
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Long-term operating lease liability |
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16,280 |
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16,870 |
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Total Liabilities |
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26,828 |
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29,227 |
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Commitments and Contingencies |
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Stockholders’ Equity: |
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Common stock, $0.00001 par value, 150,000,000 authorized at June 30, 2024 and December 31, 2023, and 49,583,358 and 49,350,788 shares issued and outstanding at June 30, 2024 and December 31, 2023, respectively |
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— |
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— |
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Additional paid-in capital |
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518,988 |
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512,617 |
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Accumulated deficit |
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(327,351 |
) |
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(287,308 |
) |
Accumulated other comprehensive loss |
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(183 |
) |
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539 |
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Total Stockholders’ Equity |
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191,454 |
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|
225,848 |
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Total Liabilities and Stockholders’ Equity |
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$ |
218,282 |
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|
$ |
255,075 |
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Corporate Presentation August 2024 Exhibit 99.2
Legal Disclosure This presentation contains forward-looking statements, all of which are qualified in their entirety by this cautionary statement. Many of the forward-looking statements contained herein can be identified by the use of forward-looking words such as "may", "anticipate", "believe", "could', "expect", "should", "plan", "intend", "estimate", "will", "potential" and "ongoing", among others, although not all forward-looking statements contain these identifying words. These forward-looking statements include statements about the initiation, timing, progress, results and cost of our research and development programs and our current and future preclinical studies and clinical trials, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available and our research and development programs; our ability to successfully manufacture our drug substances and product candidates for preclinical use, for clinical trials and on a larger scale for commercial use, if approved; the ability and willingness of our third-party strategic collaborators to continue research and development activities relating to our development candidates and product candidates; our ability to commercialize our products, if approved; our ability to obtain funding for our operations necessary to complete further development and commercialization of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates; the size and growth potential of the markets for our product candidates and our ability to serve those markets; our financial performance; our expected cash runway into the second half of 2026; and the implementation of our business model, including strategic plans for our business and product candidates. Except as otherwise noted, these forward-looking statements speak only as of the date of this presentation, and we undertake no obligation to update or revise any of such statements to reflect events or circumstances occurring after this presentation. Because forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified and some of which are beyond our control, you should not rely on these forward-looking statements as predictions of future events. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC), as well as discussions of potential risks, uncertainties, and other important factors in our other subsequent filings with the SEC, which are available on the SEC's website at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur and actual results could differ materially from those projected in the forward-looking statements. We caution you not to place undue reliance on the forward-looking statements contained in this presentation. This presentation discusses product candidates that are under preclinical or clinical evaluation and that have not yet been approved for marketing by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. Until finalized in a clinical study report, clinical trial data presented herein remain subject to adjustment as a result of clinical site audits and other review processes. No representation is made as to the safety or effectiveness of these product candidates for the use for which such product candidates are being studied. This presentation 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 other 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 other jurisdiction.
Well Positioned with Multiple Near-Term Clinical Catalysts Precision Therapy Platform Developing a novel class of drugs called virus-like drug conjugates (VDCs) Direct tumor cell killing and immune activation Focal treatment approach to deliver durable response Large Market Opportunity In Areas of Unmet Need Ocular Oncology >60,000 patients/yr (US/EU)2 Urologic Oncology ~500,000 patients/yr (globally)3 Key Upcoming Catalysts Multiple clinical data readouts expected within next 6-12 months, including early Phase 1 bladder data Cash expected to fund operations into 2H 2026 Late-Stage Clinical Development Phase 3 in Primary Uveal Melanoma Ongoing FDA SPA1 Agreement 1. Special Protocol Assessment (SPA). 2. See sources on slide 9 of this presentation. 3. Bladder cancer. Putnam & Assoc. Epidemiology Analysis.
Clinical Pipeline Across Multiple Solid Tumor Indications Program OTHER SOLID TUMORS OCULAR ONCOLOGY Preclinical Phase 1 Phase 2 Phase 3 Planned Milestones Metastases to the Choroid (Multiple primary cancers with metastasis to the choroid, e.g., Breast and Lung) Primary Uveal Melanoma Ocular Surface Cancers Bladder Cancer (Non-Muscle Invasive (NMIBC) and Muscle Invasive (MIBC)) Other HSPG* Expressing Tumors 2024 – Phase 2 initiation YE 2024 – Initial Phase 2 data October 2024 – Early Phase 1 NMIBC data 2024 – Phase 3 enrollment ongoing September 2024 – Phase 2 end of study data *Virus-like drug conjugates (VDCs) bind to a subset of modified tumor associated glycosaminoglycans (GAGs) that are part of the heparan sulphate chain of heparan sulfate proteoglycans (HSPGs). Schiller et al. Viruses 2022, 14(8), 1656
Bel-sar is a Potential First-in-Class Therapy for Multiple Solid Tumors
Bel-sar (AU-011) is a VDC Designed with Dual Specificity to Reduce Potential for Off-target Effects: Selectively binds to tumor cells (not to local healthy tissue) Activated only at site of laser administration Fleury MJJ et al. Mol Biotechnol. 2014;56(5):479-86. Kines RC, et al. Int J Cancer. 2016;138(4):901–11. Kines RC, et al. Mol Cancer Ther. 2018;17(2):565–74. Kines RC, et al. Cancer Immunol Res. 2021;9:693–706. HPV, human papillomavirus; mHSPG, modified heparan sulphate proteoglycan; NIR, near infrared; VDC, virus-like drug conjugate; VLP, virus-like particle. Bel-sar (AU-011) VDCs selectively deliver direct tumor cell killing and immune activation Virus-like particle (VLP) Non-replicating viral capsid (no genetic material) Derived from HPV Multivalent binding to mHSPGs on solid tumor cells Light-activatable molecules VLP conjugated to ~200 molecules of phthalocyanine dye Activated by standard NIR laser Virus-like drug conjugates (VDCs) are a novel technology platform 6
Disruption of the tumor cell membrane and pro-immunogenic cell death by necrosis leads to T cell activation and immune-mediated tumor cell killing Bel-sar is a VDC with a novel dual mechanism of action Kines RC, et al. Int J Cancer. 2016;138(4):901–11. Kines RC, et al. Mol Cancer Ther. 2018;17(2):565–74. Kines RC, et al. Cancer Immunol Res. 2021;9:693–706. DAMPs, damage-associated molecular patterns; HSPG, heparan sulfate proteoglycan; VDC, virus-like drug conjugate; VLP, virus-like particle. Bel-sar, AU-011 Reactive oxygen species disrupts cell membrane and organelles
Ocular Oncology Therapeutic Area Bel-sar Target Indications: Primary Uveal Melanoma Metastases to the Choroid Ocular Surface Cancers
Bel-sar Opportunities in Ocular Oncology Represent a Multi-billion-dollar Addressable Market Ocular Oncology Total Addressable Market (US/EU) ~66,000 patients/year Ocular Surface Cancers Retinoblastoma Primary Uveal Melanoma Metastases to the Choroid ~11,000 patients/year1 ~20,000 patients/year1 ~500 patients/year2 ~35,000 patients/year3 1. ClearView & Putnam & Assoc. Epidemiology Analysis Choroidal Melanoma and Choroidal Metastasis 2. American Cancer Society- Retinoblastoma statistics 3. Includes Conjunctival Melanoma, Primary Acquired Melanosis, Squamous Cell Carcinoma and Ocular Surface Squamous Neoplasia (https://pubmed.ncbi.nlm.nih.gov/12788119/; https://pubmed.ncbi.nlm.nih.gov/19628487/; https://pubmed.ncbi.nlm.nih.gov/8676629/; https://pubmed.ncbi.nlm.nih.gov/29511061/; https://pubmed.ncbi.nlm.nih.gov/9037556/) Bel-sar (AU-011) is an investigational product candidate. The effectiveness and safety of bel-sar have not been established, and bel-sar is not approved for use in any jurisdiction. ~80% of patients are diagnosed at the early stage (indeterminate lesions (ILs) and small tumors) Current radiotherapy treatment Leaves up to 87% of patients with major irreversible vision loss ~100 Ocular Oncologists in US/EU — focused call point opportunity <20 Field Based Team — Intend to add small sales force to launch globally
Primary Uveal Melanoma—High Unmet Medical Need Primary Uveal Melanoma is a Rare and Life-Threatening Ocular Cancer with No Drugs Approved 1. Heiting, G. Iris/uvea of the eye. Accessed Oct. 3, 2023. https://www.allaboutvision.com/en-gb/resources/uvea-iris-choroid/ 2. Kaliki S, Shields CL. Uveal melanoma: relatively rare but deadly cancer. Eye (Lond). 2017;31(2):241-257. doi:10.1038/eye.2016.275 3. Clearview & Putnam & Assoc. Market Research Most common primary intraocular cancer in adults2 Impacts ~11,000 patients in US/EU per year3 ~80% patients diagnosed with early-stage disease3 Choroid is 90% of the uvea1 50% of patients develop metastasis within 15 years (metastatic uveal melanoma)2 choroid Uvea: Choroid, Ciliary Body and Iris
Current Treatment Paradigm for Uveal Melanoma Indeterminate Lesions Small Melanomas Risk Factors Growth Small CM Observation Incidence: Patients US/EU1 Local – Early (~8,000) Local – Late (~2,300) Metastatic (~2,000) SIZE (mm): Small Medium Large Metastatic Radiotherapy Radiotherapy 1 2.5–3 >10 Enuc. 1. Each figure represents ~250 persons. Shields CL et al. Choroidal and ciliary body melanoma. Available at: https://eyewiki.aao.org/Choroidal_and_Ciliary_Body_Melanoma. Accessed May 2, 2024. Epidemiology analysis for choroidal melanoma and choroidal metastasis by ClearView Healthcare Partners and Putman. Enuc., enucleation. CM, Choroidal Melanoma. Systemic Chemotherapy (KIMMTRAK®)
High Morbidity Associated with Current Standard of Care 1. Jarczak J, Karska-Basta I, Romanowska-Dixon B. Deterioration of visual acuity after brachytherapy and proton therapy of uveal melanoma, and methods of counteracting this complication based on recent publications. Medicina (Kaunas). 2023;59(6):1131. 2. Tsui I, Beardsley RM, McCannel TA, Oliver SC, et al. Visual acuity, contrast sensitivity and color vision three years after iodine-125 brachytherapy for choroidal and ciliary body melanoma. Open Ophthalmol J. 2015;9:131-5. 3. Shields CL et al. Arch Ophthalmol. 2000;118(9):1219-1228. 4. Peddada KV et al. J Contemp Brachytherapy. 2019;11(4):392-397. 5. Jarczak J et al. Medicina (Kaunas). 2023;59(6):1131. 6. Shields CL et al. Curr Opin Ophthalmol. 2019;30(3):206-214. 7. Kaliki S, Shields CL. Eye 2017;31(2):241-257. AE, adverse event; BCVA, best-corrected visual acuity; HRVL, high-risk for vision loss. Up to 87% of Primary Uveal Melanoma Patients Become Legally Blind Over Time in the Eye Treated with Radiotherapy1,2 Radiotherapy3–7 Adverse Event Surgeries secondary to AEs (e.g., cataracts) 40%+ Radiation retinopathy 40%+ Neovascular glaucoma 10% Dry eye syndrome 20% Strabismus 2%+ Retinal detachment 1-2% Vision loss (≥15 letters) ~70% Long-term legal blindness (≤20/200) ~90% Serious Adverse Event Scleral necrosis 0-5% Enucleation/eye loss 10-15% Severe vision loss (≥30 letters) in HRVL ~90%
c Bel-sar has the Potential to be the First Approved Therapy in Primary Uveal Melanoma No radiation-related morbidity Preservation of vision Local tumor control Opportunity to treat early and reduce risk of metastases Improvement in safety and quality of life Bel-sar is Delivered by Simple Suprachoroidal Injection Goals of Treatment Light Activation with Standard Ophthalmic Laser In-Office Procedure Two ~2 minute Injections Two ~5 minute Lasers Bel-sar (AU-011) is an investigational product candidate. The effectiveness and safety of bel-sar have not been established, and bel-sar is not approved for use in any jurisdiction.
Phase 2 Trial – Dose Escalation and Expansion with Suprachoroidal Administration Patient Population Representative of Early-Stage Disease: Small Choroidal Melanoma and Indeterminate Lesions Trial Design – Enrollment Complete (n=22) One Cycle = Doses on days 1, 8 and 15 N=10 1- 2 Doses (n=9); 2 cycles-6 doses (n=1) N=11** 3 Cycles (9 doses) 1 dose- 20 μg x 1 Laser 1 dose- 40 μg x 1 Laser 1 dose- 40 μg x 2 Lasers 2 doses- 40 μg x 2 Lasers QWx2 Cohort 1 (n=1) Cohort 2 (n=3*) Cohort 3 (n=2) Cohort 4 (n=3) Cohort 5 9 doses- 80 μg x 2 Lasers QWx3 3 cycles Cohort 6 (n=up to 10) 2 Cycles (n=1) 3 Cycles (n=2) 6-9 doses- 40 μg x 2 Lasers QWx3 Up to 3 cycles Subtherapeutic Regimens Therapeutic Regimen Goal: To Determine Safety, Optimal Dose and Therapeutic Regimen with Suprachoroidal Administration Endpoint Endpoint Definitions Tumor Progression Growth in Tumor Height ≥0.5mm or ≥1.5 mm in Largest Basal Diameter (LBD) Visual Acuity Loss Decrease from Baseline: ≥15 letters Tumor Thickness Growth Rate Change in Rate of Growth of Tumor Thickness *Cohort 2: 2 subjects were planned; third subject was additionally enrolled due to dose error in 1 subject **12 patients enrolled, 1 subject who discontinued after 1 cycle due to unrelated SAEs is not included in data analysis (n=11). ClinicalTrials.gov Identifier: NCT04417530 ; AU-011-202
Phase 2 Interim Data Demonstrates Tumor Control, Vision Preservation and a Favorable Safety Profile Subtherapeutic Therapeutic Tumor Progression: change from baseline in thickness ≥0.5mm; or in LBD ≥1.5mm confirmed by at least one repeat assessment August 3, 2023, data on file Aura Biosciences Vision acuity loss definition based on ETDRS BCVA letter score (≥ 15 letters from baseline) Median Change in BCVA in Phase 3 Eligible Patients with Therapeutic Regimen (n=10) Months 80% Tumor Control Rate 90% Visual Acuity Preservation Rate <20% Grade 1 AEs Vision Loss (15 letters)
SPA Agreement with FDA Supports Global Phase 3 Trial Design Fast Track and Orphan Drug Designations Time to Composite Endpoint: Tumor Progression or Visual Acuity Failure Time to Tumor Progression Primary Endpoint First Key Secondary Endpoint Enrollment (N=~100) Randomize (2:1:2) 80 µg bel-sar treatment arm (n=40) 40 µg bel-sar treatment arm (n=20) Sham control arm (n=40) 15 Month Primary Efficacy Analysis An SPA Indicates Concurrence by the FDA that the Design of the Trial can Adequately Support a Regulatory Submission SPA Agreement SPA – Special Protocol Assessment
Kaplan-Meier analysis simulation of Phase 2 interim data support assumptions for the potential success of Phase 3 trial with high statistical significance Progression-free probability Days Progression-free probability Log-rank test P = 0.0012 Log-rank test P = 0.0023 Time to tumor progression Time to composite endpoint Change from baseline in thickness ≥0.5 mm or in LBD ≥1.5 mm confirmed by at least one repeat assessment 3 cycles, n=10 Subtherapeutic (≤2 cycles), n=10 Time to tumor progression or vision acuity failure (≥15 letter loss in ETDRS-BCVA), whichever occurs earlier 0.0 0.2 0.4 0.6 0.8 1.0 0 100 200 300 400 500 0.0 0.2 0.4 0.6 0.8 1.0 0 100 200 300 400 500 + Censored + Censored Study duration 12 months. Participants either had an event or were censored at the last visit; some had their Week 52 visit after 365 days. Any events at the final visit are assigned to the actual time of that visit. Log-rank test p-value based on unsimulated original Kaplan-Meier curves. BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; LBD, largest basal diameter. August 3, 2023 data on file, Aura Biosciences. ClinicalTrials.gov Identifier: NCT04417530; AU-011-202.
Phase 3 trial design P < 0.005 93% power (Δ20) Actual data (Δ60) >99% power P < 0.05 Robustness Analysis of Phase 2 interim tumor control rates Overall rate in Phase 2 2x “worse” than Phase 2 2x “worse” than Phase 2 Actual rate with documented growth in Phase 2 Overall rate in Phase 2 94% power (Δ30) Actual data (Δ60) >99% power Same dose, regimen, route of administration, range of tumor sizes and reading center as Phase 2 trial Similar population to Phase 2 participants receiving the therapeutic regimen Enriching for early documented growth; Phase 3 randomization stratified by growth rate ClinicalTrials.gov Identifier: NCT06007690; AU-011-301. Phase 2 Interim Data Support Phase 3 Assumptions
Bel-sar Opportunities in Ocular Oncology Represent a Multi-billion-dollar Addressable Market Ocular Oncology Total Addressable Market (US/EU) ~66,000 patients/year Ocular Surface Cancers Retinoblastoma Primary Uveal Melanoma Metastases to the Choroid ~11,000 patients/year1 ~20,000 patients/year1 ~500 patients/year2 ~35,000 patients/year3 1. ClearView & Putnam & Assoc. Epidemiology Analysis Choroidal Melanoma and Choroidal Metastasis 2. American Cancer Society- Retinoblastoma statistics 3. Includes Conjunctival Melanoma, Primary Acquired Melanosis, Squamous Cell Carcinoma and Ocular Surface Squamous Neoplasia (https://pubmed.ncbi.nlm.nih.gov/12788119/; https://pubmed.ncbi.nlm.nih.gov/19628487/; https://pubmed.ncbi.nlm.nih.gov/8676629/; https://pubmed.ncbi.nlm.nih.gov/29511061/; https://pubmed.ncbi.nlm.nih.gov/9037556/) Bel-sar (AU-011) is an investigational product candidate. The effectiveness and safety of bel-sar have not been established, and bel-sar is not approved for use in any jurisdiction. Majority originate from breast and lung cancer Burdensome Standard of Care with Radiation Morbidities Daily treatments of radiotherapy for 4 weeks ~100 Ocular Oncologists in US/EU — focused call point opportunity <20 Field Based Team — Intend to add small sales force to launch globally
Metastases to the Choroid – Phase 2 Trial Expected to Begin in 2024 Cohort 1 N=3 patients 80µg 1 cycle Cohort 2 N=3 patients 160µg 1 cycle Cohort 3 N=3 patients 200µg 1 cycle Cohort 4 N=3 patients 200µg 2 cycles Safety/Dose-limiting Toxicity Efficacy Change in Tumor Size Change in Vision Letter Score Study Objectives Study Population Patients with Unilateral, Unifocal Metastases to the Choroid Breast or Lung Primary No Changes in Concurrent Systemic Medications Planned Planned Study Design (n=12*) Highlights: Primary Endpoint at One-month Post-treatment; Possibility to See Tumor Shrinkage and Vision Improvement *3+3 Design. Each cohort to have a minimum of 3 and a maximum of 6 patients.
Urologic Oncology Therapeutic Area Bel-sar Target Indications: Non-muscle invasive bladder cancer Muscle invasive bladder cancer
Bladder Cancer is a Global High Unmet Medical Need ~500,000 New cases/ year globally1 >200,000 NMIBC New cases/year US, Europe & Asia1 New cases/year US, Europe & Asia1 >60,000 MIBC Non-Muscle Invasive Bladder Cancer Muscle Invasive Bladder Cancer Recurrence, multiple TURBT surgeries, Progression of Disease, Loss of Bladder/Cystectomy Progression of Disease, Loss of Bladder/Cystectomy, Metastasis and Survival Unmet Need Unmet Need Bladder cancer. Putnam & Assoc. Epidemiology Analysis.
Current Treatment Paradigm for Non-Muscle Invasive Bladder Cancer Prevalence Patients (US)1,2 (~80,000) (~20,000) Progression Low grade – Low & intermediate risk High risk papillary disease CIS – BCG unresponsive BCG >6 tx Intravesical Chemotherapy (~4,000) TURBT recurrence Intravesical gene therapy (Adstiladrin®) Systemic immunotherapy (Keytruda®) Cystectomy TURBT recurrence High risk adjuvant therapy Adjuvant therapy Intravesical immunotherapy (Anktiva®) Each figure represents 1000 persons. Holzbeierlein JM et al. J Urol. 2024 Apr 25:101097JU0000000000003981 [epub ahead of print]. Holzbeierlein JM et al. J Urol. 2024 Apr;211(4):533-538. Internal Aura epidemiology of market size data on file. BCG, Bacillus Calmette-Guérin; TURBT, transurethral resection of the bladder. BCG >6 tx Intravesical Chemotherapy Intermediate risk adjuvant therapy
Bel-sar as Potential Front-Line Therapy in NMIBC may be Optimized for In Office-based Procedure Goals of Treatment with Bel-sar Reduce Risk of Recurrence Stimulate Anti-tumor Specific T Cell Response Focal Treatment with Direct Tumor Cell Killing Avoid TURBT /Operating Room No Virus Replication or Viral Shedding Lasers and Bladder Injections (e.g. Botox) are Commonly Used Bel-sar’s Local Administration Aligned with Current Urologic Oncology Practice Bel-sar has a Dual Mechanism of Action and its Local Administration is Aligned with Clinical Practice
Phase 1 trial for bladder cancer designed to evaluate safety, feasibility and MoA 21 participants Bel-sar alone Bel-sar + focal light activation Part 1 (n=5) Part 2 (n=16) Study objectives TURBT and cystectomy patients NMIBC and MIBC patients Safety & dose-limiting toxicity Focal distribution of bel-sar Feasibility of technique Focal necrosis Markers of immune activation Completed Ongoing No treatment-related AEs, SAEs, or dose-limiting toxicities were seen in the 5 patients NMIBC n=10 MIBC n=6 AE, adverse event; MIBC, muscle invasive bladder cancer; MoA, mechanism of action; NMIBC, non–muscle invasive bladder cancer; SAE, serious adverse event; TURBT, transurethral resection of bladder tumor. Clinicaltrials.gov identifier: NCT05483868; AU-011-102.
Clinical Complete Response with Immune Activation after Single Dose Confirmed by Histopathology DAY 1 Biopsy TURBT Biopsy Day 1 Day 1 Day 2 Day 3-7 Bel-sar (AU-011) TURBT- transurethral resection of bladder tumor Day 9 Ph 1- Preliminary Data Light Activated Cohort (n=1) Day 1 Diagnostic biopsy shows non- invasive, low grade urothelial carcinoma Injection of Bel-sar (100ug) performed within tumor and below tumor (Aura present w/ Urologist) Day 2 Urologist performs Light activation with 689nm infrared light (50J/cm2) (~5 min duration) (Aura present w/ Urologist) Day 9 Urologist performs TURBT in area where tumor used to be present. Biopsy shows denuded urothelial mucosa, no cancer cells; focal ulcer and chronic inflammation (eosinophils/lymphocytes)
Clinical Complete Response with Immune Activation after Single Dose Confirmed by Histopathology in Part 2 First Patient Papillary urothelial carcinoma Pre-injection bladder biopsy demonstrating low-grade papillary urothelial carcinoma; non-invasive. Post-treatment TURBT demonstrating necrosis, inflammatory infiltrate, and no residual carcinoma. Circled region shows area of necrosis; arrow indicates edge of inflammatory infiltrate. Evidence of complete response by absence of tumor cells, as well as immune activation, after single dose treatment in first patient 7 days after bel-sar treatment Example of papillary carcinoma (Ta) H&E stain Necrosis Immune infiltrate H&E, hematoxylin and eosin; TURBT, transurethral resection of the bladder. Clinicaltrials.gov identifier: NCT05483868; AU-011-102.
Company Highlights Ocular Oncology Therapeutic Area Primary Uveal Melanoma – Global Phase 3 CoMpass Trial: Trial actively enrolling Special Protocol Assessment (SPA) Agreement with FDA Phase 3 assumptions supported by Phase 2 data Metastases to the Choroid – Phase 2 trial planned to initiate in 2024 Second ocular indication potentially doubles market opportunity1 Initial data expected by year end 2024 Urologic Oncology Therapeutic Area Bladder Cancer – Phase 1 Trial Clinical complete response in first patient with single dose Company expects to present early non-muscle invasive bladder cancer data from ongoing Phase 1 trial at a urologic oncology investor event in October 2024 Corporate Strong cash position – expected to fund operations into 2H 2026 Experienced leadership team across functions ClearView & Putnam & Assoc. Epidemiology Analysis Choroidal Melanoma and Choroidal Metastasis. Bel-sar (AU-011) is an investigational product candidate. The effectiveness and safety of bel-sar have not been established, and bel-sar is not approved for use in any jurisdiction.
Appendix: Phase 2 Primary Uveal Melanoma Trial – Interim Data
High Local Complete Response Rate at 12 months Follow-up* Dose/Regimen Total Patients (n) Total Patients (n) Tumor Control Rate Subtherapeutic Regimens Single dose up to 2 cycles 10 20% (2/10) Therapeutic Regimen 3 Cycles (n=11) 11 73% (8/11) 3 Cycles and Phase 3 eligible (n=10)* 10 80% (8/10) * One subject with circumpapillary tumor that did not meet Phase 3 criteria is not included Subtherapeutic Therapeutic High Tumor Control Rates with Therapeutic Regimen in Phase 3 Eligible Patients with Active Growth Dose Response: Subtherapeutic vs Therapeutic Regimen >90% Completed 12 Months Tumor Progression: change from baseline in thickness ≥0.5mm; or in LBD ≥1.5mm confirmed by at least one repeat assessment August 3, 2023, data on file Aura Biosciences *A local complete response, or CR, in early-stage choroidal melanoma is described as tumor control and complete arrest of tumor growth by ocular oncologists. Based on Phase 2 interim data, August 3, 2023.
High Tumor Control Rates Observed in Phase 3 Population Treated with Therapeutic Regimen in Phase 2 Progression Definition based on Tumor Thickness (Increase ≥0.5mm) Change from Baseline in Tumor Thickness Over 12 Months Treatment Timeframe Follow-up Timeframe Change from Baseline in Tumor Thickness (mm) Change from Baseline in Tumor Thickness (mm) Patients who had documented growth at entry (n=6) Patients who did not have documented growth at entry (n=4) Progression Definition based on Tumor Thickness (Increase ≥0.5mm) Change from Baseline in Tumor Thickness Over 12 Months Treatment Timeframe Follow-up Timeframe All patients with documented growth at entry (n=10) Subtherapeutic Regimens (n=10) Active Growth and 3 Cycle Regimens (n=10) Phase 2 Interim Data Demonstrated Tumor Control Rate of 80%, with 90% of Patients at 12 Months of Follow Up Based on Phase 2 interim data, August 3, 2023.
Bel-sar Therapeutic Regimen in Phase 2 Interim Data Achieved High Tumor Control Rates, with Complete Cessation of Growth Among Responders with Phase 3-eligible Tumors Tumor progression defined as change from baseline in thickness ≥0.5 mm; or in LBD ≥1.5 mm confirmed by at least one repeat assessment. aOne participant with circumpapillary tumor that did not meet phase 3 criteria is not included. bTumor thickness growth rates/slopes estimated using Mixed Models for Repeat Measures (MMRM); random intercept and slope model for Historical and Study periods. LBD, largest basal diameter. ClinicalTrials.gov Identifier, NCT04417530: AU-011-202. August 3, 2023, data on file Aura Biosciences. Participants with tumor control at 12 months, % Phase 3-eligible participantsa 80% tumor control rate at 12 months among phase 3-eligible patients In phase 3-eligible tumors, the 3-cycle regimen was successful with complete cessation of growth among responders (n=8/10; P < 0.0001b) Post-treatment actual Post-treatment projected Pre-treatment actual
34 80% (8/10) of these trial participants were at high risk of vision loss with tumors < 3 mm to the fovea or optic nerve BCVA change from baseline (ETDRS letter score) Median change in BCVA in Phase 3-eligible participants with therapeutic regimen (n=10)a Study month >90% of participants completed 12 months aOne participant with circumpapillary tumor that did not meet phase 3 criteria is not included. bVision acuity loss defined as ≥15 letters decrease from baseline in ETDRS BCVA letter score. BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study. ClinicalTrials.gov Identifier, NCT04417530: AU-011-202. August 3, 2023, data on file Aura Biosciences. 0 6 9 12 3 3 1 −1 − 3 − 5 − 7 − 9 − 11 − 13 − 15 Vision loss thresholdb (−15 letters) Median BCVA change from baseline Visual Acuity was Preserved in 90% of Participants Receiving a Bel-sar Therapeutic Regimen Based on Phase 2 Interim Data
Phase 2 Interim Safety Data Supports Potential to be First Line Treatment in Primary Uveal Melanoma Adverse Event Radiotherapy* Bel-Sar+ Surgeries secondary to AEs+ (e.g., Cataracts) 40%+ 0% Radiation Retinopathy 40%+ 0% Neovascular Glaucoma 10% 0% Dry Eye Syndrome 20% 0% Strabismus 2%+ 0% Retinal Detachment 1-2% 0% Vision Loss (≥15 letters) ~70% ~5% Serious Adverse Event Radiotherapy* Bel-Sar+ Scleral Necrosis 0-5% 0% Enucleation/Eye Loss 10-15% 0% Severe Vision Loss (≥30 letters) in HRVL** ~90% 0%++ * Certain data in this presentation are based on a cross-trial comparisons and are not based on any head-to-head clinical trials. Cross-trial comparisons are inherently limited and may suggest misleading similarities or differences. Results of head-to-head comparisons may differ significantly from those set forth herein. +Related to bel-sar or laser **73% (16/22) of patients in Phase 2 SC trial were at high risk for vision loss Table presents percentage of subjects with AEs related to bel-sar or laser by severity and overall; subjects with more than 1 AE are counted in the highest severity group *Treatment-emergent AEs related to bel-sar or laser in 1 patient each or <5% (anisocoria, conjunctival edema, cystoid macular edema, pupillary reflex impaired, retinal pigment epitheliopathy, salivary gland enlargement) August 3, 2023, data on file Aura Biosciences Ongoing Phase 2 Safety Outcomes with SC Administration All Treated Subjects (n=22) Drug/Laser Related Adverse Events >5% Subjects* Grade I Grade II Grade III Total Anterior Chamber Inflammation 18% 0 0 18% Anterior Chamber Cell 9% 0 0 9% Eye Pain 9% 0 0 9% No Posterior Inflammation, No SAEs and No Grade 3 Related Adverse Events *J. Contemp Brachytherapy. J. 2019 Aug; 11(4): 392–397.; Arch Ophthalmol. 2000;118(9):1219-1228; Curr. Opin. Ophthalmol. 2019 May;30(3):206-214; Eye 2017 Feb;31(2):241-257 **High-Risk Vision Loss (HRVL) are those subjects with tumors <3mm to fovea or optic nerve AEs – Adverse Events; SAEs – Serious Adverse Events; SC - Suprachoroidal