Aura Biosciences Q3 2026 loss widens to $32.1M
All 108 CoMpass participants have completed treatment visits; Aura says topline data from the 15-month primary endpoint remain on track for the second half of 2027.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Filing Summary
Aura Biosciences, Inc. reported a third-quarter 2026 net loss of $32.1 million, compared with $26.1 million in the year-earlier quarter. Research and development expenses were $24.7 million versus $22.2 million, while general and administrative expenses were $10.3 million versus $5.7 million. Aura reported cash, cash equivalents and marketable securities totaling $297.2 million as of September 30, 2026, which it believes will fund operations into the first half of 2029.
The Phase 3 CoMpass trial of bel-sar is fully enrolled with 108 participants; all have completed treatment visits and are in a 24-month follow-up period. The trial is under an FDA Special Protocol Assessment, and topline data from its 15-month primary endpoint are on track for the second half of 2027. Aura established a supply relationship with a contract development and manufacturing organization and is establishing designated capacity for bel-sar development and commercial supply. It completed an organizational restructuring in the third quarter, incurring approximately $4.5 million in charges. An update on its other early-stage ocular oncology programs is expected in the first quarter of 2027.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Moderate point. Forward-looking: it has not happened yet and may not happen.CoMpass: 108 participants completed treatment visits; topline on track for 2H 2027.
Negative
- Moderate pointQuarterly net loss widened to $32.1 million from $26.1 million in 2025.
Filing Explained
At
8-K Event Classification
Key Figures
Key Terms
Special Protocol Assessment regulatory
primary endpoint medical
choroidal melanoma medical
contract development and manufacturing organization technical
marketable securities financial
Earnings Snapshot
Aura believes its current cash, cash equivalents and marketable securities are sufficient to fund operations into the first half of 2029.
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What is AURA's cash runway?
When are AURA's Phase 3 CoMpass trial results expected?
Why did AURA's general and administrative expenses increase?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): |
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(Former Name or Former Address, if Changed Since Last Report)
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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Trading |
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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 November 9, 2026, Aura Biosciences, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2026. 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 November 9, 2026, 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.
Cautionary Note Regarding Forward-Looking Statements
Statements contained under this Item 8.01 and in certain of the materials filed herewith regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. 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; statements regarding the Company’s expectations for an improved quality of life of patients after treatment with belzupacap sarotalocan (“bel-sar”) and changes to the treatment paradigm for patients; the Company’s ability to efficiently develop existing product candidates and discover new product candidates; the Company’s ability to successfully manufacture its drug substances and product candidates for preclinical studies, for clinical trials and on a larger scale for commercial use, if approved; the pricing and reimbursement of the Company’s product candidates, 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 additional 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; statements regarding the Company’s beliefs and expectations for the high unmet medical need for an effective local treatment in ocular oncology to preserve organ function; 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 first half of 2029; 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 studies and clinical trials may not be predictive of future results in connection with future clinical trials; the risk that early or 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 Special Protocol Assessment agreement with the U.S. Food and Drug Administration for the Company’s Phase 3 trial; 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 U.S. 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 or in the materials filed herewith 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 |
Press Release dated November 9, 2026. |
99.2 |
Corporate Presentation of the Company. |
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: |
November 9, 2026 |
By: |
/s/ Natalie Holles |
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Natalie Holles Chief Executive Officer and President (Principal Executive Officer) |
Exhibit 99.1
Aura Biosciences Reports Third Quarter 2026 Financial Results and Recent Business Highlights
Phase 3 CoMpass trial on track for topline data in 2H 2027; all participants have completed treatment visits
Established relationship with industry-leading CDMO providing designated manufacturing capacity for bel-sar
Early choroidal melanoma investor and analyst virtual event planned for December 8, 2026
Expected cash runway into 1H 2029
BOSTON, MA – November 9, 2026 – Aura Biosciences, Inc. (NASDAQ: AURA) (“Aura” or the “Company”) a clinical-stage biotechnology company developing a potentially transformative first-in-class therapy for patients with ocular cancers, today reported financial results for the third quarter ended September 30, 2026, and provided a business update.
“During the third quarter, we continued to execute against our focused ocular oncology strategy and build the operational capabilities needed for our next stage of development,” said Natalie Holles, Chief Executive Officer of Aura Biosciences. “With all treatment visits completed in the CoMpass trial, our team is focused on ensuring excellence in all elements of the bel-sar program as we advance toward topline pivotal data in the second half of next year and position bel-sar as the first potential vision-preserving front-line therapy for early choroidal melanoma.”
Recent Business Highlights
Phase 3 CoMpass Trial in Early Choroidal Melanoma
Enrollment is complete with 108 participants in the Phase 3 CoMpass trial of belzupacap sarotalocan (bel-sar) for the treatment of early choroidal melanoma, the most common primary tumor of the eye which carries an approximately 50% risk of advancing to metastatic disease. As of the third quarter of 2026, all participants have completed their treatment regimen and are in the 24-month follow-up observation period. The trial is on track to deliver topline data from the 15-month primary endpoint in the second half of 2027.
The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA). The SPA represents alignment with the FDA on the trial design and planned analyses to support a potential Biologics License Application (BLA) of bel-sar. If successful, bel-sar would be the first approved front-line vision-preserving therapy for patients with early choroidal melanoma, providing a meaningful new treatment option where no FDA-approved drug therapies currently exist.
Additional Ocular Oncology Programs
Aura continues to advance the development of bel-sar in metastases to the choroid and cancers of the ocular surface in ongoing early clinical trials. In the first quarter of 2027, Aura expects to provide an update on both programs, including details on disease burden, trial design, and timelines to future data read-outs from these studies.
Operational Updates
During the quarter, Aura established a new supply relationship with an industry-leading contract development and manufacturing organization (CDMO) with extensive commercial experience in the manufacture of viral vector-based medicinal products. In a key element of the relationship, Aura and its CDMO partner are establishing manufacturing capacity which will be designated for bel-sar development and commercial supply production.
“We are very pleased to enter this new CDMO relationship, which we believe positions bel-sar for regulatory and commercial success as we advance toward topline data and completion of the CoMpass study,” said Susan Abu-Absi, Ph.D., Chief Operating Officer of Aura Biosciences. “Designated capacity is intended to provide us with long-term control over our production scheduling, and we look forward to working with our new partner to advance this important element of the bel-sar program.”
Upcoming Events
Aura will host an early choroidal melanoma investor and analyst virtual event on Tuesday, December 8, 2026, from 7:30-9:00 a.m. ET. Members of Aura’s management team will be joined by key opinion leader, Dr. Arun Singh, Director of the Department of Ophthalmic Oncology in the Cole Eye Institute of the Cleveland Clinic. The event will address the current treatment paradigm and unmet need, and an updated analysis of the epidemiology of early choroidal melanoma. To register for the virtual event, click here.
Aura also announced that Natalie Holles, Chief Executive Officer and President, will participate in the following upcoming investor conferences in the fourth quarter of 2026:
The live webcast of the events 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 webcasts will be archived for 90 days following the presentation date.
Third Quarter 2026 Financial Results
About Aura Biosciences
Aura Biosciences is a clinical-stage biotechnology company developing bel-sar, a potentially transformative, first-in-class front-line vision-preserving therapy for patients living with ocular cancers. Bel-sar represents an entirely novel approach to treating ocular cancers via its dual mechanisms of action of acute tumor necrosis and secondary anti-tumor immune activation. The Phase 3 registration study of bel-sar in early choroidal melanoma, the largest patient segment of uveal melanoma, is fully enrolled, and earlier stage studies in metastases to the choroid and cancers of the ocular surface are ongoing. Aura's mission is to improve outcomes for patients living with ocular cancers by delivering a therapy that not only arrests tumor growth but also preserves vision and quality of life.
For more information, visit aurabiosciences.com. Follow us on X, @AuraBiosciences, and visit us 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 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; statements regarding Aura’s plans and expectations for its ongoing and future clinical trials of bel-sar in multiple oncology indications, including with respect to clinical trial initiations; statements regarding the timing and plans for the Company’s Phase 3 CoMpass trial in early choroidal melanoma, including the timing of topline data; statements regarding Aura’s expectations for an improved quality of life of patients after treatment with bel-sar and changes to the treatment paradigm for patients; statements regarding Aura’s expectations for the estimated patient populations and related market opportunities for bel-sar; statements regarding Aura’s manufacturing plans and relationships, including the establishment of designated manufacturing capacity; statements regarding the Company’s expected cash runway; and statements regarding potential strategic discussions.
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 early or 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 reliance on third-party manufacturers; 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 Relations Contact:
Alex Dasalla
Head of Corporate Affairs
IR@aurabiosciences.com
Aura Biosciences, Inc.
Condensed Consolidated Statements 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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Nine Months Ended |
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2026 |
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2025 |
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2026 |
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2025 |
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Operating Expenses: |
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Research and development |
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$ |
24,742 |
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$ |
22,178 |
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$ |
83,451 |
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$ |
68,403 |
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General and administrative |
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10,320 |
|
|
|
5,728 |
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34,546 |
|
|
|
17,151 |
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Total operating expenses |
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35,062 |
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27,906 |
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|
117,997 |
|
|
|
85,554 |
|
Total operating loss |
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|
(35,062 |
) |
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|
(27,906 |
) |
|
(117,997 |
) |
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|
(85,554 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
|
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||||
Interest income, including amortization and accretion income |
|
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3,017 |
|
|
|
1,815 |
|
|
6,514 |
|
|
|
5,087 |
|
Other income (expense) |
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17 |
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|
|
(13 |
) |
|
172 |
|
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|
(72 |
) |
Total other income |
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3,034 |
|
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|
1,802 |
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6,686 |
|
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5,015 |
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Loss before income taxes |
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(32,028 |
) |
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|
(26,104 |
) |
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(111,311 |
) |
|
|
(80,539 |
) |
Income tax provision, net |
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(38 |
) |
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(26 |
) |
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(77 |
) |
|
|
(93 |
) |
Net loss |
|
$ |
(32,066 |
) |
|
$ |
(26,130 |
) |
$ |
(111,388 |
) |
|
$ |
(80,632 |
) |
Net loss per common share—basic and diluted |
|
$ |
(0.29 |
) |
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$ |
(0.40 |
) |
$ |
(1.22 |
) |
|
$ |
(1.39 |
) |
Weighted average common stock outstanding—basic and diluted |
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|
111,072,722 |
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|
65,936,672 |
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91,287,699 |
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58,084,093 |
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Comprehensive loss: |
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|
|
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|
|
|
|
|
|
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||||
Net loss |
|
$ |
(32,066 |
) |
|
$ |
(26,130 |
) |
$ |
(111,388 |
) |
|
$ |
(80,632 |
) |
Other comprehensive income (loss): |
|
|
|
|
|
|
|
|
|
|
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||||
Unrealized gain (loss) on marketable securities |
|
|
(855 |
) |
|
|
57 |
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|
(1,223 |
) |
|
|
(168 |
) |
Currency translation adjustment |
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(47 |
) |
|
|
(13 |
) |
|
(247 |
) |
|
|
(26 |
) |
Total other comprehensive income (loss) |
|
|
(902 |
) |
|
|
44 |
|
|
(1,470 |
) |
|
|
(194 |
) |
Total comprehensive loss |
|
$ |
(32,968 |
) |
|
$ |
(26,086 |
) |
$ |
(112,858 |
) |
|
$ |
(80,826 |
) |
Aura Biosciences, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)
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September 30, 2026 |
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December 31, 2025 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
|
$ |
41,669 |
|
|
$ |
59,515 |
|
Marketable securities |
|
|
255,564 |
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|
|
84,726 |
|
Prepaid expenses and other current assets |
|
|
5,865 |
|
|
|
5,498 |
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Total current assets |
|
|
303,098 |
|
|
|
149,739 |
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Restricted cash and deposits |
|
|
768 |
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|
|
768 |
|
Right-of-use assets—operating lease |
|
|
14,560 |
|
|
|
15,828 |
|
Other long-term assets |
|
|
1,167 |
|
|
|
471 |
|
Property and equipment, net |
|
|
2,024 |
|
|
|
2,624 |
|
Total Assets |
|
$ |
321,617 |
|
|
$ |
169,430 |
|
Liabilities and Stockholders’ Equity |
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|
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||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
|
1,722 |
|
|
|
1,549 |
|
Short-term operating lease liability |
|
|
3,316 |
|
|
|
3,243 |
|
Accrued expenses and other current liabilities |
|
|
16,299 |
|
|
|
13,591 |
|
Total current liabilities |
|
|
21,337 |
|
|
|
18,383 |
|
Long-term operating lease liability |
|
|
12,853 |
|
|
|
14,134 |
|
Total Liabilities |
|
|
34,190 |
|
|
|
32,517 |
|
Commitments and Contingencies |
|
|
|
|
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Stockholders’ Equity: |
|
|
|
|
|
|
||
Common stock, $0.00001 par value, 500,000,000 and 150,000,000 shares authorized at September 30, 2026 and December 31, 2025, respectively, and 103,950,771 and 63,587,777 shares issued and outstanding at September 30, 2026 and December 31, 2025, respectively |
|
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
|
919,897 |
|
|
|
617,433 |
|
Treasury stock, at cost, 6,922,870 shares held at September 30, 2026 and no shares held at December 31, 2025 |
|
|
(39,093 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(591,806 |
) |
|
|
(480,418 |
) |
Accumulated other comprehensive loss |
|
|
(1,572 |
) |
|
|
(102 |
) |
Total Stockholders’ Equity |
|
|
287,427 |
|
|
|
136,913 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
321,617 |
|
|
$ |
169,430 |
|
November 2026 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 nonclinical, 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 efficiently develop our existing product candidates and discover new product candidates; 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; 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 risk that the FDA may disagree with our clinical trial designs, even with the Phase 3 SPA agreement; statements regarding our beliefs and expectations for the high unmet medical need for an effective local treatment in ocular oncology to preserve organ function; 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 first half of 2029; 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.
Aura is well-positioned to become the leader in ocular oncology Aura is Positioned to Become the Global Leader in Ocular Oncology Transform the Treatment Paradigm in Early Choroidal Melanoma Potential to deliver the first curative, vision-preserving therapy in early choroidal melanoma Patients face risks of vision loss, morbidity and metastatic disease with current SoC Execute from a Position of Strength CoMpass, Phase 3 trial fully enrolled – supported by FDA SPA agreement Positive Phase 2 data support high statistical powering of Phase 3 design Unlock a Compelling Commercial Opportunity Potential blockbuster opportunity with no FDA approved therapies Focused call point with potential for favorable reimbursement model Build the World’s Leading Ocular Oncology Franchise Synergies across indications with large patient populations with significant unmet need Opportunity to expand into other forms of ocular cancer SOC, standard of care FDA, Food and Drug Administration SPA, Special Protocol Assessment
a Includes conjunctival melanoma, primary acquired melanosis, squamous cell carcinoma and ocular surface squamous neoplasia.1-5 1. Yu G-P, et al. Am J Ophthalmol. 2003;135(6):800–6. 2. Triay E, et al. Br J Ophthalmol. 2009;93(11):1524–8. 3. Newton R, et al. Lancet. 1996;347(9013):1450–1. 4. Dalvin LA. Br J Ophthalmol. 2018;102(12):1728–34. 5. Sun EC, et al. Cancer Epidemiol Biomarkers Prev. 1997;6(2):73–7. 6. Epidemiology analysis for choroidal melanoma and choroidal metastasis by ClearView Healthcare Partners and Putnam. 7. Kaliki S and Shields CL. Eye (Lond). 2017;31(2):241–57. CM, choroidal melanoma; SoC, standard-of-care. Ocular Oncology: High Unmet Need with No Vision-Sparing Therapies Highly Synergistic Opportunities in a Potential Multi-Billion-Dollar Addressable Market Ocular surface cancers ~35,000/yra,1–5 Early choroidal melanoma ~11,000/yr6 Metastases to the choroid ~20,000/yr6 Choroidal melanoma (CM) is the most common primary intraocular cancer in adults7 ~80% of patients are diagnosed with early-stage disease6
PoC, proof-of-concept. ClinicalTrial.gov identifiers: phase 3 choroidal melanoma (CoMpass) NCT06007690; phase 2 metastases to the choroid NCT06643884. Clinical Pipeline Across Ocular Oncology Program Preclinical Phase 1 Phase 2 Phase 3 Early Choroidal Melanoma Metastases to the Choroid Cancers of the Ocular Surface Topline data from the 15-month primary endpoint remain on track for 2H 2027
MoA, mechanism of action; VLP, virus-like particle. A Novel, Targeted Therapeutic Modality Unique tumor selectivity VLP-drug conjugate targets a key receptor molecule expressed in the early stages of malignant tumor transformation Dual MoA Targeted cytotoxicity and immune activation; potential to generate lasting anti-tumor T-cell memory Tumor and mutation-agnostic >100 cell lines >15 animal tumor models High potency ~200 cytotoxic molecules per VLP; demonstrated picomolar efficacy in multiple animal tumor models
Bel-sar’s Dual Mechanism of Anti-Tumor Activity Pro-immunogenic necrosis leads to T cell activation and immune-mediated tumor cell killing 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. Bel-sar, belzupacap sarotalocan; DAMPs, damage-associated molecular patterns; HSPG, heparan sulfate proteoglycan; VDC, virus-like drug conjugate. 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. Release of DAMPs induces anti-tumor immunity Bel-sar treatment is designed to be cytopathic to resident suppressor cells, reducing the immune-suppressive microenvironment and contributing to anti-tumor immunity Reactive oxygen species disrupts cell membrane and organelles Targeted Cytotoxicity and Long-Term Anti-Tumor Immune Memory
Bel-sar is Administered as a Targeted In-Office Procedure with the Potential for Durable Benefit Bel-sar, belzupacap sarotalocan. No radiation- related morbidity Vision preservation Local tumor control Reduce metastasis risk with early treatment Improve safety and quality of life Two injections (2 min. each) 30 min. apart 10–30 min. procedure Delivery via suprachoroidal injection Light activation with standard ophthalmic laser Suprachoroidal
a Each figure represents ~250 persons. 1. Singh AD, et al. Ophthalmology. 2005;112(10):1784–89 (U.S. population). 2. Shields CL, et al. Choroidal and ciliary body melanoma. Available at: https://eyewiki.aao.org/Choroidal_and_Ciliary_Body_Melanoma Accessed September 9, 2024. 3. Epidemiology analysis for choroidal melanoma and choroidal metastasis by ClearView Healthcare Partners and Putnam. Bel-sar, belzupacap sarotalocan; CM, choroidal melanoma; Enuc., enucleation. Bel-sar: Potentially Frontline Vision-Sparing Anti-Tumor Treatment for Largest CM Patient Segment Observation | ‘Watch and Wait’ Incidence: patients US/EUa 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. Systemic chemotherapy (KIMMTRAK®) Prevalence of choroidal nevi ranges from 4.6–7.9% in Caucasians1 Early choroidal melanoma Bel-sar Potential Market
Subtherapeutic and therapeutic dose ranges determined via post-hoc analysis One cycle = Doses on days 1, 8, and 15. a 12 patients enrolled, 1 patient who discontinued after 1 cycle due to unrelated SAEs is not included in data analysis (n=11). b Cohort 2:2 participants were planned; third participant was additionally enrolled due to dose error in 1 participant. Bel-sar, belzupacap sarotalocan; LBD, largest basal diameter; QW, every week. ClinicalTrials.gov Identifier, NCT04417530: AU-011-202. Data on file, Aura Biosciences. Phase 2 Trial In Early Choroidal Melanoma Open-label, dose-escalation study of bel-sar delivered via suprachoroidal administration Trial Design (n=22) Endpoints Tumor progression Growth in tumor height ≥0.5 mm or ≥1.5 mm in LBD relative to baseline Visual acuity loss ≥15 letters decrease from baseline Tumor thickness growth rate Change in rate of growth of tumor thickness 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 QW x 2 9 doses: 80 μg x 2 lasers QW x 3, 3 cycles Subtherapeutic Dose Range (N=10) 1–2 doses (n=9); 2 cycles (6 doses; n=1) Therapeutic Dose Range (N=11)a 3 cycles (9 doses) Cohort 1 (n=1) Cohort 2 (n=3b) Cohort 3 (n=2) Cohort 4 (n=3) Cohort 5 (n=3) Cohort 6 (n=10) 6–9 doses: 40 μg x 2 lasers QW x 3, up to 3 cycles (20 µg) (40 µg) (40 µg) (80 µg) (240–360 µg) (720 µg) Total intended dose
Bel-sar has Demonstrated a Favorable Safety Profile No posterior inflammation No treatment-related SAEs No grade 3–5 treatment-related AEs * Table presents participants with AEs related to bel-sar or laser by severity and overall; participants with >1 AE are counted in the highest severity group. AEs, adverse events; bel-sar, belzupacap sarotalocan; IQR, interquartile range; SAE, serious adverse events. ClinicalTrials.gov Identifier, NCT04417530; AU-011-202. Data on file, Aura Biosciences. All treated participants (n=22)* Drug/laser-related adverse events Grade I Grade II Grade III-V Total Anterior chamber inflammation** 4 (18.2%) 0 0 4 (18.2%) Anterior chamber cell** 2 (9.1%) 0 0 2 (9.1%) Eye pain 2 (9.1%) 0 0 2 (9.1%) Anisocoria 1 (4.5%) 0 0 1 (4.5%) Conjunctival edema 1 (4.5%) 0 0 1 (4.5%) Cystoid macular edema 1 (4.5%) 0 0 1 (4.5%) Pupillary reflex impaired 1 (4.5%) 0 0 1 (4.5%) Salivary gland enlargement 0 1 (4.5%) 0 1 (4.5%) **Median duration 6 days (IQR: 3–10 days); All resolved with no or minimal treatment; If topical steroids given, median treatment duration 6 days Phase 2 Safety Outcomes (Bel-sar/Laser-Related)
High Local Complete Response Rate at 12 Months Follow-Up 80% tumor control ratea at 12 months among the 10 Phase 3-eligible patients in the 3-cycle cohorts 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. bOne participant with circumpapillary tumor that did not meet phase 3 criteria is not included. IQR, interquartile range. ClinicalTrials.gov Identifier, NCT04417530; AU-011-202. Data on file, Aura Biosciences. Participants with tumor control at 12 months, % Dose/ Regimen n Tumor control rate, % Subtherapeutic regimen ≤2 cycles 10 20% (2/10) Therapeutic regimen 3 cycles, phase 3-eligibleb 10 80% (8/10) Phase 3-eligible participants High Tumor Control Rates with Therapeutic Regimen in Phase 3-Eligible Patients Median dose (IQR): 720 µg (390–720) 140 µg (80–160)
Rate of tumor growth ± SE, mm/yr P < 0.0001 Rate of Tumor Growth with Bel-sar Treatment In Phase 3-Eligible Patients, the 3-Cycle Regimen Resulted in Cessation of Growth Among Responders (N=8) Tumor thickness growth rates/slopes estimated using Mixed Models for Repeat Measures (MMRM); random intercept and slope model for Historical and Study periods. bel-sar, belzupacap sarotalocan;.ClinicalTrials.gov Identifier, NCT04417530; AU-011-202. Data on file, Aura Biosciences. Post-treatment actual growth rate Untreated projected growth rate Pre-treatment actual growth rate
Median Change in BCVA in Phase 3-Eligible Participants with Therapeutic Regimen (N=10)a Visual Acuity Was Preserved in 90% of Phase 3-Eligible Patients Receiving a Bel-sar Therapeutic Regimen 80% were at high risk of vision loss with tumors < 3 mm to the fovea or optic nerve 90% visual acuity preservation supports the potential for bel-sar to be a front-line therapy for early-stage disease a One participant with circumpapillary tumor that did not meet phase 3 criteria is not included. BCVA, best-corrected visual acuity; bel-sar, belzupacap sarotalocan; ETDRS, early treatment diabetic retinopathy study . ClinicalTrials.gov Identifier, NCT04417530; AU-011-202. Data on file, Aura Biosciences. Vision loss threshold (−15 letters) BCVA change from baseline (ETDRS letter score) Study week (relative to first dose in Cycle 1) Vision preservation in 9/10 participants Loss of 18 letters in one patient with progression of preexisting juxtafoveal fluid under fovea -5 0 5 -5 -10 -15 0 13 26 39 52
a Early choroidal melanoma, small choroidal melanoma or indeterminate lesions. b 40 µg bel-sar arm included for masking; excluded from statistical analysis. bel-sar, belzupacap sarotalocan; BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; FDA, United States Food and Drug Administration; LBD, largest basal diameter; SPA, special protocol assessment. ClinicalTrials.gov Identifier, NCT06007690; AU-011-301. Phase 3 Registration Study is Fully Enrolled Special Protocol Assessment, Fast Track and Orphan Drug Designations 80 µg bel-sar 40 µg bel-sarb Sham control Participants with Early Choroidal Melanomaa (N=108) Sites in North America, Europe, Middle East and Asia-Pacific Regions Randomization 2:1:2 15-month primary efficacy analysis 24-month follow-up period First Key Secondary Endpoint Time to composite endpoint Primary Endpoint Time to tumor progression Increase in tumor thickness ≥0.5 mm or ≥1.5 mm in LBD Tumor progression Increase in tumor thickness ≥0.5 mm or ≥1.5 mm in LBD Visual acuity failure ≥15 decrease in ETDRS-BCVA letter score from baseline OR Objective Determine efficacy and safety of bel-sar vs sham control for treatment of early choroidal melanoma On track for topline data 2H 2027
Phase 3 CoMpass Trial is Highly Powered for Success Based on Phase 2 Results Kaplan-Meier Simulation of Time-to-Event Endpoints Using Phase 2 Data 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; FDA, United States Food and Drug Administration; LBD, largest basal diameter; SPA, special protocol assessment. ClinicalTrials.gov Identifiers: NCT04417530; AU-011-202 (phase 2); NCT06007690; AU-011-301 (phase 3). Data on file, Aura Biosciences. Therapeutic n=10 Subtherapeutic n=10 Time to Tumor Progression Time to Composite Endpoint
a Includes conjunctival melanoma, primary acquired melanosis, squamous cell carcinoma and ocular surface squamous neoplasia.2-6 1. Epidemiology analysis for choroidal melanoma and choroidal metastasis by ClearView Healthcare Partners and Putnam. 2. Yu G-P, et al. Am J Ophthalmol. 2003;135(6):800-6. 3. Triay E, et al. Br J Ophthalmol. 2009;93(11):1524-8. 4. Newton R, et al. Lancet. 1996;347(9013):1450-1. 5. Dalvin LA. Br J Ophthalmol. 2018;102(12):1728-1734. 6. Sun EC, et al. Cancer Epidemiol Biomarkers Prev. 1997;6(2):73-7. Bel-sar, belzupacap sarotalocan. Bel-sar Has a Significant Commercial Opportunity to Expand into Additional Ocular Oncology Indications ~35,000/yr Opportunity to transform the field of ocular oncology with the first potentially curative, vision-preserving therapy Addressable market (US/EU) ~20,000/yr Early choroidal melanoma1 Metastases to the choroid1 POTENTIAL TIMELINE SEQUENCING FOR SUBSEQUENT INDICATIONS ~11,000/yr Bel-sar’s Potential Value Drivers Potential to be first approved therapy in all three disease states Development and regulatory synergies Focused call point (~100 ocular oncologists in US/EU) with potential expansion to retina specialists Buy-and-bill reimbursement Ocular surface cancersa,2–6
Aura is well-positioned to become the leader in ocular oncology Aura is Positioned to Become the Global Leader in Ocular Oncology Advancing the development of bel-sar in ocular oncology Under current operating plan, expected cash runway is into 1H 2029 Opportunity to build a durable leadership position in ocular oncology Highly powered Phase 3 CoMpass trial on track for topline data in 2H 2027 Refined Strategic Focus Key Upcoming Value Driver Disciplined Capital Allocation Long-term Value Potential
Appendix
Phase 2 Baseline Characteristics All Study Participants a High risk for vision loss defined as tumor edge within either 3 mm of foveal center or 3 mm of optic disc edge. BCVA, best-corrected visual acuity; ETDRS, Early Treatment Diabetic Retinopathy Study; LBD, largest basal diameter. Data on file, Aura Biosciences. All patients (n=22) Female (%) 54.5 White, not Hispanic or Latino (%) 100 Subretinal fluid at screening (%) 100 Orange pigment at screening (%) 86.4 Documented growth prior to screening (%) 86.4 (100% of therapeutic group) Mean age at screening (years, ± SD) 59.2 (±16.5) Mean baseline BCVA in study eye (ETDRS letters, ± SD) 83.2 (±7.2) Mean baseline LBD (mm, ± SD) 8.5 (±1.4) Mean baseline tumor thickness (mm, ± SD) 2.0 (±0.5) Mean tumor distance to closest vision-critical structure at screening (mm, ± SD) 2.0 (±2.3) Tumors at high risk for vision loss (%)a 73% (80% [8/10] of therapeutic group)
Bel-sar, belzupacap sarotalocan. ClinicalTrials.gov Identifier, NCT06007690; AU-011-301. Phase 2 Data Support Phase 3 Assumptions Phase 3 trial design P < 0.005 93% power (Δ20) Actual data (Δ60) >99% power P < 0.05 Robustness Analysis of 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