AI Earnings Predictions for Aura Biosciences Inc. (AURA)

EX-99.1

2 aura-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Aura Biosciences Reports Second Quarter 2026 Financial Results and Recent Business Highlights

Phase 3 CoMpass trial fully enrolled with 108 patients, exceeding enrollment target; on track for topline data in 2H 2027

Strategic operating plan refined to focus on development of bel-sar in ocular oncology

Interim NMIBC data reinforce bel-sar’s potential for durable efficacy and favorable safety profile; NMIBC program being strategically deprioritized to focus company resources on ocular oncology

Organizational restructuring and disciplined capital allocation strategy to align with ocular oncology focus extend expected cash runway into 1H 2029

Strengthening leadership team with appointments of experienced industry executives as Chief Operating Officer, Chief Regulatory and Quality Officer, and Chief People Officer to position Aura for next stage of growth

BOSTON, MA – August 11, 2026 – Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a potentially transformative first-in-class therapy for patients with ocular cancers, today reported financial results for the second quarter ended June 30, 2026, and provided a business update.

"Completing enrollment in our Phase 3 CoMpass trial of bel-sar for early choroidal melanoma positions us well for the next phase of our company’s evolution to become a leading ocular oncology company," said Natalie Holles, Chief Executive Officer of Aura Biosciences. "Given the promising therapeutic profile of bel-sar and the significant unmet need for a new treatment in this field, we are prioritizing our efforts and resources on delivering meaningful development milestones, providing ocular oncologists with frontline, vision-preserving treatment options for patients, and creating long-term value for shareholders."

Recent Business Highlights

Early Choroidal Melanoma

The Phase 3 CoMpass trial, the first registration-enabling study in patients with early choroidal melanoma, is fully enrolled with 108 patients, which exceeded the enrollment target. Topline data from the 15-month primary endpoint remain on track for the second half of 2027, consistent with previously communicated guidance.

The trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA), reflecting alignment with the FDA on the trial design and planned analyses to support a potential Biologics License Application (BLA). If successful, belzupacap sarotalocan (bel-sar) has the potential to become the first approved frontline 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 clinical development of bel-sar in metastases to the choroid and cancers of the ocular surface. The Company is increasing resources directed toward both programs to support more robust clinical data generation in support of future development. Aura expects to provide an update on both programs, including guidance on study completion, in Q1 2027.

NMIBC Program Update

Interim data from the ongoing Phase 1b/2 dose-escalation study of bel-sar in non-muscle invasive bladder cancer (NMIBC) demonstrate an encouraging early clinical profile. Among intermediate-risk patients treated with bel-sar alone (n=8) or with TURBT (n=8), 81% of patients achieved an objective response at 3 months, including 69% with a complete response at that timepoint. Responses have shown strong early durability: among evaluable patients who have reached the 9- (n=4) or 12-months (n=3) timepoints, 100% of evaluable patients remain disease-free at time of assessment. Three-month data collection is ongoing in the high-risk cohorts.

Bel-sar continues to demonstrate a favorable safety profile, with all treatment-related adverse events limited to Grade 1 events, no dose-limiting toxicities, and no treatment-related serious adverse events. These data provide encouraging early clinical proof-of-concept for intratumoral delivery of bel-sar and support the potential utility of this route of administration for ocular cancers.

While these early data are encouraging, as part of its strategic refocus on ocular oncology, the Company is minimizing resource allocation toward the NMIBC program on a going forward basis. The Company remains committed to the care of patients and intends to complete data collection through the protocol-defined 12-month follow-up period to preserve optionality for value creation in the context of future potential strategic discussions.

Organizational and Leadership Updates

Aura has streamlined its operating plan and organizational structure to focus resources in ocular oncology, including a reduction in force of approximately 20% of the workforce. Together with disciplined capital allocation, these actions are expected to

EX-99.1

2 aura-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

Aura Biosciences Reports First Quarter 2026 Financial Results and Business Highlights

Phase 3 CoMpass trial advancing toward enrollment completion, supporting 2H 2027 topline data

Natalie Holles appointed Chief Executive Officer and President and member of the Board of Directors

Strengthened balance sheet with oversubscribed $299 million equity financing; cash position expected to fund operations into 2H 2028

BOSTON, MA – May 11, 2026 – Aura Biosciences, Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing precision therapies for solid tumors designed to preserve organ function, today reported financial results for the first quarter ended March 31, 2026, and provided recent business highlights.

“We are entering a pivotal period for Aura as we advance our Phase 3 CoMpass trial toward enrollment completion and potential registration,” said Natalie Holles, Chief Executive Officer of Aura Biosciences. “Bel-sar has the potential to become the first frontline, vision-preserving therapy for patients with early choroidal melanoma, and we are on track to deliver topline data from the CoMpass trial in the second half of 2027. Supported by our strengthened balance sheet, we are focused on executing against these priorities and translating this progress into long-term value for patients and shareholders.”

Recent Pipeline Developments

Early Choroidal Melanoma

The ongoing Phase 3 CoMpass trial is the first registration-enabling study in early choroidal melanoma. This global, randomized Phase 3 trial is evaluating bel-sar versus a sham control. The trial is advancing toward enrollment completion, which is expected by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

Bel-sar has the potential to become the first frontline vision-preserving therapy in this setting. The Company previously received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and the European Medicines Agency and Fast Track designation from the FDA for the treatment of early choroidal melanoma. The CoMpass trial is under a Special Protocol Assessment agreement with the FDA.

Metastases to the Choroid

The ongoing Phase 2 clinical trial of bel-sar in metastases to the choroid continues to enroll patients. The study is designed to include patients with choroidal metastases arising from a range of primary solid tumors and to evaluate early proof-of-concept based on a four-week efficacy endpoint. The Company remains on track to report early data from this trial in 2026.

Cancers of the Ocular Surface

The Company is initiating a Phase 1 proof-of-concept trial in Australia to assess safety, feasibility and tumor response through histopathologic evaluation at a 2–4-week time point. Development activities for this program are ongoing, with early proof-of-concept data expected in 2026.

Bladder Cancer

The ongoing Phase 1b/2 trial evaluating additional doses and cycles of bel-sar across intermediate- and high-risk non-muscle invasive bladder cancer (NMIBC) patients continues to advance, with initial 3-month clinical data expected mid-2026.

The trial is evaluating two approaches: immune ablative and neoadjuvant. In the immune ablative arm, bel-sar is given in two cycles without a transurethral resection of the bladder tumor (TURBT). In the neoadjuvant arm, bel-sar is given in two cycles before TURBT. Patients are monitored for response, recurrence (at 3, 6, 9, and 12 months), and safety.

Corporate Updates

As previously announced on May 4, 2026, the Company’s Board of Directors appointed Natalie Holles as Chief Executive Officer and President and member of the Board of Directors, effective April 30, 2026. Ms. Holles succeeds Elisabet de los Pinos, Ph.D., the Company’s founder, who stepped down from her roles as Chief Executive Officer and President and a member of the Board of Directors, effective on the same date.

First Quarter 2026 Financial Results

• As of March 31, 2026, the Company had cash and cash equivalents and marketable securities totaling $114.7 million. On May 5, 2026, the Company completed an underwritten public offering of common stock and pre-funded warrants, which included the underwriters’ full exercise of their option to purchase additional shares of common stock. After deducting the underwriting discounts and commissions and estimated offering expenses, the Company received approximately $280.8 million in net proceeds from the offering, of which it subsequently used approximately $39.0 million to repurchase all the shares of its common stock held by Matrix Capital Management Master Fund, LP in the previously announced stock repurchase. The Company believes its current cash and cash equivalents and marketable securities, together with the net proceeds of the offering to the Company, are sufficient to fund its operations into the second half of 2028.

• Research and developme

8-K

false 0001501796 0001501796 2026-04-30 2026-04-30

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): April 30, 2026

Aura Biosciences, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-40971

32-0271970

(State or Other Jurisdiction of Incorporation)

(Commission

File Number)

(IRS Employer Identification No.)

80 Guest Street

Boston, Massachusetts

02135

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 617 500-8864

Not Applicable

(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:

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange

on which registered

Common Stock, $0.00001 par value per share

AURA

The Nasdaq Global Market

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 1.01.

Entry into a Material Definitive Agreement.

On April 30, 2026, Aura Biosciences, Inc. (the “Company”) and Matrix Capital Management Master Fund, LP (“Matrix”) entered into a stock purchase agreement (the “Repurchase Agreement”) pursuant to which the Company has agreed to repurchase, in a privately negotiated transaction, up to 6,922,870 shares of its common stock, which the Company believes represents all shares of its common stock held by Matrix as of the date of this Current Report on Form 8-K (this “Current Report”). Pursuant to the Repurchase Agreement, the Company expects to fund the repurchase using a portion of the net proceeds from the sale of its common stock in the underwritten equity offering that the Company separately announced on May 4, 2026 (the “Equity Offering”), after deducting underwriting discounts and commissions, that are in excess of $200 million, inclusive of any such net proceeds that the Company may receive in connection with the exercise, if any, of the underwriters’ option to purchase additional shares of the Company’s common stock in the Equity Offering. The Company will repurchase the shares from Matrix at a price per share equal to the price per share at which the underwriters will purchase shares from the Company in the Equity Offering (the “Stock Repurchase”), subject to certain conditions. Based on such price per share of the Equity Offering, which the Company separately announced on May 4, 2026 as $5.64, the Company expects to repurchase the 6,922,870 shares of the common stock held by Matrix. The shares being repurchased will become authorized but unissued shares. Prior to giving effect to the Equity Offering and the Stock Repurchase, Matrix held approximately 10.8% of our outstanding common stock based on the number of shares of common stock outstanding as of April 15, 2026.

The closing of the Stock Repurchase is expected to occur no earlier than two business days after the closing of the Equity Offering.

The Stock Repurchase is conditioned upon the closing of the Equity Offering and certain other conditions. We cannot provide any assurance that the Stock Repurchase will occur on the terms described herein, or at all. The description of, and other information in this Current Report regarding, the Stock Repurchase are included for informational purposes only. Nothing in this Current Report should be construed as an offer (i) to sell, or the solicitation of an offer to purchase, any of our common stock that we may repurchase, or (ii) to repurchase, or the solicitation of an offer to sell, any of our common stock.

The Repurchase Agreement and related arrangements and transactions were reviewed and approved by the audit committee (the “Audit Committee”) of the Company’s Board of Directors (the “Board”), which is charged with reviewing related party transactions, and is composed of three independent directors who