Aura Biosciences Inc 2025年季度报告

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the quarterly period endedMarch 31,2025OR ☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF1934 For the transition period from ___________________ to ___________________Commission File Number:001-40971 AURA BIOSCIENCES, INC. (Exact Name of Registrant as Specified in its Charter) Delaware32-0271970(State or other jurisdiction ofincorporation or organization)(I.R.S. EmployerIdentification No.)80 Guest StreetBoston,MA02135(Address of principal executive offices)(Zip Code)Registrant’s telephone number, including area code: (617)500-8864 (Former Name or Former Address, if Changed Since Last Report) Securities registered pursuant to Section 12(b) of the Act: Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of theSecurities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to filesuch reports), and (2) has been subject to such filing requirements for the past 90 days.Yes☒No☐ Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to besubmitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorterperiod that the registrant was required to submit such files).Yes☒No☐ Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smallerreporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smallerreporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer☐Accelerated filer☐Non-accelerated filer☒Smaller reporting company☒Emerging growth company☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition periodfor complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐ Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).Yes☐No☒ As of May 9, 2025, the Registrant had50,268,758shares of common stock, $0.00001 par value per share, outstanding. Summary of the Material Risks Associated with Our Business Our business is subject to numerous material and other risks and uncertainties that you should be aware of inevaluating our business. These risks are described more fully in Part II, “Item 1A—Risk Factors,” in this QuarterlyReport on Form 10-Q and include, but are not limited to, the following: •We have incurred significant net losses since our inception and anticipate that we will continue to incurlosses for the foreseeable future.•Raising additional capital may cause dilution to our existing stockholders, restrict our operations or requireus to relinquish proprietary rights to our technologies or product candidates.•Our ability to generate revenue and achieve profitability depends significantly on our ability to achieve ourobjectives relating to the discovery, development, regulatory approval and commercialization of our productcandidates.•We are heavily dependent on the success of belzupacap sarotalocan, or bel-sar, our only product candidateto date.•If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for bel-sar, wewill not be able to commercialize, or will be delayed in commercializing, our product candidates, and ourability to generate revenue will be materially impaired.•Wehave initiated but not yet completed a pivotal clinical trial nor have we commercialized anypharmaceutical products, which may make it difficult to evaluate our future prospects.•If we fail to develop additional product candidates, or obtain additional indications of our first productcandidate, our commercial opportunity could be limited.•The U.S Food and Drug Administration’s agreement to a Special Protocol Assessment with respect to thestudy design of our global Phase 3 trial of bel-sar for the treatment of early-stage choroidal melanoma doesnot guarantee any particular outcome from regulatory review, including ultimate approval, and may not leadto a successful review or approval process.•We rely on third parties to conduct our clinical trials and some aspects of our research and preclinicaltesting, and expect to continue to do so, and those third parties may not perform satisfactorily, includingfailing to meet deadlines for the completion of such trials, research or testing.•We currently rely on third-party contract development and manufacturing organizations, or CDMOs, for theproduction of clinical supply of bel-sar and may continue to rely on CDMOs for the production of commercialsupply of bel-sar, if approved. This reliance on CDMOs increases the risk that