AURA

Item 1A—Risk Factors,” in this Annual Report on Form 10-K 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 incur losses for the foreseeable future, which raises a risk regarding our ability to continue as a going concern. ▪ Our auditors have issued a “going concern” audit opinion. ▪ Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us 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 our objectives relating to the discovery, development, regulatory approval and commercialization of our product candidates. ▪ We are heavily dependent on the success of belzupacap sarotalocan, or bel-sar, our only product candidate to date. ▪ If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for bel-sar, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired. ▪ We have initiated but not yet completed a pivotal clinical trial nor have we commercialized any pharmaceutical 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 product candidate our commercial opportunity could be limited. ▪ The U.S.
Food and Drug Administration’s agreement to a Special Protocol Assessment with respect to the study design of our global Phase 3 trial of bel-sar for the treatment of early choroidal melanoma does not guarantee any particular outcome from regulatory review, including ultimate approval, and may not lead to a successful review or approval process. ▪ We rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and expect to continue to do so, and those third parties may not perform satisfactorily, including failing 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 the production of clinical supply of bel-sar and may continue to rely on CDMOs for the production of commercial supply of bel-sar, if approved.
This reliance on CDMOs increases the risk that we will not have sufficient quantities of such materials, product candidates, or any therapies that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts. ▪ If bel-sar or any future product candidates do not achieve broad market acceptance, the revenue that we generate from their sales may be limited, and we may never become profitable. ▪ If the market opportunity for bel-sar is smaller than we estimate or if any regulatory approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially. ▪ Our ability to compete may decline if we do not adequately protect our proprietary rights, and our proprietary rights do not necessarily address all potential threats to our competitive advantage. ▪ If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to pursue our business strategy and continue as a going concern will be impaired, could result in loss of markets or market share and could make us less competitive. ▪ Artificial intelligence presents risks and challenges that can impact our business including by posing security risks to our confidential information, proprietary information, and personal data. ▪ Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses. ▪ Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval. ii PA RT I Item 1.
Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with early choroidal melanoma (defined as small choroidal melanoma and/or indeterminate lesions) and is also in clinical development for other ocular oncology indications and bladder cancer.
We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in our ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with early choroidal melanoma.
Moreover, we intend to assess the safety and efficacy of bel-sar in treating a range of other solid tumors, beginning with metastases to the choroid and bladder cancer where bel-sar is in clinical development, as well as in cancers of the ocular surface.
In a Phase 2 study (ClinicalTrials.gov ID: NCT04417530) evaluating suprachoroidal, or SC, administration of bel-sar for the first-line treatment of early choroidal melanoma, patients were closely monitored over a twelve-month follow-up period to assess tumor control, visual acuity preservation, and tumor growth rate.
We believe bel-sar has the possibility to transform the field of ocular oncology beyond choroidal melanoma and we are expanding clinical development in two additional indications: metastases to the choroid and cancers of the ocular surface.
We continue to enroll patients in an ongoing Phase 2 clinical trial in metastases to the choroid and we are initiating a Phase 1 proof-of-concept trial in cancers of the ocular surface.
Beyond ocular cancers, bel-sar is in clinical development in bladder cancer.
Bladder cancer is the ninth most common cancer worldwide and the majority of cases are diagnosed early as non-muscle invasive bladder cancer, or NMIBC, with a prevalence of approximately 80,000 cases per year in the United States.
In 2025, we announced positive data from our Phase 1 trial in NMIBC ( NCT05483868 ).
Based on the positive results from the completed Phase 1 trial, we are advancing the clinical development of bel-sar in NMIBC.
We have an ongoing Phase 1b/2 trial in NMIBC evaluating additional doses and cycles in intermediate and high-risk NMIBC patients.
We are developing bel-sar in several indications in ocular oncology, with the goal of treating tumors, preserving vision and preventing blindness in patients.
Our lead indication is a potential multi-billion dollar addressable market opportunity.
Viruses. 2022;14(8):1656. mHSPG , modified heparan sulphate proteoglycan; NMIBC , non-muscle-invasive bladder cancer; PoC , proof of concept. .
We envision the potential for development of other oncology therapeutic areas in addition to ocular and urologic cancers.
Anthony Gibney, our Chief Financial and Business Officer, is an experienced biotechnology leader and former investment banker who brings over 30 years of experience dedicated to leading and advising biotechnology companies across their businesses, including corporate strategy, business development, finance and investor relations, among others.
Following his investment banking career, he has worked as Chief Business Officer at Achillion Pharmaceuticals, Inc. and Iveric Bio, Inc. and as Chief Business and Financial Officer at Fog Pharmaceuticals, Inc.
Key elements of our strategy to accomplish this objective include: ▪ Complete the ongoing global Phase 3 CoMpass trial of bel-sar as a first-line treatment of early choroidal melanoma and pursue U.S.
If approved, this would represent the first therapy for early choroidal melanoma as a potential first-line treatment option, reserving radiotherapy for a second-line treatment option.
There are approximately 50 ocular oncologists in the United States and approximately 50 ocular oncologists in Europe, representing a focused call point and providing an opportunity for our company to capture the value of the market with a focused sales team globally. ▪ Expand the development of bel-sar in additional ocular oncology indications, including metastases to the choroid and cancers of the ocular surface .
We continue to enroll patients in the ongoing Phase 2 clinical trial in metastases to the choroid.
Metastases to the choroid has an annual incidence rate of 20,000 patients in the United States and Europe.
In addition, we plan to conduct a Phase 1 proof-of-concept trial of bel-sar for cancers of the ocular surface, including both melanomas and squamous cell carcinomas, that has an incidence rate of 35,000 patients a year in the United States and Europe, based on strong interest from the ocular oncology community to develop better treatment options for patients. ▪ Advance the development of bel-sar in NMIBC.
We believe that bel-sar has the opportunity to become a front-line treatment option with a paradigm shifting approach driven by its unique dual mechanism of action and the possibility to generate a robust cell mediated immune response against the tumor to prevent recurrence and progression of the disease.
As such, we are currently evaluating two different front-line interventions in the ongoing Phase 1b/2 trial: neoadjuvant treatment prior to transurethral resection of bladder tumor, or TURBT, and immune-ablative treatment (without TURBT), with the opportunity to not only evaluate the dose and treatment regimen but also to assess durability of response for up to 12 months in patients with intermediate and high-risk NMIBC.
Our Strengths in Ocular Oncology Bel-sar is in development in multiple indications in ocular oncology: early choroidal melanoma, metastases to the choroid, and cancers of the ocular surface.
We believe bel-sar has several strengths that support our goal of developing bel-sar as a potential vision-sparing therapy in ocular oncology, including: ▪ Demonstrated clinical utility in choroidal melanoma, with Phase 2 end of study results in patients at twelve months of follow-up who received three cycles of therapy in Cohorts 5 and 6, and who match the criteria for our ongoing global Phase 3 trial. ▪ Tumor control rate of 80% (8/10) and visual acuity preservation rate of 90% (9/10), with the majority of patients being at high-risk for vision loss with tumors close to the fovea or optic disc. ▪ Favorable safety profile, with no posterior inflammation, treatment-related serious adverse events or grade three to five treatment-related adverse events reported .
Early Choroidal Melanoma Early choroidal melanoma is our most advanced clinical program, with an ongoing global Phase 3 trial.
We have received Orphan Drug Designation, or ODD, for the treatment of early choroidal (also referred to as uveal) melanoma from the FDA and the European Medicines Agency, or EMA, and Fast Track Designation from the FDA for the treatment of early choroidal melanoma.
Early choroidal melanoma patients are defined as patients with small choroidal melanoma and/or indeterminate lesions representing approximately 8,000 patients in the United States and Europe.
Distribution of Stages of Choroidal Melanoma Cases We are developing bel-sar as a potential first line vision-sparing treatment option for intervention in early choroidal melanoma, avoiding the need for radiotherapy and potentially reducing the risk of metastasis for these patients with early therapeutic intervention.
There is an urgent unmet medical need for an effective, vision-sparing therapy and the availability of such a therapy may encourage treatment of early choroidal melanoma at the time of early detection.
Bel-sar in Early Choroidal Melanoma Bel-sar is a VDC consisting of an HPV-derived VLP and a phthalocyanine dye, a light activated cytotoxic payload.
We believe that patients with early choroidal melanoma would gain the most advantage from bel-sar treatment.
Clinical Development Plan in Early Choroidal Melanoma: Phase 1b/2 Intravitreal Study: This study evaluated the safety and efficacy of bel-sar delivered via intravitreal, or IVT, administration followed by light activation in a dose escalation design in 56 patients.
The Phase 2 study was an open-label, ascending single and repeat dose escalation trial in patients with early choroidal melanoma designed to evaluate the safety, tolerability and efficacy of up to three cycles of bel-sar treatment.
We expect to complete enrollment for this Phase 3 trial by mid-2026, with topline data for the 15-month primary endpoint anticipated in the second half of 2027.

and 258 more.

Gone since FY2024

Item 1A—Risk Factors,” in this Annual Report on Form 10-K 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 incur losses for the foreseeable future. ▪ Raising additional capital may cause dilution to our existing stockholders, restrict our operations or require us 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 our objectives relating to the discovery, development, regulatory approval and commercialization of our product candidates. ▪ We are heavily dependent on the success of belzupacap sarotalocan, or bel-sar, our only product candidate to date. ▪ If we are not able to obtain, or if there are delays in obtaining, required regulatory approvals for bel-sar, we will not be able to commercialize, or will be delayed in commercializing, our product candidates, and our ability to generate revenue will be materially impaired. ▪ We have initiated but not yet completed a pivotal clinical trial nor have we commercialized any pharmaceutical 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 product candidate our commercial opportunity could be limited. ▪ The U.S.
Food and Drug Administration’s agreement to a Special Protocol Assessment with respect to the study design of our global Phase 3 trial of bel-sar for the treatment of early-stage choroidal melanoma does not guarantee any particular outcome from regulatory review, including ultimate approval, and may not lead to a successful review or approval process. ▪ We rely on third parties to conduct our clinical trials and some aspects of our research and preclinical testing, and expect to continue to do so, and those third parties may not perform satisfactorily, including failing 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 the production of clinical supply of bel-sar and may continue to rely on CDMOs for the production of commercial supply of bel-sar, if approved.
This reliance on CDMOs increases the risk that we will not have sufficient quantities of such materials, product candidates, or any therapies that we may develop and commercialize, or that such supply will not be available to us at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts. ▪ If bel-sar or any future product candidates do not achieve broad market acceptance, the revenue that we generate from their sales may be limited, and we may never become profitable. ▪ If the market opportunity for bel-sar is smaller than we estimate or if any regulatory approval that we obtain is based on a narrower definition of the patient population, our revenue and ability to achieve profitability will be adversely affected, possibly materially. ▪ Our ability to compete may decline if we do not adequately protect our proprietary rights, and our proprietary rights do not necessarily address all potential threats to our competitive advantage. ▪ If we lose key management personnel, or if we fail to recruit additional highly skilled personnel, our ability to pursue our business strategy will be impaired, could result in loss of markets or market share and could make us less competitive. ▪ Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses. ▪ Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant influence over matters subject to stockholder approval. ii PA RT I Item 1.
Our lead candidate bel-sar is in late-stage clinical development for the treatment of patients with primary choroidal melanoma and is also in clinical development for other ocular oncology indications and bladder cancer.
We are evaluating the safety and efficacy of bel-sar as a potential vision-sparing therapy in our ongoing global Phase 3 CoMpass trial for the first-line treatment of adult patients with small choroidal melanoma and indeterminate lesions, or early-stage choroidal melanoma.
Moreover, we intend to assess the safety and efficacy of bel-sar in treating a range of other solid tumors, beginning with metastases of the choroid and bladder cancer where bel-sar is in clinical development.
In a Phase 2 study (ClinicalTrials.gov ID: NCT04417530) evaluating suprachoroidal, or SC, administration of bel-sar for the first-line treatment of early-stage choroidal melanoma, patients were closely monitored over a twelve-month follow-up period to assess tumor control, visual acuity preservation, and tumor growth rate.
We believe bel-sar has the possibility to transform the field of ocular oncology beyond choroidal melanoma and we plan to expand clinical development in two additional indications: metastases to the choroid and cancers of the ocular surface.
We have initiated a Phase 2 clinical trial in metastases to the choroid and have activated sites with patients in prescreening.
We also plan to continue to advance our preclinical work designed to be IND-enabling in cancers of the ocular surface.
Beyond ocular cancers, bel-sar is in early-stage clinical development in bladder cancer.
Bladder cancer is the ninth most common cancer worldwide and it is diagnosed early as non-muscle invasive bladder cancer, or NMIBC, with a prevalence of approximately 80,000 cases per year in the United States.
In March 2025, we announced positive data from our Phase 1 trial in NMIBC ( NCT05483868 ).
We are developing bel-sar in a number of indications in ocular oncology, with the goal of preserving vision and preventing blindness in patients.
Our lead indication is a potential multi-billion dollar market opportunity.
Viruses. 2022;14(8):1656. mHSPG , modified heparan sulphate proteoglycan; MIBC , muscle invasive bladder cancer; NMIBC , non-muscle-invasive bladder cancer .
We envision the potential for development of additional therapeutic areas in addition to ocular and urologic cancers.
Amy Elazzouzi, our Senior Vice President, Finance, interim principal financial officer and interim principal accounting officer, has served as Director of Finance and Operations at KEW Group, Inc. and Controller at AVEO Pharmaceuticals, Inc.
Key elements of our strategy to accomplish this objective include: ▪ Complete the ongoing global Phase 3 CoMpass trial of bel-sar as a first-line treatment of small choroidal melanoma and/or indeterminate lesions and pursue U.S.
If approved, this would represent the first therapy for primary choroidal melanomas as a potential first-line treatment option for small tumors and indeterminate lesions, reserving radiotherapy for a second-line treatment option.
There are approximately 50 ocular oncologists in the United States and approximately 50 ocular oncologists in Europe, representing a focused call point and providing an opportunity for our company to capture the value of the market with a manageable sales team globally. ▪ Expand the development of bel-sar in additional ocular oncology indications, starting with metastases to the choroid and cancers of the ocular surface .
Metastases to the choroid has an annual incidence rate of 20,000 patients in the Unites States and Europe.
In addition, we are advancing bel-sar for cancers of the ocular surface, including both melanomas and squamous cell carcinomas, that has an incidence rate of 35,000 patients a year in the United States and Europe, based on strong interest from the ocular oncology community to develop better treatment options for patients. ▪ Advance the development of bel-sar in NMIBC.
We believe that bel-sar has the opportunity to become a front-line treatment option with a paradigm shifting approach driven by its unique dual mechanism of action and the possibility to generate a robust cell mediated immune response against the tumor to prevent recurrence of the disease.
As such, our goal is to evaluate two different front-line interventions in a Phase 1b/2 trial: neoadjuvant treatment in combination with transurethral resection of bladder tumor, or TURBT, and immune-ablative treatment (without TURBT), with the opportunity to not only evaluate the dose and treatment regimen but also to assess durability of response at up to 12 months in patients with intermediate and high-risk NMIBC.
Our Strengths in Ocular Oncology Bel-sar is in development in multiple indications in ocular oncology: early-stage choroidal melanoma, metastases to the choroid, and cancers of the ocular surface.
We believe bel-sar has several strengths that support our goal of developing bel-sar as a potential vision-sparing therapy in ocular oncology, including: ▪ Demonstrated clinical utility in choroidal melanoma, with Phase 2 end of study results of patients at twelve months of follow-up who received three cycles of therapy in Cohorts 5 and 6, and who match the criteria for our ongoing global Phase 3 trial. ▪ Tumor control rate of 80% (8/10) and visual acuity preservation rate of 90% (9/10), with the majority of patients being at high-risk for vision loss with tumors close to the fovea or optic disc. ▪ Favorable safety profile, with no posterior inflammation, treatment-related serious adverse events or grade three to five treatment-related adverse events reported .
Primary Choroidal Melanoma Primary choroidal melanoma is our most advanced clinical program, with an ongoing global Phase 3 trial.
We have received Orphan Drug Designation, or ODD, for the treatment of early-stage choroidal (also referred to as uveal) melanoma from the FDA and the European Medicines Agency, or EMA, and Fast Track Designation from the FDA for the treatment of early-stage choroidal melanoma.
Early-stage patients are defined as patients with small choroidal melanoma and/or indeterminate lesions representing approximately 8,000 patients in the United States and Europe.
Distribution of Stages of Choroidal Melanoma Cases We are developing bel-sar as a potential first line vision-sparing treatment option for early intervention in small choroidal melanoma and/or indeterminate lesions, avoiding the need for radiotherapy and reducing the risk for metastasis for these patients.
There is an urgent unmet medical need for an effective, vision-sparing therapy and the availability of such a therapy may encourage treatment of small choroidal melanomas and indeterminate lesions at the time of early detection.
Bel-sar in Primary Choroidal Melanoma Bel-sar is a VDC consisting of an HPV-derived VLP and a phthalocyanine dye, a light activated cytotoxic payload.
We believe that patients with small choroidal melanoma or indeterminate lesions would gain the most advantage from bel-sar treatment.
Clinical Development Plan in Primary Choroidal Melanoma: Phase 1b/2 Intravitreal Study: This study evaluated the safety and efficacy of bel-sar delivered via intravitreal, or IVT, administration followed by light activation in a dose escalation design in 56 patients.
The Phase 2 study was an open-label, ascending single and repeat dose escalation trial in patients with early-stage choroidal melanoma designed to evaluate the safety, tolerability and efficacy of up to three cycles of bel-sar treatment.
If warranted by the data, we plan to submit the results of the Phase 3 trial to support approval of bel-sar for the treatment of primary small choroidal melanoma and indeterminate lesions.
As we previously reported, there was an administrative error in the original International Nonproprietary Name, or INN, application (INN: belzupacap sarotalocan) with the World Health Organization, or WHO.
In subsequent communications with the WHO, the WHO has confirmed an amendment to the existing INN allowing the continued use of belzupacap sarotalocan.
Retrospective natural history study to evaluate long-term visual acuity benefit versus plaque brachytherapy The ability to demonstrate tumor control with long-term visual acuity preservation supports the potential of bel-sar to become the SoC for the first-line treatment of patients with small choroidal melanoma/indeterminate lesions compared to an invasive radiotherapy procedure that leaves most patients with irreversible vision loss and other long-term comorbidities.

and 197 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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