ADDED
These risks are described more fully in Part II, 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.
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.
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.
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.
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.
mHSPG , modified heparan sulphate proteoglycan; NMIBC , non-muscle-invasive bladder cancer; PoC , proof of concept.
REMOVED
These risks are described more fully in Part II, 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.
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.
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.
We are developing bel-sar in a number of indications in ocular oncology, with the goal of preserving vision and preventing blindness in patients.
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.