ADDED
These risks include, but are not limited to, the following: Risks Related to Our Limited Operating History, Financial Position and Capital Requirements There is no guarantee that our acquisition of Pre-Acquisition Damora in November 2025 will increase stockholder value.
We are a preclinical stage biotechnology company with a limited operating history on which to assess our business; we have no products that have been administered to humans or approved for commercial sale, which may make it difficult to evaluate our current business and likelihood of success and viability.
We will require substantial additional capital to finance our operations in the future.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research programs or future commercialization efforts.
Risks Related to Our Discovery, Development and Commercialization We face competition from entities that have developed or may develop product candidates for the diseases addressed by our product candidates.
Our programs are in the preclinical stages of development and may fail in development or suffer delays that materially and adversely affect our viability.
If we or our current or future collaborators are unable to complete development of or commercialize our product candidates, or experience significant delays in doing so, our business will be materially harmed.
We are substantially dependent on the success of DMR-001, and our anticipated future clinical trials of such product candidate may not be successful.
If we do not achieve our projected development objectives in the time frames we announce and expect, the commercialization of our product candidates may be delayed which may harm our reputation and prospects, increase our expenses and cause our stock price to decline.
Preclinical and clinical development involves a lengthy and expensive process that is subject to delays and with uncertain outcomes, and results of earlier studies and trials may not be predictive of future clinical trial results.
REMOVED
These risks include, but are not limited to, the following: We will require substantial additional capital to finance our operations.
If we are unable to raise such capital when needed, or on acceptable terms, we may be forced to delay, reduce and/or eliminate one or more of our research and drug development programs, future commercialization efforts or other operations.
We have incurred significant net losses since inception, and we expect to continue to incur significant net losses for the foreseeable future.
Following our strategic transaction with Bridge Medicines in October 2024, our focus is now on the development of GB3226 (previously referred to as BRM-1420) and GB1211.
If we fail to execute successfully on this realigned strategic focus, our business and prospects will be adversely affected.
Our business is highly dependent on the success of our product candidates, GB3226 and GB1211, as well as any other product candidates that we advance into the clinic.
All of our product candidates require significant preclinical and/or clinical development before we may be able to seek regulatory approval for and launch a product commercially.
Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in this Annual Report on Form 10-K.
If we are unable to secure adequate additional funding, we will need to reevaluate our operating plans and may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, delay, scale back or eliminate some or all of our development programs, relinquish rights to our intellectual property on less favorable terms than we would otherwise choose, or cease operations entirely.
If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.