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RISK FACTORS SUMMARY Below is a summary of the principal factors that make an investment in our common stock speculative or risky.
If we are unable to successfully identify predictive biomarkers to identify patient populations most likely to benefit from our ecDTx, or develop a diagnostic to enable patient selection for our ecDTx, or if we experience significant delays in doing so, we may not realize the full commercial potential of our ecDTx.
Interim, topline, and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
We rely on third parties to conduct our clinical trials and preclinical studies, manufacture our ecDTx, package, label, ship, store, and distribute our ecDTx, and supply products used as combination agents in our clinical trials, and these third parties may not perform satisfactorily or at an acceptable cost, which could delay, prevent, or impair our development or commercialization efforts.
Securities and Exchange Commission (SEC), and other government agencies, including due to government shutdowns, other funding shortages, policy changes, leadership changes, layoffs or significant personnel turnover, or public health concerns could impede development and potential marketing approval of our ecDTx and our ability to raise capital.
We occupy our corporate headquarters under a long-term non-cancellable lease which may limit our operating flexibility and could adversely affect our liquidity and results of operations.
We may engage in strategic transactions that could impact our liquidity, increase our expenses, and divert management s attention from other business priorities.
If we are unable to obtain, maintain, defend, and enforce patent or other intellectual property protection for our ecDTx or technology, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our ecDTx may be adversely affected.
Our information technology systems, or those of any of our service providers, may fail or suffer security incidents and other disruptions, which could result in a material disruption of our ecDTx development programs, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability, or otherwise adversely affecting our business.
The trading volume and price of our common stock have been and may continue to be highly volatile, and purchasers of our common stock could incur substantial losses.
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In addition, while we are responsible for all of the disclosure contained in this report and we believe the industry, market, and competitive position data included in this report is reliable and based on reasonable assumptions, such data involve risks and uncertainties and are subject to change based on various factors, including those discussed below under the section titled Risk Factors Summary and in Part I, Item 1A, Risk Factors.
All of our other ecDTx programs are still in the preclinical or discovery stage.
If we are unable to successfully develop an ecDNA diagnostic to enable patient selection for our ecDTx, or if we experience significant delays in doing so, we may not realize the full commercial potential of our ecDTx.
The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
Our lead ecDTx, BBI-355, is a novel, oral, selective inhibitor of checkpoint kinase 1 (CHK1), which manages replication stress associated with gene amplification in cancer cells.
BBI-355 demonstrated CHK1 inhibition and tumor regressions in oncogene amplified preclinical cancer models, including those enabled by ecDNA, and is currently being studied in a first-in-human, Phase 1/2 clinical trial in patients with oncogene amplified cancers.
We refer to this trial as POTENTIATE ( P recision O ncology T rial E valuating N ovel T herapeutic I nterrupting A mplifications T ied to e cDNA).
We expect to have preliminary clinical proof of concept safety and antitumor activity data of BBI-355 in the second half of 2025.
Our next program is directed at a previously undrugged kinesin target that we identified as essential for proper ecDNA segregation and inheritance during cancer cell division.
We are advancing our Kinesin program through drug discovery and expect to select a development candidate by mid-2025 and submit an investigational new drug application (IND) in the first half of 2026.