ADDED
As of February 26, 2026, the registrant had 346,597,289 sh ares of Class A common stock and 1,000,000 shares of Class B common stock outstanding.
You can identify these statements by words such as anticipate, assume, believe, continue, could, estimate, expect, intend, may, might, objective, ongoing, plan, potential, predict, project, should, will, would, or the negative of these terms or other similar expressions that are predictions of or indicate future events and future trends.
You should consider carefully the risks and uncertainties described in the section titled Risk Factors as part of your evaluation of an investment in our securities: Our near-term prospects are significantly dependent on the commercialization of IBTROZI (talectrectinib).
If we are unable to successfully commercialize IBTROZI, our ability to generate meaningful revenue or achieve profitability will be materially and adversely affected.
We have limited experience as a commercial company and our sales, marketing, and distribution of IBTROZI may be unsuccessful or less successful than anticipated.
If the market opportunities for IBTROZI are smaller than we believe, our revenue may be adversely affected, and our business may suffer.
IBTROZI may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
The successful commercialization of IBTROZI and our other product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies.
Failure to obtain or maintain adequate coverage and reimbursement for IBTROZI or our other product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
If competitors develop products, product candidates or technologies that are superior to or more cost-effective than IBTROZI, it would significantly impact the development and commercial viability of IBTROZI, which would severely and adversely affect our financial results, business and business prospects, and the future of IBTROZI, and might cause us to cease operations.
REMOVED
As of February 28, 2025, the registrant had 337,678,855 sh ares of Class A common stock and 1,000,000 shares of Class B common stock outstanding.
You can identify these statements by words such as anticipate, assume, believe, could, estimate, expect, intend, may, plan, should, will, would, and other similar expressions that are predictions of or indicate future events and future trends.
You should consider carefully the risks and uncertainties described in the section titled Risk Factors as part of your evaluation of an investment in our securities: Our clinical-stage product candidates as well as our other pipeline assets will require significant further investment and regulatory approvals prior to commercialization.
The FDA recently accepted for priority review the NDA for taletrectinib and we will need to obtain regulatory approval, manufacture sufficient commercial supply, build a U.S.
commercial organization, and make other substantial investments before we generate any revenues from product sales.
Additionally, raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights.
If we do not obtain regulatory approval for and successfully commercialize our product candidates in one or more indications or we experience significant delays in doing so, we may never generate any revenue or become profitable.
Our level of indebtedness and debt service obligations could adversely affect our financial condition and make it more difficult for us to fund our operations, and impose numerous other obligations and restrictions that will limit our operational flexibility.
We may encounter substantial delays in our preclinical studies or clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drug could be compromised.