ADDED
Unless expressly stated otherwise, the statements contained in this Annual Report on Form 10-K have been prepared as if we were going to remain an independent company.
ii Summary of Principal Risks Associated with Our Business Following our entry into that certain Agreement and Plan of Merger (the Merger Agreement), dated as of March 24, 2026, by and among us, Merck Sharp Dohme LLC (Parent) and Thailand Merger Sub, Inc.
We are a clinical-stage oncology company with a limited operating history and no products approved for commercial sale.
We will require substantial additional funding to finance our operations and achieve our goals.
Failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
Our business is heavily dependent on the successful development, regulatory approval and commercialization of our current and future product candidates, particularly our lead product candidate, TERN-701.
Our development programs may target indications that do not have a clearly defined regulatory pathway.
For such indications, there is a heightened risk that we will not be able to gain agreement with regulatory authorities regarding an acceptable development plan, that the outcome of our clinical trials will not be favorable or that, even if favorable, regulatory authorities may not find the results of our clinical trials to be sufficient for marketing approval.
This may make it difficult to predict the timing and costs of the clinical development of our product candidates.
If we are unable to obtain, maintain and enforce effective intellectual property protection directed to our current and any future technologies that we develop, or if the scope of patent protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets.
REMOVED
ii Summary of Principal Risks Associated with Our Business We are a clinical-stage biopharmaceutical company with a limited operating history and no products approved for commercial sale.
We will require substantial additional financing to achieve our goals, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce or terminate our product development programs, commercialization efforts or other operations.
Our business is heavily dependent on the successful development, regulatory approval and commercialization of our current and future product candidates.
Our development programs are focused on product candidates for the treatment of chronic myeloid leukemia, or CML, and obesity.
For one or more of these programs, we may not be able to gain agreement with regulatory authorities regarding an acceptable development plan, the outcome of our clinical trials may not be favorable and, even if favorable, regulatory authorities may not find the results of our clinical trials to be sufficient for marketing approval.
This makes it difficult to predict the timing and costs of the clinical development of our product candidates.
iii If we are unable to obtain, maintain and enforce intellectual property protection directed to our current and any future technologies that we develop, others may be able to make, use or sell products substantially the same as ours, which could adversely affect our ability to compete in the market.
China s economic, political and social conditions, as well as government policies, could affect our ability to operate our business.
Company Overview We are a clinical-stage biopharmaceutical company developing a portfolio of small-molecule product candidates to address serious diseases, including oncology and obesity.
Our programs are based on mechanisms of action that have achieved proof-of-concept in clinical trials in indications with significant unmet medical needs.