ADDED
The number of outstanding shares of the registrant s common stock, par value $0.01 per share, as of February 17, 2026 was 775,372,700 .
We have not yet demonstrated an ability to successfully complete development of any product candidates, and a Biologics License Application ( BLA ) that has been accepted for filing, such as the BLA relating to the HARMONi study, may not ultimately lead to regulatory approval and commercialization of ivonescimab.
Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials conducted by us or Akeso (as defined in Part I, Item I Business, Company Overview), as well as any interim results thereof, may not be predictive of future trial results and may negatively impact the size and scope of our ongoing or future Phase III clinical trials.
Our business is subject to the risks associated with doing business in China, including impacts from tariffs, data security laws and regulations, and restrictions on data transfer.
Our ability to obtain and maintain conditional marketing authorizations in the EU and other countries in our Licensed Territory (as defined in Part I, Item I Business, Akeso Collaboration and License Agreement) may be more limited in number as well as scope of the relevant authorizations and subject to several conditions and obligations that could prevent us from continuing to market our products.
The Company s current lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody intending to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF (as defined in Part I, Item I Business, Company Overview, Ivonescimab) compound into a single molecule.
On December 5, 2022, the Company entered into the License Agreement with Akeso, Inc.
and its affiliates (collectively, Akeso ) pursuant to which the Company has in-licensed intellectual property rights related to ivonescimab (as amended, the License Agreement ).
On June 3, 2024, the Company entered into the Second Amendment with Akeso to expand its territories covered under the License Agreement to also include Latin America, including Mexico and all countries in Central America and South America, the Middle East and Africa.
In May 2025, we announced topline results from our multiregional, double-blinded, placebo-controlled, Phase III study HARMONi.
REMOVED
The number of outstanding shares of the registrant s common stock, par value $0.01 per share, as of February 18, 2025 was 737,679,704 .
We have not yet demonstrated an ability to successfully complete development of any product candidates.
Clinical development involves a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials conducted by us or Akeso, as well as any interim results thereof, may not be predictive of future trial results and may negatively impact the size and scope of our ongoing or future Phase III clinical trials.
Our business is subject to the risks associated with doing business in China.
Our ability to obtain and maintain conditional marketing authorizations in the E.U.
and other countries in our Licensed Territory may be more limited in number as well as scope of the relevant authorizations and subject to several conditions and obligations that could prevent us from continuing to market our products.
The Company s current lead development candidate is ivonescimab, a novel, potential first-in-class bispecific antibody intending to combine the effects of immunotherapy via a blockade of PD-1 with the anti-angiogenesis effects of an anti-VEGF compound into a single molecule.
On December 5, 2022, the Company entered into a Collaboration and License Agreement (the License Agreement ) with Akeso, Inc.
and its affiliates (collectively, Akeso ) pursuant to which the Company has in-licensed intellectual property related to ivonescimab.
On June 3, 2024, the Company entered into an amendment to the License Agreement with Akeso to expand its territories covered under the License Agreement to also include the Latin America, Middle East and Africa regions (collectively, and as expanded, the "Licensed Territory").