ADDED
For purposes of this calculation, the registrant has excluded the market value of all shares of its common stock reported as beneficially owned by the executive officers, directors and other affiliates of the registrant.
This determination of affiliate status is not necessarily a conclusive determination for other purposes.
As of March 24, 2026, the registrant had 65,467,187 shares of common stock, $0.0001 par value per share outstanding.
We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future.
If we are unable to raise capital when needed, or on acceptable terms, we may be unable to complete the development and commercialization of ficerafusp alfa or any future product candidates.
We face significant competition from other biotechnology and pharmaceutical companies, and our operating results will suffer if we fail to compete effectively.
Our business is dependent on our ability to advance ficerafusp alfa and future product candidates through clinical trials, obtain marketing approval and ultimately commercialize them.
Unfavorable global economic and geopolitical conditions could adversely affect our business, financial condition, stock price and results of operations.
You should read this Form 10-K and the documents that we reference in this Form 10-K and have filed with the Securities and Exchange Commission, or the SEC, as exhibits hereto completely and with the understanding that our actual future results may be materially different from any future results expressed or implied by these forward-looking statements.
is the owner of the Bicara trademark, as well as certain other registered trademarks, trademark applications and unregistered trademarks and service marks, including design versions of some of these trademarks.
REMOVED
The registrant s common stock began trading on the Nasdaq Global Market on September 13, 2024.
As of March 24, 2025, the registrant had 54,523,326 shares of common stock, $0.0001 par value per share outstanding.
We have incurred significant financial losses since our inception and anticipate that we will continue to incur significant financial losses for the foreseeable future; We will require additional funding in order to finance operations beyond 2029.
If we are unable to raise capital when needed, or on acceptable terms, we could be forced to delay, reduce or eliminate our product development programs or commercialization efforts.
Unless otherwise expressly stated, we obtained this industry, business, market, and other data from our own internal estimates and research as well as from reports, research surveys, studies, and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data and similar sources.
is the owner of the Bicara trademark, as well as certain other trademarks, including design versions of some of these trademarks.
This approach was deployed in the development of our lead program ficerafusp alfa, formerly BCA101, where we believe the bifunctional design can potentially improve upon the therapeutic profile of immunotherapies and targeted therapies by addressing resistance mechanisms and limiting off-target toxicity, therefore, enhancing the treatment effect and tolerability for targeted patient populations with cancer.
Our lead program ficerafusp alfa is a bifunctional antibody that combines two clinically validated targets, an epidermal growth factor receptor, or EGFR, directed monoclonal antibody with a domain that binds to human transforming growth factor beta, or TGF- .
Through this dual-targeting mechanism, ficerafusp alfa has the potential to exert potent anti-tumor activity by simultaneously blocking both cancer cell-intrinsic EGFR survival and proliferation, as well as the immunosuppressive TGF- signaling within the TME.
Ficerafusp alfa directs the TGF- inhibitor into the immediate TME through the binding of EGFR on tumor cells, which we believe will lead to durable responses and an increase in overall survival, or OS, while reducing the adverse effects typically associated with systemic TGF- inhibition.