ADDED
As of March 11, 2026, the registrant had 57,288,750 shares of common stock, $0.0001 par value per share, outstanding.
We may find it difficult to enroll patients in our Phase 2 clinical trial for silevertinib in patients with newly diagnosed EGFR-altered glioblastoma (GBM) or our future product candidates.
We have entered into a license agreement and may form or seek further collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
federal government shutdown or reduced resources, new or increased international tariffs and retaliatory tariffs, new laws and regulations or amendments to existing laws and regulations in the U.S.
and foreign countries, trade protection measures, economic sanctions and economic slowdowns or recessions that may result from such developments which could harm our research and development efforts as well as the value of our common stock and our ability to access capital markets; and other material risks and uncertainties, including those discussed in Part I, Item 1A, Risk Factors in this Annual Report.
Our lead clinical-stage program, silevertinib (formerly BDTX-1535), a brain-penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor, is currently being studied in a Phase 2 clinical trial in patients with epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC).
We plan to initiate a randomized Phase 2 trial of silevertinib in newly diagnosed patients with EGFR altered glioblastoma (GBM) in the second quarter of 2026.
In addition to our lead program, silevertinib, our pipeline also includes an outlicensed clinical-stage product candidate and one development-stage product candidate.
While the third-generation EGFR inhibitor osimertinib has been shown to exhibit some CNS penetrance and delay the progression of CNS metastases, there are few options remaining to patients with P-loop C-helix compressing mutations (PACC, a subset of non-classical mutations) that are insensitive to osimertinib.
Moreover, there are no therapies approved for the treatment of patients when resistance to osimertinib presents due to the acquired resistance mutation C797S.
REMOVED
As of February 28, 2025, the registrant had 56,662,222 shares of common stock, $0.0001 par value per share, outstanding.
We may find it difficult to enroll patients in our Phase 2 clinical trial for BDTX-1535 or our future product candidates with the genetic mutations that these product candidates are designed to target.
If we are unable to obtain and maintain patent and other intellectual property protection for BDTX-1535, BDTX-4933, BDTX-4876, our MAP drug discovery engine and our other product candidates and technology, or any other product candidates or technology we may develop, or if the scope of intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to commercialize BDTX-1535 or any of our future product candidates or technology may be adversely affected.
We may form or seek collaborations or strategic alliances or enter into additional licensing arrangements in the future, and we may not realize the benefits of such collaborations, alliances or licensing arrangements.
Data collection is governed by restrictive regulations governing the use, processing and cross-border transfer of personal information.
Our lead clincal-stage program, BDTX-1535, a brain-penetrant, fourth-generation epidermal growth factor receptor (EGFR) MasterKey inhibitor, is currently being studied in a Phase 2 clinical trial in patients with epidermal growth factor receptor mutant (EGFRm) non-small cell lung cancer (NSCLC) and in an investigator-sponsored trial in patients with glioblastoma (GBM) with EGFR alterations.
We are actively evaluating partnership opportunities for a second clinical-stage program, BDTX-4933, a brain-penetrant, RAF MasterKey inhibitor targeting KRAS, NRAS and BRAF alterations in solid tumors.
Our pipeline includes two clinical-stage product candidates and one development-stage product candidate.
While the third-generation EGFR inhibitor osimertinib has been shown to exhibit some CNS penetration and delay the progression of CNS metastases, there are few options remaining to patients when resistance presents due to the acquired resistance mutation C797S or to P-loop C-helix compressing mutations (PACC, a subset of non-classical mutations) that are insensitive to osimertinib.
BDTX-1535 has been observed to be highly brain-penetrant in preclinical tumor models and in the clinical setting.