ADDED
As of February 19, 2026, 68,364,979 shares of the registrant s common stock, $0.0001 par value per share, were issued and outstanding.
Inadequate funding for the FDA, the SEC and other government agencies could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business may rely, which could negatively impact our business.
Healthcare reform measures could adversely affect our business.
If we are unable to protect our intellectual property effectively, we may be unable to prevent third parties from using our technologies, which would impair our competitive advantage.
Certain rights that we in-license from third-parties are not within our control, and we may be negatively impacted if we lose those rights.
We may be subject to stockholder litigation, thereby diverting our resources, which could materially adversely affect our profitability and results of operations.
We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), metastatic triple negative breast cancer ("mTNBC") and Chronic Myelomonocytic Leukemia ("CMML").
There are several ongoing clinical trials of onvansertib in multiple indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed SCLC, unresectable locally advanced or metastatic TNBC and CMML.
RAS-mutated mCRC Program: CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial to assess the efficacy of two doses of onvansertib (20mg and 30mg) in combination with FOLFIRI and bevacizumab or FOLFOX and bevacizumab, compared with FOLFIRI or FOLFOX and bevacizumab (SOC) alone, for the treatment of confirmed metastatic and unresectable colorectal cancer (mCRC) in patients with a KRAS or NRAS mutation in the first-line setting.
Trial endpoints include objective response rate ("ORR"), progression-free survival ("PFS") and duration of response ("DoR") together with pharmacokinetics, and pharmacodynamics and safety assessments.
REMOVED
As of February 20, 2025 , 66,524,294 shares of the registrant s common stock, $0.0001 par value per share, were issued and outstanding.
Risks Related to Our Business We will need to raise substantial additional capital to develop and commercialize, our product candidate, onvansertib, and our failure to obtain funding when needed may force us to delay, reduce or eliminate our product development programs or collaboration efforts.
We are focusing our clinical program in indications such as RAS-mutated metastatic colorectal cancer ("mCRC"), as well as in investigator-initiated ongoing or planned trials in metastatic pancreatic ductal adenocarcinoma ("mPDAC"), small cell lung cancer ("SCLC"), and triple negative breast cancer ("TNBC").
There are several ongoing and planned clinical trials of onvansertib in multiple indications: one trial (CRDF-004) in first-line treatment in patients with RAS-mutated mCRC, and investigator-initiated trials in first-line mPDAC, relapsed SCLC and unresectable locally advanced or metastatic TNBC.
RAS-mutated mCRC Program: CRDF-004 Randomized Clinical Trial in First-Line RAS-mutated mCRC CRDF-004 is a Phase 2 open-label, randomized multi-center clinical trial of onvansertib in combination with SoC FOLFIRI and bevacizumab or SoC FOLFOX and bevacizumab for the first-line treatment of patients with RAS-mutated mCRC.
The primary objectives of the CRDF-004 trial are to evaluate onvansertib s safety and efficacy in combination with the SoC, as well as to evaluate two doses of onvansertib, 20mg and 30mg, given in combination with SoC, against SoC alone.
The primary endpoint of the trial is objective response rate ("ORR").
Progression-free survival and duration of response will be secondary endpoints.
This trial is conducted in partnership with Pfizer Ignite, an end-to-end service for biotech companies, and it is expected to enroll approximately 90 evaluable patients.
The FDA has agreed that a seamless trial with an interim endpoint of ORR, with duration of response, is acceptable to pursue accelerated approval, with progression-free survival and trend in overall survival being the endpoints for full approval.