Onconova Reported FY2021 and Updated Its Clinical Trials In Progress. Onconova reported a loss of $16.2 million or $(0.96) per share for FY2021. Importantly, the company reiterated its development schedule for the announcement of clinical data and the start of new clinical trials. Cash on hand on December 31, 2021 was $55.1 million or $2.64 per share.Narazaciclib Continues Patient Treatment In Its Dose Escalation Trials. Narazaciclib is currently in two trials testing increasing doses and different administration schedules. The US trial is enrolling patients in its fourth cohort dosed at 160 mg once daily. The China trial is testing its fifth cohort at 200mg in cycles of daily dosing for three weeks followed by one week off. Data from these trials will be used to evaluate the dose and schedule to design Phase 2.Rigosertib Continues To Progress In Several Trials. Rigosertib is currently enrolling patients in a Phase 1/2 dose escalation trial in combination with nivolumab (Opdivo) in non-small cell lung cancer with KRAS mutations. This combination is based on rigosertib's activity as an immune modulator that recruits T cells into the tumor microenvironment, and could potentially improve the response rate and outcomes for checkpoint inhibitors therapy.Rigosertib Data From Phase 2 Provides Encouraging Proof Of Concept Data. In December 2021, Onconova announced data from a Phase 2 trial in advanced squamous cell carcinoma secondary to a RDEB (recessive dystrophic epidermolysis bullosa) in which showed a durable complete response without signs of metastatic disease. While this was a single patient with a rare disease, we believe its strong effect supports the mechanism of action and further trialsConclusion: Onconova continues to advance narazaciclib through the dose escalation trials. Data from its two trials will be used to select a dose and administration schedule for Phase 2 that will position it against the current drugs in the class. With several clinical trial data milestones and new trials expected over the next months, we are reiterating our Outperform rating and $11 price target. Read More >>