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OncoNova (ONTX) will present overall results from the Phase 2 trial of oral rigosertib in transfusion-dependent, lower risk MDS at the American Society of Hematology, or ASH, Annual Meeting in December 2013.
Onconova stock has reached a near term bottom and will start to make a move back upwards. Tomorrow abstracts are released for the 2013 ASH meeting and we believe this will act as a strong reversal point for the sentiment in the stock.
I believe the Onco sell-off has been caused by a misunderstanding of a supplemental P3B trial initiated by Baxter. When a trial shows a good signal, a supplemental trial will almost always have LESS patients enrolled. In this case, 90 patients are enrolled in the supplemental, while 270 in the main P3, The lesser numbers of patients tells us that the signal is likely to be good.
A W pattern has formed as of yesterday, signaling a possible bottom reversal and a move back to $18.
Onconova has three near-term catalysts that should regain interest for investors:
1. Onconova expects to present Phase II data for Rigosertib Oral in lower risk MDS in December 2013. The company states:
“We reported initial response and safety data from the first Phase 2 trial in June 2013 and expect to complete enrollment and present overall results from this trial in December 2013. Upon completion of the first Phase 2 trial, we will meet with the FDA to discuss an approval pathway for rigosertib Oral as a first-line treatment in lower risk MDS patients. We expect to complete enrollment in the second Phase 2 trial in lower risk, transfusion-dependent MDS patients who have failed erythroid stimulating agents in the second half of 2014.”
2. Onconova expects to present Phase III data for Rigosertib IV in higher risk MDS in the fourth quarter of 2013 or the first quarter of 2014. The company states:
“We completed enrollment of 270 patients in this trial in May 2013 and expect to report top-line overall survival results in the fourth quarter of 2013 or the first quarter of 2014. Of the 30 evaluable MDS patients in four early-stage Phase 1/2 trials of rigosertib IV involving 39 refractory MDS patients, we observed objective responses in 12 patients, five of which were complete bone marrow responses. To our knowledge, there are no other current Phase 3 trials in this patient population. If we achieve positive results in this trial, we intend to submit a New Drug Application, or NDA, to the FDA in the second half of 2014, and a Marketing Authorization Application, or MAA, to the European Medicines Agency, or the EMA, by the fourth quarter of 2014 or the first quarter of 2015 for marketing approval of rigosertib IV.”
3. Onconova expects to present Phase III data for Rigosertib IV in pancreatic cancer in the fourth quarter of 2013 or the first quarter of 2014. The company states:
“We are conducting a multi-center Phase 3 trial of rigosertib IV in combination with gemcitabine, a widely used chemotherapy drug, for the first-line treatment of metastatic pancreatic cancer patients. In March 2013, we completed enrollment of 150 patients in this trial and we expect results of the pre-planned interim analysis for overall survival in the fourth quarter of 2013 or the first quarter of 2014. The American Cancer Society estimates that 45,200 new cases of pancreatic cancer will be diagnosed in the United States in 2013.”
With several huge catalysts in the very near term, Onconova is under speculation valued at today’s market cap of about $440M. Investors have yet to investigate the value of these results should they be positive. In our opinion, Onconova could trade near a $900M market cap before data is released. This would equate to a stock price of about $45 per share.
