Lead headline was that they plan to use the proceeds of the recent financing mainly to fund P2 trials for 427 in first-line metastatic lung and pancreatic cancer. According to slides 20 and 24 of the presentation (posted on the OGXI website) these trials will each enroll around 120 patients and will begin in 2013 with data due in late 2015 or 2016. That means, according to slide 25, that the $53.8mm they raised in the financing will extend their cash runway by only about a year from their pre-financing estimate, i.e., their cash will now last into 2015 instead of into 2014. If you add the $53.8mm from the financing to the $64.9mm they had on hand as of 12/31/11 you get $118.7mm, which after you net out the $18.3 they still have to contribute to the P3 trials for 011 under their deal with Teva leaves them with about $100mm to develop 427. I'd have thought that might last longer than into 2015 but I guess running 5 randomized trials (2 in prostate, which are partly or fully grant-funded, 1 in bladder, 1 in lung, and 1 in pancreatic) is expensive.
Oh well, if SYNERGY succeeds the milestones should give them plenty of cash to complete all the P2 trials for 427 without another fund-raise, although they'd probably still have to partner its development into P3. If SYNERGY flops, we're probably looking at another financing in 2014.
Starting additional P2 trials for 427 isn't going to do anything for the pps in the near term but if they have reason to believe, as they claim, that it may be effective in lung and pancreatic I guess they had to get the ball rolling.
Well, he didn't rule it out completely. He said he wasn't sure the data would be meaningful given the small number of patients enrolled, and in any event they'd have to discuss it with Teva which they haven't done.
A couple of other points from the CC:
He reiterated that they expect to complete enrollment in SYNERGY, and to initiate the AFFINITY and lung trials for 011 and the Zytiga trial for 427, later this year.
On the AFFINITY trial, even though it will pair 011 with Cabazitaxel in second-line patients who previously received docetaxel, if successful they hope to get a label that would allow them to use 011 with Cabazitaxel in both first and second line patients. They said that of course they can't be sure the FDA would agree to that.
When asked about partnering 427, Scott said that with the recent financing there's no current need since they can continue to develop 427 in P2 trials for new indications. (He added that they're always having conversations with potential partners though.) If the P3 trials for 011 are successful, that might generate enough cash for them to take 427 through P3 without a partner, although they would certainly consider partnering if the terms were attractive.
I've listed to the Needham presentation a couple of times now. To me it seems clear that the primary purpose of the financing was to support the two new 427 trials on slide 20:
NSCLC 120 patient P2 in chemo naive metastatic NSCLC with platinum and Pemetrexed +/- 427, and
Pancreas, 120 patient P2 with chemo naive metastatic pancreas with Abraxane +/- 427. The assumption is Abraxane trials will be positive so will use this agent but also can use Gemcitabine instead if need be.
In bringing up these proposed trials he says "it's really for that reason we wanted to do the financing now."
SYNERGY's outcome is looming as more important than ever. If it succeeds, it makes success in all the other trials appear more likely. The market would have to take note of the fact that OGXI would have a robust pipeline, with ongoing P3 trials for 011 in second line prostate and lung (assuming they go forward) and P2 trials for 427 in prostate (probably pre-chemo), bladder, lung, and pancreatic. And they'd have the resources to move it all forward, with Teva funding the remaining cost of the 011 trials and those milestones of up to $370mm plus royalties probably ensuring that OGXI wouldn't have to dilute any further (though it might have to partner 427). But if SYNERGY fails, the other trials lose a lot of credibility and OGXI will have to raise funds to keep the doors open and continue to develop 427 beyond 2015. It wouldn't spell the end of OGXI and the other trials could still succeed, but it would be very unpleasant.
I feel pretty sure they're going forward with the second-line prostate trial in 2H of this year. They've never minced words about it and have been clear as to the design: 011 +/- Cabazitaxel and prednisone. And it makes sense that if SYNERGY were to succeed Teva would want proof that 011 works with Cabazitaxel as well as docetaxel, given that Cabazitaxel is gaining market share. I'm a little less confident about the lung trial, given all the false starts and the fact that they still haven't settled on a design. But in the end I think it will happen.
You'd probably know better than I whether this sort of thing is done, but I don't see them releasing data from the SATURN trial. They've given the impression that they enrolled only a fraction of the planned 300 patients before giving up, so the data would hard to interpret. Not that Teva and OGXI won't make every effort to do so, but I think they'll do it privately.