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Replies to post #227421 on Avid Bioservices Inc (CDMO)
07/25/15 11:48 AM
Joe Shan....Finally, two investigator-sponsored trials continued to enroll patients, evaluating bavituximab combination treatment regimen in patients with advanced melanoma or rectal adenocarcinoma. While it’s important to note that these studies are being conducted independently under investigator-held INDs and thus we do not have control over the timing of the data, with that said data from the rectal adenocarcinoma trial will be presented at the American Society for Radiation Oncology’s Annual Meeting in October. I look forward to providing you an update on our future clinical advancements.
George Zavoico - JonesTrading
Well, which brings me to my final question, the significant spend of your upcoming Phase 2 and Phase 2/3 and continuing SUNRISE trial. Part of it seems to be offset by the Avid revenue. But how – and Paul you mentioned how you are managing the capital resource – various sources of capital, how – do you want to talk about the burn rate, expected burn rate, do you want to talk a little bit about how you might consider partnering any of these programs in the near future to help offset some of those costs?
Paul Lytle - Chief Financial Officer
I mean, we are very common with other biotech companies and that we operate in a fairly capital-intensive industry. That being said, we are actually a very unique company in that we actually generate revenues. And as I mentioned earlier, we are increasing our revenue guidance this year to $30 million to $35 million with the $40 million backlog. We have our bavituximab program, which is a I/O compound in Phase 3 development that we own the 100% of the rights to. That brings tremendous partnering opportunities to the table. And that’s one of our goals here internally is to partner ex-U.S. and to drive the value here in the U.S. for ourselves. So, I think we are going to be looking at lot of those things to kind of balance our financial resources and these are just a couple of sources that we have available to us that not all companies have.
Steve King - President and Chief Executive Officer
Yes, I think George in addition to that, I mean, I think if you look at it from a timing standpoint, as we are kind of completing enrollment in the SUNRISE trial and so that kind of moves more and more towards completion of that study will actually be ramping up these other studies and that’s important for a couple of reasons, but also from an expenditure standpoint that as we expect to see the cost associated with SUNRISE go down, we will see the cost of these other trials go up sort of replace it, but to add that potential value as a go forward.
Paul Lytle - Chief Financial Officer
And that’s a good point, Steve, that we actually strategically aligned kind of the completion of enrollment with the current SUNRISE trial with the initiation of these other Phase 2 trials, so...
George Zavoico - JonesTrading
And then I suppose the additional trials also act as leverage in any partnering discussions you might be engaged in right now?
Paul Lytle - Chief Financial Officer
Absolutely.
This is how I would respond - we have both the common and preferred available to us and we plan to use whichever vehicle makes most sense at the time, depending on the amount needed, the current share price, the likely investor(s), etc., etc.
YES. Here is Joe Shan....As a reminder, SUNRISE is designed as a Phase 3 registration trial and has two planned interim analyses. The first interim analysis, which will be conducted when 33% of the targeted overall survival events are reached, is for futility and the second interim analysis for futility or predictive success, will be conducted at 50% of events. To protect the integrity of this double-blind trial, an independent data monitoring committee has been established to evaluate safety data on an ongoing basis and make recommendations to Peregrine as to when the trial should be unblinded. As the interim analyses are triggered after pre-specified numbers of trial events are reached, in this case, deaths, we cannot, at this point, guide to when these might be reached, but we will be sure to provide updates as soon as we can.
This is SK....With that, I will outline a number of upcoming milestones. Regarding our SUNRISE Phase 3 second line non-small cell lung cancer study, on track, we are on track for completing patient enrollment by year end 2015. We have planned IDMC interim analysis at 33% and 50% of targeted overall survival events as those are reached, with estimated unblinding of the trials to occur approximately near the calendar year end of 2016.
This is NOT from the CC....Registration is available to anyone who wishes to participate. Please visit the ImVacS site for further details regarding registration. If you are affiliated with a Govt. Agency / Academic Institution / Hospital you may qualify for a discounted rate. Here is the link to the registration page....
https://chidb.com/reg/imt/reg.asp
