Avid Bioservices Inc (CDMO)

[cjgaddy]

Excerpts+Slides from CEO S.King’s 3-5-13 COWEN Talk (Boston)

Mar4-6 2013: “Cowen’s 33rd Annual Health Care Conf.”, Boston
http://www.cowen.com/conferences/upcoming-conferences

CEO Steven King’s 24 min. Presentation – Cowen/Boston
3-5-2013 WEBCAST Replay: http://ir.peregrineinc.com/events.cfm
Direct: http://wsw.com/webcast/cowen10/pphm

Selected Slides & Excerpts from CEO Steven King’s 3-5-13 Presentation at COWEN/Boston:







SK/06: “…we have significant clinical experience with bavituximab, with 17 clinical studies enrolled, over 450 pts. treated. Throughout that clinical experience, the drug appears safe & well-tolerated, alone and in combination with other therapies. We’ve established a good safety database, in which we can drive further clinical development…”






SK/09-11 [2nd-Line NSCLC Ph2B Trial]: “…we had what appeared to be very promising results in ORR’s, PFS, and OS, and in fact we presented that OS data in Sept2012. And then something unexpected happened later in Sept. when we discovered that during the process of running the trial there had been discrepancies in preparation of bio-coding. This started a major look at the clinical trial. We took a step back and really evaluated the entire trial from top to bottom. Very comprehensive data collection, testing the investigational product; we recalled products from the field – over 90% of the vials were retrieved, literally 1000’s of vials were tested. We tested addl. patient samples for the presence of bavituximab, and we did a full review of the immunogenicity testing results. As a result of this investigation, we determined that there was no evidence of any impact in the 3mg arm, so in fact those pts. appeared to have received 3mg dosing throughout the trial. However, we did see clear evidence of dose-switching between the placebo & 1mg arms of the study. So, at that point, and we announced this in January, we really felt the best way forward was then to combine the active 1mg Bavi arm with the placebo arm, and treat that as the control arm. It was really the only way to adequately analyze the data. We recognized that we were putting ourselves at a disadvantage from a results standpoint, by putting active drug in the control arm, however given the fact that we would never be able to tell at what points these pts in the 2 arms had received the other treatment, this is the best way forward. So, in February we announced the results of this data analysis, and we think what we have is still, even though we’ve taken a hit from a statistical as well as from a trial standpoint, we still have what we think are very compelling results for moving this program into Phase III clinical development. The combined control arm has a MOS of about 7.3 mos. vs. 11.7 mos. in the 3mg group. Those results have a HR of .73 and a P-value of .217 – very good numbers actually for a small Phase II study, and we think really gives us a great basis in which to design a Phase III trial. In addition, we built onto our Safety database, reporting a good safety profile in combination with Docetaxel. The next steps for us are an EOP2 meeting, which is planned for Q2-2013. At that time, we’ll lay out the results of this study and our plans for Phase III. We’re currently looking at about a 600-pt. Phase III study, with an interim data look, in which we’ll be a able to take an initial probably blinded look at the data as we go into the Phase III and then be able to complete it depending on the results of that initial review. Our goal remains to initial a Phase III by yr-end. While we’re undergoing these prep’s for the EOP2 meeting and for Phase III, we’re also simultaneously continuing our partnering discussions – our goal on the partnering front is to continue to pursue partnerships that we can bring on board sort of in conjunction with the beginning of this Phase III trial by yr-end. As we get further into the year, we’ll certainly be evaluating the best options for starting the Phase III and we’ll execute those at that time…”












SK/15 [IST’s]: “…We expect addl. data points coming this year from the other (IST) studies that have been ongoing. In particular, we’re interested in the results from the Liver Cancer study in combo with Sorafenib. Here again, we’ve had a good safety profile. This can be a very important combination & indication as we move forward with partnering discussions – Liver Cancer, a major indication throughout the Asian-Pacific region…”








SK/19 [Cotara]: “…our current strategy here is to secure a commercial partner, or partners], in order to move this forward. Cotara is an Orphan Drug indication, so what we’re looking for are partners with experience in Orphan Drugs, and particularly in marketing & sales of those drugs, that can be participants in a major Phase III study. Our goal is to bring the partnering discussions and the clinical trial preparations to fruition probably by the beginning part of 2014 and be in a position to initiate that study and to execute it over a couple of year time-period.”


SK/21 [Avid]: “On the corporate side, we have a successful bio-manufacturing business, Avid Bioservices, which has actually seen some pretty steady growth over the past few years. In fact, we’re projecting about $18+mm in 3rd-party revenue for this FY which ends 4-30-2013. In addition, as of Oct. 31st 2012, we had about a $30mm revenue in backlog, so that is future business that’s already been booked into the facility. In addition to generating revenues and really turning this into a profitable business, Avid is also very important to us as a drug development company – we manufacture all of our own products and it enables us to be Phase III- and eventually Commercial-ready for both Bavituximab & Cotara. Those are expensive undertakings, especially during Phase III & preparing for commercialization, and this will allow us to do that in a very cost-effective manner.”


SK/22 [Financials]: “So, take a look at our financial highlights, and these are a little bit stale – we actually have our Earnings Call next Tuesday (Mar. 12 2013)…”




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