Avid Bioservices, Inc.

Avid Bioservices, Inc.

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Biotechnology

Avid Bioservices, Inc. (CDMO) Q1 2015 Earnings Call Transcript

Published at 2014-09-09 16:30:00
Executives
Christopher Keenan – Senior Director, Investor Relations Steven W. King – President and Chief Executive Officer Paul J. Lytle – Chief Financial Officer Joseph S. Shan – Vice President, Clinical and Regulatory Affairs Jeff T. Hutchins – Vice President of Preclinical Research
Analysts
Joseph Pantginis – Roth Capital Partners, LLC Roy Buchanan – Piper Jaffray George B. Zavoico – MLV & Co.
Operator
Good day ladies and gentlemen and welcome to the Peregrine Pharmaceuticals, Incorporated First Quarter Fiscal Year 2015 Financial Results Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, this conference call is being recorded. I would now like to turn the call over to Christopher Keenan of Peregrine's Investor Relations group. Mr. Keenan, you may begin.
Christopher Keenan
Thank you, Nicholas. Good afternoon and thank you for joining us. On today’s call, we’ve Steve King, our President and Chief Executive Officer; Paul Lytle, our Chief Financial Officer; Joe Shan, our Vice President of Clinical and Regulatory Affairs and Jeff Hutchins, our Vice President of Preclinical Research. Steve will begin by providing a brief overview of the Company's progress over the last quarter, including advances in our SUNRISE Phase III trial, the achievements coming from our preclinical immuno-oncology development program and the Investigator-Sponsored Trials or ISTs and the Company’s strategy for the remainder of the fiscal year 2015. Jeff will then detail preview the advances rising from our IO program with Joe then reviewing specific progress made in the SUNRISE trial. Paul will then finish with a summary of our financial results for the first quarter of fiscal year 2015, as well as provide an update on our wholly-owned subsidiary, Avid Bioservices. After our prepared remarks, we welcome your questions. Before we begin, we would like to remind you that during the call, we will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ. These forward-looking statements reflect our current views about future events and financial performance, and are identified by the use of terms and phrases such as believe, expect, plan, anticipate, on target, and similar expressions identifying forward-looking statements. These risks include, but are not limited to, the risk factors detailed from time-to-time in our filings with the Securities and Exchange Commission, including, but not limited to the Quarterly Report on Form 10-Q for the first quarter fiscal year 2015 ended July 31, 2014, which was filed today. Investors should not rely on forward-looking statements because they are subject to a variety of risks, uncertainties and other factors that could cause actual results to differ materially from our expectations. And we expressly do not undertake any duties to update forward-looking statements, whether as a result of new information, future events or otherwise. With that, I'll turn the call over to Steve. Steven W. King: Thanks, Chris, and thanks to all of you for participating in this afternoon’s call. We are continuing to execute and deliver based on the plans we laid out on our last quarterly call. We continued the expected global expansion of the bavituximab SUNRISE Phase III trial that now has over 130 worldwide clinical sites, nearing the total number of sites we expected to have involved in the study in order to keep us on track to meet our enrollment goals. In addition, we saw the completion of enrollment in an important licer cancer study combining bavituximab with sorafenib. And we expect to have data from this study as well as data from a front-line non-small cell lung cancer study over the coming months. Joe will update you on clinical development during his prepared remarks. In addition of the clinical trails many of which have also have translational data points built into tie together pre-clinical data with the clinic. We have also continued to build momentum in our pre-clinical collaborations which now number in the dozens. We are evaluating new combinations and dosing strategies combining bavituximab with chemotherapy, radiation and immune-oncology approaches including those targeting CTLA-4, PD-1 as well as other downstream immune checkpoints. In addition we are evaluating combinations with other immune based approaches including vaccines and adjuvants. It is important to have a robust collaboration program so that we can identify those combinations and approaches that truly standout and thus support advancing to the clinic. Data from these studies will also play a critical role in our ongoing discussions with potential corporate partners. We have already started to see the fruits of these collaborations with very encouraging results in preclinical models of melanoma, Colon Cancer and most recently breast cancer when combining bavituximab with other immune check point inhibitors. Perhaps the most exciting thing about this data when taken as a whole is that the data are remarkably consistent with respect to increases in mature T-cells, and in particular CD8 both positive signals of immune activation. In the studies like these that answer key questions and allow us to formulate the most ideal clinical pathway forward, we expect to be able to share this data and more over the coming months at key scientific and medical conferences. Jeff will update you on the collaboration front during his prepared remarks. This is an exciting time in the battle against cancer with new approvals for immuno-oncology agents such as Ono and Merck’s anti-PD-1 antibodies which recently received regulatory approval. This opens the door for new clinical development avenues for novel bavituximab combinations that are already supported by preclinical data we have generated in a number of solid tumor animal models. We are in a unique position with a late stage clinical program for an antibody with a unique immunotherapy mechanism of action that appears to be an ideal fit for combination with approved immunotherapy treatments such as the anti-PD-1 antibodies. Truly an exciting time for cancer treatment options and for the bavituximab program. In addition of the development efforts we also continue to see a solid performance from our wholly-owned manufacturing subsidiary Avid Bioservices that coming off a record year has already begun 2015 strongly with 5.5 million in third-party contract revenue for the quarter and the expansion of our client base. Paul Lytle will update you on the Avid developments as well as the rest of the financial highlights during his discussion. In summary, we have continued to make significant progress across all aspects of the company. That has us positioned for data presentations, continued revenue performance and getting closer to the data from the pivotal SUNRISE trial as well as the ongoing expansion immuno-oncology development program. With that I will now turn the call over to Jeff, to discuss pre-clinical development efforts. Jeff. Jeff T. Hutchins: Thanks, Steve. The purpose of our broad, highly collaborative pre-clinical approach is to guide the direction of future clinical trials in this rapidly evolving IO space. Our goal is to identify the most robust immune-oncology combinations that unlock the full capacity of anti-tumor response without systemic immune related side effects. The breadth of this approach speaks to the wisdom of working directly with highly recognized individual experts in the space. We are now seeing and presenting the fruits of these efforts and yielding encouraging statistically significant results to date. And most importantly building the pre-clinical rational to help guide our future clinical trial designs. To that end, we’ve shown this progress of our immuno-oncology program, with data recently presented at ImVacS The Annual Immuno Therapies and Vaccine Summit highlighting the combination of a PS-Targeting antibody equivalent to bavituximab and an anti-PD-1 antibody in an immune competent animal model of breast cancer. Results shows statically significant tumor suppression, while also demonstrating a significant increase in tumor fighting CD8 T-cells that are into the tumor like environment, compared to an anti PD-1 antibody alone. Additional data from this study as well as a follow-up data from our melanoma study will be presented at the 29th Annual Meeting for the Society of Immuno Therapy and Cancer SITC to be held in November. As Steve mentioned these data align with what we have seen in models of colon and melanoma. And as such warrant expanded investigation with further immune checkpoint inhibitors, agonist, adjuvants and therapeutic vaccines. With that I’ll turn the call over to Joe to update you on our clinical programs. Joseph S. Shan: Thanks, Jeff. Let me start by giving a quick update on our Phase III lung cancer trial SUNRISE. With nearly 140 clinical sites now opened for enrollment planned site activation is nearing completion and we remain on track to complete enrollment of approximately 600 patients by the end of calendar year 2015, with two planned interim analyses that are event driven. As I mentioned during our call, just a couple of months ago, in conjunction with site activation and enrollment activities, we are implementing an ongoing site engagement and educational initiative for investigators and thought leaders in conjunction with scientific and medical conferences, including the upcoming European Society for Medical Oncology or the ESMO Congress later this month. And turning some of our other pipeline indications starting with liver cancer. Today we announced the completion in enrollment of 38 patients in the Phase II part of a Phase I/II IST evaluating bavituximab in combination with sorafenib in patients with advanced hepatocellular carcinoma. We are continued to be encouraged by the updates from the principal investor Dr. Adam Yopp of the University of Texas Southwestern Medical Center, in Dallas and we look forward to his presentation of the full clinical results at a future conference. Meanwhile, as part this tril we have been able to generate translational data showing immune changes in patient tumor samples which are consistent with the immuno modulating mechanism observed in preclinical models. These data will be presented at the 29th Annual Meeting of the Society for the Immunotherapy of Cancer at the beginning of November. Today we also announced that data from the Phase Ib investigator-Sponsored Trial evaluating bavituximab in combination with carboplatin and pemetrexed in 25 patients with previously untreated stage IV non-small cell lung cancer has been accepted for presentation as at the 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology to at the end of October. And lastly, as you have just heard from Jeff, we continued to generate preclinical data to inform clinical development about bavituximab in breast cancer. We are also looking forward to the manuscript publication of the final result of the Phase I trial which combine bavituximab and paclitaxel in the near future. Recall preliminary results demonstrated an encouraging 85% tumor response rate in patient with HER2-negative metastatic breast cancer. So as you can see several ISTs are expected to readout over the next few months and these clinical results together with our expanding preclinical I-O pipeline support not only extending the potential combination uses of bavituximab in the clinic, but also advancing clinical development in breast cancer and liver cancers as resources permit. And with that I’ll turn the call over to Paul. Paul J. Lytle: Thank you Joe. Now turning to our financials, it’s important to note that we continue to closely manage our operations inline with our cap position while balancing our various sources of capital. One important source of capital is derived from our contract manufacturing business where we generated $5.5 million in revenue this quarter and we anticipate that contract manufacturing revenue will be between $19 million and $23 million for the full fiscal year as mentioned on the previous call. In addition, we supplemented our cap position this quarter with $9.5 million in net proceeds received from the sale of Series E Preferred Stock sold at $25 per share. This funding vehicle represents less-dilutive capital to the company since its convertible into common shares at a conversion price of $3 per share. With these additional sources of capital and taking into consideration our statement of operations we ended the quarter with over $73 million in cash. And based on our current projections this represents sufficient capital to execute on our business plans for at least the next 12-months. Now turning to our statement of operations, we saw an expected increase in our net loss this quarter as we continue to execute on our number one R&D goal advancing the Phase III SUNRISE trial. As we invested in the Phase III trial R&D spend increased to approximately $10 million this quarter thereby increasing our net loss to approximately $13 million. As a result, we saw a similar increase in our cash burn from operations to $11 million this quarter representing our net loss minus non-cash expenses. Our financial goals are centered on maintaining a solid cash position and investing these proceeds into our novel, immuno-oncology program led by bavituximab and the Phase III SUNRISE trial. We will continue to closely manage our operations in line with our cash position while balancing the various sources of capital. To look forward to keeping you updated on our progress and we will now open the call up for your questions. Nicolas
Operator
(Operator Instructions) And our first question comes from the line of Joe Pantginis with ROTH Capital Partner. Your line is now open. Please proceed with your question. Joseph Pantginis – Roth Capital Partners, LLC: Hey guys good afternoon and thanks for taking the question. A couple questions if you don’t mind some logistics here, I guess with regard to the site openings that’s great progress about 130 sites you said an enrollment trends that’s you’ve seeing how well have they been tracking with your projections before the study started. Steven W. King: Yes, I think we haven’t given a lot of additional details other than you know the fact that again that trial is also getting up to close to full steam as far as number of sites involved in the study and it most critical with of course once you get all the sites up running and that’s when you reach the maximum enrollment rates. So at this point, I mean we are simply saying that we are on track for the initial estimate of less than two-year enrollment and if we start to deviate significantly one way or another from that, we’ll let everyone know but at this point we feel comfortable that we are on track. Joseph Pantginis – Roth Capital Partners, LLC: Okay that’s fair and then with regard to I know Joe mentioned maybe at SITC we would be seeing some translational data from the liver cancer studies, so I was just wondering if there is any potential teaser there and then the next layer for that question is with regard to your business development – ongoing business development activities, have you seen any change in the tenor of those discussions with the recent approval of Keytruda. Steven W. King: Sure, I can get things started and then maybe turn it over to Jeff and Joe for a little bit more color as far as the translational work goes, but, yes I mean I think there has been an awful lot of interest spurred by the recent regulatory success of the Anti-PD-1 antibodies and moving those into the marketplace, I think that clearly opens up some very nice opportunities down the road for new clinical trials that can be run , but also in ways to best use bavituximab, because again we really feel like we are in a unique position with the late-stage immuno-oncology agent that should – really looks like it should be a perfect fit with these agents that are now coming on to the market from a combination standpoint. So I think that’s definitely heated up the discussions, as well as all the translational data and other study related data from the preclinical models that we've been running. As far as the you know kind of a teaser, I think we've said right from the beginning that one of the things we've been looking for out of the number of the Investigator-Sponsored Trials are really the correlative data that goes along with the animal studies we've completed showing the – basically the symptom you know the symptomatic changes in the profile of the immune cells that are present in the tumor microenvironment and more broadly in the animals themselves, so that’s kind of data in general that of course we’re looking to present. I’ll let Jeff or Joe add a little bit to that. Jeff T. Hutchins: : Joseph S. Shan: Yes, I think the totality of the immune changes of course the CD8 changes are interesting but you know we basically are recapitulating all of the pre-clinical steps within the immune system changes within the tumor. So it’s more than just CD4, CD8 Treg for example; there is a lot of information on it we’ll be sharing. Steven W. King: Then eventually they expand on that obviously the ability to then correlate this with patient outcomes and this is all very important data from a partnering standpoint also and this is exactly the kind of data that is driving a lot of interest we are seeing now from both partnering standpoint as well as of course from collaborative standpoint. In particular with data like liver cancer as you stated before our goal is actually with partnering liver cancers is a huge indication throughout the Asia-Pacific region so that’s clearly very attractive next potential target outside of non small cell lung cancer for some of those territories. Joseph Pantginis – Roth Capital Partners, LLC: Okay thanks a lot of guys. That was helpful. Steven W. King: Thanks Joe.
Operator
Thank your. Our next question comes from the line of Charles Duncan with Piper Jaffray. Your line is now open. Please proceed with your question. Roy Buchanan – Piper Jaffray: Hi, guys this is Roy in for Charles. Thanks for taking my question. Just quick one I think I wonder if you going to bit more detail about the combo programs with vaccines and adjuvants specifics around which vaccines and adjuvants maybe what we might see over the next 12-months. Steven W. King: Jeff address it. Jeff T. Hutchins: Sure, well we can go back quite a ways to published data where actually radiotherapy works quite well as an adjuvant and a vaccine if you will. So what we are trying to do is go back and really revisit some of those early observations now that we understand how well bavituximab does as to re-polorize those myeloid cells that are so important in vaccine presentation and so forth. So you really could go through and re-evaluate some of the recent failures in clinical vaccines and really ask the question now if you re-polarize and change the local micro environment around the tumor will these vaccine now be much more effective. So that really summaries our excitement around this area. Roy Buchanan – Piper Jaffray: Okay is there any specific I guess platform or technology that you are looking at service dendritic cell or… Jeff T. Hutchins: Well as Steve mentioned, we have a number of collaborations that really cover all these areas and its not really - it’s really a focus in a sense to make sure we are hitting the right combination to put really if you will put the immune system back together to respond appropriately to the tumor. Steven W. King: Yes, and our goal is to look at all the different areas so we just haven’t been out public with what the collaborations are, but goal is to touch on the dendritic cell vaccines as well as antigen based vaccines where we see some promising results and things we can build on from again this growing body of evidence of the immune system changes we are seeing with the changes in the tumor associated macrophages as well as some of the other immune components. Roy Buchanan – Piper Jaffray: Okay that make sense and Jeff and you probably can’t answer this because it’s kind of an enrollment question maybe but do you have any expectations on when we might see the first interim for SUNRISE?
Joe Shan
Yes, it is really impossible to predict obviously its event driven so at this point we’re not trying to project that. Roy Buchanan – Piper Jaffray: Okay.
Joe Shan
We will focus on enrolling the patients and you know. Steven W. King: Yes. Jeff T. Hutchins: Collect when… Steven W. King: It’s obviously event-driven, so there are other variables besides just the enrollment patterns themselves, and just how the patients are doing, and what have you. Roy Buchanan – Piper Jaffray: Okay, thank you.
Operator
Thank you. (Operator Instruction) Our next question comes from the line of George Zavoico with MLV & Co. your line is now open, please receive with your question. George B. Zavoico – MLV & Co.: Hi everyone. Good afternoon and thanks for taking my questions. A brief on first regarding the breast cancer data the last time this data was presented, there were four patients still on therapy. And you said in your press release that the results might be revealed in the publication. Do you anticipate that happening before an update at a medical conference which is sort of the usual sequence of events?
Joe Shan
Not necessarily, the investigator has prepared a manuscript which we expect that to be submitted for publication shortly. So it’s going to contain obviously the results previously, but in a more fuller description and then we will have some updates on the clinical endpoint like progression-free survival for example. George B. Zavoico – MLV & Co.: Okay. So there will be new date obviously then. Steven W. King: Yes. George B. Zavoico – MLV & Co.: With regard to patents, this whole – bavituximab is an immune checkpoint inhibitor, sort of a new look to the antibody; it wasn’t how it was originally conceived. Does that present an opportunity for you to file the new patents for method of use in combination with immune checkpoint inhibitors or how does that effect or improve your patent portfolio on bavituximab or PS-Targeting antibodies if at all?
Steve King
Yes, sure I mean I think that obviously as we've gone through the development stages we've filed additional patents that build on the original patents particularly with different combinations as you were saying and new ways to look at how the drug is used and so we think that those certainly help broadened the estate, certainly some of the combinations are covered well beyond the original patent, the original patents that cover things like the antibody and the targeted cell. And so yes, we are always continuing to evaluate new inventions, the impacts of those on the overall portfolio, length of time per coverage and we feel pretty comfortable that at this point we have everything pretty much covered from what we currently have in the clinic and you know again that’s an ongoing process and it never stops and we have number of committees that do nothing, but simply look at those sort of aspects of the development of the drug. George B. Zavoico – MLV & Co.: Okay so we can anticipate perhaps some extensions in the patent life here then for certain combinations it sounds like. With regard to the budget Paul, you outlined – when do you expect – how long you expect the cash to last, what exactly is included in the budget, because the – what you’re implying with all the results that are coming out in breast and liver, it seems that it would be behoove you to try and get into additional trials in other indications as quickly as possible. And with liver results coming out the breast results coming out, it’s quite possible that the next trial could start next year. If we find the right partners or if we just decided to go on your own. If there any of those new indications included in your budget?
Paul Lyte
Right now George, that’s a very good question, our goal right now is really executing on the Phase III trial, the SUNRISE trail obviously that’s currently in our budget. When we talk about having sufficient cash resources to fund our operation for at least the next 12-months that’s the conservative estimate that so we really mean at least the next 12-months when we project up 12-months or so in terms of providing that type of forecast. So this is a conservative type estimate when we put out our projections. So in terms of new indications you hit the target we do want to start some new collaborations that could come through other funding opportunities that could come through partnering opportunities and other avenues. So we are definitely going to pursue that we are as excited as you to initiate some of these new studies and we just want to make sure first and foremost we can execute on the Phase III trial first and then as new opportunities come to fruition when we can expand our R&D pipeline to include some other things
Steven King
Just to extend on that, the one of the points Paul made on partnering is very important because really at this point bringing on board a partner may help us to complete executing the clinical trial, like bringing in capital, but from an operations standpoint, the trial is already underway and basically is on track. So, when we think about partnering we’re really looking at expanding into some of these new indications, and clearly Breast Cancer & Liver Cancer are right now are at the top of the list, based on the totality of the preclinical & clinical data we've generated to-date. We view that as a great way to move the program forward to expand it, and really then also be able to cover commercialization in various territories. George B. Zavoico – MLV & Co.: Okay and final question is kind of philosophical in the sense that the immune checkpoint space has been very exciting lately and you have made an effort to educate everyone about the potential bavituximab in that space and yet if you look at your market capitalization since about April it really hasn’t moved very much and apart from the spike in March, it really hasn’t moved much since January, so what do you attribute, if you wish to comment on it the sort of plateau performance and what can you do, what do you think you can do to help change that perception. Steven W. King: We are approaching this on a number of different fronts. First is getting out and really kind of telling the story to as many funds and institutions within the investment space. I think also the kind of collaborations that we've entered into and the presentation of clinical data at these key medical & scientific conferences is also critical, because up to the last few years we typically may not have been present that most of the major immunotherapy-type conferences, whereas now, clearly, we are constant figures at these conferences and presenting data. I think maybe even most importantly is that our data is very consistent with what people are showing with other test systems. So, it really is resonating with people in a way it hasn’t in the past. But, it’s a ground effort – it’s publications, presentations. And then, of course, clinical data will eventually trump all that, and that’s the reason that executing on the Phase III SUNRISE trial is so important as a backbone to getting the recognition for this program. It’s just going to be continuing to execute, be on the road. I think, the more the word gets out there, we think the more we’ll be clearly in the middle of the space. As I said in the prepared remarks, to me we’re in a really unique position because, while there’s a lot of interest in immunotherapy, there’s not many that are in the middle of their pivotal Phase III study like we are. We view that is a real benefit and I think something it will drive a lot of interest because once a drug’s on the market now, of course, it opens up all kind of avenues for combinations and others ways to use the drug. We’re really looking forward to continuing to execute on that and take advantage of sort of that position being more advanced than a lot of the other immune checkpoints at this point. George B. Zavoico – MLV & Co.: All right thanks. Good luck with continuing in that direction. Thank you. Steven W. King: Yes, thanks George. Paul J. Lytle: Thanks George.
Operator
Thank you. And with no further questions in the queue, I’d like to turn the call back over to Mr. Steve King, CEO for any closing remarks. Steven W. King: I’d like to thank you all again for participating in today’s call. We have begun the fiscal year well positioned with clinical data expected in the near-term from multiple trials as well as pre-clinical data from our immune-oncology program. As we said, earlier we believe that we are in a unique position and feel this is an important time for the company and its programs as we work to understand the full potential of this novel immunotherapy. So again, thank you and we look forward to updating you with this progress throughout the quarter.
Operator
Ladies and gentlemen thank you for participating today’s conference. This does conclude the program. And you may all disconnect. Have a good day everyone.