Immunomedics' (IMMU) CEO Cynthia Sullivan on Q4 2014 Results - Earnings Call Transcript

| About: Immunomedics, Inc. (IMMU)

Immunomedics, Inc. (NASDAQ:IMMU)

Q4 2014 Results Earnings Conference Call

August 26, 2014, 10:00 AM ET


Peter Pfreundschuh - VP, Finance and CFO

Cynthia Sullivan - President and CEO

David Goldenberg - Chairman, CMO and CSO


Chris Marai - Oppenheimer

Ling Wang - Chardan Capital Markets

Boris Peaker - Cowen and Company

Difei Yang - R F Lafferty & Co.


Good morning, ladies and gentlemen. Thank you for standing by. Welcome to the Immunomedics Inc. Fourth Quarter and Fiscal Year 2014 Financial Results Conference Call. As a reminder, this call is being recorded. Today is Tuesday, August 26th, 2014.

With us on the call this morning are Dr. David M. Goldenberg, Chairman, Chief Scientific Officer and Chief Medical Officer; Cynthia Sullivan, President and CEO; and Peter Pfreundschuh Vice President, Finance and CFO.

I would now like to turn the conference over to Peter Pfreundschuh, Chief Financial Officer of Immunomedics. Please go ahead.

Peter Pfreundschuh

Good morning, and welcome to our earnings call. I will begin with a summary of our current financial condition. Cynthia Sullivan, our President and CEO will follow with her update on our lead investigation antibodies as well as other important developments since our last earnings call. Finally, Dr. Goldenberg will report us on the status for our two solid tumor antibody drug conjugate programs, before we open up the call for questions and answers.

Before we begin, I'd like to remind everyone that during this call, we will be making forward-looking statements, made pursuant to the Private Securities Litigation Reform Act of 1995.

Such statements may involve significant risks and uncertainties and actual results could differ materially from those expressed or implied during this call. For factors that could cause such differences, please refer to our regulatory filings with the Securities and Exchange Commission and most recently, our Annual Report for the year ended fiscal June 30th, 2014.

Now, let me start with the financials. I hope everyone has had a chance to review the financial results that we released yesterday afternoon. The earnings report is available on our company website at

Total revenues for the fourth quarter of fiscal year 2014, which ended on June 30, 2014, were $1.2 million as compared to total revenues of $1.4 million for the same quarter last fiscal year. A decrease of $0.2 million in total revenues this quarter was primarily due to $0.1 million lower research and development revenue from reduced grant activity.

Total costs and expenses for the three months period ended June 30, 2014 were $13.1 million as compared to $9 million for the same period in 2013, representing an increase of $4.1 million or 46%.

This increase was driven primarily by $3.4 million higher research and development expenses, mostly related to the Phase III clinical trials of Clivatuzumab Tetraxetan for the treatment of patients with pancreatic cancer and increased manufacturing cost for materials used for the antibody drug conjugates’ clinical trials. Additionally, there was $0.7 million increase in legal and professional fees.

Net loss attributable to our stockholders this quarter was $11.8 million or $0.13 per basic share, compared to net loss attributable to our stockholders of $7.7 million or $0.09 per basic share for the same quarter in fiscal 2013.

The increase in net loss this quarter was primarily due to higher cost in research and development from increased clinical trial expenses and increased legal and professional fees.

Total revenues for fiscal year 2014 were $9 million as compared to $5 million for fiscal 2013. A $4 million in total revenues in the fiscal year were primarily due to $4.6 million of licensing fee revenue earned during fiscal 2014 from the fulfilment of company’s obligations under the Algeta Service Agreement, as amended.

Total costs and expenses for the fiscal year ended June 30, 2014 were $44.6 million as compared to $35.8 million for the same period in 2013, representing an increase of $8.8 million or 25%.

This increase was primarily driven by $5.3 million higher research and development expenses, mostly related to the initiation of the Clivatuzumab Tetraxetan Phase III clinical trial for the treatment of patients with pancreatic cancer and manufacturing costs for materials used for the antibody drug conjugates’ clinical trials.

And increase in general and administrative expenses of $2.1 million, primarily due to higher legal and professional cost of $2 million and the cost of licensing fees and other revenue of $1.2 million related to the Algeta Service Agreement, also contributed to the higher total costs and expenses in fiscal year 2014.

Net loss attributable to our stockholders for the fiscal year ended June 30, 2014 was $35.4 million or $0.42 per basic share as compared to a net loss of our stockholders of $11.4 million or $0.15 per basic share for fiscal year 2013.

The increase in net loss of $24 million in fiscal 2014 resulted primarily from $16.7 million arbitration settlement and $2.6 million insurance proceeds, both received during the previous year, and $5.3 million of increased research and development spending in fiscal 2014 as previously described.

The company has no long-term debt as of June 30, 2014. Cash and cash equivalents and marketable securities totaled $41.8 million. We continue to make significant strides with our investigational solid cancer therapy programs during fiscal year 2014.

To support further development of our robust mid to late stage clinical pipeline, which includes Clivatuzumab tetraxetan and Phase III clinical trials for the treatment of patients with pancreatic cancer and the two antibody drug conjugate programs, cash requirements for fiscal year 2015 are expected to be approximately $41 million.

This summarizes our financial results for the fourth quarter and the fiscal year ended 2014. At this point, I'm going to turn the call to Cindy.

Cynthia Sullivan

Thank you, Peter, and good morning everyone. Since our last earnings call, our partner UCB has confirmed during their conference call discussing their half year 2014 results that the two Phase III EMBODY trials evaluating Epratuzumab in patients with lupus have been fully enrolled and that topline result will be available in the first half of 2015.

This is an important milestone for Epratuzumab and we look forward to the Phase III data readout for this important indication.

As noted in my last earnings call, we're very encouraged with the results of Epratuzumab that have been produced in UCB's Phase IIb EMBLEM study and the open-label extension arm.

In particular, Epratuzumab has improved the quality of life for some patients by managing this debilitating diseases and lowering their dependence on corticosteroid use. According to UCB's website, the size of the lupus market in France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States combined is estimated to be approximately $420 million based on 2009 data.

Under the terms of our original licensing agreement with UCB and the amendment agreement we entered into in December 2011, we're entitled to receive up to $145 million in cash payments and a $20 million in equity investments in regulatory milestone payments. And up to $260 million related to the achievement of specified product sales milestones. We're also entitled to royalties ranging from the mid-teens to the mid-20 percentage of aggregate annual net sales during the product royalty term.

In addition, UCB has until December 2016 to exercise the warrant approaches to 1 million shares from us for $8 per share. As a reminder, Epratuzumab has fast-track status in the U.S. for treating patients with lupus.

Moving to our antibody drug conjugate or ADC program, during the fourth quarter, IMMU-132 received from the FDA, fast-track status for small cell lung cancer therapy as well as orphan drug designation for treating patients with pancreatic cancer.

Previously, the FDA has also granted orphan drug designation to IMMU-132 for the treatment of small cell lung cancer. Designations for other solid cancer therapies are pending and we will share that information with you as soon as it's becomes available.

Meanwhile, we continue to make significant progress in patient enrollment in specific tumor types in the current Phase II studies which we plan to complete before the end of this calendar year. David will provide you with more details on the current status of our ADCs following my update.

Discussions on the licensing of these assets as well as our unlabeled antibodies and platform technologies are ongoing. We look forward to reporting these events as they occur, but at this time I can not comment further on these activities.

For clivatuzumab tetraxetan for 2014 Annual Meeting of American Society of Clinical Oncology, we reported final results from the randomized phase Ib study in patients pancreatic cancer having two or more prior therapies.

In 29 patients treated in Arm A with a combination of yttrium 90 clivatuzumab tetraxetan and low-dose gemcitabine as a radiosensitizer and overall disease response rate of 41% was reported including two patients or 7% with partial response and one patient -- and 10 patients or 34% with stable disease as test response.

The median overall survival for this group of patients was 3.9-month which was statistically significant improvement over the 2.8-month in the 29 patients in Arm B who received only the radiolabeled antibody.

Patients who received multiple cycles of the combination therapy had the best outcome with the median survival of 7.9-month. This was statistically significant compared to the median survival of 3.4-month in patients receiving multiple cycle of only yttrium 90 labeled clivatuzumab tetraxetan.

Most important of all, I am pleased to report the two patients in the combination Arm are still alive as of the end of July and continued to be followed for survival. They are now 19 and 21 months since the start of their clivatuzumab tetraxetan treatment.

For the Phase III PANCRIT-1 trial, clinical trial site initiations are taking a bit longer than we anticipated due mainly to regulatory processes in different territory. Right now, we have nine clinical sites opened to patient enrollment. We are working with our clinical research organization to ramp up site opening.

We believe once we have all the sites up and running, enrollment will be fairly rapid which is what we experienced in our Phase Ib trial. We now expect the trial will be fully enrolled in the second half of 2015 with top line results expected in the first quarter of 2016.

To complete this Phase III, we will require additional funding. Consequently, we plan to continue pursuing sources of financing including potential payments from partners, licensing arrangements for products and technologies or other financing sources. We also have the ability to reduce our cash flow spending requirement for fiscal year 2015 if necessary after considering certain planned discretionary spending.

Now let me switch to the arbitration proceeding with Takeda and Nycomed concerning the licensing and collaboration agreement for veltuzumab which we executed with Nycomed in 2008.

The hearing portion of this process was concluded last week. Each party's counsel is expected to file post-hearing submissions in October 2014. The decision by the arbitrator is expected within two months of the post-hearing submission.

With regard to the punitive class action lawsuit filed in February -- on February 27, 2014, allege that the company and certain current and former officers and directors failed to disclose and/or made material misstatements in our public filings relating to the termination of the Nycomed agreement on June 24th 2014, the District Court entered an order appointing a lead plaintiff and a lead counsel in this matter.

Relating to the class action lawsuit or two separate shareholder derivative complaints filed against the company. The complaints alleged among other things the company and certain directors and the officers reached fiduciary duties for disseminating faults and misleading information relating to the termination of Nycomed agreement and that braches in fiduciary duty caused the damages to the company and shockholders.

The company has submitted a motion to dismiss one of these two complaints or in the alternative to stay the action pending the outcome of the punitive class action lawsuit. We believe that the allegations in the class action complaints and in the derivative complaints are without merit an intent to defend the lawsuits vigorously.

Company does not believe these matters, even it’s adversely adjudicated or settled, would have a material adverse effect on financial condition, results of operation or cash flows.

So, at this point, I’ll hand the call over to David.

David Goldenberg

Good morning. As Cindy just mentioned the Phase II trials with our antibody-drug conjugates' with the therapy of solid cancer are progressing well. At the 2014 American Society of Clinical Oncology or ASCO annual meeting in June, we reported a total of 56 patients not including the 15 patients with pancreatic cancer has been enrolled into the multicenter trial for IMMU-132 which is now called (inaudible).

Results from 48 patients with at least one computed tomography or CT assessment were presented at the meeting of which 34 patients or 71% has rate of disease control. They included seven patients showing partial responses with tumor shrinkage of 30% or more by resist criteria covering five different cancers types, two with small-cell lung cancer, two with triple negative breast cancer and one each with, colorectal, non-small cell lung esophageal cancers.

We have now renewed 108 patients not counting the 15 patients with pancreatic cancer. This means that from June to now, we enrolled more than 50 patients in less than three months, even after failing multiple prior therapies these patients generally responded well to IMMU-132.

In 91 patients with at least one CT assessment, 39 patients or 43% has stable disease as their best response and 11 patients or 12% reported a partial response for a combined disease control rate of 55%, before new partial responders, including two patients with triple negative breast cancer, one patient each with non-small-cell cancer and urinary bladder cancer.

In total, we have now four partial responders in triple negative breast cancer, two each in small-cell and non-small cell lung cancers and one each in urinary bladder, colorectal, and esophageal cancers.

With the addition of urinary bladder cancer, six different types of solid cancer have responded to IMMU-132 with 30% or more tumor shrinkage, despite having their prior therapy.

We are most encouraged with the results in patients in triple negative breast cancer. In addition to the four partial responders we also observed eight patients with stable disease yielding a disease control rate of 75% in 16 and four progressors amongst CT assessable.

These patients had a median of five prior therapies with cancer that is very aggressive and difficult to treat particularly after failing other therapies. Currently, there are no targeted treatments available to triple negative breast cancer. As the term suggests, triple negative breast cancer define those that are negative for estrogen and progesterone receptors as well as human epidermal growth factor receptor 2 or Her-2.

This type of breast cancer comprises about 15% to 20% of Wnt-1 breast cancers. The disease is more prevent in young an African and American woman. Despite the fact that initial responses with chemotherapy are high, triple negative breast cancer characteristically has a higher recurrence rate and is perhaps the most difficult type of breast cancer to treat successfully with current cytotoxic drugs. The median survival for patients with metastatic triple-negative breast cancer is estimated to be 13 months.

We will also be assessing with our advisors, the prospect of moving IMMU-132 to a registration trial in patients with metastatic triple-negative breast cancer. But we will do this concurrently with our out-listening discussions.

Switching to our results in pancreatic cancer, which are supported by a grant of the National Cancer Institute, the IMMU-132 study enrolled 15 patients with advanced pancreatic cancer who have failed the median of two prior therapies. One patient was not evaluated due to clinical progression.

In the 14 CD assessable patients, nine patients or 64% have stable diseases as their past response. These results are very encouraging since responses are expected to be poorer with each successive treatment, and especially in such a difficult to treat malignancy as pancreatic cancer.

In our trial, however, the duration of stable diseases exceeded those after the last therapy before our agent was given. Patients treated with IMMU-132 reported a median time to progression of 12.7 weeks, which was better than the median 8.0 weeks estimated from our their last prior therapy.

Our plan for IMMU-132 in this indication will include a combination with other drugs in an earlier setting of this disease.

The IMMU-130 clinical trial in metastatic colorectal cancer continues to enroll patients. So far, we have enrolled 58 patients and are looking to expand this Phase II study further to obtain additional information on the optimal dose for indication.

Surprisingly, one of our patients has shown a confirmed 87% tumor shrinkage which may, in fact, be a complete response. But we need to keep measuring the residual tumor over the next months.

This patient has been under our investigational treatment for about one year. I will provide updates on these two studies that the 2014 World ADC Summit in San Diego in October where we'll be speaking on both the pre-clinical and clinical aspects of these promising agents.

I have also been invited to present this work at plenary session of the forthcoming AACR NCI EORTC meeting in Barcelona, Spain in November. I plan to explain why the ADC agents from Immunomedics are different from others in clinical trials.

As noted by Cindy, we plan to complete these two Phase II studies before the ending of this calendar year. At that point, we will decide on the future development of these assets which may include a Phase III trial and triple-negative breast cancer and possibly further trails in other cancer types.

Thank you for your continued support and patience and we will now have questions.

Question-and-Answer Session


(Operator Instructions)

Our first question comes from the line of Chris Marai with Oppenheimer. Your line is open.

Chris Marai - Oppenheimer

Hi, good morning guys. Thanks for taking my question. First, I really wanted to focus on your lupus program with Epratuzumab, I was wondering if you could perhaps comment on the dose response that you had seen in earlier studies, how that might be related to the mechanism of action of the drug? And why you believe that the dose selected here are appropriate for the Phase III trial?

And then secondly, with respect to the Phase III trial, will you be looking at steroid disappearing outcomes? I saw that data really from your Phase II extension study and thought it was very promising. Just wondering if you can elaborate on that a little bit. Thank you.

David Goldenberg

I think we'll split the answer. This is Dave Goldenberg. The first question as to the optimal dose, it was interesting that there was bell-shaped curve or the lower dose and the very high dose was not as active as the middle range doses.

This is consistent with prior studies and it was also consistent with some laboratory studies we did on the mechanism of action. So, there seems to be an optimal range. It isn’t a pure dose escalation in the sense to high -- the more you give, the better the result is.

And this has to do with, we believe, what we described in a publication in Blood this last year or so on the mechanism of Trogocytosis, which I don't want to go into right now. It’s a little complicated, but it sort of explains that Epratuzumab can not only affect CD22 which is its target on the B cell, but also affects other B cell antigens and one of them, particularly CD19 is very implicated in autoimmune diseases, particularly lupus.

So, 22 and 19 and possibly also 20, are very important targets and we found in the laboratory work that there was an optimal dose range which actually was very consistent to what we're seeing clinically.

On the second part of the question, I'll turn it over to Cindy.

Cynthia Sullivan

Sure. Yeah, Chris I can confirm that the reduction, obviously, in corticosteroid use is extremely important in these patients and that the protocol does address that.

Chris Marai - Oppenheimer

Okay, great. And then just I guess touching base on the dose response where this dose matters, again, with respect to patients near trial did you find that the response was homogenous or heterogeneous among patients, was there a lot of inter-patient variability I guess, is the easy way to put that question.

Cynthia Sullivan

See, the response specifically related to the lupus program is scored with a composite scoring system involving BILAG, SLEDAI and physicians' global assessment. So, through those three different, although heavily-weighted to BILAG, patients as a result, then have more of a consistent read out in terms of response.

Chris Marai - Oppenheimer

Okay. And do you have any biomarkers that sort of confirms in human in the clinic there -- that you - what you had seen with respect to dose response and potentially mechanism of action?

Cynthia Sullivan

The ANA and anti-dsDNA tests are performed, but with regard to any other specific biomarkers, UCB has not commented on that.

Chris Marai - Oppenheimer

Okay, great. And then one last quick follow-up here. Just with respect to your cash position, how does the lupus program and potential milestones from that really come into, I guess, your strategy with respect to potential partnering or other vehicles for raising [inaudible] methods.

Cynthia Sullivan

So, other than dividing as I just did with regulatory and sales-based milestones, we have not given any more direction with regard to specific milestone events.

Chris Marai - Oppenheimer

Okay. Thank you.


Our next question comes from the line of Ling Wang with Chardan Capital Markets. Your line is open.

Ling Wang - Chardan Capital Markets

Hi good morning. Thank you for taking my questions. So, for the ADC program, David, I'm sorry I probably don't quite follow, so for the IMMU-132, can you clarify what is your further development plan in terms of -- in the patients?

And also are you going to provide update for both IMMU-132 and 130 at AACR EORTC conference?

David Goldenberg

First to the second question, there will be an update that's in November that will be when these Phase II trials are very advanced, we think that will be completed at the end of December, but enrolment will probably be completed much earlier and the reason we're giving to the end of the year is that a lot of patients -- fortunately for the patients, we expect will continue to do well, so we won't have final results as to duration of response, but we'll have sufficient results to talk of response and, of course, the safety aspects.

So, I think at the EORTC NCI AACR meeting, I will be able to give an important talk on both the development of this agent, why it is a paradigm change in the ADC field, why it's so different than others and the basis of that, of course, will be the clinical results.

And I'm hopeful by then that the numbers will, of course, continue to support the initial results that I just discussed.

In terms of the first part of the question with tumor types, we're in a good position that six different cancers that have received many prior therapies and patients who are progressing when they came into the trial have shown not only a durable disease control, but more importantly, a partial response.

The category of tumor that has -- on a percentage basis shown the best response, these triple negative breast cancers, as I mentioned, if you do the math on it, which I didn’t do for you, because I was hoping you would tell me this, about 25% of these patients are showing a partial response and these patients have received the median of five prior therapy there is really no acceptable therapy in triple negative breast cancer. Most therapies are the same as they are given in the invasive like breast cancers that are not triple negative.

So a targeted therapy like we have for Her-2 -- in the Her-2 positive breast cancer is not available in triple negative breast. The median survival of patients with metastasis disease is 13 months which is very bad.

So we and our investigators are very encouraged in that indication. I think it will also be active in non-triple negative or regular breast cancer, but we haven’t studied it in the clinic. We studied it preclinically and the results are also very good.

So I think taking an indication, it is a great medical need where there is no real targeted therapy that has been successful, separates us very much in this field. I hope that by the time we complete the Phase II, these numbers will be reinforced with just larger number of patients and we will maintain the same response rate.

And the question, then is, of course, how durable is the response rate. So far it looks good, but we certainly need to wait to the end of the year to have a larger numbers and waiting time to talk about durability of response.

The triple negative breast cancer is a paradox. It’s a kind of cancer which does respond well to initial therapies, but then it shows no survival benefits. So they all relapse very quickly and that's called the paradox of triple negative breast cancer therapy.

We think we can make a paradigm change there. I haven’t seen a cancer in any of our trials that has rolled so quickly. We have a lot of investigators interested in this tumor type and we are really very pleased with their interest in continuing to enroll patients evidently it must mean that they see a benefit. And so we are seeing a lot of patients coming in for registration. And therefore I hope that this triple negative breast cancer aspect of our larger trial would be completed very quickly.

Ling Wang - Chardan Capital Markets

Great. Just a follow-up. I mean, assuming the data was a part in this indication, you assume the partnership discussion is also ongoing. I just wanted to get your thought whether your next step in this program might, you know, contingent about potential development partnership on board.

David Goldenberg

Well, I don’t like to discuss conditions or contingencies. But I won't say -- honestly, we had very early in the Phase I good results. We started discussions with many parties. And that everyone knew we were doing a Phase II and we needed to focused on what the most promising indication is and we are coming to that point as I just discussed with you.

I don’t want to disadvantage some of the others. I have been very impressed with the results we have seen in a non-small cell lung cancer, in addition to small cell lung cancer and surprising results in urinary bladder cancer.

So we think we have multiple indications. But the one that seems to be with the greatest data support medical need that could make a change in the management of these patients is triple negative breast cancer. And now we have a plan. We have a process. We think we know how to move forward in this first indication and obviously others. So I think the level and the nature of our discussions with outside parties will be changed.

Ling Wang - Chardan Capital Markets

Okay. Great. Thank you.


Our next question comes from the line of Boris Peaker with Cowen. Your line is open.

Boris Peaker - Cowen and Company

Good morning. I just had a few questions on the lupus program, with Epratuzumab available out there and some patients are getting toxic treatment. I am just curious, are those patients are going to be excluded from your clinical trials or you are going to have some of these pre-treated patients as part of your trials?

Cynthia Sullivan

Boric, I believe patients could have had prior biologic therapy coming into the Phase III program. But there was a specific washout period.

Boris Peaker - Cowen and Company

Okay. And so if -- I mean, I am just curious in terms of kind of your thoughts if you could patients that have had prior biologic therapy, likely the ones that are going to go into the trial or the ones that have failed in the past, I mean, do you think that's -- first of all, how many -- what fraction of patients would fall within that category and how do you think that that might the clinical study?

Cynthia Sullivan

Yeah, I am sorry. Absent having the date of readout and prior therapies for these patients, I can not estimate what that number is.

Boris Peaker - Cowen and Company

Got you. And I just had a question on the antibody drug conjugate platform, I mean, if we look around, it seems that the business case for a lot of these things and there are being multiple partnerships and there is seems to be a lot of interest from the pharma side, just curious if any of your programs or since you have fully owned them, position for partnering you are developing like partnership packs, are specific clinical studies done internal preclinical studies done at the request of potential partners or kind of where that platform is?

David Goldenberg

Well, I can not get specific as you can imagine. But during the discussions we have had over the last year, there have been questions that we did address and have been addressing to answer all of the issues. Don’t forget the pharmaceutical industry has been prejudice to believe that the supertoxic agent with a ratio of conjugation of maybe two to four drugs per IgG is the optimal approach.

We are coming with a paradigm change. We are saying that is not correct. And we are trying to prove by showing that we have a better therapeutic index that is we can give more drug. We can localize more drug to the tumor without increasing toxicity to the patient.

And we are giving eight drug -- seven to eight-drug conjugates for antibody molecule which is twice that of other companies or technologies. We are giving a drug which is not supertoxic, it’s not sub-animal or toxicity but animal. And yet because of that we able to deliver more antibody to the tumor and we are able to, I think, have a better therapeutic index.

We confirm this in animal studies that we presented this at the American Association for Cancer Research, so I am not speaking out turn here, by showing that if you take antibody drug conjugate, let's say, in this case IMMU-132, and you estimate you measure how much of the SN-38 or the active drug is in the tumor compared to when you gave the parent drug or (inaudible) which also works by releasing SN-38, we find we have 120, 125 more SN-38 delivered in the tumor. And yet we are not producing more toxicity in these animals.

So this is an animal or preclinical example of what we are seeing clinically. So it’s fitting together and we are getting more and more data in the patients in terms of how much of the drug is circulating, how much is its released where the antibody is going and this is all coming together with a picture which I believe is going to support that there is a paradigm change necessary, -- the stock that has been resolved -- that has resulted in big investments in a lot of antibody drug conjugates of the past may change. And I am told that even some of our competitors are now looking at less toxic drugs conjugated on antibody.

So I am going to discuss all of this in Barcelona. I hope putting in perspective with a lot of clinical data to support these considerations which I think are changed from what has been happening in the ADC field over the last five years.

Boris Peaker - Cowen and Company

Well, thank you very much for that detailed explanation.


Our next question comes from the line of Difei Yang with R F Lafferty. Your line is open.

Difei Yang - R F Lafferty & Co.

Hi, good morning. Thanks for taking my question. Just a quick one with regards to the lupus program. So, is it -- would you share with us your perception with regards to the competitive pressure in that market, especially when Epratuzumab gets approved. If you have any thoughts -- more particularly if you have any thoughts regards to Anthera Pharmaceuticals product?

David Goldenberg

I think since Benlysta got approved, the -- our enthusiasm that an agent can get approved in lupus was elevated. There was disappointment for about 50 years that nothing came along. Epratuzumab, I think, I'm not sure, no I'm not -- I don't do intelligence on -- in this three areas. My focus is probably the most advanced product in coming along for lupus, I believe -- and I'm very gratuitous on this that it differentiates considerably from the Benlysta. And I'm not sure about what is coming behind Epratuzumab.

Certainly, Epratuzumab has a quite different mechanism of action then Benlysta and many of the other products that are being developed. It has a very unusual high safety profile so far from what we've seen in all the trials. I don't think we have to worry about some of the limitations that have been put on other autoimmune diseases, agents which are very immunosuppressive.

This does deplete some of the B-cells, but not all of them. So, 35% to 40% depletion means these patients are still capable of exercising immune responses to all sort of agents that come.

It's also an agent that acts very fast compared to what we've seen with Benlysta. So, there are so many differentiating characteristics and I hope we will see as we saw in the Phase 2 trial that gives corticosteroids bearing, which to me is the big difference in these -- the life of these patients.

Corticosteroids are wonder drugs, but they are also disaster drugs. They destroy many systems of the body as they are given chronically over many years. So, that to me would be one of the most important things. Fast responsive, corticosteroids bearing, and a safety profile that I hope differentiates from whether cytotoxic related agents that have been given in the past and are still being given in lupus, including rituximab.

I think this may mean that Epratuzumab can be given over many years repeatedly to such patients hopefully without inducing a resistance, but we need to do the studies to see that. But so far, in terms of its safety profile, it's very low, if any, cause of anti-bodies to the two Epratuzumab and it is not very immunogenic so far or pretend that this could be a very important agent and the open label studies that have been going on first in the Phase 2 trial that will be continuing in the Phase 3, I hope and I'm confident, we'll support this view.

Difei Yang - R F Lafferty & Co.

Thank you.


Thank you. And at this time, I'd like to hand the conference back over to Cynthia Sullivan for her closing remarks.

Cynthia Sullivan

So, we thank you all very much for joining us this morning. On behalf of the entire management team, I'd also like to thank you for your continued support and interest in Immunomedics.


That does conclude today's teleconference. You may now disconnect. Thank you. And have a great day.

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