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Edited Transcript of IMMU earnings conference call or presentation 7-Aug-19 9:00pm GMT

Q2 2019 Immunomedics Inc Earnings Call

MORRIS PLAINS Aug 8, 2019 (Thomson StreetEvents) -- Edited Transcript of Immunomedics Inc earnings conference call or presentation Wednesday, August 7, 2019 at 9:00:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Behzad Aghazadeh

Immunomedics, Inc. - Executive Chairman

* Chau Cheng

Immunomedics, Inc. - Senior Director of Investor Relations

* Scott A. Canute

Immunomedics, Inc. - Executive Director

* Usama Malik

Immunomedics, Inc. - CFO & Chief Business Officer

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Conference Call Participants

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* Christopher Lawrence Howerton

Jefferies LLC, Research Division - Equity Analyst

* Corinne Jenkins

Goldman Sachs Group Inc., Research Division - Research Analyst

* Matthew Kelsey Harrison

Morgan Stanley, Research Division - Executive Director

* Philip M. Nadeau

Cowen and Company, LLC, Research Division - MD and Senior Research Analyst

* Shanshan Xu

Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst

* Robert Burns

H.C. Wainwright & Co., LLC, Research Division - Equity Research Associate - Biotech

* Yige Guo

Guggenheim Securities, LLC, Research Division - Associate

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Presentation

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Operator [1]

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Good afternoon, ladies and gentlemen. Thank you for standing by. As a reminder, this call is being recorded. Today is Wednesday, August 7, 2019. At this time, I would like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics.

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Chau Cheng, Immunomedics, Inc. - Senior Director of Investor Relations [2]

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Thank you, Lara. 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 therefore, actual results could differ materially from those expressed or implied on this call. For factors that could cause such differences, please refer to our regulatory filings with the Securities and Exchange Commission.

With us on the call today with prepared remarks are Dr. Behzad Aghazadeh, Executive Chairman; and Usama Malik, Chief Financial Officer. Also on the call for Q&A is Scott Canute, Executive Director. Following the prepared remarks, we will open the call up for questions. Thank you. Behzad?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [3]

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Thank you, Chau, and good afternoon, everyone, and thank you for joining us. First and foremost, let me begin with an update on our BLA resubmission efforts. I'm pleased to report that we remain on track to meet our guided resubmission time line of early fourth quarter of 2019. As noted by Scott in our last earnings call, our goal is to have not only a high-quality resubmission but also a successful reinspection. I'm very thankful and appreciative of the hard work our manufacturing, quality, regulatory and clinical colleagues have delivered so far as we move towards our objectives and time lines.

While Samsung is not part of our BLA resubmission plan, they are nonetheless important in our overall strategic plan to scale our global supply capacity for long-term supply of sacituzumab govitecan. To that end, I'm also pleased to report that the work being conducted at Samsung BioLogics is progressing well, and we remain on track to establish Samsung as our primary source of commercial antibody in time to meet the anticipated demand of this valuable asset after FDA approval of our BLA.

A quick update on the CEO and CMO search. We are in active search mode and are looking for the right candidates. With the current arrangement of me stepping into the Executive Chairmanship and Scott spearheading our BLA submission efforts, the company continues to execute well against our key strategic priorities, giving us the opportunity to take our time to fill the CEO position. We're going about this search very thoughtfully to make sure we get the right person, one who can build on the potential of our unique ADC platform and take the company to the next level.

For the CMO position, we've moved quickly to bring onboard an industry veteran who previously helped us on various projects as a consultant and has now stepped into an advisory interim CMO role supported by a very strong fully staffed clinical team. While our robust clinical programs are advancing extremely well under this setup, we're eager to fill the CMO position on a permanent basis, and that search is ongoing.

Moving on to clinical updates. We're very pleased to have reached our target enrollment in the ASCENT study in less than 20 months and are grateful to the patients, their families and caregivers who have participated in our studies. We believe this rapid pace is testament to the unmet need in late-stage metastatic triple-negative breast cancer and the confidence of our investigators in the safety and efficacy of our ADC to provide a meaningful clinical benefit to patients.

Based on our current projected event trajectory and time lines associated with central review, database lock and analysis, we expect top line readout from ASCENT to occur mid-2020.

Building on the ASCENT momentum and leveraging the existing relationship with breast cancer specialists, we have launched the registrational Phase III TROPICS-02 in HR-positive, HER2-negative metastatic breast cancer, which accounts for 70% of all breast cancers. This randomized global study has dosed the first patients who have failed at least 2 prior chemo regimens for metastatic disease. With progression-free survival and overall response rate serving as co-primary endpoints, the study allows for an analysis of overall response rate on a prespecified number of patients as a basis of potential accelerated approval submission.

Enrollment of the targeted 400 patients is expected to take approximately 18 months.

For TROPHY-U01 in urothelial cancer, the study is enrolling as expected, and we remain pleased with the progress towards a 2019 year-end enrollment completion. As a reminder, once we've recruited a prespecified number of patients with sufficient follow-up, we will have the opportunity to conduct an interim analysis. We anticipate reporting these results at an appropriate scientific venue. The successful interim analysis will provide us the opportunity to file for Breakthrough Therapy Designation.

To further unlock the potential of sacituzumab govitecan, we have initiated, for the first time, a Trop-2-enriched study in various difficult-to-treat cancers. Dosing of the first patient in the non-small cell lung cancer cohort is expected in the third quarter.

Finally, we have 2 updates on PARP inhibitor combination studies to report. The first one is with Rucaparib, in collaboration with Clovis, in second-line metastatic triple-negative breast cancer and other cancers. That study is now open for patient enrollment. The second study is a new Phase Ib/II study initiated by Dr. Aditya Bardia and sponsored by the Massachusetts General Hospital to study sacituzumab in combination with Pfizer's PARP inhibitor, talazoparib, in patients with metastatic triple-negative breast cancer previously treated with no more than 1 prior therapeutic regimen for metastatic disease.

And with that, I will turn the call over to Usama for an overview of our financials before opening the call for Q&A.

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Usama Malik, Immunomedics, Inc. - CFO & Chief Business Officer [4]

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Thank you, Behzad. As with our last earnings call, I will provide top line results here and ask everyone to refer to our quarterly filing as well as this afternoon's earnings release for additional details.

Total costs and expenses were $67.2 million for the quarter and $146.8 million for the 6 months ended June 30, 2019, compared to $52.8 million for the comparable quarter and $90.9 million for the 6 months ended June 30, 2018. The increases were due primarily to additional expenses in research and development and sales and marketing partially offset by decreases in G&A expenses. The increases in R&D costs were mostly attributable to activities related to preparation for the approval and commercial launch of sacituzumab in metastatic triple-negative breast cancer and expanded clinical development of sacituzumab in other indications.

Net loss attributable to stockholders was $76 million or $0.40 per share for the quarter ended June 30, 2019, compared to $117 million or $0.68 per share for the comparable quarter ended June 30, 2018. Net loss attributable to stockholders was $163.3 million or $0.85 per share for the 6 months ended June 30, 2019, compared to $152.6 million or $0.91 per share for the 6 months ended June 30, 2018.

As of June 30, 2019, we had approximately $433 million in cash, cash equivalents and marketable securities, which included the $65 million upfront payment received from the licensing agreement with Everest Medicines for Greater China. The number of outstanding shares was 192 million and the fully diluted count was 205 million. We believe our projected financial resources are adequate to support our clinical development plan for sacituzumab, further build our clinical and manufacturing infrastructure and fund our operations through 2020.

This concludes our second quarter 2019 financial results. Operator, please open the call up to questions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) We have your first question coming from the line of Paul Choi with Goldman Sachs.

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Corinne Jenkins, Goldman Sachs Group Inc., Research Division - Research Analyst [2]

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This is Corinne Jenkins on for Paul. I was just hoping you could talk a little bit about how you see the competitive landscape evolving with Trop-2 ADCs, particularly as you start to study sacituzumab in NSCLC and with Daiichi Sankyo presenting data for their Trop-2 ADC at WCLC this fall.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [3]

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Sure. Thanks. I think not much really has changed in the triple-negative setting. We haven't -- we've seen, as you just touched on, the data from the Trop-2 ADC from Daiichi, which was in the early number of patients with limited follow-up. And I think on the one hand, it was comforting to see a Trop-2 as a validated target, which we were, I think, spearheaded that with our asset. But beyond that, we haven't seen the follow-up data, and we look forward to getting an update on that, I think, in early September, in the lung setting. In the triple-negative setting, however, I think, clearly, we just announced today that we've reached our target enrollment in our randomized Phase III study. We have over 500 patients treated. We're on track to file for an accelerated approval on our Phase I cohort in that setting. So I think in terms of just experience and time lines, I don't really foresee anything changing for the foreseeable future in that lead indication.

With respect to other updates and then with checkpoint inhibitors and earlier lines of setting, some positive, some negative developments in the quarter. Again, none of that really reads into our initial target indication. In fact, some of the positive developments, I think, might just perhaps lend themselves to an earlier adoption of our asset as the majority of patients, unfortunately, will progress after initial lines of therapy, checkpoints or otherwise. So I think in that regard, again, not much has dramatically changed since we last spoke.

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Operator [4]

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We have your next question coming from the line of Phil Nadeau with Cowen & Company.

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Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [5]

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Congrats on the progress. A few on upcoming events. First on the manufacturing issues and work that you're doing with just perhaps a couple of months till you complete the filing. I'm curious if you'd be willing to give us any more information on what work you are doing and what are some of the issues that remain to be solved before you can refile.

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Scott A. Canute, Immunomedics, Inc. - Executive Director [6]

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Yes. Thanks for the question. The short answer is we put a comprehensive, deep and broad plan in place shortly after we got the CRL, as we communicated on the previous call -- last call that we had. And we're sticking to the time line. We're tracking very well with it. We're getting the things done that we needed to. We've not had to add anything really to the plan that we put together several months ago. And it's just execute, execute, execute.

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Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [7]

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Has there been anything unexpected as you've done your work? Any unforeseen challenges that maybe you weren't aware of after immediately filing the CRL?

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Scott A. Canute, Immunomedics, Inc. - Executive Director [8]

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I mean nothing that you wouldn't see in normal manufacturing operations. I mean things do happen from time to time in manufacturing, but you have an organization that is built to deal with those, identify them and deal with them and has not impacted our time line. So still very highly confident that we will be able to refile in early fourth quarter.

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Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [9]

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Perfect. Second question is on the time lines for the ASCENT study, because I'm sure there's a lot of concern that those could come up before the PDUFA date. Behzad, just to play devil's advocate, why wouldn't the data beforehand, if the trial is fully enrolled now, you had maybe 4 months for the median PFS event to be hit, a couple of months to clean up the data, is it possible that we get the results in the first quarter of 2020?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [10]

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No. Again, I think today, we gave guidance on when we expect the results to read out. What's important is, first of all, this is based, as we said previously, we would take another sweep of the data and provide the update as soon as practical. So I think, clearly, that now has occurred. And based on where we see the events and where we see the triggering event to occur, it's a little more involved than what you laid out. I think you've sort of broad-strokes got the moving parts. But just to walk you through the sequence of events, it's going to be that on a local review, we will get a triggering event that will then trigger the final set of scans to be sent for central adjudication. You have to factor in the time line it takes for that to occur. There are multiple reviewers on a central basis that need to review it. That work needs to be completed, sent back to us, and that will then establish when, in fact, we will declare the trigger to have occurred, namely an event based on central review, not local review. That then will trigger a series of steps, iterative steps of database cleanup followed by the analysis period, and we sort of -- when you piece those parts together, we arrive at that mid-2020 time line and not what you proposed, which would be substantially sooner than that.

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Philip M. Nadeau, Cowen and Company, LLC, Research Division - MD and Senior Research Analyst [11]

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Perfect. Okay. That makes sense. And then the last question just on the interim urothelial data. Have you decided upon a venue in which to release that data to investors? And is it possible that we don't see it actually in the second half of this year, maybe early 2020 at someplace like ASCO-GU?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [12]

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Yes, Phil, I think what we'll probably do in that regard is just wait when and if the venue has been identified and the conference would allow us to reveal that. It would be inappropriate to sort of speculate on which conference until we have that clarity or are allowed to speak to it. So I'd sort of ask to stay tuned. And when we have the update, we'll be certain to provide it.

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Operator [13]

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We have your next question coming from the line of Raghuram Selvaraju with H.C. Wainwright.

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Robert Burns, H.C. Wainwright & Co., LLC, Research Division - Equity Research Associate - Biotech [14]

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This is Rob on for Ram. Just a few clinical ones for me. Looking at CDK 4/6 usage in the first-line setting for HR-positive HER2-negative metastatic, could you talk a little bit about your current thoughts regarding maybe potential combinations with fulvestrant in the second-line setting post CDK 4/6 inhibitor use? And if you are, just maybe what sort of timetable that could look like?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [15]

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I missed -- sorry, can you just -- you -- we want to make clear, which drug you were proposing a combination study with?

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Robert Burns, H.C. Wainwright & Co., LLC, Research Division - Equity Research Associate - Biotech [16]

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I'm sorry. I was talking about fulvestrant in the second-line setting.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [17]

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Fulvestrant we don't have a specific trial planned in that setting. So beyond the TROPICS study that we've now announced that we've enrolled patients, there's really nothing to report on the study that you're proposing.

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Robert Burns, H.C. Wainwright & Co., LLC, Research Division - Equity Research Associate - Biotech [18]

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Okay. And could you provide a little more color on any of the combinations with Imfinzi for -- in SCLC, TNBC and urothelial? Just when they're slated to begin and what may be some potential time lines are looking like since we really haven't seen anything on ct.gov as of yet.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [19]

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Yes. Those trials, I would say, are run by AstraZeneca. So beyond just giving you sort of broad-stroke guidance, which I believe they will be starting in the fourth quarter, they're not really under our control. So I can't, unfortunately, give you more clarity around that.

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Robert Burns, H.C. Wainwright & Co., LLC, Research Division - Equity Research Associate - Biotech [20]

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Okay. I understand. That makes sense. And then my final question, just looking at the recent Phase I/II trial with talazoparib in TNBC on the ct.gov, it looks like the inclusion criteria does not really stipulate whether these patients need BRCA or HRR mutations to be included in the trials. Just wondering if you could clarify whether or not these patients actually have to have these mutations to be included.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [21]

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They do not. There -- some of those parameters are of interest. And so that information will be collected. But there is no prerequisite that they need to have BRCA mutations or others. It's an all-comer study.

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Robert Burns, H.C. Wainwright & Co., LLC, Research Division - Equity Research Associate - Biotech [22]

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Okay. So do you imagine doing maybe a subset study later on or a subset analysis?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [23]

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Certainly. I think that based on -- depending on what the data where they lead us to, but our hope is that we -- the combination will sensitize non-BRCA tumors as well. And so that's the information that we're looking to glean from these studies, both with Pfizer and with the Clovis asset.

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Operator [24]

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We have your next question coming from the line of Shanshan Xu from Berenberg Markets.

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Shanshan Xu, Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst [25]

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This is Shanshan Xu from Berenberg Capital Markets. So following Phil's path, I would like to play the devil's advocate as well. Given that ASCENT it's truly the confirmatory trial for IMMU-130 in triple-negative breast cancer, so even if the time line for this ASCENT readout is pushed out to mid-2020, if the readout on the PFS is negative, what could be the regulatory implication on IMMU-132, granted that it could have been approved by the FDA by then?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [26]

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Yes, Shanshan, I just want to be -- clarify that we didn't push out time lines, this is the first time we're announcing time line. So that is, in fact, when the study will read out. With respect to what might occur should the trial read out negatively, it's really hard to -- for me to speculate given that: a, first of all, we would anticipate, and we continue to anticipate a positive readout. But obviously, the scenario painting would be one that the FDA would likely want to understand perhaps the data, whether there are subsets that would be positive. It's really a speculation to suggest that we would be able to predict what would happen. Our expectation would be that if we file on time, we should receive approval and that study should, in fact, be the supportive confirmatory study for a full approval in the U.S. and could be the basis of the European submission for full approval in Europe.

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Shanshan Xu, Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst [27]

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Great. So another question for your urothelial carcinoma pivotal trial, do you expect it to recapitulate what has happened in terms of the efficacy in your prior Phase I/II trial?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [28]

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Yes. There's really no reason to believe that the drug would behave differently given that we've studied it now in a number of tumor types in the Phase I study, and these were meaningful number of patients. But the TROPHY study, just to remind you, requires a prior checkpoint. And we had a number of patients in this study in Phase I that had prior checkpoints, and there was really no discernible difference in efficacy. But we look forward to presenting that data and hopefully recapitulating what was previously presented. But we remain blinded to that study until we're boarded. And again, no reason that given the safety profile and the efficacy has been established in a variety of settings, but until we have that data in hand, it's obviously a speculation.

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Shanshan Xu, Joh. Berenberg, Gossler & Co. KG, Research Division - Analyst [29]

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That's helpful. Maybe last one from me. Can you please remind us what is the cutoff value of the Trop-2 expression in the basket trial? And is it the same for non-small cell lung cancer versus small cell lung cancer versus other types of metastatic solid tumors?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [30]

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Sure. The trial is designed so that we will start with a 25% cutoff. But we have the ability to then raise that to higher levels. Beyond that, I think the way the design is -- the study is going to enroll is that we will start with a pilot cohort in non-small cell lung cancer and then expand into the other subgroups. Likely based on what we see, we'll then establish the right cutoff for the other tumor types.

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Operator [31]

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We have your next question coming from the line of Chris Howerton from Jefferies.

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [32]

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Congratulations as well on the progress. So I think the first for me is maybe for Scott or Behzad. After you submit, resumbit the BLA, could you remind us what we can expect in terms of the review cycle time and what required activities might need to happen from the FDA's perspective, such as the facility inspection?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [33]

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Do you want to take that?

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Scott A. Canute, Immunomedics, Inc. - Executive Director [34]

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Yes. Sure, absolutely. So we'll refile the BLA, they've got 2 weeks, FDA has 2 weeks with which to accept the resubmission. The review clock starts when we refile. It's in the FDA's hands how long that review clock takes. Given where we're at and the fact that we do, in fact, need a pre-approval inspection, they can get inspection any time after that point. They can come in very quickly, and we would -- what we -- ultimately, the FDA's decision. We're hopeful that they'll come in quickly. We're trying to make this as clean as we possibly can. And again, they're very willing and have shown substantial interest in making this -- to get this drug approved. We're very confident in what we've done so far. We're going to make this submission very clean, so it's easy for them to review. The pre-approval inspection should go very well based on our plan and how we're executing against it. And while, ultimately, it's in the FDA's review in terms of how long they take, we're optimistic that while they could take up to 6 months that the review clock and review time and approval time would be shorter than that. Ultimately, it's the FDA's call though.

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [35]

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Got it. Okay. Sure. And then, I guess, maybe as a follow-up on the urothelial carcinoma, again, obviously, Seattle Genetics recently submitted an indication. So just curious if anything's changed from a strategic perspective within that indication, and maybe speculation in terms of competitive advantages 132 might have in that space.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [36]

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Yes, Chris, I think we've known for some time that these 2 assets was likely when they be on the market potentially side by side. And I think we've talked in the past about targeting different -- having different targets. In our case, targeting Trop-2, which is obviously distinct from where EV targets as well as a different toxin and safety profile. And I think from what we hear from the clinical community is that there will likely be a role for both and possibly for both in the same patients. If they progress, unfortunately, due to disease progression with the use of one, it will likely be relegated to the other drug. And the question then becomes which one first. And I think that there's a group that might think that Seattle is earlier then they would have that benefit. On the other hand, there's also a big desire on the part of the physician to make sure they use the safer product first, in this particularly frail population of elderly men, this is particularly challenging patient population. And I think in that instance, I think the safety profile of our drug, the longer duration that patients can benefit from if that were to recapitulate from the Phase I study that we saw. I'll remind you, our response rate were in the 30-some-percent rate with a DOR north of 12.51. Beyond that, the neuropathy is a big, big differentiator between the 2. I think it's important to understand in the pivotal study,

In the case of EV, I believe, baseline neuropathy was an exclusion criteria, we are treating an all-comer population. And so there are clear differences between the safety profile of the drug. There will be differences likely in the efficacy profile of the drug, whether it's response rate, duration. And we'll just have to see how the market sees the 2. But I really don't foresee a situation, which is one product takes all because we already are encountering patients that have progressed on EV and they're likely encounter patients that have progressed on Trop-2 prior studies that we have treated patients in.

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Christopher Lawrence Howerton, Jefferies LLC, Research Division - Equity Analyst [37]

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Okay. Great. That's helpful. And maybe last one for me, for Usama, obviously, you're able to get a really attractive deal from Everest in China. Any updates on -- thinking of other ex U.S. deals, any update you want to provide on that aspect with respect to the business development.

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Usama Malik, Immunomedics, Inc. - CFO & Chief Business Officer [38]

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Sure. Thanks, Chris. Yes, we're very happy with the deal with Everest and as I reported in my remarks, we did get the $65 million in upfront payment. We continue to work with them to file their IND and start a number of trials so that we can get the product to Greater China in additional indications as well. Beyond that, we've previously commented that we will -- we are continuing to look at other opportunities in, what I would call, rest of the world, which is ex U.S. and ex Europe, and we're continuing to pursue those. And as it pertains to Europe itself, we've also previously mentioned that we have a registrational approach there that we've been discussing with regulators in Europe.

And as it pertains to commercialization there, we'll continue to explore our options there, whether we go it alone or we seek partnership will be dependent on a number of factors, including the types of terms and economics and the risks associated with the market at the appropriate time.

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Operator [39]

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We have your next question coming from the line of Michael Schmidt from Guggenheim.

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Yige Guo, Guggenheim Securities, LLC, Research Division - Associate [40]

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This is Yige on for Michael. Our first question is on the ASCENT trial. So overall survival is the secondary endpoint of the study, just wondering what is the hurdle for the overall survival in this patient population. And also, do you guys -- can you guys provide some color on the powering assumption of this study? And we also have a question on financials. It seem both R&D cost and SG&A were down compared with last quarter. Can you maybe provide some color on the reason? And how should we think of the operating cost into 2020?

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [41]

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Sure. I'll take the first 2 and hand it to Usama for the ASCENT. Just quickly in reverse order, on the powering, we've not previously provided powering, nor will we do that on this call other than to say that we're very well powered for the primary endpoint, likely well powered or well powered in order to also have something worthwhile to see on the secondary endpoint OS. With respect to the hurdle, it's a secondary endpoint. So there's not a specific hurdle per se. Obviously, you don't want that signal to go in the wrong direction. So that's important to see and hopefully be supportive on the other extreme of the PFS signal that you see. But there's no hurdle per se. I would say that, obviously, if you have a good trend or a strong supportive evidence of the PFS benefit, also reflected in the OS, that would be important especially for the European market where pricing does look at the totality of the data beyond just the approved indication or the labeled indication.

So while PFS forms the basis of both regions in terms of what the regulators would like to see from an approval standpoint, we believe OS is likely going to be helpful, especially on the pricing side in Europe. On the question of spend R&D and SG&A, Usama?

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Usama Malik, Immunomedics, Inc. - CFO & Chief Business Officer [42]

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Yes. So quarter-on-quarter, as we just mentioned in the prepared remarks, this quarter was about $15 million more than what we spent in similar quarter last year predominantly driven by additional R&D expenses. And so we just launched the ER-positive study, we just -- Behzad just mentioned, the Trop-2 in basket study, that's around the corner, so investments there. And as you know, at this stage that we're in, we are expensing development costs across CMC and manufacturing.

So that's -- and given the fact that we're also in a refiling period, there's some additional expenses there that account for the increase. As it pertains to forward-looking spend, we've not given guidance on that. I think you can look at sort of the trajectory over the last 6 or 8 quarters and see kind of where we're trending. Once we have approval and we go to market commercially, we'll think about how we want to provide guidance at that point.

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Operator [43]

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And we have your question coming from Matthew Harrison from Morgan Stanley.

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Matthew Kelsey Harrison, Morgan Stanley, Research Division - Executive Director [44]

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Two for me. I guess first, can you broadly talk about how we should think about commercial ramp? And when -- I mean I know you've had these people, and you're obviously -- you've got the partnership with J&J for the year. I'm just trying to think about how we should think about any of that changing once you refile and if there's anything that happened there. And then I have a second follow-up on the urothelial study.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [45]

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When you talk about commercial ramp, you're talking about the ramp in commercial spend once we file or you're talking about the...

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Matthew Kelsey Harrison, Morgan Stanley, Research Division - Executive Director [46]

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Yes. I'm just trying to understand, if there should be any significant change to the commercial spend that you already have in place, I guess.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [47]

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Yes. I think we basically are fully staffed, more or less, on the sales front. There will be additionals in terms of -- sales reps, I should say. In terms of just launch preparation cost as well as in the launch period, there are always additional marketing spend that you incur, which are third-party activities. We're not in a position to really provide guidance, but there certainly will be increased activities. But in terms of head count, there'll be additional hires to build out the marketing organization. But certainly, the heavy lift, if you will, that the larger organization remains intact, as you referenced, the J&J relationship we have, which is obviously a very productive way to keep our team together. That should not dramatically change on the spend front.

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Matthew Kelsey Harrison, Morgan Stanley, Research Division - Executive Director [48]

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Okay. And then the follow-up question is on the urothelial study. I guess can you just talk to what the hurdle rate is to declare efficacy here? I guess what I'm asking is -- my understanding is this is Simon 2-stage design, and I thought the ability to declare that you can stop the study at the interim is quite high in Simon 2-stage. So can -- maybe you can just address that a little bit.

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Behzad Aghazadeh, Immunomedics, Inc. - Executive Chairman [49]

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We haven't really gone into details on what the interim hurdle is. What I would say is that the hurdle is, I think that perhaps more insightful or the best way to think about it is, if you think about what you would expect to see in this setting, high single-digit, low double-digit responses on -- if you look back on therapy. Anything that separates meaningfully from that would I think be viewed by the regulators and the clinical community is beneficial. And that's what we hope to have. Obviously, our prior data significantly surpasses that level. So there's a lot of room between what background would be and what would be meaningful to the clinical community. Having said that, we certainly hope that we can recapitulate prior data. We'll just have to see how it takes out. The design in 2 stage sort of our enrollment is going pretty well. So I don't think we would, at this point, anticipate any sort of interim would prevent us from completing enrollment. We'll have to see how that plays out. Does that answer the question, Matt?

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Matthew Kelsey Harrison, Morgan Stanley, Research Division - Executive Director [50]

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Yes.

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Operator [51]

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At this time, I would like to hand the conference back over to Chau Cheng for his closing remarks.

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Chau Cheng, Immunomedics, Inc. - Senior Director of Investor Relations [52]

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Yes. On behalf of the entire leadership team, I'd like to thank you all very much for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.

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Operator [53]

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That does conclude today's conference call. You may now disconnect. Thank you, and have a great day.