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Immunomedics Inc (IMMU)
Q1Â 2020 Earnings Call
May 6, 2020, 5:00 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Good afternoon, ladies and gentlemen, thank you for standing by. As a reminder, this call is being recorded, today, Wednesday, May 6th, 2020.
At this time, I would like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics.
Chau Cheng -- Senior Director-Investor Relations
Thank you, Jimmy. 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. Factors that could cause such a difference include the uncertainty associated with pharmaceutical development and regulatory approval process as well as difficulty in forecasting sales, revenues and expenses.
More information about the risks and uncertainties faced by Immunomedics is contained with the caption Risk Factors included in the company's periodic reports filed with the Securities and Exchange Commission, including the company's Annual Report on Form 10-K for the year ended December 31st, 2019.
With us on the call today with prepared remarks are Dr. Behzad Aghazadeh, Executive Chairman; and Usama Malik, our Chief Financial Officer and Chief Business Officer. Also on the call for Q&A are Harout Semerjian, President and Chief Executive Officer and Brendan Delaney, Chief Commercial Officer.
Following the prepared remarks, we will open the call up for questions. Thank you. Behzad?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you, Chau. Good afternoon everyone, and thank you for joining us. We entered 2020 with strong momentum. While the first quarter was primarily focused on completing the FDA review and executing on ongoing priorities, the last several weeks have been monumental for the company. The hard work, commitment and dedication of our colleagues at Immunomedics over the last three years have culminated into a series of accomplishments that establish us as a fully integrated commercial biopharmaceutical company. The approval of Trodelvy by the FDA exemplifies our commitment to deliver breakthrough therapies to help transform the lives of those with hard-to-treat cancers. This commitment is further demonstrated by our commercial team. We were successful in making Trodelvy available to people with mTNBC shortly upon FDA approval. As noted in our press announcement this past Monday, Trodelvy was shipped to our specialty distributors last week and the first patient was treated with commercial product exactly a week ago today, exactly one week after FDA approval.
Equally importantly, our regulatory and market access teams have already completed the national drug rebate agreement with the centers for Medicare and Medicaid services. As a result of our teams mobilizing quickly, for Medicaid specifically, states are now generally obligated to cover Trodelvy as of July 1st, three months ahead of our scheduled timeline and a big win for Medicaid patients. The Rebate Agreement is also prerequisite for Medicare. Another key event this year is the early halting of Phase 3 ASCENT study due to compelling evidence of the efficacy across multiple endpoints. We have begun the process of cleaning the database, which will result in database lock and ultimately the unblinding of the study. Top line readout remains on track for mid-2020. We also look forward to the top line data from the first cohort of 100 patients who were previously exposed to platinum-based and PD-1 and PD-L1 inhibitor therapies in the TROPHY U-01 study of patients with metastatic urothelial cancer.
As previously disclosed, these data could potentially support a BLA submission for accelerated approval to the FDA which has recently granted Trodelvy Fast Track designation in this indication. For the second cohort of patients who are platinum ineligible and have progressed after prior checkpoint inhibitor therapy and abstract containing early results has been accepted for poster presentation at this year's ASCO virtual meeting. An additional abstract from a Phase 1/2 study of Trodelvy in patients with previously treated metastatic endometrial cancer has also been accepted for poster [Phonetic] presentation at the same conference.
In other clinical developments, we have entered into a clinical collaboration with the Dana-Farber Cancer Institute and Merck to study the combination of Trodelvy with pembrolizumab and anti-PD-1 antibody in two separate Phase 2 studies. The first study enrolled approximately 110 patients newly diagnosed with PD-L1 negative mTNBC. These patients will be randomized to receive the combination of Trodelvy and pembro versus Trodelvy alone. The same combination of Trodelvy and pembro will be used in the second randomized study in approximately 110 hormone treatment and chemo refractory patients with PD-L1-positive, hormone receptor positive, HER2-negative metastatic breast cancer. Both studies will have PFS or progression free survival as the primary endpoint. Overall survival, overall response rate, duration response and clinical benefit rate will be used at secondary endpoints.
Financially, the company completed an oversubscribed public offering and we have added approximately $465 million to our balance sheet. Furthermore, the approval of Trodelvy triggered a $60 million contractual milestone payment from Everest Medicines, our partner in China, who recently announced the approval by the Chinese regulatory authority to initiate a pivotal Phase 3 study of Trodelvy in mTNBC in China, which they plan to begin in the first half of 2020.
At this exciting inflection point of the company's growth, I'm also pleased to announce that Dr. John Stubenrauch has been appointed Senior Vice President, Global Head of Manufacturing. John is a seasoned executive with decades of experience with companies like AstraZeneca and Merck. He brings a strong foundational background in global commercial manufacturing. John will spearhead the initiatives that continue to scale our global supply chain, ensure supply continuity and focus across the goods optimization. With John's new role, Dr. Morris Rosenberg is stepping down as Chief Technology Officer with the company, which will be effective later in May. I would like to thank Morris, who was seminal in helping us develop our initial clinical and commercial supply chain and manufacturing processes. Morris will be pursuing a new opportunity closer to his home in the Pacific Northwest, that is focused on new product development. We wish him the very best in his future endeavor and will keenly follow his progress. Thank you, Morris. I know you're listening.
Usama will now go over the financials.
Usama Malik -- Chief Financial Officer, Chief Business Officer
Thank you, Behzad. As in the past, please refer to our quarterly filing as well as our earnings release this afternoon for additional details of our results. Total cost and expenses were $82 million for the three months ended March 31st, 2020 compared to $79.6 million for the comparable quarter ended March 31st, 2019. The increase is primarily due to a $4.3 million increase in R&D expenses and $0.2 [Phonetic] million increase in sales and marketing expenses, partially offset by a $2.1 million decrease in G&A expenses. Interest expense was $13.5 million for the three months ended March 31st, 2020 compared to $10 million for the comparable quarter March 31st, 2019. The increase was due primarily to changes in the fair value of our debt balances as a result of the agreement with Royalty Pharma.
Net loss was $93 million or $0.44 per share for the quarter ended March 31st, 2020 compared to a net loss of $87.3 million, also $0.46 per share for the comparable quarter ended March 31st, 2019. As of March 31st, 2020, the company had $540 million in cash, cash equivalents and marketable securities.
On May 1st, 2020, the company closed on its previously announced underwritten public offering of common stock with net proceeds of approximately $464 million. The number of outstanding share after the capital raise were $231 million and the fully diluted count was $242 million. As Behzad alluded to earlier, we expect to receive $60 million from Everest Medicines triggered by FDA approval of Trodelvy. We believe our projected financial resources are adequate to support the commercial launch of Trodelvy in the United States, in mTNBC, continue to expand the clinical development programs for Trodelvy, invest in the broader clinical development of the ADC platform, continued scale up of manufacturing and manufacturing process improvements and general working capital requirements.
This concludes our first quarter 2020 financial results, and I will pass it back to Behzad.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Before we open it up for questions, a few words to update on the impact of the coronavirus pandemic is having on our business. With a shelter in place recommendations taking effect, we quickly moved to remote access and work from home for all non-essential personnel. We've implemented stringent onsite monitoring and as much as feasible undertaking social distancing measures for essential onsite staff, who predominantly are comprised of colleagues in our manufacturing and quality operations. As a result, thankfully, operations have been minimally impacted to-date.
With respect to our ongoing clinical trials, we announced in late March that we were pausing enrollments of new patients and activation of new sites. While it is early to assess the precise extensive disruption to the conduct of our trials, we are confident that the impact will be manageable. In particular, the pivotal Phase 3 ASCENT study, which completed enrollment in mid-2019 was halted following the independent DSMC recommendation. We anticipate very limited impact from the pandemic. The pivotal 100 patient cohort of platinum eligible urothelial cancer and the TROPHY U-01 study also fully enrolled as of October 2019 and had significant follow-up already completed pre-COVID-19. So again, we do not anticipate significant impact.
And finally, following persistent request from investigators, the Phase 3 TROPiCS-02 study of Trodelvy in hormone receptor positive HER2 negative metastatic breast cancer will be resuming enrollment beginning later this month at select sites that have been carefully vetted for their ability to ensure normal clinical trial operations and patient safety. On behalf of all of my colleagues at Immunomedics, our thoughts and well wishes are with those impacted by the coronavirus pandemic.
Further, I would like to express our thanks to the workers who are providing essential services and helping mitigate the disruption to our lives, as well as recognize the medical personnel who are combating this disease on the front lines. I would also like to extend my special gratitude to my colleagues at Immunomedics who continue to work tirelessly toward fulfilling our mission of delivering these breakthrough medicines to patients in need. As the lines between the days of the week, the evenings and nights and the weekends have blurred, we find ourselves often putting in even more hours than prior to the outbreak. I understand this phenomena is playing out across our sector and know that also beyond, may this all pass soon.
Operator, please open the call for questions.
Questions and Answers:
Operator
Thank you. [Operator Instructions] Our first question comes from Phil Nadeau with Cowen & Company. Your line is now open.
Phil Nadeau -- Cowen & Company -- Analyst
Phil, do you have us on mute?
Operator
Once again our next question comes from Phil Nadeau with Cowen & Company. Your line is currently open.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Operator, we're getting emails from folks that are having hard time getting on the Q&A line. Is there -- can you check the lines?
Operator
[Operator Instructions]
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Let's move to the next question please.
Operator
The next question in the queue comes from Michael Schmidt with Guggenheim. I'm sorry.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Operator, I have a note here that says there are some issues with the dial-in, all sound has dropped.
Operator
One moment please. Speakers, are you able to hear me?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yeah, we can hear you.
Operator
Understood. One moment, we're testing the audio for now. The next question in the queue, it goes to Michael Schmidt with Guggenheim. Your line is now open.
Michael Schmidt -- Guggenheim Partners -- Analyst
All right, can you hear me?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yes, we can Michael. I don't know how much or what we have to say, you heard?
Michael Schmidt -- Guggenheim Partners -- Analyst
Yeah, I don't know. I just see the operator. Well anyways, why don't I just ask the question. The one I had was on TROPiCS-02. I appreciate the comment you made on enrolling the study and the investigator enthusiasm. We've gotten some questions really on understanding the read-through about success probability of this study from the ASCENT trial. And maybe if you could just help us understand the timing potentially of the interim analysis that you've talked about, which is based on response rate and also help us understand how we should think about potential benchmarks and the control arm in this trial?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Sure, Michael. Thanks. Look, we haven't provided timing on when the interim might occur and that was even before the coronavirus pandemic to close. And it's really too early to judge exactly what happens from here on up until the time when we slowed enrollment or stopped initiating new study sites, we were enrolling extremely well. And so once we resume here, hopefully we can regain momentum pretty quickly and that will then inform us when we would take that interim and as we get closer, we'll certainly communicate the timelines. But my hope is that the delays or disruptions will be very limited and then entirely manageable.
With respect to the benchmark, what we generally said is obviously these are distinct patient populations with triple-negative on the one hand, on the other hand, in the very late line in refractory setting where we're studying then struggling TROPiCS-02. We were told by the physician community that the patient population presents themselves with a very similar outlook to the triple-negative community. And the chemo options available to them are in fact very much the same ones that they would be using in the triple-negative opportunity. Setting in those are exactly what the combined control arm, which is cape, gem, Eribulin and Vinorelbine.
So as a result, my expectation would be, and based on some literature work that we've done, obviously on retrospective albeit some of them are more recent contemporary in the study. I would expect response rates on the order of high single-digit, low double-digit, and I would expect duration of responses of perhaps three or so months, very much similar to the triple-negative opportunity. Now that is -- I wanted to heavily caveat that based on literature and the feedback we're getting and obviously this is why we're running the study. But those are generally the benchmarks I would use, which is why I'm hopeful and encouraged by this assessment by the DSMC on a sense that it will hopefully also translate over into what to read -- what the TROPiCS-02 will read out at.
Michael Schmidt -- Guggenheim Partners -- Analyst
Great. Thanks. Then maybe just a question on Trodelvy and the initial experience. I realize it's only been a short amount of time since the drug has been on the market. But just wondering if you could just share a little bit of initial feedback and whether the initial experience has met your expectations so far?
Brendan Delaney -- Chief Commercial Officer
Yeah. Michael, how are you. It's Brendan Delaney. Yeah. So I would say that so far so good, it's early as you recognized. But I think we managed the launch, especially in these first two weeks on an almost an hourly basis. And we're meeting all the tactical implementation and things from that perspective. So certainly internally, I think we're meeting all our guidelines. I think it was important as we announced that the drug was available within days, which was an important kind of milestone that we were holding ourselves to because, we know patients are waiting. And so far, so good I would say. I think the feedback from the physicians, as you can imagine, physicians are excited for their patients obviously, but the reaction to the prescribing information and the support services and top to bottom, what we put out there is pretty well received so far. So it's early, but so far so good. We're pleased.
Michael Schmidt -- Guggenheim Partners -- Analyst
Okay, great. Thanks. I'll hop back in the queue.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thanks, Michael.
Operator
Thank you. [Operator Instructions] Our next question comes from Peter Lawson with Barclays. Your line is now open.
Peter Lawson -- Barclays PLC -- Analyst
Hi, thanks for taking my questions and congratulations on the progress. As we think about the launch, what type of metrics do you anticipate providing going forward and kind of the milestones you're setting yourself internally. How are you kind of viewing the successful launch? And I guess that's particularly pertinent, if we think about -- in this time kind of social distancing. Thank you.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Sure. Maybe I'll start there, Peter and then hand it also over to Brendan. And welcome to the party here, Peter. Look forward to working with you in the future. Look, obviously sort of two sets of ways to answer your question. One is perhaps more traditional metrics that we'd be tracking internally and I'm pretty sure we're not going to share those. And then obviously in the COVID environment, we'd also put in place a number of new measures that we want to make sure as a proxy that we'll be tracking to have, Brendan sort of speak to it a little bit on both of those. I think just from what we expect in the near-term, we certainly don't anticipate to be providing directional detailed guidance in the near-term, it's very, very early days. We'll need a little more reps under our belt before we're willing to do that.
On the other hand, it's sort of pretty straightforward if our prevalence numbers and opportunity in the US hold true. We certainly want to report revenues, we'll also tie that to pass number of accounts and we'll get a better sense over-time with the duration of therapy or what the average weight and sort of the actual sort of utilization of Trodelvy with respect to vials, etc. All of that will feed into what the overall revenue trajectory might look like, as well as, on the margins also gross to net adjustments, so very much traditional metrics that we'll be providing visibility into.
Brendan, do you want to comment on any kind of early -- on the metrics.
Brendan Delaney -- Chief Commercial Officer
Yeah. And so Peter just to add on to what Behzad was saying. Across these function we've pretty robust, key performance indicators in place. And if I remind obviously, sales targets, not just the dollar targets, but also the calls, calls frequency, the standard stuff that you would have, marketing, obviously measuring some of the promotional programs in that way and also obviously the market access side as well, measuring the quality of our access and some of that stuff we may choose to share along the way just to give you a sense of payer kind of reaction to the launch. So all of that is in place and being tracked as you would expect.
I think you also had a question on what I interpreted as a COVID type of kind of look at the launch and then the metrics. I think, from that perspective we're measuring things a little differently because many of our interactions are virtual interactions, where an interaction that might've been face to face in this time has been a video conference or a teleconference. So we're adjusting a little bit for that. But in general, I would say I'm pleased given the circumstances that how our team is executing in this kind of these odd times of launching a drug within this pandemic. And from that, where physicians are excited about the drug and they're making time for our representatives to educate and they're doing it proactively, right? So not only, are they looking to engage our folks proactively, because of the excitement, the drug, they're also taking steps to get the drug on formulary in their institution and things, there is a groundswell of excitement there, which is great to see. So I think so far so good. Nothing replaces a face to face interaction, I would say that we can claim that, but we're pleasantly surprised with how effective some of our virtual kind of means of communications if you will have been, because we didn't plan for it for around two and a half, three months. We had an early start on it and our teams are enabled with the right technology and from that perspective we're doing what we need to do and driving awareness these early days.
Peter Lawson -- Barclays PLC -- Analyst
Great, thank you. Just a quick follow-up around TROPHY study, is that more of a year end readout?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
They're a little hard to give the right guidance to some extend we're bound by which conference that we'll actually take place and when we submit. So as soon as we have that submission that takes place and accepted we'll -- as it is conventional around the time of the abstracts title releases is what we'll communicate.
Peter Lawson -- Barclays PLC -- Analyst
And I see you'd probably prefer a non-virtual conference. Just any comments around that?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
I think, we'd all prefer one of those if they return.
Peter Lawson -- Barclays PLC -- Analyst
Okay. Thanks so much. Thanks for taking the question.
Brendan Delaney -- Chief Commercial Officer
Thank you.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thanks Peter.
Operator
Thank you. And our next question comes from Phil Nadeau with Cowen & Company. Your line is now open.
Phil Nadeau -- Cowen & Company -- Analyst
Thanks for taking my questions. Apologies for before, I think I was cut off. Just one question on the launch of Trodelvy, I apologize if this was asked. Given the COVID situation, are women able to get prescribed Trodelvy through telemedicine or virtual visits or are there any requirements for reimbursement or whatnot that they actually have to go into the physician's office? And I apologize if you've already addressed this, but I'm kind of curious, how it could impact your uptake?
Brendan Delaney -- Chief Commercial Officer
I haven't addressed that specifically, but as far as a patient being prescribed, I'm sure there can be some councils, which is now reimbursed as you know Phil with telemedicine and those types of councils, as far as patient obviously has to come in to receive the infusion. From what we hear from physicians, those patients because of the aggressiveness of the disease and the urgency in the later line setting, those patients are still coming in and being scheduled. So as far as how it works and where that can be done potentially remotely, I think some institutions are actually considering that and there are dealing with councils from telemedicine, but the infusions need to happen obviously in the clinic and those appointments are being scheduled from what we hear from the oncologists out there.
Phil Nadeau -- Cowen & Company -- Analyst
And second question is on the TROPiCS study. The press release news feed is going to resume in May. What are your latest expectations for when enrollment could complete and therefore when we could see the interim analysis?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
So Phil, that question was asked. We'll answer it again. We haven't said really previously, obviously guidance had been year end full enrollment. For the interim, we only need a subset of patients, we haven't quantified that and until we get back into the game here with patient enrollment and see what that trajectory looks like. Leading up to the stoppage, we obviously have very strong momentum. So we hope to be able to resume that at least in the centers that we're opening. And once we get a better handle on and we get closer to the timeline, we'll share that. Overall, I hope that we come out of this in next time we get on the phone with you all.
Brendan Delaney -- Chief Commercial Officer
We'll be able to narrow that down back and give a cleaner view of what the impact is. But my hope is that it will be perhaps as non or very, very minimal impact to prior directional updates that we've given in terms of enrollment timelines, but it's really too early to assess that.
Phil Nadeau -- Cowen & Company -- Analyst
Great. And then last question from me is just on second line reimbursement. In the past, Immunomedics has suggested that the data that you had in house could be sufficient if presented at a medical meeting or published to get compendia listing and second line reimbursement in triple-negative breast cancer. What are your more recent plans for allowing reimbursement second line and maybe moving up Trodelvy into the second line, even in the absence of another trial?
Brendan Delaney -- Chief Commercial Officer
Yeah. So I don't recall, it was receptive triple-negative, talking about Phase, second line data being published for NCCN or in fact were only as part of our IHC studying the product in that setting. But we haven't generated data in second line setting. What we might have discussed in prior conversations is the fact that the front line therapy, especially for PD-L1 positive patients is now Tecentriq with Abraxane. And the label as written for Trodelvy is two part therapies in the metastatic sedate, not necessarily specifying what kind of therapies and in which sequence they need to be administered. So we are obviously going to stick with a third line opportunity with respect to how we detail it based on the label. But whether individual physicians might want to make the case that patient has seen two priors in the frontline setting because of the combination would perhaps qualify them for Trodelvy. And that the insurance companies accept that. That's obviously a conversation that happens between the physician and the reimbursement authorities. But now, it's not something that we would be promoting.
Phil Nadeau -- Cowen & Company -- Analyst
Got it. Thanks for taking my questions and congrats again on the progress.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you, Phil.
Operator
Thank you very much. And our next question comes from Joe Catanzaro with Piper Sandler. Your line is now open.
Joe Catanzaro -- Piper Sandler -- Analyst
Hey guys, thanks for taking my questions here and apologies if these were already asked. Maybe one first on the launch and recognizing that it's early days, but any sense whether you're seeing quick switches off single agent chemo ahead of documented progression on Trodelvy, whether physicians are reaching for it very quickly knowing the poor outcomes that patients may have with single agent chemo. And then I just have a follow-up on ASCO presentation.
Brendan Delaney -- Chief Commercial Officer
Yeah, Joe, it's Brendan. I think it's too early to tell, but outside of being very early, I'm not sure will -- based on the type of data that we'll have here, which is basically 867 data at the institution level, it's going to be difficult to get that type of data. Now one can speculate over time as we get enough experience in duration of therapy with chemotherapy at the end of the day, it's going to be very hard to -- it's going to be very hard to get into that type of detail on where those patients are coming from.
Joe Catanzaro -- Piper Sandler -- Analyst
Okay. Got it. Fair enough. And then maybe one on ASCO, specifically the endometrial presentation. Can you just remind us, we've seen data for sacituzumab within endometrial yet, how do Trop-2 levels compare in this indication? And the data from this cohort actually informed your decision to include endometrial in the Trop-2 enriched basket trial? Thanks.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Sure. I don't think we've previously discussed much around endometrial and certainly not that Trop-2 levels. This is a study that's been done as an IHC that we've sponsored. And it was sort of independent of us including it as part of our basket. So let's just wait until we see the data and whether the profile supports advancing it and sort of further development. It's certainly something we'll keenly sort of follow here in the near-term and decide as we get to that point.
Usama Malik -- Chief Financial Officer, Chief Business Officer
Joe, just to follow up on that. So this is Dr. Santin from Yale, who's conducting the study. He'll be presenting -- he's previously published some preclinical results again with sacituzumab in endometrial, also talking about expression of Trop-2 in that specific tumor type that you can reference.
Joe Catanzaro -- Piper Sandler -- Analyst
Great. Thanks so much and congrats on the progress here.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you.
Operator
Thank you. And our next question comes from Jim Birchenough with Wells Fargo Securities. Your line is now open.
Nick Abbott -- Wells Fargo Securities -- Analyst
Good afternoon, it's Nick on for Jim this afternoon. On the newly announced TNBC trials, why partnered with Merck and Dana-Farber versus say a company-sponsored Phase 2/3 trials presumably but around expansion into Phase 3 more rapidly?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
I'm sorry -- I just didn't hear -- the question came a little bit muffled on the call. Could you ask it again please?
Nick Abbott -- Wells Fargo Securities -- Analyst
Yeah, let me repeat. On the newly announced TNBC trials, why partnered with Merck and DFCI when presumably a company-sponsored Phase 2/3 trial would allow you to expand more rapidly into Phase 3?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yeah. So it's a good question to have. One doesn't preclude the other, this is something that there was a lot of excitement by the other two parties to do this study. And we have already discussed the financials, but it's something that we generally will provide some drug and it's a great way to generate more excitement and get data quickly.
Obviously, Dana-Farber has been a supporter of Trodelvy all along and so this I think is going to go pretty quickly as well, but certainly one doesn't preclude the other. And as we free up our families and resources and these go from one class to the other and certainly something that we are, it's a high on our radar and we look forward to studying and launching the programs. But it's generally always a good idea to get more information and more signal out of various potential combination partners and this is one very I think elegant way of doing it without incurring too much expenses on our capital as well as on our resources, which are very valuable I suppose.
Nick Abbott -- Wells Fargo Securities -- Analyst
And then the second one, you have some ongoing trials with Talzenna on TNBC and Rubraca on solid tumors. When should we expect to hear something about those trials?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
You're talking about two studies of sacituzumab in outside of the breast and lung and you would see no indication.
Nick Abbott -- Wells Fargo Securities -- Analyst
With Talzenna, the PARP inhibitor combination.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
A combination with BSO, actually maybe I'll make an overarching statement with respect to all the partnered studies. So in the case of the PARP study you're referring to that's being conducted by Clovis and they're doing all the works. So the timelines are a little bit covered by them. And the same holds true in the combinations of PD-L1 with AstraZeneca and with Roche. So the timeline in those instances, because they're run by the companies it's really governed by them and we can't really comment on when we might see the data.
Nick Abbott -- Wells Fargo Securities -- Analyst
Okay. And then just last one from me, as noted in the press release, the recent raise will help invest in the ADC platform including IMMU-130 and IMMU-140. So what should we expect as communications about ADC is beyond Trodelvy?
Brendan Delaney -- Chief Commercial Officer
No, I think unfortunately there's sort of an early going into a little bit perhaps unexciting and that we first have to now that we are up and running in launch and hopefully get other supplies for Trodelvy or we can divert our attention on a manufacturing standpoint to getting some of these pipeline assets moving. Alternatively, we'll be looking for other manufacturing partners that could potentially manufacture the program.
The challenge whenever you have an ADC is just the long lead time with respect to making the product and then doing all the PPQ runs and validating the product. But in the very near-term, there won't be unfortunately much news flow other than perhaps as we progressed to these early periods of finding the manufacturing capacity and then moving it along. That's sort of the updates really expect until this product reaches the clinic. In the case of -- these have generated meaningful data as we can perhaps move quickly once we reach that point. But again, for the very near-term, it's supposedly going to be around the manufacturing and supply chain aspects of it.
Nick Abbott -- Wells Fargo Securities -- Analyst
Okay, great. Thank you very much.
Brendan Delaney -- Chief Commercial Officer
Thank you.
Operator
Thank you. And our next question comes from Roger Song with Jefferies. Your line is now open.
Roger Song -- Jefferies LLC -- Analyst
Thank you. Thank you for taking the question. So maybe just a couple from me. So as I can see for the newly announced Trodelvy with pembrolizumab, the combo study. So it seems that you're studying both PD-L1 positive and negative. And I'm just curious, how do we expect Trodelvy where performing both setting given, you test both TNBC and HR-positive?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Right. So the HR-positive population, we're studying it in PD-L1 negative.
Usama Malik -- Chief Financial Officer, Chief Business Officer
Positive greater than 1%.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Greater than 1%, in the triple-negative indication, we're looking at PD-L1 negative patients. So you have to just make that, I just want to make sure you understand the distinction between the two populations. One is PD-L1 positive greater 1%, less than 1%. Triple-negative is the less than 1% PD-L1 negative. In general, I would say that we don't believe but we only have very limited data but I don't think prior checkpoint or PD-L1 expression levels will be a important marker with respect to the activity for Trodelvy.
Obviously it's important marker with respect to activity on the checkpoint, but this study will hopefully generate some interesting signals to show that first of all the agents combined will be tolerable and then either agent can contribute to activity and perhaps even in this ideal world, PD-L1 negative patient into a responding patients for the combination of the two i.e. turning a cold tumor hot through perhaps mechanism of a chemo stimulants here.
Roger Song -- Jefferies LLC -- Analyst
Got it. Yeah, that makes sense. Thank you. Maybe another kind of quick question for the OpEx. So I noticed the R&D cost was sequentially lower than last quarter. And just curious what should we think about this moving forward given way to deal kind of launching new studies and in your indication?
Usama Malik -- Chief Financial Officer, Chief Business Officer
Yeah, absolutely. So keep in mind that as a pre-revenue company, we were expensing across the board, so even manufacturing expenses were captured in R&D. Moving forward as a commercial company, obviously the reporting on those expenses will change and where they get reported. As it pertains to our development plan, I think we're pretty transparent about that. There were a number of studies that we launched last year that will be culminating this year and other studies that are closing out this year. So on balance, we expect the R&D spend to remain pretty consistent unless we launch additional new studies. And the balance that changing on the R&D expense is very incremental really. So you don't really see a change there.
Roger Song -- Jefferies LLC -- Analyst
Got it. Yeah. Thank you. Yeah, that's helpful. Thank you. Congrats again.
Usama Malik -- Chief Financial Officer, Chief Business Officer
Thank you.
Operator
Thank you. And our next question comes from Matthew Harrison with Morgan Stanley. Your line is now open.
Vikram Purohit -- Morgan Stanley -- Analyst
Hi, this is Vikram on for Matthew. Congrats on the quarter. And thanks for taking the question. Could you help us -- the patient for the cohort two from TROPHY U-01, which will be presented at ASCO?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yes. What is the question with respect to those patients?
Vikram Purohit -- Morgan Stanley -- Analyst
Yeah. So what what level of efficacy we are expecting -- that kind of --
Brendan Delaney -- Chief Commercial Officer
I think this will be, I think the first time that we will be presenting data in the study, I certainly don't want to sort of form on the data presentation. I think generally speaking, the efficacy in this population is not going to be that different to the chemo eligible population in the front-line setting. So I think anything that differentiates in the refractory setting above the 10% or so threshold is it's going to be a meaningful advance for these patients also.
Vikram Purohit -- Morgan Stanley -- Analyst
Okay. That's helpful. Also could you comment a little bit more on the process of [Indecipherable] sites for TROPiCS-02 study at any specific or detail the challenges and the corresponding care?
Usama Malik -- Chief Financial Officer, Chief Business Officer
You mean in relation to the enrollment?
Vikram Purohit -- Morgan Stanley -- Analyst
Yes.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
The question is what is the impact going to be or I guess I just missed it. I'm sorry. We are reinitiating enrollments into the study later this month at select sites that we specifically have evaluated to make sure that they can actually manage a patient from the very early days throughout their whole treatment period, including all the follow-ups and safety and efficacy assessments required. And once we get back into that mode, we'll get a better sense of what that trajectory looks like. Coming into this period, enrollment was very robust and our hope is that we can quickly stop picking up steam again. And as soon as we get a handle on it, we'll give an update on what the overall impact is going to be with our enrollment timelines. Previous to COVID, we have said end of year 2020 has full enrollment, we'll always need to restart enrollment and see how that goes whether we can stay on track or not. My hope is that we can get up quickly and hopefully any impact -- if there is an impact, it's going to be a minimal, but it's just impossible to predict that.
Vikram Purohit -- Morgan Stanley -- Analyst
Okay. Got it.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Any other questions, operator?
Operator
[Operator Instructions] I'm showing no questions at this time. I'd like to hand the conference back over to Chau Cheng for his closing remarks.
Chau Cheng -- Senior Director-Investor Relations
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.
Operator
[Operator Closing Remarks]
Duration: 43 minutes
Call participants:
Chau Cheng -- Senior Director-Investor Relations
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Usama Malik -- Chief Financial Officer, Chief Business Officer
Brendan Delaney -- Chief Commercial Officer
Phil Nadeau -- Cowen & Company -- Analyst
Michael Schmidt -- Guggenheim Partners -- Analyst
Peter Lawson -- Barclays PLC -- Analyst
Joe Catanzaro -- Piper Sandler -- Analyst
Nick Abbott -- Wells Fargo Securities -- Analyst
Roger Song -- Jefferies LLC -- Analyst
Vikram Purohit -- Morgan Stanley -- Analyst
