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Immunomedics Inc (IMMU)
Q4Â 2019 Earnings Call
Feb 27, 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 is Thursday, February 27, 2020. At this time, I would like to turn the conference over to Chau Cheng, Senior Director of Investor Relations of Immunomedics.
Chau Cheng -- Secretary & Senior Director-Investor Relations
Thank you, Sarah. Before we begin, I would 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 and Chief Business Officer. Also on the call for Q&A is 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, Charles. Good afternoon everyone and thank you for joining us. With the foundation we laid in 2019, 2020 promises to be an exciting year for Immunomedics. Our top priority for 2019 was the resubmit a high quality BLA for sacituzumab govitecan or SG in late-line metastatic triple-negative breast cancer or mTNBC. To that end, we are pleased to have resubmitted BLA in November 30 and received notification from the FDA in December that the BLA was accepted for filing with a PDUFA date assigned of June 2, 2020. Consistent with industry practice, we're not going to provide details of our regulatory interactions as we are now in an ongoing FDA review period, other than to say we are pleased with the progress to-date. Beyond that, we are keenly looking forward to the FDA action on or before the June 2 PDUFA date. It goes without saying that our near-term number one priority and mission is the approval of sacituzumab govitecan. For all the hard work that has enabled us to reach this point and to get us over the finish line, I'm grateful to my colleagues in manufacturing, quality regulatory affairs and safety.
During 2019, we also laid the foundation for a number of upcoming clinical readouts. Let me begin with ASCENT, our confirmatory Phase III study of sacituzumab govitecan versus treatment of choice in third-line mTNBC patients. It took less than 20 months to complete enrollment of more than 500 patients in the US and Europe into this study. We attribute the success of the unmet need and our investigators excitement in the ability of SG to help patients who are in dire need of new viable treatment options. Since the end of enrollment in July 2019, we've been monitoring the number of events that will trigger the unblinding of this study. As of the most recent sweep, topline readout remains on target for mid-2020 readout. Meanwhile, we are witnessing the same level of enthusiasm from breast cancer KOLs for TROPiCS-02, our registrational Phase III study in hormone receptor positive HER2- metastatic breast cancer, which we launched last summer. This breast cancer subtype is about 3 times the size of TNBC population. For patients who fail hormonal and CDK46 treatments and two lines of chemotherapy, the same unmet need exist as in late line mTNBC. Given that in this late-line setting, commonly used chemotherapy options offer similarly poor result rate, response rates and PFS in the range of two to three months, comparable to the advanced stage mTNBC patients, we believe a positive ASCENT readout could bode well for SG in TROPiCS-02 which follows a very similar trial design and has the same four chemotherapies in the control arm. Complete enrollment of the targeted 400 patients in TROPiCS-02 is expected by the end of 2020. As previously disclosed, the study allows for an analysis based on overall response rate of a prespecified subset of patients which could form the basis of a potential accelerated approval submission.
To further address the critical unmet need for patients with breast cancer in September 2019, we entered into a clinical collaboration with Roche to potentially advance SG to earlier lines of breast cancer treatment. Using its novel cancer immunotherapy development platform MORPHEUS, Roche is studying SG combined with Tecentriq against Abraxane plus Tecentriq, the recently approved doublet for patients with newly diagnosed mTNBC. In the curative setting, our collaboration with the German Breast Group, which was announced in September 2019 will assess SG as a monotherapy in a multinational Phase III study in approximately 1,200 high-risk patients with HER2- breast cancer who do not achieve a pathological complete response following standard new adjuvant therapy. These collaborations, together with our internal development programs, underscore our goal to establish SG as a foundational therapy in breast cancer. Collectively, they are designed to address virtually every stage of treatment in TNBC at the same time bolstering our competitive positioning in HR-positive HER2- metastatic disease.
Additionally as a patient-focused company, I'm proud to announce that working in close collaboration with the FDA, we instituted an expanded access program for mTNBC patients earlier this year. This program demonstrates our commitment to transform the lives of patients with hard-to-treat cancers. Moving onto metastatic urothelial cancer, at the ESMO 2019 Congress last September, we reported in an oral presentation interim results from TROPHY U-01, showing encouraging 29% response rate in 35 patients treated previously with platinum based and immune checkpoint inhibitor therapies. This result was highly consistent with the previously reported clinical activity of SG in this setting. With the enrollment of the 400 patients completed in October 2019, we expect results from this cohort to be available in the second half of 2020. This data could potentially support an accelerated approval submission. We also expect the signal seeking second cohort of 40 cist ineligible patients to be fully enrolled data this year. Importantly, as in breast cancer, we believe SG's favorable efficacy and safety profile could make it a strong combination partner in urothelial cancer as well. As such, today we are announcing that we've brought in TROPHY U-01 to include a third exploratory cohort of SG and Keytruda in combination in patients who have relapse or are refractory to platinum-based therapies, but are naive to checkpoint inhibitor therapy. We expect the first patient to be enrolled in the very near term. For earlier stage studies, we initiated the multi-cohort open label Phase II TROPiCS-03 study in July 2019 and dosed the first patient with non-small cell lung cancer in October. This is the first biomarker enrich study we have launched to help us to answer the question if enrichment for TROP-2 expression could lead to higher responses. We hope to have a preliminary answer later this year or early next based on enrollment.
Another early phase study was launched this month by Dr. Alessandro Santin, professor obstetrics, gynecology and reproductive sciences at Yale University who initiated a Phase II study to investigate SG in patients with persistent or recurrent endometrial cancer. Dr. Santin had previously treated a patient with a recurrent widespread treatment resistant uterine serous carcinoma with a dramatic response and in preclinical studies, Dr. Santin found that endometrial cancers over excess stroke-2 and are sensitive to SG. To help support this robust clinical development activities we bolstered our balance sheet in December through a public equity offering for approximately $273 million. We also raised non-equity capital in April 2019 when we licensed SG to Everest medicines for Greater China, South Korea and certain Southeast Asian countries for $65 million upfront and $60 million to be received upon US FDA approval. We're also eligible to receive development and sales milestone payments of up to $710 million as well as escalating tiered royalties that begin in the mid-teens, making the partnership the largest single asset biologics license agreement for Greater China to date.
In other successful partnership we entered into last year was the promotion agreement with Janssen to provide detailing services for the FGFR inhibitor Balversa. This agreement will conclude at the end of March of this year. Importantly, the Jans agreement has allowed us to maintain our commercial footprint. As a result, our commercial team is actively preparing for launch readiness and we believe we are well positioned to commercialize SG upon approval on or before the June 2 PDUFA date.
A few noteworthy updates on building out our organization. Earlier this month, I was thrilled to announce that Dr. Loretta Itri has agreed to join us as a permanent Chief Medical Officer. Loretta is a highly accomplished pharmaceutical executive with decades of experience and a strong track record of bringing innovative drugs to market for multiple biopharma organizations. In her new role at Immunomedics, Loretta will lead all research and clinical development, regulatory and medical affairs activities. I've had the pleasure of working with Loretta since the spring of 2019 when she was a consultant for the company. Under her leadership, we've made tremendous advances across multiple pivotal or registrational studies as well as establishing collaboration with some of the world's top biopharmaceutical companies and cancer centers to move SG up in line of breast cancer treatment and broaden it to other Trop-2 expressing cancers. I look forward to standing by her side when we unveil the numerous clinical readouts that lie in the not too distant future.
This evening in a separate press release, we also announced and are honored to have Robert Azelby join Immunomedics Board of Directors. Bob joins us at a critical juncture as we are preparing for the first commercial launch pending FDA approval. He brings to Immunomedics over 28 years of biopharmaceutical experience with a deep focus on commercial operations. Bob was CEO of Alder BioPharmaceuticals until its recent acquisition by Lundbeck. Previously he served as the Chief Commercial Officer of Juno Therapeutics where he helped guide the organization through a period of rapid growth and ultimately to a $9 billion acquisition by Celgene. Prior to Juno, Bob spent 15 years at Amgen leading the US Oncology business. He holds a B.A. from the University of Virginia and an M.B.A. from Harvard Business School.
And finally, our objective remains to have a CEO in place ahead of commercial launch and we're optimistic to meet that goal. And with that let me reiterate that 2020 is going to be an exciting year for Immunomedics. We have a number of key events we are planning to have including potential commercial launch of SG in the US, the ASCENT read out, the TROPHY U-01 topline readouts and completion of TROPiCS-02 enrollment.
And with that, Usama?
Usama Malik -- Chief Financial Officer, Chief Business Officer
Thank you, Behzad. As in past earning calls, I will provide topline results here and ask that you refer to our annual filing as well as our earnings release this afternoon for additional details. As noted by Behzad moments ago, we expect to receive a $60 million payment from Everest upon the potential approval of SG in the US. In addition, even though the Janssen agreement expires at the end of March, in terms of revenue, we are eligible to receive royalties and milestone payments based on Balversa sales throughout 2020. Total costs and expenses were $91.5 million for the quarter and $325 million for the year ended December 31, 2019 compared to $87.4 million for the comparable quarter and $235.4 million for the year ended December 31, 2018. The increases were primarily due to an increase in R&D expenses, mostly attributable to activities related to preparation for the approval and commercial launch SG for patients with at least two prior lines of treatment for mTNBC in the United States and CRL remediation costs including outside manufacturers organization services cost and external consulting services to improve our manufacturing and regulatory functions. The increase in R&D costs were partially offset by decrease in G&A expenses, which is primarily due to decreased legal and advisory expenses resulted from reduced reliance on outside legal counsel, as well as a decrease in other and consulting services, partially offset by an increase in labor costs. Net loss was $99.6 million or $0.50 per share for the quarter ended December 31, 2019 compared to a net loss of $93.5 million, also $0.50 per share for the comparable quarter-ended December 31 2018. For the year ended December 31, 2019, net loss was $357 million or $1.84 per share compared to a net loss of $310 million or $1.74 per share for the year ended December 31, 2018. As of December 31 2019, we had $613 million in cash, cash equivalents and marketable securities, the number of outstanding shares was 213 million and the fully diluted count was 225 million. We believe our projected financial resources are adequate to accelerate commercial launch readiness, pending FDA approval of SG in the United States in mTNBC, continue to expand the clinical development programs for SG, continued scale up of manufacturing and manufacturing process improvements and general working capital requirements.
This concludes our fourth quarter and full year 2019 financial results. Operator, please open the call up to questions.
Questions and Answers:
Operator
Thank you.
[Operator Instructions]
Our first question comes from the line of Tazeen Ahmad with Bank of America. Your line is now open.
Tazeen Ahmad -- Bank of America -- Analyst
Good afternoon. Thanks for taking my questions guys. So maybe with that, I'll ask you the one that I've been getting inbounds on the most which is with the ASCENT study set to read out not too long, let's say, topline, not too long after your PDUFA for SG, why do you still, it makes more sense, still think it makes more sense for FDA to approve the drug on time by the PDUFA versus waiting a little bit longer just to see the topline data and maybe you could also walk us through what work would need to be done once you got the topline data to deliver all the detailed information to the agency as well? Thanks.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Sure. Thanks for the question Tazeen. So first of all, it's really not on me or my decision whether to wait for that data or not. It's the FDA's decision obviously, but I think our timelines are pretty clear, the PDUFA is pretty clear. I can assure you, mid 2020 is somewhat after the June 2 day, it's actually quite hard to predict exactly when that event, when the triggering event will occur. We're getting closer by the day. But at the same time, there are not very many events that remain as a result of, if you will, the error bars around when that triggering event will occur is not necessarily narrowed and by extension our topline readout, we have a sense of roughly when it might come but it's subject to a lot of variability, obviously ultimately based on when the triggering event occurs. So I think the timelines are pretty well laid out and our broadly communicated included the agency. And so I think if the PDUFA June 2 date stands and I will really refrain from further commenting on the dialog we've had with the agency. Beyond giving those sort of ranges. With respect to the work that remains, once we hit the triggering events, that has to get adjudicated. So we will be notified by the local assessment and then the batches. The last set of sort of patients get shipped off to the central adjudication and it's only based on central adjudication that we will then call the event of having occurred, which will then trigger in a series of data cleanup efforts by our CRO, you do a database assessment and try and reach a, if you will, a quality database, at which point you can lock it. It's usually a probably a iterative process because the very first time. You do such a data cut, not the data cut, sorry a database assessment, you will find a larger than acceptable, number of data gaps. And then the field force goes out collects the data comes back and that's iterated until you reach the point of an acceptable database. And at that point, the database is locked and within a few weeks, the top line results will become available. That whole process is not any significant to undertaking. Beyond that information, compiling the informations, providing that to the FDA is generally another four to six months once it's put into the right format and shunted to the appropriate gateways to the FDA.
Tazeen Ahmad -- Bank of America -- Analyst
Okay, thanks for that. Appreciate it.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you. Operator?
Operator
Our next question comes from the line of Varun Kumar with Cantor Fitzgerald. Your line is now open.
Varun Kumar -- Cantor Fitzgerald -- Analyst
Good afternoon everyone and thanks for taking the questions. First on sacituzumab pricing. Maybe Behzad, if you can help us understand. Given it's being tested in different population, how are you thinking about the pricing with ongoing bladder cancer, triple-negative breast cancer and lung cancer studies ongoing?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Sure. Maybe I'll have Brendan comment here. I will note that obviously, we will refrain from providing pricing. In fact, we haven't established the pricing, but Brendan, maybe you can walk through sort of the puts and takes of the various aspects of our dialog and debate around.
Brendan Delaney -- Chief Commercial Officer
Yes I think we've been doing a lot of work obviously on pricing since for going back 18 months and we continue to update our pricing research for room. I think obviously we feel we're in a very strong position when you think about what the main levers are, the unmet need obviously in triple-negative is very high. The patient population is relatively small and our value proposition, we think is very strong. So in the initial launch, I think our positioning is strong. I think -- we continue to follow analogs, that's all I'll say without commenting and we do that continuously. But we also, but we also keep in mind, we think our drug has play in many indications and we keep all of those indications in mind for future planning of how a price at launch would play into those indications as well. So without providing any further detail I think that's kind of our general approach to pricing at this point.
Varun Kumar -- Cantor Fitzgerald -- Analyst
Thank you very much. And just one follow-up on urothelial cancer. Now, if I understand correctly, the Keytruda combo will be in I-O naive, but it will be post-chemo. If that's correct, can you say what's the rationale of going after post-chemo setting and not and in frontline?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Well, chemo is still the mainstay therapy for the first-line in that setting. And then, generally patients go on to either checkpoints and obviously we've seen data from checkpoint in addition to EV most recently. I think it's going to be hard to unseat chemo in the very near-term until we have established the rolled in combination with Keytruda. So that's the logic behind that.
Varun Kumar -- Cantor Fitzgerald -- Analyst
Thank you Behzad. That's all from me.
Operator
Thank you. Our next question comes from the line of Michael Schmidt with Guggenheim. Your line is now open.
Michael Schmidt -- Guggenheim -- Analyst
Hey guys, thanks for taking my question. And question on the TROPiCS-02 study. I think Behzad, you talked about potential read-through here from the ASCENT resolved. Can you just remind us what the efficacy bar is in the HER2- patient population relative to metastatic triple negative patients for the chemotherapy arm?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yes, Michael. With respect to, if you're referring to regulatory bar, then really I think the agency rarely if ever establishes an absolute number, what I would say is that the unmet need is very similar. Chemos in this setting have shown high single-digit, double digit response rates two, three months PFS and our data essentially very much as the same as the triple-negative population in that setting for the chemo arm. And our drug in metastatic breast has shown essentially very similar response rates and PFS is albeit on single-arm data as we did for triple-negative. So, both the chemo side of the equation looks the same as well as the activity side of SG look the same, and keep in mind, compared to the current ASCENT approval path where we are filing on single-arm data on response rate and duration. That's part of the application that's in sort of the FDA. This interim readout will be randomized response rate between active and control arm. So, it's not necessarily a bar, per se, because it is a randomized controlled study and you're going to get a response rate on both arms. And if it's sufficiently differentiated, it would form potentially the basis of an extended approval. Does that make sense? Is that clear?
Michael Schmidt -- Guggenheim -- Analyst
Yeah, it does, thanks. Makes sense. And just you mentioned the two new studies and triple-negative breast cancer in the pipeline setting that in the adjuvant setting, but just wondering where you are in studies that you were planning in combination with infancy Imfinzi in the past? Are those still being planned as dose or ongoing?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yes, so, as you know, those studies are being run by the partners in the case of Imfinzi by AstraZeneca, in the case of Tecentriq by Roche, and so they control the timelines, but they are absolutely planned and a leasing in one instance I think with the -- in the case of Roche, we expect a Q1 or imminent start of that study, but we don't control the timelines.
Michael Schmidt -- Guggenheim -- Analyst
Okay, perfect. Thank you.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you.
Operator
Thank you. Our next question comes from the line of Matthew Harrison with Morgan Stanley. Your line is now open.
Connor Meehan -- Morgan Stanley -- Analyst
Hi, everyone. Thanks for taking the question. This is Connor Meehan on for Matthew. So one quickly on metastatic urothelial, when do you think you could have initial data for and you see in combination with KEYTRUDA? And then just quickly versus Seattle Genetics in forda mafodotin [Phonetic], I guess how is that going to inform your investment in urothelial cancer going forward? Thank you.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Sorry, it's really too early to judge exactly when data comes, but I think the unmet need is pretty dramatic. And based on our ASCO-GU interactions, there's tremendous demand and support for this arm to open. So, allow us to get into it. We expect first patient to come on therapy I think in March. So, once we get a handle on how enrollment goes, we'll certainly be able to provide some timeline with respect to when the readout would occur. But I would follow sort of similar trials in the past and extrapolate at least for now, what the timeline could look like between first patient and when data might be available. In this case, a lot of excitement, so hopefully enrollment will go somewhat swiftly.
With respect to the data of EV, certainly impressive data in many regards, I think there was clearly potential areas of differentiation in particular on the safety side and duration on therapy. All of this is really cross talk comparisons. And those are hardly perfect and so all I can report back from ASCO-GU is that we really didn't sense any change in interest and excitement for our program and ultimately, if our data recapitulates and we can get through an accelerated approval pathway, we would probably follow very similar path at EV as followed, there's absolutely reason to believe that our drug works after EV, ahead of EV and vice versa given that we're targeting different antigens and moiety. So as a result, I would hope and think that the approval path is still open, despite there being other agents available already. And that's sort of the hypothesis under which we're operating, and where our discussions currently are with the agency.
Connor Meehan -- Morgan Stanley -- Analyst
Great, thank you.
Operator
Thank you. Our next question comes from the line of Phil Nadeau with Cowen & Company. Your line is now open.
Phil Nadeau -- Cowen & Company -- Analyst
Good afternoon. Thanks for taking my questions. A few follow-up questions on clinical trials. First, follow up to Michael's question on the TROPiCS-02 interim, can you give us a sense when after enrollment completion, that interim could be triggered and so when we could see those results?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
So, I'm a little confused which study are you referring to? Oh, the HER2-pos -- yes, TROPiCS-02, yes, I just was sort of -- since you followed up, I thought you were on the urothelial. The interim we have not disclosed, but it's in a subset of the patients. And once you have better visibility into the enrollment, it's going I would say ahead of schedule on the enrollment side. So stay tuned and we'll provide that update. But it is a response rate assessment. So it would obviously come well ahead of any ultimate full enrollment and trial readout. Sorry, not full enrollments, but the readout of the trial. [Speech Overlap].
Phil Nadeau -- Cowen & Company -- Analyst
That's helpful. And then second, you did mention a number of investigator-sponsored studies. There's two that we're aware of that you didn't mention, I was just wondering if you could discuss them. One is, I think it's called the NeoSTAR study, that's looking at sacituzumab as a neoadjuvant therapy. Those recently posted on clinical trials.gov, any information there. And then the second is this discussion about a study at Dana Farber, that's looking at the combination of sacituzumab and KEYTRUDA. We can actually find that one on clinicaltrials.gov. Is that a real study or is that -- are those rumors unfounded?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yes, so both of these studies we have not announced yet, I think they're not rumors, they are based on reality. But as you might know, until all of the contracts are fully signed and the final docs are put on the Is and the Ts are crossed, we're not in a position to announce it. I think in one instance, the study I think you were referring to was actually discussed by one of the investigators with some of the folks out there and we've had that question be brought to us. But it is in fact the study of -- intent is to study our program in combination with the PD-1 with the catheter -- of KEYTRUDA in the frontline setting of TNBC in one case and in metastatic breast, HER2 positive -- negative -- yes positive setting and the other case, both frontline combination with checkpoints.
And then the other study, again, that you mentioned, the first one in the neoadjuvant TNBC is, again, is a study that we hope to initiate and we're in the final stages. So, please allow us to sort of be all signed off from all sides and be in a position to maybe release that publicly.
Phil Nadeau -- Cowen & Company -- Analyst
Okay, great. And then last question from me, just on the manufacturing inspection associated with the refiling to BLA. Has that occurred, and you're not going to comment on that what is your disclosure strategy post that inspection? Will you disclose when it happened? Or will we just have to wait for the PDUFA date?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Think it's the latter, Phil, unless there's some very material updates that we feel pressing need to provide, I would look forward to the to the FDA action on the refile BLA.
Phil Nadeau -- Cowen & Company -- Analyst
Perfect. Thanks for taking my questions.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you, Phil.
Operator
Thank you. Our next question comes from the line of Chris Howerton with Jefferies. Your line is now open.
Chris Howerton -- Jefferies -- Analyst
Great. Thanks for taking the questions. I think, most of my material questions were asked at this point. But it was mentioned in the press release that you're looking to invest more in the pipeline for the other ADC. So, just curious what if any plans we might hear about updates, particularly, I think for CRC, it was the most advanced that I remember in the past? So any updates you could give us on the pipeline would be appreciated? Thank you.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Yes thanks, Chris. It's certainly been our intention and desire to start investing in the pipeline. Obviously, our focus has been on the quality operations and the refiling for the majority of 2019. And that's where most of our manufacturing activities were focused on. In parallel, we're very interested in moving 130 forward, which is the ADC that you're referring to in colorectal. This is will be the first indication.
Frankly, we're still limited from a manufacturer standpoint as our facility in New Jersey is dedicated to sacituzumab. And we are looking to bring other capacity online, CMO, I think third-party CMOs, that will take on the manufacturer. So, from the time we actually trigger the investments and have the contracts at the time we have material unfortunately, these ADCs will take a bit of time to manufacture and go through the whole IND process. But stay tuned and that is certainly one of the developments. News flow will be perhaps quiet, but nevertheless, it's laying the foundation for the future of the company beyond SG.
Chris Howerton -- Jefferies -- Analyst
Great, OK. And then maybe just a quick follow up, any updates in terms of the tech transfer and the scale up at Samsung Biologics?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Everything remains on track, the intense is, as we discussed previously to have PAS, which is what that formal fighting mechanism is called to have that ready and to be able to submit that as close as possible to the FDA approval of SG when you need the approval before you can do that. But there is also some work left. Generally, everything remains on track and everything we're seeing -- we're delighted to see, but we don't need it urgently. And they're already going as New Jersey should be able to deliver drug to the market for the very near-term called the first 12 to 18 months or so as we said previously, based on our projected demand needs, and that we are comfortably within that timeframe as of now. Obviously, that will add subject to future developments and getting FDA approval of Samsung, but knock on wood, things are progressing well.
Chris Howerton -- Jefferies -- Analyst
Okay. Thanks for taking the questions and congratulations on the progress.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you very much.
Operator
Thank you. Our next question comes from the line of Paul Choi with Goldman Sachs. Your line is now open.
Jenkins -- Goldman Sachs -- Analyst
Hi, this is Jenkins [Phonetic] on for Paul. I just wondering if you could remind us what percentage of patients with non-small cell lung cancer overexpress Trop-2 and to what extent that's currently diagnosed or tested for?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
So [Indecipherable], I unfortunately cannot remind you as we don't actually know that number. That's part of one of the things we're looking to establish as part of this TROPiCS-03 study. But so far, what I would say and we were dealing with a relatively small numbers although the numbers are growing, we're getting a sense of where that is. And I was sort of book ended with probably north of a quarter and south of 75%. So, almost comfortably where you want it to be. Not so rare that it's irrelevant and not so frequent, that maybe enrichment and only improve on the previously would signal, but it's really too early to know on either one, whether it is in fact in that range, and what the results would be. And I have unfortunately lost track of your second question.
Jenkins -- Goldman Sachs -- Analyst
To what extent is that tested for?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
One of the things that are coming -- I would admit it's not part of a standard panel as the validated tests only became available very recently. So this would become something that -- if it plays out over time, we would certainly have to make its way into the testing paradigm, but it's not part of the standard panels currently.
Jenkins -- Goldman Sachs -- Analyst
Okay, great. Thank you very much.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you.
Operator
Thank you. Our next question comes from the line of Shanshan Xu with Berenberg Capital. Your line is now open.
Emily Bodnar -- Berenberg Capital -- Analyst
Hi, this is Emily Bodnar on for Shanshan. Thanks for taking my questions. I just had a question about the metastatic UC market size. So, first Seattle Genetics when they approved EV, they stated that the size was about 2,000 to 4, 000 patients. And on your corporate presentation, we saw its about 8,000. So I was just wondering if you could please walk us through your assumptions for the market size?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Usama, do you want to take?
Usama Malik -- Chief Financial Officer, Chief Business Officer
Hi, guys. This is Usama. You can find these numbers in our corporate deck as well. But in the third-line setting, the numbers range around 8,000 to 10,000 patients overall. Now, if you're talking about 2.000 to 4,000 for Sea Gen, that may be the number that they're going after. But the total market size is bigger than that. So, I think you quoted 8,000, I think that's approximately where we're aligning as well.
Emily Bodnar -- Berenberg Capital -- Analyst
Okay. And this the number that you would expect to be able to draw?
Usama Malik -- Chief Financial Officer, Chief Business Officer
That is a non-addressable market as we know today.
Emily Bodnar -- Berenberg Capital -- Analyst
Okay, great. And if I just ask a follow up for TROPiCS-03, can you just remind us if this is an all corner trial or if you enrich enrollment based on TROP-2 expression level?
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
No, certainly, this is a trial that enriches for TROP-2 levels.
Emily Bodnar -- Berenberg Capital -- Analyst
Okay, thank you.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thank you.
Operator
Thank you. Our next question comes from the line of Jim Birchenough with Wells Fargo. Your line is now open.
Yan -- Wells Fargo -- Analyst
Hi, thanks for taking the questions. This is Yan [Phonetic] and dialing in for Jim. Just a couple of quick ones on the newly added CPI naive cohort in the TROPHY-U-01 study. How did you determine the size of that cohort? Is this just a exploratory arm or does it have the potential to become a more substantial study? And lastly, it looks like from the clinicaltrials.gov site that the clinical sites number, it was reduced from 70 to 40. So, just wondering what are the reasons for removing some of the sites? Thanks.
Usama Malik -- Chief Financial Officer, Chief Business Officer
Hi, this is Usama again. So, I think if you're looking at clinictrials.gov, you'll see that the first stage of the trial is recruiting 60 patients, it is found in two stages. So based on the results from the first stage, we can expand the cohort for potential registration or pivotal study at that point. The reduction of the site is just a better experience with the sites to recruit at.
Yan -- Wells Fargo -- Analyst
Got it. Very helpful. Thank you.
Behzad Aghazadeh -- Executive Chairman of the Board of Directors
Thanks very much.
Operator
At this time, I would like to hand the conference back over to Chau Cheng for closing remarks.
Chau Cheng -- Secretary & Senior Director-Investor Relations
On behalf of the entire leadership team, I would like to thank you all for joining us this afternoon. We look forward to updating you in the future on our ongoing progress.
Operator
[Operator Closing Remarks]
Duration: 38 minutes
Call participants:
Chau Cheng -- Secretary & 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
Tazeen Ahmad -- Bank of America -- Analyst
Varun Kumar -- Cantor Fitzgerald -- Analyst
Michael Schmidt -- Guggenheim -- Analyst
Connor Meehan -- Morgan Stanley -- Analyst
Phil Nadeau -- Cowen & Company -- Analyst
Chris Howerton -- Jefferies -- Analyst
Jenkins -- Goldman Sachs -- Analyst
Emily Bodnar -- Berenberg Capital -- Analyst
Yan -- Wells Fargo -- Analyst
