Spectrum Pharmaceuticals, Inc.
Q1 2020 Earnings Call Transcript

Published: 8 May 2020

[Operator:]

Good afternoon. My name is Rich and I will be your conference operator today. At this time, I would like to welcome everyone to the Spectrum Pharmaceuticals' First Quarter 2020 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. [Operator Instructions]Let me now hand the call over to Robert Uhl from Westwicke ICR. Robert, you may begin your conference.

[Robert Uhl:]

Thank you, Rich, and good afternoon, everyone. Thank you for joining us today for Spectrum Pharmaceuticals' First Quarter 2020 Financial Results Conference Call. Our first quarter financial results press release was sent out earlier this afternoon and is available on our website at www.sppirx.com. Joining me on the call today from Spectrum Pharmaceuticals will be Joe Turgeon, President and CEO; Kurt Gustafson, Chief Financial Officer; and Dr Francois Lebel Chief Medical Officer.Before we get started, I would like to reference the notice regarding forward-looking statements included in today's press release. This notice emphasizes the major uncertainties and risks inherent in the forward-looking statements that we will make this afternoon. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results, expressed or implied by such forward-looking statements.With that, let me hand the call over to Joe Turgeon, CEO of Spectrum.

[Joseph Turgeon:]

Thank you, Robert, good afternoon and thank you for joining the call today. Before I begin, I'd like to thank all of the healthcare workers across America for their hard work, their dedication and bravery in battling this pandemic head on. They're truly acting like heroes and these are really unprecedented times. The COVID-19 pandemic has put the entire biotech industry the unknown and unpredictable territory.Spectrum is no different. But having said that, we've made changes to our business processes to adapt to this new situation and have made significant progress thus far in 2020. The progress we'll discuss today really speaks to the innovative and small company spirit that our employees embrace and take extreme pride. It also speaks to the strong investigator interest in our pipeline as we aspire to bring new solutions to cancer patients.Now, we've partnered with our clinical trial sites as they navigate this pandemic and have advanced our pipeline. We continue to enroll patients in studies as evidenced by the completion of the enrollment of Cohort 3 in the ZENITH20 clinical trial. This cohort study in the frontline patients with Exon 20 insertion mutations in lung cancer. Additionally, we've been able to dose the first patient in the same-day dosing study for ROLONTIS. If successful, this study may provide important insight regarding the timing of drug administration in the long-acting GCSF therapeutic category. Bottom line, we're not immune to the effects of the pandemic, but we're finding creative and innovative ways to continue to move our company and our programs forward.So now let me turn to some brief updates on these programs. ROLONTIS is our late-stage drug product candidate that's currently under active review at the FDA for the treatment of chemotherapy-induced neutropenia with a PDUFA date of October 24, 2020. If approved, ROLONTIS could be the first novel granulocyte-colony stimulating factor available to healthcare providers in over 15 years. Our launch preparations for ROLONTIS are actively underway. As the PDUFA date approaches we have already put key leadership personnel in place and will accelerate our commercial build out as we approach the launch date.We're planning to launch with a lean and effective commercial infrastructure to maximize the impact of ROLONTIS. We're closely monitoring the evolving market dynamics and believe that launching this novel asset will benefit patients, our customers and our shareholders. We're looking forward to its potential approval into competing in this multi-billion dollar growth factor market.Poziotinib, our second late-stage clinical asset targets hard to treat genetic mutations in lung cancer. We're conducting the ZENITH20 clinical trial in this patient population which currently has no approved therapy. Following the presentation of our Cohort 1 results at the virtual AACR meeting last week, we outlined our strategy for the program. This strategy is simple. We need to determine if optimization of dosing allows patients to stay on drug longer without interruption and increased responses. Our strategy incorporates an efficient study design that will enable us to quickly determine if the adjustments we are making will have a positive impact on patient outcomes. Dr Francois will go into more details in this in just a few minutes.We continue to drive the development of our two late-stage assets and the pursuit of new business development opportunities that will complement our pipeline and our capabilities. As I look ahead, I believe we are well-positioned to execute on our goals. We've got a resilient team and that continues to drive our business forward, a strong financial position and an exciting pipeline.And with that, I'd like to turn the call over to Kurt to review the financials. Kurt?

[Kurt Gustafson:]

Thanks, Joe. Our SG&A expense for the first quarter of 2020 was $14.8 million versus $16 million in the previous year. R&D expense was $16 million versus $21.9 million. The decrease in R&D expense relates primarily to purchases of ROLONTIS drug substance in the prior-year period, which did not repeat in this quarter.Other income expense was a loss of $9.8 million versus a loss of $10.2 million in the prior year quarter. The loss in both periods was primarily related to changes in the market value of our costly Khasi [ph] securities. Our net loss for the quarter from continuing operations was $40.6 million versus $39.8 million in the comparable period in 2019. On a non-GAAP basis, which primarily backs out stock compensation costs, our loss for the quarter was $25 million versus $29.2 million in the prior year period.We ended the quarter with $178 million in cash plus marketable securities. The overall change in cash was $46 million, however, $11 million of this change was a result of the decrease in the value of our [indiscernible] which declined to $20 million compared to $31 million at the beginning of the quarter due to the increased market volatility we've seen. Operating cash burn, which is a better measure of our actual cash outflow was $33 million for the first quarter. This is consistent with where we have been the last few quarters.Joe mentions our strategy for poziotinib. We have taken a hard look at our spend for this program and as we've said, the focus of this approach is to determine whether the new dosing for Cohort 5 can increased tolerability and thus improve efficacy. We have rationalized spending on this program to make sure any expenditure serves the goal of achieving a timely decision on this program.With that, let me now hand the call over to Francois to cover updates on our clinical programs.

[Francois Lebel:]

Thanks, Kurt. Hello, everyone. I'm going to start by providing a brief update regarding our late-stage asset for ROLONTIS, which is under active review by the FDA. This is a novel long-acting granulocyte-colony stimulating factor and we are seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive cancer chemotherapy.We are having a typical interaction with the FDA as they review our file and our PDUFA date remains October 24 of this year. The BLA is based on robust clinical data from two large pivotal randomized controlled trials. In both studies, ROLONTIS met the pre-specified endpoint of non-inferiority in duration of severe neutropenia and met all of the secondary endpoints. The safety profile was similar to pegfilgrastim. Our clinical investigation of ROLONTIS is continuing. Last week, we announced the dosing of the first patient in a clinical trial to evaluate ROLONTIS when administered on the same day as chemotherapy. The trial will look at the duration of severe neutropenia when ROLONTIS is administered at three different time points following standard chemotherapy in patients with early stage breast cancer. Approximately 45 patients will be enrolled in this Phase 1 open labeled trial with equal randomization to the three dosing time points.The novel structure as well as positive preclinical data provide us an opportunity to further explore the pharmacodynamic properties of ROLONTIS administered the same day as chemotherapy in cancer patients. This study will allow us to scientifically reexamine the way neutropenia is managed in patients who receive myelosuppressive chemotherapy. Same-day dosing could enhance compliance and minimize a patient treatment burden by simplifying logistics. We will be presenting an abstract highlighting our preclinical data on same-day dosing in a rodent model at the AACR Virtual Annual Meeting next month. We will update you on the logistic of the presentation as we get closer to the date.Now, let me shift gear to poziotinib. We are conducting these ZENITH20 clinical trial to investigate poziotinib for the treatment of Exon 20 insertion mutation in non-small cell lung cancer. Exon 20 mutation are among the most difficult to treat and the patients and their physician are in search of effective treatment options as there are no approved therapies for this indication. ZENITH20 is a multi-center multi-cohort trial evaluating lung cancer patients with this specific mutation.Last week, we presented results from Cohort 1 at the AACR virtual Annual Meeting. Following that meeting, we announced some changes to our strategy on ZENITH20 study. This change are the result of our further understanding of pozi's data from Cohort 1. As stated before, when you look at the waterfall plot showing responses, there is undeniable activity, even though we did not reach our primary endpoint.We now believe that the 16-milligram once-daily dose might have been too high to administer all at once and led to frequent dose interruptions and dose reductions, 88% of patients at some sort of dose interruption from therapy, which we believe prevented the drug from demonstrating its full potential. The half-life of poziotinib is approximately eight hours, as we described in our discussion last week. Typically when you have a half-life of less than 12 hours, the drug is generally administered two to three times per day.As a result, we have amended the ZENITH20 protocol to include various new dosing schedule. This amendment will impact Cohorts 4 through 7. As a reminder, Cohort 1 through 3 are fully enrolled. For Cohorts 4, 6 and 7, new patients coming into the study will receive 8-milligram BID dosing. In Cohort 5, new patients entering the trial will be randomized to 10-milligram once a day or 6-milligram or 8-milligram BID. An additional learning from our analysis of Cohort 1 was that some sites supported their patient more successfully with earlier use of steroids and we have implemented this change into the amended protocol.One of the concerns about using a lower dose is loss of efficacy. Let me remind you that at 8-milligram BID, we're actually using the same daily dose. However, our pharmacokinetic modeling suggests that this dose paradigm will deliver a better PK profile. BID dosing should allow us to achieve both of our goals, reducing treatment-related adverse events that are frequently a function of Cmax while not losing anti-tumor pressure at trough level by staying above the critical IC50 value. We are planning to release the results for Cohort 2 mid-year with results for Cohort 3 during the second half of the year.Rapid enrollment in our BID cohorts is a key priority for the company. The challenges of the current pandemic make it difficult for me to give you an exact timeline for Cohort 5 data readout. However, our investigators are motivated and the team is focused to act with urgency despite the challenge of COVID-19 pandemic.Finally, we have recently completed additional analysis of Cohort 1 data. We will have an oral poster presentation at the upcoming Virtual ASCO meeting in late May. The presentation will cover activity and durability of responses in various subgroups of Cohort 1 in previously-treated EGFR Exon 20 non-small cell lung cancer patients.Now, I'll turn it back to Joe.

[Joseph Turgeon:]

Thank you, Dr. Francois and thank you, Kurt. I think you can see for Dr. Francois' remarks that Spectrum continues to make progress on our pipeline. I'd like to thank our team for their hard work and dedication in these very difficult times.With that, operator, let's open the line for questions.

[Operator:]

Thank you so much. [Operator Instructions] I'm seeing Maury Raycroft. Your line is now open.

[Unidentified Analyst:]

Hi, this is Kevin Strang [ph] for Maury. I just wanted to ask for the recently-initiated trial looking at same-day administration with chemotherapy. Can you elaborate on what on when you might get results and what expectations you might have on the data? And then also could you see that data getting added to the marketing label at the time of approval?

[Joseph Turgeon:]

Yes. Firstly, let me describe what is the case, Kevin, and thanks for the question - and I'll have Dr. Francois talk to the clinical aspects around it, what it means. But first of all, what this means in same-day dosing, to make sure everyone understands, is that currently today when you get your myelosuppressive chemotherapy, you get your chemo, you actually have to go home and come back the next day to get your GCSF, to get your protection. Or, you have to have a device put on you which some people like, a lot of people don't like for many, many reasons. So that's the current situation. And in the past, the innovative product did try a trial that failed to try and do this because doctors, nurses who actually use the product with the patients and also the patients would really benefit right after the chemo. Within an hour or two, you could give that shot. It would be fantastic. We really, really change what you could do with these patients. So that's what's trying to be done. It hasn't worked in the past. We have a different novel molecule, so that's what's important.Why this would be important? Dr Francois, why don't you walk through the other parts of the question on the timing and the potential for label?

[Francois Lebel:]

Sure. Thank you, Joe. So yes, I think the important aspect, Kevin, here, is that this molecule, ROLONTIS is novel. So this is not a biosimilar. And when you actually look at the product characteristic which are somewhat unique here, we have different potency, we have more bone marrow resident time, the half-life is different - so all of those characteristic, taken with some of the preclinical data that we've already generated, and as I indicated in my remarks, we're going to present some data in rodent at AACR - all of this makes us believe that the behavior of this molecule could be different and allow us this time to potentially provide the drug at the same time or just after the chemotherapy during the same medical visit.As to your question as to the original label. The original label in the BLA currently will not have this particular characteristic included in the BLA, but we're planning ahead. We have restated that the PDUFA date still stand and we're preparing, if you want, for the next wave of things in development for ROLONTIS. I hope that answers your question.

[Unidentified Analyst:]

Yes. That was great, thank you. And then for my last question, I was wondering for the ZENITH Cohort 3. If you could provide any perspective into whether those naive healthier patients are staying on treatment longer and maybe getting fewer dose reductions at the standard 60 milligram dose than Cohort 1?

[Francois Lebel:]

Yes. It's a good question. I think you're right on. Patient who are treatment-naive like we have in Cohort 3 and 4, one would expect that they would be able to - they're in much better condition. Their bone marrow have not beaten up with rounds of chemotherapy or some other therapy like the checkpoint inhibitor where they might have bad pneumonitis or other complication. So one would expect that they would be more tolerant of adverse events, potentially, but we don't know yet and we are not guiding. We're going to look at the data later and because we also want to have duration of response and we have guided that for Cohort 3, will be in the second half of the year.

[Unidentified Analyst:]

Great, thank you.

[Joseph Turgeon:]

Thanks, Kevin.

[Operator:]

Okay, thank you so much. And then, we now have the second question. It's from the line of Ed White. Ed, your line is now open.

[Joseph Turgeon:]

Hey, Ed.

[Ed White:]

Hey, Joe. How are you?

[Joseph Turgeon:]

Good, thank you.

[Ed White:]

Good, good. So just a couple of questions. Cohort 5 with the new dosing strategy, has the first patient has been enrolled yet?

[Francois Lebel:]

We just opened year on Cohort 5. The amendment was accepted by the FDA and we're deploying at various sites currently. So we have not made any announcement about the enrollment status at this point.

[Ed White:]

Okay. Thanks, Francois.

[Francois Lebel:]

Sure, Ed.

[Ed White:]

And just on Cohort 2, first of all, is there any reason to believe that Cohort 2 would have a different outcome than what we saw in Cohort 1? And then you're talking about having data in the middle of the year. I'm just wondering if that's going to be just the press release or if you're thinking of hosting a conference call for that data if it is similar to Cohort 1?

[Francois Lebel:]

I'll take that question, Joe.

[Joseph Turgeon:]

Yes, go ahead.

[Francois Lebel:]

I don't think we finalized how we're going to release the data. It will be high-level data mid-year. In terms of what to expect with the result, Cohort 2 was also - patient were receiving a starting dose of 16 milligram in one sitting, so there could be issues of tolerance. But HER2 is a different patient population and it would not be totally surprising that we would see different response rate in that particular patient population. It's hard to predict. They're all powered independently. So we're going to have to wait and wait for the results.

[Joseph Turgeon:]

Ed, the only thing I'll add is we just don't know like Dr. Francois says, it is a more homogeneous population and HER2. In other words you don't have the wide range of mutations like you do in EGFR, but we don't know if that will make a difference or not yet until we see the data.

[Ed White:]

Okay. Thanks, Joe, and thanks, Francois. And then, just few questions on ROLONTIS. First on the same day trials, since it is open label, are we going to get an interim look at the data or we will be waiting for the trial to conclude before seeing something from that?

[Francois Lebel:]

So we, we have internally set - I mean it's an open trial, you're absolutely correct. So we will have access to the data as we progress. And we have an internal target as to the minimal amount of patient that we will need to see data on before making any kind of announcement as to the proof of concept. So I don't think I can specify any data at this point and the other thing, we'll have to see how it goes. A Phase 1 study, especially during the pandemic here, I'm sure you're aware that other companies are having a lot of difficulty IQVIA, ICON have made some statement about their serious inability to reach sites, etcetera, to monitor trial. We have been reasonably in good shape so far, but we'll have to see how it goes. We have entered the first patient, we're thrilled about that and we'll have to see how it progresses and then we'll update you in a timely fashion.

[Ed White:]

Okay. And then my last question, is my second ROLONTIS question is just how should we be thinking about the launch and more importantly, how are you thinking about the launch? With what we're seeing now, salespeople can't go into the hospitals, they can't go into the doctor's offices. Are you planning for virtual launch? Or since the PDUFA is not until October, are you planning on more of a traditional launch of the drug? Thanks.

[Thomas Riga:]

Hey, Ed. It's Tom Riga. I hope you're well. We are actually doing contingency planning. Given the timing of our PDUFA date and the launch timing, we very well may find ourselves in the more traditional launch camp. But I think it's prudent to contingency plan, because today we don't know. But independent of the launch vehicle whether it's whether it's virtual or live, we're thrilled to launch into this multi-billion dollar market. And how we think about this launch, Ed, I think it comes down to three things

[Ed White:]

Thanks, Tom. And just one last question on that, are you all set as far as supply goes? Has the pandemic affected your supply at all?

[Thomas Riga:]

Yes. It's a great question. We manufacture the drug substance in Korea. The manufacturing today is ongoing Korea is actually ahead of the United States. But yes, you heard in Kurt's prepared remarks, we had purchased inventory. I wish I could tell you we had some crystal ball, but we didn't but fortuitously we do have launch supply state-side and we believe we'll be ready to go, pending that approval.

[Ed White:]

Great. Good luck with the launch. I'll talk to you soon.

[Thomas Riga:]

Thanks, Ed.

[Joseph Turgeon:]

Thank you, Ed.

[Operator:]

All right, thank you so much. And one last question from the line of Michael Schmidt. Michael, your line is now open.

[Joseph Turgeon:]

Hey, Michael.

[Charles Zhu:]

Hey, guys. This is Charles Zhu, on for Michael Schmidt. Thanks for taking my question and congrats on the quarter. I do have a question on the ROLONTIS commercialization and pricing contracting dynamics. Given that contracts in this marketplace tend to I guess, be the most value at potentially in the commercially-insured segments of this population, how do you think about the potential impact of COVID shifting the payer mix of these patients potentially from commercial to Medicaid? And how that fits into your assumptions and how you may approach the commercialization in launch?

[Thomas Riga:]

Hey, Charles. Thanks for the question. It's Tom again. I think we're going to close eye on that. I think the segment of business in how it shifts is something that we will need to be prepared for. If I just give you a little bit of color on how the market is evolving today, there is a compression at the lens of ASP between the innovator in the biosimilars. That ultimately is through CMS as the basis of the Medicare population. But I think what we are really enthusiastic about is having the ability to provide predictable contracting value to our customers, whether it be a third party payer, a community oncologist, the government, or a hospital as the novel entity, we will have that ability uniquely to do that. If the dynamics of patients shifts from one segment to the next, we will have a strategy to address each of those segments and we will just keep a close eye on how that shifts and what ultimately, we need to do as a go-forward plan when we launch.

[Joseph Turgeon:]

Hey, Charles, this is Joe. I'm going to add one thing, and Tom is spot on. When you think about COVID, first of all, many cancer centers are not in hospitals. Some are, but many are not which is a good thing because they're not treating COVID. But for those patients who watch and wait today, I think it will be even more important to doctors with COVID to say, 'Listen, if I'm going to give you a myelosuppressive agent, the last place I want you is immuno compromise and going to a hospital with this going on.' I think the white blood cell factors become even more important. So some of those patients in the past, maybe would watch it late. I thought I'd just throw that in there.

[Robert Uhl:]

Did we lose them, operator?

[Operator:]

All right. So we have now another question from George [ph]. George, your line is now open.

[Unidentified Analyst:]

Yes, hi. I have invested in the company and as a businessman, I like to look the competition and probably familiar with OncLive, are you guys familiar with Dr. Ross Camidge? Hello?

[Joseph Turgeon:]

I don't know Dr. Camidge. I don't know if anybody else does.

[Unidentified Analyst:]

Okay. Well, the reason was on OncLive, he compared TAK-788 who just recently, last week we see breakthrough designation. Something on unfortunately unforeseen poziotinib didn't receive and he was comparing the two. When he was saying that, poziotinib hits the wild-type of the Exon 20 insertions as opposed to hitting the insertion itself. I don't know if I explained that properly on layman, and he said that the TAK-788 does the reverse, therefore, will be more successful. And he said this about six months ago. Could you give us your point of view on that?

[Joseph Turgeon:]

Dr. Francois, why don't you give you opinion there?

[Francois Lebel:]

Sure. So you're correct that TAK-788 is also a drug being developed for Exon 20 mutations. So they both affect what's called a wild-type EGFR and there is something we call selectivity, which is the ratio of how much of the inhibition that these drugs can afford or do is wild-type versus the mutated EGFR. So Takeda as you are stated as presented in the past in certain cell line that they were showing that they might be a little more selective. However, when we're done at MD Anderson, and at OMNI, our co-developer, we got different results, not in words, we don't see as clearly that one drug is more selective than the other. So that's in vitro with cell line. What really matters as I'm sure you can appreciate, is what are going to be the result in the clinic.We have results for Cohort 1, we demonstrated activity there - undeniable activity. However, it was not as we wanted. But we have other cohorts as you well know and the Cohort 1 are not necessarily predictive of the outcome of Cohort 2, 3, 4 and for that matter in 5 when we are going to change the dosing, that one sitting versus BID. So there is no question, Takeda looks like they have some interesting results and we'll have to see as the data comes in and we'll see if - it may end up that two drug move forward here. It could happen and the other thing you got to remember is that poziotinib right now, we have dosed more than 1,000 patients at different dose and schedule. Takeda is not as advanced that way. So over time here we might uncover that there are different adverse events that are uncovered and we're pretty confident right now.We understand quite well the side effect profile of pozi, we understand and we believe on the basis of the data and modeling we've done that we could mitigate the amount of adverse events we see and we're anxious to see the result of Cohort 5 when we give the drug BID. So I guess the short answer is, stay tuned and we'll see more data, which drug will come to markets first and which one is more promising.

[Unidentified Analyst:]

Great, thanks for that. I have one real quick question, if possible.

[Joseph Turgeon:]

Sure.

[Unidentified Analyst:]

Hello? Yes, great. Regarding ROLONTIS. Again as a layman, I don't know much about Phase 3 trials, but it seems to me [indiscernible] we've should have done that there pretty through their good size both of them - to give you the short question, what do you think the chances are of these two Phase 3 clinical trials being accepted by the FDA?

[Joseph Turgeon:]

Yes. First of all, for a layman, let me tell you, George, I think it was that you're asking good questions. What I can tell you...

[Unidentified Analyst:]

We have a lot of money involved. So, work hard for it. I'm sure you appreciate that.

[Joseph Turgeon:]

Yes, I do and I appreciate that, too, that's why they're good questions. The two trials we have, number one, there are over 600 patients - 643 patients as I recall - to Phase 3. This is under a SPA, which is a special protocol assessment and what that means, George, is that we worked with the agency, the FDA to develop the actual protocol, which they agreed. We were in tandem with them. They agreed with the protocol. If you have seen the data on both separate Phase 3 or in a presentation of combining the two trials together, the results were outstanding. We hit all our primary and secondary endpoints. Actually, it's what's called a non-inferiority trial. In other words, all we had to demonstrate is we were non-inferior to the standard of care which is the drug that's on the market today, and we certainly did that. You can argue in the first cycle, we actually showed some superiority although it's a non-inferiority trial.So we feel really good about the data that we've submitted. All I can tell you, it's under active review as we speak. The PDUFA date, which means the date of approval is October 24. That still stands despite the pandemic. We're on active review and active work with the agency, so we're hoping that we can get an approval this year.

[Unidentified Analyst:]

Great. I hope that's the case for everybody involved. I know in cancer, nothing is simple, even the way it's administered. Do you see any difficulties how it could be administered or hospital not adapting it for any reason?

[Joseph Turgeon:]

Tom, why don't you take that? That's right up your alley.

[Thomas Riga:]

Hey, George.

[Unidentified Analyst:]

Thanks for taking my call.

[Thomas Riga:]

From administration, it's actually sub-queue injection. So all the products in the space are administered the same way. I think nurses - as Nurse's Day yesterday and Nursing Month, they are an invaluable part of the HCP team and largely due to the administration. So I see no barrier with administration of ROLONTIS or any of the products in this category, for that matter.

[Unidentified Analyst:]

Fantastic. I hope that's the case.

[Joseph Turgeon:]

George, I'll add one other thing. I just want to know the same gauge needle, which means the size of the needle is exactly the same as the existing products. The size of the of the vial or the amount of solution you're actually injecting is the exact same. So there is no differences there. Sometimes if you have a larger gauge needle or if they have more solution being pushed in, you can have more injection site reactions, patients and nurses and healthcare providers wouldn't like it. But we have the same gauge needle in the same amount of solution going in. Although it's about only half the dose of the current product because of it is a novel in different product. So we're excited to go compete there and get a crack at it.

[Unidentified Analyst:]

Listen, good luck. I know that pozi didn't work out initially, but what I understand, this is your specialty. You launched them last, so I think things are looking good.

[Joseph Turgeon:]

Well, yes, we had a lot of help. But yes, this is a market, there are several of us here. Inside out, Tom Riga, there is no one better than him to lead this parade and I'll be involved myself. So we're looking forward to it.

[Unidentified Analyst:]

Well, guys, good luck. Good luck for everybody involved and the especially the patients. It's nice speaking with you.

[Joseph Turgeon:]

You got it. Thank you, George.

[Unidentified Analyst:]

Thank you.

[Operator:]

[Operator Instructions] We now have a question from Mayank Mamtani. Your line is now open.

[Joseph Turgeon:]

Hey, Mayank.

[Sahil Kazmi:]

Good afternoon, team. This is Sahil Kazmi on for Mayank. Just a couple of questions from us. A quick follow-up on ROLONTIS. Maybe relative to the Onpro at-home administration, how do you think about the same-day dosing in the context of the post-COVID world and then maybe a quick follow-up on pozi afterwards.

[Thomas Riga:]

I'll take that one. Thanks for the question. I think first of all for the PDUFA date in October, that label will be a non-inferiority label and we are thrilled to be able to compete in that space. Same day, next day, that will be next day at launch, and we are bullish on our ability to take meaningful share of that market and be very competitive. So that's I think first and foremost. I think the fact that this is an innovative novel asset really enables us to explore the full development and if same-day dosing pans out to be successful. I think it will be very relevant commercially. I think the benefits of Onpro, you see it in the share. It still maintains as a relatively high share in that space, but I think there is also complexities that go with that to get to the true stickiness of the concept of a device.I think if you could eliminate that with a real development program that uniquely allows you to differentiate, it could be valuable, but that's down the road. Our focus today for October 24, will be to competitive in a non-inferiority next-day traditional long acting GCSF market.

[Sahil Kazmi:]

Good. Yes, that's helpful. And maybe a brief follow-up for Dr. Francois. Could you clarify what the development path is there beyond the Phase 1 trial that's ongoing right now?

[Francois Lebel:]

On ROLONTIS or pozi?

[Sahil Kazmi:]

On ROLONTIS, relative to the same-day dosing.

[Francois Lebel:]

Oh, I see. Well, as you know, the most important thing right now in late stage is the active review of the BLA with the FDA. The Phase 1, it's obviously early and with a concept here that if we could successfully give it because of the unique characteristic of the product on the same day as the chemotherapy, that potentially could be a game-changer. So we're very interested in that. We'll have to see whether or not what the data we've seen on the basis, the modeling pharmacokinetic, pharmacodynamic as well as the road and model you'll very soon. It's hard for us to predict until we see the data what the path would be after in terms of how do we go forward. We're focused on the BLA approval at this point.

[Sahil Kazmi:]

Great. Now, that makes sense. And then just a brief one on pozi. Could you discuss maybe how you plan to monitor the hypothesis of whether BID dosing is having the effect that you're seeing in sort of pharmacokinetic studies and kind of are there interim analysis along the way in each cohort that's going to enroll new patients?

[Francois Lebel:]

Yes. Cohort 5 is an open trial. So there will be and it does have central imaging though, but there will be a regular looking at the data, if you want. Once we get back from our central imaging lab, the result of the data, the monitoring of safety is on an ongoing basis. So we will decide and obviously will guide the street over time as to if we see what we want to see in terms of the number of drug interruption and potentially those reduction over time. But we still need to - we can't just conclude at the first sign of anything. We need to understand as well if we're getting response, the durability of response and does that modify the course of this option [ph]. So obviously we'll update you, but we don't have to necessarily fully-enroll Cohort 5. We will be able to get some insight, gain insight before we fully enroll.

[Sahil Kazmi:]

Great, thanks for taking my questions. Looking forward to the presentation next month.

[Francois Lebel:]

Good.

[Operator:]

And there are no further questions at this time. Joe, you may proceed.

[Joseph Turgeon:]

I'd like to thank everybody on the call today for your interest in Spectrum Pharmaceuticals. I will tell you that we will be participating in the upcoming Jefferies Virtual Healthcare Conference in early June. In the meantime, if you have further questions or need any additional information, feel free to contact us at any time. And I'd like to thank everybody again for their interest in Spectrum. Stay safe and we appreciate you're being on the call. Thank you, Operator.

[Operator:]

Thank you so much. And this concludes today's conference. Thank you all for participation. You may now disconnect.