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Spectrum Pharmaceuticals Inc (SPPI)
Q1Â 2020 Earnings Call
May 8, 2020, 11:30 p.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
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. [Operator Instructions]
Let me now hand the call over to Robert Uhl from Westwicke ICR. Robert, you may begin your conference.
Robert Uhl -- Investor Relation
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 -- Chief Executive Officer
Thank you, Robert, and 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 their 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 into 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 in. 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 three and the ZENITH20 clinical trial. This cohort is studying the front line 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 a 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 granular cytology stimulating factor available to healthcare providers in over 15 years. Our launch preparations for ROLONTIS are actively under way. 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 and to competing in this multibillion-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 one 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 adjustment we are making will have a positive impact on patient outcomes. Dr. Francois will go into the more details on 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 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 -- Chief Financial Officer
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 CASI 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 a decrease in the value of our CASI holdings, 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 five and 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 -- Chief Medical Officer
Thanks, Kurt. Hello, everyone. I'm going to start by providing a brief update regarding our late stage asset, ROLONTIS, which is under active review by the FDA. ROLONTIS is a novel, long-acting, granular site colony stimulating factor and we are seeking an indication for the treatment of neutropenia in patients receiving myelosuppressive cancer chemotherapy. We're 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 prespecified endpoint of noninferiority 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 dosing of the first patient in a clinical trial to evaluate ROLONTIS when administered on the same-day as chemotherapy. The trial looked 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 I open-label 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 logistics of the presentation as we get closer to the date.
Now let me shift gear to poziotinib. We are conducting the ZENITH20 clinical trial to investigate poziotinib for the treatment of exon 20 insertion mutation in non-small cell lung cancer. Exon 20 mutations 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 multicenter, multi-cohort trial evaluating lung cancer patient with the specific mutation. Last week, we presented results from cohort one at the AACR Virtual Annual Meeting. Following that meeting, we announced some changes to our strategy on ZENITH20 study. These changes 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 wide to administer all at once and led to frequent dose interruptions and dose reductions. 88% of patients had some sort of dose interruption from therapy, which we believe prevented the drug from demonstrating its full potential. Half life of the half life 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 four through 7. As a reminder, cohorts one through three are fully enrolled. For cohorts 4, six 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 to six or 8-milligram BID.
An additional learning from our analysis of cohort one 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 DISTO's 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, midyear, with results for cohort three 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 time line for cohort five 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 one 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 -- Chief Executive Officer
Thank you, Dr. Francois and thank you, Kurt. I think you can see from Dr. Francois's 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.
Questions and Answers:
Operator
[Operator Instructions] Okay. So I'm seeing Maury Raycroft. Your line is now open.
Kevin Strang -- Jefferies -- Analyst
Hi, This is Kevin Strang 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 around the data? And then also, could you see that data getting added to the marketing label at the time of approval?
Joseph Turgeon -- Chief Executive Officer
Yes. First, let me describe what it is, just as the case, Kevin. And I'll have Dr. Francois talk to the clinical aspects around it, what it means. But first of all, what this means on 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 with some people like a lot of people don't like and 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. I really will really, really change the way what you could do with these patients.
So that's what's trying to be done and hasn't worked in the past. We have a different novel molecule. So that's what's important, why this would be important. And Dr. Francois, why don't you walk through the other parts of the question on the timing and the potential for label?
Francois Lebel -- Chief Medical Officer
Sure. So yes, I think the important aspect, Kevin, here is that the this molecule, ROLONTIS is novel. So this is not a biosimilar. And when you actually look at the product characteristic with our 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 characteristics and 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, right? We are we have restated that the PDUFA date is still stand and we're preparing, if you want, for in the next wave of things in development for ROLONTIS. I hope that answers your question.
Kevin Strang -- Jefferies -- Analyst
Yes, that was great. 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 16-milligram dose than cohort 1?
Francois Lebel -- Chief Medical Officer
Yes. So it's a good question. So I think you're right on here, patients who are treatment naive, like we have in cohort three and 4, are one would expect that they would be able to they're in much better condition. They have not their bone marrow have not beaten up with rounds of chemotherapy or some other therapy like the checkpoint inhibitor, where they might have had 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, it will be in the second half of the year.
Operator
And then we now have the second question. It's from the line of Ed White. Your line is now open.
Ed White -- HC Wainwright -- Analyst
Thanks, Hey, Joe. How are you?
Joseph Turgeon -- Chief Executive Officer
Good, good.
Ed White -- HC Wainwright -- Analyst
So just a couple of questions. On cohort five with the new dosing strategy, has the first patient been enrolled yet?
Francois Lebel -- Chief Medical Officer
So we just opened, you know, cohort five 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 -- HC Wainwright -- Analyst
And then 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 on cohort 1? And then you're talking about adding data in middle of the year, I'm just wondering if that's going to be just a press release or if you're thinking of hosting a conference call for that data, if it is similar to cohort 1?
Francois Lebel -- Chief Medical Officer
So I'll take that question, Joe?
Joseph Turgeon -- Chief Executive Officer
Yes.
Francois Lebel -- Chief Medical Officer
So and the I don't think we've 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 two was also patients 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's 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 result.
Joseph Turgeon -- Chief Executive Officer
Yes. Ed, the only thing I'll add is we just don't know like Dr. Francois says, it is a more homogeneous population in 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 -- HC Wainwright -- Analyst
Okay. And then just two questions on ROLONTIS. First, on the same-day trial, since it is open label, are we going to get an interim look at the data? Or will we be waiting for the trial to conclude before seeing something from that?
Francois Lebel -- Chief Medical Officer
So 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 patients 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 date at this point. And the other thing we'll have to see how it goes. A Phase I study, especially during the pandemic here, I'm sure you're aware that other companies are having a lot of difficulty IQV Icon have made some statement about their serious inability to reach sites, etc, to monitor a 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 -- HC Wainwright -- Analyst
Okay. And then my last question is just 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 a virtual launch? Or since it's not going to the PDUFA is not until October, do you think are you planning on more of a traditional launch of the drug?
Thomas Riga -- Chief Operating Officer
Yes, it's Tom Riga. 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 virtual or live, we're thrilled to launch into this multibillion-dollar market.
In how we think about this launch, Ed, I think it comes down to three things: volume, price and share. Right now, the volume in this market over the last five years in the U.S. has been consistent at about one million units dispensed a year. And even recently, NCCN has come out with updated guidelines to encourage additional growth factor use to ultimately keep people out of the ERs, given the pandemic. So from a unit perspective, this market has been consistent at one million units.
I think in pricing, we have seen the really rational pricing by the biosimilars. And I think that ultimately speaks to this market staying as a robust market. Today, it's about $3 billion. And what's happening is the ASPs are actually compressing between biosimilars as well as the innovator. And that ultimately creates a really competitive space, which is our sweet spot.
And then I think the third one is share, on what do you believe you can achieve. And we are just thrilled to get into this market, whether it be virtual or live at the point of launch, but we will be ready, and we're thrilled to have an opportunity to compete.
Ed White -- HC Wainwright -- Analyst
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 -- Chief Operating Officer
Yes. So that's a great question. We manufacture the drug substance in Korea. That the manufacturer today is ongoing. Korea is actually ahead of the United States. But as 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 launched supply stateside, and we believe we'll be ready to go pending that approval.
Ed White -- HC Wainwright -- Analyst
Great. Good luck with the launch. I'll talk to you soon.
Francois Lebel -- Chief Medical Officer
Thank you, Ed.
Operator
And one last question from the line of Michael Schmidt. Your line is now open.
Charles Zhu -- Guggenheim -- Analyst
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, like contracts in this marketplace tend to, I guess, the most value-add potentially in the commercially insured segments of these 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 and launch?
Thomas Riga -- Chief Operating Officer
Charles, thanks for the question. It's Tom again. I think we're going to keep a close eye on that. I think the segment of business and 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 and the biosimilars. And 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 a novel entity, we will have that ability uniquely to do that. And if the dynamics of patients shift 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 -- Chief Executive Officer
Charles, this is Joe. I'm going to add one thing and Tom's 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 immunocompromised 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 who in the past maybe would watch and wait. So I thought I'd just throw that in there.
Operator
All right. So we have now another question from George Junis. Your line is now open.
George Junis -- Analyst
Yes, hi, I've invested in the company and as a businessman, I like to look at the competition. And we're probably familiar with OncLive. Are you guys familiar with Dr. Ross Camidge,? Hello?
Joseph Turgeon -- Chief Executive Officer
Yes. I don't know Dr. Camidge. I don't know if anybody else does.
George Junis -- Analyst
Okay. Well, the reason was on OncLive, he compared TAK-788, who just recently last week, received breakthrough designation, something unfortunately poziotinib didn't receive. And he was comparing the 2. When he was met, he was saying that poziotinib hits the wild-type of the exon 20 insertions as opposed to hitting the insertion itself. Probably not explain that properly in layman and he said that TAK 88 sorry, TAC-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 -- Chief Executive Officer
Dr. Francois, why don't you give your opinion there?
Francois Lebel -- Chief Medical Officer
Sure. So you're correct that TAK-788 in is also a drug being developed for exon 20 mutations. So they both affect what's called a wild-type EGFR and there's something we call selectivity, which is the ratio of how much of the inhibition that can this drug can afford or do is wild-type versus the mutated EGFR.
So Takeda, as you have stated, has presented in the past in certain cell line, that they were showing that they might be a little more selective. However, when work done at MD Anderson and at Omni co-developer, we got different results. In other 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. And we have results for cohort 1, we demonstrated activity there, undeniable activity. However, it was not as high as we wanted. But we have other cohorts, as you well know. And the cohort one are not necessarily predictive of the outcome of cohorts 2, 3, four and for that matter, in 5, when we're going to change the dosing and the that one sitting versus BID. So there's 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 2 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 five when we give the drug BID. So I guess, the short answer is stay tuned. And we'll see with more data, which drug is will come to market first and which one is more promising.
George Junis -- Analyst
Great. I have one more quick question, if possible.
Joseph Turgeon -- Chief Executive Officer
Sure.
George Junis -- Analyst
Hello? Yes. Great. So regarding ROLONTIS. Again, as a layman, I don't know much about Phase III trials. But it seems to me that other research have done that they're pretty they're pretty good size, both of them. To give you the short question, what do you think the chances are of these two Phase III clinical trials being accepted by the FDA?
Joseph Turgeon -- Chief Executive Officer
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 about...
George Junis -- Analyst
Well there's a lot of money involved. Yes, I worked hard for it. I'm sure you appreciate that.
Joseph Turgeon -- Chief Executive Officer
Yes, I do. And I appreciate that, too. And that's why a good question. Listen, the two trials we have, number one, there were over 600 patients, 643 patients, as I recall, two Phase IIIs. This is under an 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, and they agreed with the protocol. If you have seen the data on both separate Phase IIIs or in a presentation of combining the two trials together, the results were outstanding. We hit all our primary and secondary end points. You actually it's what's called a noninferiority 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 noninferiority 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. And that still stands despite the pandemic. The we're on active review and active work with the agency. So we're hoping that we can get an approval this year.
George Junis -- Analyst
Great. I hope that's the case for everybody involved. Just the I know cancer, nothing simple, even the way it's administered. Do you see any like difficulties, how it could be administered? Or hospital is not adopting it for any reason?
Joseph Turgeon -- Chief Executive Officer
Now, Tom, why don't you take that? That's right up your alley.
Thomas Riga -- Chief Operating Officer
George, from administration, it's actually it's a subcu injection. So all of the products in the space are administered the same way. I think nurses as Nurses Day was yesterday and Nursing Month, they are an invaluable part of the HCP team. And they largely do the administration. So I see no barrier with administration of ROLONTIS or any of the products in this category for that matter.
George Junis -- Analyst
That's the case. Yes.
Joseph Turgeon -- Chief Executive Officer
George, I'll add one other thing. I just want you 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 vial or the amount of solution you're actually injecting is the exact same. So there's no differences there. Sometimes if you have a larger gauge needle or if you 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 and the same amount of solution going in, although it's about only half the dose of the current product because it's anything novel and different products.
So we're excited to go compete there and get a crack at it.
George Junis -- Analyst
Listen, good luck. I know with pozi, things didn't work out initially. But what I understand is this is your specialty. You launched. So I think things are looking good.
Joseph Turgeon -- Chief Executive Officer
Well, yes. I had a lot of help but yes, this is a market that several of us here know inside out, Tom Riga, there's no one better than him to lead this parade and I'll be involved myself. So we're looking forward to it.
Operator
[Operator Instructions] We now have a question from Mayank Mamtani. Your line is now open.
Sahil Kazmi -- B. Riley FBR -- Analyst
Hey, Good afternoon. This is Sahil Kazmi on for Mayank. Just a couple of questions from us. A quick follow-up on ROLONTIS. Maybe relative to the kind of on pro 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.
Francois Lebel -- Chief Medical Officer
Yes, I'll take that one. I think first of all, for the PDUFA date in October, that label will be an 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 in our ability to take meaningful share of that market and be very competitive. So that, 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 a relatively high share in that space. But I think there's 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 could be valuable, but that's down the road. Our focus today for October 24 will be to be competitive in a noninferiority, next day traditional, long-acting GCSF market.
Sahil Kazmi -- B. Riley FBR -- Analyst
Great. 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 I trial that's ongoing right now?
Francois Lebel -- Chief Medical Officer
On ROLONTIS or pozi you're talking?
Sahil Kazmi -- B. Riley FBR -- Analyst
On ROLONTIS relative to the same-day dosing.
Francois Lebel -- Chief Medical Officer
I see. So well, as you know, the look, the most important thing right now in late-stage is the active review of the BLA with the FDA. The Phase I, it's obviously early, and we there's a concept here that if we could successfully give it because of the unique characteristic of the product, on the first on the same-day as the chemotherapy that potentially could be a game changer. So we're very interested and that. We'll have to see whether or not what the data we've seen on the basis of modeling, pharmacokinetic, pharmacodynamic as well as the rodent model yes and then you'll so 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 and we're focused on the BLA approval at this point.
Sahil Kazmi -- B. Riley FBR -- Analyst
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 analyses along the way in each cohort that's going to enroll new patients?
Francois Lebel -- Chief Medical Officer
Yes. So the cohort five is an open trial. So there will be and it does have central imaging, though, so there will be 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, we'll 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 post reduction over time. And but we we can't just conclude at the first sign of anything. We need to understand as well if getting response to durability of response and does it modify the course of the so we'll 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 -- B. Riley FBR -- Analyst
Great, thanks for taking my call. So I'm looking forward to the presentation next month.
Operator
And there are no further questions at this time. Joe, you may proceed.
Joseph Turgeon -- Chief Executive Officer
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 Health Care 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 your being on the call. Thank you, operator.
Operator
[Operator Closing Remarks]
Duration: 49 minutes
Call participants:
Robert Uhl -- Investor Relation
Joseph Turgeon -- Chief Executive Officer
Kurt Gustafson -- Chief Financial Officer
Francois Lebel -- Chief Medical Officer
Thomas Riga -- Chief Operating Officer
Kevin Strang -- Jefferies -- Analyst
Ed White -- HC Wainwright -- Analyst
Charles Zhu -- Guggenheim -- Analyst
George Junis -- Analyst
Sahil Kazmi -- B. Riley FBR -- Analyst
