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Spectrum Pharmaceuticals (SPPI) Q4 2021 Earnings Call Transcript

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Spectrum Pharmaceuticals (NASDAQ: SPPI)
Q4 2021 Earnings Call
Mar 17, 2022, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Thank you for standing by, and welcome to the Spectrum Pharmaceuticals fourth quarter 2021 earnings call. [Operator instructions] As a reminder, today's program may be recorded. I would now like to introduce your host for today's program, Kurt Gustafson, executive vice president and chief financial officer. Please go ahead.

Kurt Gustafson -- Executive Vice President and Chief Financial Officer

Thank you, operator, and good afternoon to everyone. Thank you for joining us today for Spectrum Pharmaceuticals fourth quarter and full year 2021 financial results conference call. Our fourth quarter and full year 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 Tom Riga, president and CEO; 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.

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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 Tom Riga, CEO of Spectrum.

Tom Riga -- President and Chief Executive Officer

Good afternoon, and thank you for joining us on today's call. It is a pleasure to address this audience for the first time as the president and CEO of Spectrum. The responsibility of representing our employees, investors and corporate partners is both a privilege and a responsibility I take with great pride. I accepted this position with the full understanding of the past realities and the future opportunities of the company.

I believe the company is at a pivotal moment in its history, and I expect to provide a disciplined, pragmatic and objective leadership approach to capitalize on the opportunities in front of us. It has been helpful to engage, listen and communicate with many of our investors, analysts and stakeholders. I've appreciated the open, candid and productive discussions thus far, and intend for those engagements to continue as we chart our path forward. The first two months of the role have been fast-paced, productive and focused on advancing our late-stage programs.

Let me provide the highlights. In January, we made a strategic decision to restructure and streamline our operations to focus on our late-stage product opportunities with the ultimate goal of gaining two FDA approvals this year. The restructuring was an opportunity to take a hard look at the organization and to rightsize the company to meet the core business objectives while also optimizing our cash runway. We reduced our staff by approximately 30% and expect to see a reduction in our operating cash burn by 20% to 25%.

With making decisions that impact staff is never easy, but in this case, necessary. We also strengthened our partnership with Hanmi Pharmaceuticals, which included a $20 million equity investment and amendments to the licensing and supply agreements for both poziotinib and eflapegrastim. The amendments will allow us to maximize our near-term cash flows and provide improvements to our cost of goods. Furthermore, we recently announced the addition of Juhyun Lim to the board of directors.

Juhyun currently serves as the president of global strategy and planning at Hanmi Pharmaceuticals. We look forward to her leadership and input on our board as we seek to achieve our shared goal of bringing both products to market in the U.S. A solid partnership with Hanmi is critically important to Spectrum as our late-stage assets stem from their development pipeline and FDA approvals will allow them to advance their position in the U.S. At this point, the partnership dynamics between our companies has never been stronger.

As it relates to our late-stage assets, let me start with poziotinib. On February 11, we announced the FDA accepted our NDA and assigned a PDUFA date of November 24, with the initial indication for the treatment of patients with previously treated, locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 mutations. This product has a Fast Track designation, and there are currently no approved treatments for this indication. We believe that poziotinib could have first mover advantage in this area of high unmet medical need.

Our team is actively working with the agency as they conduct their review of poziotinib. Gaining an FDA approval for this indication is a top priority. Since filing, we announced additional positive data at the ESMO TAT meeting for the first-line, treatment-naive lung cancer patients harboring HER2 exon 20 insertion mutations. Francois will cover this in more detail in his remarks.

As we think about the broader strategy for poziotinib, we will focus our resources in areas of significant unmet medical need and high patient prevalence. This strategy is shaped by the clinical data that we observed from our own studies, the competitive landscape, relative risk, and cost of the investment required. For example, beyond HER2, there was interesting, preclinical data presented at the AACR Triple meeting, showing synergy between poziotinib and KRAS G12C inhibitors. This combination would fit our strategic intent as the unmet medical need is real, and the target patient population is significant.

Equally as important to our strategy is defining where we will not spend our resources going forward. To date, our studies in EGFR exon 20 insertion mutations have not met their primary endpoints despite demonstrating strong clinical activity. In addition, there are now two drugs approved in this space. As a result, we will no longer be pursuing poziotinib as a stand-alone therapy for EGFR patients.

In summary, we have an NDA under review with an action date in November. Additionally, we see a clear development strategy for this asset that will be guided by clinical data and analytics to optimize our resources and help patients in need. Now let me shift to eflapegrastim. Today, we announced that the BLA has been resubmitted to the FDA for review.

This is a significant step forward in bringing this novel therapy to patients. We would expect this to be a Class II review with a 30-day acceptance in a six-month review cycle. The resubmission followed the remediation of manufacturing deficiencies at our drug substance facility. In our Type A meeting with the FDA, they have indicated that an in-person reinspection of the facility in South Korea will be required.

We look forward to working with the FDA through their review process. Moving forward, we will be referring to the product as eflapegrastim in no longer calling it ROLONTIS. We were informed by the FDA that our conditionally approved name would no longer be valid as there is now a potential conflict with another product, which is currently under review. We have proposed a new name for the agency with the resubmission, but until that new name is approved we will revert to the scientific name.

As you can see, we are working diligently on our two key programs with a strong sense of urgency and excitement. We are focused on gaining two FDA approvals later this year. Over the past few months, we have made substantial progress on these programs, streamlined our operations, elevated our corporate partnerships and are executing on our core business objectives. Finally, I'd like to take a moment to thank Kurt for his years of service to Spectrum and the valuable insight he has provided as his time as CFO.

He played an important role in the company, and we all wish him well in his future endeavors. We have an active search underway to replace the CFO role, and we'll keep you posted as we make progress. With that, I will now turn the call over to Dr. Lebel for a more detailed update on our clinical development programs.

Francois Lebel -- Chief Medical Officer

Good afternoon, everyone. I'm glad to be with you on today's call. Let's start with our top achievement, the acceptance of our pozi NDA, for our initial indication is a major step toward advancing the treatment for patients with HER2 exon 20 mutation in non-small cell lung cancer. The filing is based on our positive data from Cohort 2 of the ZENITH20 clinical trial, which consisted of patients with locally advanced or metastatic non-small cell lung cancer, harboring HER2 exon 20 insertion mutation who had failed previously.

We believe pozi has the potential to be the first to market for this specific indication, an area of great unmet medical need. We were encouraged by the positive results presented at the recent ESMO TAT Congress by Dr. Sun from the British Columbia Cancer Agency in an oral presentation. We now have two positive cohorts from our pozi program.

This data from the ZENITH20 study that included a total of 70 patients who received 16-milligram per day of oral poziotinib. The first 48 patients in the cohort received 16 milligram once daily with an additional 22 patient dosed at 8 milligrams twice daily. The primary endpoint was an ORR evaluated centrally by an independent image review committee. Pozi met the primary endpoint in this 70 frontline patients with an ORR of 41% and an evaluable patient ORR of 50%.

The lower bound of 30% exceeded the required prespecified criteria of 20%. The median duration of response was 5.7 months with one patient on drug for 19 months. The 8-milligram BID dosing allows better tolerance and nearly 20% lower dose reductions. Treatment-related Grade 3 or higher adverse events were as expected with rash, stomatitis, diarrhea and paronychia being the most come.

Importantly, the incidence of Grade 3 or higher pneumonitis continues to be low at 3% or two patients only and no drug-related deaths. The ORR for 16-milligram QD and 8-milligram BID dosing schedule was 44% and 36%, respectively, and were not statistically different. The duration of response in PFS were similar between the two groups. We are pleased with these positive results as this is the second successful HER2 Cohort of ZENITH20.

Our main priority is to gain an approval as soon as possible to address the unmet medical need. There have been questions on whether we could seek a first-line indication based on positive Cohort 4 data with the same PDUFA date of November 24. The short answer is no. The bar for approval in the treatment-naive population is often higher than in the relapsed setting.

The range of possibility could include a full phase 3 program or perhaps, something less, given the unmet medical need. We plan to meet with the FDA to align on the regulatory strategy for the first-line setting. Now let me shift to some other poziotinib data that was presented at the AACR Triple Meeting late last year, Dr. John Heymach groups at the MD Anderson presented interesting preclinical data, demonstrating the synergistic activity of pozi when combined with KRAS inhibitors in KRAS G12C mutant-specific cell lines.

The preclinical data show that inhibition of EGFR, HER2, HER3 and HER4 signaling was necessary to demonstrate synergy when combining pozi and a KRAS G12C inhibitor. These results highlight the importance of a potent and Pan inhibitor of the ErbB family of proteins. This combination of pozi and G12C inhibitor warrants further investigation. We continue to make solid progress on our clinical development programs and regulatory strategy for both of our late-stage products.

We will keep you posted as we achieve additional key milestones through the balance of the year. I will now turn it over to Kurt for a discussion of our fourth quarter financials.

Kurt Gustafson -- Executive Vice President and Chief Financial Officer

Thank you, Francois. Let me begin with the fourth quarter figures. Total research and development expenses were $18 million in the quarter, as compared to $47.2 million in the same period of 2020. The favorability is primarily related to the charge we took in the fourth quarter last year to discontinue the development of our second manufacturing site for eflapegrastim.

SG&A expense was $18.9 million in the quarter, compared to $15.7 million in the same period of 2020. SG&A expenses were higher in this quarter as we recorded a $4.9 million severance expense for our former CEO. Approximately half of that expense is noncash and was associated with the acceleration of equity compensation. The net loss for the quarter was $39.8 million or $0.26 per share, compared to a net loss of $49.9 million or $0.36 per share in the comparable period of 2020.

On a non-GAAP basis, the net loss was $26.4 million or $0.17 per share, compared to a non-GAAP net loss of $28.9 million or $0.20 per share in the comparable period of 2020. I won't cover the 12-month numbers in detail. But on a non-GAAP basis, the figures for SG&A, R&D and operating income were very similar year over year. With slight reductions to SG&A and slight increases in R&D in 2021 relative to 2020.

You'll find all of these figures in the press release that was just distributed. We ended the fourth quarter with approximately $101 million in cash plus marketable securities, compared to $134 million at September 30, 2021. As Tom mentioned, we received a strategic equity investment from Hanmi in January of $20 million. So a pro forma cash balance, including the equity investment from Hanmi is $121 million.

Cash burn in the fourth quarter was $33 million, and operating cash burn was approximately $30 million. The primary difference is related to the unrealized losses on equity securities. The pro forma cash, combined with the restructuring announced in January that will reduce operating cash burn by 20% to 25% is expected to extend the company's cash runway into 2023. That concludes our prepared remarks, and I'd like to open the call for questions.

Operator?

Questions & Answers:


Operator

[Operator instructions] Our first question comes from the line of Maury Raycroft from Jefferies. Your question, please.

Kevin Strang -- Jefferies -- Analyst

Hi. This is Kevin Strang on for Maury. Just want to say congrats, Kurt, and good luck in the future. And also, thank you for taking my questions.

And just wanted to first ask about the status of your confirmatory trial. What do you think the FDA means by substantially enrolled? And what is your confidence that you'll be able to reach cycle by your PDUFA date?

Tom Riga -- President and Chief Executive Officer

Yeah. Francois will take that one, Kevin.

Francois Lebel -- Chief Medical Officer

Sure. So we plan to give you an update on the PMR at the later date. Our practice has been that we make announcement about design and details of a trial once we enroll the first patient. So what I can tell you today is that actually, we have initiated the confirmatory study.

We secured our first Central IRB approval, and we are operating with a great sense of urgency, to the point you're making, we're very aware that we need to show significant enrollment. The FDA does not define what they mean. And I think, we think that being able to demonstrate good momentum is critical, and that's why we are proceeding and the whole team is proceeding with great urgency as we speak.

Kevin Strang -- Jefferies -- Analyst

Great. Thanks. And then just for my follow-up question. For Cohort 5, so you said you're not going to pursue EGFR.

Is it possible that you leave the study open for HER2 patients to support a possible dosing update to label or for additional info for the FDA? Or do you plan on shutting down that cohort?

Tom Riga -- President and Chief Executive Officer

Yeah. Good question, Kevin. We plan on keeping the HER2 component of that open and allowing that to continue to enroll for a number of reasons. Dosing is one of them, but also to capture additional data.

But the EGFR components of that will be closed down.

Kevin Strang -- Jefferies -- Analyst

OK. Great. Thanks. And I'll hop back in the queue.

Tom Riga -- President and Chief Executive Officer

Thanks.

Operator

Thank you. Our next question comes from the line of Ed White from H.C. Wainwright. Your question, please.

Tom Riga -- President and Chief Executive Officer

Hey, Ed.

Ed White -- H.C. Wainwright and Company -- Analyst

Hi, Tom. Thanks for taking my questions. And Kurt, it's been a real pleasure working with you this past 10 years. I really appreciate all of your help over the years.

Kurt Gustafson -- Executive Vice President and Chief Financial Officer

Thanks, Ed. Appreciate that.

Ed White -- H.C. Wainwright and Company -- Analyst

So maybe just the first question on something Francois just said, about the first-line patients -- in the past, he said that Cohort 4 was a potential pivotal study. And now I believe he said that you could need a phase 3, but you have to talk to the FDA first. I'm just curious as to what might have changed over the years to give you the thought that you might have to run another phase 3 study?

Tom Riga -- President and Chief Executive Officer

Yeah, Ed, thanks for the question. I think that's ultimately something that I have made to call on because, we just got the data. We need to speak to the agency. And there's been a lot of questions about, can we simply include that data with our current file? Or how should we think about it? And I think the reality here is, until we have a formal Type A meeting with the agency to share this particular data against how they're thinking about the frontline indication, I don't want to leave with an expectation that this is going to either be included with the existing indication that's submitted or even that of an sNDA.

Certainly could be. I mean accelerated approval, there is a big unmet medical need, but there is a range of possibilities and until we have that formal engagement, which we will have, we wanted to make sure that we were clear on how we were seeing.

Francois Lebel -- Chief Medical Officer

Hey, Ed. I would add to that that what I said is actually quite consistent to what we've said before. As you know, the first four cohorts were what we call registration level in terms of how they were executed. They had prespecified endpoints.

They had a central IRB -- not IRB, but Data Safety Monitoring Board and review process. So we've met the primary endpoint. So obviously, that positions us quite well. But we've also said in the past that there would have to be a judgment about durability of response, the safety profile and whatever other product would be on the market at the time that this would happen.

So all these factors are going to be called into questionnaire or we will have to discuss with the agency. So there's no -- a set back here. It's purely that we have to go and present all the data to the agency and see where they're going. You probably know as well that in first line, it's always the bar is a little larger than in second line.

So those are some of the other elements that are part of our decision and what's coming full.

Ed White -- H.C. Wainwright and Company -- Analyst

OK. Thanks, Francois. And how should we be thinking about a potential label in second line? Is there the possibility of getting the 8-milligram BID dosing? Or are you thinking it has to be 16-milligram to start?

Tom Riga -- President and Chief Executive Officer

Yeah, that's a great question. So you know that the Cohort 2 was dosed at 16 milligrams QD and through Cohort 5 and a number of the work that we've done have produced a pretty healthy body of evidence in the BID setting. So we'll wait and see until the label negotiation part of the discussion with the agency occurs. But we are seeing that 16 QD is certainly a safe and effective dose.

And I think over time, we have learned to optimize some of the tolerability and abate some of the AEs here with the BID dosage. So I think that will be a key topic when we get to label negotiations with the agency, and we're simply not at that point of the review cycle, which will be coming here shortly.

Ed White -- H.C. Wainwright and Company -- Analyst

Thanks, Tom. And perhaps, a last question for Kurt. With the restructuring and then also with the potential launch of two products by year-end, how should we be thinking about the progression of SG&A and R&D expenses over the course of the year, where are you as far as the commercial team is and how we should be thinking about additions over the course of the year?

Kurt Gustafson -- Executive Vice President and Chief Financial Officer

Yeah. No, thanks, Ed. The specific guidance that we gave related to cash burn, so operating cash burn, it fluctuates a little bit but over the course of 2021, was roughly around $30 million a quarter. And we said post the restructuring, we expect that number to be down 20% to 25%.

I'm not going to get into specifics around how to break things down between SG&A and R&D, just kind of cash is probably the most relevant number to be thinking about here for us. I guess the caveat to this is obviously the restructuring happened in the first quarter. So -- and Q1 is always traditionally our higher burn quarter. So Q1 is going to have some extra costs associated with the restructuring.

And so the realization of that really is something that starts in Q2 and kind of goes on from there. As it relates to commercial team, Tom, do you want to --

Tom Riga -- President and Chief Executive Officer

Yeah. And I think the guidance that we've given with the cash runway is assuming that those launches are funded. And as I think about the commercial team, we intend to do this with a competitive and lean group. Even despite the restructuring, we believe we've capped some world-class commercial talent.

In the oncology ecosystem, even in a post-COVID environment one, continues to consolidate; and two, access continues to be a challenge, and I don't see that changing. So I think having a lean infrastructure is the right approach. And I think we are -- we have the right team in place to get these products off the ground successfully.

Ed White -- H.C. Wainwright and Company -- Analyst

OK. Great. Thanks for taking my questions.

Tom Riga -- President and Chief Executive Officer

Thanks, Ed.

Kurt Gustafson -- Executive Vice President and Chief Financial Officer

Thanks, Ed.

Operator

Thank you. Our next question comes from the line of Reni Benjamin from JMP Securities. Your question, please.

Reni Benjamin -- JMP Securities -- Analyst

Hey, good afternoon, guys. Let me add, Tom, my congratulations. And Kurt, sorry to see you go, but best of luck in the new position. It was great interacting with you, of course.

So just maybe a quick question on pozi. In terms of the review, right, Tom, you mentioned you had Fast Track, this is a single-arm study. And I was a little bit -- I couldn't figure out why the FDA would grant you guys' standard review instead of a priority review, unless I've made my calculations wrong. Can you just talk to us a little bit about the review process and why it appears to be a standard review?

Tom Riga -- President and Chief Executive Officer

Yeah. That's a great question, Ren. So you're right. We do have an accelerated approval with a phase 2, single-arm study, and it does have Fast Track.

I think the -- what you're referring to is, we were not given a priority review. We were given a standard review. So I try not to get into the mind of the FDA and their thinking on that. I do know that we're thrilled to have a PDUFA date in November.

And the pace of the interactions with the agency and how we're progressing through the regulatory process, we are pleased with thus far. And we're going to make sure that we're ready to rock and roll here so that we can address this unmet need here in November.

Reni Benjamin -- JMP Securities -- Analyst

Got it. OK. And then just in regard to the exploratory cohorts, I think it's five to seven. Can you just give us an update as to what's happening there? Are they -- since they were exploratory to begin with and you guys are making headcount reductions and reevaluating the programs, could those also potentially be closed?

Tom Riga -- President and Chief Executive Officer

Yeah. So what I was trying to accomplish in my prepared remarks with our strategies, we're going to look at unmet need, prevalence and investment. And when I look at what would be last would be the Cohort 5 for the frontline HER2 population, which we will certainly keep for a number of strategic reasons. And then I think when you start looking at six and seven and you look at the need, the prevalence and the cost of keeping a large ZENITH20 study open, I think it really calls into question if those are going to stay open.

We will make that decision here very shortly. We haven't finally aligned on it. But as I'm thinking about the lens of strategy of how we need to expel our resources and focus our energies, there are other avenues that I think present higher unmet need and a greater opportunity for pozi to be successful.

Reni Benjamin -- JMP Securities -- Analyst

Got it. OK. That makes sense. And then just switching gears to, I'll just shorten it as, efla, if you don't mind, the efla BLA.

It's six months. Within 30 days, you're going to know whether they've accepted it. I thought that the majority of the issues -- the large majority of the issues or deficiencies, all had to do with the manufacturing plant. I could be wrong on that.

But it seems like they would have to go like right away and start doing an in-person inspection. Am I thinking about that correctly? Or is this something that I don't know, there's a lot of work that needs to be done during the initial part of the review, the inspection lines of getting done toward the tail end. And then I just worry about things like delays in the inspection like we ran into your first time. I just wanted to kind of get your thoughts as to how this process kind of maps itself out.

Tom Riga -- President and Chief Executive Officer

Yeah, let's unpack that. So the CRL focused really on two things: It identified manufacturing challenges, both at the drug product facility and the drug substance facility. Subsequently, we had a Type A meeting with the FDA where the issue at the drug product facility, which had nothing to do with, ROLONTIS was cleared and was not a gating item to resubmission. So really, the sole challenge from the CRL was the remediation efforts at the drug substance facility in Korea.

Now we have worked very closely with our partner on the remediation and capital plan that resulted from that initial inspection and ultimately announced today that we resubmitted. So a Class II resubmission is what I was articulating at a 30-day acceptance in a six-month clock. So that date will put you around September. And I think you're right, in that, the gating item, as far as we know, is the reinspection of that facility.

And typically, that would happen at some point after the acceptance when they can get to Korea. Now will there be challenges with them traveling to Korea given the COVID realities of what we had in the past? I don't have a crystal ball, but I do know that the FDA is conducting international inspections today. We don't see it as a barrier today, but we're going to keep an eye on it, and we're looking forward to them scheduling that date and getting to Korea to conduct the inspection.

Reni Benjamin -- JMP Securities -- Analyst

Terrific. Great, guys. Thanks very much for taking the questions.

Operator

Thank you. Our next question comes from the line of Mayank Mamtani from B. Riley Securities. Your question, please.

Mayank Mamtani -- B. Riley Financial -- Analyst

Hi, team. Thanks for taking our questions, and congrats on kicking off the year with nice progress on regulatory front. Actually, first question, if I may ask on Dr. Heymach's data recently presented.

Have you approached or have been approached by any of the KRAS G12C companies to start doing some initial dose finding work for the combination product?

Tom Riga -- President and Chief Executive Officer

Yeah. Great question, Mayank. As you know, KRAS mutations in lung cancer have long been thought to be undruggable. Now we find ourselves with one product on the market, another under active review and several others in development.

And I think each of them have a number of combination work ultimately trying to enhance, to raise and differentiate them. And I think the work that was presented at the Triple Meeting is certainly interesting, and we are in conversations with a number of them, intend to act on it. It fits really the strategic ethos of where we want to take this asset in that. There is a big unmet need and the patient population there is certainly prevalent.

So more to follow.

Mayank Mamtani -- B. Riley Financial -- Analyst

OK. Great. And then on the frontline phase 3 study that you guys are thinking about, could you just give me a little bit of color what could be the comparator arm there? And what sort of response rate or PFS kind of endpoint you might be looking at? And I'm going to assume this is going to be eight -- mg BID, pozi you're going to look at in that setting?

Tom Riga -- President and Chief Executive Officer

No. Let me clarify that one, Mayank. So a phase 3 program is really conditional on us having a conversation with the FDA. So we tried to provide just a broad range of outcomes of what could happen with that.

But we believe we have a successful cohort. And we'll mention -- we'll talk about the PMR at a later date. But I think we need to go sit with the FDA and talk specifically about the frontline indication. And I think that would ultimately refine the regulatory strategy.

And at that point, we would come back to you and say, here is the path, which could range from -- there's a phase 3 program if necessary and here's the comparator, likely chemotherapy doublet plus or minus IL or if there's an accelerated approval, a different path. So we're simply saying, we want to go sit with the FDA, have this conversation and then update the regulatory strategy post that meeting.

Mayank Mamtani -- B. Riley Financial -- Analyst

So maybe just following up on that. Should we just assume that there's going to be a spend around one phase 3 study this year, which is the study that FDA has required for allowing for accelerated approval and has to be enrolled to a certain extent. Is that fair?

Tom Riga -- President and Chief Executive Officer

That's absolutely fair.

Mayank Mamtani -- B. Riley Financial -- Analyst

OK. And have you -- just in terms of your data updates for the rest of the year, when should we expect to hear more on the Cohort 4, 8-mg BID and then also some other data from Cohort 5 on the lower dose but more frequent dosing?

Francois Lebel -- Chief Medical Officer

So obviously, we -- as I indicated in my -- I think in my answer a little earlier. So we're going to update you on the PMR. And answering a lot of the questions you raised there. But at a later date.

We're just not going to go there today. As to the other cohorts and arms and dosing work that we've done, there is a number of communication that we will do in the future. I'm just not ready today to give you the exact time but we're working. Obviously, we have -- usually we present all our data at appropriate scientific venue.

And especially, now that some of them are reopening for in-person, and we certainly look forward to add to the body of evidence supporting the safety and efficacy of pozi.

Mayank Mamtani -- B. Riley Financial -- Analyst

Yeah. Thanks for taking my question. I look forward to definitely seeing you in-person at one of these conferences. And Kurt, you'll be very much missed.

And wishing you all the best for your next chapter.

Kurt Gustafson -- Executive Vice President and Chief Financial Officer

Thank you.

Francois Lebel -- Chief Medical Officer

Thank you, Mayank.

Tom Riga -- President and Chief Executive Officer

Thanks, Mayank.

Operator

Thank you. This does conclude the question-and-answer session of today's program. I'd like to hand the program back to Tom Riga for any further remarks.

Tom Riga -- President and Chief Executive Officer

Thank you all for your participation on today's call and your interest in Spectrum. If you have any further questions, please feel free to reach out at any time. Have a great day.

Operator

[Operator signoff]

Duration: 40 minutes

Call participants:

Kurt Gustafson -- Executive Vice President and Chief Financial Officer

Tom Riga -- President and Chief Executive Officer

Francois Lebel -- Chief Medical Officer

Kevin Strang -- Jefferies -- Analyst

Ed White -- H.C. Wainwright and Company -- Analyst

Reni Benjamin -- JMP Securities -- Analyst

Mayank Mamtani -- B. Riley Financial -- Analyst

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