Earnings Call Transcript - GERN Q3 2020

Operator, Operator

Good afternoon. My name is Lisa, and I will be your conference operator today. I would like to welcome everyone to the Q3 2020 Geron Earnings Conference Call. I would now like to turn the call over to Ms. Suzanne Messere. Please go ahead, ma'am.

Suzanne Messere, Executive

Thank you, Lisa, and good afternoon, everyone. Thank you for joining us for today's conference call. I am joined today by Dr. John Scarlett, Geron's Chairman and Chief Executive Officer; Olivia Bloom, the company's Chief Financial Officer; and Aleksandra Rizo, our Chief Medical Officer. After the market close today, we announced our third quarter 2020 financial results and recent events by a press release. It is available on our website under www.geron.com/investors. In addition, a live webcast of this call is available on our website and will be archived for 30 days. Before we begin, please note that this presentation and question-and-answer session will contain forward-looking statements relating to Geron's plans, expectations, timeline, beliefs, statements of potentiality, and projections. These include, without limitation, those regarding the timelines for completion of enrollment in and the results from the IMerge and IMpact clinical trials, that Geron's existing financial resources will be sufficient to fund operations into the second half of 2022, and that imetelstat has the potential to be disease modifying. These and other forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include, without limitation, those regarding the COVID-19 pandemic significantly impacting the timelines for enrollment and results of the clinical trials and/or drug supply; that the company may be unable to overcome all the clinical safety, efficacy, technical, scientific, operational, manufacturing and regulatory challenges to meet the expected timelines for IMerge and IMpactMF; that in clinical trials, imetelstat may be unsafe or fail to demonstrate that it is disease-modifying or efficacious; that regulatory authorities may not permit the further development of imetelstat on a timely basis or at all; and that Geron may need additional financial resources before the end of 2022 for the development and commercialization of imetelstat. Detailed information on the above risks and uncertainties and additional risks, uncertainties, and factors that could cause actual results to differ materially from those in the forward-looking statements are explained under the heading Risk Factors in Geron's quarterly report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made and the facts and assumptions underlying the forward-looking statements may change. On today's call, Dr. Scarlett plans to make a few introductory comments, after which Ms. Bloom will cover the recent debt financing, third quarter financial results, and 2020 guidance. Dr. Rizo will provide clinical development updates regarding the ongoing IMerge Phase III clinical trial in lower-risk myelodysplastic syndrome or MDS; the upcoming IMpactMF Phase III trial in refractory myelofibrosis, or MF; and recent data announcements, including publication of the IMerge Phase II data in the Journal of Clinical Oncology, also known as JCO, and the 10 abstracts accepted for presentation at this year's American Society of Hematology, or ASH, annual meeting. Dr. Scarlett will then finish the call with closing remarks. I will now turn the call over to Dr. John Scarlett, Geron's Chairman and CEO.

John Scarlett, CEO

Thanks, Suzanne. I'd like to welcome everyone to our third quarter 2020 conference call. Before we begin, I'd like to make a few comments on the COVID-19 pandemic and how we're managing. In compliance with state and local rules and for the health and safety of our employees, access to our offices remains closed and our employees are working from home. We also continue to limit business travel to essential business needs only. Although all of us would like to return to our normal pre-COVID schedules and routines, employee productivity and efficiency continue to be very high. Later in the call, Aleksandra will comment on the effect of COVID on our clinical activities. In the third quarter, we actively pursued our clinical, regulatory, and publication plan for the imetelstat program. Enrollment in the ongoing IMerge Phase III clinical trial in lower-risk MDS and start-up activities for the upcoming Phase III clinical trial in refractory MF, which we have named IMpactMF, continued to progress. We also secured orphan drug designation in lower-risk MDS in Europe, received acceptance for presentation of all 10 abstracts submitted to the ASH annual meeting, published IMerge Phase II data in the Journal of Clinical Oncology, and strengthened our balance sheet with a loan facility that provides additional financial flexibility to further support our plans for imetelstat development going forward. We continue to work toward completing enrollment in IMerge in the first quarter of 2021. However, given the recent resurgence of the COVID-19 pandemic, there are uncertain and unpredictable impacts on clinical trial activities. Due to these challenges, we now believe the trial will most likely be fully enrolled in the second quarter of 2021. As long as enrollment is completed by the end of the first half of 2021, we continue to expect top line results from IMerge to be available in the second half of 2022, as previously guided. Regarding the IMpactMF trial, based on current feedback from clinical sites that are planned to participate, we continue to expect that trial to be open for screening and enrollment in the first quarter of 2021.

Olivia Bloom, CFO

Thank you, Chip, and good afternoon, everyone. As of September 30, 2020, we had approximately $274 million in cash, cash equivalents, and current and noncurrent marketable securities. Our cash position reflects net proceeds of approximately $140 million from a public offering in May 2020 and approximately $24 million in initial net proceeds for a nondilutive $75 million loan facility that closed at the end of the third quarter. The loan facility will be available to Geron through year-end 2022 in three tranches subject to certain terms and conditions including the achievement of specific clinical, financial, and regulatory milestones. The loan facility provides us with access to nondilutive financial resources to support the imetelstat development program as well as working capital and general corporate purposes. Based on current planning assumptions, we estimate our current financial resources to be sufficient for our operations until the end of 2022. During which time we plan to reach two significant inflection points: top line results for the IMerge Phase III clinical trial in low-risk MDS and completion of patient enrollment for the upcoming IMpactMF Phase III clinical trial in refractory MF. Overall, the financial results for the third quarter and year-to-date periods were in line with our expectations. Operating expenses for the three and nine months ended September 30, 2020, were generally higher compared to the same period in 2019 due to headcount increases in 2019 across the company, increased activity for the IMerge Phase III clinical trial in low-risk MDS, start-up activities for the upcoming IMpactMF Phase III clinical trial in refractory MF, and costs associated with validating imetelstat manufacturing processes. Importantly, our manufacturing and quality teams recently accomplished an operational milestone in establishing our imetelstat supply chain. Our clinical sites are now starting to receive Geron-manufactured imetelstat and placebo in the IMerge Phase III. This achievement helped assure uninterrupted drug supply for both current and future clinical trials as well as enables Geron-manufactured materials to be included in the current Phase III registration-enabling trial. We plan to use the same manufacturers that produce these clinical materials for potential future commercial manufacture of the drug. We expect operating expenses to be higher in the second half of 2020 compared to the first half as we begin to support two Phase III clinical trials of imetelstat, the ongoing Phase III and the upcoming IMpactMF Phase III. Regarding financial guidance for 2020, we are reiterating our expectation of operating expense burn to range from $70 million to $75 million. Financial guidance is based on a set of assumptions at a point in time. If the company's plans change causing assumptions to be revised, we expect to update guidance at that time.

Aleksandra Rizo, CMO

Thanks, Olivia, and good afternoon, everyone. Before I discuss the recently published imetelstat data, I'd like to give a brief update on our Phase III clinical trials in refractory MF and lower-risk MDS. The clinical protocol for our upcoming Phase III clinical trial in refractory MF, called IMpactMF, has been finalized, and the trial is now listed on clinicaltrials.gov. We continue to expect the trial to be open for screening and enrollment in the first quarter of 2021. Start-up activities are ongoing and include site selection, engagement of vendors, building of the clinical database, and more. In the IMpactMF trial, the final analysis for the primary endpoint of overall survival or OS is event-driven and is planned to be conducted after more than 50% of the patients enrolled in the trial have died. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of death events for the final analysis have occurred. If the pre-specified statistically significant difference in OS between the two treatment arms is met at the interim analysis, it is possible that data from the interim analysis could support the registration filings. Moving on to the ongoing IMerge Phase III clinical trial in lower-risk MDS, enrollment for this trial continued to progress in the third quarter. In August, all 92 of the originally planned clinical sites were open for enrollment. To address enrollment delays related to the COVID-19 pandemic experienced earlier this year, we implemented several enrollment-boosting activities. These include engaging clinical science liaisons to interface directly with the clinical sites, establishing a digital presence for the trial, and expanding the number of clinical sites in existing and new countries. We currently expect to open approximately 30 new clinical sites, although, at this time, only a handful are open. As a result, we believe the full benefit of the additional sites has not yet been realized. We expect almost all of these sites to be open for screening and enrollment by the end of 2020. Our team internally is continuing to target completion of enrollment in IMerge by the end of the first quarter. Despite our efforts, given the recent resurgence of the COVID-19 pandemic, particularly in many of the countries where IMerge is being conducted, and the uncertainty and unpredictability regarding the impact on clinical trial activities coming in winter, we now believe it is most likely the trial will be fully enrolled sometime in the second quarter of 2021. However, it is important to note that as long as enrollment is completed by the end of the first half of 2021, we continue to expect top line results to be available in the second half of 2022, which is consistent with our previous guidance. As announced in a press release last week, the data from the IMerge Phase II trial in lower-risk MDS was published in the well-respected Journal of Clinical Oncology or JCO. We believe this publication further indicates the recognition of the importance of the IMerge data by experts in the MDS field. As you may recall, meaningful and durable transfusion independence with imetelstat treatment has been highlighted consistently in previous medical conference presentations as it is in the JCO article. The median duration of transfusion independence of 21 months is a critical clinical outcome for these transfusion-dependent patients. Moreover, as reported, approximately 30% of the patients were transfusion-free for over a year. To our knowledge, this is the longest duration of transfusion independence reported in lower-risk MDS patients. In addition to the durable transfusion independence, a decrease in SF3B1, one of the key mutations correlated with ineffective erythropoiesis in lower-risk MDS, was observed in the trial although only a small number of patient samples were available for testing. Of critical importance, the duration of the transfusion-free period was correlated with the decrease of the SF3B1 mutation. Patients that had the highest decrease of SF3B1 also had the longest transfusion-free period. To put this data in context, recall that telomerase is continuously upregulated in malignant stem and progenitor cells, resulting in malignant hematopoiesis. As a telomerase inhibitor, imetelstat selectively targets malignant cells, which have continuously upregulated telomerase, to induce their death and enable potential recovery of normal hematopoiesis. Decrease in disease mutations, such as the SF3B1 mutation, is an indicator of potential impact on the malignant cells of the underlying disease, which suggests disease-modifying activity. In addition, observations of clinical outcomes, such as the durable transfusion-free period experienced by the patients in IMerge Phase II, indicate potential recovery of normal hematopoiesis, suggesting disease-modifying activity. Therefore, we believe both the durable transfusion independence and the reduction in the SF3B1 mutation observed in the IMerge Phase II suggest disease-modifying activity for imetelstat treatment in these patients. Regarding ASH, yesterday we announced that a total of 10 abstracts have been accepted, of which four would be oral presentations. In summary, the data and analysis reported in all of the abstracts support our Phase III clinical trial and highlight the clinical benefits observed in both the Phase III IMerge and IMbark trial. There are several abstracts covering the IMbark Phase II study, including new data on patient-reported outcomes, data on improved OS in triple-negative MF patients as well as biomarker data and analysis supporting the on-target activity of the drug. Also, there are two abstracts categorized as trials in progress that provide further details of the trial design for the ongoing IMerge Phase III and the upcoming IMpactMF Phase III. This afternoon, I would like to focus on the data suggesting potential disease-modifying activity of imetelstat from the IMbark Phase II trial in relapsed/refractory MF that were reported in two of the ASH abstracts. One of the ASH abstracts, #346, which is scheduled for an oral presentation, reports new analysis from the IMbark Phase II trial that shows significant dose-dependent reduction of the mutation burden of key driver mutations for MF as measured by reduction in the variant allele frequency or VAF of the mutation. The data showed that the patients who had reduction in VAF had prolonged median OS of 31 months versus 21 months for those patients that did not have reduction in VAF. The abstract concludes that depletion of cytogenetically abnormal clones and reduction in mutation burden, together with the improvement in median life, further demonstrates that imetelstat has disease-modifying activity by targeting malignant cells. The second abstract in MF, #658, which is scheduled for an oral presentation, describes a set of data from the IMbark Phase II showing that there was a correlation between the improvement in fibrosis and improved median OS. In other words, the patients that had at least one degree of fibrosis improvement had significantly longer survival than those who had worsening of fibrosis. In conclusion, we believe that the data from the JCO publication and these two abstracts highlight imetelstat's impact on the malignant cells responsible for the underlying disease as well as the clinical outcomes of durable transfusion independence for lower-risk MDS patients and improved overall survival for relapsed and refractory MF patients. Taken together, these data continue to build the clinical and biomarker evidence suggesting disease-modifying activity, which we believe differentiate imetelstat from other treatments for low-risk MDS and refractory MF. Now I'd like to hand the call back to Chip.

John Scarlett, CEO

Thanks, Aleksandra. In closing, I would like to reiterate that we continue to advance both the IMerge and IMpactMF Phase III clinical trials. Through medical conferences like ASH and in scientific and clinical journals, we continue to raise awareness of imetelstat's disease-modifying data. We are also pleased to report that we have established our own imetelstat supply chain, which will allow Geron-manufactured materials to be included in the current Phase III registration-enabling trials, which is an important step towards NDA readiness. Finally, we've also strengthened our balance sheet to further support our plans for imetelstat development going forward. We believe that these efforts will help establish Geron as a leader in hematologic myeloid malignancies, thus creating long-term shareholder value. So with that, we'd like to answer your questions. I'll turn the call back over to our operator, Lisa.

Operator, Operator

The first question comes from Gil Blum with Needham & Company.

Gil Blum, Analyst

I'm on here for Chad. So maybe a bit of a strange question, is there any overlap between the IMerge and IMpactMF study sites?

John Scarlett, CEO

Aleksandra, can you take that overlap between the two studies and sites, in terms of sites?

Aleksandra Rizo, CMO

Yes, there are sites that are overlapping for sure between the two studies.

Gil Blum, Analyst

Got you. And it looks like you have a very big ASH ahead of you, lots of presentations. What can you share about some plans for KOL outreach and those kinds of activities, considering this is a virtual format?

John Scarlett, CEO

Go ahead.

Aleksandra Rizo, CMO

Yes. I mean it's a good question. And then again, you just gave the answer, I guess. Because it's a virtual meeting, at the moment, we have not planned KOL activities but that's at the moment. However, we will be sponsoring a few of the educational sessions that will be at ASH.

Gil Blum, Analyst

And kind of the last. We know that getting your own supply of imetelstat gives you flexibility and control over your own supply chain. Is there any situation in which that supply chain would be affected by the ongoing pandemic?

John Scarlett, CEO

So far, Gil, we don't see that as a major risk. Much of our supply chain is in South Korea, which is probably one of the best-controlled countries so far. So I would comment on that. Secondly, we've managed all of these activities, which were very substantial during the height of the pandemic. So while it's impossible to say 'never,' I think it's a pretty low risk right now.

Gil Blum, Analyst

Excellent. And congratulations on all progress.

John Scarlett, CEO

Thanks.

Aleksandra Rizo, CMO

Thanks.

Operator, Operator

Your next question comes from the line of Bonnie Quach with Stifel.

Bonnie Quach, Analyst

This is Bonnie on for Steve Willey. I wanted to ask more about the enrollment of the IMerge study. Is the patient population that you're enrolling so far somewhat similar to the patient population enrolled in the Phase II trial, in terms of RS-positive and RS-negative, as well as transfusion burden? Because I remember the Phase II patients had pretty high transfusion burden.

John Scarlett, CEO

Correct. I'll let Aleksandra answer that first. If you had more, I may take them. Go ahead.

Aleksandra Rizo, CMO

Right. So the inclusion and exclusion criteria for the Phase III part of the study have not changed compared to the Phase II part defined for the target patient population, which means that we are still enrolling patients regardless of the presence or absence of ring sideroblasts. We are still enrolling patients that had at least four units prior to enrollment on the study prior to the randomization of the study. So again, we are enrolling the same patient population from the target population.

Bonnie Quach, Analyst

And for the MDS patients to achieve transfusion independence but then end up needing transfusions again, is there any evidence of potential for achieving durable transfusion independence again with continued treatment? Is this something you've looked into?

Aleksandra Rizo, CMO

Absolutely, that has been reported in a few patients at the last EHA. We do have patients who achieved transfusion independence, but for some reason had to receive transfusions again, and then they became transfusion independent once more.

Bonnie Quach, Analyst

And just a small follow-up to that. How do you see this playing out in a real-world study in terms of keeping patients on drugs once they've gone back to receiving transfusions again?

Aleksandra Rizo, CMO

How we see it is that if I understand your question correctly, you're asking what occurs in the real world when a patient has achieved transfusion independence but then needs a transfusion. Are they going to stop the drug, or might they continue taking it? Is that what you meant?

Bonnie Quach, Analyst

Yes.

John Scarlett, CEO

Okay. I'll let Aleksandra handle that.

Aleksandra Rizo, CMO

Yes, at this point, I don't see any reason for them to stop. If a patient is independent from transfusions and is benefiting from the drug, feeling better, and doesn't need transfusions, I believe they would want to keep receiving treatment. Therefore, I don't foresee an issue with continuing treatment for patients even if they eventually need transfusions again.

John Scarlett, CEO

Yes. And I think just to answer the question very directly, if a patient, for whatever reason, requires a transfusion, these patients are used to requiring different levels of transfusion, et cetera. So if they require a transfusion, I think our experience suggests that they would likely continue to give imetelstat an opportunity to keep them transfusion-free again. It goes back to the question that you asked before, what happens to patients who quit having transfusion independence? Do they then reestablish transfusion independence after getting a transfusion? If can the drug continue to work? The answer is unequivocally yes. So I think because of that, the likelihood is that investigators, or in this case, treating physicians and patients, would have a very high incentive to continue the drug, even if there was an interruption of their transfusion-free period.

Aleksandra Rizo, CMO

Yes, I just wanted to add, go ahead, Bonnie.

Bonnie Quach, Analyst

Oh, no. I have nothing. Please go ahead.

Aleksandra Rizo, CMO

I just wanted to add one more item. I know we are discussing transfusion independence, but recall in our study, we have 68, about 70% of the patients who have hematologic improvement. Those are the patients that actually have a decreasing need for transfusions. So it's a large proportion of patients that benefit from our drug, irrespective of whether they eventually achieve transfusion independence, which still happens in a large proportion, 42% of the patients. But again, 68 have hematologic improvement and decrease in transfusion needs. So I believe that's really a good reason to stay on the drug.

Operator, Operator

Our next question comes from the line of Charles Duncan with Cantor Fitzgerald.

Charles Duncan, Analyst

John and team, congrats on continued enrollment in IMerge and the manufacturing milestone as well as the ASH abstracts. I had a couple, so I'm going to try to be quick. First of all, with regard to IMerge and the enrollment discussion around 1Q or 2Q next year, is it the result of an observed kind of change in enrollment patterns, or getting new sites up and running in terms of executing on that, or just prudence?

John Scarlett, CEO

I'll take that, Charles. Thanks for the question. So first of all, let me make a couple of comments. Look, we debated for a long time about how to characterize the uncertainty that was caused by COVID and also the comment that many experts believe that the worst is yet to come. At the same time, we have not yet begun to see the kind of broad-based self-imposed holds, similar to what we saw early in spring and summer of the year when sites were initially feeling the first effects of COVID. So what we are seeing is that sites are beginning to adapt to enable patient treatment to continue. These are kind of the unknowns at this point. How severe is the increase going to be this fall and winter? How effective are the measures employed by these sites to stay open? How effective are they going to be despite increasing numbers of COVID cases? How effective will our enrollment-boosting activities be at the existing sites? And how many of these new sites will come online by the end of the year? As we said, we hope that most will come on, but again, COVID makes this all pretty tough. So our best assessment was that we believe it's most likely that we'll be fully enrolled in the second quarter. But I really want to make the point that we feel like that was the best and most responsible way to weigh and communicate these various scenarios. But I do want to be really clear that if we achieve that by the end of the second quarter, we will still be on track and on time for our top line results as previously communicated.

Charles Duncan, Analyst

Okay, yes. And I understand that's an event-driven study, so there may be a little bit of conservatism in that as well. And it sounds like it's a prudent thing in terms of the enrollment on IMerge. Are you detecting the same kind of level of enthusiasm around the profile of imetelstat for investigators in terms of enrolling patients as you did when you launched this study?

John Scarlett, CEO

Yes, I'll let Aleksandra comment on that.

Aleksandra Rizo, CMO

Yes, I can reaffirm that the situation is as described. The data published in JCO has significantly increased enthusiasm. We are collaborating closely with key opinion leaders in the field. Although I previously mentioned that there might not be an event at ASH, we feel confident about the engagement and interest from the KOLs in our study and the principal investigators participating in it.

Charles Duncan, Analyst

Okay. That's helpful. And then with regard to the IMpactMF trial, which I got to tell you, I really like because it says something more to me than the previous study names. Can you just remind me, or maybe I should go to clinical trials, but can you remind me the event rate that you were assuming in IMpactMF or kind of the time to event that you're looking at going in on that?

Aleksandra Rizo, CMO

I don't think that information will be available on clinicaltrials.gov, so we have not published it. The study is event-driven, and we plan to conduct an interim analysis when 70% of the events required for the final analysis have occurred. At that time, we will determine if there is a statistically significant difference between the two groups. This data could potentially be used to support a filing, which is 70% of the 50% needed at the conclusion of the study.

Charles Duncan, Analyst

Okay. But the kind of time to that, you really haven't published and I can understand why. Is that clear? Is that the answer?

Olivia Bloom, CFO

Charles, this is Olivia. Just to remind you, as of now, we're projecting that it's in the first half of 2023 potentially for the interim, and the final, potentially first half of 2024.

Charles Duncan, Analyst

Okay. And then last question is regarding manufacturing. So it's cool to see that you folks have been able to get that up and running despite the challenges of COVID. I guess I'm wondering if any patients have been dosed with older drug or the drug from Janssen. And is there any bridging or anything, or can you handle kind of the comparisons through analytical methods?

John Scarlett, CEO

Let me address that. Essentially, we are utilizing the same manufacturing process. The sponsorship has changed, but the majority of the processes and the companies involved in contract manufacturing remain the same. Now, this is entirely under our direction and sponsorship. All patients treated so far in the MDS study have received material produced by Janssen and under their sponsorship. The change will involve introducing new material made under our sponsorship into the study as it moves forward. While this situation is not high-risk due to the consistency of the process, we need to fulfill a regulatory requirement to ensure that what is expected to be the final commercial process and group is being used in the Phase III study. I believe we have successfully avoided any significant missteps here and have likely met an important regulatory requirement.

Charles Duncan, Analyst

Got it. Okay, congrats on the progress.

John Scarlett, CEO

Sure.

Operator, Operator

Your next question comes from the line of Tom Shrader with BTIG.

Thomas Shrader, Analyst

Thank you for the update, as always. I have a quick question about IMpact. Regarding the interim look, is that a minimal alpha spend, making the standard very high? Is that a reasonable expectation for us, or does the drug need to perform exceptionally well?

Aleksandra Rizo, CMO

I would say that it's a reasonable alpha that we've allocated for the interim analysis. And again, is there a statistically significant difference, Tom, right? So it is reasonable, but there has to be a statistically significant difference, and thereby, it is possible still to have the data from the interim to support the registration.

Thomas Shrader, Analyst

Okay. Got it. And I was a little surprised by first-half interim in '23 and first-half full for '24. A lot of these trials enroll sort of very slowly. And once they get rolling, they enroll like mad. Do you expect this to enroll more linearly because all the centers are well established and the patients are pretty well known, kind of an unusually linear forecast you see in enrollment?

Aleksandra Rizo, CMO

Yes. I don't think we can predict the pattern for this study specifically. However, again based on clinical oncology experience in general, as you say, most of the enrollment happens towards the end of the study. But I mean I just don't think I can comment or predict how that will be for the study.

Thomas Shrader, Analyst

All right. One more. So you're starting to talk about mutant clones and treatment rates. And do telomerase lengths correlate with any of the mutant clones? At this point, it's not so relevant, but is it validating the mechanism of the drug as originally proposed?

Aleksandra Rizo, CMO

If I had to choose among telomere length, telomerase activity, and hTERT, I would consider telomere length the least important due to the challenges in accurately measuring it. We have reliable assays and strong correlations with telomerase activity and hTERT as pharmacodynamic markers linked to clinical outcomes in our studies, but that consistency does not apply to telomere length.

Operator, Operator

Your next question comes from the line of Justin Zelin with B. Riley Securities.

Justin Zelin, Analyst

Team, congrats on all the progress and also on the accepted abstracts at ASH. So I found one of the abstracts on the PRO data to be interesting that you have here. And I'm curious whether you'll be capturing similar PRO-type data in the IMpactMF study, whether it be fatigue measures or pruritus in the trial?

Aleksandra Rizo, CMO

Thank you for that question. So yes, as you noticed already in the Phase II study, we used a lot of measures that are typically used for registration studies. So yes, we will be using again the EORTC QLQ-C30, the BPI. So all the right scales through the significance of the patient-reported outcomes and benefits.

Justin Zelin, Analyst

Got it. That's great. And then maybe just turning over to manufacturing. So I understand the process that you've outlined there, Chip, and congrats again on that milestone. But I just wanted to confirm that you don't expect the FDA will ask you for any type of analytical comparability study or bridging study that needs to be done between the different material batches that you've had in your studies.

John Scarlett, CEO

I'm not an expert in manufacturing within the company, but I don't believe there will be a necessity for a separate clinical study, as we haven't significantly changed the process. However, there will be various comparisons of the materials used, as long as they remain within certain parameters. These comparisons wouldn't be classified as a clinical study; they would be analytical comparisons, which typically occur at some level with different manufacturing batches. I believe those comparisons will be conducted, but I am not personally aware of any requirement for a clinical study to confirm that the materials remain the same.

Justin Zelin, Analyst

I understand. That's great and it's very helpful to hear. Congratulations on all the progress, and I'm looking forward to seeing all the ASH presentations.

John Scarlett, CEO

Okay. Thanks.

Operator, Operator

That concludes our Q&A session for today. I would now like to turn the call back over to Dr. John Scarlett.

John Scarlett, CEO

Well, thanks, everybody, for joining us today. We really look forward to sharing the achievement of several milestones in the remainder of this year, including the presentations to be made at ASH. Everyone, please stay healthy and safe. And we look forward to the next time we get a chance to at least talk, if not meet in person. I think that concludes our call today, operator. Thank you.

Operator, Operator

This concludes today's conference. You may now disconnect.