Geron (GERN) Q4 2017 Earnings Conference Call Transcript

Geron (GERN 2.79%)
Q4 2017 Earnings Conference Call
March 19, 2018 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Once again, ladies and gentlemen. Welcome to Geron's Fourth-Quarter and Full-Year 2017 Earnings Conference Call. At this time all participants are in a listen-only mode. Later we will conduct a question-and-answer session and instructions will be provided at that time.

[Operator instructions]. Now, I'd like to introduce your host for today's conference Anna Krassowska, head of investor relations. Please go ahead.

Anna Krassowska -- Director of Investor Relations

Thank you, John. Good morning, everyone, and thank you for joining us for the Geron's Fourth-Quarter and Year-End 2017 Earnings Call. With me this morning are Dr. John Scarlett, our president and chief executive officer; and Olivia Bloom, our executive vice president, finance, and chief financial officer.

On Friday we issued a press release that reported results for the fourth quarter and year ended December 31, 2017. This release can be found on our website at www.geron.com. Today's call is also being webcast live on our website and will be available for replay through April 20, 2018.Before we begin, please note that except for statements of historical fact, the statements during this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitations, statements regarding, the expectations, plans, timelines and prospects for imetelstat, including the continued development of imetelstat by Janssen through the IMbark and IMerge clinical trials, and data from the clinical trial suggest imetelstat is safe and effective but Janssen will make a continuation decision and that Geron expects it to occur by the end of the third quarter of 2018, potential milestones and payments under the Janssen collaboration agreement and financial or operating projections or requirements.

These 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 whether imetelstat shows safety and efficacy in IMbark and IMerge, Janssen decides to continue developing imetelstat and provides a positive continuation decision and, if so, informs Geron by the end of the third quarter of 2018, the FDA and other help authorities or IRBs or any other factors required that IMbark and/or IMerge be delayed or discontinued and Geron will actually receive continuation milestone and royalty payments from Janssen on the terms in the collaboration agreement. Additional information and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron's periodic reports filed with the Securities and Exchange Commission under the heading 'Risk Factors', including Geron's Annual Report on Form 10-K for the year ending December 31, 2017. 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.

Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.We will begin today's call with a summary of the 2017 fourth-quarter and annual operating results from Olivia and then Chip will review ongoing activities of the imetelstat clinical trials being conducted by Janssen. Olivia?

Olivia K. Bloom -- Executive Vice President, Finance, Chief Financial Officer, and Treasurer

Thanks, Anna. Good morning. For the fourth quarter of 2017, we reported a net loss of $7.4 million, or $0.05 per share, compared to $8.5 million, or $0.05 per share for the comparable 2016 period. For the year ended December 31, 2017, we reported a net loss of $27.9 million, or $0.18 per share, compared to $29.5 million, or $0.19 per share for the comparable 2016 period.Revenues for the fourth quarter of 2017 were $191,000, compared to $94,000 for the comparable 2016 period.

Revenues for the year ended December 31, 2017, were $1.1 million, compared to $6.2 million for the comparable 2016 period. Revenues in 2016 included the full recognition of an upfront payment of $5 million from Janssen Pharmaceuticals Inc. under a license agreement that was signed in September 2016 for certain rights of specialized oligonucleotide backbone chemistry and novel amidates.Research and development expenses for the fourth quarter of 2017 were $2.5 million, compared to $4.1 million for the comparable 2016 period. Research and development expenses for the year ended December 31, 2017, were $11 million, compared to $18 million for the comparable 2016 period.

The overall decrease in research and development expenses in 2017, compared to 2016 primarily is due to lower costs for our proportionate share of clinical development expenses under the imetelstat collaboration with Janssen Biotech Inc. and reduced personnel-related costs.General and administrative expenses for the fourth quarter of 2017 were $5.5 million, compared to $4.8 million for the comparable 2016 period. General and administrative expenses for the year ended December 31, 2017, were $19.3 million, compared to $18.8 million for the comparable 2016 period. The overall increase in general and administrative expenses in 2017, compared to 2016 primarily is a net result of higher non-cash stock-based compensation expense and increased consulting cost partially offset by lower legal costs.Interest and other income for the fourth quarter of 2017 were $375,000, compared to $321,000 for the comparable 2016 period.

Interest and other income for the year ended December 31, 2017, was $1.4 million, compared to $1.2 million for the comparable 2016 period. The increase in interest and other income for 2017, compared to 2016 primarily reflects higher yields on the company's marketable securities portfolio. We ended 2017 with $109.2 million in cash and investments.For 2018, we are projecting an operating expense burn between $25 million to $30 million of which approximately $10 million to $12 million is expected to be for our proportionate share of cost to support the IMbark and IMerge trials under the Janssen collaboration; approximately $8 million to $9 million for personnel-related costs and approximately $7 million to $9 million for corporate cost such as business development, legal, accounting, IT and facilities. This projection does not include any changes to the imetelstat development program or any acquisition costs associated with acquiring a new oncology asset, program or company and any subsequent development cost related to such an acquisition.

Of course, if such potential changes were to occur, we would need to update our projections and depending on the timing and magnitude of those changes, we would need to seek additional capital. Maintaining sufficient financial resources enables us to promptly respond to such potential changes.I will now turn the call over to Chip to review recent company events. Chip?

John A. Scarlett -- President, Chief Executive Officer, and Director

Thanks, Olivia. Good morning, everyone, and thank you for joining. This morning I'll start my remarks with a summary of the results from the latest internal data review conducted by Janssen on the IMbark and an update on the projected timing of the protocol-specified primary analysis for IMbark and the subsequent potential continuation decision from Janssen. I'll then conclude with the status of the IMerge trial including a recap of the data that was recently presented at the American Society for Hematology, or ASH, Annual Meeting that was in last December.As a reminder, IMbark is a Phase 2 clinical trial designed to test two doses of imetelstat, 9.4 milligrams per kilogram or 4.7 milligrams per kilogram administered every three weeks in the intermediate-2 or high-risk MF patients who are refractory to or have relapsed after treatment with the JAK inhibitor.

The planned March 2018 data review was primarily conducted to enable a protocol amendment that will allow the long-term treatment and follow-up of patients in the trial including for survival. In reviewing the data which was based on January 2018 data cut, the collaboration's Joint Steering Committee or JSC made the following observations.First, the safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies and no new safety signals were identified. Second, outcome measures for efficacy including spleen volume responses and reductions in total symptom score remain consistent with the prior data reviews. Third, with a median follow-up of approximately 19 months as of the January 2018 data cut, the median overall survival has not been reached in either dosing arm.Following the state of review, the JSC implemented a number of actions.

First, the trial is being officially closed to new patient enrollment. From the first enrolled patient in September of 2015 to the last patient enrolled in October of 2016, more than 100 patients have been enrolled in IMbark. This number is expected to be adequate to assess overall survival. Patients who remain in the treatment phase may continue to receive imetelstat and until the primary analysis, all safety and efficacy assessments are being conducted as planned in the protocol including following patients to the extent possible until death to enable an assessment of overall survival.

Second, based on the rate of deaths occurring in the trial, the JSC determined that the IMbark protocol-specified primary analysis which includes an assessment of overall survival will begin by the end of the second quarter of 2018. Upon the completion of the protocol-specified primary analysis, the main trial will be completed. As a third action, the JSC determined that Janssen will amend the IMbark protocol to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive imetelstat per investigator discretion. During the extension phase, standard data collection will primarily consist of safety information.

Patients will be continued to be followed for survival.The assessment of survival is important because we believe that a new treatment that could confirm improved would represent meaningful clinical outcome for patients who are relapsed or refractory to the only approved MF treatment today. As experience with JAK inhibitors increases both in the real world and clinical trials settings, we know that the majority of MF patients fail or stop JAK inhibitor treatment and data from recent literature and other sources suggest that the survival of these patients is limited. For example, an analysis of real-world data conducted by Janssen and presented at ASH in 2016 reviewed treatment patterns and outcomes of MF patients from two U.S. medical claims databases.

This analysis suggested that once patients fail or discontinue ruxolitinib, mean overall survival is approximately seven months. Three other recently published independent papers describing outcomes of MF patients after discontinuing JAK inhibitor treatment either in the context of a clinical trial or through commercial supply estimated median overall survival of approximately 14, 15, or 16 months respectively. Thus imetelstat potentially could address a significant unmet medical need if its use is associated with survival that is meaningfully longer than 14 to 16 months.Moving to Janssen's decision making, as we've commented previously, the completion of the protocol-specified primary analysis for IMbark is the trigger for the continuation decision by Janssen. Following completion of that analysis, Janssen must notify us of their decision whether to maintain the license rights and continue the development of imetelstat or the continuation decision.

With the protocol-specified primary analysis for IMbark expected to begin in the second quarter of 2018, we expect Janssen to make its continuation decision by the end of the third quarter of 2018. Although the completion of the protocol-specified primary analysis for IMbark is the trigger for the continuation decision by Janssen, we expect data in MDS from IMerge to contribute important information about imetelstat.So let me review that data that was recently presented at ASH in December. These data support our hypothesis that imetelstat may have the potential to suppress the proliferation of malignant progenitor cell clones to allow the recovery as a normal hematopoiesis in patients with hematologic malignancies. As we've described previously, IMerge is the ongoing trial with imetelstat in patients with lower risk MDS syndromes, being conducted by Janssen.

IMerge is in two parts. Part 1 is a Phase 2 open-label single-arm trial administering imetelstat intravenously every four weeks at a dose of 7.5 milligrams per kilogram. Part 2, not yet initiated, is designed to be a Phase 3 study that will be conducted after Part 1 is completed and is designed to confirm in a randomized and controlled trial the efficacy and safety of imetelstat in the patient population as well as dosing used in Part 1.To be enrolled in IMerge, all patients must have relapsed after or be refractory to treatment within ESA. In addition, patients must be dependent on red blood cell transfusions requiring at least 4 units of red cells during an eight-week period prior to entry to the trial.

Among the 32 patients enrolled in IMerge, red blood cell transfusions dependency was high, the median red blood cell transfusion burdened at the entry to the trial with six units per eight weeks ranging from four to 14 units. In lower-risk MDS patients, chronic anemia is a predominant clinical problem. Treatment within an erythropoiesis-stimulating agent or ESA such as EPO can provide an improvement in anemia but the effect is transient. As a result, many patients become dependent on frequent red blood cell transfusions to manage symptoms of anemia and fatigue.

Transfusion dependency is associated with poor survival because of toxicity associated with an overload as well as potential infections and allergic reactions. The ultimate goal for most trials of investigational agents in lower risk MDS is to enable patients to become transfusion independent for as long as possible. Therefore, the primary endpoint for both parts of IMerge is the rate or percentage of patients who achieve red blood cell transfusion independence for at least a consecutive 8-week period. This has been a key regulatory endpoint in many disorders associated with anemia and transfusion requirements.Secondary endpoints in IMerge include the rate of 24-week transfusion independence and the rate of hematologic improvement.

Hematologic improvement is the degree to which the frequency of transfusions is reduced and increases in serum hemoglobin levels are observed. In addition, various measures have the durability of these transfusion and hematologic responses to imetelstat treatment are also being assessed for IMerge.Data presented at ASH were from the first 32 patients enrolled in Part 1 of IMerge using an October 2017 data cut with a median follow-up of 66 weeks. I'll give the results of the whole 32 patient cohorts first. 38% of these patients achieved red blood cell transfusion independence lasting for at least eight weeks.

16% of patients did not require a transfusion for at least 24 weeks with the median duration of transfusion independence exceeding one year and sustained rises in hemoglobin by at least 1.5 grams per deciliter from pre-treatment levels. These efficacy results represent clinically meaningful outcomes with a profound impact on a patient's quality of life and provide further supportive data that imetelstat exhibits potential disease-modifying activity by suppressing the malignant progenitor cell clones that drive the underlying disease.It's also worth noting that almost all patients experienced some reduction in transfusion burden with the average relative transfusion burden being reduced by approximately two-thirds compared to baseline levels. Also, the rate of greater than eight-week red blood cell transfusion independence did not differ based on the presence of ring sideroblasts, indicating activity of imetelstat across different subtypes of MDS.Now, in addition to the analysis of all 32 patients in Part 1, Janssen also evaluated the results of imetelstat treatment in a subset of patients who'd received certain prior treatments which I would like to comment on next. So to set the stage for evaluating the results of imetelstat treatment in this subset of patients, let me first comment that in the U.S.

hypomethylating agents or HMAs are approved for the treatment of both lower-risk and high-risk MDS patients and the immunomodulatory agent lenalidomide is approved for the approximately 15% of lower-risk MDS patients with the deletion the short arm of chromosome 5, the so-called del(5q) abnormality.Physicians in the U.S., particularly outside of the main academic centers, use both HMAs and lenalidomide broadly in lower-risk MDS because there are limited alternative treatment options available. In contrast, in Europe, HMAs are not approved for lower-risk MDS, nor is lenalidomide approved for non- del(5q) patients. As a consequence, very few, if any, lower-risk European patients are treated with either lenalidomide or an HMA at least until their disease progresses and they can be characterized as higher-risk MDS patients.The original inclusion and exclusion criteria in IMerge did not restrict the number or type of other prior MDS patients [Inaudible] treatments the patient was allowed to have received before entering the trial. Among the 32 patients enrolled in Part 1, we subsequently observed that a subset of 13 patients had not received prior treatment with either an HMA or lenalidomide and also did not have a del(5q) chromosome abnormality.

This 13 patient subset showed remarkably increased durability and rate of transfusion independence compared to the overall trial population. 54% of these patients achieved red blood cell transfusion independence lasting for at least eight weeks while 31% achieved an RBC transfusion independence lasting for at least 24 weeks, compared to 38% and 16% respectively in the overall trial population. These were very impressive efficacy outcomes.From a safety perspective, imetelstat's profile in Part 1 was consistent with prior clinical trials of imetelstat in hematologic malignancies and no new safety signals were identified. The adverse events were similar between the overall trial population in the 13-patient subset.

The most frequently reported adverse events were cytopenias which were predictable, manageable with dose reduction or delays and reversible in most cases. Cytopenias included Grade 3 and Grade 4 neutropenia and thrombocytopenia. Dose reductions or cycle delays due to adverse events were required for 59% of patients.In addition to the [Inaudible] ASH in which these results were reported, these data were also discussed in detail by Dr. Azra Raza, an MDS expert and one of the clinical investigators for IMerge, during an event for investors that we hosted at the end of last year.

The webcast of that event is still available on our website and if you haven't already listened to it, I would encourage you to do so.We and Janssen believe that the results from the 13-patient subset who were naïve to lenalidomide and HMAs and who lacked the del(5q) chromosomal abnormality suggested imetelstat could offer lower-risk MDS patients a much-needed alternative prior to preceding to HMAs and lenalidomide treatment. Lower rates of 8-week transfusion independence have been reported previously for both HMAs and lenalidomide in similar lower-risk MDS patient populations. In comparison to the 54% 8-week transfusion independence rate observed for imetelstat, the rate observed for HMAs was 17% and 27% was observed for lenalidomide with no better safety profiles at imetelstat. As such we expect that targeting this lower-risk MDS population would not reduce the population of patients potentially eligible for imetelstat but instead sequence imetelstat ahead of HMAs and lenalidomide in the treatment paradigm.As we announced in July last year, Part 1 of IMerge was reopened to enroll approximately 20 additional patients who are non-del(5q) and naïve to HMA and lenalidomide treatment.

This is intended to increase the experience and confirm the benefit-risk profile of imetelstat in this refined target population. With the approximately 20 additional patients, the total number of patients in Part 1 who are representative of the refined target patient population will be approximately 30 which was the sample size originally proposed in the protocol for Part 1 on which a decision to move to Part 2 would be based.Enrollment of patients to the expanded Part 1 began in November of last year and was completed in November of this year, which was faster than anticipated, highlighting both the unmet need in this patient population and interest in imetelstat among clinical investigators. So we look forward to this very important year for imetelstat and Geron.Before we open the call to questions, I will mention that our search and evaluation process to identify and evaluate oncology products, programs, or companies for potential acquisition continues.So with that, operator, let's open the call to questions, please.

Questions and Answers:

Operator

[Operator instructions]. Our first question comes from Charles Duncan with Piper Jaffray. Your line is now open.

Charles Duncan -- Piper Jaffray -- Managing Director

Morning, folks. Thanks for taking my question and congrats on the progress in the quarter. So had a couple of questions. I'll try to be quick.

First of all, with regard to the IMbark protocol amendment to allow patients to remain on drug following the primary efficacy analysis, Chip, I'm wondering if you could provide us a little bit more color. Is that really driven by some blinded clinical observations or do you see it just as good practice? And can you provide any color on the number of patients that remain on drug out of the roughly 100 enrolled?

John A. Scarlett -- President, Chief Executive Officer, and Director

Thanks, Charles. Well, first of all, the amendment to continue to follow patients predominantly for survival is really mostly based on a couple of things, I'd say. First of all, it's technically required because we were at the end of the specified treatment period in the original IMbark protocol that was begun quite a few years ago now. So in order to continue to follow patients, we just needed to amend the protocol, get it approved through ethics committees and so forth.

So that's really, I would say, the principal driver. And obviously, the reason we wanted to do that is because we still have not seen median survival reached in either of the original arms in the study. So we'd like to continue at least through that point in time. So that really dictates the protocol amendment, predominantly one of timing.Sorry, the second question that you had was?

Charles Duncan -- Piper Jaffray -- Managing Director

Yeah, you probably can't answer this, but in terms of the number of patients that remain on the drug, do you have any information on that that you can provide?

John A. Scarlett -- President, Chief Executive Officer, and Director

No, we've not been giving those numbers as we've gone along and I think we're going to continue to not do so.

Charles Duncan -- Piper Jaffray -- Managing Director

OK. And then you did a nice job of summarizing some recent reviews, what happens to patients post-JAK inhibitors and what to expect there at least historically. And, I guess, I'm wondering when you consider the patient population of MF patients that have been on the JAK inhibitors in the trial, do you think that the sample is reflective of the broader patient population. And if so, could you help us understand are they all post-Jakafi patients or are there some of the patients who have been on JAK inhibitors in clinical trials other than Jakafi.

John A. Scarlett -- President, Chief Executive Officer, and Director

Sure. So I do think that this population was quite similar to the broader patient population. That comes from a couple of observations. First of all, we had really no specified exact type of JAK inhibitor that patients had to have been previously exposed to.

Obviously, the vast majority of them were exposed to Jakafi itself, to ruxolitinib, but we certainly have modest numbers of patients who had been exposed to other potential JAK inhibitors. I would call out particularly momelotinib, fedratinib, and pacritinib. I'm not sure the exact numbers. I would say probably the majority just because of when the timing of the study was momelotinib but there have been, as far as I recall at least, at least small numbers of pretty much all of the investigational agents at one time or another after patients had failed them but the vast majority were actually clearly post-Jakafi or ruxolitinib.

Charles Duncan -- Piper Jaffray -- Managing Director

OK, that's helpful. And the last question is hopping over to IMerge. I guess I'm wondering when would you anticipate the next update and could this perhaps be at or before Janssen continuation decision?

John A. Scarlett -- President, Chief Executive Officer, and Director

This is my own opinion and I don't have a specific reason for saying it but I think it's unlikely that we'll be giving any specific information between now and then. Obviously, we try to hold most of our data for scientific meetings and we're still ways away from the typical meeting where this would go which would be ASH, the end of the year, but I don't really know. I mean, we haven't really discussed these precise plans for either publication of top line or revelation of top-line data or, for that matter, other possible abstracts. So I don't really know right now.

I wouldn't be holding my breath though. I think that this data is maturing very nicely. So let's wait and see.

Charles Duncan -- Piper Jaffray -- Managing Director

OK, very good. Thanks for taking my questions.

Operator

Thank you. Our next question comes from Chad Messer with Needham & Company. Your line is now open.

Chad Messer -- Needham & Company -- Managing Director

Great, thanks. Good morning. Thanks for taking my question. So for IMbark, it seems like the promise here is a drug for JAK failures that has potentially a good survival benefit but perhaps not as much efficacy on some of the traditional efficacy parameters like spleen volume.

Is that a fair characterization of what the data are telling us so far? And if so, does that make mechanistic sense?

John A. Scarlett -- President, Chief Executive Officer, and Director

Chad, thanks for the question. It's a very interesting and good question. I think one of the things that we've pointed out in the past and I would point out again is that when most people think about spleen volume response rates and, for that matter, total symptom score reductions, they really hearken back to the original, rather, I thought, impressive data shown by ruxolitinib in frontline patients and, in fact, not only in frontline patients but really the first patients to ever be exposed to a JAK inhibitor in any way, shape or form. And you'll recall that there was a fair amount of variability even there.

The FCR in COMFORT-I which was a U.S.-based study was 42% in patients who were treated with ruxolitinib, frontline. Remember again, frontline.In COMFORT-II, the European study, that same basic population of patients, the FCR was 29%. And then I think the other thing to look at then is to say "All right. Well, we're not in the frontline." We are definitely not in the frontline.

We are in patients who are at the far end of the other part of the spectrum, if you look at, for example, the momelotinib data, not necessarily with regard to momelotinib but even with regard to the best available therapy arms, so in SIMPLIFY-2 the best available therapy are included, 88% of those patients got ruxolitinib. Now, these are patients who are second-line exposed and there they only had a 5.8% spleen volume reduction by the typical methodology. PERSIST-2 had about half of the patients roughly had ruxolitinib treatment in their BAT arm and that was only 3%.So my point is really that when you take second-line patients or, in our case, truly relapse or refractory patients, I think, looking at spleen volume response rates and trying to judge those against first time ever exposed to JAK patients very early on, relatively early on in their treatment paradigm, I think you can be misled. So that's why we've actually ended up looking predominantly at survival which is the ultimate outcome that everybody cares about.

So I personally believe that patients would not be staying on the drug if they were not getting the benefit and I also think that if we are able to confirm significant survival benefit in these patients who really have no other alternatives that this will be potentially a very useful drug.How that plays out in a regulatory process and so forth, I'm not a 100% sure, nobody is, but I do think that we should not overlook the relative value of other measures beyond spleen volume response and especially in drugs that are not really designed specifically to reduce the products of the disease that are thought to be related to spleen volume increase.

Chad Messer -- Needham & Company -- Managing Director

OK, great. Thanks for that. It's very helpful.

Operator

Thank you. Our next question comes from Alex Schwartz with Stifel. Your line is now open.

Alex Schwartz -- Stifel Financial Corp. -- Vice President

Hi, John [Inaudible]. Congrats on median OS not being reached. And thank you for taking the question. So the first question I had, can you talk more about the 4.7 mg/kg arm and if these patients remained on that dose the entire time or was the proposed Janssen protocol amendment accepted and at what months did these patients crossover to higher dosing?

John A. Scarlett -- President, Chief Executive Officer, and Director

So there are patients who remained in 4.7 milligrams per kilogram arm and did not cross over to the 9.4. I don't think we've ever actually given any specifics around that and I'm trying to remember exactly when we implemented those protocol changes.

Olivia K. Bloom -- Executive Vice President, Finance, Chief Financial Officer, and Treasurer

It was in October 2016. That's when Janssen did the first data review and it was at that time determined that the low-dose arm, the 4.7 mg/kg, didn't warrant further investigation. So patient enrollment in that arm was closed. A protocol amendment was processed at that time giving the investigators the option whether to leave their 4.7 patients on that arm, or they could dose-escalate to 9.4.

That was based on investigator choice.

John A. Scarlett -- President, Chief Executive Officer, and Director

So that was toward the end of 2016 and that's when some patients dose escalated up to 9.4 but there were a meaningful number of patients who remained on 4.7. So did that answer your question?

Alex Schwartz -- Stifel Financial Corp. -- Vice President

Yes, it did. Thank you. And then a second question I had, kind of given the unmet need in MF patients after Jakafi and your OS data to date and maybe a more permissive FDA, any sense that you need to run a Phase 3 trial and what size might that be or rather Phase 2 data that you have today and maybe 100 patients may be sufficient for an NDA filing? Any thoughts around that?

John A. Scarlett -- President, Chief Executive Officer, and Director

Well, honestly, anything that I would say would be highly speculative. We're still in the midst of a lot of development here. I'll give you some general thoughts, Alex, about that. You actually prefaced the question with some interesting prefaces, one of them was a more permissive FDA.

I don't know if that's true or not but I would say the following. Historically, as I think everyone on the call probably knows, you need a control arm in order to make a correct and an appropriate scientific assessment of overall survival because you can be surprised by relative changes in patient populations and so forth. And so that's historically been the regulatory standard would be to present OS data in the context of a control arm. We don't have a control arm here.

So that's why we've been using historical data and have kind of upended the literature in order to look for that.I will say this. I think that you can make broad generalizations as we have here about what we're seeing and how it compares to the literature which is now fairly consistent. 14 to 16 months appears to be the median OS for patients in a number of different follow-up studies carefully done in academic centers in terms of median OS after failing or coming off of JAK inhibitors and predominantly ruxolitinib. So you can judge, as you also prefaced, we haven't reached the median OS yet.How that will play out regulatorily will demand really some careful thought around the world and also probably some level of interaction with experts.

At the moment, I don't think we're prepared to say what our plans are with regard to that whether there will be an NDA filed, how that will actually go forward. We wouldn't want to be getting out ahead of some of those discussions and we still kind of need to reach median OS in order to really know where we are. So that's where, I would say, things stand today.

Alex Schwartz -- Stifel Financial Corp. -- Vice President

OK, excellent. Well, thank you for the additional clarity and congrats on the progress.

Operator

Thank you. Our next question comes from Philip Lee with Mangrove Partners. Your line is now open.

Philip Lee -- Mangrove Partners -- Analyst

Hi. Thank you for taking my questions. I have two quick questions. The first is when you enrolled the IMbark trial, were there any minimum platelet counts necessary for the patients who enrolled or is there any information you can give us regarding their platelet counts?

John A. Scarlett -- President, Chief Executive Officer, and Director

Yes, we required at least 75,000 platelets.

Philip Lee -- Mangrove Partners -- Analyst

OK, thank you. And my second question is if you could give us any additional data regarding the ECOG Status and how that's stratified between 0, 1, and 2 at baseline for people enrolled in IMbark?

John A. Scarlett -- President, Chief Executive Officer, and Director

We have not released that. That would be part of a publication. That's usually not something that's focused on as much in this field. Even though, I appreciate your interest in this subject.

So we haven't really given that.

Philip Lee -- Mangrove Partners -- Analyst

OK, thank you very much.

Operator

Thank you. This concludes our question-and-answer session for today. So I'd like to turn the conference back over to Anna Krassowska.

Anna Krassowska -- Director of Investor Relations

Thank you, everyone, for joining us this morning. I just wanted to make a note that we will be attending the Needham Healthcare Conference next week on March 27. So maybe we'll see some of you there and we will be giving a webcast presentation. So thank you all.

Operator

Thank you. Ladies and gentlemen, that does conclude today's conference. Thank you very much for your participation. You may all disconnect.

Have a wonderful day.

Duration: 47 minutes

Call Participants:

Anna Krassowska -- Director of Investor Relations

Olivia K. Bloom -- Executive Vice President, Finance, Chief Financial Officer, and Treasurer

John A. Scarlett -- President, Chief Executive Officer, and Director

Charles Duncan -- Piper Jaffray -- Managing Director

Chad Messer -- Needham & Company -- Managing Director

Alex Schwartz -- Stifel Financial Corp. -- Vice President

Philip Lee -- Mangrove Partners -- Analyst

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