Q2 2023 Geron Corporation Earnings Call
Good afternoon, everyone welcome to the Geron Corporation second quarter 2023 earnings Conference call I am Erin Thank God, Johns Vice President of Investor Relations and corporate communication.
I'm joined today by several members of <unk> management team, Dr. John Scarlett, Chairman and Chief Executive Officer, Olivia Bloom Executive Vice President and Chief Financial Officer, Dr. If a seller executive Vice President and Chief Medical Officer, and Neil <unk> Executive Vice President of <unk>.
Strategy, and Chief commercial Officer, and Doctor Angiographic line Executive Vice President and Chief operating Officer before we begin. Please note that during the course of this presentation and question and answer session. We will be making forward looking statements regarding future events performance plans expectations and other.
Projection, including those relating to the therapeutic potential and potential regulatory approval and that helps that anticipated clinical and commercial events and related timelines. The sufficiency of Durham financial resources and other statements that are not historical fact.
Actual events or results could differ materially.
Therefore, I refer you to the discussion under the heading risk factors in <unk> quarterly report on Form 10-Q for the quarter ended June 30th 2023, which identifies important factors that could cause actual results to differ materially from those contained in the forward looking statements Geron undertakes no duty.
Their obligation to update our forward looking statements with that I will turn the call over to chip.
Thanks, Darren good afternoon, everyone. Thanks for joining us today.
During this most recent quarter was punctuated by important achievements, which support our evolution from a late stage clinical development company towards one with future substantial commercial capabilities.
Foremost among these achievements was the submission in mid June of a new drug application for <unk> in lower risk Mds.
This was the first NDA ever submitted for telomerase inhibitor and reflects our team's dedication.
<unk> and focus on groundbreaking and innovative drug development over many years.
Other important milestone, which included presentations at both <unk> and <unk>, new data and analyses from the emerge phase III lower risk Mds trial.
These data contributed to the evidence for a compelling <unk> efficacy profile, including durable continuous transfusion independence as well as substantial increases in serum hemoglobin <unk>.
Broad responses across Mds subtypes, including and ring Sideroblast positive and negative patients as well as in high transfusion burden patients were also reported.
Further the presentations reflected strong evidence for potential disease modifying activity.
As well as patient reported outcomes of improved fatigue, and <unk> treated patients.
<unk> will comment in more detail on these clinical data updates later on this call.
Collectively these data distinguish amatol stat from other treatments for patients with lower risk Mds that are available commercially for.
Or that are in development today.
Based on our market research, including perspectives gained from both academic and community Hematologists. We believe the broad hematology community considers <unk> chat and important potential treatment option for patients with lower risk Mds.
Our market insights show that health status positioned to become a new standard of care in lower risk Mds, particularly for difficult to treat subgroups, who have very limited options today.
As a result, we believe the total addressable market and lower risk Mds for image Hallstatt is approximately $3 5 billion in.
In 2033.
In order to execute on that large of an opportunity where in a full court press to push forward, our launch readiness and expect to be ready for a U S. Commercial launch upon potential approval in early 2024.
Neil will re <unk> the latest <unk> market research in lower risk Mds and launch readiness update in more detail later on this call today.
Another important element of <unk> value proposition is impact MF or pivotal trial evaluating <unk> in myelofibrosis patients, who are relapsed or refractory to JAK inhibitors.
This is the only phase III clinical trial in myelofibrosis, using overall survival as a primary endpoint.
We believe a positive outcome could transform the treatment landscape for these MF patients who have limited treatment options and a dismal survival outlook.
They will be providing further detail on enrollment and the impact MF trial later on the call.
Based on our current planning assumptions for both enrollment and death rates in the trial today, we are updating our guidance for the interim analysis to be expected in the first half of 2025 and for the final analysis can be expected in the first half of 2026.
From a financial resource perspective, we have approximately $400 million on the balance sheet as of the second quarter close.
This gives us the financial wherewithal to funding potential successful launch in lower risk Mds and also to support operations through the first year of launch.
Olivia will comment during the call on the status of warrant exercises and our expectations regarding our cash runway based on these current financial resources.
Before I turn this call over to say I'm very pleased to announce today the appointment of Scott channels as John's New Chief Legal officer, following Stephen Rosenfield retirement at the beginning of this month.
Stephen King the Chief legal officer, Jon since shortly after I came to the company more than a decade ago.
And both I and the board are deeply grateful for Stephens partnership and contribution to Jerome since then.
I'm personally very pleased for Stephen that Youll now be able to enjoy as much deserved retirement.
Prior to joining <unk> as our new executive Vice President Chief Legal Officer, and corporate Secretary Scott Samuels recently served as the general counsel of Beijing, where he built a large global legal and compliance team oversold launches of three internally developed drug products in the U S Europe and China.
Developed a global healthcare compliance program and lead key strategic transactions with Amgen Novartis intelligent, which of course is now BMS.
Prior to Beijing, Scott with the assistant General Counsel, and then acting General counsel at area, where he managed the company's legal affairs, including SEC compliance and governance, corporate governance, and key licensing and distribution agreements prior to <unk> acquisition by Takeda.
I believe Scotts experience technical expertise and history of success in building legal and compliance organizations to meet the needs of a commercial company.
<unk> is what our current.
Many new employees are focused on as we pursue the future evolution and growth of Jeremy.
Both the board and I greatly look forward to working with Scott.
With that I'll turn the call over to pay for our regulatory and clinical development update.
Thank you Chad and good afternoon to everyone on the call.
As chip mentioned, we are thrilled to have submitted our <unk> new drug application in June 2023 for the treatment of transfusion dependent anemia in adult patients with low to intermediate one risk Mds.
With Dell to respond or have lost response to or ineligible for erythropoiesis stimulating agent or Esa as permitted under <unk> fast track designation, we have requested that the FDA granted priority review of the NDA.
You expect FDA will communicate potential acceptance of the NDA within 60 days of submission that is sometime in mid August and reveal of the Paducah date for such a review.
Under a priority review scenario, we would expect potential NDA approval timing in the first quarter of next year.
Understanding of review, we would expect potential approval timing in the second quarter of 2024.
To expand them Intelsat potential reach outside of the U S. We remain on track to submit a marketing authorization application in the European Union for lower risk Mds in the fourth quarter of 2023.
As we await potential commercialization in the U S. We initiated an expanded access program or EAP in June 2023.
This is a program that enables us to make <unk> available to clinicians and patients prior to FDA approval.
Treatment of low risk Mds patients in this program is based on the protocol approved by FDA, which requires each treating physician to apply for access for their patients. We've heard physicians in both academic and community settings expressed the need for new treatment options for their lower risk Mds patients and we are pleased to be able to offer this expanded access program.
To the low risk Mds community.
Patients treated with <unk> and the expanded access program are expected to ultimately be transitioned to commercial supply within three months after a potential future FDA approval of the drug.
As Jim described at <unk>, we presented new data and analyses from emerge.
These data further differentiate <unk> from existing treatments and support its role as a potential new standard of care in lower risk Mds.
The content of these presentations for also reported on June 14th during the Geron hosted Investor event.
We encourage investors to access the archived webcast, which is available on the investor portion of our web site under events there.
There you can hear hematologic malignancy key opinion leaders and emerge investigators Dr. <unk>, Pos Becker and Rami can murchie present these data in detail.
For the purposes of our call today I will provide an overview of the key points of Intelsat differentiation highlighted in our outgoing <unk> presentation.
First the clinically meaningful and durable transfusion independence or Ti experience by Mattel's battery to patients in emerge is unprecedented for patients with lower risk Mds.
We observed a highly statistically significant improvement in Ti rates in amatol stat treated patients for eight week 16 week, and 24 week Ti compared with placebo.
More exciting with three months of additional follow up nearly 20% of <unk> treated patients experienced a one year ti.
Which represents approximately 60% of AMETEK that 24 week responders.
Additionally, heme malignancy kols at Alco and EI noted that statistically significant improvement of anemia with a median hemoglobin rise of three six grams per deciliter for <unk> saturated eight week Ti responders.
As a very important point of differentiation.
Second our breath of clinically meaningful responses observed across key mds subgroups, including difficult to treat populations such as those without rain thunderblast.
Our RF negative patients.
As well as high transfusion burden patients and those with high serum IPOH level. Please.
These patient populations have not been studied with most other agents used to treat the anemia of lower risk Mds, nor have such results been seen with other treatments.
At <unk>, we presented important new subgroup analysis, showing that the rate and durability of Ti for 24 week Ti responders is similar across key lower risk Mds subgroups.
<unk> status prior transfusion burden IPF Ross dress category for baseline serum Epo levels.
Third we have presented robust evidence of <unk> potential to alter the underlying biology of lower risk mds by reducing or eliminating malignant clone.
And <unk> treated patients we saw a reduction in mutation burden as measured by variant allele frequency or that further.
Furthermore, new data on cytogenetic responses and reductions in bone marrow RSO supported <unk> mechanism of action.
<unk>. These data indicate that <unk> may have disease modifying potential in patients with lower risk Mds.
Fourth data on patient reported outcomes presented at <unk> were also very encouraging these.
These data describe a sustained meaningful improvement in fatigue for <unk> treated patients versus placebo.
This specific patient reported outcome is of particular importance because lower risk Mds patients.
<unk> fatigue that is not fully alleviated by red blood cell transfusions.
Additionally, many of the current treatments for lower risk Mds are associated with an increase in fatigue in.
<unk> is the first treatment we are aware of to show an improvement in patient reported fatigue and lower risk Mds patients.
And emerge phase III and consistent with prior clinical experience grade three four thrombocytopenia and neutropenia is where the most frequently reported adverse events.
Unlike several of the treatments and Hematologists armamentarium, such as HMA, Lenalidomide, which may cause cause prolonged mindless depression.
Severe cytopenia is associated with <unk> that was short lived resolving to grade two or lower and less than four weeks in most cases and most importantly, only rarely resulted in severe clinical consequences, such as bleeding or infection.
In total the emerge clinical data support our profile for them until such that if approved we believe will serve as a very impactful option for the treatment of transfusion dependent anemia in lower risk Mds patients.
Next I'd like to discuss impact MF, our second phase III trial, and the top that in patients with JAK inhibitor relapsed refractory myelofibrosis.
Today treatment in myelofibrosis is dominated by JAK inhibitors or therapies with other mechanisms of action in combination with JAK inhibitors.
The currently available therapies have been approved based on their ability to improve symptom and reduce fundamentally.
Approximately 75% of patients discontinue JAK inhibitor after five years and once they do so they face a dismal overall survival of approximately 11 to 16 months.
We believe that <unk> could be transformational for these patients.
And the Embarq phase two study and JAK inhibitor relapsed refractory MF patients for overall survival in <unk> treated patients was 30 months or nearly double compared to gain darkle control.
Additionally, a comparison of embark phase two data to real world data from a closely matched cohort of patients confirmed improvement in overall survival and lower risk of death for image help that treated patients compared with patients treated with best available therapy.
Importantly, and embarked there was strong evidence of the disease modifying potential of <unk> in relapsed refractory MF with.
With improvements in bone marrow fibrosis.
And reduction in key MF driver mutations and these reductions correlated to improve survival and other clinical outcomes.
These data were the basis for the design and initiation of the impact MF Phase III study and JAK inhibitor relapsed refractory MF patients with overall survival as the primary endpoint.
The impact of MF protocol I'll call for a planned interim analysis in approximately 35% of the planned enrolled patients have died and the final analysis, what over 50% of the planned enrolled patients have died.
As in Oh at study the timeline for the interim and final analyses depends not only on enrollment rate, but also on death rate.
Today based on achieving over 40% enrollment and impact MF and our planning assumptions for enrollment in death rates in the trials. We are updating our guidance for the interim analysis be projected in the first half of 2025 and for the final analysis to be in the first half of 2026.
Because these analyses are event driven and it is uncertain, whether actual rates for enrollment and events for reflect current planning assumptions. The results may be available at different times and currently projected.
As can be expected for studying an indication for which there are multiple ongoing trials.
<unk> on clinical site personnel resources due to the COVID-19, pandemic and other competing trial, but in MF have led to some challenges in recruitment and enrollment we are working closely with the IMF community and our clinical trial sites and recruitment for the trial and continue to plan to announce when the trial is 50% enrolled.
As Chad mentioned this is the first and only myelofibrosis trial with overall survival as the primary endpoint.
Our investigators remain very excited about this study and the potential of a new treatment that can improve survival for these patients who currently have few treatment options and dismal survival rates.
We are also pleased to report that the first patient with doses June and the investigator led phase III impress trial that is evaluating <unk> in patients with relapsed refractory acute myeloid leukemia or high risk Mds.
This trial is based on preclinical publications that described the role of telomerase, and AML disease progression and which have reported that inhibiting <unk> in both MAU and human derived AML models.
<unk> and potentially depletes leukemic stem cells, thus impairing leukemic progression.
Okay lapsed refractory AML and higher risk Mds are high unmet need areas and we look forward to understanding more about the potential efficacy of <unk> in this patient population.
With that let me turn the call over to Aneel to provide a commercial update.
Neil.
Thank you Phil and good afternoon, everyone.
Very pleased with the status of our commercial readiness activities are not on track to achieve launch readiness by Amit <unk>. He has already described several significant methods that support the potential NIM or does it start launch, including important regulatory progress as well.
Unprecedented month's data presented.
Meetings with deeply support <unk> value proposition messaging.
In particular, the piano data reporting improvement benefit D. Dimer does start as an important differentiator and will be a critical element prepared interactions.
This quarter, we also advance critical work by obtaining significant insights from our market research efforts.
Just on the latest lower risk Mds data presented at <unk> and <unk> and competitiveness.
For a full review of this market research, we therefore, youll do the Investor day and think about that.
He mentioned.
For purposes of today's call.
Highlights key takeaways from that market research presentation.
First an alignment with them common feedback on the grounds that Vasco.
On my desk market research from practicing academic and community for Madonna just across U S European markets confirmed.
<unk> phase III data has been received favorably.
The compelling <unk> data across subgroups.
Option in transfusion burden hemoglobin visors meaningful durability of response balanced with a predictable adverse event profile with manageable type of opinions.
Second continued hematologist feedbacks supports the MSL side, the opportunity across DSA relapsed refractory August negative and oddest augmented subtypes as well as high transfusion burden patients.
Third these hematologists indicated that it does start to is likely to become a new standard of care and post Esa experience.
<unk> experienced frontline patients.
Second in line lower risk Mds patients as well as an important new option for frontline Esa ineligible patients.
Equal Evan is greater than 500.
All of these insights are instrumental to our understanding of <unk> potential place in the market and our engagement strategy with physicians with that I'll turn the call over to Olivia plentiful financial update Olivia.
Thanks, Danielle and thanks to everyone on the call for joining us today.
Please refer to the press release, we issued this afternoon, which is available on our web site for detailed financial results.
As expected operating expenses were higher for the three and six months ended June 32023 compared to the prior period.
The increase in R&D expenses for the three and six month periods of 2023 <unk>.
Compared to the same periods in 2022.
Primarily reflect higher clinical trial costs for.
For increased activity for both phase III trials and the phase one trial in frontline MF.
Increased personnel related costs for additional head count.
Higher consulting costs to support regulatory submission and greater epitope that manufacturing costs in preparation for potential commercialization in the first half of 2024 and low risk Mds.
The increase in general and administrative expenses for the three and six months ended June 32023.
Compared to the same periods in 2022.
Primarily reflects.
Higher personnel related expenses for additional head count and increased costs for new commercial preparatory activities.
We continue to expect non-GAAP total operating expenses.
Up to $210 million for the full year of 2023.
This financial guidance may be revised in the future upon notification from the FDA of the potential approval timing for <unk> in low risk Mds.
Turning to our financial resources.
As of June 32023.
We had approximately $402 million in cash and marketable securities.
This balance includes approximately $17 8 million and proceeds from warrant exercises.
That we received in the second quarter of 2023.
And the first half of 2023 in total we have received approximately $77 $6 million in warrant proceeds.
Which leaves approximately $32 million and potential future warrant proceeds remaining to be exercised.
Based on our current operating plans and our expectations regarding the timing of the submission and potential acceptance and approval of our NDA by the FDA for Intelsat in low risk Mds and.
And the subsequent potential U S commercial launch in the first half of 2024 as.
As well as the revised guidance on timing of the interim and final analyses for impact to MFS.
We believe that our existing financial resources and estimated revenue will be sufficient to fund our projected operating requirements through the end of the third quarter of 2025.
If projected exercise proceeds of approximately $32 million from remaining outstanding warrants are added to our current financial resources and estimated revenues then we believe such aggregated financial resources will be sufficient to fund our projected operating requirements.
The end of 2025.
With that I will now hand, the call back to chip for closing remarks.
Thanks, Olivia I'd.
I would like to close by reiterating what an exciting time. This is for <unk> for <unk> and for the Mds community.
Based on our unprecedented phase III data in lower risk Mds.
And in all corners of enthusiasm from the medical community, we believe that <unk> could transform the standard of care in lower risk Mds.
We're also very proud to be pioneering the first study in myelofibrosis with overall survival as the primary endpoint.
We believe that a potentially disease modifying treatment that improves survival could be transformational for these patients who have failed JAK inhibitors and have limited options.
As a result.
We will stay the course with this phase III trial, especially given it some bench potential for value creation for patients and shareholders alike.
Finally, we look forward to the expected momentum in the months to come as we continue to execute on our commercial readiness plan and ultimately to potential U S launch of Intelsat and the first half of 2024.
So operator with that let's open the call to Q&A.
Perfect. Thank you I would like to ask a question. Please press star followed by the number one on your telephone keypad again that is star one.
And we do have.
Our first person in the queue.
Capital. Please go ahead.
Yes, Hey, good afternoon.
And congrats on the NDA submission.
So maybe starting with one question for Aneel.
For for low risk Mds, assuming that we get approval here in the near future. What early launch metrics do you believe will be important to showcase.
And highlight the initial stages of launch.
Okay.
Yes.
Thank you Paul.
I think for US, it's really embarking Doug.
Full coverage across the reimbursement policies, all both academic and community centers.
But can you any critical for any new drug launch.
Our expectation that we have on group broadly in the market.
And make sure that the policy will be.
And blogs.
That's really critical and important new drugs.
Good afternoon.
We are also wanted to measure uptake across both academic and community channels.
Four acquisitions under type locations that whole dynamic I'm sorry.
Since these will be early days.
We'll obviously continue to monitor for durability of response.
Questions that may come up at all.
Reimbursement in coatings garden, two possible doctors in the very early days of launch.
And from a supply chain perspective, making sure that.
The drop through specialty distributors going into patients properly.
Also we'll have.
Patients activator.
And so to say.
As to ensure seamless distribution of the drug and rising prices with inflation. So those would be the first few things.
Okay perfect.
And then.
For the impact MF study.
Just curious as the enrollment rate be impacted because of any potential competition from other clinical studies.
And can you maybe add additional clinical trial sites to streamline the enrollment there or is that not an option.
Thank you wanted to take that.
Sure. Thanks for the question.
Despite the fact that these patient cap.
A high unmet need for alternative to JAK inhibitor therapies or indeed, as you mentioned.
A number of other ongoing clinical trials in this space and it's not so much the competition for pain.
Patients necessarily for the trials, it's more of the resources and the <unk>.
Staffing given that myelofibrosis is an orphan and rare disease.
Ltd.
Research stopped that.
Jim.
Be devoted to study so I think that is part of the.
So that is part of that.
The delay in enrollment.
Regardless me.
You need to believe in the study and the likelihood of a positive readout and the potential for the <unk> to change the course of MF treatment.
Okay got it and one last question on the competitive landscape for myelofibrosis here.
We're anticipating data for the combo from morphosis in the second half.
Frontline myelofibrosis.
Assuming that this study hits its endpoint.
Does that in any impact your development strategy.
In Myelofibrosis and post rock station.
Okay.
Sure.
Sure.
It doesn't necessarily it doesn't change the current status of our phase III study, which is looking at patients who have failed JAK inhibitor and are not eligible for JAK inhibitor.
Patients.
Either they were treated on a clinical trial or as part of standard of care in the community will there'll be eligible.
For the impact MF trial, and I think regardless of the.
Readout former focus there is still an unmet need for patients after they fail JAK inhibitor.
Okay.
Okay, great. Thanks, very much for taking the questions.
Thanks Kelvin.
Alright. Our next question comes from the line of Robert Driscoll Robert Please go ahead.
Hi, This is Sam on for Robert today, Thanks for taking my questions.
Just wondering how you might be able to address any doctor concerns or apprehension around.
Temporary cytopenia is associated with <unk> treatment head of commercialization or if there are any other potential gating factors to brought uptake that youre working to address.
Why don't you go ahead first.
Oh, sorry go ahead.
Okay.
So let me start first Robert Mondavi basically dumped in Israel. So we have shared the full salespeople file of our drugs.
By month study results with a broad set of physicians both immunity.
Academic across both the U S.
Key European markets.
But we have received multiple times over the last few years has been the focus monetization remains on the diamond side convenience.
The notion data and more specifically on the clinical consequences, especially leading infections and hospitalizations.
And they have also compared the downside because of Masimo omnipod.
Overall, we see very similar conclusions from both academic and community doctors.
Back to the Eagle Ford that.
Is.
Anybody out of the time of launch all side, many expensive experiences that managing toxicities.
Setting.
<unk> given long term familiar David that Jim Sandgren.
And they also state that then obviously Miami Bedfast patients.
<unk> clinical experience with the drug more closely so our expectation is given the very high efficacy results.
Good mechanistic rationale for why these type of thing is the fact that predictable and the fact that <unk>.
Clinical consequences, there should be really good and it would be medical affairs teams, our entire teams and will continue to focus on education.
The linkage to the mechanism of action of the habits of your understanding of what we expect polymer cell factories and financials.
If you would like to add anything clinically from ESI.
Sure I completely agree and echo with what any of that and the feedback that we hear.
It really is from Hematologists they are comfortable managing cytopenia is.
Understanding them.
Knowing what measures to take in order to support their patients once we explain the.
Timing the reverse ability and most importantly, the lack of.
Prolonged cytopenia and lack of severe infections are severe bleeding on there really.
Once there is an understanding that it helped too.
Allay any possible concerns, but mostly in the in the hands of Hematologists they feel quite comfortable managing these cytopenia and also in the upcoming months as Neil mentioned, we will have training.
Our medical affairs team and also.
More.
Insight into.
Cytopenia in further like presentations or publication.
Thank you that's helpful. And then just one last one here just kind of wondering if there are any key differences between the value proposition for <unk> in the U S versus the EU.
Just based on the current treatment paradigms for each region.
Okay.
I think let me take that yes, so let me take that question Robert with EU.
As you can imagine the most important thing in Europe is to establish broad based reimbursement each of the countries is ready to turn.
And more severely encouraging abaga murdo start unnoticed MBS efficacy data.
All showing the data that payers have repeatedly asked Paul.
This includes <unk> data it includes <unk>, notwithstanding sisters that they would really like to see.
And that is very positive news for us because their durability of BR.
And the auto value proposition is very strong.
So our goal there is to establish pricing.
All lithia markets in sequence.
I can maybe repaying we believe.
Within Europe .
In U S.
Dan.
The void here.
We have a concentrate good sir all thought of physician universe.
And just to make sure that the Amazon.
<unk> launch really well and these physicians.
Hey, Dan.
In terms of commercial value obviously.
As you know it's price dependent.
U S market is a marsh.
Can be.
More dollar value.
Okay Margaret.
But the adoption and the need to put them at those background pretty equally across both the U S.
Thank you very much.
Thanks, Sam Thanks.
Our next question comes from the line of Karen Jenkins Cornyn. Please go ahead.
Yeah. Good afternoon, everyone, maybe a couple from me.
The EAP what can you share regarding kind of the initial demand youre seeing for that program.
<unk>.
Where are the pockets of that demand coming from.
How are you managing through that program ahead of the launch.
Sure I can take that this is J.
Expanded access protocol was recently opened in improving really at the bridge.
Or.
The mechanism for patients received and metallic dock prior.
To approval and commercialization.
<unk>.
Wait at the EAP protocol is structured is that.
The patient care providers and physicians.
Laser request on an individual patient basis.
Sure.
Yeah.
Enrolment into the protocol and then Dennis very similar too.
Any other type of clinical trial protocol.
Early on in <unk>.
Our opening of it and we don't yet have a sense of.
But.
The kinetics of the enrollment.
Okay understood.
And then maybe separately I think I saw the press release, you expect the growth in terms of employees to be up to about 160 by the end of the year at that point, how much additional hiring or you need to do to be prepared for the launch.
Brian just I'll, let me out question.
So that total.
Just not include a sales force that is going to need to be hired for launch.
Because that is the timing of that hiring is going to be dependent on the produced and then I'll hand, the microphone over to Neil to talk about the size of the sales force and what's going to be necessary.
Yes.
Our previous guidance Gordon on that answer.
Sales force expansion will be ready for both online and that expectation is national competitor.
Maggie.
We said, we expect commercial organization will be someday.
200 <unk> hundred.
Randy.
Full time people, including sales and the commercial team supporting us.
Across medical affairs, as well as the commercial side.
Okay. Thank you.
Alright. Our next question comes from the line of <unk> Gill. Please go ahead.
Hi, good afternoon.
Thanks.
Taking a question.
Maybe they're simple one first so we expect.
News on some FDA feedback soon in August .
Also about an advisory committee at that point or.
Could that take a little longer.
I'll take that one Gil ordinarily wouldn't know about an advisory committee, either plus or minus at that time.
The agency is usually very focused on.
Since the NDA for review.
Theyre lingo.
The filing of the NDA, that's the one thing that we can count on.
We would next expect to hear possibly by the end of the month of August .
Something further about the actual producer date, assuming that its accepted.
Which would give any given indication of whether it was a priority or a standard review.
If and when.
There would be an advisory committee meeting and <unk>.
Quite uncertain window, when that would be announced or requested or posted it can come quite late in the in the review cycle. It can come a little bit earlier, but there is no specific timing for that.
I don't think we would have any feel for for that right now.
Thank you for that clarification, maybe a bit of a broader question.
The nickel one.
Is there any understanding regarding the non responders.
In low risk Mds.
Is this just because the primary because it's too far longer.
What are your insights on patients who seem to not respond.
That's great question Gil sorry, you're asking about patients, who probably don't achieve ti.
A lot of those patients, though they may not achieve.
100% transfusion independence, they may have reductions in transfusion burden.
They may have increases in hemoglobin improvement in symptoms or other quite possibly like intangible benefits or or benefits that were.
Not routinely assess the study.
So we continue to look into that and we continue to look into it there.
Alrighty predictors of patients who will achieve ti in terms of <unk> mutation or <unk> or anything like that and have not yet seen anything.
Notable distinguishing patients with GTI from those who don't.
Okay.
Thanks for taking my questions.
Thanks, a lot.
Yes.
Our next question comes from the line of truly truly please go ahead.
Hi, this is <unk>.
Macwillie at Stifel.
Just have a one quick question regarding impact MF.
With the 40% if I remember correctly with 40% of par.
Patients enrolled in this study now can.
Can you guys, maybe talk a little bit about how so basically the weather or the inventory that you will have observed to date is in.
In line with your expectation and also can you also.
Give us a little bit of color on maybe the efforts are.
Anything that you're doing to expedite enrollment in impact on that thank you.
Sure. This is <unk> I'll take that question.
Regarding the event rates.
Given that this is a.
Blinded study, although the patients know, which arm, they're randomized to we are blinded to the data.
To what patients are taking when we look at the analysis as a whole. So we cannot comment on the event rate until basically either of the interim or the final analysis when that study is unblinded.
But just to say also that the.
40% enrollment.
Contrast that with 35% of the enrolled patients.
Having died as when the interim is triggered.
So and then to move to your second question about.
Efforts to expedite or to boost enrollment we have had an ongoing effort.
End of last year early this year.
Included site visits and investigator engagement and additional resourcing to.
To encourage enrollment and boost enrollment we continue to receive enthusiastic feedback from investigators.
For the study and for enrolling patients in the study and we hope that.
The efforts that we've put in to date will.
Continue to bear fruit and we will see.
That that helps and maintains our enrollment.
That's helpful. Thank you very much.
Perfect and as a reminder, if you would like to ask a question. Please press star one.
Our next question comes from Joel Beatty, Joe. Please go ahead.
Hi, Thanks for taking the question.
So I just wanted to follow up on the previous question on impact.
So with our guidance now being four interim readout in.
First half of 2025.
Is that timing driven solely by the enrollment rate or does that also take into consideration is that.
Right on a blended basis.
Yeah.
Thanks for the questions now.
It takes into account the current enrollment rate than what we've seen in enrollment now that the study has been open for some time, we have the better.
Or more of a sense now for the pace of enrollment.
But the event rate is based on the initial one from the assumption built into the study.
And at this time, we have it.
Recalibrating to be in that rate.
Got it thanks and then.
Andrea.
<unk> has passed can you discuss what you see as the opportunity to capture market share in Rs negative patients, which is as I understand that the majority of the market and also where loss status have showed a negative trend on the primary endpoint.
Hi, Neil.
I can yes.
My question so.
Thank their data.
Is very clear.
What we are seeing.
In terms of sequencing post <unk>, an update on all the data that came out with Automotives MBS.
In Addis negative patients. These strong preference will position remains in Mendoza.
Specialty in patients who.
Previous meet GSA Peter.
And that is.
Pretty overwhelming both from <unk> perspective, as well as form.
European perspective, so that is very consistent and I think that is in line with what we know previously from the pace study.
And also obviously from the command is filed in the frontline setting. So we feel good about the meadows.
Like me to become the standard of care.
<unk> negative patients, especially the Esa.
<unk> patient population, which would be the vast majority and that is irrespective of transfusion burden for that group of patients.
There's a validation from the data that came out for miners.
Okay.
Terrific and then one last question is on <unk>.
Operating expenses up a bit from about $40 million in Q1 to about $52 million in Q2 could you help with the increase in the context and give us a sense of what that trajectory and expenses might look like over the next quarter or two.
Yes, Joel it's all about.
<unk>.
So as I mentioned, and we're still maintaining our overall annual guidance of up to $210 million of non-GAAP expense.
And as I think I've said on previous calls that I Didnt anticipate.
Getting towards the second half.
The ramp in expenses, especially not only as a more intensified commercial type efforts, but also as we are manufacturing.
Commercial with great inventory getting ready for launch as well and so thats, where youre seeing the increase happening here in the second quarter in comparison to the first quarter or is it networks increased expenses related to manufacturing costs as well as I would say increased cost for consulting expenses as we as we are.
Submitted all of the regulatory filings related to the NDA and then al.
The heart of getting everything ready for the MAA filing here in fourth quarter of 2023.
Great. Thank you.
Thanks, Joe.
Okay and there are no further questions. So at this time I would like to turn it back over to Eric Frankel.
Thank you so much for joining us today, we appreciate you taking the time to listen and participate.
Forward to keeping you updated on our progress.
That concludes today's call you may disconnect.
Okay.
That concludes today's call you may disconnect.
Yeah.