Q1 2021 Geron Corp Earnings Call
John A. Scarlett: 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. Thanks, Olivia, and good afternoon, everyone. During the first quarter of 2021, we continue to make progress in our two Imetelstadt Phase 3 studies with registrational intent. First, enrollment continues to increase in the ongoing Emerge Phase 3 trial.
Ladies and gentlemen, this is the operator today's conference is scheduled to begin momentarily until that time your lines will again be placed on hold and thank you for your patience and.
Again. This is the operator today's conference is scheduled to begin momentarily until that time your lines will again be placed on hold and thank you for your patience.
John A. Scarlett: This trial is evaluating Emmetelstad and transfusion-dependent, lower-risk MDS patients who have relapsed or refractory to erythropolis stimulating agents or ESAs. Last December, we had completed half of the planned enrollment of 170 patients in this trial. I'm happy to report that as of today, we have now achieved 75% of the planned enrollment.
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John A. Scarlett: We continue to expect this trial to be fully enrolled in the second half of this year and for top-line results to be available as early as the end of 2022 or in the first half of 2023. Next, in Impact MF, our second phase three trial that's evaluating Emmetelstad in patients with intermediate two or high-risk myeliprosis who are refractory to prior treatment with the jack inhibitor, we recently announced the first patient being ghosted.
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John A. Scarlett: This trial is the first trial of its kind in refractory MF patients with overall survival as a primary endpoint. Based on our current planning assumptions, we continue to expect the planned enrollment of 320 patients in this trial to be complete in 2024. Next, we are progressing on our preliminary activities for NBA and commercial readiness, which include long-lead time manufacturing and quality activities, as well as developing a comprehensive organizational foundation to support a high growth and commercial stage company.
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John A. Scarlett: Lastly, we look forward to presenting new data and analyses from our Phase 2 trials in Telstatt at the upcoming European Hematology Association meeting, IHA, with the two abstracts that we submitted. The abstracts will be available online at eahaweb.org on May 12th. Looking ahead over the next three years, we remain committed to achieving top-line results in Emerge Phase 3, gaining regulatory approval of Imitelstat, and commercially launching this highly differentiated drug and how much lower it's going to be. With that, I'll turn the call over to Alexandra. Thank you, Chief. And good afternoon, everyone.
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Good day, and thank you for standing by and welcome to the Q1 2021 Geron earnings conference call on.
Alexandra: As supported by our compelling phase two data, we believe in health that it's clearly differentiated from the currently available treatment for lower-risk MDS patients who are relapsing or refractory to ESA. Our numerous publications and presentations have reported meaningful and durable transfusion independence in high transfusion burden patients after treatment within a TELCAD, including a median duration of transfusion independence of 20 months. In our Emerge Phase 3 trial, as Chief mentioned previously, we have now achieved 75% of the planned enrollment.
At this time all participants are in a listen only mode.
For the speakers remarks, there will be a question and answer session to ask a question. During the session you will need to press star one on your telephone if you require any further assistance. Please press star zero and.
I would now like to hand, the conference over to your Speaker today Olivia Bloom. Please go ahead.
Great. Thank you.
And good afternoon, everyone.
Welcome to this conference call to discuss Geron first quarter 2021 financial results and recent company events.
I'm joined today by Dr. John Scarlett, Geron, Chairman and Chief Executive Officer, and Dr. Alexander Rizzo Geron, Chief Medical Officer.
Alexandra: It appears patients are becoming more comfortable living in their homes to participate in clinical trials, possibly due to the increasing vaccination rates and a decreasing number of severity of COVID cases in many of the countries where our sites are located. Moving on to our second, phase three trial, impacts on men. Last month, we ghosted the first patient in that trial. This was an important milestone in developing a metastal for refractory miles of grovesy patients. Patients who fail or no longer respond to jack inhibitor treatment have a median overall survival of only approximately 14 to 16 months.
After the market close day, we announced our first quarter 2021 financial results via press release, which is available on our website.
In addition on archive of this webcast will be available on our website for 30 day.
Before we begin please note that this presentation and question and answer session will contain forward looking statements relating to geron plans expectations and timelines.
Statements.
Statements of Potentiality and projections. These include without limitation those regarding.
The expected timelines for completion of enrollment of and the results from the merch phase III and impact and that clinical trials and submission of an NDA for.
Alexandra: This is a clear indicator of the unmet needs in this patient population. As Chief mentioned, ImpactMX is the only study in refractory MS with overall survival as a primary endpoint. As the clinical results from this study are event-driven, the final analysis is planned to be conducted after more than 50% of the patients planned to be involved in the trial have died. An interim analysis is planned to be conducted after approximately 70% of the total projected number of best events for the final analysis have occurred. The number of events required to conduct the interim analysis could occur before enrollment is complete, as these events will accumulate throughout the enrollment period.
And the potential for positive outcomes from emerge phase III and impact MF.
Potential approval of <unk> by regulatory authority and its commercialization.
Expectation that geron current financial resources will be sufficient to fund operations until the end of 2022 and that is operating expense burn in 2021 will be between $108 million and $112 million and that <unk> has the potential to be disease, modifying and alter the course of Mds and MMS.
These and the other forward looking statements involve risks and uncertainties that could cause actual results to differ materially from those and such forward looking statements.
These risks and uncertainties include without limitation those regarding for the company may be unable to overcome all the enrollment clinical safety and efficacy technical scientific operational manufacturing and regulatory challenges to meet the expected timelines for the emerge phase III and impact and that clinical trial.
Alexandra: Based on current planning assumptions, our expected timeline for impact on the study remains the same as we've previously guided, with full enrollment and interim analysis projected to occur in 2024, and the final analysis in 2025. They're actively conducting site initiation activities around the world and recruiting patients. The currency plans to engage over 180 sites across five continents.
Due to COVID-19 or otherwise.
And the phase III clinical trials and hotels that may not seem to be on state or efficacious as and the phase II trials and may not and demonstrate that is efficacious and disease modifying.
That regulatory authorities may not permit for further development and Mattel Scott on a timely basis or at all and may not approve it for commercialization and that geron may need additional financial resources before the end of 2022 for the development and commercialization of and that's helped that.
Alexandra: We plan to employ similar enrollment-boosting strategies for Impact that we used for Emerge Phase 3, among others. We will retain clinical sanitary zones to interact with sites, forward patients, and their physicians to the potential benefits of participating in Impact MS. We will also utilize social media tactics to help drive patient awareness and recruitment. I look forward to the upcoming EHAT 2021 virtual Congress in June when our investigators will present new clinical data and analysis from our phase two trial.
Detailed information on the above risks and uncertainties and additional risks uncertainties and factors that could cause actual results to differ materially from those and the forward looking statements are explained under the heading risk factors and you're on quarterly report on form 10-Q for the quarter ended March 31 and 2021.
Filed with the Securities and Exchange Commission.
Undue reliance should not be placed on forward looking statements, which speak only as of the day. They are made and the fact that and assumptions underlying the forward looking statements may change.
Alexandra: The abstracts for these presentations will be available online later. This presentation will once again highlight the potential of metastasis to redefine the standard of care for NDS and MS patients. Now, I'd like to hand a call over to Olivia to discuss our first quarter financial results. Olivia?
And now I will turn the call over to Dr. Scarlett Geron.
Thanks for Libya, and good afternoon, everyone.
During the first quarter of 2021, we continue to make progress on our two and the <unk> phase III studies with Registrational intent for enrollment continues to increase and on ongoing emerge phase III trial midst.
Olivia Kyusuk Bloom: Thank you, Alexandra, and good afternoon again, everyone. As of March 31, 2021, the company had approximately $245 million in cash and marketable security, which we expect will be sufficient to fund our operations until the end of 2022. The increase in operating expenses for the first quarter of 2021 compared to the same period in 2020 was primarily driven by higher development expenses.
Trial is evaluating and Intelsat and transfusion dependent lower risk Mds patients, who are relapsed or refractory to Richard please for stimulating agents for Esa.
December we had completed half of the planned enrollment of 170 patients from this trial on the.
Happy to report that as of today, we have now achieved 75% of the plant.
We continue to expect this trial to be fully enrolled and the second half of this year and for top line results should be available as early as the end of 2022, where and the first half of 2023.
Olivia Kyusuk Bloom: This increase in R&D expenses includes higher clinical development costs associated with our two ongoing phase three clinical trials, as well as the initiation of long lead time manufacturing and quality activities, such as manufacturing validation batches of Emmett Health staff. These validation activities conducted in collaboration with our contract manufacturers are the cornerstones for the planned NDA for MET HealthS and lower risk MDF that we expect to file in 2023, assuming positive top-line results for new merge phase three.
Next and impact enough, our second phase III trial.
Evaluating and Mattel serving patients with intermediate two or high risk myelofibrosis, who were refractory to prior treatment with a JAK inhibitor and we recently announced the first patient being dosed. This trial is the first trial and its kind and refractory MF patients with overall survival as the primary endpoint based on our current planning assumptions we can.
Can you to expect.
We expect the planned enrollment of 320 patients for this trial to be complete and 2024.
Olivia Kyusuk Bloom: These validation batches will also provide the main data and information by which the commercial shelf life of MITELCbat will be set at the time of product launch. General and Administrative expenses for the first quarter of 2021 increased slightly compared to the same period in 2020.
Next we are progressing on our preliminary activities for NDA and commercial readiness, which include long lead time manufacturing and quality activities as well as developing a comprehensive organizational foundation to support our high growth and commercial stage company.
Lastly, we look forward to presenting new data and analyses from our phase II and Intelsat.
Olivia Kyusuk Bloom: This increase reflects our initial work to transform Geron into an enterprise, fully prepared to rapidly ramp up both size and complexity in order to support potential commercialization efforts. Upon execution of our debt facility in September 2020, we drew down $25 million of the $75 million potential commitment. As a result, interest expense for the first quarter of 2021 was $743,000.
Trials at the upcoming European Hematology Association meeting <unk>.
With the two abstracts that we submitted the.
For the abstracts will be available online and web.
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Looking ahead over the next three years, we remain committed to achieving top line results and emerge phase III gaming.
Gaining regulatory approval of Intelsat and commercially launching this highly differentiated drug and low risk Mds.
With that I'll turn the call over to Alexandria Alexandria.
Olivia Kyusuk Bloom: For net other income in the first quarter of 2021, we sold all of our holdings in an equity investment, resulting in a net realized gain of $1.2 million, including foreign currency translation adjustment. I'd like to conclude my comment by reaffirming our 2021 financial guidance. We continue to expect operating expense burn to range from $108 million to $112 million.
Thank you chip and good afternoon, everyone.
And supported by our compelling phase two data and we believe and that's helped that it's clearly differentiated from the currently available treatments for lower risk Mds patients, who are relapsed and refractory to Esa.
Our numerous publications and presentations have reported meaningful and durable transfusion independent and high transfusion burden patients after treatment cigarette sales debt, including a median duration of transfusion independence of 20 months.
Olivia Kyusuk Bloom: This burn includes cost to support ongoing, say, three clinical trials, produce validation batches of inventory of imitelftheta contract manufacturers, and to begin preparing regulatory filings for approval and commercial readiness. Financial Guidance is based on a set of assumptions at appointment time, and if the company's plans change, causing assumptions to be revised, then we will update guidance at that time. With that, we have concluded our prepared remarks this afternoon. I will hand the call back to CHIP and ask the operators to open the line for questions.
And our March phase III trial, as Chad mentioned previously we have knowledge and 75% of the planned enrollment.
It appears and patients are becoming more comfortable leaving their homes to participate and clinical trials, possibly vs are increasing vaccination rates and low decreasing number of severity of COVID-19 cases, and many of the countries for our sites are located.
Moving on to our second phase III trial impacts on that.
Olivia Kyusuk Bloom: Thank you. At this time, I would like to remind everyone that in order to ask a question, press star, then the number one on your telephone keypad. Again, that is star, then the number one on your telephone keypad.
Last month, we dosed the first thing something that trial.
And was an important milestone and developing for mitel sought for refractory myelofibrosis patients.
Operator: We'll pause for just a moment to compile a Q&A roster. We have our first question coming from the line of Justin Walsh with B Riley Securities. Your line is open.
Patients who fail for no longer respond to JAK inhibitor treatment have on.
Median overall survival of only approximately 14 to 16 months.
A clear indicator of the unmet need and these patient population.
John A. Scarlett: Hi, thanks for taking the question and congratulations on the progress. Can you give us some color on what types of analyses we can expect at EHA and potential read-through to phase three trials? Yeah, I think, unfortunately, Justin, the embargo rules prevent us from really commenting on the Miha abstracts or their content until they're published, and that happens on Wednesday, so we expect to, we expect to comment at that point in time.
As chip mentioned impact on that is the only studying and refractory and that overall survival is the primary endpoint.
Yes.
As declining called results from this study day event driven thus.
The final analysis is planned to be conducted after more than 50% of the patients planned to be enrolled in the trial have died.
I think for my analysis is planned to be conducted after approximately 70% of the total projected number of death events for the final analysis have occurred.
John A. Scarlett: All right, then maybe just, I don't know if you can comment on this. I'm wondering if the data cutoff for the abstract will be the same as what we see at the conference itself. Alex, do you want to comment?
The number of events required to conduct the interim analysis could occur before enrollment is complete.
These events and we look through to all day enrollment period.
John A. Scarlett: I was referring to the commenting chip; I would just wait for the abstract to come online. Okay, thank you then. I'll have one more quick question here then. I'm just curious.
Based on current planning assumption, our expected timeline for inflection on that study remains the same as you previously guided for.
For the full enrollment and the interim analysis is projected to occur in 2024 and.
Adam: I'm correct in thinking that in impact MS, you do not enroll patients who are receiving investigational therapies, correct? It's just current best available therapy, and then assuming that I'm right about that, do you think that if you're having challenges in enrolling rapidly enough, if you'd been able to change the enrollment criteria, or not, that potentially has some implications for your survival analysis. Go ahead, Adam.
And the final analysis and 2025.
We're actively conducting site initiation activities around the world and recruiting patients.
We currently plan to engage over 180 sites across five continents.
We plan to employ similar enrollment boosting strategy for impact on that debt.
For us for emerge phase III.
Among the others.
And again clinical path for them to interact with bi polar and patients and their physicians to the potential benefits of participating and in fact on that.
Adam: Right, suggesting you are correct. At the moment, we do not allow enrollment of patients who are on other investigational therapies. You know, we will just have to wait and see how things evolve. But typically, in clinical trials, you do not allow patients on investigational treatment to come on your trial as well. Got it. Thank you for the questions. Thanks, Justice.
We will also utilize social media tactics.
Help drive patient awareness and recruitment.
I look forward to the upcoming <unk> 2021 virtual Congress in June when our investigator presented new clinical data and analysis from our phase II trials.
And the abstract for these presentations will be available online later this week.
This presentation will once again highlight and a pulse has potential to redefine the standard of care for Mds and MF patients.
Bonnie: We have our next question coming from the line of Boniquot, which is open. Hi, this is Bonnie on behalf of Steve Wiley at the Diefel. I just have a few small questions about enrollment in the emerging trial and the impact of COVID. Do you have any thoughts on the effect of COVID on the type of patients enrolled? And, for example, do you think that the patient population would skew more towards those with a higher transfusion burden since they're more willing to take the additional risks of going to a hospital and partaking in a clinical trial? And also, do you anticipate seeing more posted Patterset patients? Any color would be helpful; thanks.
Now I'd like to hand, the call over virtual <unk> to discuss our first quarter financial results.
Olivia.
Thank you Alexandra and.
Good afternoon again, everyone.
As of March 31, 2021, the company had approximately $245 million and cash and marketable securities.
Which we expect will be sufficient to fund our operations until the end of 2022.
The increase in operating expenses for the first quarter of 2021 compared to the same period and 2020 was primarily driven by higher development expenses.
Alexandra: Okay. Sure, I can take that shift. So, I mean, it's interesting. So I'll give first an overall kind of feeling about the enrollment, and then maybe I'll answer your two specific questions. So although we are seeing that the number of COVID-19 cases is declining in certain regions, other regions are experiencing a resurgence, right? And then we have these new variants that are coming up as well.
This increase and R&D expenses include higher clinical development costs associated with our two ongoing phase III clinical trials.
As well as the initiation of long lead time manufacturing and quality activities.
Such as manufacturing validation batches and the Tulsa.
Steve validation activities conducted in collaboration with our contract manufacturers are cornerstone for the planned NDA for <unk> debt and lower risk Mds that we expect to file in 2023, assuming positive topline results for new merge they free.
Alexandra: So it's really the, it's really, undecidable or uncertain, you know, about the pace at which the clinical trial patients may normalize. However, you know, at the moment, it is likely, like you are speculating, to say that maybe patients with a higher transfusion rate will be involved in a clinical trial. It's just very difficult to comment on that.
These validation batches will also provide the main data and information by which the commercial shelf life and Intelsat will be set at the time of product launch.
General and administrative expenses for the first quarter of 2021 increased slightly compared to the same period and 2020.
Alexandra: The good side is that myself has really worked well in these patients. So, you know, if we had them on the trial, I wouldn't be worried about it. So I think that that was one of your questions, and I'm sorry, I'm breaking on the other one. So one was the, oh, the Lus Fighter sets and the possible effects of the Lus Fighter sets. I mean, Lyspice is doing great, right
This increase reflects our initial work to transform <unk> into an enterprise fully prepared to rapidly ramp in both size and complexity in order to support potential commercialization efforts.
Upon execution of our debt facility in September 2020, we drew down $25 million of the $75 million potential commitment.
Alexandra: The launch has been robust, and that validates the unmet need in the market potential for this patient population. Remember that the label for Luspercept is in R's negative, sorry, RIS positive patients only, whereas our trial allows enrollment for all low-risk ambient patients, irrespective of the presence of Rincideroblast. So while there might be some small impact on the patients that are positive, which let's remember it's not more than 20%. We do not expect to have any impact on the majority or on a bigger portion of the patient populations in lower S-MDS patients.
And as such interest expense for the first quarter of 2021 for $743000.
For net other income and the first quarter of 2021, we sold all of our holdings and and equity investments, resulting in a net realized gain of $1 2 million.
Including foreign currency translation adjustments.
I'd like to conclude my comments by reaffirming our 2021 financial guidance.
We continue to expect operating expense burn to range from $108 million to $112 million.
And this burn includes cost to support two ongoing phase III clinical trials produce validation batches with them and talked at our contract manufacturers and to begin preparing regulatory filings for approval and commercial readiness.
Bonnie: Great, thank you so much. Thanks, Bonnie. Thank you. This concludes the Q&E portion of the call, and we'll hand it over to John Scarlett, Chief Executive Officer, for closing remarks. Well, thanks very much for joining us today. It's been a busy earnings season, so we appreciate everyone who had the opportunity to dial in and participate. We're very excited about the progress we're making to bring this very important drug to patients. We're planning for Jaron to become a commercial company in 2023 with the potential launch of Mattelstat and low-risk MDS. The markets for both lower-risk MDS and refractory MS are highly attractive, and we look forward to sharing more updates with you as we progress through the year. Thanks, everyone.
Financial guidance is based on a set of assumptions at a point and time and if the company's plans change, causing assumptions to be revised then we will update guidance at that time.
With that we've concluded our prepared remarks this afternoon.
I will hand, the call back to chip and ask the operator to open the line for questions.
Thank you at this time and would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad.
Again that is star then the number one on your telephone keypad, we'll pause for just a moment to compile the Q&A roster.
We have our first question coming from the line of Justin Walsh with B Riley Securities. Your line is open.
And.
Hi, Thanks for taking my question and congratulations on the progress can you give us some color on what types of analyses you can expect that <unk> and central read through to the phase III trials.
Yeah, I think unfortunately, Justin.
And the embargo.
Rules prevent us from really commenting on the hubs.
Abstracts or their content.
Until their published and Thats happens on Wednesday so.
Got it correct two we expect to add a comment at that point and John Alright.
And then maybe just I don't know if you can comment on this I'm wondering if the.
The data cutoff for the abstract do you expect that will be the same as what we see at the conference itself.
Alex do you want to comment.
Tom.
I would refrain from commenting chip I would just sit and wait for the abstracts to come on line.
Okay. Thank you and I'll have one more.
Quick question here then.
I'm just curious.
Alright.
And I'm correct in thinking that impact MF.
And you do not enroll patients to receive receiving investigational therapies craft is just current best available therapy, and then assuming that that's that im right on that.
John A. Scarlett: Thank you. Theeus, and so on the other, and so on the other.
Do you think that for you. If you are having challenges and enrolling rapidly announced that you'd be able to change the.
And the enrollment criteria or would that potentially have.
And some implications for your survival analysis.
Go ahead on.
Alright, and suggesting you're correct at the moment, we do not allow enrollments that are on other investigational therapies.
And we will just have to wait and see how housings evolve, but typically on clinical trials and do not allow patients on investigational treatment to come on your trial as well.
Got it thank you for the question.
Thanks, Justin.
We have our next question coming from the line of Bonnie Quach with Stifel. Your line is open.
Hi, This is Bonnie on for Steve Wiley at Stifel.
I'm not sure I just want a few small questions about enrollment and the emerge trial and the impact of COVID-19.
And do you have any thoughts on the effect of COVID-19.
On the type of patients enrolled and for example, do you think that the patient population would skew more towards those.
Those with a higher transfusion burden and since they are more willing to take the additional risks of going to a hospital and partaking in a clinical trial and also do you anticipate similar.
Patterns that patients any color would be helpful. Thanks.
Okay.
Sure I can take that so I think.
I think for us and South East first and overall.
Kind of a skewing of the enrollment and then maybe I'll answer it.
For two specific questions.
And although we are seeing that the number of the COVID-19 cases and declines in certain regions other regions, our experienced and research on US right. So and then we have this new variant and set that are coming up as well. So it's really the it's really unpredictable or answered, but you know John.
I'll start.
About <unk> of which the clinical trial for instance may normalize however.
At the moment right.
It is likely just like you all are speculating to say there may be patients with a higher transfusion burden and will be enrolled on on clinical trial, and just very difficult to comment on that liquid five and fat and muscle subs really works well and these patients. So you know if we have them on the trial and.
I wouldn't be worried about it but I think that that points on that.
One of your questions and I'm, sorry, I'm blanking on the other one so one was that there was fire subs and <unk>.
And the possible effects of <unk> and Spider sense.
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I mean I'm sorry for please bring drain drive the launch has been robust and and that validates the unmet need and the market potential and these patient population.
And remember that the label for <unk>, and RF and negative I'm, sorry in Rs positive patients only whereas our trials.
<unk> enrollment for all low risk Mds patients irrespective of presence of ring sideroblast, so while there might be.
And some small impact on the patients that are always positive which lets remember.
Both more than 20% and we do not expect to have any impact on the majority of your on the bigger portion of the patient populations and low risk Mds patients.
Great. Thank you so much.
Yeah.
Thanks Bonnie.
Thank you. This concludes the Q&A portion of the call and will hand, it over to John Scarlett Chief Executive Officer for closing remarks.
Well. Thank you very much for joining us today. So it's been a busy earning season. So we appreciate everyone who had the opportunity to Darwin and participate.
Yeah.
We're very excited about the progress, we're making and bring this very important drug for patients with.
Planning for Geron to become a commercial company and 2023 with the potential launch of Intelsat and low risk Mds.
The markets for both low risk Mds and refractory MF are highly attractive and we look forward to sharing more updates with you as we progress through the year, thanks, everyone and.
Have a good afternoon.
This concludes today's conference call. Thank you for participating you may now disconnect.
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