Geron (GERN) Q1 2021 Earnings Call Transcript

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Geron (GERN 1.74%)
Q1 2021 Earnings Call
May 10, 2021, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good day and thank you for standing by and welcome to the Q1 2021 Geron earnings conference call. [Operator instructions]. I would now like to hand the conference over to your speaker today, Olivia Bloom. Please go ahead.

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

Great. Thank you, Celine and good afternoon, everyone. Welcome to this conference call to discuss Geron's first-quarter 2021 financial results and recent company events. I am joined today by Dr.

John Scarlett, Geron's, chairman and chief executive officer; and Dr. Aleksandra Rizo, Geron's chief medical officer. After the market closed today, we announced our first-quarter 2021 financial results via press release, which is available on our website. In addition, an archive of this webcast will be available on our website for 30 days.

Before we begin, please note that this presentation and question-and-answer session will contain forward-looking statements relating to Geron's plans, expectations, time lines, beliefs, statements of potentiality and projections. These include, without limitation, those regarding the expected time lines for completion of enrollment of and the results from the IMerge Phase 3 and IMpactMF clinical trials and submission of an NDA, the potential for positive outcomes from IMerge Phase 3 and IMpactMF, potential approval of imetelstat by regulatory authorities and its commercialization, the expectation that Geron's current financial resources will be sufficient to fund operations until the end of 2022 and that its operating expense burn in 2021 will be between $108 million and $112 million and imetelstat has the potential to be disease-modifying and alter the course of MDS and MF. These and other forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include, without limitations, those regarding that the company may be unable to overcome all the enrollment, clinical, safety, efficacy, technical, scientific, operational, manufacturing and regulatory challenges to meet the expected time lines for IMerge Phase 3 and IMpactMF clinical trials due to COVID or otherwise, that in the Phase 3 clinical trial, imetelstat may not prove to be as safe or efficacious as in the Phase 2 trial and may not demonstrate that it is safe, efficacious and disease modifying, that regulatory authorities may not permit the further development of imetelstat 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 imetelstat.

Detailed information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are explained under the heading Risk Factors in Geron's quarterly report on Form 10-Q for the year ended March 31, 2021, filed with the Securities and Exchange Commission. Undue relied 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. And now, I will turn the call over to Dr. Scarlett.

John?

John Scarlett -- Chairman and Chief Executive Officer

Thanks, Olivia and good afternoon, everyone. During the first quarter of 2021. We continue to make progress in our two imetelstat Phase 3 studies with registrational intent. First, enrollment continues to increase in our ongoing IMerge Phase 3 trial.

This trial is evaluating imetelstat and transfusion-dependent, low-risk MDS patients, who are relapsed or refractory to erythropoiesis-stimulating agent 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. 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.

We're in the first half of 2023. Next, in IMpactMF, our second Phase 3 trial that's evaluating imetelstat and patients with intermediate to or high risk myelofibrosis, who are refractory to prior treatment with a JAK inhibitor, we recently announced the first patient being dosed. This trial is the first trial of it's kind in refractory MF patients with overall survival as the primary endpoints. Based on our current planning assumptions, we continue to expect the planned enrollment of 320 patients for this trial to be complete in 2024.

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 a high growth in commercial stage company. Lastly, we look forward to presenting new data and analyses from our Phase 2 imetelstat trials at the upcoming European Haematology Association meeting EHA, with the two abstracts that we submitted. The abstracts will be available online at .ehaweb.org on May 12. Looking ahead, over the next three years, we remain committed to achieving top-line results in IMerge Phase 3, gaining regulatory approval of imetelstat and commercially launching this highly differentiated drug in low-risk MDS.

With that, I'll turn the call over to Aleksandra. Aleksandra?

Aleksandra Rizo -- Chief Medical Officer

Thank you, Chip and good afternoon, everyone. As supported by our compelling Phase 2 data, we believe imetelstat is clearly differentiated from the currently available treatments for low-risk MDS patients, who are relapsed or refractory to ESA. Our numerous publications and presentations have reported meaningful and durable transfusion independence in high transfusion burdened patients after treatments within imetelstat, including a median duration of transfusion independence of 20 months. In our IMerge Phase 3 trial, as Chip mentioned previously, we have now achieved 75% of the planned enrollment.

You will see as patients are becoming more comfortable leaving their homes to participate in clinical trials, positive reviews of 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 3 trial, IMpactMF. Last month we dosed the first patient in that trial. This was an important milestone in developing imetelstat for refractory myelofibrosis patients.

Patients who fail or no longer respond to JAK inhibitor treatment, have a median overall survival of following approximately 14 to 16 months. It is a clear indicator of the unmet needs in this patient population. As Chip mentioned, IMpactMF is the only study in refractory MF with overall survival as a primary endpoint. As the timing of results from this study is event-driven.

the final analysis is planned to be conducted after more than 50% of the patient's plan to be enrolled in the trial have died. Hence, interim analysis is planned to be conducted after approximately 70% of the total projected number of death 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 accrue throughout the enrollment period. Based on current planning assumptions, our expected timeline for IMpactMF study remains the same as we've previously guided.

Before enrollment, an interim analysis is projected to occur in 2024 and the final analysis in 2025. We're actively conducting site initiation activities around the world and recruiting patients. We currently plan to engage over 120 sites across five continents. We plan to employ similar enrollment boosting strategies for IMpactMF that be used for IMerge Phase 3.

Among the others, we will retain clinical staff to interact with site patients and their physicians to the potential benefits of participating in IMpactMF. We will also utilize social media tactics to help drive patient awareness and recruitment. I look forward to the upcoming EHA 2021 Virtual Congress in June when our investigators present new clinical data and analysis from our Phase 2 trials. The abstracts for these presentations will be available online later this week.

This presentation will once again highlight imetelstat's potential to redefine the standard-of-care for MDS and MF patients. Now, I'd like to hand the call over to Olivia to discuss our first-quarter financial results. Olivia?

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

Thank you, Aleksandra 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. This increase in R&D expenses include higher clinical development costs associated with our two ongoing Phase 3 clinical trials, as well as the initiation of long lead-time manufacturing and quality activities, such as manufacturing validation batches of a imetelstat.

These validation activities conducted in collaboration with our contract manufacturers are cornerstones for the planned NDA for imetelstat in lower-risk MDS that we expect to file in 2023 assuming positive topline results from IMerge Phase 3. These validation batches will also provide the main data and information by which the commercial shelf-life of imetelstat 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. This increase reflects our initial work to transform Geron into an enterprise fully prepare 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. As such, interest expense for the first quarter of 2021 was $743,000. 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 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.

These burns includes cost of support two ongoing Phase 3 clinical trials, produce validation batches of metelstat at contract manufacturers, and to begin preparing regulatory filing for approval and commercial readiness. Financial guidance is based on a set of assumptions at a point in 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 lines for questions.

Questions & Answers:

Operator

[Operator instructions] We have our first question coming from the line of Justin Walsh with B. Riley Securities. Your line is open.

Justin Walsh -- B. Riley Securities -- Analyst

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 central read through to the Phase 3 trials?

John Scarlett -- Chairman and Chief Executive Officer

Yeah, I think, unfortunately Justin the embargo rules prevent us from really commenting on the EHA abstracts or their content until they're published and that happens on Wednesday. So we expect to comment at that point in time.

Justin Walsh -- B. Riley Securities -- Analyst

All right. Then maybe just I don't know if you can comment on this. I'm wondering if the data cut-off for the abstract you expect that will be the same as what we see in the conference itself?

John Scarlett -- Chairman and Chief Executive Officer

Alex you want to comment?

Aleksandra Rizo -- Chief Medical Officer

I would refrain from commenting too, but I would just wait for the abstract to come online.

Justin Walsh -- B. Riley Securities -- Analyst

OK, thank you. And then I'll have one more quick question here then. I'm just curious, I'm correct in thinking that IMpactMF you do not enroll patients who are receiving investigational therapies practice, just current best available therapy and then assuming that that's -- that I'm right on that, do you think that if you're having your challenges in enrolling rapidly enough that you'd be able to change the enrollment criteria, or would that potentially have some implications for your survival analysis?

John Scarlett -- Chairman and Chief Executive Officer

Go ahead Alex.

Aleksandra Rizo -- Chief Medical Officer

Right, suggesting you're correct. At the moment, we do not allow enrollments that are on other investigational therapies. No, we will just have to wait and see how things evolve. But typically on clinical trials, you do not allow patients on investigational treatments to come on your trial as well.

Justin Walsh -- B. Riley Securities -- Analyst

Got it. Thank you for the questions.

John Scarlett -- Chairman and Chief Executive Officer

Thanks, Justin.

Operator

We have our next question coming from the line of Bonnie Quach with Stifel. Your line is open.

Bonnie Quach -- Stifel Financial Corp -- Analyst

Hi. This is Bonnie on from Steve Willey at Stifel. I just have a few small questions about enrollment in the IMerge 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 toward 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 anticipate seeing of course luspatercept patients? Any color would be helpful.

Thanks.

John Scarlett -- Chairman and Chief Executive Officer

Aleks?

Aleksandra Rizo -- Chief Medical Officer

Sure. I can take that. So, I think, it's interesting, so I'll give first an overall, kind of, viewing of the enrollment and then maybe I'll answer to your two specific questions. So although, we are seeing that the number of the COVID-19 cases is declining in certain regions, other regions are experiencing resurgence, right? And then we have these new variants that are that are coming up as well.

So it's really the -- it's really unpredictable or uncertain of the -- about the pace at which the clinical trial, for instance, may normalize. However, we -- at the moment, right, it is likely that you are speculating to say that maybe patients with a higher transfusion burden will be enrolled in a clinical trial, it's just very difficult to comment on that. The good side is that, its stuff that's really worked well in these patients. So if we had them on the trial, I wouldn't be worried about it.

So I think that was kind of one of your questions. And, I'm sorry, I'm breaking on the other one. So one was the -- the luspatercept and the possible effects of luspatercept. I mean, luspatercept is doing great.

All right? The launch has been robust, and that validated the unmet needs and the markets potential in this patient population. Remember that the label for luspatercept is in RS negative -- sorry, in RS positive patients only. Whereas our trial allows enrollment for all low risk MDS patients, irrespective of presence of ring sideroblast. So while there might be some small impact on the patients that are RS positive, which let's remember, it's not more than 20%.

We do not expect to have any impact on the majority or on the bigger portion of the patient populations in low risk MDS patients.

Bonnie Quach -- Stifel Financial Corp -- Analyst

Great. Thank you so much.

John Scarlett -- Chairman and Chief Executive Officer

Thanks, Bonnie.

Operator

Thank you. This concludes the Q&A portion of the call and we'll hand it over to John Scarlett, chief executive officer, for closing remarks.

John Scarlett -- Chairman and Chief Executive Officer

Well, thanks very much for joining us today. So it's been busy earning season so we appreciate everyone who had the opportunity to dial in and participate. We're very excited about the progress we're making. We're bringing this very important drug to patients.

We're planning for Geron to become a commercial company and 2023 with the potential launch of the imetelstat low risk MDS. The markets for both low 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, and have a good afternoon.

Operator

[Operator signoff]

Duration: 21 minutes

Call participants:

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

John Scarlett -- Chairman and Chief Executive Officer

Aleksandra Rizo -- Chief Medical Officer

Justin Walsh -- B. Riley Securities -- Analyst

Bonnie Quach -- Stifel Financial Corp -- Analyst

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