Ladies and gentlemen, thank you for standing by and welcome to the Third Quarter 2019 Geron Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers presentation there will be a question-and-answer session.

[Operator Instructions] I would now like to hand the conference over to your speaker today Suzanne Messere. Please go ahead..

Thank you, Lisa, and good morning, everyone. Thank you for joining us for our third quarter conference call. I'm joined today by Dr. John Scarlett, Geron's Chairman and Chief Executive Officer; and Olivia Bloom, the company's CFO, and Dr. Aleksandra Rizo, our Chief Medical Officer.

After the market closed yesterday, we announced our third quarter 2019 financial results via press release. It is available on our website under www.geron.com/investors. This morning, management will discuss the information from yesterday’s press release. A live webcast of the call is available on our website and will be archived for 30 days.

Before we begin, please note that except for statements of historical fact, this presentation and question-and-answer session contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investors are cautioned that such forward-looking statements include any of the company's plans, expectations, timelines, beliefs, statements of potentiality and projections and without limitation, those regarding to – those regarding that the topline results from the Phase III portion of IMerge are expected to be available by mid year 2022; that there will be an end of Phase II meeting with the FDA by the end of the first quarter 2020; that Geron may potentially develop imetelstat for relapse/refractory MF patients; and that Geron's 2019 operating expenses will be $80 million to $85 million.

All of these forward-looking statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements.

These risks and uncertainties include, without limitation, those regarding that the company may be unable to overcome all the clinical, safety, efficacy, technical, scientific, operational, manufacturing and regulatory challenges to enable the topline results from the Phase III portion of IMerge to be available by mid-year 2022; that regulatory authorities may not permit the further development of imetelstat on a timely basis or at all; that the company may decide not to develop imetelstat for relapsed/refractory MF patients; and that there may be unexpected operating expenses or events that cause the $80 million to $85 million 2019 financial guidance to be revised.

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 under the heading Risk Factors in Geron's quarterly report on Form 10-Q for the quarter ended September 30, 2019, filed with the SEC.

Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change.

Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances. With that, I'd like to turn the call over to Dr. John Scarlett, Geron's Chairman and CEO.

Chip?.

Thanks, Suzanne, and good morning, everyone. Geron continues to execute on its key 2019 imetelstat development plans with the achievement of several important milestones this past quarter. We assumed full control of all development for imetelstat by completing the transition of the program back to Geron from Janssen at the third quarter.

This means that in addition to the US we’re now responsib e for both IMerge and IMbark in all countries where the trials are being conducted. In August we opened the Phase III IMerge trial for screening and enrolment. In October we announced the first patient and dose.

More recently in September we announced that the FDA granted fast track designation to imetelstat for the treatment of adult patients with intermediate to high-risk myelofibrosis whose disease has relapsed after or is refractory to JAK inhibitor treatment. This is the same patient population of the study in Geron’s IMbark Phase II clinical trial.

With no marketed drug specifically approved for relapsed/refractory MF there's a significant unmet medical need for this indication.

FDA's Fast Track program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and that are supported by data that demonstrate the potential to address an unmet medical need.

We view the fast track designation positively as it provides opportunities for more frequent interactions with the FDA, the ability to submit sections of new drug applications on a rolling basis and eligibility to request priority review of FDA.

On the call today Olivia will review our third quarter financial results and expectations around future development costs. Next Aleksandra will comment on the abstracts that were published yesterday morning to the upcoming American Society of Hematology annual meeting that will be held in December and the current status of the Phase III IMerge trial.

After that I'll sum up the call with you. So I'd like to turn the call over to Olivia our CFO who will review financial results for the third quarter.

Oliva?.

Thank you Chip and good morning everyone. For the third quarter of 2019 we reported a net loss of $15.2 million or $0.08 per share compared to $5.6 million or $0.03 per share for the third quarter in 2018.

Net loss for the first 9 months of 2019 was $39.5 million or $0.21 per share compared to $19.7 million or $0.11 per share for the first 9 months of 2018. Revenues for the 3 and 9 months ended September 30 2019 were $131000 and $289000 respectively compared to $165000 and $691000 for the same period in 2018.

Revenues for the 3 and 9 months ended September 30, 2019 and 2018 including royalty and license fee revenues under various non-imetelstat license agreements.

The decline in revenue reflects a reduction in the number of active research license agreements in 2019 related to the company's telomerase reverse transcriptase or hTERT technology as a result of patent expiration on the underlying technology.

Total operating expenses for the 3 and 9 months ended September 30, 2019 were $16.1 million and $42.8 million respectively compared to $7 million and $22.2 million for the comparable 2018 period.

Research and development expenses for the 3 and 9 months ended September 30, 2019 were $11.1 million and $27.1 million respectively compared to $2.7 million and $8.4 million for the same period in 2018.

The increase in research and development expenses compared to the same period in 2018 primarily reflects costs for the transition of the imetelstat program including resuming sponsorship of the ongoing imetelstat clinical trials; expenses for start-up activities for the Phase III IMerge trial and higher personnel-related costs with expanding developments.

General and administrative expenses for the 3 and 9 months ended September 30, 2019 were $5 million and $15.6 million respectively compared to $4.3 million and $13.8 million for the same period in 2018.

The increase in general and administrative expenses compared to the same periods in 2018 primarily reflects higher corporate and patent legal costs and increased personnel-related expenses for additional headcount to support the development organization.

Interest and other income for the 3 and 9 months ended September 30, 2019 were $1 million and $3.3 million respectively compared to $1.1 million and $2.2 million for the comparable 2018 period.

The overall increase in interest and other income in 2019 compared to the same period in 2018 primarily reflects higher yields on our increased marketable securities portfolio. We ended the third quarter of 2019 with $159.3 million in cash and marketable securities.

Since May 2019 we have raised cumulative net cash proceeds of approximately $19.3 million from the sales of an aggregate of 13,214,867 shares of common stock under an at market issuance sales agreement, after deducting sales commissions and other offering expenses payable by us.

We expect these net cash proceeds to provide additional financial flexibility as we advance the imetelstat development program. The funds will support future development costs including the IMerge Phase III trial. As Chip mentioned we completed the transition of the imetelstat program from Janssen at the end of the third quarter of 2019.

Last quarter in June we signed a clinical supply agreement with Janssen to purchase certain inventories of drug product drug substance and raw materials for imetelstat manufacturing.

Under the supply agreement we will pay Janssen approximately $7.5 million for drug product upon shipment of the product to our specified drug storage and distribution centers. We have also agreed to pay up to approximately $6.7 million for drug substance and raw materials upon testing and confirmation such materials meet certain specifications.

We are not obligated to purchase materials that do not have testing and conform to our quality specifications. We expect delivery of materials under the supply agreement and any testing to be completed by the end of December 2019 upon which we will recognize the associated expenses in accordance with the accrual method of counting.

We expect cash payments to Janssen for the materials to occur in the first quarter of 2020.

As such we are reaffirming our 2019 guidance and continue to expect total operating expenses to range from $80 million to $85 million of which approximately $20 million to $25 million represents onetime costs that includes imetelstat program transition activity from Janssen to Geron.

And purchases of materials to supply the IMErge Phase III trial and prepare for new drug manufacturing. As you know we began the year with approximately $183 million in cash and marketable securities. We estimate our year-end cash and marketable securities to be approximately $145 million to $150 million.

This projection includes our 2019 operating expense guidance adding back certain liabilities that will be paid in 2020 such as the purchase of Janssen materials, interest income to be earned in 2019, and the $19.3 million in net cash proceeds raised under the ATM program.

As of October 31 Geron has 42 employees and plans to grow to a total of approximately 45 to 50 employees by year-end 2019 of whom half will be research and development personnel. With that I will turn the discussion to Aleksandra. .

Imetelstat alone; ruxolitinib alone; a combination of ruxolitinib and imetelstat given simultaneously; and a combination of ruxolitinib and imetelstat given sequentially.

In the second set of experiments mice were transplanted with either MF [screen] [ph] cells or normal cord blood cells and then treated with 1 of the 4 regimens as used in the first set of experiments.

In both set of experiments the sequential treatment of ruxolitinib followed by imetelstat resulted in significant reductions in the numbers and the functions of the malignant hematopoietic stem and progenitor cells originating from the MF [screen] [ph] compared to either treatment alone or the simultaneous treatment regimen.

Furthermore in both set of experience the sequential treatment regimen did not affect the hematopoietic stem and progenitor cells originating from the normal cord blood cells. The results from these experiments provide a potential [additional application] [ph] of imetelstat in treating MF.

Because the complexities involved with combining 2 therapies with overlap in toxicities has not been explored. Further research would be needed to determine the appropriate dose and schedule of the combination treatment before we could decide to pursue this as a potential treatment regimen for MF.

In the meantime since imetelstat has shown single-agent activity in various hematologic malignancies we intend to prioritize our efforts on advancing imetelstat as an individual treatment regimen. The second abstract accepted for ASH was in a new category called trials in progress.

Abstracts for this category described innovative clinical trials that have not reached their primary endpoint to provide opportunities for early engagement and collaboration amongst translational clinical and industry investigators [indiscernible] and regulators.

In addition abstracts in this category enhances the visibility of ongoing clinical trials to [indiscernible] patient recruitment. We are pleased that the Phase III IMerge trial has been included in these new categories and details of the trial design will be presented in a poster.

Many aspects of the Phase III trial design including the primary and secondary endpoint, the target patient population and the dose and schedule of imetelstat administration remain consistent with the Phase II portion of the trial.

In addition to the presentation of the 2 abstracts we also look forward to the upcoming ASH Annual Meeting and [indiscernible] 3 additional educational symposia and we'll have the opportunity to connect to the investigators and KOLs who will be actively involved in patient recruitment and enrollment.

With regard to the phase of IMerge trial startup activities we have recently hosted 2 meetings, one in U.S. and one in Europe for investigators and participating site personnel. The reception of these meetings have been very positive. The first patient was dosed in October and approximately 30% of the sites are open for enrollment.

At this stage of the trial it is too early to determine what the enrollment dynamics will be since less than 50% of the sites are open and many of the sites that are expected to be high enrollers particularly in Europe has yet to be opened. We expect to have a better sense of enrollment dynamics by the end of the first quarter of 2020.

Going forward we plan to provide qualitative updates on enrollment during our quarterly conference calls. We also expect to announce when half of the patients have been enrolled in the trial and when the trial is fully enrolled. Based upon our current planning assumptions we continue to expect top line results by midyear 2022.

And now I'll turn the discussion back to Chip. .

Thanks Aleksandra. Moving on to MF. As discussed previously we're currently in the process of preparing to conduct an end of Phase II meeting with the FDA by the end of the first quarter of 2020 and will subsequently announce our decision regarding any potential future late-stage development plans for relapsed/refractory MF.

This decision will be influenced by among other things the nature of our discussions with the FDA by our assessment of what would be required to achieve clinical and regulatory success in this indication including the cost and duration of any potential clinical trials required for regulatory approvals in the United States and European Union.

So in summary we're a much different company today than we were a year ago. We continue to make great progress in 2019 from building a solid foundation of in-house expertise in hematology/oncology and in late-stage development to dosing the first patient in the Phase III IMerge clinical trial.

We're focused on opening sites to enable patient recruitment and enrollment for the Phase III and on preparing for the end of Phase II meeting with the FDA in relapse/refractory MF.

All of the development activities completed to date and plan for the future support the development of imetelstat as a potential treatment to address unmet medical needs in hematologic myeloid malignancies. We look forward to the remainder of this pivotal year as we continue to execute on our 2019 development plans.

We believe our accomplishments will translate into shareholder value over the long term. So with that we're now happy to answer your questions and we'll turn the call back to the operator. .

[Operator Instructions] And our first question comes from the line of Charles Duncan from Cantor Fitzgerald. .

This is Pete Stavropoulos on for Charles. One question regarding -- so we have a potential approval of luspatercept and I was wondering whether you think you may have a difficulty enrolling RS-positive patients into the study given that the physicians [indiscernible] towards an approved drug.

If so how do you think that may affect the overall study timeline? And would you consider enrolling patients that relapse or refractory to luspatercept into the IMerge study. .

[indiscernible] take that question. So I mean as we just mentioned, right, we are open for screening and enrolment and we expect to be pretty far along in the enrolment process by the time of the PDUFA date for luspatercept and that [indiscernible] approval in Europe during the second half of 2020.

So we would expect to be close to completing enrollment by that time. And based upon what we know today we believe that it is unlikely that a potential approval of luspatercept to impact our enrolment timeline. .

Okay. And for the abstracts for ASH you're going to present nonclinical data for the regimen of sequential treatment of a JAK inhibitor with [indiscernible]. So is there a possibility of adding an MF – an arm into the MF study for this treatment regimen.

And you think it's going to be one of the list of topics with the FDA at the end of Phase II meeting. .

As I mentioned right more work would need to be done to pursue a clinical study with the combination and so that would include careful exploration of the overlapping toxicities between the 2 drugs.

At the moment our resources and [indiscernible] are focused on advancing imetelstat as single-agent treatment such as the IMerge Phase III clinical trial and also we work hard on determining the potential regulatory path. For relapsed-refractory MF we believe at the moment it should stay our focus. .

Okay.

And can you speculate as to why sequential dosing rather than simultaneous dosing may have a greater reduction in MF [hematopoietic] [ph] and progenitor cells ?.

Right. Yes. So we – yes, I can give you some flavor of that. And as you might know ruxolitinib been reported to be a DNA damaging agent and not an anti-apoptotic agent.

So with the experiments with the sequential treatment what happens is that you first induce DNA damage into these MF malignant cells and after that you induce an anti-apoptotic agent like imetelstat therefore the combination has an additive or synergistic effect if you will on the malignant cells. That’s the hypothesis..

Thank you very much and congrats on the progress for the quarter..

Our next question comes from the line of Tom Shrader from BTIG. .

This is [indiscernible] for Tom. I just have one on IMerge.

Could there be any incremental data from the Phase II trial between now and when we first expect data from the Phase III study?.

In other words any kind of interim analysis or any kind of other data is that the question? Or did I miss that?.

I think she asking whether we'll have any follow-up data from the Phase II portion of IMerge in the future. . .

At the moment we do not plan to have that at least not at the next ASH or EHA conference. We will look at the data as it evolves and we'll let you know if that change. .

And our next question comes from the line of Gil Blum from Needham & Company. .

Just a quick one about modeling. I just want to make sure I understood. So we expect a pretty significant tick up on Q4 R&D expenses.

Is that a good way to look at this?.

Yes Gill. As you probably have seen through the year there has been a steady increase in the pickup in both R&D and G&A expense. Especially R&D obviously for the start-up activities for the Phase III as well as the hiring of individuals into the development team. .

All right. But my question is more of -- am I expecting a very significant increase mostly in the fourth quarter to be almost like a one-off investment. .

Yes, and that's as a result as I mentioned about the purchases of the supply materials that are coming from Janssen.

But if you add the two together that's almost $14 million, and because we expect the delivery and the testing activities to be completed by the end of the year I need to accrue them for accounting purposes and those expenses may hit in 2019 even though the cash will hit - the cash outlay will not hit till the following quarter. .

Got you. That helps. And just one more about ASH. It seems like we're going to get a pretty exciting ASH for myelofibrosis, we're getting some data from Constellation I understand and there's more data coming out of [indiscernible].

But do you guys think maybe relapsed/refractory myelofibrosis is getting kind of highlighted in this upcoming ASH?.

I think it's always a good news for patients to have new data for potential new drugs available for them. I mean the -- you're right. There are a few abstracts that are both in frontline and relapsed/refractory MF. The [indiscernible] clearly continues to show clinical benefit however you analyze the data.

Again imetelstat has a different mechanism of action than [indiscernible]. So that's where we stay focused and differentiate. In terms of the Constellation data that is being reported as you mentioned again both [indiscernible] Frontline and relapsed/refractory MF just as an observation right that the data is intriguing and it's early.

And it remains to be seen how the data will mature. So yes I mean it's good ASH for myelofibrosis as you say. .

Excellent. Thanks for taking my questions and congratulations on the progress in this quarter..

Thanks very much. .

[Operator Instructions] And this ends the Q&A session. I will turn the call over to Dr. John Scarlett for closing remarks. .

Thanks everybody for joining us today. look forward to reporting continued progress as we go forward here. Have a good day. Bye. .

Ladies and gentlemen this concludes today's conference call. Thank you for participating. You may now disconnect..