Geron Corporation (GERN) Q4 2018 Earnings Report, Transcript and Summary

Good day, ladies and gentlemen and welcome to Geron’s Fourth Quarter and Year End 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. [Operator Instructions]. As a reminder, this call maybe recorded. I would now like to introduce your host for today’s conference, Ms. Suzanne Messere, Head of Investor Relations. You may begin.

Thank you, Catherine, and good afternoon, everyone. Thank you for joining us for today’s conference call. I am joined today by Dr. John Scarlett, Geron’s Chairman and Chief Executive Officer; and Olivia Bloom, the Company’s Chief Financial Officer. After the market closed, we announced our fourth quarter and year end 2018 results via press release. It is available on our website under www.geron.com/investors. On the call today, management will discuss recent events, fourth quarter highlights, financial results, guidance and upcoming milestone before answering your questions. A live webcast of the call is also available on our website and will be archived for 30 days. Before we begin, please note that except for statements of historical fact, the statements during this conference call and question and answer are forward-looking statements made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These include, without limitation, statements regarding, the expectations, plans, timelines and prospects for the Imetelstat and Geron including without limitation that patients screening and enrollment for the Phase 3 portion of IMerge will begin by mid-year 2019, that IND and Imetelstat clinical development program will transfer to Geron by the end of the second and third quarters of 2019 respectively, that more mature data from the Phase 2 portion of IMerge will be available and submitted for presentation at a medical conference in 2019. That Geron will outline its decision regarding the potential for late-stage development of Imetelstat and relapsed/refractory myelofibrosis patients by the end of the third quarter of 2019, that the Company’s operating expenses will be between $65 million to $70 million in 2019 and other beliefs and plans, expectations and projections that are not historical facts constitute forward-looking statement. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties include without limitation risks and uncertainties related to timing of the transfer of the IND and Imetelstat clinical development program to Geron and the ability of Geron to commence the Phase 3 portion of IMerge by mid-year 2019 and to come to a decision regarding potential late-stage development in MF by the end of the third quarter of 2019. Additional information and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the SEC, under the heading Risk Factors, including Geron’s annual report on Form 10-K for the year ending December 31, 2018. 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. I will now turn the call over to Dr. John Scarlett, Geron’s Chairman and CEO. Chip?

Thanks, Suzanne. I would like to welcome everyone for our fourth quarter and year end 2018 conference call. On today’s call, Olivia will discuss fourth quarter and year end financials as well as 2019 projected guidance. I’ll then discuss our plan for 2019, which build on data announced at the ASH Annual Meeting last December. After that, we’ll open the call for questions. So, in 2018 after regaining the rights to Imetelstat, we put plans in place to advance Imetelstat development program towards potential approval and commercialization. Based on this plan, we expect 2019 to be a pivotal year for Geron. At a high level during 2019, we expect to complete the transfer of the imetelstat IND from Janssen to Geron, to begin the phase 3 trial in lower risk MDS and to evaluate potential late-stage development in myelofibrosis as well as evaluate other myeloid hematology-oncology indications for Imetelstat. To enable these activities this year we are recruiting a development team with robust hematology-oncology expertise. This began in mid-January with Israel Gutierrez who joined as Vice President of Pharmacovigilance and Safety. Israel has 20 years of experience in drug safety and medical affairs at Pharmacyclics, Exelixis, Genentech, Celgene and Permeon where he was a member of the hematology-oncology development teams. Israel’s responsibilities at Geron are to lead our clinical drug safety risk management and compliance efforts include product safety-related recommendations and decisions. At the end of January we announced that Aleksandra Rizo join the Company as Chief Medical Officer and as a member of the company's Executive Management Committee. Dr. Rizo will be responsible for directing Imetelstat’s clinical strategy including designing a product development plan for current and potential future indications. Functions under her oversight include clinical science, clinical operations, data management, biostatistics, clinical pharmacology, translational research and medical affairs. Aleksandra has more than 10 years of experience in hematology-oncology clinical development, leading teams through the entire drug development process from Phase 1 through Phase 3 clinical trials and regulatory submissions. At Janssen she was compound development team lead for all Phase 1 myeloid hematology assets and global clinical leader for all late-stage myeloid assets including acting of the clinical lead for the imetelstat development program for over three years. In these roles Aleksandra had oversight and leadership responsibilities for overall clinical development strategy, study designs, execution and data interpretation for all related programs, again including the Imetelstat program. In addition, she was a core member of Janssen’s hematology strategy team and in this role participated in and led diligent projects evaluating perspective Hema product candidates. In the year prior to joining us, Aleksandra was the Executive Director of Strategy and a Clinical lead for the myeloid hematology programs at Celgene Corporation. While there, she led both submission activities within the myeloid hematology portfolio and participated in strategic and business development initiatives. Since coming to Geron, Dr. Rizzo is clearly assimilating extremely well and is very busy. She is acting with her ex-Janssen colleagues as well as members of our team to ensure that all aspects of the IND transfer are on track and that we are fully up to speed on all elements of the clinical data. In addition, she's been very involved with the planning for the start of the Phase 3 MDS clinical trial, as well as meeting with KOLs as part of the transition from Janseen to Geron. And of course she is extremely busy with recruiting activities. We anticipate that Aleksandra will likely join us on future conference calls. Overall, we’re very happy to have both of these exceptional individuals joining our company forward and look forward to discussing other important new hires within our development team in the future. So, I’d like to turn the call over to Olivia, our CFO, who will review our fourth quarter and year-end 2018 financial results, as well as projected 2019 guidance. Olivia?

Thank you, Chip, and good afternoon, everyone. For the fourth quarter of 2018, we reported a net loss of $7.3 million or $0.04 per share, compared to $7.4 million or $0.05 per share for the comparable 2017 period. For 2018, we reported a net loss of $27 million or $0.15 per share compared to $27.9 million or $0.18 per share for 2017. Revenues for the fourth quarter of 2018 were $375,000 million compared to $191,000 for the comparable 2017 period. Revenues for 2018 and 2017 were each $1.1 million and included royalty and licensee fee revenues under various non-Imetelstat license agreements. We adopted a new revenue recognition accounting standard as of January 1, 2018 using the modified retrospective transition method. Revenue for 2018 is presented under the new accounting standard, but revenue for 2017 has not been adjusted and continues to be reported under accounting standards used historically. Therefore, there is a lack of comparability between the periods presented. However, we do not expect the adoption of the new revenue recognition accounting standard to have a material impact to our financial statements on an ongoing basis. Total operating expenses for the fourth quarter of 2018 were $10 million compared to $8 million for the comparable 2017 period. Total operating expenses for 2018 were $32.1 million compared to $30.2 million for 2017. Research and development expenses for the fourth quarter of 2018 were $5.1 million compared to $2.5 million for the comparable 2017 period. Research and development expenses for 2018 were $13.4 million compared to $11.0 million for 2017. The increase in research and development expenses for the fourth quarter and year-to-date 2018 periods compared to comparable 2017 periods. primarily reflects increases in Geron’s share of Imetelstat development costs under the former collaboration agreement with Janssen where our share increased from 50% to 100% as of the termination date of the collaboration agreement, and additional costs for our CRO and other consultants to support the transition of the Imetelstat program from Janssen to Geron. General and administrative expenses for the fourth quarter of 2018 were $4.9 million compared to $5.5 million for the comparable 2017 period. General and administrative expenses for 2018 were $18.7 million compared to $19.3 million for 2017. The decrease in general and administrative expenses in 2018 compared to 2017 primarily reflects the net result of reduced personnel related expenses, including lower stock-based compensation expense, partially offset by higher consulting expenses and higher patent legal expenses due to the termination of the Imetelstat collaboration with Janssen, as imetelstat patent costs previously were being shared by the two companies on a 50/50 basis. Interest and other income for the fourth quarter of 2018 was $1.1 million, compared to $375,000 for the comparable 2017 period. Interest and other income for 2018 was $3.3 million compared to $1.4 million for 2017. The increase in interest and other income for 2018 compared to 2017 primarily reflects higher yields on our marketable securities portfolio. We ended the year with $182.1 million in cash, cash equivalents, restricted cash and current and non-current marketable securities, which is sufficient to commence the planned Phase 3 clinical trial in lower-risk MDS. Moving on to projected 2019 guidance. We expect operating expenses to increase as we assume full responsibility for the development and potential commercialization of Imetelstat. For fiscal year 2019, we expects its operating expense burn to range from $65 to $70 million, of which approximately $10 to $15 million represents one-time costs, such as Imetelstat program transition activities from Janssen to Geron, including the transfer of the IND sponsorship, and purchase of raw materials and other supplies in preparation for new drug manufacturing. In addition to the one-time costs, the 2019 guidance includes higher personnel costs for the expansion of the internal development team, and new cost associated with opening a New Jersey office and starting and supporting the global Phase 3 clinical trial in low-risk MDS. The 2019 projection assumes the total number of employees for the company to grow to approximately 30 to 40 by year-end 2019 of which half of this total will be R&D personnel representing various functions including clinical operations, data management, clinical sciences, clinical development, biostatistics, medical affairs, pharmacovigilance and drug safety, quality, regulatory, and manufacturing. The 2019 guidance includes modest cost to evaluate potential other indications for Imetelstat in the latter part of the year. But the guidance does not include any late-stage clinical cost for MF as assessment of the potential for future MF development has not been completed. Financial guidance is based on a set of assumptions at a point in time and if those assumptions change significantly as a result of company activity and events then we expect to update the guidance at that time. And with that, I will turn the discussion back to Chip. Chip?

Thanks, Olivia. That’s great segue to our 2019 objective. Our first objective in 2019 is the transition of the Imetelstat program back to Geron. We’re on track for the IND transfer to take place by the end of the second quarter and for the transfer of the majority of the program by the end of the third quarter of 2019. We expect transfer of the manufacturing activities to be completed by the end of the third quarter of 2020. We’re diligently managing the transfer of the IND in order to enable the start of enrolment of the Phase 3 trial and lower-risk MDS by mid year. In order for us to complete the transfer we need to obtain clinical, regulatory, biometric and safety information from Janssen to create our own data basis in monitoring systems. In addition, Janssen needs to transfer all regulatory filings as well as preclinical CMC and vendor information. We’re also preparing clinical supplies and readying our internal processes and systems to ensure compliance study conduct for both of the ongoing Imetelstat Phase 2 clinical trials. Once the IND transfer has been completed, our next 2019 objective is to commence screening and enrolment for the Phase 3 clinical trial for Imetelstat and lower-risk MDS by mid-year. Data from the Phase 2 portion IMerge that were reported at ASH in December support our decision to move forward to the Phase 3. The ASH presentation December reported results from 38 patients enrolled in the Phase 2 portion of IMerge. All 38 eight patients were transfusion dependent with low or Intermediate-1 risk, non-del(5q) MDS who had relapsed or refractory to prior treatment within erythropoiesis stimulating agent and who were naïve to treatment with a hypomethylating agents or lenalidomide. The baseline – sorry, the median baseline transfusion burden was eight units of packed red cells given within an eight period of time represent -- representing a high transfusion burdened patient population. Across the population of 38 patients the transfusion burden at baseline ranged from 4 to 14 units per eight weeks. The primary efficacy endpoint of the trial was the proportion of patients who achieved transfusion independence for at least eight consecutive weeks, also known as an eight-week TI rate. Key secondary endpoints include durability of respond as assessed by 24-week TI rate, as well as the breadth of response through reduction and transfusion burden and responses across MDS sub-types. I’d like to highlight some of the main outcomes reported at ASH in December which encourage us to continue further development of Imetelstat and lower-risk MDS. First, the eight-week TI rate was 37%. We believe this is a strong response. Patients in a similarly designed study of the lenalidomide and non-del(5q) lower-risk MDS patients achieved an eight-week TI rate of only 27%. Second, the 24-week TI rate was 26%. To put this perspective, this means that about 70% of the patients who achieved an eight-week TI went on to achieve a 24-week TI. This is an excellent results indicating significant durability of the transfusion independence and Imetelstat treated patients. Third, the Hematologic improvement-erythroid rate known as HI-E was 71%, which means that 71% of the patients had a reduction of at least four units of packed red cells over eight weeks compared to baseline. Again, this is an excellent result. Drug other than Imetelstat in a protocol similar to IMerge have struggled show an HI-E rate of greater than 50%. Lastly, patient had a mean relative reduction of transfusion burden from a baseline line of 68%. Meaning, that across all patients regardless of whether they achieved an eight-week TI. Imetelstat treatment resulted in a mean reduction of 68% in the number of units transfused. In our market research physicians who treat MDS patients value such meaningful reductions in transfusion burden because of the reduction in cost and improvements in quality of life associated with reducing transfusions to this degree. To put these results in further context, I’d like to say few words about the data presented at ASH in December from the Medalist trial of Luspatercept, which was a Phase 3 clinical trial and compare those data that I just described for Imetelstat treated patients in the Phase 2 portion of IMerge. The lowest MDS patients studied in Medalist had many similarities to these patients studied in IMerge. They failed ESAs and had become transfusion dependent. They were non-del(5q) and they were naive to both lenalidomide and HMAs. However, there was an important distinction. The baseline meeting number of pretreatment transfusions for the medalist patients with five packed cells over eight weeks compared to eight units over eight weeks for the IMerge patients. Notably, 29% of the medalist patients had a baseline transfusion burden of less then four units per eight weeks, those patients would not have been eligible for our IMerge trial where we require transfusion burden of greater than or equal to four units of eight weeks. When we look at the efficacy results for the two drugs in the two studies, the overall eight-week TI rates were quite similar, 37% for Imetelstat treated patients and 38% from Luspatercept. However, upon further analysis of the data from the ASH presentation and the Luspatercept patients with the transfusion burden of greater than or equal to four units per eight-week, that is the population with the baseline transfusion burden consistent with that of the Imetelstat patients in IMerge, the eight-week TI rate declined to 38% to approximately 20%. Based on these data from medalist, we expect that Luspatercept, which has a relatively benign adverse affect profile is likely to be used predominantly in patients with low transfusion burdens. In contrast the Phase 3 portion of IMerge will continue to enroll only patients who have a transfusion burden of at least four units of packed cells for eight weeks. In conclusion, the efficacy results from the Phase 2 portion of IMerge presented at ASH showed clinical benefit including in patients with high transfusion burden and suggest that Imetelstat has a potentially important role to play in transfusion dependent lower-risk MDS. As of the October 26, 2018 data cutoff for the IMerge ASH presentation, the median duration of transfusion independence had not been reached. Since there are still a few handfuls of patients continuing on treatment in the Phase 2 portion of IMerge, we expect more mature data to be available in 2019 and anticipate submitting such data for presentation at a future medical conference. Another objective in 2019 is to outline a decision regarding the potential for late-stage development of Imetelstat in MF by the end of the third quarter. While the data from the Phase 2 IMerge clinical trial including new overall survival data presented at ASH in December suggest a meaningful survival outcomes in relapsed refractory MF patients, the potential clinical path forward is yet to determined. The ASH presentation reported that median OS for the 9.4 mg per kilogram dosing are almost 29.9 months in a poor prognosis relapsed refractory patient population where they’re currently no approved treatments today. Other observational studies have similar patient population at academic medical centers published recently in medical literature have reported median OS ranges of approximate 12 to 14 months after failure of or discontinuation from Litinib. Our decision whether to continue late-stage development in MF will be influenced by our assessment of what would likely be require to achieve clinical success in regulatory approval including the cost and duration of any potential clinical trials. To inform this assessment we will conduct discussions with key opinion leaders over the coming month and we expect discussions with regulatory authorities to begin after the IND is transferred back to Geron. Our key organizational objective in 2019 is to build our development team by recruiting senior personnel with late stage hematology-oncology expertise. There are three core reasons for doing this. The first is to provide for outstanding execution of the Phase 3 clinical trial and lower-risk MDS. This includes full engagement with key opinion leaders and clinical investigators who will form an influential group of supporters as we meet our commercialization. The second is, having the organizational expertise and capacity to allow us to maximize Imetelstat value by evaluating potential additional indications including MF and perhaps other key malignancies in the future. The third is that having in-house scientific and clinical capabilities enables us to evaluate, attract and develop additional hematology-oncology assets that can be added to our franchise in the future. Our plans to open an office in Northern New Jersey should be very helpful in recruiting senior personnel with late-stage hematology-oncology clinical drug development expertise as well as enhancing efficient support for global clinical trials including the many European sites we will have for the Phase 3 IMerge trial. In summary, we look forward to 2019 being a pivotal year for the future of both Imetelstat and Geron. We believe we’re firmly on the path to create value for patients and investors alike. So with that, we’d like to answer the questions. And I’ll turn the call back over to our operator.

Thank you. [Operator Instructions] Our first question comes from Chad Messer with Needham & Company. Your line is open.

Thanks. Good evening, and appreciate you taking my questions. Just a couple from me. First, on this more mature MDS data, you mentioned median transfusion independence wasn't reached and you kind a called out maybe we could get that. Wondering if you could discuss what -- what you think a good readout on that would be, and also anything else to look for in that more mature dataset? Any kind of subsets or any other analyses that we might keep our eye open for?

Sure. Thanks Chad. Well, I think first of all, the form of the analysis will be very similar to that which we did -- which was presented at ASH. That's pretty much a quite a comprehensive evaluation of any drug being developed in lower-risk MDS, I don’t think we’re going to really change from that. It will also offer the opportunity to do a comparison as in particular patients who were involved in the second cohort, who were enrolled in the second cohort continue to mature into the window of time that we expect to see potential efficacy outcomes. So, I think the main thing to be looking for are really of the efficacy outcomes which include not only median transfusion independence et cetera, but also eight-week TI, 24-week TI, HIE and other classical measurements. Of course, there will be an update on safety as well.

Okay. Thanks to that. And then, you talked about potentially exploring other indications, wondering if it were possible for you to expand on that a bit more. I know in the past Chip, we’ve discussed AML as a possibility on that list. Just allow me to hear thoughts on that or for any other particular myeloid malignancies for Imetelstat?

Sure. Well, as you know, we’ve actually seen activity in all of the myeloid hema-malignancies that have been studied. Although to more or less degree according to the size of the study et cetera, so we obviously presented ET and those results were in the back-to-back paper from Dr. Tefferi on MF in the drill in 2015. We’ve just talked about MDS and further follow on MF. So the other big indication that remains is, as we say, Chad, its AML. AML is a complex disease. It’s frankly difficult to treat. And so we will be doing some work for sure in assessing where a drug like Imetelstat with its mechanism of action might best be positioned within the treatment paradigm for AML. I don’t think we’re ready to discuss that yet or discuss the type of studies if any that might occur. But I think there is sufficient number of preclinical studies and other indications, as well as this sort of broad-brush activity in kissing-cousin myeloid hema-malignancies to sort of justify a deeper dive on that. I don’t really have a whole lot more to say about that. But I’d like to emphasize for everyone listening on the call that even though this is – that’s exciting and its interesting and potentially the value, really the first job of this team and our company is to get our Phase 3 lower-risk MDS clinical trial and up and running and then evaluating the potential MS strategy. Once we’ve achieved that we can turn our attention to these potential other Imetelstat indications and potentially other product candidates actually.

Great. Thanks for that, and absolutely understand what your job one is. We just had plenty of times since the ASH to discuss some of those other things. So I appreciate you getting down on the weave with me a little bit. Thanks.

Okay.

Thank you. And our next question comes from Julian Harrison with BTIG. Your line is open.

Hi. Julian on for Tom. Thanks for taking my questions. First off, just curious how we should be thinking about Imetelstat for myelofibrosis in the context of the Fedratinib NDA acceptance earlier this week?

Sure. Well, first of all, we kind of know about Fedratinib about what you do from reading publications et cetera and understanding some of its past history as well as some of the more recent data. I think the way I would put it is that it's a very – it’s a JAK inhibitor, very different mechanism of action. Most of the emphasis has been as you would expect on spleen volume reduction, total symptom score, presumably being driven by changes in cytokines associated with inhibition of the JAK-STAT pathway. So I think it’s probably best compared to Ruxolitinib. The only other thing I can say that I gleaned in reading those papers and I don't have any other inside information of any nature as to what in the submission et cetera, is to say that the -- I think that Imetelstat potential survival advantage still looks extremely attractive. And I think that there will likely be very different potential uses of these various products based on the different mechanisms of action. But beyond that until we see deeper into how the agency deals with it and perhaps any additional information coming out, I don’t think I had to lot more to say about that.

Okay. Got it. Thanks. That’s helpful. And for my last question, regarding the Phase 3 portion of IMerge, should we expect an interim readout? And if so when might that occur assuming enrolment starts by midyear?

Yes. Thank. No. I don't think you should expect an interim readout. We have a lot of confidence based on a couple of different elements of this – of the design of this study. And I’d kind of comment about that. The data from the Phase 2 which we just described is really awfully strong from our perspective. The phase 3 trial we use the same patient population, same efficacy endpoint and same dosing regimens of Phase 2. And it has a Phase 3 design, it’s based on interactions of Phase 3 regulators. So I don’t think we feel the need right now to do an interim analysis to check for how things are tracking or any of the usual reasons that one would do in interim analysis. So that’s not in our plan as it stands today.

Okay, great. Thanks very much.

Sure.

Thank you. And our next question comes from George Zavoico with B. Riley FBR. Your line is open.

Hi, everyone. Thanks for the update and everything. I have a question about Luspatercept, because it's possible that by the time your trial starts or soon maybe halfway through or partway through, Luspatercept might be approved and marketed. How do you see that perhaps interfering, if you will, in any way, with the conduct and execution of your Phase 3 trial?

George, as far I know, the Luspatercept -- I don’t think we expect Luspatercept approvals before we would start our Phase 3. I’m not even sure to be honest with you when or if the NDA’s been filed. I don’t think it’s been filed yet, but…

April 2019.

April 2019 is when it's been announced, I guess, that Celgene plans to file it. So I don't think that will interfere with our study, though presumably while reviewing both of the enrolments Luspatercept, even if it gets a very quick review et cetera, should not -- I would not expect it to be available during the bulk of that enrolment. I think secondarily the more important thing is that, at least so far from what we can see, the two drugs really are -- I don't know where they're aimed. I'm not going to speak for Celgene in that regard. But they seem to have a different profile. Obviously, they’ve a very different mechanisms of action, and I think our perspective is that the patient who we've certainly gotten plenty of in our phase 2 and expect plenty of in our phase 3, which will be higher transfusion burdened patients -- remember we had on average eight units per eight weeks of transfusion, pre-treatment transfusion burden, compared to a lower number, five, for Luspatercept Medalist trial. Clearly we're probably going to end up with a somewhat different patient population. So -- and by the way, on the other side, Luspatercept clinical, the safety profile was benign, and so I wouldn't be surprised to see clinicians being more interested in Luspatercept earlier, and maybe the patients who are more difficult to treat, we may end up getting those. Whatever the case may be, I see the two drugs -- we've always seen the two drugs sharing the market, and I don't see anything different to suggest that that won't be true in the future. I think we will have enthusiastic investigator support and patient support of phase 3.

Okay. That's great to hear. That's great to hear. And finally, for the IND, you mentioned about manufacturing. Is JAK inhibitor from Imetelstat and [indiscernible] pass over, too, or do you have to still make the stuff for -- make it for the phase 3 trial?

Yes, no, we have drug ready to go, obviously. The Imetelstat supply chain has been cranking away, and we do -- we are able to access drug made at Janssen. But we will need to bring that supply chain fully back under our control as part of the transition, and that's actually -- and then we have to make drug beyond that to support future uses and perhaps. So I think that the point to the story is that that's got a longer tail on the transition than some of the purely clinical and regulatory items. And that was always contemplated in the agreement that we had with Janssen, so this is really just a reflection of what we anticipated in the event that Janssen did not continue development. And that's pretty much going according to plan.

Okay. Thanks very much, Chip and Olivia.

And thanks, George, for participating. I appreciate it.

Thank you. And I'm showing no further questions at this time. I'd like to turn the call back to Dr. Scarlett for any closing remarks.

Thanks, everybody, for joining us today. And we look forward to sharing the achievement of several objectives throughout the coming year with you. Thanks a lot, and have a good day. Bye.

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's program. You may all disconnect. Everyone have a great day.