Geron Corporation (GERN) Earnings Call Transcript & Summary

Good day, and welcome to the Geron Corporation Annual Meeting of Stockholders. I would now like to turn the conference over to John Scarlett. Please go ahead, sir.

Thanks very much. Welcome to the 2020 Geron Corporation Annual Stockholders Meeting. It's now 8:00 a.m. Pacific Time, and the meeting will please come to order. My name is Dr. John Scarlett, and as President, Chief Executive Officer and Chairman of Geron Corporation, I'll be presiding over this meeting. The meeting is scheduled to last for 1 hour. In light of the COVID-19 pandemic, for the safety of all our stockholders and personnel and taking into account recent federal, state and local guidance, we're holding this year's annual meeting in a virtual meeting format only via the Internet with no physical in-person presence. This virtual meeting format enables any stockholder to vote real time during the meeting and to submit questions while the meeting is in process. A few housekeeping notes. If you experience any technical problems during the meeting, please call (800) 586-1548 for assistance, again, (800) 586-1548 for assistance. To facilitate a dialogue with our stockholders, we have utilized a pre-meeting question forum where stockholders could submit questions ahead of today's meeting. We'll be addressing those questions during the Q&A session. If you'd like to ask a question at any time during the meeting, please type your question in the box and submit -- press the Submit button. We'll get to as many questions as we can during the time allotted for today's meeting. The audio webcast of today's meeting will be available for replay approximately 1 hour following the conclusion of the meeting through July 5, 2020. If you've not already submitted your vote, click on the Vote Now button on the right side of your screen. Later in the meeting, I'll announce when the polls have closed. Before we begin the official business of the meeting, I would like to introduce the members of our Board of Directors who are present on the webcast today. We're very fortunate to have an outstanding Board with diverse knowledge and experience. Karin Eastham, Lead Independent Director; Dawn Bir; Dr. Bryan Lawlis; Dr. Susan Molineaux, Elizabeth O'Farrell, and Dr. Robert Spiegel. Joining me today to answer questions are Olivia Bloom, our Executive Vice President of Finance, Chief Financial Officer and Treasurer; Dr. Aleksandra Rizo, our Executive Vice President, Chief Medical Officer; and Suzanne Messere, Head of Investor Relations. In addition, we have other members of our management team on the webcast today. Melissa Behrs, Executive Vice President, Chief Business Officer; Andrew Grethlein, Executive Vice President, Chief Operating Officer; Anil Kapur, Executive Vice President, Commercial Strategy and Chief Commercial Officer; and Stephen Rosenfield, Executive Vice President, Chief Legal Officer and Corporate Secretary. Also present are representatives from Ernst & Young, our independent registered public accounting firm. Stephen Rosenfield will act as the Secretary of the meeting and has been appointed Inspector of Elections to examine and count the proxies and ballots at this meeting. Mr. Rosenfield has taken and subscribed the customary oath of office to execute his duties with strict impartiality. We will file this oath with the records of the meeting. As Secretary, Mr. Rosenfield has presented me with a complete list of stockholders of record of the common -- company's common stock on April 9, 2020, the record date. Additionally, he's reported to me that notice of this meeting was given to all stockholders of record as of April 9, 2020. Mr. Rosenfield has informed me that more than a majority of the total number of shares outstanding and entitled to vote are present in person or by proxy at this meeting, constituting a valid quorum. A quorum being present, this meeting is declared open, and we will now proceed with our business. This meeting -- this morning, our meeting will proceed as follows: first, I'll conduct the official business of the 2020 annual meeting. During this part of the meeting, please limit any questions you have to those which relate to the formal business at hand. Next, we'll provide an update on the company. And following that, we will open the meeting to questions. So the time is 8:05 a.m. Pacific Time on June 5, 2020, and the polls are now open for voting on all matters to be presented. The polls will be closed to voting after we go through the matters to be voted on. You do not need a vote if you have already sent in a signed proxy or voted online or by telephone, unless you would like to change your vote. Each share of common stock is entitled to 1 vote. On our agenda today are 4 proxy proposals to be voted on. I will first have each one of them formally moved and seconded, and then we will proceed to voting. So the first matter to be voted on is the election of the 3 Class 3 members of the Board of Directors for a 3-year term. Nominations are now in order for candidates for Class 3 directors to serve until the 2023 Annual Meeting of Stockholders or until their successors are duly elected and qualified. The current Board of Directors has recommended the election of, and I move to elect the following nominees as Class 3 directors: Karin Eastham, Dr. Bryan Lawlis and Dr. Susan Molineaux. May I have a second?

I second the motion.

Thank you. A motion to elect the named nominees as Class 3 Directors has been made and seconded. The proxy statement addresses the subject of stockholder nominations for elections of the Board of Directors. The secretary informs me that no such nominations were received within the time frames outlined in the proxy statement. The next item of business is a vote to approve an amendment to the company's 2018 equity incentive plan to increase the number of shares of the company's common stock issuable thereunder by 5,700,000 shares. I move that an amendment to the company's 2018 equity incentive plan to increase the number of shares of the company's common stock issuable thereunder by 5,700,000 shares be approved. May I have a second?

I second the motion.

Thank you. A motion has been made and seconded to approve an amendment to the company's 2018 equity incentive plan to increase the number of shares of the company's common stock issuable thereunder by 5,700,000 shares. The next item of business is a nonbinding advisory vote on the compensation paid to Geron's named executive officers as disclosed in the 2020 proxy statement. I move that the compensation made to Geron's named executive officers as disclosed in the 2020 proxy statement be approved on a nonbinding advisory basis. May I have a second?

I second the motion.

Thank you. A motion has been made and seconded to approve on a nonbinding advisory basis, the compensation paid to Geron's named executive officers as disclosed in the 2020 proxy statement. The next item of business is the ratification of the selection of the company's independent registered public accounting firm. The Audit Committee of the Board of Directors has selected Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2020, and is seeking stockholder ratification of the appointment. I move that the selection of Ernst & Young be ratified. May I have a second?

I second the motion.

Thank you. A motion has been made and seconded to ratify the selection of the Audit Committee of the Board of Directors of Ernst & Young LLP. We will now proceed to vote on the previously discussed motions. All Geron shareholders entitled to vote at this meeting have the ability to do so online. If you have not yet voted or if you would like to change your previously cast vote, please do so now via the website by clicking on the Vote Now button on the right side of your screen. We'll wait a few minutes to allow stockholders present to cast their votes. [Voting]

The time is 8:08 -- sorry, 8:09 a.m. Pacific Time, and the polls are now closed for voting. According to the preliminary report of the Inspector of Election, Ms. Eastham, Dr. Lawlis and Dr. Molineaux have each been elected as a Class 3 Director. The amendment to the company's 2018 equity incentive plan to increase the number of shares of the company's common stock issuable thereunder by 5,700,000 shares has been approved. The compensation for the named executive officers as disclosed in the 2020 proxy statement has been approved on a nonbinding advisory basis and the selection of Ernst & Young LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2020, has been ratified. A full tally of the votes will be filed with the Securities and Exchange Commission on Form 8-K on or about June 9, 2020. That concludes the business portion of the meeting. I move that the formal meeting be adjourned. May I have a second?

I second the motion.

All in favor, say aye. [Voting]

Those oppose, say no. [Voting]

This meeting is adjourned. Okay. Well, with the formal business completed, we can move to the second part of the annual meeting. I'm joined by Olivia Bloom, our CFO; Dr. Aleksandra Rizo, our Chief Medical Officer; and Suzanne Messere, our Head of Investor Relations. First, I'd like to share some highlights of our -- from our first quarter earnings conference call last week. And then we'll address some of the frequently asked questions we've received ahead of this meeting from stockholders. After that, we'll open the line to questions from those of you participating online before we end the meeting at 9:00 a.m. PT. Before we begin though, Suzanne will read the forward-looking statements. Suzanne?

Thanks, Chip. I would like to welcome everyone again, and thank you all for joining us today in our new virtual format. As a quick reminder for stockholders participating online, if you would like to ask a question during this part of the meeting and assuming you have entered a control number upon entering the virtual meeting, please click on the link for questions to submit your questions. We hope to address a majority of questions already sent either through proxyvote.com or to the IR inbox during our prepared remarks, and we plan on taking several questions from the virtual format once we have concluded our prepared remarks. 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 notes regarding the time lines for completion of enrollment of and the results from the ongoing Phase III IMerge and planned refractory MF clinical trial that Geron's existing financial resources will be sufficient to fund operations into the second half of 2022 and potential revenue. These and the 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 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 expected time lines for the IMerge and planned refractory MF clinical trial. That regulatory authorities may not permit the further development of imetelstat on a timely basis or at all. That the COVID-19 pandemic may significantly impact the time line for both the enrollment and the results of the clinical trials and/or drug supply and that competition or other factors, result in lower than projected revenue. 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 quarter ended March 31, 2020, 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. Back to you, Chip.

Thanks, Suzanne. To start, I'd like to summarize the main points from our first quarter earnings conference call last week. The webcast from that call is still available on our website. On the call last week, I shared my conviction that today, Geron is a fundamentally different company. It's a company in which all the pieces necessary to become a leader in the treatment of hematologic myeloid malignancies are now in place. We have a novel drug and a unique target with meaningful clinical activity and indications with significant unmet need. We have 2 Phase III trials, 1 of which is ongoing and 1 of which is in the start-up phase with planned enrollment to begin in the first quarter of 2021. Both of these Phase III trials are based on compelling Phase II data. Finally, we have a highly experienced team to execute all aspects of drug development as well as the financial resources to reach significant value inflection points for stockholders. Data from our Phase II trials differentiate imetelstat compared to other agents. As we continue to treat and follow patients in our Phase II IMerge clinical trial in lower risk MDS, data continue to mature and improve. Our data indicate meaningful and durable transfusion independence or TI, is achievable with imetelstat treatment. Patients experience a high rate of transfusion independence that is similar in both RS positive and RS negative patients. Our lower-risk MDS abstract was accepted for an oral presentation this year at the European Hematology Association Annual Conference, which we call EHA. It describes remarkably longer durability. For the first time, we are reporting 29% of the imetelstat treated patients in the IMerge Phase II were transfusion free for at least 1 year with the longest transfusion free period being 2.7 years in 1 patient. In addition, the new median duration of transfusion independence is 88 weeks, which, to our knowledge, is the longest median duration of transfusion independence reported to date in the non-del(5q) lower-risk MDS setting. Finally, the substantial rises in hemoglobin levels reported for this study suggests potential recovery of normal hematopoiesis in patients treated with imetelstat. Specifically, 75% of the 8-week TI responders showed a hemoglobin rise of greater than 3 grams per deciliter during the transfusion free interval when compared to the pretreatment levels. A hemoglobin rise of this magnitude is not achievable with a blood transfusion or growth factor treatment. We believe that this increase in hemoglobin, together with the durability of transfusion independence observed is indicative of the disease-modifying activity with imetelstat treatment and also aligns with imetelstat's mechanism of action. As expected for the mechanism of action of a telomerase inhibitor, imetelstat has the potential to inhibit the uncontrolled proliferation of malignant stem and progenitor cells and to potentially enable recovery of normal hematopoiesis. The Phase III IMerge trial continues to enroll patients. As of the end of April 2020, approximately 68% of the original planned clinical sites for the IMerge Phase III clinical trial in lower-risk MDS were open for enrollment. As we previously announced, COVID-19 has had a significant impact on site initiations and enrollment in this trial. And during the Q&A session, Aleksandra will provide additional information on how we're responding to this. Our current expectations are that enrollment will be completed by the end of the first quarter of 2021, and that top line results will become available in the second half of 2022. Imetelstat also represents a highly differentiated therapy to address the unmet need in patients with intermediate 2 or high-risk myelofibrosis who are nonresponsive to JAK inhibitor therapy. In our Phase II imetelstat trial, imetelstat treated MF patients who are relapsed or refractory to JAK inhibitors exhibited a median overall survival that compared very favorably to both historical controls as well as to a real-world data or RWD analysis of closely matched patients who discontinued JAK inhibitors and who were treated with best available treatment. 3 abstracts, which will be presented in poster form at the upcoming EHA Virtual Conference reported recent IMbark data analysis that provide further support to the OS results from IMbark. Based on the IMbark data and the regulatory clarity obtained during our recent interactions with FDA, we've designed a randomized Phase III trial in MF patients who are nonresponsive to a JAK inhibitor. We expect this trial to be open for screening and enrollment in the first quarter of 2021. Patients eligible for this trial will be required to be refractory to a JAK inhibitor, which is planned to be defined as patients who have had an inadequate spleen response or symptom response after treatment with a JAK inhibitor for at least 6 months and who have received an optimal dose of a JAK inhibitor for at least 2 months during that treatment period. Given this definition, we believe that refractory MF patients meeting these criteria will not benefit from further JAK inhibitor treatment, which is why the control arm of best available therapy or BAT, will exclude JAK inhibitors. In the imetelstat treatment arm, 9.4 milligrams per kilogram of imetelstat will be administered intravenously every 3 weeks. The primary endpoint for the trial is planned to be overall survival. We believe that this is the first trial in refractory MF to use OS as a primary endpoint. An interim analysis of OS is planned to be conducted after approximately 70% of the total projected number of deaths for the final analysis have occurred. In the interim analysis, if the prespecified statistical criteria is met, then we expect such data may support registration of imetelstat in refractory MF. If the prespecified OS criterion is not met at the interim analysis, the trial will continue to the final analysis. Under current assumptions, we expect to complete patient enrollment in the second half of 2022 to conduct an interim analysis in the first half of 2023 and to conduct a final analysis in the first half of 2024. However, both the interim and final analyses are event-driven and could occur on different time lines than currently expected. We believe that if this planned Phase III trial in refractory MF is successful, imetelstat will be the first drug to demonstrate a survival benefit in this poor prognosis patient population. We believe both the lower-risk MDS and refractory MF indications represent very substantial unmet medical need. If we are successful in bringing imetelstat to the market for both indications, we believe they represent a combined annual revenue potential of approximately $1.25 billion in the U.S. and approximately $2.5 billion worldwide. Successful execution of our plans depends on the in-house development team we recruited last year, alongside the strong management team we have internally to support them. This development team covers clinical operations, clinical science, regulatory affairs, biostatistics, pharmacovigilance, manufacturing, quality, translational research, program management and commercial strategy. The continuity of experience with imetelstat from our former Janssen colleagues as well as the talented professionals who joined from other companies have enhanced our ability to reestablish development operations at Geron quickly. Close collaboration and teamwork across all of the development and support functions in the company is a crucial component to achieving our goals. I've yet to meet a Geron employee who does not exhibit dedication, focus and commitment to advancing imetelstat to meet the needs of patients we serve. This is one of, if not, the best team I've ever worked with. And due to our successful public offering recently completed, today, we have the money to achieve our development plans in 2 Phase III indications. We expect the expected estimated net cash proceeds to Geron from the public offering to be approximately $140 million after deducting the underwriting discount and estimated offering expenses payable by the company. Based on current planning assumptions, we estimate that these net proceeds, together with our existing financial resources, will provide sufficient funds for operations into the second half of 2022 when we expect to achieve top line results for the IMerge Phase III clinical trial in lower-risk MDS and completion of patient enrollment for our planned Phase III clinical trial in refractory MF. It's been particularly gratifying to see the response to investors to this transaction, including leading biotechnology special investors such as EcoR1 Capital, Great Point Partners, New Enterprise Associates, or NEA, RA Capital Management and Samsara BioCapital. They joined with other investors in making a very significant investment, which we believe shows a strong affirmation of both imetelstat and Geron. Before we move on to address some of the questions we've received from stockholders in advance of the meeting, I would like to extend a thank you for -- to our long-term Geron and imetelstat supporters, including the contributors at imetelstat.

So our first question relates to refractory MF. And the question is, do you expect improved OS results in the Phase III compared to the Phase II? Aleksandra, I'll direct this question to you.

Thanks, Chip. Well, we expect to confirm the overall survival results from our IMbark Phase II trial in our planned Phase III clinical trial in refractory MF. As a reminder, the median OS of 28.1 months observed in our IMbark trial is almost twice that being reported in historical data of 14 to 16 months.

Our next question relates to our ongoing IMerge Phase III clinical trial. The question is, why do you need an additional 40 sites? Again, I'll direct this question to Aleksandra.

Okay. So as we previously announced, COVID-19 has had a significant impact on site initiations and enrollment in the trial. We are doing everything we can to ensure we meet our enrollment goals in IMerge. We are contacting our clinical investigators to ascertain their ability to recover from COVID and to regain the momentum in enrollment we had before the pandemic. We're working with our CRO on enrollment boosting initiatives such as virtual investigator meetings and further engagements with advocacy groups. Now on top of these activities, we're evaluating the addition of potentially 6 new countries and approximately 40 new clinical sites to enhance the rate of enrollment. We also expect the recent EHA data to further drive interest of investigators, which will help enrollment.

Thanks, Alex. We had a number of questions related to accelerated approval for both MF and MDS. For MF, the question centered around why wasn't real-world data or RWD used for an accelerated approval? And is accelerated approval still an option in MF? In MDS, the question is, could you pursue accelerated approval in MDS based on durability? I want to go and direct these questions to Aleksandra.

I will start with MF first. It has been decided that RWD can validate the importance of the OS observation from the IMbark Phase II clinical trial. The RWD analysis conducted in collaboration with the Moffitt Cancer Center provided strong support for us to move forward with a randomized Phase III clinical trial with OS as a primary endpoint. The use of RWD is an evolving concept for the FDA. RWD so far has been used solely to support supplemental approvals. We are not aware that RWD has ever been used as a primary means to obtain an NDA approval. In any event, our clinical plan in MF do not include an assumption for accelerated approval. We are very excited to have the opportunity to potentially demonstrate OS in a randomized Phase III clinical trial in MF patients who are refractory to a JAK inhibitor. To our knowledge, this would be the first trial in refractory MF to use OS as a primary endpoint and it's a quite differentiator for imetelstat in this poor prognosis patient population when compared to approved treatment or those in development. Moving on to MDS. Our plans do not include an assumption for accelerated approval because we have an ongoing randomized Phase III clinical trial with the registration intent.

Thanks, Aleksandra. I'll direct our next question to Olivia. Olivia, the question was, what was the rationale for such a large financing at this time?

Thank you. The recent financing was timed to take advantage of the regulatory clarity we received on our Phase III MF trial design from the FDA and the recent lower-risk MDS and MF data reported at EHA. The pricing and sizing of this financing reflects the magnitude of capital needed to provide a cash runway to take us to 2 very important inflection points in the second half of 2022. The top line results for IMerge and the completion of enrollment for the planned Phase III trial in refractory MF. Without a financing of this size and at this time, we would not have been able to move forward with the planned Phase III trial in refractory MF without jeopardizing the funding needed for the IMerge Phase III clinical trial.

Thanks, Olivia. We've received a number of questions regarding additional indications for imetelstat. One such question is, are you still planning on pursuing AML as an indication or any other indications? Aleksandra, would you like to take this?

I can do that, Chip. So at this time, we are prioritizing the 2 Phase III clinical trials. The ongoing IMerge Phase III and the planned Phase III trial in refractory MF. Therefore, we are currently not planning to pursue the previously announced proof-of-concept study in high-risk MDS and AML or any other such study.

Thanks. Another question submitted prior to the meeting today relates to the competitive landscape. And the question is, are there any drugs in development that can make a claim of disease modification? Aleksandra?

Constellation Pharma has a BET inhibitor that is being studied in MF. And that they believe has a disease-modifying activity due to observed fibrosis improvement. We have yet to see any data related to overall survival, which we believe is a strong indicator for disease modification. So we are waiting to see how their data matures.

Okay. Thanks, Alex. I'll take the next question related to business development. And that question was, when is the best time to license ex U.S. rights of imetelstat and why? So our response is that the ideal partner for us would bring not only funding for our current program but also the ability to potentially expand imetelstat into multiple indications as well as provide an opportunity to have imetelstat commercialized globally. Building and cultivating relationships with potential partners who can meet these criteria will take time and effort and achieving such a partnership is uncertain and typically a lengthy process. Our next question is what are your upcoming milestones? I'll direct this question to Suzanne.

Thanks, Chip. For the IMerge Phase III clinical trial in lower-risk MDS, we expect to complete enrollment in the first quarter of 2021 and expect top line results in the second half of 2022. For the planned Phase III clinical trial in refractory MF, we expect to open the trial in the first quarter of 2021, complete enrollment in the second half of 2022, conduct an interim analysis in the first half of 2023, which could support registration of imetelstat in refractory MF and conduct a final analysis in the first half of 2024. A summary of these development priorities can be seen in our latest corporate slide deck, which is available in the Investors section of our website. As you know, we had 4 abstracts that were accepted for presentation at EHA, which is scheduled to commence a week from today. The MDS abstract includes remarkable long-term durability and was accepted for an oral presentation. 3 MF abstracts were accepted as poster presentations and substantiate the OS data observed in IMbark and support the planned Phase III clinical trials in refractory MF.

Thanks, Suzanne. We had several questions about executive compensation. The first question is, what is Geron's compensation philosophy? So I would like to take this opportunity to expand a bit on this. The physicians, scientists, engineers, quality control experts, the attorneys, accounting professionals, others who are leading the charge in biotechnology and pharmaceutical companies are some of the most sought-after executives and employers in the San Francisco Bay Area and Northern New Jersey. The competition for their skills is intense among scores of companies, both large and small. So a main component of our compensation philosophy at Geron is to compensate our employees in a way that enables us to attract, motivate and retain them for the long challenging journey embodied by drug development today. Accordingly, we offer competitive compensation packages that include a base salary, an annual cash bonus opportunity and a grant of stock options. Each employee's annual bonus opportunity is tied directly to the achievement of specific goals for the individual as well as overall company performance through the achievement of company goals. This supports another component of our compensation philosophy at Geron, which is to reward for performance. The use of stock options has several purposes. They promote employee retention since the vesting of such stock options occurs over time, encouraging achievement of longer-term goals and its strategies. In addition, stock options facilitate employee ownership in Geron finally, because the benefit from stock options only occurs on stock price appreciation. The interest of employees align with the interest of our stockholders, which is another component of our compensation philosophy. We utilize several mechanisms to ensure that our compensation packages and compensation plans are competitive with similarly situated companies in terms of number of employees, market cap and so forth. Before making an employment offer, we compare all components of the compensation package to market data relevant for the individual position in order to maintain competitiveness as well as fairness across the organization which is another component of our compensation philosophy. The Compensation Committee of the Board of Directors also retains a compensation services company, Radford, as an independent compensation consultant answerable only to the committee and not to me as the CEO or any other member of the management team. Radford recommends to the committee a number of companies that comprise defined peer group can be used to benchmark individual executive compensation, including base salaries, bonuses as a percentage of base salaries and equity stock option grants. Radford also provides biotechnology company compensation survey data we use in benchmarking non-executive and Board compensation. It should be noted that the Compensation Committee approves the compensation packages for all the executive officers and the Board as a whole approves my compensation. The checks and balances inherent in our compensation plans are described at length in the compensation, discussion and analysis section of the proxy. I urge any of you who have questions regarding how we administer executive compensation to read that section. It's not just boiler plate. We spend a lot of time writing it because we believe it's important information for you, our stockholders to consider and understand. So this leads me to the second question regarding compensation. What is the purpose of the company's stock option program? Simply put, and as I noted just a few minutes ago, we utilize our stock option plan to induce employees to come and work for us instead of our competitors to retain them and to align with stockholders by giving them an opportunity for future reward based on an increasing stockholder value, i.e., stock price. The last question we received about compensation is what are inducement grants? And who are the people who are receiving them? Options granted to new hires are granted as material inducement to employment in accordance with NASDAQ rules and are referred to as inducement grants. We are required by NASDAQ to publicly disclose when inducement grants are made both to executive and nonexecutive employees. Inducement grants are used at the time of hiring to attract and retain talent. They also diminish the need to use cash signing bonuses, which are also sometimes used by companies to attract and retain talent in a highly competitive hiring environment. In order to maintain employee confidentiality, we do not disclose the names of employees receiving inducement grants, except for senior executives when they are named in a press release. As has been discussed previously, it may be helpful to point out that the majority of our new hires receiving inducement grants in the past 1.5 years are research and development professionals who are responsible for advancing the development of imetelstat. So I'd now like to hand the meeting over to Suzanne, who will moderate the Q&A from stockholders participating online. Suzanne?

Thanks, Chip. At this time, I would like to invite questions from online participants. [Operator Instructions] I will now read the first question. I would like to know specific plans and time lines for the approval of imetelstat. Chip?

Yes. I'll take that. So the question again related to approval of imetelstat. And I'd like to make the comment. We've commented about this specifically in a number of occasions, that we've now added an additional 3 months to our expectations for enrollment of completion -- for enrollment completion and top line results and so it's also safe to assume that our original expectation of a potential approval by the end of 2023 has been extended by 3 months as well.

Thanks, Chip. Okay. So our next question is about competition. What differentiates imetelstat in hematologic myeloid malignancies?

Alex, I think you were going to take that.

Yes, I can take that one. So I mean, imetelstat is a unique with a novel mechanism of action, the targets that telomerase enzyme. The telomerase enzyme is up-regulated in malignant stem cells only. And they are imetelstat's target, selectively due to malignant stem and progenitor cells and inducing their death, if you will, and apoptosis. And with that, it's enabling recovery of the normal hematology. So this is where we believe imetelstat shows the differentiating disease-modifying activity. And we are not aware of any other drugs that are currently in development or are approved in MDS, MMF that have this ability.

Okay. Suzanne.

Okay. Thanks, Aleksandra. Okay. So our next question. If the company wants to remain an independent entity, what solid steps have been planned and are being instituted to avoid a hostile takeover? So I think really what the question is, does Geron have a poison pill in place? And I believe that...

Olivia.

Olivia. Yes.

Yes. Olivia, you want to take that one?

Sure. I'll take that one. Okay. Although we don't have a poison pill in place for potentially combating a hostile takeover, we have several other mechanisms in place that may inhibit potential hostile acquisition bids, including the following: our certificate of incorporation provides our Board of Directors with the authority to issue up to 3 million shares of undesignated preferred stock and the issuance of such shares of preferred stock may delay or prevent a hostile takeover. In addition, provisions in our charter and bylaws may make it substantially more difficult for a third-party to affect a hostile takeover. These include preventing stockholders from taking actions by written consent, our Board is separated into 3 different classes with each class having a 3-year term of office, which prevents all of the Board members from being elected in any 1 year. And there are also specific procedures for nominating directors and submitting proposals for consideration at stockholder meetings. Back to you, Suzanne.

Thanks, Olivia. The next question is about, again, competition and how does imetelstat compare to luspatercept?

Okay. I'll take that one. Thanks. Well, first of all, I think that I would make the broader comment that in addition to a novel mechanism of action and the potential for disease-modifying activity, the Phase II data in low-risk MDS is showing high rates of transfusion independence is achievable with both RS positive and RS negative patients. And luspatercept has been studied in Phase III and has a label in the United States only for RS positive patients and does not include RS negative patients, and we are studying both. We've also demonstrated remarkable durability, which is of the transfusion free intervals, which is quite impressive and compare favorably to the Phase III data for luspatercept. I would refer people in general to Slide 15 in the corporate presentation deck that's on the website. We actually provide a sort of apples-to-apples comparison. And I would make a couple of comments with regard to that now. I think you can probably follow along even if you're not able to access that instantly on the -- on your computers. So -- and I'd also like to make a comment that this is a comparison between Phase II data, which is uncontrolled in the case of IMerge Part 1 in MEDALIST -- in the MEDALIST data, which was a Phase III controlled clinical trial, which was the basis for the registration of luspatercept in the United States and presumably will be coming in Europe with positive CHMP opinion. That was published a short while ago. So both of the patient populations in which we -- the 2 companies have studied low-risk MDS patients are quite similar. They're -- none of the patients in either study come had the non-del(5q) or have the del(5q) chromosomal abnormality. So they were all non-del(5q). And all of them were relapsed and refractory to erythropoiesis stimulating agents or ESAs. The critical difference between the 2 populations was that in MEDALIST, the luspatercept study, not only did they only include RS positive patients only, but also they had a lower median baseline transfusion burden. So they weren't as significantly burdened with transfusions at the baseline compared to the patients in IMerge part 1. The median baseline transfusion burden for luspatercept patients was 5 units over 8 weeks compared to 8 in patients with -- in the IMerge study. However, even more importantly, the luspatercept study allowed patients in who had only 2 or 3 units per 8 weeks of baseline transfusion burden, 29% of their patients, therefore, had less than 4 units for 8 weeks. And that -- that, when you sort of normalize for that and take those patients out of the analysis, which we're able to do with much of the data that has been presented for the luspatercept results, we have a 42% 8-week transfusion-free interval compared to 32% for luspatercept. I think probably the most important is that we had -- 32% of patients have a 24-week or greater RBC-TI rate. That's the first measure of durability. That's not been reported or assessed for luspatercept to our knowledge. And the 1-year RBC-TI rate, as I mentioned in my prepared remarks, is 29% for imetelstat compared to not having been reported or assessed as far as we know for luspatercept in the MEDALIST study. So the last point is that the median duration of transfusion-free interval for imetelstat in the IMerge Phase II results was 88 weeks. And the median duration of transfusion-free interval in the luspatercept study for -- was -- the MEDALIST study was 31 weeks. So I think that we see a very, very good comparison here and one that indicates excellent durability for our product in the Phase II study. Next question, Suzanne.

Okay. Thanks, Chip. So I have 2 questions for Aleksandra. The first question is what is the significance of excluding JAK inhibitors from the control arm and your trial design? And the second question is -- is there enough information to date to suggest transformation to AML is altered in both MDS and MF? Aleksandra?

Okay. So let me start with the first one, right? So the significance of the exclusion of JAK-i in the BAT. What Chip in his remarks described the inclusion criteria for the MS Phase III study. Now because all, per the criteria, all of the patients will be nonresponsive to a JAK inhibitor, it would not make sense to include a JAK inhibitor in the BAT control arm. Now the significance of that is that excluding JAK-i in our control arm now allows our trial to be similar to the BAT arm in the RWD analysis that we've done, in which imetelstat was associated with substantial improvement in the overall survival when compared to the BAT. The second question regarding the transformation to AML with the treatment of imetelstat, right? So I believe that in both of the study, we currently do not have enough information to make any conclusions regarding this.

Okay. Thank you, Aleksandra. Our next question is for Olivia. Should we anticipate further dilution ahead of an IMerge data readout?

Thanks, Suzanne. As stated earlier, based on our current assumptions, the recent financing provides a cash runway through the second half of 2022. If there is a need for additional funding that cannot be satisfied by raising non-dilutive capital such as partnering or debt, then we would have to consider an additional equity financing. However, at this time, I would say, with the proceeds from this recent public offering, we currently do not expect to use the ATMs this year or next.

Thanks, Olivia. Our next question relates to patent protection. What is the patent protection for imetelstat? Do the patents that Janssen -- I'm not going to actually ask that question. So really, what the question is, can you provide an overview of our patent? And that one...

Sure. Yes. This is Chip. I'll take that. So the composition of matter of patent protection for imetelstat in the U.S. is through 2025 with potential patent extension through 2030. There's also a potential overlapping exclusivity period due to imetelstat's orphan drug designation. In addition, there are methods of use patents, including a patent for use in MDS and MF, that is expected to remain enforced until 2033. For competitive reasons, we don't really comment on the extent of our patent portfolio in its entirety but that's a good overview. Thanks.

Thanks, Chip. [Operator Instructions] And I think right now, we don't have any more additional questions.

Okay.

So I'm going to -- Yes. Sorry.

Go ahead. Is there anything else Suzanne, or are we...

Back to you Chip. I think we answered all the questions for today. So back to you.

All right. Well, thanks very much. I'd like to say on behalf of the Board, the management and the employees of Geron, we hope you found today's discussion to be helpful and informative and not too clunky doing it all virtually. I will say I sincerely hope we're able to do this in-person in the coming years, but we will see how times change. In the meantime, thanks to our many stockholders for supporting imetelstat and Geron over the years, and we look forward to future interactions virtual or otherwise in the future. I think this -- thanks very much. I'll turn this back over to the operator then.

And thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect your lines. Take care.