Geron Corporation Reports Fourth Quarter and Full Year 2018 Financial Results and Recent Events
“We expect 2019 to be a pivotal year,” said
Building a Development Team with Hematology-Oncology Expertise
The Company recently announced the hiring of two key development executives.
Fourth Quarter 2018 Highlights
IMerge Phase 2 Data Presented Support Initiation of Phase 3 Trial in Lower Risk MDS
Data for the Phase 2 portion of IMerge were presented in an oral presentation at the
In the Phase 2 portion of IMerge, 38 patients were enrolled who were transfusion dependent with Low or Intermediate-1 risk non-del(5q) MDS who have relapsed after or are refractory to prior treatment with an ESA and naïve to treatment with a hypomethylating agent (HMA) or lenalidomide. In the trial, transfusion dependence is defined as a patient requiring a minimum of four units of red blood cells (
Primary Efficacy Endpoint:
- 37% (14/38) of patients achieved an 8-week RBC TI rate
Secondary Efficacy Endpoints:
- 26% (10/38) of patients achieved a 24-week RBC TI rate
- The rate of hematologic improvement-erythroid (HI-E) was 71% (27/38), as measured by a reduction of at least four
RBCunits over eight weeks compared with prior transfusion burden
- Mean relative reduction of
RBCtransfusion burden from baseline was 68%
Broad Clinical Activity Observed
- Similar 8-week RBC TI rates were observed in patients with baseline serum erythropoietin (sEPO) levels less than or greater than 500mU/mL
- 8-week RBC TI rates were also consistent between ringed-sideroblast (RS) positive patients and other patients
The ASH presentation reported data based on a data cut-off date of
IMbark Phase 2 Data Presented Suggest Meaningful Survival Outcome in Relapsed/Refractory MF Patients
Data from the Phase 2 IMbark clinical trial, including new overall survival data, were presented in an oral presentation at ASH on
The IMbark trial evaluated two starting dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in more than 100 patients with Intermediate-2 or High-risk myelofibrosis (MF) who were relapsed or refractory to janus kinase inhibitor (JAKi) therapy. To be eligible for enrollment in the IMbark trial, patients had to meet rigorous criteria for having failed or not responded to JAKi treatment, including documented progressive disease during or after JAKi therapy. The ASH presentation highlighted efficacy and safety data from the trial’s primary analysis, as well as overall survival (OS) data with a clinical cutoff of
The ASH presentation reported that the median OS for the 9.4 mg/kg dosing arm was 29.9 months, which suggests a meaningful survival outcome with imetelstat treatment in this poor-prognosis, relapsed/refractory patient population where there are currently no approved treatments today. Other observational studies of similar patient populations at academic medical centers published recently in medical literature have reported median OS ranges of approximately 12 to 14 months after failure of or discontinuation of ruxolitinib, a JAKi.
Geron plans to discuss the potential for late-stage development of imetelstat in MF with current IMbark investigators, other key opinion leaders (KOLs) and regulatory authorities. The Company expects to facilitate KOL discussions over the coming months. Discussions with regulatory authorities are expected to begin after the investigational new drug (IND) sponsorship has been transferred back to Geron.
The Company plans to outline a decision regarding the potential for future late-stage development in MF by the end of the third quarter of 2019. In making this decision, Geron will conduct an assessment of what would be required to achieve clinical and regulatory success, including the cost and duration of any potential clinical trials.
Imetelstat Safety Results
The safety profile reported in both ASH presentations for imetelstat-treated patients was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified. Cytopenias, particularly neutropenia and thrombocytopenia, were the most frequently reported adverse events, which were predictable, manageable and reversible.
Fourth Quarter and Year-End 2018 Results
For the fourth quarter of 2018, the company reported a net loss of
Revenues for the fourth quarter of 2018 were
Total operating expenses for the fourth quarter of 2018 were
Research and development expenses for the fourth quarter of 2018 were
General and administrative expenses for the fourth quarter of 2018 were
Interest and other income for the fourth quarter of 2018 was
Planned 2019 Activities and Milestones
Geron’s plans for 2019 primarily focus on advancing imetelstat development. The Company believes building a development team with hematology-oncology expertise is essential to executing the Phase 3 clinical trial in lower risk MDS and evaluating the potential for late-stage development in MF, as well as in the future, exploring additional indications for imetelstat and being able to pursue other innovative therapeutics in hematology-oncology. Geron expects the following activities and milestones to occur in 2019:
Transition of Imetelstat Development Program
- Complete the transfer of the IND back to Geron by the end of the second quarter.
- Complete the transfer of the imetelstat clinical development program back to Geron by the end of the third quarter.
- Actively recruit highly-experienced personnel with drug development expertise in myeloid malignancies.
- Commence screening and enrollment for the Phase 3 portion of IMerge by mid-year.
- Present more mature data from patients in the Phase 2 portion of IMerge at a medical conference.
- Conduct discussions with IMbark investigators, other MF KOLs and regulatory authorities to identify and consider potential late-stage clinical development plans for relapsed/refractory MF patients.
- Outline decision regarding the potential for late-stage development of imetelstat in MF by the end of the third quarter.
Projected 2019 Financial Guidance
The Company expects its operating expenses to increase as it assumes full responsibility for the development and potential commercialization of imetelstat. For fiscal year 2019, the Company expects its operating expense burn to range from
Geron will host a conference call to discuss fourth quarter and full year financial results and recent events at
Participants may access the conference call live via telephone by dialing domestically +1 (877) 303-9139 or internationally +1 (760) 536-5195. The conference ID is 6771719. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. If you are unable to listen to the live call, an archived webcast will be available on the Company’s website for 30 days.
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. Ongoing clinical studies of imetelstat include a Phase 2/3 trial called IMerge in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial called IMbark in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the
Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release 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 statements, include, without limitation, those regarding: (i) the prospects for imetelstat; (ii) that patient screening and enrollment for the Phase 3 portion of IMerge will begin by mid-year 2019; (iii) that IMbark and IMerge will continue; (iv) that imetelstat may have disease-modifying activity; (v) that the IND will transfer to Geron by the end of the second quarter of 2019; (vi) that the imetelstat clinical development program will transfer to Geron by the end of the third quarter of 2019; (vii) that more mature data will be available from the Phase 2 portion of IMerge and will be presented at a medical conference in 2019; (viii) that Geron will discuss with IMbark investigators, other MF KOLs and regulatory authorities the potential for late-stage clinical development of imetelstat for relapsed/refractory MF patients and will outline its decision on this matter by the end of the third quarter of 2019; (ix) that the Company does not expect the adoption of the new revenue recognition accounting standard to have a material impact to its financial statements on an ongoing basis; (x) that the Company’s operating expenses will be
Financial table follows.
CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended
|(In thousands, except share and per share data)||2018||2017||2018||2017|
|License fees and royalties||$||375||$||191||$||1,066||$||1,065|
|Research and development||5,081||2,523||13,432||11,033|
|General and administrative||4,883||5,454||18,707||19,287|
|Total operating expenses||9,964||7,977||32,139||30,320|
|Loss from operations||(9,589||)||(7,786||)||(31,073||)||(29,255||)|
|Interest and other income||1,120||375||3,291||1,416|
|Gain on settlement||1,460||—||1,460||—|
|Change in fair value of equity investment||(271||)||—||(541||)||—|
|Basic and diluted net loss per share:|
|Net loss per share||$||(0.04||)||$||(0.05||)||$||(0.15||)||$||(0.18||)|
|Shares used in computing net loss per share||186,348,551||159,339,385||176,504,996||159,224,986|
CONDENSED BALANCE SHEETS
|December 31,||December 31,|
|Cash, cash equivalents and restricted cash||$||10,844||$||16,603|
|Current marketable securities||152,714||78,351|
|Other current assets||2,500||1,016|
|Total current assets||166,058||95,970|
|Noncurrent marketable securities||18,582||14,241|
|Property and equipment, net||59||102|
Source: Geron Corporation