Geron Corporation Reports Fourth Quarter and Annual 2017 Financial Results and Recent Events
Fourth Quarter and Year-End 2017 Results
For the fourth quarter of 2017, the company reported a net loss of
Revenues for the fourth quarter of 2017 were
Total operating expenses for the fourth quarter of 2017 were
Research and development expenses for the fourth quarter of 2017 were
General and administrative expenses for the fourth quarter of 2017 were
Interest and other income for the fourth quarter of 2017 was
Fourth Quarter 2017 and Recent Events
IMerge is the ongoing Phase 2/3 clinical trial of imetelstat in red blood cell (
Medical Conference Presentation. At the
“With the preliminary data from IMerge presented at ASH, we now have clinical data in three blood cancers, ET, MF and MDS, where imetelstat exhibits potential disease modifying activity by inhibiting the progenitor cells of the malignant clones that drive the underlying diseases,” said
Investor Event. Geron hosted an analyst and investor meeting in
Clinical Development. Based on the preliminary data from the 13-patient subset, Janssen expanded Part 1 of IMerge to enroll approximately 20 additional patients who were naïve to lenalidomide and HMA treatment and non-del(5q) to increase the experience and confirm the benefit-risk profile of imetelstat in this refined target patient population. The first patient in the expanded Part 1 was dosed in
Regulatory Designation. In
IMbark is the ongoing Phase 2 clinical trial to evaluate two doses of imetelstat in intermediate-2 or high-risk myelofibrosis (MF) patients who are refractory to or have relapsed after treatment with a JAK inhibitor.
Clinical Development. Janssen completed a third internal data review of IMbark in
- The safety profile was consistent with prior clinical trials of imetelstat in hematologic malignancies, and no new safety signals were identified.
- Outcome measures for efficacy, including spleen volume responses and reductions in Total Symptom Score remain consistent with the prior data reviews.
- With a median follow up of approximately 19 months, the median overall survival has not been reached in either dosing arm.
- The trial is officially being closed to new patient enrollment. More than 100 patients have been enrolled in IMbark to date, which is expected to be adequate to assess overall survival. Patients who remain in the treatment phase may continue to receive imetelstat, and until the primary analysis, all safety and efficacy assessments are being conducted as planned in the protocol, including following patients, to the extent possible, until death to enable an assessment of overall survival.
- Based on the rate of deaths occurring in the trial, the protocol-specified primary analysis, which includes an assessment of overall survival, will begin by the end of the second quarter of 2018.
- Upon the protocol-specified primary analysis, the main trial will be completed. The IMbark protocol is being amended to establish an extension phase of the trial to enable patients remaining in the treatment phase to continue to receive imetelstat treatment per investigator discretion. During the extension phase, standard data collection will primarily consist of safety information.
Upcoming 2018 Events
Following completion of the IMbark protocol-specified primary analysis, Janssen must notify Geron whether it elects to maintain the license rights and continue the development of imetelstat in any indication (Continuation Decision). Geron expects the protocol-specified primary analysis for IMbark to begin by the end of the second quarter of 2018. As such, the company expects the Continuation Decision to occur by the end of the third quarter of 2018.
Conference Call and Webcast
Participants can access the conference call live via telephone dialing 877-303-9139 (U.S.); 760-536-5195 (international). The conference ID is 3564078. A live audio-only webcast is also available through the Investors section of our website at www.geron.com or at https://edge.media-server.com/m6/p/4hrpsmd2. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through
Geron is a biopharmaceutical company supporting the clinical stage development 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 statements regarding: (i) continued conduct by Janssen of IMbark and/or IMerge and any future clinical trials of imetelstat; (ii) the expected, anticipated and uncertain occurrence, if any, and timing of: (a) any data reviews, (b) a primary analysis, (c) any outcomes or decisions by Janssen regarding IMbark or IMerge, and (d) a Continuation Decision by Janssen; (iii) that imetelstat has potential disease modifying activity in MDS, MF, ET, or any other hematologic myeloid malignancies; (iv) that imetelstat might have disease modifying activity by inhibiting the progenitor cells of the malignant clones that drive the hematologic malignancies; (v) the safety and efficacy of imetelstat; and (vi) other statements that are not historical facts, constitute forward-looking statements. 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: (i) whether imetelstat will succeed in IMbark and IMerge by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (ii) whether the FDA or other health authorities have any additional requirements for and/or permit IMbark or IMerge to continue to proceed under the existing protocols or any amendments thereto; (iii) Janssen’s choosing to conduct data reviews of IMbark or IMerge; (iv) whether Janssen continues to conduct IMbark or IMerge or decides not to perform a primary analysis for IMbark; (v) that Janssen may terminate the collaboration agreement at any time or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, so that Geron would not obtain the anticipated financial and other benefits of the collaboration agreement with Janssen and the clinical development or commercialization of imetelstat could be delayed or terminated; (vi) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit/risk profile of imetelstat to become unacceptable; (vii) whether Janssen will make a positive Continuation Decision without renegotiating the terms of the collaboration agreement; (viii) the fact that Geron may not receive any or limited milestone, royalty or other payments from Janssen because Janssen may terminate the collaboration agreement for any reason or because imetelstat is unsuccessful developmentally or commercially; (ix) the ability of Geron and Janssen to protect and maintain intellectual property rights for imetelstat; (x) the need for future capital; and (xi) whether Geron is able to acquire any new product candidates, programs or companies to enable it to diversify. Additional 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 contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s annual report on Form 10-K for the year ended December 31, 2017. 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.
Financial table follows.
CONDENSED STATEMENTS OF OPERATIONS
Three Months Ended
|(In thousands, except share and per share data)||2017
|License fees and royalties||$||191||$||94||$||1,065||$||6,162|
|Research and development||2,523||4,120||11,033||18,047|
|General and administrative||5,454||4,755||19,287||18,761|
|Total operating expenses||7,977||8,875||30,320||36,808|
|Loss from operations||(7,786||)||(8,781||)||(29,255||)||(30,646||)|
|Interest and other income||375||321||1,416||1,192|
|Interest and other expense||(18||)||(22||)||(77||)||(83||)|
|Basic and diluted net loss per share:|
|Net loss per share||$||(0.05||)||$||(0.05||)||$||(0.18||)||$||(0.19||)|
|Shares used in computing net loss per share||159,339,385||159,147,351||159,224,986||159,045,644|
CONDENSED BALANCE SHEETS
|Cash, cash equivalents and restricted cash||$||16,603||$||13,078|
|Current marketable securities||78,351||102,035|
|Other current assets||1,016||999|
|Total current assets||95,970||116,112|
|Noncurrent marketable securities||14,241||13,954|
|Property and equipment, net||102||183|
Anna Krassowska, Ph.D.
Investor and Media Relations