The increase in research and development expenses for the three and nine month periods ending September 30, 2016, compared to the same periods in 2015, primarily reflected the net result of higher costs for the company's proportionate share of clinical development expenses under the imetelstat collaboration with Janssen, partially offset by reduced personnel-related costs resulting from the March 2015 organizational resizing and lower costs for the manufacturing of imetelstat drug product. The company expects research and development expenses to be higher in 2016 compared to 2015 as the clinical development of imetelstat continues in collaboration with Janssen. The increase in general and administrative expenses for the three and nine month periods ending September 30, 2016, compared to the same periods in 2015, primarily reflected higher non-cash stock-based compensation expense and an increased allocation of facilities and other overhead costs to general and administrative activities.Interest and other income for the three and nine months ended September 30, 2016 was $322,000 and $871,000, respectively, compared to $187,000 and $481,000 for the comparable 2015 periods. The increase in interest and other income for the three and nine month periods ending September 30, 2016, compared to the same periods in 2015, primarily reflected higher yields on the company's marketable securities portfolio. Recent Company Events
- In the third quarter of 2016, Janssen conducted planned internal reviews of initial data from IMbark TM and IMerge TM, the ongoing clinical trials of imetelstat.
- IMbark TM was designed to evaluate two dose levels of imetelstat (either 4.7 mg/kg or 9.4 mg/kg administered every three weeks) in approximately 200 patients (approximately 100 patients per dosing arm) with Intermediate-2 or High risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. The co-primary efficacy endpoints for the trial are spleen response rate and symptom response rate at 24 weeks. Janssen's review included data from 20 patients from each dosing arm who had been followed on the trial for at least 12 weeks. In this review, no new safety signals were identified and the safety profile was consistent with previous imetelstat clinical trials in hematologic myeloid malignancies. Activity in the 4.7 mg/kg dosing arm did not warrant further investigation of that dose, and this arm has been closed to new patient enrollment. In the 9.4 mg/kg dosing arm, even though at the week 12 data assessment an insufficient number of patients met the protocol defined interim criteria, this arm warranted further investigation because encouraging trends in the efficacy data were observed. New enrollment in the 9.4 mg/kg arm has been suspended while the trial continues in order to obtain additional and more mature data that includes a longer follow-up of these patients at 24 weeks. Enrolled patients in both arms are permitted to continue to receive imetelstat. Janssen has submitted a protocol amendment to health authorities that includes allowing eligible patients in the 4.7 mg/kg dosing arm to increase their dose to 9.4 mg/kg per investigator discretion.
- IMerge TM is a two-part clinical study in patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS). Part 1 is a Phase 2, open-label, single-arm design in approximately 30 patients, which has been fully enrolled, and Part 2 is a Phase 3, randomized, double-blind, placebo-controlled design in approximately 170 patients. Janssen's review of data in a subset of patients in Part 1 indicated that emerging safety and efficacy in IMerge TM is consistent with data reported from the pilot study conducted at Mayo Clinic in MDS patients. The primary efficacy endpoint for the trial is 8-week transfusion independence. IMerge TM continues unmodified at this time.
- Second internal data reviews of additional and more mature data from both trials are planned by the end of the second quarter of 2017.
- Three abstracts describing non-clinical data on imetelstat were accepted for presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition to be held in San Diego, California from December 3-6, 2016. The abstracts were published on November 3, 2016 on the ASH website at www.hematology.org.
Participants can access the conference call live via telephone by dialing 877-303-9139 (U.S.); 760-536-5195 (international). The passcode is 6488635. A live audio-only webcast is also available at http://edge.media-server.com/m/p/ci36i65z. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast through December 3, 2016.About Geron 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 in this press release regarding: (i) continued conduct by Janssen of IMbark TM or IMerge TM; (ii) Janssen obtaining additional or more mature data from IMbark TM or IMerge TM; (iii) that Janssen will conduct any additional or further data reviews in IMbark TM or IMerge TM, and the timing of such data reviews; (iv) potential outcomes of any data reviews conducted by Janssen; (v) the safety and efficacy of imetelstat; (vi) submission of a protocol amendment to health authorities; (vii) financial projections and expectations; and (viii) 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 TM and IMerge TM by overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and regulatory challenges; (ii) whether health authorities permit IMbark TM or IMerge TM to continue to proceed under the existing protocols, the referenced protocol amendment or any other amendments thereto; (iii) Janssen's ability to collect additional and more mature data from current clinical trials of imetelstat; (iv) whether Janssen continues to conduct IMerge TM or IMbark TM; (v) Geron's dependence on Janssen for the development, regulatory approval, manufacture and commercialization of imetelstat, including the risks that if Janssen were to breach or terminate the collaboration agreement or otherwise fail to successfully develop and commercialize imetelstat and in a timely manner, or at all, 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) the fact that Geron may not receive any milestone, royalty or other payments from Janssen because Janssen may terminate the collaboration agreement for any reason; (viii) the ability of Geron and Janssen to protect and maintain intellectual property rights for imetelstat; and (ix) the need for future capital. 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 quarterly report on Form 10-Q for the quarter ended September 30, 2016. 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||Nine Months Ended|
|September 30,||September 30,|
|(In thousands, except share and per share data)||2016||2015||2016||2015|
|License fees and royalties||5,108||363||6,068||1,151|
|Research and development||4,319||4,050||13,927||13,849|
|General and administrative||4,666||4,334||14,006||12,911|
|Total operating expenses||8,985||8,343||27,933||28,066|
|(Loss) income from operations||(3,877||)||27,020||(21,865||)||8,085|
|Unrealized gain on derivatives||—||—||—||16|
|Interest and other income||322||187||871||481|
|Interest and other expense||(21||)||(22||)||(61||)||(68||)|
|Net (loss) income||$||(3,576||)||$||27,185||$||(21,055||)||$||8,514|
|Net (loss) income per share:|
|Shares used in computing net (loss) income per share:|
|CONDENSED BALANCE SHEETS|
|September 30,||December 31,|
|Cash, cash equivalents and restricted cash||$||6,151||$||21,515|
|Current marketable securities||102,655||92,524|
|Other current assets||6,250||1,853|
|Total current assets||115,056||115,892|
|Noncurrent marketable securities||21,005||32,661|
|Property and equipment, net||170||207|
CONTACT:Anna Krassowska, Ph.D.Investor and Media Relations650firstname.lastname@example.org@geron.com