Full Press Release Details
Geron Corporation Reports
Fourth Quarter and Annual 2015 Financial Results
Conference Call Scheduled
for 4:30 p.m. EST Today, February 25
MENLO PARK, Calif., February 25, 2016 --
Geron Corporation (Nasdaq: GERN) today reported financial results for the fourth quarter and year ended December 31, 2015 and recent events.
Fourth Quarter and Year-End 2015
For 2015, the company reported net income of $46,000, or $0.00 per share,
compared to a net loss of $35.7 million,
or $(0.23) per share, for 2014. For the fourth quarter of 2015, the company reported a net loss of $8.5 million,
or $(0.05) per share, compared to a net loss of $8.9 million, or $(0.06) per share, for the comparable 2014
period. The company ended 2015 with $146.7 million in cash and investments.
Revenues for 2015 were $36.4 million compared to $1.2 million for 2014.
Revenues for the fourth quarter of
2015 were $220,000 compared to $178,000 for the comparable 2014 period. Revenues for 2015 included the full
recognition of the $35.0 million upfront payment from Janssen Biotech, Inc. (Janssen) as collaboration revenue
upon the company s transfer of the imetelstat license rights and completion of technology transfer-related
activities outlined under the imetelstat collaboration agreement with Janssen in the third quarter of 2015.
The upfront cash payment was received in December 2014 and recorded as deferred revenue at that time.
Total operating expenses for 2015 were $36.9 million compared to $37.5
million for 2014. Total operating expenses for the fourth quarter of 2015 were $8.9 million compared to $9.2 million for the comparable 2014 period.
Operating expenses for 2015 included restructuring charges of $1.3 million in connection with the company s organizational resizing announced in March 2015.
Research and development expenses for 2015 were $17.8 million compared
to $20.7 million for 2014. Research
and development expenses for the fourth quarter of 2015 were $4.0 million compared to $4.4 million
for the comparable 2014 period. The decrease in research and development expenses in 2015 compared
to 2014 primarily reflects the net result of lower personnel related costs due to the organizational resizing
and reduced manufacturing costs for imetelstat drug product, partially offset by higher costs for the clinical
development of imetelstat in collaboration with Janssen.
General and administrative expenses for 2015 were $17.8 million compared
to $16.8 million for 2014. General and
administrative expenses for the fourth quarter of 2015 were $4.9 million compared to $4.8 million for the comparable
2014 period. The increase in general and administrative expenses in 2015 compared to 2014 primarily
reflects higher non-cash stock-based
compensation expense.
Interest and other income for 2015 was $677,000 compared to $373,000
for 2014. Interest and other income for
the fourth quarter of 2015 was $196,000 compared to $100,000 for the comparable 2014 period. The increase
in interest and other income for 2015 compared to 2014 primarily reflects higher cash and investment
balances with the receipt of the $35.0 million upfront payment from Janssen and higher yields on the
company s marketable securities portfolio.
| Telomerase Inhibitor Imetelstat Therapy in Refractory Anemia with Ring Sideroblasts with or without Thrombocytosis (Abstract #55; oral presentation) Data were presented for safety and efficacy as of the May 10, 2015 data cut. Nine patients with a form of the myelodysplastic syndromes (MDS) known as refractory anemia with ring sideroblasts (MDS-RARS) were enrolled in the study cohort, classified as having either intermediate-1 or intermediate-2 risk disease by the International Prognostic Scoring System (IPSS). Six of nine (66.7%) patients had prior treatment with erythropoiesis stimulating agents (ESAs). Three of the eight (37.5%) patients who were dependent on red blood cell transfusions at study entry became transfusion independent, defined as not requiring transfusions for at least eight weeks. The median duration of transfusion independence was 28 weeks (range: nine weeks to 37 weeks). Adverse events were similar in nature to the adverse events reported in the MF clinical study published in the NEJM. | |
| Dynamics of Mutations in Patients with ET Treated with Imetelstat (Abstract #57; oral presentation) Data from further mutational analyses of patient samples from the clinical study in ET showed that imetelstat treatment suppressed allele burdens of multiple gene mutations in addition to the JAK2V617F, CALR and MPL mutations. | |
| Activity of the Telomerase Inhibitor GRN163L (Imetelstat) on Acute Myeloblastic Leukemia Blasts Is Enhanced by DNA Methyltransferase Inhibitors Irrespective of TERT Promoter Methylation Status (Abstract #1267; poster presentation) Data from an in vitro study showed that imetelstat has activity against samples derived from patients with high risk leukemias, and that activity was enhanced by the demethylating agent 5-azacytadine, which is currently used in the treatment of some patients with high risk MDS or acute myeloid leukemia. |
Clinical Development by
| Further information about the trial, including participating medical centers around the world, can be found at http://clinicaltrials.gov/ct2/show/NCT02426086. | |
| IMerge TM . In January 2016, the first patient was dosed in a Phase 2/3 clinical trial to evaluate imetelstat in patients with MDS. The trial, referred to as IMerge TM , will evaluate imetelstat in transfusion dependent patients with IPSS Low or Intermediate-1 risk MDS who have relapsed after or are refractory to prior treatment with an ESA. As designed, the trial consists of two parts, and a total of approximately 200 patients are expected to be enrolled. Part 1 of the trial is planned as a Phase 2, open-label, single-arm design to assess the efficacy and safety of imetelstat. Up to 30 patients are expected to be enrolled in Part 1, all of whom will receive imetelstat and be followed for safety, hematologic improvement and reduction in transfusion requirement. Before proceeding to Part 2, the data from Part 1 must support a positive assessment of the benefit/risk profile of imetelstat in these patients. The internal review of data from Part 1 to support advancing to Part 2 is expected to occur in the second half of 2016. Part 2 of the trial is planned as a Phase 3 double-blind, randomized, placebo-controlled design to compare the efficacy of imetelstat against placebo. Approximately 170 patients are expected to be enrolled in Part 2, who will be assigned randomly, in a 2:1 ratio, to receive either imetelstat or placebo. The primary efficacy endpoint is designed to be the rate of red blood cell transfusion-independence lasting at least eight weeks, defined as the proportion of patients without any red blood cell transfusion during any consecutive eight weeks since entry to the trial. A primary efficacy analysis is planned to occur 12 months after the last patient is enrolled. Further information about the trial, including participating medical centers around the world, can be found at https://clinicaltrials.gov/ct2/show/NCT02598661. |
At 4:30 p.m. EST on February 25, 2016, Geron s management will host a
conference call to discuss the
company s fourth quarter and annual results as well as recent events.
Participants can access the conference call live via telephone by
dialing 877-303-9139
(U.S.); 760-536-5195 (international).
The passcode is 48851221. A live audio-only
webcast is also available at http://edge.media-server.com/m/p/txcpdjvg.
The audio webcast of the conference call will be available for replay
approximately one hour following the live broadcast through March 25, 2016.
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.
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) timing and management of current and
potential clinical trials of imetelstat to be conducted under the collaboration agreement with Janssen,including
IMbarkTM and IMergeTM, and other potential activities
under the collaboration agreement with Janssen;
(ii) the safety and efficacy of imetelstat; (iii) the current timelines, milestones and designs of IMbarkTM and
IMergeTM , including planned reviews and analyses of clinical
data; and (iv) 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) the uncertain, time-consuming
and expensive product development and regulatory process, including whether Geron and Janssen
will succeed in overcoming all of the clinical safety and efficacy, technical, scientific, manufacturing and
regulatory challenges in the development and commercialization of imetelstat; (ii) regulatory authorities permitting
the clinical trials to continue to proceed; (iii) Janssen s ability to enroll patients in a timely manner, or
at all, in any of the current or potential clinical trials of imetelstat; (iv) the ability of Geron and Janssen to protect
and maintain intellectual property rights for imetelstat; (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) whether imetelstat can be applied to any or to multiple hematologic malignancies;
and (viii) Geron s 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, 2015. 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.
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