|Geron Discontinues GRN1005 and Restructures to Focus on Imetelstat Development in Hematologic Malignancies and Solid Tumors with Short Telomeres|
Company to Host Conference Call at 8:30 a.m. ET on Tuesday, December 4
MENLO PARK, Calif., December 3, 2012 - Geron Corporation (Nasdaq: GERN) today announced that the company has discontinued development of GRN1005, its peptide-drug conjugate designed to treat cancers in the brain. Going forward, the company will focus on the development of imetelstat, its telomerase inhibitor, in hematologic myeloid malignancies and in patients with solid tumors that have short telomeres. The company also announced a restructuring to reduce its workforce from 107 positions to 64 full-time positions, and to reduce its annual cash operating expenses from approximately $65 million in 2012 to approximately $33 million in 2013, which includes non-recurring costs of approximately $3 million associated with the restructuring and approximately $3 million for the discontinuation of clinical trials. The company expects to end 2012 with approximately $90 million in cash and investments.
Rationale for Discontinuing GRN1005
"We are very disappointed that the results of the GRN1005 program fell short of our criteria for further development," said John A. Scarlett, M.D., Geron's President and Chief Executive Officer. "Our immediate focus now is on the use of imetelstat in hematologic malignancies and solid tumors with short telomeres, which represent an opportunity for significant therapeutic advances and value creation."
Imetelstat Development in Hematologic Malignancies
Based on these results, Dr. Ayalew Tefferi, M.D., at the Mayo Clinic has begun an investigator-sponsored pilot study to evaluate safety and efficacy of imetelstat in patients with myelofibrosis, a myeloproliferative neoplasm in the same spectrum of diseases as ET. For more information about this study, please refer to http://clinicaltrials.gov/ct2/show/NCT01731951. The company is in the initial planning stages of a Geron-sponsored Phase 3-enabling study in myelofibrosis, which will be informed, in part, by data from the Mayo Clinic study. In addition, Geron intends to expand its directed program of investigator-sponsored trials in 2013 to other hematologic myeloid indications, including acute myelogenous leukemias.
Imetelstat Development in Solid Tumors Associated with Short Telomeres
In addition, Geron has appointed Craig C. Parker, as Senior Vice President, Corporate Development and as a member of the executive management team, effective immediately. Mr. Parker has over 25 years experience in the science and business of the biotechnology industry, and was most recently Senior Vice President, Strategy and Corporate Development at Human Genome Sciences, Inc., until its sale to Glaxo SmithKline in 2012.
"I sincerely thank Graham for his many contributions to Geron's programs, and wish him success in his future ventures," commented Dr. Scarlett. "I look forward to working with Olivia in her new role, for which she is highly qualified based on her many years of outstanding performance at the company, and I welcome Craig, whose extensive experience in business development and strategic analysis will complement our current team."
Participants can access the conference call via telephone by dialing 866-713-8565 (U.S.); 617-597-5324 (international). The passcode is 32236649. A live audio-only webcast is also available at http://edge.media-server.com/m/p/t9tr3r34/lan/en. The audio webcast of the conference call will be available for replay approximately one hour following the live broadcast for 30 days.
Geron is a biopharmaceutical company developing first-in-class therapies for cancer, including its telomerase inhibitor, imetelstat. 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 Geron's plans or expectations for or of: dates to obtain or present data or other results from any clinical trials; and clinical development plans or success of imetelstat, including without limitation the refinement of an assay; expecting to end 2012 with approximately $90 million in cash and investments; having annual cash operating expenses of approximately $65 million in 2012 and approximately $33 million in 2013; and incurring one-time costs for restructuring of approximately $3 million and non-recurring costs for the discontinuation of clinical trials of approximately $3 million 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: (a) regarding dates for the availability of data or other results - delays in enrollment, delays caused by institutional review boards or regulatory agencies, shortage of supply, dependence on clinical trial collaborators and safety issues; (b) regarding the development of imetelstat - those risks and uncertainties inherent in the development of potential therapeutic products, including without limitation, successful clinical trial results and the protection of Geron's intellectual property rights; and (c) regarding financial expectations - if any of (a) above, unanticipated expenses or charges may occur as a result of the resizing, or litigation were to occur. Additional information 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, 2012. 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.
Anna Krassowska, Ph.D.
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