Company Plans to Partner All Stem Cell Programs
Geron Corporation (Nasdaq: GERN) today announced that, effective immediately, the Company will focus on its first-in-class oncology programs. As a consequence, the Company will discontinue further development of its stem cell programs and is seeking partners for these novel assets.
"In the current environment of capital scarcity and uncertain economic conditions, we intend to focus our resources on advancing our Phase 2 clinical trials of imetelstat and GRN1005. These two novel and promising oncology drug candidates target major unmet medical needs and have important clinical development milestones occurring over the next 20 months," said Geron's Chief Executive Officer, John A. Scarlett, M.D. "By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital. This would not be possible if we continue to fund the stem cell programs at the current levels."
Imetelstat, Geron's lead telomerase inhibitor, is currently being evaluated in four Phase 2 clinical oncology studies for the following indications: non-small cell lung cancer, breast cancer, essential thrombocythemia and multiple myeloma. Geron expects top-line data from these trials to be available before the end of the fourth quarter of 2012. GRN1005, an LRP-directed peptide-drug conjugate, is entering two Phase 2 clinical trials this year, one for brain metastases arising from non-small cell lung cancer and the other for brain metastases from breast cancer. Geron expects top-line data from these trials to be available before the end of the second quarter of 2013.
The decision to narrow Geron's technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company's research and clinical-stage assets. With this decision, Geron is eliminating 66 full-time positions, representing 38% of its workforce. As a result, the Company expects one-time cash expenditures of approximately $5 million in the fourth quarter of 2011 and approximately $3 million in the first half of 2012. Geron expects to end 2011 with cash and investments in excess of $150 million.
Geron is seeking partners with the technical and financial resources to enable further development of its stem cell programs. "Our employees, collaborators and shareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic," said Dr. Scarlett. "Stem cells continue to hold great medical promise. We believe that our leadership role in the field and the quality of our stem cell assets — which are widely recognized as being among the most innovative, comprehensive and advanced cell therapy programs in the world — will be an important point of differentiation in our discussions to partner these assets." In order to facilitate transfer of these programs to partners, Geron will retain a core group of employees from its stem cell operations through the end of the second quarter of 2012.
Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrollment, although it will continue to follow all enrolled patients, accruing data and updating FDA and the medical community on their progress. In this trial, GRNOPC1 has been well tolerated with no serious adverse events.
Conference Call Information
Geron's Chief Executive Officer, John A. Scarlett, M.D., will host a conference call for analysts and investors to discuss changes to the Company's business on Tuesday, November 15, 2011 at 6:00 a.m. Pacific Time, 9:00 a.m. Eastern Time.
Participants can access the conference call live via telephone by dialing 866-510-0705 (U.S.); 617-597-5363 (international). The passcode is 64257143. If accessing the conference call by telephone, please dial in at least 10 minutes early to minimize any delay in joining the call. A live audio-only webcast is also available at http://www.media-server.com/m/p/92t2mq67. The audio webcast of the conference call will be available for online replay approximately one hour following the live broadcast through November 30, 2011.
About Geron's Oncology Programs
Telomerase Inhibitor Program
Geron's proprietary nucleic acid chemistry platform is being used to generate potent and specific inhibitors of telomerase, an enzyme necessary for the indefinite replicative capacity of many cancers and cancer stem cells. Imetelstat, the Company's lead drug candidate in this program, is being evaluated in two randomized Phase 2 studies, one in metastatic breast cancer, and the other in advanced non-small cell lung cancer. These indications represent two of the leading causes of death from malignancy worldwide. Imetelstat is also being evaluated in a Phase 2 study of essential thrombocythemia, a myeloproliferative neoplasm, and in a Phase 2 study of multiple myeloma. Geron expects top-line data from these four Phase 2 trials to be available before the end of the fourth quarter of 2012.
LRP-Directed Peptide-Drug Conjugate Program
Geron's LRP-directed peptide-drug conjugate program is based on molecules that deliver anti-cancer drugs to tumors in the brain, including metastases. In the conjugates, the anti-cancer drugs are linked to a peptide designed to be actively transported across the blood-brain barrier via lipoprotein receptor-related protein (LRP) pathways, predominantly LRP1. LRP1 is also upregulated in many tumors. GRN1005, the Company's lead drug candidate in this program, has three paclitaxel molecules linked to a proprietary 19 amino acid peptide, Angiopep-2. GRN1005 is entering two Phase 2 clinical trials this year, one for brain metastases arising from non-small cell lung cancer and the other for brain metastases from breast cancer. An estimated 200,000 patients in the United States are diagnosed each year with cancers that have metastasized to the brain. There are currently no approved drug therapies for treating brain metastases. Both studies are expected to start by the end of the 2011, with top-line data from these trials expected to be available before the end of the second quarter of 2013.
Oncology Discovery Program
Geron has an active discovery research program that uses proprietary chemistry to address important molecular targets in cancer. The goal of this program is to generate new IND candidates for Geron's clinical oncology pipeline.
About Geron's Cell Therapy Programs
Geron's human embryonic stem cell programs, for which the Company is seeking partnerships, include oligodendrocyte progenitor cells (GRNOPC1) for central nervous system disorders, cardiomyocytes (GRNCM1) for heart disease, pancreatic islet cells (GRNIC1) for diabetes, dendritic cells (GRNVAC2) as an immunotherapy vehicle and chondrocytes (GRNCHND1) for cartilage repair.
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 begin or obtain top-line data from any of the Phase 2 oncology clinical trials; having sufficient cash to fund the Company for 20 months to reach milestone and value inflection points without the necessity of raising additional capital; expecting to end 2011 with $150 million in cash and investments; incurring one-time cash expenditures of approximately $5 million and $3 million in 2011 and 2012, respectively; Geron's ability to partner its stem cell business; clinical development; and future operating results and expenditures, 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 Phase 2 clinical trial initiation or the availability of top-line data — delays in enrollment, delays caused by institutional review boards or regulatory agencies, shortage of supply, dependence on clinical trial collaborators, or safety issues; (b) 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, or if the Company determined it was in its best interest to raise additional capital; (c) regarding Geron's ability to partner its stem cell business — third parties' reluctance to partner, Geron's intellectual property licensors' refusal to transfer intellectual property rights from Geron to a third party; and (d) those risks and uncertainties inherent in the development of potential therapeutic products, including without limitation, the protection of Geron's intellectual property rights. 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 the Annual Report on Form 10-K for the year ended December 31, 2010 and quarterly report on Form 10-Q for the quarter ended September 30, 2011. 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.
Contacts:
Geron Corporation
Anna Krassowska, Ph.D.
Investor and Media
Relations
650-473-7765
info@geron.com
