To: Savant who wrote (3347) | 10/18/2012 8:22:57 PM | From: Savant | | | BioTime, Inc. Issues Open Letter to Shareholders of Geron Corporation
ALAMEDA, Calif., Oct 18, 2012 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) today issued the following letter to the shareholders of Geron Corporation (GERN) regarding Geron's stem cell assets:
October 18, 2012
AN OPEN LETTER TO GERON SHAREHOLDERS
Dear Geron Shareholders:
As you know, during November 2011, Geron Corporation (GERN) announced that it was discontinuing its stem cell research and development programs and its clinical trials of OPC-1, a groundbreaking product to treat spinal cord injuries manufactured from human embryonic stem cells. Nearly a year has now passed, and Geron has not announced any transaction that would provide value to either Geron or its shareholders from those stem cell assets.
BioTime, Inc. (nyse mkt:BTX) is a publicly traded company engaged in research and development of innovative new products in the field of regenerative medicine utilizing stem cells and related technology. We are prepared to propose a transaction between a recently formed, wholly owned subsidiary, BioTime Acquisition Corporation (BAC), and Geron for the purpose of enabling BAC to put the now dormant Geron stem cell assets back on track to speed the development and commercialization of innovative new products to treat degenerative diseases.
Summary of Our Proposal
Our proposal includes two transactions, one which we call the "Stem Cell Transaction" and one that we call the "Rights Offer" which are described in more detail, along with other important information, in Appendix I: Details of Our Proposal attached to this letter. Through these transactions, Geron shareholders could own up to 45% of a new publicly traded company that will own the Geron stem cell assets, $40 million of BioTime stock, certain BioTime stem cell assets, and shares of certain BioTime stem cell subsidiaries. Geron shareholders would also receive BioTime stock-purchase warrants presently valued at approximately $13 million. Geron would retain its cancer therapy business, including Imetelstat and GRN1005, and its cash and short-term liquid investments and Geron shareholders would continue to own 100% of the Geron cancer therapy business through their ownership of Geron stock.
Through the Stem Cell Transaction, Geron would transfer its stem cell assets to BAC, in exchange for which you along with the other Geron shareholders would receive shares of BAC common stock representing approximately 21.4% of the outstanding BAC capital stock. BioTime would contribute to BAC the following assets in exchange for the balance of outstanding BAC capital stock:
-- $40 million in BioTime common shares;
-- Warrants to purchase BioTime common shares ("BioTime Warrants");
-- Rights to certain stem cell assets of BioTime, and shares of two BioTime subsidiaries engaged in the development of therapeutic products from stem cells.
Through the "Rights Offer," BAC would seek to raise additional capital by offering you and other Geron shareholders the opportunity to increase your collective ownership interests in BAC to 45% by purchasing additional BAC shares, if you choose to do so. In addition to acquiring BAC common stock in the Rights Offer, if you exercise your subscription rights you would also receive warrants to purchase additional BAC common stock, which if exercised would increase your ownership in BAC. Those shareholders deciding not to purchase additional BAC shares in the Rights Offering would have the opportunity to sell their rights at prevailing market prices.
What You Can Do Now
BioTime and BAC cannot complete the Stem Cell Transaction as proposed without the approval of Geron's Board of Directors. If you want the Geron Board of Directors to pursue our proposal, we suggest that you contact the Geron Board and urge them to work with BioTime and BAC management to negotiate a definitive agreement for the Stem Cell Transaction. According to Geron's latest proxy statement, Geron shareholders wishing to communicate with the Board of Directors, or with a specific Board member, may do so by writing to the Board, or to the particular Board member, and delivering the communication in person or mailing it to: Board of Directors, c/o Stephen Rosenfield, Corporate Secretary, Geron Corporation, currently located at 149 Commonwealth Drive, Menlo Park, CA 94025. Geron's proxy statement represents that all mail addressed in this manner will be delivered to the Chair or Chairs of the Committees with responsibilities touching most closely on the matters addressed in the communication.
Very Truly Yours, Michael D. West, PhDThomas Okarma, PhD, MD Chief Executive OfficerChief Executive Officer BioTime, Inc.BioTime Acquisition Corp. Geron FounderFormer Geron CEO Former Geron CEO(1999-2011) (1990-1992)
Appendix I: Details of Our Proposal
The principal features of the Stem Cell Transaction and the Rights Offer are as follows:
The Stem Cell Transaction
-- As a Geron shareholder, you would receive one BioTime Warrant and one share of BAC Series A common stock for each 20 shares of Geron common stock you own. In total, Geron shareholders would receive 21.4% of the BAC capital stock outstanding at the consummation of the Stem Cell Transaction. BioTime would own the remaining outstanding shares of capital stock of BAC. BioTime would also hold BAC warrants that, if exercised, would increase BioTime's ownership interest by approximately 2%.
-- Geron shareholders would receive BAC Series A common stock and BioTime would own BAC Series B common stock. The BAC Series A common stock that you and other Geron shareholders would acquire, and the BAC Series B common stock that will be owned by BioTime, will be identical in almost all respects, except that having a separate Series A common stock held by Geron shareholders will enable BAC to distribute the BioTime Warrants, and to make the Rights Offer described below, exclusively to the Series A shareholders.
-- BAC would seek to have the BAC Series A common stock received by Geron shareholders listed for trading on a national securities exchange or on the OTC Bulletin Board market if exchange listing is not feasible.
-- Following the acquisition of the Geron stem cell assets, BAC would distribute the BioTime Warrants to the Geron shareholders as holders of BAC Series A common stock. The distribution would entitle you and the other BAC Series A shareholders to receive one BioTime Warrant for each BAC Series A share received in the Stem Cell Transaction.
-- The BioTime Warrants and underlying BioTime common shares would be registered under the Securities Act of 1933, as amended, and BioTime would seek to have the BioTime Warrants listed for trading on the NYSE MKT where its common shares are traded, or on the OTC Bulletin Board market if exchange listing is not feasible.
The Rights Offer
-- Under our proposal, after the Stem Cell Transaction, BAC, as a new public company, would conduct a Rights Offer to the holders of the Series A common stock to raise additional capital.
-- We presently contemplate that the Rights Offer would seek to raise approximately $39 million and would provide the Geron shareholders with the opportunity to increase their ownership interest in BAC to approximately 45% in the aggregate (without taking into account any BAC warrants) if they continue to hold their BAC Series A common stock and choose to exercise all of the subscription rights they receive in the Rights Offer.
-- In addition to acquiring BAC Series A common stock, BAC shareholders who exercise their subscription rights in the Rights Offer would also receive warrants to purchase additional BAC Series A common stock, which if exercised would increase Geron shareholders' ownership in BAC. We would propose to have BAC list those warrants on a national securities exchange or to arrange for the warrants to be traded on the OTC Bulletin Board so that the BAC shareholders could also sell their warrants at prevailing market prices.
-- BAC would also seek to have the subscription rights distributed in the Rights Offer listed for trading on a national securities exchange or over-the-counter market so that shareholders who do not wish to exercise their subscription rights could sell them at prevailing market prices.
-- If you receive subscription rights in the Rights Offer you would not be obligated to exercise those subscription rights, but instead you may choose to exercise some or all of your subscription rights in order to purchase additional BAC Series A shares and warrants, or you may sell some or all of your subscription rights, or you may simply choose to allow your subscription rights to expire unexercised.
Other Requirements
In addition to Geron Board approval noted above, the approval of Geron shareholders and BioTime shareholders may be required, depending on the structure of the Stem Cell Transaction. Registration of the BAC shares under the Securities Act of 1933, as amended (the "Securities Act"), will also be required. The Stem Cell Transaction would be subject to a variety of conditions yet to be negotiated. Further, the terms and conditions of the Rights Offer have not yet been determined and the proposed Rights Offer will not be conducted until a registration statement is filed under the Securities Act and becomes effective.
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate(TM) cell lines, HyStem(R) hydrogels, culture media, and differentiation kits. BioTime is developing Renevia(TM) (formerly known as HyStem(R)-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx(TM) currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences, Inc. markets GeneCards(R), the leading human gene database, and is developing an integrated database suite to complement GeneCards(R) that will also include the LifeMap(TM) database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap will also market BioTime research products. BioTime's lead product, Hextend(R), is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime can be found on the web at biotimeinc.com.
About BioTime Acquisition Corporation
BioTime Acquisition Corporation is a newly formed wholly owned subsidiary of BioTime, Inc., through which BioTime plans to pursue opportunities and acquire assets and businesses in the fields of stem cells and regenerative medicine.
This communication is not an offer to sell any securities or a solicitation of any vote or approval and BioTime and BAC are not offering to sell, or soliciting an offer to buy, any securities in any state where the offer or sale is not permitted.
This communication is for informational purposes only and does not constitute an offer to sell any shares of BAC common stock or warrants or a solicitation of any vote or approval, nor is it a substitute for a prospectus/proxy statement that may be included in a registration statement that may be filed with the Securities and Exchange Commission (the "SEC") under the Securities Act with respect to the proposed Stem Cell Transaction, or for a prospectus that may be included in a registration statement that may be filed under the Securities Act with respect to a Rights Offer. INVESTORS AND SECURITY HOLDERS OF GERON ARE URGED TO READ ANY PROSPECTUS/PROXY STATEMENT FOR THE STEM CELL TRANSACTION AND ANY PROSPECTUS FOR THE RIGHTS OFFER, AND ALL OTHER RELEVANT DOCUMENTS, THAT BIOTIME, BAC AND/OR GERON MAY FILE WITH THE SEC, IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. All documents referred to above, if filed by BioTime or BAC, will be available free of charge at the SEC's website Click for Detail |
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From: Savant | 10/19/2012 11:30:17 AM | | | | Geron Board to Review BioTime's Offer to Buy Stem Cell Assets
Last Update: 10/19/2012 7:57:38 AM
By Melodie Warner
Geron Corp. (GERN) said its board will review BioTime Inc.'s (BTX) offer to buy its stem cell assets.
The biopharmaceutical company said last November it would discontinue further development of its stem cell programs and eliminate 38% of its workforce in order to focus its resources on advancing two cancer drug candidates. At the time, the company said it was seeking partners with the technical and financial resources to further develop its stem cell programs.
Biotech company BioTime, in an open letter Thursday, urged Geron's shareholders to push the company's board to sell its stem cell assets to BioTime.
BioTime proposed a two-part deal that could result in Geron shareholders owning up to 45% of a new publicly traded company that owns the Geron stem cell assets, $40 million of BioTime stock, certain BioTime stem cell assets, and shares of certain BioTime stem cell subsidiaries. Geron shareholders would also receive BioTime stock-purchase warrants presently valued at roughly $13 million.
Geron on Friday said it has considered a number of alternatives with respect to its stem cell research and development programs.
Its board will review the BioTime proposal and "act in a manner that the board believes is in the best interests of Geron's stockholders," the company said.
Shares of Geron and BioTime closed Thursday at $1.52 and $3.97, respectively. Both stocks were inactive premarket. |
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From: Savant | 10/19/2012 4:44:14 PM | | | | LifeMap Sciences, Inc. Announces Addition to Board of Directors and Provides Update on Product Portfolio Development
ALAMEDA, Calif., Oct 19, 2012 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) and its subsidiary, LifeMap Sciences, Inc., today announced the appointment of Louis E. Silverman to LifeMap Sciences' board of directors.
Mr. Silverman is an experienced health care executive with board level and operating experience in health care IT, pharmaceuticals, home health care, worker's compensation managed care and revenue cycle management. From September 2009 through to its successful sale in June of 2012, Mr. Silverman was the Chief Executive Officer of privately held Marina Medical Billing Service Inc., a company focused on providing revenue cycle management services nationally to emergency room physicians. Prior to joining Marina Medical, Mr. Silverman was President and Chief Executive Officer of Lifecomm, Inc., a Qualcomm Incorporated incubated wireless health services start-up. From 2000 - 2008, Mr. Silverman was President and Chief Executive Officer of Quality Systems, Inc., a developer of medical and dental practice management software, which he led to significant revenue growth and an increase in market value from $42 million to $1.2 billion. Previously, Mr. Silverman was the Chief Operations Officer of Corvel Corporation. Mr. Silverman currently serves as a member of the Board of Directors of Questcor Pharmaceuticals, Inc., a publicly traded biopharmaceutical company focused on the treatment of patients with serious, difficult-to-treat autoimmune and inflammatory disorders. Mr. Silverman also serves on the Board of Directors of Comarco, Inc., a public company. Mr. Silverman earned a Bachelor of Arts degree from Amherst College and a Masters in Business Administration from Harvard Graduate School of Business Administration.
In addition, today LifeMap Sciences also announced progress on key development initiatives. During the final quarter of the calendar year 2012, the company expects to launch or upgrade its four database products: GeneCards(R), MalaCards, PanDaTox, and LifeMap Discovery(TM). In addition, LifeMap Sciences will launch the marketing and sales of BioTime's proprietary research product lines, including PureStem(TM) human progenitor and human embryonic stem cell lines via the company's LifeMap BioReagents(TM) portal. Another major LifeMap Sciences initiative is its therapeutic discovery collaboration with BioTime, which utilizes the LifeMap Discovery(TM) platform and leverages the LifeMap Sciences scientific team (including ten Ph.D. and four M.S. biologists and bioinformatics specialists) to research and identify those progenitor cell lines that are most likely to be useful in developing cell-based regenerative medicine therapies for a wide range of diseases. Once identified, selected cell lines will be marketed by LifeMap Sciences for research purposes via the LifeMap BioReagents(TM) portal and may be advanced into therapeutic development by BioTime and/or LifeMap Sciences.
"Adding an experienced health care executive to our Board of Directors and delivering meaningful enhancements to our product portfolio marks 2012 as a year of great progress for our company and sets the stage for continued growth and expansion into 2013," stated David Warshawsky, Ph.D., LifeMap Sciences' Chief Executive Officer.
About LifeMap Sciences, Inc. |
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From: Savant | 11/15/2012 6:39:48 PM | | | | BioTime and BioTime Acquisition Corporation Announce Combined $10 Million Financing
ALAMEDA, Calif., Nov 15, 2012 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) and its recently formed subsidiary BioTime Acquisition Corporation (BAC) jointly announced today that they have entered into a non-binding letter of intent for a $10 million investment from a private investor to provide financing for the recently announced proposed acquisition of Geron Corp.'s stem cell assets by BAC.
Under the terms outlined in the letter of intent, the investor will invest $5 million in BioTime by purchasing 1.35 million BioTime common shares at a purchase price of approximately $3.70 per share, and warrants to purchase 650,000 additional BioTime common shares with an exercise price of $5 per share and a three year term.
In addition, the investor will contribute $5 million in cash to BAC in exchange for shares of BAC common stock that, upon issuance, will represent approximately 7% of the BAC common stock then issued and outstanding, plus warrants to purchase approximately 350,000 additional shares of BAC common stock at an exercise price of $5 per share, with a three year term.
"This investment will provide BAC with financing to restart development of new products and technologies from the soon to be acquired stem cell assets," stated Michael West, PhD, Chief Executive Officer of BioTime, Inc.
"We are very pleased to receive such financial support from an investor who shares our vision of the emerging field of regenerative medicine," said Thomas Okarma, PhD, MD, BAC's Chief Executive Officer. "We look forward to the opportunity to restart research and development and to continue the effort to bring cell replacement therapies to the many patients who need them."
The letter of intent is not a binding agreement to complete the transactions. Consummation of the transactions is subject to the investor entering into definitive stock purchase agreements with BioTime and BAC, which agreements will contain additional terms and conditions.
About BioTime, Inc.
BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate(TM) cell lines, HyStem(R) hydrogels, culture media, and differentiation kits. BioTime is developing Renevia(TM) (formerly known as HyStem(R)-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx(TM) currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences, Inc. markets GeneCards(R), the leading human gene database, and is developing an integrated database suite to complement GeneCards(R) that will also include the LifeMap(TM) database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap will also market BioTime research products. BioTime's lead product, Hextend(R), is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime can be found on the web at biotimeinc.com.
About BioTime Acquisition Corporation
BioTime Acquisition Corporation is a newly formed wholly owned subsidiary of BioTime, Inc., through which BioTime plans to pursue opportunities and acquire assets and businesses in the fields of stem cells and regenerative medicine.
This communication is for informational purposes only and does not constitute an offer to sell any shares of BAC common stock or warrants or any BioTime common shares or warrants. The BAC common stock and warrants and the BioTime common shares and warrants may not be offered or sold in the United States absent registration under the Securities Act of 1933, as amended, and or an applicable exemption from registration requirements.
BioTime Forward-Looking Statements
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime or BAC, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime or BAC, particularly those mentioned in cautionary statements that are found in public filings with the Securities and Exchange Commission, and other filings that BioTime or BAC may make with the Securities and Exchange Commission. BioTime and BAC each disclaim any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: phx.corporate-ir.net.
SOURCE: BioTime, Inc.
BioTime, Inc. Peter Garcia, 510-521-3390, ext. 367 Chief Financial Officer pgarcia@biotimemail.com or Judith Segall, 510-521-3390, ext. 301 jsegall@biotimemail.com |
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From: Savant | 12/3/2012 4:28:13 PM | | | | 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 ( 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 The decision to discontinue development of GRN1005 was made after the company completed a planned interim analysis for futility for GRABM-B, the company`s Phase 2 study in patients with brain metastases arising from breast cancer. This analysis showed that there were no confirmed intra-cranial responses, as determined by an Independent Review Facility, among the first 30 evaluable patients in the trial. Data from the analysis will be presented in a poster at the San Antonio Breast Cancer Symposium on December 6. In addition, the company is discontinuing GRABM-L, its Phase 2 study in patients with brain metastases arising from non-small cell lung cancer, because of the inability to successfully enroll the trial. Geron has provided to Angiochem, Inc. notice of termination of both the exclusive license agreement under which Geron received rights to GRN1005 and an associated research collaboration and option agreement.
"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 Geron will be reporting the results of a phase 2 study of single agent imetelstat in patients with essential thrombocythemia (ET) in an oral presentation at the American Society of Hematology annual meeting on December 9. The ET study was designed to provide proof-of-concept for the potential use of imetelstat as a treatment for various hematologic myeloid malignancies, including myelofibrosis, myelodysplastic syndromes and acute myelogenous leukemias. JAK2 mutations are quantified during the trial to evaluate the effect of the drug on the malignant progenitor cells driving the disease. The top-line results from 14 patients enrolled in this study, all of whom were refractory to or intolerant of conventional therapies, showed a hematologic response rate of 100% (with 93% of patients achieving a complete response) and a molecular response rate of 86% among the seven patients who had a JAK2 mutation. These hematologic and molecular response rates, which exceeded the company`s expectations, suggest a selective inhibition of the malignant progenitor cells responsible for the patients` malignancy, and therefore potential disease-modifying activity by imetelstat that may be applicable in other hematologic myeloid 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 Published non-clinical data have demonstrated that tumor cells with short telomeres are more sensitive to telomerase inhibition with imetelstat than tumor cells with longer telomeres. To evaluate this hypothesis clinically, Geron included a pre-specified sub-group analysis of results by tumor telomere length in its randomized Phase 2 trial of imetelstat in non-small cell lung cancer. In September 2012, Geron reported that an unplanned interim safety and efficacy analysis of the data from that trial suggested a modest but not statistically significant trend in progression-free survival in favor of the imetelstat treatment arm in the overall study population (hazard ratio = 0.78). However, the pre-specified sub-group analysis suggested that imetelstat-treated patients whose tumors had short telomeres at baseline experienced a clinically meaningful, statistically significant increase in progression-free survival compared to patients in the control arm (n = 19; hazard ratio = 0.32; p = 0.042), which was not observed in imetelstat-treated patients whose tumors had medium-to-long telomeres (n = 38; hazard ratio = 0.83; p = 0.62). The company expects to present the data from the full sub-group analysis at a scientific conference in 2013. The company is working on a refined assay to prospectively measure telomere length in individual patient tumor samples, which would be required if Geron conducts a Phase 3-enabling clinical study of the effect of imetelstat in patients with solid tumors that have short telomeres.
Management Changes In connection with the restructuring, Graham Cooper, the company`s Chief Financial Officer, will be leaving the company to pursue other opportunities. Olivia Bloom, currently Vice President of Finance, Chief Accounting Officer and Treasurer, will assume the role of Chief Financial Officer effective December 7.
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."
Conference Call At 8:30 a.m. ET on December 4, 2012, Geron`s management will host a conference call to discuss the strategic realignment of the company.
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.
About Geron
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 |
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From: Savant | 12/10/2012 11:50:13 AM | | | | Geron presents positive results from Phase 2 study of imetelstat in essential thrombocythemia at the American Society of Hematology Annual Meeting Co announced positive clinical results from the Phase 2 trial of imetelstat, the company's first-in-class telomerase inhibitor, in patients with essential thrombocythemia (ET). The data, which showed rapid and durable hematologic and molecular responses in patients treated with imetelstat, were presented Sunday evening in an oral session at the 54th Annual Meeting of the American Society of Hematology in Atlanta, GA. The results from the first 14 patients enrolled in the ET study were reported. All were refractory to or intolerant of conventional therapies (hydroxyurea, anagrelide and/or interferon-alpha). Platelet counts were reduced in all patients (a 100% hematologic response rate) and normalized in 13 out of 14 patients (a 92.9% complete response rate). The allelic burden of the JAK2 V617F gene mutation decreased over time in the seven patients who had such a mutation, with substantial reductions that qualified as partial molecular responses achieved in six out of seven (85.7%) patients within three to six months of treatment with imetelstat. In the study, imetelstat was generally well tolerated. The majority of the non- hematologic adverse events were mild-to-moderate in severity, the most frequent being gastrointestinal events. |
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From: tktrimbath | 12/31/2012 10:59:23 PM | | | | My End of Year Review of GERN
INTRO Here's my semi-annual exercise to see if I remember why I own the stocks I own, and so I can check back and see if their stories have changed. I post in case it helps others too.
Geron GERN (market cap $0.184B) Geron is a leading edge biotech specializing in critical treatments for the big medical issues: organ replacement and repair, cancer treatment, and such via telomerase, stem cells, nuclear transfers, and some novel chemistry. I liked their approach. They have been bold enough to pursue some of the most powerful biological technologies that many talk about, but few act upon. Despite their boldness, they have been conservative and cogniscent of public perception and federal regulations. Such medical advances can create great companies, but are high risk, cost more, and require longer clinical trials. If successful, their technological advantages may be hard to replicate or compete against.
Sadly, 2012 seemed to be the year of cancelled clinical trials. Geron finally got out of the lab and into the patient population, but for a variety of reasons they were not as successful as they, or I, had hoped. Diversification is important in risky ventures, and fortunately Geron has had more than only technology to pursue. Unfortunately, the list seems dramatically reduced. Good news is still possible, and there has been some, but the stock price attests that the news hasn't been significant enough within the investment community.
Failure in one set of trials does not change the odds of the other trials. I must remind myself of that.
DISCLOSURE LTBH since 1999 and continuing to hold. I won't buy more because 1) I have no discretionary funds (ask my mortgage company) and because I may have enough stock if they succeed (in which case I can pay off my mortgage company). Unfortunately, I may have to sell if I can't find a job or sell my house. (I've also collected links to the other discussion boards and my other stocks over on my blog trimbathcreative.wordpress.com) |
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To: tktrimbath who wrote (3354) | 1/1/2013 1:35:41 AM | From: mcbio | | | I had pretty much left GERN for dead. But their data with imetelstat against essential thrombocythemia ( ir.geron.com ) has me rethinking. Per recent CC, they have almost 3 years of cash and they believe imetelstat works in diseases with short telomeres (this may include myelofibrosis, which they are expanding testing into). |
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From: Savant | 1/7/2013 10:40:34 AM | | | | BioTime Signs Definitive Agreement With Geron Regarding Stem Cell Assets
Investor Commits to $10 Million Financing
ALAMEDA, Calif., Jan 07, 2013 (BUSINESS WIRE) -- BioTime, Inc. (nyse mkt:BTX) and its recently formed subsidiary BioTime Acquisition Corporation (BAC) jointly announced today that they have entered into a definitive Asset Contribution Agreement with Geron Corporation (GERN) to acquire the intellectual property, including patents and patent applications, and other assets related to Geron's human embryonic stem (hES) cell programs consistent with the financial terms outlined in the letter of intent announced on November 15, 2012.
Under the definitive agreement, Geron will contribute to BAC intellectual property, certain cell lines and other assets, including the Phase 1 clinical trial of hES cell-derived oligodendrocytes in patients with acute spinal cord injury, and Geron's autologous cellular immunotherapy program. BioTime will contribute to BAC $5 million in cash, 8,902,077 BioTime common shares to be held by BAC, five-year warrants to purchase 8,000,000 common shares of BioTime at a price of $5.00 per share ("BioTime Warrants"), rights to use certain clinical grade hES cell lines, a sublicense to use certain patents for stem cell differentiation technology, and minority stakes in two of BioTime's subsidiaries, OrthoCyte Corporation and Cell Cure Neurosciences Ltd. BAC will also pay to Geron royalties on the sale of products that are commercialized, if any, in reliance upon Geron patents contributed or licensed to BAC. A private investor has also agreed to provide an equity investment of $5 million in BAC and a $5 million equity investment in BioTime in conjunction with the transaction.
Geron pioneered the field of regenerative medicine in the mid-1990s by organizing the first effort to isolate human embryonic stem (hES) cells. hES cells are early-stage stem cells that are capable of becoming all of the cell types in the human body, and therefore are widely recognized as a means of manufacturing cells that are potentially useful in regenerating tissue function for a wide array of degenerative diseases. Currently, Geron's hESC patent portfolio includes over 400 patents and patent applications that will be transferred or sublicensed to BAC. Geron obtained the first approval from the Food and Drug Administration for human clinical trials of a product manufactured from hES cells.
Geron's former hES cell programs included oligodendrocyte progenitor cells for central nervous system disorders, cardiomyocytes for heart disease, pancreatic islet cells for diabetes, dendritic cells as an immunotherapy vehicle, and chondrocytes for cartilage repair. BAC may pursue the development of therapeutic products from some or all of these cell types, depending upon a number of factors, including the expected cost of development, sufficiency of financing, the state of development of the technology acquired, regulatory considerations, anticipated market size, and competition from other companies in the applicable fields. BAC may also seek to develop other therapeutic products, taking into account the same or other applicable considerations.
"Our consistent goal at BioTime has been to consolidate the pluripotent stem cell technology platform," stated Michael West, Ph.D., Chief Executive Officer of BioTime, Inc. "With this contribution of assets, the combined intellectual property estate in the BioTime family of companies will be among the strongest in the field of Regenerative Medicine; establishing our leadership in the industry and advancing product development."
"We are excited about our approach toward consolidating the most important technologies in Regenerative Medicine," said Thomas Okarma, M.D., Ph.D., president and CEO of BAC. "Regenerative Medicine holds great promise for patients and now, with our significant collection of world class stem cell technologies, IP, and experienced management, we are positioned to help realize that promise."
Closing of the transactions under the definitive agreement is subject to certain negotiated closing conditions, including the registration of the BAC Series A common stock, the BioTime common shares contributed to BAC, and the BioTime Warrants under the Securities Act of 1933, as amended, and certain approvals by BioTime shareholders. The transaction is expected to close no later than September 30, 2013.
Upon closing of the transaction, Geron will receive BAC Series A common stock, and BioTime and the private investor will receive BAC Series B common stock in the transaction. The Series A and Series B common stock will be identical, except that BAC will be entitled to make certain distributions or pay dividends on its Series A common stock without making a distribution or paying a dividend on its Series B common stock.
Following the closing of the transaction, Geron will distribute on a pro rata basis to its stockholders the shares of BAC Series A common stock received in the transaction. Following that distribution by Geron, BAC will distribute on a pro rata basis to the holders of those shares the BioTime Warrants. The Series B common stock will be convertible into Series A common stock following the distribution of the BioTime Warrants.
Following these distributions, BioTime will own approximately 71.6%, Geron stockholders will own approximately 21.4%, and the private investor will own approximately 7.0%, of the outstanding BAC common stock. BioTime and the private investor will also receive warrants to purchase additional shares of BAC Series B common stock that would enable them to increase their collective ownership in BAC by approximately 2.2%, which would reduce the Geron stockholders' ownership in BAC to approximately 19.2%.
BAC plans to seek to list its Series A common stock, and BioTime intends to seek to list the BioTime Warrants, on a national securities exchange.
In anticipation of use by BAC, BioTime is entering into a three-year lease of an office and research facility in Menlo Park, Calif.
In a separate and related transaction, BioTime and BAC have each entered into Stock and Warrant Purchase Agreements with a private investor to provide each company with $5 million in equity financing. Under the terms of the BioTime agreement, the investor will invest $5 million in BioTime by purchasing an aggregate of 1,350,000 BioTime common shares at a purchase price of approximately $3.70 per share and warrants to purchase 650,000 additional BioTime common shares with an exercise price of $5.00 per share and a three year term. The shares and warrants will be sold to the investor in two tranches. In the first tranche, the investor will purchase 540,000 BioTime common shares and warrants to purchase approximately 260,000 BioTime common shares for $2 million subject to the conditions of the Stock and Warrant Purchase Agreement. The second BioTime investment tranche of $3 million will be funded in conjunction with the closing of the stem cell asset transaction with Geron. Closing of the second tranche of the share and warrant purchase is subject to certain additional conditions; these conditions include the closing of the stem cell asset transaction. This $5 million investment will be used to fund BioTime's $5 million cash contribution to BAC.
Under the terms of its Stock Purchase Agreement with BAC, the investor will contribute $5 million in cash to BAC in exchange for 2,136,000 shares of BAC Series B common stock that, upon issuance, will represent approximately 7% of the BAC common stock outstanding at the closing, plus warrants to purchase approximately 350,000 additional shares of BAC Series B common stock at an exercise price of $5.00 per share, with a three year term. Closing of the financing in BAC will occur in conjunction with the closing of the stem cell asset transaction with Geron, and is subject to certain conditions, including the closing of the stem cell asset transaction.
Kaye Scholer LLP and Thompson, Welch, Soroko & Gilbert LLP are acting as legal counsel to BioTime in connection with the transaction.
Additional Information and Where to Find It
All parties desiring details regarding the transaction are urged to review the definitive agreement when it is available on the Securities and Exchange Commission's (the "SEC's") website at sec.gov. In connection with the proposed transaction, BioTime will file with the SEC a proxy statement, and plans to file with the SEC other documents regarding the proposed transaction. INVESTORS AND SECURITY HOLDERS ARE ADVISED TO READ THE PROXY STATEMENT AND OTHER FILED DOCUMENTS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. Shareholders will be able to obtain a free-of-charge copy of the proxy statement and other relevant documents (when available) filed with the SEC from the SEC's website at sec.gov. Shareholders will also be able to obtain a free-of-charge copy of the proxy statement and other relevant documents (when available) by directing a request by mail or email to BioTime's Chief Financial Officer at 1301 Harbor Bay Parkway, Alameda, California 94502 or pgarcia@biotimemail.com. BioTime and Geron and certain of their respective directors and executive officers may, under the rules of the SEC, be deemed to be "participants" in the solicitation of proxies from shareholders of BioTime in favor of the share issuance and other proposals in connection with the proposed transaction. Information regarding BioTime's directors and executive officers is contained in BioTime's definitive proxy statement filed with the SEC on April 30, 2012. Information about Geron's directors and executive officers is set forth in Geron's proxy statement for its 2012 Annual Meeting of Stockholders, which was filed with the SEC on April 24, 2012. The proxy statement and other relevant documents (when available) filed with the SEC are available free of charge with the SEC are available free of charge at the SEC's website at sec.gov, and from Geron by contacting Investor Relations by mail at Geron Corporation, 149 Commonwealth Drive, Suite 2070, Menlo Park, California 94025, Attn: Investor Relations Department, or by going to Geron's Investor Relations page on its corporate website at geron.com. Additional information regarding the interests of such potential participants will be included in the proxy statement and the other relevant documents filed with the SEC (when available).
This communication is for informational purposes only and does not constitute an offer to sell any BAC common stock or warrants or any BioTime common shares or warrants or a solicitation of any vote or approval, nor is it a substitute for a prospectus that may be included in a registration statement that may be filed by BAC or BioTime with the SEC under the Securities Act with respect to the proposed transaction, or a proxy statement that will be provided to BioTime shareholders. BioTime and BAC are not offering to sell, or soliciting an offer to buy, any securities in any state where the offer or sale is not permitted.
About BioTime, Inc.
BioTime, headquartered in Alameda, Calif., is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is enhanced through subsidiaries focused on specific fields of application. BioTime develops and markets research products in the fields of stem cells and regenerative medicine, including a wide array of proprietary PureStem(TM) cell lines, HyStem(R) hydrogels, culture media, and differentiation kits. BioTime is developing Renevia(TM) (formerly known as HyStem(R)-Rx), a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-Dx(TM) currently being developed for the detection of cancer in blood samples. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's subsidiary LifeMap Sciences, Inc., markets GeneCards(R), the leading human gene database, and has developed an integrated database suite to complement GeneCards(R) that includes the LifeMap Discovery(TM) database of embryonic development, stem cell research and regenerative medicine, and MalaCards, the human disease database. LifeMap is also marketing BioTime research products. BioTime's lead product, Hextend(R), is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc., and in South Korea by CJ CheilJedang Corporation under exclusive licensing agreements. Additional information about BioTime can be found on the web at biotimeinc.com.
About BioTime Acquisition Corporation
BioTime Acquisition Corporation is a newly formed wholly owned subsidiary of BioTime, Inc., through which BioTime plans to pursue opportunities and acquire assets and businesses in the fields of stem cells and regenerative medicine.
BioTime Forward-Looking Statements
Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Statements in this press release regarding BioTime or BAC's plans, expectations or timing relating to BAC's acquisition of the stem cell assets and related transactions are forward-looking statements and these statements involve risks and uncertainties, including, without limitation, the ability of the parties to close the transaction in a timely manner or at all, the possibility that conditions to closing of the proposed transaction, including the approval of BioTime's shareholders, and the effectiveness of registration statements to be filed by BioTime and BAC with the SEC, may not be satisfied, as well as risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Additional factors that could cause actual results to differ materially from the results anticipated in these forward-looking statements are contained in BioTime's periodic reports filed with the SEC under the heading "Risk Factors" and and other filings that BioTime or BAC may make with the SEC. Undue reliance should not be placed on these forward-looking statements which speak only as of the date they are made, and the facts and assumptions underlying these statements may change. Except as required by law, BioTime and BAC each disclaims any intent or obligation to update these forward-looking statements.
To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list: phx.corporate-ir.net.
SOURCE: BioTime, Inc.
BioTime, Inc. Peter Garcia, 510-521-3390, ext. 367 Chief Financial Officer pgarcia@biotimemail.com or Judith Segall, 510-521-3390, ext. 301 jsegall@biotimemail.com |
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From: Savant | 2/1/2013 1:52:06 AM | | | | RT... LifeMap Sciences, a Subsidiary of BioTime, Announces Publication of Research Report Describing Non-Redundant Compendium of Human Non-Coding RNA Authored by GeneCards(R) Scientists
Report shows the existence of a^ 1/480,000 human non-redundant non-coding RNAs covering 71% of the human genome, slightly less than the ENCODE prediction of 80%
ALAMEDA, Calif., Jan 30, 2013 (BUSINESS WIRE) -- LifeMap Sciences, Inc., a subsidiary of BioTime, Inc. (nyse mkt:BTX), announced today the publication of a paper authored by a research group under the supervision of Prof. Doron Lancet from the Department of Molecular Genetics at the Weizmann Institute of Science describing the analysis and display of a non-redundant compendium of human non-coding RNA genes, which was made available as part of GeneCards(R) Version 3.09, released November 18, 2012. LifeMap Sciences holds the exclusive worldwide license to market GeneCards(R) from Yeda Research and Development Company Ltd., the commercial arm of the Weizmann Institute of Science.
Non-coding RNA (ncRNA) genes are increasingly acknowledged for their importance in the human genome, and are implicated in various disease processes. Therefore they are of interest to many academic and industry researchers in various biomedical fields, and to biotechnology and pharmaceutical companies engaged in discovery and development of diagnostic and therapeutic products. The ENCODE project Click for Detail, launched in 2003 has recently predicted that ~80% of all genomic territories are transcribed in one fashion or another. In the GeneCards(R) publication, in the journal Bioinformatics Click for Detail, the scientists leveraged the effective platform of GeneCards(R) to unify all ncRNA gene entries obtained from 15 different primary data sources. Overlapping entries were clustered to unified locations based on an algorithm employing genomic coordinates, resulting in a a^ 1/45-fold increase, to a total of a^ 1/480,000 human non-redundant ncRNAs, belonging to 14 classes. The total genome territory covered is 71% of the human genome, slightly less than the ENCODE prediction. This difference may be due to dataset input and computation discrepancies or may represent ncRNA genes still awaiting identification and characterization.
GeneCards(R) is a comprehensive online database that provides concise genomic information on all known and predicted human genes. With over 12 million page visits per year from hundreds of thousands of unique users worldwide, GeneCards(R) is accessed by professionals in academia, research hospitals, patent offices, and leading biotech and pharma companies. GeneCards(R) was developed, and is continuously enhanced by ongoing research, by the bioinformatics team at the Department of Molecular Genetics at the Weizmann Institute of Science in Israel, with principal investigator Professor Doron Lancet, head of the Crown Human Genome Center, and team leader Marilyn Safran.
"It is wonderful to see how GeneCards(R) allowed us to overcome the great obstacles of grand unification of ncRNA genes. This allows scientists to make discoveries on biological and disease-related roles for genes belonging to this newly open vista of the human genome," said Professor Doron Lancet, Ph.D., The Ralph D. and Lois R. Silver Professor of Human Genomics, at the Weizmann Institute of Science.
"The addition of detailed annotated ncRNAs information, while providing the big picture on ncRNAs is a significant addition to GeneCards(R)," stated Yaron Guan-Golan, Head of Marketing at LifeMap Sciences. "We have already seen substantial interest from companies and academic users to access this new information for their research and product discovery efforts. We believe that this new information, and the synergies between GeneCards(R), MalaCards, and LifeMap Discovery(TM) will significantly enhance basic research, and contribute greatly to the discovery and development of novel diagnostic and therapeutic products and technologies."
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