| From: Savant | 9/10/2012 12:59:47 PM | | | | | | Out of the blue....Geron Ends Study of Imetelstat for Breast Cancer; Cites Shorter Survival Period
Last Update: 9/10/2012 8:02:38 AM
By Melodie Warner
Geron Corp. (GERN) is discontinuing its Phase 2 study of imetelstat in metastatic
HER2-negative breast cancer because the median progression-free survival was
shorter than the comparison treatment.
The biopharmaceutical company was evaluating imetelstat in combination with
chemotherapy drug paclitaxel and comparing it to paclitaxel alone.
Geron said the median progression-free survival was 6.2 months for patients
receiving imetelstat, compared with eight months for patients receiving
paclitaxel alone.
The company also said a scheduled periodic review by its internal safety
monitoring committee found a greater number of deaths in patients taking the
imetelstat treatment. Although the absolute number of deaths was higher, there
was no statistically significant difference in overall survival.
Based on these findings, Geron decided to discontinue the breast cancer trial.
The company will continue its Phase 2 study of imetelstat in advanced nonsmall
cell lung cancer. However, a separate interim analysis of the NSCLC study
suggested a modest trend of efficacy in favor of the imetelstat arm, indicating
the prespecified success criteria in this trial are unlikely to be met. As a
consequence, Geron said it is doubtful that it will take imetelstat forward into
Phase 3 development for NSCLC.
Geron said its plans for further development of imetelstat in two hematologic
malignancies--essential thrombocythemia and multiple myeloma--haven't been
impacted by these results.
Shares closed Friday at $2.90 and were halted in premarket trading. The stock is
up 96% since the beginning of the year. |
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| From: Savant | 9/11/2012 7:36:32 PM | | | | | | UPDATE: Geron Ends Study of Breast Cancer Drug; Shares Plunge
Last Update: 9/10/2012 6:20:06 PM
--Geron halts mid-stage study on drug to treat breast cancer
--News raises concerns about drug's ability to treat other cancers
--Shares fall 56% after setting a new high for the year
(Updates throughout with comments from Geron CEO and an analyst.)
By Joseph Walker
Geron Corp. (GERN) halted a mid-stage study examining the use of its imetelstat
drug in breast cancer patients because of doubts about the drug's effectiveness.
The news raised serious questions about one of the company's two drugs in
development and sent shares of the biopharmaceutical company down more than 50%
to an all-time low, a session after setting a new 52-week high.
"I don't see a path forward clinically for imetelstat," Stifel Nicolaus analyst
Brian Klein said. "Before you had a two-pipeline company with two interesting
oncology assets, where in my mind, it's now just one."
Geron Chief Executive John Scarlett disputed that notion, saying "imetelstat is
not dead." The company is focused on testing the drug on cancers affecting the
blood, bone barrow and lymph nodes, Scarlett noted, and could apply it to other
tumors.
"Most successful anti-cancer drugs have many failures in many types of cancer and
the ones that go on to be successful have failed like this one has," Mr. Scarlett
said.
The suspension of the imetelstat breast cancer trial comes after a company
analysis showed patients given imetelstat in conjunction with chemotherapy drug
paclitaxel experienced a median of 6.2 months without the disease progressing,
compared to eight months for patients who were treated with the chemotherapy
alone.
The analysis was conducted after a routine safety review found that more
imetelstat patients had died during the study than the group undergoing just
chemotherapy. The company had been evaluating imetelstat in combination with
chemotherapy drug paclitaxel and comparing it to paclitaxel alone.
Imetelstat's toxicity profile in the breast cancer trial doesn't bode well for
its future success, said Mr. Klein from Stifel Nicolaus, who noted the trials in
breast and lung cancer were more advanced and had the greater market potential.
The results from the trials studying imetelstat in blood cancers are expected in
the fourth quarter. Geron said Monday that it was unlikely to proceed with a
separate study of imetelstat's effectiveness with lung cancer patients after an
interim analysis showed just a modest trend toward efficacy and that the trial
was unlikely to meet its goals.
CEO Scarlett said while Geron hasn't fully evaluated the financial impact from
the negative trial news, it has no restructuring or layoff plans.
"We have adequate cash today to do the studies we plan to do, that we're doing as
we speak, and as we look at our path forward, we'll make the same decisions every
company makes on what we need in terms of people and cash going forward," Mr.
Scarlett said.
The company ended its most recent quarter on June 30 with $122.3 million in cash
and investments, and reported a loss of $18.3 million.
Mr. Klein said he expects Geron, which has about 110 employees, to cut its staff
somewhere between 20% and 30% and that the company will redeploy its research and
development budget, and divert more of its research and development budget away
from imetelstat and into its other drug, the brain cancer treatment GRN1005.
GRN1005 also is in mid-stage studies with lung and breast cancer patients who
have had tumors spread to their brains. The company said it expects to announce
interim data on the breast cancer study in early December and top-line results on
both the lung and breast cancer trials in the second quarter of 2013.
Mr. Scarlett said the company is optimistic about the market opportunity for
GRN1005 because as cancer patients live longer, more of them are seeing cancer
spread to their brains. Mr. Scarlett said 35% of women with HER2 positive breast
cancer eventually developed brain tumors.
Geron shares on Monday hit an all-time low of $1.23 and closed at $1.28, down 56%
on the day. On Friday, the stock had hit a 52-week high of $2.99. |
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| To: cycleupcycledown who wrote (3345) | 10/18/2012 8:19:10 PM | | From: Savant | | | | BioTime Forms BioTime Acquisition Corporation
Subsidiary will seek to acquire assets and businesses in the stem cell and
regenerative medicine fields
ALAMEDA, Calif., Sep 28, 2012 (BUSINESS WIRE) -- --Dr. Thomas Okarma appointed
Chief Executive Officer of the new company
BioTime, Inc. (nyse mkt:BTX), an Alameda-based company engaged in research and
development of innovative new products in the field of regenerative medicine
utilizing stem cells and related technology, announced today that it has formed a
new wholly owned subsidiary, BioTime Acquisition Corporation, to pursue
opportunities and acquire assets and businesses in the fields of stem cells and
regenerative medicine. Thomas Okarma, PhD, MD, will serve as the Chief Executive
Officer and as a member of the board of directors of BioTime's new subsidiary.
Dr. Okarma is the former President and Chief Executive Officer of Geron
Corporation and served on that company's board of directors.
Since 2010, BioTime has expanded the scope of its business through strategic
acquisitions and has been continually exploring other acquisition opportunities
in its fields of interest. BioTime's strategic acquisitions include:
-- ES Cell International Pte Ltd. (ESI), a Singapore company that developed the
first human embryonic stem cells generated under conditions designed to be
compliant with current good manufacturing practices (cGMP). ESI holds significant
intellectual property assets in the stem cell field, including a patent cross
license with Geron Corporation (GERN) providing a non-exclusive, worldwide cross
license to certain patent rights owned by Geron and ESI covering the
differentiation of neural cells from human embryonic stem cells.
-- Cell Cure Neurosciences Ltd., a majority-owned subsidiary of BioTime that is
developing therapeutic products derived from stem cells for the treatment of
retinal and neural degenerative diseases. Cell Cure's lead product is
OpRegen(TM), a retinal cell product for use in the treatment of age-related
macular degeneration.
-- Glycosan BioSystems, Inc., the developer of HyStem(R) hydrogel products, from
which BioTime is developing Renevia(TM) as a biocompatible, implantable
hyaluronan and collagen-based matrix for cell delivery in human clinical
applications. As an injectable product, Renevia(TM) may address an immediate need
in cosmetic and reconstructive surgeries and other procedures by improving the
process of transplanting adipose-derived cells, mesenchymal stem cells, or other
adult stem cells.
-- Cell Targeting, Inc., the developer of peptide-based technologies that may
facilitate directing human cells derived from embryonic stem and induced
pluripotent stem cells to sites in the body where the cells can exert a
therapeutic effect. These technologies are being used by BioTime's subsidiary
OncoCyte Corporation for its research and development related to genetically
modified human embryonic stem cell-derived vascular progenitors designed to
target and destroy malignant tumors.
-- Xennex, Inc., the holder of exclusive worldwide rights to market GeneCards(R),
the leading human gene database, which was acquired by BioTime's subsidiary
LifeMap Sciences, Inc. GeneCards(R) provides concise genomic, transcriptomic,
genetic, proteomic, functional, and disease-related information on all known and
predicted human genes. In addition, LifeMap is currently developing two
additional databases: LifeMap, a database for stem cell biology, and MalaCards, a
disease database. Together, this integrated database suite will provide
state-of-the-art information and research products for the medical research
community.
"Global advances on multiple fronts of stem cell biology have established the
foundation for an integrative business approach to consolidate and translate
these discoveries into products that may revolutionize clinical medicine," said
Thomas Okarma, the new company's CEO. "Living cell therapies can now be scalably
manufactured, efficiently distributed to points of care, and tested in controlled
clinical trials. The goal of regenerative medicine is to go beyond the reach of
pills and scalpels to achieve a new level of healing that may, after a single
administration of therapeutic cells, permanently restore function to tissues and
organs damaged by chronic disease or injury. BioTime Acquisition Corporation
intends to build its business by identifying, consolidating, and commercially
developing the best available cell therapy technologies to realize the potential
of regenerative medicine. Ultimately, the goal is to bring these new therapies to
the many millions of patients who need them."
"The breadth of Dr. Okarma's experience in the field of cell-based therapeutics
is simply spectacular," said Michael D. West, PhD, BioTime's Chief Executive
Officer. "We look forward to working together with him to translate these new
scientific advances into commercial products for the large and growing markets
driven by age-related degenerative diseases."
Dr. Okarma has had a distinguished career as a physician and an innovator and
executive in the biotechnology industry. Dr. Okarma served as Geron's President,
Chief Executive Officer, and as a member of its board of directors from July 1999
until February 2011, after having previously served as that company's Vice
President of Research and Development and Vice President of Cell Therapies. In
1985, Dr. Okarma founded Applied Immune Sciences, Inc. (AIS) and served initially
as its Vice President of Research and Development and subsequently as Chairman
and Chief Executive Officer and as a director until that company was acquired by
Rhone-Poulenc Rorer in 1995. After that acquisition, Dr. Okarma served as a
Senior Vice President at Rhone-Poulenc Rorer until December 1996. From 1980 to
1992, Dr. Okarma was a member of the faculty of the Department of Medicine at
Stanford University School of Medicine. Dr. Okarma holds an AB from Dartmouth
College, an MD and PhD from Stanford University, and is a graduate of the
Executive Education program of the Stanford Graduate School of Business.
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. |
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| To: Savant who wrote (3346) | 10/18/2012 8:20:02 PM | | From: Savant | | | | BioTime Proposes Buying Geron's Stem Cell Assets
Last Update: 10/18/2012 9:37:58 AM
By Saabira Chaudhuri
In an open letter, BioTime Inc. (BTX) urged Geron Corp. (GERN) shareholders to
push Geron's board to sell the company's stem cell assets to BioTime.
Geron's shares popped 7% to $1.52 in early trading.
In November of last year, Geron said it would discontinue the further development
of its stem cell programs and will eliminate 38% of its workforce as the company
aimed to focus resources on advancing two cancer drug candidates. At the time,
the company, which said it would eliminate 66 full-time positions, said it was
seeking partners with the technical and financial resources to further develop
its stem cell programs.
In its letter, BioTime said: "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."
Geron didn't immediately respond to a request for comment.
BioTime proposed that Geron would transfer its stem cell assets to a subsidiary
of BioTime, in exchange for which shareholders would receive a 21.4% stake in the
subsidiary.
BioTime said its offer, if accepted, would allow Geron shareholders to 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 units.
Geron shareholders would also receive BioTime stock-purchase warrants presently
valued at about $13 million. Geron shareholders would continue to own the entire
Geron cancer therapy business through their ownership of Geron stock. |
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| 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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