| From: tktrimbath | 6/30/2012 10:56:08 AM | | | | | | 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 $0.226B)
Geron is the leading edge of biotech, in my opinion. They are advancing technologies for cloning, nuclear transfer, stem cells, and telomerase. Done right they can repair damage, grow organs, and control the life and death cycle of cells. They are engaged in at least 6 phase two clinical trials for cancer treatments. They own an impressive patent portfolio. Management seems to properly understand and manage public perception and the debate around some of the more sensitive issues. They have little or no debt. They could redefine medicine, using the body to tend the body in ways that exceeds Dendreon's achievements technically, clinically, and financially.
But, they survive on dilution and must continue to do so for years unless licensing fees become more significant; they cancelled a stem cell clinical trial that attempted to regrow damaged nerves, or at least increase nerve function. The stem cell portion of the business is effectively up for sale, which decreases their internal diversification. I've held them for so long that I start to wonder about the age of their patents within their portfolio.
I conduct this exercise to see if the story has changed. Geron has made progress, but disruptive technologies are slowed in their move through the conventional regulatory bureaucracy. Dendreon was delayed by years. Geron seems to have encountered similar resistance. I think they set a record number of pages for the stem cell trial, which produced an incredibly tight set of trial conditions. I don't know of any significant competitor, but delays do not benefit the company and, if the treatments are successful, delays don't benefit the patient population.
There's little else to say for now, but if they announce positive results a lot will be said in the media. Of course, I thought that about the nerve treatment study, but they didn't produce the necessary positive results.
DISCLOSURE LTBH since 1999 and continuing to hold because I may have enough stock if they succeed, and may have time to buy more at these low prices as they make progress if I have discretionary cash (which I don't - let me check my lottery tickets). 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 (3337) | 6/30/2012 8:04:09 PM | | From: Casaubon | | | | | Unfortunately, I have to disagree at this point. GERN has become just another biotech oncology cr@pshoot. The scientific literature supports multiple mechanisms by which this might pan out. However, clinically relevant results have been hard to come by. Let's hope the tumor initiating cell/DNA damage repair mechanisms plays out clinically in the next six months, or this things circling the bowl. |
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| From: Savant | 7/31/2012 1:25:19 PM | | | | | | Geron beats by $0.01, misses on revs
Reports Q2 (Jun) loss of $0.14 per share, $0.01 better than the Capital IQ Consensus Estimate of ($0.15); revenues fell 71.9% year/year to $0.13 mln vs the $0.48 mln consensus. Total operating expenses for the second quarter of 2012 were $18.6 million, compared to $21.9 million for the comparable 2011 period. Research and development expenses for the second quarter of 2012 were $12.8 million, compared to $16.5 million for the comparable 2011 period. General and administrative expenses for the second quarter of 2012 were $5.8 million, compared to $5.3 million for the comparable 2011 period. |
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| From: Savant | 7/31/2012 1:32:52 PM | | | | | | July 3rd.. Geron Corp Registers Mixed-Securities Shelf For Up To $200M
Last Update: 7/3/2012 5:22:13 PM |
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| 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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