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   Biotech / MedicalGeron Corp.


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From: Casaubon4/22/2012 1:15:04 PM
1 Recommendation   of 3549
 
DePinho and Sahin recently published on the adaptive mechanisms provoked by anti-telomerase therapy:

Cell, 2012, v.148, p.651

If anyone is interested in discussing the ramifications to GERN, I would be interested in participating in that conversation. Topics of interest would include how the FDA would respond to the potential for driving a resistance mechanism, given the potential for a sustained positive response in a subset of patients. Also, of interest would be potential oxidative defense drugs, which could be utilized in combination with anti-telomerase therapy, to potentially increase the efficacy of GRN163L.

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From: Savant5/3/2012 10:36:35 AM
   of 3549
 
Geron beats by $0.03, beats on revs
Reports Q1 (Mar) loss of $0.15 per share, $0.03 better than the Capital IQ Consensus Estimate of ($0.18); revenues fell 16.9% year/year to $1.25 mln vs the $0.7 mln consensus. Research and development expenses for the first quarter of 2012 were $15.1 million, compared to $16.8 million for the comparable 2011 period. The decrease in research and development expenses reflected reduced personnel-related costs and lower scientific supplies expenses resulting from the discontinuation of the company's stem cell programs, partially offset by increased clinical trial expenses for the enrollment of four Phase 2 clinical trials of imetelstat and two Phase 2 clinical trials of GRN1005 and increased drug product purchases and manufacturing costs related to imetelstat and GRN1005.

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From: tktrimbath6/30/2012 10:56:08 AM
   of 3549
 
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
   of 3549
 
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: Savant7/31/2012 1:25:19 PM
   of 3549
 
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: Savant7/31/2012 1:32:52 PM
   of 3549
 
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: Savant8/17/2012 11:32:39 AM
   of 3549
 
seekingalpha.com

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From: Savant8/30/2012 11:25:25 AM
   of 3549
 
Geron Started At Buy By Stifel Nicolaus

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From: Savant9/10/2012 12:59:47 PM
   of 3549
 
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: Savant9/11/2012 7:36:32 PM
1 Recommendation   of 3549
 
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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