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Biotech / Medical : Geron Corp. -- Ignore unavailable to you. Want to Upgrade?

To: LJM who wrote (3026)	5/23/2007 2:51:37 PM
From: JMarcus	Read Replies (1) \| Respond to of 3576

Here are my mostly raw notes from this year’s stockholders meeting, which was held at 8:30 AM in the company's office headquarters. First, my general impression. Tom Okarma seemed much more relaxed than last year and unlike last year the mood of the attendees was upbeat. In prior years, Okarma would arrive several minutes early, stand at the rostrum, and wait impatiently, as though he were eager to get the ordeal over with. This year he strode into the room promptly at 8:30 AM and launched right into introductions and conducting the meeting. As usual, the officers and directors sat in a phalanx in a segregated block of chairs, to the left. The attendance by individual stockholders was the largest that I can remember. I didn’t detect the presence of any analysts at the meeting. Just us plain folks and the Geron staff. The Q&A lasted longer than in prior years, but Okarma still cut off the Q&A before all the questions had been answered. Okarma hung around a while after the meeting to answer some one-on-one questions that a few attendees wanted to pose to him. An elderly woman, the only person to have asked for a paper ballot, grabbed Okarma on his way out and begged him not to be tempted to sell the company to Big Pharma. Very cute. After concluding the formal portion of the meeting, Okarma gave us the following update (apologies that the formatting of my bullet-point notes doesn't transfer well from my MS Word file). · Geron is the world leader in Telomerase and hESC (human Embryonic Stem Cell) technologies. · Its products are designed to treat cancer and major chronic diseases. · There are two broad-spectrum therapeutics in the clinic. · They are on-track to file the IND for hESC therapy by the end of 2007. · There are back-ups (should they be needed) for each of the current programs. · Geron has a strong balance sheet. · Okarma and Greenwood have been with Geron for over 10 years. Alan Colowick and Fabio Benedetti are strong recent additions. · Six products will be discussed. · GRN163L: o First and only Telomerase inhibitor in the clinic – in chronic lymphocytic leukemia, solid tumors, multiple myeloma, and lung cancer. o Broad anti-cancer activity has been shown in animal studies. It is a potent and specific Telomerase inhibitor with a good safety profile. o Excellent PK and Biodistribution properties: one per week IV administration. o Active against cancer stem cells. This is perhaps the most exciting new news o First trial (Phase I/II) is in CLL. § Sequential cohort dose escalation trial. § Two 4-week cycles of once weekly 6-hour IV infusions. There are four US sites participating. § Standard endpoints. Tumor burden reduction is main therapeutic endpoint. § So far, we have learned (this was presented at ASH in December) that as we increase the dose there is an appropriately increasing CMAX (maximum concentration in blood). The drug is behaving predictably. This is uncommon for oligonucleotide drugs. o Tumor stem cells. 163L is active against them. This has been shown in Myeloma patients. This is the only drug that has been shown to impede Myeloma stem cells. · GRNVAC1 o He alluded to the sad story of DNDN o VAC1 is first and only Telomerase mRNA dendritic cell vaccine in the clinic o Unlike DNDN, they will not have CNC problems with FDA. o The Phase I/II trial in prostate cancer. o About to initiate new trial in acute myelogenous leukemia. o The completed trial showed dramatic increase in CD8 immune cells. o After 6 vaccinations, the PSA doubling time increased dramatically. o New trial in AML will allow us to look for reduction in tumor burden within a short (6 weeks) period of time. This is a much faster look that could be achieved in a prostate cancer trial. § Hope to have some trial data by the end of 2007 § 6 trial sites o Next steps: data on Merck DNA plasmid-adenovirus platform studies · TAT2 o Orally active, small molecule Telomerase activator drug o Potential applications in multiple infectious and chronic degenerative diseases driven by Telomere shortening. o First application will by HIV/AIDS o There is a long list of cells whose aging (driven by Telomere shortening) is associated with disease. o AIDS is the first target, because lymphocytes age rapidly due to AIDS. The CD8 cells that keep the virus in check get shortened Telomeres and that allows the disease to progress. o TAT2 enhances antiviral effect of CD8 cells. TAT2 activity is blocked by a Telomerase inhibitor (GRN163L) o In test tube, TAT2 administered to CD8 cells reduces viral load, but when you add GRN163L, the viral load goes right back up again. o File IND in early part of 2008. First IND for a Telomerase activator. · hESCs o Glial cells, cardiomyocytes, and islet cells (diabetes) are the three cells that are furthest in development. But Geron has multiple other cell types in development too o Current manufacturing cell on-site is adequate to fully supply all planned clinical trials. o GERNOPC1 § FDA has agreed upon scope and content of the IND. The bar is admittedly high due to absence of external validation (due to Federal ban on funding hESC research). § IND scheduled to be submitted late this year. § The mouse studies show that a single Glial cell can mylenate over 60 axons within its proximity. The Glial cells also excrete growth factors. This has been shown to cause new axonal sprouting and growth. § Any return of sensation or increased movement in lower extremities might itself be an approvable endpoint. o GERNCM1 -- Cardiomyocytes § There is proof of concept in a large animal model of a heart attack. § We can get the cells to survive long-term when injected into an infarct. There is MRI evidence of a functional benefit in the heart of the animal whose infarct has been so treated. The improvement is quantifiable. o GRNIC1 – islet cells § Early data show survival benefit. § The hESC islets, when injected, appear to behaving in a normal manner. · Intellectual Property o First to clone the RNA component and the protein component of Telomerase · Growing list of issued and allowed US and foreign patents. · Balance Sheet o Burn is about $46M/yr · Milestones o Phase 2 in 2Q08 for 163L o VAC1 – interim date at ASH in December 2007 o TAT2 – File IND in 1Q08 o CM1 – large animal POC – MI o IC1 – large animal POC (diabetes) in 4Q07 o OPC1 – IND 4Q07 Q&A · Hired PR firm about a year ago. That has helped get Okarma in front of the press. · Merck did the vaccine deal with Geron based upon preclinical data. Clinical confirmation will drive valuation. · hESC IND package. FDA asked for 12-month safety data in many rodents. That data will be ready for 4Q07 submission. o FDA raised the bar a year ago and required more rodent data than Geron had anticipated. · TAT2’s mechanism of action. TAT2 only upregulates Telomerase in certain cells: stressed one. It is a very different mechanism that what cancer cells use. · Prop 71. Jury is still out on what benefits there will be for Geron. The focus seems to be on academic grants and not on for-profit companies. · The FDA’s IND criteria for the hESC product appear to be very objective. So Okarma is optimistic. He does not expect the FDA to politicize its IND review for OPC1, but of course one can never be sure with the current administration in Washington. Okarma mentioned that the FDA likes the scalability of the OPC1 cell line and that the FDA is impressed by Geron’s excellent QAQC for the manufacture of those cells. Marc