Geron Corporation (NASDAQ:GERN) presented its IMerge data on Sunday. And, at first blush, it looks pretty good. But it doesn’t matter a whole lot. The big key to the ASH festivities is yet to come and will be unveiled today at 1:30 PM ET (in about 90 minutes).

The reason this is the big news is because it will be details on the IMBark phase 2 study, which was the study that supposedly caused JNJ to pull out of its CLA with Geron back in late September. The inference that was made at the time was that JNJ, who could see how the study was going, didn’t like the evolution of data in IMBark and chose to not renew its CLA – to not keep paying GERN milestones and rent for the rights to imetelstat in the future in the marketplace.

Geron Corporation (NASDAQ:GERN) operates as a biopharmaceutical company. The company supports the clinical stage development of imetelstat, a telomerase inhibitor for the treatment of hematologic myeloid malignancies.

Imetelstat is “Come Go With Me” for the Geron Del-Vikings in 1957. Ie, this band doesn’t really have another song. But imetelstat is an extremely unique approach to treatment of blood cancers, and would have basically no competition in the market if it really demonstrated blockbuster potential in its phase 2 IMBark.

Today, in about 90 minutes, the company will present the very data that JNJ saw a couple months ago. The massive move lower in the stock off that CLA non-renewal tells you what the market believes we will hear today: that the study was tracking toward failure in primary endpoints.

If it looks like, based on what we see today, that this is not in fact the case, then the game is in some sense back on for Geron. The company likely needs a new partner or a buyout to support the continued development of imetelstat.

The advantage that could be cited by interested shareholders is that much of the cost of developing imetelstat has already been paid for by JNJ. However, by the same token, that is also what increases the likelihood that the data presented today will be something other than an unqualified positive as far as the basic structure of the IMBark study.

 

The Basics

Geron Corporation (NASDAQ:GERN) operates as a biopharmaceutical company. The company supports the clinical stage development of imetelstat, a telomerase inhibitor for the treatment of hematologic myeloid malignancies.

It has a sunsetting collaboration and license agreement with Janssen Biotech, Inc. to develop and commercialize imetelstat worldwide for indications in oncology, including hematologic myeloid malignancies and other human therapeutic uses. Janssen is a subsidiary of Johnson & Johnson (NYSE:JNJ). That collaboration and licensing agreement was terminated late last month, as noted above.

GERN, founded in 1990 and based in Menlo Park, California, has been running two key studies.

IMerge is a two-part clinical trial evaluating imetelstat in transfusion-dependent patients with Low or Intermediate-1 risk myelodysplastic syndromes (MDS) who have relapsed after or are refractory to prior treatment with an erythropoiesis stimulating agent, or ESA. The primary efficacy endpoint is the rate of red blood cell transfusion independence lasting at least 8 weeks. Part 1 is a Phase 2, open-label, single-arm trial of imetelstat, and Part 2 is designed to be a Phase 3, randomized, controlled trial. Part 2 has not yet begun.

IMbark is a Phase 2 trial in patients with Intermediate-2 or High-Risk myelofibrosis (MF) who have relapsed after or are refractory to prior treatment with a JAK inhibitor. This was the primary focus for the GERN/JNJ collaboration.

Geron Corporation (NASDAQ:GERN) generated sales of $165K, according to information released in the company’s most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of -20.7% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($166.6M against $4.5M).

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