Geron Fundamentals Are Improving But More Data Are Needed To Gauge Imetelstat Ultimate Success

360 Catalysts Keys 

  • Recent FDA partial removal for the Phase 2 (Myelofibrosis IST) in June 2014 improved the fundamentals for Geron lead drug, ImetelstatHowever, the trials studying Imetelstat as treatment indication for patients with multiple myeloma and polycythemia vera are still on full hold.
  • The company has enough cash going forward without needing to dilute shareholders value
  • The science on telomerase inhibitor is interesting, but it necessitates more trial data to ensured that Imetelstat is without critical side effects
  • It's difficult to gauge whether Imetelstat market penetration for myeloid cancers at this phase in the trials without additional data. Hence, this posed the impossible task of valuation whether the drug would justify Geron $470 million valuation.

What is The Story on Geron

Geron (Nasdaq: GERN) is a developmental stage biopharmaceutical, based in Menlo Park, California, focusing on the development of pharmacotherapy for hematologic myeloid cancer treatment. The company lead drug, Imetelstat, is a powerful telomerase inhibitor currently being studied in phase 2 trial as indication for the treatment of myelofibrosis, multiple myeloma, and polycythemia vera. Imetelstat Phase 2 studied on essential thrombocytopenia (ET) was initiated in January 2011 but halted by the FDA due to concerns regarding its side effects of liver toxicity. The trial investigator, Dr. Ayalew Tefferi, submitted data to the FDA that the liver toxicities were reversible. Hence, Imetelstat was granted the FDA partial removal of clinical holds on June 12, 2014, which significantly improved the drug's prospects.

How is The Stock Trading Recently

Geron has been trading up approximately 50 percent since the FDA partially removed its hold on Imetelstat study in the Myelofibrosis IST. The stock has an average trading volume of 3,359,423 shares.  For the past 52 weeks, shares traded hands in the range of $1.27 to $7.79. The stock closed up by 3 percent at $2.91 per share during the previous trading session.

Source: Yahoo Finance

Tell Me More About The Company

The company lead drug Imetelstat is a potent telomerase inhibitor being studied as treatment indication for blood cancers such as thrombocythemia or polycythemia vera, multiple myeloma, and myelofibrosis.

Telomerase is a special enzyme in our cell that adds DNA sequences to the telomeres (or DNA sequences at the end of a chromosome) to maintain the integrity of the telomeres. Without telomerase, the telomeres would lose their function and viewed as naked DNA by the cell to be degraded. Cancer cells are basically normal cells that have gone rogue and divide out-of-controlled.

By inhibiting telomerase, Imetelstat enabled the body to recognize these cancer cells as naked DNA and kill these cancerous cells harboring such naked DNA sequences.

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Disclosures: I neither own Geron nor have any financial relationships with the company, and I do not plan to initiate position in the company unless future data would be positive.

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Taylor Anderson 9 years ago Member's comment
Geron has licensed their IP to Sienna Cancer Diagnostics for developing cancer testing. The have completed the development of a Bladder cancer test that has been registered with the FDA and will begin to be used in Q3 of this year. The test cost is aprox $150 compared to a procedure the test replaces that cost $2,000. This test could reduce the cost of bladder cancer testing in the US by approximately 140 million a year. Geron owns shares of Sienna and has royalty rights for products developed using Geron IP. The product is SCD-A7. Dr Tefferi will be presenting at ASH on MF, MDS RARS, and AML ( blast phase MF). Dr Snyder from City of Hope mentioned in his May 22nd presentation that most CRs and PRs were in patient population that has the JAK2 gene mutation.