Geron Corp (GERN) Reports In-Line Q3 Loss; Imetelstat IND Clinical Hold Removed

Geron Corp (NASDAQ: GERN) reported Q3 EPS of ($0.06), in-line with the analyst estimate of ($0.06). Revenue for the quarter came in at $160 thousand versus the consensus estimate of $240 thousand.

The company also announced that the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on Geron's investigational new drug (IND) application for imetelstat. In addition, the FDA stated that Geron's proposed clinical development plan for imetelstat that is focused on high-risk myeloid malignancies, such as myelofibrosis (MF), is acceptable. The FDA acknowledged that the company does not intend to conduct further studies in, or develop imetelstat for, the treatment of essential thrombocythemia (ET) or polycythemia vera, which is consistent with the company's plans as originally disclosed in April 2013.

To address the full clinical hold, the FDA required Geron to provide follow-up information from imetelstat-treated patients who experienced liver function test (LFT) abnormalities until such abnormalities resolved to normal or baseline. Geron obtained clinical follow-up information from patients in the previously ongoing company-sponsored Phase 2 trials in ET and multiple myeloma (MM). These data were submitted to the FDA as part of the company's complete response. The company's analysis of these data concluded that in the ET trial LFT abnormalities resolved to normal or baseline in 14 of 18 follow-up patients. For the remaining four ET patients, at the time of the data cut-off, three patients showed improvement in LFT abnormalities and one patient had unresolved LFT abnormalities. Currently, two of the remaining four ET patients continue in follow-up. In the MM trial, LFT abnormalities resolved to normal or baseline in all nine follow-up patients. In addition, no emergent hepatic adverse events were reported during follow-up for either study.

The FDA also requested information regarding the reversibility of liver toxicity after chronic imetelstat administration in animals. The company submitted data from its previously conducted non-clinical toxicology studies, which included a six-month study in mice and a nine-month study in cynomolgus monkeys. In these studies, no clinical pathology changes indicative of hepatocellular injury were observed, and no clear signal of LFT abnormalities were identified.

With the lift of the full clinical hold, a multi-center Phase 2 clinical trial in MF is projected to begin in the first half of 2015.

Upcoming Investor Conference

Geron's management plans to provide an update on the company and development plans for imetelstat at the Stifel Healthcare Conference. The audio and slide presentation will be webcast and is scheduled to occur at 1:50 p.m. Eastern Time on Wednesday, November 19, 2014.

For earnings history and earnings-related data on Geron Corp (GERN) click here.

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