Geron's CEO Presents At Update On Imetelstat Clinical Development Program Conference (Transcript)

Geron Corporation (GERN)

Update on Imetelstat Clinical Development Program Conference Call

September 10, 2012 8:30 am ET


Anna Krassowska – Investor and Media Relations

John A. Scarlett – President and Chief Executive Officer

Stephen M. Kelsey – Executive Vice President, Head of Research & Development and Chief Medical Officer

Graham K. Cooper – Executive Vice President, Finance and Business Development and Chief Financial Officer


Karen E. Jay – JPMorgan Chase & Co.

Brian Klein – Stifel Nicolaus & Company, Inc.

Charles Duncan – JMP Securities

Ryan Martin – Lazard Capital Markets



Good day, ladies and gentlemen, and welcome to the Geron’s Conference Call to provide update on Imetelstat Clinical Development Program. My name is Ann and I will be your coordinator for today’s call. At this time, all participants are in listen-only mode. (Operator Instructions) We will be facilitating a question-and-answer session following the presentation.

I would now like to turn the presentation over to your host for today’s call, Anna Krassowska, Investor and Media Relations. Please proceed.

Anna Krassowska

Thank you, Ann. Good morning everyone, and thank you for joining us to hear this update on our clinical development program for imetelstat. With me on the call this morning are Dr. John Scarlett, President and Chief Executive Officer; Dr. Steve Kelsey, Executive Vice President, Head of R&D and Chief Medical Officer; and Graham Cooper, Executive Vice President, Finance and Business Development and Chief Financial Officer.

Following our remarks, we will take questions. The press release issued this morning provided an update on the imetelstat program is available on our website at Today’s call is being webcast live on Geron’s website and will be available for replay until October 10.

We would like to remind listeners that except for statements of historical facts, the statements in this conference call are forward-looking statements under the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. These include without limitation, statements regarding the timelines and plans for Geron’s research and product candidates, including anticipated timelines for clinical trial enrollment, results and data, the clinical results and therapeutic potential of Geron’s product candidates and financial or operational projections or requirements, including spending guidance, the sufficiency of Geron’s cash resources and statements regarding the potential divestiture of Geron’s stem cell business.

These statements involve risks and uncertainties that can cause actual statements to differ materially from those in such forward-looking statements. Information concerning factors that could cause actual results to differ materially from those in the forward-looking statements is contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading, Risk Factors, including Geron’s quarterly report for the quarter ended June 30, 2012.

Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.

I’ll now hand the call over to Chip .

John A. Scarlett

Thanks, Anna. I thank all of you for joining us. The purpose of the call today is to give you an update on the Imetelstat Clinical Development Program. We announced in the press release this morning that we’re discontinuing our trial in metastatic breast cancer. we’d like to give you further information regarding that decision and review for you the rest of the imetelstat development program.

I’d like to start by putting this trial into the context of the overall program. Because of the role of telomerase and extending cancer cell longevity and proliferation, we believe that inhibiting telomerase may be an effective strategy for treating a broad range of malignancies.

We designed imetelstat to inhibit telomerase and in Phase I studies of imetelstat, we established doses and schedules for Phase II that were tolerable and that achieved target exposures that were consistent with those required for efficacy and preclinical cancer models. Of those doses, telomerase inhibition was observed in patient tissue samples.

Based on these and other data, Geron designed a Phase II imetelstat program in both solid and hematologic malignancies. the tumors we chose to study were those for which we had supportive preclinical data, evidence of the disease was driven by a cancer progenitor cell proliferation and in which imetelstat could be tested either as the single-agent treatment or in combination with cytotoxic chemotherapy.

Two solid tumors, metastatic HER2-negative breast cancer and advanced non-small cell lung cancer and to liquid or hematologic tumors, essential thrombocythemia and multiple myeloma were selected for this Phase II program. We designed the Phase II imetelstat program to test multiple, independent hypotheses. therefore the findings in one study would not necessarily impact the conclusions from the others.

We’ll begin by discussing the rationale for studying imetelstat in the two solid tumor indications and at the conclusion of this call; we’ll just touch a rationale and plans for setting imetelstat and hematologic malignancies. The lung cancer solid tumor trial was designed to evaluate whether single-agent maintenance imetelstat could extend the duration of progression-free survival after tumor debulking by conventional chemotherapy had been completed.

By administering imetelstat alone in the treatment arm, we were able to use maximum doses of the imetelstat. In contrast, the metastatic breast cancer trial was designed to evaluate whether using imetelstat in combination with debulking chemotherapy could extend the duration of progression-free survival in patients.

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