Genta's Drug Timeline Likely Will Be Delayed

Genta (GNTA) is delaying the release of late-stage trial results for its experimental cancer drug Genasense, according to a Wall Street sell-side analyst.

Genasense data will now be released at a medical conference this fall, instead of this summer, as expected, says U.S. Bancorp Piper Jaffray analyst Peter Ginsberg in a research note published Thursday morning. Ginsberg says Genta executives confirmed the delay.

Earlier this month, TheStreet.com reported that Genta was still enrolling patients in all three of its Phase III clinical trials for Genasense, which would likely delay the reporting of results and push back efforts to get the drug reviewed by the Food and Drug Administration.

Genta shares were off $1.22, or just under 10%, to $11.27 in recent Thursday trading. The stock has traded as low as $10.78.

According to Ginsberg's research note, Genta is delaying the release of Genasense data at the request of its partner, Aventis (AVE). The Franco-German drug firm wants the data published at a major medical meeting, which won't happen until the fall. The exact medical meeting is not identified, but it's likely the American Society of Hematology annual meeting, which is held in December.

"As such, we now project an NDA filing in early 2003 rather than our previous expectation for a late 2002 filing," Ginsberg writes. He maintains his strong buy rating on Genta but is reducing his price target from $30 to $26. He also removed Genasense revenue from his 2003 financial model and reduced the drug's sales estimates in 2004. Ginsberg's firm has a banking relationship with the company.

Genta executives did not return phone calls seeking comment and the company has not yet issued a press release on the apparent pushback in Genasense's development timeline. This, in itself, seems to raise significant Regulation FD issues.

As recently as May 2, Genta CEO Ray Warrell told investors to expect Genasense results this summer, allowing the company to file an approval application to the FDA by the end of the year.

But an investigation by TheStreet.com uncovered that more than a dozen cancer research centers across the country are still enrolling patients in all three Genasense clinical trials. The drug is being developed initially as a treatment for melanoma, or skin cancer, and two types of blood cancers: multiple myeloma and chronic lymphocytic leukemia.

Genta's Warrell acknowledged that patients were still being accepted in the trials, but he insisted that this would not force a delay in the company's timelines.

Despite lowering his near-term financial expectations, Ginsberg remains very optimistic about Genasense's success. "As typically occurs when a partnership is struck, the pharmaceutical partner's plans for the product differ to some extent from the plans of the developer," he writes. "In the case of Genasense, it appears that such discussions may lead to a delay in the drug's filing, but we believe this timing issue to be much less important than the benefits that Aventis can provide."