You'd think that after more than a decade of research, a company without any products would have gone out of business. But in the world of product-less biotechnology, the company with the largest bankroll and the smallest burn rate has the best chance of making it through clinical trials to FDA approval. And with $45.2 million still left in the bank from a stock offering last year, Introgen
For now, Introgen is still trudging along. On Friday, it reported a first-quarter loss of $5.6 million, to bring the total loss since the company was formed to $177.9 million.
Last month, Introgen filed an amended Form S-3 with the SEC to issue up to $150 million in stock if it needs the cash to complete its FDA approval process. If Introgen could actually sell that many shares, it would be in hog heaven.
That doesn't mean you should run out and buy stock in Introgen, though. Financial survival is meaningful only if a company has products in its pipeline that will eventually win FDA approval. And so far, Introgen's leading drug candidate, the p53 tumor suppressor therapy called Advexin, has been through phase 2 or 3 clinical trials for five different types of tumors. Talk about grasping at straws.
It does appear, however, that the FDA may finally get to review Advexin. Last month, Introgen announced that it will change the efficacy evaluation criteria for its phase 3 clinical trial for treating head and neck cancer to include evaluation of biomarkers, which it hopes to submit to the FDA by the end of the year. Changing evaluation criteria after the trial has started is almost never a good sign, and in this case, it seems that Introgen was unable to enroll enough patients to get statistically significant data with the planned endpoint -- tumor response.
In February, TheStreet.com accused Introgen's management of misleading investors by data-mining in an attempt to put a positive spin on negative clinical-trial news. That theme resonates with the bears' commentary in The Motley Fool's CAPS community, which bestows just one out of five stars on Introgen's stock. Player spiritof78 sums it up nicely: "I think [you're] better off buying four lottery tickets than this company. [At] least the lottery numbers you can trust."
At this point, an investment in Introgen would certainly be going against the grain. It probably has enough money to get through the FDA review process, but that doesn't ensure that Advexin will be approved.
More Foolishness that goes against the grain:
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Fool contributor Brian Orelli, Ph.D., doesn't own share of any companies mentioned in this article. He blogs about start-up biotech companies at BabyBiotechs.com. The Fool has an ironclad disclosure policy.