Can regenerative medicine firm TNGN conjure a Medtronic partnership?

Posted: May 26, 2012 at 2:11 am

Regenerative medicine company Tengion (NASDAQ:TNGN) has always planned to take its novel tissue generating technology as far as early-stage clinical studies before finding a partner to finance later-stage work.

The companys lead program treating patients who have had their bladder removed is expected to finish phase 1 enrollment by years end. A preclinical kidney program could start human studies next year. CEO John Miclot said his goal is to adhere to those timelines. But therein lies the problem. When Tengion released first quarter financial results, the company said it has $7.3 million in cash left enough to last until September.

Tengions programs are still early stage. But apparently theyre far enough along to catch interest. In further discussing the companys financials, Miclot dropped a hint: We are also actively engaged in discussions with potential strategic partners for both of our leading programs, he said.

The Nasdaq gave Tengion a different warning last week. The exchange said Tengion does not meet the minimum shareholders equity requirement, a measure of the equity stake a companys shareholders have in a company. Tengion has until June 29 to submit a plan to regain compliance with that requirement or face delisting. If the plan is accepted, Tengion would have 180 days from the May 15 notification to regain compliance.

Tengions technology is based on research licensed from Wake Forest Universitys Institute for Regenerative Medicine and the company has made steady scientific progress despite the financial challenges. Tengions Neo-Urinary Conduit program is intended to help bladder cancer patients who have had their bladders removed. Tengion is using its technology to fashion a new conduit to carry urine from the body. Tengions preclinical Neo-Kidney Augment program, intended to help patients who have advanced chronic kidney disease, is moving toward human studies. Miclot said the goal is to file an investigational new drug application with the U.S. Food and Drug Administration in the first half of 2013 with proof of concept data from a phase 1 study expected in 2014.

If the timeline sounds aggressive, it could be because regulators are more comfortable with Tengions technology. Chief Scientific Officer Tim Bertram said on the call that the FDA has reviewed Tengions pre-clinical data from animal studies. The company had run studies on pharmacology work in animals for up to one year. The FDA is now asking the company to do studies in half that time. It illustrates to us their confidence in our work and allows us to proceed quite quickly into humans, Bertram said.

But meeting those timelines will require new financing. If Miclot is talking to potential partners, Medtronic (NYSE:MDT) must be one of them. In March 2011 Tengion raised $31.4 million in a private placement that included the Minnesota medical device maker. As part of the agreement, Medtronic has the right of first refusal to license or acquire Tengions Neo-Kidney Augment program.

Tengion has flirted with the possibility of working with another company before. In Feburary 2011, the company disclosed that discussions with another unnamed publicly-traded company for a stock-for-stock merger had terminated. At the time, the company said it had enough money to last until April of that year. The private placement that included Medtronic came just before Tengion ran out of cash.

Now, the clock is ticking again for Tengion. The company could raise more capital by issuing more stock, but it must first regain Nasdaq compliance. Medtronics rights to license or buy Tengions kidney program expire on October 31, 2013. While Tengions pressing cash needs weaken its negotiating position it can counter with the strong progress made by the kidney program. Tengion has pulled off deals under financial pressure before. By September the company will need to do one again, if not with Medtronic then with someone else.

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Can regenerative medicine firm TNGN conjure a Medtronic partnership?

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