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 company’s lead program treating patients who have had their bladder removed is expected to finish phase 1 enrollment by year’s 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.
Tengion’s programs are still early stage. But apparently they’re far enough along to catch interest. In further discussing the company’s 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 timing of a deal could not be better for Tengion. Financial pressures led the company last year to implement a cost-cutting restructuring that included layoffs and the relocation of its its Pennsylvania headquarters to its Winston-Salem, North Carolina R&D site. Tengion also faces the prospect of losing its stock listing. The Nasdaq has already informed the company its stock price does not meet minimum listing requirements and Tengion has until September 28 to address that issue. This week, Tengion shareholders voted to approve a reverse stock split intended to boost the company’s stock price. If and when a reverse stock split happens will be at the discretion of Tengion’s board of directors.
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 company’s 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.
Tengion’s technology is based on research licensed from Wake Forest University‘s Institute for Regenerative Medicine and the company has made steady scientific progress despite the financial challenges. Tengion’s 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. Tengion’s 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.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
If the timeline sounds aggressive, it could be because regulators are more comfortable with Tengion’s technology. Chief Scientific Officer Tim Bertram said on the call that the FDA has reviewed Tengion’s 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 Tengion’s 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. Medtronic’s rights to license or buy Tengion’s kidney program expire on October 31, 2013. While Tengion’s 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.
