Privately held Dara Biosciences Inc. prepared to access the public markets through a reverse merger with troubled Point Therapeutics Inc., but Dara President and CEO Richard Franco Sr. said his company sees Point Therapeutics as more than just a public shell and is "very interested" in the failed Phase III cancer drug talabostat.
The two companies signed a definitive merger agreement in which Raleigh, N.C.-based Dara will merge with a subsidiary of Wellesley Hills, Mass.-based Point Therapeutics. Dara's shareholders will own 96.4 percent of Point Therapeutics's outstanding shares of common stock after the merger, which is expected to close in the first quarter of 2008. The resulting company will be called Dara Biosciences Inc. and will apply to list its shares on Nasdaq.
News of the deal sent shares of Point Therapeutics (NASDAQ:POTP) shooting up more than 700 percent on Wednesday. The stock closed up 22 cents, or 496 percent, at 26 cents.
The merger came just in the nick of time for Point Therapeutics, which reported $3.9 million in cash at the end of the second quarter, during which it had burned through $3.4 million in operating expenses. Multiple rounds of restructuring had left the company with just two remaining employees, and it said it could face Chapter 11 bankruptcy in a matter of weeks if it did not secure a partner or buyer.
Michael Duffy, corporate secretary for Point Therapeutics, said the company "spoke to a number of parties" before deciding to do the deal with Dara.
Point Therapeutics' troubles stemmed from setbacks with its lead product, talabostat, a pain inhibitor of dipeptidyl peptidase (DPP) enzymes intended to suppress tumor growth and boost immune responses through inhibition of fibroblast activation protein (FAP).
In March, the company's shares fell 30 percent due to the failure of an open-label Phase II trial of the drug in advanced pancreatic cancer. But the real doozie came in May, when an interim analysis of two Phase III trials in non-small-cell lung cancer showed that neither was likely to meet its endpoints. The FDA subsequently halted the talabostat clinical program, and shares fell another 68 percent. (See BioWorld Today, March 2, 2007, and May 22, 2007.)
Although talabostat had shown encouraging results in Phase II trials for metastatic melanoma and chronic lymphocytic leukemia (CLL), those programs had long been on hold due to a lack of funding. Ditto for preclinical work with the long-acting DPP inhibitor PT-630 for diabetes and the vaccine adjuvant PT-510 for infectious diseases.
Now Dara plans to resurrect those programs. Franco said the company immediately will resume evaluations of talabostat in melanoma and CLL. PT-510 is "too early to comment on," he said, but PT-630 will be slotted into Dara's existing pipeline.
That pipeline already includes KRN5500, a spicamycin derivative in Phase IIa trials for neuropathic pain associated with cancer. Dara licensed the product from Tokyo-based Kirin Brewery Co. Ltd. after it failed to show efficacy against cancer but generated promising results in cancer pain. Franco said the Phase IIa trial should be finished by the first part of next year, and next steps will include expanding into diabetic neuropathy and post-herpetic neuralgia while seeking a partner for later-stage trials.
Also in the pipeline are a series of preclinical programs including DB040, a DPP-IV inhibitor for diabetes acquired from Nuada Pharmaceuticals; DB959, a PPAR delta and PPAR gamma agonist for diabetes acquired from Bayer Schering Pharma AG; DB900, a series of PPAR agonists for diabetes also acquired from Bayer; and DB200, a series of small molecules for psoriasis that Dara found by searching scientific literature.
Dara's business model seeks to avoid both "very expensive" Phase III trials and "very risky" drug discovery, Franco said. Instead, the company acquires early stage products, develops them through proof of concept and licenses them to pharmaceutical companies.
As a private company, Dara also made select investments in health care companies, including Surgi-Vision, Medeikon Corp., Medivation Inc. and SpineMedica Inc. The company would distribute any proceeds back to its own investors. For example, Dara distributed more than 2 million shares of Medivation stock worth about $25 million back to its investors in 2005.
"We are almost like a seed round investor," Franco said.
However, once Dara utilizes Point Therapeutics' listing to become a public company, any investment proceeds will "remain in the company to build the value of the company," Franco said.