Allos Therapeutics Inc. is raising $50 million in much-needed financing, with proceeds to fund an ongoing Phase III trial of its lead drug candidate, Efaproxyn.

The product merited an FDA approvable letter in June, pending results from the company's ENRICH trial to evaluate Efaproxyn in patients with brain metastases from breast cancer. When a potential European partnership deal fell through late last year, Allos decided to seek financing so it could complete the drug's trial and file an amended new drug application.

"One of our priorities over the past several months has been to put the company on a more solid financial footing," said Michael Hart, president and CEO, during a conference call Thursday to report Allos' fourth-quarter and year-end earnings. With the $50 million investment, Allos has "secured the funds necessary to complete the ENRICH trial, as well as provide additional resources to move our other compounds forward."

Westminster, Colo.-based Allos entered a securities purchase agreement with Warburg Pincus Private Equity VIII LP in a deal that could end up with Warburg owning a substantial share of the company.

Hart said Allos will sell $50 million of exchangeable preferred stock at a purchase price of $22.10 per share, a 7.5 percent discount to the 20-day trailing average closing price. That equates to a purchase price of $2.21 per share, calculated on an as-exchanged basis.

Shares of Allos (NASDAQ:ALTH) rose 36 cents Thursday, or 16.1 percent, to close at $2.59.

"Upon approval of company stockholders, on or before June 2006, each share of exchangeable preferred stock automatically is exchanged for 10 shares of common stock," Hart said, resulting "in Warburg owning about 42 percent" of Allos.

Closing is expected today. Needham & Co. Inc., of New York, is acting as the exclusive placement agent for the transaction.

Under the agreement, the company also announced that Stewart Hen and Jonathan Leff, managing directors of Warburg, will join Allos' board.

Hart said the financing was in the best interest of stockholders.

"I believe the potential for Efaproxyn and the success of ENRICH have been heavily discounted in the market due to our well-recognized need for additional capital," he said, adding that those needs tended to attract "the type of investor that trades on short-term volatility."

By securing funding, the company should be free to "evaluate future business and strategic opportunities from a position of strength," and perhaps attract longer-term investors.

Allos had $23.8 million in cash, cash equivalents and marketable securities at the end of 2004. Before the financing, the company had projected a burn rate of between $5 million and $6 million per quarter for 2005, and Hart said he doesn't anticipate that to change.

Allos reported a net loss of $5 million, or 16 cents per share, for the quarter ending Dec. 31. For the fourth quarter in 2003, the company posted a net profit of $791,000, or 3 cents per share, but those figures included a one-time gain of $5.1 million in settlement claims.

The company had a net loss of $21.8 million, or 70 cents per share, for the year, compared to a loss of $23.1 million, or 87 cents per share, for 2003.

Over the last few years, the company's stock has ridden the ups and downs of the Efaproxyn data. Shares fell 44 percent in April 2003 after a pivotal trial enrolling more than 500 patients suffering from various cancers, including non-small-cell lung cancer and breast cancer, failed to meet its statistical endpoint. However, shares jumped more than 60 percent a month later when Allos announced it was filing an NDA based on the survival rate in the breast cancer subset. Results showed the median survival time increased from 4.6 months to 8.7 months with Efaproxyn treatment vs. placebo. (See BioWorld Today, April 24, 2003, and May 30, 2003.)

Despite a recommendation from the FDA's Oncologic Drugs Advisory Committee against Efaproxyn last year, which sent Allos' shares tumbling once more, the company rebounded a short time later with the FDA approvable letter hinged on the ENRICH data. (See BioWorld Today, June 3, 2004.)

Hart said the ongoing ENRICH (Enhancing Whole-Brain Radiation Therapy in Patients with Breast Cancer and Hypoxic Brain Metastases) trial for the drug is proceeding well.

"We have defined the patient population as well as you can," he said, adding that he expects the trial to complete enrollment in the second half of 2006, with data available to market in 2007.

Efaproxyn (efaproxiral) is a synthetic small molecule designed to sensitize hypoxic tumor tissues and enhance the efficacy of standard radiation therapy.

Allos also is seeking European marketing approval for the product, though Hart said it is not likely the company would commercialize the product in Europe itself. He said Allos made "substantial progress" on finding a European partner last year, but the parties were unable to finalize financial terms.

"It's an issue of timing," he said. "We're not set up to commercialize in Europe at this point, but we do continue to discuss partnering opportunities."

In addition to Efaproxyn, Allos plans to keep moving forward with its second compound, PDX, in Phase I trials. PDX (pralatrexate) is a small-molecule cytotoxic injectable antifolate intended to treat non-small-cell lung cancer and non-Hodgkin's lymphoma.

Allos added a third product last year, in-licensing RH1, a targeted prodrug that is bioactivated by the enzyme DT-diaphorase, which is overexpressed in lung, colon, breast and liver cancer. RH1 is in Phase I studies in advanced solid tumors refractory to other chemotherapy regimens.

Allos received worldwide rights to the drug from the University of Colorado Health Sciences Center, the University of Salford and Cancer Research Technology. The agreement required Allos to make a "minimal up-front investment," Hart said, adding that the company "shoulders no additional development commitment" until the completion of the Phase I trial.