Peregrine reports a smaller loss and beefier cash position as it prepares to undertake a crucial late-stage study of its lead cancer drug
Small-cap biopharmaceutical company Peregrine Pharmaceuticals (NASDAQ: PPHM) reported its second-quarter results after the bell, and unsurprisingly, the primary focus was on the development of its lead experimental drug, bavituximab.
For the quarter, Peregrine reported a 19.8% increase in revenue to $7.35 million, compared with $6.14 million in the year-ago period, as the company saw a 21% increase in contract manufacturing revenue from its subsidiary, Avid Biosciences. As you might also have suspected, the additional clinical studies of bavituximab boosted expenses by 14.9% to $15.17 million, but still allowed Peregrine to report a smaller loss of just $7.79 million, or $0.05 per share, compared to its $8.75 million loss, or $0.08 per share last year.
The real excitement was created from Peregrine's announcement that it remains on track to begin enrolling patients in its phase 3 Sunrise trial testing bavituximab as a second-line treatment for non-small-cell lung cancer (NSCLC) by the end of the year. The trial will consist of some 600 patients globally, and pit bavituximab plus docetaxel against a control arm of docetaxel and a placebo.
In preparation for the expense of a large patient study, Peregrine has boosted its quarter-end cash position to $44.4 million from the $35.2 million it boasted two quarters ago.
In addition to being a potential second-line NSCLC treatment, Peregrine notes that it is exploring a number of investigator-sponsored trials which could include combining bavituximab with Amgen and Bayer's Nexavar to treat liver cancer, or in combination with paclitaxel to tackle breast cancer. Peregrine also mentioned the potential for a combination therapy with PD-1 antibody or CTLA-4 targeted therapies.
Shares were up 7% in after-hours as of this writing.
Peregrine puts its blinker on and moves over to the "fast" lane to the delight of shareholders.
What: Shares of Peregrine Pharmaceuticals (NASDAQ: PPHM), a clinical-stage developer of monoclonal antibodies to treat cancer, galloped higher by as much as 30% after announcing that its lead drug, bavituximab, had been granted fast track designation and that a phase 3 study, known as Sunrise, had been initiated.
So what: The initiation of the phase 3 trial doesn't come as a huge shock to anyone, but the fact that bavituximab -- Peregrine's experimental second-line treatment for non-small-cell lung cancer -- received the fast track designation is where most of today's pop is coming from. The fast track designation, which is issued by the Food and Drug Administration, allows for more frequent communication between the FDA and the company in question, and can also lead to a priority review if/when Peregrine files for a new drug application for bavituximab.
Now what: Now we wait patiently for the data from the Sunrise trial, which will include approximately 600 different patients worldwide. In mid-stage trials, bavituximab's data was impressive – a more than doubling in median overall survival (12.1 months versus 5.6 months), a 1.2 month bump higher in progression-free survival to 4.2 months, and a more than doubling of the overall response rate to 16.5% -- but it was marred by the trustworthiness of a third-party clinical labs contractor. Investors will be looking for a no-frills study this time; but if Peregrine delivers it, the sky could be the limit.
Why LightInTheBox, Peregrine Pharmaceuticals, and Cell Therapeutics Are Today's 3 Best Stocks
Not too far behind LightInTheBox in the win column was clinical-stage biopharmaceutical company Peregrine Pharmaceuticals , which galloped 14.5% higher following the announcement that lead second-line non-small-cell lung cancer drug bavituximab had gained the coveted fast track designation from the Food and Drug Administration, and that it was initiating its phase 3 study of bavituximab on approximately 600 patients. The fast-track designation could allow bavituximab to reach pharmacy shelves even faster.
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Peregrine Pharmaceuticals (NASDAQ: PPHM) Peregrine Pharmaceuticals went on a wild ride in 2012, with shares rising from roughly $0.40 to above $5 following midstage data on bavituximab, its second-line drug for nonsmall cell lung cancer, or NSCLC. The ride wouldn't last long, though, with the stock crashing down by more than 80% after Peregrine noted, just weeks later, that the data shouldn't be trusted because of errors at a third-party clinical contractor. By the time all was said and done, months later, Peregrine Pharmaceuticals had reported a statistically impressive 116% improvement in median overall survival to 12.1 months, but its data was largely dismissed by investors who didn't know what to believe.
Peregrine's phase 3 study of bavituximab known as SUNRISE will soon help decide which side is correct. The trial compares the combination of bavituximab and docetaxel against a control arm, with the primary endpoint being a statistically significant improvement in overall survival.
What's particularly unique, and the reason investors should pay close attention to Peregrine, is that bavituximab is one entrant into the extremely competitive race to develop cancer immunotherapies, which train the body's immune system to recognize and attack previously undetected cancer cells. Bavituximab works by blocking phosphatidylserine, which is an immunosuppressive molecule found on the outside of cancer cells that allows them to remain undetected by the body's immune system. If successful, bavituximab could revolutionize the second-line treatment for NSCLC, and it may hold promise as a first-line treatment, too.
Keep in mind, though, that small-cap biopharmas have a very poor track record of success when it comes to phase 3 oncology-based trials.
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