Nexvet shares fall as losses mount in fiscal 2016

Elderly Dog
Nexvet's lead drug candidates aim to treat osteoarthritis pain in dogs and cats.

Shares of Ireland-based Nexvet Biopharma ($NVET) have been on the upswing since May, rising steadily from under $3 a share to just over $4, as the company has reported encouraging progress with its two lead drugs, ranevetmab (formerly NV-01) and frunevetmab (formerly NV-02), to treat osteoarthritis pain in dogs and cats respectively. But on September 2, Nexvet’s stock dipped 10% to $3.61 on news that the company’s efforts to transition from an R&D house to a commercial enterprise continues to take a toll on its bottom line.

Nexvet announced that its net loss for its fiscal 2016, ended June 30, jumped 63% to $19.4 million ($1.68 per share), according to a press release. The company attributed the results to a $5.1 million increase in R&D expenses. Nexvet didn’t provide forecasts for 2017, saying only that it has $31.5 million in cash on hand, which is enough to get it through the year.

Ranevetmab and frunevetmab are species-specific monoclonal antibodies (mAbs) created using Nexvet’s proprietary technology, which it calls PETization. CEO Mark Heffernan said in the earnings release he was pleased with the company’s progress over the past year, and that a biomanufacturing facility it acquired in Ireland last September is now capable of producing enough quantity of its lead product candidates to supply the ongoing pivotal trials.

“In terms of our earlier stage candidates, we are progressing a number of new PETized candidates,” Heffernan said in the release. In 2015, Nexvet formed a partnership with Japan-based Zenoaq, and a few months ago the company announced that the collaboration had yielded its first product candidate: a mAb that inhibits the tumor-associated protein PD-1.

Still, with cash running short for Nexvet over the next year, investors will likely remain focused on its two leading osteoarthritis drug candidates. In May, the company announced that in a trial with 126 cats, frunevetmab produced a statistically significant improvement in pain. The company expects to begin a pivotal trial soon.

Nexvet filed for FDA approval of ranevetmab in June, based on a pivotal study in dogs that reported the drug produced a statistically significant improvement in pain vs. placebo. The drug is given as a once-monthly injection--a dosing schedule that Heffernan and his team believe will be seen as a major advantage over non-steroidal anti-inflammatory (NSAID) pills. But the competition will be stiff: Aratana Therapeutics ($PETX) and Eli Lilly ($LLY) are gearing up to hit the market soon with Galliprant (grapiprant), Aratana’s recently approved pill to treat osteoarthritis pain in dogs.

- here’s the earnings release

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