InVivo Woes Behind it as Clinicals and Board Changes Signal “Fruitful 2015”

2014 was a rollercoaster for the spinal scaffold developer, as the pilot study looked like it would take forever. That’s changed.

Neuro-Spinal Scaffold developer InVivo Therapeutics Corporation has reported financial results for the year ended December 31, 2014.

Background

We don’t cover financial results from many companies, but when one entity has such a turbulent year it’s definitely worth having a look under every rock to see how the land really lies. In this case, InVivo Therapeutics, who’s tribulations stemmed from an FDA dictat that their pilot study subjects would have to be sequential and subject to mandatory holds between patients. That decision threw InVivo into a difficult period, resulting in a calamitous share price, board changes, staff reductions, ramping R&D/clinical costs and delayed likelihood of approval.

It seems the turmoil may be largely behind the company now though, following better news on the clinical front. The first implant took place in 2014 and went well, the patient enjoying an appreciable improvement in motor and sensory function as well as complete recovery of bowel function and improvement in bladder function. The second implantation of the Neuro-Spinal Scaffold was done in January 2015 by which time the FDA had agreed to relax its earlier demand and eliminate mandatory holds between enrollment of the final three subjects. On the basis of this decision, concurrent enrollment of subjects three through five is anticipated to open by the end of March 2015. .

InVivo’s boardroom shuffling saw the appointment of five new officers, all said to bring significant depth and breadth regarding the development, approval, and commercialization of products.

Back in May last year (2014), seeing the light of approval getting further away as the clinical plan shifted, InVivo brought in approximately $16.1 million to fund the ongoing pilot trial and operations. The company also recently closed an additional round of financing, led by its largest shareholder, and received gross proceeds of $12 million leaving it with a cash position that should enable it to further advance its mission.

As a result of last year’s refocused R&D and clinical plans, the company saw its headcount reduced, accompanied by a streamlining of internal processes, all of which leaves it sounding distinctly chipper about its current prospects.

So to the financials then, which to the December year end saw it reporting a net loss of approximately $18,346,000, compared to a loss of $38,756,000, for the year ending December 31, 2013. Adjusting for other factors, this translates into a bottom line loss for the year ending December 31, 2014, of $17,970,000, compared to $19,120,000 for 2013. The company ended the year with $13,459,000 of cash and cash equivalents.

Company comments 

Mark Perrin, InVivo’s CEO and Chairman, said, “2014 was a momentous year for InVivo in every sense of the word. It’s gratifying to look back on how much we accomplished last year and exciting to see the trajectory the company is following. We are in a much better position to execute on our corporate goals than we were only 15 months ago and are significantly closer to achieving our mission: to redefine the life of the spinal cord injury patient. I’m pleased with how we’ve advanced as a company and am very much looking forward to a fruitful 2015.”

Source: Business Wire

published: March 12, 2015 in: Clinical Studies/Trials, Neuro, Spine

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