Investors have taken a chunk out of Nordic Nanovector's (OSE:NANO) market cap after getting a look at its rejigged development plan. The revision to the clinical trial strategy has pushed back a planned regulatory filing for non-Hodgkin's lymphoma (NHL) drug Betalutin from 2017 to 2019.
Oslo, Norway-based Nordic Nanovector thinks the new clinical trial strategy gives it a better shot of winning regulatory approval and building a product profile capable of capturing a slice of the market for treatments for follicular lymphoma, a form of NHL. In revising its R&D plan, Nordic Nanovector has moved a dose-finding study from the start of the planned pivotal Phase II trial to the ongoing Phase I/II program. The expanded Phase I/II trial is now set to report data in the first quarter of 2017, pushing back the start date of the pivotal study to the first half of that year.
Having been told by Nordic Nanovector as recently as August to expect a regulatory submission in 2017, investors reacted badly to news that the company will only just be getting its Phase II trial off the ground at that time. Shares in Nordic Nanovector plummeted 30% in early trading in Oslo to below NOK15, the lowest price at which they have traded in the company's short history as a public player. Nordic Nanovector went public in March, when it blasted past initial expectations to raise NOK 575 million ($71 million) in one of the largest biotech IPOs on a European exchange in 2015.
The risk of disappointing the investors that drove Nordic Nanovector to the upsized listing was one management felt it had to take to give Betalutin the best chance of succeeding in the long term. "We believe that our decision to revise the clinical development plan for Betalutin makes good strategic sense," Nordic Nanovector CEO Luigi Costa said in a statement. "In light of newly available data and experts' advice with regard to pre-dosing, we have concluded that we now have a new opportunity to determine the best regimen to take into the pivotal Phase II PARADIGME trial."
Costa thinks Nordic Nanovector has enough cash in the bank to see it through to the regulatory filing despite the date being pushed back until 2019. This outlook is based on the belief that the Phase II trial, which is shedding the dose-finding stage to become a single-arm safety and efficacy study, will enrol fewer patients than planned originally and therefore consume less cash.
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