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AquaBounty Techonologies Loss Widens As It Awaits FDA Approval

Fri, 21st Mar 2014 09:48

LONDON (Alliance News) - Aqua Bounty Technologies Inc Friday posted a widened loss in 2013, as it continued to invest in the development of its hybrid salmon product ahead of approval from the US Food and Drug Administration.

The company said it was in preliminary discussions with potential producers, which have revealed considerable interest in the product.

The company posted a net loss of USD4.7 million in 2013, widened from USD4.4 million in the previous year, as operating costs and expenses increased to USD4.9 million from USD4.4 million in 2012 but were offset by a one-off USD186,980 gain from an adjusted to a long-term royalty-based financing instrument.

The company is not yet revenue producing.

The company said it had operated under the expectation that it would receive New Animal Drug Application approval from the FDA for its AquAdvantage Salmon during 2013. The AquAdvantage Salmon is a hydbrid salmon, trout and tilapia fish that is designed to grow faster, and be more sustainable than currently farmed salmon.

The FDA must consider its responsibilities under the US National Environmental Policy Act, and prepared an Environmental Assessment of the product. It concluded on December 26, 2012that there was no significant impact. These findings were then open to public comment until April 26, 2013. The FDA has been working to finalise its environmental assessment and Finding of No Significant Impact, Aqua Bounty said.

Aqua Bounty believes that the process is almost concluded, but it has not received guidance from the FDA about timing of the approval.

In November the product was deemed not harmful to human health and the environment by Environment Canada, an agency of the Government of Canada.

AquaBounty had cash of USD1.9 million as at December 31, up from USD348,521 in the previous year. It received a short-term bridge loan from its major shareholder Intrexon Corp for USD500,000, and subsequently raised USD6.0 million in an equity placing in March 2013.

In January 2014, the company raised USD10.0 million in a placing with Intrexon, raising Intrexon's total shareholding to 59.85%.

The company said that it is working on the assumption that it will receive FDA approval in 2014, and that it has the financial resources to fund operations through to the middle of 2015. Once it has received approval for the product, it will finalise more robust plans for commercialisation, AquaBounty said.

Shares in AquaBounty were trading up 1.6% at 32.00 pence Friday morning.

By Hana Stewart-Smith;; @HanaSSAllNews

Copyright © 2014 Alliance News Limited. All Rights Reserved.

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