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Acasti Announces Third Quarter Results

LAVAL, Quebec, Jan. 14, 2014 (GLOBE NEWSWIRE) -- Acasti Pharma ("Acasti" or the "Corporation") (Nasdaq:ACST) (TSX-V:APO), a Neptune Technologies & Bioressources Inc.'s ("Neptune") subsidiary, announces its financial results for the three and nine-month periods ended November 30, 2013.

Financial Results: Three Months Ended November 30, 2013

  • Revenues were $28,000 for the quarter ended November 30, 2013, versus $424,000 for the quarter ended November 30, 2012. Sales in both years were generated from the commercialization of Onemia ®, the Corporation's medical food product. 
  • Research and development (R&D) expenses were $1,279,000 for the current quarter, up from $770,000 in the corresponding prior-year quarter.
  • Adjusted EBITDA was negative $(1,574,000) for the quarter ended November 30, 2013, versus negative $(1,048,000) in the corresponding prior-year quarter.
  • A net loss of $(3,856,000) or $(0.05) per share was recorded for the current quarter, versus a net loss of $(1,611,000) or $(0.02) per share in the same quarter last year.

The year over year net loss increase is largely due to additional R&D contract expenses related to CaPre's ® research and clinical development program, higher stock based compensation expenses and additional costs relating to Acasti's recent US$23 million public offering.

Financial Results: Nine Months Ended November 30, 2013

  • Revenues were $301,000 for the nine-month period ended November 30, 2013, versus $675,000 for the corresponding period ended November 30, 2012. Sales in both years were generated from the commercialization of Onemia ®, the Corporation's medical food product. 
  • Research and development expenses were $3,584,000 for the nine-month period ended November 30, 2013, up from $2,091,000 in the corresponding prior-year period.
  • Adjusted EBITDA was negative $(4,607,000) for the nine-month period ended November 30, 2013, versus negative $(3,024,000) in the corresponding prior-year period.
  • A net loss of $(9,059,000) or $(0.12) per share was recorded for the nine-month period ended November 30, 2013, versus a net loss of $(4,940,000) or $(0.07) per share in the corresponding prior-year period.

"Acasti recently announced a number of important milestones towards securing regulatory approval to distribute and market CaPre ® as a prescription drug in the U.S," highlighted Mr. Henri Harland, President and CEO of Acasti. "These include clearance from the US Food and Drug Administration (FDA) to initiate a pharmacokinetic (PK) study in the U.S. and the closing of a US$23 million public offering to support our research and clinical development program relating to our investigational new drug CaPre ®. With these achievements we are now moving forward with plans to seek approval from the FDA to conduct a pivotal Phase III clinical trial of CaPre® in the U.S.  This is the critical and decisive next step in our drug development program."   

"On top of these developments, Neptune continued to reach favourable settlements with the respondents named in the US International Trade Commission's (ITC) investigation into alleged composition of matter infringements of Neptune's patents, which benefits Acasti," continued Mr. Harland. "To date, Neptune has settled with eight of the ten respondents, effectively resolving the ITC investigation. These settlement agreements are a great testimonial to the strength and validity of our patent estate and demonstrate that industry peers recognize the value of our intellectual property (IP). The strategy put forward in the ITC investigation reflects our commitment to actively defend this fundamental asset. The settlements maintain IP protection for Acasti and furthermore protect its market as no licensing agreements were signed giving the right to manufacture products in the pharmaceutical field."      

Clinical Trials

Acasti continues to make significant progress in its research and clinical development program. Recently, Acasti announced that the FDA had given it clearance to initiate a PK trial in the U.S. This is a significant milestone and a key first step towards securing regulatory approval to distribute and market CaPre ® as a prescription drug in the U.S.  Quintiles, the world's largest provider of biopharmaceutical development and commercial outsourcing services, has been engaged to conduct the trial. The PK study is expected to start in the second quarter of calendar 2014 and results would be announced in the following quarter.  

Going forward the Corporation intends to amend its initial PK Investigational New Drug submission with the FDA to also request approval to conduct a Phase III trial in the U.S. The amended submission should be filed by the end of February 2014.

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