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Synageva BioPharma™ Reports 2012 Full Year Financial Results

Stocks in this article: GEVA

Synageva BioPharma Corp. (“Synageva”) (NASDAQ:GEVA), a clinical stage biopharmaceutical company developing therapeutic products for rare disorders, today reported 2012 full year financial results and provided 2013 financial guidance. Synageva’s management team will host a conference call today at 4:30 p.m. EDT to review the financial results and provide a general business update. To participate in today’s call via telephone, please dial (877) 312-5514 for U.S. callers, or (970) 315-0452 for international callers. In addition, the conference call will be webcast live from the “Webcasts & Presentations” section of the Investor Relations tab on the home page of Synageva’s website at

“2012 marked our first full year as a public company. Synageva made significant progress in advancing our lead program, sebelipase alfa. We announced recently that enrollment has started in the ARISE global, Phase 3 trial. This was a key step towards providing an effective therapy to patients suffering from LAL Deficiency,” said Sanj K. Patel, President and Chief Executive Officer of Synageva. “We continue to advance our other preclinical programs, and we entered 2013 with a strong cash balance which will be thoughtfully and strategically allocated to facilitate the achievement of our goals for 2013 and beyond.”

Recent Company Highlights

Synageva reported progress and updates on a number of key objectives during the past year including the following:

  • Presentation of three, six and nine-month data from the ongoing Phase 1/2 extension study of sebelipase alfa in adults with late onset lysosomal acid lipase deficiency (LAL Deficiency), including acceptance for publication of 12-week data in the journal Hepatology
  • Publication of recent prevalence estimates of late onset LAL Deficiency in the online version and an upcoming print edition of the journal Hepatology
  • Interactions with U.S., European and other global regulatory authorities that allowed us to begin clinical trial site initiations and dosing of the first patient in the Acid Lipase Replacement Investigating Safety and Efficacy (ARISE) global, Phase 3 trial of sebelipase alfa in children and adults with LAL Deficiency in February 2013
  • Continuation of treatment and enrollment in the Phase 2/3 trial of sebelipase alfa in infants with early onset LAL Deficiency
  • Advancement of our SBC-103 program for Mucopolysaccharidosis Type IIIB (MPS IIIB, also known as Sanfilippo B) by demonstrating reduced lysosomal substrate storage in the brain, liver and kidney tissues in a mouse model using various dosing approaches
  • Expansion of our global clinical, medical affairs and commercial infrastructure to further enhance our ability to raise awareness and help identify more patients with LAL Deficiency
  • Executed on plans to develop a redundant, commercial-scale manufacturing facility to further supply protein therapeutics for our lead programs
  • Strengthened balance sheet as a result of completing a follow-on offering in January 2013, resulting in $111.0 million of net proceeds, in addition to the Company’s $219.0 million of cash, cash equivalents and short-term investments as of December 31, 2012

2013 Key Objectives

Corporate objectives for 2013 include the following:

  • Progress enrollment in the ARISE Phase 3 trial of sebelipase alfa in children and adults with late onset LAL Deficiency
  • Progress enrollment in the Phase 2/3 trial of sebelipase alfa in infants with early onset LAL Deficiency
  • Provide updates from the ongoing Phase 1/2 extension study of sebelipase alfa in adults with LAL Deficiency including one year of treatment data
  • Continue global disease awareness programs to support identification of more affected infants, children and adults with LAL Deficiency
  • Advance SBC-103 to initiate first-in-man clinical trials for MPS IIIB in the first half of 2014
  • Advance additional pipeline programs
  • Progress towards completion of a redundant, commercial-scale manufacturing facility to further supply protein therapeutics for our lead programs

2012 Full Year Financial Results

For the year ended December 31, 2012, Synageva reported a net loss of $42.9 million compared to a net loss of $25.3 million for the corresponding period of the prior year.

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