Novavax Reports Second Quarter 2008 Financial Results
For the six months ended June 30, 2008, the Company reported a net loss of$17.1 million ($0.28 loss per share), as compared to a net loss of $16.6million ($0.27 loss per share) for the six months ended June 30, 2007. Totalcash and short-term investments as of June 30, 2008 were $35.9 millioncompared to $46.5 million as of December 31, 2007. The net cash burn for thesix months ended June 30, 2008 was $10.6 million.
The following are key achievements during the quarter as well asadditional plans for the balance of the year:
-- We completed enrollment in our Phase IIa clinical study for our H5N1pandemic influenza vaccine candidate as a continuation of the original PhaseI/IIa trial which started last year. An interim analysis in December 2007 wasfavorable, indicating that this vaccine was immunogenic at the 15 microgramand 45 microgram dose levels and was well tolerated. The Company remains onschedule to report primary immunogenicity results from the dose-rangingportion of this Phase IIa study in the third quarter of 2008.
-- We continued as planned to advance our seasonal influenza vaccineprogram through pre-clinical studies with a target of commencing human trialsin a Phase IIa study in the third quarter of 2008. The Company anticipatesthat the results from the pandemic influenza vaccine phase IIa study will beindicative of the future results from our seasonal program. The safety datagenerated in the ongoing Phase I/IIa H5N1 pandemic influenza vaccine studywill support the safety database for our seasonal program, allowing us tocommence the seasonal vaccine clinical program with a Phase IIa trial inhumans.
-- An additional Phase IIa trial of our seasonal influenza vaccine programis planned in older adult subjects (65 years of age and older) commencing inthe fourth quarter of 2008. The intent of this dose ranging study is evaluatethe immunogenicity of the seasonal influenza VLP vaccine candidate atdifferent doses to determine if there is a differentiated immunologicalresponse in this subject population. The trial will also include a comparisonof the immunogenicity of the Novavax VLP seasonal influenza vaccine candidatewith that of a vaccine that is currently approved by FDA.
-- We advanced our two vaccine discovery programs; one for VaricellaZoster (Shingles) and a second for an undisclosed disease target with the goalof progressing at least one of these candidates through proof of conceptanimal studies by the end of 2008. We expect to announce our undiscloseddiscovery vaccine during the second half of 2008.
-- We announced the completion of construction for our GMP pilot plant inthe Company's Rockville, Maryland headquarters with a ribbon cutting ceremonyheld on May 1, 2008. This facility will showcase the capability of our ready-to-use and disposable production technology in a relatively low costenvironment. Through our collaboration with GE Healthcare, we have continuedour partnering in process improvement efforts that are advancing ourmanufacturing process, validation, and vaccine yields.
-- We amended the lease for our corporate headquarters in Rockville,Maryland. The amendment (1) extended the term of the lease to January 31,2017, (2) provided us with reimbursement for up to $3.0 million in leaseholdimprovements and (3) increased the monthly installments of base rent.
-- We announced the creation of a new proprietary process to develop avaccine candidate against Severe Acute Respiratory Syndrome (SARS).
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