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FPMI: CardioPET Phase 2 Trials InitiatedMarch 22, 2012 | Comments : 0 Recommended this article: (0)
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FPMI: CardioPET Phase 2 Trials Initiated
Brian Marckx, CFA
2011 10-K Filed
FluoroPharma (FPMI) filed their 10-K for the fiscal year ending December 31, 2011 on March 16th. Operating expenses were approximately $870k and $3.4 million for the fourth quarter and full year respectively, compared to $380k and $890k for the year earlier periods.
Net loss to common (includes the $977k accrued preferred stock dividends expense) and EPS were $4.4 million and ($0.25) in 2011 compared to $954k and ($0.08) for 2012.
Cash used in operations was $2.3 million in 2011 including $711k in Q4. Cash balance at 12/31/2011 stood at $3.3 million, essentially flat from the end of Q3 and benefitting from approximately $940k in net proceeds raised from the sale of equity during the most recent quarter.
As there were no surprises in the 10-K and product development has been tracking our expectations, despite us making some relatively immaterial tweaks to our model following the year-end report, our outlook as well as $2.00 price target and Outperform recommendation all remain intact.
CardioPET Phase II Trials Initiated
CardioPET, being developed for the assessment of myocardial metabolism, is now entering phase II trials in the assessment of myocardial perfusion and fatty acid uptake in coronary artery disease patients. As we noted in our initiation report on FluoroPharma earlier this year, initiation of phase II trials for CardioPET would be a significant milestone as the agent is expected to be one of FPMI's first products to reach commercialization. If eventually approved by the FDA, CardioPET is expected to offer a better alternative to stress-testing, a very large and rapidly growing opportunity.
In early March FluoroPharma announced they signed a letter of intent with SGS Life Sciences to provide clinical research services for Phase II trials of CardioPET. The Belgian-based trial will be open label and designed to assess safety and performance of CardioPET compared to stress echocardiography, myocardial perfusion imaging (MPI) and angiography. The trial will be conducted at two sites in Belgium with results anticipated in 2H 2012 - which is inline with our previously expected timeline. Per the recent 10-K, enrollment is expected to consist of between 30 and 100 patients with known stable chronic coronary artery disease that can not undergo stress testing.
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