By Brian Marckx, CFA
FluoroPharma (OTC BB:FPMI)
filed their 10-Q for the second quarter ending June 30, 2012 about three weeks ago. Operating expenses of $851k remain inline to slightly lower than our projections and were down about $90k from the previous quarter. The company's kept a lid on expenses and cash burn while at the same time making progress with product development, recently highlighted the announcement that BFPET turned in very high quality images from the initial patients of an investigator-led study in China (see below).
Q2 net loss to common and EPS were $892k and ($0.04), comparable to our $1.0MM and ($0.04) estimates.
Cash used in operating activities was $694k in Q2, down from $847k in Q1. Cash balance was $1.7 million at 6/30/2012 compared to $2.4 million at 3/31/2012. As there continues to be no surprises relative to our assumptions regarding product development or related timelines, we have made no material changes to our prior outlook and our Outperform rating and $2.00/share price target remain intact.
BFPET Pre-Phase 2 Study Results Very Encouraging
In late July FluoroPharma announced that quality of the initial images using BFPET in a 20-patient (with coronary artery disease) investigator-led stress perfusion imaging study conducted at a hospital in Beijing China were "spectacular" and "superb". All 20 patients are expected to be imaged by early Q4. This study is similar in the expected design of the soon-to-commence phase II study where BFPET will be compared to Rb-82 and/or traditional SPECT agents such as sestamibi which suffer from certain drawbacks such as high cost or comparably (relative to BFPET) lower image quality.
Alan Fishman, principal investigator of the BFPET phase I trial (completed in 2008), notes in the press release relative to the current study that "initial results are impressive. Image quality obtained using PET is superb. BFPET shows clear diagnostic qualities as well as increased resolution, inherent in PET. The initial images look spectacular and we are confident that when all the patients are imaged, the data will further support clinical development of the agent."
We view this as an obvious towards development of BFPET, which we think could enter phase II by the current year-end and complete sometime next year. If all goes to plan, phase III trials could wrap up and an NDA filed by the end of 2015. This potentially puts BFPET on the U.S. market by 2016.
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