Cyclopharm (ASX:CYC) Managing Director & CEO, James McBrayer provides an update on its radiopharmaceutical products used in imaging, sales of Technegas and its US FDA application.
Rachael Jones: Hello, I'm Rachael Jones for the Finance News Network. Joining me from Cyclopharm Limited (ASX:CYC) is MD and CEO James McBrayer. James, welcome back to FNN.
James McBrayer: Thank you, Rachael. Nice to be here.
Rachael Jones: Now Cyclopharm Limited (ASX:CYC) is using nuclear medicine for patients. How is that progressing?
James McBrayer: It's progressing very well. We are best in class in what we do around the world. We're in 57 countries delivering our products everyday.
Rachael Jones: Now to your first off 2018 results, what were the highlights?
James McBrayer: Well, I think from the highlights certainly from the strategy point of view, Technegas is the star of the story with Cyclopharm Limited (ASX:CYC). We're in 57 countries around the world. We're generating cash. We're growing from year on year. Although it could be considered in mature markets, but we progressed in the areas of our United States (U.S) Food and Drug Administration (FDA) clinical trial. We have started to progress also in some of the clinical trials that we're involved in, in expanding the use of Technegas beyond what we're best known for, diagnosing pulmonary embolism.
Rachael Jones: Excellent. What can you tell me about Technegas and how that's progressing worldwide?
James McBrayer: Technegas, it's been around for 30 years, but it is the best in class functional ventilation imaging agent in the world. We're best known for diagnosing pulmonary embolism, blood clots in the lung. But over the last several years, we've been working towards expanding the indications into other areas, other chronic indications like asthma and Chronic Obstructive Pulmonary Disease (COPD).
Rachael Jones: How is the United States (U.S) Food and Drug Administration (FDA) clinical trial going?
James McBrayer: Very well. The clinical trial itself is a 240 patient non-inferiority study comparing our product to Xenon-133. We have five institutions in the United States (U.S) currently involved in recruiting patients. We're going to approximately 10 to 15. As of last Friday, we had 70 patients imaged to date. As part of the agreement that we had with the Food and Drug Administration (FDA), we signed a special protocol assessment agreement with the Food and Drug Administration (FDA) where it allowed us to present an interim results of our first 40 patients. We've completed those 40 patients, submitted that to the Food and Drug Administration (FDA), and they have granted us a face-to-face meeting next month in October to discuss how we might be able to expedite the recruitment process.
Rachael Jones: With all the things that Cyclopharm Limited (ASX:CYC) is involved in, do you have the cash to deliver on your objectives?
James McBrayer: Yes, certainly in the near term. When we look at what the potential is for the US market, half of the world's nuclear medicine departments are in the US. We're in the other half. We're in 57 countries, so getting into the United States (U.S) is extremely important. We have enough cash to deliver on our United States (U.S) Food and Drug Administration (FDA) clinical trial. We have enough cash to fund the smaller clinical trials that we're doing to expand the use of Technegas. Lastly and importantly for our shareholders, we're paying dividends.
Rachael Jones: Excellent. Last question now, James, what can investors expect in terms of news flow over the next 12 months?
James McBrayer: Well, certainly the largest milestone for the company is the results from our meeting next month with the United States (U.S) Food and Drug Administration (FDA), but that being said, we've already highlighted to the market that you can expect higher sales in the second half. That's traditionally the case. We seem to have more incidents of pulmonary embolism presenting itself in the Northern Hemisphere in the winter months. You'll expect higher volumes from some of our major markets in Europe, for example France, based on the fact that we've renewed our contract there. We also expect to see some growth in China.
We didn't see some growth in China based on the largest ever purchase that occurred in the end of 2016. We'll start seeing volumes return in that market in the second half.
Rachael Jones: James McBrayer, thanks for the update.
James McBrayer: My pleasure. Thank you.