Operator: [Operator Instructions] Your question comes from the line of Steve Brozak of WBB Securities.
Steve Brozak: I actually have one, but a follow-up as well because they’re related. You’ve gone over a lot of trial descriptions. How would you describe as the meaning the import of what these designations that you’ve been describing are to the trialing system? And I’ve got a follow-up after that, please.
Dr. David Mazzo: Thanks, Steve. Appreciate the question. So I think actually, it’s a very pertinent question because in the industry, we talked around the nomenclature of orphan drug designation and fast-track designation pretty freely. And I think most people might have at least a partial understanding, but I think it’s worthwhile explaining. So let’s start with fast-track desiccation. Fast-track designation allows the applicant that would be for a given product and a given indication to be eligible for accelerated approval consideration and for a more rapid review cycle with the FDA, both of which are extremely beneficial in terms of getting to market faster. It also allows for more interaction with FDA in a specialized way.
And similarly, orphan drug designation. First of all, it points to the fact that the indication will have less than 200,000 patients in a given year diagnosed with that particular indication. And as a result, it’s also eligible for more rapid review cycles, more rapid and consistent interaction with the agency. Importantly, you’re also eligible to receive grants from the orphan drug division of FDA to develop new products because often, they’re not as commercially lucrative. And finally, you get an extended period of exclusivity in the market. So that is a — this in addition to patent protection, you have some market exclusivity. So they’re actually quite valuable designations. They’re not given out freely. It’s not something that you just make an application and you’re guaranteed a result, but there’s a pretty critical review process and we were very pleased that the FDA and the EU have granted orphan drug designation for mPDAC to LSTA1 and also for GBM, Glio for LSTA1 here in the United States.
Steve Brozak: Okay. And that actually highlights the next follow-up, and I’ll pop back in the queue. You’ve got these designations, which are obviously significant. You’ve got multiple programs running with quantifiable endpoints. Your — you’ve been pretty much delivering on everything you said you were looking to do. Yet obviously, the market isn’t really viewing or understands this. What are your thoughts around on your market cap and specifically your stock price, given your execution? What do you think it is? And thanks, and I’ll hop back in the queue.
Dr. David Mazzo: Well, thanks, Steve. I actually appreciate the opportunity to address that somewhat forthright because it’s something that’s on everybody’s mind. There is a clear inconsistency with the advanced stage of our clinical programs, the positive data we’ve generated, our financial position and the fact that we continue to execute according to plan is that the plan is rather comprehensive and a rather low market cap. In fact, anyone can look and see we’re trading roughly at somewhere between 35% and 40% of our cash on hand, which is just irrational. I think we have a couple of explanations for that. The part of it is that the entire biotech market has suffered considerably since the beginning of the year with high interest rates and everybody’s stock is down.
But in our particular case, there are few unique characteristics that I think are impeding a stock advance within the short term, but that I think are available to be overcome in the long term. One of those is that we are fortunate to have a large body of our shareholders. By our calculation in rough terms, about 2/3 of our shareholders are long only holders. These are people who have bought into the Company, either when it was in its private stages or at the time of our recent merger or in recent financing, but did so because they believe in the potential of the programs. And in order to see the programs reach their maximum value, they are not trading the stock. They’re ignoring the fluctuations in stock price and in the market, they’re treating us much like they would treat an investment in a private company and they’re sitting back and waiting for the “pivotal data” that come out of these trials.
