Thomas McGovern: Great. Great to see some progress there. My next question, similar in kind of construct, I suppose, but is there any progress worth noting on your investigation to the Hemopurifier’s utility and organ transplants?
Jim Frakes: We have collaborated with an outside group and have done studies on perfusate, meaning fluid that’s gone through retrieved organs. And we are analyzing that data now with the hopes of publishing it down the line. So yes, we’ve made progress on the in vitro experiments on the transplant side.
Thomas McGovern: Great. And then finally, just real quick, if you guys could give us some type of expected time line for – I mean, I know working with the FDA, it can be very difficult to kind of approximate this, but if you have any type of visibility into how long you expect it to take for that second supplier to be approved? And then kind of a second question, then I’ll hop back into the queue, but do you guys have any time line relating to the new manufacturing facility, would you guys expect that to becoming operational? Thanks.
Jim Frakes: Guy Cipriani, our Chief Operating Officer is here and he overseas manufacturing group and regulatory. So I think this falls into his wheelhouse.
Guy Cipriani: Hi, this is Guy. So first, regarding the manufacturing site and the one that’s online, we’re currently doing engineering batches and validation batches in that facility. So we hope to be able to submit to the FDA to add that site to our IDE before the end of the year. So then we’ll have to wait some period of time after we submit to the FDA to either get it an okay or to be told we have to do some additional work. So I think in the first quarter, we’ll have clarity on that. Regarding bringing the second supplier of GNA online, that’s an ongoing process. We have some work to do to address some of the concerns still. We think we should be able to accomplish all of that in the first quarter. I think bringing the site online in the early part of the first quarter and getting the GNA clearance somewhat midway through the first quarter, if not soon.
Jim Frakes: Thank you, Guy. And Thomas, of course, we can’t predict when the FDA will approve something or come back with more questions. But all we can do is look at when we could submit our packages to them.
Thomas McGovern: Totally understandable. And just for clarity, when you refer to the first quarter, you’re referring to the third fiscal quarter for you guys, first quarter being the calendar year quarter in ’24?
Jim Frakes: Calendar year. Yes.
Thomas McGovern: Okay, understood. All right, great. Thank you take my questions. I’ll jump back in queue. Thanks, guys.
Jim Frakes: Thank you, Thomas.
Operator: The next question will come from Vernon Bernardino with H.C. Wainwright. Please go ahead.
Vernon Bernardino: Hi, guys. Thanks for taking my question. And Jim and Guy, congratulations on the new appointment. Just wanted to ask, I guess, a little bit more about the time line. Just wondering if you could map out a little bit as far as the initial what we may see as far as the in vitro work before we could see perhaps an announcement that you would think about starting the human clinical trial?
Steven LaRosa: Hi Vernon, this is Steve. So we had envisioned that those in vitro experiments would take place during November and December with the hopes of being able to enroll in early 2024.
Vernon Bernardino: Perfect. Regarding the new supply, do you have to do any GMP work as far as the new suppliers are concerned? And again, could you remind us where or how the current supply is obtained?
Guy Cipriani: Yes. So we have an existing supplier of our GNA and sector laboratories in the Bay Area in California. All of our manufacturing is done under GMP. So because this is a natural plant product, we want to have more than one supplier providing that key ingredient to us. So really, this is as part of the strategy to derisk our supply chain. At some point in the future, as we get going on our studies, we’ll probably look to see if we can do a recombinant version of the protein to even derisk it further. So these are all activities that we’re, thinking about it, we’re being very cautious in how we kind of roll them out. But we – right now, we need to mitigate any risk of supply by having more than one supplier of this key starting material.
Vernon Bernardino: As part of that work, going to evolve involve supply that is needed to dovetail with the initiation of studies? Or do you have enough supply now such that once you do get FDA approval to the supplement of your IDE that you could start studies right away?
Guy Cipriani: Yes. We are able to manufacture devices to support a study today. So we don’t have – we currently don’t have supply constraints on the GNA.
Jim Frakes: Right. Just to expand further on Guy’s comments, Vernon. So while we’re waiting for our own manufacturing facility here in San Diego to come online with FDA approval, we can easily go back to the contract research facility which is a little north of us here in Southern California. And we could run a few batches, manufacturing campaigns there. And so we don’t – things can always change. But at the moment, our feeling is supply is not a problem which is a nice change from points in the past.
