Ladies and gentlemen, thank you for standing by, and welcome to the NeuroOne Medical Technologies Corporation Second Quarter of Fiscal 2022 Earnings Conference Call. Today’s call will be conducted by the company’s Chief Executive Officer, Dave Rosa; and its Chief Financial Officer, Ron Mcclurg. Before I turn the call over to Mr. Rosa, I’d like to remind you that this conference call will include forward-looking statements within the meaning of U.S. Federal Securities laws with respect to future operations, financial results, events, trends, and performance, which are based on management’s beliefs and assumptions as of today’s call or other specified date. Forward-looking statements may involve known and unknown risks, uncertainties, and other factors, which may cause actual results to differ materially from those expressed or implied by such statements. See our earnings release and SEC filings for information regarding specific risks and uncertainties that could cause actual results to differ. Except as required by law, we undertake no obligation to update such forward-looking statements. With that said, I’ll turn the call over to Dave Rosa, CEO of NeuroOne. Dave?

Thanks, operator, and thank you to everyone attending our call this afternoon. During and since the second fiscal quarter, we remain focused on advancing our Thin Film Electrode Platform Technology with respect to both diagnostic and therapeutic applications. In addition, we made progress on reducing product costs and ensuring the ability to meet Zimmer Biomet’s expected product demand by initiating the process to qualify additional manufacturing sources. Let’s begin with diagnostic applications. Although, the FDA did not provide clearance in March 2022 to increase the duration of use from less than 24 hours to less than 30 days for our Evo sEEG product line, we feel strongly that we met the ISO 10993 standard Part 12 and Part 18 requirements for Biological Evaluation of Medical Devices. As such the company filed an appeal with the FDA in March 2022 regarding their decision. On April 14, the FDA held an official call with the company to hear our appeal. Dr. William Wustenberg renowned biocompatibility expert who provided the data analysis for our FDA submission explained the scientific rationale to the FDA as to why the company believed it met the criteria that I earlier referenced. The FDA had no questions regarding Dr. Wustenberg’s presentation and informed us that a decision would be made on our appeal by May 14 or 30 days from the date of the call. We are currently awaiting this decision. As previously disclosed, we immediately initiated a parallel path by commencing additional biocompatibility tests on the Evo sEEG product line in the event, we are not successful in our appeal. Given the length of the test and time required for the testing firm to complete the final report, we would expect to get that final report in mid-August and file our 510(k) submission thereafter if needed. We…

Thank you, Dave. Product revenue was $37,000 in the second quarter of fiscal 2022, compared to product revenue of $18,000 in the second quarter of fiscal 2021. Collaboration revenue was delayed in the second quarter of fiscal 2022, due to the FDA decision compared to collaboration revenue of $20,000 in the second quarter of fiscal 2021. Collaboration revenue in the prior year was derived from the Zimmer Development Agreement and represented the portion of the upfront initial development fee payment that was eligible for revenue recognition as of March 31. The total operating expenses in the second quarter of fiscal 2022 were $3 million compared to $2.4 million in the same period of the prior year. R&D expenses in the second quarter were $1.8 million compared with $1.3 million in the same period of fiscal 2021. SG&A expense in the second quarter of fiscal 2022 was $1.2 million compared with $1.1 million in the prior year period. Our net loss was $3.1 million for the first second quarter of fiscal 2022 compared to a net loss of $2.4 million in the second quarter of fiscal 2021. As of March 31, 2022, the company had cash of $12.9 million compared to $16.2 million at December 31 and $6.9 million at September 30, 2021, our fiscal year end. Once again, the company had no debt outstanding at March 31, 2022. That concludes my remarks. I’ll now pass it back to the operator to open up the call for questions and answers. Thank you.

Thank you. At this time, we’ll be conducting a question-and-answer session. [Operator Instructions] My first question comes from Alex Nowak with Craig-Hallum. Please proceed with your question.

Great, good afternoon, everyone. This is Connor on for Alex. I guess, first of all, I’d be interested to hear, just kind of updated conversations with Zimmer and the agreement, are they experiencing any sort of delays on their side? I know you mentioned the meeting with the neurosurgeons, so just any more color on the Zimmer piece at this point.

Yes. So Zimmer, obviously, is part of our agreement with them was that they would provide the bulk of the accessories that are needed to use this device with the robot. That is not yet done. So yes, they are still not yet done with all the accessories. The feedback that we’ve gotten from them is that things are progressing. Feedback during the meeting with physicians was positive regarding their accessories, but we’re really talking about, when I say accessories drill, a drill bit, cautery device, a ruler that’s used inside the brain. So we’re not discussing projects that typically have long timelines, especially given that most of these are accessories are really in their wheelhouse. So, but no, they’re not finished with all the accessories either.

Sure. Okay. And then I guess just thinking about this year, regardless of what happens with the FDA decision here coming up shortly, you’re planning this other study just in case, I believe it was the subacute toxicity testing. I guess, thinking about that, how should we think about costs trending throughout the year? Just any detail there would be helpful too.

Yes. Ron, do you want to take that?

Sure. The most of the costs that we’re incurring at this point in time are related to our ongoing projects and product development. Specifically, we have switched our focus in the development side to the combination device that Dave mentioned earlier, the RF ablation device, and then also working on some of those longer term products, which would be the chronic, the electrodes that would be used for chronic use, both in recording, as well as in stimulation. The – we have incurred some additional costs during primarily the second quarter, the most recent one as it relates to additional testing and components that were needed for the testing. And those were, as I said, reflected in our fiscal second quarter results. At this point in time, there will be not a material increase in any costs related to that testing. Most of that has been accounted for at this point.

Okay, sure. That’s helpful. All right. That’s it for me at this point. I’ll hop back in queue. Thanks.

Thank you.

Thank you.

Our next question comes from Ben Haynor with Alliance Global Partners. Please proceed with your question.

Good afternoon, gentlemen. Thanks for taking the questions. I was just wondering if you could provide any more color on the appeal call with the FDA. You mentioned that they didn’t ask any questions, but did they give you any kind of – I don’t know, feedbacks the right word, but information on the initial rejection or anything on that front.

Yes. So thanks for the question, Ben too. So FDA in – most of the meetings in a wide variety of topics that I’ve attended with them, there’s usually not a tremendous amount of dialogue and keep in mind, this was a one hour meeting. That’s part of the official appeal process, you’d get an hour to state your case. The FDA had – I think it was the final count was 14 individuals. So it’s – I think, kind of limiting for them as well to ask questions. But our presentation probably took about 20, 25 minutes and the point person at FDA that was really running the meeting at the end of our presentation did reach out to his team to see if there was any questions on the rationale that Dr. Wustenberg provided. And there were none. And that was really the extent of the call. But I think it was really well laid out by Dr. Wustenberg. So I’m not sure that FDA would’ve had a lot of questions on it. We did provide the presentation a few days in advance. So the FDA did have the ability to at least review the material. This wasn’t the first time they were seeing it. But that was really the bulk of the discussion other than them informing us as to when they would get back to us.

Okay. It kind of seems like a bit of an odd situation not asking any questions, but it’s understandable why it works that way. And then just if you do, if they come back and say, continue doing the test that’s about compatibility test, that you’ve already commenced, when you resubmit that if you have to, I mean this is a really any change to the submission aside from the biocompatibility test that would need to take place?

No. So that was when you look at the questions that FDA had in the latest submission, really what the issue was with this particular test. So there wasn’t anything in addition to that, that would cause us to redo anything or have to perform anything that we – any testing that we hadn’t performed before.

Okay. Okay. Got it. And then just given your activities with Zimmer, you guys going out and qualifying new suppliers, the fact that you’ve got the first order and inventory and ready to ship, it doesn’t seem like Zimmer is any less gung-ho about the product than they have. I mean, is that a fair characterization?

In my opinion, yes. I think just the mere fact that they invited us to their meeting that they had with this advisory board, all the signs that we see from them is that they’re still engaged with this program. They’re still excited and they haven’t given us any reason to think otherwise.

Okay, great. And then maybe any more color on how the spinal cord stem development’s going and anything you could share about Dr. Vomero’s background that would be relevant.

Yes. So about her background, she’s got a wealth of experience with poly image materials. So that’s the materials that we’re using today. She’s also very familiar with our – we will call it our new design without giving too much away. And we really needed to provide some additional resources. I think litmus test for us was this five-year testing. And our comfort level to say, okay, yes, we really think that that these devices will have the durability that we need. And after seeing the results, we went out and felt that we really needed to have a specific person focus on this from a development standpoint. She’s got great manufacturing experience, great thin film experience. She did a Google Search of her, you’d see her as an author in some of the papers. So my time with her has been short since she’s relatively new with the company, but I’m really shocked that how advanced she is. And even some of the ideas she has – that she has for making this spinal cord stem electrode, even more exciting than what I had originally expected. So I think what we’re going to wind up with and I don’t want to get too far on myself, but the path that, that I saw and the opportunity that I saw with the electrode, I think she’s got some other ideas to make it even more interesting with physicians. So we’ve recently gone out and brought on some both neurosurgeons as well as anesthesiologists who also placed a number of these devices and do a number of these procedures and initiated discussions with them about some of these new ideas and there’s an excitement level. We still got a lot of work to do, but I think she’s really going to accelerate the process for us. I think some of her ideas already are so much further beyond what I had even anticipated, so.

So stay tuned on that front, we might have some entry – is coming.

Yes. I think that some of the advantages that I saw with the technology, I think she’s expanding beyond that with what she feels we may be able to do with the design of this electrode. So now once we get a little further along, we’ll disclose more about what we’re doing, but I don’t want to go into too much detail at this stage.

Yes. Fair enough. Well, that’s all I had, gentlemen. Thanks for taking the questions and we’ll be in touch.

Thank you.

We’ve reached the end of the question-and-answer session. And this concludes today’s conference. You may disconnect your lines at this time and we thank you for your participation.