Financial results conference call. Currently, all callers have been placed in listen-only mode, and following management's prepared remarks, the call will be opened up for questions. If you would like to ask a question at that time, please press star one on your telephone keypad. If you need to remove yourself from the queue, press star two. At any time, if you should need operator assistance, press star zero. Please be advised that today's call is being recorded. I will now turn the call over to Nichol Ochsner, Zevra Therapeutics' Vice President, Investor Relations and Corporate Communications. Thank you, and ma'am, you may begin.
Good afternoon, and thank you for joining our call today to discuss KemPharm's third quarter 2022 financial and corporate results. Before we begin, I would like to remind our listeners that remarks made during this call may contain forward-looking statements that involve risks and uncertainties and are subject to changes at any time, including, but not limited to, statements about KemPharm's expectations regarding future operating results. Forward-looking statements are made pursuant to the Safe Harbor Provisions of the Federal Securities Law and represent management's current expectations. Actual results may differ materially. KemPharm disclaims any obligation to update or revise forward-looking statements except as required by law. For complete information regarding forward-looking statements, risks, and uncertainties can be found in KemPharm's filings with the SEC, which are available on KemPharm's website under the Investor Relations section.
Speaking on today's call will be Travis Mickle, Zevra Therapeutics' President and CEO, and LaDuane Clifton, CFO. Following the remarks, Travis and LaDuane will participate in a question and answer session. With that, it's my pleasure to introduce Travis.
Thanks, Nicole, and thanks everyone for joining today. Excuse me. For those that are not as familiar with KemPharm, I'd like to give just a brief introductory statement. KemPharm is focused on the development and discovery of novel rare CNS and neurodegenerative disorders as well as lysosomal storage diseases. While historically we have a number of other assets that have been licensed, our new focus is on the development of potential products that we could internally commercialize. That's all built on a foundation of strong science. Excuse me. Great. A little bit of allergies that have caught up with me. A strong balance sheet. Next slide, please. Just to go over briefly the recent highlights and from the press release and results from the Q3.
Of course, there's a number of different things going on with arimoclomol, and many of these we have not continuously updated. Just as a highlight, we recently had the completion of the four-year open label safety trial for arimoclomol, demonstrating a long-term effect as well as safety of arimoclomol over that time period. We've been having ongoing collaborative dialogue with the FDA. This includes meetings, submissions, back and forth with questions and answers and so forth, so a very collaborative discussion there. We've been working to bring in all the new data as well as some of the other data that we weren't expecting to have to add to the NDA. Based on all of that, we're now targeting the resubmission as early as Q3 of next year.
Azstarys continues to generate sales and milestones potential for the royalty revenue with Azstarys. We know that Corium's continuing their effort there. KP1077 development program is going well. We just announced results of the Phase I cardiovascular trial. Certainly very positive results for us, indicating we're right on the right track we wanna be with that particular program and development. With that, we do expect to initiate the Phase II trial before year-end. As LaDuane will highlight a little bit in more detail, we do have a strong balance sheet. We've had revenue from the French EAP as we expected, as well as other forms of revenue, and have ample capital to do everything that we expect to do and perhaps a lot more.
Specifically looking at the various product development highlights, just a brief overview of arimoclomol. Arimoclomol is intended for the treatment of Niemann-Pick type C. This is an ultra-rare lysosomal storage disorder, most of the symptoms being those related to neurological symptoms related to cognition, hearing loss, speech, swallowing, et cetera. We were able to acquire the product after a CRL and some financial difficulty of the former sponsor, Orphazyme, able to get it for a highly efficient sort of structure. We see this as a high-value opportunity for us, not only something that already generates revenue through the French EAP, but could really considerably advance the company into the commercial stage of these rare disorders. With that, the intended resubmission in third quarter will help advance those goals.
Next slide, please. Looking at the path to resubmission, as I mentioned there briefly, we are continuing to have this dialogue with the FDA. Again, submission of some of these studies that were completed prior to our actually getting the asset, but since the CRL has been a part of this entire process. This really, I do believe, shows the interaction with the agency as being very collaborative and for them wanting to see an advancement here. We're also working to bolster the arguments that were made in the original NDA, as well as specifically addressing each of the CRL issues. With that, something that we were not aware of was that the four-year safety trial was wrapping up and then that database would be locked and in fact the final report would be issued.
Knowing all of that, it wouldn't make any sense for us to submit that data, that entire study, the NDA associated with that without that data in there. We think it's very strong data, very supportive of our potential safety and efficacy for the product. It's certainly something that we feel is a critical piece. Looking forward, I think one question that everybody should have on their mind, we see this potential delay from our previous guidance is, you know, what else has the FDA said? The FDA has not raised any new issues or concerns. It's been really about reviewing what they didn't know from the previous filings and what has been generated since then. There's been no request for any new efficacy trial from the FDA. Very critical piece here.
No new issues than what we've already identified, as well as no new efficacy trial. We still believe that there's a very viable path, but there will always be the possibility in any regulatory submission like this that we may choose to do some additional work. We may choose to go through an appeal process as well as request either by the FDA or by KemPharm a potential for an AdCom for this particular product. Briefly looking at KP1077, this product is actually intended for the treatment of idiopathic hypersomnia as well as narcolepsy. It's 100% of serdexmethylphenidate, which is a prodrug of methylphenidate, that's already been designated as a C4 classification as far as controlled substance. This is also an orphan disease, rare disease. Idiopathic hypersomnia actually occurs less than narcolepsy.
Our intended benefit here is that we can provide higher exposure, providing more waking through a potential pathway that addresses the major symptoms of IH, including sleep inertia or waking, as well as brain fog. Looking at where we sit and what next stages are for idiopathic hypersomnia, this is our lead indication. We filed an IND earlier this year. We expect to initiate our Phase II trial before the end of the year. Everything seems to be going well there. Sites are enrolling, getting up to speed, starting to look forward to recruitment and so forth. We expect to have interim data from that Phase II trial by roughly mid-year next year. We'll provide more detail onto that, as well as top-line data before year-end next year.
After we get that study underway and perhaps even after interim data, we will initiate a second study in this time in narcolepsy. That particular case, we're looking at an add-on indication and not as our primary commercial and development program. I think that gives an update on both of our development programs as well as where the status of the company is overall. I'm gonna actually turn it over to LaDuane to provide some more details on the financial position.
Thanks, Travis. As Travis mentioned earlier in his opening remarks, we had another positive quarter, a good quarter, and specifically our balance sheet remains very strong. Revenue reported for this quarter is $2.9 million, which is net of certain liabilities associated with the arimoclomol EAP program. That's coming in as we expected. Our net loss for the quarter is about $0.19 per basic and diluted share, which was driven primarily by R&D expense and G&A expense, but again, we're offset by the net revenues. As of September 30, our cash balance was $107.4 million, and that's a decrease of about $7 million compared to the prior quarter.
It really was comprised of sort of the ongoing third-party R&D costs as well as other expenses, and notably, investment of working capital related to the French EAP program. You'll see on our balance sheet that there was an increase in accounts receivable. As we move forward, we do expect that cash flow to begin operating in the normal course. Ultimately, our cash balance based on our current operating forecast allows our resources to extend our runway into 2026. As Travis has also mentioned, to the extent that Azstarys generates royalty revenue or additional milestones, which we still see as pretty much an important thing to be looking for, that will have the effect of potentially extending that runway further. Thank you, Travis, back to you.
Thanks, LaDuane. Just looking forward as we go and review the upcoming milestones, kind of reiterate our intention to refile the NDA Q3 of next year. Anticipate, you know, of course, the quarterly revenue from the French EAP program. Azstarys will continue to monitor scripts and see how that goes. I think that those are certainly tracking in the right direction. For KP1077, we have the expectation for the trial to start by the end of the year. Interim results should be available mid-year with those particular final results by the year-end, as well as the initiation of a narcolepsy trial sometime in 2023.
Then as LaDuane highlighted again, a solid balance sheet, a lot of good possible expansion opportunities, not just with our pipeline, but through what we already have in arimoclomol and KP1077, and certainly a long runway that can only be bolstered by additional revenue. With that, I'm actually gonna turn it over and see if there's any questions?
Thank you, sir. At this time, we will open the floor for questions. If you wish to ask a question, please press star one on your telephone keypad. You may remove yourself from the queue by pressing star two. Our first question will come from Sumant Kulkarni with Canaccord. Your line is open.
Good afternoon. Thanks for taking my questions. I have a bunch here, so I'll start with one. It looks like at this time you don't have any new requests from the FDA, but has the agency already finished reviewing the new data that you've generated? If not, when do you think the FDA could finish that? And how confident are you that the FDA's new analysis will not lead to the need for a new clinical trial?
I mean, it's an ongoing sort of review. We've submitted, and I won't give particular details, but whatever we've submitted to the agency, they've fully reviewed. There will be a detailed review post-submission. I mean, that's just standard course. But they've already asked questions and weighed in on some of the information. That is not the totality of that information where we could actually file the NDA if it were. We have more to provide them as well as more, you know, to put into the NDA that they won't be able to review until then. I hope that answers your question.
Yep. It seems like the safety study is the new piece of information that is the key thing that led you to this potential, like, the delay in the potential filing. Were there any specific findings in the safety study that you might consider new or counterintuitive relative to the safety data that is already publicly known on arimoclomol? Is there any risk related to continuation of an EAP program for the product based on the new safety data?
I mean, that particular study and the results, it actually did as well measure the NPC SS. The efficacy score was continuously measured as well. Actually showed a lasting effect of arimoclomol in those patients who were in the study, which would have been not just four years, but five years in total. Additionally, there were no safety signals that were different than there was in the double-blind phase of the trial. I think the data is great. It's already been presented by Marc Patterson at two NPC conferences, including the Parseghian conference, and then the conference back in July. You know, those results are already out there. Certainly we could put those up on our website at some point here. I think they're helpful.
I think there's also results of the two failed trials that Orphazyme attempted with ALS and IBM that show, again, the safety here, 500+ patients, there's been no significant safety signal from arimoclomol in all of that. That's pretty rare to have in this type of disease, that level of safety and that many patients exposed for a long period of time.
Got it. One more before I hop back into the queue. Could you give us any details on what specific parts of a proposed NDA package may be most in need of strengthening that led to this push out of the timeline? Would you say that the new timeline is conservative related to the information needed to be generated?
Yeah, I would say it's conservative. I think, you know, the difference between March and July is Q1 to Q3, right? It doesn't certainly have to indicate a six or nine-month delay from those sort of things. When we looked at what needed to be bolstered, there was nothing. I mean, we really had all the data. It's all about putting it together. Then what has kinda led to this is the safety trial. It wasn't something we anticipated putting into the submission, so that has to go in and we really do believe it's a cornerstone of our arguments for the benefit as well as a sequential sort of submission pattern. The agency wants to see something, and they want more from that.
You know, we can't do things in parallel as much as we'd like to. It's that sequential pattern of providing more, getting feedback, going back, maybe meeting with them formally or informally that, you know, has kind of pushed it out a little bit, which again, I think is entirely very positive, because we've never received anything back, that has indicated otherwise.
Very helpful. Thank you.
Thank you. Our next question will come from Jonathan Aschoff with Roth Capital Partners. Your line is open.
Thank you, guys. Good evening. Would you break down the revenue to whatever extent you can? 'Cause it's not 100% arimoclomol from France. Can you help us out with just that nitty-gritty?
There was a portion of that that was royalties that came into us from net sales of Azstarys, our percentage of that. You'll see when we file our 10-Q, we recognized about $200,000 or so of royalty revenue on Azstarys.
Okay. It's simply about $2.7 arimoclomol, $200 Azstarys and no other line item, right?
Yes.
Thank you very much, guys.
Thank you. This does conclude the Q&A portion of today's call, and I would now like to turn it back to Travis Mickle for any additional or closing remarks.
Thank you. Thank you again for your participation in joining us today. I appreciate the good questions and additional analysis and hopefully additional color on what we're doing and what we hope to achieve, not just the remainder of this year, but next year as well. Thanks, everyone. Hope you have a nice evening.
Thank you, ladies and gentlemen. This does conclude today's KemPharm third quarter 2022 earnings call and webcast. You may disconnect your line at this time, and have a wonderful day.