Pleasure this morning of introducing Kevin Moran, Chief Financial Officer of Vanda Pharmaceuticals. Kevin.
Thanks a lot.
Thank you.
Good morning, everybody. Thanks very much for coming to the presentation, and thanks to the Wells Fargo team and Jason for having us. Very excited to be here with you. Vanda Pharmaceuticals is a global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We have three commercialized products, Fanapt, which has been approved since 2009, first in adults in schizophrenia, and more recently in adults in bipolar I disorder. We have Hetlios, which includes both the Hetlios oral capsules and the Hetlios LQ liquid formulation. Our oral capsules are approved in the US for adults with non-24-hour sleep-wake disorder, or non-24, as well as adults with nighttime sleep disturbances and Smith-Magenis syndrome, or SMS. Our liquid LQ formulation is approved for pediatric patients with nighttime sleep disturbances and SMS.
In addition to being approved in the US market, Hetlios is approved for adults with non-24 in the EU. Finally, we have Ponvory, which we acquired at the end of 2023 from Johnson & Johnson, which is approved for multiple sclerosis. In addition to our commercialized products, we have a very robust pipeline, with a number of recent and upcoming regulatory submissions, which we'll get into more detail in the subsequent slides, as well as multiple products across a wide range of therapeutic areas at various stages of clinical development. Finally, our financial position is very strong. We ended the second quarter with approximately $390 million in cash and no debt. In a bit more detail on our commercialized products, as I mentioned, beginning with Fanapt, it's currently approved in the US for adults with bipolar I disorder as well as adults with schizophrenia.
We are pursuing FDA approval for milsoperidone, which is the active metabolite of Fanapt, for the treatment of adults with bipolar I disorder and schizophrenia, and we expect to submit an NDA to the FDA in the early part of 2025. We recently announced that we'll be beginning a clinical program in major depressive disorder, expected to be initiated by the end of this year. In addition to that, we have our long-acting injectable formulation of Fanapt, where we're expected to begin a phase three program in schizophrenia by the end of 2024. In Hetlios, again, the oral capsules are approved in the US and Europe for the treatment of non-24-hour sleep-wake disorder in adults. The oral capsules and the LQ liquid formulation are also approved in the US for the treatment of nighttime sleep disturbances in adults and children with Smith-Magenis syndrome.
We're pursuing FDA approval for a number of indications for Hetlios, including insomnia and jet lag disorder. We also recently announced that we'll be beginning a program in pediatric insomnia for the Hetlios LQ formulation. Finally, on Ponvory, as mentioned, it's approved in the treatment of relapsing forms of MS, and we plan to file IND applications for Ponvory in the treatment of both psoriasis and ulcerative colitis by the end of this year. Vanda's strategic focus is on increasing revenue, both organically through our existing products that we just outlined in the indications that they're approved in, but also in additional indications through life cycle management activities, and considering increasing revenue through business development activities. We're working to advance our pipeline of both late and early stage programs, as well as focused on development of our emerging ASO platform.
We always have a consumer focus. We're focused on increasing access and affordability for patients and engaging directly with consumers wherever possible. Turning to our commercial priorities and milestones. On Fanapt, we had our commercial launch of Fanapt in bipolar I disorder. The approval of Fanapt in bipolar I disorder was in April of 2024, and a significant portion of our launch activities have commenced in the third quarter. That being said, we continue to focus on the market for schizophrenia, where we've been present for over a decade. We are pursuing FDA approval for milsoperidone for the treatment of both bipolar I disorder and schizophrenia while beginning our major depressive disorder program, as well as our long-acting injectable program of Fanapt in schizophrenia. On Hetlios, we're focused on retaining market share despite the generic competition. That's being done through a focus on patient loyalty.
We're focused on the continued growth of SMS in the US market, pursuing SMS in the European market, and pursuing FDA approvals in a host of other indications, including insomnia and jet lag disorder. We've recently announced that we'll be beginning a program for our Hetlios LQ formulation in pediatric insomnia by the end of the year. On Ponvory, our commercial launch in the existing multiple sclerosis market also commenced in the third quarter of this year, and we plan to file IND applications for psoriasis and ulcerative colitis this year. On tradipitant, we continue to pursue our FDA approval for tradipitant in patients with gastroparesis, where we have a PDUFA date on September 18th, and we're pursuing FDA approval for tradipitant in motion sickness, where we expect to file a new drug application by the end of this year.
Turning now to our research and development pipeline. As I mentioned, on Fanapt, we've got our long-acting injectable formulation, which will be in phase three for schizophrenia. On milsoperidone, we have our upcoming regulatory filing for bipolar and schizophrenia that we expect to have into the FDA by early 2025, and again, initiation of our major depression study by the end of this year. On Hetlios, we have a number of indications that we're pursuing. The one that I would focus on in terms of recent developments is our pediatric insomnia program that, again, we expect to commence this year. On Ponvory, our IND applications for psoriasis and ulcerative colitis. Beyond the programs that are on this slide, we have a number of other early stage programs at various stages of development that we'll touch on as we move through the presentation.
On Hetlios life cycle management, our jet lag disorder and insomnia programs are completed. Our delayed sleep phase disorder program is currently in phase three, where we initiated that study. Our non-24 pediatric program, we're preparing for our phase three clinical study, and our pediatric insomnia program, we're moving towards program initiation by the end of this year. On Fanapt, our bipolar I disorder program, which was approved in April of this year on the heels of positive clinical study results in December of 2022. On our long-acting injectable formulation, again, we're moving to initiate our phase three program by the end of this year, and the LAI is expected to potentially reach the market after 2026, where there's patent applications that could have us have exclusivity out into the 2040s.
On milsoperidone, our upcoming new drug application in the early part of 2025, where the potential patent applications that if issued could also extend exclusivity out into the 2040s, which would also benefit, obviously, our major depression program if we were to be successful on that front. On tradipitant, as I mentioned, we're pursuing FDA approval for gastroparesis, where our NDA has been accepted by the FDA late last year, and we have a PDUFA date this month on September 18. That filing was on the heels of our phase three study results reported in February of 2022, which we'll go into a bit more detail on upcoming slides, and our positive phase two study results, which were reported in December of 2018.
On our motion sickness program, we've now completed three clinical studies with positive results, most recently our second phase three study in May of this year, and we're moving towards our NDA filing by the end of this year. On atopic dermatitis, our program where we reported study results in February of 2020 remains on hold. On gastroparesis, as I mentioned, we've completed two clinical studies in patients with gastroparesis, and our NDA has been accepted for filing with an upcoming PDUFA date. The last approved treatment option for gastroparesis was approved over 40 years ago, and given the tremendous need in the patient community and patient prevalence, this represents a significant commercial opportunity for the company.
There's estimated to be about 6 million people in the US suffering from gastroparesis, of which about 600,000 have been diagnosed, and for the only drug approved for gastroparesis that is approved for only diabetic gastroparesis, there's approximately 300,000 prescriptions on a monthly basis of metoclopramide. Turning to the symptoms and clinical expression of gastroparesis, diabetic or idiopathic gastroparesis is characterized by chronic nausea, vomiting, delayed gastric emptying, and other additional GI symptoms. The chronic nausea has patients suffering from chronic severe and debilitating nausea, vomiting, which can lead to weight loss and hospitalization, delayed gastric emptying, which may be the cause of some of the underlying symptoms, and other GI symptoms, including abdominal pain and early fullness. A bit more detail on our clinical program.
As I mentioned, we had a phase two study that read out in December of 2018 that was a positive study, a four-week study of approximately 150 patients stratified across idiopathic and diabetic gastroparesis, where tradipitant was shown to be effective in improving nausea and the overall symptoms of patients with gastroparesis. That was followed by our phase three study, the 3301 study, which was a 12-week study, of 200 adult patients similarly stratified across diabetic and idiopathic gastroparesis. While the study did not meet its primary endpoint, when accounting for confounders, there was strong evidence of drug effect across a number of symptoms. Finally, on our expanded access program, where we've initiated an expanded access program for patients requesting access outside of the clinical studies, we've had numerous patients come through the study, with several now being on tradipitant for over a year.
On our pooled study results of the phase two and phase three study, we completed a pooled analysis of these two studies. The population was approximately three or was 342 patients. Of note, both studies were large, multi-site, randomized, double-blind, placebo-controlled studies. In the pooled analysis, tradipitant was shown to be superior to placebo in a number of key clinical parameters, including our primary endpoint parameter of daily diary nausea. The conclusion from this is that both studies demonstrate the efficacy of tradipitant in relieving the symptoms of gastroparesis. Turning now to our motion sickness program. Motion sickness is characterized by nausea and vomiting as being the core symptoms. These symptoms are often expressed as a result of the discordance between the actual and expected movements of the body.
For the primary drug used to treat motion sickness, Dramamine, there are approximately 2 million-3 million doses purchased in the US each month, also demonstrating a significant market opportunity for tradipitant in motion sickness. Our program has included a phase three, following the results of our positive phase two study, a phase three study where there were positive results in the prevention of vomiting, and a second phase three study that demonstrated the same results. The first phase three study randomized 365 patients, were on 85 mg and 170 mg tradipitant, both met the primary endpoint of preventing vomiting. The second phase three study included 316 randomized patients where the 170 mg dose met the primary endpoint and the 85 mg dose met the secondary endpoint. Our new drug application, as I mentioned, is complete and expected to be submitted by the end of this year.
In a bit more detail on our first phase three study. The 365 participants were part of 34 boat trips in coastal waters off the US, which happened from November of 2021 through April of 2023. The patients were randomized weekly on tradipitant 170 mg arm, tradipitant 85 mg arm, and placebo, approximately an hour prior to departure. The trips were four-hour trips with questionnaires of vomiting and nausea every 30 minutes, and the incidence of vomiting on tradipitant was significantly lower than placebo, with the 170 mg arm being about 18%, the 85 mg arm being about 19% as compared to placebo, which was approximately 44%. The second phase three study was a similar design with 20 boat trips in coastal waters happening between September of 2023 and April of 2024. The patients were again randomized equally between 170 mg, 85 mg, and placebo arms.
The same four-hour trips with questionnaires were conducted, and again, the incidence of vomiting was significantly lower in tradipitant on both arms as compared to placebo, with the 85 mg being 18% vomiting, the 170 mg being even better with 10% vomiting, and those both compared to the placebo of approximately 38% vomiting. Beyond those late stage programs, we have a number of other early stage programs that are progressing, beginning with our CFTR regulators. Our CFTR activator, VSJ110, is currently in an ongoing phase two study for the treatment of dry eye, where we're more than 50% enrolled. The other compound in our CFTR regulator group is the CFTR inhibitor VPO227, which has recently been granted orphan drug designation by the FDA for the treatment of cholera.
In addition to that, we have VTR297, which is an HDAC inhibitor currently in a phase two study for hematologic malignancies at sites in the U.S. and Europe, and it has a phase one study for the treatment of onychomycosis, which is a fungal infection of the nail, which was initiated earlier this year. VQW765, which is currently, where we completed a phase two study that was a single dose study in social performance anxiety. The study results were announced in December of 2022, and we're evaluating next steps on that program. Additionally, on our ASO programs, in September of 2022, we entered into an agreement with OliPass, to develop a research and development agreement to jointly develop our ASO molecules based on OliPass's proprietary technology. To that end, we've recently been granted orphan drug designation for the VCA894A compound in the CMT2S indication.
Turning now to our financial results. In our Q2 financial results, we communicated our 2024 financial guidance, which includes total revenues of $180 million-$210 million and a year-end ending cash balance of between $360 million and $390 million. As a reminder, we ended last year with just under $390 million. For Q2 2024, our financial results included $50.5 million of total product revenue, which consisted of Fanapt revenue of approximately $23 million, Hetlios product revenue of approximately $19 million, and Ponvory product revenue of approximately $8.6 million. For our full-year results through the second quarter of 2024, we had total revenues of just under $100 million, with operating expenses of approximately $117 million, all resulting in a net loss of approximately $9 million, and our Q2 ending cash balance being essentially flat with year-end 2023.
With that, I'd like to thank everybody for their interest in Vanda and look forward to providing additional updates in the future.