Let's get going. Looks like the webcast is on. So, good morning, everyone. It's our pleasure to have Vanda Pharmaceuticals with us today. Vanda has several products in the market right now for rare sleep conditions, as well as for multiple sclerosis. And we have Kevin Moran, CFO, here to present the company today.
Thanks, Annabelle. Thanks, Annabelle, and thanks to the entire Stifel team for having us here today. Very excited to share our progress updates with you guys. Vanda Pharmaceuticals is a leading global biopharmaceutical company dedicated to innovating in the service of people's pursuit of happiness. We have three commercialized products. In the U.S., we have Fanapt approved for bipolar disorder, as well as schizophrenia in adults. We have Hetlioz and the HETLIOZ LQ liquid formulation approved in the U.S. for adults with non-24-hour sleep-wake disorder in the capsule formulation, as well as adults with nighttime sleep disturbances in Smith-Magenis Syndrome. And then we have HETLIOZ LQ, the liquid formulation approved for pediatric patients with nighttime sleep disturbances in Smith-Magenis Syndrome. In addition to that, Hetlioz capsules are approved in Europe for non-24-hour sleep-wake disorder in adults.
We also have, as our third product, Ponvory, which is approved in the United States for multiple sclerosis and marketed by Vanda, which we acquired from J&J at the end of 2023. In addition to those commercial products, we have a robust pipeline with many recent and upcoming regulatory submissions and multiple products across a wide range of therapeutic areas. We have a very strong financial position ending the third quarter of 2024 with nearly $380 million in cash and no debt. In a bit more detail on our commercialized products, as I mentioned, Fanapt is approved in the U.S. for the acute treatment of bipolar I disorder and for the treatment of schizophrenia, both in adults.
We discussed on our Q3 earnings call that our sales force is in place with 150 sales representatives across the United States, progressing towards 200 representatives by the end of the year. We're also pursuing FDA approval for milsaperidone, the active metabolite of iloperidone or Fanapt, for the treatment of adults with acute bipolar I disorder, as well as schizophrenia, and we're expecting to submit an NDA for those indications in early 2025. In addition to that, we've initiated a clinical program for major depressive disorder that's expected to commence by the end of this quarter, and finally, on the Fanapt franchise, we have a phase three program for the long-acting injectable formulation, which is also expected to be initiated by the end of the year. On Helios oral capsules, again, approved in the U.S. and Europe for non-24-hour sleep-wake disorder in adults.
The oral capsules and liquid formulation are approved in the U.S. for the treatment of nighttime sleep disturbances in Smith-Magenis Syndrome. We continue to pursue FDA approval for a number of other indications for Hetlioz, including insomnia and jet lag disorder with the FDA. Finally, on the HETLIOZ LQ side, we've initiated a pediatric insomnia program, which is expected to commence by the end of the year. Finally, on Ponvory, Ponvory is indicated for the treatment of relapsing forms of multiple sclerosis. As I mentioned, we completed the acquisition from J&J at the end of 2023, and we plan to file IND applications by the end of this year for ulcerative colitis and psoriasis. Vanda Strategic Focus. Our strategic focus is increasing revenue, first and foremost, organically through our existing products and indications, but also through potentially business development opportunities such as the recently completed acquisition of Ponvory.
We're focused on advancing our pipeline, again, with robust late and early-stage programs and an emerging ASO platform. And finally, a consumer focus. Vanda is always focused on increasing access and affordability for patients and engaging directly with consumers wherever possible. Upcoming commercial priorities and milestones. As I mentioned, the commercial launch of Fanapt in bipolar disorder commenced in full in the third quarter, with our 150 sales representatives being in the field, and again, that progressing to 200 by the end of the year. We continue to be focused on the market for schizophrenia, although prioritizing the launch of bipolar disorder. We're pursuing the FDA approval for milsaperidone, again, with our NDA filing expected early next year. And we're advancing the additional expansion of indications and formulations with both milsaperidone for major depressive disorder and the long-acting injectable program for schizophrenia.
On Hetlioz, where there were generic challengers that entered the market at the end of 2022, we're focused on retaining market share despite that competition through patient loyalty, continuing Hetlioz growth for SMS in the U.S. market, pursuing FDA approval for SMS in the EU while continuing to pursue FDA approval for insomnia and jet lag disorder, and finally initiating our LQ program in pediatric insomnia. On Ponvory, we also initiated our commercial launch of Ponvory in the third quarter with our specialty sales force of approximately 30 sales representatives hitting the field, and as I mentioned, we'll plan to file IND applications for Ponvory by the end of the year in both ulcerative colitis and in psoriasis.
And then on tradipitant, where we recently received a Complete Response Letter from the FDA on our submission for gastroparesis, we're going to continue to pursue FDA approval for that indication, as well as pursuing FDA approval for motion sickness, where we've had three positive studies, including two positive phase 3 studies, and plan to submit an NDA by the end of this year. Turning to our late-stage clinical development pipeline, we'll touch on these in a bit more detail in the coming slides. On the Fanapt side, as I mentioned, we're pursuing the long-acting injectable formulation, which is moving into a regulatory filing or moving into a phase 3 program by the end of the year. milsaperidone, the regulatory filing for bipolar and schizophrenia, early 2025, and again, the initiation of our major depressive disorder trial.
Hetlioz, we covered those on the previous slides in terms of the additional indications and markets that we're pursuing, as well as Ponvory and tradipitant. On Fanapt, lifecycle management programs. Again, our phase three study for Fanapt in bipolar disorder was completed with results announced in December of 2022, and the FDA approved our application in April of this year, with our launch commencing in the third quarter of this year. The long-acting injectable formulation, again, we expect to initiate our phase three program by the end of this year, with Fanapt potentially reaching the US market sometime after 2026, and with pending patent applications that, if issued, could extend exclusivity into the 2040s. milsaperidone, which we've also previously referred to as VHX896 or P88, we expect to have our NDA submission into the FDA in early 2025.
With this application, if approved, there's pending patent applications that could extend exclusivity also into the 2040s. As I mentioned, the clinical program for potential label expansion into major depressive disorder is expected to be initiated by the end of this year. Turning now to Hetlioz. On jet lag disorder and insomnia, our clinical programs are completed, and we continue to pursue FDA approval for those indications. On delayed sleep phase disorder, our phase 3 program has been initiated and is underway. Our non-24 pediatric program remains in preparation. And finally, on our pediatric insomnia program, we're expecting to initiate that phase 3 program by the end of the year. Turning now to tradipitant. As I mentioned, we received a CRL from the FDA for our application for gastroparesis in September.
As a reminder, our phase 3 study results were reported in February of 2022, which was a 12-week study of approximately 200 patients with both idiopathic or diabetic gastroparesis. And that phase 3 studied our positive phase 2 study, where results were reported in December of 2018 and published in Gastroenterology. On our motion sickness side, as I mentioned, we have had three positive phase 3 studies, two of those being phase 3 studies, the most recent of which was reported in May of this year. And on atopic dermatitis, our clinical program continues to be on hold. Now, in a bit more detail on gastroparesis. As I mentioned, we completed two clinical studies of tradipitant and gastroparesis. Gastroparesis represents a significant unmet medical need, given the last approved treatment option was approved more than 40 years ago.
There is estimated to be about six million people in the U.S. suffering from gastroparesis, of which approximately 600,000 have been diagnosed, and where for the only approved treatment for gastroparesis, there's approximately 300,000 prescriptions on a monthly basis for metoclopramide. The symptoms and clinical expression of gastroparesis. Gastroparesis is characterized by chronic nausea, where patients suffer from chronic, severe, and debilitating nausea. Vomiting, which can lead to weight loss and hospitalization. Delayed gastric emptying, where many patients have a mechanical defect, which may be the cause of some of the underlying symptoms. And other GI symptoms, including early satiety and abdominal pain. In a bit more detail on our clinical program, our phase two program with a 2301 study was a four-week study of approximately 150 patients stratified by diabetic or idiopathic gastroparesis. And in the study, tradipitant was shown to be effective in improving nausea and overall symptoms.
The efficacy established in the four-week double-blind phase was persistent in the open label phase as well. On our phase 3 study, the 3301 study, this was a 12-week study of approximately 200 adult patients, again, stratified by 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. The open label phase remains open with now over 300 patients enrolled. Finally, on our expanded access program, where we initiated an expanded access program for patients requesting access to tradipitant outside of clinical studies, we continue to receive requests from patients reaching out to gain access, and we've now had multiple patients continuing to be on tradipitant for over a year.
On our pooled study results, Vanda completed a pooled analysis of the two clinical studies of tradipitant in gastroparesis. The population of this pooled study was 342 patients, considering relevant clinical endpoints. Both studies were large, multi-site, randomized, double-blind, placebo-controlled studies. And in the pooled analysis, tradipitant was shown to be superior to placebo in key clinical parameters, including the daily diary nausea score, which was the primary endpoint parameter. The conclusion here is that both studies demonstrated efficacy of tradipitant in relieving symptoms of gastroparesis. Turning now to our motion sickness program. Motion sickness is characterized by nausea and vomiting as the core symptoms. This is often the result of a sensory mismatch resulting in discordance between the actual and expected movement as perceived by various bodily symptoms.
To represent the significant need, approximately 2-3 million doses of Dramamine are purchased each month in the United States. Our phase 3 programs, our first phase 3 study was completed with positive results in the prevention of vomiting. That was followed by our second phase 3 study, which was completed in May of this year, which again demonstrated results in prevention of vomiting. We've commenced an open label safety study. The first phase 3 study had 365 randomized patients with 85 and 170 mg arms, and where both arms met the primary endpoint of preventing vomiting on the boats. The second phase 3 study had 316 randomized patients, again with 170 mg and 85 mg arm, with both preventing vomiting on the boats as well.
Our new drug application with these two phase 3 results and a third phase 2 result being the supporting evidence is expected to be submitted by the end of this year. In a bit more detail, on our first phase 3 study, again, the 365 participants participated on 34 boat trips in coastal waters outside the United States from November of 2021 to April of 2023. The patients were randomized between the 170 mg, 85 mg, and placebo arms approximately one hour prior to departure. There were approximately four-hour boat trips with questionnaires of vomiting and nausea every 30 minutes. And the incidence of vomiting was significantly lower in the tradipitant 170 mg arm with approximately 18% vomiting and the tradipitant 85 mg arm with approximately 20% vomiting as compared to placebo with approximately 45% vomiting.
On our second phase 3 study, there were approximately 316 participants that participated across 20 boat trips in coastal waters off the U.S. from September of 2023 to April of 2024. The participants were again randomized between the tradipitant 170 mg, 85 mg, and placebo arms. The boat trips again remained as four-hour boat trips with questionnaires every 30 minutes. The incidence of vomiting was again significantly lower in tradipitant with the 170 mg arm being approximately 10%, the 85 mg arm being approximately 18%, and placebo being approximately 38%. Turning now to our early-stage programs. We have a CFTR activator and inhibitor that are currently in development. VSJ110, our CFTR activator, has shown efficacy in a dry eye model and currently is in a phase 2 study for the treatment of dry eye with more than 50% enrollment completed.
On VPO227, our CFTR inhibitor, we have received orphan drug designation by the FDA for the treatment of cholera. In addition to that, we have VTR297 in development for hematologic malignancies, where we have an ongoing phase two study at sites in the U.S. and Europe. In addition to that, we have a phase one study for the treatment of onychomycosis, a fungal infection of the nail, which was initiated earlier this year. On social performance anxiety, we have VQW765, which is currently in development for social performance anxiety, where we had results from a phase two study reported at the end of 2022. On our ASO platform, VCA894A was granted orphan drug designation for the treatment of CMT disease caused by cryptic splice site variants within a very specific gene.
In September of 2022, we entered into a research and development agreement with OliPass Corporation to jointly develop a set of ASO molecules based on OliPass's proprietary technology. And this represents a very fast-moving, evolving development pipeline for Vanda. Turning now to our financial results. For 2024, we expect to achieve total revenues of $190-$210 million and total cash of $370-$390 million. This compares to our initial guidance of revenue of $180-$210 million and cash of $360-$390 million. Our Q3 revenue was $47.7 million, which included $23.9 million from Fanapt, $17.9 million from Hetlioz, and $5.9 million for Ponvory. For the first nine months of 2024, our revenues were approximately $146 million, with Fanapt contributing $68 million, Hetlioz $57 million, and Ponvory $21 million. And that resulted in net income for the period of a $14 million loss.
Again, we ended the third quarter with approximately $380 million of cash. With that, I'd like to thank everybody for their interest in Vanda and look forward to providing updates in the near future.