Andrew, thank you. Thank you all for being here today, those in person and anyone listening to the recast later on. Again, my name is Dave Lowrance. I'm Savara's Chief Financial and Administrative Officer. I will do the obligatory safe harbor statement regarding today's presentation. For those of you that don't know our story, have not followed Savara in quite some time, we are a clinical stage biopharmaceutical company currently focused on a single development program in a rare disease called autoimmune pulmonary alveolar proteinosis, or aPAP. aPAP is a rare chronic debilitating lung disease characterized by abnormal buildup of surfactant in alveoli or air sacs of the lung. The root cause of aPAP is an autoimmune response against GM-CSF, which is a naturally occurring protein in the body and is required for macrophages to properly clear surfactant from the alveoli.
In patients with aPAP, GM-CSF is neutralized by antibodies, essentially turning the signal off, rendering macrophages unable to clear surfactant. This alters gas exchange in the lungs and reduces blood oxygenation, which creates chronic breathlessness, cough, episodes of fever, fatigue, and can ultimately result in respiratory failure. aPAP patients are at higher risk for respiratory infections, with some developing fibrosis, and they may require a lung transplant. Unfortunately for these patients, because of the autoimmune nature of the disease, aPAP can reoccur even in a transplanted lung. On top of all of this, the journey to diagnosis can be long and complicated. aPAP is rare, and unfortunately, the symptoms are nonspecific and often lead to a misdiagnosis of a more common lung disease. In fact, the average delay caused by misdiagnosis is 18 months.
Just think about the patient journey just to get to the point of figuring out what they have. Currently, there are no approved medicines for aPAP in the U.S. or Europe. There is a rescue therapy called whole lung lavage, and this procedure is performed under anesthesia with each lung separately intubated to ventilate one side while the other is washed out with something like 20 liters -50 liters of saline. As part of this procedure, there is chest compression that is used to loosen up the surfactant, and then gravity is used to drain the fluid. Following the procedure, a patient can easily need 24 hours -48 hours on a ventilator, often in the ICU. This procedure is so intense, it can result in broken ribs, trauma to the lungs, and infections are possible.
While this treatment is effective in the short term, it does not address the underlying pathophysiology of the disease. Furthermore, it requires special expertise in order to perform the whole lung lavage, and therefore only a few centers are able to perform this procedure. In our view, a whole lung lavage is definitely not the answer, and that's why we're developing MOLBREEVI, our novel inhalation solution. Let's look specifically at MOLBREEVI. MOLBREEVI is a novel inhaled biologic. It is recombinant human GM-CSF that is dosed at 300 micrograms once daily. MOLBREEVI is delivered using a proprietary investigational eFlow nebulizer that's been optimized for our drug. This is a drug device combo with a nebulization time of about three to five minutes. Our device partner, PARI, currently has five other FDA-approved nebulizers based on the same eFlow technology.
In June of last year, we were extremely excited to report the top-line results from our phase III pivotal clinical trial in IMPALA-2. IMPALA-2 is the largest and longest placebo-controlled trial conducted in aPAP. The trial met its primary endpoint, with MOLBREEVI achieving statistically significant improvement in DLCO compared to placebo at week 24. Moreover, significant improvement was sustained at week 48, demonstrating durability of effect. Beyond improvements in the gas exchange, MOLBREEVI showed evidence of clinical benefit for all three secondary endpoints, including statistically significant improvements in SGRQ total score at week 24, SGRQ being a patient-reported outcome tool. MOLBREEVI also showed numerically greater improvements in SGRQ activity score and exercise capacity at both weeks 24 and 48. Importantly, 97% of patients completed the double-blind treatment period, and there were no withdrawals due to drug-related adverse events.
100%, all 100% of the patients who completed this double-blind period opted to continue into the 96-week open label extension. With the strong results from our IMPALA-2 study, we really believe we have a winning opportunity here. From real-world retrospective outcomes data published online in the journal ERJ Open Research, K-Series retrospectively evaluated five aPAP patients who received MOLBREEVI through a European single patient access supplied by Savara. Following treatment with MOLBREEVI with a mean duration of a little over four years, improvements in disease severity were shown across pulmonary gas transfer as well as activities of daily living. Furthermore, while four of the five patients had had at least one whole lung lavage prior to treatment with MOLBREEVI, none of the five patients had a whole lung lavage after having a year of treatment.
I can't tell you how exciting it is to see data like that validating all the information that we have. These outcomes suggest that treatment with MOLBREEVI may address the underlying pathophysiology of aPAP, resulting in improved lung function, decreased disease burden, and reduction of clinical symptoms. With all of that information, now transitioning over to the regulatory front, at the end of March, we announced that we completed the submission of the BLA to the FDA and have requested priority review. We are in the 60-day window and should be hearing from the FDA soon. If priority review is granted, that could give us a potential PDUFA date around the end of November of this year. In parallel, we remain on track to submit the MAA in the EU and the U.K. by the end of the year. A lot is happening on the regulatory front.
How does this all translate to a commercial opportunity? Let's specifically look at MOLBREEVI and then take a look at the diagnosed prevalence with which MOLBREEVI will be treating these patients. Published literature says that there are between 6 and 26 patients per million, and that's based on three studies analyzing health claims data or regional registries. Obviously, that's quite a big range, so naturally, we conducted our own work to better understand the prevalence of aPAP in the United States. Based on that information, utilizing claims data analysis of over 300 million lives, based on ICD-9 and ICD-10 codes, we identified approximately 3,600 aPAP patients in the U.S.
In addition to the identified patients, we applied a machine learning model to the same claims database and found an additional 3,700 patients in the U.S. that are undiagnosed but are either highly likely or likely to have aPAP. While they're not diagnosed, meaning they have no ICD-9 or ICD-10 code, their claims history mirrors those of diagnosed patients. Thus, we believe the current aPAP market opportunity in the U.S. is significant. In total, if you combine the known and the potential patients in the U.S., we would have greater than 7,000 patients, which equates to about 10-12 patients per million, which, by the way, is in the middle of the EPI range. Now, if we specifically focus on the known 3,600 aPAP patients, we know the centers and the places where they're being treated.
It is our goal to get line of sight to 1,000 of these patients by launch. Now, that 1,000 number is arbitrary. It is something that we put a stake in the ground over, but it gives us something to orient around for the first couple of years of launch. Ultimately, our full intent is to get line of sight into all 3,600 patients. What do I mean by line of sight? It is going beyond the claims database. It means actually confirming those number of patients that are out there, where they are being treated, how they are being treated, and how often they are going to seek treatment. This also means that by the time we launch, we are going to have relationships with the pulmonologists and the centers where these folks are treated. That is going to help us when we launch into the sales activities for MOLBREEVI.
This slide says that we have about 450 patients line of sight already, but as an update, I'm here to tell you we now have well over 500 patients line of sight. With four MSLs recently joining the company and our market development team being put in place over the next couple of months, we believe that these resources are going to enable us not only to meet that 1,000 patient line of sight, but perhaps even exceed it. Additionally, we've done some market research to get insights into prescribing and reimbursement sentiment. Our key stakeholders have indicated strong interest in MOLBREEVI, as we would expect. 83% of U.S. pulmonologists reported they would likely prescribe and indicated a willingness to use it across disease severity.
We also interviewed U.S. payers representing approximately 90 million commercial and Medicare lives, testing various orphan price levels within the $300,000-$500,000 per patient per year range. The results were really encouraging. Payers recognize the disease burden of aPAP and see the need for a non-invasive treatment option. Importantly, 87% of the payers indicated that they intend to provide coverage with a simple pre-authorization criteria and were not concerned about the impact on the pharmacy budget. Lastly, we heard from patients that they were excited about the potential for a new non-invasive treatment option like MOLBREEVI, and if approved, 100% of the patients indicated a strong willingness to ask their doctor about treatment.
Over a year ago, this is pre-data, so pre-data from IMPALA-2, which we announced last June, and at risk, we launched aPAP ClearPath, a free, simple blood antibody test to provide an easy, accurate way to test for aPAP. Furthermore, we evolved the test and in March of this year launched a dried blood spot version. This means that physicians can rule out or rule in an aPAP diagnosis with only a fingerprick blood sample and can get those results in about seven days. Currently, we're using this testing platform as a pilot program with an interstitial lung disease clinic at the University of Florida. We believe ILD clinics could have an enriched patient population for undiagnosed aPAP patients, and the aPAP ClearPath test may help to rule in or rule out aPAP diagnosis much more quickly.
All right, so given our level of confidence around the potential for MOLBREEVI, we've started to build out our U.S. commercial team prior to approval. This team is going to be about 25 to 30 individuals, including leadership, and will be responsible for profiling accounts, gaining that line of sight into patients that we just talked about, and expanding our disease state awareness campaigns and testing initiatives. The leader of the team's already started, and we're in the process of hiring the regional directors right now, which will include approximately 12 territory managers being onboarded by the middle of this year, and the rest of the team joining later in 2025. Of course, they're going to start as a market development team, and then assuming approval, will transition over into our sales team.
Clearly, there's a ton of excitement at Savara, and we cannot wait to bring the potential of MOLBREEVI to patients. A quick look at our financials. At the end of the first quarter, we had a little over $172 million in cash and short-term investments. We also executed a $200 million debt facility with Hercules Capital at the end of March, and we have communicated that that gives us a cash runway into the second half of 2027. We are thrilled with the investor support that we have at Savara, as well as the amount of coverage that we have, which is from eight equity research analysts. In summary, I'm going to leave you with this.
With 3,600 aPAP patients today, a pricing power of between $300,000 and $500,000 per patient per year, which is in line with other recently launched orphan drug analogs, there's tremendous upside for the future of Savara. Remember, aPAP is a chronic autoimmune disease that, unfortunately for patients, is not going away. With biologic exclusivity of 12 years in the U.S. and likely much longer, given we think there's little risk for a biosimilar to be a competitor, MOLBREEVI could provide a long and durable revenue stream with blockbuster potential. Thank you very much.