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Savara Inc. (SVRA) Q1 2019 Earnings Call Transcript

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Savara, Inc. (NASDAQ: SVRA)
Q1 2019 Earnings Call
May 9, 2019, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Welcome to the Savara Conference Call. At this time, all participants are in listen-only mode. An audio webcast of this call will be available on the Investors section of Savara's website at savarapharma.com. This call is subject to copyright and is the property of Savara. Recording, reproduction, and transmission of the call without the expressed written consent of Savara is strictly prohibited. As a reminder, today's call is being recorded.

I would now like to turn the conference over to Anne Erickson, Head of Investor Relations and Corporate Communications at Savara.

Anne Erickson -- Head of Investor Relations and Corporate Communications

Good afternoon and thank you, everyone, for joining us on today's call. A press release reporting our first quarter 2019 financial results was issued earlier today, May 9, 2019, and can be found on the Investors section of our website at savarapharma.com. If you have not received this release or if you'd like to be added to the company's distribution list, please email me at ir@savarapharma.com.

This call is also being webcast live and approximately one hour after the call a replay will be available on the company's website and will remain available for the next 30 days. A telephone replay will also be available through May 16.

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Please note that today's conference call and webcast contain forward-looking statements within the meaning of the federal securities laws, including statements regarding the company's strategy, goals, product candidates, clinical studies, and financing matters. Such statements are subject to significant risks and uncertainties, including those described in our press release issued today, Thursday, May 9, 2019, and our recent SEC filings on Forms 8-K, 10-K and 10-Q. Actual results or performance may differ materially from the expectations indicated by our forward-looking statements due to those risks and uncertainties. We caution you to not place undue reliance on any of the forward-looking statements, which speak only as of today.

As usual, we will take analyst questions at the end of the call. However, we would also like to encourage shareholders on the call to submit questions via email to ir@savarapharma.com. Time permitting, we will address these questions alongside others received by our team.

Joining me on the call today are Rob Neville, Chief Executive Officer; Taneli Jouhikainen, President and Chief Operating Officer; Dave Lowrance, Chief Financial Officer.

I'll now turn the call over to Rob.

Rob Neville -- Chief Executive Officer

Thank you, Anne, and good afternoon, everybody. I do appreciate you dialing into our first quarter call for 2019. Expanding on the press release just issued, I will give you a quick update on our business progress and the plans for the coming months. Taneli will then share some important Molgradex developments as well as cover some of our future plans on the combination antibiotic we acquired last year. And then, as usual, Dave will provide a summary of our financial results.

So, let me start by letting you know that over the last few quarters our primary focus has remained constant and that is preparing for the near-term data readout from IMPALA, a pivotal Phase 3 study of Molgradex in autoimmune pulmonary alveolar proteinosis or aPAP.

We noted there's a growing interest in the Savara story and so for those of you who may be new to the call, aPAP is a chronic autoimmune disease caused by the formation of autoantibodies against GM-CSF, leading to a buildup of excess surfactant in the lungs. In a healthy lung, GM-CSF bonds to macrophages, activating their ability to process lipids and proteins and recycle surfactant. In a diseased lung, GM-CSF autoantibodies impair the function of the macrophage, compromising the healthy balance of surfactant production and recycling.

Molgradex is the first investigational and health therapy design to overcome disease by placing the dysfunctional GM-CSF and enabling macrophages to restore balance in the lungs. If not properly treated, aPAP can lead to a progressive respiratory impairment, lung infections, and ultimately respiratory failure or pulmonary fibrosis requiring a lung transplant.

Currently, the only treatment option available to patients is a whole lung lavage. This is an invasive procedure performed under general anesthesia. It comes with significant burden and risks and doesn't stop the underlying cause of the disease.

For more detailed information on this debilitating disease, please make sure to read our upcoming blogs and you can find them on our IR page of our website. In fact, we recently posted one from Dr. Trapnell, a leading physician in KOL and aPAP. And most notably from Dr. Trapnell's blog was his perspective on the transformative potential of inhaled GM-CSF for the treatment of aPAP. So, I do encourage you to sign up for the alerts, these postings, and specifically read Dr. Trapnell's recent piece.

With the aPAP program, we have an extraordinary opportunity to develop a therapy that has the potential to fundamentally change the way this progressive and chronic disease is managed by providing a noninvasive maintenance therapy that may address the root cause of the disease and ultimately improve lung function and quality of life without the need for invasive whole lung lavages.

Consistent with previous guidance, we are on track for a June disclosure of the top-line results from 24-week planted period of the Phase 3 IMPALA study. I would like to remind you that we will be submitting the full data sets from this 24-week period for presentation at an upcoming scientific conference and for potential publication in a peer-reviewed journal. Therefore, in June, we expect to report only the top-line data to ensure that we don't break the policies associated with these conferences or journals.

Positive results from IMPALA would facilitate the submission of a BLA in the first half of 2020, with an anticipated launch later in 2020 or early 2021. Please remember that IMPALA has a 24-week open label period following the placebo-controlled portion of the study. And that is why our BLA filing will happen in the first half of next year and not sooner after the disclosure of the top-line results.

On that note, I'm sure that many of you saw the press release earlier in the week announcing that Molgradex received Fast Track Designation by the FDA for aPAP. This designation means that Molgradex may be eligible for rolling review, which would allow us to submit our BLA in sections as they're completed instead of waiting until the entire application is finalized. Fast Track also indicates that we're eligible for priority review, assuming we meet the relevant criteria and we are confident that we will meet those criteria.

We are very pleased with this designation, as it serves as an acknowledgment of the high unmet therapeutic need in aPAP and it underscores how transformative Molgradex could be in treating the disease.

We continue to be extremely encouraged by the strong enrollment into IMPALA-X, our optional open-label extension study that allows patients to continue on treatments for up to three additional years beyond the completion of the IMPALA study. With approximately half of the IMPALA clinical sites offering enrollment into IMPALA-X, this provides us with a mechanism for offering compassionate use and participate in countries and also allows us to collect longer term safety data.

At the end of Q1 2019, 25 out of 26 eligible patients enrolled in the extension study. We interpret this nearly 100% patient retention rate as an indicator of patient satisfaction with the treatment, especially given that all patients rolling into IMPALA-X will have been on active drug for at least six months, including those patients who were initially in the placebo arm, with two-thirds of the patients having been on active drug for a full-year.

As we near the data readout, let me quickly remind you of the additional reasons why we are confident in the program. Firstly, the pathogenesis of aPAP is well-known and the efficacy of inhaled GM-CSF is well-characterized through numerous physician-sponsored studies and case reports. Adding exogenous GM-CSF to overcome the impact of GM-CSF autoantibodies is a logical treatment concept.

No. 2, the IMPALA study is extremely well powered statistically, not only for the primary endpoint, but also for the key secondaries. Recall that we are over 95% powered to show 10 millimeter mercury improvements in the primary endpoint and 90% powered or above for the key secondary endpoints. We believe that our assumed effect size of 10 millimeter mercury for the primary endpoints is conservative, as it's lower than the observed range of about 12 to 18 in the key published studies.

Regarding the secondaries our assumed effect size of 50 meters for the six-minute walk was demonstrated in the TESARO study and the 10 points improvement for the St. George's Respiratory Questionnaire is within the range of improvements demonstrated in idiopathic pulmonary fibrosis, or IPF, but the response rates not as dramatic as expected in aPAP.

And, finally, our continuous dosing arm in IMPALA, which will be compared to placebo in the primary analysis, applies a higher cumulative dose than used in most of the published studies, which typically import an alternating dosing regimen. In addition, the delivery device, PARI eFlow nebulizer, delivers about 40% to 50% of the drug to the lung, which is higher than the 10% to 25% of positive dose of a typical jet nebulizer used in the published studies.

Turning to our other Molgradex program, everything is progressing as planned with the fully enrolled OPTIMA study. This is a Phase 2a clinical study evaluating Molgradex for the treatment of nontuberculous mycobacterial, or NTM, lung infection. And we continue to expect top-line results from this 32-patient open-label study in Q1 of next year.

In line with guidance, we recently initiated a new study within the Molgradex franchise called ENCORE. This Phase 2a study is very similar to OPTIMA's design and evaluates Molgradex for treatment of NTM and people living with cystic fibrosis.

Although Molgradex for NTM program is still relatively early stage, we are very optimistic about its potential. Molgradex for NTM takes an anti-infective immunotherapy approach and, if successful, could materially change the way refractory lung infections are treated. Unlike antibiotics that target bacteria directly, Molgradex attempts to boost the body's natural defenses, potentially helping the immune system clear the infection. If we see an effect in NTM, there's considerable blue sky potential for this approach in numerous other chronic lung infections.

And, lastly, let's move to our other program in cystic fibrosis and that's the AeroVanc program, inhaled vancomycin for the treatment of MRSA lung infection. Enrollment of the primary analysis population of the Phase 3 AVAIL study, and that is subjects between 6 and 21 years of age, continues to be challenging. Currently, the study has enrolled a total of 153 patients out of the target 200. With 279 patients screened, we are seeing a screen failure rate of approximately 50%. That is definitely higher than we had anticipated. The screen failures are largely due to pulmonary exacerbations occurring between the time of screening and randomizations, and more recently, an especially tough flu season.

However, these high screen numbers reinforce that we are clearly reaching a large number of patients affected by MRSA and the exacerbations prior to randomization demonstrate a high disease burden and need for a better treatment. Multiple efforts are under way to boost enrollments, including the activation of new sites and a long list of other efforts to help us complete enrollment by Q3 of this year.

In response to numerous requests from patients and investigators, and as added incentive to enroll in the study, we are also considering an expanded access program for patients to complete the study. Similar to IMPALA-X, this would allow patients to remain on drug following the end of the study until such time as the drug would hopefully receive FDA approval. With all these activities, we reiterate our guidance for enrollment completion and do remain steadfast in our efforts to have top-line data in the second quarter of 2020.

Now I will turn the call over to Taneli.

Taneli Jouhikainen -- Chief Operating Officer

Thank you, Rob, and good afternoon, everybody. I would first like to focus your attention to our commercial and manufacturing efforts for Molgradex and thereafter describe our plans for one of our earlier stage programs, the combination antibiotic we acquired last year from Cardeas Pharma.

Based on the confidence we have in the IMPALA data read, we have begun and are well under way with the commercial preparations necessary to ensure an effective launch. Among the key work streams, we initiated a large quantitative market research project with U.S pulmonologists and aPAP patients to better understand the nuances of the aPAP market landscape, including disease awareness, the patient journey through diagnosis to obtaining care, prevailing treatment practices, as well as any obstacles in all of these areas.

To support the effort of defining best practices, of developing international guidelines, and assisting with disease data education, our key opinion leader development is well under way and expanding, with an inaugural global steering committee meeting of our KOLs just prior to the American Thoracic Society meeting in Dallas next week.

Activities to support our market access strategy include in-depth pricing and reimbursement research, focusing now on interviews with U.S payers designed to test our plans for evidence presentation and pricing considerations. Additional market access research is also being conducted with health authorities in key European markets. This research will facilitate a two-step process, initially looking at pricing within the context of preapproval expanded access programs, which can then serve as benchmarks for eventual post-approval pricing in Europe.

In parallel, we continue our work on health economics and outcomes research in the U.S and Europe. This work currently centers on defining the full economic impact of diagnosing and treatment of aPAP, and includes gaining input from the UK's NICE Policy Institute on specific economic modeling. This is important not only for the UK commercial launch, but also more broadly, as payers in other regions commonly refer to the economic modeling established NICE.

Finally, likely the most critical success factor of our commercial strategy will be identifying and finding the aPAP patients. While there are many moving parts to this effort, one major driver will be ensuring the GM-CSF autoantibody blood test that's more widely available. Right now, as many as half of aPAP patients are still diagnosed through bronchoscopy and a lung biopsy, an invasive and uncomfortable procedure that can sometimes yield false-negative results.

As often seen with other orphan diseases, increased awareness and better testing associated with a new therapy can lead to a considerable increase in diagnosis. Even in the absence of a new therapy, this has been shown to be true in Japan, where awareness of aPAP is higher and they have a more centralized approach to diagnosing and treating the disease. Over the last seven years, the Japanese have seen a consistent increase in patients being diagnosed with aPAP. And their recently published updated prevalence estimate of aPAP is 22 patients per million people, which is as much as three times higher than the earlier estimate of seven per million.

While we don't yet have data to suggest the same is true for the U.S. or the rest of the world, we do believe that increased awareness of aPAP, coupled with a simple diagnostic blood test and an effective approved therapy, is likely to increase the number of identified patients in all regions.

As our commercial work streams advance over the course of the next year, we look forward to sharing more of our findings and insights with all of you.

With regards to manufacturing, on the last call, we spoke about our progress in validating the production of the drug substance at commercial scale. I'm happy now to report that we recently entered into a new commercial manufacturing and supply agreement with our longtime drug substance manufacturing partner, Gema Biotech. Under the terms of this agreement, Gema will exclusively supply us with GM-CSF expressed from Savara's proprietary cell line. So, wrapping up on Molgradex, we very much look forward to sharing the IMPALA top-line results with you shortly. So, please stay tuned. These are exciting times.

Okay. So, let's then move on to our exploratory program. As part of a strategy to expand our pipeline through indication expansion and product acquisitions, we acquired the amikacin/fosfomycin inhalation solution from Cardeas Pharma. In a Phase 2 study completed by Cardeas, this combination antibiotic demonstrated excellent antimicrobial efficacy in the lungs, but unfortunately failed to show consistent benefit on top of IV antibiotics in ventilator-associated pneumonia.

Going forward, we will refocus the development of the product to non-cystic fibrosis bronchiectasis patients with chronic lung infection and frequent pulmonary exacerbations. Non-CF bronchiectasis is a chronic lung disease characterized by abnormal widening of the airways associated with chronic infection. The disease is estimated to impact well over a 100,000 people in the U.S., with similar prevalence in Europe and elsewhere in the world.

As bronchiectasis is predominantly found in older adults, the aging population is making this disease an increasingly prevalent yet rare disease. Currently, the unmet medical need is high, as there are no therapies specifically approved for bronchiectasis, although oral macrolides and inhaled antibiotics are frequently used off-label.

Our own market research indicates that new safe and effective therapeutics are in high demand among bronchiectasis-treating clinicians. Patients with bronchiectasis is typically present with a chronic productive cough and lung infection, malaise, and increased hospitalizations due to pulmonary exacerbation, all of which negatively impact quality of life. The underlying pathology in bronchiectasis is a mix of infection, reduced immune response, and inflammatory damage of the lungs.

Amikacin is a potent antibiotic against common pathogens in bronchiectasis, particularly pseudomonas aeruginosa. Fosfomycin, on the other hand, improves the killing activity of amikacin against a number of gram-negative bacteria, and also has activity against gram-positive bacteria common in bronchiectasis, including MRSA.

Recent scientific research has shown that patients with bronchiectasis often have defective function of neutrophils, the most abundant type of immune cells fighting infection. And interestingly for us, that neutrophil dysfunction can be reversed by treatment with GM-CSF.

So, while both amikacin/fosfomycin and Molgradex have therapeutic potential in patients with bronchiectasis as stand-alone products, the opportunity to combine these two products allows us to pursue our dual strategy of combining locally administered, effective antibiotics with an anti-infective immunotherapy in the form of Molgradex, each having different, potentially synergistic mechanisms of action.

Our first application of this dual strategy is already being pursued in the two Phase 2 studies of NTM lung infection that Rob reviewed earlier, where Molgradex is administered on top of standard of care oral antibiotics.

Our first clinical study of amikacin/fosfomycin in bronchiectasis will be a Phase 2 study to investigate the efficacy of amikacin/fosfomycin and Molgradex separately and in combination in reducing the bacterial infection load in patients with recurrent exacerbations. The study will apply a randomized crossover design, with wash-out periods between the therapeutic arms.

Results of the study will not only establish the potential utility of these products alone or in combination for bronchiectasis, but will also help direct our approach to future studies and indications. We anticipate enrollment to start later this year or early 2020 after the release of new GMP product batches by a manufacturer we are now bringing online.

We are well aware that bronchiectasis has been a difficult target for the biopharmaceutical industry, but this is also where the opportunity lies. Through our extensive interactions with world experts in the field and our analysis of past trials, we now have a good sense of what is needed to be successful for this indication. Equally important, based on our market research among pulmonologists, infectious disease specialists, and primary care physicians who regularly treat bronchiectasis, we believe this to be a very attractive market, given its size, the level of unmet need, and our expectation that uptake of a safe and effective therapeutic approach would be rapid and broad.

As with our other programs, we very much look forward to eventually providing you more detailed information about our learnings and thinking, as well as regularly updating you on our progress regarding this pioneering program.

And now I'll hand the call over to Dave for a financial update.

David Lowrance -- Chief Financial Officer

Thanks, TJ, and hello, everyone. Savara incurred a net loss attributable to common stockholders for the three months ended March 31, 2019 of $12.1 million, or $0.34 per share, compared with a net loss attributable to common stockholders of $26.8 million, or $0.86 per share, for the three months ended March 31, 2018.

Research and development expenses were $10 million for the three months ended March 31, 2019, compared with $8.5 million for the three months ended March 31, 2018. This was primarily due to $1.9 million of increased costs associated with the development of Molgradex.

General and administrative expenses for the three months ended March 31, 2019 were $2.8 million, compared with $1.8 million for the three months ended March 31, 2018. This increase was primarily due to personnel costs and other legal accounting insurance and operating activities.

As of March 31, 2019, Savara had a carrying value of its debt of approximately $24.7 million and had cash, cash equivalents, and short-term investments of approximately $105.2 million.

In summary, we are approaching a pivotal data readout with a strong balance sheet, thus ensuring that we are sufficiently funded into the latter part of next year. Advancing our pipeline while closely managing our expenses will position us for sustainable success.

And now I'll hand the call back to Rob for closing remarks.

Rob Neville -- Chief Executive Officer

Thank you, Dave, and thanks, everyone on the call. As we've outlined, we are embarking on what could be a better year for Savara. With the imminent readout from our Phase 3 IMPALA study, followed by multiple catalysts from our development pipeline in the launch of our new non-CF bronchiectasis study, we are positioned for growth in the short-term that we believe can be sustained over the long-term.

At Savara, we are successfully executing against our plans and building an orphan lung disease company that will address unmet medical need for transformative treatment paradigms, while advancing a scientific understanding of a growing number of orphan lung diseases.

We do appreciate your continued support and look forward to sharing our successes with you. At the beginning of the call, Anne encouraged shareholders to submit questions via email to ir@savarapharma.com. If time permits, we will answer these and other questions that we've received.

And with that, I would like to turn the call back to Jake for any analyst questions.

 Questions and Answers:

Operator

We will now begin the question-and-answer session. To ask a question, you may please press "*1" on your touchtone phone. If you are using a speakerphone, please pick up your handset before pressing the keys. To withdraw your question, please press "*2". At this time, we will pause momentarily to assemble our roster.

The first question comes from David Steinberg with Jefferies. Please go ahead.

David Steinberg -- Jefferies -- Analyst

Thanks and good afternoon. I have a couple questions. First, could you give us a little more granularity on your Molgradex commercial effort? Do you have anything to share regarding the pricing reimbursement, health economics, or development of the PAP foundation? To that end, on the last point, how are you thinking of approaching and finding those patients? And then the second question has to do with business development. Could you give us your latest thoughts of the ex-U.S. strategy for Molgradex? Is Japan a specific interest? And what about the EU as a whole or individual territories? Thank you.

Rob Neville -- Chief Executive Officer

So, hey, David, this is Rob. Thank you for your questions. It was good having dinner with you the other night. Let me answer the second question first, as far as interest in Molgradex into Japan. We have partnered that already in Japan and we are interested, obviously, in Europe and we expect to take ourselves into some of the key geographies and then partner some of the remaining geographies. As far as granularity on the health economics, I will hand to Taneli to respond to that.

Taneli Jouhikainen -- Chief Operating Officer

So, thank you, David. I think let me first start with perhaps the most important part, which is finding the patients. So, right now, our research is focused on a number of different database researches, which allows us to cover a remarkably high proportion of all U.S. patients. So, this means claims database research where we can access the actual diagnosed patients, we can access the doctors and their locations who are treating these patients, we can also access what treatments are being given, including information about the broadness of the use of whole lung lavage. And so this constitutes the core of the information that we're right now pulling together and it will then be boosted by our disease state education in the rollout of the diagnostic more broadly, hopefully through the commercial lab that will organize it all for us. And we believe this all to put us in a good position come launch.

In terms of the pharma economic modeling, I can't share much more detail right now about that. We will be rolling out different elements of our learnings as we go forward after the data read. And this will then also include perhaps more understanding of the reimbursement approach and whatnot. But then, as you know, we're not going to disclose the details of pricing until the time of launch.

David Steinberg -- Jefferies -- Analyst

Okay. Thank you.

Operator

The next question comes from Liisa Bayko with JMP Securities. Please go ahead.

Liisa Bayko -- JMP Securities -- Analyst

Hi. Thanks for taking the question. First question is about bronchiectasis. So, very interesting choice of indication. Can you maybe provide some background as to the evidence for this combination in bronchiectasis and what we should expect from the study?

Taneli Jouhikainen -- Chief Operating Officer

So, the evidence really is based on the antimicrobial effect that we know the combination to have, and also from similar aminoglycoside-type antibiotics in bronchiectasis itself. And, Liisa, apologies, your second question was what exactly?

Liisa Bayko -- JMP Securities -- Analyst

Oh, I haven't asked that yet. But I just wanted to maybe just talk about kind of the thoughts on enrolling kind of over 40 patients in four months. Can you maybe kind of walk us through that for the CF study?

Rob Neville -- Chief Executive Officer

For the AVAIL study?

Liisa Bayko -- JMP Securities -- Analyst

Yes.

Rob Neville -- Chief Executive Officer

So, Liisa, as you may recall in IMPALA, we had almost a huge hurdle in the last quarter that we were able to successfully enroll and still hit our guidance. And so, like I said earlier, we remain steadfast. It is a hurdle but we've got a number of activities under way. Many of these were started a while back and just starting now to bear fruit. So, we remain committed to our guidance and we will certainly give you any update if we don't think we're going to hit that.

Liisa Bayko -- JMP Securities -- Analyst

Okay, great. Thanks.

Operator

The next question comes from Dewey Steadman with Canaccord. Please go ahead.

Dewey Steadman -- Canaccord Genuity -- Analyst

Hey, guys. Thanks for taking the question. Hey, guys. Thanks for taking the question. I guess on ami/fos and bronchiectasis. In terms of what the FDA is looking forward, do you think it's going to be more functional endpoints, like FEV1 or quality-of-life endpoints, like that walk distance or something like that, or can they focus only on -- or do you think they will focus only on microbiological endpoints?

And then on R&D, it's been trending around $10 million a quarter. Is that a good run rate moving forward as you have all these studies under way? Thanks.

Rob Neville -- Chief Executive Officer

Taneli will answer the first one.

Taneli Jouhikainen -- Chief Operating Officer

Right. So, Dewey, it is very clear that microbiology as an endpoint for non-CF bronchiectasis will not carry a product through approval. Lung function also, given the pathology of the disease, is not a good marker and not a good endpoint. So, pivotal studies for this indication will entail use of pulmonary exacerbation as an endpoint. And there is now ample precedent of using that and the FDA have made their expectations quite clear. So, we have a pretty good regulatory path in front of us. Our first study, though, will be essentially a surrogate endpoint study simply to test our dual-treatment strategy approach and also gain some more quantitative understanding of some of the results related to the selected patient population.

David Lowrance -- Chief Financial Officer

Hey, Dewey. And then on the second part about the R&D spend. While we don't give specific guidance on the quarter, what I can comment on is that, as we've just said, there's a focus on AVAIL today and into our Q3. And so those activities that Rob talked about that are rolling on, certainly there is expense there. We also mentioned the amikacin/fosfomycin study. So, we've got new costs coming in there and then we also talked about our filings. So, if you think about all that. And what we are committed to is ensuring that our cash gets us well through our readouts and deep into 2020 or so.

Dewey Steadman -- Canaccord Genuity -- Analyst

Great. And just to follow up on that exacerbations, what exactly does FDA classify as exacerbation? What kind of diagnostic criteria are there to determine that a patient is having an exacerbation.

Taneli Jouhikainen -- Chief Operating Officer

Well, that is, of course, something where companies have some freedom to suggest what they feel is best. We are big believers in simplicity in this respect, meaning, typically, the most reliable way to find an exacerbation is to see if patients were treated with antibiotics by the physician. And also the more sensitive your recording system is, it seems that the better the differentiation then between a drug and a placebo.

Dewey Steadman -- Canaccord Genuity -- Analyst

All right, great. Thank you.

Operator

The next question comes from Michael Higgins with Ladenburg Thalmann. Please go ahead.

Michael Higgins -- Ladenburg Thalmann Financial Services -- Analyst

Thank you. Thanks, guys, for taking the questions. I just wanted to clarify, as we are getting close to IMPALA data, if you have any updates from the CRO along the way? That may include things like the number of patient in the trials, reasons for discontinuation rates, anything like that at all that you're getting.

Rob Neville -- Chief Executive Officer

So, Michael, thanks for being on the call. So, we enrolled 139 patients. We have not disclosed the discontinuation rate. What we have said is that it's low. But beyond that, we've not disclosed any specific numbers.

Michael Higgins -- Ladenburg Thalmann Financial Services -- Analyst

Okay. That's helpful. Thanks. If you look out at Europe, actually even in U.S., if you can give us an update on the marketing strategy and, specifically, how many reps you may have in both of those regions?

Taneli Jouhikainen -- Chief Operating Officer

So, Michael, the number of reps is still somewhat undefined and it depends on a number of factors from our research. We're envisioning right now the number of sales reps in the U.S. to be in the region of 30-40, that range. In Europe, it will vary country-by-country. And in terms of our own efforts of commercialization, the exact geography has not been yet finally set, in terms of what we do ourselves compared to what we partner.

Michael Higgins -- Ladenburg Thalmann Financial Services -- Analyst

Okay. And then the determination of the European strategy, does it follow from the discussions with potential European partners or do you look at the data and make a decision? What's kind of the begetting factor there?

Taneli Jouhikainen -- Chief Operating Officer

We have three options in Europe, basically. Either we go it alone or we partner or we do what is called a rent-to-buy option, where a partner sets up a salesforce to launch the product and then we have an option to capture that salesforce any number of years after launch. And we are, in parallel, considering all of these options. And so, right now, that's all I can say of ongoing discussions.

Michael Higgins -- Ladenburg Thalmann Financial Services -- Analyst

Okay. And then just a quick follow-up. The decision there, is that something you make after you've got data and once you're talking with partners or how do you make that decision? Not looking for an answer, just trying to get your thought process, I guess.

Taneli Jouhikainen -- Chief Operating Officer

Well, all of these discussions have, first, our own preparations and our sense of what exactly will be needed in the key markets, as well as then, in parallel, considerations of different strategies of potential partner candidates as well as this middle-ground option of a rent-to-buy. The terms of all those impact our decision and also the specifics of the how to do, in terms of our own commercialization. That perhaps opens up a little bit of our thinking, but I do apologize, I can't be more specific at this point.

Rob Neville -- Chief Executive Officer

And, Michael, just to add some color. So, what our intention is is, in June, when we announce the top-line results, we will then spend a lot more time. We're already working on the commercial launch plans and we will be able to say a lot more at that point. We are just holding it until we have the technical risk behind us.

Michael Higgins -- Ladenburg Thalmann Financial Services -- Analyst

Fair enough. I appreciate it. Thanks for the color, guys. Thanks.

Operator

Again, if you have a question, please press "*1".

Anne Erickson -- Head of Investor Relations and Corporate Communications

I think, if there are no questions -- this is Anne -- I got a couple of questions that came in over email. The first one is: given that a whole lung lavage results in an improvement in AADO2, could whole lung lavages in the placebo group negatively impact the results of the study? And, given that, do you hope not to see many lavages? Taneli, do you want to take that one?

Taneli Jouhikainen -- Chief Operating Officer

Sure, sure. Okay. So, what you need to realize is that, if patients do require a whole lung lavage, it is a rescue treatment. And, of course, we allow that for our patients in all treatment arms. But that threshold of having a whole lung lavage done is actually quite high. And so you definitely wouldn't expect to see whole lung lavages in patients who are steady and essentially at their baseline over the course of the six-month period. The patients who would get lung lavages will deteriorate from baseline and that will trigger then their lung lavage.

So, this means that, on average, patients who get lung lavage during the study are certainly not expected to improve. Some may, some actually will probably worsen even with the lavage. So, overall, the answer is no, we're not concerned about this at all, in terms of interfering with our other endpoints. And this also means that we actually hope to have more lavages rather than less, because the lung lavage is arguably the most important of our clinical endpoints. And so the more, the better, in terms of statistical power. And, therefore, whatever results we see there, I think we'll have a good shot with enough lavages to actually show statistical significance as well, as long as there are enough of them.

Anne Erickson -- Head of Investor Relations and Corporate Communications

And I got one more question that came in. I've not heard of Gema Biotech. How did you select them as your manufacturer for drug substance?

Taneli Jouhikainen -- Chief Operating Officer

Okay, Anne, let me take that as well. So Gema is actually a very natural choice for us. First of all, they are the company who developed the cell line that is now the source of our GM-CSF. They have also manufactured all of the clinical supplies; of course, also the nonclinical supplies. But, very importantly, we are able to essentially continue in the same plant, with the same equipment, same everything as we have done for the clinical trial. So, that eliminates a lot of regulatory risk in our opinion.

And Gema is a company with a long history of biologicals development. They have very high science and quality standards. Just great people. And, in fact, it's a company that was founded and is currently 100% owned by the Struengmann brothers. And for those who don't these gentlemen, they were the founders of a German generics company, Hexal, which is now owned by Novartis. So, through that ownership and their history of operations in the biotech area, we're in very solid hands there. And we couldn't be more pleased with the quality of our collaboration. And so this represents a totally true partnership instead of a mere fee-for-service engagement, which is perhaps more typical in contract manufacturing.

Rob Neville -- Chief Executive Officer

Well, thank you for those questions on the IR front from investors. I appreciate that.

Anne Erickson -- Head of Investor Relations and Corporate Communications

And that's it. I think we have no more questions coming in. Thank you, everybody, for joining the call.

Operator

This concludes our question-and-answer session. I would like to turn the conference back over to Rob Neville for any closing remarks.

Rob Neville -- Chief Executive Officer

I think we've got it. Thank you, everybody. Those were really good questions. And this is obviously the most exciting time. I've now been at Savara 11 years and this is now the most exciting month coming up in June. So, we look forward to announcing the results then. So, take care. Thank you. Bye.

Operator

The conference is now concluded. Thank you attending today's presentation. You may now disconnect.

Duration: 44 minutes

Call participants:

Anne Erickson -- Head of Investor Relations and Corporate Communications

Rob Neville -- Chief Executive Officer

Taneli Jouhikainen -- Chief Operating Officer

David Lowrance -- Chief Financial Officer

David Steinberg -- Jefferies -- Analyst

Liisa Bayko -- JMP Securities -- Analyst

Dewey Steadman -- Canaccord Genuity -- Analyst

Michael Higgins -- Ladenburg Thalmann Financial Services -- Analyst

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