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Operator
Good day, ladies and gentlemen, and welcome to the ObsEva Fourth Quarter 2017 Earnings Conference Call. (Operator Instructions) As a reminder, this conference call may be recorded.
I would now like to turn the conference over to Mario Corso, Senior Director, Investor Relations. You may begin.
Mario Corso
Thank you, operator. Good morning or afternoon, everyone, and welcome to today's call to review ObsEva's fourth quarter and year-end 2017 results and business update. On this call, I'm joined by Ernest Loumaye, our Co-Founder and Chief Executive Officer; Jean-Pierre Gotteland, our Chief Scientific Officer; and Tim Adams, our Chief Financial Officer.
During the call today, we will make forward-looking statements, and we remind you of our safe harbor language. We will make forward-looking statements, including, but not limited to, statements relating to financial results and trends; the process and timing of anticipated future development of ObsEva's product candidates; our gonadotropin-releasing hormone, or GnRH, receptor antagonist, OBE2109; our oxytocin receptor antagonist, nolasiban; and our PGF2alpha receptor antagonist, OBE022; including clinical trial results and potential regulatory pathways toward gaining approval of our product candidates in the U.S., Europe and Asian countries as well as the therapeutic and commercial potential of ObsEva's product candidates.
These forward-looking statements are based on ObsEva's current expectations and inherently involve significant risks and uncertainties. ObsEva's actual results and timing of events could differ materially from those anticipated in such forward-looking statements and as a result of these risks and uncertainties, which include, without limitation, risks related to ObsEva's development programs; clinical trial time lines and results; the uncertain clinical development process, including adverse events; the success cost and timing of all development activities and clinical trials; the market potential for ObsEva's product candidates; the accuracy of ObsEva's estimates regarding expenses, capital requirements and the need for financing; and other risks detailed in the risk factors and elsewhere in ObsEva's U.S. Securities and Exchange Commission filings and reports, including its 20-F report to be filed on or around March 9, 2018, 20-F report filed on April 21, 2017, and F1 form filed on December 30, 2016. ObsEva undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a result of new information, future events or changes in its expectations.
I will now turn the call over to Ernest Loumaye, our Chief Executive Officer.
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Thank you, Mario. Good morning. On today's call, we'll provide a business update, including clinical trial progress for the year and year-end 2017 financial results and our outlook for achieving key future clinical milestones.
The fourth quarter of 2017 saw ObsEva end its first year as a publicly traded company, which was a year of laying the groundwork for clinical trials in our 4 ongoing development program in the field of women's health and fertility medicine, setting the stage for clinical trial results on each of our 3 new chemical entities in 2018: our lead compound, the oral GnRH antagonist or OBE2109; our oral oxytocin antagonist, nolasiban; and OBE022, our oral prostaglandin F2alpha inhibitor.
I would like now to take a few minutes to provide an update on the status of all 3 compound in each indication. I will start by reviewing our announcement that took place last month, positive top line results of our double-blind, placebo-controlled Phase III IMPLANT2 clinical trial of nolasiban for improving the outcome of assisted reproduction or IVF procedures.
IMPLANT2 included 778 women across more than 40 facility centers in Europe. Nolasiban 900-milligram or placebo was administered orally as a one-time dose 4 hours prior to embryo transfer or ET, which can occur either 3 days or 5 days after egg retrieval. The primary endpoint of this clinical trial was ongoing pregnancy at 10 weeks post embryo transfer. The primary endpoint of IMPLANT2 was successfully achieved with 10 weeks ongoing pregnancy rate of 35.6% for patients who receive nolasiban as compared to a rate of 28.5% for patient who receive placebo, a 25% relative increase with a p-value of 0.031.
The nolasiban benefit was particularly evident among the 50% of the patients who underwent embryo transfer 5 days post-egg retrieval. Those patients achieved a 10-weeks ongoing pregnancy rate of 45.9% versus 34.7% on matched placebo, a p-value of 0.034. We view this 11% absolute and 32% relative improvement to be highly clinically meaningful and especially impressive as this was achieved with a single embryo transfer. This is in contrast to trials that were conducted in the past with atosiban where it utilized a range of 2 to 4 embryo [transfers].
We are very pleased by this result as the standard of IVF care is now predominantly on day 5 for embryo transfer, especially in the U.S. where in 2015, already more than 60% of fresh embryo transfer according to CDC were performed on day 5. In Europe, the data from 2012 indicate that 40% of embryo transfers and perhaps growing to approximately 50% now based on our investigator feedback are performed on day 5.
In addition, such an outstanding pregnancy rate following a single embryo transfer may further support the evolution of IVF practice toward single embryo transfer rather than multiple embryo transfer, which are often associated with multiple pregnancies. We believe there is an increasing fieldwork focus on the downside of multiple pregnancy, twins or triplets, which is leading to premature birth and its related neonatal mortality, short- and long-term morbidity as well as its tremendous cost.
Also of major importance, the safety and tolerability profile of nolasiban in IMPLANT2 appear very strong, with no difference from placebo in rates of discontinuation, treatment emergent adverse events or serious adverse events. We look forward to receiving live birth rate data from this clinical trial in the fourth quarter of 2018 as well as the 28-days neonatal follow-up later in that same quarter, knowing that in past results, live birth rates are often very close from week 10 clinical pregnancy rate.
Wrapping up our discussion of nolasiban, our next steps are to request meeting with regulatory authorities in the U.S. and Europe to solicit feedback on any additional clinical trial requirements beyond IMPLANT1 and 2 as well as the appropriate path forward to regulatory submissions. We have always been anticipating the need to conduct additional clinical trial work at U.S. facility clinics.
In Europe, we intend to propose a submission based upon IMPLANT1 and 2 but recognize that there could be requests for additional supportive clinical trial work. We plan on conducting this meeting as soon as possible, currently estimating mid-2018 and intend to communicate findings on our next steps shortly thereafter, with a goal of commencing additional clinical trial before the end of 2018.
In summary for nolasiban, we are very pleased with the IMPLANT2 results and believe continued investment in this compound is fully justified. Given the global reach of infertility, which is impacting about 10 persons of reproductive-aged couples, i.e., [180 million] couples worldwide, and resulting in more than 1.6 million ART treatments each year worldwide. We are very enthused about the strong global commercial potential that exists with an expected relatively small required promotion infrastructure.
Now turning to our lead asset, OBE2109, the oral GnRH antagonist for the treatment of endometriosis and uterine fibroids. During 2017, we made significant progress in the development of OBE2109, which we believe has best-in-class potential for both the uterine fibroid and endometriosis indication. Last year, we initiated and began enrolling patients into our 2 Phase III clinical trials, PRIMROSE 1 and PRIMROSE 2, for uterine fibroid treatment. Recall that these studies are 2 double-blind, placebo-controlled Phase III international clinical trials in women with heavy menstrual bleeding associated with uterine fibroids.
Planned enrollment is approximately 1,000 patients in total, with the primary endpoint of reduction of heavy menstrual bleeding as measured by alkaline hematin method. We are pleased by the ongoing interest among both physicians and patients. We expect the PRIMROSE studies to enroll over the course of 2018 and complete patient recruitment by the end of that year and continue to anticipate primary endpoint clinical data to be available in the second half of 2019. Importantly, we believe our PRIMROSE development program to be novel with the inclusion of dose administered both with and without hormonal add-back therapy.
We also achieved another major milestone in 2017 with OBE2109, the completion of patient enrollment into our Phase IIb EDELWEISS clinical trial for the treatment of endometriosis. The EDELWEISS trial enrolled approximately 330 patients in the U.S. and Europe. Top line results with 3 months of treatment remain on track for mid-2018. Similar to the goal of our fibroid program, we are seeking to identify 2 therapeutic dosing options, one with the potential for alleviating patient symptoms at level of estrogen suppression that will not meaningfully decrease bone mineral density, thereby not necessitating hormonal add-back therapy; and one with a more profound estrogen suppression requiring add-back estrogen to counteract bone loss.
Wrapping up now on OBE2109. We are very enthused that our large clinical development program is progressing according to plan. Importantly, 2018 is also the year that the oral GnRH antagonist class may see its first regulatory approval as AbbVie has disclosed a PDUFA date for Elagolix. We view this event as the beginning of bringing important treatment to the large population in need of new treatment alternatives, an estimate 2.5 million women diagnosed and treated for endometriosis and 4 million women for uterine fibroids in the U.S. alone.
We remain focused on providing a potential best-in-class therapy with ID PK/PD characteristics and flexible dosing option, appealing to the broadest proportion possible of this diverse patient group in need of new treatment alternatives.
And finally, onto our third pipeline program, the potential first-in-class oral and selective prostaglandin F2alpha receptor antagonist, OBE022, being developed to treat preterm labor. Following completion of an extensive preclinical Phase I clinical program for OBE022 in the first half of 2017, we achieved our goal in late 2017 of beginning a Phase IIa proof-of-concept trial known as PROLONG. This trial will measure PK, safety and contraction inhibition, targeting delay of delivery by 2 to 7 days in women who are in acute preterm labor between 24 and 34 weeks of gestation. PROLONG is being initiated in 7 countries outside of the United States with OBE022 added into the standard of care, atosiban.
This clinical trial is being conducted in 2 parts with an open label Part A measuring PK and safety in 8 patients, followed by a placebo-controlled, double-blind Part B, subsequently enrolling up to 120 patients with follow-up extending from day 14 post-treatment to neonatal delivery and infant follow-up.
We intend to announce initial clinical trial from Part B in up to 60 patients in late 2018. We look forward to this first data in pregnant women on which positive conclusion on safety and efficacy could represent a promising advance in treating acute preterm labor in light of a synergistic mechanism of action with standard of care, atosiban, in Europe and lacking an approved standard of care in the United States.
Summing up, 2017 was a year of tremendous progress in operational account work with the company achieving all its strategical objectives with 2018 bearing the fruit of our labor with multiple clinical start-up readout.
I will now turn the call over to our CFO, Tim Adams, for a financial overview. Thank you.
Timothy M. Adams - CFO
Good afternoon, everyone, and thank you for joining us on the call today. I will provide a brief description of our results for the fourth quarter and the full year of 2017 and also our current financial position.
Starting with our income statement. Net loss for the fourth quarter of 2017 was $17.1 million or $0.48 per diluted share, which compares to a net loss of $11.1 million or $0.51 per diluted share in the fourth quarter of 2016. The full year net loss for 2017 was $66.9 million or $2.25 per diluted share as compared to $30.2 million or $1.40 per diluted share in the prior year. This increase in net loss during 2017 was primarily driven by investment in our research and development programs.
Research and development expenses were $13.9 million for Q4 of 2017 and $54.9 million for the full year of 2017 compared to $8.2 million and $23.7 million in the prior year period. This increase in investment is attributed to our clinical trial progress with all 3 of our development compounds.
G&A expense for the fourth quarter of 2017 was $3 million and $12.6 million for the full year 2017 compared to $3.1 million and $6.5 million in the prior year periods. This increased expense level includes the cost of becoming a public company, additions to our staff and approximately $8.9 million of noncash share-based compensation expense for the full year 2017.
Our cash balance at December 31, 2017, was $110.8 million, which reflects a $14 million use of cash in the quarter. Our cash used in operations was consistent with our expectation that cash used in the second half of 2017 would be similar to the $28 million used in the first half of 2017. Both the $14 million fourth quarter amount and the approximate $56 million cash used from operations for the full year 2017 reflected spending in support of our 3 pipeline assets, which included continued enrollment of our Phase IIb EDELWEISS study in endometriosis for OBE2109; initial Phase III enrollment of the PRIMROSE 1 and 2 clinical trials in the treatment of uterine fibroids; completion of patient recruitment in our Phase III IMPLANT2 clinical trial of nolasiban in Europe; and the commencement of the PROLONG study of OBE022 in preterm labor.
In addition, we received approximately $56 million, net of fees and expenses, from our private equity offering completed in October of 2017. Our existing cash continues to be sufficient to fund our operations into the second half of 2019.
In summary, we are very pleased with all the progress made in 2017 and look forward to the data readouts in 2018 and continuing on with our development programs with the goal of becoming a commercial company serving the needs of women's health and infertility.
And with that, we would turn the call back to the operator for questions.
Operator
(Operator Instructions) Our first question comes from the line of Kennen MacKay of RBC Capital Markets.
Slanix Paul T. Alex - Assistant VP
This is Slanix on for Kennen. Ernest, a question for you on nolasiban, to start. Just wanted to get a sense of the timing of your meetings with the various regulators and whether the live birth data might be a gating factor to determining whether additional studies might be needed and what the dynamic there might be?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes. So in terms of timing for consultation, we have decided to go first to the FDA. We're going to request that I'd be meeting in the coming days. They have 60 days to grant a meeting, and then we have 30 days to get the official minutes after the meeting. So I think by midyear, we will have a very clear feedback from the FDA. Based on that feedback, we will consult the European agency, which will probably happen in September, as we mentioned in the introduction, with a proposal to file with IMPLANT1, IMPLANT2, and see whether we could go right or not with this data package. I don't think that the -- for the second question, I don't think the live birth rate is going to be critical for the registration process. I mean, clearly, authorities want to see a live birth rate. First, we know based on experience in our previous trials as well as in many published studies that the difference between week 10 clinical pregnancy rate and live birth is really minimal. And therefore, we are reasonably confident that there will be no difference in the outcome of live birth rate. In addition, as we know, between week 10 and live birth rate, you may have events which are unrelated to the treatment. And therefore, I think that we will see this live birth rate as more as a supportive data and supportive safety rather than a primary efficacy endpoint.
Slanix Paul T. Alex - Assistant VP
Great. And if I could just follow up with a quick question on 2109 as well. As we look towards the upcoming endometriosis readout, just wanted to get a sense from you in terms of what you're hoping to see in terms of potential impacts, the design of a potential Phase III trial and specifically, any differences that you envision versus the design of some of your competitors like, say, Elagolix?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes. So what we expect to receive answer -- information to develop the Phase III program is, first, confirmation of efficacy in terms of pain control with a 200-milligram dose and also confirmation that for that dose, the vast majority of patients require add-back therapy. And that we are already confident based on the PK/PD study we have done. The second information we are looking for with this trial is to see what dose, 50, 75 or 100, will provide the best option for controlling pain without the need for add-back therapy in the majority of patients. Our current assumption is 75- or 100-milligram, but data would confirm that. We expect that 50-milligram may be suboptimal, and that would be the third information derived from this EDELWEISS study. Moving forward then, we will have 2 dosing regimens in the Phase III, the high dose with add-back and a moderate dose without add-back.
Operator
Our next question comes from the line of Alethia Young of Crédit Suisse.
Alethia Rene Young - Research Analyst
When you think about the whole platform or maybe OBE2109, how do you think about partnering? Do you think after the IIb, it's the right time to maximize the opportunity? And what kind of terms might be most attractive here?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes. Thank you, Alethia. Currently, we have the resource to pursue the development of both nolasiban and 2109. The target physician -- population is different as nolasiban has a limited number of IVF centers, and 2109 is a broader population of physicians. For nolasiban, it's really a place for us to develop a commercial organization. For 2109, I think it's too early as we are aiming at Phase III readout for the 12-month therapy in 2020, H1 2020. And then we will see what are the options for us in terms of 2109. For the moment, we keep all the value within the company, except maybe for Asia where we are looking if the recent opportunity or not for nolasiban in IVF. So in summary, we continue to keep all the product within the company. We may look for an Asia deal on ART if it's really attractive, otherwise, we develop it ourselves in China. And we will see probably in 2019, late '19, what are the best options for the company in terms of commercialization.
Alethia Rene Young - Research Analyst
And just another question around this, on the commercial side, just I've started to see the commercials, I guess, that AbbVie are putting out at least here in the United States. And I just wanted to kind of get your perspective on these, kind of think this will help kind of prime the market for you guys even though you could potential be entering third there, or how long do you think the market actually will take to be prime until there's a high awareness for this?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes. As you know, AbbVie will enter the market first on endometriosis with 2 dosing options, once a day or twice a day, and for the fact that means you have to time versus meal. We think it's very positive for the class -- or all companies dealing with this class of drug to see AbbVie launching their product in endometriosis increasing awareness. And you see already in the media in the U.S. how awareness of endometriosis is growing. Now we will come later on, but with a product which has some significant potential, convenience and option for the patients. So yes, we see that very positively. And the PDUFA date for them is in Q2 this year, so we'd see that very soon.
Timothy M. Adams - CFO
Alethia, it's Tim. I would just add to Ernest's comments. As you know, the market for both fibroids and endometriosis in the U.S. and around the world are just enormous markets. So there's clearly room for more than one player here. And we do think it's a good thing for AbbVie to get out to the market, begin to educate both the physicians and the patients and open up what we think is just a huge market opportunity that can accommodate more than one player.
Operator
Our next question comes from the line of Ram Selvaraju of H.C. Wainwright.
Raghuram Selvaraju - MD in Equity Research & Senior Healthcare Analyst
Just very quickly, firstly on nolasiban, can you frame for us the significance of the embryo transfer at day 5 endpoint and if that is likely to be something that you use exclusively in the future clinical trials that are going to be conducted?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes, Ram. So indeed, as we published recently during the release of the data, we have a larger and a more significant difference after day 5 versus the day 3 embryo transfer. First, I don't think we are necessarily abandoning a day 3 embryo transfer. There are some effects, which was a little bit larger in IMPLANT1 study. But definitively, we will focus on day 5. Also, in United States, as the market is moving to day 5 for most of the fresh embryo transfer and also for the frozen embryo transfer, we believe that at this stage, for the U.S. study to support an NDA, we will focus on day 5 embryo transfer exclusively.
Raghuram Selvaraju - MD in Equity Research & Senior Healthcare Analyst
Okay. And then with respect to the development of 2109 specifically in endometriosis, can you comment on how large the Phase III studies might be relative to the direct competitor drugs, given the fact that you anticipate being able to pursue the option of no add-back therapy? Would this have any significant impact on the clinical trial sizes that you envisage in Phase III, just that element?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Sure. I think an order of magnitude in terms of patient would be close to what we see for the fibroids, about 500 patients per Phase III, and we intend to do 2 Phase IIIs for pain control in endometriosis. The study supports at least non-add-back group and an add-back group. I think before finalizing that, we would need to see what is the amplitude in terms of pain reduction we observed or in terms of responder rate between placebo group and active because that will be the opportunity to fine-tune the study size. But I would say that based on what we have seen with fibroids and the power we have in this study, around 500 subjects per trial is what we estimate at this stage.
Raghuram Selvaraju - MD in Equity Research & Senior Healthcare Analyst
Okay. And then very quickly, on the PROLONG study and the OBE022. Obviously, it's a relatively early-stage versus your other clinical-stage candidates. But I wanted to ask whether strategically, you're thinking about 22 as being a compound that could potentially be commercialized using an overlapping sales effort for nolasiban or whether these are likely to be very, very dramatically different indications and therefore would require separate sales infrastructure?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes. If I understand well your question, currently, we are testing OBE022 on top of atosiban-administered IV for 48 hours for preterm labor. Why do we do it? First, because we have seen a synergistic effect in animal models, and we have seen also a good drug-drug interaction in terms of safety or concerns on safety. We -- it's difficult to recruit patients in preterm labor. Imagine that you're a woman coming midnight with premature contraction, asking whether she wants to receive a placebo or a new drug is extremely difficult. And therefore, on top of the scientific rationale, there was a conservative approach to say, look, Mrs. Smith, you are going to have the standard of care top in Europe and on top of that, you will have an additional chance to keep your baby and have your contraction being stopped. Now we don't want to overspeculate at this stage what would be the next step. Assuming good efficacy and safety, we may continue the combination in Europe, but we may also decide to go as a stand-alone drug. It's clear, and I don't want to spend too much time on that, that in the United States, atosiban is not registered. And therefore, if you want to combine it to a tocolytic, we will have to use it off-label tocolytic like, for example, nifedipine. But that's complex and a little bit too early. I think the parity show that this new mechanism of action is effective and that our drug is safe. And then we will develop, based on this data, further strategy which may be different in different continents.
Raghuram Selvaraju - MD in Equity Research & Senior Healthcare Analyst
Okay, that's very helpful. Just one question for Tim, if I may. Could you clarify for me what the stock-based compensation was in the fourth quarter and whether you expect that to be at similar levels going forward?
Timothy M. Adams - CFO
Ram, it was approximately $2 million in the fourth quarter. It was $9 million approximately for the full year. And that should be a comparable number as we move forward into 2018.
Operator
Our next question comes from the line of Ian Somaiya of BMO Capital.
Mayur Amrat Somaiya - Analyst
If I can follow up on one of the earlier questions as it relates to the EDELWEISS Phase IIb study. Ernest, can you share with us your goal? Is the goal to achieve maximum response or get higher proportion of patients respond irrespective of add-back therapy? Or are you trying to -- is the goal of the study to, I guess, determine a dose where you're avoiding add-back therapy but getting to the responses that are maybe less robust?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
I mean, the ideal scenario would be that we have a dose which is very effective and require add-back, that's granted, that's going to be 200-milligram; and then to have a dose, which can achieve maybe a close efficacy with no add-back therapy. Nevertheless -- or at a lower dose. Nevertheless, we have to be realistic. And I think that with the no add-back dose, we'll probably have a response rate which is somewhat lower maybe, but still a very significant proportion of the patients. And that would also address the need for the patient who may have pain control with the high dose and add-back therapy but would have either a safety issue or contraindication or a tolerance issue due to, for example, spotting and breakthrough bleeding. So our expectation is that to have a significant proportion of patients who, by taking a dose not requiring add-back, will be able to continue; and a fraction of that population say, look, maybe it's not effective enough, you better take a high dose with add-back therapy. I think it will be clear, obviously, with the EDELWEISS data, and we will be more precise on what are these doses delivering.
Mayur Amrat Somaiya - Analyst
Okay. And just a follow-up to that. The EDELWEISS is, correct me if I'm wrong, will be the first time we see the impact on bone marrow density. We haven't seen that data before. So can you just speak to what you're seeing in terms of the earlier data sets that gives you comfort or confidence that you can have a no add-back dose that's potentially more effective than some of your competitors?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
You're right that we will have, for the first time with 2109, a bone mineral density. We will have those data in September because, as you remember, we have the primary endpoint, which is pain control at 12 weeks. We will see that by midyear. And 3 months later, we will have the readout at 24 weeks as we need 24 weeks to see -- to pick any significant impact on bone mineral density. So I think it's too early to tell you whether we are extremely confident on how a dose can work without add-back therapy. I think the rationale in the estradiol level that we have seen in Japanese population are very comforting, but I think we will have more information for you in September.
Operator
(Operator Instructions) Our next question comes from the line of Biren Amin of Jefferies.
Biren N. Amin - MD and Senior Equity Research Analyst
Ernest, what are your impressions of the uterine fibroids market given we've seen some safety issues with Esmya arise in Europe? And how do you think that helps 2109's positioning in the U.S., if Esmya isn't approved in the U.S. or if it comes with a black-box warning?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes. Yes, I mean, for us, it was, I have to say, a sad information to learn that there was potentially a safety issue with Esmya. As you remember, we developed it and we registered it, and there was no evidence of any concern when we were in charge of that compound development. We have to be also rigorous, and the jury is still out. I think that the feedback from the European agency will be in May. We know also that the PDUFA date has been postponed by a quarter in the United States. I mean, clearly, it's a different class of GnRH -- than the GnRH antagonist. So it's not going to have any impact on the safety of GnRH antagonist class. It's completely -- chemically, mechanism of action is very different. So I think we will see. We will see how this Esmya [survivor] can develop. But clearly, GnRH antagonist are there, we believe, to capture a good part of the fibroid market.
Biren N. Amin - MD and Senior Equity Research Analyst
Got it. And then just on nolasiban, I'm trying to understand the timeline to meet with EMA. I think if I heard correctly, the meeting is going to occur in September, which is after your FDA meeting. Do you think the FDA meeting would influence the outcome with EMA?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes. Yes, by 2 means: first is that I think authorities here are sensitive to and listening to feedback that we receive from the FDA. I mean, they have no obligation and they are absolutely independent, but we cannot ignore that the feedback of the FDA will share it with them and has a positive impact. Two, as you remember, we are going to submit this one Phase III -- have them to submit with one Phase III. And in case they feel that they need additional supportive data, we would be in a position to say, well, we have a U.S. study, which is already starting. By that time, we could have additional data. So I think that it's helped us to indeed optimize the process in Europe by knowing and starting our clinical trial in the United States.
Biren N. Amin - MD and Senior Equity Research Analyst
Got it. And then maybe if I can have a question on 022. The data at your end, will that data have -- or will that include the 36-week data, which is I think typically what FDA looks at from a registration standpoint, or what probably gives you some confidence in designing a Phase III study? And I guess, what should we expect on that endpoint from the Phase II trial? What would be a good result?
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
Yes, yes. This is a Phase IIa because it's a high dose versus placebo, and therefore, we expect to conduct afterwards a Phase IIb with a dose finding. What we expect for that trial is that we see a difference in terms of patient not delivering at day 7 after initiation of treatment. So that's the focus. But obviously, we will record day 14 and timing of delivery, and we will follow up the neonatal. All the information will be available. By the end of the year, we will have, if I remember well, day 14 data, not the completion of pregnancies.
Operator
Thank you. And I'm showing no further questions at this time. I'd like to hand the call back to Ernest Loumaye for any closing remarks.
Ernest Loumaye - Co-Founder, CEO & Director (Leave of Absence)
So time to thank you, everyone, for taking the time to join ObsEva Fourth Quarter 2017 Update Call. As you have seen, we are pleased with our progress to date and are focused on providing potential best-in-class therapeutic alternatives across a range of women's health disease and fertility conditions. We really appreciate your support and look forward to updating you on our progress again next quarter.
As always, don't hesitate to reach out to Tim Adams or Mario Corso for any follow-up questions. And this concludes our call. Thank you.
Operator
Ladies and gentlemen, thank you for participating in today's conference. That does conclude today's program. You may all disconnect. Everyone, have a great day.