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ObsEva SA (NASDAQ:OBSV)
Q3 2019 Earnings Call
Nov 11, 2019, 2:00 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the ObsEva Third Quarter 2019 Financial and Business Update and IMPLANT4 Trial Results Conference Call. [Operator Instructions] I would now like to hand the conference over to your speaker Mr. Mario Corso. You may begin.

Mario Corso -- enior Director, Investor Relations

Thank you, operator. This is Mario Corso, Senior Director, Investor Relations at ObsEva. Good morning or afternoon to our listeners, and welcome to today's call.

ObsEva issued two press releases this morning, one disclosing Phase III results from the IMPLANT4 clinical trial of nolasiban in women undergoing embryo transfer following in-vitro fertilization, and the other the disclosure of our third quarter 2019 financial results and business update.

On today's call, I'm joined by Ernest Loumaye, our Co-Founder and Chief Executive Officer; Jean-Pierre Gotteland, our Chief Scientific Officer; Wim Souverijns, our Chief Commercial Officer; Tim Adams, our Chief Financial Officer; and Beth Garner, our Chief Medical Officer.

During today's call, ObsEva management will be making 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 oxytocin receptor antagonist, nolasiban, our gonadotropin-releasing hormone receptor antagonist, linzagolix, and our prostaglandin F2 alpha receptor antagonist, ObE022. These forward-looking statements will include comments about expected clinical trial results and regulatory pathways in the US, Europe and Asia as well as the therapeutic and commercial potential of ObsEva's products.

These forward-looking statements are based on ObsEva's current expectations and the inherently involve risks and uncertainties. ObsEva's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements. Risks and uncertainties include, without limitation, those related to ObsEva's development programs, clinical trial timelines and results, the uncertain clinical development process including adverse events, the success, cost and timing of all development activities in 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 filings with the US Securities and Exchange Commission, including a 6-K report for the three months ended September 30, 2019, to be filed on or around November 11, 2019, as well as other reports filed on Form 6-K and 20-F.

ObsEva undertakes no obligation to update any forward-looking statements as a result of new information, future events or changes in expectations, except as required by law.

I will now turn the call over to Ernest Loumaye, our Chief Executive Officer.

Ernest Loumaye -- Chief Executive Officer

Thank you, Mario.

Today we disclosed results of the Phase III IMPLANT4 trials of nolasiban in women undergoing embryo transfer following in-vitro fertilization. We are surprised and obviously very disappointed that the trial did not meet its primary endpoint. The 10 weeks pregnancy rate for women receiving nolasiban was 40.5%. This is a rate of 39.1% for women on placebo with a p-value of 0.745. As to safety, nolasiban was well tolerated. No difference between placebo and nolasiban were observed.

As this result did not confirm the positive results observed in our first Phase III trials of nolasiban, we have decided to discontinue the current development program for nolasiban in IVF. However, we will assess whether there is potential for nolasiban in other indications.

We remain fully committed to continuing the development of our innovative pipeline, focused on addressing unmet needs in women's health and pregnancy. We are focusing our effort and resource on the four ongoing Phase III trials of linzagolix for uterine fibroids and endometriosis and our Phase II program for OBE022 for the treatment of acute preterm labor.

We have very important data results for both of this compound this quarter, with the PRIMROSE 2 trials of linzagolix in heavy menstrual bleeding due to uterine fibroid and an interim update in 60 patients from the prolonged trial of OBE022 in preterm labor. We consider both of this compound to be potentially best-in-class and look forward to sharing prior results soon.

PRIMROSE 2 recruited approximately 500 women with heavy menstrual bleeding or HMB due to uterine fibroids. It is a standard primary endpoint of reduction in HMB as measured by the alkaline hematin method. The trial includes a low dose of linzagolix, 100 milligram without add-back therapy and a high-dose 200 milligram, including add-back therapy. Importantly, we are the only company developing a dose without add-back therapy for the uterine fibroids indication, which we believe is a critical point of differentiation of targeting the large and diverse US patient population.

The 100 milligram dose achieved a response rate in the range of 40% to 50% without clinically significant impact on BMD, bone mineral density. We believe this provides a differentiation needed to be competitive in the market as none of the other GnRH antagonist under development can offer a way to control symptoms without requiring exogenous hormone through add-back therapy to mitigate bone loss. Therefore, this could be the de facto first-line dose with our highest dose option, 200 milligram with add-back would be available for patients not responding to the lower dose.

Additionally, we expect a readout of six months data for PRIMROSE 1, our second Phase III trial in uterine fibroids in the second quarter of next year.

With approximately 4 million women in the US diagnosed and treated, we believe that the unmet needs in uterine fibroids is tremendous. Oral contraceptives are often an ineffective treatment option to reduce menstrual bleeding. GnRH antagonists are primary used short term as a bridge to surgery, and surgery is costly and invasive. In addition, as we mentioned in our previous call, the EDELWEISS 2 and 3 -- the three trials assessing the efficacy and safety of linzagolix in women with endometriosis-associated pain are well under way, both in the US and Europe. Similarly to uterine fibroids, we are developing both a partial suppression, first-line option without add-back therapy as well as a full suppression option with add-back therapy.

For the Phase IIa PROLONG study of OBE022 in pregnant women from 24 to 34 weeks of gestation experience in preterm labor, we expect an interim update in 60 patients later this quarter. Following the open label part A of the trial concludes earlier this year, we have seen an acceleration in the randomization part B of the trial in recent months, which compared treatment with atosiban alone versus OBE022 added to atosiban. The trial IDMC is scheduled to conduct its second review soon now in 60 patients versus 30 earlier this year.

In addition to safety, we will receive information on any initial efficacy signal that OBE022 may be able to prolong pregnancy compared to atosiban alone, but are not conducting statistical or futility analyses at this interim time point as previously mentioned.

Importantly, the unmet medical need is likely greater in preterm labor than any other area that we are pursuing with 500,000 annual case in both Europe and in the US and exceedingly high medical risk to the mother and baby as well as financial cost for neonatal intensive care unit and clinic care that amounts to billions of dollars annually.

In conclusion, we regret not being able to improve outcome with nolasiban for women undergoing IVF. Due to our multi-asset strategy, we have the opportunity to develop two potentially best-in-class innovative assets, one of which is in late-stage Phase III. We continue to believe we have the right strategy of building a portfolio of promising assets, addressing significant unmet need in the field of women's health.

I will now turn the call over to our CFO, Tim Adams, for a brief financial review. Tim?

Tim Adams -- Chief Financial Officer

Thank you, Ernest, and good morning, everyone.

I would like to spend a few minutes outlining third quarter results and our updated financial outlook.

Our net loss for the third quarter 2019 was $27.6 million or $0.63 per share. This compares with a net loss of $18.6 million or $0.42 per share for the third quarter of 2018. The year-over-year increase in net loss was largely attributed to increased spending on the clinical development for nolasiban and linzagolix.

Research and development expenses were $21.9 million for the third quarter of 2019 versus $15.9 million for the third quarter of 2018. This increase resulted from the expansion and continued progress with the clinical trial development for nolasiban and linzagolix.

G&A expense in the third quarter of 2019 was $4.9 million as compared to $3.1 million for the third quarter of 2018. This increase is primarily attributed to higher staff costs and precommercial activities for nolasiban.

Our cash balance as of September 30, 2019, was $91 million as compared to $138.6 million at year-end 2018. Of note, the 9/30 cash balance includes the first $25 million loan from our credit facility with Oxford Finance. Cash used in operations during the third quarter was $26.9 million, reflecting continued spending in support of our pipeline. We also made a $5 million milestone payment to our partner, Kissei, related to the start of the Phase III EDELWEISS trials in endometriosis.

Based upon our year-to-date spend and preliminary revisions to our nolasiban and precommercial spend, we now estimate our full year 2019 cash investment to be between $96 million and $99 million. This is less than our previous estimate of $105 million to $110 million cash used for 2019.

And finally, a quick update on the revised cash runway. Based on the $91 million of cash at September 30, our preliminary revised spending plans, and assuming we draw another $25 million on the Oxford loan, our updated cash runway can fund our operations into the first quarter of 2021. We remain committed to the continued development of our innovative pipeline and we will continue to invest appropriately with four Phase III trials ongoing for linzagolix and a Phase II trial for OBE022.

With that, operator, we can now take questions.

Questions and Answers:

Operator

[Operator Instructions] And our first question comes from Kennen Mackay with RBC Capital Markets. You may proceed.

Kennen Mackay -- RBC Capital Markets -- Analyst

Hey, thank you for taking the questions. I was hoping, maybe this morning you could help us understand a little bit around the potential to reduce R&D spend and how much sort of the current run rate in R&D is coming from IMPLANT4 or spent on the IVF program, I think that would be incredibly helpful going forward. And then I was just wondering on any additional clarity in terms of how much of you have remaining following the quarter or as of today? And again, share the disappointment in the IVF results.

Tim Adams -- Chief Financial Officer

Hey Kennen, good morning. It's Tim. Yeah, let me start with that. So we will not pursue the IMPLANT3 trial for nolasiban, which was scheduled for the US market. I think as we have shared with investors previously that, that trial was much more expensive than what we saw with IMPLANT4 over in Europe. So we will see significant savings in nolasiban because we're not going forward with IMPLANT3. There are some additional CMC costs and some other things related to the program that we won't incur. So that will be the primary component.

When the financials come out back in the MD&A, you will see the detail of the R&D spend for this quarter was approximately $22 million. The lion's share of that goes to linzagolix. It was a little bit over $14 million. So roughly two-thirds plus. Then our additional staff costs. So the run rate in the third quarter for nolasiban was approximately $3 million. But again, that was at the tail end of IMPLANT4 and before IMPLANT3 really got started.

So again, our plans for revision are preliminary. This has all come at us very quickly, certainly the disappointment of the results.

And then I think your second question related to the Oxford loan. So it's a $75 million facility. And there were three tranches. The first tranche of $25 million was drawn back in August when we signed the deal with Oxford. The second tranche was subject to positive results from nolasiban that we will not be drawing. And then the third tranche is available to us mid next year upon the readout of both PRIMROSE 1 and 2. So we have to wait for that second PRIMROSE to read out before we control that third tranche of $25 million.

Operator

And our next question comes from Ami Fadia with SVB Leerink. You may proceed.

Ami Fadia -- SVB Leerink -- Analyst

Good morning. Obviously, I share a disappointment on the nolasiban data. Can you help us sort of remind us on the linzagolix data that's expected before the year-end? Maybe remind us what we're looking for in the data and how confident you are in this study being positive. And secondly, with the discontinuation of the nolasiban program, what are your thoughts around the OBE022 study and your development plans around that? Thank you.

Ernest Loumaye -- Chief Executive Officer

Yes, Fadia. For the linzagolix PRIMROSE trial, you are well aware that it's a responder rate analysis in terms of heavy menstrual bleeding. That means that -- but it's a proportion of patients achieving a bleeding below 80 milliliter over a period of 28 days at the end of the treatment. So the GnRH

antagonists are usually leading to a responder rate around 70% of the subjects, and we expect with our high dose add-back therapy to be around 70% of responder. For the low dose, we are the only one to have -- we have no figure in fibroid but indirect evidence because in the endometriosis population, the 100 milligram dose led to an amenorrhea rate of 55%.

But if you extrapolate that to the fibroid population and there are reasons to do that, that means that it should be above 55% because indeed amenorrhea mean no bleeding and patient between 80 milliliter and zero bleeding will still be responder. However, so I think we are comfortably waiting for this data. Now, we are a little bit conservative, and we are setting it as an objective between 40% and 50% because -- and I will ask Wim to justify that why is it -- even a 40% is important in this population.

Wim Souverijns -- Chief Commercial Officer

Yes, thanks, Ernest. So Ami, the reason why that number comes up is that we try to assess from what point on would a drug that has an option to control symptoms without the use of add-back become commercially relevant. And as soon as we hit the 40% to 50%, there will be a significant opportunity for us to capture market share because first of all, there is a segment of women that physiologically is not able to take or should not take add-back therapy, with a high BMI [Indecipherable] diabetes, cardiovascular complications, you're supposed not to take hormone replacement therapy.

So if you hit a 40% response rate, 40%, 50%, one in two, you would respond, those women definitely would be a key target for us. And then on top of that, in terms of market expansion, the second segment are those women that technically could take add-back therapy, but really have expressed a preference of not to take exogenous hormones. And so that is the -- I would say, in the second wave of a commercial launch with the second segment of patients that we could go after. If we are below 30%, it becomes much harder to justify a commercial opportunity there. But as of 40%, 50%, we think there is definitely a value for us.

Ami Fadia -- SVB Leerink -- Analyst

And if I could just follow up, what percent of the target patient population falls within that segment of high BMI, cardiovascular risk, etc.?

Ernest Loumaye -- Chief Executive Officer

We don't have a figure on that. But what is clear that, when we compare our EDELWEISS population, which is about 32, the endometriosis versus the fibroids, the fibroids is on average 42 years old, and that's a tranche of age where you have more hypertension, insulin, glucose intolerance, obesity and so forth. But we cannot give a precise figure. And maybe, Wim, you can help us.

Wim Souverijns -- Chief Commercial Officer

Yes, we're actually -- Ami, we're actually running currently research to assess that, to actually get a qualitative number behind that. But as Ernest said, there is definitely a significant population in that age group that will fall in that category.

Elizabeth Garner -- Chief Medical Officer

The prevalence of fibroids is also much higher in African-American women who are more likely to be having those conditions.

Ernest Loumaye -- Chief Executive Officer

Yeah. Thank you, Elizabeth.

Ami Fadia -- SVB Leerink -- Analyst

And could you talk about the OBE022 program?

Ernest Loumaye -- Chief Executive Officer

Yes, certainly. Well, you should remember a couple of years ago, we started with nolasiban on preterm labor. It was extremely difficult to recruit patient in our clinical study for preterm labor pregnant women. And obviously, when the IVF emerged, and we thought it was a better priority for the drug. With OBE022, we are very pleased to see that the way we designed the trial, which is adding to standard of care has been really offering an acceleration of patient recruitment. And indeed, if we recruit nine patients during our first year, we have now about 70% within the next year and -- I mean, the year so far, 2019. So I think it's good news. There is a demand. There is willingness to test, and indeed, we recruit patients.

Now we should also be reasonable on what we expect of this first 60 patients. Clearly, it's a safety. And we did it already after 30 patients. Giving a new chemical entity to pregnant women to have a healthy baby at the risk obviously of preterm labor is really a big step forward. And so the safety is the prime information we are looking for.

On top of that, we are obviously recording when did they take the drug, when did they deliver and so forth. And therefore, we will be able to see, if we start to see a signal on the 30-patient placebo versus 30-patient treatment in terms of prolongation of pregnancy, whether it's how many patients did not deliver at day seven or what is the mean time from taking the drug to delivery. And there is a last information we are looking for, is that we are low enrollment of single-term pregnancy but also twins. And we are probably around 30% to 40% of the patients treated which are twins. And that's our lowest, according to the protocol, to adapt for the next 60 patients.

For example, if we see a trend in one of the two group and a net benefit in this group, we may decide to go only for twins or to go only for single term or to keep both. So this information, this assessment is going to be important. Safety, initial efficacy signal and adaptation of the trial to optimize the information we are collecting.

Ami Fadia -- SVB Leerink -- Analyst

Got it. Thank you.

Operator

And our next question comes from Martin Auster with Credit Suisse. You may proceed.

Mark Connolly -- Credit Suisse -- Analyst

Hi, everyone. This is Mark on for Marty. Thanks for taking my questions. I guess, first, I know previously you discussed the potential China partnership for nolasiban to bring an additional capital. And so with today's nolasiban news, does this change your strategy in terms of how you think about linzagolix? For instance, are you considering potential linzagolix partnerships to bring in extra capital and to help market the drug?

Ernest Loumaye -- Chief Executive Officer

Yeah. First, I think it's premature to decide what we're going to do in China with nolasiban. I think that -- let's see if there is appetite to explore other things with nolasiban in China. I think that it's too early because we got the data yesterday. But initial contact indicate that, yes, we should continue to talk and see if yes or no, there is an opportunity.

Two, you're right that in terms of linzagolix, we have considered potential partnership, essentially in the United States. Nothing is decided. We think that when the results will be available, discussion will accelerate. But you're right, that's maybe a way also to contribute to financing the company.

Mark Connolly -- Credit Suisse -- Analyst

Got it. And then just one question on uterine fibroids. I guess I was just -- could you help me understand the regulatory path in uterine fibroids post the Phase III top line results and specifically, what's your expectation on timing of regulatory filing?

Ernest Loumaye -- Chief Executive Officer

Yes. We have in our two trial, PRIMROSE 1 and 2, 12 months of treatment. In the European trial, we have six months placebo versus six months is active. And in the US trials, we have a 12-month placebo arm versus active. So that mean we are generating data for long-term chronic treatment of the drug which is not necessarily the case for the competition. Now, the primary endpoint in both study is at month six of the treatment. Now what we are going to have is a 12 month data for both trial by Q4 next year, and we intend in 2H 2020 to consult the EMA and the FDA in terms of filing strategy. We are not actually developing a specific plan or at least discussing publicly a specific plan. But our current understanding is that it would be first a filing of EMA, followed by a filing with the FDA.

Mark Connolly -- Credit Suisse -- Analyst

Perfect. Thank you.

Operator

And our next question comes from Eric Joseph with JPMorgan. You may proceed.

Eric Joseph -- JPMorgan -- Analyst

Thanks for taking my question. I guess I'd be curious to get your latest impression of commercial expectations for the GnRH class in uterine fibroids and how those might contrast versus what we're seeing with a competitive product in endometriosis where, I guess, lower uptake has been a little bit lower than expected? I mean, are you -- I guess, should we be thinking about product reception being different in uterine fibroids or are there different hurdles to access the reimbursement? Thanks.

Wim Souverijns -- Chief Commercial Officer

Thanks, Eric. It's Wim here. Yes. So the first thing I think that we need to remember is that both of these indications, there are millions of women that are really suffering from either heavy menstrual bleeding or pain associated with endometriosis. So the opportunity is definitely there. The unmet need is absolutely there. It's true that in endometriosis, the AbbVie launch probably has been a little bit below expectations. But this is a marathon. It's not a sprint. And AbbVie have the challenge to enter a totally new area within totally new class of drugs [Indecipherable] a bit of education and training.

And particularly, I think, on the payer side, we see, one, landscape changing in the US and, b, also target audience with the OB/GYNs who are probably not as used to the challenges of prioritization and [Indecipherable]. So I think in large part, that is kind of explaining the slower uptake. We believe that the opportunity is still there. And in fibroids, there's potentially even a better chance of having a bit faster uptake because in this class oral contraceptives are less effective and surgery is often the treatment that is used which is expensive and invasive. Patients want to avoid that. So we believe that endometriosis and fibroids differ in that regard. And so entering for us, first, in the fibroids market, after AbbVie has basically established practices for dealing with the payer side that really accelerated the uptake.

Eric Joseph -- JPMorgan -- Analyst

Got it. That's helpful. Thanks for taking the question.

Operator

And our next question comes from Jameson Kao with BMO Capital Market. You may proceed.

Jameson Kao -- BMO Capital Market -- Analyst

Hi. This is Jameson [Indecipherable]. Thanks for taking our questions and sorry about the trial results. Given the experience and knowledge gained in IVF from the nolasiban program, would you be looking for other therapies or drug mechanisms for the space? And on a separate but related question, I know you briefly mentioned China. But would you be looking for other opportunities to explore with nolasiban? Thank you.

Ernest Loumaye -- Chief Executive Officer

Yes. I think for the moment, our top priority is keeping the cash to bring home linzagolix and OBE022 in the next, I would say, 15 months, really to make sure we can progress full speed in development. That mean that we do not expect to conclude any in-licensing within the upcoming months. Nevertheless, you know that we have been looking at additional opportunities, and we will continue to do that. But I think we will not do it in the upcoming months.

For nolasiban, I think that we have to be very clear. We are not going to spend more cash on this program for the moment. And we need really to better understand what would be the parameter on which we can work because it's true that it's extremely frustrating. I mean, the Phase II show clearly a difference between 900 and placebo. It was not statistically significant because relatively small p-value given the number of subjects. The IMPLANT2, statistically significant, with a very nice p-value and very relevant clinical difference. But this comes with a surprise. So again, let's be clear, no cash on that. But we'll do some homework to assess whether there are other opportunities around that field with nolasiban in the upcoming months.

Jameson Kao -- BMO Capital Market -- Analyst

Thank you. That's very helpful.

Operator

And our next question comes from Raghuram Selvaraju with HC Wainwright. You may proceed.

Edward Marks -- HC Wainwright -- Analyst

Hello. This is Edward Marks on for Ram. Sorry to hear about these results. I'm just wondering when we can expect these data to be presented in full. And as you kind of touched on in the previous question, I'm just wondering in a preliminary sense, what do you think might be the reason for these results considering all the positive results that you just went through that you had seen in previous trials?

Ernest Loumaye -- Chief Executive Officer

We don't have a clear answer to that question. What I can certainly tell you is that all the quality control check have shown that the study was properly conducted, properly randomized. The patient has the expected level of nolasiban. So I think that unfortunately these data are fully valid, and we don't expect to discover any issue with that. So we have to accept that. We look for a list of subgroups that -- by the way, we analyze also in the IMPLANT2, and we did not find any unbalance as far as we have seen in term of one subgroups potentially biasing the results.

So really, we don't have currently an explanation why. But again, with the previous observation as well as the study we have done on mechanism of action, confirming some very specific activity of nolasiban on the uterus and the endometrium around implantation time, I think we need more time to investigate that. But again, let's be reasonable. We don't want to spend more money on that now and gamble on any, I would say, short-term conclusions.

Edward Marks -- HC Wainwright -- Analyst

Understood. And then in terms of just presenting that data, would it be in a publication or a presentation at a conference?

Ernest Loumaye -- Chief Executive Officer

We have not yet discussed, but I think it should be obviously sooner or later be presented. Yeah, sure. But we have not yet considered that.

Edward Marks -- HC Wainwright -- Analyst

Okay. Thank you. I appreciate you for taking the questions.

Ernest Loumaye -- Chief Executive Officer

Thank you.

Operator

And our next question comes from Biren Amin with Jefferies. You may proceed.

Biren Amin -- Jefferies -- Analyst

Yeah. Hi, guys. Thanks for taking my questions. Ernest, on OBE022 when can we expect to have the 24 month follow-up data on the part A portion?

Ernest Loumaye -- Chief Executive Officer

Again, 24 months follow-up of the Part A of OBE022. Now, we are following the babies up to delivery and we have six months follow-up. I do not remember the 24 months data for OBE022. I'm a little bit lost, Biren. Maybe we -- go ahead.

Biren Amin -- Jefferies -- Analyst

Because I think if I look at your R&D deck from last year, I think it showed that there was going to be 24 month infant follow-up with final part A mean analysis.

Ernest Loumaye -- Chief Executive Officer

[Indecipherable] I'm lost.

Biren Amin -- Jefferies -- Analyst

No, no. [Indecipherable].

Ernest Loumaye -- Chief Executive Officer

Baby born?

Biren Amin -- Jefferies -- Analyst

Baby born.

Ernest Loumaye -- Chief Executive Officer

Yeah.

Biren Amin -- Jefferies -- Analyst

And then I need to double-check by when [Indecipherable].

Ernest Loumaye -- Chief Executive Officer

Yeah. Okay, OK, OK. Okay, I was...

Biren Amin -- Jefferies -- Analyst

Okay. And then, I guess, on the part B, for the 30 patients, what can we expect in terms of efficacy? I guess you'll follow the gestational timeliness, and then -- so what can we expect there? And FDA had an Advisory Committee with Makena. Were there any key learnings that you took away from that that could help you with this program?

Ernest Loumaye -- Chief Executive Officer

Yes. So indeed, now we are following the pregnancy progression from start of treatment to delivery and then follow-up of the baby. So what we are defining, it's a list of endpoints, how many patients deliver or not after 48 hours, after seven days, time to delivery, number of premature babies versus term babies and so forth. We will have 30 patients in the placebo and 30 patients in the active group, and therefore, we are going to see all these endpoints and see whether there is a trend toward the prolongation of pregnancy by one or more of this parameter in the OBE022 group.

But I think upfront and in the protocol, we make it clear, we are not going to do a futility analysis because it's much too small a sample size. Now, if we have a problem, that means that, for example, the OBE022 exposed patients deliver systematically earlier than the other, that would be obviously a question to be addressed. We don't expect that for sure, but that means that the limit of the efficacy data interpretation, we are going to have.

Now for the Makena, I think that maybe I'll ask Elizabeth to comment also on that. On my side is that means that, indeed, they want to see not only a delay in delivery, but a reduction of severe morbidity after delivery. And saw -- I think that but it's a hormonal treatment and this reminds them [Indecipherable] they want to have a relatively long-term infant follow-up. Elizabeth, your view on that?

Elizabeth Garner -- Chief Medical Officer

Yes. I mean, I think even bigger picture learnings from that [Indecipherable] it's clear that preterm labor continues to be a big challenge, right, and a huge unmet need. And physicians and patients really believe/believes in Makena, and there was great hesitancy to pull the drug even in a setting of negative results. That shows you how much more there is this need. And so that gives us of course additional drive to want to find a solution.

Biren Amin -- Jefferies -- Analyst

Got it. Thank you.

Operator

Ladies and gentlemen, this concludes our Q&A portion of today's call. I would now like to turn the call over to Ernest Loumaye for any closing remarks.

Ernest Loumaye -- Chief Executive Officer

So I'd like to thank you to everyone who has joined us on today's call. Stay tuned for the critical milestone this quarter. First, Phase III linzagolix result in patients suffering from heavy menstrual bleeding due to uterine fibroids. In the interim, we will be presenting and meeting with investors at two conferences this month. The Credit Suisse Healthcare Conference on November 13 and the Jefferies London Healthcare Conference, November 2021. This ends our call. Thank you, everybody.

Operator

[Operator Closing Remarks]

Duration: 39 minutes

Call participants:

Mario Corso -- enior Director, Investor Relations

Ernest Loumaye -- Chief Executive Officer

Tim Adams -- Chief Financial Officer

Wim Souverijns -- Chief Commercial Officer

Elizabeth Garner -- Chief Medical Officer

Kennen Mackay -- RBC Capital Markets -- Analyst

Ami Fadia -- SVB Leerink -- Analyst

Mark Connolly -- Credit Suisse -- Analyst

Eric Joseph -- JPMorgan -- Analyst

Jameson Kao -- BMO Capital Market -- Analyst

Edward Marks -- HC Wainwright -- Analyst

Biren Amin -- Jefferies -- Analyst

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