Q3 2021 Dare Bioscience Inc Earnings Call

Welcome to the conference call hosted by Dr. A bioscience to review the company's financial results for the quarter ended September 32021, and to provide a general business update. This call is being recorded my name is Abigail and I will be your operator today.

With us today are Sabrina Martucci, Johnson, you raised president and Chief Executive Officer.

Anastasia nerve as Chief strategy Officer, and Lisa Walters Hoffert, <unk>, Chief Financial Officer MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to our third quarter 2021 financial results and business update call for dairy Bioscience. Our plan today is to review last quarter's results discuss developments since our last call in August and use the time to highlight objectives and milestones anticipated for the balance of 2021.

As well as insights into 2022.

Before we begin I would like to remind you that today's discussion will include forward looking statements within the meaning of federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1995.

Any statements made during this call that are not statements of historical facts should be considered forward looking statements actual results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties you should not place undue reliance on forward looking statements forward looking statements are qualified in their entirety by the cautionary statements in the company's SEC.

These filings, including our Form 10-Q for the quarter ended September 32021, which was filed today as long as our annual report on Form 10-K for the year ended December 31, 2020 filed on March 30th 2021.

I would also like to point out that the content of this call includes time sensitive information that is current only as of today November 10th 2021 Die undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.

Dairy is solely and squarely focused in women's health our strategy is to identify develop and bring to market a diverse portfolio of differentiated prescription therapies that prioritize women's health and wellbeing expand treatment options and improve outcomes, primarily in the areas of contraception.

Fertility and vaginal and sexual health.

Prioritizing women's health is of course, good for women and through this focused approach of addressing unmet needs with candidates that have the potential to be first line or first in category auctions.

Having meaningful commercial opportunity and in many instances can be developed via a five or five btu regulatory path, allowing us to move directly into later stage clinical development and potentially shortening the overall development cycle for the U S.

Our strategy seeks to create value and yield benefits for all of our stakeholders.

Significant progress on several key clinical and corporate initiatives with the portfolio was achieved during the third quarter and we are actively advancing clinical development and strategic partnerships to maximize the value of our pipeline candidates.

Specifically this summer, we announced a grant for up to $48 9 million over approximately five years to support one of our preclinical stage contraceptive program.

Positive phase one data for our home and therapy product candidates their HR Q1.

The FDA accepted our NDA for <unk>, one for priority review with the Paducah target date of December 7th 2021.

And we entered into a collaborative research and development agreement also known as the creator under which a pivotal phase III clinical study of overprint and will be supported by the end I see HD contraceptive development program and conducted within its contraceptive clinical trials network.

Additionally in September we initiated a phase one two clinical study of Dare BVA, one our proprietary investigational formulation of tamoxifen for intra vaginal administration to treat vulvar and vaginal atrophy in women with or at risk for hormone receptor positive breast cancer.

And we're also continuing to enroll patients in our phase <unk> respond study evaluating <unk> cream three 6% as a treatment for female sexual arousal disorder.

And for this fourth quarter, we have three important objectives. The FDA action on our NDA for <unk> one.

Plans to announce the commercial strategy for this bacterial vaginosis product candidate and we expect to submit an investigational device exemption or IDE for over trained to be able to commence the pivotal phase III contraceptive trial in 2022.

So while our portfolio includes several programs my comments today will focus on our NDA stage Derby, one program or for clinical development stage candidates all of which are utilizing different API that targeting different indications bacterial vaginosis sexual health contraception hormone therapy and breast cancer survivor.

Your ship vaginal atrophy treatment.

So I'll start with <unk>, which is in the vaginal health category as bacterial vaginosis, specifically, which impacts an estimated 21 million women in the United States alone.

In the third quarter as I mentioned, we announced that the FDA accepted for filing the NDA for <unk> for the treatment of bacterial vaginosis and they granted this application priority review and set a prescription drug user fee Act at Paducah date of December seven 2021.

As a reminder, the FDA grants priority review to applicants and applications for potential drugs that if approved would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition.

And bacterial vaginosis is a condition that can cause serious health risks and very disruptive symptoms.

It has always been our goal to bring to market a product with the potential to improve outcomes and convenience for millions of suffers and we believe <unk> has demonstrated the potential to do that.

Current FDA approved branded products indicated for the treatment of bacterial vaginosis have clinical cure rates in the range of only 37% to 68%.

In the der BV free Phase III study, a single vaginal dose of Derby, one achieve clinical cure rates of 70% to 81%.

Specifically the Derby free study met its primary endpoint demonstrating that as a primary therapeutic intervention a single vaginal dose of Derby. One was statistically superior to placebo at the day 21 to 30 test of cure visit in the modified intent to treat population that was 70% compared to 36% of subjects clinically cleared.

The placebo group and Additionally, <unk> demonstrated clinical cure rates of 77% at the day 21 to 30 test of cure visit and 81% at the day seven to 14 assessment visit in the per protocol population compared to 43, and 30% for placebo cream respectively.

Derby. One has received both qualified infectious disease product <unk> and fast track designations from the FDA for the treatment of bacterial vaginosis and under the Q I D. P designation if approved we expect ABV, one who received five years of market exclusivity. In addition to the three years available for having generated new clinical data.

Sure.

We are in active strategic discussion then engaged in other activities to support a robust market launch of <unk>, one and 2022 if approved.

And we plan to announce our commercialization strategy for <unk> one in the U S by year end, John will provide some additional color in a moment.

Before we do that I wanted to talk a little bit about the other programs. So next in the sexual health category I'll now provide an update on Tadalafil cream three.

6%, which is our investigational product to address her version of erectile dysfunction.

In March of this year, we commenced our phase <unk> clinical study evaluating <unk> as an investigational cream formulation of Sildenafil with the active ingredient in viagra for topical administration to treat female sexual arousal disorder FSA D.

As a C. D is a physiological condition characterized by the inability to obtain or maintain sufficient genital arousal during sexual activity and of the various types of female sexual dysfunction disorders is most analogous to erectile dysfunction in men.

<unk> represents a large unmet need with an estimated 10 million women in the U S experiencing distress from symptoms of low or no sexual arousal and actively seeking treatment no FDA approved products exists today to treat FSD. Despite the fact that the FSA D market is estimated to be as Cigna.

Again, if not more so as the erectile dysfunction market in both the U S and the rest of the world. If our clinical development is successful identical cream has the potential to be the first FDA approved FSA D treatment option.

We are actively enrolling subjects in the phase <unk> respond clinical study evaluating <unk> cream as a potential treatment for FSA D. At sites located across the United States. Our study protocol has planned an interim analysis to evaluate power calculations and trial size and then once we conduct that analysis will.

Providing some guidance on the anticipated timing for the topline data readout from the trial.

I'd now like to provide an update on our investigational product over printing a potential first in category option in the over $7 billion contraceptive category.

So in the third quarter as I mentioned, we announced a creator with the Eunice Kennedy Shriver National National Institute of Child, Health, and human development or Nics D, which is part of the National Institutes of health or NIH. This is for a pivotal phase III study of evergreen.

The creative reflects the NSC HTS continued support for the development of <unk> and will allow us to leverage the tremendous development expertise of the NIH in contraceptive clinical studies and to share the costs of the pivotal phase III study.

Specifically <unk> is our novel hormone free monthly contraceptive candidate, whose commercial U S. Reits are under a license agreement with Bayer. The next stage of clinical development for Overprint is this pivotal phase III contraceptive study that we will conduct under the creative with NFC HD.

Grant funding previously provided by NSE HD supported the conduct of our pre pivotal clinical study of evergreen.

In order to initiate the pivotal phase III study, we must have an FDA cleared <unk> in place. We currently plan to file the IDE for <unk> by the end of 2021 and pending the Fda's review and clearance of the IDE to initiate this study in 2022 in terms of the pivotal study.

Dara will be responsible for providing clinical supplies of overprint and coordinating the interactions with in preparing and submitting supported regulatory documents to the FDA.

DRA and NAC HD together will each provide medical oversight for the trial and we'll work together to prepare the final report of the trial results.

U S commercial rights for <unk> are under that license agreement with Bayer under the agreement Dara received access to Barry's extensive clinical and market expertise expertise through and up to approximately 80 hours per week and advisory support while we retain control over overprint development and regulatory approval process.

Barry has that right to obtain that exclusive license to commercialize the product in the U S. Following completion of the pivotal clinical trial being undertaken by Dore in Eni's, HD and by making a $20 million payment to Dara.

We will also be entitled to receive commercial milestone payments potentially totaling $310 million. In addition to double digit tiered royalties on net sales.

Next for the estimated 45 million women in the U S and are approaching menopause, let's talk about our investigational hormone therapy product <unk> one.

We believe our unique intraregional rain or IV, our platform technology offers a versatile drug delivery system in women's health with the potential to deliver different active drugs at different rates, and thereby improved convenience and outcomes across multiple indications.

This IV our drug delivery technology was developed by Dr. Bob Langer from the Massachusetts Institute of Technology and Dr. William Crowley from Massachusetts General Hospital, and Harvard Medical School and the first application of this versatile technology that we've clinically tested is dare <unk>, one, which specifically is an investigational.

28 day, interventional brain for hormone therapy, containing bio identical estradiol and bio identical progesterone for the treatment of the Weser motor symptoms of menopause and the agenda to urinary syndrome associated with menopause.

In June we announced positive topline results from a phase one clinical trial of <unk>, one that we conducted in Australia.

For some women hormone therapy as a highly effective treatment for the symptoms associated with menopause, such as the hot flashes in the vaginal dryness and it may also prevent bone loss and fracture. So the delivery of hormone therapy over 28 consecutive days with no daily intervention supports dare <unk> has potential to be a <unk>.

First in category offer offering an option.

<unk> ease of use and continuous dosing to women suffering from menopausal symptoms.

There are currently no FDA approved products that continuously deliver hormone therapy with both estradiol and progesterone together over multiple consecutive weeks as is the design of dairy HR Q1.

Our clinical development strategy is to leverage the existing safety and efficacy data on the active ingredients and der HRT, one yesterday, all in progesterone and to seek approval using the 500 <unk> regulatory pathway in order to obtain marketing approval of their HR two one in the U S. We are in the process of updating our regulatory and clinical.

Development strategy given these positive phase one data and we will be providing guidance on next steps with this program as soon as possible.

We have not yet commenced clinical testing of our second application of this novel IV, Our technology, specifically fr <unk> one for the prevention of preterm birth in luteal phase support during IVF procedures. However, we have received a grant from the NIH for certain non clinical activities, but the potential for additional NIH funding.

To support the phase one study of Dare <unk> and we will continue to provide updates as those activities advance.

And finally for the more than $3 eight as you know more than $3 8 million women in the U S have a history of breast cancer and hormone receptor positive is the most common type of breast cancer and the prevalence of vulvar and vaginal atrophy in postmenopausal breast cancer survivors is estimated to be 42 to <unk>.

70%, we would like to provide an option for those women and that is in our program Dear BVA one.

As I mentioned in my opening remarks, we initiated a phase one two clinical trial in Australia in the third quarter for this breast cancer survivorship vaginal atrophy treatment program Dare BVA, one <unk> BVA one is our proprietary investigational formulation of tamoxifen for vaginal administration to treat veeva.

As a non promotional approach to addressing BVA it could be an important option for women with a history of or at risk for hormone receptor positive breast cancer DVA is often the outcome of effective breast cancer treatments and it can lead to vaginal discomfort, including painful intercourse, which as you can imagine.

Causes significant distress for many women an appropriate treatment for Veeva is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor positive breast cancer. So BVA one <unk> BVA one may offer a solution for these women and for others for whom hormonal treatment is not an option.

We currently expect to report topline data from the <unk> BVA one phase one two study during 2022.

I will now turn the call over to John to provide a strategic update on Derby one thank.

Thank you Sabrina the Derby one partnering process has been purposely aligned with the Derby, one regulatory process with the NDA for Derby, one under priority review by the FDA, we have accelerated the three main commercialization strategies under discussion which include a straight out license to a strategic partner, where the partner is solely responsible for commercialization.

<unk> in exchange for milestone and royalty payments to Dore, a second scenario, where we strategically partner Derby, one, but retain the option to have a role in the commercialization of the product and the third scenario, where we can play a direct and active role in commercialization that includes being able to fully market the product through an introduction.

Via a partnership with a full service contract sales organization or CSO, all three options remain under active discussion as we approach the December 7th or <unk> target action date, and as a company we reflected across our entire portfolio of product candidates. We are really focused on providing better therapeutic options for women in the context of <unk>.

The one we are motivated to find the right commercial structure for the brand because we believe it should be the new standard of care for the treatment of bacterial vaginosis and as Sabrina previously mentioned currently available FDA approved treatment options for bacterial vaginosis work about half the time on average.

What has been particularly insightful for us and our team based on real time market insights that we mentioned during our previous update call is there is a fundamental underestimation of the effectiveness of the currently approved products. Both on the part of the health care providers and the payers. We believe this is likely due to the lack of innovation in the category and the lack of promote.

<unk> for bacterial vaginosis products.

And based on our market research and our current understanding of the market. It's our belief that <unk> will be the top promoter brand in the category at the time of its launch if it's approved that will give <unk>, one commercial team, whether thats <unk> or partner a dominant share of voice in the category and that's an important point as those of you who are familiar with pharmaceutical marketing can occur.

Appreciate being able to dominate share of voice is generally viewed as a key performance indicator for success and in addition to being able to dominate share of voice. We expect the end market messaging feature of the differences in clinical cure rates for <unk> versus other FDA approved products as well as positive data on the patient experience in <unk>.

Our Dear BV free study, we saw positive patient reported data that suggests <unk> was able to rapidly resolve some of the most bothersome symptoms of bacterial vaginosis for patients, including the vaginal odor and vaginal discharge when you add the potentially best in class clinical cure rates in the category with the opportunity.

For the patients who experienced rapid relief of some of the most bothersome symptoms all by the way you achieved with a single administration, a onetime vaginal dose we believe that the product is well positioned for success pending ongoing discussions with the FDA and approval of our NDA I'd also like to highlight another insight from the recent round of market research specific to pay.

<unk>.

Payers as many of you know are absolutely critical to success of any new product and Thats, particularly true for women's health and our research has showed that payers are very interested in products that positively impacts patients who have been previously treated for bacterial vaginosis or what you might call recurrent patients. The good news for us and for Dare BV one is that the <unk>.

BB free study data suggests derby, even ones potential to produce the same high clinical cure rate and recurrent patients as in patients who have never been treated for bacterial vaginosis. Therefore, any positive impact on recurrent patients is viewed as a key factor that could influence payer coverage considerations for Derby. One. So in summary, we are encouraged with the progress of our disc.

<unk> specific to <unk> commercialization, we are excited about the prospect of bringing important new therapeutic option to women and health care providers and with that I'm going to turn the call over to Lisa to give you a financial update.

Thank you John and thank you all for joining US today I would now like to summarize <unk> financial results for the period ending September 32021, as you know dairy business model is to assemble advance and monetize a portfolio of novel product candidates in women's health as a result, our expenses consist of corporate overhead.

Portfolio acquisition, and maintenance costs, and research and development or R&D activities to advance our candidates through clinical and regulatory milestones, including approval for the quarter ended September 32021, <unk> General and administrative expenses were approximately $2 2 million.

And our R&D expenses were approximately $10 $7 million.

The quarter's increase in R&D expenses compared with the same period in 2020, primarily reflects increases in the cost of clinical and regulatory affairs and other development activities related to the ongoing <unk> three 6% phase <unk> respond clinical trials and manufacturing and regulatory activities.

For <unk>, our comprehensive loss for the quarter was approximately $13 million.

During the nine months ended September 32021, net cash proceeds from financing activities were approximately $59 8 million and primarily reflected sales of stock under our ATM program. We ended the quarter with approximately $45 $6 million in cash and cash equivalent.

As of November eight 2021, we have approximately 76 6 million shares of common stock outstanding.

I'd like to take a moment to highlight a few other arrangements that we expect will favorably impact our cash burn going forward.

As we've discussed in the past recall that under Australia's current research and development tax incentive program eligible companies conducting research and development activities in Australia may be eligible to file for and receive up to 43, 5% of their eligible expenses at the cash payment the following year.

We intend to apply for the maximum amount allowed for reimbursement under the program in early 2022 based on our allowable R&D expenses related to the dairy <unk>, one and the <unk> BVA one clinical trials that are ongoing in this current year 2021.

Second as Sabrina had mentioned under the Credo with Eni CHD Gerry's agreed to contribute $5 5 million.

Between July 2021, and April one 2023 for the total estimated cost to conduct a phase III pivotal clinical study of overprint to date, we have paid $1 $5 million of that amount.

<unk> will also be responsible for providing the clinical surprised of over overpaying for this study and the <unk> will be responsible for the other costs related to the conduct of the pivotal study and we will also manage the payment of expenses to third parties we.

We believe the NAC hd's countries contraceptive trial experience and financial support should allow for the completion of the <unk> pivotal study in an efficient and cost efficient manner.

Finally grants has continued to be an attractive source of non dilutive funding for <unk> and we will continue to use our existing grants for allowable expenses and to explore and apply for additional grant funding in the future.

In closing, we will endeavor to be creative collaborative and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value.

We also encourage all investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources, our risk factors in our Form 10-Q for the quarter ended September 32021, which we filed today as well as in our annual report on Form 10-K for the year end.

December 31, 2020 that was filed on March 30th.

I would now like to turn the call over to the operator for questions and answers.

Thank you for attending the conference call to ask a question you will need to pass star one on your telephone.

We draw your question back to found a husky defend levels of compile the Q&A roster.

Again, you will need to press star one on your telephone.

Our first question comes from the line of <unk> <unk> with Roth Capital Partners. Your line is now open.

Hey, Thanks for taking my question and congrats on the gasoline things, where they had nice update and you have three quick ones I'm just kidding.

I think the first one is just whats needed to be completed.

So between <unk> and the second one is more the SSAT program or the response study was just wondering if you could comment on the endpoints being used.

Notice that this will be the first therapy approved.

Okay.

The pros are using and things like that and then lastly on the idea of our technology. Just wondering if you plan to do some additional P.

Patients not patients, but investor education, and things like that since this is now being used for two program. Then I don't know maybe are you keeping considering perhaps even if with Baird.

Thank you first of all those are great great questions, all three of them and really happy to have the opportunity to answer them. So first of all on the <unk>.

The easiest way to think about it because it's a little backwards, how we normally think about things in drug development, but.

The ITE is in many ways similar to <unk> I know it sounds backwards, because we've already completed a human study with evergreen and that wouldn't happen. If you were on the drug side, but the device division lead the review of Evergreen.

As a combination product and so the Iga follows that completion of that pre pivotal study that we did but the way to think about it as it has.

Kind of all the all the aspects in it that you would expect to have an IND to give the agency comfort that we would be going into.

A phase III trial.

And so all the kind of manufacturing the non clinical and in this case also our human proof of concept pre pivotal study.

We conducted so all of that goes into the into the <unk> and I've mentioned on previous calls.

It's actually really nice about working with the device division, leading the review of the FDA that both divisions are wonderful.

But the device division as they provide the sponsor opportunities to engage with them.

Multiple times, if you'd like to before you even file your Iga. So they have a different set of meeting standards.

So it is helpful for a sponsor to have this kind of conversations just to make sure. We are clear on what the expectations are for what to go get an IV, but bottom line, it's quite similar to an IND and our plan is right.

Right now to work on getting that into the FDA before the end of this year.

<unk>.

<unk> slaps her most bothersome symptoms and captures importantly improvement in those most bothersome symptoms of the condition and so in the case of female sexual arousal disorder distress is actually one of her most bothersome aspects of the condition and it's linked to the diagnosis. So it's again I can't say off.

And that's how similar it is to erectile dysfunction. So just like erectile dysfunction has a physical component in men in terms of the lack of sexual response to.

<unk> activity, there's also that that sort of mental component of the distressed that it causes so very analogous so our primary endpoint as a co primary endpoint that will evaluate her level of distress.

With her or her sexual response, and then importantly, again is analogous as we can be.

It's looking at that physical genital arousal response that she is experiencing and so that is the co primary endpoint.

Just on a lot of historic data frankly in the sexual dysfunction field across a variety of different sexual dysfunction indications and reflects the content validity work to target those specific questions. It really reflect what's most bothersome to her that's the primary endpoint, but because this is a face to be in because of the F. D.

Is is very collaborative with the sponsor that's doing something new like this this trial includes a number of secondary an exploratory endpoints as well so that we can really get a clear understanding from this trial of.

What what does she really noticed in terms of what's happening how is that reflected in a response for her and it's really designed to allow us to advance and design. The best Phase III program possible and that interim analysis is designed really for powering reasons that because when you're using a patient and pointed out come for the first time.

Estimates based on lots of nice published data on your power calculations, but FTA.

FTA allow sponsors this kind of an opportunity for an interim analysis for powering specifically around the use of new endpoints like this so we obviously you wanted to take advantage of that.

And then third your question was around the Ivy our technology and educating investors, it's great feedback and we really should take an opportunity to do that.

It's a great technology, there was as I mentioned developed initially by Bob Langer.

She and Bill Crowley and it's really designed to give a lot of flexibility in how you deliver a product vaginally to women. It's a great platform technology anytime you want to deliver something over weeks or months.

And that's really how we're leveraging it into your point. Yes. These are the first two places that we're looking to use the technology, but but we do view it as a platform in our portfolio as a way to deliver drugs anytime you are thinking about something she may need of over multiple days because it provides the convenience of not having.

To have daily dosing it provides the convenience of.

Still able to achieve systemic therapeutic levels of drugs as we've demonstrated with a church you one for his trial and progesterone, but without first pass metabolism. So often can avoid certain side effects or dosing limitations.

That might otherwise be present, but we will continue as the programs advance to really educated about the technology because it is truly a platform in a portfolio.

And thank you for the three right great questions.

Welcome.

Our next question comes from the line this crease malice with H C. Wainwright <unk> line is now open.

Hello, everyone, though are you all doing all thanks, so much for taking my question. So our trip to the first is you know, we're getting pretty close to the B B one could use a date and open the commercialization wood looks like Dr. Sg&a's depends only modestly increases quarters. So how should you think about the email for Q and beyond kind of given the.

You might want more.

Great well, great great question on that and.

And really that's because.

Something that we've mentioned.

A couple of times previously, but maybe I can give a little more color around.

As John highlighted we obviously are doing certain activities to prepare for an ultimate hopefully commercial launch.

That product pending FTA approval of the NDA and.

And a lot of that is really around the patient journey the landscape the paperwork that that John highlighted nicely on today's call.

But a lot of the real activities come in a product like this after you have the final labeling from the FDA. So there are certain manufacturing activities that simply are not feasible until we have the final label.

From the FDA and and really the procurement and development of the promotional pieces and things like that and because rent strategic discussions as well around commercialization strategy, there's no need for us to to ramp kind of personnel or anything like that right. So really the way to think about it is a lot of those.

Activities will come after the.

Could you for days and really because the partnering strategy will have such a significant impact on what if any of those expenses are borne by dore more to follow on that as we as we shine some light on that.

Okay, great. Thank you and then just one on Ah over pretty really so you're you're mentioning you know the truth that you can get this feedback for the I D from the F. D. A have you heard anything sofa, what's what's kind of it looked like regarding the trial, you said and when you're 20.

Me too so should we expect top one data by the end of the year by the end of 22.

Yeah, great Great. Great question. So we have shared previously that we have taken advantage of this process that the FDA device division allows for what's called Presubmission meetings with them for your I D.

Now to be clear their high level meetings, they down the under the pre submission process. The FDA doesn't actually review anything you know it.

Most analogous to a pre IMD kind of meeting process, where you you get to tell the FDA, what you're thinking what you're planning and they tell you kind of big picture conceptually does that makes sense is that a good idea or not but really the review of the ITE happens when you submit it.

The device Division is also different from from the drive division in the sense that it is very common for an I D submission process to be iterative, meaning that you submit they finally, so our goal is to submit before the end of the year.

D. A reviews and they can come back to you in a few ways. They can come back to you and say Hey, we were really hoping to see X y Z. Please resubmit right go do that and resubmit.

Before we let you start your face free trial.

Actually very very common.

To happen second is they could tell you you know.

We need you to do X y Z, but just go ahead and do that and submitted to us and as soon as you do that you're good to go you don't have to resubmit, the full ITE or third they can say great job you're gonna go to start the phase III.

<unk> is a very I mean, what's exciting about evergreen is how am completely novel and disruptive it has the potential to be in the contraceptive category, but as a novel prize product one of the things that.

We will certainly be an area of consideration of the FDA is the final design of that pivotal study. So drug drug division typically requires 12 months studies device Division typically requires six months studies.

But the device division is not typically accustomed to looking at monthly products most of the device division products or things like condoms and die.

I have friends that are on demand products raise the drug division is more accustomed to that so to your question on when to expect data, we're going to know a lot more about that after the FTA has an opportunity to review our I D and gives us definitive feedback.

There's there's clear views on typically number of cycles and things like that that you need to study, but in terms of duration for really a safety perspective, we're not going to know that but typically contraceptive.

Contraceptive trials are open label, which does provide the sponsor an opportunity to to look at data without.

Kind of statistical penalties you'd have otherwise.

And <unk>.

Sure to pick points in times to do kind of interim analysis and share them and so certainly as we learn more about the FDA expectations, we will be able to guide more around what is going to be.

Possible or not in 2022 and so at this point all we can really say is that we plan to initiate.

In 2022 pending the SDA clearance of that ITE and once we get further into that process will be able to provide a lot more a lot more guidance around timelines.

Awesome. Thank you so much.

Yeah.

And as a reminder to ask a question you will need to press star one on your telephone.

Our next question comes from the line of Komara hobbies Brookline. Your line is now open.

Hi, I'm <unk> for Tomorrow.

<unk>.

With too much sugar please.

[laughter].

We got you refuse to Green club, but the plan next year I was just wondering how do you see the patient enrollment.

The rest of your <unk> your students seem to coach the pandemic.

You may have had discussions with M I H <unk>.

He has been going on that.

Yeah. Thanks, Thanks to all the questions, Dave and so great.

Really great question, and we absolutely have been having a discussion with the NIH because.

Interesting at the <unk> at the beginning of the pandemic.

The NIH found in other contraceptive studies that they had going at that time that it actually and now I'm talking about March of 2020, when we went into shutdown.

And sheltering in place they found that it had a very significant impact on enrollment and in fact they halted.

Certain of their contraceptive development programs at that time, because simply as one might anticipate women were not comfortable at that time contemplating.

Ah contraceptive clinical trial in the midst of a pandemic, where there weren't vaccines and there was a lot of uncertainty and importantly, there were a lighter shelter in place mandates clear.

Clearly, we're still in a strange world.

As it pertains to.

To Covid and so certainly as a company. We certainly didn't want did not want to contemplate trying to run this trial in 2020 and.

And quite frankly, we weren't sure that it would be the right thing to do in 2021, either right that some of our planning and timing.

But we do believe in the N H.

I can't obviously speak for the NIH, but I can't speak to our planning conversations with them is that we both feel comfortable.

That in in 2022, and given other programs that have resumed in the contraceptive clinical development category.

And how enrollment is going with those studies that is quite reasonable to go ahead and think about starting a contraceptive clinical trial at that time.

Having said all of that we see it right changes real time, so but.

But hopefully.

We're reaching a point, where where the COVID-19 situation is hopefully only going to get a little easier to manage and predict.

But that's the thinking right now is that it it should be feasible to go ahead and start a trial like this in in 2022.

Right <unk>.

But the beautiful thank you.

Yeah. Just wanted a quick question, which is what should the DVA Stadium, Australia. This is already but are you planning for a potential fifth street in Australia.

And how similar other regulatory requirements here in U S. W. Australia.

Yeah, and so let's say, we really <unk>.

Love our collaborators in Australia, we have certain clinical research organizations that we work with there and then.

Right [laughter].

And women's health that we work with there and they are exceptional collaborators for phase one and even a phase one to trial like the VBA one study and it would also be an exceptional place to consider having.

Sites a couple sites ranked.

Coupled to a few sites for a phase two a bigger phase two or phase III program.

Not really fees.

Feasible.

Really think about your entire right clinical trial enrolling they're just they don't have the population and they don't have the number of investigators that are really specialized in women's health. Those are the ones that were working with right now.

To conduct.

Later stage trials, but it's absolutely a great venue to be a participant in a later stage trial and what works so beautifully about the phase one stage programs and why we have been so I would say prolific and and running our phase one programs in Australia is because you can and because of the nature of our programs, where often using a new.

Known active ingredient right not a new chemical entity, but unknown. It allows us to pursue a regulatory process. It's very different to what you would have to go into the us if we can get into phase. One is specifically, it's simply an ethics Committee review so much more.

More expeditious and.

Paperwork burden.

Is much less than what's required for an indie but as you advance into later stage trials in Australia, not not so much that it gets to be kind of the same as.

As required in the U S. But it still has the benefit of that wonderful tax incentives R&D rebate that Lisa outlined so it is it will always be a place that we consider for sites for later stage programs.

But it is a place that we are trying to do as much of our phase one work there as possible because it makes it.

It's 43% specifically on the rebate, but the reality is things are less expensive there in general so lot of real financial benefits to conducting our phase one program Sir.

Thank you. Thank you for being my questions.

Great. Thank you those are great questions as well.

And there are no further questions I'll know tend to call back over to MS. Johnson for closing remarks.

Thank you. Thank you so much I really appreciate everyone taking the time this afternoon to hear about our updates in our ongoing commitment to really drive value for all of our shareholders and stakeholders.

And in closing hopefully you've got the sense that 2021 has been so far a year with a number of meaningful developments and more potential meaningful development. So some of which we've already accomplished and some of which are yet to come and so during the remainder of the year. We really look forward to keeping you updated on our progress against the remain.

Any important 2021 objectives and those milestones and specifically also regarding the milestones that we believe will set us up to achieve important objectives across the portfolio in 2022 and beyond.

So thank you so much and we look forward to keeping you updated.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating how may now disconnect.

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