Q1 2021 Dare Bioscience Inc Earnings Call

Okay.

Welcome to the conference call hosted by Dara Bioscience to review the company's financial results for the quarter ended March 31st 31, 2021, and two of that a general business update. This call is being recorded my name is Ryan and I'll be your operator today with us today are Sabrina.

Mark do you see Johnson, <unk>, President and Chief Executive Officer.

John Fair.

Chief.

The strategy officer, and Lisa Walters Hoffert <unk> chief.

<unk> Financial Officer MS. Johnson. Please proceed.

Thank you and good.

And welcome to our first quarter 2021 financial results and business update call for day Bioscience.

Our plan today is to review the last quarter's results discuss developments since our last call in March and used the time to highlight objectives and milestones anticipated for 2021.

Before we begin I'd like to remind you that today's discussion will include forward looking statements within the meaning of and federal Securities laws, which are made pursuant to the safe Harbor provision to 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 and used.

Should not place undue reliance on forward looking statements forward looking statements are qualified in their entirety by the cautionary statements and the company's SEC filings, including our form 10-Q for the quarter ended March 31, 2021, which was filed today as well as our annual report on form 10-K for the year ended December 31, 2020 that was filed on March 30th 2021.

I would also like to point out that the content on this call includes time sensitive information that is current only as of today May 13 2021 day.

<unk> undertakes no obligation to update any forward looking statements to reflect new information and developments. After this call except as required by law.

Dairy is a leader and women's health innovation, and we are squarely focused on improving the lives and wellbeing and women.

Our value creation strategy is to accelerate availability of new prescription products for women by selecting and advancing product candidates that we believe have the potential to be first and category and first line and has a meaningful commercial opportunity.

We currently have for clinical stage programs and the areas of vaginal health sexual health contraception, and menopause and most of my remarks today will address these candidates.

2021 could prove to be a meaningful year for us the advances and momentum in 2020 across the portfolio really set the stage for us to reach and important portfolio objectives in 2020 one.

I'm going to start the call and heads up and I'm also going to end the call with a summary of the potential meaningful development for die. This year. This year alone since there are many of them and those of you and new to the dairy story and will likely appreciate hearing this list of 2020 milestone and try and 21 [laughter] milestones repeated.

So first and the area of bacterial Vaginosis and vaginal health for Derby Day, One program. During 2021, we intend to submit the NDA.

Enter into and announced a strategic commercialization agreement and had the producer goal date, which could result in FDA approval by year end.

In the area of sexual health, specifically, our Sudanophilic cream program for female sexual arousal disorder or phase two b clinical study is ongoing and we seek to have topline data by the year and 2020 one.

In the area of contraception are over Prime program, we intend to file our investigational device exemption from clean application. This year I E. In the fourth quarter to enable a pivotal study start in 2020 two.

And in the area of vaginal sexual health, specifically menopause or Dare HR T. One program is in phase one and we do anticipate having that study top line data this quarter and core to quarter two.

And then in additionally, I'm going to talk a little bit about our vaginal atrophy program and vaginal and sexual health, specifically and for hormone receptor positive breast cancer, where we seek to initiate a phase one clinical trial later this year.

So I'll start first with that and vaginal health programs, specifically bacterial vaginosis, our derby might be the one program.

So as you know we ended 2020 with and announcement of the positive top line data from the day Airbnb free Phase III study of Derby day, one for the treatment and bacterial vaginosis and as I mentioned were preparing to submit a new drug application or NDA with the FDA this quarter.

Completing this clinical study on time and on budget. Despite the operational constraints of the pandemic with and accomplishment about which we are certainly proud and it also allowed for some lessons learned that we were applying now towards sedan and fill phase <unk> study and I'll address that shortly.

For those of you who are new to die I'd like to just take a minute to highlight the unique attributes of Derby day, one the positive results of our completed phase III study and our next steps with the NDA submission and commercialization strategies.

So PD one is a novel investigational thermosetting bio adhesive hydrogel, it's formulated with Clinton of clindamycin phosphate and 2% as a first line single administration and vaginal treatment for bacterial vaginosis.

Bacterial vaginosis is the most common vaginal condition in women of reproductive age affecting 21 million women are estimated in the United States.

And it causes very disruptive symptoms for her a vaginal odor and discharge and it's importantly linked to health risks, including preterm birth sexually transmitted infection post surgical infection and pavlik inflammatory disease.

Current FDA approved treatments have clinical cure rates and a range of only 37% to 68% leading to and resolve symptoms and linked to high rates of recurrence.

For this reason and 2018, we identified bacterial vaginosis is a persistent unmet need impacting a large number of women and we set about finding a potential solution. We selected dare BV one in light of the ability and the bio adhesive hydrogel demonstrated and in early clinical studies to keep the antibiotic clindamycin.

Which is a proven and broad spectrum antibiotic that is bacteria static and inhibits protein synthesis resident over multiple days simply put an order for an antibiotic to be affected and the vaginal environment. It must remain present.

We believe the single dose convenient and said this unique clear bio adhesive hydrogel provided such an opportunity.

And in our Derby day, three phase III study <unk> demonstrated the potential for improved clinical cure rates versus credit branded FTA approved marketed vaginal and oral products for the treatment of bacterial vaginosis.

Specifically in.

And the modified intent to treat population the clinical cure rates for Dare BV, one where 70% at the test of cure visit which occurred 21 to 30 days. After studied drug administration that was the primary end point and 76% at the assessment visit that occurred seven to 14 days after study drug administration.

Importantly in the per protocol population, which includes only those patients and the modified intent to treat population who didn't have a major protocol violation or who didn't receive or do we see any other bacterial vaginosis therapy for any reason the clinical cure rates and that group for 77% at day 21 to 30 and <unk>.

81% at day seven to 14.

And further these results were achieved and what we believe was a representative patient population, including a large proportion of patients who reported having one or more episodes of bacterial vaginosis and the 12 months before they were randomized into the study.

Specifically, 75% of the intent to treat population reported at least one prior episode of bacterial Vaginosis and the 12 months before the study and nonetheless, the dare BV, one demonstrated a 70% clinical cure rate at day 21 to 30 in this population.

And in addition, this was the first study conducted under the new 2019, FDA guidance for bacterial vaginosis treatment.

The new guidelines required debt all subjects in the M. ITT population not only meet the clinical diagnostic criteria for bacterial vaginosis, but at baseline and they also had to meet the bacterial morphology classification or Nugent score of at least seven and reflective of bacterial vaginosis.

So given these data we believe Derby one is positioned to be an important first line option for the treatment of bacterial vaginosis and as mentioned, we're planning to submit that NDA to the FDA This quarter Q2.

Members of our team had before joining Dara had been involved and numerous successful NDA submissions, but we're excited now a diary just be submitting our first NDA as a company.

Derby day, one as a fast track and qualified infectious disease product designation. This allows for a priority review request at the time of the NDA submission, if our requested and granted by the FDA. The NDA could have it could do for action date by the end of 2020 one.

A 2021 FTA approval would allow for commercialization of Derby day, one and 2022.

That's ongoing strategic discussions and other activities to support a robust market introduction of D. I B B, one and 2022, if approved or underway. This year, we plan to finalize and announce the commercialization strategy for Derby be one and the U S.

I should note that we expect to launch strategy to be relatively straightforward given that antibiotics are frequently used to treat bacterial infections and vaginal administration of a drug for vaginal bacterial infection like bacterial vaginosis is common and often preferred by both clinicians and patients since it provides a targeted localized treatment.

Versus the systemic exposure to antibiotics.

So we believe this ability to leverage existing knowledge may expand our options for commercializing Deere BV, one and John's going to discuss this in greater detail shortly and you'll provide additional insights on how we seek to capture maximum strategic value for our shareholders in our approach to the process.

I'm now going to transition to sexual health and specifically speak about our sedan and feel cream program and a phase <unk> study that's ongoing.

Sure. It's identical cream is an investigational cream formulation of Sudan, it fill which is the active ingredient and viagra.

Our formulation has been developed for topical administration to treat female sexual arousal disorder.

Female sexual arousal disorder, or FSA D is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal response during sexual sexual activity and of the various types of female sexual dysfunction disorders. It's the most analogous to erectile dysfunction and Matt.

And.

FSA D. Similarly represents a large unmet need with an estimated 10 million women and the U S experiencing distress from symptoms of low or no sexual arousal and actively seeking treatment.

There are no FDA approved products today to treat FSA D. Despite the fact that FSA D market is estimated to be as significant and if not more so than the erectile dysfunction market and both the U S and the rest of the world.

In March of this year, we commenced the phase two the respond clinical study evaluating <unk> cream as a potential treatment for FSA D.

We're targeting completion of the study and having top line data by year end 2021.

If clinical development and successful identical cream has the potential to be the first FDA approved FSA day treatment option.

The phase two B response study will evaluate tadalafil cream compared to placebo and pre and Peri menopausal women over a period of 12 weeks at home they use the product at home and this will follow both and non drug and a placebo run in period.

Patient reported outcome or pro instruments will be used to screen eligible women with FSA D and to measure achievement at the primary efficacy endpoint, namely improvement and that localized general sensation of arousal response and reduction in the distress that women with FSA day experience.

In the months ahead, we will provide updates on our progress towards having top line data by year end.

Women, who have suffered far too long without viable interventions to address FSA D. So we're excited to be working at the cutting edge of research focused on women's sexual health and to advance and potential first in category treatment option for women.

And now going to transition to talk about overtraining and the contraceptive category over Prime is our novel investigational hormone free monthly Intervet General contraceptive.

As you'll likely recall, we entered into a commercial partnership agreement with bear in January of last year and since that time, we've been working in collaboration with Bayer to prepare for the next stage of clinical development, which is a pivotal contraceptive study.

People often ask about their level of involvement.

With the program right now and as you may recall under the terms of the agreement bear provides up to two full time equivalents for advisory support or put another way that's up to 80 hours per week of advisory support on the program.

So our teams meet multiple times each week and the meetings include interactions across functional areas, including manufacturing clinical regulatory and medical affairs, and importantly commercialization planning.

The ongoing work is designed to ensure that pending successful completion of the pivotal study and FDA approval, we are ready as partners.

I'd like to be the one where the pre commercial activities and the bacterial vaginosis space, we expect to be straightforward.

So this for over prime will likely be a little heavier given that its a disruptive product for which there are no comparable products on the market today.

Prior to the launch of Marina Bay are needed to prepare the market for the introduction of what was then a revolutionary hormone interest.

And device today Marine is a popular contraceptive bring and with annual revenue of the marine and family of products exceeding $1 billion. So likewise, we expect over free and will require education and pre commercialization activities, which is why we selected bear as a commercial partner for our unique investigational monthly.

Non hormonal interventional contraceptive overprint and why we entered into that partnership when we did and advance into pivotal study.

Our next significant regulatory step for over premium bulbs filing and IDE with the FDA.

As we must have and approved IV and placed an order to initiate our pivotal contraceptive study.

And one pivotal contraceptive studies necessary for approved registration. So our current plan is to file the ITE for over print and the fourth quarter of this year.

We are designing the pivotal study to evaluate the use of a premium for a period of at least six months and up to 12 months and pending the clearance and by the I D E and the pivotal phase III clinical study commenced and is planned for the first quarter of next year 2022, and enabling a six month data readout by the end of 2020 two.

I wanted to ask a little bit now about the H O T. One program and menopause and then briefly with on F. Archie one for.

Preterm birth and NVA one.

So our unique Intraregional ring platform technology offers a versatile drug delivery system and women's health with the potential to deliver different active drugs at different rates, which can improve convenience and outcomes across multiple indications as exemplified by the programs. We're advancing today the IV our technology was developed.

By doctors, Bob Langer from M. I T and Bill Crowley from the Massachusetts General Hospital, and Harvard Medical School and the first application of this technology that we are clinically testing is what we called Dare HR T. One.

Which is an investigational 28 day international rain containing bio identical estradiol and bio identical progesterone deliberate together for the treatment of debate on motor and the genital urinary syndrome associated with menopause.

Earlier this year, we announced that enrollment in that phase one study that we're conducting and Australia is complete.

The objective and the phase one is to evaluate the ability of dare HRT one to achieve its dual release objectives as well as the ability of the IV, our technology and general to release two different active drugs that two different rates is targeted and we expect to report top line data this quarter.

Our second application of the same technology platform is dear FRG, one which is and.

Investigation, Orange vaginal ring being developed to deliver Bioidentical progesterone alone over a 14 day day period, and that's for the prevention of preterm birth, as well as broader agudio face support as part of and Ivy asked for in vitro fertilization regimen.

You may recall that we were granted and award in 2020 by the Eunice Kennedy Shriver National Institute of Child Health and human develop development, which is a division of the NIH to support our preclinical development activities for dairy F. Archie one and that we may be eligible to receive up to approximately $2 3 million and total and grant funding to support the continued.

<unk>, including the phase one clinical trial that were targeting for 2020 two.

And before I turn it over to my colleague and finally, I just want to mention a little bit about the Deere BVA one phase one studies since we are planning to commence that this year.

So dare BVA and one is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vulva, vaginal atrophy or BVA and a non hormonal approach to addressing BVA. It could be an important option for women with or at risk for hormone receptor positive breast cancer.

And is off and the outcome of and effective breast cancer treatment regimen, and so one of the unpleasant side effects of DVA is painful and of course for many women and appropriate treatment for BVA is supplemental estrogen. However, estrogen may pose a risk to women at risk for hormone receptor positive breast cancer.

S. R. Dare BVA, one may offer solution for these women and others for whom hormonal treatment is not an option for their BVA, we plan to commence that phase one clinical trial and the second half for this year in Australia. That's also leveraging our Australia and subsidiary and the specific.

R&D rebates that are available there.

I'm now going to turn the call over to John to provide a business and corporate partnership update.

Thank you Sabrina and with our first NDA submission planned for later this quarter. We are entering an exciting time for dare BV. One as noted during our March call. We are advancing our partnership discussions and parallel with Jeremy If you want to regulatory developments and believe that we are well positioned to execute a definitive commercialization agreement and to enel.

And so our commercialization strategy before the end of this year. We believe that there is broad collision awareness of bacterial vaginosis and based on stakeholders. We've spoken to we believe that this category is ready for a new potentially more effective and more convenient prescription option and what is currently available it's our belief that a onetime vaginally.

Libert product with the potential delivered the best clinical cure rates and the category will be a welcomed addition to the bacterial vaginosis diagnosis and treatment plan for the health care providers, who routinely diagnose and treat the serious and often persistent condition.

As we discussed on our last call Derby one's differentiated product profile gives us a lot of optionality as it relates to how we go to market and and the interest of doing the right thing by patients and other key stakeholders. We are exploring all options to make sure. We identify the most effective way to get the product into the hands of patients. If we have regulatory success. These.

Options range from a full out license, where dara would likely be eligible to receive milestones and royalty payments, but where dara has no role and commercialization through to a scenario, where dara plays a more active role and commercialization.

And in addition to planning for the go to market strategy and the U S. We are actively explore and commercialization options with potential partners outside of the U S. So we look forward to continuing to keep you apprised of our partnership progress for both the U S and ex U S opportunities and with that I will turn it over to Lisa for financial update.

Thanks, John Hey, everybody and thanks for joining our call today I would now like to summarize <unk> financial results for the quarter ended March 31 2021.

As you know dairy business model is to assemble advance and monetize and portfolio of novel product candidates and women's health as a result, our expenses consist of corporate overhead portfolio acquisition and maintenance costs and research and development for R&D activities to advance our candidates through clinical and regulatory.

Milestones, including approval for the quarter ended March 31, 2021 Gary's general and administrative expenses were approximately $1 $9 million and research and development expenses were approximately $5 $7 million for quarters, increasing R&D expenses compared to the same period and 22.

<unk>, primarily reflects increases related in the cost related to clinical and regulatory affairs and other development activities related to so many people cream gear BV one.

On the plane and Dare HR Piedmont.

Our comprehensive loss for the quarter was approximately 7.7 dollars $3 million.

During the first quarter of 2021 net cash proceeds from financing activities were approximately $11 4 million and represented net proceeds from sales of common stock under our ATM program equity line and warrant exercises, we ended the quarter with approximately $7 7 million and <unk>.

Cash and cash equivalents.

Between April 1st and May 10th Gary received additional net cash proceeds of approximately $2 $6 million from sales of our common stock.

Following these activities and as of May 10 to 2021, we had approximately 49 4 million shares of common stock outstanding.

During the balance of 2021 and we will seek to continue to manage our cash resources efficiently and to access capital in a thoughtful manner and.

And there are two areas I'd like to highlight the first is group.

<unk> had been and attractive source of non dilutive funding for Gary and we recognize grant funding in the statement of operations as a reduction to our R&D expense.

And we will continue to use our existing grants for allowable expenses and you intend to explore and to apply for additional grant funding.

Second is our S. Three shelf registration statement, we intend to explore a variety and financing options for our company using our existing S. Three in addition to the ATM program that is currently in place with SBB Leerink.

Lastly, we will endeavor to be creative and opportunistic and seeking the capital and we need to build value to advance our candidates we.

We encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources and our risk factors in our form 10-Q for the quarter ended March 31, 2021 that was filed today as well as our annual report on form 10-K for the year ended December 31.

2020 that was filed on March 30th 2021.

I would now like to turn the call over to the operator for Q&A.

Thank you for attending the conference call at this time, if you do have a question and Easter Press Star then the number one on your telephone keypad for knee.

Question thing and extolled and one for any questions.

And our first question comes from the line of Jacob genre from Roth Capital Partners.

And nice things by the upbeat candidly be almost half for clinical programs and really exciting I think just a few questions. The first one starting with diabetes and one.

One is how do you guys, perhaps elaborate on the market opportunity and how you imagine you are dragging and position I think the mid day dimension was no antibiotics and income lean in on this.

Non systemic but I was just lucky messages and provide some clarity from from online and came to be and how you foresee this being positioned and how big this market is.

Yeah that is and that's a great question. Thank you for it and and let me give some perspective on the market and on specifically really dare BV, one and some of the differentiating factors with the product. So as I noted there are 21 million women in the United States with bacterial Vaginosis and about 15.

Percentage of 15% to 20% depending on the data that you look at our or in the health care system and are actively seeking treatment and so those are definitely the immediate you know targeted patient population that debt one would be going after it's a highly recurring condition. So 50% of women have recurrent disease and 60% of women of and treated for at least one.

<unk> and the last 12 months and so highly recurrent condition and that tends to be very representative of the patients who are seeking treatment. So that's the market landscape today and as I mentioned, the cure rates for the products that are available today are 37% to 68%, but it's an important notes there.

And as we mentioned many clinicians and patients really prefer a vaginal treatment for vaginal condition, and particularly when you're when you're dealing with antibiotics and youre dealing with something recurrent right you're wanting to avoid systemic exposure to antibiotics whenever possible right just as a medical society and me and.

And patient group, so vaginal really preferred and if you look at the vaginal methods the cure rates and the currently marketed FDA approved vaginal methods of 37 to <unk>, 64%, but just 37 53 on that intent to treat basis and that 64 as per protocol.

And so as you heard our data.

There their stand alone just right there stand out against the pack in terms of the cure rates that we saw so on and modified intent to treat basis compared to that 37 to 53, we saw.

70 of the vaginal products, we saw 70%.

Percentage or 76% if you're looking at the day.

Day, seven to 14 and on that per protocol basis and to the 60 for we're seeing 77 to 81.

The product really stands out in terms of the ability to to demonstrate a cure. So that's first and foremost, but importantly, it's also a super convenient. It's a single administration, it's a clear vaginal gel and it is very bio adhesive, meaning it really stays in place and that's why likely we're seeing the cure rate that we do so in terms of differentiate and the marketplace does.

And we're gonna be two important factors you also saw on the cure rates and how that response rate at day seven to 14.

We were also very excited about just the patient perception and the in the study we look to share more about some of these findings and publications, but it was very well received by the patient population and study.

And and they had a really positive response and electronic diaries for the product as well. So we're really excited about this product is one we're providing clinicians with the right opportunities to prescribe it for their patients and patients to try it.

And we're very optimistic about what they're going to see and experience.

And very different from the other treatments that are available for them today.

Yes.

And anything I Miss team that debt when they add to that.

And I would just add I mean, if you look at the for the product profile of this product really solves for a lot of other problems that are currently exists for women, who are who are experiencing victory.

And we're delivering and that convenient one time dose we have highest clinical cure rates for the study was done in a heavily pretreated population and still just demonstrate the highest clinical cure rates. When we revealed this kind of a profile to providers. As an example are payers and it really resonate. So we are very excited we don't want to overdrive and we were very excited about the opportunity.

And maybe one work and one more question and then.

And then we'll move on.

Yeah, Yeah definitely I think the other one for me is just about dietary T. One day trying to figure out you know what.

What we should be looking for in the readout, that's coming up shortly.

And nothing great question. Thank you for asking so so.

Indulge me I'm going to take a step back on the H O T. One program and just share a couple of other things about this program, which is why we're so excited about it which is.

It's a 28 day vaginal ring. So it's designed for her to leave it in place for 28 days and it's delivering estradiol and progesterone together, which are the two hormones and if you're you're administering hormone therapy, which the North American Menopause Society recommends for women, who are suffering from the visa motor symptoms of menopause and the general to urinary syndrome of menopause.

And.

As a treatment because there are a number of benefits of hormone therapy, but they're really recommending a non oral route whenever possible and so this product is to our knowledge. The first it's really following those recommendations and administering the product and the way that's convenient for her so its vaginal and so one try and every time.

And eight days and it's that non oral and with both of the hormones together, which is also what they recommend and.

And hopefully at some of the lowest effective dose possibles of the two hormones. So in terms of what you should expect from this study.

It's really designed as a phase one it's a PK study. So we're looking to demonstrate the appropriate levels of the hormones and we do have comparator products.

Debt, we're comparing to and the trials. So that we can get a sense of how the PK holds up against those products and in the phase one, but we did also have some ex egg safety and acceptability assessments as well so as we report the data you should expect to.

On here about the PK findings, which is obviously first and foremost important but also.

You know any safety findings and the study and and some some sense of how the women and this study accepted that technology.

Things that again congrats on the progress.

Thank you.

And the next question we have comes from Doug <unk> from H C. Wainwright.

Hi, everyone, a crispy on its ear on for Doug.

I got two quick ones are the first one is about the BV one.

And.

So while I'm sure as I'm sure you're aware, there's a huge agency backlog on.

For your approval inspections, and how do you think that could potentially affect your NDA approval and.

Priority voucher.

We view.

You are heading into Q compared to some of the standard review.

Yeah.

Yeah really interesting question.

You know I will say, it's been interesting because we are dealing with the infectious disease division right at the at the FDA. This is a serious infectious disease condition and facts we have.

Qualified infectious disease product designation and fast track and those designations really are designed to help sponsors that are working in an area, where there really has been and identified.

Serious unmet need and to make it possible to have more timely interactions with the agency and that's you know we're also able to apply as you noted for the a priority review.

And so to date I can only speak to date, we have found the interactions to absolutely be timely responses.

And as one would hope.

<unk> a program like this with the agency and we haven't felt.

Any sort of implications of the busyness at the agency and specifically the potential busyness of the specific division that were working with during a global pandemic.

And with all their dealing with so so we haven't seen that.

On.

Obviously can't know what's to come but at least from what we've experienced to date, we haven't felt that to date.

And then from a manufacturing perspective, obviously, we're doing everything we need to do to be ready and as you know sometimes depending on the manufacturer. They don't always do those inspections right. They can they can opt to not deemed that necessary for your product.

So they do have some some optionality as an agency as well in terms of how to approach it for.

And for a program like this given some of the other designation and said we have if if if it's relevant to do so and if it becomes necessary for instance.

Got you and then just.

One quick one about the overprint.

You said you're on track for submission for for Q, what if any are the gating events for this submission.

Another great great questions today, so and as some of you may remember.

And remember with other train.

We had originally been looking at filing the I D last year.

And.

For a number of reasons, primarily obviously associated with kind of world events. It really created an opportunity for us to tell.

You step back and take advantage of some of the opportunities that are actually a little bit unique with the device division and the FTAA, which is where <unk> is.

It's the lead review division for other pre and where they provide an opportunity for a sponsor for sponsors so chooses to have interactions with the agency and preparation for the ITE and it's a little bit different and what happens with <unk> with.

With Cedar, where you get your kind of pre IMD meeting and.

You get you get one shot so so you're allowed to have a little more interaction with the agency and so we definitely took advantage of that process.

And so that we could.

And to your point.

Do work for the ITE that maybe we wouldn't have otherwise felt was necessary, but may have been relevant down the road or may have been relevant for the PMA or could have even implications on how the pivotal study books and so we really use those interactions and have taken the time to do.

Non clinical and manufacturing related activities to support the submission and then based on those plans the submission timing was really related.

To those activities as well as.

Kind of a mindset on our part that it for a contraceptive study where you have to enroll women who are willing to get pregnant right.

Even though youre demonstrating hopefully the effectiveness of your contraceptive and you enroll women at risk of pregnancy for.

For a number of factors as well we felt that that was a trial probably best started in 2020 two.

Even though the world is opening up and we're clearly felt comfortable starting this identical study this year and obviously, we felt very comfortable last year running bacterial vaginosis contraception is a little different so for all those reasons everything was timed along those lines and so the IGT E filing is timed based on given the plans there and of the work we wanted to do.

To support the idea of submission and kind of how we could time it given our.

2020, two starch and working backwards from that that's how we came up to the fourth quarter. So its manufacturing, it's it's non clinical activities.

It's writing.

It's all of that leading up to most importantly at 2020 to start which was.

Looking at having some data readout by the end of 2020 two so that's how we got to that timeline.

Awesome. Thanks, so much for the color.

Yeah.

Absolutely.

And the next question that we need to have on the line comes from one of which shipped and then.

And then from Brooklyn.

Hi, I'm shahbandar, calling in for Kumar from Brooklyn.

Thanks for the update with regards to these two views on study so you're going to see creep for AK steel.

Pete.

Assuming the results at the end of COVID-19 going one are in line with expectations could you. Please provide some color about your future plans and Goodman.

And our plans for commercialization of the product.

Yes, yes, thanks for asking about that program, it's definitely one debt, where we're quite enthusiastic about here given the unmet needs and the category and and given that we're using the same active that's and viagra and you know is a P. D. Five PDE five inhibitor, which it should have some utility and this condition. So in terms of next steps.

The phase two b is really designed to.

To demonstrate.

Demonstrate a and C efficacy of the product and is also designed to allow us to evaluate a number of different endpoints. So as I mentioned upfront we are the first sponsor.

Moving forward against this indication and been working with the FDA on this because there are no FDA approved treatments and so as a result, it's been a very collaborative process with the FDA around designing a phase two b that allows us to have obviously the pre declared.

And the declared primary endpoint, but also a number of secondary and exploratory endpoints. So that these data can really become the basis for planning the phase III program.

And going forward from there. So this study is a 12 week study.

The FDA guidance documents and give some guidance on whats required for female sexual arousal disorder in phase III.

But this study itself is going to be very much providing a lens for us of what to take forward into phase III in terms of end point could be the same could be one of the exploratory.

And that we take forward into phase III and then we will also provide some input into duration of study. So the guidance document currently says 24 weeks for phase III.

But we'll have some nice insights into a 12 week study and how that looks for the syndication which is different from some of the other female sexual dysfunction indications had been studied previously which are more psychological and.

And need more time, so in terms of that and what comes next is.

There's the phase III program to run and then from a commercialization perspective.

Positive outcome on the phase two we expect to have a lot of Optionality with this program in terms of partnering opportunities of decisions that we can make on on whether we involve our strategic partner in the development, whether we involved and strategic partner and commercialization.

Whether we take it forward on our own and frankly, that's a nice point for me to make about the portfolio in general what's really interesting about our portfolio, we think as a company and having built such a diverse portfolio with so many independent outcomes and different programs for different indications at different stages of development. It really gives us.

A lot of Optionality, we've really structured a portfolio that allows us as a company Dara with our stakeholders our shareholders to decide what is the best way to create value and we can do that on a program basis and on an aggregate basis is it a partner is it to go alone is it too.

Co develop isit to develop on our own and that's really the lens that we've been using as we've looked at the evergreen partnership has been looking at BV, one and absolutely you know as we hopefully get to a successful for the NFL Phase T V. That's exactly how we'll be looking at that program, given what's coming behind it as well.

So definitely more to follow on that but thank you for the question.

That's very helpful. Thank you so much just from.

No question.

Curious on the newly advantages on organizing our BVA coil.

And Australia.

And the U S.

Yes, so and.

Thanks for asking that as well so I, Australia provides familiar and interesting opportunities that we just touched on briefly on this call, but we've mentioned and some other calls which is.

You can proceed with a clinical trial and Australia.

With programs like ours as you know, we we leverage that five or five btu regulatory pathway pretty heavily across our portfolio, which means we are dealing with well understood well known actives, we're just applying them either and novel dosage forms are novel indications to create these first and category opportunities, but what that means if you're going to run a clinical program in Australia and.

It means you can actually run and human clinical program without the equivalent of the time and paperwork and often additional non clinical studies that are required for an IND submission and the U S. So it allows you to actually run things in parallel and get that human data in parallel on or before youre doing some of the other work that would be needed for.

And 90 submission and that human study actually becomes part of your R&D and supportive of your eye and D submission, which can also mean that you're then expediting advancing the program in the United States into phase two there.

And therefore, so it offers a lot of advantages from that perspective, just from a time perspective, but it also offers a cost advantage is we have a subsidiary in Australia and I'll, let Lisa chat right now a little bit just to give you a sense of the kind of rebate structure cash rebates that we get from having that subsidiary in Australia. When we do research there.

Yeah and just.

England, and Sabrina said, the the cash advantages of Australia first of all the expenses and general are a little bit lower for conducting a clinical study, but the government has and R&D tax incentive program and pleased for certain programs and certain activities. So we have to track, but we at the end of the year can apply for.

Basically a refund on a portion of the expenses that we expense during the course of the year and it can be up to 43.5%. That's the current kind of maximum rebate. So as Sabrina said for the ability to start the trial a little earlier because of some of the regulatory issues and then also the cash.

Cost of that.

Being a little bit lower really makes a lot of sense to do some of our earlier studies there if we can.

Yeah, so you'll see that whenever it makes sense.

It is our strategy to run the phase ones whenever we can in Australia now with that as Archie one we have the nice grant potential from the NIH up to $2 3 million to from the phase one and the U S. So when we get non dilutive funding like that and it's paid for we absolutely will do that and the U S as required under those grants.

But otherwise Australia, as a really attractive option for us.

Sounds great. Thank you so much for taking my questions.

Thank you.

And at this time, there and no other Christian Thank you Charles I'd like to turn on participating.

Great well, thank you and and thank you all for taking the time. This afternoon to hear about the recent updates and our strategies to improve options and health outcomes for women and our ongoing commitment to drive value for all of our dairy stakeholders.

So in closing 2021, as you're hearing is a year with a number of potential meaningful developments for DRA all independent of each other.

Across the portfolio and I'd like to take a moment to summarize them so with dare BV one so we're in.

Bacterial vaginosis program, we're intending to submit that NDA.

Enter into and announced a strategic commercialization agreement and hopefully have a difficult day, which could result in and FDA approval by year end.

With our sexual health programs and NFL cream for female sexual arousal disorder. As we were just talking about our phase two b clinical study is ongoing and we are hopeful of having top line data by year end.

With over pre and also as we've discussed for going to be filing.

Our intent is to file that IDE and the fourth quarter and.

To enable a pivotal study start in 2020 two as we discussed and then as we were talking about with our enterprise program Dare HR T. One that phase one clinical study top line data readout is expected this quarter, so keep an eye out for that.

And then as we were just discussing we are very much looking forward to starting that phase one clinical study with our BVA one program for women seeking and non hormonal approach to vaginal atrophy, including women with hormone receptor positive breast cancer, So watch for that as well this year.

And we look forward to keeping you updated on our progress against these.

And these important 2021 objectives and throughout the year. Thank you again for your time today.

And this does conclude today's call and email and now disconnect.

Yeah.