Q4 2020 Dare Bioscience Inc Earnings Call

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Welcome to the conference call hosted by Dai Bioscience to review the company's financial results for the year ended December 31st 2020 and to provide a general business update. This call is being recorded my name is Sarah and I will be your operator today with US today are Sabrina Martucci, Johnson, <unk>, President and Chief Exec.

<unk> Officer, John Fair Die as Chief strategy Officer, and Lisa Walters Hoffert, <unk> Chief Financial Officer.

MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to our 2020 financial results and business update call for di Bioscience.

Our plan today is to review last year's financial results discuss notable achievements since our last call in November and use the time to highlight developments and milestones anticipated for 2021.

Before I 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 on 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.

From 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 filings, including our annual report on form 10-K, and on form and our quarterly reports on form 10-Q.

I would also like to point out that the content of this call includes time sensitive information that is current only as of today March 32021 die undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.

As you know Dara as a leader in women's health innovation, and we are squarely focused on improving the lives and well being of 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 in category and first line and have meaningful commercial opportunity with four clinical stage programs in vaginal health sexual.

Health contraception in menopause.

Despite the unique challenges posed for all of us during 2021, we achieved two important corporate first in 2021 with.

We started the year in January by announcing our first commercial partnership agreement with Bayer for other printing commercialization rights.

We believe that this partnership not only validates the overprint commercial opportunity and allows the diary to benefit from bears expertise in development and regulatory affairs and commercialization of a first in category contraceptive products for women.

But with opportunity for 20 million clinical milestone up to $310 million in commercial milestone payments plus double digit tiered royalties on net sales, but it also can provide capital to support broader portfolio objectives.

Then we ended the year in December with the completion of our first portfolio Phase III study.

Typically we announced positive top line data from the Dare BV free phase III study of Dare BV, one for the treatment of bacterial vaginosis position.

Positioning diary for our first NDA submission.

The advances in 2020 across the portfolio set the stage for meaningful portfolio objectives in 2021.

So for those of you who are new to dairy 'twenty 'twenty. One it's an interesting time to get to know us on.

Prior three positive clinical readouts across three different portfolio programs. The phase one thermography study first identify crane and the pre pivotal study of other train booked announced in 2019 and the day Air B V. One phase III that I, just mentioned announced in 2020 and enable us to target to more clinical Readouts Andrew.

The NDA filing and potential approval action in 2021.

The 2021 key portfolio objectives include the following which encompasses not just the three programs I already mentioned, but two additional clinical stage development programs as well.

We'll cover each of these in more detail during today's call, but here are the highlights as we look forward in 2021.

For <unk> one.

The new drug application the NDA submission the potential could do for action and strategic commercialization agreement.

So the NFL cream, the phase <unk> clinical study commencement and potential top line data.

Over training the investigational drug exemption submission.

Their HR T. One phase one clinical study top line data and Dare DVA, one initiation of phase one clinical study.

So I'm going to start first with <unk>, One Derby day, one is our novel investigational thermosetting bio adhesive hydrogel formulated with clindamycin phosphate, 2% as a first line single administration vaginal treatment for bacterial vaginosis.

We announced the successful completion of the Dare BD free phase III clinical study in <unk> 2020.

Dare BV, one demonstrated best in class curative potential from that most common vaginal infection in women of reproductive age affecting an estimated 21 million women in the U S.

Bacterial vaginosis causes very disruptive symptoms for her a vaginal odor and discharge and as importantly linked to health risks, including preterm birth sexually transmitted infections post surgical infection and pelvic inflammatory disease.

It is estimated that 16% of these women have symptomatic disease and studies have shown recurrence rates of up to 60% within 12 months of treatment.

The Derby D. Free study demonstrated derby once potential to provide improved clinical cure rates and improved patient outcomes compared to those of current branded prescription products for the treatment of bacterial vaginosis, which says current products have cure rates in the 37% to 68% range, including in both of them on.

Fight intent to treat population, which is the primary efficacy assessment in FDA guidance documents as well as the per protocol population does current branded vaginal prescription products are at the lower end of that range with the vaginal product share rate of 37% to 54% on a modified intent to treat basis.

And 64% on a per protocol basis.

As I mentioned in our Phase III study Derby D V. One delivered better clinical cure rate values than those who'd been demonstrated by the currently marketed FDA approved vaginal and oral products for the treatment of bacterial vaginosis on both the modified intent to treat and the per protocol population basis specifically.

Specifically in the modified intent to treat population the clinical cure rates for Derby, we want on the Derby free study, where 70% at the test of cure visit which occur 21 to 34 30 days. After the study administration. The primary end point and 76% at the assessment visits that occurred just seven to 14 days.

After study drug administration, compared to 36% and 24% from placebo cream respectively.

In the per protocol population, the clinical cure rates for Derby, the one where 77% at the day 21 to 30 endpoint analysis and 81% at the day seven to 14 compared to 42, and <unk> 30 for placebo cream respectively.

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

75% of the intent to treat population.

And in addition, this was the first study conducted under the new 2019, FDA guidance for bacterial vaginosis treatment that requires that all subjects in our modified intent to treat population that primary endpoint population not only meet the clinical diagnostic criteria for bacterial vaginosis, but at baseline.

Also need to meet the bacteria morphology classification or a nugent score of at least seven reflective of bacterial vaginosis.

Given these data we believe Derby day, one is to dish is positioned to be an important first line option for the treatment of bacterial vaginosis and were working to advance Derby day, one towards regulatory approval in the U S. The NDA submission to the U S food and drug administration. The FDA is planned for the second quarter.

The private candidates fast track and qualified infectious disease product designation allows for a priority review request at the time of NDA submission, which if granted by the FDA could lead to a 2021 producer goal date, specifically that means that as long as the NDA submitted.

By June 30 assets at 2021, we would be notified of acceptability of the filing by July 31st 2021, and whether priority review is granted and if priority review is granted the Paducah action date would be prior to December 31 2021.

At 2021, FTA approval would allow for commercialization of Derby one in 2022.

Ongoing strategic discussions and other activities to support a robust market introduction in 2021, and 'twenty 'twenty, two if approved and that's underway.

In 2021, we intend to finalized and announced the collaboration strategy for Dare BV, one commercialization in the U S. G.

John will discuss this in greater detail shortly and we will provide additional insights on how we seek to capture maxon on strategic value for our shareholders in our approach to the process.

I'm now going to talk about sort of NFL cream three 6%. So see that until cream is an investigational cream formulation of <unk>. The active ingredient in viagra for topical administration to treat female sexual arousal disorder or FSA D.

D is a physiological condition characterized by the inability to attain or maintain sufficient general arousal during sexual activity.

And of the various types of female sexual dysfunction disorders. It is the most analogous to erectile dysfunction in men.

As I say D 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.

Nonetheless, no FDA approved products exist today to treat FSA D. Even though the FSC D market is estimated to be as significant if not more so as the erectile dysfunction market in both the U S and the rest of the world.

On March 24th we announced that we commenced our phase two be respond clinical study evaluating <unk> cream as a potential treatment for FSA D with a top line data readout targeted for year end 2021.

If clinical development is successful <unk> cream has the potential to be the first FDA approved FSA day treatment option.

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

Patient reported outcome or pro instruments will be used to screen eligible women with FSA.

And to measure achievement of the primary efficacy endpoint, namely improvement in localized genital sensations of arousal and reduction in the distress that women with FSA do you experience.

Commencing this study now positions us for a potential top line data readout by the end of 2021 and over the next several months, we will provide updates on our progress towards that target.

Women, who have suffered far too long without a viable intervention to address FSA D. So it is exciting to be working at the cutting edge of research focused on women's sexual health and to advance a potential first in category treatment option for women suffering with FSA D.

We are very much looking forward to keeping you updated on our progress this year with that program.

Nachman talk about over prime.

Overprint is our novel investigational hormone free monthly <unk> contraceptive.

As already mentioned, we entered into a commercial partnership agreement with bear in January of 2020 on the heels of that positive pre pivotal data announcement in 2019.

People often ask how involved there is currently in the program given under the terms of our agreement with <unk> and with that dairy is responsible for the ongoing regulatory interactions on the upcoming pivotal trial to support the FDA submission.

Well as you may recall under the terms of the agreement bear provides up to two full time equivalents at this point for advisory support so put another way up to 80 hours per week of advisory support to Dara.

Thus our teams meet multiple times per week and these meetings include interactions across functional areas, such as manufacturing clinical regulatory medical affairs and commercialization planning.

Unlike bacterial vaginosis, where clinicians have familiarity with the concept of a onetime vaginal treatment and are very familiar with bacterial vaginosis.

In turn reduces the amount of preparation that's required prelaunch.

The pre commercialization activities are critical with a disruptive product like overprint that is so unlike any contraceptive available today.

Similar to the launch preparation work that Baer had to undertake before they successfully launched the Marina franchise. The first one on releasing entry uterine device franchise to the $1 billion plus revenue represents today there is over pre work underway already to ensure that pending successful completion.

As shown on the pivotal study and FDA approval, we are ready as partners.

In terms of next steps on that path to commencing that pivotal study for FDA registration the I T E submission to the FDA is planned for the fourth quarter of 2021.

This is a requirement for initiating a pivotal contraceptive clinical study in the U S.

We are designing this study to evaluate over free and when used over a period of at least six months and up to 12 months and will seemed to confirm alignment with the FDA on the study's design prior to commencement.

Pending clearance of the IDE E. The pivotal phase III clinical study commencement is planned for the first quarter of 2022, enabling a six month data readout by the end of 2022.

I'm now going to touch on Dare <unk>.

Dare HR T. One is our unique investigational 28 day Intravascular ring, our IV are containing bio identical estradiol and bio identical progesterone for the treatment of the visa motor symptoms and genital urinary syndrome associated with menopause on.

On March 22nd we announced completion completion of the enrollment in the phase one clinical study in Australia, and we expect top line data readout in the second quarter of 2021.

The IV, our drug delivery technology used in dairy Churchy, one was developed by Dr. Bob Langer from MIT and Dr. Bill Crowley from the Massachusetts General Hospital, and Harvard Medical School and its an important platform for DRA as we believe it offers a versatile drug delivery system in women's health with the potential to improve convenience.

<unk> and outcomes.

In fact, our dare SRT one program utilizes the same vaginal ring technology and is being developed to deliver bioidentical progesterone over a 14 day period for the prevention of pre term birth and brought our moody or face support as part of an in vitro fertilization or IVF regimen, you may recall that a grant awarded in 2020 by the units.

Shriver National Institute of Child Health and human development, a division of the NIH is supporting our preclinical development activities for Dare F. R. T. One and that we may be eligible to receive up to $2 3 million in total grant funding in support of continued development of Dare FRG, one including that phase one clinical trial that were targeting for 2022.

<unk>.

The objective of the Dare <unk> phase one where we just completed enrolment is to evaluate the ability of dare <unk> to achieve its dual release objectives as well as the ability of the IV our technology to release two different active drugs at two different rates.

As Lisa will discuss shortly conducting the phase one study activities through our subsidiary in Australia is an example of an approach similar to securing the non dilutive grant funding that I just talked about two day capital efficient as it makes us eligible to receive future R&D tax incentives in the form of cash payments back to Dara.

Through Australia as R&D tax incentive program.

Finally, before I turn it over to my colleagues I wanted to just mention the Deere BVA one phase one study that we plan to commence this year that I mentioned upfront.

So dare BVA, one is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vulvar and vaginal atrophy or BVA in women with or at risk of hormone receptor positive breast cancer.

We plan to commence the phase one clinical study in the second half of 2021 in Australia, where we plan to leverage that development tax incentives. Currently 43, 5% of every eligible dollar spent as a cash payment back to the company.

With that I'm now going to turn it over to John to provide a business and corporate partnership update.

Thank you Sabrina we're entering an exciting time for <unk> as the NDA submission will move us one step closer to the introduction of this important new product for the treatment of bacterial vaginosis. We continue to be impressed with the level of interest in the product candidate as we are seeing broad activity from large strategic pharmaceutical manufacturers as well as emerge.

<unk> specialty health care companies interested in adding a new and differentiated products to their portfolio as we've communicated in the past we look forward to announcing our commercialization strategy for Dare BV. One following the execution of a definitive agreement. However, because we are often asked about timing I wanted to start by providing some context on.

Our process I can reiterate that we believe it's in our best interest to continue to advance our partnering discussions in parallel with our regulatory discussions, which we believe day risks and adds value to the Derby. The one program, we have the flexibility to work in parallel because of the clinician awareness of bacterial vaginosis.

Notices and the straightforward product profile of <unk>, one, which mitigates some of the traditional market softening efforts required with an LTE or a new therapeutic indication. We believe that we are positioned to execute a definitive commercialization agreement before the end of the year.

And as we think broadly about our commercialization strategies. We also have considerable optionality on what type of commercialization partnership structure. We can contemplate. The fact that we have a portfolio of multiple women's health products in development means that all forms of structures are viable from direct involvement in commercialization to a caller.

<unk> with a contract sales organization to a complete commercial out license similar to the deal we executed with bear for over Prime where bear has complete responsibility for commercialization.

Being able to play a role in the commercialization of Deere BV. One is much more tangible for us today than it was 18 months ago and the reasons for that are driven by the appreciable reduction in the size and scale of our field force that we believe would be required to reach the targeted number of healthcare providers to make the brand successful.

With the implementation of remote and virtual provider detailing driven almost entirely by the COVID-19 pandemic organizations like ours can achieve a much greater efficiency and scale more quickly with fewer full time resources and thus reduced expense.

Doctors have adjusted their workflow to accommodate virtual visits with sales representatives and we believe this will continue even after the pandemic is over all of this taken together provides us greater optionality to pick the commercialization partnership structure that we believe is best suited for dare BV, one for patients and for our shareholders.

In summary, given the data from the Dare BV free phase III study and the compelling value proposition of Dare BV. One all options are on the table.

Turning briefly to overprint I want to reiterate some of the comments Sabrina made about the bear partnership we believe our relationship with bear continues to be value additive for both companies. Our two organizations are operating synergistically across a number of key work streams ranging from manufacturing regulatory Affairs Medical Affairs and brand.

Planning, which includes pre commercialization planning, we anticipate that this collaboration will only grow stronger in the coming months as we plan to coordinate our efforts both internally and externally in preparation for the filing of the IV later this year and enrollment of the pivotal clinical trial in 2022.

Finally, I wanted to say a few words about the strength of the Dore brand in the broader women's health ecosystem, we have been and will continue to be active on a number of fronts to seek to continue to drive value into and through our pipeline whats new about that for this year is that Dori Dori brand has been elevated in our.

<unk> both on the development side and the partnering side has translated into real interest from a variety of stakeholders to help us continue to develop and deliver new and differentiated products into the category.

So we are really excited to embark on what we think is the next growth phase for Dara and look forward to keeping you updated as collaboration exploration and discussions advance with that I will turn the call over to Lisa.

Thank you John and thank you all for joining us today.

I share Sabrina and John's excitement and I'm grateful to our entire team for their incredible efforts over the past year I would now like to summarize gerry's financial results for the year ended December 31 2020.

<unk> 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 activities to generate the clinical and other data necessary to advance our candidates through regular.

Tori milestones, including approval.

For the year ended December 31, 2020, Dairies general and admin.

General and administrative expenses were approximately $6 $5 million license expenses were approximately $83000 and research and development or R&D expenses were approximately $28 million. In addition to personnel costs of our R&D team the year's R&D expenses, primarily.

Reflect the costs of the Dare BV free phase III study activities related to over prime and preclinical development activities for <unk>, one and as you know the Dare <unk>. One program is supported by our our grant from the Bill and Melinda Gates Foundation.

Our comprehensive loss for the year was approximately $27 $4 million.

During the year net proceeds net cash proceeds from financing activities were approximately $25 $1 million and.

Any sales of stock the exercise of warrants and loan proceeds.

Total cash received during the year 2020 was approximately $29 5 million, reflecting the financing activities activities I just described as well as cash from grants a license fee payment and the Australian R&D incentive cash rebate.

We ended the year with approximately $4 $7 million in cash and cash equivalents.

Following year end two between January one and March 29, 2021, Gary received additional cash of approximately $11 $5 million consisting.

Consisting of approximately 11 3 million net of fees from sales of common stock under our ATM program and equity line facility approximately 50000 from warrant exercises and approximately $139000 program funding.

Following these activities as of yesterday March 29 shares of common stock outstanding or approximately $47 3 million.

In late January dairy public float exceeded $75 million, meaning that we could use our existing form S. Three shelf registration statement without being subject to the restrictions imposed by the SEC's baby shelf rules.

Our public float that exceed $75 million adds tremendous flexibility and could enable us to explore a variety of financing options that were not available to us in 2019 or 2020.

We intend to file a new form S. Three shelf registry chasing statement with the SEC that will replace our existing shelf registration and.

And which ones are effective can be used over the next three years, allowing us to explore different financing options over time.

As we have done in the past, we will attempt to do so in a manner that protects and enhances shareholder value.

In addition to my commentary few agreements commitments and arrangements worth highlighting given that they should collectively served to reduce our cost of development during the coming year 2021, and help us manage our cash resources efficiently.

First green.

<unk> been an attractive source of non dilutive funding for dairy and we recognize grant funding in our statement of operations as a rejection to research and development expenses. During 2020, we recognized $3 7 million of grant funding as an offset to our R&D expenses related to overpaying.

Daryl Ark, one and Dare Fr T. One.

To date, we have received grant money from the Union Kennedy Shriver National Institute of Child, Health, and human development, and the Bill and Melinda Gates Foundation we.

We will continue to use our existing grants for allowable expenses and we intend to continue to explore and to apply for additional grant funding in the future.

Second the terms of our agreement with health decisions and avid mean provide for commitments of certain staff resources as well as expense rate reductions for development activities related to our programs.

These arrangements are expected to provide additional time and cost efficiencies in 2021 as well.

And finally as Sabrina had mentioned under Australia's research and development tax incentive program. We received approximately 192000 in cash during 2020 and during the first quarter of 2021, we applied for a refundable cash credit of $268000 based on the eligible.

Expenses incurred in connection with our Dare HRT, one phase one clinical study.

Currently the program allows for eligible company to receive up to 43, 5% of their eligible R&D expenses.

We will continue to explore a variety of ways to raise cash capital to advance our product candidates and to satisfy our working capital needs. Since inception, we have raised cash through the sale of our equity.

For M&A transaction warrant and option exercises non dilutive grants and license fees.

We will endeavor to be creative and opportunistic in seeking the capital we need to build value as we advance our candidates and to be highly efficient in the use of such capital.

A word about COVID-19, we are continuing to monitor the pandemic.

And its potential impact on many aspects of our business due to the many uncertainties surrounding the pandemic, including vaccination rates and efficacy rates and governmental responses. We are unable to predict with any reasonable accuracy, the full financial and business impact on our company at this time.

We encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources and our risk factors will be which will be filed in the 10-K with the SEC now as you know we typically file our 10-K about a half an hour before our earnings call but.

It's like we'll have it to day the SEC website was down so keep an eye out and we will file that 10-K as soon as we can.

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

Thank you for attending the conference call.

If you would like to ask the question you will need to press Star then one on your telephone to withdraw your question. Please press the pound key again that is star then one if you would like to ask a question.

Our first question comes from the line of the <unk>.

<unk> <unk> with Roth Capital Partners. Your line is now open.

Hey, guys. Thanks for all the updates a lot of different programs ongoing said Julien.

You know what the update is on each of them shows just starting with the first one year for diabetes and one was just kind of curious.

You were not to get the priority review, we'll do it.

Specced in approval say in March.

Yeah, Great and this is Sabrina so great question Yeah. The priority review allows a six month review from the day you filed because this is.

If I'm a <unk> two pathway so from the day, we file if it's not priority review then yes, you would expect that producer to be towards the end of the first quarter.

Okay. Thanks, and then in terms of the partnership.

I know John mentioned that you know.

Oh on the positive.

Being able to do remote and virtual as long as doughbelly establish markets, whether potash you guys can be more involved in so I was just wondering in terms of you know kind of boosting your cash balance are you going to prioritize on.

On cash that is not a priority if you're just looking for someone that can really handled the launch.

That is really an exceptional question and so let me try to articulate how we look at it.

On.

We really are looking at what is the best.

Partnership for this asset right. What is the best partnership that is going to maximize the accretive potential to dara to our shareholders and frankly access to women because that isn't that's the beginning in the end of what matters and what gets you there right. So.

So what is that best partnership structure and there are a number of things we're looking to balance in that equation. So we're looking for who is best positioned to commercialize it successfully to the target clinicians who is best positioned to deliver that message and who's best positioned.

And to give the product the attention that it deserves in order to achieve its value and success.

And how does our big picture diary objectives beyond Derby, even one day of BV one play into that.

And so I think you know what you saw with Oba Preen should give you a sense of how we think about this we take each asset on its own merits. So as we talked about today with <unk>. We felt that it was absolutely critical to that program to have.

The only company that has in recent days built a brand new contraceptive category.

<unk> fully launched into that category and created a $1 billion brand as the partner and so we didn't feel with that program that it made sense for us to have any involvement with that program. It was the right thing to do to hand, it off to bear.

As we think about Deere BV, one for all the reasons I and John communicated on this call. This particular program for a lot of reason gives us a lot more optionality on how we think about partnerships and how we think about that trade off that you mentioned so just like Overtrain. There was tradeoff do you take a lot of money upfront or do you take more on the backend and who's going to make the pre.

<unk> as big as it can possibly be and who do you want by your side to do that.

So just like we did with evergreen will look at all the possibilities and as with Evergreen. We are very fortunate to be advancing programs that people are excited about.

You know that the partnership landscape is excited about and that gives us optionality. So I know I did not directly answer your question because I can't.

But hopefully I gave you a net perspective that we are absolutely weighing all of that were weighing the value of the near term dollars that could come in under certain deal structured towards.

Yes.

You know on the front end versus the pros and cons of us having some ability to play a role in this process on how all of that also translates into cash flows and just like we talked about with the Bayer deal where partnerships also our way of funding non dilutive, we how that translated into all of that as well so.

Stay posted as John mentioned, we will definitely keep people updated and hopefully you got some clarity today that you know as these discussions are progressing and as our regulatory process towards that NDA is progressing we're finding it definitely is in our best interest to keep the conversation going in parallel and not to rush a process. So that we get.

The best outcome for our shareholders.

Do you think we know and then you're guiding Oh between thanks for the color on some of that play from Roche activities are kind of underway on was just curious as to what might be driving that timing of the IV. He know what has been happening with just some additional clarity on that.

And I think I just had another quick one here as well in terms of the timing of the net milestone payback because you said that could be helpful for even a supporting evolved moved up the rest of your pipeline as well.

Two more great question. So in terms of the <unk> process. So as as those of you who've been following Dara for a while you may remember that that we were hopeful to.

To get overprint, moving faster right at the beginning of the Covid Penn before the Covid pandemic in early 2020.

We had our sights on you know getting getting going faster with the evergreen program with them.

The Covid pandemic and also with the opportunity that actually the regulatory pathway that overprint goes through which is the C. D. R. H pathway, it's a PMA.

Low things that you don't get to do during the Cedar pathway, which it allows for almost unlimited.

Opportunities to have pre submission meetings with with the FDA and talk about things. There was also manufacturing and non clinical work that we always knew would be required as well and so in light of all those factors, we recalibrated the timelines for the program while at the same time balancing what was always.

One of ours in bearings objectives, which was to to have some data in 2022 right. As we were kind of looking forward towards the regulatory process and so what we've been doing over this period is some of that non clinical work. Just you know the studies that are required for any kind of regulatory filing in terms of different.

On safety talks all that stuff.

It's a little bit different when you're going through the PMA process in an NDA, but nonetheless that that those types of activities.

<unk> manufacturing activities as I mentioned.

We've spent more time planning the pivotal studies that we've used the luxury of not wanting to start this particular trial.

Right in the midst of the trend the pandemic just because it's a contraceptive study and we have heard from all of our advisers that contraceptive studies are particularly had been particularly challenging Derek commented by environment and are very close collaborators at NIH had funded the pre pivotal study had guided that they had actually stopped a number of their studies. So for all those reasons we.

You know we focused on other things so that is what's driving it on the timeline and looking at getting that filing in the end of this year and then to your question.

The readout in 2022, and how that aligns with the milestone payment from Bayer, which is really I think what you're asking the $20 million milestone payment for the pivotal study.

As I mentioned in my comments part of our discussions with the FDA that will not be able to be finalized until the ITE is cleared is finalizing alignment on the duration of the pivotal studies 612 months, what kind of day to exactly as is required.

Hormone free products have typically been devices have been six months, but monthly vaginal contraceptive products have been 12 months.

So this is a discussion with the FDA on duration, we know, though from contraceptive products that.

Clinical outcomes.

At six months are very predictive of what youre going to see it 12 months or is it going to be the same at 12 months or even slightly potentially better at 12 months contraceptive rates don't go down between six and 12 months. So we've aligned that whatever the ultimate package is that needs to be submitted to the FDA we.

As long as we start this study next year, we will be in a position to read out six month contraceptive data by the end of 2022, whether or not that triggers the milestone payment and the contract is going to depend on.

What the ultimate required pivotal study is.

But the final pivotal study is whether it's six or 12 months because that payment is due.

Based on a certain timeframe, we haven't disclosed all the details are redacted in confidential treatment request in the filings with the SEC on the contract, but it's payable on a certain time after completion of the study so if the six months.

Contraceptive effect, if not the completion of that completion is not right. There at 2022, but as in 2023, that's when that timing would happen.

Thanks for the additional people.

They can watch anything me Anthony on AT&T day in April many of them in the second.

And just need to get some more details on what are you hoping to see in the data and should we interpret the data when it does come out and then perhaps maybe you can put in the context of how they read out to you now.

Put you in a good position for subsequent next steps.

Yeah, and then I'll and then I'll, let I'll move on to the next question in the queue. After this one you've had awesome questions I'm excited to get to answer these on HR T. One.

To your point the data is going to come in the second quarter and its phase one right. So we're really looking at PK data. We're looking at drug release date over this 28 day period and to see that we've met our objectives.

As you May recall this work has already been on and sheep sheep are a great model for vaginal ring technologies, because you can use full form factor for humans vaginal ring and the sheep.

So we've already demonstrated this in sheep. So this is an opportunity to do this now in women, obviously importantly.

And also tier two similar to what we've done in sheep see if theres any adverse events vaginally that.

Our unexpected so those are really what we're gonna look forward, we're going to look at confirmation of that same nice PK data that we saw on the sheep and were going on for both of the two active the progesterone and estradiol and then we're also going to look at those any vaginal effects.

And in terms of why it's also interesting for the F. R. T. One program, which is the progesterone program, where we have the NIH funding.

Up to $2 3 million to support the phase one is because it's the same progesterone and we are looking in the HR T. At some of the same doses.

All the doses that some of the same doses that we would consider for the progesterone ring. So it's actually kind of a nice early peek at what those PK data might look like so it also helps us plan.

For that phase one.

Where we're collaborating with you on age.

For <unk> one.

And then obviously next steps would be for the HRT one program to progress it into phase two which once we have the phase one data we can decide how we want to proceed with that program.

Thanks for bringing on Nick Congrats again on the update.

Thank you.

Thank you. Our next question comes from the line of Jason Mccarthy with Maxim Group. Your line is now open.

Hi, This is Joanne Lee on the call for Jason Mccarthy, Thanks for taking the questions and congratulations on your progress in the quarter on for my first question I guess is regarding dark view on we all saw the great data you put out in the fourth quarter for the TV, one asset which was in line with the previous results announced earlier on this study I understand.

N D. Some machine is planned for Q2 I was just wondering if theres been any recent discussions with FDA on what would some of the responses you heard or and if not do you guys plan on having a sort of a pre NDA.

Meeting with the FDA, we're obviously looking forward to this emission an announcement on the Paducah day.

Yeah, absolutely so.

We had guided previously and thanks for the reminder, because I neglected dimension on today's call and I and I, probably should've. We had guided previously that we would definitely you now have pre NDA discussions with the FDA.

Hopefully you you've gathered from even from my evergreen comments that we'd like to take advantage of opportunities to engage with the FDA.

We've done it a lot on.

On our Evergreen program and then it go program and and and absolutely. Similarly on Dear Derby. The wind we find those pre NDA discussions.

Well any of the meetings types of meetings that we have with the FDA, but pre NDA discussions are obviously, a really helpful way to do everything a sponsor can to mitigate risk with your submission right to to make sure that anything that you have questions about you have an opportunity to ask them.

You can take the Fda's.

Guidance and suggestions and.

Advice.

Into consideration as you prepare the NDA. So yes that is something that we do as a company and we never disclosed the exact timing of those events and exactly where we are in that process, but absolutely.

Pre NDA communication with the FDA is a critical and important part of our NDA filing strategy.

Oh, great that was helpful. Thank you. So there's been a lot of exciting activities surrounding the PV on asset, but I sort of shifting focus to the F. C. D program. It was nice to hear that the phase <unk> study initiated earlier this year, assuming the results at the end of this year are positive could you briefly just walk us through what are some of the future steps.

The company following completion of this current study to get that done a full cream onto the market.

Yeah, and thank you for asking about that product because I hate to use the word excited when I'm talking about that product. There's just really no other way to describe it like we have been very excited about starting this study. This is another one that we had really had had hoped to enable to start last year and we just felt that last year was not the right year with all the uncertainties to start this trial so.

We were chomping at the bit to get this study going because it is such an interesting program. It's such a significant unmet need we had reached the alignment with the FDA on the primary endpoint you know on we announced that at the end of 2019. So this is definitely something we are looking forward to getting going so we're very excited.

And what you maybe those of you who are involved at that time may recall that part of our discussions with the FDA to a line on the phase two b design and the endpoint was to really start laying the foundation to your question of what does the entire program look like what does the phase III booked.

Like what are the expectations because their guidance document which is out there there is a 2016 guidance document.

It it leaves a lot kind of open to the sponsor and open to the sponsor to discuss with the FDA. So in terms of what we expect net so this phase two b is designed to.

Used as a primary endpoint what came out of our content validity work as likely the best primary endpoint to take forward into phase III, but part of the alignment with the FDA was that this study would include a number of exploratory secondary and exploratory endpoints that also.

Looked very good in our content validity works so an important aspect of the phase two b is picking.

What is the right endpoint it may be the one we picked as primary it maybe a different one.

To take forward into the phase III program. So that really is an important consideration in the phase two b and in terms of what the phase III will look like then the guidance document with the FDA does currently stipulate 24 weeks as duration versus 12 weeks.

That we have in the phase two be.

It's not clear whether that will continue to be the standard for female sexual arousal disorder that was really designed around high proactive desire disorder, which is a CNS condition. So that is certainly going to be an area of discussion, but right now the guidance says 24 week study from phase III.

And we have already discussed with the FDA that we would need two phase III. So while this is a five O five btu program, because we're leveraging the safety of Sudan or Phil It's oral sedan infill in men for different indications and this is vaginal administration said the expectation will be two phase III trials. So after the phase two b.

Hoping for success on the next step would be to have that end of phase two meeting with the FTAA on a line on the phase III.

Based on that.

And then get going on right.

Okay. Thank you so much for those details on again for taking the question on we're really excited to hear any additional updates in the coming quarter. Thank you.

Hugh.

Thank you. Our next question comes from the line of Douglas Tsao with H C. Wainwright. Your line is now open.

Hi, good afternoon, thanks for taking the questions I'm, just curious with the hormone replacement therapy products going into phase one when we look at your portfolio you've sort of taken.

Different approaches in terms of when you want a partner assets have you given sort of initial thought when or how far along in terms of development you would want to take those.

Great. Thank you for asking that question because John.

<unk> kind of touched on it until it is comments, where he you know he he talked about the fact that you know we are.

We're kind of always in discussions with companies and that very much is true.

So as you know he he mentioned we.

Are in active discussions kind of at all times.

Across our portfolio.

As we should be right. That's our business we partner on the front end and we create partnership opportunities in the back into and everywhere in between to your question.

So we do and it really depends on the program and it depends on cash.

The appetite for investment in development. So one of the reasons that we were able to form Dara and we were able to assemble the exciting portfolio that we assembled as quickly as we did in and under such attractive terms as we did is because the market right. Now is fragmented there's a lot of innovation out there. There's as we are doing a lot of opportunities to have first.

Category products, while still leveraging a 500 <unk> two pathway just by being Super creative in how you are delivering them for her so you can really make it more convenient make it more convenient and improve outcomes and that matters. In these indications that are not life threatening but are very much life altering.

And there is commercial entities and we've been so excited to watch the news you know.

On Oregon on and Merck over the last couple of weeks and Theres more of a you know nice to see more of that happening, but there hasn't been as much commitment to invest in development of women's health sales.

Doug it's definitely something that we are constantly exploring with potential collaborators in the U S and outside of the U S and when it makes sense for a particular program and we think it makes sense for our shareholders. We will absolutely take advantage of those opportunities.

Just as a follow up to that question I mean, so far.

Yeah.

Partnership activity has been sort of on a program by program basis for your company and you know when I look at you there are certain things that sort of.

Good fit in different buckets, and I had you ever engaged in multi product collaborations partnership discussions just because I think there's some maybe a little bit earlier stage development that could sort of.

Into that bucket.

We have all conversations absolutely no youre absolutely.

We explore all kinds of partnering opportunities.

And we're very active in that all the time.

Okay.

It's what we need to be doing and it's what we do.

And we're very proud of our portfolio by the way I mean, we're able to have those those kind of conversations because we have in our beliefs simple like.

Our premier portfolio of women's health development stage assets, so and they are different like you said so it does facilitate all kinds of different conversations.

Okay, great. Thank you so much.

Congrats on the progress.

Thank you.

Thank you there are no further questions I will now turn the call back to MS. Sabrina Martucci Johnson for closing remarks.

Well. Thank you all for taking the time this afternoon to.

To hear our update and all the great questions and then our chance to share everything that transpired during 2021 in spite of the pandemic.

Our commitment to our company goals of improving options and outcomes for women men and driving value for all of our dairy stakeholders under any operating environment.

So we are grateful to our exemplary team as Lisa mentioned.

And and shareholder support frankly that made our 2020 achievements possible and as we look ahead. Our 2021 plans demonstrate a feature of our business model that is core to its value driving potential and Doug and his questions Gary touched on that which is namely the variety of our programs and the diversity of our women's health indications.

And the development stages of our programs and that really enables us to direct our resources and investment across the portfolio in ways that can advance the programs programs against numerous milestones simultaneously in a time and capital efficient manner and so and.

And we've demonstrated that even in a challenging environment and so we look forward to keeping you updated on our progress against the key 2021 objectives that we discuss today across five of our different clinical stage programs and indications. This year. So thank you so much for your time today.

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

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