Q2 2021 Dare Bioscience Inc Earnings Call

August 12, 2021

[music].

Thank you all for standing by and welcome to the conference call hosted by Diary Bioscience to review the Companys financial results for the quarter ended June 32021, and to provide a general business update.

Please note that this call is being recorded this is Jesse and I'll be your operator today with US today are Sabrina Martucci, Johnson, <unk>, President and Chief Executive Officer.

<unk> Fair, Darius Chief strategy Officer, and Lisa Walters Hoffert, <unk>, Chief Financial Officer MS. Johnson. Please proceed.

Thank you good afternoon and welcome.

Second quarter, 2021 financial results and business update call for <unk> Bioscience.

Our plan today is to review last quarter to.

Discuss developments since our last call in May and use the time to highlight objectives and milestones anticipated for the balance of 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 of 1995 any statements made during this call that are not statements of historical facts should be considered forward looking statements.

All results or events to differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties.

You should not place undue reliance on forward looking statements forward looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended June 32021, which was filed today as well as our annual report on Form 10-K for the year ended December 31, 2020 filed on March 13th 2010.

Anyone.

I would also like to point out that the content of today's call includes time sensitive information that is current only as of today August 12, 2021 Guy undertakes no obligation to update forward looking statements to reflect new information or developments. After this call except as required by law.

<unk> is 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.

Acting and advancing product candidates that we believe has the potential to be first in category and first line and have meaningful commercial opportunities.

We currently have four clinical stage programs in the areas of vaginal health sexual health contraception in menopause and one product in the breast cancer supportive care categories due to enter phase one and most of my remarks today will address these candidates.

The first half of 2021 has been quite eventful for donor egg EMEA announcements, we were able to make over the last two months have been the type of updates that every CEO and choice making.

We announced positive phase one data for our hormone therapy product and up to $48.9 million grant over the course of five years for one of our preclinical contraceptive program.

Collaborative research agreement with the NIH to co financially support and co conduct our phase III study for an investigational contraceptive evergreen and just this week, we announced the FDA acceptance and priority review of our NDA for bacterial Vaginosis product candidate with a December seven 2021 producer.

Target action date.

It has definitely been a meaningful coupons for Dara and we hope it will continue to prove to be a meaningful year for us given what we have yet to come.

With that backdrop I'll now provide some additional context on his accomplishment and specifically dive deeper on the relevant updates related to our four clinical stage programs.

As well as that supportive care cancer program.

In the vaginal health category of bacterial Vaginosis, which impacts an estimated 21 million women in the United States I'll start with their PD one.

During the second quarter of 2021 and in line with archiving, we submitted a new drug application or NDA to the FDA.

We requested a priority review at that time that submission.

We announced that the FDA accepted for filing the NDA for <unk>, one for the treatment of bacterial vaginosis and the FDA granted this application priority review and set a prescription drug user fee act or produce a gate at December seven 2021, she wanted to target completion of its review of the NDA.

The FDA granted priority review to applications for potential drugs that if approved would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition.

The NDA, we filed is supported by positive results from the <unk> phase III randomized multicenter double blinded placebo controlled clinical trial evaluating <unk> in women diagnosed with bacterial vaginosis.

Condition that can cause serious health effects and risks and it's very disruptive in terms of the symptoms and as I mentioned, it's estimated to affect approximately 21 million revenue in the United States.

Jeremy do you want is an investigational thermosetting bio adhesive hydrogel containing clindamycin phosphate, 2%. That's designed as a one time vaginally administrator minister treatment for bacterial vaginosis.

The acceptance of this NDA marks a major milestone not only for <unk> as a company, but importantly for the millions of women that are impacted by bacterial vaginosis. It is our goal as a company to bring to market market products and products like this that it has the potential to improve outcomes and convenience for women.

As <unk> demonstrated that has the potential to do in the phase III study, whereas single vaginal Joseph Derby D. One achieved clinical cure rates in the range of 70% to 81%.

Specifically the results from the D. R. D D. Free study demonstrated there because he wants to potential to improve clinical cure rates in a convenient one time dose compared to those of currently FDA approved branded products indicated for the treatment of bacterial vaginosis.

Patients in this study were evaluated during three clinic visits gave one which is screening event position day seven to 14, which you can enter assessment visits and a 21% to 30, which was the test of cure visit the.

The study met its primary endpoint demonstrating that if it primary therapeutic intervention a single vaginal dose of D. R. D. B, one with statistically superior to placebo at that day 21 to 30.

Assessment in the modified intent to treat population, specifically, 70% compared to 36% of subjects clinically cared. Additionally.

Additionally, there could be one demonstrated a clinical cure rates of 77% at day 21 to 30, and <unk> 81, and 85% at day seven to 14 in the per protocol population compared to 43% and 30% for placebo clean respectively.

Current FDA approved products have clinical cure rates in the range of only 37% 68%.

<unk> has received both qualified infectious disease product or <unk> as well as fast track designation from the FDA for the treatment of bacterial vaginosis.

I know the Q ITT designation if approved we expect Derby D. One will receive five years of market exclusivity. In addition to the three years available for having generated new clinical data.

Ongoing strategic discussions and other activities to support a robust market launch of <unk>, one and 2022, if approved are underway and we plan to finalize and announce the commercialization strategy for <unk> in the U S by year end, John will be providing additional color and an homage.

And the sexual health category I'll now provide an update on today, so cream three 6% our investigational products to address her version of erectile dysfunction.

In March of this year, we commenced our phase <unk> clinical study evaluating <unk> cream and investigational cream formulation has to bear to fill the active ingredient in background for topical administration to treat female sexual arousal disorder or S. S. A D.

S. A D is a physiological condition characterized by the inability to obtain or maintain sufficient general arousal drink sexual activity and of the various types of female sexual dysfunction disorders. It is most analogous to erectile dysfunction in men.

FSA 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.

FDA approved products exist today to treat FSA D.

Despite the fact that the FSA 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.

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

We are actively enrolling subjects into the phase <unk> respond clinical study evaluating <unk> as a potential treatment for FHA D at sites located across the country.

During our last call. We said we would continue to provide updates on the progress of the phase two B response study and the potential impact of COVID-19 are unexpected timeline.

We are monitoring this closely and particularly given the evolving COVID-19 guidance and case loads across the country.

We feel it's challenging to confirm anticipated timing for the top line data readout until we complete the planned interim analysis to determine the ultimate size of the study.

We've recently seen the pace of enrollment at certain sites declined because of those sites being in locations, where the case was there higher and adhering to government guidelines recommended reductions or changes in their operations intended to reduce the spread of COVID-19.

Due to the impact potentially on the pace of enrolment overall for the trial, resulting from governmental recommendation or order is intended to reduce the spread of COVID-19 or from other effects related to COVID-19, we cannot predict with reasonable certainty at this time when the interim analysis will be conducted a Rumble report topline data from the trial.

As we have done to date, we will continue to provide updates as the trial continues and we can better project timelines.

Now I'd like to provide an update on our investigational product <unk> a potential first in category option in the over $7 billion U S contraceptive category.

Last month, we announced that we entered into a cooperative research and development agreement, which is also known as a creator with a unit Kennedy Shriver National Institute of child Health and human development and ice.

Ph D for short, which is part of the National Institute of Health or NIH. This is for the pivotal phase III study of evergreen.

<unk> will allow us to leverage the tremendous development expertise at the NIH in contraceptive clinical studies and to share the cost of the pivotal phase III study.

Overprint is our novel hormone free monthly contraceptive candidate, who U S. Commercial rights are under a license agreement with Bayer.

The next stage of clinical development for Overprint is this pivotal phase III contraceptive study that we will be conducting under the creator with Eni's DHT.

Grant funding was previously provided by <unk> and it supported the conduct of our pre pivotal clinical study of evergreen.

Current agreement reflects the Ni's HD continued support for the development of other brain and will allow us to leverage the contraceptive clinical trial expertise of N. A S. H D. While also sharing the cost of the phase III study with NFC HD.

Specifically the study will be supported by N S. Hd's contraceptive development program our CBT.

G D. P oversees the contraceptive clinical trial network with <unk>, which was established in 1996 to conduct studies of investigational contraceptive and the study will be conducted with the CCT and wishes Ni's ghd contractor health decisions.

<unk> will be responsible for driving the clinical supplies of overtraining and coordinating interactions with in preparing and submitting supportive regulatory documentation to be FDA.

<unk> and <unk> will each provide medical oversight for the trial and final data review and analysis and we'll work together to prepare to final reports in trial results.

Under the Cray that we'd already have agreed to contribute $5.5 million towards the total estimated cost to conduct a pivotal phase III study and the NAC HD will be responsible for the remaining costs related to the conduct of the study and they will manage containment of expenses to help decisions the clinical trial.

While sites and the other parties involved with the study.

Lisa will discuss this arrangement in more detail shortly.

As I mentioned earlier, the U S commercial rights forever planar under our license agreement with Bayer.

Bear in dairy entered into this exclusive license agreement for the commercial rights to <unk> in January 2020 under the agreement. We received access to Bayer has extensive clinical and market expertise through up to approximately 80 hours per week and advisory support and we maintain control over claims development and regulatory approval.

Process.

There has the right to obtain exclusive rights to commercialize the product in the U S. Following the completion of the pivotal clinical trial being undertaken by us with the NFC HD.

If they're in its sole discretion and make the payment to <unk> of $20 million, which we intend to apply for reimbursement of our portion of the clinical study and manufacturing cost cost of the program.

And at that point, the exclusive license to commercialize <unk> in the U S will become effective we will also be entitled to receive commercial milestone payments potentially totaling $310 million. In addition to double digit tiered royalties on net sales.

In order to initiate the pivotal phase III study, we must have an FDA cleared investigational device exemption or IBD at place. We currently plan to file an IV for over print in the fourth quarter of this year and then pending the Fda's review and clearance of the IDE E. We intend to initiate that pivotal phase III study in 2000.

'twenty two.

Next for the estimated 45 million women in the U S, who are approaching or embedded pause, let's talk about our investigational hormone therapy product their HR Q1.

So during the second quarter and in line with our guidance, we reported the positive top line data from our phase one clinical study of Dare HRT, one, which we conducted in Australia.

We believe this unique international Bank platform technologies offers a versatile drug delivery system in women's health with the potential to deliver different active drugs at different rates, and thereby improving convenience and outcomes potentially across multiple indications.

The idea of drug delivery technology was originally developed by Dr. Robert Langer from MIT and Dr. William Crowley from the Massachusetts General Hospital, and Harvard Medical School and its first application of this first of all the technology, that's being clinical testing, but clinically tested is the state their HR Q1 use of it which is an investor.

Additional 28 day intra vaginal delivery of hormone therapy be it the rain and the rain contains both in this case bioidentical estradiol and Bioidentical progesterone for the treatment of invasive motor symptoms and the genital urinary symptoms and syndrome associated with menopause.

On June 28, we announced the positive topline results from a phase one clinical study of dairy chart, you want us failure.

That randomized open label three arm parallel group Phase. One study was designed to evaluate the pharmacokinetics of Deere HR Q1, and approximately 30 healthy post menopausal women with attack you drive the primary objective of the study was to describe these pharmacokinetic or PK parameters.

Two different dose combinations over 28 days.

Secondary objectives of this study were to assess the safety and Tolerability of <unk>, one and to compare this systemic exposure exposure of the extra Dayal, which importantly is the active form of the therapeutic hormone for therapeutic hormone replacement purposes.

As well as estrogen and progesterone from dairy to Archie wanted over 28 days and compare those against a combination of FDA approved oral estrogen and oral progesterone products evaluated in that same phase one study.

The levels of estradiol released from both the lower and higher against formulation and peer HR. She wanted evaluated in the study achieved or exceeded the levels that were targeted for hormone therapy.

Levels of estradiol for hormone therapy for either the base or motor subjects or the vaginal symptoms of menopause were established by reviewing PK levels that have been published for FDA approved products for both the treatment of Vms as well as the agenda to urinary symptoms of menopause.

Based on the estradiol PK data in their HR Q1 into phase one study the results support the potential FDA or HR to want as an effective hormone therapy for both <unk> and motor symptom and vaginal symptoms associated with menopause the levels of progesterone importantly, released from both.

<unk> versions of their HR Q1, as I was in the study.

<unk> met the objectives of releasing progesterone and specifically progesterone is used in hormone therapy to reduce the impact of estrogen on non target sites, such as being too many trends and to prevent estrogen induced endometrial hyperplasia.

In addition, the treatment was well tolerated with the most common adverse events consisting of.

Vaginal symptoms that are consistent with other vaginal products.

<unk> also had a high level of respectability and steady with over 80% of subjects on either the low or high dose version, the big Turkey, one product reporting the IPR and comfortable or very comfortable and additionally over 80% of the subjects in each dose group stated that they were either.

Somewhat or very likely to use the IV arm for women's health condition, where disease is she needed it.

For some women and hormone therapy is a highly effective treatment for the symptoms associated with menopause like the hot flashes in the vaginal black Fridays and it may also prevent bone loss and fracture.

The delivery of hormone therapy over 28 consecutive days with no daily intervention support dare <unk> potential to be a first in category option offering ease of use and continuing dosing to women suffering from menopausal symptoms. There are currently no FDA approved products that.

Continuously deliver on hormone therapy, with both estradiol and progesterone together over multiple consecutive weeks.

We plan on submitting that data from that phase one clinical study for publication in a peer reviewed journal.

And our clinical development strategy is to leverage the existing safety and efficacy data on the active ingredients and day, our HR Chi won the estradiol and progesterone and to utilize the FDA 500, <unk> pathway in order to obtain marketing approval of their HR two one in the U S.

We are in the process of updating our regulatory and clinical development strategy. Given these positive phase one data and will provide guidance on the next step for this program as soon as possible.

And finally before I turn it over to John and Lisa.

Wanted to talk about the approximately $3.8 million women in the U S. Two in the history of breast cancer hormone receptor positive <unk> such a positive is the most common type of breast cancer and the prevalence of Bolivar and vaginal atrophy or VBA in post menopausal breast cancer survivors is estimated to be 42.

70%.

I would like to provide a supportive care option for those women.

There may be a one.

As I mentioned in my opening remarks, we plan on initiating a phase one clinical studies later this year in Australia for this breast cancer supportive care program data deviate one.

One is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vaginal atrophy.

Non hormonal approach to addressing Bachelor atrophy, it can be an important option for women with a history out or at risk for hormone receptor positive breast cancer.

BVA is often the outcome of the affected breast cancer treatments and one of the unpleasant side effects. The BVA is painful intercourse for many women an appropriate appropriate treatment for BVA is supplemental estrogen.

However, estrogen may pose a risk to the women at risk for hormone receptor positive breast cancer and hence their BVA. One may offer solution for these women and others for whom hormonal treatment is not an option.

We plan to commence that phase one clinical study in the second half of this year in Australia and look forward to providing updates on the progress of that program.

I'll now turn it over to John to provide a business at corporate partnership that partnership update on our two latest stage program specifically their PD, one and the other three.

Thank you Sabrina now that the NDA for <unk> has been accepted for filing by the FDA and priority review has been granted we anticipate acceleration across the three main commercialization strategies, we've been progressing in parallel given that the Bayer BV one partnering process has been strategically and purposefully.

Aligned with the <unk> regulatory process.

Both scenarios include straight out license to a strategic partner with a partner is solely responsible for commercialization in exchange for milestone and royalty payments to Dara.

Just on the revenue generated by product the SEC.

Scenario, where we strategically partner Derby, one, but retain the option to have a role in the commercialization of the product and.

And finally, a scenario we can play a direct and active role in commercialization that includes influencing the go to market and planning.

<unk>, including the market introduction through a strategic partnership with a full service contract sales organization. All three options are currently under discussion.

Principally in the context of their PD, one and really across all of our product candidates. We are focused on doing what's best for women, which was to ensure that these products have broad commercial access and that benefits all of our stakeholders specifically our investors. We will use this lens to help guide us through our process and to solidify the best.

<unk> opportunity for the introduction of <unk> if approved.

As many of you know women diagnosed with bacterial vaginosis or challenged off to routinely defined interventions that can rapidly address the signs and symptoms of infection and also addressing resolve the underlying confection itself.

Currently available FDA approved treatment options work about half the time on average is our belief that <unk> product profile will appear will appeal to both patients and providers as it has the potential to provide a clinically meaningful improvement over currently approved FDA products, particularly in terms of a better opportunity for us.

Clinical cure, which includes resolution of the signs and the symptoms of the infection.

And in parallel with our strategic partnering discussions for <unk>. We are actively executing other commercial introduction work streams, such as manufacturing and market access with the goal of allowing us and our strategic partner to execute against our robust 2022 launch should we receive FDA approval in December of this year.

In summary, we are encouraged with the progress of the Derby one program.

We are excited at the prospect of bringing this important new therapeutic option to women and providers and we believe that we are well positioned to communicate our definitive commercialization strategy before the end of this year.

So I'd also like to take a moment to highlight the ongoing partnership with Bayer for our hormone free monthly contraception product candidate overprint.

We're delighted to report that the partnership is progressing as well if not better than <unk> expected bear as part of their commitment to provide up to two full time equivalents in an advisory capacity to support the development stage of the program has been actively supporting Dr rate across all of the key functional areas, including CMC regulatory.

<unk> as well as strategic planning to have formed downstream commercialization to <unk>.

Optimize the introduction of this exciting new product candidate if it's approved as Im sure. Many of you know there is a worldwide leader in the car category and that was one of the key drivers behind our decision to partner overprint at this stage of clinical development, we believe that our <unk> partnership with Bayer is a clear example of our commitment to doing what is best.

For our stakeholders, our shareholders and for women, which is core to our strategy here at Durect.

So we look forward to keeping you updated on the Bayer partnership as well as other key strategic initiatives Youre Dory and with that I will now turn the call over to Lisa to give you a financial update.

Thanks, John Hey, everyone. Thanks for joining us today I would now like to summarize <unk> financial results for the quarter ended June 32021.

<unk> business model is to assemble advance and monetize a portfolio of novel product candidates in women's health as a result, our expenses consistent corporate overhead portfolio acquisition, and maintenance costs and research and development or R&D activities to advance our candidates through clinical and regulatory milestones.

Including approval.

For the quarter ended June 32021, <unk> general and administrative expenses were approximately $1.8 million.

And our R&D expenses were approximately $7.3 million the quarter's increase in R&D expenses compared to the same period in 2020, primarily reflects the increased cost of clinical and regulatory affairs and other development activities related to <unk> cream Derby one over.

Green and der HR team one.

Our comprehensive loss for the quarter was approximately $9.2 million.

During the six months ended June 30th 2021, net cash or cash proceeds raised from financing activities were approximately $24.6 million and reflected sales of common stock under our ATM program equity line and warrant exercises.

We ended the quarter with approximately $9.1 million in cash and cash equivalents.

Subsequent to the quarters in between July one and August 10, 2021, Gary received additional net cash proceeds of approximately $25.4 million.

From sales of common stock under our ATM program.

In addition in July we received an initial cash payment of approximately $11.4 million and non dilutive grant funding to support the development of <unk>.

The entire grant awarded for up to $48.9 million the future payments contingent upon the <unk>, one program, achieving specified development and reporting milestones.

As of August 10, 2021, we had approximately $70.5 million shares of common stock outstanding.

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

So first is it recall that under Australia's current research and development tax incentive program eligible companies conducting R&D activities in Australia may file for and receive up to 43, 5% of their eligible expenses as a cash payment in the following year, we completed our.

Dare <unk> phase one study in Q2 and intend to initiate our gear BVA phase one study in 2021, both conducted through our Australia subsidiary.

During the first half of this year in 2021, we received a cash payment of $250000 and that is in U S dollar value in connection with Derek <unk> steady expenses that we incurred last year in 2020.

We intend to apply for the maximum amount eligible for reimbursement under the program in early 2022 based on allowable R&D expenses related to <unk>, one and <unk> BVA one incurred this year in 2021.

Second as Sabrina discussed a bit earlier in July we announced a cooperative research and development agreement or accretive with the <unk> for the pivotal phase III study of overpaying.

The agreement will allow <unk> to leverage the tremendous contraceptive clinical trial expertise of DNI CHD, while also sharing the cost of the phase III pivotal study.

Under the Credo dairy dairy has agreed to contribute $5.5 million between July 2021, and April one 2023 towards the total estimated cost to conduct a pivotal phase III study.

The Nics, Steve will be responsible for the other costs related to the conduct of the pivotal study and we will manage the payment of expenses to third parties.

We believe the NAC Hp's contraceptive trial experience and financial support will allow for the completion of the overprint pivotal phase III study.

In an efficient and cost effective manner.

Third grants have been at very attractive source of non dilutive funding for <unk> and we will continue to use our existing grants for allowable expenses and to explore and applied for additional grant funding in the future.

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

We encourage all 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 June 32021 of which was filed today.

As well as our annual report on Form 10-K for you.

Year ended December 31, 2020 that was filed on March 30 of 2021.

I would now like to turn the call back over to Jesse our operator.

Thank you speakers participants we will now begin the question and answer session.

To ask a question over the phone you May press the star key followed by the number one.

To withdraw your question you May press the pound Keith.

Again, Thats star one to ask a question.

<unk> to withdraw your request.

Okay.

First question is from the line of <unk> <unk> of Roth Capital Partners. Your line is now open.

Hi, Thanks for taking my question just have a few year I think the point is floor <unk>. So congrats on the Paducah date, that's happening before the end of the year.

Just kind of curious if the.

Approval processes that include any specs and up your manufacturing facility and then were still so just curious as to who is doing the manufacturing of the product.

Hi, Thanks for the question.

Yes, so in terms of whether you know you don't want to.

Prudent inspection.

Those are done at the discretion of the FDA often you are pre approval inspections theyre not always held.

At this time you know given that we just received the NDA.

Acceptance to file I'm not really in a condition to answer that question, but definitely we'd be happy to keep people updated over time.

And then we have not disclosed the manufacture of this product is it other than to say, it's a third party contract manufacturer that reviews.

That is really an expert in the manufacturing of vaginal creams and gels.

Our business and they have.

This is not their first time through a process like this so they were very well versed in commercialization and.

FDA potential infection.

Thanks, Sabrina and then John also mentioned some manufacturing efforts in market asks efforts can you elaborate on that if possible.

Europe is doing and how you're thinking about that also in terms of.

I suppose.

Helping with the partnership that come that are giving you more leverage I suppose.

Yeah definitely.

<unk> noted, we're very purposely have been managing our commercialization strategy partnership process in parallel with the regulatory process, which really puts us in a nice strategic position that we are kind of.

Fortunate to be able to do with a product like this given the understanding of the indication.

And also the work that we can be doing in parallel to ensure that no matter, which approach. We then strategically take the product is well set up to be successful and so on the manufacturing front.

That really means continuing to work with our third party, which is very easy for us to do because they are third party manufacturer and therefore, it's very easy to to get things ready and then hand that off to someone if that makes sense.

And so that includes all of the work that we would need to basically have the commercial supply ready to support.

Any sort of regulatory process inspection process at the manufacturer.

And the scaling and everything that's needed to ensure that commercial supply is ready when we are ready to watch the product in and have labeling and all that good stuff. So so theres all that work, obviously ongoing with a manufacturer and then work that happens behind the scenes.

To support that right to support our market introduction in terms of utilization and things like that that need to happen.

All of that is going on on the commercial side in terms of manufacturing and then on the market access side, which we all know is such an important.

Factor in consideration there is work that frankly, no matter what.

What.

What path, we take to launching this product is going to serve the product well to have in place.

And maybe John if I can turn it over to you to just say a couple of words about the landscape analysis market access some of that work that we're doing to prepare for that.

Yes, sure and thanks. Thanks for the question. So yeah, we feel really really view this as fundamental to their strategic launch of the asset whether that's the <unk>.

Scenarios that we've outlined during the call. So we want to be prepared to understand the patient journey might be prepared to understand the market access levers, we're going to need to pull.

Product makes it to market, whether that's in context or in conjunction with a partner.

We also want to understand the landscape that we're going into now the good news is a lot of this is already well known and well understood.

The beauty of bacterial Vaginosis is it's a very well known very well understood.

Peter category, so for us, it's really finding that way to differentiate the product in context of the segment, we're talking to so whether that's a payer whether that's a provider whether that's a patient and thats really what this work is going to support moving forward.

Thanks, Shannon and then just another follow up there I think the third scenario you mentioned floor commercialization was perhaps influence in the market strategy and so I was just wondering.

You were too.

Have your own sales team.

How long do you think that could take to get the product out there, meaning how do you think it will.

The impact of product launch or the timing of the launch and then how many sales folks do you think youre going to need to have on board for this product.

Yeah, So maybe I'll I'll answer this on a on a high level.

And and then we should probably.

Wrap up your question, which you've been great.

What else can get in but in terms of a high level. Let me. Let me just say a couple of words about this so in terms of timing of launch.

Really we've been managing this process or whichever one of these.

Potential path, we choose in the end.

The timing really would be the same in terms of the launch timing. So so part of what we've been wanting and helping we're communicating clearly is that because of the nature of this product and the nature of the therapeutic category.

Have the luxury of being able to time the product process for strategic commercialization in parallel with the regulatory process.

And not negatively impact impact of launch timing. So so nicely whichever way. We go the timeline is really the same.

In terms of what would be required to launch I also wanted to make sure. One thing is clear which is you know as.

We think about the launch of this product.

And frankly this pertains to nearly every program in our portfolio.

It's the same call point.

We're talking about the same universe of nurse practitioners and clinicians physicians.

Manage these indications and in some cases some of them might be a little bit higher decile and others, depending on the indication, but it's really the same call universe until it also that's one of the reasons that we have the flexibility of thinking about strategically what might make sense in terms of inactive participation by dore in.

The DB one commercialization because we have a whole portfolio of other women's health products behind.

The DB, one, which you have that same call point.

And and we believe that there are ways that if we were electing to move forward with the strategic partners chip scenario with a contract sales organization that there would be a way to do this responsibly financially and economically and strategically and so beyond that that's really at this point and all I'm prepared to say in terms of the strategy.

<unk> until we have more to reveal specifically I'd like Joe to give specifics.

But but hopefully that gives you a little bit of context of how we're thinking about it I would think about the market. How we're thinking about the launch and importantly that we're moving the process forward in a way that we believe is best for the product that's the Dore best for our shareholders.

And that included in a manner that doesn't.

Delay of launch or negatively impact of launch timing.

Thanks Elena.

Next question is from the line of Doug Tsao of H C. Wainwright. Your line is now open.

Okay.

Hello.

Okay.

Again, dovetail with HC Wainwright your line is open.

Hi can everyone hear me.

Yeah, Yeah yeah.

Yeah, Hey, everyone, a crispy all of US here on for Doug. So so congrats on the quarter, particularly on the NDA acceptance. So we just have two questions.

The first is can you give us some more detail on.

The overprint.

This is going in Europe aside from the cost savings what do you see as the main benefits of the collaborate collaborative research and development agreement and how do you think it's going to impact the study and then I have one more after that.

Great Great question and thanks, Thanks for asking about that that evergreen arrangement. So I'll start first with the E U.

We're progressing with those activities.

<unk> it really is a matter of pulling together it would be.

The non clinical and manufacturing related.

Information, we've shared before that we really do.

[laughter] evidential silver lining of the Covid time, particularly last year to take advantage of opportunities to have.

Interactions with the FDA as we're planning the evergreen program and so the I V E filing it's really a combination of those discussions and the work that came out of it. So so that's underway and as we mentioned we're planning to get that filed.

In the fourth quarter of this year.

And along those lines you know we have been.

Obviously, you're speaking with the NIH and <unk>, specifically for some time about evergreen as I mentioned in my opening remarks.

<unk>.

Funded through a grant the pre pivotal studies.

Frankly led to our partnership with there.

On this program and so they've been involved with over three with from a data perspective from from our clinical work from day one.

On the program and so and.

It had been very helpful throughout that process and so when the opportunity arose when it was clear that there was an interest on their part to continue that collaboration into the pivotal study. It was clearly a really positive outcome for the program and I will tell you specifically why and it really falls into three categories. So one obviously we've talked about.

It is the financial support.

We embraced non diluted funding strategically for our programs and clearly did so in this case as well, it's a great opportunity to two.

To offset some of our some of our costs and particularly in light of the <unk>.

The financial arrangement, then that we have with their downstream so.

And our ability to maintain control over the over the clinical trial. So that's obviously positive but the other two reasons that the collaboration is so positive.

Has to do with first kind of planning for success and then executing first expense. So planning for success is really the work that that we're working with them now.

You asked about the E filing and part of that I E submission that goes in is of course, the pivotal study protocol and being able to work with the NIH on the actual protocol design along with Bayer we have now just significantly.

Increased demand tower and women tower on designing that phase III trial, and really thinking about from the Bayer perspective, all of the things that we're going to want to have from a commercial lens right to make sure. The brand has a robust opportunity it deserves but from an age perspective, because their clinical trials network has had so much.

Variance running.

Clinical trials.

Across a variety of different types of studies and types of products, they're bringing to the protocol design that lens of what's been successful of what's been challenging what they would like to see happen with over prime, but we and Bayer she'd like to see happen with evergreen. So there's that benefit in terms of whats going actually into the <unk> and then there's <unk>.

Executing for success and executing for success is really going to be helped by the fact that we get to leverage our already existing great relationship with health decisions. They have worked with us.

To date on all of our clinical development programs until we have a very strong as you may remember a strategic partnership with health decisions. So through this collaboration we get to work with health decisions again on the execution because that to the NIH likes to work with as well for their contraceptive programs.

And then we will have their whole contraceptive clinical trials network very experienced clinical trial list in contraception specifically.

As sites for the study so we believe all of those factors.

The obviously the financial support but importantly, the operational support that we get to tap into both before the idea submitted and then subsequently for the trial conduct is why this was such a great strategic relationship for us to have for the phase III.

Awesome. Thank you that's very helpful. So just one quick one.

You mentioned about your core competency is given this type of non dilutive funding and you made two major announcements over the last.

Or so so can you kind of tell us a little bit more about your strategy for securing such funding how much effort to devote to this and should we expect any more such funding in the near future.

Thank you that's it that's it that's a wonderful question and and we are.

We're humble at Gary that we are very proud.

These accomplishments because these are not these kinds of relationships in the kind of funding that came forward through both of these relationships that were talking about the.

The $48.9 million for the Denmark, One program and then the the co funding from the NIH for day Evergreen Phase III.

Those are not trivial amount.

Amounts, obviously and the work that goes into establishing those relationships.

The diligence that those parties do [laughter] on us and our ability to execute is quite considerable and so it's not just a matter of time and patience and submitting but it's also a matter of frankly, Gary executing and our track record of execution.

That has really enabled the kind of relationships at those kind of levels with a name and so it certainly is an ongoing part of our strategy as we touched on we really like to look at all sources of funding that can help advance our portfolio we are.

We have assembled a portfolio of very interesting potential first in category products across a variety of indications many of which have this opportunity for non dilutive funding. So we do continue to apply as you notice we can choose to wait just to break the news until we know we got the grant them even though.

These kind of efforts are not just Dave.

Days and months eight years in the making and so we you know clearly it's something we've focused on across the portfolio and we are certainly hopeful that we will continue to be successful.

Awesome. Thank you very much.

Yes.

Next question is from the line of Kumar Roger of Brookline Capital markets. Your line is now open.

Congratulations on all the probe this and thanks for taking my questions.

First with regard to BV one.

Alright meeting.

And also in terms of <unk>.

Enabling this questions on label expectations. When you start to expect a big base and how we start going to impact your strategy income from partnerships.

Yeah, Great Great question. So I think the first part broke up it kind of gives me that interactive you expected a panel meeting.

PD, one as a guidance document out it's a pretty straightforward indication. So it's not something we would anticipate.

In terms of the labeling and what we might expect in labeling and how that impacts the partnering strategy.

What I would say on that is that again there are approved products for bacterial vaginosis. So one can definitely look at the you know the approved products in terms of what is typical to go into the label.

<unk> section 14 around the clinical outcomes and so that's definitely helpful for us.

It has.

Sort of range that evolved over the years of just different products or get approved every time and so that certainly is something that we're looking at and we'd like to take into consideration.

But you know clearly we can look at the existing product labels to get a sense of.

The information has to be good communicated and it is typically communicated in those labels along the lines of what we shared with the cure rates for the primary endpoint.

Typically that modified intent to treat population at a test of cure visit which in our case is day, 21% to 30, but in some cases, it's been day seven to 14, depending on the product and the time at which it is approved.

And in terms of how our labeling can impact the partnering process.

Again, what I would say is we've been we've been very thoughtfully managing this process and managing it in parallel with certain.

Regulatory kind of milestones and objectives that we've been advancing the programs and advancing the program through this process and so we will definitely keep everyone updated.

Guided that we expect to have something that we can share with you more definitively around the commercialization strategy to support that 2020 to launch by the end of this year.

And that certainly aligns with.

This regulatory process.

Okay and with regard to oil theme as you think about the pivotal trial.

How are you thinking in terms of expectations for the full index.

And also what are your thoughts on exclusion.

Great.

Yeah. So a nice nice question about how do we think about the clinical outcomes with over trained and so that the studies that we've conducted to date that the Postcoital test study, which is the pre pivotal study it used as a surrogate marker for contraceptive effectiveness.

This point in time those are really the best data, we can point to to what we would expect overtime.

<unk> to how we would expect it to perform.

It uses that.

The likely typical use effectiveness rates is what dose.

That pre pivotal Postcoital test study is predictive of.

And so when we look at the outcome of that study and then we look at other contraceptive studies that have been published that has done the pre pivotal post Codell test Chegg study and then gone on to run full pregnancy prevention contraceptive effectiveness studies.

The findings would be indicative of a product that should have a typical use effectiveness of 86% to 91%. So that puts it just right right below the range of hormonal methods, which are 91% typical use effectiveness method because that's what the PCT trial. The Postcoital test trial that we ran.

Would be predictive of.

In terms of.

The actual pregnancy prevention, right, which which by the way effectiveness rate, which tends to be kind of a day that can be used for effective integrated like the inverse of your program.

So.

You will know that definitively once we conduct the clinical trial that we've been talking about the phase III, but based on the pre pivotal that's the range that we would be predicting based on this outcome.

And for that for the non hormonal methods I should add that that would be quite quite promising I mean this is one of the reasons that there is there is so much interest.

By a variety of parties like they're at the NIH and evergreen, it's because for that non hormonal methods apart from the the intrauterine device, which is implanted. It's it's it's challenging to achieve that level of effectiveness. The only products that I've ever historically done that are the diaphragms.

They're the only product vaginal gel vaginal spermicide do not have that level, they've got 27 Pearl index.

Condoms do not have that level to do a little bit better there 82% effective.

But so certainly diaphragms had been able to achieve it but their quiet period total method. So the ability to achieve that kind of affecting this level with a once a month product would be quite promising for the field and we're certainly hopeful that that evergreen goals will deliver the way that the postcode our pet study predicted.

And in terms of the exclusion criteria.

Oh, I'm, sorry, yes, so that should be fairly what we you'd have been looking at is fairly standard.

For for contraceptive.

Studies, so it they're pretty unusual in terms of the expectations. Both on what's required for inclusion and exclusion and so we right now are expecting that it will quite closely mirror.

Pending obviously feedback from the FDA, but what we're looking at with quite closely mirror.

Other countries such as effectiveness studies.

Okay, great. Thank you so much.

Yeah.

Okay.

Thank you participants I will now turn the call back over to Sabrina Johnson for final remarks.

Well. Thank you everyone for taking the time this afternoon for the call for the great questions. We really appreciate that we took the time to hear about or we can update our strategies to improve options and health outcomes for women with what we're doing.

Ongoing commitment to drive value for all our stakeholders. So in closing 2020 ones a year with a number of potential meaningful developments for Dara some of which we already accomplished and talk about and talked about today and some of which have yet to come and go during the remainder of the year. We definitely look forward to keeping you updated on our <unk>.

Brad against the important 2021 objective and the guidance the milestones that we believe will set us up to achieve important objective across the portfolio in 2022 and beyond as well. So thank you for your time today.

And that concludes today's conference. Thank you all for joining.

You may now disconnect.

Yes.

Yeah.

[music].

Thank you all for standing by and welcome to the conference call hosted by Dara Bioscience to review the Companys financial results for the quarter ended June 32000.

21 and to provide a general business update please.

Please note that this call is being recorded this is Jesse and I'll be your operator today.

With us today are Sabrina Martucci, Johnson, Dare's, President and Chief Executive Officer.

John Fair Cra's Chief strategy Officer.

And Lisa Walters Hoffert <unk> chief.

Chief Financial Officer MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to our second quarter 2021 financial results and business update call for Dar Bioscience.

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

Payments made during this call that are not statements of historical facts should be considered forward looking statements.

Actual results or events to differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties you should not place undue reliance on forward looking statements forward looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended June 32021.

<unk> filed today as well as our annual report on Form 10-K for the year ended December 31, 2025 on March 30 of 2021.

I would also like to point out that the content of today's call includes time sensitive information and apply only as of today August 12, 2021, sorry undertakes no obligation to update forward looking statements to reflect new information or developments. After this call except as required by law.

Jared is 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.

Electing everything I'm, saying product candidate that we believe has the potential to be first in category and first one and has a meaningful commercial opportunity.

We currently have four clinical stage programs in the areas of vaginal health sexual health contraception in menopause.

One product in the breast cancer supportive care category skin cancer phase one.

And most of my remarks today will address these candidates.

The first half of 2021 has been quite eventful for Dara.

And the announcements we were able to make over the last few months have been the type of updates that every CEO and choice making.

We announced positive phase one data for our hormone therapy product and up to $48.9 million dollar grant over the course of five years for one of our preclinical contraceptive program.

Collaborative research agreement with the NIH to co financially support and co conduct our phase III study for an investigational contraceptive ever plane and just this week, we announced the FDA acceptance and priority review of our NDA for bacterial Vaginosis product candidate with a December seven 2021 producer.

Target action date.

It has definitely been a meaningful coupons for Dara and we hope it will continue to prove to be a meaningful year for us given what we have yet to come.

With that backdrop I'll now provide some additional context on his accomplishments and specifically dive deeper on the relevant updates related to our four clinical stage programs.

As well as that of supportive care cancer program.

And the vaginal health category of bacterial Vaginosis, which impacts an estimated 21 million women in the United States I'll start with their PD one.

During the second quarter of 2021 and in line with our Titan, we submitted a new drug application or NDA to the FDA.

We requested a priority review at that time, our submission we.

We announced that the FDA accepted for filing the NDA extra gear PD, one for the treatment of back to Europe. After Nexus and the FDA granted this application priority review and set a prescription drug user fee act or could use a gate of December seven 2021. She wanted to target completion of its review of the NDA.

The FCA granted priority review to applications for potential drugs that if approved would provide a significant improvement in the safety or effectiveness of the treatment of a serious condition.

The NDA, we filed was supported by positive results from the <unk> three phase III randomized multi center double blinded placebo controlled clinical trial evaluating <unk> in women diagnosed with bacterial vaginosis.

Conditions that can cause serious health effects and rich and it's very disruptive in terms of the sentence and as I mentioned, it's estimated to affect approximately $21 million revenue in the United States.

CRB one is an investigational thermosetting bio adhesive hydrogel containing the bias in phosphate 2%. That's designed as a one time vaginally administrator minister treatment for bacterial vaginosis.

The acceptance of this FDA marks a major milestone not only for Dar as a company, but importantly for the millions of women that are impacted by bacterial vaginosis. It is our goal as a company at your branch Marty market products and products like that but it has the potential to improve outcomes and convenience for women.

As Derby D. One demonstrated it has the potential to do in the phase III study, whereas single vaginal Joseph Derby D. One achieved clinical cure rates in the range of 70% to 81%.

Specifically the results from the Derby the French study demonstrated guarantee he wants to potential to improve clinical cure rate in a convenient one time dose compared to those that are currently FDA approved branded products indicated for the treatment of bacterial vaginosis.

Patients in this study we're evaluating three clinic visits gave one which is screening and randomization day seven to 14 when she can interim assessment visit at day 21 to 30, which was the test of cure visit.

The study met its primary endpoint demonstrating that as a primary therapeutic intervention a single vaginal dose of <unk>, one was statistically superior to placebo at that day 21 to 30.

I just meant in the modified intent to treat population.

Typically 70% compared to 36% of subjects currently cured.

Additionally, they are busy one demonstrated a clinical cure rates of 77% a day trying to wear 30 day 81, and 85% at day seven to 14 in the per protocol population compared to 43% and 30% for placebo claim respectively.

Current FDA approved products have clinical cure rates in the range of only 37, 68%.

<unk> has received both qualified infectious disease product or <unk> as well as fast track designation from the FDA for the treatment of bacterial vaginosis.

I know the Q I D. P designation if approved we expect Airbnb one will receive five years of market exclusivity. In addition to the three years available for having generated new clinical data.

Ongoing strategic discussions and other activities to support a robust market launch of Derby. These one and 2022 if approved are underway and we plan to finalize and announce the commercialization strategy for <unk> in the U S by year end, John will be providing additional color on our knowledge.

And the sexual health category I'll now provide an update on today, so crazy three 6% our investigational products to attract her version of erectile dysfunction.

In March of this year, we commenced our phase <unk> clinical study evaluating <unk> as a crane and investigational cream formulation of <unk> to fill the active ingredient.

For topical administration to treat female sexual arousal disorder or S. S. J D.

S. S. A V is a physiological condition characterized by the inability to obtain or maintain sufficient genital arousal sexual activity.

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

FSA D represents a large unmet need with an estimated 10 million women in the U S experiencing distress.

Tens of low or no sexual arousal and actively seeking treatment.

No FDA approved products exist today to treat FSD.

Despite the fact that the <unk> 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.

If our clinical development is successful with ethical crane has the potential to be the first FDA approved at the JV treatment option.

We are actively enrolling subjects into the phase <unk> clinical study evaluating <unk> as a potential treatments reference J D at sites located across the country.

During our last call. We said we would continue to provide updates on the progress of the face to be response study and the potential impact of COVID-19 are unexpected timeline.

We are monitoring this closely and particularly given the evolving COVID-19 guidance and case loads across the country.

We feel it's challenging to confirm anticipated timing to the top line data readout until we complete the planned interim analysis to determine the ultimate size of the study.

We have recently seen the pace of enrollment at certain sites declined because of those sites being in locations, where the case was there higher in adhering to government guidelines recommending reductions or changes in their operations intended to reduce the spread of COVID-19.

Due to the impact potentially on the pace of enrolment overall for the trial, resulting from governmental recommendation or order is intended to reduce the spread of COVID-19, or some other effects related to COVID-19, we cannot predict with reasonable certainty at this time when the interim analysis will be conducted a one will report topline data from the trial.

As we have done to date, we will continue to provide updates as the trial continues and we can better project timelines.

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

Last month, we announced that we entered into a cooperative research and development agreement, which is also known as a creator with the unit Kennedy Shriver National Institute of child Health and human development and.

Ph D for short, which is part of the National Institute of Health or NIH. This is for the pivotal phase III study of evergreen.

<unk> will allow us to leverage the tremendous development expertise at the NIH in contraceptive clinical studies and to share the cost of the pivotal phase III study.

<unk> is our novel hormone free monthly contraceptive candidate, who is U S. Commercial lives are under a license agreement with Bayer.

The next stage of clinical development for Overprint is this pivotal phase III contraceptive studies that we will be conducting under the creator with DNI CHD.

Grant funding was previously provided by NFC HD and it supported the contact of our pre pivotal clinical study of evergreen. The current agreement reflects the NII Chd's continued support for the development of other crane and will allow us to leverage the contraceptive clinical trial expertise of NFC HD while also.

So sharing the cost of the phase III study with <unk>.

Specifically the study will be supported by <unk> contraceptive development program, our CVT ESG.

GDP overseas, the contraceptive clinical trial network or <unk>, which was established in 1996 to conduct studies of investigational contraceptive and the study will be conducted with the <unk> with his NII CHD contractor health decisions.

<unk> will be responsible for driving the clinical supplies about retraining and coordinating interactions with in preparing and submitting supportive regulatory documentation to the FDA.

Dara and Ni's HD will each provide medical oversight for the trial and final data review and analysis and we'll work together to prepare the final report to trial results.

Under the Cray that we either already have agreed to contribute $5.5 million towards the total estimated cost to conduct a pivotal phase III study and the NAC H D will be responsible for the remaining costs related to the conduct of the study and they will manage containment of expenses to help decisions the clinical trial.

<unk> site and the other targets involved with the study.

Lisa will discuss this arrangement in more detail shortly.

As I mentioned earlier, the U S commercial rights, Robert Rainer under our license agreement with Bayer.

Bear in dairy entered into this exclusive license agreement for the commercial rights to <unk> in January 2020.

Under the agreement we received access to bear its extensive clinical and market expertise through up to approximately 80 hours per week and advisory support.

And we maintain control over development and regulatory approval process.

There has the right to obtain exclusive rights to commercialize the product in the U S. Following the completion of the pivotal clinical trial being undertaken by us with the NSE HD, if they're in its sole discretion and make the payment to <unk> of $20 million, which we intend to apply for reimbursement of our portion of the clinical studies manufacturing costs cost of it.

The program.

In order to initiate the pivotal phase III study, we must have an FDA cleared investigational device exemption or IDE place. We currently plan to file an IV for over print in the fourth quarter of this year and then pending the FDA to review and clearance of the <unk>, we intend to initiate that pivotal phase III study in.

2022.

Next for the estimated 45 million women in the U S who are approaching our embedded pause, let's talk about our investigational hormone therapy product their HR Q1.

So during the second quarter and in line with our guidance, we reported the positive top line data from our phase one clinical study of <unk>, one, which we conducted in Australia.

We believe this unique international rig platform technologies offers a versatile drug delivery system revenue child with the potential to deliver different active drugs at different rates, and thereby improving convenience and outcomes potentially across multiple indications.

The IV our drug delivery technology was originally developed by Dr. Robert Langer from MIT and Dr. William Crowley from the Massachusetts General Hospital, and Harvard Medical School and its first application of this first of all the technology, that's being clinical testing clinically tested is the state their HR Q1 use of it which is in <unk>.

Destination, all 28 day intra vaginal delivery of hormone therapy be it rain and the rain contains both in this case bioidentical estradiol and Bioidentical progesterone for the treatment of debate their motor symptoms and the genital urinary symptoms and syndrome associated with menopause.

On June 28, we announced positive topline results from our phase one clinical study of dairy Cherokee One Australia.

That randomized open label three arm parallel group Phase. One study was designed to evaluate the pharmacokinetics of deer coupons and approximately 30 healthy post menopausal women with intact you derive the primary objective of the study was to describe these pharmacokinetic or PK parameters of two different dose combination.

Over 28 days checking.

Secondary objectives of this study were to assess the safety and Tolerability of Derek <unk>, one and to compare the systemic exposure of the estradiol, which importantly is the active form of the therapeutic hormone for therapeutic hormone replacement purposes, as well as a strong and progesterone from there.

Archie one every 28 days and compare those against a combination of FDA approved oral estrogen and oral progesterone products evaluated in that same case study.

The levels of estradiol released from that at the lower end higher against formulation of their HR. She wanted evaluated in the study achieved or exceeded the levels that were targeted for hormone therapy.

Our current level of divestiture die Aqua hormone therapy for either of the base of motor suggests or the vaginal symptoms of menopause were established by reviewing PK levels that have been published for FDA approved products for most of the treatment of VNS as well as the agenda to urinary symptoms of menopause and based on the estradiol PK data.

Their HR Q1 in the phase one study the results support the potential FDA or HR to want as an effective hormone therapy.

Both the motor symptoms and vaginal symptoms associated with menopause the levels of progesterone importantly release from both versions of their HR Q1 guidance study also met the objectives of reducing progesterone and specifically progesterone it's used in hormone therapy.

Is the impact of estrogen or non target sites, such as being to atria and should that estrogen induced endometrial hyperplasia.

In addition, the treatment was well tolerated with the most common adverse events consisting of.

Vaginal symptoms that are consistent with other vaginal products.

<unk> also had a high vol. A is flexibility in the study with over 80% of subjects.

On either the low or high dose version of the Big Turkey, one product reporting the ABR at comfortable or very comfortable and additionally over 80% of the subjects in each dose group stated that they were either somewhat or very likely to use the IV arm for women's health condition, where disease issue need to get.

For some women and hormone therapy is a highly effective treatment for the symptoms associated with menopause like the hot flashes in the vaginal dryness and it may also prevent bone loss and fracture.

The delivery of hormone therapy over 28 consecutive days with no daily intervention support Dare <unk> potential to be first in category option offering ease of use and continuing dosing to women suffering from menopausal symptoms. There are permanently no FDA approved products that can.

Tenuously deliver on hormone therapy, with both estradiol and progesterone together over multiple consecutive weeks.

We plan on submitting that data from that phase one clinical study for publication in a peer reviewed journal.

And our clinical development strategy is to leverage the existing safety and efficacy data on the active ingredients and did our HR Q1, the extra dial and the progesterone and to utilize the FDA 500, <unk> pathway in order to obtain marketing approval of <unk> in the U S.

We are in the process of updating our regulatory and clinical development strategy. Given these positive phase one data and will provide guidance on the next step which is program as soon as possible.

And finally before I turn it over to John Alicia.

Want to talk about the approximately $3.8 million women in the U S. Do you have a history of breast cancer.

Up to a positive outcome and a hunter was such a positive is the most common type of breast cancer and the prevalence of Bolivar and vaginal atrophy or BVA in post menopausal breast cancer survivors is estimated to be 40% to 70%.

I would like to provide a supportive care option for those women.

There may be a one.

As I mentioned in my opening remarks, we plan on initiating a phase one clinical studies later this year in Australia for this breast cancer supportive care program data DVA one here.

One is our proprietary investigational formulation of tamoxifen for vaginal administration to treat vaginal atrophy.

A non hormonal approach to addressing Bachelor atrophy. It can be an important option for women with a history out or at risk for hormone receptor positive breast cancer.

We plan to commence that phase one clinical study in the second half of this year in Australia and look forward to providing updates on the progress of that program.

I'll now turn it over to John to provide a business at corporate partnership that partnership update on our two latest stage program, specifically their PD, one and <unk>.

Thank you Sabrina now that the NDA for <unk> has been accepted for filing by the FDA and priority review has been granted we anticipate acceleration across the three main commercialization strategies, we've been progressing in parallel given that the <unk> partnering process has been strategically and purposely.

Aligned with the <unk> regulatory process.

Both scenarios include straight out license to a strategic partner, where the partner is solely responsible for commercialization in exchange for milestone and royalty payments based on the revenue generated by the product the second scenario.

Where are we strategically partner Derby, one, but retain the option to have a role in the commercialization of the product.

And finally, a scenario we can play a direct and active role in commercialization that includes influencing the go to market and planning.

Strategy, including our market introduction through a strategic partnership with a full service contract sales organization. All three options are currently under discussion.

Strategic opportunity for the introduction of Airbnb, one if approved.

As many of you know women diagnosed with bacterial vaginosis or challenged often routinely defined interventions that can rapidly address the signs and symptoms of infection and also address resolve weak underlying confections itself.

Currently available FDA approved treatment options work about half the time on average it's our belief that <unk> product profile will appear will appeal to both patients and providers as it has the potential to provide a clinically meaningful improvement over currently approved FDA products, particularly in terms of a better opportunity for us.

Clinical cure, which includes resolutions of the signs and the symptoms of the infection.

In summary, we are encouraged with the progress of the Derby one program.

We're excited at the prospect of bringing this important new therapeutic option to women and providers and we believe that we are well positioned to communicate our definitive commercialization strategy before the end of this year.

So I'd also like to take a moment to highlight the ongoing partnership with Bayer for our hormone free monthly contraception product candidate overprint.

We're delighted to report that the partnership is progressing as well if not better than we could have expected bear as part of their commitment to provide up to two full time equivalents in an advisory capacity to support the development stage of the program has been actively supporting door right across all of the key functional areas, including CMC regulatory.

<unk> as well as strategic planning to have formed downstream commercialization to <unk>.

Optimize the introduction of this exciting new product candidates. If it's approved as I'm sure. Many of you know there is a worldwide leader in the car category and that was one of the key drivers behind our decision to partner overprint at this stage of clinical development, we believe that our overwriting partnership with Bayer is a clear example of our commitment to doing what is best.

For our stakeholders, our shareholders and for women, which is core to our strategy here at Dore.

Thanks, John Hey, everyone. Thanks for joining us today I would now like to summarize <unk> financial results for the quarter ended June 32021.

<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 or R&D activities to advance our candidates through clinical and regulatory milestones.

Including approval.

For the quarter ended June 32021, <unk> general and administrative expenses were approximately $1.8 million.

And our R&D expenses were approximately $7.3 million the quarter's increase in R&D expenses compared to the same period in 2020, primarily reflects the increased cost of critical regulatory affairs and other development activities related to <unk> cream Derby one over.

Green and their HR team one.

Our comprehensive loss for the quarter was approximately $9.2 million.

During the six months ended June 32021, net cash or cash proceeds raised from financing activities were approximately $24.6 million and reflected sales of common stock under our ATM program equity line and warrant exercises.

We ended the quarter with approximately $9.1 million in cash and cash equivalents.

Subsequent to the quarters in between July one and August 10, 2021, Gary received additional net cash proceeds of approximately $25.4 million from.

From sales of common stock under our ATM program.

In addition in July we received an initial cash payment of approximately $11.4 million and non dilutive grant funding to support the development of <unk>.

The entire grant awarded for up to $48.9 million with future payments contingent upon the dare <unk> program, achieving specified development and reporting milestones.

As of August 10, 2021, we had approximately $70.5 million shares of common stock outstanding.

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

So first is recall that under Australia's current research and development tax incentive program eligible companies conducting R&D activities in Australia may file for and receive up to 43, 5% of their eligible expenses as a cash payment in the following year, we completed our.

<unk> phase one study in Q2 and intend to initiate our gearing DVA phase one study in 2021, both conducted through our Australia subsidiary during.

During the first half of this year in 2021, we received a cash payment of $250000 and that is in U S dollar value in connection with Derek <unk> steady expenses that we incurred last year in 2020.

Second as Sabrina discussed a bit earlier in July we announced a cooperative research and development agreement or <unk>.

With the <unk> for the pivotal phase III study of overpaying. The agreement will allow <unk> to leverage the tremendous contraceptive clinical trial expertise of Eni's DHT, while also sharing the cost of the phase III pivotal study.

Andrew the creator Gerry Gerry has agreed to contribute $5.5 million between July 2021, and April one 2023 towards the total estimated cost to conduct a pivotal phase III study.

The <unk> will be responsible for the other costs related to the conduct of the pivotal study and we will manage the payment of expenses to third parties.

We believe the Nics vies contraceptive trial experience and financial support will allow for the completion of the overpaying pivotal phase III study in an efficient and cost effective manner.

Third grants have been a very attractive source of non dilutive funding for <unk> and we will continue to use our existing grants for allowable expenses and to explore and apply for additional grant funding in the future.

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

As well as our annual report on Form 10-K for the year.

Year ended December 31, 2020 that was filed on March 30 of 2021.

I would now like to turn the call back over to Jesse our operator.

Thank you speakers participants we will now begin the question and answer session.

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Okay.

First question is from the line of <unk> <unk> of Roth Capital Partners. Your line is now open.

Hi, Thanks for taking my question just have a few year.

The first is floor Dara D. The one so congrats on the Paducah date at that's happening before the end of the year, which is kind of curious if the pool.

Approval process has been included in inspection up your manufacturing facility and then were still so just curious as to who is doing the manufacturing.

For the product.

Hi, Thanks for the question.

Yes, so in terms of whether you know you don't want.

Prudent inspection.

They're down at the discretion of the FDA often there are pre approval inspections theyre not always held.

At this time.

Given that we just received the NDA.

Acceptance to file I'm not really in a position to answer that question, but definitely we'd be happy to keep people updated over time.

And then we have not disclosed the manufacture of this product is it other than to say, it's a third party contract manufacturer that we use.

That is really an expert in the manufacturing of vaginal creams and gels, that's what they do for our business.

They have.

This is not their first time through a process like this.

We're very well versed in commercialization and.

FDA potential infection.

Thanks, Sabrina and then John also mentioned some manufacturing efforts in market Asics efforts can you elaborate on that if possible for the RFP is doing and how you're thinking about that also in terms of.

I suppose I'm help.

Helping with the partnership that <unk>, giving you more leverage I suppose.

Yeah definitely.

Fortunate to be able to do with a product like this given the understanding of the indication.

And also the work that we can be doing in parallel to ensure that no matter, which approach. We then strategically takes the product is well set up to be successful and so on the manufacturing front.

And so that includes all of the work that we would need to basically have the commercial supply ready to support.

Any sort of regulatory process inspection process that the manufacturer.

And the scaling and everything that's needed to ensure that commercial supply is ready when we are ready to watch the product in and have labeling and all that good stuff. So so theres all that work, obviously ongoing with that manufacturer and then work that happens behind the scenes.

To support that right to support the market introduction in terms of utilization and things like that that need to happen.

All of that is going on on the commercial side in terms of manufacturing and then on the market access side, which we all know is such an important fact.

Factor in consideration there is work that frankly, no matter, what what path, we take to launching this product is going to serve the product well to have in place.

And maybe John if I can turn it over to you to just say a couple of words about the dull landscape analysis market access some of that work that we're doing to.

Prepare for that.

Sure and thanks. Thanks for the question. So yeah, we feel really really view this as fundamental to the strategic launch of the asset whether that's.

The scenarios that we've outlined during the call. So we want to be prepared to understand the patient journey might be prepared to understand the market access levers, we're going to need to pull when the product makes it to market, whether that's in context or in conjunction with a partner.

And we also want to understand the landscape that we're going into now the good news is a lot of this is already well known and well understood.

The beauty of bacterial Vaginosis is it's a very well known very well understood.

Therapeutic category so for us, it's really finding that way to differentiate the product in context of this segment. We are talking to so whether that's a payer whether that's a provider whether that's a patient and thats really what this work is going to support moving forward.

Thanks, Shannon and then just another follow up there I think the third scenario you mentioned floor commercialization was perhaps influence in the market strategy and so I was just wondering if you were to pass.

You have your own sales team.

How long do you think that it would take to get the <unk> out there, meaning how do you think it will inflect.

Impact of product launch at that time of the launch and then how many sales folks do you think youre going to need to have on board for this product.

Yeah, So maybe I'll I'll answer this on a on a high level.

And and then we should probably.

Wrap up your question, which you've been great. So someone else can get in but.

In terms of a high level, let me let me just say a couple of words about this so in terms of timing of launch.

Really we've been managing this process or whichever one of these.

Potential path, we choose in the end.

The timing really would be the same in terms of the launch timing. So so part of what we've been wanting and hoping we're communicating clearly is that because of the nature of this product and the nature of the therapeutic category.

Have the luxury of being able to time the product process for strategic commercialization in parallel with the regulatory process and.

And not negatively impact impact of launch timing. So so nicely whichever way. We go the timeline is really the same.

In terms of what would be required to launch I also wanted to make sure. One thing is clear which is you know as.

As we think about the launch of this product and frankly this pertains to nearly every program in our portfolio.

It's the same call point.

We're talking about the same universe of nurse practitioners and clinicians physicians.

That manage these indications and in some cases some of them might be a little bit higher decile and others, depending on the indication, but it's really the same call universe and two it also that's one of the reasons that we have the flexibility of thinking about strategically what might make sense in terms of an active participation by dore.

The BV one commercialization because we have a whole portfolio of other women's health products behind.

Heightened DB, one, which you have that same call point.

Hey in terms of this strategy until we have more to reveal specifically I'd like Joe to give specifics.

But that hopefully that gives you a little bit of context of how we're thinking about it how we think about the market. How we think about the launch and importantly that we're moving our process forward in a way that we believe is best for the product that's the Dore best for our shareholders.

And that includes in a manner that doesn't.

Delay of launch or negatively impact of launch timing.

Thank you Sabrina.

Next question is from the line of Doug Tsao of H C. Wainwright. Your line is now open.

Okay.

Hello.

Again, dovetail with HC Wainwright your line is open.

Hi can everyone hear me yeah.

Yes, yes.

Yeah, Hey, everyone, a crispy all if youre on for Doug Tsao, So congrats on the quarter, particularly on the NDA acceptance. So we just have two questions.

The first is can you give us some more detail on.

The overprint IV process is going and you know aside from the cost savings what do you see as the main benefits of the collaborate collaborative research and development agreement and how do you think it impacts the study and then I have one more after that.

Great Great question and thanks, Thanks for asking about that fed evergreen arrangement. So I'll start first with the E U.

We're progressing with those activities.

To file the <unk>. It really is a matter of point together it would be.

The non clinical and manufacturing related.

Information.

<unk> shared before that we really do.

[laughter] evidential silver lining of the Covid time, particularly last year to take advantage of opportunities to have.

Interactions with the FDA as we're planning the evergreen program and so the IV filing it's really a combination of those discussions and the work that came out of it. So so that's underway and as we mentioned we're planning to get that filed.

In the fourth quarter of this year.

And along those lines you know we have been.

Obviously, you're speaking with the NIH and Nic's, specifically for some time about evergreen as I mentioned in my opening remarks.

<unk>.

Funded through a grant the pre pivotal studies that that frankly.

Frankly led to our partnership with bear on this program and so they've been involved with every screen with from a direct perspective from from our clinical work from day, one on the program and so and.

It had been very.

Helpful throughout that process and so when the opportunity arose when it was clear that there was an interest on their part to continue that collaboration into the pivotal study. It was clearly a really positive outcome for the program and I'll tell you specifically why and it really falls into three categories. So one obviously, we've talked about is is the financial support.

Right.

We embraced non dilutive funding strategically for our programs and clearly did so in this case as well, it's a great opportunity to to.

To offset some of our cost of some of our costs and particularly in light of the.

The financial arrangement that we have with their downstream so.

And our ability to maintain control over the over the clinical trial. So that's obviously positive but the other two reasons that the collaboration is so positive.

Have to do with first.

Planning for success and then executing first expense. So planning for success is really the work that that they are working with them now.

You asked about the E filing and part of that.

E submission that goes in is of course, the pivotal study protocol and being able to work with the NIH on the actual protocol design along with Bayer we have now just significantly increased.

Increased demand tower and women tower on designing that phase III trial, and really thinking about from the Bayer perspective, all of the things that we're going to want to have from a commercial lens right to make sure. The brand has the robust opportunity it deserves but from an age perspective, because their clinical trials network and has so much.

Variance you're running.

Clinical trials.

Across a variety of different types of studies and types of products, they're bringing to the protocol design that blends out what's been successful what's been challenging what they would like to see happen with over prime, but we had bayer she'd like to see happen with overprint. So there's that benefit in terms of whats going actually into the <unk> and then there's <unk>.

Executing for success in executing for success is really going to be helped by the fact that we get to leverage our already existing great relationship with health decisions. They have worked with us.

To date on all of our clinical development programs and so we have a very strong as you may remember a strategic partnership with health decisions. So through this collaboration we get to work with health decisions again on the execution because that to the NIH likes to work with as well for their contraceptive programs.

And then we will have their whole contraceptive clinical trials network very experienced clinical trial list in contraception specifically.

As sites for the study so we believe all of those factors.

Awesome. Thank you that's very helpful. So just one quick one.

You mentioned about your core competency is getting this type of non dilutive funding and Joe you made two major announcements over the last.

Or so so can you kind of tell us a little bit more about your strategy for securing such funding how much effort to devote to this and should we expect any more such funding in the near future.

Thank you that's it that's a wonderful question and and we are.

We're humble at Guy that we're very proud.

Of these.

These accomplishments because these are not these kinds of relationships in the kind of funding that came forward through both of these relationships that were talking about the the $48.9 million for the gearbox one program and then the the co funding from the NIH for the Evergreen phase III.

Those are not trivial.

Amounts, obviously and the work that goes into establishing those relationships.

Diligence that those parties do [laughter] on us and our ability to execute is quite considerable and so it's not just a matter of time and patience and submitting but it's also a matter of frankly, Gary executing and our track record of execution.

That has really enabled the kind of relationships at those kind of levels with EMEA and so it certainly is an ongoing part of our strategy has reached the touched on.

Like to look at all sources of funding that can help advance our portfolio we are.

Even though these kinds of efforts are not just.

Days or months, but years in the making and so we you know clearly it's something we've focused on across the portfolio and we are certainly hopeful that we will continue to be successful.

Awesome. Thank you very much yet.

Yes.

Next question is from the line of Kumar Roger of Brookline Capital markets. Your line is now open.

Congratulations on all the probe this and thanks for taking my questions.

First with regard to BV, one do you expect a meeting.

And also in terms of.

Labeling questions on label expectations. When do you expect to take place and how we start going to impact your strategy in terms of the partnership.

Yeah, Great Great question. So I think the first part I mean, it broke up it kind of gives me that suggested we expect to the panel meeting.

BB when there is a guidance document out and it's a pretty straightforward indication. So it's not something we would anticipate.

In terms of.

The labeling and what we might expect in labeling and and how that impacts our partnering strategy.

Particularly section 14 around the clinical outcomes and so that's definitely helpful for us.

It has.

Sort of range that evolved over the years that different products will get improved over time and so that certainly.

It's something that we're looking at and we'd like to take into consideration.

But you know clearly we can look at the existing product labels to get a sense of how the information is typically communicated and it is typically communicated in those labels along the lines of what we shared with the cure rates for the primary endpoint.

And in terms of how our labeling can impact the partnering process.

Again, what I would say is we've been we've been very thoughtfully managing this process and managing it in parallel with certain <unk>.

Regulatory kind of milestones and objectives as we've been advancing the programs and.

Advancing the program through this process and so we will definitely keep everyone updated.

Guided that we expect to have something that we can share with you more definitively around the commercialization strategy to support that 2020 to launch by the end of this year.

And that certainly aligns with.

This regulatory process.

Okay and with regard to oil theme as you think about the pivotal trial.

How are you thinking in terms of expectations for the full index.

And also what are your thoughts on profit.

Great.

Yeah. So nice nice question about how do we think about the clinical outcomes with over trained and so that the studies that we've conducted to date that the post Codell test study, which is the pre pivotal study it used as a surrogate marker for contraceptive effectiveness.

This point in time those are really the best data, we can point to to what we would expect.

Overhearing to how we would expect it to perform.

It uses.

The likely typical use effectiveness rates is what dose.

That pre pivotal Postcoital test study is predictive of.

And so when we look at the outcome of that study and then we look at other contraceptive studies that have been published that has done the pre pivotal post Codell test type study and then gone on to unfold pregnancy prevention contraceptive effectiveness studies.

Would be predictive of.

In terms of.

The actual pregnancy prevention, right, which which by the way effectiveness rank, which tends to be kind of that to be effective.

I would like to reiterate as like the inverse of your program.

So.

And for that for the non hormonal methods I should add that that would be quite quite promising I mean this is one of the reasons that there is there is so much interest.

By a variety of parties like they're at the NIH and evergreen, it's because for that non hormonal methods apart from the the intrauterine device, which is implanted it is challenging to achieve that level of effectiveness. The only products that have ever historically done that are the diaphragms.

They're the only product vaginal gel vaginal spermicide do not have that level of they've got a 27 Pearl index.

Condoms do not have that level, they do a little bit better there 82% effective.

So the only diaphragms, they've been able to achieve it but their quiet period total method. So the ability to achieve that kind of affecting this level. The once a month products would be quite promising for the field.

And we're certainly hopeful that that evergreen goals will deliver the way that the first quarter past studies predicted.

And in terms of the exclusion criteria.

Oh, I'm, sorry, yes, so that should be fairly what we.

When looking at it's fairly standard.

For for contraceptive.

Studies, so they're pretty unusual in terms of the expectations. Both on what's required for inclusion and exclusion and so we right now are expecting that it will quite closely mirror.

Pending obviously feedback from the FDA, but what we're looking at would probably closely mirror.

Other countries such as effectiveness studies.

Okay, great. Thank you so much.

Yes.

Yeah.

Okay.

Thank you participants I will now turn the call back over to Sabrina Johnson for final remarks.

Well. Thank you everyone for taking the time this afternoon for the call for the great questions. We really appreciate that we took the time to hear about or we can update it's our strategies.

Prove options and health outcomes for women and that's what we're doing.

Ongoing commitment to drive value for all of carry stakeholders. So in closing 2021, the year with a number of potential meaningful developments for Dara some of which we already accomplished and talk about and talked about today and some of which have yet to come and so during the remainder of the year. We definitely look forward to keeping you updated on our <unk>.

Brett against the important 2021 objective as it goes to the milestones that we believe will says that to achieve important objectives across the portfolio in 2022 and beyond as well. So thank you for your time today.

And that concludes today's conference. Thank.

Thank you all for joining.

You may now disconnect.

Q2 2021 Dare Bioscience Inc Earnings Call

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