Q3 2020 Dare Bioscience Inc Earnings Call
This call is being recorded.
My name is Chris and I'll be your conference operator today.
Well just today or Sabrina March would be Johnson, Dorries, President and Chief Executive Officer, John Fair Diaries, Chief strategy Officer, and Lisa Waters, Hoffert, Dorries, Chief Financial Officer.
MS. Johnson. Please proceed.
Thank you.
Okay.
I'm trying to financial results and business update call for diary by a science. We are looking forward to discussing our third quarter results, reflecting on some important achievements to date and 2020, highlighting anticipated developments and milestones for the remainder of 2020 and providing some perspective regarding our plans for 2021.
But before I begin I'd 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.
Any statements made during this call that are not statements of historical facts should be considered forward looking statements actual risk.
Results or events could differ materially from those anticipated or implied by these statements due to known and unknown risks and uncertainties you should not place undue reliance on forward looking statements forward looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our annual report on form 10-K for the year ended December 31st train 18.
Which was filed on March 27, 2020, and our quarterly report on form 10-Q for the quarter ended September Thirtyth 2020, which was filed today.
I would also like to point out that the content of this call includes time sensitive information that is crazy only as of today November 12 2020.
Hi Tech undertakes no obligation.
And to update any forward looking statements to reflect new information or developments. After this call except as required by law.
Now as you know Daria as a leader in women's health innovation, and we are squarely focused on improving the lives and well being of women.
Our value creation strategy is to accelerate availability of new prescription.
For women by selecting and advancing product candidates that we believe have the potential to be first in category and first line and have meaningful commercial opportunity with four clinical stage programs in vegetal house sexual health contraception and menopause.
As we approach the end of 2020, we are.
Particularly looking forward to our phase three top line data readout for our Dare BV one program this year.
Dare BB wine is our potential new first line option for bacterial bad you notice a serious condition that is estimated to affect approximately 21 million women in the us alone many.
Many of the existing therapies.
They are considered to be less than adequate and dare BV. One has the potential to deliver a meaningful improvement in the clinical cure rate over the current FDA approved products.
We are excited to report that enrollment in the phase three study was completed last month and all subjects have also completed their last visit.
We therefore expect.
Back to announce top line data before the end of this year.
During today's call, we will provide additional context on the upcoming Dare BV, one phase three read out as well as next steps toward regulatory submission and the partnering strategy to support eventual market introduction and commercialization.
We will also provide.
Dates on activities to support ongoing development of our novel contraceptive candidate Overtrain and investigational hormone free monthly that general contraceptive under a license agreement with Bayer a world leader in the branded contraceptive market.
And we'll discuss activities, we plan to commence in 2021, including the.
Obese TV for a potential first in category to Dennis So cream program, which is the only program to our knowledge being developed to address female sexual arousal disorder or FSC D. The most analogous to the female sexual dysfunction disorders to rectal dysfunction in men.
Before we provide updates on our anticipated near term value.
Okay drivers, including those regulatory and corporate partnering milestones as well as planned topline data read outs occurring each year for the next three years of calls across several product candidates, we do want to spend a moment, reflecting on the accomplishments to date.
They had been quite a year of firsts for all of us that Purdue.
You did achieved a number of important first that we believe serve as validation of our strategy and our forward looking opportunities.
We started the year in January by announcing our first commercial partnership agreement, specifically bear the marketers of the billion dollar global Marina contraceptive franchise, and Delray announced away.
The license agreement under which bear can exclusively commercialize over frame our potential first in category contraceptive investigational product in the United States. Upon the satisfaction of certain conditions in the agreement, which include a 20 million dollar payment to us by Bayer payable and bears sole discretion. Following the completion of a pivotal trial of overpaying.
Under the license agreement were also eligible to receive up to 310 million in commercial milestone payments plus tiered royalties on net sales in the double digits too.
To our knowledge the transaction, we entered into with bare represents the largest such transaction for any development stage contraceptive in terms of the aggregate disclose mild.
Milestone value.
We believe the transaction validates not only the over preen commercial opportunity, but also darice business model of strategic partnerships to provide capital and achieve commercial objectives.
Shortly after the start of the year as with all life Science companies, we had to contend with the impact of the.
COVID-19 pandemic on our general business operations, and our anticipated clinical and regulatory milestones. However, we were fortunate in that we were able to recalibrate our activities to better align with the limitations of the current environment.
Enabling us to continue to advance our clinical stage programs towards the target topline data readout.
Previously projected.
As a result in June we commenced our first phase III trial at dollar tree, which is a major milestone on its own and we are excited to confirm that we expect to have that top line data readout from the Dare Baby BV free trial, our pivotal study of deer, VB one for the treatment of bacterial about Genesis this year.
Per our previous guidance.
Assuming a positive outcome, we believe the dare BV free phase three study positions us for a new drug application or end da submission in the first half of 2021 and potentially also regulatory action in late 2021.
We were also able to.
Vance another novel program into the clinic during 2020, our Dare HRT, one program, which utilizes our innovative agile ring technology. Originally developed at MIT and offers a potentially new and more convenient way to address the visa motor symptoms associated with men applies in.
In the U.S. alone more than the 45.
It would be in women are estimated to be approaching or are in menopause.
We're excited to share with you that we have been successfully enrolling patients into our dare HR T. One phase one study utilizing a cost and time efficient strategy that leverages, our subsidiary in Australia, and thus our eligibility to receive R&D tax.
Yes incentives in the form of cash payments for conducting the clinical research in Australia.
We started this study our first phase one in Australia through our subsidiary in July and we expect to have top line results in the first half of 2021. If successful. This study could provide important clinical data not only for the Debra.
HRG, one product candidate as a potential treatment for the visa motor symptoms of menopause as I mentioned, but also for dare F. Archie one which utilizes the same badgeville ring technology and also delivers bio identical progesterone as you may recall, we are developing dare f. Archie one as a more convenient treatment option for the prevent.
Action of preterm birth, and broader rutile phase support as part of an in vitro fertilization regimen.
Another exciting development for diarrhea was announced in August when we announced we received a notice of award for a grant from the Eunice Kennedy Shriver National Institute of Child Health and Human development, a division of the NIH to support that phase one clinical.
Study of dairy at 41.
NIH funding is awarded in phases. So the NIH CHD Award granted to date is approximately 300000 and then we may be eligible to receive an additional award for that next segment of the project outlined in our grant application for up to a total of approximately.
Then 2.3 million in grant funding to support that Dare F. R. T. One phase one human clinical study.
And in line with our non dilutive funding strategy in 2020, we also announced in 2020, the receipt of a total of 2.4 million in funding under the current grant for our user controlled the long acting.
18, reversible contraceptive program Dare Lark, one from the Bill and Melinda Gates Foundation.
Dare Lark wine is a potential breakthrough technology as the first long acting user controlled reversible contraceptive solution and its been supported by approximately 20.5 million in grant funding from the Bill.
The Melinda Gates Foundation today.
That's if I were summing up the year 2020, 2020 has been a year of firsts and a year of important milestones for DARI as highlighted in the partnerships. The study initiation the non dilutive capital accomplishments that we have been talking about and we look forward to continuing.
That momentum in 2021.
With that said I'd like to provide some perspective on what we expect in 2021.
First as I mentioned, there are a number of important milestones associated with the Dare BB one program.
Dare BV, one which is designed as a one in done Badgeville administration of 2%.
Thank clindamycin phosphate in a novel Thermosetting hydro gel formulation has the potential.
Central to deliver a meaningful improvement in the clinical cure rate over the current FDA approved products for bacterial imagine notices.
As we previously reported data from an investigator initiated proof of concept study demonstrated a clinical cure rate of 86%.
Hi, I'm a valuable subjects in the study at the test of cure visit that occurred at day seven to 14 days after that single administration of Dare BB one.
In comparison, the currently marketed FDA approved product for the treatment of bacterial that geneticists have clinical cure rates ranging from the mid thirtys to the high sixtys on a percentage.
Your basis.
If scared BV, one delivers a clinical cure rate in the phase three pivotal study that demonstrates superior efficacy compared to that current standard of care range of mid Thirtys to high Sixtys, We believe Deere BV wind could become a new front line treatment option for women diagnosed with bacterial that Genesis.
Importantly, dare BB, one received both fast track and qualified infectious disease product designation from the FDA for the treatment of bacterial badge analysis.
We plan to request a pre anda meeting with the FDA for early 2021, such that we can submit that India in the first half of 2000.
21, assuming the dare BV free study is successful.
Given that we have that fast track and qualified infectious disease product status. The NDS should be eligible for priority review, which if granted would allow for a 2021 PDUFA date and assuming approval in early 2022 commercial line.
In the U.S.
Given the prevalence of bacterial that unisys and the potential benefits of the dare BB one treatment compared to the current standard of care. We are pleased with the partnering prospects and structure is being contemplated for eventual commercialization.
We've always plan to partner this program post the phase.
Laundry study to have the ultimate Optionality on deal structure.
John is going to provide additional insights on how we are approaching the process to capture maximum strategic value for our shareholders, but I want to take this moment to thank our investors for supporting us and putting us in this position to complete the phase III study and exercise.
This optionality that partnering on the heels of those data provide.
We also anticipate important milestones first identical cream and over preen programs in 2021.
In the first quarter of 2021, we anticipate commencing the phase Twob study versus NFL cream, Brazil.
Positioning.
Being asked for a potential top line data readout of that phase Twob study by the end of 2021.
Our potential first in category. So Dennis So Korean program is the only drug product to our knowledge being developed to address female sexual arousal disorder FSC D.
And the potential FSC D market is estimated to be as significant.
Forget if not more so as the erectile dysfunction market in the U.S.
So Dennis will cream as I mentioned has the potential to be the first FDA approved product for female sexual arousal disorder.
And being the most analogous condition to erectile dysfunction in men.
We have selected to that it felt would.
The active ingredient in tablets for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men.
Market research suggest that 33% of women in the U.S. stages 21 to 60 experienced symptoms of low or no sexual arousal and 16% are distressed and our sales.
This solution to improve their condition, let's.
Let's put that in perspective.
In the context of erectile dysfunction, the prevalence of complete erectile dysfunction is estimated to be only 5% of met at age 40, increasing to only about 15% at age 70.
The other.
He phase three candidate in our portfolio is over preen we.
We expect to commence our overprint pivotal study by year end, 2021, which should position us to report topline data for that pivotal study by year end 2022.
As I mentioned ever print is an investigational hormone free monthly virginal contraceptive.
There are currently in development for the prevention of pregnancy, if approved it could be the first monthly non hormonal contraceptive product with the potential to offer a new and compelling option for the ever increasing number of women seeking more reliable convenient and hormone free and monthly contraceptive solutions.
Worldwide sales of the first monthly hormonal contraceptive product Nuvaring were 879 million for 2019.
Over the next several months, we intend to continue regulatory manufacturing and nonclinical activities to advance that ever print program.
We've been using the last several months to align with the FDA.
On the development plan and submission strategy and will continue to utilize the next several months to leverage that pre submission process with the FDA to continue those discussions and prepare to file an investigational device exemption application are ideal for Oprah frame in the second half of 2021 Penn.
Pending the FDA review and.
Clearance of the I'd, we plan to initiate that pivotal study by year end 2021, as I mentioned to support that top line data readout by year end 2022.
If successful we expect this one studies data to support the marketing approval for over print in the U.S. as well as countries outside the U.S. as well.
In addition to the late stage programs already mentioned Dare BB, one so Dennis I'll cream and overpowering.
In 2021, we also anticipate that top line readout for our phase one study of their HR Chyone. The candidate for the treatment of surveys or motor symptoms of menopause and to initiate phase one related activities for both are there.
For a t. one program, which as I mentioned has funding from the NIH and our Dare VVA. One program you may recall that dare VVA. One is our hormone free treatment for valvular badgeville atrophy hormone receptor positive breast cancer population.
Our 2020 results and our 2021 plans demonstrate a feature of.
Our business model that is core to its value driving potential.
Namely the variety of our programs and the diversity of our women's health indications and development stages of our programs enable us to direct our resources and investment across the portfolio in ways that can advance.
Programs against numerous milestones simultaneously in both a time in a capital efficient manner as we have demonstrated even in this challenging environment.
Of course, we recognize that the pandemic and restrictions put in place to slow the spread of COVID-19, do have the potential to disrupt.
Dr business, an increase anticipated development costs and timelines for our product candidates and we will definitely continue to closely monitor the rapidly evolving circumstances career.
Currently however, we remain on track to deliver top line clinical study results and regulatory milestones on the target Toplines timelines Weve just discussed.
I'll now turn the call over to John to provide a business and corporate partnership update thank.
Thank you Sabrina strategic partnerships are core to our model, particularly when it comes to how we plan to unlock value for shareholders and achieve commercialization objectives for our portfolio the level of interest in our portfolio has been and continues to be.
Strong both from well established large pharmaceutical companies as well as mid sized and emerging companies both us and global we are actively advancing partnership discussions that we believe will allow us to maximize downstream commercial execution and provide access to the broadest patient population in the respective therapeutic categories by being good.
Good stewards of these products and partnerships. We believe we can have a positive impact on the lives of women while at the same time delivering shareholder value for those of you familiar with the women's health category. You will appreciate that health care provider dynamics create commercial efficiencies and allow for a targeted call point across multiple indications.
So there are a number of established and emerging entities, meaning commercial companies in the category looking for opportunities to enhance their portfolios and amortize their field sales force costs, which we expect will give us a lot of flexibility in terms of partnership partnership structures timing of partnerships and also finding.
The best fit opportunity to create value for our shareholders and especially as we transition from a commercial excuse me from a development portfolio to a commercial portfolio.
As an example, we believe our agreement with bear for our investigational monthly hormone free vaginal ring over preen provides us with a robust commercial economic structure in the form of.
Milestones and royalties while at the same time gives over premium maximum commercial opportunity by putting the launch and commercialization in the hands of our partner bear as they look to expand or billion dollar contraceptive franchise beyond Marina and beyond the long acting market segment, but we also have the flexibility to look for partnership opportunities for other.
Other product candidates, which may include elements, such as co promotion strategic cost sharing risk sharing and commercial structures, where DARI takes more of an active role without bearing the burden of the commercialization infrastructure and associated expenses, given our portfolio of potential first in line at first in category product candidates and the underlying commercial potential of these cana.
Candidates, we have the flexibility to consider structure that range from directly managing commercial capability to partnering or co promoting our products or to fully licensing the commercial rights and this essentially means we can do what we believe is best for Dory and our shareholders. In every case, we are fortunate to have such a unique and diversified portfolio.
It allows us to be in a position to consider all of these structures, which we are currently dealing with their PD, one and for dare be one we are specifically interested in opportunities that we believe will prioritize the product in a way that will allow us to unlock the most value for health care providers for patients and for payers as well as shareholders. So we look forward to providing you.
With additional insights on the Dare BT, one partnership and commercialization strategy. Following the topline data announcement later this year and with that I'm going to turn the call over to Lisa for a financial update.
Thank you John and thanks to all of you for joining us today.
Now I'd like to summarize diary financial results for the quarter ended September Thirtyth 2000.
20, as you know Gary this is not only to assemble advance and monetize and 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 activity to generate the clinical and other data necessary to advance.
For candidates through regulatory milestones, including approval.
For the quarter just ended September Thirtyth 2020, DARI general and administrative expenses were approximately $1.4 million license expenses were approximately $25000 and research and development or R&D.
<unk> expenses were approximately $6.2 million. In addition to the personnel cost of our R&D team. This quarters R&D expenses, primarily reflects costs of the ongoing therapy. He one phase III study.
Activities related to over pricing.
In preclinical development activities for Daryl Ark one.
With the Dare Lark, one programs supported by our grant from the Bill and Melinda Gates Foundation.
Our comprehensive loss for the quarter was approximately $7.6 million.
Net cash provided by financing activities for the nine months ended September Thirtyth 2020 was approximately $16.7 million.
Such proceeds were generated primarily from sales of stock under our ATM or at the market facility and equity line the exercise of warrants and loan proceeds we ended the quarter with approximately 5.4 million in cash and cash equivalents.
Now there were several developments over the past few months worth highlighting given.
Given their current and anticipated impact on our cash burn in operating expenses.
As Sabrina discussed earlier in August we announced the receipt of a notice of award of a $300000 grant from the Eunice Kennedy Shriver National Institute of Child Health and human development in support of the Phase one clinic clinical.
The city of Dare F. R T. One.
She also noted get there may be guarding may be eligible to receive an additional 2 million award in further supported the phase one study of Dare F. R. T. One for a total of up to $2.3 million in funding based on the grant application submitted.
In September.
We announced the receipt of 900000 of funding that remained under the preexisting grant from the Bill and Melinda Gates Foundation to support their Lark, one development activities and this brings total funding from the foundation for that program to approximately $20.5 million recall that grant proceeds are recognized in our financial statements as.
The reduction or an offset to allowable cost associated with the dare Lark one development program.
Also in September we announced an agreement with avid media under which Abbvie will provide contract product development Laboratory services with the team of specifically assembled the team specifically assembled to support the advancement of.
Of of DARI innovative pipeline in a manner that is both time and cost efficient cost efficient.
In July we commenced our phase one study of Dare HRG, one in Australia, and we intend to apply for the maximum refundable cash credit then available under Australian R&D tax incentive program.
Currently the program allows for eligible company to receive up to 43.5% of their eligible R&D expenses in the form of a cash payment the following year.
So in summary based on these activities, we believe the Australian R&D tax incentive program, our NIH grant for Dare F. R. T. One the.
The Melinda Gates Foundation grant for Dare Lark, one and our partnerships with advertising as well as health decisions, which we discussed during our previous earnings call well collectively served to reduce our cost of development in the months ahead and help us to manage our resources efficiently.
Now subsequent to the quarter's end or for.
For us it's the period October October Onest through November 11, we took steps to further strengthen our cash position by raising approximately $4.5 million net of fees from sales of our common stock under our ATM and equity line follow.
Following these activities and as of yesterday November 11 shares.
As of our common stock outstanding were approximately 38 million.
We will continue to explore ways to access additional capital to advance our product candidates and to satisfy our working capital needs. Since our inception, we have raised cash through the sale of our equity securities M&A transactions.
Warrant and option exercises Nondilutive grants and license fees, we will endeavor to be creative and opportunistic in seeking capital that we need to not only maintain but to build value as we advance our candidates and to be highly efficient in the use of such capital.
In terms of COVID-19 and has to be.
Touched on we are continuing to monitor the pandemic its associated restrictions and their potential impact on our business, our financial condition results of operation, including their potential to adversely affect our ongoing and planned clinical trials and our ability to Billy to raise additional capital.
When needed.
Due to the many uncertainties surrounding the pandemic, including governmental responses, we are unable to predict with any reasonable accuracy, the full financial and business impact on our company at this time.
We encourage investors to review the more detailed discussion of our financials and financial condition liquidity and.
Little resources and the risk factors in the 10-Q that we filed today and to also review our audited financial statements and related notes and risk factors included in our 10-K that was filed on March 27 2020.
I would now like to turn the call over to Chris our operator for Q and a.
Okay. Thank you.
And as a reminder to ask a question for Scott one of the political will.
George Your question. Please press the pound key.
Please stand by opportunity roster.
And our first question comes from the line of Dora July with Roth Capital Partners. Your line is now.
Hi, guys. This is ed by from Matt.
Just had a couple of questions here and thanks again for the update I think the first one just has to do with what everyone. Probably is focused on year. The Donna for diabetes. One does expected before the end the year. If that is you know really encouraging and supportive of.
You know a filing just kind of line now.
How you are thinking about partnership like you're looking for I think you said John was going to provide some details on that so what are you looking for in a partner could you take this Florida alone are you definitely plan to have partners.
Yeah, and maybe I'll take this.
Opportunity to and this is really speaking of course, Ted to reinforce some of the comments that John made to read to really kind of point out how we're addressing that question for you. So.
So one of the things about Darian our portfolio as we both touched on is that it's a very diverse diversified portfolio. We have a number of candidates at various stages in phases of development.
Matt and so that really does allow us to consider a number of types of different transaction structures rights on the one hand, you have the type of transaction that we did with bear for over Preen, which we felt was definitely the right transaction for that product with a partner like bear that has demonstrated they can build over a billion dollars contraceptive brand and with that.
That's the right thing for shareholders to take it with other aspects of our person fully on products like there would be the one we have a lot of flexibility to consider a variety of structures for a few reasons why there are variety of structures that can continue to be accretive for shareholders and there is a lot of ways you can take product to commercialization and they can.
Preclude different structures that range from co promotion to out partnering to fully licensing to managing commercial infrastructures. There's a variety of approaches that we can take and with a product like deer VB. One specifically, we can really actually contemplate all of those approaches. So so it is.
Intended to be and we think has the potential to be a first line product.
Which is obviously a really great opportunity for anyone in the women's health category, whether they have a commercial infrastructure.
In the category Invecture about Genesis or not.
It's a great addition to any women's health portfolio, but also unlike over.
In Crane, we're not looking for someone who can actually build a brand new therapeutic category overprint is so unique that a partnership like like bear is so important to build that category. So hopefully what you heard from John's comments and I am reinforcing is that we are talking to a number.
Potential partners around VB one.
But we are looking at a full range of structures and possibilities.
As it pertains to that and in the end we are going to select the structure that we think best fits with dairy strategic objectives and shareholder value and the beauty is that we have a lot of flexibility in what we select because.
Sales of how we're structured today.
Yeah, and I would just echo thats exactly what I wrote down actually when you asked the question. So it's really about maintaining our optionality really creating value for shareholders and making sure. We're maximizing the opportunity and then really finding that best fit opportunity that best fit partnership structure. So that's to be determined obviously, we never announce anything until we have something.
You know to announce but know that we're working hard on the backend to make that happen.
Thank you and then another thing I was just wondering in terms the structuring of the deal is it possible that you could doing to dental bill.
Too bad because that's progressing very well and I think there are some synergies now.
Yes. Thank you first of all.
Before.
Recognizing that we have a portfolio of products and it does give me an opportunity to say I mean, one of the beauties of having a portfolio and I touched on this in my comments and I want to take this opportunity to reinforce that.
That fact that we have a variety of programs that they are diversified across indications and development stage.
Not only does it give us the opportunity as I mentioned to deploy our resources and very creative ways and deploy investment in creative ways and create opportunities to advance things simultaneously that have very different risk profiles and timeline profiles, even in a challenging environment, but the other thing it allows us to do frankly is all.
Ways be in front of all of the players in the women's health space and also continue to look at a variety of creative structures that dollar is uniquely suited to do in the women's health category to our knowledge. We're the only company that has a portfolio of this nature of these kind of first in category opportunities across therapeutic indications.
And as you noted that unique mix of our portfolio can.
Provide unique partnership opportunities. So we are always always exploring you know what is going to make the most sense and as John noted partnerships. It's about who is the other party what structure makes sense, but sometimes also timing.
So we're we're weighing all of those variables as we look at and for Daryl maybe one for instance, we specifically purposely made a decision as I mentioned up front to partner after.
Phase three top line readout, because that puts us in the strongest potential for that program, but as you noted other programs provide different types of partnership opportunity.
The reason, we will explore those fully.
Thanks, guys looking forward to the data.
Yes, you are we [laughter]. Thank you.
Thank you and as a reminder, ladies and gentlemen, if you would like to ask a question on the strong Q1 can you touch tone telephone to draw your questions.
And as the pound.
Our next question comes from the launch of Jason Kolbert Dawson.
Dawson James Your line is open.
Hi, guys. Congratulations on a lot of fronts preservation of capital on the balance sheet I see that as positive and keeping your options open and when it comes to partnering in terms of BV.
Juan I think it would be helpful for me and maybe for others. If you could just remind us of the trial powering and the therapy assumptions. So that we can just re familiarize yourself with the probabilities of you know.
Of hitting the primary endpoint and what would be perceived as.
You know great data thanks.
Thank you for that question and that opportunity to highlight that show.
Let's start with the current standard of care today. So the current standard of care have cure rates in the mid thirtys to the mid Sixtys.
So that's all you're after FDA approved.
Products for Vectra about Genesis and that includes oral as well as badge and all methods.
The challenge with bacterial imagine as his treatment is that.
Many of the treatments on the market require administration over several days, which is often challenging both in terms of compliance in that outcomes.
So on top of the cure rates you have the challenges and just how those many of those products are administered and so.
But however.
They tend to rely upon to have the same antibiotics predominantly metro.
Veterinary dollar clindamycin. So in the case of BV wind, we are using to per.
Same clindamycin, its a dosage form and a antibody.
Antibiotic that has been previously studied in bacterial Badging Insys has a cure rate in that range that I talked about.
The challenge and physicians typically inpatient prefer of agile administration in this indication because of the types of syn.
Symptom she's experiencing there's benefit to delivering something that Italy.
Given also that it's a highly recurrent condition. So you want to avoid as much as possible recurrent administration of oral antibiotics. The challenge with agile administration is frankly, just keeping the product where it needs to be.
So products tend to leak out badge.
Finally, and that is likely what has negatively impacted the cure rates of antibiotics like clindamycin that really our time core they need to be present, you need to have the resident to fight the infection. So the innovation and Debbie VB. One is that drug delivery platform. It's the hydrogen thermosetting hydro gel formulation that is quite this good.
He says and thermosetting so becomes more so went to teeter body temperature and not one and done delivery. So it's just one administration of of the product.
So she only has to do it once it.
In terms of you I'm going to turn to the cure rate in the trial design. So the nice thing about back to imagine nuances in terms of clinical studies.
And is that pretty much you know weve across time essentially.
As products have been developed and back to your original says they're looking at some permutation whether booking a two or three or four but it's always been kind of the same sort of clinical signs and symptoms that distinguish the condition and become part of the cure.
Sure.
Calculation and in the recent years the FDA actually in 2018 finalize their guidance. So typically youre looking and now you're specifically looking at whether there is resolution in a very distinctive agile odor that is present.
Very distinctive agile discharge that its president with spectra of engineers is.
And then you're looking for a reduction.
Specific percent reduction down to below 20% in a type of cell called clue cells that are associated with this sort of you know inflammatory sort of response.
So that that is how you determine cure and like I said that that same array of symptoms.
Mentioned mph is looked at as well has been looked at kind of across time of the products that have been approved for back to your budget is so.
So with our program given that the range right now of the approved treatment is mid thirtys to mid Sixtys.
Most of them with few exceptions are multiple dose administration.
There are.
Onetime badgeville and onetime oral but most of the products or multiple dose administrations.
Frankly, a cure rate in that high end of that range is great.
Because this is a onetime administration, it's a very clean formulation, it's a statically because of how bioadhesive. It is there are some features and benefits that are.
Our attractive to potential user and this is all data by the way. There were also had captured in the phase three is around that acceptability and her perception of the product.
That.
Investigator initiated pilot study using that same criteria, but at day seven to 14 Im going to talk about.
The time points in the second showed that 86% cure rate in it and it maintained in that 80 range even out today 21 to 30, and so you know we love to see cure rate in that range, but your question of like what do we need we don't need that range, we'd love to see it you know anything that shows an improvement over.
The standard today of the mid Thirtys to mid Sixtys and given that this is a onetime bajirao clear gel formulation is definitely very attractive.
In terms of the trial design and what you should expect so we announced in the Q that there were a total of just over 300 patients that we ended up enrolling in the study.
Little bit higher than we.
That did so one thing I'll say is that you're hearing a lot about co bid and impact of coded on studies.
We did not see any impact.
On enrollment in that study and in fact, we ended up over our enrollment target because of how how fast enrollment was going and you know what we need to do.
To support that and so we ended up a little higher than than what we had expected which is fine.
It's two to one active to placebo. The primary endpoint is that test of cure assessment that I talked about that badger loader discharge and crew sales returning to.
Non BV state.
At day 21 to 30.
[music].
So I'll I'll also highlight that our clinical programs. This spring.
You know if you're going to pick two clinical programs to run during covered I would say, our BV wine and our HR team one program to reset of our portfolio, where the obvious choices for us. They are both 30 day studies, so they're fairly quick for the patient.
In terms of duration of commitment and they allowed us frankly to get a lot of really valuable information that we are now using as we're planning for us with NFL cream, an overprint studies, which are which are longer you know what your longer than a month.
So in terms of why you should expect we own when we announce topline it's really.
Really around that primary endpoint, which is test of cure.
In.
You know the active arm versus placebo.
And we're looking for statistical separation between the two.
Of course, thank you that was really really helpful. On that was a great reminder, for me good luck. Thanks.
Thank you.
Yes, we are we're obviously you.
No really exciting excited about it it's always.
The first phase threes is super exciting.
For one year at a company.
Thank you.
And this concludes today's question and answer session I will now turn the call back disagree no more to Johnson.
For any closing remarks.
Yes. Thank you we went a little longer than anticipated. So thank you with your your patience and sorry to have to start the Q and a little earlier than we hope, but thank you all for attending the conference call.
We really appreciate you taking the time this afternoon, so I do want to take a couple of minutes.
So I really want to leave a couple of minutes just to.
Brian we talked about so.
As I mentioned, we're really looking forward to wrapping up 2020 without phase three top line data readout for Dare BV wine and we're looking for the milestone events that we planned in 2021 and to get to move forward on those so specifically I just want to close the call with a reminder of what we're expecting in terms of theirs.
Some key milestones for our mid and late stage programs for the remainder of this year and then like I said going into 2021, so as we've been discussing for Dare BV. One we've got that phase three top line data read out before the end of this year, assuming a positive outcome. The data from this study would lead to a series of regulatory activities to support that Andy Ace.
Submission in the first half of 2021, which is our target and as we've been talking about as well that strategic partnership to support the commercialization in the United States.
So Dennis so for our arousal disorder program as I mentioned, we intend to and plan to start that phase Twob study.
In the first quarter.
2021, we expect that should support a top line data read out by the end of 2021 for that phase two b.
And then as I mentioned also overprint activities to support the pivotal study start by year end 2021 or are certainly something we're working on and that we believe would continue to allow for top line data readout by the end of 2000.
Me too.
As I touched on briefly but want to remind be on the lookout for the dare HRT one phase one top line data readout in the first half of 21, and then as I mentioned you know, we also expect to be making announcements in 2021 about the phase one related activities for both the Dare F. Archie one program under that NIH Grant.
Rent as well as Dear VVA, one in that breast cancer population.
And as John noted in addition to the clinical and regulatory milestones and as we've been discussing in the Q and a.
We will of course continue to focus on our ongoing partnering activities and opportunities to monetize our pipeline of potential.
First in categories Womens health products.
Across the entire portfolio as we've been discussing and across geographies as John mentioned, so we look forward to keeping you updated on our progress and we are grateful certainly obviously to our team, but importantly to our shareholders for their commitment and dedication to our mission. So thank you for taking the time.
Today.
Thank you ladies and gentlemen. This concludes today's conference call. Thank you for participating and I'll just.
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