Q2 2020 Dare Bioscience Inc Earnings Call
And to provide a general business update.
This call is being recorded.
Names Krish and I'll be your operator today.
Well this today or Sabrina Martucci, Johnson, Dorries, President and Chief Executive Officer, John Fair, The race, Chief strategy Officer, and Lisa Waters Hoffert, No raised Chief Financial Officer Mr. Johnson. Please proceed.
Thank you well go try financial results and business update call for die by the science, we're looking forward to discussing our second quarter results in highlighting recent developments and anticipated milestones for the remainder 2020 and beyond.
Before we begin I'd like to remind you that today's discussion will include forward looking statements within the meaning of federal Securities laws that you made pursuant to the safe Harbor provision at the private Securities Litigation Reform Act of 1995 I statements made during this call they're not statements of historical facts you considered forward looking statements.
Actual results or events could differ materially from those anticipated or implied by these statements do the I know I've known risks and uncertainties and so therefore, you should not place undue reliance on forward looking statements for these savings are qualified in their entirety by the cautionary statements in the company's FCC filings, including our annual report on form 10-K for the year I did.
December 31st training team, which is filed on March 27, 2020, and our quarterly reports on form 10-Q for the quarter ended June Thirtyth 2020, which was filed today.
I also like to point out to the contents of this call include time sensitive information that is correct only as of today August 12 2020.
Dairy takes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.
[laughter].
As you know Jari is a leader in women's health innovation, and we're squarely focused on improving the lives and well being a button.
Our value creation strategy is to accelerate availability of new prescription products for women by selecting and advancing product candidates that we believe has the potential to the first thing category and first line and have meaningful commercial opportunity. This clinical stage programs in contraception Badgeville health effects.
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Our contraception pipeline includes our novel contraceptive candidates over cream and investigational hormone free must see badge O'connor contraceptive to send your license agreement with bear a world leader in the branded contraceptive market.
It includes Denmark, one a potential first in category long acting user controlled contraceptive the development of which has received substantial funding from the bill and Melinda Gates Foundation.
It also includes dare RH, one a novel contraceptive target that has the potential to be the first contraceptive solution that can be used by women and men.
And Oh, RB to afford to win for potential six and 12 month injectable contraceptive.
Contraception as you May know is one of the largest categories in women's health accounting for over 5 billion in prescription sales in the U.S. alone.
In addition to our contraceptive pipeline, we're developing a potential new first line option for the more than 20 million women in the U.S. estimated to be affected by bacterial back units is a persistent and serious infection that is not adequately addressed by currently available therapies.
Our product candidate Dare VB one.
Currently in a phase three clinical trial with anticipated topline read out this year.
Has the potential to deliver a meaningful improvement in the clinical cure rate over the current ft approved products.
And our potential first in categories did any so cream program is the only program to our knowledge being developed to address female sexual arousal disorder or FX a D. The most analogous to the female sexual dysfunction disorders to erectile dysfunction in bad.
And the estimated ethics AG market is expected to be adds significant if not more so as the of rock child dysfunction market in both the U.S. and the rest of the world.
In terms of near term anticipated value drivers. We're currently conducting two clinical studies and anticipate having top line data read out each year for the next three years across four different indications with four unique product candidates.
And we've maintained the pace of our product development and regulatory activities necessary to remain on track to achieve key clinical and regulatory objectives that we have previously disclosed.
That was all life science companies, we continue to monitor the impact of the Cobot 19 pandemic on our general business operations, and our anticipated clinical and regulatory milestones.
Today, though we have been 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.
[noise], namely we commit to clinical trials. This year that we felt were the most conducive to run during the restrictions that koby 19 imposes on in person visit frequency and steady contact.
Specifically in June we initiated that pivotal phase three clinical trial of Dare BD, one for the treatment it back to imagine it says.
As I mentioned previously back to imagine if this is a condition estimated impact over 20 million women in the U.S. alone.
And this phase three trial is assessing their BD, one as a potential new treatment for this acute infection.
So much women are not postponing care. According to our study investigators and that's we initiated this study and remain on track to report the studies topline results by the end of this year.
[noise] Dare VB, one is a novel thermosetting bioadhesive hydrogen containing clindamycin phosphate, 2% and it's being developed as a one time bad you know administration for the treatment it back to your imagination.
As we previously reported data from an investigator initiated proof of concept study demonstrated a clinical cure rate of 86% of a valuable subjects in that study at the test of cure visit that occurred seven to 14 days after a single administration of Dare BD one.
In comparison currently marketed ft approved products for the treatment of act here that you know says have clinical cure rates ranging from mid Thirtys to high sixtys on a percentage cured basis.
It's dare be anyone delivers a similarly high clinical cure rate in the phase three pivotal study, we believe there BT one could become a new frontline treatment option for women diagnosed with back to about geneticists.
[noise] Directv why did we see both fast track and qualified infectious disease product designation from the F.D.A. for the treatment effect here that you know says.
A drug they received fast track designation is eligible for more frequent meetings with the FDA disgusted drugs in development plan and ensure collection of appropriate data needed to support drug approval more frequent written communication from the FDA about such things as a design and the clinical trials and eligibility for it.
Celebrate approval in priority review, it's relevant criteria are met.
Turning to another candidate we believe will be a value driver in July we announced that we initiated our phase one clinical study of Dare H R. T y.
A novel International being designed to deliver non oral bio identical hormone therapy for the treatment of menopausal symptoms.
[noise] Dare age or T. One is designed to deliver bio identical after dial and bio identical progesterone continuously over 28 day period, and it's being developed as a potential new option for hormone therapy for the treatment evade the motor symptoms, commonly called hot flashes and agenda to urinary symptoms.
Ben it's hard to prevent bone loss in fracture associated with menopause.
More than 45 million women in the U.S. are approaching or in menopause.
The north American minutes onto side here in the hands, which is known for its thought leadership and evidence base menopause treatment guidelines supports the use of hormone therapy in Perry and postmenopausal women and recommends administering both after to introduce symptoms and progesterone to prevent thickening of the Union wall.
And observes that non oral routes of administration may offer advantages over or they administered therapy.
Dear HR T. One has the potential to see the first ft approved interventional, bringing or Ivy our products to meet the NAND guidelines.
We believe the phase one study of dare each or T. One goal for quite important scientific information for both their HR T. One, but also for Dare F. R. T. One which is another candidate in our portfolio, but she's why did that same IDR technology as dare H.R.T. wine and that same bio identical forget.
John It's an active ingredient.
Specifically that this phase one study will evaluate the ability you dare HFC wind to achieve its target dual release objectives.
As was the ability of the IDR technology to release two different active at two different rates.
In addition, we anticipate collecting useful pharmacogenetic characteristics of the bio identical progesterone alone, which can be expected to directly apply to Dear F. Archie one which is our bio identical progesterone only ivy are that we are developing as part of in Invitro fertilization regimens with your face support.
As well as the more convenient treatment often option for prevention of pre term birth.
The phase one study of their HR T. One is being conducted by our wholly owned Australian subsidiary at specialty Women's health sites in Australia.
This is going to provide an overview on the Australian tax incentive program for which our subsidiary will apply for cash payments for eligible study expenses, which will offset cost to the program.
We expect free port the topline data from this study in the first half of 2021.
Turning now choice it NFL cream and other preen studies, we believe we'll be in a position to commence both of these studies and 2021 and still maintain our prior guidance with respect to top line data readout for those programs.
Specifically first it and so Crane program, we expect to report topline results to the planned phase Twob study in 2021.
You may recall that we announced in December 2019, the important to mind that we reached with the FDA on the phase Twob study design as a novel patient reported outcomes, which I'll refer to it pro instruments she'd be measured to assess the achievement of the primary efficacy endpoint.
So then it so cream, 3.6% has the potential to be the first ft approved product for female sexual arousal disorder.
As I mentioned earlier FX C.D. is the female sexual dysfunction disorder, most analogous to erectile dysfunction in that.
And so that we sell is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagras for the treatment of reptile dysfunction in men.
Our seed NFL cream is a topically administered formulation of that seems to the NFL, which means that active ingredient is delivered in a Korean formulation that is it's like locally by women to the general tissue. It's designed to increase local blood flow and thereby improve that general Ralph will respond to using that same.
Same pathway, that's acted in erectile dysfunction medications for men.
Well the oral version of to Dennis all its affected for men. This side effects associated with the oral formulation are particularly challenging for women and therefore oral deliver is delivery is not an optimal way to achieve that same around the response and limit.
With the potential to deliver sit NFL and in fact acting cream. They can be applied locally. The formulation has been designed to offer those same benefit to that increased blood flow and improvement in that general sexual Ralph response with ouch, the systemic issues observed with the oral formulation.
[noise] as I also mentioned, we believe the Epas safety market is as big or bigger than the erectile dysfunction market.
Market research suggests at 33% of women in the U.S. Ages 21 to 60 experienced symptoms of low or no sexual around.
And 16%, which is approximately 10 million women in the U.S.
Our distressed and they're seeking a solution to improve their condition.
To put the market opportunity for an F. FDA approved FSC de treatment in context.
The prevalence for the mail version erectile dysfunction is estimated to be just 5% of men age 40, increasing to just about 15% at age 70.
The plan phase to be steady incidentally, so cream will utilize that agreed upon pro instrument to measure achievement in the primary efficacy endpoints, namely improvement of localize general sensation tip arousal and reduction in distress and remember that the safety experience.
We continue to focus our efforts on preparing to initiate that phase Twob study such is preparing the electronic diary and conducting other startup activities as long as other nonclinical activities to support that future NDS submission.
As I noted that phase TV study is designed to evaluate genetic acquaint cream versus placebo over a 12 week dosing period by study subjects in their own home setting and that'll followed with a non drug and a placebo run in period and as I mentioned earlier, we expect to report top line results of the study by.
By year end 2021.
And we expect to report topline data for our planned pivotal study for evergreen by yearend 2022.
Other green as I mentioned upfront is our investigator investigational hormone free monthly Badgeville contraceptive.
Currently in clinical development for the prevention of pregnancy.
If approved it could be the first monthly non hormonal contraceptive product.
And earlier this year bear the marketers of the billion dollar global Marina franchise.
All right now our license agreement under which bear can exclusively commercialize ever printing in the United States. Upon the satisfaction if certain conditions in the agreement, which included $20 million payment to us by their payable appear sole discretion. Following the completion of our pivotal trial of evergreen.
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.
There is supporting our development and regulatory process for ever frame.
Biting internal experts in advisory capacity.
These resources have already added value to the planning and implementation of the as a preclinical regulatory manufacturing and pre commercialization planning work streams.
More information about the terms to the agreement can be found in our filings with the FCC.
We believe the licensing agreement with fair is validation of our.
Water strategy, and certainly confirmation of evergreens market potential as the first must be non hormonal contraceptive product.
There is committed to bringing to market innovation in women's health and maybe only company as I mentioned to Delta contraceptive brand family brand family and accepted a billion dollars.
With regards to ever created over the next several months, we intend to continue the regulatory manufacturing and non clinical activities needed to advance the programs.
We've been using the last several months to really to align with the FDA on the development plan and this emission strategy and we're going to continue to utilize the next several months to.
On go and keep on going those discussions to leverage this pre submission process with the FDA and continue to discussions as we prepare to file an investigational device exemption application or I'd for ever Crane.
In light of these discussions and our intent to commence enrollment into pivotal contraceptive effective and safety study of overprint in 2021.
Our plan is to file the idea next year, and then pending FDA review and clear to the I'd. He we would plan to go ahead and initiate the study before year I 2021.
That supports that time when supports a topline data read out by year end 2022, as we have guided.
And if successful we expect that study data to support marketing approvals for as a premium in the U.S. Europe and other countries worldwide.
We believe that's a variety of our programs and the diversity of our women's health indications and development stages enable us to direct our resources and our investment across the portfolio in ways that allow us to advance our programs as we have continued to do in this challenging environment.
Of course, we recognized that the cobot 19 pandemic any restrictions put in place to slow it's Brad have the potential to disrupt business and increase anticipated development costs and timelines for our product candidates and will therefore continue to closely monitor that rapid evolving circumstances.
Currently however, we remain on track to deliver the topline clinical results is misguided as well as the regulatory milestones on the target timelines, we just discussed.
We believe our financing strategies, such as our aftermarket program and the equity line establish earlier this year together with the flexibility in capital allocation afforded by our business model provides optionality on how and when we raised scout capital that support and aligns with enhancing.
Shareholder value.
Further we expect that pricing structures and dedicated staff and expertise in clinical development of women's health products provided under our agreement with the contract research organization helped decisions that we announced in May well continue to support acceleration of clinical development of our reproductive health assets.
In a capital efficient manner.
And with that I'll now turn the call over to John to provide a business and corporate partnership update.
Thank you Sabrina and good afternoon, everyone I'm pleased to provide you with a brief update on our ongoing alliance with bear support the continued development over brain for its first in category contraceptive potential the relationship continues to be highly productive and value additive and our collective teams have achieved achieved alignment across key areas, including clinical nonclinical.
We work streams.
There as we mentioned is a worldwide leader in branded contraceptive sales and marketing and their insights and expertise as applied to overprint continue to be invaluable in our opinion.
And those would be familiar with our story know that partnerships and out licensing transactions are core to our model. We remain very encouraged by the level of interest in our portfolio and we continue to proactively pursue meaningful partnership opportunities with well established and emerging companies. Both in the U.S. and global that are focused on delivering new innovation to women naturally well.
More to say, if and when agreements are executed, but I want to highlight at this time that this is a priority focus for our company and we are actively exploring partnerships that we believe will allow us to officially advance the portfolio and achieve the broadest commercial access opportunity possible well at the same time maximizing shareholder value.
With that I will turn it over to Lisa to give you a financial update thanks, John Hey, everyone and thanks for joining US today I would now like just summarized our financial results for the quarter ended June Thirtyth 2020.
Juries business model is to assemble advanced 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 cost and research and development activity to generate the clinical in other data necessary to advance our candidates through regulatory milestone.
Loans, including approval.
For the quarter ended June Thirtyth, 2020, Dairies general and administrative expenses were approximately $1.6 million license expenses were approximately $21000 and research and development or R&D expenses were approximately $5.6 million. In addition to the personnel costs of our RF.
The team our primary research and development expenses. This quarter included worked to prepare for and just start hard there may be one pivotal phase three study.
Ongoing regulatory affairs and other work related to overpowering.
And preclinical development activities for Dare Lark, one which is Sabrina had noted are supported by our grant from the Bill and Melinda Gates Foundation.
Our comprehensive loss for the quarter was approximately $7.1 million.
Net cash provided by financing activities for the six month ended June Thirtyth were approximately $11.3 million. This represented cash from sales of stock under our aftermarket or ATM facility and equity line exercise of warrants and options and loan proceeds we ended the quarter.
With approximately 5.3 million in cash and cash equivalents.
Now there were several developments over the last four and a half mines that are worth highlighting given their current and anticipated future impact on both our cash burn and our operating expenses. So first in April we received final notice of award of approximately $731000 of the total $1.9 million in Grand fun.
Moving from the NIH for certain over preclinical development activities.
When moneys are received under this NIH grant they are recognized in our financial statement as a reduction to the over preen program development costs.
In May we announced a partnership with helps decisions, which is the CR ROE specializing in women's health clinical research and diagnostic development.
This agreement provides for dedicated resources and new pricing structures, both of which together with helps decisions expertise in established relationships are expected to accelerate the clinical development of key programs and to do so in various case in a cost efficient in capital efficient manner.
In June we announced the receipt of the $1.6 million, an additional grant funding from the Bill and Melinda Gates Foundation, just important development activities related to down Lark one.
Grant proceeds in this case are recognizing our financial statement as a reduction or or an offset to the allowable costs associated with the dare Lark one development program.
And finally in July as Sabrina had noted instead I would expand upon we initiated a phase one study of our Dare HR T. One program in Australia.
The Australian government had created attractive incentives for conducting research and development in the country.
Currently Australia's research and development tax incentive gives 43.5% of every dollar spent by eligible companies on eligible R&D activities back to those companies in the form of a cash payment.
At the conclusion of the Phase one study our Australian subsidiary intends to apply for the maximum refundable cash credit then available under this program.
[noise]. So in summary, we believed that the Australian R&D tax incentives are NIH grant proceeds from that Bill and Melinda Gates Foundation Grant and our partnership with health decisions will collectively served to reduce our cost of development in the months ahead and help us to manage our cash resources efficiently.
Subsequent to the quarter's end so in our case this would be from July Onest through August 11th we took steps to further strengthen our cash position by raising approximately $3.5 million net of fees from sales of stock under our ATM equity line and from warrant exercises follow.
I mean these activities shares of our common stock outstanding on August 11 were approximately 31 point sixmillion.
We will continue to explore ways to access additional capital to advance our product candidates and to satisfy our working capital needs and other liquidity requirements for the next 12 months.
Since our inception, we have raised cash through a variety of ways from the sale of equities M&A transactions, Lauren an option exercises non dilutive grants and license fees.
We will endeavor to be creative an opportunity opportunistic in seeking capital.
And we need to not only maintain but to build the value as we advance our candidates, but we also seek to be highly efficient with the use of such capital.
In terms of Cobot 19, as Sabrina discussed we are continuing to monitor the pandemic is it's associated restrictions and their potential impact on our business financial condition and results of operations, including the potential to adversely affect our ongoing and planned clinical trials and our ability to raise capital when needed.
Okay.
Due to the rapidly evolving circumstances and 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, our liquidity and capital resources and our risk factors in the 10-Q filed today and to also review our audited financial statements related notes and risk factors included in our 10-K, which was filed on March 31st 22.
Right.
I would now like to turn the call back to Sabrina.
Thank you and I will turn the call back over to the operator, who can now open the lines for any questions.
Thank you and as a reminder to ask a question you need to press star one of your telephone.
Joe Your question. Please press the pound key.
Please stand by what we compile the Q1 a roster.
Our first question comes from Milan meet been Weinstein with Aegis capital Your line is out.
Okay.
Hi, good afternoon.
Sabrina olefin John Thanks for taking my question that congrats on the progress in the quarter.
Well move moving pieces here I guess just to start with.
You moved their age for T. One up so maybe just philosophically kind of what was behind the decision and just in general how do you decide kind of which products moving to containers.
Thank you anything that's a that's a really great questions. So there are definitely a number of factors that are involved and you know because everything in our portfolio pretty much has an opportunity first and category right. So they're all super exciting from our perspective opportunities and they're all products. We also select.
Good for the portfolio because their potential attractiveness to partners.
With the H R. T. One program in particular, we saw a few really compelling reasons to want to get that program moving forward.
So if you'll indulge me I'll highlight each of them.
Why is from a marketing commercial perspective I touched on the fact that this has the potential to be the first product frankly to actually meet the NAND guidelines in terms of delivering the hormones.
In a way that is non oral non says you know non systemic delivering them badgley and in a very convenient. Once every 28 day route with both hormones together and there are significant data demonstrating that hormone replacement in women, who can use day I'm can be very impactful and not only addressing those since.
That she experiences amenitized, but importantly, also cardiovascular and bone health as well so the program from a market potential is very interesting, we obviously want to moving forward.
On a practical consideration as well this phase one study is quite efficient from two perspectives and these are my other two points of that I wanted to make in terms of how we selected to advance. This one right now.
One is conducting the study you know in Australia, certainly offers as some and.
Very meaningful cash [laughter] incentives in terms of the cash rebate. So it essentially with that currently 43% we re they basically cuts the cost of conducting the study to tell almost in half and so it makes it a very capital efficient plays to conduct to study and also right now in the cities and centers that were working with.
With their cobiz situation. It was very practical study to get up and running.
From that perspective.
And further it really gives us an opportunity to not only validate.
H.R.T. wine in our portfolio, but because HR T. One is delivering together, both progesterone and extra dial and we have another similar vegetal ring in our portfolio, that's delivering only progesterone. The exact same progesterone in the exact same type of agile ring.
Third reason as is an exciting programs advance at this time is that.
We're basically it's like a two for one [laughter] you know not only are we getting phase one data on HR T. One, but we're getting basically phase one data at the same time.
On F. R T. One and F. R. T. One is that progesterone only 14, Dave agile ring that we are looking to move forward for not only pre term birth, which is obviously a very important condition to give women an option that is going it has potentially much more convenient that anything that's available to them today in terms of.
Injections are bad general gels that have to be does frequently.
But also as part of any Invitro fertilization protocol, where women need progesterone for video face support and similarly, the options available today are very cumbersome.
So hopefully those three reasons gave you a sense.
This particular program the market opportunity the practicality of running the trial when it cobot environment has a very cost efficient way and the fact that really its valid going and can be validation for two of our programs such as one are wide led us to move that program and that study forward.
In the portfolio.
That being able to pick that frankly without affecting the timelines for other read assets right. It doesn't in any way disrupt.
Maybe one data read out this years to them. So read out there we're targeting for the end of next year and overpaying for the year thereafter show.
Nice way to slotted into the portfolio without disrupting the other programs are traveling.
Great. Thank you that's really interesting.
Comprehensive answer and so I guess.
Another thought a question here on the pipeline in terms of the competitive dynamics and when themselves and you have a number of products that are coming along.
Have you seen anything in the landscapes, that's shifting in terms of competitive dynamics, there unless you think differently about Europe. The portfolio priorities now I guess versus six or 12 months ago.
Another great question Nathan Thank you.
I have to say it is it's something that you know we look at all the time, we look at in the context of making sure that we are using our shareholders and our donors and our you know our money as absolutely wisely and strategically as we can choose to build value. So we really do critically bucket.
Portfolio at all times can make sure that we're prioritizing programs in the right way and we also use that outward focus lens to make sure that we continue to have the most robust portfolio in women's health really across.
The most persistent unmet needs and interesting indications. So it is something that we go through very frequently and frankly with the beginning of co fit Coker said, we did it quite seriously looking across our portfolio because at the beginning of the pandemic really.
Affecting companies and with the shelter in place. We also wanted to take a hard look at what trials can we conduct right now how can we keep our timelines on track and how can we use our our dollars adds efficiently to.
Really build value robustly in a time period, where for a lot of companies, it's probably hard to do.
And so that's a very long answer a long way of saying, Yes me than we do that all the time and we came out the other I know that still very happy with our portfolio and you know continuing to feel that really across the portfolio. The programs are relevant they're continuing to have that potential to address some of them as purchase persist.
And that D needs and maybe most important given our business model I Partnerable and address those commercial needs that the companies that are focused and investing in this health care space are interested in.
Great. Thanks for being in just a final question for me in an ongoing conversations one of the fuel that keeps coming up is the perennial under investment that's going on in women's health and enough to comment on the U.S., but I guess this question is really about the international markets for your future products is maybe called.
Thanks for the commercial arena, what do you see opportunity in key markets like Europe, and Asia and those investment in women's health in those markets a lag behind the U.S.
Yeah money I'm going to turn over to John to give you. Some perspective, because you know you need to draw a lot of we've been doing is as you mentioned talking all the time [laughter] onto all of my potential partners.
The U.S. in Europe, and as Hill as he'll share. The interest has been you know robust really across continents, you know in our portfolio, but let me let him know thanks to that I think it's a great question I think it dovetails nicely with your previous question too, which I will just to add to that that's one of the reasons. We look at categories that can really be first in category or options.
Every person category. So that we're not immediately competing with something that's already there and that by the way plays very well across the globe not just across the country because all of these opportunities really become a innovation in a themselves and so we look at our European opportunities there as bigger as rich as they are the U.S. and those discussions are you know.
Really have been really meaningful and as I mentioned, we've only talk about them. When they are something to talk about but we are in really deep discussions are across a variety of assets in the portfolio across a variety of territories. So more to come on that but great question. Thanks Roswell.
Hi, guys. Thank you so much for taking my questions and congrats again on your progress in the quarter.
Thank you very appreciate it.
Thank you and again, ladies and gentlemen, as a reminder to ask a question for me to press Star one of your telephone into Joe. Your question. Please press the pound key please stand by we can probably 20 Ross.
Your next question comes from the London, Jason Mccarthy with Maxim Group. Your line is now open.
Hi, guys. This is Joanne Lee on the call for Jason Mccarthy. Thank you for taking my question and congrats on the progress this quarter I just one from me I know, there's a lot going on with activity grew by the company pipeline feared over praying Darby be one all entering its a pivotal.
Stage and I was just wondering if you could perhaps expand a little more on your DARI large one program I'm. If I recall this product was acquired through the Microchips acquisition and I was just wondering if you could provide some details on the timeline for this program and it's perhaps if the study design an endpoint could possibly reflect those if overprint they're both.
The team contraceptive space.
Yes. Thank you for asking about that program, it's it's one where.
There's just a lot of interest [laughter] in that in that program really across constituents.
In that and the women's health space because it is such a novel technologies to just for the benefit of everyone.
They're block one as I mentioned today user controlled long acting reversible contraceptive technology. It's in implanted device that really allows the user the flexibility to have.
Effective contraceptive over several years.
But have the ability to turn it on or off as needed without removal of the device. So this is a very very significant innovation in the contraceptive category. There really is not anything like that certainly you know available at this time and that is why for instance, the don't love The Gates Foundation.
Jim which as you mentioned that front has been has.
Contributed quite significantly to the development of this technology you know has been continuing with their grant funding of the product at this stage and its development. It's a preclinical programs still we are in the midst of animal studies.
With that technology really looking at that drug release. It is designed to release hormonal contraception.
In this case, obviously the technology itself is an exceptional platform that can be used flank frankly for any indication where someone wants to deliver drug over long period of time and have the flexibility to increase or decrease dose or turned on or off so while we're obviously exploring contraception first this work that the bill on the billing.
And the Gates Foundation of and funding really is validation for the technology in general and the platform in general. So at this point you know it's in that preclinical stage, but we're definitely excited.
With with this work, which will continue into next year and hope to have some exciting news to share from that in terms of what the next stages are with the with the program. After we complete this preclinical assessment.
Okay. Thank you that was really helpful. Thanks for those details then again congratulations on progress.
Thank you.
Thank you.
And ladies and gentlemen, this does conclude today's question and answer session. I will now turn the call back to Sabrina Martucci Johnson for any closing remarks.
Well, thank you Chris and thank you all for taking the time this afternoon.
So maybe as summarized on you know as we highlighted will continue to focus our near term efforts on the conduct of our Dear BD one phase three study this year.
With the topline data expected by the ended this year.
He talked about the Dare HRG, one study is underway and well continue those activities and obviously, we'll continue all the startup activities and other non clinical work necessary to support our overall program program objectives for both to the NFL and other crane and as I mentioned keeping them on track for those respective.
Topline data Readouts in 2021 and 2022.
And we'll also continue to focus is John touched on our ongoing partnering activities and we.
Really opportunities to monetize our pipeline of potential first and category Women's health products. So we look forward sincerely to keeping you updated on our progress and we remain very grateful to the obviously, our entire team, but frankly to our shareholders for their commitment and dedication to our mission and particularly now during these challenging times.
So thank you all for taking the time today.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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