Q1 2020 Earnings Call
Quarter ended March 31st 2020 and to provide a general business update.
This call is being recorded my name is Victor and that will be operator for today.
That's today, our Sabrina Martucci Johnson.
<unk>, President and Chief Executive Officer.
Jon Ferrando race, Chief strategy Officer, and Lisa Walters offer their diary, Chief Financial Officer Mr. Johnson. Please proceed.
Thank you and welcome to our financial results in business update call for died by a science. We are looking forward to discussing our first quarter results and highlighting the recent developments and anticipated milestones for 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, 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 actual 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 FCC 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 March 31st.
2020, which was filed today.
I'd also like to point out that the content of this call include time sensitive information that is correct only as of today March May 14 2020.
Daria undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.
So as you know durasert bio pharmaceutical companies squarely focused on improving device and well being of women primarily in the areas of contraception badge, it'll help sexual health and fertility.
Our value creation strategy is to accelerate availability of new prescription products in women's health by selecting and advancing product candidates that we believe have the potential to be first in category in first line.
On our last call we discussed the impact of the coded 19 pandemic on our general business operations, I'm as well as I anticipated clinical and regulatory milestones.
As we discussed we believe the uniqueness of our business model allows us to react quickly to changes in circumstances and since then we have maintained the pace of our product development and regulatory activities necessary to remain on track to achieve the clinical and regulatory objectives, we discussed.
Namely we remain on track to conduct and report top line results. This year for a phase three clinical trial of Dare BB, one for the treatment of bacterial batch analysis.
I condition estimated 10 pad.
Over 20 million women in the U.S. alone.
We're also confirming our prior guidance with respect to parse it any feel cream program. We expect to report topline results of the planned phase Twob study of today, so cream and 2021.
We believe our suddenly so cream candidate has the potential to be the first ft approved treatment option for female sexual arousal disorder.
The female sexual dysfunction disorder, most analogous to erectile dysfunction in men.
And finally, we continue to anticipate reporting topline results in 2022 for our planned pivotal clinical trial of other brain, our investigational hormone free monthly contraceptive with the potential to be a first in category product and his U.S. commercial rights are under a license agreement with bear.
We believe it the variety of our programs and the diversity of our women's health indications and development stages enable us to direct our resources and investment across the portfolio in ways that enable us to advance our programs in this challenging environment.
Of course, we recognized that the Kobin 19 pandemic and the restrictions put in place to slow it's Brad have the potential to disrupt our business.
As most of potential to increase anticipated development costs.
And timelines for our product candidates and therefore, we continue to closely monitor the rapidly evolving circumstances.
However, currently we remain on track to deliver top line clinical study results and regulatory milestones on the timelines we've discussed.
We believe our financing strategies, such as our aftermarket program in the equity line. We recently established together with the flexibility in capital allocation afforded by our business model provide optionality on how and when we raise capital that supports and aligns with enhancing shareholder value.
Further we expect the pricing structures and the dedicated staff with expertise in clinical development of women's health products provided under the agreement with health decisions that we announced this week can support acceleration of clinical development of our reproductive health assets in a capital efficient manner.
We'd like to spend a little more time now to review our plans for the Dare BB one phase three study and the data read out this year and next steps with our sit NFL cream and evergreen programs.
We'll also provide additional insights into our partnership with health decisions as well as an update on partnering activities in general and our first quarter financial results.
I'll start with Directv one for next year about geneticists.
Dare VB, one is a novel thermosetting bioadhesive hydrogen containing clindamycin clindamycin phosphate, 2% and it's being developed as a one time that general administration for the treatment of baby as I mentioned, a highly prevalent condition estimated to affects more than 20 million women in the U.S. and one.
As Weve previously reported data from an investigator initiated proof of concept study demonstrated a clinical cure rate of 86% other valuable subjects. In this study at the test of cure visit that occurred seven to 14 days after that single administration of Dare VB one.
In comparison currently marketed ft approved products for the treatment of baby have clinical cure rates ranging from the mid thirtys to the high sixtys on a percentage cured basis.
If dare VB, one delivers a similarly high clinical cure rate in the phase three pivotal study.
We believe dare VB, one could become a new frontline treatment option for women diagnosed with Bebe.
Dare BD one has received both fast track and qualified infectious disease product designation from the FDA for the treatment of baby.
Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and sell an unmet medical need.
Drugs every sees fast track designation is eligible for more frequent meetings with the FDA to discuss the drugs development plan and ensure collection of appropriate data needed to support drug approval more frequent written communication from Sta about such things as the design of the proposed clinical trial and eligibility for accelerated approval.
And priority review if relevant criteria are met.
Our fast track designation for Dare BB, one underscores that baby is a serious infection for which current treatment options are inadequate and it validates stare BV ones potential to addressing unmet medical need.
As we've indicated in our recent posting on clinical trials Dot Gov, we expect to commence enrollment in our phase three clinical study of Dare BB one in July.
With an anticipated top line data read out by the end of 2020.
Based on the FDA guidance document on developing drugs for treatment of BB and recent discussions we've had with the FDA. The phase three study will include a placebo control and assess the primary endpoint as clinical cure a BV defined as the resolution as specified clinical signs and symptoms from the baseline visit acid test.
Care visit to occur 21 to 30 days after enrollment in this study.
If this single phase three study in approximately 220 women and the Nonclinical studies to be conducted in parallel with the phase three our successful we intend to file a new drug application for Dare BB one in 2021.
I'll now talk about you NFL crane.
We announced in December 2019, the important no mine met we reached with the FDA on the Phase G. B study design and the novel patient reported outcomes or pro instruments to be used to measure achievement of the primary efficacy endpoint.
So that it so cream, 3.6% has the potential to be the first ft approved product for female sexual arousal disorder or FSC D.
As I say d. is the female sexual dysfunction disorder, most analogous to erectile dysfunction in men and said that Phil is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of erectile dysfunction in men.
So then it though cream our formulation is a topical administration formulation of sit NFL, which means the active ingredient is delivered in a cream formulation. That's applied locally to the bad you don't tissue, it's designed to increase local blood flow and thereby improve the genital arousal response utilizing the same.
Pathway that is active in erectile dysfunction medications for men.
While oral status those affected for men the side effects associated with the oral formulation or particularly challenging for women and therefore world deliveries not an optimal way to achieve the same arousal response in women with.
With the potential to deliver sit NFL enough fast acting cream that can be applied locally. The formulation has been designed to offer the benefits of increased blood flow and improvement in the general sexual around the response without the systemic issues observed with the oral formulation.
We believe the EPA say D market is as big or bigger than the erectile dysfunction market market research suggests that 33% of women in the U.S. Ages 21 to 60 experience symptoms of low or no sexual arousal and 16% of them are 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 FDA approved FSC de treatment in context. The prevalence. It complete erectile dysfunction is estimated to be about 5% of men at age 40, increasing to 15% at age 70.
The planned phase Twob study of sit NFL cream will utilize the agreed upon pro instruments to measure achievement of the primary efficacy endpoint, namely improvement in that localize general sensation of a rapid response and reduction in the distressed that women, but that the safety experience.
Over the next month, we'll focus our efforts on preparing to initiate that phase Twob study such as preparing the electronic diary and conducting other startup activities as well as other non clinical activities to support future and D.A. submission.
That's based TV studies designed to evaluate so then a green versus placebo over 12 weeks of dosing by study subjects in their home setting following both the non drug and placebo run in period as I mentioned, we expect to report topline results of the study before the end of 2021.
And now I'll talk briefly about evergreen.
Oh, the brain is an investigational hormone free monthly Badging all contraceptive currently in clinical development for the prevention and pregnancy. If approved it could be the first monthly non hormonal contraceptive product.
Earlier this year bear the marketers as a billion dollar Marina contraceptive franchise, and diary announced a license agreement under which bear Ken exclusively commercialize ever present in the United States. Upon the satisfaction if certain conditions in the agreement, which included 20 million dollar payment to us by bear payable.
Their sole discretion following the completion of a pivotal trial of over brain.
Under the license agreement were also eligible to receive up to 310 million in commercial milestone payment payments plus tiered royalties on net sales in the double digits.
Barry supporting our development.
Regulatory process for other preen by providing internal experts in an advisory capacity.
These resources have already added value to the planning and implementation of the over pre clinical regulatory manufacturing as well is the pre commercialization planning work streams.
More information about the terms of the agreement can be found in our filings with the Securities and Exchange Commission.
We believe the licensing agreement with bear is validation of our broader strategy and confirmation of over praise market potential as the first monthly non hormonal contraceptive product.
There is committed to bringing to market innovation in women's health and they are the only company to has built a contraceptive brand family in excess of $1 billion.
Over the next several months, we intend to continue the regulatory manufacturing and other non clinical activities to advance the program.
We plan to file an investigational device exemption application or I'd. He for over pressure this year and pending the FDA review unclear as to the I.D., we plan to initiate a pivotal contraceptive effectiveness and safety clinical study of over brain.
If successful we expect this study to support marketing approvals of ever Crane in the U.S. Europe and other countries worldwide.
We believe we can commence this study even in 2021 and still report top line data in 2022 as projected.
I'll now turn the call over to jump on to provide a business and corporate partnership update.
Thanks, Sabrina to follow up on some of the remarks made by sprinter concerning our relationship with bear we're pleased to announce we've implemented a really robust alliance management framework with bear facilitating effective connectivity and communication with their global team.
Framework enables us to leverage their internal expertise and align on clinical manufacturing development regulatory planning and the potential launch strategy for overprint in the United States.
Sabrina mission Bear is the current real time World leader and contraceptive sales and marketing their insights and expertise across a wide range of functional areas, including commercial planning have been invaluable.
We believe our agreement with bear for the commercialization of overpowering is a validating event for the overprint contraceptive technology and for Dory.
Our relationship with bear has raised our profiled women's health, which has been a great tailwind for us as we actively engage on a number of fronts across our portfolio and continue to execute against our broader strategy and engage with potential partners on subsequent collaborations and follow on transactions.
For those of you familiar with the Darice story, you know that partnerships and out licensing transactions are core to our model and one of the imperatives for our company is to ensure we have a pipeline of differentiated assets and to keep those assets moving along an aggressive development continuum in a cost in time efficient manner.
To that end, we announced an alliance with health decisions a full service contract research organization were CRL specializing women's health clinical research and diagnostic development to help us advanced our portfolio program.
The pricing structure in the agreement along with the opportunity to have dedicated staff with expertise in clinical development and women's health products is expected to accelerate the clinical development of our key programs in a resource efficient manner helped decisions is the statistical and clinical coordinating a center for the Nic HD, which is a huge.
Net of the National Institutes of health were NIH, they've conducted over 40 clinical trials in contraception and their active across a number of therapeutic areas that are aligned with our portfolio and we have successfully worked with health systems on prior clinical studies, including the successful post cordele test or PCG clinical study overprint and we're currently working with them on the ERP.
Plan their BB one phase three study in back to you all that analysis.
As I mentioned the agreement health decision includes dedicated resources and new pricing structure, when combined with health health decisions clinical expertise robust network their relationships with key investigators in the women's health community. We expect this alliance to be will enable us to accelerate our clinical programs and our pipeline.
In order to maintain the high level of interest in our portfolio that we've seen over the past several months and to execute on our partnering strategy. It's incumbent upon us to continue deliver against meaningful clinical and regulatory milestones and we believe our new relationship with health decisions will strengthen our ability to do that and enable us to provide new solutions to address persistent unmet need in.
Women's health.
And with that I'll turn it over to Lisa for a financial update.
Hey, John and thanks to all of you for joining US today I'd now like to summarize DARI financial results for the quarter ended March 31st 2020.
Sorry business model is to assemble advance and monetize a portfolio of novel product candidates in women.
As a result, our expenses tend to fall into three categories corporate overhead portfolio acquisition and maintenance costs and research and development expenses related to clinical non clinical and preclinical work to generate safety and efficacy data and advance our candidates through clinical and regulatory milestones.
For the quarter ended March 30, Onest 2020, DARI General and administrative expenses were approximately 1.9 million license expenses were $12500 and research and development expenses were approximately $2.4 million.
During the quarter, our research and development activities included or to prepare for the initiation of video BD. One pivotal phase three study. This July histogram mentioned regulatory and other activities related to over Crane.
Work on two of our Bacchanal rings, one for hormone replacement therapy, and that star HRG, one and the other pregnancy maintenance Dar F. R. T. One work on her Badgeville Tamaxifen candidate jar VVA one.
Activities related to the Microchip space contraceptive program that we acquired in November of 2019 and personnel cost of the R&D team.
Our comprehensive walks through the quarter was approximately $4.3 million.
Net cash provided by financing activities for the quarter ended March 30, Onest 2020, with approximately 6.9 million and consisted of net proceeds from the sale of stock under our ATM and proceeds from Wharton warrant and option exercises. We ended the first quarter with approximately $5 million in cash and cash equivalents.
We will need to access additional capital to advance our programs, particularly our three later stage programs to satisfy our working capital needs. Our other liquidity requirements over the next 12 months.
Since our inception, we have raised cash through private placements in public offerings of our equity security M&A transactions, the exercise of warrants and options for cash Nondilutive grants and license fee.
We will endeavor to be created an opportunity, but opportunistic in seeking capital and to be efficient in Houston such capital.
Subsequent to the ended the quarter, we took steps to further strengthen our cash position.
On April 1st we announced the receipt of a third notice of award of approximately $731000 in grant funding from the NIH toward certain development costs of over three of which 428000 has since been applied for and receipt.
We raised additional cash of approximately $2 million net of fees through may 12th of it of this month.
<unk> from sales of stock under our ATM.
On April 23rd we announced a purchase agreement with Lincoln Park capital fun for the potential sale of up to $15 million in shares of our common stock.
30 over at 36 month period, with the tiny and the amount of any such sales to be controlled by us and subject to satisfaction of conditions and limitations under the purchase agreement as you may have seen we recently filed an S. One registration statement and a prospectus related to this purchase agreement.
Following although these activities as of May 12, we have approximately 26.6 million shares of common stock outstanding.
In terms of coding 19, its dobrynin mentioned, we are continuing to monitor the pandemic, it's associated restrictions and the potential impact on our business, our financial condition results of operation, including potentially to adversely affect our planned clinical trials, our ability to raise additional capital when needed.
Due to rapidly evolving circumstances, and many uncertainties around the pandemic.
Including its severity in duration and the implementation and easing of various governmental restrictions we are unable to predict with any reasonable accuracy, the full financial and business impact on our company at this time.
We also encourage investors to review the more detailed discussion of our financial his financial condition, our liquidity capital resources and our risk factors in the 10-Q that was filed today and to also review our audited financial statements and related nodes and the risk factors included in our 10, Hey that was filed.
On March 27 2020.
I'd like to now turn the call back over to the operator.
Thank you asked the question you only need to press star one on your telephone.
To withdraw your question press the pound key.
Please standby model, we completed the K roster.
And our first question will come from a line of Yasmeen Rahimi from Roth capital you may begin.
Hi team listens racially hang on for me I mean, you were taking your question.
So two questions first can you provide some color on how much faster the partnership with health decision allows you to move the clinical program and what type of discounts fewer Stephen clinical trial costs by working with your partner and on the Paul. Thank you.
Yes. Thank you and this is Sabrina. Thank you for that question as best I enjoy noted we're really excited about that partnership and you kind of hit on really the two key benefits one being the efficiencies. It provides is in time, which I'll address and also the fact that it's really going to allow us to advance our programming cost efficient manner.
Because of the type of pricing structures that are part of that arrangement. So some examples in terms of time efficiencies as John noted part of the agreement.
Includes basically a dedicated team that is assigned to delray and our programs.
We will have the opportunity to continue working with that teams who by the way we already worked with on our own Supreme successful oppose Quintette study will be able to continue to work with them on our dare BB, one program and as well another programs as we advance amended this partnership and so what that means is that team continues to work with us in a very seamless way so.
So certain activities that in a normal clinical research organization relationship that you might not be able to engage in into you literally like signed your contract and were really officially formal way right at beginning of steady startup mode. We can do those things real time significantly sooner and as an example.
There's conversations we have about you know over praying for instance that you know that studies that starting tomorrow that we can be having those conversations now with them. So that when we're ready to pull the trigger it really gives us that efficiencies. So it's the team that's dedicated and is the ability to engage with them really like an extension.
One of the diary.
And family.
And in terms of that pricing structures, there's some nice and optionality under how we structure the partnership to allow us to really receive efficiencies in terms of pricing structures that can come in a variety of forms we haven't disclosed the details for confidential reasons that tells decisions of course by on suffice it to say.
Really represents a benefit to us and our shareholders in terms of how the pricing structures are designed for clinical trial programs that we pursue you know both in terms of a more favorable pricing structure. Obviously because were very preferred partner, but also just in terms of how those are structured in terms of the.
Timing of payments and things like that that can often benefit us and our shareholders in terms of when we have to deploy the capital against the programs.
Okay. Thank you that's very helpful and sort of following up on the partnership. Our second question is on can you share with us how many sites. So the partnership involved and the personnel included and what types of child are their expertise. Thank you.
Yes sure. So so help decisions is very focused in women's health. That's the reason that partnership with such a great one for us to contemplate in terms of their clinical research expertise and capabilities as John alluded to there part of the clinical trials network. That's part of the NIH is contraceptive.
Research Division that includes a deterrent its large number of sites that are part of that clinical trials network and being involved in that they'd supported the conduct of 40 studies through that kind of relationship and partnership but they are broadly associated women's health not just in contraception, but broadly him.
I'm in health and so weve, specifically structured our relationship with them in the therapeutic areas, where they clearly have expertise and that includes for sure contraception that general help us the VB one program as well as you know areas such as fertility in general Gynecologic health and so you know we're really love.
Joining me areas, where they've already demonstrated great clinical success and outcome and acumen and relationships and in terms of the staff that that we receive a dedicated staff. It it really it runs the gamut of kind of all the different functional areas that you need for an effective and efficient contacted the clinical.
Trial. So that includes your you know monitors and project manager you know as well as leads in the area of you know statistics and design and all those parameters. So it's it's really a group that represents all the functional capacity that we need to effectively run the clinical trial.
Okay. Thanks, so much of the detail that's very helpful and congrats.
Thank you so much.
Thank you and our next question will come from the line, Jason Kolbert from Dawson, James maybe again.
Hi, guys, congratulations on preserving a timeline and your balance sheet, which is [laughter].
No not an easy thing to do with what's going on with Covance I guess, yeah, you're very welcome.
I guess I'd like to understand how you've been able to do that clinically I mean, it just seems like the you know elective procedures have been in chaos why you feel confident that you can maintain these timelines. If you could just kind of tell us a little bit about what its stake and then maybe contracting with this particular.
See our ROE as a piece of that Paul So I don't know.
Yes, Jason. Thank you that is that's really a great question and and there are a couple of things at play one that I wish we could take credit for and we can't luck.
As one would have it the clinical trial that you now was with most critical for us as a company in terms of the data read out. This year is our back to you imagine as this program and as you very appropriately mentioned you know clinicians are not seeing patients for elective procedures are things that are not urgent and they're doing as much telemedicine is they can right.
Whenever possible, but back to your imagine usage.
It is a really you can only be and you know diagnosed and treated but the badgeville exam and it is a very very bothersome condition for the women that are affected the theyve kind of side effects of the condition in terms of agile odor and discharge or bothersome and now that this is a condition where women today in the Kobin world.
Our still actively seeking a health care provider and a health care provider needs to actively see them. So to your point based on our relationship with health decisions.
Which started obviously as I mentioned with the other preen studies. So it's a relationship that we've had for some time as we started.
Talking about our back to you have edginess this program and in light of this cobot environment, we obviously hatched and some very real conversations with them and the sites that we had identified for the study as to their ability to continue to conduct the study on the timeline that we have communicated and do you know, whether we would see delays and you know really across.
The board both in terms of you know, our obviously working closely with health decisions and the efficiencies at that provides but also with all of the conversations we've had with all the sites that have been identified on to begin enrollment in July into the study you know everyone. There's still seeing patients. There is still seeing back to you imagine as his patients and.
They they you know everyone is believes we can be on track you know with this study really because of that condition. So it is a a little bit of you now circumstance right that this is a condition where women are still going in.
Just either clinicians, which helps and it's one where obviously the relationship with health decisions is important and as it pertains to sit NFL and other train.
Similarly, we've been able to really look at our programs critically in the light of co bed and look at our planned activities and recalibrate a little bit if necessary in terms of maybe the sequencing of certain activities or how we can do certain things.
To keep the programs on their timelines.
And with both over Preen Incidentally, Phil we had to that factors working in our favor. One is there are our startup activities with both of them that we need to engage in another non clinical activities. You know that we can be doing right now that are going to be needed for the ultimate regulatory filings that we can you know those things.
Aren't impacted or delayed and we can go ahead and take advantage of the time to get those out of the way and then like I mentioned things like electronic diary for this identical program that can happen right now even before we enrolled subjects. So a combination of those factors and then just though the lead times for our timelines.
You know that we had built really allowed us for that flexibility as well to stay on track.
Thanks, a lot of thank you for asking the question shore and just a follow up is you know when I look at the market volatility as the result of covert there Ben just some wild swings in both directions and one of the things that I see that that's translated in it's a very significant increase in.
Hi volume days and so my assumption is that on those high volume days, you're taking advantage of those with the ATM and that's how you were able to preserve the balance sheet for now is that fair.
Yeah. Its lease the reported you know in in the quarter. We we've had some ATM activities and to your point, it's it's a great.
Wave for us too.
Bringing capital.
And you know Sun is put in place shares right in the market in a very efficient manner.
That can preserve shareholder value preserve the pricing on those days, but to your point give us that optionality.
On the way that is take advantage of the volatility that exists in the market without hurting data mental stock price. So it's gone up a no brainer as a tool that you now that yeah, I mean, when I look at kind of what's going on you know shored up placing stock with truly fundamental institutional investors to take advantage.
The volatility we're seeing just makes good good business. So thank you very much really appreciate the update talk talk Jason. Thank you. So much. Thanks for your comments really appreciate it.
Thank you at our next question will come from I know.
Lee anchor Yeah, I guess from Brooklyn capital.
You may begin.
Hi, Sabrina Hi, Lisa.
Thanks for joining the call.
A couple of questions. One I just wonder do you do you expect your R&D expenses to remain route two and a half million a corner for the rest of this year.
Yeah, I'll, let me say addressed that but just did a high level I think it's helpful for people listening and we're learning about dark gray to understand our our R&D expenses will very much Barry.
You know they lease who uses a term lumpy, which is probably a really great way to describe them as <unk> program kind of ebb and flow and as activities ebb and flow. So friendship for the Dare BB one program, we've guided it's a $10 million spend all in through the NDA.
Filing that obviously is not all happening this year some of that happened last years. Some of its happening next year as I mentioned, we love to make that filing in 2021.
And it's not going to be straight lined either [laughter] over the course, you know what we at this year than to be straight line. So it is going to ebb and flow and there's no great way for us to to guide other than that high level like.
Yeah, and I would just and Sallie I, just would add to that but clearly our goal is to start and they do your BD one study in July.
Once we start actively enrolling there'll be some expenses, but is to reduce that it's not.
Not a straight line because we kind of can turn certain other activities preclinical and clinical on and off based on the cash we have available and also the market environment. So.
Thank you for asking.
Okay I have another question on Overpaying trial I'm, just curious how many patients or you can or will be enrolled.
Yes, so with with the Crane and again just high level quick background for those who may not be as familiar but other crane is a combination product. It's it's regulated with the device division of the FDA meeting their review.
That's for al event, because it's a little bit different than our hormonal product. So typically would pull a nominal products.
Yeah, you're looking at you know typically 2000 or so subjects.
You know the and expose to the product to support a registration on the device division, it's typically around 250 subjects.
And so yes, so big difference.
Which makes obviously a difference in terms of time in stand on so that.
Yeah helpful with the program and so as I mentioned, we are in the process of you know working on the I'd. He submission that is planned for this year once that process completed and we had that FDA clearance on that we're going to be able to give very very specific guidance on you know exactly how many subjects, but that is going to work.
And for that division of the FDA and we don't expect treated differently.
So I'm curious with this type of a product what will be the placebo control.
Yes, So contraceptive studies and you you forensic over for whatever reasons I'm not sure why they do them its way that there is no placebo arm so everybody got all.
That contraceptive product, everyone and okay.
Yes, and you look at pregnancy rates over the course of the trial duration and they're either there's there's six to 12 months I'm typically nine duration studies, so you're looking at pregnancy rates, but everyone is exposed to your study drug <unk> okay.
All right well. Thank you very much very helpful. Yes. Thank you.
Regulations on good progress.
Thanks very much.
Thank you and our next question will come for line, though Jim a lawyer from a lines global you may begin.
Hi, guys. Thanks for taking my question I just had a quick question on.
The studies cannot assuming 100 of medicine on the locked in five to prevent recurrence of better legend ounces.
No that's.
Put against me I know, it's come out today. This at old News network, Yes, you will walk through how that impacts or speak to them the market for Oh.
For Bbs.
Yeah, no Jim Thanks for asking that question and thanks for being on top of that because I just came out today.
Yes, so if you think about again.
Help me for a second just take take a step back on back to imagine as it's when you think about the condition. There's there's really two things we think about with back to imagine is in managing the women.
Who are dealing with the condition one is treating the acute infection. So when she has that acute infection, you really want to get it under control as quickly as inefficiently as possible because of the newson side effects I mentioned, obviously, the odor and the discharge, but it's also associated with pre term birth and infertility.
So it's an important infection to get under control. So why do you want to get that infection under control quickly and that's what dare BB. One is targeted to doing right, that's where the 86% cure rate that was seen in the.
Investigator initiated phase to be is so important given its comparison to the standard of care right now ft approved where the cure rates are 30 to mid Sixty's.
That publication that came out today, which were also super excited about seeing and following is really looking at.
Non antibiotic approaches to preventer slowed the recurrence of infection, So women, who get this condition and often these are the women who have them as bothers. Since intends also unfortunately get several bound to the condition per year, so three or more so those are women who have recurrent infections.
And so not only you trying to get rid of the infection as quickly as possible acutely. When she has you know a bad out you're also trying to delay kind of increase the time or reduce the rate of recurrence and that's what the.
The probiotic products, but not to the July product that was reported is looking to do and we think that's also a very exciting approach and an important approach in the category, Yeah, and I would just said as John I would you say it I think we think its complimentary to get there may be one in a sense that we're treating the underlying infections or resolve it and then this product is something that can provide.
Future recurrence yep.
So rising tide lifts all boats I would think I agree with that absolutely right.
Yes.
Thank you thanks, Jim.
Thank you.
And our next question on console IMO Nathan one thing for Omegas capital you may begin.
Hi, Sabrina always said John Thanks for taking my question.
Have a big picture question, along so Dennis will cream and.
The indication.
Maybe you could give us.
I'm not your thoughts on how awareness on the condition has evolved historically and sort of opined on how that could evolve overtime.
Great question that and it's a condition that you know obviously were very passionate about and I agree timing for the question. She because you actually had a call yesterday with one of our key opinion leaders, we work with Dr. Sharon Kings Berg just around that program and talking about just that the awareness.
The condition that the comfort that people can have talking about it.
Looking at if you think about what happened in the erectile dysfunction category. You know go back in time before by a grand after Niagara and the Openedge that people talk about it and you know in its cobot environment. Theres also some really interesting trend to tell and that is stand and how people are using telemedicine and it brought out some interesting fact.
In terms of people being more open with telemedicine about talking about conditions like this that maybe they weren't coming forward with about before in a more internet.
You know clinical in the office setting and so.
There's definitely a lot more awareness in general about the condition that is going to continue in our belief to grow and enhance as we advance is program through clinical development and that creates more awareness and conversations about the condition. So we really do expect it to follow a very similar market awareness.
Kind of trajectory that erectile dysfunction did with the advent of new pharmaceutical treatment both during their development and once they came on the market and so we really expect to similar trajectory on today and frankly with this program as it advances and frankly this cobot environment has also given us some insights into potentially even new tools and.
New ways to think about it and talk about it to create an environment, where women can feel very comfortable on speaking out similar to men do now with erectile dysfunction, which is important because frankly. This is just as distressing to women as erectile dysfunction is tonight.
Great. Thank you so much.
Thank you.
Thank you and I'm actually not showing any further questions at this time I'd like to turn it back go to Sabrina for any closing remarks.
Great. Thank you everyone for taking the time. This afternoon. We appreciate it and maybe just to summarize our partnership with bear that we talked about is off to a great start and we're really looking forward to along and productive relationship with bear as we work to advance the evergreen program through clinical development and bringing that new.
Evasion into the contraceptive category and as we mentioned our partnership with health decisions.
Is a nice adjunct to that you know with the expectation that it's going to help us to accelerate the clinical development of our reproductive health programs in both the time and as we talked about cost efficient manner as well. In addition, we'll continue to focus on near term efforts on the kind that other gare veeva want VB one phase three study this year.
As we've discussed with the topline data expected before the ended the year and we'll continue those studies startup activities and the other non clinical work that we alluded to necessary to support our overall program objectives for both identical cream and evergreen and we look forward to keeping you updated on our progress and we.
We remain grateful to the entire diary team and importantly to our shareholders for their commitment and dedication to our mission, particularly now so with that we thank you and look forward to keeping you informed.
Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.
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