Q1 2022 Dare Bioscience Inc Earnings Call

May 12, 2022

Welcome to the conference call hosted by the array Bioscience to review the company's financial results for the quarter ended March 31, 2022 and to provide a general business update. This call is being recorded my name is <unk> and I'll be your operator with US today are Mr.

Sabrina Martucci, Johnson, <unk>, President and Chief Executive Officer, Mr. John Fair, <unk>, Chief strategy Officer, and MS. Lisa Walters Hoffert <unk> chief.

<unk> Financial Officer MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to our first quarter of 2020 financial results and business update call for dairy Bioscience. Our plan today is to review our first quarter results.

<unk> developments since our last call in March and use the time to review our business strategy and highlight our objectives and milestones anticipated for 2022.

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 1095.

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 SEC filings, including our annual report on Form 10-K for the year ended December 31, 2021, which is filed on.

March 31 2022.

I'd also like to point out that the content of this call includes time sensitive information that is current only as of today may 12 2022.

<unk> undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.

As you know Darius solely and squarely focused in women's health, it's our <unk>, it's our belief that prioritizing women's health is not only good for the many women whacking effective convenient therapeutic choices, but also for a broad set of stakeholders, including their families partners and of course our shareholders.

We typically use these calls to update you on the milestones we've achieved to date and the upcoming milestones that we anticipate and we will do that today, we will provide an update on the collaboration with Oregon on to commercialize that shadow clindamycin phosphate vaginal gel, 2% and the launch targeted for later this year.

The <unk> phase III clinical studies that we look to initiate in collaboration with the NIH and with advisory support from a commercialization collaborator Bayer.

Our suite NFL cream female sexual arousal disorder phase <unk> clinical study.

And the two other programs with clinical Readouts anticipated this year.

However, before we do that in light of the strategic objectives. We have already achieved were two for two in terms of entering into commercialization collaboration agreements for our most advanced programs. We wanted to take a few minutes to clearly articulate the why and the how specifically before providing portfolio in <unk>.

Financial updates I'd like to take a few minutes to review our business strategy and our approach to building value.

We started the company because we recognized a few factors about this therapeutic category that are somewhat unique to women's health and together create a compelling opportunity.

First a number of persistent unmet needs in women's health continue to exist indications that are not life threatening but her life altering and we're there for our products that can improve outcomes and convenience can be compelling.

Because I've heard unique biology, we believe that these persistent unmet needs can in many cases be addressed with a well characterized active pharmaceutical ingredient or API.

Delivered in a different way such as that general versus oral orphan indication that has not yet been addressed in women such as to Dennis <unk> for female sexual arousal disorder.

Use of Wildcat Arcturus API is expected to mitigate development risk time and cost.

By customizing the delivery route for her when can still have a first line or first in category opportunity with meaningful commercial opportunity.

Third the companies with a robust commercial footprint in women's health, often do not have a commensurate internal development effort in women's health and thus those companies tend to grow their portfolios through product licenses and acquisition.

This GAAP creates an opportunity for developed focused companies to women's health as evidenced by the transactions in the category not just the licensing agreement that Dara has entered into with Oregon on Embraer to date, but the other transaction these and other companies with the commercial footprint and women's health have also executed.

Entered into to commercialization collaborations one with Oregon on and one with Bayer and have done so with relatively modest capital deployment and leveraging FTIR NIH grants for four of our programs and NIH collaborative research agreement for one of our programs and our foundation grant of nearly $50 million for one of our preclinical.

Programs.

Creating a diverse pipeline of product candidates that utilize different API or different delivery routes and target different indications such that the successful outcome for one product candidate is independent of the outcome of others has been a foundation to our strategy.

Our strategy also involves selecting a candidate both the drug and the delivery vehicle for each indication that represents an opportunity should personalized treatment options for women. Both in terms of the unique biology of women and overall convenience for women.

Our current portfolio includes drug delivered via vaginal rings, a viscous hydrogel, a proprietary cream a soft gel capsule and implant and injectable. Our current portfolio also includes numerous programs that utilize those well characterized API and that therefore have been or that we expect to <unk>.

<unk>.

The FDA 500, <unk> regulatory pathway.

The five O fab two regulatory path has the potential to shorten the overall development time and cost to obtain and marketing approval in the U S. As was the case with <unk> for which we obtained FDA approval just three years after acquiring rights to the program and with just a single pivotal clinical study.

We consider many factors when evaluating new product candidates for our portfolio since those factors ultimately impact potential funding, including non dilutive funding for the development of those products as well as commercialization strategies and opportunities to enter into collaboration such as those that we have already establish.

To date with organized <unk> Shadow and Bayer for <unk>.

In terms of process, we start with the persistent unmet need we talk to women advocates and health care providers to identify areas within women's health that have high unmet needs in some cases approved therapies for an indication exist, but the therapies are perceived as not sufficiently effective or convenience.

For the women using them in other cases, there are no FDA approved therapies for the indication.

Once we identify an area of unmet need we create a target product profile to address the need.

Lens through which we evaluate each potential Canada is that it must have the potential to be a first line or first in category option and to achieve product revenues that would be attractive to a potential commercial collaborator, giving us optionality in terms of how we take the product to market if development is successful.

Our portfolio has been built based on the unmet needs, we identified and target product profiles regenerated and by acquiring or in licensing candidates that we believe have the potential to meet the target product profile and thats demonstrate the characteristics. The features the outcomes necessary to achieve a.

First line or first in category product for the indication.

Because we seek to leverage well characterized API in many cases, the prospective candidates have proof of concept data and are well positioned for dara to accelerate their development as we did with shadow via our development expertise and our clear commitment to women's health.

Most of our current portfolio candidates have been in licensed or acquired under a financial model designed to allow us to focus our capital on product development and to give us flexibility that we need to achieve an accretive accretive commercialization strategy.

This model features modest or no upfront cash consideration milestone payments, if and as candidates successfully advanced through development and if a candidate is ultimately approved commercial payment obligations are intended to allow dara to commercialize the product directly or with a commercial collaborator and approach.

It differs a large portion of the potential consideration until program has successfully advanced and they contemplate potential commercial collaborators has enabled us to assemble a portfolio of eight assets, one FDA approved and seven in development in a cash efficient manner and put us in the position to enter into the cloud.

<unk>, we have to date with Oregon on Embraer.

When we add a product candidate to our portfolio. We believe we will have we will have the opportunity to launch it ourselves or to collaborate with a third party to fund and execute its commercialization.

Ultimately, we select the approach that we believe will provide the greatest access to women and achieve the highest peak sales and the least amount of time, because we believe that's best for all stakeholders women and our shareholders given the stage of our current portfolio and the market dynamics in a therapeutic.

Categories for our most advanced programs <unk> and <unk>, we believe the best Avenue to generate value for DRA and its shareholders is via the external commercialization collaborations or out license agreements rather than attempting to commercialize these assets on our own.

Opportunities to enter into such collaborations or ultimately contingent on developing differentiated products that demonstrate the potential to be first line or first in category.

In summary, our business model involves identifying the areas of high unmet needs in women's health identifying identifying innovative solutions to address such needs accelerating the innovation through development at a time and cost efficient manner and executing on our commercialization strategy best suited to create value for our <unk>.

And our shareholders to date, we've elected to use our expertise and our funds to advance our portfolio of candidates through late stage development and in <unk> case through FDA approval and to collaborate with larger organizations with established sales forces in greater resources and women's health to conduct the market launch and ongoing.

<unk> commercialization efforts.

I'll now turn it over to John for our portfolio update.

Thank you Sabrina I will start with a bacterial vaginosis and our first FDA approved product Zasyadko bacterial vaginosis is the most common cause vaginitis worldwide and is estimated to affect approximately 21 million women in the U S. The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbes.

And can lead to symptoms of odor and discharge.

Oregon on shares our commitment to advanced critically needed innovation in women's health and we believe that organized commercial capabilities will ensure that zao shadow reaches women most impacted by this condition through.

Through its strong commercial capabilities and expertise in women's health, we're going on is in a unique position to bring Saar shadow to market and provide women across the U S access to this important option.

Under our license agreement with Oregon onto commercialized Zasyadko DRA will receive a $10 million cash payment from organon upon closing of the transaction and will be eligible to receive potential milestone payments of up to $182 million as well as tiered double digit royalties based on net sales closing of the <unk>.

Transaction is subject to review under Hart, Scott Rodino Antitrust improvement Act and other customary conditions.

Transaction is expected to close in Q2 of 2022 and <unk> is expected to be available commercially.

The U S in Q4 of 2022.

Moving on to Overprint, our novel hormone free monthly contraceptive candidate, who is U S. Commercial rights are under a license agreement with Bayer we are targeting commencement. This year of we expect to be the single pivotal study necessary to support a pre market approval submission to the FDA in order to initiate the pivotal phase III study we must have.

<unk>, an FDA approved IV in place we initiated the process for <unk> in early 2022, and pending the Fda's review and approval of the IGT, we seek to initiate the pivotal study in 2022.

Based on our communications with the FDA in terms of steady sample size and duration, we expect that at least 200 subjects completing 12 months of over pre news will be adequate under our creator with a Eunice Kennedy Shriver National Institute of health and human development or Nics.

Which is part of the National Institute of Health NIH together, we are currently preparing for the pivotal phase III study of overprint.

Under our license agreement with Bayer to commercialize overprint Dara has access to bear his extensive clinical manufacturing and commercialization resources in an advisory capacity for approximately 80 hours per week, while Dara retains full control over overprint development and regulatory approval process. There has the right to obtain exclusive rights to <unk>.

<unk> in the U S. Following the completion of the pivotal phase III study by making a $20 million payments to Dara.

Thereafter, Dore will be entitled to receive commercial milestone payments potentially totaling $310 million. In addition to double digit tiered royalties on net sales.

Turning our attention to <unk> cream is our investigational product to address her version of erectile dysfunction.

Female sexual arousal disorder, or <unk> is a physiological.

Condition characterized by the inability to obtain or maintain sufficient genital arousal during sexual activity.

There are currently no FDA approved therapeutics, we continue to enroll women in the phase two be respond clinical study evaluating so identical cream as a potential treatment for <unk> <unk> at.

At sites across the country. Our study protocol has a planned interim analysis to evaluate power calculations and trial sizing we expect to conduct that analysis. This year after which we will provide guidance on anticipated timing for top line data from the trial.

Derek <unk>, one is our unique <unk> ring or IV are designed to deliver bio identical estradiol and progesterone continuously over a 28 day period as part of a hormone therapy regimen, we announced positive topline results from our phase one study of Dare <unk> in 2021 and in April of 2022, we announced the start of a new <unk>.

Phase one two clinical study of Dare HRT won this open label study will evaluate the PK of lower and higher dose versions of Dare <unk> won the same two versions evaluated in the first phase one study in roughly 20 healthy post menopausal women over approximately three consecutive months of use the study will also collect safe.

Usability acceptability and symptom relief data. This study is being conducted in Australia by our Australian subsidiary to take advantage of the clinical and financial benefits of doing so we expect to report topline data from the phase one two study during the fourth quarter of 2022.

And finally, we will provide a brief update on dare BVA, one more than $3 8 million women in the U S have a history of breast cancer or are considered survivors hormone receptor positive breast cancer is the most common type of breast cancer diagnosis, and the prevalence of Volvo and vaginal atrophy or BVA in postmenopausal breast cancer survivors.

Estimated to be between 42, and 70% we would like to provide an option for these women.

<unk> one is our proprietary investigational formulation of tamoxifen for vaginal administration to treat veeva as a non hormonal approach to addressing BVA. It could be an important option for women with a history of or at risk for hormone receptor positive breast cancer.

As many of these women are not ideal candidates for standard estrogen based interventions, we initiated a phase one two clinical study in Australia in the third quarter of 2021 for this breast cancer survivorship vaginal atrophy treatment program and we expect to report topline data from <unk> BVA one phase one two study during the second half of 2022.

Thus in terms of anticipated milestones for 2022, we look forward to keeping you updated on one product launch, which we're extremely excited about one pivotal phase III study start which we're also very excited about in two data readouts and with that I will now turn the call over to Lisa.

Thanks.

And thanks to all of you for joining US today I would now like to summarize <unk> financial results for the quarter ended March 31, 2022, which I will refer to as the current quarter or the first quarter of 2022.

As you know <unk> business model is to assemble advance and monetize a portfolio of novel product candidates in women's health as a result, our expenses consist of corporate overhead portfolio acquisition, and maintenance costs and research and development or R&D activities, while our general and administrative expenses or G&A.

Tend to be somewhat predictable throughout the year, our R&D expenses will vary with our clinical preclinical manufacturing regulatory and other activities related to advancing our portfolio of candidates. So for the first quarter of 2022, our G&A G&A expenses were approximately $2.

$6 million.

Our R&D expenses were approximately $5 $8 million. The current quarter's R&D expenses were approximately 1% greater than the same period in 2021, and they primarily reflect the costs and activities related to the ongoing so that infill cream phase <unk> respond clinical study and manufacturing and regulatory.

Activities related to overproduce.

Our comprehensive loss for the current quarter was approximately $8 $4 million.

We ended March 31, 2022, with approximately $39 3 million in cash and cash equivalents.

Subsequent to the end of the quarter. So from April one through May 10th we received approximately $1 2 million in net proceeds from additional sales of stock under our ATM.

In addition, as John just mentioned, Gary will receive a $10 million cash payment from Oregon on upon the closing of the transaction under the license agreement for <unk>, which we currently expect to occur in this quarter. In addition, Jerry will be entitled to receive a cash payment of $2 5 million.

Upon the first commercial sale of its <unk> in the U S as well as potential future milestone payments of up to $180 million and tiered double digit royalties based on net sales.

<unk> is expected to become available commercially in the U S. In the fourth quarter of 2022.

As of May 10, Jerry had approximately $84 7 million shares of common stock outstanding.

In closing as we've said before we will endeavor to be creative collaborative and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value.

We also encourage investors to review the more detailed discussion of our financials and financial condition, our liquidity and capital resources and our risk factors in our Form 10-Q for the quarter ended March 31, 2022, which was filed this afternoon. So today as well as our annual report on Form 10-K for the year end.

December 31, 2021, which was filed on March 31 of 2022.

I would now like to turn the call over to our operated operators so delfin take it away.

Thank you Lisa. Thank you for attending the conference call. We will now conduct the question and answer session and we wanted to ask a question you will need to press star one again telephone keypad once again star one hour.

Our first question is Rob zombie genre of Roth Capital Partners. Please go ahead.

Hello, Thanks for taking my questions and things, but really the background on the company and the strategy. So the first one for many years.

As dashi auto as part of the commercial launch plans can you kind of update us on where you are with the manufacturing process.

Yeah definitely and thanks for the questions and thanks for being on the call and for your comments, yes. So as we had guided previously so manufacturing activities to support the commercial launch are definitely underway and as we had anticipated those commercial supplies would be available.

At the earliest in the summer timeframe and so based on that.

It's where the timing for the launch that we're working on in collaboration with Oregon on his fourth quarter, that's where that is aligned with.

So we are working.

Closely with Oregon on that as they prepare for the launch later this year.

And to support that obviously.

We expect that transaction to close in the second quarter.

Thanks, Sabrina and then the follow up here just for Overpaying regarding next steps can you. Please clarify what those are and then I know John commented on the sample size that might be necessary and just wanted to confirm with the FDA had okayed or you guys are still leading to.

Discuss those.

Yes, great questions about <unk> and so the IV process with the FDA is a little bit different than what many of us are accustomed to with an <unk> process.

So for instance in the case of Evergreen and the process is actually in part predicated on the pre pivotal study that we did in the.

<unk> steady, which which led to our collaboration with Bayer.

So that actually all happened before you even get to the Iga phase and then niv process. They allow the IGD process to include whats called pre submission I'd pre submission. So that you can actually have collaborative discussions with the FDA to address questions and.

To make sure that ultimately Youre ITE is really set up to support the IDE approval and that you have all the information that you need to be successful to transitioning to a pivotal study that is going to meet their expectations for a PMA and so thats the process that we initiated earlier this year.

And so to your question therefore on the.

Size of the pivotal study, yes, the feedback that John shared in terms of that expectation around 200 subjects out to the 12 month time point, So which is basically 13 cycles 13 menstrual cycles women have.

More than one cycle turns out per month.

If you add them all up in a year. So it's 13 cycles.

That is based on the discussions with the FDA and their communication and expectations for the pivotal study and so what's so important about is starting the process. The way we did with the ITE is as John also mentioned, we have a collaboration with the NIH.

As well as with Bayer.

And so starting this discussion process as part of the whole E.

Ultimately IDE approval process and getting some clarification on both input we wanted to share with the FDA about what we'd like to be doing in the pivotal study based.

Significantly on feedback from there to support ultimate commercialization and from the NIH to support successful conduct.

It allows us to have that discussion with the FDA and then go back.

Our collaborators bear in the NIH does it as we're planning that pivotal study that we are going to be running in collaboration with the NIH. It allows us to really do a lot of work in preparation.

Earlier than one might otherwise normally be able to start in terms of starting now to identify sites and speak with sites.

Ensure that theyre going to be interested in this study and ensure that they're going to be able to execute against the study and we're really excited to be working with the NIH in their clinical trial contraceptive network because of the experience that they have so we.

We look forward to giving more updates.

As this process proceeds and as we can give some more clarity on timing.

The pivotal study starts that we're targeting this year, but but that hopefully gives you a little more perspective on kind of the background the process with the FDA and then importantly on the pivotal study design kind of that Big picture of design, which is really critical for us to understand as quickly as we could because that also as you can.

I appreciate obviously feeds into just making sure we have manufacturing supply and.

And all of a site setup to really execute against a successful study.

Okay. Thanks, and then the last one year.

With the market the way it is folks who really.

Checking on cash balances in spend and a phase <unk> study coming up.

A lot of folks are kind of curious about what that financial obligation might be and I know, it's probably at the NIH with human the credit agreement.

They can help offset some of those costs and so was just wondering if you can put into.

Clear terms as to what your financial obligation might be as it relates to the phase III <unk> study and then thanks again for taking my question.

Absolutely. Thank you for that so obviously right. This is something that I think all companies in todays market landscape are paying close attention to and honestly it's markets like these where.

Yeah.

We're grateful to have the kind of collaborations that we have and to have frankly, the kind of infrastructure and capital requirements that we have which are really really really manageable in the context of the sector in general. So so I'll start first with just as Lisa mentioned just to give some perspective G&A two six.

For the quarter to <unk> 5 million for the quarter. So that gives you some perspective, our fixed cost G&A is about $10 million for the year right. So very manageable, particularly given our cash balance that we used to talked about the almost $40 million for the quarter and then on top of that the monies that are expected to come in just from that.

The closing in the.

First commercial sale of <unk> our shadow.

But in addition to that importantly is what you touched on in terms of the question around Overtrain part of what we are also really worked hard to do is to secure non dilutive funding wherever it strategically makes sense for the portfolio and that also creates a situation where our cash balances and the cash we have on hand.

It just gives us a lot of flexibility and puts us in a position to endure the kind of market.

That we are all dealing with right now and not to mentioned, obviously, having an FDA approved product.

Oregon.

Has the ability to launch it feels good to say specifically for <unk>, we entered into a collaboration with the NIH, which has us sharing the cost of that pivotal study and importantly, dore portion portion of the.

<unk> cost of the clinical study is $5 5 million.

Five of which has already been paid basically to the NIH right. So that those funds have already gone to the NIH because thats part of preparing for the trial.

Commencement. This year is ensuring that those resources are in where there is essentially like an escrow account. So that they can start utilizing the resources for the various startup activities that I talked about like working with the sites finalizing the protocol all of that good stuff.

So you know.

We have a lot of flexibility with our brand we have a portfolio of programs that yes on the one hand, we're advancing but on the other hand, the capital required to do so and hit the milestones.

That we've been talking about this year the pivotal studies start the.

The two data Readouts, we have this year, both of which are being conducted in our subsidiary in Australia, which.

Minimises expenses that she can for phase one because the overall costs are lower.

We're really well positioned for all of that and beyond so.

So thank you for asking great question, and and we definitely appreciate the sensitivity to that.

Thank you.

Our next question is with Douglas Tsao from H C. Wainwright. Please go ahead Sir.

Good afternoon, thanks for taking the questions.

Just curious you referenced having access to the NIH.

Network for executing the ovarian study I'm just curious from an operational standpoint, how much do you think.

That will ultimately accelerate your enrollment versus what you would have maybe done.

On a standalone basis or without it.

Yes. Thank you that's it.

I like that question and it's timely because we just had a lot of them.

Great meetings to kind of drive home why collaborations like this are more than just the money that they bring to the table.

Because it is the <unk> conference last week, the American College of physicians that gynecologists and so it's a nice opportunity to connect with some of our collaborators and.

The value of collaborating with the NIH on something like that is that the NIH in their particularly their group that does these and their contraceptive clinical trials network.

Is it group that.

Participates in a number of clinical.

Trials in contraception, specifically, frankly more than DRA or even our partner Bayer right more than we as individual companies would be doing on our own because they get to see trials across different organizations and different funding institutions and so and then <unk>.

Having that coordinated through the NIH in a way that an individual collaborator.

Would not be able to share certain insights with us from an NIH perspective, there are insights that big picture. The NIH can share. So what it's really allowed us to do is have information and insights around operational strategy for the trial that.

As effective as Dara can be and I think we've shown that we can be very effective with our execution on the dark shadow phase III trial in 2020 during COVID-19.

We can certainly be effective and navigate this things, but but having that kind of answered. It is helpful. So for instance, <unk> been able to talk with us around.

Enrollment rates and dropout rates and and give us a sense of at a site level and at a high level, what they've seen across different different trials.

In terms of expectations nothing proprietary they don't share anything in appropriate with us, but they are able to have that big picture perspective to guide our strategies. So.

So all of that has been really helpful and to your point Doug.

Inside that if we were operating individually with those sites, we wouldn't have at the same level.

Okay.

And then just another question if I might.

A little bit of a follow up maybe to the prior question just around the broader capital markets.

You, obviously have a number of product candidates, even beyond sort of what you would have thought.

A year ago, we thought lets you should've bead assets.

You have the number sort of right behind them.

Just.

The current situation affect sort of how you evaluate data does it make you more conservative about what you might see just does that mean that some programs you might have a higher hurdle.

Perhaps in a three year capital environment.

To advance.

Not sure if that yet.

Absolutely it does make sense and I would say one of the things that we have always tried to do from from day one.

Is the thoughtful and capital efficient and what that means that doesn't mean literally.

Be inexpensive.

What that means is doing exactly what youre talking about every day every day is a new day looking at the information in hand real time right.

What is the best way to deploy capital today does this program still stand up is this program is still truly differentiated are these data.

Supportive of that are we going to be able to secure a commercialization strategy that is truly accretive for this product.

Where does it stand in the competitive landscape is it still holding up so we do that if we do that real time and we've navigated.

Challenging times before where we had to make decisions around which programs to push faster, which programs to to go slower whether it was based on new information, we wanted to generate or basis based on the environment. I mean, I go back to Covid 2020, and that seems like 100 years ago now, but when that you started.

We werent flushed with capital we had to make decisions of what to do with the capital that we had in the best way to create shareholder value and we decided to move quickly with our <unk> program and go ahead and execute effectively on that phase III trial.

We also decided that it makes sense to move quickly on our <unk> one program and.

And generate that phase one data because for a program like that phase one data is proof of concept that you have ultimately a product.

That can advance.

And and we part of that year you May remember, we didn't think that was the right year to start the <unk> phase IV.

Had reached alignment with the FDA on what that program would take but we were we were worried about starting that trial in such an uncertain COVID-19 environment.

We've had to do this real time and the beauty of having the kind of portfolio that we have is that we have that ability to pivot.

In ways that accompany.

Accompany maybe without as Richard portfolio might be a little more constrained to do we have an opportunity to pivot to deploy capital in a way where we can still be advancing things, we can still be creating value, but doing it responsibly with the capital on hand, and doing it responsibly without having to take measures that may be aren't as favorable for our shareholders.

But still creating value and the other leg of that is deploying against our assets non dilutive funding whenever we can we have now received four different.

Have received grants are for different programs now from the NIH.

We have a foundation grant of almost $50 million.

Those grants are primarily directed at our preclinical programs and to help advance those programs with the exception of evergreen where the NIH funded our external cost of our pre pivotal study and we have the NH collaboration for <unk>. So.

Doug we look at it every way we look at it at prioritize prioritizing capital responsibly against the programs in a particular environment that we think are best suited to create value in that environment.

We look at the opportunity for grants and then sometimes yes, we look at.

Potentially not pedal to the metal, but not as fast.

As as we maybe could have in a different environment and we have the flexibility to execute against all three of those tools.

Okay, great. Thank you so much that's super helpful.

Yes.

Thank you and our next question is with Kumar Roger Brookline Capital markets. Please go ahead Sir.

Thanks for taking my question, so one more on green.

Where are you in terms of.

Please stop me from collaboration ought to be getting closer to the end of that burn.

I'm ready to move forward with the IV filing.

And once the Ids cleared how quickly are you able to start the clinical trials yes.

Yeah, Great Great question, so in terms of the <unk> process.

That process is proceeding we don't typically give.

Too much detail about our discussions ongoing discussions with the FDA other than to say what matters about the process is that it's been.

Working with the FDA and on a process that really aligns with the.

The second part of your question our plans to commence the pivotal study.

So that process is very much in line with when we have been talking with the NIH and with the sites.

The plans on when we'd like to commence.

The more serious obviously enrollment activities that you can't commence until the ideas.

<unk>.

So the timeline that we have been working with and with the FDA on is very much aligned with that.

And in terms of that what are the reasons that we wanted to start the process with the FDA and have as our first item on the list.

Getting input from the FDA on the pivotal protocol and making sure that what we were planning was aligned with their expectations for a pivotal study that would support an ultimate PMA was so that to your point, we could start doing work now.

Now.

With the NIH with the collaborator sites too.

Yeah.

With that clarity on the protocol that you cant do without that clarity on the protocol. So so we've already been talking with the sites and talking with UNH and working with them.

Collaboratively to get ready for this study, but in terms of specifics.

We will have more to guide on later this year, but but it's on target to support that pivotal study start this year.

Okay.

With regard to exactly our goal.

Pre commercialization activities.

Interaction thinking about pricing.

East Agra amount, taking care of a falloff from home.

Enrollment are you guys, having right now with regard to guard.

Yeah, So under our agreement with Oregon on there they're responsible for all of those things are all activities that.

Oregon Anvil to play against and Thats the value of having an organ on.

As a partner is their expertise and their capabilities there.

I can say this quite comfortably about both of our collaborations with working on and with there. These are wonderful collaborators. They they really value what it brings to the table they value our insights and our input and we get to half.

A nice participating seat at the table around these commercialization strategies and discussions and things like that ultimately organon will execute it.

Organize plan to execute under our shadow and we want it to be organized plan.

Execute because thats why we picked them was for that ability, but it's really wonderful how truly collaborative they are and our partnership with fair is also in terms of.

Really, allowing dara to be not a financial participant in the process.

Because we're going to uncover as all of that but to have a seat at the table to give our insights and expertise that we've gained working so closely on the product.

And one more on the refunds are good on that.

HD part of this.

On <unk>.

Long acting injectable hardball on.

Perfect.

So what is the timeline.

When this gets funded.

When do you think you will have data from these studies.

Yeah, Great question, so as I as I mentioned in.

And a couple of has touched on.

A few times today grant funding is really useful as a wonderful tool to allow us to continue to advance, particularly our preclinical programs right where those.

Those are great dollars non dilutive dollars to be able to put against that and this particular grant from the NIH. So it's actually our third contraceptive program to get a grant from the NIH we.

Received NH SPRI grants for <unk>, and our <unk> implant and this is for the Adair injectable.

Contraceptive that we have in preclinical development.

Being developed as the.

The opportunity to deliver a six month or a 12 months contract hormonal contraceptive via just one or two injections per year, whether it's six months or 12 months and this particular grant was to really get more insights as we're preparing its in preclinical stages now, but we're always trying to gear up and get ready to move.

Into phase one and beyond this particular grant is to make sure we're really clear on understanding user preferences.

We're an innovation like this will fall in the method mix the women most likely too.

Be interested in it and also the duration.

Of the contraceptive action.

As 12 months joined needed is six months sufficient so that we can make sure that we are designing our phase one program and beyond as this program is getting.

Advanced to that.

That really is going to be differentiated commercially strong and going back to all the points I made upfront in the opening comments, making sure that it's positioned well as a differentiated product that gives us a lot of optionality around commercialization collaborations. So this is intended to gather some of that data from a market.

Perspective that can be very very very helpful and influential in those discussions and we're getting ready to go right away.

Yeah.

Great. Thanks, so much.

Awesome. Thank you.

Thank you.

No more questions on the queue and with that I will turn the call over back to MS. Johnson for closing remarks, great.

Great well. Thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of <unk> stakeholders, the women to health care providers and our shareholders with our diverse portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and wellbeing XP.

<unk> treatment options and improved outcomes, primarily in the areas of contraception fertility vaginal and sexual health and today as we've discussed we have seven candidates in various stages of development and one FDA approved products expected to launch commercially in the fourth quarter of this year, we sincerely look forward to keeping you updated on our progress against the <unk>.

'twenty two objectives and milestones we set for our candidates under development as well as activities with Oregon on that we've been discussing regarding massage shadow launch to thank you for taking the time. This afternoon, and we look forward to keeping you updated.

And this concludes today's conference call. Thank you everyone for your participation you may now all disconnect.

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Welcome to the conference call hosted by the array Bioscience to review the Companys financial results for the quarter ended March 31, 2022 and to provide a general business update. This call is being recorded my name is <unk> and I will be your operator with us today are Mr.

Welcome to Johnson, <unk>, President and Chief Executive Officer, Mr. John Fair <unk> Chief.

<unk> strategy officer, and MS, Lisa Walters Hoffert <unk> chief.

<unk> Financial Officer MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to our first quarter of 2022 financial results and business update call for <unk> Bioscience. Our plan today is to review our first quarter results discuss developments since our last call in March and use the time to review our business strategy and highlight our objectives and milestones anticipated.

For 2022.

Before I begin I would like to remind you that today's discussion will include forward looking statements within the meaning of federal Securities laws, which are made pursuant to the safe Harbor provisions of the private Securities Litigation Reform Act of 1095.

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

March 31 2022.

I'd also like to point out that the content of this call includes time sensitive information that is current only as of today May 12, 2022 diary undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.

As you know Darius solely and squarely focused in women's health. It's <unk>, it's our belief that prioritizing women's health is not only good for the many women whacking effective or convenient therapeutic choices, but also for a broad set of stakeholders, including their families partners and of course our shareholders.

We typically use these calls to update you on the milestones we've achieved to date and the upcoming milestones that we anticipate and we will do that today, we will provide an update on the collaboration with Oregon on to commercialize Zasyadko clindamycin phosphate vaginal gel, 2% and the launch targeted for later this year.

The <unk> phase III clinical studies that we look to initiate in collaboration with the NIH and with advisory support from our commercialization collaborator Bayer.

Our suite NFL cream female sexual arousal disorder phase <unk> clinical study.

And the two other programs with clinical Readouts anticipated this year.

Financial updates I'd like to take a few minutes to review our business strategy and our approach to building value.

We started the company because we recognized a few factors about this therapeutic category that are somewhat unique to women's health and together create a compelling opportunity.

A number of persistent unmet needs in women's health continue to exist indications that are not life threatening but her life altering and were therefore are products that can improve outcomes and convenience can be compelling.

Second because of her unique biology, we believe that these persistent unmet needs can in many cases be addressed with a well characterized active pharmaceutical ingredient or API.

<unk> delivered in a different way such as vaginal versus oral or for an indication that has not yet been addressed in women such as to Dennis <unk> for female sexual arousal disorder.

Use of well characterized API is expected to mitigate development risk time and cost.

But by customizing the delivery route for her when can still have a first line or first in category opportunity with meaningful commercial opportunity.

This gap creates an opportunity for developed focused companies to women's health as evidenced by the transactions in the category not just the licensing agreement that Dara has entered into with Oregon on Embraer to date, but the other transaction these and other companies with the commercial footprint and women's health have also executed.

As a result of these three factors in the not quite five years since going public we have assembled a portfolio of one FDA approved product in seven investigational product candidates the potential product candidates entered into to commercialization collaborations one with Oregon on and one with bear and have done so with relatively modest.

Just capital deployment and leveraging FTIR NIH grants for four of our programs and NIH collaborative research agreement for one of our programs and our foundation grant of nearly $50 million for one of our preclinical programs.

Creating a diverse pipeline of product candidates that utilize different API as a different delivery routes and target different indications such that the successful outcome for one product candidate is independent of the outcome of others has been a foundation to our strategy.

Our strategy also involves selecting a candidate both the drug and the delivery vehicle for each indication that represents an opportunity to personalized treatment options for women. Both in terms of the unique biology of women and overall convenience for women.

Our current portfolio includes drug delivered via vaginal rings, a viscous hydrogel, a proprietary cream, our softgel capsule and implant in an injectable. Our current portfolio also includes numerous programs that utilize those well characterized <unk> API and that therefore have been or that we expect to develop.

<unk>.

The FDA 500, <unk> regulatory pathway.

The 500 <unk> two regulatory path has the potential to shorten the overall development time and cost to obtain and marketing approval in the U S. As was the case with <unk> for which we obtained FDA approval just three years after acquiring rights to the program and with just a single pivotal clinical study.

To date with organized <unk> Shadow and Bayer for <unk>.

In terms of process, we start with the persistent unmet need we talk to women advocates and health care providers to identify areas within women's health that have high unmet needs in some cases.

<unk> therapies for an indication exist, but the therapies are perceived as not sufficiently effective or convenient for the women using them in other cases, there are no FDA approved therapies for the indication.

Once we identify an area of unmet need we create a target product profile to address the need.

First line or first in category product for the indication.

Because we seek to leverage well characterized apis in many cases, the prospective candidates have proof of concept data and are well positioned for dara to accelerate their development as we did with our shadow via our development expertise and our clear commitment to women's health.

This model features modest or no upfront cash consideration milestone payments, if and as candidates successfully advanced through development and if it candidly is ultimately approved commercial payment obligations are intended to allow <unk> to commercialize the product directly or with a commercial collaborator and approach.

It differs a large portion of the potential consideration until program has successfully advanced and that contemplates potential commercial collaborators has enabled us to assemble a portfolio of eight assets, one FDA approved and seven in development in a cash efficient manner and put us in the position to enter into the cloud.

<unk>, we have to date with Oregon on Embraer.

Ultimately, we select the approach that we believe will provide the greatest access to women and achieved the highest peak sales and the least amount of time, because we believe that's best for all stakeholders women and our shareholders given the stage of our current portfolio and the market dynamics in a therapeutic.

Categories for our most advanced programs <unk> and <unk>, we believe the best Avenue to generate value for Dara and its shareholders is via external commercialization collaborations or out license agreements rather than attempting to commercialize these assets on our own.

Opportunities to enter into such collaborations or ultimately contingent on developing differentiated products that demonstrate the potential to be first line or first in category.

In summary, our business model involves identifying the areas of high unmet needs in women's health identifying identifying innovative solutions to address such needs accelerating innovation through development at a time and cost efficient manner and executing on our commercialization strategy best suited to create value for our <unk>.

And our shareholders to date, we've elected to use our expertise and our science to advance our portfolio of candidates through late stage development and in <unk> case through FDA approval and to collaborate with larger organizations with established sales forces in greater resources and women's health to conduct the market launch and ongoing.

<unk> commercialization efforts.

I'll now turn it over to John for our portfolio update.

And can lead to symptoms of odor and discharge, Oregon on shares our commitment to advanced critically needed innovation in women's health and we believe that organize commercial capabilities will ensure that our shadow reaches women most impacted by this condition.

Under our license agreement with Oregon on to commercialize our Shadow DRA will receive a $10 million cash payment from organon upon closing of the transaction and will be eligible to receive potential milestone payments of up to $182 million as well as tiered double digit royalties based on net sales.

Closing of the transaction is subject to review under Hart, Scott Rodino antitrust improvements acts and other customary conditions.

The transaction is expected to close in Q2 of 2022 and <unk> is expected to be available commercially.

The U S in Q4 of 2022.

Pivotal study necessary to support a pre market approval submission to the FDA.

In order to initiate the pivotal phase III study, we must have an FDA approved IV in place we initiated the IV process for <unk> in early 2022, and pending the Fda's review and approval of the IDE, we seek to initiate the pivotal study in 2022.

Based on our communications with the FDA in terms of steady sample size and duration, we expect that at least 200 subjects completing 12 months of overpaying use will be adequate under our credo with a Eunice Kennedy Shriver National Institute of Health and human development or Nics, HG, which is part of the National Institute of Health NIH.

Other we are currently preparing for the pivotal phase III study of overprint.

Under our license agreement with Bayer to commercialize overprint Dara has access to bear his extensive clinical manufacturing and commercialization resources in an advisory capacity for approximately 80 hours per week, while Dara retains full control over <unk> development and regulatory approval process. There has the right to obtain exclusive rights to <unk>.

<unk> in the U S. Following the completion of the pivotal phase III study by making a $20 million payment to Dara.

Thereafter, Dore will be entitled to receive commercial milestone payments potentially totaling $310 million. In addition to double digit tiered royalties on net sales.

Turning our attention to <unk> cream is our investigational product to address her version of erectile dysfunction.

E mail sexual arousal disorder, or <unk> is a physiological condition characterized by the inability to obtain or maintain sufficient genital arousal during sexual activity for which there are currently no FDA approved therapeutics, we continue to enroll women in the phase two be respond clinical study.

Evaluating so identical cream as a potential treatment for <unk>.

Sites across the country. Our study protocol has a planned interim analysis to evaluate power calculations and trial sizing we expect to conduct that analysis. This year after which we will provide guidance on anticipated timing for top line data from the trial.

Dear HR Q1 is our unique <unk> or IV are designed to deliver bio identical estradiol and progesterone continuously over a 28 day period as part of a hormone therapy regimen, we announced positive topline results from our phase one study of Dare <unk> in 2021 and in April of 2022, we announced the start of a new.

New phase one two clinical study of Dare <unk> won this open label study will evaluate the PK of lower and higher dose versions of Dare <unk> won the same two versions evaluated in the first phase one study in roughly 20 healthy post menopausal women over approximately three consecutive months of use the study will also collect.

Safety usability acceptability and symptom relief data. This study is being conducted in Australia by our Australian subsidiary to take advantage of the clinical and financial benefits of doing so we expect to report topline data from the phase one two study during the fourth quarter of 2022 and.

And finally, we will provide a brief update on <unk> BVA, one more than $3 8 million women in the U S have a history of breast cancer or are considered survivors. The hormone receptor positive breast cancer is the most common type of breast cancer diagnosis, and the prevalence of Volvo and vaginal atrophy or BVA in post menopausal breast cancer survivors.

Estimated to be between 42, and 70% we would like to provide an option for these women.

As many of these women are not ideal candidates for standard estrogen based interventions, we initiated a phase one two clinical study in Australia in the third quarter of 2021 for this breast cancer survivorship vaginal atrophy treatment program and we expect to report topline data from <unk> Phase one two study during the second half of 2022, thus in terms.

Anticipated milestones for 2022, we look forward to keeping you updated on one product launch, which we're extremely excited about one pivotal phase III study start which we're also very excited about in two data readouts and with that I will now turn the call over to Lisa.

Thanks.

Thanks to all of you for joining us today I would now like to summarize <unk> financial results for the quarter ended March 31, 2022, which I will refer to as the current quarter or the first quarter of 2022.

For the first quarter of 2022, our G&A G&A expenses were approximately $2 6 million and our R&D expenses were approximately $5 8 million.

The current quarter's R&D expenses were approximately 1% greater than the same period in 2021, and they primarily reflect the costs and activities related to the ongoing so that infill cream phase <unk> respond clinical study and manufacturing and regulatory activities related to over pre.

Our comprehensive loss for the current quarter was approximately $8 4 million.

We ended March 31, 2022, with approximately $39 3 million in cash and cash equivalents subsequent to the end of the quarter. So from April one through May 10th we received approximately $1 2 million in net proceeds from additional sales of stock under our ATM.

In addition, as John just mentioned DRA will receive a $10 million cash payment from Oregon on upon the closing of the transaction under the license agreement for <unk>, which we currently expect to occur in this quarter. In addition, Jerry will be entitled to receive a cash payment of $2 5 million.

Upon the first commercial sale of <unk> in the U S as well as potential future milestone payments of up to $180 million and tiered double digit royalties based on net sales.

<unk> is expected to become available commercially in the U S. In the fourth quarter of 2022.

As of May 10, Jerry had approximately $84 7 million shares of common stock outstanding.

In closing as we've said before we will endeavor to be creative collaborative and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value.

At December 31, 2021, which was filed on March 31 of 2022.

I'd now like to turn the call over to our operated operators so delfin take it away.

Thank you Lisa. Thank you for attending the conference call. We will now conduct a question and answer session and we wanted to ask a question you will need to press star one again telephone keypad once again right.

One hour.

Our first question is Rob zombie genre of Roth Capital Partners. Please go ahead.

Hello, Thanks for taking my questions and things, but really the background on the company and the strategy. So the first one for many years.

As <unk> as part of the commercial launch plans can you kind of update us on where you are with the manufacturing process.

At the earliest in the summer timeframe and so based on that.

That's where the timing for the launch that we're working on in collaboration with Oregon on his fourth quarter, that's where that is aligned with.

So we are working.

Closely with Oregon on on that as they prepare for the launch later this year.

And to support that obviously.

We expect that transaction to close in the second quarter.

Thanks, Sabrina and then the follow up here just for Overpaying regarding next steps can you. Please clarify what those are and then I know John commented on the sample size that might be necessary.

Just wanted to confirm with DMT had okayed or you guys are still leading to discuss those.

Yeah, great questions about <unk> and so on the <unk> process with the FDA is a little bit different than what many of us are accustomed to with an <unk> process.

So for instance in the case of Evergreen and the process is actually in part predicated on the pre pivotal study that we did and the outcome of that study, which which led to our collaboration with Bayer.

So that actually all happened before you even get to the Iga phase and then niv process. They allow the process to include whats called pre submission I'd pre submission. So that you can actually have.

Collaborative discussions with the FDA to address questions and to make sure that ultimately Youre Iga is really set up to support the IDE approval and that you have all the information that you need to be successful to transitioning to a pivotal study that is going to meet their expectations.

<unk> for a PMA and so thats the process that we initiated earlier this year and so to your question therefore on the.

Size of the pivotal study, yes, the feedback that John shared in terms of that expectation around 200 subjects out to the 12 month time points, So which is basically 13 cycles 13 menstrual cycles women have.

More than one cycle it turns out per month.

If you add them all up in a year. So it's 13 cycles.

As well as with Bayer.

And so starting this discussion process as part of the whole E. Ultimately IDE approval process and getting some clarification on both input we wanted to share with the FDA about what we'd like to be doing in the pivotal study based significantly on feedback from there to support ultimate commercialization.

And from the NIH to support successful conduct.

It allows us to have that discussion with the FDA and then go back.

Our collaborators bear in the NIH, so that as we're planning that pivotal study that we're going to be running in collaboration with the NIH. It allows us to really do a lot of work in preparation.

Earlier than one might otherwise normally be able to start in terms of starting now to identify sites and speak with sites in <unk>.

We look forward to giving more updates.

As this process proceeds and as we can give some more clarity on timing.

The pivotal study start that we're targeting this year, but but that hopefully gives a little more perspective on kind of the background. The process with the FDA and then importantly on the pivotal study design kind of that Big picture of design, which is really critical for us to understand as quickly as we could.

That also as you can appreciate obviously feeds into just making sure we have manufacturing supply and.

And all the site setup to really execute against a successful study.

Okay. Thanks, and then the last one year.

With the market the way it is folks who really.

Checking on cash balances in spend and a phase <unk> study coming up.

A lot of folks are kind of curious about what that financial obligation might be and I know plenty at the NIH agreement the credit Union.

They can help offset some of those costs and so we just wonder if you can put into.

Clear terms as to what your financial obligation might be as it relates to the phase III <unk> study and then thanks again for taking my questions.

Absolutely. Thank you for that so obviously right. This is something that that I think all companies in todays market landscape are paying close attention to and honestly it's markets like these where.

Yeah.

Closing in.

First commercial sale under our shadow.

But in addition to that importantly is what you touched on in terms of the question around Overtrain part of what we have also has really worked hard to do is to secure non dilutive funding wherever it strategically makes sense for the portfolio and that also creates a situation where our cash balances and the cash we have on hand.

Just gives us a lot of flexibility and puts us in a position to endure the kind of market.

That we are all dealing with right now and not to mentioned, obviously, having an FDA approved product.

That organization.

Has the ability to launch it feels good to say specifically for <unk>, we entered into a collaboration with the NIH.

Which has us sharing the cost of that pivotal study and importantly, dore portion portion of the.

<unk> cost of the clinical study is $5 5 million.

Five of which has already been paid basically to the NIH right. So that those funds have already gone to the NIH because thats part of preparing for the trial.

So you know.

We have a lot of flexibility with our brand we have a portfolio of programs that yes on the one hand, we are advancing but on the other hand, the capital required to do so and hit the milestones.

That we've been talking about this year the pivotal studies start.

The two data Readouts, we have this year, both of which are being conducted in our subsidiary in Australia, which.

Minimizes expenses that she can for phase one because the overall costs are lower.

We're really well positioned for all of that and beyond so.

So thank you for asking great questions and and we definitely appreciate the sensitivity to that.

Thank you Anna.

Our next question is.

Douglas Tsao from H C. Wainwright. Please go ahead Sir.

Good afternoon, and thanks for taking the questions.

Just curious.

Wrenched, having access to the NIH.

Network for executing yogurt bring study I'm just curious from an operational standpoint, how much do you think.

That will ultimately accelerate your enrollment versus what you would have maybe John on a standalone basis or without it.

Yes. Thank you that's it.

I like that question and it's timely because we just had a lot of them.

Great meetings to kind of drive home why collaborations like this are more than just the money that they bring to the table.

Because it is the <unk> conference last week, the American projects traditions in gynecology and so it's a nice opportunity to connect with some of our collaborators and.

The value of collaborating with the NIH on something like that is that the NIH in their particularly their group that does these and their contraceptive clinical trials network.

Is it group that.

Participates in a number of clinical.

Trials in contraception, specifically, frankly more than DRA or even our partner like they're right more than we as individual companies would be doing on our own because they get to see trials across different organizations and different funding institutions and so and then <unk>.

Having that coordinated through the NIH in a way that an individual collaborator would not be able to share certain insights with us from an NIH perspective, there are insights that big picture. The NIH can share. So what it's really allowed us to do is have information and insight to round up.

<unk> strategy for the trial that.

As effective as Dara can be and I think we've shown that we can be very effective with our execution on the dark shadow phase III trial in 2020 during COVID-19.

We can certainly be effective and navigate these things, but that having that kind of answered. It is helpful. So for instance, <unk> been able to talk with us around.

Enrollment rates and dropout rates and and give us a sense of at a site level and at a high level, what they've seen across different different trials.

In terms of expectations nothing proprietary they don't share anything inappropriate with us, but they are able to have that big picture perspective to guide our strategies. So.

So all of that has been really helpful and to your point, Doug. It's it's inside that if we were operating individually with those sites, we wouldn't have at the same level.

Okay.

And then just another question if I might.

A little bit of a follow up maybe to the prior question just around the broader capital markets.

You, obviously have a number of product candidates, even beyond sort of what you would have thought.

A year ago, you should've bead assets.

And you have the number sort of right behind them.

Yes.

The current situation.

Sort of how you evaluate data does it make you more conservative about what you might see just does.

That mean that some programs might have a higher hurdle than.

Perhaps in a three year capital environment.

To advance.

Not sure if that.

Absolutely does make sense and I would say one of the things that we have always tried to do from from day one.

Is the thoughtful and capital efficient and what that means that doesn't mean literally.

Be inexpensive.

What that means is doing exactly what youre talking about every day every day is a new day looking at the information in hand real time right.

What is the best way to deploy capital today does this program still stand up is this program is still truly differentiated are these data.

Supportive of that are we going to be able to secure a commercialization strategy that is truly accretive for this product.

Where does it stand in the competitive landscape is it still holding up so we do that if we do that real time and we've navigated.

<unk> times, before where we had to make decisions around which programs to push faster, which programs to to go slower whether it was based on new information, we wanted to generate or basis based on the environment. I mean, I go back to the Covid 2020, and that seems like a 100 years ago now, but when that you started.

We also decided that it makes sense to move quickly on our <unk> one program.

And generate that phase one data because for a program like that phase one data is proof of concept that you have ultimately a product.

That can advance.

And and and we parse that year you may remember, we didn't think that was the right year to start the <unk> phase IV.

<unk> reached alignment with the FDA on what that program would take but we were we were worried about starting that trial in such an uncertain COVID-19 environment.

So we've had to do this real time and the beauty of having the kind of portfolio that we have is that we have that ability to pivot.

In ways that.

A company, maybe with that as Richard portfolio might be a little more constrained to do we have an opportunity to pivot to deploy capital in a way where we can still be advancing things, we can still be creating value, but doing it responsibly with the capital on hand, and doing it responsibly without having to take measures that may be aren't as favorable for our shareholder.

But still creating value and the other leg of that is deploying against our assets non dilutive funding whenever we can we have now received four different.

We have received grants are for different programs now from the NIH rehab.

We have a foundation grant of almost $50 million.

We look at it every way we look at it at prioritize prioritizing our capital responsibly against the programs in a particular environment that we think are best suited to create value in that environment.

We look at the opportunity for grants and then sometimes yes, we look at.

Potentially not pedal to the metal, but not as fast.

As as we maybe could have in a different environment and we have the flexibility to execute against all three of those tools.

Okay, great. Thank you so much that's super helpful.

Yes.

Thank you and our next question is with Kumar Roger Brookline Capital markets. Please go ahead Sir.

Thanks for taking my question, so one more on green.

Where are you in terms of this.

Please help me some collaboration model be getting closer to the end of the burn.

We're ready to move forward with the IV filing.

And once the Ids cleared how quickly are you able to start the clinical trials.

Yeah, Great Great question, so in terms of the Iga process.

That process is proceeding we don't typically give.

Too much detail about our discussions ongoing discussions with the FDA.

Other than to say what matters about the process is that it's been.

Working with the FDA and on a process that really aligns with the.

The second part of your question our plans to commence the pivotal study.

So that process is very much aligned with when we have been talking with the NIH and with the sites.

Just the plans on when we'd like to commence.

The more serious obviously enrollment activities that you can't commence until the IDE is approved.

So the timeline that we have been working with and with the FDA on is very much aligned with that.

And in terms of that one of the reasons that we wanted to start with the process with the FDA and have as our first item on the list.

With the NIH with the collaborator sites too.

With that clarity on the protocol that you cant do without that clarity on the protocol. So so we've already been talking with the sites and talking with UNH and working with them.

Collaboratively to get ready for this study, but in terms of specifics.

We will have more to guide on later this year, but.

It's on target to support that pivotal study start this year.

Okay.

With regard to exactly our goal.

Pre commercialization activities.

Interaction thinking about pricing.

He's also taking care of a falloff from home enrollment are you guys, having very small with regard to guard.

Yeah, So under our agreement with Oregon on there they're responsible for all of those things are all activities that.

Oregon on will deploy against and Thats the value of having an organ on.

As a partner is their expertise and their capabilities there.

I can say this quite comfortably about both of our collaborations with working on and with there. These are wonderful collaborators. They they really value what <unk> brings to the table they value our insights and our input and we get to half.

A nice participating seat at the table around these commercialization strategies and discussions and things like that ultimately organon will execute it.

It's organized plan to execute under our shadow and we want it to be organized plan.

Execute because thats why we picked them was for that ability, but it's really wonderful how truly collaborative they are and our partnership with Bayer is also in terms of.

Really allowing.

<unk> to be not a financial participant in the process.

Because we're going on covers all of that but to have a seat at the table to give our insights and expertise that we've gained working so closely on the product.

And one more on the recent good on that front.

CHD part of this.

On <unk>.

Long acting injectable hard ones aren't perfect.

So what is the timeline.

When these get funded and when do you think you will have data from these studies.

Yeah, Great question, so as I as I mentioned.

And a couple of has touched on.

A few times today grant funding is really useful as a wonderful tool to allow us to continue to advance, particularly our preclinical programs right, where those are great dollars non dilutive dollars to be able to put against that and this particular grant from the NIH. So it's actually.

Our third contraceptive program to get a grant from the NIH, we received NH SPRI grants for <unk> and our <unk> implant and this is for the Adair injectable contraceptive that we have in preclinical development.

Being developed as the.

The opportunity to deliver a six months or 12 months contract hormonal contraceptive via just one or two injections per year, whether it's a six month or 12 months and this particular grant was to really get more insights as we're preparing its preclinical stages now, but we're always trying to gear up and get ready to move.

Into phase one and beyond this particular grant is to make sure we're really clear on understanding user preferences.

We're an innovation like this will fall in the method mix the women most likely too.

Be interested in it and also like the duration.

Of the contraceptive action.

As 12 months join needed is six months sufficient so that we can make sure that we are designing our phase one program and beyond as this program is getting.

Advanced to that.

That really is going to be differentiated commercially strong and going back to all the points I made upfront in the opening comments, making sure that it's positioned well as a differentiated product that gives us a lot of optionality around commercialization collaboration. So this is intended to gather some of that data from a market.

Perspective that can be very very very helpful and influential in those discussions and where we're getting ready to go right away.

Yeah.

Great. Thanks, so much.

Awesome. Thank you.

Thank you.

There are no more questions at the queue and with that I will turn the call over back to MS. Johnson for closing remarks.

Great well. Thank you all for taking the time this afternoon to hear about our recent updates and our ongoing commitment to drive value for all of <unk> stakeholders, the womens healthcare providers and our shareholders with our diversified portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and wellbeing.

And treatment options and improved outcomes, primarily in the areas of contraception fertility vaginal and sexual health and today as we have discussed we have seven candidates in various stages of development and one FDA approved products expected to launch commercially in the fourth quarter of this year, we sincerely look forward to keeping you updated on our progress against the import.

'twenty two objectives and milestones we set for our candidates under development as well as activities with Oregon on that we've been discussing regarding the Zasyadko launch. So thank you for taking the time. This afternoon, we look forward to keeping you updated.

And this concludes today's conference call. Thank you everyone for your participation you may now all disconnect.

Q1 2022 Dare Bioscience Inc Earnings Call

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