Q3 2023 Dare Bioscience Inc Earnings Call

November 9, 2023

Welcome to the conference call hosted by by Dori Bioscience to review the company's third quarter financial results and to provide a general business update.

Call is being recorded my name is Chris and I'll be your operator for today.

With us today from <unk> are Sabrina Martucci, Johnson, President and Chief Executive Officer.

John Fair, Chief commercial officer and.

Lisa Walters Hoffert, Chief Financial Officer.

MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to the dairy Bioscience financial results and business update call for the quarter ended September 32023.

Today, We will review, our third quarter results and discuss developments and expectations for our pipeline and portfolio.

While 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 SEC filings, including our Form 10-Q for the quarter ended September 32023, which was filed today.

I would also like to point out that the content of this call includes time sensitive information.

That is current only as of today November nine 2023, dairy undertakes no obligation to update any forward looking statements to reflect new information or developments. After this call except as required by law.

For those of you joining us via webcast you should be able to access the presentation slides from within the webcast module.

We've included these slides to provide some additional context to our portfolio that you may find helpful. While you listen to the call.

Slide deck is also available on the Investor Relations section of our website under presentations and events and webcast and will remain on the site for two weeks.

Okay.

As you know our sole focus of diet is women's health.

Women's health products make up 27% of total blockbuster products, while contributing to 35% of total blockbuster sales and there continues to be many unmet needs in the market.

We believe we have an exceptionally strong pipeline of product candidates that positions us well for the short medium and long term.

I'm excited to share today. The recent strides we've made to advance innovative therapies for women with our most promising near term opportunities.

Since the beginning of the third quarter, we have had several important achievements first we achieved our first commercial milestone for <unk>, which was the initial shipment of the product associated with the launch.

Second we shared additional positive data from our phase <unk> response study of Sudan neutral cream, which has the potential to be the first FDA approved treatment for any form of sexual arousal disorder in women.

And third we made further progress toward patient enrollment for the anticipated start of our pivotal phase III study of Overtrain, our potentially first in class hormone free monthly international contraceptive candidate.

Overall, we continue to advance our key pipeline programs each of which if approved represents a potential first line or first in category opportunity.

Additionally, we are actively engaging our commercialization collaborators, including leading players in women's health, Oregon on and Behr as we steadily execute on our mission to accelerate innovative treatments that women want and need.

I'll now provide an update on our potentially disruptive late stage candidates sedan, it's all cream and over prime.

Then John will provide an update on Saar Shadows launch and Lisa will review our financial results for the quarter ended September 30th.

So let's start with the dentist sell cream, which is our investigational therapeutic candidate to treat female sexual arousal disorder, or FSA D and female sexual interest arousal disorder or S. S. IAG.

Last week, we announced additional updates from our phase two B response study results in preparation for our confirmed upcoming end of phase two FDA meeting this year.

So data show, which is a PDE five inhibitor is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of E. D. Erectile dysfunction in men, which was undoubtedly one of the most successful prescription products ever launched.

Our sildenafil cream is an investigational proprietary topical treatment cream formulation, specifically designed to be used on demand at the time of sexual activity to increase blood flow to the genital tissue in women.

If development is successful so that is a cream has the potential to be the first FDA approved product to treat any form of arousal disorder in women.

Women, who experience no or low sexual arousal are bothered by and dissatisfied with their sex lives, they're frustrated with their sexual problems. They experienced guilt about their sexual difficulties and they are likely to feel sexually in adequate inferior and embarrassed.

Market research suggests that approximately 20 million women in the U S. H 'twenty, one to 60 experience symptoms of low or no sexual arousal and approximately 10 million women are considered distressed and actively seeking treatment.

We believe this is a promising untapped market given the numerous equivalent products approved for men not only viagra, but also cialis and levitra to name a few.

Last week, we announced additional positive data from our phase two B response study of Sudan, and sour cream, having completed our study analyses in preparation for upcoming FDA meeting.

Importantly, these additional analyses indicate that we can use our phase <unk> study approach in phase III.

Specifically this means we can propose a phase III study with the same co primary endpoint structure that we used in phase two b, which assesses arousal sensation and evaluates concerns related to the difficulties with sexual arousal.

And two that we can propose that in the phase III study, we evaluate sedan, if a crane in a broader patient population of women that includes not only women with arousal disorder, only or FSA D. But also those with arousal plus desire disorder, otherwise stated as women with female sexual.

Interest arousal disorder S S IAG.

This would be the first ever phase III pivotal study of a therapeutic candidate for the treatment of arousal disorder and women and we remain on track for end of Phase two meeting with the FDA This year.

We look forward to keeping you updated on those developments.

Now I'd like to turn to evergreen.

Overprint is our investigational potentially first in category hormone free monthly intra vaginal contraceptive.

We have been working closely with our phase III study vibrator, the National Institute of child, Health and human development or N C. H D of the NIH.

On the pivotal study planned to start later this year.

The pivotal phase III study of a premium is being supported by N. Chd's contraceptive development program, which oversees the contraceptive clinical trials network or <unk>, which was established in 1996 to conduct studies of investigational contraceptive like overprint.

We remain on track to start enrolling patients. This fourth quarter of 2023, and we will issue an announcement after the first patient is enrolled.

As a reminder, this study is a multicenter single arm non comparative pivotal phase III contraceptive study of evergreen to evaluate its effectiveness as a contraceptive along with its safety and usability.

Based on our communications to date with the FTA. If successful we believe that only the single registration study will be required to support a pre market approval application submission with the F. D. A.

We believe evergreen has the potential to be a disruptive product in the contraceptive category and potentially life changing for women, who cannot take hormone based therapies, such as some cancer patients or those who would prefer not to do so.

In fact survey data indicate that nearly 85% of women would prefer and monthly option with a lower hormone that send the oral birth control pill.

In addition to providing innovation as a non hormonal contraceptive.

Clear differentiation and disruptive potential of ever brain isn't its convenience and potential efficacy. It's convenience includes easily monthly views and self administration without requiring action at the time of intercourse with target efficacy approaching hormonal birth control methods.

There are currently no FDA approved monthly hormone free contraceptive.

And based on market research approximately 35 million women in the U S are potential candidates for <unk>.

We see parallels to Nuvaring when it entered the market as the first monthly Intervet general hormonal contraceptive and timber arena when it entered the market as the first hormone releasing intrauterine system.

And bear, which commercialize Marina is a leader in commercializing contraceptive products in the United States and they hold the U S commercial rights to <unk> under a license agreement with us.

In summary, I am very excited about the progress we've made on our late stage programs since our last call in August.

As the only company solely focused on developing women's health products Dara is developing first in category products, our investigational products or some of the most potentially disruptive candidates for women in decades, and we collaborate with leading companies to commercialize and deliver these treatments to as many women as Pos.

The ball.

And as you'll hear from Lisa later on this call. We do all of this with thoughtful and efficient capital deployment and leveraging non dilutive sources of capital wherever feasible.

I'll now turn it over to John to provide a commercial update on the Oregon on Zasyadko launch as well as other print and pre commercialization activities underway in collaboration with Bayer.

Thank you Sabrina as a reminder, dust shadow clindamycin phosphate vaginal gel as Lynn <unk> antibiotic for single dose vaginal administration indicated for the treatment of bacterial vaginosis or BV in female patients 12 years of age and older in the United States as many of you know we're going on recently launched disaster.

Although the product is in the channel as of last month and the initial focus in Q4 is on high BB prescribers in the U S aligned to end of year product availability in select retail pharmacies as we have communicated on previous calls organized go to market strategy Leverages, the knowledge and experience of the established next one on <unk>.

<unk> team working on believes there is a roughly 95% overlap of health care providers, who prescribe their contraceptive product nexplanon that also have the potential to prescribers oxi auto based on provider treatment patterns and to drive product pull through their skilled market access team is meeting with customers to reviews.

Because of the strong relationships. The organon sales team has with these health care providers, we expect them to be well positioned to detail Shadow looking ahead to our phase III trial initiation for <unk>. We are excited to begin phase III study activities with our U S. Commercial collaborator bear in parallel our team has been collaborating with.

Bear on key downstream commercial initiatives intended to ensure a seamless transition from clinical development to commercial introduction. These activities will help set the foundation to maximize the value of this disruptive technology with that I'll turn the call over to Lisa.

John and thanks, everyone for joining us today I would now like to summarize <unk> financial results for the third quarter of 2023.

For those of you who are newer to the story <unk> business strategy is to assemble and advance our portfolio of differentiated products product candidates that address meaningful unmet needs that we've identified in women's health and then to monetize the value of our portfolio of clinical and regulatory advances over the near and long term.

The investment required to build in advance of portfolio includes corporate overhead portfolio acquisition and maintenance costs and of course, the ongoing research and development or R&D expenses.

During the third quarter of 2023, our general and administrative or G&A expenses were approximately $2 7 million unchanged from G&A expenses recognized during the third quarter of 2022.

Our R&D expenses, which vary from period to period based on clinical and preclinical manufacturing regulatory and other activities across our entire portfolio were approximately $6 7 million and.

Primarily reflects the costs related to the <unk> cream phase <unk> clinical trial, and manufacturing and regulatory affairs activities related to <unk> planned phase III study.

While my comments are focused largely on our expenses I should note that during the third quarter. We also recognized license fee revenue of $1 million under our global license agreement with Oregon on our comprehensive loss for the third quarter was approximately $8 3 million.

We ended the third quarter with approximately $13 9 million in cash and cash equivalents and as of November eight we had approximately $98 6 million shares of common stock outstanding.

So moving to the fourth quarter of 2023 under our license agreement with the Organon, we will receive a $1 $8 million commercial milestone payment as a result of the first shipment of Sochi auto in connection with its launch in the U S. During the quarter thereafter, we will receive tiered double digit royalties based on net sales as.

Well as additional potential milestones of up to $180 million over time now.

Now that the sales efforts have commenced by organ on dairy dairy will begin to recognize estimated revenues in our financial statements, reflecting the royalties from <unk> net sales.

It goes without saying that we at <unk> are thrilled that Saatchi art, who is now available in the U S and I look forward to reporting on Saatchi <unk> Saatchi art is progress in the months ahead for all <unk> stakeholders.

I started my remarks with a review of our business strategy. So it now feels appropriate to take a moment and review our financial strategy.

Since our inception, we have made fiscal responsibility a top priority maintaining a lean and focused team in managing our overhead costs closely.

In the current challenging market, we have reduced costs and are exploring additional opportunities to reduce costs, when appropriate and where appropriate but seeking to do so without compromising our focus on investing and cultivate cultivating our leading product candidates.

We are looking at a wide range of opportunities to fund our high quality portfolio, including more creative and innovative vehicles that other companies may not have access to.

Based on conversations to date, we've been buoyed by the depths in advance of our portfolio and our pipeline and we are actively pursuing options to raise capital as.

As we've said previously and as Sabrina just noted we will endeavor to be creative collaborative and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value.

Again as a reminder, these include but are not limited to non dilutive grants similar to those that we have obtained to finance many of our preclinical programs equity sales license agreements structured financings and strategic collaborations and alliances we have explored and will continue.

To explore a variety of options to fund our upper operations advance our candidates monetize the value of our assets and build shareholder value.

We encourage investors to read the more detailed discussion of our financials financial condition liquidity capital resources and risk factors in our Form 10-Q for the quarter ended September <unk> 2023, which was filed today as well as in our annual report on Form 10-Q for the year ended December 31 two.

22, which was filed on March 30th of 2023.

I would now like to turn the call over to the operator for Q&A.

Thank you.

I would like to ask a question. Please press Star then one on your telephone keypad again star one if you'd like to ask a question.

The first question is from Katherine Nowak with Jones trading your line is open.

Hi, good afternoon, Thanks for taking my question.

A couple of an overprint.

Firstly do you plan to issue periodic updates regarding enrollment and is it possible that we might expect to see updates on some of the efficacy endpoint potentially before the topline data readout.

Okay.

Hi, Thank you for the great questions and thanks for asking about evergreen I'm, obviously very excited that this study is starting.

In terms of providing updates that definitely is our intention as we've.

As a reminder to people. The study duration is 13 cycles, which is about 12 months.

We do really want to keep people informed as the study progresses. So that's definitely our intent.

The first announcement, you'll get is that first patient enrolled and then we do intend to keep people updated as enrollment progresses, you know as.

As we have information that that's that is suitable for that.

And in terms of provide.

Providing data updates that that's really a fantastic question as well because as as you probably noted in the comments. It is a non comparative study, which means everyone's on over brain everyone gets ever print in the study and in contraceptive studies, you're looking at pregnancy rates over time.

Having said that right now there's not necessarily a plan to disseminate any data before the study is completed however.

That is something that certainly we are discussing with our collaborators at the NSE HD, who are collaborating with us on the study in terms of the merits of doing that and whether or not there might be a situation where that makes sense.

So we will keep you posted on that as well.

Great.

And can you remind me you know.

The estimated cost of this overprint study and to what extent, it's already funded in some part by NTIC H D.

Yeah.

So just as a reminder for everyone and thank you for asking the question. So that we can do that because it's kind of a nice position to be in to have a phase III study starting that actually we already paid for.

And so the way the collaborative research agreement works with the NAC HD is we have already provided into an account basically granted that creator.

$5 million towards the cost of the study.

And then obviously the nics is providing resources as well to cover the cost of the study and right now we're working through the contraceptive clinical trial network, which is the 20 sites that DNA CHD workspace on these types of studies and so that's you know those costs in our funding to the.

NIH was really based on our determination with them and our CRA partner that they work with on these studies in terms of the anticipated cost and needs of the programs.

Obviously, there's always the potential for us to provide additional funding under circumstances for instance, if we felt we wanted to add sites or things like that but right. Now. The study is funded for what is planned currently it's obviously underway and based on the funding that's been provided and also just.

The way the Nics exchange as their contracts.

That really even and we actually touched on this in our 10-Q related to questions. We might get about what happens if there's a government shutdown or even just the way they do their contracts that kind of obligates the funds out till.

Through the third quarter of next year so.

So that's the plan right now with the study.

Okay.

Helpful. And then if I can just get in one more until done a sale claim.

So as you're moving this product into pivotal studies are you considering partnerships.

With all the planes off shadow either regional or U S based and at what point do you think it makes sense to start having those partnering discussions.

Yeah. So as you know as we noted upfront we're very proud that we are in collaboration with some of our readers in women's health, including Organon end, there and as you've noted we've entered into those partnerships and different times through different program. So with evergreen as you noted we entered into that.

Collaboration before the phase III trial.

Whereas with Oregon on drop Shadow, we entered into that collaboration after that product was taken all the way through registration.

Every product is different obviously is.

I hope its obvious given everything we've talked about today. So that it fell cream is a very interesting program. There is nothing approved for female sexual arousal disorder.

And and so given that it's an interesting program. There is a lot of interest in the program from a lot of different stakeholders as a company. We always look at what makes the most sense in terms of ultimately where can we build the greatest value for shareholders.

Which I am myself, a shareholder as well so we look at all the different aspects and possibilities and so as you've seen historically, we've considered partnerships at different times in the trajectory of the program as Lee said commented strategic partnerships are certainly a non dilutive way ive funding certain activities.

But we are also very much had a practice of wheel will we don't talk about those things in advance.

When when the time is right and that partnership is in place and it makes sense then we would talk about it but we obviously consider all the possibilities for every program.

And really look at all the ways that we can fund our portfolio to build value and with something like sedan Intel cream given.

Given us first in category product and there are no FDA approved treatments.

There's interest in a program like that.

So we have but so what's nice about that I should stress as it puts <unk> in a nice position.

And being able to think about what makes sense for Dara and our shareholders.

Got it that's very helpful. Thank you well thanks, so much for taking my questions.

Absolutely.

The next question is from Douglas Tsao with H C. Wainwright Your line is open.

Sure.

Along those lines, it's a little better so clean in terms of seeking a partner.

Has any of the sort of stakeholders that you've spoken with expressed interest in having a voice and helping design the phase three program.

Because obviously you do such novel program.

And the clinical development program could go in a lot of different directions.

Yeah. Another great question so.

You know I think if.

If I may take a sit back on honestly NFL cream program, because I think as many people know and I know you know and particular, Doug like this is a first strike the phase <unk> trial with.

With the first ever study of its kind conducted in this patient population and as a result, Dara had to do a lot of work to work really closely with the FDA on the design of this study and with a lot of the thought leaders in the field of sexual health to really think about you know what what are the endpoints.

What is the patient population, how do we categorize them in this exploratory study so we could come out the other end the way, we have which I couldn't be more thrilled to have come out. The other end of it with basically now you know having really define the patient population in the study endpoints that we can take forward into the phase III and have the phase two be really be a roadmap for that and.

I say all of that to say.

Really in the field of women's health and women's sexual health.

Quite frankly, Dara is seen as very much the thought leader.

In this area and I will say you know every every organization who has.

Thought about sexual dysfunction in women, and particularly arousal disorder incident infill cream specifically has certainly.

Look to Dore.

As the leader in this area in the work we've done already with the FDA and then the work that we've done with all of the thought leaders to prepare for this end of phase two meeting and design a phase III program that makes sense.

So not to say that you know.

Companies may or may not want to have a say in what that development program looks like but I think it's it's really wonderful to be in a position, where we're able to say and not into both the stay away, but just state reality, we've done more work in this therapeutic category than anyone has and we're very much seen as the experts in the lead.

<unk>.

Great that's really helpful.

Brito I guess, an overprint, obviously primary endpoint is basically just preventing pregnancy app are there any other.

Any other endpoints in the study that we should be focused on thank you.

Thanks for asking that.

We know this is one where we've done a we did a lot of work with their in the design of the study and as you know contraceptive trials you know on the one hand, it's very cut and dry I mean youre looking at.

Whether or not someone gets gets pregnant.

But because of a premium is such an innovative disruptive technology.

There are a number of things that we can bear aligned on that we would also be collecting.

In this study in terms of just the to her experience.

With the product.

So question is really around.

Things that are captured on electronic diary around her experience with the product or use of the product.

So that we have you know those insights.

And then additionally, you know because it's a once a month product again. Similarly, there are aspects of that that we're hoping to collect in the data from the trial again kind of related to that experience perspective.

As well as safety there are a number of safety endpoints in this study as well to really demonstrate kind of the convenience and safety of using a product of this nature. So when we ultimately do you report the findings it will be very much as I alluded to in my in my comments, absolutely it's about efficacy, but we.

<unk> also worked very closely what's there to make sure in this study that we're collecting a lot of.

Really useful right and to John's point about commercialization useful data around usability and the patients and sort of her experience with the product.

Okay, great. Thank you so much.

Yes.

Okay.

We have no further questions at this time I'll turn it back to MS. Johnson for any closing remarks.

Great well, thank you and thanks, everyone for taking the time this afternoon and I know, it's a busy time of year, earning season. So I. Appreciate you dialing in to hear about a recent updates.

And our ongoing commitment to drive value for all of <unk> stakeholders by addressing unmet needs in women's health and as you heard today, we are prioritizing women's health and wellbeing by working to expand treatment options, where none exist or improve the current standard of care to address persistent unmet needs. We're working closely with our <unk>.

Collaborators, including the leading players we talked about today in women's health, Oregon on end there to bring these treatments to women around the world who need them and ultimately we believe we are uniquely positioned to improve quality of life for millions of women of women. We look forward to keeping you updated on our progress toward the mile.

Stones, we discussed today. Thank you so much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Please wait the conference will begin shortly.

Okay.

Right.

Yes.

Okay.

[music].

Welcome to the conference call hosted by by Dori Bioscience to review the company's third quarter financial results and to provide a general business update.

This call is being recorded my name is Chris and I'll be your operator for today.

With us today from Dori are Sabrina Martucci, Johnson, President and Chief Executive Officer, John Fair, Chief Commercial Officer.

Lisa Walters Hoffert, Chief Financial Officer Mr.

MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to the dairy Bioscience financial results and business update call for the quarter ended September 30th 2023.

Today, We will review, our third quarter results and discuss developments and expectations for our pipeline and portfolio.

To support it or implied by these statements due to known and unknown risks and uncertainties you should not place undue reliance on forward looking statements forward looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our Form 10-Q for the quarter ended September 32023, which was filed today.

I would also like to point out that the content of this call includes time sensitive information there.

For those of you joining us via webcast you should be able to access the presentation slides from within the webcast module.

We've included these slides to provide some additional context to our portfolio that you may find helpful. While you listen to the call.

Slide deck is also available on the Investor Relations section of our website under presentations and events and webcast and will remain on the site for two weeks.

Okay.

As you know our sole focus of diet is women's health.

Women's health products make up 27% of total blockbuster products, while contributing to 35% of total blockbuster sales and there continues to be many unmet needs in the market.

We believe we have an exceptionally strong pipeline of product candidates that positions us well for the short medium and long term.

I'm excited to share today. The recent strides we've made to advance innovative therapies for women with our most promising near term opportunities.

Since the beginning of the third quarter, we have had several important achievements first we achieved our first commercial milestone for dash, Seattle, which was the initial shipment of the product associated with the launch.

Second we shared additional positive data from our phase <unk> response study of Sudan, Hicksville cream, which has the potential to be the first FDA approved treatment for any form of sexual arousal disorder in women.

Overall, we continue to advance our key pipeline programs each of which if approved represents a potential first line or first in category opportunity.

I'll now provide an update on our potentially disruptive late stage candidates sedan, it's all cream and over prime.

Then John will provide an update on Saar Shadows launch and Lisa will review our financial results for the quarter ended September 30th.

Last week, we announced additional updates from our phase <unk> response study results in preparation for our confirmed upcoming end of phase two FDA meeting this year.

If development is successful so that is a cream has the potential to be the first FDA approved product to treat any form of arousal disorder in women.

Women, who experience no or low sexual arousal are bothered by and dissatisfied with their sex lives. They are frustrated with their sexual problems. They experienced guilt about their sexual difficulties and they are likely to feel sexually in adequate inferior and embarrassed.

We believe this is a promising untapped market given the numerous equivalent products approved for men not only viagra, but also cialis and levitra to name a few.

Last week, we announced additional positive data from our phase two B response study of Sudan, and sour cream, having completed our study analyses in preparation for upcoming FDA meeting.

Importantly, these additional analyses indicate that we can use our phase <unk> study approach in phase III.

Interest arousal disorder S S IAG.

We look forward to keeping you updated on those developments.

Now I'd like to turn to evergreen.

Overprint is our investigational potentially first in category hormone free monthly intra vaginal contraceptive.

We have been working closely with our phase III study vibrator, the National Institute of child, Health and human development or N. I C. H D of the NIH.

On the pivotal study planned to start later this year.

The pivotal phase III study of ever print is being supported by Ni Chd's contraceptive development program, which oversees the contraceptive clinical trials network or <unk>, which was established in 1996 to conduct studies of investigational contraceptive like overprint.

We remain on track to start enrolling patients. This fourth quarter of 2023, and we will issue an announcement after the first patient is enrolled.

Based on our communications to date with the FTA. If successful we believe that only this single registration study will be required to support a pre market approval application submission with the F. D. A.

In fact survey data indicate that nearly 85% of women would prefer and monthly option with a lower hormone do send the oral birth control pill.

In addition to providing innovation as a non hormonal contraceptive the clear differentiation and disruptive potential of ever brain isn't its convenience and potential efficacy. It's convenience includes easily monthly views and self administration without requiring action at the time of intercourse.

With target efficacy approaching hormonal birth control methods.

There are currently no FDA approved monthly hormone free contraceptive and.

And based on market research approximately 35 million women in the U S are potential candidates for evergreen.

We see parallels to Nuvaring when it entered the market as the first monthly Intervet General hormonal contraceptive and Timna arena when it entered the market as the first hormone releasing intrauterine system.

And bear, which commercialize Marina is a leader in commercializing contraceptive products in the United States and they hold the U S commercial rights to <unk> under a license agreement with us.

In summary, I am very excited about the progress we've made on our late stage programs since our last call in August.

The ball.

And as you'll hear from Lisa later on this call. We do all of this with thoughtful and efficient capital deployment and leveraging non dilutive sources of capital wherever feasible.

I'll now turn it over to John to provide a commercial update on the Oregon on Zasyadko launch as well as other print and pre commercialization activities underway in collaboration with Bayer.

So the product is in the channel as of last month and the initial focus in Q4 is on high BB prescribers in the U S aligned to end of year product availability in select retail pharmacies as we have communicated on previous calls organized go to market strategy Leverages, the knowledge and experience of the established next one on <unk>.

So because of the strong relationships. The organon sales team has with these health care providers, we expect them to be well positioned to detail Shadow looking ahead to our phase III trial initiation for over Prime. We are excited to begin phase III study activities with our U S. Commercial collaborator bear in parallel our team has been collaborating with.

John and thanks, everyone for joining us today I would now like to summarize <unk> financial results for the third quarter of 2023 for those of you who are newer to the story <unk> business strategy is to assemble and advance our portfolio of differentiated products product candidates that address meaningful unmet needs that we've identified.

In women's health, and then to monetize the value of our portfolio of clinical and regulatory advances over the near and long term the investment required to build and advance our portfolio includes corporate overhead portfolio acquisition and maintenance costs and of course, the ongoing research and development or R&D expenses.

During the third quarter of 2023, our general and administrative or G&A expenses were approximately $2 7 million unchanged from G&A expenses recognized during the third quarter of 2022, our R&D expenses, which vary from period to period based on clinical and preclinical.

Manufacturing regulatory and other activities across our entire portfolio were approximately $6 7 million and primarily reflects the costs related to the <unk> cream phase <unk> clinical trial, and manufacturing and regulatory affairs activities related to <unk> planned phase III study.

We ended the third quarter with approximately $13 9 million in cash and cash equivalents.

And as of November eight we had approximately $98 6 million shares of common stock outstanding.

As well as additional potential milestones of up to $180 million over time.

Now that the sales efforts have commenced by organ on dairy dairy will begin to recognize estimated revenues in our financial statements, reflecting the royalties from <unk> net sales.

It goes without saying that we at <unk> are thrilled that Saatchi art, who is now available in the U S and I look forward to reporting <unk> progress in the months ahead for all <unk> stakeholders.

I started my remarks with a review of our business strategy. So it now feels appropriate to take a moment and review our financial strategy.

Since our inception, we have made fiscal responsibility a top priority maintaining a lean and focused team in managing our overhead costs closely.

We're looking at a wide range of opportunities to fund our high quality portfolio, including more creative and innovative vehicles that other companies may not have access to.

Based on conversations to date, we have been buoyed by the depth in advance of our portfolio and our pipeline and we are actively pursuing options to raise capital as.

As we've said previously and as Sabrina just noted we will endeavor to be creative collaborative and opportunistic in seeking the capital needed to meet our objectives and to build shareholder value.

To explore a variety of options to fund our upper operations advance our candidates monetize the value of our assets and build shareholder value.

22, which was filed on March 30 of 2023.

I would now like to turn the call over to the operator for Q&A.

Thank you.

If you would like to ask a question. Please press Star then one on your telephone keypad again star one if you'd like to ask a question.

The first question is from Katherine Nowak with Jones trading your line is open.

Hi, good afternoon, thanks for taking my questions.

A couple on overpaying.

Do you plan to issue periodic updates regarding enrollment and is it possible that we might expect to see updates on some of the efficacy endpoint potentially before the topline data readout.

Hi, Thank you for the great questions and thanks for asking about ever train them. We're obviously very excited that this study starting.

In terms of providing updates that that definitely is our intention as we've as a reminder to people. The study duration is 13 cycles, which is about 12 months.

So that's how long the women in this study will be using overtrain over the course of that period and as we've guided in terms of how long. The study will take beyond that it really comes down to the enrollment rate and so we do really want to keep people informed as the study progresses. So that's definitely our intent I'm. The you know the first announcement, you'll get is that first.

Patient enrolled and then we do intend to keep people updated as enrolment progresses.

As we have information that that's that is suitable for that.

And in terms of.

Providing data updates that that's really a fantastic question as well because as as you probably noted in the comments it isn't noncompetitive study, which means everyone's on over brain, everyone gets ever print in the study and in contraceptive studies, you're looking at pregnancy rates over time.

Having said that.

Right now you know theres not necessarily a plan to disseminate any data before the study is completed however that is something that certainly we are discussing with our collaborators at the N. I C. H D who are collaborating with us on the study.

In terms of the merits of doing that and whether or not there might be a situation where that makes sense.

So we will keep you posted on that as well.

Great and can you.

You remind me.

Yeah.

Estimated cost of this other pain study and to what extent is already funded and some parts I N C. H D.

Yeah, and so just as a reminder for everyone and thank you for asking the question. So that we can do that because it's kind of a nice position to be in to have our phase III studies, starting that said actually we already paid for.

And so the way the collaborative research agreement works with the NAC HD is we have already provided into an account basically granted that create a.

$5 million towards the cost of the study.

And then obviously the Nics D is providing resources as well to cover the cost of the study and right now we're working through the contraceptive clinical trial network, which is the 20 sites that DNA CHD workspace on these types of studies and so that's you know those costs in our funding too.

To the NIH was really based on our determination with them and our.

CRA partner that they worked with on these studies in terms of the anticipated costs and needs of the programs.

Obviously, there's always a potential for us to provide additional funding under circumstances for instance, if we felt we wanted to add sites or things like that but right. Now. The study is funded for what is planned currently it's obviously underway and based on the funding that's been provided and also just the.

The way the nics deemed as their contracts you know that really even.

And we actually touched on this in our 10-Q related to questions, we might get about what happens if there's a government shutdown, even just the way they do their their contracts that kind of obligates. The funds out till you know through the third quarter of next year. So.

So that's the plan right now with the study.

Okay.

Helpful. And then if I can just get in one more.

Well Dennis L claim.

So as you are moving this product into pivotal studies are you considering partnerships.

As you did with older planes oxiana, either regional or U S based and at what point do you think it makes sense to start having those partnering discussions.

Yeah.

Yeah. So as you know as we noted upfront we're very proud that we are in collaboration with some of our readers in women's health, including organ on end there and as you've noted we've entered into those partnerships and different times through different programs. So with evergreen as you noted we entered into that collaboration.

Before the phase III trial.

Whereas with Oregon on drop Shadow, we entered into that collaboration after that product was taken all the way through registration.

Every product is different obviously is.

I hope its obvious given everything we've talked about today. So that is a cream is a very interesting program. There is nothing approved for female sexual arousal disorder.

And and so given that it's an interesting program. There's a lot of interest in the program from a lot of different stakeholders as a company. We always look at what makes the most sense in terms of ultimately where can we build the greatest value for shareholders.

Which I am myself, a shareholder as well so we look at all the different aspects and possibilities and so as you've seen historically, we've considered partnerships at different times in the trajectory of our program as Lee said commented strategic partnerships are certainly a non dilutive way of funding certain activities.

But we are also very much had a practice of you know wheel will we don't talk about those things in advance.

When when the time is right and that partnership is in place and it makes sense then we would talk about it but we obviously consider all the possibilities for every program.

And really look at all the ways that we can fund our portfolio to build value and with something like sedan until cream given us first in category product and there are no FDA approved treatments.

There there's interest in a program like that.

So we have but so what's nice about that I should stress is it puts you know dairy in a nice position.

And being able to think about what makes sense for Dara and our shareholders.

Got it that's very helpful. Thank you well thanks, so much for taking my questions.

Absolutely.

The next question is from Douglas Tsao with H C. Wainwright Your line is open.

Sure.

Along those lines, it's a little bit up they'll clean in terms of seeking a partner.

Hum.

Has any of the sort of stakeholders that you've spoken with expressed interest in having a voice.

In helping design the phase III program, because obviously you do such novel program and the clinical development program could go in a lot of different directions.

Yeah. Another great question. So you.

You know I think if I may take a sit back on honestly NFL cream program, because I think as many people know and I know you know and particular, Doug like this is a first strike the phase <unk> trial with.

The first ever study of its kind conducted in this patient population and as a result, Dara had to do a lot of work to work really closely with the FDA on the design of this study and with a lot of the thought leaders in the field of sexual health.

Do you really think about you know what what are the endpoints.

What is the patient population, how do we categorize them in this exploratory studies. So we can come out the other end the way, we have which I couldn't be more thrilled to have come out. The other end of it with basically now you know having really define the patient population in the study endpoints that we can take forward into the phase III and have the phase two be really be a roadmap for that and I say.

All of that to say.

Really in the field of women's health and women's sexual health.

Quite frankly.

<unk> is seen as very much the thought leader.

In this area and and I will say you know every every organization who has <unk>.

<unk> thought about sexual dysfunction in women and particularly arousal disorder incident cream, specifically has certainly.

Look to Dara.

As the leader in this area in the work we've done already with the FDA and then the work that we've done with all of the thought leaders to prepare for this end of phase two meeting and and design.

Phase III program that makes sense.

So not to say that you know compass.

Companies may or may not want to have a say in what that development program looks like but I think it's it's really wonderful to be in a position, where we're able to say and not in the both the seaway, but just state reality, we've done more work in this therapeutic category than anyone has and we're very much seen as the experts in the lead.

<unk>.

Great that's really helpful and Sabrina I guess, an overprint, obviously primary endpoint is basically just preventing pregnancy or are there any other.

Any other endpoints in the study that we should be focused on thank you.

Thanks for asking that.

Whether or not someone gets gets pregnant.

But because evergreen is such an innovative disruptive technology.

There are a number of things that we can bear aligned on that we would also be collecting in this study in terms of just the cadence of her experience.

With the product.

So you know questions really around things that are captured on electronic diary around her experience with the product her use of the product.

So that we have you know those insights.

We have also worked very closely with there to make sure in this study that we're collecting a lot of.

Really useful right and to John's point about commercialization.

Useful data around usability and the patients and sort of her experience with the product.

Yeah.

Okay, great. Thank you so much.

Yep.

We have no further questions at this time I will turn it back to Mr. Wilson for any closing remarks.

Great well, thank you and thanks, everyone for taking the time. This afternoon I know, it's a busy time of year, earning season. So I. Appreciate you dialing in to hear about a recent updates.

Our ongoing commitment to drive value for all of <unk> stakeholders by addressing unmet needs in women's health and as you heard today, we are prioritizing women's health and wellbeing by working to expand treatment options, where none exist or improve the current standard of care to address persistent unmet needs. We're working closely with our collaborators.

Operators, including the leading players we talked about today in women's health, Oregon on end there to bring these treatments to women around the world who need them and ultimately we believe we are uniquely positioned to improve quality of life for millions of women.

Of women, we look forward to keeping you updated on our progress towards the milestones we discussed today. Thank you so much.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

Q3 2023 Dare Bioscience Inc Earnings Call

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