Q2 2023 Dare Bioscience Inc Earnings Call

Okay.

Welcome to the conference hosted by Diary Bioscience to review the company's financial results for the quarter ended June 30, 'twenty to 'twenty, three and to provide a general business update.

Call is being recorded my name is Mark and I will be your operator today, well yesterday are Sabrina Martucci, Johnson diaries, President and Chief Executive Officer.

John Fair, Darius Chief commercial officer, and Lisa Walters Hoffert <unk>.

Financial Officer MS. Johnson. Please proceed.

Thank you good afternoon, and welcome to the financial results and business update call for the quarter ended June 30th 2023 for jewelry bioscience.

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 the slides to provide some additional context on our portfolio that you may find helpful. While you listen to the call.

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

Today, We will review, our second quarter results and discuss developments and expectations for Josh Shadow commercialization and for two of our late stage investigational products are hormone free monthly Intraregional contraceptive candidate overtraining and Sildenafil cream, three 6%, which is being developed as a treatment for arousal disorder in.

Women.

Before we 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 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.

And for 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 June 30th tried try three 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 August 10th try 23.

<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 a reminder, at jewelry women's health is our sole focus we believe that innovation in women's health needs to be a priority and we believe investment in women's health would be efficient and disproportionately impactful.

Given that women control, 80% of U F U S health care purchasing decisions.

And that although only 1% of health care research dollars are invested in women's health.

Women's health products, Nonetheless, make up 27% of total products generating over 500 million in revenue annually and contribute to 35% I've told a blockbuster sales.

We are working to identify and advance new therapies that provide additional choices and improve outcomes. So that we can make a difference in the lives of women everywhere.

Our current innovation efforts are focused in contraception, vaginal health reproductive health menopause sexual health and fertility.

Our portfolio includes one F D. A approved product, which is being commercially launched by Oregon on and five clinical development stage candidates three of which are in are nearing phase III development.

Today, I will provide development updates on two of the late stage candidates over print and so then it fell cream.

John will provide an update on Josh Shadow and Lisa will review our financial results for the quarter ended June 30th.

So, let's start with food I feel cream.

That's all cream is our investigational candidate to treat sexual arousal disorder in women.

Arousal disorder in women is characterized by the inability to achieve a sufficient physical response to sexual stimulation.

Causes clinically significant distress and the various types of female sexual dysfunction disorders arousal disorder. In women is most analogous to erectile dysfunction or E D in med.

So that a show which is a phosphodiesterase five inhibitor is the active ingredient in a tablet for oral administration currently marketed under the brand name Viagra for the treatment of EG in men.

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

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

Market research suggests that 16% of women in the U S Ages 21 to 60 or approximately 10 million women are distressed from experiencing no or low sexual arousal and are actively seeking solutions to improve their condition in comparison, the prevalence of complete Aegean.

Men is estimated to be about 5% of Mad at age 40, increasing to about 15% at age 70.

Women, who experienced no or low sexual arousal are bothered by and or are just satisfied with their sex lives. They are frustrated with their sexual problem. They experience guilt about their sexual difficulties and they are likely to feel sexually inadequate inferior and embarrassed.

Sounds familiar like what men with erectile dysfunction experience.

As men did before affected E. D treatments women are suffering in silence and affected by a feeling of shame and embarrassment.

We are working to change that for women by developing a treatment that can address their lack of physical arousal response, which we believe in turn will improve their sexual interest and reduce dissatisfaction with their sex lives.

As the effective E D treatment stage from that.

On June 1st we reported topline results of the exploratory phase to be respond clinical study accidental cream and on July 11th we reported additional positive data from the study and hosted a webinar with Kols key opinion leaders to further discuss the findings from the <unk>.

<unk>.

For those of you who missed those updates I wanted to take a moment today to highlight some of the key results and outcomes of the phase two be respond study and the implications for future development.

Now the purpose of the exploratory phase to be respond study was to test the sensitivity of several patient reported outcomes also referred to as pro F.

You can see endpoints and their ability to determine a treatment effect of Sudan, if a cream compared to placebo.

To inform the ongoing development of Sudan info cream.

The study also served as a validation study of exploratory endpoints that could be candidates efficacy endpoints in a phase III study of sitting at for cream.

Because there are no currently FDA approved treatments for any form of arousal disorder and women. There are no efficacy endpoints that had been previously approved for use in a phase III pivotal study for potential treatment of those disorders.

In the phase <unk> study the synthetic so cream treated group showed improvements in multiple aspects of the sexual experience, including arousal lubrication achievement and pleasure of orgasm and sexual desire.

The data indicates that as compared to placebo. So then it's all cream had a therapeutic effect based on several of the exploratory pros.

The data from the phase two B response study we believe.

Certain of the primary secondary and exploratory endpoints based on that study could be candidate endpoints in a phase III study of Sudan, NFL cream halved.

Having now completed this pioneering work in the fields of arousal disorder in women, we look forward to reviewing the data with the FDA, including discussing the data from assessments as early as before an eight week Mark after randomization and continuing the development of Sydney, So cream, including our objective of initiating the first ever phase.

Three pivotal study of a therapeutic candidate for the treatment of arousal disorder in women.

It is our belief that a candidate that can successfully address the significant unmet need of arousal disorder in women represents one of the largest opportunities in women's health today we.

Therefore, I believe that to Dennis so cream represents a promising clinical candidate any meaningful valuation driver for our company.

So is that it's all cream has the potential to be the first FDA approved product to treat any form of arousal disorder in women and we remain committed to working with our development partner SSG and the F. D. A to move this candidate forward.

We are continuing to analyze the data from the phase two B response study and are targeting an end of phase two meeting with the FDA before the end of this year before the end of 2023 which if successful would support phase III commencement in early 'twenty 'twenty four.

Following clinical development, which we expect will include two pivotal phase III studies, we intend to leverage the existing safety and efficacy data on the active ingredient incident, if a cream to utilize the fda's 505, two pathway to obtain marketing approval in the U S.

We look forward to keeping you updated on this program, particularly as we collaborate with the FDA on the phase III program.

Now I'd like to turn to overprint.

<unk> is our investigational potentially first in category hormone free monthly Intravascular contraceptive.

There truly is nothing like it on the market today.

While a monthly hormone containing vaginal ring product has been available for several years Nuvaring peak sales reached nearly $1 billion.

There is no hormone free counterpart with a similar monthly interventions dosing format.

We have been working closely with our phase III collaborator and I C. H D of the NIH on the pivotal study planned to start later this year.

Specifically the pivotal phase III study of overprint is being supported by the N. I C. H D's contraceptive development program, which oversees the contraceptive clinical trials network or C. C. T. N established in 1996 to conduct studies I've investigational contraceptives, we expect to commence subject in raw.

In the fourth quarter of this year.

This study is a multicenter single arm non comparative set pivotal phase III contraceptive study of over <unk> to evaluate its effectiveness as a contraceptive device along with its safety and usability.

Based on our communications with the FDA. If successful this will be the single registration study required to support the pre market approval application submission with the F D. A.

Now a few details on the study this is a non comparative study, meaning all women we use over prime there is no placebo in this study.

We will target having approximately 250 subjects complete 12 months, that's 13 menstrual cycles of juice based.

Based on typical dropout rates for contraceptive studies, we will look to enroll more than double of our target number of Completer Ronson once enrollment is well underway and we have a clear sense of dropout rates. In this study will be able to provide guidance on when to expect study completion.

The primary objective of this study is to assess pregnancy rates over 13 cycles.

Primary end point will be using a Perl index typical use Perl index. This is the common primary end point for contraceptive product candidates.

Secondary objectives are looking at the contraceptive effectiveness on a typical use pregnancy probability basis, they've been 13th cycles.

As well as safety and acceptability.

We recognize that while much work had been done over the last 20 years to improve hormonal contraception.

Fritz to innovate non hormonal options have lagged and therefore, we believe it overprint has the potential to be a disruptive product in the contraceptive category as Nuvaring was when it entered the market as the first monthly interventional contraceptive delivering hormones and asthma rain. It did when it entered the market as the first hormone releasing.

Intrauterine system.

Speaking of Marina Bear a leader in commercializing contraceptive products in the United States holds the U S commercial rights to overprint under our license agreement with us.

Yeah.

I will now turn it over to John to provide a commercial update on the Saar Shadow launch activities as well as on commercial preparedness activities for our development candidates overprint and still benefit cream.

Thank you Sabrina as a reminder, zasyadko clindamycin phosphate vaginal gel as <unk> anti bacterial for single dose vaginal administration indicated for the treatment of bacterial vaginosis and female patients 12 years of age and older in the United States.

Oregon on our global commercial collaborator believes there is roughly a 90% overlap of health care providers, who prescribe <unk> contraceptive product next blom and have the potential to be prescribers of zasyadko based on provider treatment patterns because of these strong relationships the Oregon on sales team.

With these health care providers, we expect organon to be well positioned to details asciano and drive product prescriptions and pull through on day. One of launch we believe that zasyadko should be well positioned for commercial success, given the knowledge and experience of organized Nexplanon sales team coupled.

But theyre planned marketing and payer outreach initiatives as we have outlined on previous calls and we plan to provide further updates once the product is on the market working on and are working towards a U S launch as soon as feasible.

Looking ahead to our later stage programs in parallel with the <unk> Phase III study activities. Our team has been busy working with our collaborator Bayer on key commercial initiatives to ensure a seamless transition from clinical development to commercial introduction, we have organized a cross functional team to align and activate on tea.

She aspects of the brand, including packaging messaging and key opinion leader targeting these activities will help set the foundation for additional downstream post approval sales and marketing activities.

And finally, we are truly excited about the progress on this identified cream program as we continue to analyze the data we are planning to implement a robust medical communication strategy to make sure. We are educating all of the key stakeholders in women's health and sexual health on key.

Because of the condition, including pathophysiology and quality of life issues and plan to work with our colleagues on the medical side to ensure broad dissemination of this information we will have more information on these initiatives moving forward, but we remain very excited about the opportunity to bring forward a first in category.

Solution lifestyle benefit cream that has the potential to improve the lives of millions of women dealing with sexual disorder and bring a much needed new option for providers that currently have nothing to prescribe them with that I will turn the call over to Lisa.

Thank you John and thanks for all of you for joining today I would now like to summarize <unk> financial results for the quarter ended June 30th 'twenty, 'twenty, three which I will refer to as the current quarter or the second quarter.

As you know dairies business model is to assemble and advance our portfolio of differentiated product candidates that address meaningful and that means that we've identified in women's health and then to monetize the value of the 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 ongoing research and development or R&D expenses.

During the second quarter, our general and administrative or G&A expenses were approximately $2 $9 million or R&D expenses, which vary from period to period based on our clinical preclinical and manufacturing regulatory and other activities across our entire portfolio were.

At least $6 million and primarily reflected the cost associated with it so that if a cream phase <unk> respond clinical trial that Sabrina just summarized and manufacturing and regulatory affairs activities related to overprint planned phase III study.

Our comprehensive loss for the current quarter was approximately $8 $7 million.

We ended the current quarter with approximately $13 $3 million in cash and cash equivalents and as of August 19, 2023, we had approximately $87 8 million shares of common stock outstanding.

Under our license agreement with the Oregon on for Saatchi Auto we received $1 million in July and we are entitled to receive $1 $8 million. Following the first commercial sale.

Thereafter, we will be eligible to receive potential additional milestone payments of up to $180 million as well as tiered double digit royalties based on the shadows in it there.

We are continuing to explore a variety of options to fund our operations and advance our candidates monetize the value of our assets and build shareholder value.

These alternatives include but are.

We're not limited to non dilutive grants like the one we recently received from the NIH for a preclinical candidate.

Equity sales license agreement structured financings and strategic collaborations or alliances.

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

We encourage all investors to review the more detailed discussion of our financials, our financial condition liquidity capital resources risk factors in the Form 10-Q for the quarter ended June 30th 2023, which we filed today and in our annual report on Form 10-K for the year ended December 31.

2022, which was filed on March 30th 2023.

I would now like to turn the call over to the operator.

Yeah.

Thank you for attending the conference call at this time I would like to remind everyone in order to ask a question Press Star then the number one on your telephone keypad at Star then the number one on your telephone keypad.

Your first question comes from the line of Catherine Novack with junk research Catherine Your line is now open.

Hi, Good afternoon. Thanks for taking my question I guess, just you know a couple of questions on Overplaying can you remind us what still gating to the initiation of the study and you know what are some key inclusion exclusion criteria that you are anticipating that Mike.

Effect of screen rate and enrollment rate of the study.

Yeah, great questions and thanks for your questions as always and in terms of what's gating. The start of the study where we're really gearing up to be ready to go. So as I've mentioned in my comments today were working with the NIH D. N S. H D. I'm on the conduct of the study and they actually held an investigator meeting with the investigators.

So were identified for the Prime study actually last December .

So these investigators have been excited and prime for awhile.

You may recall, there were some comments from the F. D. A when we got our I T E approval to move forward with the study with some recommendations on some tweaks around considerations around the protocol that they encouraged us to make to ensure that it would meet all their expectations and so we have done that and then we've been getting the.

<unk> kind of Reoriented to the protocol and ready to go and so we're really preparing to initiate enrollment now in the fourth quarter and then obviously, we've been you know manufacturing with our partner to prepare for that so we're super excited to get started I'm, obviously and you know all the pieces are coming together and are on.

Like right now for that in terms of and and and all the sites as I mentioned at the clinical trial there networks. The contraceptive clinical trial network sites that are participating.

Supporting in the study so its about 20 sites right now that are participating in the study and so they are you know, they're all set up in terms of the key and kind of inclusion exclusion criteria, it's pretty standard for for contraceptive studies so patience.

You now have to be of a certain age them. They have to be in a committed partnership they have to have a commitment to have certain number of sexual events.

You know every month, so you know they did.

Can't have certain you know medical conditions that would be pretty standard in the contraceptive study to be exclusionary. So there's nothing really unique in terms of the inclusion and exclusion criteria for this study.

What we do see that with contraceptive studies that as we've looked across a number of the contraceptive studies that have been conducted over the years and that's one of the nice things about working with the NIH and the contraceptive clinical trial network is that we get the benefit of a lot of other [laughter] studies they've done for you know further sponsors in Prague.

<unk>, what we've seen is that the.

Difference, we've seen kind of meaningful frankly differences in dropout rates and screening rates across different contraceptive studies and those all can obviously impact kind of your timelines and enrollment and that's one of the reasons that I stated in my comments you know we want to get our particular study going and dispatch.

The other day and age right in this environment and then get a sense of what those metrics look like and then that'll allow us to to give kind of strong predictions on okay. Here is when we expect the study to complete but in terms of initiating them and you know we're targeting that for the for the fourth quarter and are very much looking forward to getting started.

So hopefully that answered your questions. Yeah that was very helpful. Just I'm curious if you can talk about the expected geographic spread of the 20th side I'm curious what you're seeing in terms of enrollment dynamic based on I guess, you would say political environment, yeah like I go to <unk>.

[laughter] productive right and you know what the level of interest across different areas.

Yeah Fantastic question. So the sites are are spread across the country. So you know pretty pretty good diversity across the country in terms of where the sites are.

And that also means there's some diversity in terms of.

It kind of what the reproductive right you know right landscape is in the in the particular state you know where that site is well we've seen across the board and these are investigators that have all participated in you know lots of contraceptive studies and a very experienced in that regard you know their view is that.

Obviously.

It's it's a factor rate, it's something that people are considering and certainly people that are signing up for a contraceptive study by definition they have to be open to the fact that they may get pregnant right. It's an investigational product and so they have to be aware that that you know that that is a factor and where.

They reside you know that may be more meaningful to them than you know maybe in a different state.

In terms of you know what their propensity and in comfort with that is but all of the sites feel that you know it none of them have really projected that it would change how they and anticipate enrollment progressing them because you know their view is that it.

It's always a consideration anyhow and then in general people, who tend to participate in contraceptive studies.

You know generally have a a good acceptance of the fact that they may get pregnant and are prepared for that outcome.

But it's definitely something that has been discussed right and then as we think of it.

You know the sites I would say the states, where there's been a lot of interest beyond this contraceptive clinical trial network, because we get lots of inquiries beyond that if people who want to participate in the evergreen study.

I will say they do tend to be in them.

I would see sites that have great access to contraceptives and so I think they're just state states and sites that are just excited to get even more projects out there.

Yeah.

Okay that makes sense and good.

Lastly, can you remind us you know.

Estimated cost of the study and how much.

But between you and your partner at that age.

Yeah. So the waiver create is set up with the NIH. So we are like tow running the study together right. So and we have a responsibility for all of the clinical supply. So that we bear 100% of the cost of providing the overtrain supplies for the study and then the way the accretive works is D.

<unk> puts funds into basically to the NIH basically into an account for use in this study. So we have contributed <unk> 5 million.

To date to that account, there's another 500000 to be you'd anticipate right now providing them you know later this year.

To support this study as well.

And those funds.

Should be sufficient however, you know clinical trial costs can.

Theory, right as you've said he's progressed things happen right or if we added additional sites. So there are a number of factors that could change the cost of the study and so if that happens then we and the NIH would come together and decide you know what our contribution would be what their contribution would be is.

If that were to happen and and adjust accordingly, but right now like we've put our our money's there.

And and those are the funds along with support from the NIH to conduct this study.

Okay. That's very helpful. Thanks for taking my questions have a great afternoon, yeah. Thank you.

Again, if you would like to ask a question Press Star then the number one on your telephone keypad.

Yes.

Your next question comes from the line of Michael Anthem.

Michael.

Oh.

I'm, sorry, but I.

I think we.

We lost Michael.

Okay. So there are no further questions at this time I would like to turn the call back over to our centers.

Alright, well. Thank you for taking the time this afternoon to hear about our recent updates and ongoing commitment to drive value for our stakeholders women health care providers and our shareholders with our diverse product portfolio, we seek to bring to market differentiated prescription therapies that prioritize women's health and wellbeing expand treatment.

<unk>, where none exist enhance outcomes, where current standard of care has meaningful shortcomings and improved ease of use for women, where a more compelling form factor can drive adoption, primarily in the areas of contraception vaginal health reproductive health menopause sexual health and fertility, we definitely look forward to keeping you update.

Our progress towards the milestones will be discussed today, specifically or Josh you had a product launch and first commercial sale by Oregon on as John mentioned, we are working together to achieve a 2023 launch as soon as feasible.

Patient enrollment in the phase III clinical study of over frame, our investigational potential first in category hormone free monthly Intraregional contraceptive, whose U S. Commercial rights are under the license agreement with Bayer and as we just discussed we expect that single pivotal study to support <unk> pre market approval application.

And enrollment is targeted to commence this fourth quarter of this year.

We're also looking forward to our end of phase two meeting with the FDA and Finalization of the phase III protocol for the next to them to fill cream study.

In addition, we look forward to announcing data later this year from our phase one study evaluating a vaginal gel formulation of <unk> called connect being developed as a treatment for menstrual pain, and France as well as ongoing activities related to I N D and phase three and phase two preparations for our two menopause program.

<unk>.

Hormone therapy for the visa motor symptoms of menopause and air hormone free blah, blah vaginal atrophy treatment respectively.

So with that I. Thank you again for your time today and for your support thank you.

Yeah.

This concludes today's conference call you may now disconnect.

Yeah.

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Yeah.

Okay.

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