Daré Bioscience Q2 2023 Earnings Call Transcript

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August 10, 2023

There are 5 speakers on the call.

Operator

Welcome to the conference hosted by Tare Bioscience to review the company's financial results for the quarter ended June 30, 2023 and to provide a general business update. This call is being recorded. My name is Mark, and I will be your operator today. With us today are Sabrina Martucci Johnson, Dare's President and Chief Executive sir, John Fair, Dare's Chief Commercial Officer and Lisa Walters Hofford, Dare's Chief Financial Officer. Ms.

Operator

Johnson, please proceed.

Speaker 1

Thank you. Good afternoon, and welcome to the financial results and business update for the quarter ended June 30, 2023 for Dare Bioscience. For those of you joining us via webcast, you should be able to access 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, Events and Webcasts and will remain on the site for 2 weeks.

Speaker 1

Today, we will review our Q2 results and discuss developments and expectations for Zaciato commercialization And for 2 of our late stage investigational products, our hormone free monthly intravaginal contraceptive candidate Ovaprene and Sildenafil Cream 3.6 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 of the 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 June 30, 2023, which was filed today.

Speaker 1

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 10, 2023. Dare undertakes no obligation to update any forward looking statements to reflect new information or developments to this call, except as required by law. As a reminder, at Dare, 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.

Speaker 1

S. Healthcare purchasing decisions And that although only 1% of healthcare research dollars are invested in women's health, women's health products nonetheless make up 27% Of total products generating over $500,000,000 in revenue annually and contribute to 35% of total 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 Our portfolio includes 1 FDA approved product, which is being commercially launched by Organon and 5 clinical development stage candidates, 3 of which are in or nearing Phase 3 development. Today, I will provide development updates On 2 of the late stage candidates, Ovaprene and Sildenafil Cream.

Speaker 1

John will provide an update on Zaciano And Lisa will review our financial results for the quarter ended June 30. So let's start with Sildenafil Cream. Sildenafil 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 that causes clinically significant distress And of the various types of female sexual dysfunction disorders, arousal disorder in women is most analogous to erectile dysfunction or ED in men. Sildenafil, which is a phosphodiesterase 5 inhibitor is the active ingredient in a tablet for oral currently marketed under the brand name Viagra for the treatment of ED in men.

Speaker 1

Sildenafil Cream is an investigational proprietary Topical cream formulation of Sildenafil 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, Sildenafil Cream has the potential to be the 1st 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 10,000,000 women are distressed from experiencing no or low sexual arousal and are actively seeking solutions to improve their condition.

Speaker 1

In comparison, the prevalence of complete ED in men is estimated to be about 5% of Men at age 40 increasing to about 15% at age 70. Women who experience no or low sexual arousal are bothered by And or are dissatisfied with their sex lives. They're frustrated with their sexual problem. They experience guilt about their sexual difficulties And they are likely to feel sexually inadequate, inferior and embarrassed. Sound familiar?

Speaker 1

Like what men with erectile dysfunction experience? As men did before effective ED treatments, women are suffering in silence and are affected by a feeling of shame and embarrassment. We are working to change this 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 ED treatments did for men. On June 5, we reported top line results of the exploratory Phase 2b respond Clinical study of Sildenafil 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 study. For those of you who missed those updates, I wanted to take a moment today to highlight some of the key results and outcomes Efficacy endpoints and their ability to determine a treatment effect of Sildenafil Cream compared to placebo to inform the ongoing development of Sildenafil Cream.

Speaker 1

The study also served as a validation study of exploratory endpoints that could be candidate efficacy endpoints in a Phase 3 study of Sildenafo Cream. Because there are no currently The approved treatments for any form of arousal disorder in women. There are no efficacy endpoints that have been previously approved for use in a Phase 3 pivotal study for potential treatment of those disorders. In the Phase 2b study, the Sildenafil 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, Sildenafil Cream had a therapeutic effect based on several of the exploratory PROs.

Speaker 1

The data from the Phase 2b RESPOND study, we believe, certain of the primary, secondary and exploratory endpoints Based on that study could be candidate endpoints in a Phase 3 study of Sildenafil Cream. Having now completed this pioneering work in the field of arousal We look forward to reviewing the data with the FDA, including discussing the data from assessments as early as the For an 8 week mark after randomization and continuing the development of Sildenafil Cream, including our objective of initiating the first ever Phase 3 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 believe that Sildenafil Cream represents a promising clinical candidate in a meaningful valuation driver for our company. Dazenafil Cream has the potential to be the 1st FDA approved product to treat any form of arousal disorder in women.

Speaker 1

And we remain committed to working with our development partner SST and the FDA to move this candidate forward. We are continuing to analyze the data from the Phase 2b response study and are targeting an end of Phase 2 meeting with the FDA before the end of this year, for the end of 2023, which if successful would support Phase 3 commencement in early 2024. Following clinical development, which we expect will include 2 pivotal Phase 3 studies, we intend to leverage the existing safety and efficacy data on the active ingredient in Sildenafil Cream to utilize the FDA's 505(2) 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 3 program.

Speaker 1

Now I'd like to turn to Ovaprene. Ovaprene is our investigational potentially 1st in category hormone free monthly intravaginal 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 $1,000,000,000 There is no hormone free counterpart with a similar monthly intravaginal dosing format.

Speaker 1

We have been working closely with our Phase 3 collaborator, NICHD of the NIH on the pivotal study planned to start later this year. Specifically, the pivotal Phase 3 study of Ovaprene is being supported by the NICHD's Contraceptive Development Program, which oversees the Contraceptive Clinical Trials Network, or CCTN, established in 1996 to conduct studies of investigational contraceptives. We expect to commence subject enrollment in the Q4 of this year. The study is a multicenter, single arm, non comparative pivotal Phase 3 contraceptive study of Ovaprene 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 FDA.

Speaker 1

Now a few details on the study. This is a non comparative study, meaning all women will use Ovaprene. There is no placebo in this study. We will target having approximately 250 subjects complete 12 months, That's 13 menstrual cycles of use. Based on typical dropout rates for contraceptive studies, we will look to enroll more than double of our target number Once enrollment is well underway and we have a clear sense of dropout rates in this study, we'll be able to provide guidance on when to expect study The primary objective of the study is to assess pregnancy rates over 13 cycles.

Speaker 1

Primary endpoint will be using a PEARL Index, typical use PEARL Index. This is the common primary endpoint for contraceptive product candidates. Secondary objectives are looking at the contraceptive effectiveness on a typical use pregnancy probability basis over 13 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, And efforts to innovate non hormonal options have lagged and therefore we believe that Ovaprene has the potential to be a disruptive product In the contraceptive category, as NuvaRing was when it entered the market as the 1st monthly intravaginal contraceptive delivering hormones And as Mirena did when it entered the market as the first hormone releasing intrauterine system. Speaking of Mirena, Bayer, a leader in commercializing Contraceptive products in the United States holds the U.

Speaker 1

S. Commercial rights to Ovaprene under a license agreement with us. I will now turn it over to John to provide a commercial update on the Xatiado launch activities as well as on commercial preparedness activities for our development candidates ovaprene and sildenafil Cream.

Speaker 2

Thank you, Sabrina. As a reminder, zaciadoclindamycin Phosphate vaginal gel is a lebcosamide antibacterial for single dose vaginal administration indicated for the treatment of bacterial vaginosis in female patients 12 years of age and older in the United States. Organon, our global commercial collaborator, Believe there is roughly a 90% overlap of healthcare providers who prescribe their contraceptive product Nexplan and have the potential to be prescribers of Xatiado based on provider treatment patterns. Because of these strong relationships, The Organon sales team has with these health care providers, we expect Organon to be well positioned to detail Xatiado and drive product prescriptions and pull through on day 1 of launch. We believe that Zaciato should be well positioned for commercial success Given the knowledge and experience of Organon's Nexplanon sales team, coupled with their 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.

Speaker 2

Organon and Daria are working towards Looking ahead to our later stage programs in parallel with the Ovaprene Phase 3 study activities, Our team has been busy working with our collaborator, Bear, 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 Key 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 the Sildenafil 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 aspects 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, We remain very excited about the opportunity to bring forward a first in category solution like Sildenafil 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.

Speaker 2

With that, I will turn the call over to Lisa.

Speaker 3

Thank you, John, and thanks for all of you for joining today. I would now like to summarize Dare's financial results for the quarter ended June 30, 20 23, which I will refer to as the current quarter or the second quarter. As you know, Dare's business model is to Temple in advance a portfolio of differentiated product candidates that address meaningful unmet needs that we've identified in women's health And then to monetize the value of the portfolio's clinical and regulatory advances over the near and long term. The investment required To build and advance a portfolio includes corporate overhead, portfolio acquisition and maintenance costs and ongoing research and development or R and D expenses. During the Q2, our general and administrative or G and A expenses were approximately $2,900,000 Our R and D expenses, which vary from period to period based on our Clinical, preclinical, manufacturing, regulatory and other activities across our entire portfolio were approximately $6,000,000 And primarily reflected the cost associated with the Sildenafil Cream Phase 2b RESPOND clinical trial that Sabrina just summarized and manufacturing and regulatory affairs activities related to Ovaprene's planned Phase 3 study.

Speaker 3

Our comprehensive loss for the current quarter was approximately $8,700,000 We ended the current quarter With approximately $13,300,000 in cash and cash equivalents. And as of August 9, 2023, we had 87,800,000 shares of common stock outstanding. Under our license agreement with Organon for Zacciato, we received $1,000,000 in July, and we are entitled to receive $1,800,000 following the first commercial sale. Thereafter, we will be eligible to receive potential additional milestone payments of up to $180,000,000 as well as tiered double digit royalties based on 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 not limited to, non dilutive grants like the one we recently received from the NIH for a preclinical candidate, Equity sales, license agreements, structured financings and strategic collaborations or alliances.

Speaker 3

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 financial condition, liquidity, capital resources, risk factors in the Form 10 Q for the quarter ended June 30, and in our annual report on Form 10 ks for the year ended December 31, 2022, which was filed on March 30, 2023. I would now like to turn the call over to the operator.

Operator

Thank you for attending the conference call. Your first question comes from the line of Catherine Novak with Jones Research. Catherine, your line is now open.

Speaker 4

Hi, good afternoon. Thanks for taking my question. I guess just a couple of questions on Ovaprene. Can you remind us what's still gating of the study and what are some key inclusion exclusion criteria that you are anticipating that might Affect the screen rate and enrollment rate of the study?

Speaker 1

Yes. Great questions. And thanks for your questions as always. In terms of what's gating the start of the study, we're really gearing up to be ready to go. So as I've mentioned in my Comments today, we're working with the NIH, the NICHD, on the conduct of the study and they actually held An investigator meeting with the investigators who identified for the Ovaprene study actually last December.

Speaker 1

So these investigators Have been excited and primed for a while. You may recall there were some comments from the FDA when we got our IDE Approval to move forward with the study with some recommendations on some tweaks, around, considerations around the protocol that they You know, 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 sites Kind of reoriented, to the protocol and ready to go. And so we're really preparing to initiate enrollment now in the Q4.

Speaker 1

And then obviously, we've Manufacturing, with our partner to prepare for that. So we're super excited to get started, obviously, And all the pieces are coming together and are on track right now for that. In terms of and all the sites, As I mentioned, the clinical trial, the networks, the contraceptive clinical trial network sites that are participating in the study. So it's about 20 sites right now that are participating in the study. And so they are all set up.

Speaker 1

In terms of The key and kind of inclusion exclusion criteria, it's pretty standard for contraceptive studies. So patients You know, have to be of a certain age. They have to be in a committed partnership. They have to have a commitment to have certain number of sexual events Every month. So they can't have certain medical conditions that would be pretty standard in Contraceptive study to be exclusionary.

Speaker 1

So there's nothing really unique, in terms of the inclusion and exclusion criteria for this study. What we do see though with contraceptive studies that, as we've looked across a number of this contraceptive studies that have been conducted over the years and that's one of the nice Things about working with CNAH and the contraceptive clinical trial network is that we get the benefit of a lot of other, studies they've done for further Sponsors and products, 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. We want to get our particular Study going in this particular day and age, right, in this environment and then get a sense of what those metrics look like and then that will allow us To give kind of strong predictions on, okay, here's when we expect the study to complete.

Speaker 1

But in terms of initiating enrollment, we're targeting that for for the Q4 and are very much looking forward to getting started. So hopefully that answered your questions.

Speaker 4

No, that was very helpful. Just curious if you can talk about the expected geographic spread of the 20 sites. I'm curious what you're seeing in terms of enrollment dynamic based on, I guess, you would say the political environment.

Speaker 1

Yes. I want to ask, Scott, yes.

Speaker 4

In productive rights and what's the level of interest across different areas of the U. S?

Speaker 1

Yes. Fantastic question. So the sites are spread across the country. So pretty good diversity across country in terms of where the sites are, and that also means there's some diversity in terms of Kind of what the reproduction right landscape is in the particular state where that site is. What we've seen across the board and these are investigators that have all participated in lots of contraceptive studies And are very experienced in that regard.

Speaker 1

Their view is that obviously it's a factor, right? 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 is a factor. And where they reside, that may Be more meaningful to them than maybe in a different state in terms of what their propensity and comfort with that is. But all of the sites feel that none of them have really projected that it would change how they anticipate enrollment Progressing, because their view is that it's always a consideration anyhow.

Speaker 1

And then in general, people who tend to In contraceptive studies, generally have 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 as we think of, the sites, I would say the states There's been a lot of interest beyond this contraceptive clinical trial network because we get lots of inquiries beyond that of people who want to participate in the evergreen study. I will say they do tend to be in, I would say, sites that have great access to contraceptives. And so I think they're just states and sites that are just excited to get even more products out there.

Speaker 4

Okay. That makes sense. And just lastly, can you remind us estimated cost of the study and how much The split the cost split between you and your partner at the NIH?

Speaker 1

Yes. So the way that CRADA is set up with the NIH, So, we are co running the study together, right? So, and we have a responsibility for all of the clinical supplies. So that we bear 100% of the cost, providing the Ovaprene supplies for the study. And then the way that CRADA works is Dare Puts funds into basically to the NIH basically into an account for use in this study.

Speaker 1

So we have contributed our 5,000,000 to date to that account. There's another 500,000 that we would Right now, providing later this year to support the study as well. And those funds should be sufficient. However, clinical trial costs can Very, right. As you've said, these progress things happen, right?

Speaker 1

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 Then we and the NIH would come together and decide what our contribution would be, what their contribution would be If that were to happen and adjust accordingly. But right now, like we've put our monies there And those are the funds along with support from the NIH to conduct the study.

Speaker 4

Okay. That's very helpful. Thanks for taking my questions. Have a great afternoon.

Speaker 1

Yes. Thank you.

Operator

Your next question comes from the line of Michael Aulta. Michael? Okay. So there are no further questions at this time. I would like to turn the call back over to presenters.

Speaker 1

All right. Well, thank you for taking the time this afternoon to hear about our recent updates and ongoing commitment to drive value for our Dare stakeholders, Women, 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 well-being expand treatment options where none exist, enhance outcomes where current standard of care has meaningful shortcomings and improve 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 updated on our progress towards the milestones we discussed today, Specifically, our Xatiatto product launch and first commercial sale by Organon. As John mentioned, we are working together to achieve a 2023 launch as soon as Seizable, patient enrollment in the Phase 3 clinical study of Ovaprene, our investigational potential first in category hormone free monthly intravaginal Ultrasceptiv, whose U.

Speaker 1

S. Commercial rights rendered the license agreement with Bayer. And as we just discussed, we expect that single pivotal study to support Ovaprene's pre market approval application and enrollment is targeted to commence this Q4 of this year. We're also looking forward to our end of Phase 2 meeting with the FDA and finalization of a Phase 3 protocol for the next odenfilcreme study. In addition, we look forward to announcing data later this year from our Phase 1 study evaluating a vaginal gel formulation of covalent being developed as a treatment for menstrual pain and cramps as well as ongoing activities related to And Phase 3 and Phase 2 preparations for our 2 menopause programs, hormone therapy for the vasomotor symptoms in menopause And a hormone free vulvovaginal atrophy treatment respectively.

Speaker 1

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

Operator

This concludes today's conference call. You may now

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Key Takeaways

  • Positive Phase 2b results for Sildenafil Cream support its potential as the first FDA-approved treatment for female sexual arousal disorder, with an end-of-Phase 2 meeting targeted by year-end and a Phase 3 pivotal program planned for early 2024.
  • Enrollment of the pivotal Phase 3 study for Ovaprene, a hormone-free monthly intravaginal contraceptive, is expected to begin in Q4 2023 under NICHD collaboration, using a single-arm design and a Pearl Index primary endpoint to support a PMA submission.
  • The commercial launch of Zaciato (clindamycin phosphate vaginal gel) is on track for late 2023 by partner Organon, delivering $1.0 million upfront to Dare with $1.8 million upon first sale and up to $180 million more in milestones plus tiered royalties.
  • In Q2 2023, Dare reported a comprehensive loss of $8.7 million, ending the quarter with $13.3 million in cash; R&D expenses were $6.0 million and G&A expenses were $2.9 million.
  • Dare’s pipeline spans one FDA-approved product and five clinical-stage candidates in contraception, vaginal health, menopause and fertility, with upcoming data expected on a gabapentin menstrual pain gel and two menopause treatments.
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