Q2 2022 Dare Bioscience Inc Earnings Call

Good afternoon. My name is Joanne, and I will be your conference operator today. At this time, I would like to welcome everyone to the Darais BioScience Incorporated Q2 2022 conference call.

All lines have been placed on mute to make sure there is no noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star, followed by the number one on your telephone keypad. If you would like to withdraw your question again, press star. Ms. Johnson, you may begin your conference.

Wonderful, thank you. Good afternoon and welcome to our second quarter 2022 financial results and business update call for Delray Bioscience. Our plan today is to review our second quarter results, discuss development since our last call in May, and use the time to review our business strategy and highlight our objectives and milestones anticipated for the rest of 2022.

Before we begin, I would like to remind you that today's discussion will include forward-looking statements within the meaning of the 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 fact 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 now place a reliance on forward-looking statements.

Forward-looking statements are qualified in their entirety by the cautionary statements in the company's SEC filings, including our annual report on Form 10-K for the year ended December 31, 2021, which was filed on March 31, 2022, and our quarterly report on Form 10-Q for the quarter ended June 30, 2022, 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 9, 2022. DARI undertakes no obligation to update any forward-looking statements to reflect new information or developments after this call except as required by law.

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

We work to accelerate innovative differentiated product options in contraception, vaginal health, sexual health, and fertility, that expand treatment options where none exist, that enhance outcomes where current standard of care has meaningful shortcomings, and that improve ease of use for women where a more compelling form factor can drive adoption.

Why? Because these are compelling markets impacting millions of women and we have seen that innovation in these areas has led to commercially successful brands.

Let's look at contraception. There are 73 million women in the US ages 15 to 49.

The first monthly intervaginal ring contraceptive, Nuvaring, peaked at $900 million annual revenue. The first hormone-releasing intrauterine system contraceptive, Mirena, peaked at $1.2 billion. And what about menopause? There are 47 million new entrants to the menopause and post-menopause market each year. The first estrogen hormone therapy, Premarin, peaked at $2 billion in annual revenue. And how about arousal problems?

There are 10 million women estimated to have arousal problems significant enough to seek treatment. Now, while we can't point to the success of the first arousal product for women yet, since there is no FDA-approved product for female sexual arousal disorder, the first product for the analogous male condition erectile dysfunction Viagra peaked at $2 billion in annual sales. The New York Postivo Bohgan Institute of Cancer's

Novel products that provide new features and flexibility have the potential to become meaningful brands.

So what are the next big ideas in women's health?

Well, at DARE, we believe these are the four novel contraceptive candidates or potential candidates in our portfolio.

The first hormone-free monthly contraceptive candidate, Oviprene.

First 6-12 month injectable, ADARE 204214. First long-acting reversible contraceptive system, DARE Lark 1. And a hormone-free contraceptive target for men and women, DARE RH1.

We believe it's the three vaginal health programs in our portfolio. Our FDA approved product, Zosciato, plindamycin phosphate vaginal gel 2% treatment for bacterial vaginosis in a single dose vaginal administration.

Our product candidate, DARE HRT1, the first hormone therapy, bioidentical estradiol and progesterone monthly intravaginal ring. And our product candidate, DARE VVA1, the first hormone-free vaginal atrophy therapy for women with hormone receptor-positive breast cancer.

We believe it's the sexual health product candidate in our portfolio, the first topical cream with the same active ingredient as Viagra being evaluated as potential first in category treatment for female sexual arousal disorder, or FSAD. And the pregnancy management product candidates in our portfolio, DARE FRT1 and PTB1, IVR are designed to release bioidentical progesterone over 14 days.

So, yes, it's our belief that prioritizing women's health is good for the many women lacking effective or convenient therapeutic choices and good for a broad set of stakeholders, including their families and partners and, yes, of course, our shareholders.

And it's our belief that the programs in our portfolio represent a compelling opportunity overall, given that strategic partners are looking for meaningful market potential for differentiated products. Providers are looking for first line and first in category product opportunities to address unmet patient needs. And investors are looking for a diverse pipeline with independent outcomes to mitigate risk and enhance the overall commercial opportunity. And women.

We'll continue to seek innovative options to help them navigate their needs and preference over the course of a lifetime.

The Dari portfolio is built on these core principles, meaningful market opportunities, product candidates for women with first-line or first-in-category potential, and a highly diversified pipeline that often leverages well-known and well-characterized active pharmaceutical ingredients or API. And a great example of the execution of these core principles can be found in our FDA-approved product Zosciato.

In the case of Zaxiado, use of a well-characterized API mitigated the development risk, the time, and cost as compared to new molecular entities.

As with Zaxiado, that 505B2 regulatory pathway that's possible for non-neomolecular entities is planned for most of our development candidates.

Why is that important? Well 505B2 candidates have a 23% probability of success of advancing from phase 1 to approval and a 67% likelihood of success advancing from phase 3 to approval versus just 6% and 38% respectively for new molecular entities.

And let's talk about multiple delivery platforms. Persistent unmet needs require creative new approaches designed for her.

Novel delivery platforms allow us to configure the most relevant API for the condition in a dosage form and delivery duration that has an opportunity to improve outcomes.

This can lead to first in category products while using that well-characterized API that allows us to use that 505b2 regulatory pathway.

The commercial value in women's health has been evidenced by differentiated brands and recent transactions in the category.

Anyone following the category knows that women are often the most frequent consumers of healthcare. They manage 80% of the healthcare dollars in the household. Recent transformational pharma transactions are a good reminder of the global opportunity for differentiated women's health brands.

We continue to drive our portfolio forward to deliver value as evidenced by our anticipated milestones.

The milestones we expect our programs to achieve in 2022 alone include a product launch, a phase 3 initiation, and we have two data readouts will be the focus of our call today. Specifically.

In terms of the milestones, Zaxiado, the Clindamycin phosphate vaginal gel 2% for bacterial vaginosis.

We have that commercial launch planned and targeted for the fourth quarter of this year, so more on that to follow. OVAPRINE, our Home and Free Monthly Contraceptive, we're going to talk about the IDA approval process and the pivotal phase three study commencement that's planned for the fourth quarter this year.

VVA1, our vaginal atrophy program treatment for women with breast cancer, that's one of the phase one, two study top line data readouts anticipated this year for the fourth quarter.

Here are HRT1, the hormone therapy for the treatment of menopausal symptoms. That Phase 1-2 study top-line data is anticipated fourth quarter this year. And so that is so CREAM, our Female Sexual Arousal Disorder Program. The Phase 2B study top-line data target data announcement is pending an interim analysis for study sizing which is planned for this year.

So, shortly, I'll turn the call over to John to provide an update on the collaboration with Oregon On to commercialize Zaxiado and the launch targeted for later this year, as well as to provide an update on various of the anticipated program milestones this year. But first, I want to address some questions we've received regarding OVAPRINE, and particularly to provide some perspective on our IDE-related discussions with the FDA. Thank you.

As I mentioned, we're targeting commencement this year of what we expect to be the single pivotal phase three study necessary to support a premarket approval or PMA submission to the FDA.

In order to initiate the pivotal phase 3 study, we must have an FDA approved IDE in place.

We initiated the IDE process for OVAPRINE in early 2022.

You may remember that the device division of the FDA is leading a review of Oviprene. There is no predicate device for Oviprene in that there is no existing FDA approved product that the FDA can use to compare with Oviprene.

As such, Oviprin will be reviewed via a PMA and not a 510K submission.

While the regulatory process for such a novel product via a PMA can require more interactions and research to support the approval, the benefit is a clearly differentiated product.

We've seen firsthand how challenging the contraceptive payer process can be, and thus are pleased to be working on such a clearly differentiated product, even if it means more FDA discussions and time to prepare for the pivotal study than would be required if overprene were not so clearly differentiated.

Those of you following the company the last couple of years may recall that we've been utilizing the pre-submission process with the FDA to align with the FDA on certain biocompatibility, chemical characterization, and animal studies to support the safety profile of oviprene, such as a nine-month chief study which was completed and demonstrated the safety of oviprene over several months of use.

We've also been discussing the Phase III study protocol with the FDA, and Bayer, our commercialization collaborator from Overprene, has contributed to these and other discussions with the FDA.

Based on these ongoing interactions with the FDA and the IDE process for Obiprene that we initiated in early 2022, we anticipate continuing the IDE process into the third quarter and subject to the FDA's approval of the IDE, we are targeting the investigator meeting for the fourth quarter of 2022, that preparatory step to commence the pivotal study. Based on communications with the FDA in terms of study sample size and duration, we expect that at least 200 subjects

Completing 12 months of overprene use will be adequate. The Phase III study will be conducted under our Cooperative Research and Development Agreement, or CRADA, with the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, which is part of the National Institute of Health, or NIH.

We look forward to collaborating with the NIH and Bayer on the ongoing development of this potential first in category contraceptive.

With that, I will now turn it over to John for additional portfolio updates.

Thanks, Sabrina. Given the stage of our current portfolio and market dynamics in the therapeutic categories specific to Zashiato and Oveprene, we believe the best avenue to generate value for Darae and its shareholders is via external commercialization collaboration or outlicense agreements rather than attempting to commercialize these assets on our own. Opportunity to enter into such collaborations are ultimately contingent upon developing differentiated products that demonstrate the potential to be first line or first in category.

So let me begin with bacterial vaginosis and our first FDA-approved product, Zaxiado. As we've mentioned on previous calls, bacterial vaginosis is the most common cause of vaginosis worldwide and is estimated to impact approximately 21 million women in the US.

The condition is a result of an overgrowth of bacteria including Gardnerella vaginalis, an anaerobic bacterium which disrupts the balance of natural vaginal microbiome and can result in symptoms such as vaginal odor and discharge. Organon, our global collaborator for Zaciado, shares our commitment to advance critically needed innovations in women's health and we believe that Organon's unique focus on women's health coupled with their strong commercial capabilities will ensure that Zaciado reaches the women most impacted by this condition.

We believe that Organon is uniquely positioned to bring Zosteriado to market and drive patient and provider awareness and utilization of Zosteriado based on its unique and differentiated product characteristics. Thanks.

Under our license agreement with Oregonon to commercialize Zaxiado, we received a $10 million cash payment from Oregonon after the license became effective in June . And we are also eligible to receive potential milestone payments of up to $182.5 million, as well as tiered double digit royalties based on net sales. Zaxiado is expected to be available commercially in the US in the fourth quarter of this year.

While we're still very early in our collaboration at Organon, our experience with the various Organon functional teams, including sales and marketing, market access, and really the broader commercial leadership team, has been overwhelmingly positive. We have been collaborating with Organon to accelerate the integration of the Zashiaado brand into their larger women's health franchise and Organon is very focused and highly driven commercial organization in our estimation.

We will be in a better position to provide you with more substantive commercial updates after the product launches, but I can assure you that our team is very pleased with the level of effort organized putting into building the Zaxiado brand.

So let me transition now to commercial activities underway for Overprene, our novel hormone-free monthly contraceptive candidate whose U.S. commercial rights are under a license agreement with Bayer. As a reminder, as part of our license agreement with Bayer to commercialize Overprene, Dari has access to Bayer's extensive clinical, manufacturing, and commercialization resources in an advisory capacity for approximately 80 hours per week while Dari retains full control over Overprene's development and regulatory approval process.

FAIR has the right to obtain exclusive rights to commercialize overpreming in the US following the completion of the pivotal Phase III study by making a $20 million payment to DARE. Thereafter, DARE is entitled to receive commercial milestone payments potentially totaling $310 million in addition to double digit tier royalties on net sales.

As Sabrina noted earlier, OVAPRINE is a distinct and novel form of contraception without an FDA-approved predicate and without a generic equivalent. Bayer has proactively initiated pre-commercialization activities, including discussions with payers, providers, and women, and their commercial team is uniquely focused on identifying the key drivers and points of differentiation that will resonate with payers, providers, and patients.

Many of you know that Bayer has a unique leadership position in the hormonal contraceptive category with the Mirena franchise, and they are looking to establish a similar leadership position in the hormone-free category with Ovaprene.

They are actively engaging payers and providers to gain meaningful insights into the best way to position over-preing to maximize market uptake.

Turning now to Sudenafil cream, our investigational product to address female sexual arousal disorder, which as Sabrina mentioned is really akin to her version of erectile dysfunction, FSAD is a physiological condition characterized by the inability to attain or maintain sufficient genital arousal during sexual activity. Currently there are no FDA-approved therapeutics for this condition, which means our Sudenafil cream has the potential to be the first and only FDA-approved product in the category. As we previously mentioned, we started the Phase IIb RESPOND clinical study in 2021.

evaluating Sudenafil cream as a potential new treatment for FSAD at sites across the country. The immediate interest in the study was so overwhelming that there were over 10,000 online inquiries about the study in the first few months post initiation. As this is a first of its kind phase 2B study, we want to be best positioned to learn as much as we can about the endpoints being evaluated and the characteristics of women most responsive to Sudenafil cream. As such, we've been cautious and thoughtful relative to our enrollment criteria.

characterizing each subject and her partner by a series of medical exams, interviews, and screen periods.

We are continuing to enroll women in the study at a deliberate pace. We believe that there are thousands of women that will be exceptional candidates for this product if it's approved, but are not optimal candidates for the Phase 2B program since, as many of you know or are aware, investigational studies place more demands on subjects than would otherwise be expected with an approved product.

Our study protocol has a planned interim analysis to evaluate the confidence intervals in trial sizing, and we expect to conduct that analysis this year, after which we'll provide guidance on the anticipated timing for top-line data from this trial.

Turning our attention to DARE HRT1, our investigational intervaginal ring or IVR, designed to deliver bioidentical estradiol and bioidentical progesterone continuously over a 28-day period as part of a hormone therapy regimen.

As you may recall, we announced positive top-line results from the Phase 1 study of DARE-HRT1 in 2021, and in April 2022, we announced the start of a new Phase 1-2 clinical study. This open-label study will evaluate PK of lower and higher-dose versions of DARE-HRT1, the same two versions evaluated in the first Phase 1 study, in approximately 20 healthy postmenopausal women, over approximately three consecutive months of use.

And incidentally, many of the women that are participating in this study also participated in the first phase one study.

In addition to PK data, this study will also collect safety, usability, acceptability, and symptom relief data, giving us a more robust data package and providing us with some preliminary evidence of efficacy.

As with the previous study, this study is being conducted in Australia through our Australian subsidiary to take advantage of the clinical and financial benefits of doing so. We expect to report top-line data from this Phase I-II study during the fourth quarter of 2022. Thisoys

Finally, we can turn our attention to DARE VVA1. As previously noted, more than 3.8 million women in the U.S. have a history of breast cancer or are considered survivors. Hormone receptor-positive breast cancer is the most common type of breast cancer diagnosis, and the prevalence of vulvar and vaginal atrophy, or VVA, in post-menopausal breast cancer survivors is estimated to be between 42 and 70 percent.

Currently, there are no FDA-approved products to address this very challenging condition in this very important patient population, and we would like to provide a new first-in-class option for these women. DARE-VVA1 is our proprietary investigational formulation of tamoxifen for the vaginal administration treatment of VVA. And as a nonhormonal approach to addressing VVA, it could be an important new prescription option for women with a history of or at risk for hormone receptor-positive breast cancer, as many of these women are not ideal candidates for standard estrogen-based interventions.

We initiated the Phase 1-2 study in Australia earlier this year, and the third quarter of 2021 for breast cancer survivor shifts in the program. We'll have an update for you by the end of this year. And we expect to report top-line data for this, as I mentioned, in the first, excuse me, Phase 1-2 study during the second half of 2022, later this year. So in terms of near-term catalysts, we look forward to keeping you updated on the launch of Zaxiado, our FDA-approved product for the treatment of bacterial vaginosis, our collaboration with Orgonon, who is a global leader in women's health, our pivotal study star for our potential first in category contraceptive program, Oviprine.

which is subject to a license agreement for commercialization in the U.S. with BEAR, who maintains a global leadership position in contraception, as well as two data readouts from our Phase 1-2 DARE HRT1 program and our DARE VVA1 program.

I will now turn the call over to Lisa to provide a financial update. Thank you, John , and thanks everyone for joining us today. I would now like to summarize DARI's financial results for the quarter ended June 30, 2022, which I will refer to as the current quarter or the second quarter of 2022.

Daria's business model is comprised of two parts. The first is to assemble in advance a portfolio of differentiated product candidates that address meaningful and met needs that we've identified in women's health. The investment required to do this includes corporate overhead, portfolio acquisition and maintenance costs, and ongoing research and development or R&D expenses.

The second part of our model involves monetizing the value of our portfolio's clinical and regulatory advances over the near and long term. There are many ways to do this and generate value from products with differentiated outcomes and one approach includes securing payments upfront and over time in the form of license fees, commercial milestones, and royalties on net product sales.

For Dari, this occurred during the second quarter of 2022 when we recognized revenue of 10 million from the upfront license fee due in connection with the closing of our global license agreement for Zaxiado with Organon. As my colleagues have mentioned, Dari will be entitled to receive additional milestones and royalties once Zaxiado is commercially launched.

But back to the current quarter.

Our general and administrative, or GNA expenses, were approximately $2.8 million. Our R&D expenses, which vary from quarter to quarter based on our clinical, preclinical, manufacturing, regulatory, and other portfolio activities, were approximately $6.8 million.

The current quarters R&D expenses were actually about a half a million dollars less than the comparable period for 2021, and primarily reflected the cost of the ongoing sildenafil cream Phase IIB RESPOND clinical trial and manufacturing and regulatory affairs activities related to overpre.

We ended the current quarter with approximately 32 million in cash and cash equivalents.

Then in July , we received additional cash payments of $18 million, representing the $10 million license fee from Oregon on and a cash disbursement of approximately $7.9 million under our existing grant to fund the Darryl Arc 1 program.

As touched upon earlier, under our license agreement with Organon, we will be entitled to receive a cash payment of $2.5 million upon the first commercial sale of Zaciado and tiered double digit royalties based on net sales. Again, the launch is expected to occur in the fourth quarter of 2022.

And thereafter, in addition to the ongoing net sales royalties, Dari will also be eligible to receive future milestones of up to $180 million in the aggregate based on commercial sales and other developments.

Now during our quarterly calls, we've highlighted the importance of non-dilutive sources of funding to our strategy.

These include grants, collaborations, and tax credits.

The $7.9 million payment received in July is part of a larger grant established to finance the development of our novel Dare Lark One program over multiple years.

In addition, we have received other grants in varying amounts from the NIH and the NICHD to fund a variety of development and market research activities related to Oviprene, Darol Lark 1, ADARE, and DAR PTB1.

In terms of collaborations, our CIRADA with the NIH allows Dari to share the cost of the overpre and pivotal study with the NIH and also to tap into the NIH's extensive experience in conducting contraceptive studies.

And finally, in connection with our studies being conducted currently in Australia, we will continue to apply and receive partial reimbursement for our eligible R&D expenses, which is currently up to 43% of eligible expenses occurred in Australia for those studies.

As of August 8, 2022, Dari had approximately 84.8 million shares of common stock outstanding.

UR shareholders recently approved an increase in our authorized shares to $240 million.

We want to thank you for your approval of this proposal at our 2022 Annual Meeting as it will allow us to explore and potentially pursue financing and other transactions using shares of our common stock over multiple years in the future as opportunities arise.

But in closing, to reiterate before, we will endeavor to be creative, collaborative, and opportunistic in seeking the capital necessary to advance our candidates and build shareholder value.

We also encourage investors to review the more detailed discussion of our financial conditions, liquidity, capital resources, and risk factors in our Form 10Q for the quarter ended June 30, 2022, which was filed today, as well as our annual report on Form 10K for the year ended December 31, 2021, which was filed on March 31, 2022.

I would now like to turn the call back over to the operator for questions.

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