On March 30, 2023 Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, reported financial results for the year ended December 31, 2022 and provided a company update (Press release, Daré Bioscience, MAR 30, 2023, View Source [SID1234629622]).

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"Daré announced a number of positive developments related to our existing portfolio since the beginning of 2022 which serve to benefit all of our stakeholders. We entered into an exclusive global license agreement with Organon for commercialization of our first FDA-approved product, XACIATO. We completed two Phase 1/2 clinical studies in Australia and announced positive topline data for both. We received FDA approval of our IDE application for Ovaprene, allowing us to conduct a single arm, open-label pivotal contraceptive efficacy study and we hosted an investigator meeting. Finally, we completed subject screening for our exploratory Phase 2b RESPOND clinical study of Sildenafil Cream, 3.6% for female sexual arousal disorder and are targeting the second quarter of 2023 to announce topline data. We seek to continue the progress made over the past fifteen months by moving these candidates forward in development in 2023 and 2024," said Sabrina Martucci Johnson, President and CEO of Daré Bioscience.

"During 2022, we received $24.1 million in non-dilutive funding which included a $10.0 million cash payment upon the the license agreement with Organon for XACIATO becoming effective, $13.3 million received under grants, and a research and development cash rebate of $0.8 million from the Australian government for clinical work performed in Australia in 2021. Daré will continue to explore ways to operate our business efficiently and to fund our portfolio in a manner we believe will be favorable to our shareholders," added Ms. Johnson

"Our focused efforts to deliver differentiated innovation in women’s health have resulted in 12 development programs across 9 distinct indications, with more than 5 milestone events anticipated in 2023, 3 products in or nearing phase 3 development, 2 potentially transformational collaborations with leaders in women’s health product commercialization, Bayer and Organon, and 1 FDA approved product, XACIATO. Strategic additions to our portfolio in 2022 include global rights to a promising, antimicrobial glycerol monolaurate, which has the potential to be a first-in-category multi-target antimicrobial for vaginal administration. We also added two new candidates to our portfolio—DARE-PDM1 and DARE-LBT—that leverage our proprietary vaginal thermosetting hydrogel technology used in XACIATO. We commenced a Phase 1 study in the first quarter of 2023 for DARE-PDM1, a candidate that delivers the NSAID diclofenac vaginally for the treatment of primary dysmenorrhea, and we received grant funding for DARE-LBT to assess our proprietary hydrogel technology’s potential to deliver live biotherapeutics to support vaginal health. The ability to leverage a platform technology that has recently undergone successful preclinical and clinical testing and regulatory review could offer both time and cost advantages in the development of new candidates to address meaningful unmet needs in women’s health."

2022 Year and Q1 2023 In Review

Period Portfolio Asset Development /Outcome
Q1-2022
March XACIATOTM Announced exclusive global commercialization agreement with Organon
Q2-2022
April DARE-HRT1 Commenced Phase 1/2 study
May DARE-ADARE 204 & 214 Received $249,000 NIH grant award
June XACIATOTM Organon global commercialization agreement became effective; $10 M received in July
Q3-2022
July DARE-LARC1 Received $8 million of grant funding
August GML, antimicrobial glycerol monolaurate Signed exclusive global technology license with Hennepin Life Sciences
August Sildenafil Cream, 3.6% Announced expected timing for completion of enrollment of Phase 2b RESPOND clinical study based on interim analysis
Q4-2022
October DARE-HRT1 Announced positive topline efficacy data from Phase 1/2 study
October Ovaprene Received IDE approval for pivotal study
November Sildenafil Cream, 3.6% Completed subject screening for exploratory Phase 2b RESPOND clinical study
November DARE-LBT1 Received $585,000 grant funding
November DARE-VVA1 Announced positive topline data from Phase 1/2 study
December DARE-LARC1 Received $4.4 million grant funding
December Ovaprene Investigator kick-off meeting with NICHD for pivotal study
Q1-2023
January DARE-HRT1 Announced positive topline pharmacokinetic (PK) data from Phase 1/2 study
February DARE-PDM1 Commenced Phase 1 study

Portfolio Summary

XACIATOTM (clindamycin phosphate) vaginal gel, 2%:

A clear, colorless, viscous gel to be administered once intravaginally as a single dose for the treatment of bacterial vaginosis in female patients 12 years of age and older. Please click here for full prescribing Information.

3Q-2022: $10.0 million cash payment received under license agreement with Organon to commercialize XACIATO
4Q-2022: Organon market access team began meeting with customers and preparing for a U.S. launch
2Q-2023: First commercial sale expected, triggering a $2.5 million milestone to Daré
Bacterial vaginosis is the most common cause of vaginitis worldwide and is estimated to affect approximately 23 million women in the U.S.1 The condition results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms of odor and discharge. In addition to being the most common type of vaginal infection in women of reproductive age and having bothersome symptoms, bacterial vaginosis has been associated with certain increased health risks, including pre-term labor and infertility.1, 2

Ovaprene:

A novel, investigational hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer HealthCare.

4Q-2022: FDA approved an Investigational Device Exemption (IDE) application for a single arm, open-label pivotal contraceptive efficacy study over 12-months (13 menstrual cycles) and provided additional study design considerations
4Q-2022: Investigator meeting held (with the NICHD) for the pivotal Phase 3 clinical study
Mid-2023: Anticipated initiation of subject recruitment for the pivotal Phase 3 clinical study
The planned pivotal Phase 3 clinical study will be conducted under a Collaborative Research and Development Agreement with the U.S. Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH).

Sildenafil Cream, 3.6%:

A proprietary, investigational cream formulation of sildenafil, the active ingredient in Viagra, for topical administration to treat female sexual arousal disorder.

4Q-2022: Completed subject screening for exploratory Phase 2b RESPOND clinical study
2Q-2023: Topline data announcement targeted for Phase 2b RESPOND clinical study
DARE-HRT1:

A unique, investigational intravaginal ring (IVR) designed to deliver bio-identical estradiol and progesterone continuously over a 28-day period for the treatment of menopausal symptoms, including moderate to severe vasomotor symptoms, as part of a menopausal hormone therapy regimen.

4Q-2022: Positive topline efficacy data reported from Phase 1/2 clinical study
1Q-2023: Positive topline PK data reported from Phase 1/2 clinical study, and anticipated plans to progress to a single Phase 3 study announced
DARE-VVA1:

A proprietary, investigational formulation of tamoxifen for intravaginal administration to treat vulvar and vaginal atrophy in women without the use of hormones.

3Q-2021: Phase 1/2 clinical study initiated in Australia
4Q-2022: Positive topline safety, tolerability, PK and pharmacodynamics data reported from Phase 1/2 clinical study
Financial Highlights for the Year ended December 31, 2022

Cash and cash equivalents: $34.7 million at December 31, 2022, compared to $51.7 million at December 31, 2021.
General and administrative expenses: $11.2 million in fiscal 2022 as compared to $8.4 million in the prior year, with the current year’s increase primarily attributable to an increase in professional services expenses, stock-based compensation expense, personnel costs, general corporate overhead expenses, and expenses related to commercial-readiness activities for XACIATO.
Research and development expenses: $30.0 million in fiscal 2022 as compared to $30.6 in the prior year. The current year’s R&D activities across our entire portfolio of 12 development candidates primarily reflected expenses related to the ongoing Sildenafil Cream, 3.6% exploratory Phase 2b RESPOND clinical trial, manufacturing and regulatory affairs activities related to Ovaprene, costs related to development activities for XACIATO, and costs related to development activities for our preclinical programs and Phase 1 and Phase 1-ready programs.
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