Business Overview
milestone payments from Organon. We anticipate the first commercial sale of XACIATO in the U.S. in the first half of 2023.
Our current portfolio includes three product candidates in advanced clinical development:
•Ovaprene®, a hormone-free, monthly contraceptive;
•Sildenafil Cream, 3.6%, a proprietary cream formulation of sildenafil for topical administration to the vulva and vagina for the treatment of female sexual arousal disorder; and
Our portfolio also includes six product candidates in Phase 1 or Phase 1/2 clinical development or that we believe are Phase 1-ready:
•DARE-VVA1, a proprietary formulation of tamoxifen for intravaginal administration being developed to treat moderate to severe vulvar vaginal atrophy in women with or at risk for hormone-receptor positive (HR+) breast cancer;
•DARE-204 and DARE-214, injectable formulations of etonogestrel designed to provide contraception over 6-month and 12-month periods, respectively;
•DARE-FRT1, an intravaginal ring containing bio-identical progesterone for broader luteal phase support as part of an in vitro fertilization treatment plan; and
•DARE-PTB1, an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth.
In addition, our portfolio includes four pre-clinical stage product candidates:
•DARE-LARC1, a contraceptive implant delivering levonorgestrel with a woman-centered design that has the potential to be a long-acting, yet convenient and user-controlled contraceptive option;
•DARE-GML, an intravaginally-delivered potential multi-target antimicrobial agent formulated with glycerol monolaurate (GML), which has shown broad antimicrobial activity, killing bacteria and viruses;
•DARE-LBT, a novel hydrogel formulation for vaginal delivery of live biotherapeutics to support vaginal health; and
•DARE-RH1, a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel.
years, but we also expect such expenses will be supported by non-dilutive funding provided under a grant agreement we entered into in June 2021.
Recent Events
Termination of 2021 ATM Sales Agreements
Initiation of Phase 1 Study of DARE-PDM1
Positive Topline Data from DARE-HRT1 Phase 1/2 Clinical Study
Receipt of Payment Under 2021 DARE-LARC1 Grant Agreement
Receipt of Grant to Develop Novel Hydrogel Formulation for Vaginal Delivery of Live Biotherapeutics to Support Vaginal Health
Positive Topline Data from DARE-VVA1 Phase 1/2 Clinical Study
As discussed in ITEM 1. “BUSINESS,” in Part I of this report, in November 2022, we announced topline data from our Phase 1/2 clinical study of DARE-VVA1.
Subject Screening Completed for Exploratory Phase 2b RESPOND Study of Sildenafil Cream, 3.6%
Ovaprene IDE Application Approval for Phase 3 Clinical Study
Research and Development Expenses
•laboratory and vendor expenses related to the execution of nonclinical studies and clinical trials;
•contract manufacturing expenses, primarily for the production of clinical supplies;
•transaction costs related to acquisitions of companies, technologies and related intellectual property, and other assets;
•milestone payments due to third parties under acquisition and in-licensing arrangements we incur, or the incurrence of which we deem probable; and
•internal costs associated with activities performed by our research and development organization and generally benefit multiple programs.
License fee expenses consist of up-front license fees and annual license fees due under our in-licensing arrangements.
General and Administrative Expenses
Recently Issued Accounting Standards
Critical Accounting Policies and Estimates
Revenue Recognition
Royalties. For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, we
recognize revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, we have not recognized any royalty revenue.
Stock-Based Compensation
Stock options or stock awards with performance conditions issued to non-employees who are not directors are measured on the grant date and recognized when the performance is complete. Refer to Note 10 to our consolidated financial statements included in this report for more information.
Grant Funding
Clinical Trial Expense Accruals
Results of Operations
Comparison of the Years ended December 31, 2022 and 2021
The following table summarizes our consolidated results of operations for the years ended December 31, 2022 and 2021, and the change in the applicable category in terms of dollars and percentage:
Gain on extinguishment of note
We did not recognize any revenue for the year ended December 31, 2021.
General and administrative expenses
The increase of approximately $2.9 million in general and administrative expenses from 2021 to 2022 was primarily attributable to increases in (i) professional services expenses of approximately $1.5 million, (ii) stock-based compensation expense of approximately $406,000, (iii) personnel costs of approximately $363,000, (iv) general corporate overhead expenses of approximately $307,000, and (v) expenses related to commercial-readiness activities for XACIATO of approximately $294,000.
Research and development expenses
License fee expenses
Other income and gain on extinguishment of note payable
The increase of $435,230 in other income from 2021 to 2022 was primarily due to an increase in interest earned on cash balances in 2022.
Liquidity and Capital Resources
Plan of Operations and Future Funding Requirements
Cash Flows
$ 47,004,620
Net cash used in operating activities
Net cash used in investing activities
Cash used in investing activities during the years ended December 31, 2022 and December 31, 2021 was related to purchases of property and equipment of approximately $63,000 and $15,000, respectively.
Net cash provided by financing activities
License and Royalty Agreements
Other Contractual Obligations
Off-Balance Sheet Arrangements
We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under applicable SEC rules.
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