DARE BIOSCIENCE, INC. Management's Discussion and Analysis of Financial Condition and Resultsof Operations (form 10-Q)

Published: 2022-05-12 16:08:26 ET DARE

•Ovaprene, a hormone-free, monthly contraceptive; and

Our portfolio also includes four product candidates in Phase 1 clinical development or that we believe are Phase 1-ready:

•DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring, or IVR, for the treatment of menopausal symptoms, including vasomotor symptoms, as part of hormone therapy following menopause;

•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 these pre-clinical stage potential 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;

•ADARE-204 and ADARE-214, injectable formulations of etonogestrel designed to provide contraception over 6-month and 12-month periods, respectively; and

•DARE-RH1, a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel.

XACIATO

Our Pipeline: Clinical-Stage Programs

Ovaprene

Sildenafil Cream, 3.6%

DARE-HRT1

DARE-VVA1

DARE-FRT1 and DARE-PTB1

We are conducting development activities in preparation for Phase 1 clinical studies of DARE-FRT1 and DARE-PTB1. We do not expect to commence clinical development of these product candidates in 2022.

Recent Events

Global License Agreement with Organon to Commercialize XACIATO

Initiation of Phase 1/2 Clinical Study of DARE-HRT1

As discussed above, in April 2022, we announced initiation of our Phase 1/2 clinical study of DARE-HRT1 in Australia.

Financial Overview

Revenue

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 fees consist of up-front license fees and annual license fees due under our in-licensing arrangements.

General and Administrative Expense

Critical Accounting Policies and Estimates

Results of Operations

Comparison of Three Months Ended March 31, 2022 and 2021 (Unaudited)

We did not recognize any revenues for either of the three months ended March 31, 2022 or 2021.

General and administrative expenses

Research and development expenses

License fees

For further discussion of these license fees, see Note 3 to our unaudited condensed consolidated financial statements contained in this report.

Other income

Gain on extinguishment of note payable

Liquidity and Capital Resources

Plan of Operations and Future Funding Requirements

Cash Flows

11,374,540

(6,841)

Net increase (decrease) in cash and cash equivalents $ (12,357,176) $ 2,990,684

Net cash used in operating activities

Cash used in operating activities for the three months ended March 31, 2022 included the net loss of $8.4 million, decreased by non-cash stock-based compensation expense of approximately $0.5 million. Components providing operating cash were an increase in accrued expenses of approximately $0.4 million and an increase in accounts payable of approximately $0.7 million. Components reducing operating cash were an increase in prepaid expenses of approximately $4.3 million, a decrease in deferred grant funding of approximately $0.8 million, and an increase in other receivables of approximately $0.6 million.

Net cash used in investing activities

Cash used in investing activities for three months ended March 31, 2022 was approximately $4,600.

No cash was provided by or used in investing activities for the three months ended March 31, 2021.

Net cash provided by financing activities

No cash was provided by financing activities for the three months ended March 31, 2022.

License and Royalty Agreements

Other Contracts

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.

--------------------------------------------------------------------------------