•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.
Our Pipeline: Clinical-Stage Programs
Sildenafil Cream, 3.6%
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.
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.
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
For further discussion of these license fees, see Note 3 to our unaudited condensed consolidated financial statements contained in this report.
Gain on extinguishment of note payable
Liquidity and Capital Resources
Plan of Operations and Future Funding Requirements
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
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.
© Edgar Online, source Glimpses