In a July 12 research note, ROTH Capital Partners analyst Zegbeh Jallah reported that Daré Bioscience Inc. (DARE:NASDAQ) entered a development agreement regarding its product Ovaprene, with one of the National Institutes of Health. Ovaprene is Daré's monthly, hormone-free intravaginal ring contraceptive.
"We find this new agreement advantageous from a cost perspective, and swift advancement of the program should get Daré closer to commercialization," wrote Jallah.
Jallah provided the details and purpose of the arrangement. Daré's new Cooperative Research and Development Agreement (CRADA) is with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The CRADA specifically is in relation to an upcoming Phase 3 Ovaprene study, which will assess the product's efficacy and safety in about 250 women.
Per the CRADA, Daré will supply Ovaprene for the study, pay $5.5 million in four tranches toward the study costs and handle regulatory submissions and communications. The NICHD will pay all over development costs.
This is "an agreement which we find to be a very cost effective and strategic move for Daré, as Phase 3 studies can cost up to $17.5-plus million," Jallah commented.
Daré will also get support from the NICHD Contraceptive Development Program (CDP), which has ample experience with designing and carrying out contraception studies.
This assistance from the CDP is "crucial, in our view, as the study design can indeed determine the success/failure of clinical studies," Jallah wrote.
As for a potential timeline for advancing Ovaprene, Jallah indicated, Daré intends to file an investigational device exemption application for it in Q4/21. Then, the U.S. Food and Drug Administration should say whether it will require six or 12 months of data for approval.
The Phase 3 study could commence as early as Q1/22, noted Jallah, with six-month topline data, a major catalyst, available by year-end 2022.
In another major development, Jallah reported, Daré partnered with Bayer to help commercialize Ovaprene. According to that agreement, once the Phase 3 study is completed, Bayer may opt to exclusively commercialize the contraceptive in the U.S. Should it decide to, Bayer would pay Daré a $20M opt-in payment as well as up to $310M in commercial milestones and low double-digit royalties on net sales "for what could be a blockbuster product."
"Daré's commercial partnership with Bayer could be quite lucrative as Ovaprene advances to become the first approved, monthly nonhormonal contraceptive," wrote Jallah.
ROTH has a Buy rating and an $11 per share price target on Daré, making the stock a possible fivebagger. Its current share price is around $1.86.
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