In a July 12 research note, Roth Capital Partners analyst Zegbeh Jallah reported that Daré Bioscience Inc. (DARE:NASDAQ) entered a development agreement with the National Institutes of Health regarding its product Ovaprene. 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 is specifically 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 other 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" more than $17.5 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 6 or 12 months of data for approval.
The Phase 3 study could commence as early as Q1/22, noted Jallah, with 6-month top-line 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 non-hormonal contraceptive," wrote Jallah.
Roth has a Buy rating and an $11 per share price target on Daré; its current share price is around $1.55.[NLINSERT]
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Disclosures from ROTH Capital Partners, Dare Bioscience Inc., Company Update, July 12, 2021
Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.
ROTH makes a market in shares of Daré Bioscience, Inc. and as such, buys and sells from customers on a principal basis.
Shares of Daré Bioscience, Inc. may be subject to the Securities and Exchange Commission's Penny Stock Rules, which may set forth sales practice requirements for certain low-priced securities.
ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.