In a May 16 research report, analyst Yasmeen Rahimi indicated that ROTH Capital Partners initiated coverage on Daré Bioscience Inc. (DARE:NASDAQ) with a Buy rating and $6 per share price target. Daré is a clinical-stage biopharmaceutical company that is developing innovative products for women's reproductive health.
With its lead asset, Ovaprene, a hormone-free contraceptive in the form of an intravaginal ring that is replaced monthly, Daré could "capture a significant market share given [the product's] efficacy, safety and simple use," Rahimi purported. This is because the contraceptive market, which is immense, needs innovative products.
The analyst pointed out that Ovaprene being hormone free is a huge advantage for Daré, as hormones cause adverse side effects in many women that may make them intolerable, including mood swings, breast tenderness, weight gain, decreased libido and more. Additionally, it is recommended that most women not be on hormones for extensive time periods.
As far as progress along the regulatory path, Ovaprene "faces minimal regulatory hurdles," Rahimi noted. The product will be reviewed on behalf of the FDA by the Center of Devices and Radiological Health, a process already established by "previously approved hormonal devices, most notably Caya's diaphragm," and therefore positive for Ovaprene's chances of approval. The FDA's Center for Drug Evaluation and Research could also want a say regarding approval, however, because the device releases a substance, a mix of spermiostatic agents.
In mid-May, Daré launched a Phase 2 trial of Ovaprene in 25-plus women to determine its efficacy over five menstrual cycles, which "will be measured by the proportion of women with an average of fewer than five progressively motile sperm per high powered field two or three hours after intercourse," explained Rahimi. Topline results from this study are anticipated in H2/19. If results are favorable, the company will then conduct a Phase 3 trial in 250 women over a six-month time frame. Data from that trial would be available in about H2/21.
As for the rest of its pipeline, Daré is advancing a topical sildenafil, or Viagra in a cream form, for treatment of female sexual arousal disorder, sufferers of which experience a "persistent inability to attain sexual arousal or to maintain arousal until the completion of a sexual activity," Rahimi reported. The product works by stimulating genital blood flow, thereby providing a "safe and effective and 'on demand' solution to attain sexual arousal."
Next is a meeting with the FDA to determine a protocol and the endpoints for Phase 2b and Phase 3 trials of the sildenafil product. Once those are established, the company plans to begin the Phase 2b study, hopefully in H2/18.
Also, Daré recently added some new products to its line-up. One is an intravaginal ring platform for delivering one or more drugs, including hormones and larger molecules, in precise dosages and at specific release rates. To date, this methodology has been shown to be effective in sheep.
Another is PT-101, "a vaginal formulation of tamoxifen for vulvar and vaginal atrophy treatment in breast cancer patients contraindicated for hormones," Rahimi said. Closure of the May merger agreement with Pear Tree Pharmaceuticals to secure the rights to PT-101 is pending.
Daré Bioscience's stock is currently trading at around $1.10 per share.
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Disclosures from ROTH Capital Partners, Daré Bioscience Inc., Company Note, May 16, 2018
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.
An Associated Person owns debt or equity securities of Juniper Pharmaceuticals.
Within the last twelve months, ROTH has received compensation for investment banking services from Daré Bioscience, Inc.
ROTH makes a market in shares of Daré Bioscience, Inc. and Juniper Pharmaceuticals and as such, buys and sells from customers on a principal basis.
Shares of Daré Bioscience, Inc. and Juniper Pharmaceuticals 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.
Within the last twelve months, ROTH has managed or co-managed a public offering for Daré Bioscience, Inc.
ROTH and/or its employees, officers, directors and owners own options, rights or warrants to purchase shares of Aethlon Medical, Inc. stock.
Shares of Aethlon Medical, Inc. may not be eligible for sale in one or more states.
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.
