Daré Bioscience. (NASDAQ: DARE) is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s reproductive health. Daré’s lead product candidate, Ovaprene, is a non-hormonal, monthly contraceptive ring that is currently in clinical studies.
2017 was a year of transformative growth for Daré Bioscience as it established a strong foundation for its goal of building a preeminent company in “Women’s reproductive health.” From a liquidity and financial flexibility perspective, the Company expects that its year-end cash balance of approximately $7.56 million would enable it to fully fund an important clinical study evaluating Ovaprene, which, if approved, has the potential to fill a significant gap in the marketplace as the first woman-initiated non-hormonal contraceptive providing protection over the course of several weeks.
Upcoming Milestone: The company is having Multiple milestones and value drivers expected between mid-2018 and late 2019 from two Phase 2 programs, each positioned to be first in the category.
On July 16th, the company announced that it has entered into an asset transfer agreement with Hydra Biosciences, Inc. for the transfer of all of Hydra’s interest in certain intellectual property relating to Hydra’s CatSper ion channel target portfolio.
As per management, CatSper represents a novel target for non-hormonal contraceptives for both men and women. Inhibiting CatSper prevents sperm from achieving the hyperactive motile state required for fertilization. The potential for a first-in-class non-hormonal male or female contraceptive option aligns with the objectives of the foundations and government agencies that fund contraceptive research, and as such the company will be pursuing grant funding to support the near-term research.
Prior to this on May 15th, the company announced the initiation of its post-coital test (PCT) clinical trial for its lead product candidate Ovaprene®, a monthly non-hormonal contraceptive vaginal ring. The initiation of this clinical trial is an important milestone for DARE. The data from the study is expected to be available in the second half of 2019. If there is demonstration of feasibility in the PCT clinical trial, the Company intends to prepare and file an Investigational Device Exemption (IDE) with the FDA to commence a pivotal clinical trial to support marketing approvals of Ovaprene in the United States, Europe, and other countries worldwide.
Additionally, in the first quarter of 2018, DARE announced the addition of Topical Sildenafil, a product with the potential to be the first product approved for Female Sexual Arousal Disorder and raised approximately $10.4 million in net proceeds through the sale of equity securities to continue its development into Phase 2b. The Company intends to communicate with the U.S. Food and Drug Administration in mid-2018 regarding the Phase 2b study of Topical Sildenafil.
The company’ human clinical development activities remain focused on its lead programs Ovaprene® and Topical 5% Sildenafil Citrate Cream. In parallel, DARE continues to screen, identify, and access technology that is highly differentiated and novel. With the CatSper intellectual property from Hydra Biosciences, DARE is delivering on its commitment to advance unique innovation that addresses persistent unmet needs and that provides it with strategic optionality.
Analysts tracking the stock believes that DARE’s innovative pipeline of products has the opportunity to unlock significant value for its equity holders and deliver medicines that are more aligned with women’s specific needs. The company continues to actively identify and evaluating additional candidates that, like Ovaprene™ in contraception and Topical Sildenafil for FSAD, have the potential to address critical gaps in the treatment options.
Taking all this into consideration, the market cap of just $14.392 million and share now ruling at $1.26, can move to a level of $6.00 in next six months.
Dare Bioscience (NASDAQ: DARE) most recent Analyst Ratings History
About the Company: Daré Bioscience® is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s reproductive health. It is driven by a mission to identify, develop and bring to market a diverse portfolio of novel therapies that expand treatment options, improve outcomes and facilitate convenience for women. The company’s initial focus is on contraception, vaginal health, and fertility.
Ovaprene™ is a clinical stage, non-hormonal contraceptive ring intended to provide protection over multiple weeks of use, require no intervention at the time of intercourse, and fill a void in today’s contraception method mix. It represents a new approach to contraception and if approved, will serve a new birth control category.
Topical Sildenafil for Women With FSAD: SST-6007 incorporates sildenafil, the same active ingredient in Viagra®, in a proprietary cream formulation that is specifically designed to locally increase blood flow to the vulvar-vaginal tissue in women, leading to a potential improvement in genital arousal response and overall sexual experience.
Female sexual arousal disorder (FSAD) is characterized by a persistent or recurrent inability to attain or to maintain sexual arousal until the completion of sexual activities. As many as thirty-three percent of women in the U.S. (21 to 60 years old) experience symptoms of low or no sexual arousal.
- Merger agreement with Pear Tree Pharmaceuticals, Inc. On May 7th, the company announced it has entered into a merger agreement with Pear Tree Pharmaceuticals, Inc., a development-stage women’s biopharmaceuticals company. Daré has entered into the above merger agreement to secure the rights, currently owned by Pear Tree, to develop PT-101, a proprietary vaginal formulation of tamoxifen, as a potential treatment for vulvar and vaginal atrophy (VVA) in patients with hormone-receptor-positive breast cancer, including estrogen receptor-positive (ER-positive) and progesterone receptor-positive (PR-positive) breast cancer.
- Funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): On April 30th, announced that it received a Notice of Award for the first $224,665 of the anticipated $1.9 million in grant funding from NICHD, a division of the National Institutes of Health (NIH). The award will be applied to important clinical development efforts supporting Daré’s lead product candidate Ovaprene™, a non-hormonal, non-daily intravaginal ring being studied for pregnancy prevention.
- Exclusive license to Juniper Pharmaceuticals’ intravaginal ring technology: On April 25th, DARE announced today it had secured an exclusive license to Juniper Pharmaceuticals’ intravaginal ring technology, including Juniper’s three preclinical candidates. The capabilities of the intravaginal ring platform will greatly expand DARE’ ability to identify and meet unmet needs in women’s sexual and reproductive health.
- Completed stock purchase transaction between Daré Bioscience, Inc. (formerly known as Cerulean Pharma Inc.) and Daré Bioscience Operations, Inc. in July 2017.
- Entered into a worldwide license and development agreement for a clinical Phase 2b stage asset, Topical Sildenafil, for the treatment of Female Sexual Arousal Disorder in February 2018.
- The Company intends to communicate with the U.S. Food and Drug Administration in mid-2018 regarding the Phase 2b study of Topical Sildenafil. As per management the addition of Topical Sildenafil to its portfolio reflects its commitment to developing unique and differentiated products for women’s reproductive health, including contraception, sexual health, and vaginal health. Pending these discussions, the Company anticipates commencing a Phase 2b study of Topical Sildenafil in the fourth quarter of 2018.
- Entered into a worldwide development and option agreement for novel injectable formulations of etonogestrel seeking to provide contraceptive protection for periods of six and 12 months in March 2018.
The company plans to request a meeting with the FDA to discuss the Phase 2 and three trial designs for Topical Sildenafil in FSAD patients in the first half of 2018. Currently, the planned Phase 2 trial is expected to evaluate the product candidate under real-life conditions in women with FSAD. Clinical endpoints are expected to include patient-reported outcomes (PROs) using validated questionnaires, and FDA’s input will be requested on the proposed PROs and questionnaire tools as well. The objective of Phase 2 and three trials is to establish the efficacy and safety of SST’s Topical Sildenafil for this proposed use to support future regulatory applications to bring a necessary new treatment for women to commercial markets.
Industry highlights and demand drivers:
- The current contraceptive method mix still fails to meet the needs of all women.
- The global market for contraception was $19 billion in 2015 and is estimated to grow over 6% to $33 billion in 2023.
- 40 million women of reproductive age in the U.S. are currently using a contraceptive method, about 62% of the population. Fifty percent of them are using a short-acting reversible method.
- Women’s health therapeutics global market is expected to reach $22 billion by 2018.
Latest Quarter Financial position:
- As of March 31, 2018, Daré had cash of $15.625 million. The Company believes existing cash balances will be sufficient for Daré to complete a postcoital test clinical trial of Ovaprene and advance Topical Sildenafil into Phase 2b.
- DARE is a development stage company that has not yet generated revenue.
- The net loss for the quarter ended March 31, 2018, was $7.665 million.
Key risk factors and potential stock drivers:
- The positive outcome of the upcoming catalyst (as outlined above), would be the critical near-term trigger for the company.
- Company’s ability to maintain its liquidity and financial flexibility to fund its incremental capital requirements.
- In the biotechnology/pharma sector, the field and science are rapidly changing and evolving. Therefore, new companies are emerging, and regulatory risk always exists for the players in the industry.
- On Friday, July 20th, 2018, DARE closed at $1.24, on volume of 239K shares exchanging hands. Market capitalization is $14.16 million. The current RSI is 48.56.
- In the past 52 weeks, shares of DARE have traded as low as $1.25 and as high as $1.37
- At $1.24, shares of DARE are trading above its 50-day moving average (MA) at $1.23 and below its 200-day moving average (MA) at $1.79
- The present support and resistance levels for the stock are at $1.17 & $1.43 respectively.