|Over a week ago|
Dare Bioscience files to sell 5.01M shares of common stock for holders 16:1505/1505/15/20
Dare Bioscience reports Q1 EPS (18c), consensus (29c) » 08:0305/1405/14/20
"The first quarter…
"The first quarter was an active one for Dare, beginning with the commercial licensing agreement with Bayer for Ovaprene and continuing with important progress in advancing the development of each of our later-stage product candidates," said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. "There is continued uncertainty with respect to the impact of the COVID-19 pandemic on businesses and economies across the world. However, we are on track to start the DARE-BV1 pivotal clinical study in July and report topline data for the study before the end of the year. In addition, we currently believe that we will be able to report topline data for our planned Phase 2b study of Sildenafil Cream, 3.6% in female sexual arousal disorder in 2021 and topline data for our planned pivotal contraceptive study of Ovaprene in 2022. On today's conference call, we plan to review meaningful updates on our later-stage clinical programs, recent financing developments and the innovative alliance with Health Decisions that we announced on Monday and that we believe will accelerate our clinical development efforts in a time and cost-efficient manner."
Dare Bioscience, Health Decisions form strategic partnership for novel pipeline » 08:4505/1105/11/20
Dare Bioscience announced…
Dare Bioscience announced that the companies have signed a partnership agreement under which Health Decisions will exclusively provide CRO services within the United States to support the clinical development of Dare's innovative pipeline of novel programs designed specifically to address persistent unmet needs in the areas of contraception, fertility, and broader gynecological disorders. Dare and Health Decisions have successfully worked together on prior Dare clinical studies, including the post-coital test clinical study of Ovaprene. The partnership agreement provides for dedicated resources and new pricing structures, which, together with Health Decisions' expertise, site network and relationships with key opinion leaders and investigators, are expected to accelerate clinical development of key programs in a capital-efficient manner. Under the terms of the agreement, Health Decisions will be Dare's exclusive provider of CRO services within the United States for all of Dare's reproductive health assets for an initial three-year period, provided that Health Decisions has the expertise, resources and availability to perform the clinical research services that Dare requires. This includes the assets that Dare has or may have in development for pregnancy and delivery, contraception, infertility, polycystic ovarian syndrome and endometriosis during that period. In exchange for CRO exclusivity, Health Decisions will provide a core team of personnel dedicated to supporting all of Dare's development programs covered by the agreement, including Dare's pivotal clinical study of Ovaprene(R), a hormone-free, monthly contraceptive whose U.S. commercial rights are under a license agreement with Bayer, and the planned DARE-BV1 Phase 3 study in bacterial vaginosis, with topline data expected in 2020.
|Over a month ago|
Dare Bioscience files to sell 7.5M shares of common stock for holders 16:0605/0105/01/20
Dare Bioscience CEO to participate in Infectious Disease Virtual Conference » 08:0604/2804/28/20
Dare Bioscience announced…
Dare Bioscience announced that Sabrina Martucci Johnson, President and Chief Executive Officer, will participate in a panel discussion during the Infectious Disease Virtual Conference presented by Maxim Group on May 5, 2020. Ms. Johnson will be a member of the panel discussing non-antibiotic anti-infectives, scheduled from 10:30 a.m. to 12:00 p.m. Eastern Time. During the panel discussion, Ms. Johnson will share insights from the Company's DARE-BV1 development program. DARE-BV1, a novel thermosetting bio-adhesive hydrogel formulated with clindamycin phosphate 2%, is an investigational product for the treatment of bacterial vaginosis, one of the most common vaginal infections. The Company plans to initiate a Phase 3 study of DARE-BV1 during 2020, have topline data available by the end of the year and submit a new drug application for DARE-BV1 with the FDA during the first half of 2021.
Dare Bioscience initiated with a Buy at Brookline » 16:1604/2704/27/20
Brookline analyst Sally…
Brookline analyst Sally Yanchus initiated coverage of Dare Bioscience with a Buy rating and $7.50 price target.
Dare Bioscience announces common stock purchase agreement up to $15M » 08:2404/2304/23/20
Dare Bioscience announced…
Dare Bioscience announced it entered into a $15 million common stock purchase agreement and registration rights agreement with Lincoln Park Capital Fund. Under the terms and conditions of the purchase agreement, Dare will have the right, from time to time and at its sole discretion, to sell up to $15M of its stock to LPC over a 36-month period, subject to a registration statement covering the resale by LPC of shares issued and sold under the purchase agreement being filed and declared effective by the Securities and Exchange Commission and satisfaction of the other conditions in the purchase agreement. Dare will control the timing and amount of any sales to LPC, and LPC is obligated to make purchases in accordance with the purchase agreement. Any common stock that is sold to LPC will occur at purchase prices that correlate to the market prices of Dare's common stock at the time Dare initiates each sale and with no upper limits to the per share price LPC may pay to purchase such common stock. As part of the agreement, LPC agreed not to cause or engage in any direct or indirect short selling or hedging of the Company's common stock. No warrants are being issued in this transaction, and there are no limitations on the Company's use of proceeds from sales to LPC under the purchase agreement. Furthermore, the purchase agreement does not contain any rights of first refusal, participation rights, penalties or liquidated damages provisions in favor of any party. The Company will issue 285,714 shares of its common stock to LPC in consideration for its commitment to purchase shares under the purchase agreement. The agreement may be terminated by Dare at any time, in its sole discretion, with no additional cost or penalty.
Dare Bioscience receives third notice of award from NIH division for Ovaprene » 08:0704/0104/01/20
Dare Bioscience (DARE)…
Dare Bioscience (DARE) announced it received a Notice of Award of $730,722 in a grant supporting the Ovaprene postcoital test clinical study research from the Eunice Kennedy Shriver National Institute of Child Health & Human Development, a division of the National Institutes of Health. Having previously received two tranches under the grant, this final tranche brings the total funds under the grant to nearly $2M. The NIH issued this final notice of award for the PCT project after reviewing data from the completed PCT clinical study and commercialization plans for Ovaprene, an investigational hormone-free, monthly contraceptive. Ovaprene is a clinical-stage, hormone-free vaginal contraceptive intended to provide pregnancy prevention for multiple weeks. Requiring no intervention at the time of intercourse, if approved, Ovaprene could fill a void in today's contraception alternatives. The award will fund the balance of the costs associated with the completed Ovaprene PCT clinical study, a multi-center, open-label, non-significant risk device pre-pivotal trial. In November 2019, Dare announced positive topline results from the PCT study, where, in all women and across all cycles evaluated, it prevented virtually all sperm from entering the cervical canal, a surrogate marker for contraceptive effectiveness. The topline results from the PCT clinical study support continued clinical development of Ovaprene and its potential to be the first hormone-free, monthly contraceptive option for women. This notice of award follows the January 2020 announcement of an exclusive licensing agreement between Dare and Bayer (BAYRY), in which Bayer may commercialize Ovaprene in the United States once approved by the Food and Drug Administration.
Dare Bioscience price target lowered to $4 from $6 at Roth Capital » 11:0903/3103/31/20
Roth Capital analyst…
Roth Capital analyst Yasmeen Rahimi lowered the firm's price target on Dare Bioscience to $4 from $6 and keeps a Buy rating on the shares. The analyst noted that with the company's major licensing deal for Ovaprene with Bayer (BAYRY) done, Dare's "key priority in 2020 will be partnering its other five assets: two clinical and three soon to enter the clinic." Rahimi said that the most advanced program is DARE-BV1, which is set to enter Phase 3 studies in bacterial vaginosis, or BV, in 2020, and the next asset up after that is topical sildenafil, which will soon be entering Phase 2b studies in female sexual arousal disorder, or FSAD.
Dare Bioscience reports FY19 EPS (97c), consensus (94c) » 08:0203/3003/30/20
"During the fourth…
"During the fourth quarter of 2019 and into early 2020, we made considerable progress against our longer-term strategic and operational objectives, particularly with our later-stage candidates Ovaprene, DARE-BV1, and Sildenafil Cream, 3.6%. This progress has helped position us for what we expect to be a transformative year for Dare. In 2020, we expect to achieve a number of important milestones that we believe will deliver value to our shareholders," said Sabrina Martucci Johnson, President and CEO of Dare. "We started 2020 with the announcement of our exclusive licensing agreement with Bayer, a world leader in women's health, for U.S. commercial rights to Ovaprene, our investigational hormone-free, monthly contraceptive. Our agreement with Bayer is perhaps the most significant deal in our company's history as we are eligible to receive a $20 million payment to reimburse Ovaprene clinical development costs and commercial milestone payments potentially totaling up to $310 million, in addition to tiered, double-digit royalties on net sales. Moreover, we believe that Bayer is the ideal partner for Ovaprene, given its track record in women's health and unparalleled expertise commercializing first-in-category contraceptive products. We ended 2019 with the announcement of the positive Ovaprene data that led to the partnership with Bayer, as well as important alignment with the FDA on the planned DARE-BV1 Phase 3 clinical study for the treatment of bacterial vaginosis and on the planned Phase 2b clinical study of Sildenafil Cream, 3.6% for Female Sexual Arousal Disorder. We are currently on track to conduct and report topline results from the planned Phase 3 study of DARE-BV1 before the end of 2020, as well as to report topline results of the planned Sildenafil Cream, 3.6% Phase 2b study in 2021 and the planned Ovaprene pivotal study in 2022. As a result of the COVID-19 pandemic, these are unprecedented times, circumstances are rapidly evolving, both from a macroeconomic perspective and in our industry, and we will continue to assess our circumstances and development timelines. We believe our unique accelerator model, with our variety of programs and diversity of indications and development stages, enables us to react quickly to the highly dynamic and uncertain environment that we find ourselves facing today. As a result, we believe we are well-positioned to deliver the topline clinical data and regulatory actions projected over the next three years."