Full Press Release Details
Bioscience Announces Common Stock Purchase Agreement for up to $15 Million with Lincoln Park Capital Fund, LLC
Dar access to capital at Dar 's discretion with any proceeds available to help fund portfolio advancement, such
as the Phase 3 program for Sildenafil Cream, 3.6%, a potential first-in-category treatment for female sexual arousal disorder using the
same active ingredient as in Viagra
DIEGO, October 21, 2024 (GLOBE NEWSWIRE) - Dare Bioscience, Inc. (NASDAQ: DARE), a leader in innovation
for the health and wellbeing of women, today announced it entered into a $15 million common stock purchase agreement and registration
rights agreement with Lincoln Park Capital Fund, LLC ("LPC"), a Chicago-based institutional investor.
the terms and conditions of the purchase agreement, Dar will have the right, from time to time and at its sole discretion, to
sell up to $15 million of its stock to LPC over a 24-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 ("SEC")
and satisfaction of the other conditions in the purchase agreement. Dar will control the timing and amount of any sales to LPC,
and LPC is obligated to make purchases in accordance with the purchase agreement. LPC will purchase any common stock sold under the purchase
agreement at prices based on prevailing market prices of Dar 's common stock at the time Dar initiates each sale.
There is no upper limit to the per share price LPC may pay to purchase such common stock.
are excited to once again enter into such a transaction with LPC. Proceeds from our similar agreement with LPC in 2020 assisted with
the funding of our Phase 3 registration study of XACIATO (clindamycin phosphate) vaginal gel 2%, leading to an FDA approval,
and this transaction may similarly provide Dar with access to capital at times that we control to help us advance our portfolio
of novel investigational products in women's health, including importantly Sildenafil Cream, 3.6%, a potential first-in-category
treatment for female sexual arousal disorder, where we are in ongoing discussions with the FDA regarding the Phase 3 design and where
we have estimated that a Phase 3 study will be approximately $15 million in direct costs," said Sabrina Martucci Johnson, President
and Chief Executive Officer of Dar Bioscience.
part of the agreement, LPC has 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 shares of its common stock to LPC in
consideration for its commitment to purchase shares under the purchase agreement. Dar may terminate the purchase agreement at
any time, in its sole discretion, with no additional cost or penalty.
description of the purchase agreement and registration rights agreement is in the Company's Current Report on Form 8-K, which the
Company intends to file with the SEC today.
offer and sale of the securities by Dar to LPC in the above transaction have not been registered under the Securities Act of
1933, as amended (the "Securities Act"), or registered or qualified under any state securities laws, and therefore may not
be offered or sold in the United States absent registration under the Securities Act or an applicable exemption from such registration
requirements, and registration or qualification and under applicable state securities or "Blue Sky" laws or an applicable
exemption from such registration or qualification requirements. This press release does not constitute an offer to sell or the solicitation
of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale
would be unlawful prior to the registration or qualification under the securities laws of such state.
Bioscience is a biopharmaceutical company committed to advancing innovative products for women's health. The company's mission
is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and
well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health,
menopause, sexual health and fertility.
first FDA-approved product to emerge from Dar 's portfolio of women's health product candidates is XACIATO
(clindamycin phosphate) vaginal gel 2%, a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in female patients
12 years of age and older, which is under a global license agreement with Organon. Organon commenced U.S. marketing of XACIATO in the
fourth quarter of 2023. Dar 's portfolio also includes potential first-in-category candidates in clinical development: Ovaprene ,
a novel, hormone-free monthly intravaginal contraceptive whose U.S. commercial rights are under a license agreement with Bayer; Sildenafil
Cream, 3.6%, a novel cream formulation of sildenafil, the active ingredient in Viagra , to treat female sexual arousal disorder (FSAD);
and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal hormone therapy. To learn more
about XACIATO, Dar 's full portfolio of women's health product candidates, and Dar 's mission to deliver
differentiated therapies for women, please visit www.darebioscience.com.
Bioscience leadership has been named on the Medicine Maker's Power List and Endpoints News' Women in Biopharma 2022. In 2023,
Dar 's CEO was honored as one of Fierce Pharma's Most Influential People in Biopharma for Dar 's contributions
to innovation and advocacy in the women's health space. Dar Bioscience placed #1 in the Small Company category of the San
Diego Business Journal's 2023 Best Places to Work Awards.
may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors
section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Dar
will use these channels to distribute material information about the company and may also use social media to communicate important information
about the company, its finances, product and product candidates, clinical trials and other matters. The information Dar posts
on its investor relations website or through social media channels may be deemed to be material information. Dar encourages investors,
the media, and others interested in the company to review the information Dar posts in the Investors section of its website and
to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels
the company may use to communicate information will be posted in the Investors section of Dar 's website.
cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements.
Forward-looking statements, in some cases, can be identified by terms such as "believe," "may," "will,"
"estimate," "continue," "anticipate," "design," "intend," "expect,"
"could," "plan," "potential," "predict," "seek," "should," "would,"
"contemplate," "project," "target," "objective," or the negative version of these words
and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Dar 's
ability to access capital under its purchase agreement with LPC at times and in amounts it desires to help advance development of its
investigational products, including the Phase 3 program for Sildenafil Cream, 3.6%, the potential for Sildenafil Cream, 3.6% to demonstrate
safety and effectiveness in treating female sexual arousal disorder, and Dar 's belief that its product candidates, including
Sildenafil Cream, 3.6%, if approved, could be first-in-category products. As used in this press release, the description of a product
candidate as "first-in-category" is a forward-looking statement relating to the potential of the candidate to represent a
new category of product if it were to receive marketing approval for the indication for which Dar is developing it. Forward-looking
statements involve known and unknown risks, uncertainties and other factors that may cause Dar 's actual results, performance
or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking
statements in this press release, including, without limitation, risks and uncertainties related to: Dar 's ability to raise
additional capital when and as needed to advance its product candidates, execute its business strategy and continue as a going concern;
the limits on Dar 's ability to sell stock to LPC under the purchase agreement at times it may desire to raise additional
capital; Dar 's ability to develop, obtain FDA or foreign regulatory approval for, and commercialize its product candidates
and to do so on communicated timelines; failure or delay in starting, conducting and completing clinical trials of a product candidate;
Dar 's ability to design and conduct successful clinical trials, to enroll a sufficient number of patients, to meet established
clinical endpoints, to avoid undesirable side effects and other safety concerns, and to demonstrate sufficient safety and efficacy of
its product candidates; Dar 's dependence on third parties to conduct clinical trials and manufacture and supply clinical
trial material and commercial product; the risk that positive findings in early clinical and/or nonclinical studies of a product candidate
may not be predictive of success in subsequent clinical and/or nonclinical studies of that candidate; the risk that data from the Phase
2b RESPOND study of Sildenafil Cream, 3.6% may not be predictive of positive results of any future clinical study; the risk that the
FDA, other regulatory authorities, members of the scientific or medical communities or investors may not accept or agree with Dar 's
interpretation of or conclusions regarding the study data; the risk that development of a product candidate requires more clinical or
nonclinical studies than Dar anticipates; the loss of, or inability to attract, key personnel; the effects of macroeconomic conditions,
geopolitical events, public health emergencies, and major disruptions in government operations on Dar 's operations, financial
results and condition, and ability to achieve current plans and objectives; the risk that developments by competitors make Dar 's
product or product candidates less competitive or obsolete; difficulties establishing and sustaining relationships with development and/or
commercial collaborators; failure of Dar 's product or product candidates, if approved, to gain market acceptance or obtain
adequate coverage or reimbursement from third-party payers; Dar 's ability to retain its licensed rights to develop and
commercialize a product or product candidate; Dar 's ability to satisfy the monetary obligations and other requirements
in connection with its exclusive, in-license agreements covering the critical patents and related intellectual property related to its
product and product candidates; Dar 's ability to adequately protect or enforce its, or its licensor's, intellectual
property rights; the lack of patent protection for the active ingredients in certain of Dar 's product candidates which
could expose its products to competition from other formulations using the same active ingredients; product liability claims; governmental
investigations or actions relating to Dar 's product or product candidates or the business activities of Dar , its