Full Press Release Details
Bioscience Secures $22 Million in Non-Dilutive Strategic Royalty Financing to Advance Phase 3 First-in-Category Women's Health
Product Candidates through Key Catalysts
million of non-dilutive capital at close provides significant capital to achieve objectives
achieving a pre-specified return threshold, XOMA will make upside-sharing milestone payments to Dare representing 50% of the future
payments otherwise payable to XOMA
allows Dar to focus on advancing Phase 3 first-in-category investigational products Ovaprene , a potential first
FDA-approved hormone-free intravaginal monthly contraceptive, and Sildenafil Cream, 3.6%, a potential first FDA-approved treatment for
female sexual arousal disorder through key catalysts
announced royalty financing remains outstanding, bringing royalty-based capital committed to $34 million
DIEGO, April 30, 2024 - Dar Bioscience, Inc. (NASDAQ: DARE), a leader in women's health innovation, today announced
it has closed a royalty monetization transaction with XOMA (US) LLC. Dar received $22 million in gross proceeds at close and,
following a pre-specified total return to XOMA, XOMA will make upside-sharing milestone payments to Dar equal to 50% of all remaining
cash flows sold to XOMA under the transaction.
monetization of future net royalty and net milestone payments based on net sales of XACIATO (clindamycin phosphate) vaginal gel
2% under our license agreement with Organon, along with a low single digit minority interest in net payments related to future revenue
from our Phase 3 candidates, Ovaprene and Sildenafil Cream, accelerates potential cash flows from the future commercial success of XACIATO
and such product candidates, providing us with non-dilutive capital at an opportune time to drive shareholder value through the continued
advancement of Ovaprene and Sildenafil Cream, both of which are first-in-category and represent large market opportunities," said
Sabrina Martucci Johnson, President and Chief Executive Officer of Dar Bioscience.
this transaction ensures that Dar and our shareholders have the opportunity to participate meaningfully in XACIATO economics
as commercialization progresses. The structure of these agreements also underscores the significant potential of Ovaprene and Sildenafil
Cream, with Dar retaining the significant majority of future economics and the ability to achieve attractive margins through
retained net sales and all commercial milestones. This transaction exemplifies our commitment to being creative, collaborative and opportunistic
in seeking capital at an attractive cost to advance our potential first-in-category Phase 3 candidates to deliver value for all Dar
transaction involves the sale of (a) the remaining royalties and potential milestones based on net sales of XACIATO payable to Dar
under its global license agreement with Organon after deducting (i) all amounts due on such royalties and milestone payments to third-party
licensors, and (ii) all payments owed by Dar under its existing royalty interest financing agreement with United in Endeavour,
LLC, (b) 25% of the potential $20 million payment due to Dar under its license agreement with Bayer relating to Ovaprene, in
the event Bayer, in its sole discretion, elects to make the payment1, and (c) a 4% synthetic royalty on net sales of Ovaprene
and a 2% synthetic royalty on net sales of Sildenafil Cream, subject to an automatic decrease to 2.5% and 1.25%, respectively, as described
below. Once XOMA achieves a pre-specified total return on its investment, XOMA will pay to Dar 50% of each successive $22 million
that XOMA receives under the transaction agreements, and, once XOMA achieves another pre-specified total return on its investment, the
synthetic royalty rates on net sales of Ovaprene and Sildenafil Cream will automatically decrease to 2.5% and 1.25%, respectively, which,
after taking into account the $11 million payments to Dar after XOMA achieves the initial pre-specified total return, results
in a lower effective royalty rate.
Cowen, a division of TD Securities, acted as exclusive financial advisor to Dar Bioscience on the transaction. Mintz, Levin,
Cohn, Ferris, Glovsky and Popeo, P.C. served as Dar 's legal advisor while XOMA was advised by Gibson, Dunn & Crutcher
information regarding the transaction is available in Dar 's Current Report on Form 8-K filed with the Securities and Exchange
- Dar retains 75% of the potential $20 million payment and has no downstream obligations with respect to such payment.
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
use of proceeds from its transaction with XOMA, potential ongoing milestone payments from XOMA, the potential for lower effective synthetic
royalty rates on net sales of Ovaprene and Sildenafil Cream, Dar 's expectation that proceeds from the transaction will
provide sufficient capital to advance Ovaprene and Sildenafil Cream through key catalysts, the continued advancement of Ovaprene and
Sildenafil Cream, the potential market opportunity for Ovaprene and Sildenafil Cream, if approved, and Dar 's ability to
deliver value for all Dar stakeholders. In addition, 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; 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 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 data from clinical studies of its product candidates; 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