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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d)
of
the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): December 21, 2023
DARÉ
BIOSCIENCE, INC.
(Exact
name of registrant as specified in its charter)
| Delaware |
|
001-36395 |
|
20-4139823 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
3655
Nobel Drive, Suite 260
San
Diego, CA 92122
(Address
of Principal Executive Offices and Zip Code)
Registrant’s
telephone number, including area code: (858) 926-7655
Not
Applicable
(Former
name or former address, if changed since last report.)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2. below):
| ☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| |
|
| ☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| |
|
| ☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
| Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
| Common
stock |
|
DARE |
|
Nasdaq
Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item
1.01 | Entry
into a Material Definitive Agreement. |
Royalty
Interest Financing Agreement
On
December 21, 2023 (the “Effective Date”), Daré Bioscience, Inc. (the “Company”) entered into a Royalty
Interest Financing Agreement (the “Agreement”) with United in Endeavour, LLC (“United”), pursuant to which the
Company sold to United the right to receive certain royalty payments from the Company for a purchase price of up to $12 million. The
Company received $5 million from United on the Effective Date (the “Initial Investment Amount”) and between January 1, 2024
and December 31, 2026, the Company may, in its sole discretion, elect to receive three additional payments from United of up to an aggregate
of $7 million (each a “Supplemental Discretionary Investment Amount,” and collectively the “Total Supplemental Discretionary
Investment Amount”).
Under
the Agreement, the Company has agreed to make payments to United, until such time when United has received aggregate payments equaling
a 12% internal rate of return (the “IRR”) on the Initial Investment Amount and the Total Supplemental Discretionary Investment
Amount, if any (the “Hard Cap”). Until such time as the IRR has been achieved, the Company has agreed to make payments to
United equal to (i) from the Effective Date through December 31, 2025, 50% of the amount of royalty payments remaining
after all amounts that are due and payable and actually paid by the Company to any licensor or sublicensee on the royalty payments
generated and received by the Company on net sales of XACIATO™ by Organon have been deducted (the “Net Royalty
Payments”), (ii) from January 1, 2026 through December 31, 2029, 75% of the Net Royalty Payments, and (iii) from the
Effective Date through December 31, 2029, 10% of the amount of milestone payments remaining after all amounts that are due and payable
and actually paid by the Company to any licensor or sublicensee on the milestone payments generated and received by the Company on net
sales of XACIATO by Organon have been deducted. After December 31, 2029, the Company will be required to make certain additional
payments to United to the extent United has not received payments equaling the Hard Cap by December 31, 2029, December 31, 2033, and
December 31, 2034, respectively. In addition, if United has not received payments equaling the Hard Cap by December 31, 2035 and the
Company has other sources of assets or income besides XACIATO sufficient to complete such payments, the Company has agreed to
pay United quarterly payments evenly divided over a two-year term, such that United will have obtained the IRR, taking into account
all other payments received by United from the Company under the Agreement. United’s right to receive payments will terminate when
United has received the Hard Cap.
The
Company shall have the right, but not the obligation, at any time (the “Call Option”), to repurchase all of the Purchased
Interest from United at a repurchase price equal to the Hard Cap, calculated as of the date of the exercise of the Call Option.
The
Agreement contains representations and warranties, covenants, indemnification obligations, and other provisions customary for transactions
of this nature and will terminate on the date that is the earlier of (i) the date upon which the payment of the purchased interest
in respect of XACIATO is made in full to United, and (ii) the payment to United of an aggregate amount equal to the Hard Cap.
Warrants
In
connection with the Agreement, the Company issued to United a warrant (the “Initial Warrant”) to purchase up to 5,000,000
shares of the Company’s common stock, par value $0.0001 per share (the “Common Stock”). In addition, for every $1,000,000
of Supplemental Investment Amount, the Company has agreed to issue 1,000,000 additional warrants to purchase 1,000,000
shares of Common Stock, for an aggregate of up to 7,000,000 warrants to purchase 7,000,000 shares of Common Stock (collectively
the “Additional Warrants,” and together with the Initial Warrant, the “Warrants”).
The
Warrants are exercisable, in full or in part, at any time prior to the fifth (5th) anniversary of their issuance date at an exercise
price of $0.3467 per share, subject to customary anti-dilution adjustments in the event of certain future stock dividend, stock
split, stock combination, recapitalization or other similar transaction of the Company as set forth in the Warrants. The Warrants may
be exercised for cash in an amount equal to the aggregate exercise price, or if at the time of exercise there is no effective registration
statement registering for resale the shares underlying the Warrants, then in lieu of paying the aggregate exercise price, the holders
of the Warrants may elect a cashless exercise in accordance with the terms of the Warrants. Prior to the issuance of shares of Common
Stock upon exercise of the Warrants, the Warrant holders are not entitled to vote or be deemed the holder of shares of Common Stock,
provided that Warrant holders are entitled to receive, simultaneously with holders of the Common Stock, dividends and other distributions
made to such holders of Common Stock.
The
foregoing summary of the Agreement and Form of Warrant does not purport to be complete and is qualified in its entirety by reference
to the Agreement and the Form of Warrant, which the Company intends to file with its Annual Report on Form 10-K for the year ending
December 31, 2023, with certain private or confidential provisions or terms redacted.
| Item
2.03 | Creation
of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement
of a Registrant. |
The
information set forth in Item 1.01 of this Current Report on Form 8-K with respect to the Agreement is hereby incorporated by reference
into this Item 2.03.
| Item
3.02 | Unregistered
Sales of Equity Securities. |
The
information set forth in Item 1.01 of this Current Report on Form 8-K above is incorporated herein by reference. The Company issued the
Warrants and offered the shares of Common Stock underlying the Warrants in reliance on Section 4(a)(2) of the Securities Act of 1933,
as amended.
| Item
7.01 | Regulation
FD Disclosure. |
On
December 26, 2023, the Company issued a press release announcing the Company’s entry into the Agreement. A copy of the press
release is furnished as Exhibit 99.1 and incorporated herein by reference.
The
information in Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1 attached hereto) is being furnished pursuant to Item
7.01 and shall not be deemed to be filed for purposes of Section 18 of the Exchange Act, or otherwise be subject to the liabilities of
that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the
Exchange Act, whether made before or after the date hereof and regardless of any general incorporation language in such filing.
| Item
9.01 | Financial
Statements and Exhibits. |
(d)
Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
| |
DARÉ
BIOSCIENCE, INC. |
| |
|
| Dated:
December 26, 2023 |
By: |
/s/
Sabrina Martucci Johnson |
| |
Name: |
Sabrina
Martucci Johnson |
| |
Title: |
President
and Chief Executive Officer |
Exhibit
99.1
Daré
Bioscience Secures $12 million in Royalty-backed Investment Structure $5 million at closing and up to $7 million of additional committed
funding
SAN
DIEGO, December, 26, 2023 – Daré Bioscience, Inc. (NASDAQ: DARE), a leader in women’s health innovation, today announced
it has entered into a royalty-backed financing agreement that provides Daré with $5 million at closing and up to an additional
$7 million through three tranches over time at Daré’s option. The financing structure entitles the investor to a percentage
of the royalties and milestones to be received by Daré under its global license agreement for XACIATOTM with Organon
only until the investor achieves a targeted return on investment.
“This
advance against a percentage of future net payments we receive under our license agreement for XACIATO provides us with capital at an
opportune time to drive shareholder value through the continued advancement of our late-stage portfolio of product candidates,”
stated Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer. “This financing exemplifies our commitment
to being creative, collaborative and opportunistic in seeking capital at an attractive cost to advance our late-stage candidates –
all of which represent a first-in-category opportunity – while seeking to continue to deliver value for all Daré stakeholders.”
Terms
of the Agreement
Daré
received $5 million from the investor at closing and has the option to draw an additional $7 million in tranches of up to $3 million
each through December 31, 2026. Once the investor receives a targeted internal rate of return (IRR) of 12% on all advances, all future
royalty and milestone payments related to XACIATO revert to Daré. Daré may terminate the agreement at any time by repaying
the amounts advanced plus the IRR.
In
connection with the closing, Daré issued to the investor a five-year warrant to purchase an aggregate of 5 million shares of Daré’s
common stock at an exercise price of $0.3467 per share, representing a 10% premium to the prior day’s closing price. In addition,
in connection with each future advance of $1 million, if any, Daré agreed to issue additional five-year warrants to purchase up
to 1 million shares of common stock at an exercise price of $0.3467 per share.
Additional
information regarding the transaction is available in Daré’s Current Report on Form 8-K filed with the Securities and Exchange
Commission today.
About
Daré Bioscience
Daré
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.
Daré’s
first FDA-approved product, XACIATO™ (clindamycin phosphate) vaginal gel 2% is 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. Daré’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 to treat female sexual arousal disorder (FSAD) and/or female sexual interest/arousal disorder (FSIAD) utilizing
the active ingredient in Viagra®; and DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for menopausal
hormone therapy. To learn more about XACIATO, Daré’s full portfolio of women’s health product candidates, and Daré’s
mission to deliver differentiated therapies for women, please visit www.darebioscience.com.
Daré
Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023,
Daré’s CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions
to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San
Diego Business Journal’s 2023 Best Places to Work Awards.
Daré
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. Daré
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 Daré posts
on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors,
the media, and others interested in the company to review the information Daré 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 Daré’s website.
Forward-Looking
Statements
Daré
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 the
continued advancement of Daré’s late-stage portfolio of product candidates and Daré’s ability to deliver value
for all Daré stakeholders. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may
cause Daré’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: Daré’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; Daré’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; Daré’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; Daré’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 Daré’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 Daré 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 Daré’s operations, financial results and condition, and ability to achieve current plans and
objectives; the risk that developments by competitors make Daré’s product or product candidates less competitive or obsolete;
difficulties establishing and sustaining relationships with development and/or commercial collaborators; failure of Daré’s
product or product candidates, if approved, to gain market acceptance or obtain adequate coverage or reimbursement from third-party payers;
Daré’s ability to retain its licensed rights to develop and commercialize a product or product candidate; Daré’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; Daré’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 Daré’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 Daré’s product or
product candidates or the business activities of Daré, its commercial collaborators or other third parties on which Daré
relies; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global
trends toward health care cost containment; cybersecurity incidents or similar events that compromise Daré’s technology
systems or those of third parties on which it relies and/or significantly disrupt Daré’s business; and disputes or other
developments concerning Daré’s intellectual property rights. Daré’s forward-looking statements are based upon
its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements
are expressly qualified in their entirety by these cautionary statements. For a detailed description of Daré’s risks and
uncertainties, you are encouraged to review its documents filed with the SEC including Daré’s recent filings on Form 8-K,
Form 10-K and Form 10-Q. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date
on which they were made. Daré undertakes no obligation to update such statements to reflect events that occur or circumstances
that exist after the date on which they were made, except as required by law.
Contacts:
Media
and Investors on behalf of Daré Bioscience, Inc:
Camilla White / Simona Kormanikova
Dentons Global Advisors
DareBioscience@dentonsglobaladvisors.com/ 1.212.466.6450
Source:
Daré Bioscience, Inc.
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