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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Large Accelerated Filer
|
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o
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Accelerated filer
|
o
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Non-accelerated filer
|
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x
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Smaller reporting company
|
x
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Emerging growth company
|
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x
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|
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|
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•
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Inability to continue as a going concern;
|
•
|
Inability to raise additional capital, under favorable terms or at all;
|
•
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Inability to successfully attract partners and enter into collaborations on acceptable terms;
|
•
|
Failure to select or capitalize on the most scientifically, clinically or commercially promising or profitable indications or therapeutic areas for our product candidates due to limited financial resources;
|
•
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Inability to develop and commercialize our product candidates;
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•
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Failure or delay in starting, conducting and completing clinical trials or obtaining United States Food and Drug Administration, or FDA, or foreign regulatory approval for our product candidates in a timely manner;
|
•
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A change in the FDA’s primary oversight responsibility;
|
•
|
A change in regulatory requirements for our product candidates, including the development pathway pursuant to Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or the FDA's 505(b)(2) pathway;
|
•
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Unsuccessful clinical trial outcomes stemming from clinical trial designs, failure to enroll a sufficient number of patients, higher than anticipated patient dropout rates, failure to meet established clinical endpoints, undesirable side effects and other safety concerns;
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•
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Negative publicity concerning the safety and efficacy of our product candidates, or of product candidates being developed by others that share characteristics similar to our candidates;
|
•
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Inability to demonstrate sufficient efficacy of our product candidates;
|
•
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Loss of our licensed rights to develop and commercialize a product candidate as a result of the termination of the underlying licensing agreement;
|
•
|
Monetary obligations and other requirements in connection with our exclusive, in-license agreements covering the patents and related intellectual property related to our product candidates;
|
•
|
Developments by our competitors that make our product candidates less competitive or obsolete;
|
•
|
Dependence on third parties to conduct clinical trials and to manufacture product candidates;
|
•
|
Dependence on third parties to supply clinical supplies and raw materials, drugs and other materials required to produce a finished product and to produce the quantities needed;
|
•
|
Failure of our product candidates, if approved, to gain market acceptance or obtain adequate coverage for third party reimbursement;
|
•
|
A reduction in demand for contraceptives caused by an elimination of current requirements that health insurance plans cover and reimburse certain FDA-cleared or approved contraceptive products without cost sharing;
|
•
|
Lack of precedent to help assess whether health insurance plans will cover our product candidates;
|
•
|
The reimbursement environment relating to our product candidates at the time we obtain regulatory approval, if ever;
|
•
|
Difficulty in introducing branded products in a market made up of generic products;
|
•
|
Inability to adequately protect or enforce our, or our licensor’s, intellectual property rights;
|
•
|
Lack of patent protection for the active ingredients in certain of our product candidates which could expose those product candidates to competition from other formulations using the same active ingredients;
|
•
|
Higher risk of failure associated with product candidates in pre-clinical stages of development that may lead investors to assign them little to no value and make these assets difficult to fund;
|
•
|
Disputes or other developments concerning our intellectual property rights;
|
•
|
Actual and anticipated fluctuations in our quarterly or annual operating results;
|
•
|
Price and volume fluctuations in the stock market, and in our stock in particular, which could subject us to securities class-action litigation;
|
•
|
Failure to maintain the listing of the Company’s common stock on the Nasdaq Capital Market or another nationally recognized exchange;
|
•
|
Litigation or public concern about the safety of our potential products;
|
•
|
Strict government regulations on our business, including various fraud and abuse laws, including, without limitation, the U.S. federal Anti-Kickback Statute, the U.S. federal False Claims Act and the U.S. Foreign Corrupt Practices Act;
|
•
|
Regulations governing the production or marketing of our product candidates;
|
•
|
Loss of, or inability to attract, key personnel; and
|
•
|
Increased costs as a result of operating as a public company, and substantial time devoted by our management to compliance initiatives and corporate governance practices.
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Page
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Item 1.
|
||
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|
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Item 2.
|
||
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Item 3.
|
||
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Item 4.
|
||
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||
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|
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Item 1.
|
||
|
|
|
Item 1A.
|
||
|
|
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Item 2.
|
||
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|
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Item 3.
|
||
|
|
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Item 4.
|
||
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Item 5.
|
||
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Item 6.
|
||
|
|
|
|
PART I.
|
FINANCIAL INFORMATION
|
|
September 30,
2019 |
|
December 31,
2018 |
||||
|
(unaudited)
|
|
|
||||
Assets
|
|
|
|
||||
Current assets
|
|
|
|
||||
Cash and cash equivalents
|
$
|
2,435,120
|
|
|
$
|
6,805,889
|
|
Other receivables
|
37,839
|
|
|
31,037
|
|
||
Prepaid expenses
|
770,506
|
|
|
403,097
|
|
||
Total current assets
|
3,243,465
|
|
|
7,240,023
|
|
||
Property and equipment, net
|
5,905
|
|
|
9,396
|
|
||
Other non-current assets
|
632,648
|
|
|
577,968
|
|
||
Total assets
|
$
|
3,882,018
|
|
|
$
|
7,827,387
|
|
Liabilities and stockholders’ equity
|
|
|
|
||||
Current liabilities
|
|
|
|
||||
Accounts payable
|
$
|
352,243
|
|
|
$
|
459,705
|
|
Accrued expenses
|
1,536,587
|
|
|
631,351
|
|
||
Total current liabilities
|
1,888,830
|
|
|
1,091,056
|
|
||
Other liabilities
|
183,196
|
|
|
9,711
|
|
||
Total liabilities
|
2,072,026
|
|
|
1,100,767
|
|
||
Commitments and contingencies (Note 8)
|
|
|
|
|
|
||
Stockholders' equity
|
|
|
|
||||
Preferred stock, $0.01 par value, 5,000,000 shares authorized; None issued and outstanding
|
—
|
|
|
—
|
|
||
Common stock, $0.0001 par value; 120,000,000 shares authorized; 16,683,411 and 11,422,161 shares issued and outstanding, respectively
|
1,668
|
|
|
1,143
|
|
||
Accumulated other comprehensive loss
|
(112,402
|
)
|
|
(96,728
|
)
|
||
Additional paid-in capital
|
42,077,455
|
|
|
35,791,972
|
|
||
Accumulated deficit
|
(40,156,729
|
)
|
|
(28,969,767
|
)
|
||
Total stockholders' equity
|
1,809,992
|
|
|
6,726,620
|
|
||
Total liabilities and stockholders' equity
|
$
|
3,882,018
|
|
|
$
|
7,827,387
|
|
|
Three months ended September 30,
|
|
Nine months ended September 30,
|
||||||||||||
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||||||
Operating expenses
|
|
|
|
|
|
|
|
||||||||
General and administrative
|
$
|
1,318,986
|
|
|
$
|
1,175,049
|
|
|
$
|
3,903,545
|
|
|
$
|
3,635,413
|
|
Research and development expenses
|
1,966,230
|
|
|
1,446,548
|
|
|
6,172,192
|
|
|
4,750,823
|
|
||||
License expenses
|
133,333
|
|
|
—
|
|
|
408,333
|
|
|
350,000
|
|
||||
Impairment of goodwill
|
—
|
|
|
—
|
|
|
—
|
|
|
5,187,519
|
|
||||
Total operating expenses
|
3,418,549
|
|
|
2,621,597
|
|
|
10,484,070
|
|
|
13,923,755
|
|
||||
Loss from operations
|
(3,418,549
|
)
|
|
(2,621,597
|
)
|
|
(10,484,070
|
)
|
|
(13,923,755
|
)
|
||||
Other income
|
25,471
|
|
|
47,122
|
|
|
86,703
|
|
|
101,492
|
|
||||
Net loss
|
$
|
(3,393,078
|
)
|
|
$
|
(2,574,475
|
)
|
|
$
|
(10,397,367
|
)
|
|
$
|
(13,822,263
|
)
|
Deemed dividend from trigger of down round provision feature
|
—
|
|
|
—
|
|
|
(789,594
|
)
|
|
—
|
|
||||
Net loss to common shareholders
|
$
|
(3,393,078
|
)
|
|
$
|
(2,574,475
|
)
|
|
$
|
(11,186,961
|
)
|
|
$
|
(13,822,263
|
)
|
Foreign currency translation adjustments
|
$
|
(15,378
|
)
|
|
$
|
(18,721
|
)
|
|
$
|
(15,674
|
)
|
|
$
|
(59,952
|
)
|
Comprehensive loss
|
$
|
(3,408,456
|
)
|
|
$
|
(2,593,196
|
)
|
|
$
|
(11,202,635
|
)
|
|
$
|
(13,882,215
|
)
|
Loss per common share - basic and diluted
|
$
|
(0.20
|
)
|
|
$
|
(0.23
|
)
|
|
$
|
(0.76
|
)
|
|
$
|
(1.32
|
)
|
Weighted average number of common shares outstanding:
|
|
|
|
|
|
|
|
||||||||
Basic and diluted
|
16,683,411
|
|
|
11,422,161
|
|
|
14,756,213
|
|
|
10,499,982
|
|
Three Months Ended September 30, 2019
|
||||||||||||||||||||||
|
|
|
|
|
Additional
|
|
Accumulated
other |
|
|
|
Total
|
|||||||||||
|
Common stock
|
|
paid-in
|
|
comprehensive
|
|
Accumulated
|
|
stockholders'
|
|||||||||||||
|
Shares
|
|
Amount
|
|
capital
|
|
loss
|
|
deficit
|
|
equity
|
|||||||||||
Balance at June 30, 2019
|
16,683,411
|
|
|
$
|
1,668
|
|
|
$
|
41,942,062
|
|
|
$
|
(97,024
|
)
|
|
$
|
(36,763,651
|
)
|
|
$
|
5,083,055
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
135,393
|
|
|
—
|
|
|
—
|
|
|
135,393
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,393,078
|
)
|
|
(3,393,078
|
)
|
|||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,378
|
)
|
|
—
|
|
|
(15,378
|
)
|
|||||
Balance at September 30, 2019
|
16,683,411
|
|
|
$
|
1,668
|
|
|
$
|
42,077,455
|
|
|
$
|
(112,402
|
)
|
|
$
|
(40,156,729
|
)
|
|
$
|
1,809,992
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Nine Months Ended September 30, 2019
|
||||||||||||||||||||||
|
|
|
|
|
Additional
|
|
Accumulated
other |
|
|
|
Total
|
|||||||||||
|
Common stock
|
|
paid-in
|
|
comprehensive
|
|
Accumulated
|
|
stockholders'
|
|||||||||||||
|
Shares
|
|
Amount
|
|
capital
|
|
loss
|
|
deficit
|
|
equity
|
|||||||||||
Balance at December 31, 2018
|
11,422,161
|
|
|
$
|
1,143
|
|
|
$
|
35,791,972
|
|
|
$
|
(96,728
|
)
|
|
$
|
(28,969,767
|
)
|
|
$
|
6,726,620
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
344,712
|
|
|
—
|
|
|
—
|
|
|
344,712
|
|
|||||
Issuance of common stock via public offering, net
|
5,261,250
|
|
|
525
|
|
|
5,151,177
|
|
|
—
|
|
|
—
|
|
|
5,151,702
|
|
|||||
Deemed dividend from trigger of down round provision
|
—
|
|
|
—
|
|
|
789,594
|
|
|
—
|
|
|
(789,594
|
)
|
|
—
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(10,397,367
|
)
|
|
(10,397,367
|
)
|
|||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
(15,674
|
)
|
|
—
|
|
|
(15,674
|
)
|
|||||
Balance at September 30, 2019
|
16,683,411
|
|
|
$
|
1,668
|
|
|
$
|
42,077,455
|
|
|
$
|
(112,402
|
)
|
|
$
|
(40,156,729
|
)
|
|
$
|
1,809,992
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, 2018
|
||||||||||||||||||||||
|
|
|
|
|
Additional
|
|
Accumulated
other |
|
|
|
Total
|
|||||||||||
|
Common stock
|
|
paid-in
|
|
comprehensive
|
|
Accumulated
|
|
stockholders'
|
|||||||||||||
|
Shares
|
|
Amount
|
|
capital
|
|
loss
|
|
deficit
|
|
equity
|
|||||||||||
Balance at June 30, 2018
|
11,422,161
|
|
|
$
|
1,142
|
|
|
$
|
35,754,872
|
|
|
$
|
(59,311
|
)
|
|
$
|
(23,478,740
|
)
|
|
$
|
12,217,963
|
|
Public offering costs
|
—
|
|
|
—
|
|
|
(77,737
|
)
|
|
—
|
|
|
—
|
|
|
(77,737
|
)
|
|||||
Public offering costs
|
—
|
|
|
—
|
|
|
(3,464
|
)
|
|
—
|
|
|
—
|
|
|
(3,464
|
)
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
39,991
|
|
|
—
|
|
|
—
|
|
|
39,991
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(2,574,475
|
)
|
|
(2,574,475
|
)
|
|||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
(18,721
|
)
|
|
—
|
|
|
(18,721
|
)
|
|||||
Balance at September 30, 2018
|
11,422,161
|
|
|
$
|
1,142
|
|
|
$
|
35,713,662
|
|
|
$
|
(78,032
|
)
|
|
$
|
(26,053,215
|
)
|
|
$
|
9,583,557
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Nine Months Ended September 30, 2018
|
||||||||||||||||||||||
|
|
|
|
|
Additional
|
|
Accumulated
other |
|
|
|
Total
|
|||||||||||
|
Common stock
|
|
paid-in
|
|
comprehensive
|
|
Accumulated
|
|
stockholders'
|
|||||||||||||
|
Shares
|
|
Amount
|
|
capital
|
|
loss
|
|
deficit
|
|
equity
|
|||||||||||
Balance at December 31, 2017
|
6,047,161
|
|
|
$
|
605
|
|
|
$
|
25,541,210
|
|
|
$
|
(18,080
|
)
|
|
$
|
(12,230,952
|
)
|
|
$
|
13,292,783
|
|
Issuance of common stock
|
375,000
|
|
|
37
|
|
|
736,698
|
|
|
—
|
|
|
—
|
|
|
736,735
|
|
|||||
Net proceeds from issuance of common stock and warrants
|
5,000,000
|
|
|
500
|
|
|
9,377,216
|
|
|
—
|
|
|
—
|
|
|
9,377,716
|
|
|||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
58,538
|
|
|
—
|
|
|
—
|
|
|
58,538
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(13,822,263
|
)
|
|
(13,822,263
|
)
|
|||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
(59,952
|
)
|
|
—
|
|
|
(59,952
|
)
|
|||||
Balance at September 30, 2018
|
11,422,161
|
|
|
$
|
1,142
|
|
|
$
|
35,713,662
|
|
|
$
|
(78,032
|
)
|
|
$
|
(26,053,215
|
)
|
|
$
|
9,583,557
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nine months ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Operating activities:
|
|
|
|
||||
Net loss
|
$
|
(10,397,367
|
)
|
|
$
|
(13,822,263
|
)
|
Non-cash adjustments reconciling net loss to operating cash flows:
|
|
|
|
||||
Depreciation
|
3,491
|
|
|
1,263
|
|
||
Stock-based compensation
|
344,712
|
|
|
58,538
|
|
||
Non-cash lease expenses
|
10,549
|
|
|
—
|
|
||
Acquired in-process research and development
|
—
|
|
|
507,000
|
|
||
Impairment of goodwill
|
—
|
|
|
5,187,519
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Other receivables
|
(6,802
|
)
|
|
203,928
|
|
||
Prepaid expenses
|
(367,409
|
)
|
|
(238,378
|
)
|
||
Other current assets
|
—
|
|
|
193,495
|
|
||
Other non-current assets
|
138,719
|
|
|
105,692
|
|
||
Accounts payable
|
(107,463
|
)
|
|
(39,803
|
)
|
||
Accrued expenses
|
905,236
|
|
|
276,062
|
|
||
Other liabilities
|
(30,463
|
)
|
|
8,900
|
|
||
Net cash used in operating activities
|
(9,506,797
|
)
|
|
(7,558,047
|
)
|
||
Investing activities:
|
|
|
|
||||
Purchases of property and equipment
|
—
|
|
|
(11,836
|
)
|
||
Acquisition of Pear Tree and Hydra asset
|
—
|
|
|
(507,000
|
)
|
||
Net cash used in investing activities
|
—
|
|
|
(518,836
|
)
|
||
Financing activities:
|
|
|
|
||||
Net proceeds from issuance of common stock and warrants
|
5,151,702
|
|
|
10,114,452
|
|
||
Net cash provided by financing activities
|
5,151,702
|
|
|
10,114,452
|
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(15,674
|
)
|
|
(59,952
|
)
|
||
Net change in cash and cash equivalents
|
(4,370,769
|
)
|
|
1,977,617
|
|
||
Cash and cash equivalents, beginning of period
|
6,805,889
|
|
|
7,559,846
|
|
||
Cash and cash equivalents, end of period
|
$
|
2,435,120
|
|
|
$
|
9,537,463
|
|
Supplemental disclosure of non-cash operating and financing activities:
|
|
|
|
||||
Operating right-of-use assets obtained in exchange for new operating lease liabilities
|
$
|
231,698
|
|
|
—
|
|
|
Deemed dividend from trigger of down round provision
|
$
|
789,594
|
|
|
—
|
|
|
|
|
|
|
1.
|
ORGANIZATION AND DESCRIPTION OF THE BUSINESS
|
•
|
DARE-BV1, a novel thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% to be administered in a single vaginally delivered application as a first line treatment for bacterial vaginosis, or BV;
|
•
|
Ovaprene®, a hormone-free, monthly vaginal contraceptive;
|
•
|
Sildenafil Cream, 3.6%, a proprietary cream formulation of sildenafil for topical administration to the vulva and vagina for treatment of female sexual arousal disorder, or FSAD;
|
•
|
DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for the treatment of vasomotor symptoms (VMS) as part of a hormone replacement therapy following menopause;
|
•
|
DARE-VVA1, a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy, or VVA, in patients with hormone-receptor positive breast cancer; and
|
•
|
DARE-FRT1, an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth and for fertility support as part of an in vitro fertilization treatment plan.
|
•
|
ORB-204 and ORB-214, 6-month and 12-month formulations of injectable etonogestrel for contraception; and
|
•
|
DARE-RH1, a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel.
|
2.
|
GOING CONCERN
|
3.
|
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
|
•
|
Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities.
|
•
|
Level 2: inputs other than level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities.
|
•
|
Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.
|
4.
|
ACQUISITIONS
|
5.
|
STOCK-BASED COMPENSATION
|
|
Number of Shares
|
|
Weighted Average
Exercise Price
|
|||
Outstanding at December 31, 2018 (1)
|
1,635,790
|
|
|
$
|
11.08
|
|
Granted
|
698,000
|
|
|
0.79
|
|
|
Exercised
|
—
|
|
|
—
|
|
|
Canceled/forfeited
|
(508,745
|
)
|
|
32.24
|
|
|
Expired
|
(70
|
)
|
|
59.48
|
|
|
Outstanding at September 30, 2019 (unaudited) (1)
|
1,824,975
|
|
|
$
|
1.25
|
|
Exercisable at September 30, 2019 (unaudited)
|
412,471
|
|
|
$
|
2.23
|
|
|
Three Months Ended
September 30, |
Nine Months Ended
September 30, |
||||||||||||
|
2019
|
|
2018
|
2019
|
|
2018
|
||||||||
Research and development
|
$
|
27,081
|
|
|
$
|
5,494
|
|
$
|
78,780
|
|
|
$
|
5,994
|
|
General and administrative
|
108,312
|
|
|
34,497
|
|
265,932
|
|
|
52,544
|
|
||||
Total
|
$
|
135,393
|
|
|
$
|
39,991
|
|
$
|
344,712
|
|
|
$
|
58,538
|
|
|
|
Three Months Ended
September 30, 2019 |
|
Nine Months Ended
September 30, 2019 |
Expected life in years
|
|
10.0
|
|
10.0
|
Risk-free interest rate
|
|
2.58%
|
|
2.58%
|
Expected volatility
|
|
121%
|
|
121%
|
Forfeiture rate
|
|
0.0%
|
|
0.0%
|
Dividend yield
|
|
0.0%
|
|
0.0%
|
Weighted-average fair value of options granted
|
|
$0.75
|
|
$0.75
|
6.
|
STOCKHOLDERS’ EQUITY
|
Shares Underlying
Outstanding Warrants
|
|
Exercise Price
|
|
Expiration Date
|
|
2,906
|
|
$
|
120.40
|
|
December 1, 2021
|
3,737
|
|
$
|
120.40
|
|
December 6, 2021
|
17,190
|
|
$
|
60.50
|
|
January 8, 2020
|
6,500
|
|
$
|
10.00
|
|
April 4, 2026
|
3,720,500
|
|
$
|
0.98
|
|
February 15, 2023
|
3,750,833
|
|
|
|
|
|
7.
|
LEASED PROPERTIES
|
Years ending December 31:
|
|
||
Remainder of 2019
|
$
|
27,665
|
|
2020
|
112,943
|
|
|
2021
|
67,595
|
|
|
Total future minimum lease payments
|
208,203
|
|
|
Less: Difference between future minimum lease payments and discounted operating lease liabilities
|
25,007
|
|
|
Total operating lease liabilities
|
$
|
183,196
|
|
8.
|
COMMITMENTS AND CONTINGENCIES
|
9.
|
GRANT AWARD
|
10.
|
NET LOSS PER SHARE
|
Potentially dilutive securities
|
|
Three Months Ended
September 30, |
|
Nine Months Ended
September 30, |
||||||||
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
||||
Stock options
|
|
1,824,975
|
|
|
1,605,790
|
|
|
1,824,975
|
|
|
1,605,790
|
|
Warrants
|
|
3,750,833
|
|
|
3,750,833
|
|
|
3,750,833
|
|
|
3,750,833
|
|
Total
|
|
5,575,808
|
|
|
5,356,623
|
|
|
5,575,808
|
|
|
5,356,623
|
|
11.
|
SUBSEQUENT EVENTS
|
•
|
DARE-BV1, a novel thermosetting bioadhesive hydrogel formulated with clindamycin phosphate 2% to be administered in a single vaginally delivered application, as a first line treatment for bacterial vaginosis, or BV;
|
•
|
Ovaprene®, a hormone-free, monthly vaginal contraceptive;
|
•
|
Sildenafil Cream, 3.6%, a proprietary cream formulation of sildenafil for topical administration to the vulva and vagina for treatment of female sexual arousal disorder, or FSAD;
|
•
|
DARE-HRT1, a combination bio-identical estradiol and progesterone intravaginal ring for the treatment of vasomotor symptoms (VMS) as part of a hormone replacement therapy, or HRT, following menopause;
|
•
|
DARE-VVA1, a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy, or VVA, in patients with hormone-receptor positive breast cancer; and
|
•
|
DARE-FRT1, an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth and for fertility support as part of an in vitro fertilization treatment plan.
|
•
|
ORB-204 and ORB-214, 6-month and 12-month formulations of injectable etonogestrel for contraception; and
|
•
|
DARE-RH1, a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel.
|
•
|
expenses incurred under agreements with consultants and clinical trial sites that conduct research and development activities on our behalf;
|
•
|
laboratory and vendor expenses related to the execution of nonclinical studies and clinical trials;
|
•
|
contract manufacturing expenses, primarily for the production of clinical supplies;
|
•
|
transaction costs related to the acquisition of technologies and related intellectual property; and
|
•
|
internal costs that are associated with activities performed by our research and development organization and generally benefit multiple programs.
|
|
Three Months Ended September 30,
|
|
Dollar
|
||||||||
|
2019
|
|
2018
|
|
Change
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
General and administrative expense
|
$
|
1,318,986
|
|
|
$
|
1,175,049
|
|
|
$
|
143,937
|
|
Research and development expenses
|
1,966,230
|
|
|
1,446,548
|
|
|
519,682
|
|
|||
License expenses
|
133,333
|
|
|
—
|
|
|
133,333
|
|
|||
Total operating expenses
|
3,418,549
|
|
|
2,621,597
|
|
|
796,952
|
|
|||
Loss from operations
|
(3,418,549
|
)
|
|
(2,621,597
|
)
|
|
(796,952
|
)
|
|||
Other income
|
25,471
|
|
|
47,122
|
|
|
(21,651
|
)
|
|||
Net loss
|
(3,393,078
|
)
|
|
(2,574,475
|
)
|
|
(818,603
|
)
|
|||
Deemed dividend from trigger of down round provision feature
|
—
|
|
|
—
|
|
|
—
|
|
|||
Net loss to common shareholders
|
(3,393,078
|
)
|
|
(2,574,475
|
)
|
|
(818,603
|
)
|
|||
Other comprehensive loss:
|
|
|
|
|
|
|
|||||
Foreign currency translation adjustments
|
(15,378
|
)
|
|
(18,721
|
)
|
|
3,343
|
|
|||
Comprehensive loss
|
$
|
(3,408,456
|
)
|
|
$
|
(2,593,196
|
)
|
|
$
|
(815,260
|
)
|
|
Nine Months Ended September 30,
|
|
Dollar
|
||||||||
|
2019
|
|
2018
|
|
Change
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
General and administrative expense
|
$
|
3,903,545
|
|
|
$
|
3,635,413
|
|
|
$
|
268,132
|
|
Research and development expenses
|
6,172,192
|
|
|
4,750,823
|
|
|
$
|
1,421,369
|
|
||
License expenses
|
408,333
|
|
|
350,000
|
|
|
$
|
58,333
|
|
||
Impairment of goodwill
|
—
|
|
|
5,187,519
|
|
|
$
|
(5,187,519
|
)
|
||
Total operating expenses
|
10,484,070
|
|
|
13,923,755
|
|
|
$
|
(3,439,685
|
)
|
||
Loss from operations
|
(10,484,070)
|
|
|
(13,923,755)
|
|
|
(3,439,685
|
)
|
|||
Other income
|
86,703
|
|
|
101,492
|
|
|
$
|
(14,789
|
)
|
||
Net loss
|
(10,397,367)
|
|
|
(13,822,263)
|
|
|
$
|
3,424,896
|
|
||
Deemed dividend from trigger of down round provision feature
|
(789,594
|
)
|
|
—
|
|
|
789,594
|
|
|||
Net loss to common shareholders
|
(11,186,961
|
)
|
|
(13,822,263
|
)
|
|
(2,635,302
|
)
|
|||
Other comprehensive loss:
|
|
|
|
|
|
||||||
Foreign currency translation adjustments
|
(15,674)
|
|
|
(59,952)
|
|
|
$
|
44,278
|
|
||
Comprehensive loss
|
$
|
(11,202,635
|
)
|
|
$
|
(13,882,215
|
)
|
|
$
|
2,679,580
|
|
|
Nine Months Ended September 30,
|
||||||
|
2019
|
|
2018
|
||||
Net cash used in operating activities
|
(9,506,797
|
)
|
|
(7,558,047
|
)
|
||
Net cash used in investing activities
|
—
|
|
|
(518,836
|
)
|
||
Net cash provided by financing activities
|
5,151,702
|
|
|
10,114,452
|
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(15,674
|
)
|
|
(59,952
|
)
|
||
Net increase (decrease) in cash
|
$
|
(4,370,769
|
)
|
|
$
|
1,977,617
|
|
|
|
|
|
Incorporated by Reference
|
|
|
|
|
||||
Exhibit
Number
|
|
Description of Exhibit
|
|
Form
|
|
File No.
|
|
Filing Date
|
|
Exhibit No.
|
|
Filed Herewith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
10.1*
|
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.1
|
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
31.2
|
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.1
|
|
|
|
|
|
|
|
|
|
|
#
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
32.2
|
|
|
|
|
|
|
|
|
|
|
#
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.INS
|
|
XBRL Instance Document
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.SCH
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.CAL
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.DEF
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.LAB
|
|
XBRL Taxonomy Extension Label Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
|
|
|
|
|
|
|
|
|
|
|
|
101.PRE
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
|
|
|
|
|
|
|
|
X
|
|
|
Daré Bioscience, Inc.
|
|
|
|
Date: November 12, 2019
|
By:
|
/s/ Sabrina Martucci Johnson
|
|
|
Sabrina Martucci Johnson
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
Date: November 12, 2019
|
By:
|
/s/ Lisa Walters-Hoffert
|
|
|
Lisa Walters-Hoffert
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
1.
|
Purpose
|
2.
|
Participants
|
3.
|
Administration
|
4.
|
Bonus Determinations
|
(a)
|
Performance Goals. A Participant may receive a cash bonus payment under this Plan based upon the achievement of one or more performance objectives that are established by the Compensation Committee and relate to financial and operational metrics with respect to the Company or any of its subsidiaries (the “Performance Goals”), including the following: developmental, clinical or regulatory milestones; clinical trial results; business development and financing milestones; acquisitions or strategic transactions; revenue; expense levels; total shareholder return; earnings before interest, taxes, depreciation and amortization; net income (loss) (either before or after interest, taxes, depreciation and/or amortization); changes in the market price of the Company’s common stock; economic value-added; sales or revenue milestones; operating income (loss); cash flow (including, but not limited to, operating cash flow and free cash flow); return on capital, assets, equity, or investment; gross or net profit levels; productivity; expense efficiency; margins; operating efficiency; customer satisfaction; publications; reimbursement decisions; working capital; earnings (loss) per share of the Company’s common stock; sales or market share; number of customers or units of products sold; and operating income and/or net annual recurring revenue, any of which may be (A) measured in absolute terms or compared to any incremental increase, (B) measured in terms of growth, (C) compared to another company or companies or to results of a peer group, (D) measured against the market as a whole and/or as compared to applicable market indices and/or (E) measured on a pre-tax or post-tax basis (if applicable). Further, any Performance Goals may be used to measure the performance of the Company as a whole or a business unit or other segment of the Company, or one or more product lines or specific markets. The Performance Goals may differ from Participant to Participant.
|
(b)
|
Calculation of Performance Goals. At the beginning of each applicable performance period, the Compensation Committee will determine whether any significant element(s) will be included in or excluded from the calculation of any Performance Goal with respect to any Participant. In all other respects, Performance Goals will be calculated in accordance with the Company’s financial statements, generally accepted accounting principles, or under a methodology established by the Compensation Committee and which is consistently applied with respect to a Performance Goal in the relevant performance period. The Compensation Committee shall determine when a performance period begins and ends.
|
(c)
|
Target; Minimum; Maximum. Each Performance Goal will have a “target” (100 percent attainment of the Performance Goal) and may also have a “minimum” hurdle and/or a “maximum” amount.
|
(d)
|
Bonus Requirements; Individual Goals. Except as otherwise set forth in this Section 4(d): (i) any bonuses paid to Participants under this Plan shall be based upon objectively determinable bonus formulas that tie such bonuses to one or more performance targets relating to the Performance Goals (certain Performance Goals may be given more weight than others), (ii) bonus formulas for Participants shall be adopted in each performance period by the Compensation Committee and communicated to each Participant and (iii) no bonuses shall be paid to Participants unless and until the Compensation Committee makes a determination with respect to the attainment of the performance objectives relating to the Performance Goals. Notwithstanding the foregoing, the Compensation Committee may adjust bonuses payable under this Plan based on achievement of one or more individual performance objectives or pay bonuses (including, without limitation, discretionary bonuses) to Participants under this Plan based on individual performance goals and/or upon such other terms and conditions as the Compensation Committee may in its discretion determine.
|
(e)
|
Individual Target Bonuses. The Compensation Committee shall establish a target bonus opportunity for each Participant for each performance period (the “Target Bonus”). For each Participant, the Compensation Committee shall have the authority to apportion the Target Bonus so that a portion of it is tied to attainment of Performance Goals and a portion of it is tied to attainment of individual performance objectives.
|
(f)
|
Employment Requirement. Subject to any additional terms contained in a written agreement between the Participant and the Company or any of its subsidiaries, the payment of a bonus to a Participant under this Plan with respect to a performance period is conditioned on the Participant’s employment by the Company or its subsidiary on the bonus payment date. If a Participant was not employed by the Company or its subsidiary for an entire performance period, the Compensation Committee may pro rate the bonus based on the number of days employed during such period.
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5.
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Timing of Payment
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(a)
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With respect to Performance Goals established and measured on a basis more frequently than annually (e.g., quarterly or semi-annually), the Performance Goals will be measured as of the end of each performance period and after such period has ended; provided, that with respect to any Performance Goals that are dependent on financial metrics as reported in the Company’s periodic reports filed with the U.S. Securities and Exchange Commission for any particular period, such Performance Goals will be measured after the applicable periodic reports have been so filed. If the Performance Goals and/or individual goals for a performance period are met, payments will be made as soon as practicable following the end of such performance period, but not later than 74 days after the end of the fiscal year in which such performance period ends.
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(b)
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With respect to Performance Goals established and measured on an annual or multi-year basis, Performance Goals will be measured as of the end of each such performance period (e.g., the end of each fiscal year) and after such period has ended; provided, that with respect to any Performance Goals that are dependent on financial metrics as reported in the Company’s periodic reports filed with the U.S. Securities and Exchange Commission for any particular period, such Performance Goals will be measured after the applicable periodic reports have been so filed. If the Performance Goals and/ or individual goals for any performance period are met, bonus payments will be made as soon as practicable, but not later than 74 days after the end of the relevant fiscal year.
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(c)
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For the avoidance of doubt, bonuses earned at any time in a fiscal year must be paid no later than 74 days after the last day of such fiscal year.
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6.
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Amendment and Termination
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1.
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I have reviewed this Quarterly Report on Form 10-Q of Daré Bioscience, Inc.;
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2.
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Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3.
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Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4.
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The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
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a.
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Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
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b.
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Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
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c.
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Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
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d.
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Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
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5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
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b.
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Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
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/s/ Sabrina Martucci Johnson
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Sabrina Martucci Johnson
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President and Chief Executive Officer
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(principal executive officer)
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|
1.
|
I have reviewed this Quarterly Report on Form 10-Q of Daré Bioscience, Inc.;
|
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
|
4.
|
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
|
5.
|
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
/s/ Lisa Walters-Hoffert
|
Lisa Walters-Hoffert
|
Chief Financial Officer
|
(principal financial officer)
|
|
/s/ Sabrina Martucci Johnson
|
Sabrina Martucci Johnson
|
President and Chief Executive Officer
|
(principal executive officer)
|
|
/s/ Lisa Walters-Hoffert
|
Lisa Walters-Hoffert
|
Chief Financial Officer
|
(principal financial officer)
|