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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
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Large Accelerated Filer
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o
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Accelerated filer
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o
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Non-accelerated filer
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x
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Smaller reporting company
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x
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Emerging growth company
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o
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•
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Inability to continue as a going concern;
|
•
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Inability to raise additional capital, under favorable terms or at all, including as a result of the effects of the COVID-19 pandemic;
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•
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Inability to successfully attract partners and enter into collaborations on acceptable terms;
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•
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A decision by Bayer HealthCare LLC to discontinue its commercial interest in Ovaprene® and/or to terminate our license agreement;
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•
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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, including as a result of matters beyond our control such as the effects related to geopolitical actions, natural disasters, or public health emergencies or pandemics, such as the COVID-19 pandemic;
|
•
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A change in the FDA Center assigned primary oversight responsibility for our combination product candidates;
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•
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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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•
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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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•
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Inability to demonstrate sufficient efficacy of our product candidates;
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•
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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;
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•
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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;
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•
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Developments by our competitors that make our product candidates less competitive or obsolete;
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•
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Dependence on third parties to conduct nonclinical studies and clinical trials of our product candidates;
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•
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Dependence on third parties to supply and manufacture clinical trial materials and, if any of our candidates are approved, commercial product, including components of our products as well as the finished product, in accordance with current good manufacturing practices and in the quantities needed;
|
•
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Interruptions in, or the complete shutdown of, the operations of third parties on which we rely, including clinical sites, manufacturers, suppliers, and other vendors, from matters beyond their control, such as the effects related to geopolitical actions, natural disasters, or public health emergencies or pandemics, such as the COVID-19 pandemic, and our lack of recourse against such third parties if their inability to perform is excused under the terms of our agreements with such parties;
|
•
|
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;
|
•
|
Uncertainty as to whether health insurance plans will cover our product candidates even if we successfully develop and obtain regulatory approval for them;
|
•
|
Unfavorable or inadequate reimbursement rates for our product candidates set by the United States government and other third-party payers even if they become covered products under health insurance plans;
|
•
|
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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Item 2.
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Item 3.
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Item 4.
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Item 1.
|
||
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Item 1A.
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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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Item 5.
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||
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Item 6.
|
||
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|
|
|
PART I.
|
FINANCIAL INFORMATION
|
|
March 31,
2020 |
|
December 31,
2019 |
|||||
|
(unaudited)
|
|
|
|||||
Assets
|
|
|
|
|||||
Current assets
|
|
|
|
|||||
Cash and cash equivalents
|
$
|
5,047,325
|
|
|
$
|
4,780,107
|
|
|
Other receivables
|
429,722
|
|
|
555,210
|
|
|||
Prepaid expenses
|
3,844,764
|
|
|
1,108,615
|
|
|||
Total current assets
|
9,321,811
|
|
|
6,443,932
|
|
|||
Property and equipment, net
|
51,582
|
|
|
63,531
|
|
|||
Other non-current assets
|
840,572
|
|
|
935,325
|
|
|||
Total assets
|
$
|
10,213,965
|
|
|
$
|
7,442,788
|
|
|
Liabilities and stockholders’ equity
|
|
|
|
|||||
Current liabilities
|
|
|
|
|||||
Accounts payable
|
$
|
1,531,497
|
|
|
$
|
1,083,183
|
|
|
Accrued expenses
|
1,690,626
|
|
|
2,098,653
|
|
|||
Deferred grant funding
|
1,089,064
|
|
|
2,019,674
|
|
|||
Current portion of lease liabilities
|
404,395
|
|
|
410,896
|
|
|||
Total current liabilities
|
4,715,582
|
|
|
5,612,406
|
|
|||
Deferred license revenue
|
1,000,000
|
|
|
—
|
|
|||
Contingent consideration
|
1,000,000
|
|
|
1,000,000
|
|
|||
Lease liabilities long-term
|
284,200
|
|
|
389,556
|
|
|||
Total liabilities
|
6,999,782
|
|
|
7,001,962
|
|
|||
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; 24,700,553 and 19,683,401 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively
|
2,470
|
|
|
1,968
|
|
|||
Accumulated other comprehensive loss
|
(125,569
|
)
|
|
(102,625
|
)
|
|||
Additional paid-in capital
|
51,612,721
|
|
|
44,564,674
|
|
|||
Accumulated deficit
|
(48,275,439
|
)
|
|
(44,023,191
|
)
|
|||
Total stockholders' equity
|
3,214,183
|
|
|
440,826
|
|
|||
Total liabilities and stockholders' equity
|
$
|
10,213,965
|
|
|
$
|
7,442,788
|
|
|
Three months ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Operating expenses
|
|
|
|
||||
General and administrative
|
$
|
1,861,765
|
|
|
$
|
1,277,180
|
|
Research and development
|
2,379,804
|
|
|
1,693,391
|
|
||
License fees
|
12,500
|
|
|
112,500
|
|
||
Total operating expenses
|
4,254,069
|
|
|
3,083,071
|
|
||
Loss from operations
|
(4,254,069
|
)
|
|
(3,083,071
|
)
|
||
Other income
|
1,821
|
|
|
31,231
|
|
||
Net loss
|
$
|
(4,252,248
|
)
|
|
$
|
(3,051,840
|
)
|
Foreign currency translation adjustments
|
$
|
(22,944
|
)
|
|
$
|
7,621
|
|
Comprehensive loss
|
$
|
(4,275,192
|
)
|
|
$
|
(3,044,219
|
)
|
Loss per common share - basic and diluted
|
$
|
(0.18
|
)
|
|
$
|
(0.27
|
)
|
Weighted average number of common shares outstanding:
|
|
|
|
||||
Basic and diluted
|
23,799,396
|
|
|
11,422,161
|
|
Three Months Ended March 31, 2020
|
||||||||||||||||||||||
|
|
|
|
|
Additional
|
|
Accumulated
other |
|
|
|
Total
|
|||||||||||
|
Common stock
|
|
paid-in
|
|
comprehensive
|
|
Accumulated
|
|
stockholders'
|
|||||||||||||
|
Shares
|
|
Amount
|
|
capital
|
|
loss
|
|
deficit
|
|
equity
|
|||||||||||
Balance at December 31, 2019
|
19,683,401
|
|
|
$
|
1,968
|
|
|
$
|
44,564,674
|
|
|
$
|
(102,625
|
)
|
|
$
|
(44,023,191
|
)
|
|
$
|
440,826
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
160,841
|
|
|
—
|
|
|
—
|
|
|
160,841
|
|
|||||
Issuance of common stock
|
3,308,003
|
|
|
331
|
|
|
5,222,356
|
|
|
—
|
|
|
—
|
|
|
5,222,687
|
|
|||||
Issuance of common stock from the exercise of warrants
|
1,699,000
|
|
|
170
|
|
|
1,664,850
|
|
|
—
|
|
|
—
|
|
|
1,665,020
|
|
|||||
Stock options exercised
|
10,149
|
|
|
1
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,252,248
|
)
|
|
(4,252,248
|
)
|
|||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
(22,944
|
)
|
|
—
|
|
|
(22,944
|
)
|
|||||
Balance at March 31, 2020
|
24,700,553
|
|
|
$
|
2,470
|
|
|
$
|
51,612,721
|
|
|
$
|
(125,569
|
)
|
|
$
|
(48,275,439
|
)
|
|
$
|
3,214,183
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||
Three Months Ended March 31, 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
|
—
|
|
|
—
|
|
|
97,968
|
|
|
—
|
|
|
—
|
|
|
97,968
|
|
|||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(3,051,840
|
)
|
|
(3,051,840
|
)
|
|||||
Foreign currency translation adjustments
|
—
|
|
|
—
|
|
|
—
|
|
|
7,621
|
|
|
—
|
|
|
7,621
|
|
|||||
Balance at March 31, 2019
|
11,422,161
|
|
|
$
|
1,143
|
|
|
$
|
35,889,940
|
|
|
$
|
(89,107
|
)
|
|
$
|
(32,021,607
|
)
|
|
$
|
3,780,369
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Operating activities:
|
|
|
|
||||
Net loss
|
$
|
(4,252,248
|
)
|
|
$
|
(3,051,840
|
)
|
Non-cash adjustments reconciling net loss to operating cash flows:
|
|
|
|
||||
Depreciation
|
11,949
|
|
|
1,150
|
|
||
Stock-based compensation
|
160,841
|
|
|
97,968
|
|
||
Non-cash operating lease cost
|
(55,786
|
)
|
|
419
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Other receivables
|
125,488
|
|
|
(135,676
|
)
|
||
Prepaid expenses
|
(2,736,149
|
)
|
|
(201,129
|
)
|
||
Other non-current assets
|
38,682
|
|
|
55,233
|
|
||
Accounts payable
|
448,314
|
|
|
(134,087
|
)
|
||
Accrued expenses
|
(408,027
|
)
|
|
59,478
|
|
||
Deferred grant funding
|
(930,610
|
)
|
|
—
|
|
||
Deferred license revenue
|
1,000,000
|
|
|
—
|
|
||
Net cash used in operating activities
|
(6,597,546
|
)
|
|
(3,308,484
|
)
|
||
Financing activities:
|
|
|
|
||||
Net proceeds from issuance of common stock
|
5,222,687
|
|
|
—
|
|
||
Proceeds from the exercise of common stock warrants
|
1,665,020
|
|
|
—
|
|
||
Proceeds from the exercise of stock options
|
1
|
|
|
—
|
|
||
Net cash provided by financing activities
|
6,887,708
|
|
|
—
|
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(22,944
|
)
|
|
7,621
|
|
||
Net change in cash and cash equivalents
|
267,218
|
|
|
(3,300,863
|
)
|
||
Cash and cash equivalents, beginning of period
|
4,780,107
|
|
|
6,805,889
|
|
||
Cash and cash equivalents, end of period
|
$
|
5,047,325
|
|
|
$
|
3,505,026
|
|
Supplemental disclosure of non-cash operating and financing activities:
|
|
|
|
||||
Operating right-of-use assets obtained in exchange for new operating lease liabilities
|
$
|
—
|
|
|
$
|
231,698
|
|
|
|
|
—
|
|
|||
|
|
|
|
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, 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.
|
•
|
A microchip-based, implantable drug delivery system and a contraceptive application of that technology utilizing levonorgestrel that is designed to provide user-controlled, long-acting, reversible contraception
|
•
|
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.
|
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.
|
|
Fair Value Measurements
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
Balance at March 31, 2020
|
|
|
|
|
|
|
|
||||||||
Current assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
5,047,325
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,047,325
|
|
Other non-current liabilities:
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,000,000
|
|
|
$
|
1,000,000
|
|
Balance at December 31, 2019
|
|
|
|
|
|
|
|
||||||||
Current assets:
|
|
|
|
|
|
|
|
||||||||
Cash and cash equivalents
|
$
|
4,780,107
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
4,780,107
|
|
Other non-current liabilities:
|
|
|
|
|
|
|
|
||||||||
Contingent consideration
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
1,000,000
|
|
|
$
|
1,000,000
|
|
4.
|
ACQUISITIONS
|
5.
|
STOCK-BASED COMPENSATION
|
|
Number of Shares
|
|
Weighted Average
Exercise Price
|
|||
Outstanding at December 31, 2019
|
1,889,775
|
|
|
$
|
1.21
|
|
Granted
|
707,000
|
|
|
1.06
|
|
|
Exercised
|
(10,149
|
)
|
|
0.01
|
|
|
Canceled/forfeited
|
—
|
|
|
—
|
|
|
Expired
|
—
|
|
|
—
|
|
|
Outstanding at March 31, 2020
|
2,586,626
|
|
|
$
|
1.17
|
|
Exercisable at March 31, 2020
|
568,118
|
|
|
$
|
1.86
|
|
|
Three Months Ended
March 31, |
||||||
|
2020
|
|
2019
|
||||
Research and development
|
$
|
46,380
|
|
|
$
|
24,703
|
|
General and administrative
|
114,461
|
|
|
73,265
|
|
||
Total
|
$
|
160,841
|
|
|
$
|
97,968
|
|
|
|
Three Months Ended
March 31, 2020 |
Expected life in years
|
|
10.0
|
Risk-free interest rate
|
|
0.86%
|
Expected volatility
|
|
121%
|
Forfeiture rate
|
|
0.0%
|
Dividend yield
|
|
0.0%
|
Weighted-average fair value of options granted
|
|
$1.00
|
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
|
6,500
|
|
$
|
10.00
|
|
April 4, 2026
|
2,021,500
|
|
$
|
0.98
|
|
February 15, 2023
|
2,034,643
|
|
|
|
|
|
7.
|
LEASED PROPERTIES
|
|
|
||
Remainder of 2020
|
$
|
334,000
|
|
2021
|
363,000
|
|
|
2022
|
42,000
|
|
|
Total future minimum lease payments
|
739,000
|
|
|
Less: Difference between future minimum lease payments and discounted operating lease liabilities
|
50,000
|
|
|
Total operating lease liabilities
|
$
|
689,000
|
|
8.
|
COMMITMENTS AND CONTINGENCIES
|
9.
|
GRANT AWARD
|
10.
|
NET LOSS PER SHARE
|
Potentially dilutive securities
|
|
Three Months Ended
March 31, |
||||
|
|
2020
|
|
2019
|
||
Stock options
|
|
2,586,626
|
|
|
2,190,360
|
|
Warrants
|
|
2,034,643
|
|
|
3,750,833
|
|
Total
|
|
4,621,269
|
|
|
5,941,193
|
|
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; and
|
•
|
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, or 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.
|
•
|
A microchip-based, implantable drug delivery system and a contraceptive application of that technology utilizing levonorgestrel that is designed to provide user-controlled, long-acting, reversible contraception
|
•
|
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 acquisitions of companies, technologies and related intellectual property, and other assets; and
|
•
|
internal costs that are associated with activities performed by our research and development organization and generally benefit multiple programs.
|
|
Three Months Ended March 31,
|
|
Dollar
|
||||||||
|
2020
|
|
2019
|
|
Change
|
||||||
Operating expenses:
|
|
|
|
|
|
||||||
General and administrative
|
$
|
1,861,765
|
|
|
$
|
1,277,180
|
|
|
$
|
584,585
|
|
Research and development
|
2,379,804
|
|
|
1,693,391
|
|
|
686,413
|
|
|||
License fees
|
12,500
|
|
|
112,500
|
|
|
(100,000
|
)
|
|||
Total operating expenses
|
4,254,069
|
|
|
3,083,071
|
|
|
1,170,998
|
|
|||
Loss from operations
|
(4,254,069
|
)
|
|
(3,083,071
|
)
|
|
(1,170,998
|
)
|
|||
Other income
|
1,821
|
|
|
31,231
|
|
|
(29,410
|
)
|
|||
Net loss
|
$
|
(4,252,248
|
)
|
|
$
|
(3,051,840
|
)
|
|
$
|
(1,200,408
|
)
|
Other comprehensive loss:
|
|
|
|
|
|
|
|||||
Foreign currency translation adjustments
|
(22,944
|
)
|
|
7,621
|
|
|
(30,565
|
)
|
|||
Comprehensive loss
|
$
|
(4,275,192
|
)
|
|
$
|
(3,044,219
|
)
|
|
$
|
(1,230,973
|
)
|
|
Three Months Ended March 31,
|
||||||
|
2020
|
|
2019
|
||||
Net cash used in operating activities
|
(6,597,546
|
)
|
|
(3,308,484
|
)
|
||
Net cash provided by financing activities
|
6,887,708
|
|
|
—
|
|
||
Effect of exchange rate changes on cash and cash equivalents
|
(22,944
|
)
|
|
7,621
|
|
||
Net increase (decrease) in cash and cash equivalents
|
$
|
267,218
|
|
|
$
|
(3,300,863
|
)
|
+
|
|
Portions of this exhibit have been redacted in compliance with Regulation S-K Item 601(b)(10). The omitted information is not material and would likely cause competitive harm to the Company if publicly disclosed.
|
||||||||||
#
|
|
Furnished herewith. This certification is being furnished solely to accompany this report pursuant to U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated herein by reference into any filing of the registrant whether made before or after the date hereof, regardless of any general incorporation language in such filing.
|
|
|
Daré Bioscience, Inc.
|
|
|
|
Date: May 14, 2020
|
By:
|
/s/ Sabrina Martucci Johnson
|
|
|
Sabrina Martucci Johnson
|
|
|
President and Chief Executive Officer
|
|
|
(Principal Executive Officer)
|
|
|
|
Date: May 14, 2020
|
By:
|
/s/ Lisa Walters-Hoffert
|
|
|
Lisa Walters-Hoffert
|
|
|
Chief Financial Officer
|
|
|
(Principal Financial and Accounting Officer)
|
1.
|
Amendments to the Original Agreement. As of the Effective Date:
|
a.
|
The second sentence of Section 4(d) of the Original Agreement is hereby amended and restated in its entirety to read as follows:
|
b.
|
The second sentence of Section 4(g) of the Original Agreement is hereby amended and restated in its entirety to read as follows:
|
2.
|
Miscellaneous. Except as specifically provided in this Amendment No. 1, no other amendments, revisions or changes are made to the Original Agreement. All other terms and conditions of the Original Agreement remain in full force and effect. This Amendment No. 1 may be attached to and shall form a part of the Original Agreement. This Amendment No. 1 may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same instrument. Delivery of an executed counterpart of a signature page to this Amendment by facsimile or in electronic format (e.g., “pdf”) or by other electronic means shall be effective as delivery of a manually executed counterpart of this Amendment No. 1. This Amendment No. 1 will be binding upon and inure to the benefit of the parties hereto and their respective heirs, executors, personal representatives, successors and permitted assigns.
|
|
COMPANY
Daré Bioscience, Inc.
|
|
|
By:
|
/s/ WILLIAM H. RASTETTER
|
Name:
|
William H. Rastetter, Ph.D.
|
Title:
|
Chair of the Compensation Committee of the Board of Directors
|
|
|
|
|
|
EXECUTIVE
|
|
|
|
/s/ SABRINA MARTUCCI JOHNSON
|
|
Sabrina Martucci Johnson
|
|
|
1.
|
Amendments to the Original Agreement. As of the Effective Date:
|
a.
|
The second sentence of Section 4(d) of the Original Agreement is hereby amended and restated in its entirety to read as follows:
|
b.
|
The second sentence of Section 4(g) of the Original Agreement is hereby amended and restated in its entirety to read as follows:
|
2.
|
Miscellaneous. Except as specifically provided in this Amendment No. 1, no other amendments, revisions or changes are made to the Original Agreement. All other terms and conditions of the Original Agreement remain in full force and effect. This Amendment No. 1 may be attached to and shall form a part of the Original Agreement. This Amendment No. 1 may be executed in counterparts, each of which shall be deemed to be an original and all of which together shall be deemed to be one and the same instrument. Delivery of an executed counterpart of a signature page to this Amendment by facsimile or in electronic format (e.g., “pdf”) or by other electronic means shall be effective as delivery of a manually executed counterpart of this Amendment No. 1. This Amendment No. 1 will be binding upon and inure to the benefit of the parties hereto and their respective heirs, executors, personal representatives, successors and permitted assigns.
|
|
COMPANY
Daré Bioscience, Inc.
|
|
|
By:
|
/s/ WILLIAM H. RASTETTER
|
Name:
|
William H. Rastetter, Ph.D.
|
Title:
|
Chair of the Compensation Committee of the Board of Directors
|
|
|
|
|
|
EXECUTIVE
|
|
|
|
/s/ LISA WALTERS-HOFFERT
|
|
Lisa Walters-Hoffert
|
|
|
|
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/ Sabrina Martucci Johnson
|
Sabrina Martucci Johnson
|
President and Chief Executive Officer
|
(principal executive officer)
|
|
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)
|