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Item 9A. Controls and Procedures

2022-03-31 compared with 2021-03-30 · 323 added, 878 removed, 719 unchanged (63% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures

We maintain disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) designed to provide reasonable assurance that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

At the conclusion of the year ended December 31, 2020, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures.

Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) were effective as of December 31, 2020 at the reasonable assurance level.

Based on an evaluation, performed under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures (as defined in Rule 13a-15(e) of the Exchange Act) were effective as of December 31, 2021 at the reasonable assurance level.

Management’s Report on Internal Control Over Financial Reporting

9 unchanged sentences

OTHER INFORMATION

In January 2018 we entered into a common stock sales agreement with H.C.

Wainwright & Co., LLC, or Wainwright, relating to the offering and sale of shares of our common stock from time to time in an ATM offering through Wainwright, acting as sales agent.

In accordance with the agreement, on March 29, 2021, we provided notice

to Wainwright to terminate the agreement.

The agreement will terminate on April 3, 2021.

Under the agreement, Wainwright was entitled to a commission at a fixed commission rate equal to 3.0% of the gross proceeds per share sold under the agreement and we provided Wainwright with customary indemnification rights.

We are exploring entering into a new sales agreement for an ATM offering, but there can be no assurance that we will establish a new ATM facility.

DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS

Not applicable.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

Set forth below are the names, ages, board committee assignments, tenure, class, and certain biographical information of each of the members of our board of directors as of March 29, 2021.

In accordance with our certificate of incorporation and by-laws, our board of directors is divided into three classes, with one class of directors standing for election each year, for a three-year term.

Name Age Committees Director

Since Class**

Blanchard 56 Compensation November 2019 III

Grossman, M.D.

48 Audit, Nominating & Corporate Governance April 2018 I

66 Nominating & Corporate Governance* October 2014 I

Sabrina Martucci Johnson 54 None July 2017 III

Matz, CPA 61 Audit* September 2018 II

Rastetter, Ph.D.

72 Compensation* January 2014 II

Steele, J.D., L.L.M.

65 Audit, Compensation July 2017 II

* Committee chairperson

** The term for Class I directors ends at our 2021 annual meeting of stockholders.

The term for Class II and III directors ends at the annual meeting of our stockholders to be held in 2022 and 2023, respectively.

Blanchard joined our board of directors in November 2019 following our acquisition of Microchips Biotech, Inc., or Microchips.

Blanchard served as President and Chief Executive Officer of Microchips, which prior to the merger, was a venture-backed biotechnology company developing implantable drug delivery products, from 2014 through the company's acquisition by Daré.

Blanchard currently serves as President and Chief Executive Officer of Anika Therapeutics, Inc., a publicly traded biotech and medical devices company, a position she has held since April 2020, and before that she served as its Interim Chief Executive Officer since February 2020.

From July 2018 to July 2019, Dr.

Blanchard served as President and Chief Executive Officer of Keratin Biosciences, Inc., a privately-held biotechnology company created in July 2018 by the business combination of Microchips and KeraNetics, LLC.

From 2000 to 2012, Dr.

Blanchard was an officer of Zimmer, Inc., a medical device company focused on musculoskeletal products, serving as Senior Vice President, Chief Scientific Officer, and general manager of Zimmer Biologics.

Since 2012, Dr.

Blanchard has also been a principal of Blanchard Consulting, LLC, which provides scientific, regulatory, and business strategy consulting services to medical device companies and private equity clients.

Prior to Zimmer, Dr.

Blanchard built and led the medical device practice at Southwest Research Institute while also serving as an adjunct professor at the University of Texas Health Science Center, both in San Antonio, Texas.

Some of her work led to the creation of Keraplast Technologies, LLC.

Blanchard also serves on private equity and venture backed company boards as well as the board of Anika Therapeutics, Inc.

She previously served on the board of directors of SeaSpine Holdings Corporation, from July 2015 to May 2019, and of Neuronetics, Inc., from February 2019 to June 2020.

Blanchard was elected to the National Academy of Engineering, among the highest professional distinctions accorded to an engineer.

Blanchard received her Masters of Science and Ph.D.

in Materials Science and Engineering from the University of Texas at Austin and her Bachelor of Science in Ceramic Engineering from Alfred University.

She is also a member of the National Academy of Engineering.

Our board of directors believes that Dr.

Blanchard is qualified to serve on our board of directors due to her extensive leadership experience with several life science companies, her experience with product development, and her experience as a director of life science companies.

Grossman, M.D.

Grossman has been a member of our board of directors since April 2018 and currently serves as the Chief Executive Officer of IgGenix, a company developing first-in-class therapies for people limited by food allergies and other severe allergic conditions.

From 2015 to 2020, Dr.

Grossman served as Chief Executive Officer of Medicines360.

Medicines360 is a global non-profit women’s health pharmaceutical company that developed the FDA-approved contraceptive IUD LILETTA ® (52-mg levonorgestrel-releasing intrauterine system).

From 2011 to 2014, Dr.

Grossman served on the board of directors of Medicines360, and from 2014 to 2018 she served as Chair of AlliancePartners360, a wholly owned subsidiary of Medicines360 that serves the non-profit, public benefit mission of Medicines360 of expanding access to medicines for women regardless of their socioeconomic status, insurance coverage, or geographic location.

From 2013 to 2014, Dr.

Grossman served as President and

Founding Chief Executive Officer of Sense4Baby, Inc.

Grossman served as a Medical Director at Ethicon Endo-Surgery, part of the Johnson & Johnson family of companies, from 2010 to 2013.

From 2008 to 2010, Dr.

Grossman was the Founder and Chief Executive Officer of JG Limited LLC, a consulting company providing services to medical technology companies and non-profit organizations in the areas of clinical and commercial strategy.

From 2005 to 2008, Dr.

Grossman was Founder and President of Gynesonics, an early stage medical device company focused on minimally invasive solutions for women’s health which developed the first intrauterine ultrasound-guided radiofrequency ablation device for fibroid tumors.

Grossman holds numerous patents, has published several peer-reviewed articles and conducted research at the Beth Israel Deaconess Medical Center, one of the teaching hospitals of Harvard Medical School.

Grossman received her M.D.

from Thomas Jefferson University, Jefferson Medical College.

Our board of directors believes that Dr.

Grossman is qualified to serve on our board of directors due to her extensive experience in women’s health, her executive leadership experience with several life science companies, and her experience with product development and commercialization.

Kelley served as a member of Cerulean’s board of directors beginning in October 2014 and joined the Board following the closing of the Cerulean/Private Daré stock purchase transaction.

Kelley has been developing drugs in oncology and immunology for over 30 years.

Kelley also serves as a member of the board of directors of Deciphera Pharmaceuticals, Inc.

and IDEAYA Biosciences, Inc.

From 2011 until its acquisition by Merck & Co.

Kelley served on the board of ArQule, Inc.

and, from 2016 until its acquisition by Merck & Co.

in 2019, she served on the board of Immune Design Corp.

She was a director at VBL Therapeutics, Ltd.

from 2018 until 2020.

From 2008 to 2011, Dr.

Kelley served as Chief Medical Officer of the Multiple Myeloma Research Consortium and its sister organization, the Multiple Myeloma Research Foundation.

Previously, Dr.

Kelley held positions at Bayer Healthcare Pharmaceuticals and Bayer-Schering Pharma, including Vice President, Global Clinical Development and Therapeutic Area Head—Oncology, where she led the Bayer team responsible for the development and worldwide regulatory approval of Nexavar ® (sorafenib).

Prior to joining Bayer, Dr.

Kelley worked at Bristol-Myers Squibb in Oncology and Immunology drug development ultimately serving as Executive Director, Oncology Clinical Research, at the Bristol-Myers Squibb Pharmaceutical Research Institute.

Kelley was a Fellow in Medical Oncology and Clinical Fellow in Medicine at Dana-Farber Cancer Institute, Harvard Medical School, and a Fellow in Medical Oncology and Pharmacology at Yale University School of Medicine.

Kelley also serves as an Entrepreneur-in-Residence at the Yale University Office of Cooperative Research.

Kelley received her M.D.

from Duke University School of Medicine.

Our board of directors believes that Dr.

Kelley is qualified to serve on our board of directors due to her experience in life sciences and clinical development and her experience as a director of life sciences companies.

Sabrina Martucci Johnson .

Johnson founded Private Daré in 2015 and served as its President and CEO and as member of its board of directors since its inception and until the closing of the Cerulean/Private Daré stock purchase transaction, at which point she was appointed as Chief Executive Officer and a member of the board of directors of the combined company.

Johnson is a life sciences executive committed to advancing improvements in women’s healthcare.

Previously, Ms.

Johnson served as the Chief Financial Officer of the California Institute for Biomedical Research (now part of The Scripps Research Institute), from May of 2015 to July of 2017, and served as President of WomanCare Global Trading, a specialty pharmaceutical company in female reproductive healthcare with commercial product distribution in over 100 countries, from October of 2014 to May of 2015, and Chief Financial Officer and Chief Operating Officer from July 2013 to October 2014.

Johnson provided financial consulting services to the WomanCare Global family of companies, including the United Kingdom-based non-profit division, from November 2012 to July 2013.

From 2002 until its sale in 2010, Ms.

Johnson served as Chief Financial Officer of Cypress Bioscience, Inc., a publicly-traded pharmaceutical company, and in addition served as its Chief Operating Officer from 2008 until its sale in 2010.

Johnson began her career in the biotechnology industry as a research scientist with Baxter Healthcare, Hyland Division, working on their recombinant factor VIII program, and later held marketing and sales positions with Advanced Tissue Sciences and Clonetics Corporation.

Johnson currently serves on the boards of Aethlon Medical, Inc., a publicly-traded company developing immunotherapeutic technologies to combat infectious disease and cancer;

the YWCA of San Diego County, as past president;

BIOCOM, as board VP of Industry, and the Clearity Foundation, as board chair.

Additionally.

Johnson serves on the Board of Advisors of Tulane University School of Science & Engineering, and on the Audit Committee of Project Concern International.

Johnson is also past co-president of Women Give San Diego, which funds non-profit organizations serving women and girls in San Diego, and formerly served on the board of Planned Parenthood of the Pacific Southwest, Athena San Diego, and as the Chair of the University of California San Diego (UCSD) Librarian's Advisory Board.

Johnson has a Masters of International Management degree with honors from the American Graduate School of International Management (Thunderbird), a MSc.

in Biochemical Engineering from the University of London, University College London and a BSc.

in Biomedical Engineering from Tulane University, where she graduated magna cum laude.

Our board of directors believes that Ms.

Johnson is qualified to serve as the Company’s Chief Executive Officer and as a member of our board of directors due to her leadership experience in life sciences, women’s

reproductive healthcare, development and commercial distribution of healthcare products, capital raises, and her experience as an officer in life sciences and women’s reproductive healthcare non-profit and for-profit companies, including publicly traded companies.

Matz joined our board of directors in September 2018.

Matz currently serves as a member of the board of directors of One Stop Systems, Inc.

a company focused on high-performance edge computing.

Matz retired as the Senior Vice President and Chief Financial Officer for The Cooper Companies in November 2016.

Additionally, he served as the company’s Chief Risk Officer.

The Cooper Companies is a publicly traded, global medical device company that operates through two business units, CooperVision and CooperSurgical.

He previously was the Vice President and Chief Financial Officer for CooperVision from May 2010 to December 2011.

Prior to joining the company Mr.

Matz held key management roles in finance and marketing at Agilent Technologies and Hewlett Packard.

He began his career at KPMG and is a CPA with an active certification.

Matz graduated from the University of San Francisco with a Bachelor of Science in Business and the University of Pennsylvania, The Wharton School’s Advanced Management Program.

Matz is also a National Association of Corporate Directors (NACD) Board Leadership Fellow.

Our board of directors believes Mr.

Matz’s experience as a chief financial officer and chief risk officer of a company within the women’s health industry and his corporate experience and skills in financial functions, including planning, reporting, and audit, in risk management, in managing internal growth and in capital markets and corporate strategy qualifies him to serve as a member of our board of directors and to fill the important role of “audit committee financial expert.”

Rastetter, Ph.D.

Rastetter served as a member of Cerulean’s board of directors beginning in January 2014 and as Chairman from June 2016 until the closing of the Cerulean/Private Daré stock purchase transaction, at which time he joined the board of directors of the combined company.

Rastetter has been chairman of our board of directors since July 2019.

Rastetter currently serves as Chairman of the board of directors of Neurocrine Biosciences, Inc.

and Fate Therapeutics, Inc., and as a member of the board of directors of Grail, Inc.

(a privately-held company) and of Regulus Therapeutics, Inc.

Rastetter co-founded Receptos, Inc., a biopharmaceutical company, where he previously held the roles of Acting Chief Executive Officer from 2009 to 2010, and Director and Chairman of the board of directors from 2009 to 2015.

Rastetter served on the board of Illumina, Inc., a leading public genomic technology company, from 1998 until January 2016, and as Chairman from 2005 to 2016.

Rastetter was a Partner at the venture capital firm of Venrock Associates from 2006 to 2013.

Prior to his tenure with Venrock, Dr.

Rastetter was Executive Chairman of Biogen Idec Inc.

and was previously Chairman and Chief Executive Officer of Idec Pharmaceuticals.

Prior to Idec, he was Director of Corporate Ventures at Genentech, Inc.

Rastetter held various faculty positions at the Massachusetts Institute of Technology and Harvard University and is an Alfred P.

Sloan Fellow.

Rastetter holds a S.B.

from the Massachusetts Institute of Technology and received his M.A.

from Harvard University.

Our board of directors believes that Dr.

Rastetter is qualified to serve on our board of directors due to his extensive experience in the biotechnology industry, his broad leadership experience with several public and private biotechnology companies, and his experience with financial matters.

Steele, J.D., LL.M.

Steele served as an advisor to Private Daré since its inception in 2015 and until the closing of the Cerulean/Private Daré stock purchase transaction, at which time she joined the board of directors of the combined company.

Steele previously served as Senior Vice President, General Counsel and Secretary of InterMune, Inc., a publicly-traded biopharmaceutical company, from 2004 to 2014.

From 1998 to 2003, Ms.

Steele served as Vice President of Legal Affairs for Elan Pharmaceuticals, a publicly traded pharmaceutical company.

Steele currently serves on the board of directors of Alveo Technologies Inc., a privately-held medical diagnostics company, and Nacuity Pharmaceuticals, Inc, and GLAdiator Biosciences, both of which are privately-held biopharmaceutical companies.

Steele previously served on the board of Alios Biopharma and Targanta Therapeutics, both of which were biotechnology companies focused on the research and development of therapeutic compounds prior to their respective acquisitions.

Steele received a B.A.

from the University of Colorado, a J.D.

from the University of California, Hastings College of the Law, and an LL.M.

in Taxation from New York University School of Law.

Our board of directors believes that Ms.

Steele is qualified to serve on our board of directors due to her expertise in legal matters, her prior experience as general counsel of a public company and her involvement with a number of private biotechnology companies.

Executive Officers

Set forth below are the names, ages, offices held, tenure, and certain biographical information of each of our executive officers as of March 29, 2021.

Name Age Offices Executive Officer Since

Sabrina Martucci Johnson 54 Chief Executive Officer, President, Secretary and Director July 2017

Lisa Walters-Hoffert 62 Chief Financial Officer July 2017

John Fair 50 Chief Strategy Officer March 2020

Johnson’s biographical information is included above with those of the other members of our board of directors.

Lisa Walters-Hoffert .

Walters-Hoffert co-founded Private Daré in 2015 and served as its Chief Business Officer since its inception and until the closing of the Cerulean/Private Daré stock purchase transaction, at which time she was appointed Chief Financial Officer of the combined company.

Walters-Hoffert currently serves as a member of the board of directors of Flux Power Holdings, Inc., a publicly-traded company, and as chair of its audit committee, and she has been nominated to serve on the board of directors of Altamont Pharma Acquisition Corp., a blank check company that, in March 2021, filed a registration statement under the Securities Act for its initial public offering.

During the 25 years prior to founding Private Daré, Ms.

Walters-Hoffert was an investment banker focused primarily on serving small-cap public companies in the technology and life sciences sectors.

From 2003 to 2015, Ms.

Walters-Hoffert worked for Roth Capital Partners, most recently serving as Managing Director in the Investment Banking Division, overseeing the firm’s San Diego office and its activities with respect to medical device, diagnostic and specialty pharma companies.

Walters-Hoffert has held various positions in the corporate finance and investment banking divisions of Citicorp Securities in San José, Costa Rica and Oppenheimer & Co, Inc.

in New York City, New York.

Walters-Hoffert currently serves as a member of the board of directors of the Elementary Institute of Science.

She has served as a member of the board of directors of the San Diego Venture Group, as past chair of the UCSD Librarian’s Advisory Board, as past chair of the board of directors of Planned Parenthood of the Pacific Southwest, and as past chair of the audit committee of the Clearity Foundation.

Walters-Hoffert graduated from Duke University with a B.S.

in Management Sciences, magna cum laude.

Fair joined Daré in 2018 as its Chief Business Development Officer and was promoted to its Chief Strategy Officer in March 2020 where he is responsible for licensing, acquisitions, strategic partnering and corporate strategy.

Prior to joining Daré, Mr.

Fair was managing director of Capital F Consulting, a privately held consulting firm focused on healthcare consulting, capital raising and investor communications.

From January 2015 to September 2016, Mr.

Fair was President and Chief Operating Officer of Evofem, Inc., a specialty healthcare company developing products for women's health, microbiome and infectious disease.

In that role, Mr.

Fair was responsible for commercial strategy, operations and product development.

From December 2012 to December 2014, Mr.

Fair held senior level roles at Evofem, Inc.

and its global product distribution partner, WCG.

Previously, Mr.

Fair served in a number of executive level roles for specialty healthcare and venture backed healthcare services businesses.

Fair has a broad therapeutic experience that includes oncology, hematology, virology and women's health.

Fair began his career as a portfolio strategy and insights consultant and supported numerous brands and franchises in the pharmaceutical, over-the-counter and consumer healthcare markets.

Fair holds a master's degree from University of Pennsylvania, Perelman School of Medicine, a B.A.

from Rider University, where he graduated magna cum laude, and has completed executive education in corporate strategy, mergers and acquisitions at Stanford University Graduate School of Business.

Family Relationships;

Arrangements;

Legal Proceedings

There are no family relationships among any of our directors and executive officers.

There are no arrangements or understandings with another person under which our directors and officers was or is to be selected as a director or executive officer.

Additionally, none of our directors or executive officers is involved in any legal proceeding that requires disclosure under Item 401(f) of Regulation S-K.

Code of Conduct and Ethics

We have adopted a Corporate Code of Conduct and Ethics and Whistleblower Policy that applies to all our employees, including our chief executive officer and chief financial and accounting officers.

We will provide any person, without charge, a copy of our Corporate Code of Conduct and Ethics and Whistleblower Policy upon written request to Investor Relations, Daré Bioscience, Inc., 3655 Nobel Drive, Suite 260, San Diego, California 92122.

We also post on our website a copy of our Corporate Code of Conduct and Ethics and Whistleblower Policy at www.darebioscience.com.

Information contained on the website is not incorporated by reference in, or considered part of, this report.

We intend to disclose any changes in our Corporate Code of Conduct and Ethics and Whistleblower Policy or waivers from it that apply to our principal executive officer, principal financial officer, or principal accounting officer by posting such information on the same website or by filing with the SEC a Current Report on Form 8-K, in each case if such disclosure is required by SEC or Nasdaq rules.

Audit Committee and Audit Committee Financial Expert

The audit committee of our board of directors is an audit committee established in accordance with Section 3(a)(58)(A) of the Exchange Act.

The audit committee provides advice with respect to our financial matters and assists our board of directors in fulfilling its oversight responsibilities regarding:

(i) the quality and integrity of our financial statements, (ii) our compliance with legal and regulatory requirements, (iii) the evaluation of the adequacy and effectiveness of internal controls, (iv) the review and assessment of potential risk factors, (v) the review of the qualifications, independence and performance of our independent registered public accounting firm and (vi) the engagement and retention of our independent registered public accounting firm.

Our board of directors has determined that each member of the audit committee—Mr.

Grossman and Ms.

Steele—is able to read and understand fundamental financial statements, including our balance sheet, income statement and cash flow statement.

Our board of directors has also determined that Mr.

Matz qualifies as an “audit committee financial expert,” as defined in Item 407(d)(5) of Regulation S-K, and that each member is independent as defined under applicable Nasdaq rules and meets the independent requirements contemplated by Rule 10-3A under the Exchange Act.

Changes in Stockholder Nomination Procedures

There have been no material changes to the procedures by which stockholders may recommend nominees to our board of directors since such procedures were last described in our proxy statement filed with the SEC on June 19, 2017.

The information required by this item will be included in the Company's 2022 Proxy Statement and is incorporated in this report by reference.

EXECUTIVE COMPENSATION

The compensation committee of our board of directors assists our board in discharging its responsibilities in respect of compensation of our executive officers.

The compensation committee is currently comprised of three non-employee members of our board, Cheryl R.

Blanchard, Ph.D., William H.

Rastetter, Ph.D.

Steele, J.D., L.L.M.

Executive compensation is intended to attract and retain qualified executive officers and to align the interests of our executive officers with those of our stockholders by incentivizing and rewarding achievement of business objectives that our board of directors and its compensation committee believe will enhance company value and by promoting commitment to long-term success.

As a clinical-stage biopharmaceutical company, these objectives are to be accomplished primarily by positioning us to successfully execute our drug product development and regulatory approval efforts and to translate those efforts, over time, into greater value for our stockholders through revenues and income from commercialization of, or strategic collaborations with respect to, our product candidates.

Our current executive compensation program primarily includes (1) base salary, (2) annual performance-based incentive compensation, and (3) long-term incentive compensation in the form of stock options with the goal of aligning the long-term interests of executive officers with those of our stockholders and otherwise encouraging the achievement of superior results over an extended time period.

With respect to our executive compensation program, the compensation committee also:

(1) reviews competitive practices and trends to determine the adequacy of our executive compensation program;

(2) reviews and considers participation and eligibility in the various components of our total executive compensation package;

and (3) as deemed necessary or appropriate, approves employment contracts, severance arrangements, change in control provisions and other agreements.

We have a formal policy for the timing of granting annual equity awards to our existing employees, including our named executive officers, to provide for a consistent process and to ensure the integrity and efficiency of the company’s award process.

Under this policy, annual equity awards will be granted on the date of the compensation committee’s first regularly scheduled meeting held each year, subject to the compensation committee’s ability to change the annual grant date for any particular year if the compensation committee determines that granting annual awards on such date would not be in the company’s best interest.

Decisions regarding the compensation of our chief executive officer are determined by our board of directors after taking into account the recommendations of its compensation committee and the independent compensation consultant to the compensation committee.

The compensation committee annually reviews and recommends to our board corporate objectives relevant to compensation of our chief executive officer, evaluates performance in light of those objectives, and recommends to our board compensation levels based on that evaluation.

Our chief executive officer may not be present during any deliberations or voting with respect to her compensation.

Decisions regarding the compensation of our other employees are generally determined by the compensation committee after taking into account the recommendations of its independent compensation consultant.

The table below shows the compensation awarded to or paid to, or earned by our named executive officers for the years ended December 31, 2020 and 2019.

Fair was not a named executive officer for the year ended December 31, 2019, and therefore information in the table below is provided only with respect to his compensation for the year ended December 31, 2020.

2020 Summary Compensation Table

Name and Principal Position Fiscal

Awards ($) (1) Non-equity incentive plan compensation

($) (2) All Other

Compensation ($) (3) Total

Sabrina Martucci Johnson 2020 $ 368,225 $ — $ 272,845 $ 182,271 $ 13,241 $ 836,582

President and Chief Executive Officer 2019 $ 334,750 $ — $ 140,534 $ 142,269 $ 11,200 $ 628,753

Lisa Walters-Hoffert 2020 $ 294,580 $ — $ 66,262 $ 92,793 $ 12,952 $ 466,587

Chief Financial Officer 2019 $ 267,800 $ — $ 54,051 $ 79,671 $ 11,200 $ 412,722

John Fair 2020 $ 294,580 $ — $ 66,262 $ 92,793 $ 7,320 $ 460,955

Chief Strategy Officer

(1) The amounts in this column represent the grant date fair value, determined in accordance with ASC Topic 718, Compensation-Stock Compensation (ASC Topic 718), of stock options granted to the applicable individual.

Stock Based Compensation to our consolidated financial statements included in this report for details as to the assumptions used to determine the fair value of the awards.

(2) Amounts represent performance bonuses earned for the years indicated.

(3) Amount reflects Company 401(k) match.

The Company provides the named executive officers with health, medical and other non-cash benefits generally available to all employees, which are not included in these columns pursuant to SEC rules.

Narrative to Summary Compensation Table

As reflected in the table above, the 2020 compensation of our named executive officers consisted of three primary components:

(1) base salary;

(2) equity compensation in the form of stock options;

and (3) performance-based cash compensation.

Base Salary .

The 2020 annual base salary of our named executive officers was as reported in the "salary" column of the summary compensation table.

Option Awards .

Our named executive officers were each granted a stock option during 2020.

Stock options are a key tool in our pay-for-performance philosophy and align the interests of our employees, including our named executive officers, with our stockholders’ interests.

Stock options are inherently performance-based, and automatically link executive pay to stockholder return, as the value realized, if any, by the recipient from a stock option depends upon, and directly proportionate to, the appreciation in our stock price.

In preparation for making 2020 executive officer compensation decisions, our compensation committee evaluated the appropriate form of long-term incentive compensation and determined to use stock options as the primary incentive for long-term compensation in part because of the foregoing reasons.

Annual Performance-Based Bonus Opportunity .

In July 2019, our board of directors, upon the recommendation of its compensation committee, established a performance-based bonus plan that provides annual bonus opportunities for all employees, including our named executive officers.

The performance-based bonus plan provides for cash bonus payments based upon the achievement of performance objectives related to financial and operational metrics (the “performance objectives”), which may include, among others:

developmental, clinical or regulatory milestones;

business development and financing milestones;

and strategic transactions.

Performance goals are established for each performance period (which is generally from January 1 to December 31 of each year) by our board of directors upon the recommendation of its compensation committee or by the compensation committee.

Our board of directors or its compensation committee may adjust bonuses payable under the performance-based bonus plan based on achievement of individual performance goals or pay

bonuses (including, without limitation, discretionary bonuses) to participants under the performance-based bonus plan based upon such other terms and conditions as our board of directors or its compensation committee may in their discretion determine.

Each participant will have a targeted bonus opportunity set for each performance period.

The achievement of the performance goals will be assessed as of the end of the applicable performance period and after such period has ended;

however, if any performance goal is based on financial metrics reported in our periodic reports for any particular period, the achievement of such performance goal will be determined after the applicable periodic report has been published.

In January 2021, our board of directors met to consider, among other things, the level of achievement of the performance objectives established for the 2020 performance period under our performance-based bonus plan.

The 2020 performance bonus opportunity for our employees, including our named executive officers, was based on our achievement of seven performance objectives.

These objectives were established in early 2020 before the COVID-19 pandemic and did not take into account the potential impact of the pandemic on our business or operations.

Five of the objectives related to the achievement of clinical or preclinical development milestones or business development goals for certain of our product candidates, including our three lead product candidates (DARE-BV1, Ovaprene® and Sildenafil Cream, 3.6%), and the other two related to securing capital to advance the development of our product candidates.

The weighting for the performance objectives was up to 65% in the aggregate for the achievement of the operational and business development objectives and up to 35% in the aggregate for securing capital.

The bonus amount for each employee is determined by multiplying the aggregate weighting percentage for all the performance objectives by the applicable employee’s target bonus amount.

The 2020 target bonus amounts for Ms.

Walters-Hoffert and Mr.

Fair were 55%, 35%, and 35%, respectively, of their respective 2020 annual base salary.

The compensation committee of our board of directors and our board of directors, as the case may be, has the sole discretion to apply a weighting of 0 to 150% against the target bonus percentage.

After careful review of the level of achievement of the 2020 performance objectives, our board of directors, upon the recommendation of its compensation committee, determined to award a 90% aggregate weighting to the achievement of the performance objectives for all of our employees, including our named executive officers.

In determining to award a 90% aggregate weighting to the achievement of the 2020 performance objectives, our board of directors and its compensation committee considered a wide-range of factors, including, among others:

the effect of the COVID-19 pandemic on our business and operations and ensuring that compensation appropriately reflects operating performance that is reasonably within management's control;

the extraordinary response of our employees to the unprecedented challenges that arose during 2020 related to the pandemic, including advancing the clinical development of our product candidate programs that could be efficiently conducted during the pandemic, such as the DARE-BV1 Phase 3 clinical study and the DARE-HRT1 Phase 1 clinical study, and recalibrating the execution of our other product candidate programs, such as for Ovaprene and Sildenafil Cream, 3.6%, that could have faced challenges in the conduct of their clinical studies due to the pandemic, while maintaining the overall timelines of those product candidate programs on track by focusing instead on necessary non-clinical development activities that could be efficiently conducted during the pandemic;

steps management implemented designed to protect the health and safety of our employees and other stakeholders while ensuring our ability to keep our product candidate programs on track;

responsibly managing expenses without sacrificing long-term growth opportunities and the potential to achieve greater stockholder value;

the influence of compensation practices on our ability to attract and retain qualified and key employees;

the weight associated with each performance objective and whether the objective had been partially or fully met;

the degree to which progress occurred toward the achievement of an objective;

and the level of significance of achieving each objective to our company, taking into account the impact of the pandemic on our business operations and plans.

Accordingly, Ms.

Johnson earned a performance bonus equal to 90% of 55% of her 2020 annual base salary, or $182,271, Ms.

Walters-Hoffert earned a performance bonus equal to 90% of 35% of her 2020 annual base salary, or $92,793, and Mr.

Fair earned a performance bonus equal to 90% of 35% of his 2020 annual base salary, or $92,793.

In establishing the various components of our executive officer compensation program, the compensation committee considers annually, among other factors, the target total cash compensation (consisting of both base salary and target bonus amounts) of our executive officers against market data to ensure that our executive officer compensation program as a whole is positioned competitively to attract and retain qualified executive officers and that the total compensation opportunity for our executive officers is aligned with our corporate objectives and strategic needs.

To make the target total cash compensation of our executive officers competitive with companies of similar size with product candidates in similar stages of development, the 2021 base salaries for each of Ms.

Walters-Hoffert and Mr.

Fair was increased by 10% and the target bonus amounts, which is at-risk pay, for the 2021 performance period for Ms.

Walters-Hoffert and Mr.

Fair was set at 70%, 40%, and 40%, respectively, of their respective 2021 annual base salaries.

Employment Agreements and Termination of Employment & Change in Control Arrangements

We have written agreements with each of Ms.

Walters-Hoffert and Mr.

Fair governing the terms of their employment with us.

The following is a summary of the material terms of such agreements, as amended to date, necessary to an understanding of the information disclosed in the summary compensation table.

Each executive is eligible to receive an annual base salary, which may be adjusted at the discretion of our board.

In our sole discretion, each of our named executive officers is eligible to receive an annual bonus, the amount of which if any, will be based on the applicable executive’s performance and our company’s performance as measured against performance objectives and determined by the compensation committee and/or our board of directors.

Each executive is entitled to (1) participate in all equity, pension, savings and retirement plans, welfare and insurance plans, practices, policies, programs and perquisites of employment applicable generally to our senior executives, (2) receive reimbursement for reasonably incurred business expenses and (3) receive paid vacation and holiday time in accordance with policies generally applicable to our senior executives.

Subject to earlier termination, including in the event of death, the employment agreement with each of Ms.

Johnson and Ms.

Walters-Hoffert provides for a two-year term (which lapsed in August 2019) that automatically renews for successive one-year terms unless either party provides notice of her intent not to renew at least 60 days prior to the applicable expiration date.

Johnson and Ms.

Walters-Hoffert may terminate her respective employment for good reason after giving us 14 days to correct or “cure” the circumstances giving rise to a termination for good reason, or for any reason other than for good reason a upon at least 14 days’ prior written notice.

We may terminate the employment of Ms.

Johnson and Ms.

Walters-Hoffert without prior written notice for cause, without cause on 14 days’ prior written notice, or in the event of the executive’s disability.

Their employment agreement automatically terminates upon the executive’s death.

Our agreement with Mr.

Fair is "at will," meaning that either he or we may terminate his employment at any time and for any reason, with or without cause.

The following table summarizes our obligations and the payments and other benefits to which Ms.

Johnson and Ms.

Walters-Hoffert may be entitled if her employment is terminated for the reason specified, other than in connection with a change of control, which is discussed in the paragraph below the table.

Termination Accrued

Obligations (1)

Cash Payments (2)

Other Benefits (2)

• By us for cause.

• By the executive without good reason.

• Executive’s death or disability.

• Executive elects not to renew agreement.

We must pay the executive any accrued obligations as of the date of termination None.

• By us other than for cause.

• By the executive with good reason.

• We elect not to renew agreement.

We must pay the executive any accrued obligations as of the date of termination We must pay the executive:

(1) any accrued but unpaid bonus (or a pro rata portion of such bonus) as of the date of termination;

and (2) an amount equal to a specified number of months of the executive’s then-current base salary.

We must provide the executive continuing health benefits coverage for a specified number of months.

(1) Consists of any earned but unpaid base salary, unpaid expense reimbursements, and any vested benefits the executive may have under any employee benefit plan, in each case, as of the date of termination.

(2) Payment and benefits are conditioned on (a) the executive’s continued compliance with her obligations under the employment agreement related to confidentiality and non-interference and intellectual property covenants and (b) the executive (or her estate) executing and delivering a full release of all claims in favor of Daré.

(3) The number of months is 12 for Ms.

Johnson and 9 for Ms.

Walters-Hoffert.

Under the terms of our employment agreements with Ms.

Johnson and Ms.

Walters-Hoffert, if their respective employment is terminated by us without cause or by the executive for good reason, in each case, within three months prior to or 12 months following a change of control, then, subject to the applicable executive's continued compliance with customary confidentiality, intellectual property assignment and similar obligations to us, and subject to the delivery of a full release of claims in our favor by the executive, (1) the executive is eligible to receive an amount equal to a specified number of months (18 for Ms.

Johnson and 12 for Ms.

Walters-Hoffert) of the executive’s then-current base salary and target bonus at the rate in effect immediately prior to such termination, (2) the executive will receive continuing health benefits coverage for a specified number of months (18 for Ms.

Johnson and 12 for Ms.

Walters-Hoffert) and (3) any unvested and outstanding equity interests such executive may have in Daré will fully vest and accelerate.

Under the terms of our change in control policy in which our employees at vice president and above are eligible to participate, if the employment of an employee covered by such policy is terminated by us without cause or if such employee resigns for good reason, in either case, within 90 days before, or 365 days following, the effective date of a change in control, then, subject to the applicable employee's continued compliance with customary confidentiality, intellectual property assignment and similar obligations to us, and subject to the delivery of a full release of claims in our favor by such employee, the vesting of all of such employee's equity awards then outstanding that are subject solely to time-based vesting conditions that have not been satisfied will be accelerated in full.

The vesting of any equity award that is subject only to performance-based vesting condition(s) or to both performance-based vesting condition(s) and time-based vesting condition(s), will not be accelerated unless such performance-based vesting condition(s) have been satisfied as of the effective date of the termination of employment or, in the case of a termination that occurs before a change in control, as of the effective date of the change in control.

Fair is covered by our change in control policy, however, neither Ms.

Johnson nor Ms.

Walters-Hoffert are so covered.

All payments made and benefits available to each executive in connection with their employment agreement and under our change in control policy will comply with Internal Revenue Code Section 409A in accordance with the terms of such documents.

Other Benefits

We maintain a defined contribution employee retirement plan for all our employees.

Our 401(k) plan is intended to qualify as a tax-qualified plan under Section 401 of the Internal Revenue Code so that contributions to our 401(k) plan, and income earned on such contributions, are not taxable to participants until withdrawn or distributed from the 401(k) plan.

If a participant contributes 5% or more of their compensation, we match their contribution up to 4% of their annual compensation, subject to statutory limits.

We currently do not have any annuity, pension or deferred compensation plan or other arrangements for our executive officers or any employees.

Outstanding Equity Awards at Fiscal Year-End

The following table sets forth information concerning equity awards held by our named executive officers that were outstanding as of December 31, 2020:

2020 Outstanding Equity Awards at Fiscal Year-End

Option Awards

Name Date of Grant Number of

(#) Number of

Unexercisable

Sabrina Martucci Johnson 9/7/2018 108,000 84,000 $ 1.01 9/7/2028

1/29/2019 93,437 101,563 $ 0.759 1/29/2029

3/6/2020 52,500 227,500 $ 1.03 3/6/2030

Lisa Walters-Hoffert 9/7/2018 56,250 43,750 $ 1.01 9/7/2028

1/29/2019 35,937 39,063 $ 0.759 1/29/2029

3/6/2020 12,750 55,250 $ 1.03 3/6/2030

John Fair 9/7/2018 84,375 65,625 $ 1.01 9/7/2028

1/29/2019 35,937 39,063 $ 0.759 1/29/2029

3/6/2020 12,750 55,250 $ 1.03 3/6/2030

Director Compensation

With the assistance of the compensation committee, our board of directors periodically reviews and evaluates our non-employee director compensation policy.

The following is an overview of our non-employee director compensation policy during 2020, which was designed to allow us to recruit and retain individuals with the requisite experience, skills and characteristics for membership on our board of directors, and to align the interests of our directors with those of our stockholders through the grant of stock options.

Each of our non-employee directors was paid a retainer for service on our board and for each board committee on which the director served as shown in the table below.

Retainers are paid in cash in arrears in four equal quarterly installments, prorated to reflect the actual time served by the director during such quarter.

Directors may elect to receive up to 100% of their retainer in the form of awards of unrestricted shares of our common stock.

If so elected, on the first trading day of the quarter following the quarter to which the retainer relates, we would issue a number of shares of common stock equal to (x) the amount of the cash retainer that would otherwise have been payable to such director on the date of grant divided by (y) the fair market value of our common stock on the date of grant.

Directors wishing to make this election for a given calendar year must make the election on or before the last day of the prior calendar year, except that the election with respect to any year in which a director is newly elected must be made on or before June 30th of such year or such other date as determined by our board.

Annual Retainer ($)

Board of Directors

Member 35,000

Board Committees

Audit Chair 20,000

Audit Member 7,500

Compensation Chair 15,000

Compensation Member 5,000

Nominating and Corporate Governance Chair 10,000

Nominating and Corporate Governance Member 3,500

Equity Awards .

Initial Award .

Each director newly elected to our board receives an option to purchase 45,000 shares of our common stock, which vests as to 15,000 shares on each anniversary of the grant date until the third

anniversary of the grant date, subject to the director’s continued service as a director, and will become exercisable in full upon a change in control.

Annual Award .

On the date of each annual meeting of stockholders, each director that has served on our board for at least six months (and, if up for election at such annual meeting, is elected at such annual meeting) receives an option to purchase shares of our common stock, which will vest in full on the earlier of the first anniversary of the grant date or immediately prior to our first annual meeting of stockholders occurring after the grant date, subject to the director’s continued service as a director, and will become exercisable in full upon a change in control.

The number of shares subject to this annual option grant was 22,500 in 2020 and will be 30,000 in 2021.

The exercise price of each option granted under our non-employee director compensation policy is set at the fair market value of our common stock on the grant date.

Expense Reimbursement .

We reimburse our non-employee directors for reasonable travel and other expenses incurred in connection with attending board and committee meetings.

2020 Director Compensation

The following table sets forth the compensation of our non-employee directors during 2020.

2020 Director Compensation

Name Fee Earned or

Paid in Cash Option

Awards (1) All Other

Compensation Total

Blanchard, Ph.D.

$ 39,629 $ 21,806 $ — $ 61,435

Grossman, M.D.

$ 46,000 $ 21,806 $ — $ 67,806

$ 45,000 $ 21,806 $ — $ 66,806

Matz, CPA $ 55,000 $ 21,806 $ — $ 76,806

Rastetter, Ph.D.

$ 80,000 $ 21,806 $ — $ 101,806

Steele $ 47,500 $ 21,806 $ — $ 69,306

Stock Based Compensation to our consolidated financial statements included in this report for details as to the assumptions used to determine the fair value of the awards.

As of December 31, 2020, our non-employee directors had stock options outstanding to purchase the following number of shares of our common stock:

Name # of Shares Subject to

Outstanding Options

Blanchard, Ph.D.

Grossman, M.D.

Matz, CPA 90,000

Rastetter, Ph.D.

Robin Steele, J.D.,L.L.M.

The information required by this item will be included in the Company's 2022 Proxy Statement and is incorporated in this report by reference.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

The table below sets forth certain information, as of March 29, 2021, regarding the beneficial ownership of our common stock for (1) each person known by us to be the beneficial owner of more than 5% of our common stock, (2) each of our directors, (3) each of our named executive officers and (4) all of our current directors and executive officers as a group.

We have determined beneficial ownership in accordance with applicable SEC rules, and the information reflected in the table below is not necessarily indicative of beneficial ownership for any other purpose.

Under applicable SEC rules, beneficial ownership includes any shares of common stock as to which a person has sole or shared voting power or investment power and any shares of common stock which the person has the right to acquire within 60 days after the date set forth in the paragraph above through the exercise of any option, warrant or right or through the conversion of any convertible security.

Unless otherwise indicated in the footnotes to the table below and subject to community property laws where applicable, we believe, based on the information furnished to us and on SEC filings, that each of the persons named in table below has sole voting and investment power with respect to the shares indicated as beneficially owned.

The information set forth in the table below is based on 47,312,822 shares of our common stock issued and outstanding on March 29, 2021.

In computing the number of shares of common stock beneficially owned by a person and the percentage ownership of that person, we deemed to be outstanding all shares of common stock subject to options, warrants, rights or other convertible securities held by that person that are currently exercisable or will be exercisable within 60 days after such date.

We did not deem these shares outstanding, however, for the purpose of computing the percentage ownership of any other person.

Except as otherwise noted, the address for each person listed in the table below is c/o Daré Bioscience, Inc., 3655 Nobel Drive, Suite 260, San Diego, California, 92122.

Name Number of

Owned Percentage

Beneficially Owned

5% Stockholders

The Vanguard Group (1)

2,993,275 6.3%

Vanguard Index Funds (2)

2,700,357 5.7%

Named Executive Officers and Directors

Sabrina Martucci Johnson (3)

1,325,165 2.8%

Lisa Walters-Hoffert (4)

John Fair (5)

Blanchard, Ph.D.

Grossman, M.D.

Matz, CPA (9)

Rastetter, Ph.D.

Steele, J.D., L.L.M.

All directors and executive officers as a group (9 persons) (12)

2,638,658 5.5%

* Less than 1%

(1) Based on a Schedule 13G filed by The Vanguard Group, Inc.

(“Vanguard Group”) on February 10, 2021, reporting ownership as of December 31, 2020.

According to such Schedule 13G, Vanguard Group beneficially owns 2,993,275 shares of common stock, has sole dispositive power as to 2,993,275 shares of common stock, and its address is 100 Vanguard Blvd., Malvern, PA 19355.

The foregoing information has been included solely in reliance upon, and without independent investigation of, the information in such Schedule 13G.

(2) Based on a Schedule 13G filed by Vanguard Index Funds - Vanguard Total Stock Market Index Fund (“Vanguard Index Fund”) on February 8, 2021, reporting ownership as of December 31, 2020.

According to such Schedule 13G, Vanguard Index Fund beneficially owns 2,700,357 shares of common stock, has sole voting power as to 2,700,357 shares of common stock, and its address is 100 Vanguard Blvd., Malvern, PA 19355.

The foregoing information has been included solely in reliance upon, and without independent investigation of, the information in such Schedule 13G.

(3) Includes 363,103 shares of common stock issuable upon exercise of stock options.

The outstanding shares are held by The Vincent S.

Johnson and Sabrina M.

Johnson Family Trust dated February 14, 2005.

Johnson is the co-trustee of such trust and has shared investment and dispositive power over such shares.

(4) Includes 142,686 shares of common stock issuable upon exercise of stock options.

The outstanding shares are held by The Lisa Walters-Hoffert Survivor’s Trust dated October 31, 2002.

Walters-Hoffert is the trustee of such trust and has sole investment and dispositive power over such shares.

(5) Includes 176,020 shares of common stock issuable upon exercise of stock options.

(6) Includes 15,000 shares of common stock issuable upon exercise of stock options.

(7) Includes 52,500 shares of common stock issuable upon exercise of stock options.

(8) Includes 59,800 shares of common stock issuable upon exercise of stock options.

(9) Includes 52,500 shares of common stock issuable upon exercise of stock options.

The outstanding shares are held by the Matz Trust Dated December 20, 1999.

Matz is the co-trustee of such trust and has shared investment and dispositive power over such shares.

(10) Includes 59,801 shares of common stock issuable upon exercise of stock options.

The outstanding shares are held by William and Marisa Rastetter Trustees of the Rastetter Family Trust U/A Dated 09/02/2010.

Rastetter is the co-trustee of such trust and has shared investment and dispositive power over such shares.

(11) Includes 54,700 shares of common stock issuable upon exercise of stock options.

The outstanding shares are held by the Robin J.

Steele Trust DTD 1/30/2015.

Steele is the trustee of such trust and has sole investment and dispositive power over such shares.

(12) Includes 976,110 shares of common stock issuable upon exercise of stock options.

The members of this group are our three current executive officers (Ms.

Walters-Hoffert and Mr.

Fair) and our six non-employee directors (Drs.

Blanchard, Grossman, Kelley, and Rastetter, Mr.

Matz, and Ms.

Equity Compensation Plan Information

The following table sets forth information as of December 31, 2020, with respect to compensation plans (including individual compensation arrangements) under which our equity securities are authorized for issuance.

Plan Category Number of

securities to be

options, warrants

and rights (a) Weighted-

average exercise

rights (b) Number of

securities remaining

available for future

issuance under

compensation plans

securities reflected

in column a))

Equity compensation plans approved by security holders (1)

2,786,591 $ 1.16 504,516

Equity compensation plans not approved by security holders — $ — —

Total 2,786,591 $ 1.16 504,516

(1) Consists of securities issued under our 2007 Stock Incentive Plan and our Amended and Restated 2014 Stock Incentive Plan, or the 2014 Plan.

Under the 2014 Plan, the number of shares of common stock authorized and reserved for issuance automatically increases on an annual basis on the first day of each fiscal year, by an amount equal to the least of (i) 2,000,000 shares of common stock, (ii) 4% of the number of outstanding shares of our common stock on such date, or (iii) an amount determined by our board of directors.

The information required by this item will be included in the Company's 2022 Proxy Statement and is incorporated in this report by reference.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

Related Transactions

There has not been any transaction since January 1, 2019, nor is there any currently proposed, that requires disclosure Item 404 of Regulation S-K.

Company Policy Regarding Related Party Transactions

Pursuant to its charter, the audit committee of our board of directors has the responsibility to review, approve and oversee any transaction between the Company and a related person (as defined in Item 404 of Regulation S-K) and to develop policies and procedures for audit committee’s approval of such transactions.

Indemnification Agreements

As permitted under Delaware law, we have entered into indemnification agreements with our officers and directors that provide that we will indemnify the directors and officers for certain expenses, including attorneys’ fees, judgments, fines and settlement amounts incurred by such director or officer in any action or proceeding arising out of their service as a director and/or officer.

The term of the indemnification is for the officer’s or director’s lifetime.

Director Independence

As required under the Nasdaq listing standards, a majority of the members of a listed company’s board of directors must qualify as “independent,” as affirmatively determined by the board of directors.

Our board of directors consults with our legal counsel to ensure that its determinations are consistent with relevant securities and other laws and regulations regarding the definition of “independent,” including those set forth in Nasdaq listing standards, as in effect from time to time.

Consistent with these considerations, after review of all relevant identified transactions or relationships between each of our directors, or any of his or her family members, and the Company, its senior management and its independent auditors, our board of directors affirmatively determined that all of our directors, except Ms.

Johnson who is not considered independent because she is one of our executive officers, are independent directors as defined by Nasdaq Listing Rule 5605(a)(2).

The information required by this item will be included in the Company's 2022 Proxy Statement and is incorporated in this report by reference.

PRINCIPAL ACCOUNTANT FEES AND SERVICES

The following table shows the fees billed by Mayer Hoffman McCann P.C.

for our last two fiscal years.

Audit Fees (1)

$ 204,355 $ 189,180

Audit Related Fees (2)

All Other Fees (4)

Total $ 204,355 $ 189,180

(1) Audit Fees are for professional services rendered for the audit of our annual financial statements and review of financial statements included in our Form 10-Q or services that are normally provided by the accountant in connection with statutory and regulatory filings or engagements.

(2) Audit Related Fees are for assurance and related services that are reasonably related to the performance of the audit or review of our financial statements and are not included in Audit Fees.

No such services were rendered during 2020 or 2019.

(3) Tax Fees are for professional services for tax compliance, tax advice, and tax planning.

No such services were rendered during 2020 or 2019.

(4) All Other Fees are for products and services other than the services reported above.

No such services were rendered during 2020 or 2019.

Substantially all of Mayer Hoffman McCann's personnel, who work under the control of Mayer Hoffman McCann’s shareholders, are employees of wholly-owned subsidiaries of CBIZ, Inc., which provides personnel and various services to Mayer Hoffman McCann in an alternate practice structure.

Policy on Audit Committee Pre-Approval of Audit and Permissible Non-Audit Services of Independent Public Accountant

Consistent with SEC policies regarding auditor independence, the audit committee has responsibility for appointing, setting compensation and overseeing the work of our independent registered public accounting firm.

In recognition of this responsibility, the audit committee has established a policy to pre-approve all audit and permissible non-audit services provided by our independent registered public accounting firm.

All audit services for 2020 were pre-approved by the audit committee.

Prior to engagement of our independent registered public accounting firm for the next year’s audit, management will present to our audit committee the services expected to be required during that year for the following categories:

Audit services include audit work performed in the preparation of financial statements, as well as work that generally only an independent registered public accounting firm can reasonably be expected to provide, including comfort letters, statutory audits, and attest services and consultation regarding financial accounting and/or reporting standards.

Audit-related services are for assurance and related services that are traditionally performed by an independent registered public accounting firm, including due diligence related to mergers and acquisitions, employee benefit plan audits, and special procedures required to meet certain regulatory requirements.

Tax services include all services performed by an independent registered public accounting firm’s tax personnel except those services specifically related to the audit of the financial statements, and includes fees in the areas of tax compliance, tax planning, and tax advice.

Other services are those not captured in the other categories.

We generally do not request such services from our independent registered public accounting firm.

Prior to engagement, the audit committee pre-approves these services by category.

The fees for these services are budgeted and our audit committee is informed periodically throughout the year of actual fees versus the budget by category of service.

During the year, circumstances may arise when it may become necessary to engage our independent registered public accounting firm for additional services not contemplated in the original pre-approval.

In those instances, our audit committee requires specific pre-approval before engaging our independent registered public accounting firm.

Our audit committee may delegate pre-approval authority to one or more of its members.

The member to whom such authority is delegated, currently the audit committee chair, must report, for informational purposes only, any pre-approval decisions to the audit committee at its next scheduled meeting.

The information required by this item will be included in the Company's 2022 Proxy Statement and is incorporated in this report by reference.

EXHIBITS AND FINANCIAL STATEMENT SCHEDULES

4 unchanged sentences

All financial statement schedules have been omitted, since the required information is not applicable or is not present in amounts sufficient to require submission of the schedule, or because the information required is included in the consolidated financial statements and notes thereto included in this report.

Exhibits not filed or furnished herewith are incorporated by reference to exhibits previously filed with the SEC, as reflected in the table below.

We will furnish a copy of any exhibit to stockholders, without charge upon written request to Daré Bioscience, Inc., 3655 Nobel Drive, Suite 260, San Diego, CA 92122, or by calling 858-926-7655.

Incorporated by Reference

2 unchanged sentences

Filed Herewith

2.1§ Stock Purchase Agreement dated as of March 19, 2017, entered into by and among Cerulean Pharma Inc., Daré Bioscience, Inc.

and equityholders of Daré Bioscience, Inc.

named therein.

8-K 001-36395 3/20/2017 2.1

Δ Agreement and Plan of Merger, dated as of April 30, 2018, by and among Daré Bioscience, Inc., Daré Merger Sub, Inc., Pear Tree Pharmaceuticals, Inc., and Fred Mermelstein and Stephen C.

9 unchanged sentences

10-K 001-36395 03/28/2018 4.1

4.2 Warrant, dated January 8, 2015, issued to Hercules Technology Growth Capital, Inc.

8-K 001-36395 01/08/2015 4.1

4.3 Preferred Stock Purchase Warrant to purchase shares of Series D Convertible Preferred Stock issued by the Registrant to Lighthouse Capital Partners VI, L.P., as amended

S-1 333-194442 03/10/2014 10.20

4.4 Form of Stock Purchase Warrant of the Registrant to purchase shares of Series C Convertible Preferred Stock

S-1 333-194442 03/10/2014 10.19

4.2 Warrant Agreement to purchase shares of common stock of the registrant with Aquilo Partners, L.P., entered into as of October 16, 2016.

4.3(a) Form of Warrant to Purchase Shares of Common Stock (February 2018 Underwritten Offering)

9 unchanged sentences

10-Q 001-36395 11/13/2017 10.1

10.3(a) Common Stock Sales Agreement, dated January 4, 2018, by and between Daré Bioscience, Inc.

Wainwright & Co., LLC.

8-K 001-36395 01/04/2018 10.1

10.3(b) Amendment No.

1 to Common Stock Sales Agreement, dated August 24, 2018, by and between Daré Bioscience, Inc.

Wainwright & Co., LLC.

8-K 001-36395 08/27/2018 10.2

10.3(a)* Daré Bioscience, Inc.

45 unchanged sentences

10-K 001-36395 03/27/2020 10.10(d)

10.9(e) Amendment to License Agreement effective as of September 21, 2021 by and among Daré Bioscience, Inc., TriLogic Pharma, LLC and MilanaPharm LLC

10-Q 001-36395 11/10/2021 10.1

10.10(a)* 2007 Stock Incentive Plan

10 unchanged sentences

10-Q 001-36395 11/13/2014 10.4

10.12(a)* Amended and Restated 2015 Employee, Director and Consultant Equity Incentive Plan of Daré Bioscience Operations, Inc.

10-K 001-36395 03/28/2018 10.14(a)

10.12(b)* Form of Stock Option Agreement under the Amended and Restated 2015 Employee, Director and Consultant Equity Incentive Plan of Daré Bioscience Operations, Inc.

10-K 001-36395 03/28/2018 10.14(b)

10.11(a)* Employment Agreement by and between Daré Bioscience, Inc.

17 unchanged sentences

10-K 001-36395 03/27/2020 10.16

10.17 Purchase Agreement between Daré Bioscience, Inc.

and Lincoln Park Capital Fund, LLC, dated April 22, 2020

8-K 001-36395 04/23/2020 10.1

10.18 Registration Rights Agreement Between Daré Bioscience, Inc.

and Lincoln Park Capital Fund, LLC, dated April 22, 2020

8-K 001-36395 04/23/2020 10.2

10.15* Daré Bioscience, Inc.

4 unchanged sentences

S-1 333-251599 01/05/2021 10.20

10.17+ Grant Agreement between Daré Bioscience, Inc.

and the Bill & Melinda Gates Foundation effective as of June 30, 2021

10-Q 001-36395 08/12/2021 10.1

10.18+ Cooperative Research and Development Agreement entered into as of July 8, 2021 between Daré Bioscience, Inc.

and the Eunice Kennedy Shriver National Institutes of Child Health and Human Development Institute

10-Q 001-36395 11/10/2021 10.2

21.1 Subsidiaries of the registrant

12 unchanged sentences

101.PRE XBRL Taxonomy Presentation Linkbase Document X

104 Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101) X

§ All schedules (or similar attachments) have been omitted from this filing pursuant to Item 601(b)(2) of Regulation S-K.

33 unchanged sentences

MATZ Director March 31, 2022

/s/ SOPHIA ONONYE-ONYIA Director March 31, 2022

Sophia Ononye-Onyia, Ph.D.

/s/ ROBIN STEELE Director March 31, 2022

3 unchanged sentences

INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

Report of Independent Registered Public Accounting Firm

Report of Independent Registered Public Accounting Firm (PCAOB ID 199 )

Consolidated Balance Sheets as of December 31, 2021 and 2020

55 unchanged sentences

Note payable — 367,285

Current portion of contingent consideration 1,000,000 —

Contingent consideration — 1,000,000

Current portion of lease liabilities 270,546 347,712

1 unchanged sentence

Deferred license revenue 1,000,000 1,000,000

Contingent consideration, net of current portion — 1,000,000

Lease liabilities long-term — 41,844

11 unchanged sentences

Total liabilities and stockholders' equity (deficit) $ 55,807,177 $ 7,550,712

See Accompanying Notes to Consolidated Financial Statements.

See accompanying notes.

Daré Bioscience, Inc.

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Other income 2,520 1,514

Gain on extinguishment of note payable 369,887 —

Net loss $ ( 38,696,105 ) $ ( 27,400,743 )

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Net loss to common shareholders $ ( 38,696,105 ) $ ( 27,407,606 )

Foreign currency translation adjustments, net of tax 11,237 ( 5,897 )

Foreign currency translation adjustments ( 63,585 ) 11,237

Comprehensive loss $ ( 38,759,690 ) $ ( 27,396,369 )

2 unchanged sentences

Basic and diluted 61,154,157 30,091,469

See Accompanying Notes to Consolidated Financial Statements.

See accompanying notes.

Daré Bioscience, Inc.

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Balance at December 31, 2019 19,683,401 $ 1,968 $ 44,564,674 $ ( 102,625 ) $ ( 44,023,191 ) $ 440,826

Issuance of common stock via public offering, net 5,261,250 525 5,151,177 — — 5,151,702

Equity issued in consideration of acquisition 2,999,990 300 2,369,692 — — 2,369,992

Stock-based compensation — — 742,031 — — 742,031

Issuance of common stock, net of issuance costs 19,791,989 1,979 22,975,428 — — 22,977,407

Issuance of common stock from the exercise of warrants 1,825,000 182 1,785,797 — — 1,785,979

Issuance cost on equity paid in common stock 285,714 29 291,500 — — 291,529

Stock options exercised 10,149 1 — — — 1

Deemed dividend from trigger of down round provision — — 6,863 — ( 6,863 ) —

2 unchanged sentences

Balance at December 31, 2020 41,596,253 $ 4,159 $ 70,366,293 $ ( 91,388 ) $ ( 71,430,797 ) $ ( 1,151,733 )

Issuance of common stock 19,791,989 1,979 22,975,428 — — 22,977,407

Stock-based compensation — — 1,599,692 — — 1,599,692

Issuance of common stock, net of issuance costs 41,094,657 4,109 75,309,982 — — 75,314,091

Issuance of common stock from the exercise of warrants 520,985 52 500,094 — — 500,146

Issuance cost on equity line paid in common stock 285,714 29 291,500 — — 291,529

Stock options exercised 35,500 4 32,525 — — 32,529

Stock-based compensation — — 742,031 — — 742,031

Deemed dividend from trigger of round down provision — — 6,863 — ( 6,863 ) —

Issuance of common stock in connection with milestone payment 696,724 70 1,219,216 — — 1,219,286

Net loss — — — — ( 38,696,105 ) ( 38,696,105 )

1 unchanged sentence

Balance at December 31, 2021 83,944,119 $ 8,394 $ 149,027,802 $ ( 154,973 ) $ ( 110,126,902 ) $ 38,754,321

See Accompanying Notes to Consolidated Financial Statements.

See accompanying notes.

Daré Bioscience, Inc.

8 unchanged sentences

Non-cash operating lease cost ( 96,132 ) ( 162,167 )

Acquisition-related IPR&D — ( 202,096 )

Changes in operating assets and liabilities, net of impact of acquisition:

Non-cash loss on settlement of contingent liability 44,286 —

Gain on extinguishment of note payable and accrued interest ( 369,887 ) —

Changes in operating assets and liabilities:

Other receivables ( 685,149 ) 95,042

Prepaid expenses ( 622,336 ) ( 454,133 )

Other non-current assets and deferred charges 157,725 237,937

Other non-current assets 20,873 157,725

Accounts payable 1,081,749 ( 61,850 )

4 unchanged sentences

Investing activities:

Acquisition of Microchips cash — 6,143,893

Purchases of property and equipment ( 14,524 ) ( 17,625 )

Net cash provided by (used in) investing activities ( 17,625 ) 6,143,893

Net cash used in investing activities ( 14,524 ) ( 17,625 )

Financing activities:

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Cash and cash equivalents, end of year $ 51,674,087 $ 4,669,467

Supplemental disclosure of non-cash operating, investing and financing activities:

Supplemental disclosure of non-cash investing and financing activities:

Operating right-of-use assets obtained in exchange for new operating lease liabilities $ 308,533 $ —

Settlement of contingent closing consideration liability with stock issuance in connection with acquisition of business $ 925,000 $ —

Milestone payment paid in common stock $ 250,000 $ —

Issuance cost on equity paid in common stock $ — $ 291,428

Deemed dividend from trigger of down round provision $ — $ 6,863

Microchips acquisition consideration paid in equity $ — $ 2,369,992

See Accompanying Notes to Consolidated Financial Statements.

See accompanying notes.

Daré Bioscience, Inc.

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Daré Bioscience, Inc.

is a clinical-stage biopharmaceutical company committed to advancing innovative products for women’s health.

is a biopharmaceutical company committed to advancing innovative products for women’s health.

Daré Bioscience, Inc.

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and its wholly owned subsidiaries, unless otherwise stated or the context otherwise requires.

The Company is driven by a mission to identify, develop and bring to market a diverse portfolio of differentiated therapies that expand treatment options, improve outcomes and facilitate convenience for women, primarily in the areas of contraception, vaginal health, sexual health and fertility.

The Company's business strategy is to in-license or otherwise acquire the rights to differentiated product candidates in the Company's areas of focus, some of which have existing clinical proof-of-concept data, to take those candidates through mid to late-stage clinical development, and to establish and leverage strategic partnerships to achieve commercialization.

Since July 2017, the Company has assembled a portfolio of clinical-stage and pre-clinical-stage candidates.

While the Company will continue to assess opportunities to expand its portfolio, its current focus is on advancing its existing product candidates through mid and late stages of clinical development or FDA approval.

The Company's portfolio includes three product candidates in advanced clinical development:

• 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;

• Ovaprene® , a hormone-free, monthly vaginal contraceptive;

The Company is driven by a mission 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, fertility, and vaginal and sexual health.

The Company's first product, XACIATO™, which was approved by the FDA in December 2021, is a single-dose vaginal gel prescription product for the treatment of bacterial vaginosis in females 12 years of age and older.

In March 2022, the Company entered into an exclusive global license agreement with an affiliate of Organon & Co., Organon International GmbH, or Organon, to commercialize XACIATO.

XACIATO is expected to be available commercially in the United States in the fourth quarter of 2022.

The Company began assembling its diverse portfolio of clinical-stage product candidates and pre-clinical programs in 2017 through acquisitions, exclusive in-licenses and other collaborations.

The Company's programs target unmet needs in women's health in the areas of contraception, fertility, and vaginal and sexual health, and aim to expand treatment options, enhance outcomes and improve ease of use for women.

The Company's portfolio includes two product candidates in advanced clinical development:

• Ovaprene® , a hormone-free, monthly 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.

The Company's portfolio also includes three product candidates in Phase 1 clinical development or that it believes are Phase 1-ready:

• DARE-HRT1 , a combination bio-identical estradiol and progesterone intravaginal ring for the treatment of menopausal symptoms, including vasomotor symptoms, as part of a hormone therapy following menopause;

• DARE - FRT1 , an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth and broader luteal phase support as part of an in vitro fertilization treatment plan;

• DARE - VVA1 , a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy , or VVA , in patients with hormone- receptor positive breast cancer;

In addition, the Company's portfolio includes these pre-clinical stage product candidates:

• DARE-LARC1 , a combination product designed to provide long-acting, reversible contraception comprising an implantable, user-controlled wireless drug delivery system and levonorgestrel;

• ORB-204 and ORB-214 , injectable formulations of etonogestrel designed to provide contraception over 6-month and 12-month periods, respectively;

The Company's portfolio also includes four product candidates in Phase 1 clinical development or that the Company believes are Phase 1-ready:

• DARE-HRT1 , a combination bio-identical estradiol and progesterone intravaginal ring for the treatment of menopausal symptoms, including vasomotor symptoms, as part of hormone therapy following menopause;

• DARE - VVA1 , a vaginally delivered formulation of tamoxifen to treat vulvar vaginal atrophy as an option for women with hormone- receptor positive breast cancer;

• DARE - FRT1 , an intravaginal ring containing bio-identical progesterone for broader luteal phase support as part of an in vitro fertilization treatment plan;

• DARE-PTB1 , an intravaginal ring containing bio-identical progesterone for the prevention of preterm birth;

In addition, the Company's portfolio includes these pre-clinical stage potential product candidates:

• DARE-LARC1 , a contraceptive implant delivering levonorgestrel with a woman-centered design that has the potential to be a long-acting, yet convenient and user-controlled contraceptive option;

• ADARE-204 and ADARE-214 , injectable formulations of etonogestrel designed to provide contraception over 6-month and 12-month periods, respectively;

• DARE-RH1 , a novel approach to non-hormonal contraception for both men and women by targeting the CatSper ion channel.

The Company’s primary operations have consisted of, and are expected to continue to consist primarily of, product research and development and advancing its portfolio of product candidates through clinical development and regulatory approval.

The Company expects that the majority of its research and development expenses in 2021 and 2022 will support the advancement of DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%.

To date, the Company has not obtained any regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any product revenue.

The Company is subject to several risks common to clinical-stage biopharmaceutical companies, including dependence on key individuals, competition from other companies, the need to develop commercially viable products in a timely and cost-effective manner, and the need to obtain adequate additional capital to fund the development of product candidates.

The Company is also subject to several risks common to other companies in the industry, including rapid technology change, regulatory approval of products, uncertainty of market acceptance of products, competition from substitute products and larger companies, compliance with government regulations, protection of proprietary technology, dependence on third parties, and product liability.

The effect of the COVID-19 pandemic and efforts to reduce the spread of COVID-19 remain a rapidly evolving and uncertain risk to our business, operating results, financial condition and stock price.

In November 2020, the U.S.

began to experience a substantial surge in cases and hospitalizations and intensive care unit capacity became strained.

States and counties across the country imposed or re-imposed stay-at-home orders and shutdowns of non-essential businesses in efforts to reduce spread of the disease.

As of March 29, 2021, the U.S.

Food and Drug Administration (FDA) had issued emergency use authorizations for three vaccines for the prevention of COVID-19.

However, while President Biden recently said that there will be enough vaccine supply for every adult in the U.S.

by the end of May 2021, the vaccination effort in the U.S.

and elsewhere got off to a bumpy start and continues to face significant, complex challenges, and the timeline for the pandemic and its associated restrictions to end remain uncertain.

Given the high level of uncertainty regarding the duration and impact of the pandemic on the U.S.

and global economies, workplace environments and capital markets, the Company is unable to assess the full extent of the effects of the pandemic on its business.

These effects could have a material adverse impact on the Company's business, operating results and financial condition, including, without limitation, by adversely impacting the Company's ability to raise capital when needed or on terms favorable or acceptable to the Company, and increasing the anticipated aggregate costs and timelines for the development and marketing approval of the Company's product candidates.

For further discussion of risks and uncertainties related to the COVID-19 pandemic, see the risk factor titled, The COVID-19 pandemic and efforts to reduce the spread of COVID-19 could negatively impact our business, including by increasing the cost and timelines for our clinical development programs.

The Company’s primary operations have consisted of, and are expected to continue to consist primarily of, research and development activities to advance its portfolio of product candidates through clinical development and regulatory approval.

The Company has one FDA-approved product, XACIATO, which has not yet been commercially launched.

To date, the Company has not obtained any other regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any revenue.

The Company is subject to several risks common to biopharmaceutical companies, including dependence on key employees, dependence on third-party collaborators and service providers, competition from other companies, the need to develop commercially viable products in a timely and cost-effective manner, and the need to obtain adequate additional capital to fund the development of product candidates.

The Company is also subject to several risks common to other companies in the industry, including rapid technology change, regulatory approval of products, uncertainty of market acceptance of products, success of third parties in the marketing, sale and distribution of the Company's products, competition from substitute products and larger companies, compliance with government regulations, protection of proprietary technology, and product liability.

The COVID-19 pandemic remains an evolving and uncertain risk to the Company’s business, operating results, financial condition and stock price.

To date, the Company believes the pandemic contributed to a slower than expected initial pace of enrollment in its Phase 2b clinical study of Sildenafil Cream, 3.6% and delays in commencement of clinical studies and nonclinical testing for more than one of its earlier stage clinical programs, but has not had a material adverse effect on its business as a whole.

Continued uncertainty regarding the duration and impact of the pandemic on the U.S.

and global economies, healthcare systems, workplace environments and capital markets, preclude any prediction as to the ultimate effect of the pandemic on the Company’s business.

For further discussion of risks and uncertainties related to the pandemic, see the risk factor in Part I, Item 1A of this report titled, The COVID-19 pandemic has negatively impacted our business and, in the future, may materially and adversely affect our business, financial condition and results and stock price, including by increasing the cost and timelines for our clinical development programs.

BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

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The accompanying financial statements do not include any adjustments to reflect the possible future effects on the recoverability and reclassification of assets or the amounts and classifications of liabilities that may result from the outcome of the uncertainty of the Company's ability to continue as a going concern.

At December 31, 2020, the Company had an accumulated deficit of approximately $ 71.4 million, had cash and cash equivalents of approximately $ 4.7 million, and a working capital deficit of approximately $ 0.7 million.

At December 31, 2021, the Company had an accumulated deficit of approximately $ 110.1 million, cash and cash equivalents of approximately $ 51.7 million, and working capital of approximately $ 39.2 million.

For the year ended December 31, 2021, the Company incurred a net loss of $ 38.7 million and had negative cash flow from operations of approximately $ 28.8 million.

The Company’s primary uses of capital are, and the Company expects will continue to be, staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due under license agreements and its merger agreement with Microchips upon the successful achievement of milestones of the Company’s product candidates, legal expenses, other regulatory expenses and general overhead costs.

The Company’s future funding requirements could also include significant costs related to commercialization of its product candidates, if approved, depending on the type and nature of commercial partnerships the Company establishes.

The Company expects its expenses, and in particular its research and development expenses, to increase significantly in 2021 compared to 2020 as it continues to develop and seek to bring to market its product candidates, with a focus on DARE-BV1, Ovaprene and Sildenafil Cream, 3.6%

To date, the Company has not obtained any regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any product revenue, and the Company cannot anticipate if or when it will generate any revenue.

The Company has devoted significant resources to acquiring its portfolio of product candidates and to research and development activities for its product candidates.

The Company must obtain regulatory approvals to market and sell any of its products in the future.

The Company will need to generate sufficient safety and efficacy data on its product candidates for them to receive regulatory approvals and to be attractive assets for potential strategic partners to license or for pharmaceutical companies to acquire, and for the Company to generate cash and other license fees related to such product candidates.

The Company expects its primary uses of capital to be staff-related expenses, the cost of clinical trials and regulatory activities related to its product candidates, costs associated with contract manufacturing services and third-party clinical research and development services, payments due to third-party licensors upon the occurrence of commercial milestones for XACIATO and development milestones for the Company’s product candidates, legal expenses, other regulatory expenses and general overhead costs.

The Company’s future funding requirements could

also include significant costs related to commercialization of its product candidates, if approved, depending on the type, nature and terms of commercial collaborations the Company establishes.

The Company expects its expenses, and in particular its research and development expenses, to increase significantly in 2022 compared to 2021 as the Company continues to develop and seek to bring to market its product candidates, with a focus on its product candidates that have reached the human clinical study development phase.

To date, the Company has one FDA-approved product, XACIATO, which has not yet been commercially launched.

The Company has not obtained any other regulatory approvals for any of its product candidates, commercialized any of its product candidates or generated any revenue.

Commercial launch of XACIATO in the U.S.

by the Company's licensee, Organon, is expected in the fourth quarter of 2022.

Under the terms of its license agreement with Organon, the Company will receive a $ 10.0 million non-refundable and non-creditable payment following the effective date of the license agreement and will be entitled to receive tiered double-digit royalties based on net sales and up to $ 182.5 million in milestone payments as follows:

$ 2.5 million following the first commercial sale of a licensed product in the United States;

and up to $ 180.0 million in tiered commercial sales milestones and regulatory milestones.

The Company has devoted significant resources to building its portfolio of product candidates and to research and development activities related to these product candidates.

The Company or its licensees must obtain regulatory approvals to market and sell any of its product candidates in the future and to market and sell XACIATO anywhere outside the U.S.

The Company will need to generate sufficient safety and efficacy data on each of its product candidates in order to apply for regulatory approvals and for such assets to be attractive assets to potential strategic collaborators to license or to acquire, and for the Company to generate revenue through license fees, royalties on net revenues and commercial milestones related to such product candidates.

Based on the Company's current operating plan estimates, the Company does not have sufficient cash to satisfy its working capital needs and other liquidity requirements over at least the next 12 months from the date of issuance of the accompanying financial statements.

The Company needs to raise substantial additional capital to continue to fund its operations and to successfully execute its current operating plan, including the development of its product candidates.

The Company is currently evaluating a variety of capital raising options, including equity and debt financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements to cover its operating expenses, including the development of its product candidates and any future product candidates it may license or otherwise acquire.

The amount and timing of the Company's capital needs have been and will continue to depend highly on many factors, including the product development programs the Company chooses to pursue and the pace and results of its clinical development efforts.

If the Company raises capital through collaborations, strategic alliances or other similar types of arrangements, it may have to relinquish, on terms that are not favorable to the Company, rights to some of its technologies or product candidates it would otherwise seek to develop or commercialize.

There can be no assurances that capital will be available when needed

or that, if available, it will be obtained on terms favorable to the Company and its stockholders, particularly in light of the effects that the COVID-19 pandemic has recently had on the capital markets and investor sentiment.

In addition, equity or debt financings may have a dilutive effect on the holdings of the Company's existing stockholders, and debt financings may subject the Company to restrictive covenants, operational restrictions and security interests in our assets.

The Company will need to raise substantial additional capital to continue to fund its operations and to successfully execute its current strategy.

The Company will continue to seek to raise capital through the sale of shares of its common stock under its ATM sales agreements, however, when the Company can effect such sales and the amount of shares the Company can sell depends on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of its common stock and its determination as to the appropriate sources of funding for its operations.

For the foreseeable future, the Company will evaluate and may pursue a variety of capital raising options on an on-going basis, including equity and debt financings, government or other grant funding, collaborations and strategic alliances or other similar types of arrangements, to cover its operating expenses, and the cost of any license or other acquisition of new product candidates or technologies.

The amount and timing of the Company's capital needs have been and will continue to depend highly on many factors, including the product development programs the Company chooses to pursue, the pace and results of its clinical development efforts, and the nature and extent of expansion of its product candidate portfolio, if any.

If the Company raises capital through collaborations, strategic alliances or other similar types of arrangements, it may have to relinquish, on terms that are not favorable to the Company, rights to some of its technologies or product candidates the Company would otherwise seek to develop or commercialize.

There can be no assurance that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company and its stockholders.

If the Company cannot raise capital when needed, on favorable terms or at all, the Company will not be able to continue development of its product candidates, will need to reevaluate its planned operations and may need to delay, scale back or eliminate some or all of its development programs, reduce expenses, file for bankruptcy, reorganize, merge with another entity, or cease operations.

If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock.

The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

If the Company becomes unable to continue as a going concern, the Company may have to liquidate its assets, and might realize significantly less than the values at which they are carried on its condensed consolidated financial statements, and stockholders may lose all or part of their investment in the Company's common stock.

The Company's condensed consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Principles of Consolidation

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The financial statements of the Company’s wholly owned subsidiaries are recorded in their functional currency and translated into the reporting currency.

The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is reported in Accumulated Other Comprehensive Loss.

The cumulative effect of changes in exchange rates between the foreign entity’s functional currency and the reporting currency is

reported in Accumulated Other Comprehensive Loss.

All intercompany transactions and accounts have been eliminated in consolidation.

Grant Funding

The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Bill & Melinda Gates Foundation, or the Gates Foundation.

The funding is recognized in the statement of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period.

The Company receives certain research and development funding through grants issued by a division of the National Institutes of Health and the Bill & Melinda Gates Foundation, or the Foundation.

Under the Foundation grant, which the Company considers to be a research and development contract under FASB Accounting Standards Codification, or ASC, Topic 730 Research and Development , the Company granted the Foundation a Humanitarian License which gives the Foundation the right to make the funded developments accessible at an affordable price to people within developing countries.

The Company recognizes grant funding in the statements of operations as a reduction to research and development expense as the related costs are incurred to meet those obligations over the grant period.

The Company adopted this policy in 2018.

For the years ended December 31, 2020 and December 31, 2019, the Company recognized approximately $ 3.7 million and $ 1.3 million, respectively, in the statement of operations as a reduction to research and development expense.

Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant payments liability in the Company's consolidated balance sheets.

For the years ended December 31, 2021 and December 31, 2020, the Company recognized approximately $ 2.5 million and $ 3.7 million, respectively, in the statements of operations as a reduction to research and development expense.

Grant funding payments received in advance of research and development expenses incurred are recorded as deferred grant funding liability in the Company's consolidated balance sheets.

Use of Estimates

The preparation of the consolidated financial statements requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period.

Significant estimates include the fair value of stock-based compensation, and purchase accounting.

Significant estimates include the fair value of stock-based compensation.

Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results.

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Food and Drug Administration, or FDA, or foreign regulatory agencies prior to being able to sell any products.

The Company received approval from the FDA for its first product, XACIATO™, in December 2021.

There can be no assurance that the Company’s current or future product candidates will receive the necessary approvals.

If the Company is denied regulatory approval of its product candidates, or if approval is delayed, it may have a material adverse impact on the Company’s business, results of operations and its financial position.

In the event the Company receives a regulatory approval for a product, the market’s acceptance of the product remains a risk.

The Company is subject to a number of risks similar to other life science companies, including, but not limited to, risks related to the ability to license product candidates, successfully develop product candidates, successfully commercialize approved products or enter into strategic relationships with third parties who are able to successfully commercialize approved products, raise additional capital, compete with other products, and protect proprietary technology.

As a result of these and other factors and the related uncertainties, there can be no assurance of the Company’s future success.

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The Company considers cash and all highly liquid investments with an original maturity of three months or less to be cash and cash equivalents.

The Company’s wholly owned subsidiary, Microchips Biotech, Inc., has a $ 35,903 letter of credit related to the lease of real property that serves as security for future default of lease payments.

The letter of credit is collateralized by cash which is unavailable for withdrawal or for usage for general obligations and is included in cash and cash equivalents on the Company's consolidated balance sheet.

The Company’s wholly owned subsidiary, Dare MB Inc., has a $ 35,903 letter of credit related to the lease of real property that serves as security for future default of lease payments.

Concentration of Credit Risk

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$ 49,666,064 $ — $ — $ 49,666,064

Current liabilities:

Current portion of contingent consideration (2)

$ — $ — $ 1,000,000 $ 1,000,000

Balance at December 31, 2020

Current assets:

Cash and cash equivalents $ 4,780,107 $ — $ — $ 4,780,107

Cash equivalents (1)

$ 2,823,099 $ — $ — $ 2,823,099

Other non-current liabilities:

Contingent consideration, net of current portion (2)

Current portion of contingent consideration (2)

$ — $ — $ 1,000,000 $ 1,000,000

(1) Represents the cash held in money market funds.

(2) Represents t he estimated fair value of the contingent consideration potentially payable by the Company related to its acquisition of Microchips Biotech, Inc., as described in Note 4.

(1) Represents cash held in money market funds.

(2) Represented t he estimated fair value of the contingent consideration payable by the Company related to an acquisition completed in November 2019, and which was paid in September 2021, as described in Note 3.

The following table presents a reconciliation of contingent consideration, which was measured at fair value on a recurring basis using significant unobservable inputs (Level 3):

Year Ended December 31,

Balance at beginning of period $ 1,000,000 $ 1,000,000

Satisfaction of contingent consideration (1)

( 1,000,000 ) —

Balance at end of period $ — $ 1,000,000

(1) In June 2021, the contingent consideration payable by the Company related to an acquisition completed in November 2019 became due.

In September 2021, the Company issued approximately 700,000 shares of its common stock in satisfaction of the milestone payments associated with milestones achieved, as described in Note 3.

Revenue Recognition

The Company recognizes revenue is accordance with Accounting Standards Codification, or ASC, Topic 606, Revenue from Contracts with Customers , which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.

The Company recognizes revenue in accordance with FASB ASC Topic 606, Revenue from Contracts with Customers , which applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, collaboration arrangements and financial instruments.

The Company recognizes revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which it expects to be entitled in exchange for those goods or services.

To determine revenue recognition for contracts with customers, the Company performs the following five steps:

revenue recognition for contracts with customers, the Company performs the following five steps:

(i) identify the contract(s) with a customer;

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and (v) recognize revenue when (or as) the Company satisfies its performance obligations.

At contract inception, the Company assesses the goods or services agreed upon within each contract and assess whether each good or service is distinct and determine those that are performance obligations.

At contract inception, the Company assesses the goods or services agreed upon within each contract and assesses whether each good or service is distinct, and determines those that are performance obligations.

The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

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To date, the Company has not recognized any license fee revenue resulting from any of its collaborative arrangements.

For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

To date, the Company has not recognized any royalty revenue resulting from any of its collaborative arrangements.

Royalties and Commercial Milestones.

For arrangements that include sales-based royalties and milestone payments based on the level of sales, and for which the license is deemed to be the predominant item to which the royalties and milestones relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

To date, the Company has not recognized any royalty revenue or any commercial milestones resulting from any of its collaborative arrangements.

Bayer License.

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As of December 31, 2021, neither of the foregoing had occurred.

The $ 1.0 million payment is recorded as long term deferred revenue in the Company's consolidated balance sheet at December 31, 2020.

The Company will also be entitled to receive (a) milestone payments totaling up to $ 310.0 million related to the commercial sales of Ovaprene, if all such milestones are achieved, and (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue.

The $ 1.0 million payment is recorded as deferred license revenue in the Company's consolidated balance sheets at December 31, 2021 and December 31, 2020.

The Company will also be entitled to receive (a) milestone payments totaling up to $ 310.0 million related to the commercial sales of Ovaprene, if all such milestones are achieved, (b) tiered royalties starting in the low double digits based on annual net sales of Ovaprene during a calendar year, subject to customary royalty reductions and offsets, and (c) a percentage of sublicense revenue.

Potential future payments for variable consideration, such as commercial milestones, will be recognized when it is probable that, if recorded, a significant reversal will not take place.

Potential future royalty payments will be recorded as revenue when the associated sales occur.

(See Note 3, License and Collaboration Agreements.)

(See Note 3, Strategic Agreements.)

The Company determines if an arrangement is a lease at inception.

Operating leases are included in right-of-use, or ROU, lease assets, current portion of lease obligations, and long-term lease obligations on the Company's consolidated balance sheets.

Operating leases are included in other non-current assets as right-of-use, or ROU, lease assets, current portion of lease liabilities, and long-term lease liabilities on the Company's consolidated balance sheets.

ROU lease assets represent the Company's right to use an underlying asset for the lease term and lease obligations represent the Company's obligation to make lease payments arising from the lease.

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(See Note 11, Leased Properties.)

Business Combinations

Assets acquired and liabilities assumed as part of a business acquisition are recorded at their estimated fair value at the date of acquisition.

The excess of the total purchase consideration over the fair value of assets acquired and liabilities assumed is recorded as goodwill.

Determining fair value of identifiable assets, particularly intangibles, and liabilities acquired also requires management to make estimates, which are based on all available information and, in some cases, assumptions with respect to the timing and amount of future revenue and expenses associated with an asset.

Acquired In-Process Research and Development Expense

The Company has acquired, and may continue to acquire, the rights to develop new product candidates.

Payments to acquire a new product candidate, as well as future milestone payments associated with asset acquisitions which are deemed probable of achievement, are immediately expensed as acquired in-process research and development provided that the product candidate has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use.

Segment Reporting

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Its chief operating decision maker is the chief executive officer.

The Company has one operating segment, women’s reproductive health.

The Company has one operating segment, women’s health.

Research and Development Costs

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to CROs and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses.

Research and development expenses consist of expenses incurred in performing research and development activities, including compensation and benefits for full-time research and development employees, an allocation of facilities expenses, overhead expenses, manufacturing process-development and scale-up activities, fees paid to clinical and regulatory consultants, clinical trial and related clinical trial manufacturing expenses, fees paid to contract research organizations, or CROs, and investigative sites, transaction expenses incurred in connection with the expansion of the product portfolio through acquisitions and license and option agreements, milestone payments incurred or probable to be incurred for the Company's in-licensing arrangements, payments to universities under the Company’s license agreements and other outside expenses.

Research and development costs are expensed as incurred.

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Treasury Bills in determining the risk-free interest rate appropriate given the expected term.

Finally, the Company has not established and has no plans to establish a dividend policy or declare any dividends in the foreseeable future and thus no dividend yield was determined necessary in the calculation of fair value.

The Company accounts for income taxes using the asset and liability method in accordance with Accounting Standards Codification, or ASC 740, Income Taxes .

Under this method deferred income taxes are provided to reflect the tax consequences in future years of differences between the tax basis of assets and liabilities and their financial reporting amounts based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income.

The Company has not established and has no plans to establish, a dividend policy, and the Company has not declared, and has no plans to declare dividends in the foreseeable future and thus no dividend yield was determined necessary in the calculation of fair value.

The Company accounts for income taxes using the asset and liability method in accordance with FASB ASC 740, Income Taxes .

taxable income.

Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.

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At December 31, 2021, the Company did not record any liabilities for uncertain tax positions.

During each 2020 and 2019, the Company recorded no provision for income taxes.

Management evaluated the Company’s tax positions and, as of December 31, 2020, the Company has approximately $ 1.3 million of unrecognized benefits.

During each of 2021 and 2020, the Company recorded no provision for income taxes.

Management evaluated the Company’s tax positions and, as of December 31, 2021, the Company had approximately $ 1.9 million of unrecognized benefits.

The tax years 2017 to 2021 remain open to examination by federal and state taxing authorities while the statute of limitations for U.S.

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Accordingly, as of December 31, 2021 and 2020, no amounts have been accrued related to such indemnification provisions.

LICENSE AND COLLABORATION AGREEMENTS

Out-License Agreements

STRATEGIC AGREEMENTS

Strategic Agreement for Product Commercialization

Bayer HealthCare License Agreement

On January 10, 2020, the Company entered into a license agreement with Bayer, regarding the further development and commercialization of Ovaprene in the U.S.

Under the agreement, the Company received a $ 1.0 million upfront non-refundable license fee payment from Bayer.

If Bayer pays an additional $ 20.0 million to the Company after Bayer receives and reviews the results of the pivotal clinical trial of Ovaprene, which payment Bayer may elect to make in its sole discretion, the license grant to Bayer to develop and commercialize Ovaprene for human contraception in the U.S.

becomes effective.

In January 2020, the Company entered into a license agreement with Bayer, regarding the further development and commercialization of Ovaprene in the U.S.

The Company received a $ 1.0 million upfront non-refundable license fee payment from Bayer and Bayer agreed to support the Company in development and regulatory activities by providing the equivalent of two experts to advise the Company in clinical, regulatory, preclinical, commercial, CMC and product supply matters.

Bayer, in its sole discretion, has the right to make the license effective by paying the Company an additional $ 20.0 million, referred to as the Clinical Trial and Manufacturing Activities Fee.

Such license would be exclusive with regard to the commercialization of Ovaprene for human contraception in the U.S.

and co-exclusive with the Company with regard to development.

The following is a summary of the other terms of the Bayer license agreement:

Milestone & Royalty Payments .

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The Company is responsible for the pivotal trial for Ovaprene and for its development and regulatory activities and has product supply obligations.

Bayer is supporting the Company in development and regulatory activities by providing up to two full-time equivalents with expertise in clinical, regulatory, preclinical, commercial, CMC and product supply matters in an advisory capacity.

After payment of the $ 20.0 million fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S.

After payment of the Clinical Trial and Manufacturing Activities Fee, Bayer will be responsible for the commercialization of Ovaprene for human contraception in the U.S.

The initial term of the agreement, which is subject to automatic renewal terms, continues until the later of (a) the expiration of any valid claim covering the manufacture, use, sale or import of Ovaprene in the U.S.;

or (b) 15 years from the first commercial sale of Ovaprene in the U.S.

In addition to customary termination rights for both parties, Bayer may terminate the agreement at any time on 90 days' notice and the agreement will automatically terminate if the Company does not receive the $ 20.0 million fee if and when due.

In-License Agreements

Strategic Agreements for Pipeline Development

Hammock/MilanaPharm Assignment and License Agreement

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The licensed intellectual property relates to the hydrogel drug delivery platform of TriLogic and MilanaPharm known as TRI-726.

In DARE-BV1, this proprietary technology is formulated with clindamycin for the treatment of bacterial vaginosis.

In XACIATO, this proprietary technology is formulated with clindamycin for the treatment of bacterial vaginosis.

In December 2019, the Company entered into amendments to each of the Assignment Agreement and License Amendment.

In September 2021, the Company and Trilogic and MilanaPharm entered into another amendment to the License Agreement.

The following is a summary of other terms of the License Amendment, as amended:

License Fees.

A total of $ 235,000 in license fees were payable, and were paid to, MilanaPharm:

(1) $ 25,000 in connection with the execution of the License Amendment;

(2) $ 100,000 in 2019;

and (3) $ 110,000 in 2020.

A total of $ 235,000 in license fees were payable to MilanaPharm, the final installment of which was $ 110,000 paid in 2020.

Milestone Payments.

The Company will pay to MilanaPharm (1) up to $ 300,000 in the aggregate upon achievement of certain clinical and regulatory development milestones;

$ 50,000 of which was paid during the second quarter of 2020, and (2) up to $ 1.75 million in the aggregate upon achieving certain commercial sales milestones.

The Company paid MilanaPharm $ 300,000 in the aggregate upon achievement of certain clinical and regulatory development milestones;

$ 50,000 of which was paid in 2020 and $ 250,000 of which was paid in 2021.

The Company may also pay MilanaPharm up to $ 1.75 million in the aggregate upon achieving certain commercial sales milestones.

Foreign Sublicense Income.

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The royalty term, which is determined on a country-by-country basis and licensed product-by-product basis (or process-by-process basis), begins with the first commercial sale of a licensed product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim of the licensed patent rights that cover the method of use of such product or process in such country, or (2) 10 years following the first commercial sale of such product or process in such country.

Royalty payments are subject to reduction in certain circumstances, including as a result of generic competition, patent prosecution expenses incurred by the Company, or payments to third parties for rights or know-how required for us to exercise the licenses granted to it under the MilanaPharm License Agreement or that are strategically important or could add value to a licensed product or process in a manner expected to materially generate or increase sales.

Royalty payments are subject to reduction in certain circumstances, including as a result of generic competition, patent prosecution expenses incurred by the Company, or payments to third parties for rights or know-how required for the Company to exercise the licenses granted to it under the MilanaPharm License Agreement or that are strategically important or could add value to a licensed product or process in a manner expected to materially generate or increase sales.

The Company must use commercially reasonable efforts and resources to (1) develop and commercialize at least one licensed product or process in the United States and at least one licensed product or process in at least one of Canada, the United Kingdom, France, Germany, Italy or Spain, and (2) continue to commercialize that product or process following the first commercial sale of a licensed product or process in the applicable jurisdiction.

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Upon expiration of the term with respect to any licensed product or process in a country (but not upon earlier termination of the MilanaPharm License Agreement), the licenses granted to the Company under the MilanaPharm License Agreement will convert automatically to an exclusive, fully paid-up, royalty-free, perpetual, non-terminable and irrevocable right and license under the licensed intellectual property.

In addition to customary termination rights for all parties, MilanaPharm may terminate the license granted to the Company solely with respect to a licensed product or process in a country if, after having launched such product or process in such country, (1) the Company or its affiliates or sublicensees discontinue the sale of such product or process in such country and MilanaPharm notifies the Company of such termination within 60 days of having first been notified by the Company of such discontinuation, or (2) the Company or its affiliates or sublicensees (A) discontinue all commercially reasonable marketing efforts to sell, and discontinue all sales of, such product or process in such country for nine months or more, (B) fail to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fail to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to the Company.

process in such country and MilanaPharm notifies the Company of such termination within 60 days of having first been notified by the Company of such discontinuation, or (2) the Company or its affiliates or sublicensees (A) discontinue all commercially reasonable marketing efforts to sell, and discontinue all sales of, such product or process in such country for nine months or more, (B) fail to resume such commercially reasonable marketing efforts within 120 days of having been notified of such failure by MilanaPharm, (C) fail to reasonably demonstrate a strategic justification for the discontinuation and failure to resume to MilanaPharm, and (D) MilanaPharm gives 90 days’ notice to the Company.

The following is a summary of other terms of the Assignment Agreement, as amended:

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Hammock assigned and transferred to the Company all of its right, title and interest in and to the MilanaPharm License Agreement and agreed to cooperate to transfer to the Company all of the data, materials and the licensed technology in its possession pursuant to a technology transfer plan to be agreed upon by the parties, with a goal for the Company to independently practice the licensed intellectual property as soon as commercially practical in order to develop and commercialize the licensed products and processes.

A total of $ 512,500 in fees were payable, and were paid, to Hammock:

(1) $ 250,000 in connection with the execution of the Assignment Agreement;

(2) $ 125,000 in 2019;

and (3) $ 137,500 in 2020.

A total of $ 512,500 in fees were payable to Hammock, the final installment of which was $ 137,500 paid in 2020.

Milestone Payments.

The Company will pay Hammock up to $ 1.1 million in the aggregate upon achievement of certain clinical and regulatory development milestones.

The Company will pay Hammock up to $ 1.1 million in the aggregate upon achievement of certain clinical and regulatory development milestones, $ 100,000 of which was paid in 2020 and $ 750,000 of which was paid in 2021.

The remaining milestone does not relate to a bacterial vaginosis product.

The Assignment Agreement will terminate upon the later of (1) completion of the parties' technology transfer plan, and (2) payment to Hammock of the last of the milestone payments.

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In March 2017, the Company entered into a license agreement with ADVA-Tec, Inc., under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide.

The Company must use commercially reasonable efforts to develop and commercialize Ovaprene and

must meet certain minimum spending amounts per year, and $ 5.0 million in the aggregate over the first three years, to cover such activities until a final PMA is filed, or until the first commercial sale of Ovaprene, whichever occurs first.

The Company must use commercially reasonable efforts to develop and commercialize Ovaprene and must meet certain minimum spending amounts per year, including $ 2.5 million per year to cover such activities until a final PMA is filed, or until the first commercial sale of Ovaprene, whichever occurs first.

ADVA-Tec will conduct certain research and development work as necessary to allow the Company to seek a PMA from the FDA and will provide the Company with clinical trial and commercial supplies of Ovaprene, either directly or through a CMO, on commercially reasonable terms.

Under the license agreement, in addition to an exclusive license to ADVA-Tec's and its affiliates' intellectual property rights for all uses of Ovaprene as a human contraceptive device, the Company has a right of first refusal to license these patents and patent applications for additional indications.

The following is a summary of other terms of the ADVA-Tec license agreement:

Milestone Payments.

The Company will pay to ADVA-Tec:

(1) up to $ 14.6 million in the aggregate based on the achievement of specified development and regulatory milestones and (2) up to $ 20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones.

(1) up to $ 14.6 million in the aggregate based on the achievement of specified development and regulatory milestones, $ 200,000 of which was paid in 2021;

and (2) up to $ 20.0 million in the aggregate based on the achievement of certain worldwide net sales milestones.

The remaining development and regulatory milestones include:

the FDA's approval to commence a pivotal clinical trial;

successful completion of such pivotal clinical trial;

the FDA's acceptance of a PMA filing for Ovaprene;

the FDA's approval of the PMA for Ovaprene;

CE Marking of Ovaprene in at least three designated European countries;

obtaining regulatory approval in at least three designated European countries;

and obtaining regulatory approval in Japan.

Royalty Payments .

After the commercial launch of Ovaprene, the Company will pay to ADVA-Tec royalties based on aggregate annual net sales of Ovaprene in specified regions, at a royalty rate that will vary between 1 % and 10 % and will increase based on various net sales thresholds.

Unless earlier terminated, the license continues on a country-by-country basis until the later of the life of the licensed patents or final commercial sale of Ovaprene.

Unless earlier terminated, the license the Company received under the agreement continues on a country-by-country basis until the later of the life of the licensed patents or the Company's last commercial sale of Ovaprene.

In addition to customary termination rights for both parties:

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SST License and Collaboration Agreement

In February 2018, the Company entered into a license and collaboration agreement with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST, under which the Company received an exclusive, royalty-bearing, sublicensable license to develop and commercialize, in all countries and geographic territories of the world, for all indications for women related to female sexual dysfunction and/or female reproductive health, including the treatment of female sexual arousal disorder, or the Field of Use, SST’s topical formulation of Sildenafil Cream, 3.6% as it existed as of the effective date of the agreement, or any other topically applied pharmaceutical product containing sildenafil or a salt thereof as a pharmaceutically active ingredient, alone or with other active ingredients, but specifically excluding any product containing ibuprofen or any salt derivative of ibuprofen, or the Licensed Products.

The following is a summary of other terms of this license and collaboration agreement:

In February 2018, the Company entered into a license and collaboration agreement with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST, under which the Company received an exclusive, royalty-bearing, sublicensable license to develop and commercialize, in all countries and geographic territories of the world, for all indications for women related to female sexual dysfunction and/or female reproductive health, including treatment of female sexual arousal disorder, or the Field of Use, SST’s topical formulation of Sildenafil Cream, 3.6% as it existed as of the effective date of the agreement, or any other topically applied pharmaceutical product containing sildenafil or a salt thereof as a pharmaceutically active ingredient, alone or with other active ingredients, but specifically excluding any product containing ibuprofen or any salt derivative of ibuprofen, or the Licensed Products.

The following is a summary of other terms of the SST license agreement:

Invention Ownership.

The Company retains rights to inventions made by its employees, SST retains rights to inventions made by its employees, and each party shall own a 50 % undivided interest in all joint inventions.

The Company retains rights to inventions made by its employees, SST retains rights to inventions made by its employees, and each party owns a 50 % undivided interest in all joint inventions.

Joint Development Committee.

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and worldwide, and (2) between $ 10.0 million to $ 100.0 million in the aggregate upon achieving certain commercial sales milestones.

Company enters into strategic development or distribution partnerships related to the Licensed Products, additional milestone payments would be due to SST.

If the Company enters into strategic development or distribution partnerships related to the Licensed Products, additional milestone payments would be due to SST.

The Company’s license continues on a country-by-country basis until the later of 10 years from the date of the first commercial sale of such Licensed Product or the expiration of the last valid claim of patent rights covering the Licensed Product in the Field of Use.

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In April 2018, the Company entered into an exclusive license agreement with Catalent JNP, Inc.

and (b) a non-exclusive, royalty-bearing worldwide license to use certain technological information owned by Catalent to make, have made, use, have used, sell, have sold, import and have imported products and processes.

(formerly known as Juniper Pharmaceuticals, Inc., and which the Company refers to as Catalent), under which Catalent granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Catalent, to make, have made, use, have used, sell, have sold, import and have imported products and processes, and (b) a non-exclusive, royalty-bearing worldwide license to use certain technological information owned by Catalent to make, have made, use, have used, sell, have sold, import and have imported products and processes.

The Company is entitled to sublicense the rights granted to it under this agreement.

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The Company will pay an annual license maintenance fee to Catalent on each anniversary of the date of the agreement, the amount of which will be $ 50,000 for the first two years and $ 100,000 thereafter, and which will be creditable against royalties and other payments due to Catalent in the same calendar year but may not be carried forward to any other year.

The Company made the first payments in April 2019.

Milestone Payments.

The Company must make potential future development and sales milestone payments of (1) up to $ 13.5 million in the aggregate upon achieving certain clinical and regulatory milestones, and (2) up to $ 30.3 million in the aggregate upon achieving certain commercial sales milestones for each product or process covered by the licenses granted under the agreement.

The Company must make potential future development and sales milestone payments of (1) up to $ 13.5 million in the aggregate upon achieving certain clinical and regulatory milestones, $ 1.0 million of which became payable in the third quarter of 2021, and in accordance with the license agreement, the amount was offset by the $ 100,000 annual maintenance fee, resulting in a net amount of $ 900,000 paid during the third quarter of 2021, and (2) up to $ 30.3 million in the aggregate upon achieving certain commercial sales milestones for each product or process covered by the licenses granted under the agreement.

Royalty Payments .

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In lieu of such royalty payments, the Company will pay Catalent a low double-digit percentage of all sublicense income the Company receives for the sublicense of rights under the agreement to a third party.

The royalty term, which is determined on a country-by-country basis and product-by-product basis (or process-by-process basis), begins with the first commercial sale of a product or process in a country and terminates on the latest of (1) the expiration date of the last valid claim within the licensed patent rights with respect to such product or process in such country, (2) 10 years following the first commercial sale of such product or process in such country, and (3) when one or more generic products for such product or process are commercially available in such country, except that if there is no such generic product by the 10th year following the first commercial sale in such country, then the royalty term will terminate on the 10-year anniversary of the first commercial sale in such country.

The Company must use commercially reasonable efforts to develop and make at least one product or process available to the public, which efforts include achieving specific diligence requirements by specific dates specified in the agreement.

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Upon expiration (but not early termination) of the agreement, the licenses granted thereunder will convert automatically to fully-paid irrevocable licenses.

Catalent may terminate the agreement (1) upon 30 days’ notice for the Company’s uncured breach of any payment obligation under the agreement, (2) if the Company fails to maintain required insurance, (3) immediately upon the Company’s insolvency or the making of an assignment for the benefit of the Company’s creditors or if a bankruptcy petition is filed for or against the Company, which petition is not dismissed within 90 days, or (4) upon 60 days’ notice for any

uncured material breach by the Company of any of the Company’s other obligations under the agreement.

The Company may terminate the agreement on a country-by-country basis for any reason by giving 180 days’ notice (or 90 days’ notice if such termination occurs prior to receipt of marketing approval in the United States).

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Adare Development and Option Agreement

In March 2018, the Company entered into an exclusive development and option agreement with Adare Pharmaceuticals (formerly known as Orbis Biosciences, and which the Company refers to as Adare), for the development of long-acting injectable etonogestrel contraceptive with 6- and 12-month durations (ORB-204 and ORB-214, respectively).

Under this agreement, the Company paid Adare $ 300,000 to conduct the first stage of development work, Stage 1, as follows:

$ 150,000 upon signing the agreement, $ 75,000 at the 50 % completion point, not later than 6 months following the date the agreement was signed (which the Company paid in September 2018), and $ 75,000 upon delivery by Adare of the 6-month batch, not later than 11 months following the date the agreement was signed (which the Company paid in January 2019).

Upon Adare successfully completing the first stage of development work and achieving the predetermined target milestones for that stage, the Company will have 90 days to instruct Adare whether to commence the second stage of development work.

Should the Company execute its option to proceed with the second stage, it will have to provide additional funding to Adare for such activities.

Pre-clinical studies for the 6- and 12-month formulations have been completed, including establishing pharmacokinetics and pharmacodynamics profiles.

The collaboration with Adare will continue to advance the program through formulation optimization with the goal of achieving sustained release over the target time period.

The agreement provides the Company with an option to enter into a license agreement for ORB-204 and ORB-214 should development efforts be successful.

Acquired Products

Microchips Acquisition

As further discussed in Note 4.

Acquisition below, in November 2019, the Company acquired Microchips Biotech, Inc., or Microchips.

The Company acquired Microchips to secure the rights to develop an implantable, user-controlled, long-acting reversible contraception method, now known as DARE-LARC1.

The Company issued an aggregate of 2,999,990 shares of its common stock to the holders of shares of Microchips' capital stock outstanding immediately prior to the effective time of the merger.

The Company also agreed to pay the following contingent consideration to the former Microchips stockholders:

ADARE-204 and ADARE-214, respectively).

The agreement provides the Company with an option to negotiate an exclusive license agreement for the programs if the Company funds the conduct of specified development work by Adare.

MBI Acquisition

In November 2019, the Company acquired Dare MB Inc.

(formerly, Microchips Biotech, Inc.), or MBI, to secure the rights to develop a long-acting reversible contraception method, that a woman can turn on or off herself, according to her own needs.

This candidate is now known as DARE-LARC1.

At the closing of the acquisition, the Company issued an aggregate of approximately 3.0 million shares of its common stock to the holders of shares of MBI's capital stock outstanding immediately prior to the effective time of the merger.

The transaction was valued at $ 2.4 million, based on the fair value of the approximately 3.0 million shares issued at $ 0.79 per share, which was the closing price per share of the Company's common stock on the date of closing.

The shares were issued in exchange for MBI's cash and cash equivalents of $ 6.1 million, less net liabilities of $ 3.5 million and transaction costs of $ 202,000 , which was allocated based on the relative fair value of the assets acquired and the liabilities assumed.

The Company also agreed to pay the following additional consideration to the former MBI stockholders:

(a) up to $ 46.5 million contingent upon the achievement of specified funding, product development and regulatory milestones;

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The Company agreed to use commercially reasonable efforts to achieve specified development and regulatory objectives relating to DARE-LARC1.

The Company recorded $ 1.0 million in contingent consideration associated with milestone payments it expects to become payable in the first half of 2021, and if and when they become due and payable, the Company may pay the milestones in cash, shares of the Company's common stock or with some combination of both.

In June 2021, a total of $ 1.25 million of that potential additional consideration became payable upon the achievement of certain of the funding and product development milestone events, $ 1.0 million of which was recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisition and $ 250,000 of which was expensed in 2021.

In July 2021, the Company’s board of directors elected to make these milestone payments in shares of the Company’s common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $ 75,000 in cash to the stockholders’ representative in accordance with the terms of the merger agreement in satisfaction of the $ 1.25 million in milestone payments associated with milestones achieved in June 2021.

Pear Tree Acquisition

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Milestone Payments .

The Company must make contingent payments to the Pear Tree former stockholders and their representatives, or the Holders, that are based on achieving certain clinical, regulatory and commercial

milestones, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock.

The Company must make contingent payments to the Pear Tree former stockholders or their representatives, or the Holders, that become payable upon achievement of specified clinical, regulatory and commercial milestones, which may be paid, in the Company’s sole discretion, in cash or shares of the Company’s common stock.

Royalty Payments .

The Holders will be eligible to receive, subject to certain offsets, tiered royalties, including customary provisions permitting royalty reductions and offset, based on percentages of annual net sales of certain products subject to license agreements the Company assumed and a percentage of sublicense revenue.

In November 2019, the Company acquired Microchips Biotech, Inc., or Microchips, via a merger transaction in which a wholly owned subsidiary the Company, formed for purposes of the transaction, merged with and into Microchips , and Microchips survived as the Company’s wholly owned subsidiary.

Microchips is developing a proprietary, implantable drug delivery system designed to store and precisely deliver numerous therapeutic doses over months and years on a schedule determined by the user and controlled via wireless remote.

Microchips’ lead product candidate is a pre-clinical stage contraceptive application of that technology that utilizes levonorgestrel, now known as DARE-LARC1.

The Company issued an aggregate of 2,999,990 shares of its common stock to the holders of shares of Microchips' capital stock outstanding immediately prior to the effective time of the merger.

The transaction was valued at $ 2.4 million, based on the fair value of the 2,999,990 shares issued at $ 0.79 per share, which was the closing price per share of the Company's common stock on the date of closing.

The shares were issued in exchange for Microchips’ cash and cash equivalents of $ 6.1 million, less net liabilities of $ 3.5 million and transaction costs of $ 202,000 , which was allocated based on the relative fair value of the assets acquired and liabilities assumed.

The Company also agreed to pay contingent consideration payments, tiered royalty payments and a percentage of sublicense revenue as discussed in Note 3, Acquired Products—Microchips Acquisition, above.

The Company determined the transaction was accounted for as an asset acquisition as there were no outputs or substantive processes in existence as of the acquisition date.

Transaction costs of approximately $ 202,000 associated with the merger were included in the Company’s research and development expense in the fourth quarter of 2019.

PREPAID EXPENSES

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Prepaid insurance, long-term portion $ 87,891 $ 246,016

Deferred financing costs 143,002 —

Deposits 37,554 43,304

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Total accrued expenses $ 3,136,244 $ 3,359,718

VENDOR CONCENTRATION

The Company had a major vendor that accounted for approximately 23 % and 20 % of the research and development expenditures for one of the Company's late-stage product candidates for the years ended December 31, 2021 and 2020, respectively.

The same vendor also accounted for approximately 4 % and 23 % of the total accounts payable and vendor-related accrued expenses as of December 31, 2021 and 2020, respectively.

The Company continues to maintain this vendor relationship and anticipates incurring significant expenses with this vendor over the next 12 months.

The components of loss from continuing operations before provision for income taxes consists of the following (in thousands):

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Accordingly, a valuation allowance of $ 99.8 million and $ 85.3 million was established at December 31, 2021 and 2020, respectively, to offset the net deferred tax assets.

When and if management determines that it is more likely

than not that the Company will be able to utilize the deferred tax assets prior to their expiration, the valuation allowance may be reduced or eliminated.

When and if management determines that it is more likely than not that the Company will be able to utilize the deferred tax assets prior to their expiration, the valuation allowance may be reduced or eliminated.

The increase in valuation allowance of approximately $ 14.5 million and $ 22.1 million for the years ending December 31, 2021 and 2020, respectively, is primarily related to an increase in net operating losses generated during the year.

The Company has U.S.

federal net operating loss, or NOL, carryforwards available at December 31, 2020 of approximately $ 255.9 million (2019– $ 174.5 million) of which, $ 0.2 million begin expiring in 2021 unless previously utilized and $ 78.1 million that do not expire.

The Company has state NOL carryforwards of $ 221.0 million (2019 – $ 140.1 million) that begin expiring in 2031 unless previously utilized.

federal net operating loss, or NOL, carryforwards available at December 31, 2021 of approximately $ 295.2 million of which $ 0.2 million begin expiring in 2022 unless previously utilized and $ 117.6 million that do not expire.

The Company has state NOL carryforwards of $ 292.6 million that begin expiring in 2031 unless previously utilized.

The Company has U.S.

federal research credit carryforwards available at December 31, 2020 of approximately $ 4.0 million (2019 – $ 3.1 million) that begin expiring in 2027 unless previously utilized.

The Company has state research credit carryforwards of $ 2.7 million (2019 – $ 1.9 million) that begin expiring in 2022 unless previously utilized.

These federal and state research and development credits are subject to a 20% reserve under ASC 740.

federal research credit carryforwards available at December 31, 2021 of approximately $ 6.9 million that begin expiring in 2027 unless previously utilized.

The Company has state research credit carryforwards of $ 2.7 million of which $ 0.1 million begin expiring in 2022 unless previously utilized.

These federal and state research and development credits are subject to a 20% reserve under FASB ASC 740.

The difference between federal and state NOL carryforwards is primarily due to previously expired state NOL carryforwards.

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To the extent an ownership change occurs, the NOL and credit carryforwards and other deferred tax assets may be subject to limitations.

In March 2020, the Coronavirus Aid, Relief and Economic Security (“CARES”) Act was enacted and signed into law and GAAP requires recognition of the tax effects of new legislation during the reporting period that includes the enactment date.

The CARES Act includes changes to the tax provisions that benefits business entities, and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act.

The tax relief measures for businesses in the CARES Act include a five-year net operating loss carryback for certain net operating losses, suspension of the annual deduction limitation of 80% of taxable income for certain net operating losses, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property.

The CARES Act also provides other non-tax benefits to assist those impacted by the pandemic.

The Company evaluated the impact of the CARES Act and determined that there is no material impact to the income tax provision for the year ended December 31, 2020.

The Consolidated Appropriation Act (“CAA”) of 2021 was signed into law in December 2020, containing COVID-19 relief provisions as well as many tax provisions including renewals of several popular tax extenders.

The Company evaluated the impact of the CAA and determined that there is no material impact to the income tax provision for the year ended December 31, 2020.

A reconciliation of the beginning and ending amount of uncertain tax benefits is as follows (in thousands):

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No additional provision has been made for U.S.

income taxes related to undistributed foreign earnings of the Company’s wholly owned Australian subsidiary or for unrecognized deferred tax liabilities for temporary differences

related to investments in subsidiaries.

income taxes related to undistributed foreign earnings of the Company’s wholly owned Australian subsidiary or for unrecognized deferred tax liabilities for temporary differences related to investments in subsidiaries.

As such, earnings are expected to be permanently reinvested, the investments are permanent in duration, or the Company has estimated that no additional tax liability will arise as a result of the distribution of such earnings.

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STOCKHOLDERS’ EQUITY

October 2021 ATM Sales Agreement

In October 2021, the Company entered into a sales agreement with SVB Leerink LLC to sell shares of its common stock from time to time through an "at-the-market," or ATM, equity offering program under which SVB Leerink acts as the Company's agent.

The Company agreed to pay a commission equal to 3 % of the gross proceeds of any common stock sold under the agreement, plus certain legal expenses.

Shares of the Company's common stock sold under the agreement will be issued pursuant to the Company's shelf registration statement on Form S-3 (File No.

333-254862) and the base prospectus included therein, originally filed with the SEC on March 30, 2021, and declared effective on April 7, 2021, and the prospectus supplement dated October 13, 2021 relating to the offering of up to $ 50.0 million in shares of the Company's common stock under this sales agreement, and any subsequent prospectus supplement filed with the SEC related to this ATM equity offering program.

During 2021, the Company sold approximately 7.1 million shares of common stock under this agreement for gross proceeds of approximately $ 16.3 million and incurred offering expenses of approximately $ 537,000 .

April 2021 ATM Sales Agreement

In April 2021, the Company entered into a sales agreement with SVB Leerink to sell shares of its common stock from time to time through an ATM equity offering program under which SVB Leerink acts as the Company's agent.

Under the sales agreement, the Company may issue and sell up to $50.0 million of shares of its common stock.

The Company agreed to pay a commission equal to 3% of the gross proceeds of any common stock sold under the agreement, plus certain legal expenses.

Any shares of the Company's common stock sold under the agreement will be issued pursuant to the Company's shelf registration statement on Form S-3 (File No.

During 2021, the Company sold approximately 26.0 million shares of common stock under this agreement for gross proceeds of approximately $ 46.9 million and incurred offering expenses of approximately $ 1.6 million.

2018 ATM Sales Agreement

In January 2018, the Company entered into a common stock sales agreement under which the Company may sell shares of its common stock from time to time in “at the market offerings” of equity securities (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, the "Securities Act").

The Company will pay a commission of up to 3 % of the gross proceeds of any common stock sold under this agreement plus certain legal expenses.

The common stock sales agreement was amended in August 2018 to refer to the Company’s shelf registration statement on Form S-3 (File No.

333-227019) that was filed to replace the Company’s shelf registration statement on Form S-3 (File No.

333-206396) that expired on August 28, 2018.

During 2020, the Company sold 12,577,703 shares of common stock under this agreement for gross proceeds of approximately $ 15.8 million and incurred offering expenses of approximately $ 594,000 .

The Company did not sell any shares under this agreement during 2019.

April 2019 Underwritten Public Offering

In April 2019, the Company closed an underwritten public offering of 4,575,000 shares of its common stock at a public offering price of $ 1.10 per share.

The Company granted the underwriters a 30-day over-allotment option to purchase up to an additional 686,250 shares which was exercised in full on April 12, 2019.

Including the over-allotment shares, the Company issued a total of 5,261,250 shares in the underwritten public offering and received gross proceeds of approximately $ 5.8 million and net proceeds of approximately $ 5.2 million after deducting underwriting discounts and offering expenses.

On April 22, 2020, the Company entered into a purchase agreement, or the Purchase Agreement, and a registration rights agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park.

Under the terms and subject to the conditions of the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $ 15.0 million of the Company’s common stock.

Such sales of common stock by the Company may occur from time to time, at the Company’s sole discretion, subject to certain limitations, until May 19, 2023.

On April 22, 2020, in accordance with the Purchase Agreement, the Company issued 285,714 shares of its common stock, or the Commitment Shares, to Lincoln Park in consideration for its commitment to purchase shares under the Purchase Agreement.

The Company filed a registration statement on Form S-1 (File No.

333-237954) to register the resale by Lincoln Park of up to 7.5 million shares of the Company's common stock issued or issuable to Lincoln Park under the Purchase Agreement, including the Commitment Shares, and such registration statement was declared effective by the SEC on May 12, 2020.

The Company filed a registration statement on Form S-1 (File No.

333-251599) to register the resale by Lincoln Park of up to 6.4 million additional shares of the Company's common stock issued or issuable to Lincoln Park under the Purchase Agreement, and such registration statement was declared effective by the SEC on January 7, 2021.

In January 2018 the Company entered into a common stock sales agreement with H.C.

Wainwright & Co., LLC, or Wainwright, relating to the offering and sale of shares of its common stock from time to time in an ATM equity offering program through Wainwright, acting as sales agent.

In March 2021, the Company provided notice to Wainwright to terminate the agreement, and the agreement terminated in April 2021.

Under the agreement, Wainwright was entitled to a commission at a fixed commission rate equal to 3 % of the gross proceeds per share sold under the agreement.

During 2021, the Company sold approximately 3.3 million shares of common stock under this agreement for gross proceeds of approximately $ 7.7 million and incurred offering expenses of approximately $ 245,000 .

During 2020, the Company sold approximately 12.6 million shares of common stock under this agreement for gross proceeds of approximately $ 15.8 million and incurred offering expenses of approximately $ 594,000 .

In April 2020, the Company entered into a purchase agreement, or the Purchase Agreement, and a registration rights agreement with Lincoln Park Capital Fund, LLC, or Lincoln Park.

Under the terms and subject to the conditions of the Purchase Agreement, the Company had the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park was obligated to purchase up to $ 15.0 million of the Company’s common stock.

The Company incurred legal, accounting, and other fees related to the Purchase Agreement of approximately $ 374,000 .

These costs are amortized and expensed as shares are sold under the Purchase Agreement.

As of December 31, 2020, there was approximately $ 175,000 of unamortized costs recorded as a prepaid in the Company's consolidated balance sheet.

During 2020, the Company sold, and Lincoln Park purchased, 7,214,286 shares under the Purchase Agreement for gross proceeds to the Company of approximately $ 8.0 million and recognized offering expenses of approximately $ 236,000 .

Under the Purchase Agreement, on any business day until May 19, 2023, the Company may direct Lincoln Park to purchase up to 200,000 shares of common stock, each, a Regular Purchase.

The Company may increase the share amount it directs Lincoln Park to purchase under a Regular Purchase to up to 250,000 shares or up to 300,000 shares if the closing sale price of the Company's common stock is not below $ 1.50 or $ 3.00 , respectively, on the business day on which the Company initiates the purchase, subject to adjustment for any reorganization,

recapitalization, non-cash dividend, stock split or other similar transaction as provided in the Purchase Agreement.

However, Lincoln Park’s maximum commitment in any single Regular Purchase may not exceed $ 1.0 million.

The purchase price per share for each Regular Purchase will be the lower of (i) the lowest sale price of the Company's common stock on the business day on which the Company initiates the purchase and (ii) the average of the three lowest closing sale prices of the Company's common stock during the 10-business day period immediately preceding the business day on which the Company initiates the purchase.

In addition to Regular Purchases, the Company may also direct Lincoln Park to purchase other amounts of common stock as accelerated purchases and as additional accelerated purchases, subject to limits specified in the Purchase Agreement, at a purchase price per share calculated as specified in the Purchase Agreement, but in no case lower than the minimum price per share the Company stipulates in its notice to Lincoln Park initiating these purchases.

In addition, under applicable Nasdaq rules, the Company may not issue or sell to Lincoln Park under the Purchase Agreement more than 4,941,089 shares of its common stock, or the Exchange Cap, unless (i) the Company obtains stockholder approval to issue shares in excess of the Exchange Cap or (ii) the average price of all applicable sales of the Company's common stock to Lincoln Park under the Purchase Agreement equals or exceeds $ 1.0117 (which represents the closing sale price per share of the Company's common stock on the day before the Company entered into the Purchase Agreement, plus an incremental amount).

In addition, the Company may not sell shares to Lincoln Park under the Purchase Agreement if such sale would result in Lincoln Park beneficially owning more than 9.99 % of the Company's then outstanding shares of common stock.

Those costs were amortized and expensed as shares were sold under the Purchase Agreement, and as of December 31, 2021 there were no unamortized costs.

During 2021, the Company sold, and Lincoln Park purchased, approximately 4.8 million shares under the Purchase Agreement for gross proceeds to the Company of approximately $ 7.0 million and recognized offering expenses of approximately $ 175,000 .

During 2020, the Company sold, and Lincoln Park purchased, approximately 7.2 million shares under the Purchase Agreement for gross proceeds to the Company of approximately $ 8.0 million and recognized offering expenses of approximately $ 236,000 .

As of December 31, 2021, the Company had sold and Lincoln Park had purchased a total of $ 15.0 million of the Company's common stock under the Purchase Agreement, and no more shares of common stock may be sold by the Company to Lincoln Park under the Purchase Agreement.

Common Stock Warrants

In February 2018, the Company closed an underwritten public offering in connection with which the Company issued to the investors in that offering warrants that initially had an exercise price of $ 3.00 per share and are exercisable through February 2023.

In February 2018, the Company closed an underwritten public offering in connection with which the Company issued to the investors in that offering warrants exercisable through February 2023 that initially had an exercise price of $ 3.00 per share.

The warrants include a price-based anti-dilution provision, which provides that, subject to certain limited exceptions, the exercise price of the warrants will be reduced each time the Company issues or sells (or is deemed to issue or sell) securities for a net consideration per share less than the exercise price of those warrants in effect immediately prior to such issuance or sale.

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In April 2019 and July 2020, in accordance with the price-based anti-dilution provision discussed above, the exercise price of these warrants was automatically reduced to $ 0.98 per share and to $ 0.96 per share, respectively, and as a result of the triggering of the anti-dilution provision, $ 0.8 million and $ 6,863 , respectively, was recorded to additional paid-in capital.

During the year ended December 31, 2020, warrants to purchase an aggregate of 1,825,000 shares of common stock were exercised for gross proceeds of approximately $ 1.8 million.

No warrants were exercised during the year ended 2019.

During 2021, warrants to purchase an aggregate of 520,985 shares of common stock were exercised for gross proceeds of approximately $ 0.5 million.

During 2020, warrants to purchase an aggregate of 1,825,000 shares of common stock were exercised for gross proceeds of approximately $ 1.8 million.

As of December 31, 2021, the Company had the following warrants outstanding:

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1,374,515 $ 0.96 02/15/2023

6,500 $ 10.00 04/04/2026

1,895,500 $ 0.96 02/15/2023

The authorized capital of the Company consists of 120,000,000 shares of common stock with a par value of $ 0.0001 and 5,000,000 shares of preferred stock with a par value of $ 0.01 per share.

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STOCK-BASED COMPENSATION

The 2015 Employee, Director and Consultant Equity Incentive Plan

In connection with the business combination transaction in July 2017 between the Company and Daré Bioscience Operations, Inc., a privately held Delaware corporation, or Private Daré, the Company assumed the Private Daré 2015 Employee, Director and Consultant Equity Incentive Plan, or the 2015 Private Daré Plan and each then outstanding award granted thereunder, which consisted of options and restricted stock.

Based on the exchange ratio for the business combination transaction and after giving effect to the reverse stock split effected in connection with the closing of that transaction, the outstanding options and restricted stock awards granted under the 2015 Private Daré Plan were replaced with options to purchase 10,149 shares of the Company’s common stock with a correspondingly adjusted exercise price and 223,295 shares of the Company’s common stock.

All of the options that were assumed were exercised as of December 31, 2020.

No awards may be granted under the 2015 Private Daré Plan following the closing of the business combination transaction.

2014 Employee Stock Purchase Plan

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Amended and Restated 2014 Stock Incentive Plan

The Company maintains the Amended and Restated 2014 Plan, or the Amended 2014 Plan.

The Company maintains the Amended and Restated 2014 Stock Incentive Plan, or the Amended 2014 Plan.

There were 2,046,885 shares of common stock authorized for issuance under the Amended 2014 Plan when it was approved by the Company's stockholders in July 2018.

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As of December 31, 2021, unamortized stock-based compensation expense of approximately $ 3.7 million will be amortized over the weighted average period of 2.7 years.

As of December 31, 2020, 504,516 shares of common stock were reserved for future issuance under the Amended 2014 Plan.

As of December 31, 2021, 201,855 shares of common stock were available for future award grants under the Amended 2014 Plan.

Outstanding at December 31, 2019 (1)

1,889,775 $ 1.21

Granted 906,965 1.06

Exercised ( 10,149 ) —

Forfeited ( 578,445 ) 28.52

Expired ( 70 ) 59.48

Canceled/forfeited — —

Outstanding at December 31, 2020 2,786,591 $ 1.16

1,889,775 $ 1.21

Granted 2,052,075 2.31

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Outstanding at December 31, 2021 4,717,602 $ 1.65 8.11 $ 2,998,680

2,786,591 $ 1.16 8.33 $ 993,981

Options exercisable at December 31, 2021 2,319,775 $ 1.43 7.49 $ 1,993,377

Options vested and expected to vest at December 31, 2021 4,717,602 $ 1.65 8.11 $ 2,998,680

(1) Includes 10,149 shares subject to options granted under the 2015 Private Daré Plan assumed in connection with the Cerulean/Private Daré stock purchase transaction.

(1) Includes 10,149 shares subject to options granted under an equity incentive plan assumed in connection with an acquisition.

Compensation Expense

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LEASED PROPERTIES

The Company's lease for its corporate headquarters ( 3,169 square feet of office space) commenced on July 1, 2018 and terminates on July 31, 2021.

The lease provides the Company with an option to extend the term of the lease for one year .

Microchips, which the Company acquired in November 2019, leases general office space in Lexington, Massachusetts and warehouse space in Billerica, Massachusetts.

The Lexington lease commenced on July 1, 2013 and terminates on September 30, 2021.

The Billerica lease commenced on October 1, 2016 and terminates on March 31, 2022.

The Company's lease for its corporate headquarters ( 3,169 square feet of office space) commenced on July 1, 2018.

In February 2022, the Company entered into an amendment to extend the term of the lease for two years such that the term now expires on August 31, 2024.

(See Note 14, Subsequent Events.)

MBI, a wholly owned subsidiary the Company acquired in November 2019, leases general office space in Lexington, Massachusetts and warehouse space in Billerica, Massachusetts.

The Lexington lease commenced on July 1, 2013.

In February 2022, the Company entered into an amendment to extend the term of the lease for three years such that the term now expires on December 31, 2025.

(See Note 14, Subsequent Events.) The Billerica lease commenced on October 1, 2016 and terminates on March 31, 2022.

Under the terms of each lease, the lessee pays base annual rent (subject to an annual fixed percentage increase), plus property taxes, and other normal and necessary expenses, such as utilities, repairs, and maintenance.

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The depreciable lives of operating leases and leasehold improvements are limited by the expected lease term.

At December 31, 2020, the Company reported operating lease right of use assets of approximately $ 240,000 in other non-current assets, and approximately $347,000 and $ 42,000 , respectively, in current and non-current other liabilities on the consolidated balance sheet.

At December 31, 2021, the Company reported operating lease right of use assets of approximately $ 216,700 in other non-current assets and approximately $ 270,500 in current liabilities on the consolidated balance sheet.

Total operating lease costs were approximately $ 561,000 and $ 435,000 for the years ended December 31, 2021 and 2020, respectively.

Operating lease costs consist of monthly lease payments expense, common area maintenance and other repair and maintenance costs and are included in general and administrative expenses in the consolidated statement of operations.

Cash paid for amounts included in the measurement of operating lease liabilities was approximately $ 461,000 for the year ended December 31, 2020, and these amounts are included in operating activities in the consolidated statement of cash flows.

Cash paid for amounts included in the measurement of operating lease liabilities was approximately $ 462,000 for the year ended December 31, 2021, and these amounts are included in operating activities in the consolidated statements of cash flows.

Further, at December 31, 2021, operating leases had a weighted average remaining lease term of 0.56 years.

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COMMITMENTS AND CONTINGENCIES

CRADA with NICHD for the Pivotal Phase 3 Study of Ovaprene

In July 2021, the Company entered into a Cooperative Research and Development Agreement, or the CRADA, with the U.S.

Department of Health and Human Services, as represented by the Eunice Kennedy Shriver National Institute of Child Health and Human Development, or NICHD, for the conduct of a multi-center, non-comparative, pivotal Phase 3 clinical study of Ovaprene, or the Ovaprene Phase 3.

The Ovaprene Phase 3 will be conducted within NICHD’s Contraceptive Clinical Trial Network with NICHD contractor Health Decisions Inc., a contract research organization, providing clinical coordination and data collection and management services for the Ovaprene Phase 3.

The Company and NICHD will each provide medical oversight and final data review and analysis for the Ovaprene Phase 3 and will work together to prepare the final report of the results of the Ovaprene Phase 3.

The Company is responsible for providing clinical supplies of Ovaprene, coordinating interactions with the FDA, preparing and submitting supportive regulatory documentation, and providing a total of $ 5.5 million in payments to NICHD to be applied toward the costs of conducting the Ovaprene Phase 3.

NICHD will be responsible for the other costs related to the conduct of the Ovaprene Phase 3.

In 2021, in accordance with the payment schedule under the CRADA, the Company made aggregate payments of $ 1.5 million of the total amount payable to NICHD.

The Company's remaining obligation under the CRADA at December 31, 2021 is $ 4.0 million.

Contingent Consideration

In connection with the acquisition of Microchips, the Company agreed to pay contingent consideration based upon the achievement of specified funding, product development and regulatory milestones.

The Company recorded $ 1.0 million in contingent consideration liability associated with milestone payments expected to become payable in the first half of 2021 in its consolidated balance sheet at December 31, 2020.

In April 2020, due to the economic uncertainty resulting from the impact of the COVID-19 pandemic on the Company's operations and to support its ongoing operations and retain all employees, the Company applied for a loan under the Paycheck Protection Program, or the PPP, of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, administered by the U.S.

As discussed in Note 3 above, in connection with the acquisition of MBI, the Company agreed to pay additional consideration of up to $ 46.5 million to the former stockholders of MBI contingent upon the achievement of specified funding, product development and regulatory milestones.

In June 2021, a total of $1.25 million of that potential additional consideration became payable upon the achievement of certain of the funding and product development milestone events, $ 1.0 million of which was previously recorded as contingent consideration on the Company's consolidated balance sheets upon the completion of the MBI acquisition and $250,000 of which was

expensed in 2021.

In July 2021, the Company’s board of directors elected to make these milestone payments in shares of the Company’s common stock, to the extent permissible under the terms of the merger agreement with MBI, and, in September 2021, the Company issued approximately 700,000 shares of its common stock to former stockholders of MBI and paid $75,000 to the stockholders’ representative in accordance with the terms of the merger agreement in satisfaction of the $1.25 million in milestone payments associated with milestones achieved in June 2021.

In April 2020, due to the economic uncertainty resulting from the impact of the COVID-19 pandemic on the Company's operations and to support its ongoing operations and retain all employees, the Company applied for and received a loan of $ 367,285 under the Paycheck Protection Program, or the PPP, of the Coronavirus Aid, Relief, and Economic Security Act, or CARES Act, administered by the U.S.

Small Business Administration, or the SBA.

The Company received a loan of approximately $ 367,000 .

Under the terms of the PPP, the loan proceeds could be used for "qualifying expenses" and, subject to specified limitations in the CARES Act and under the terms of the PPP, certain amounts of the loan, including accrued interest, may be forgiven if used for qualifying expenses.

Qualifying expenses include payroll costs, costs used to continue group health care benefits, mortgage interest payments, rent payments, utility payments, and interest payments on other debt obligations.

In September 2020, the Company submitted its forgiveness application.

The Company recorded a note payable plus accrued interest for the loan in the amount of approximately $ 369,600 in

its consolidated balance sheet at December 31, 2020.

In January 2021, the Company was notified that the principal balance of the PPP loan and all accrued interest was fully forgiven by the SBA.

Subsequent Events.

In January 2021, the Company was notified that the principal balance of its PPP loan and all accrued interest, which together totaled $ 369,887 , were fully forgiven by the SBA.

The Company recorded a gain on extinguishment of note payable and debt forgiveness income with respect to such loan forgiveness in the first quarter of 2021.

Legal Proceedings

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Employment Agreements

Certain executive officers are entitled to payments if they are terminated without cause or as a result of a change in control of the Company.

Upon termination without cause, and not as a result of death or disability, each officer is entitled to receive a payment of an amount equal to six to twelve months of base salary and to receive continuing health benefits coverage for periods ranging between six to twelve months following the termination of employment or until such officer is covered under a separate plan from another employer.

Upon termination other than for cause or for good reason within three months prior to or twelve months following a change in control of the Company, each officer will be entitled to receive a payment of an amount equal to nine to eighteen months of base salary and target bonus and to receive continuing health benefits coverage for periods ranging between nine to eighteen months following the termination of employment.

Certain executive officers of the Company are entitled to payments if their employment is terminated by the Company without cause, if they resign for good reason, if their employment agreements are not renewed, or if their employment is terminated by the Company without cause or if they resign for good reason, in each case, within three months prior to or 12 months following a change in control of the Company.

Upon termination by the Company without cause, if they resign for good reason, if their employment agreements are not renewed, such executives are entitled to receive a payment of an amount equal to either nine or twelve months of base salary and to receive continuing health benefits coverage for periods equal to either nine or twelve months following the termination of employment or until such officer is covered under a separate plan from another employer.

If their employment is terminated by the Company without cause or if they resign for good reason, in each case, within three months prior to or 12 months following a change in control of the Company, such executives will be entitled to receive a payment of an amount equal to either twelve or eighteen months of base salary and target bonus and to receive continuing health benefits coverage for periods ranging between twelve and eighteen months following the termination of employment.

In addition, upon a change in control of the Company, each officer’s outstanding unvested options will fully vest and accelerate subject to the conditions outlined in such officer’s employment agreement.

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The Company made matching contributions of approximately $ 160,000 and $ 136,000 during the years ended December 31, 2021 and 2020, respectively.

NIH Grant Funding

The Company has received notices of awards and grant funding from the National Institutes of Health, or the NIH, to support the development of Ovaprene and DARE-FRT1.

The NIH issues notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment.

If the Company receives payments under the award, the amounts of such payments are recognized in the statement of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period.

Since 2018, the Company has received approximately $ 1.9 million of grant funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the NIH, for clinical development efforts supporting Ovaprene.

The most recent and final notice of award the Company received was for approximately $ 731,000 in April 2020, substantially all of which has been funded to date.

The Company recorded credits to research and development expense for costs related to the NIH award of approximately $ 595,000 and $ 1.2 million for the years ended December 31, 2020 and December 31, 2019, respectively.

At December 31, 2020, the Company recorded a receivable of approximately $ 12,000 for expenses incurred through such date that it believes are eligible for reimbursement under the final notice of award received in April 2020.

In August 2020, the Company received a notice of award of a grant from the NIH to support the development of DARE-FRT1.

The award in the amount of $ 300,000 was for what is referred to as the "Phase I" segment of the project outlined in the Company's grant application, which is to occur during the period of August 2020 through July 2021.

NICHD Non-Dilutive Grant Funding

The Company has received notices of awards and non-dilutive grant funding from NICHD to support the development of Ovaprene, DARE-PTB1 and DARE-LARC1.

NICHD issues notices of awards to the Company for a specified amount, and the Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment.

If the Company receives payments under the

award, the amounts of such payments are recognized in the statements of operations as a reduction to research and development activities as the related costs are incurred to meet those obligations over the period.

Since 2018, the Company has received approximately $ 1.9 million of non-dilutive grant funding from NICHD for clinical development efforts supporting Ovaprene.

The final notice of award the Company received was for approximately $ 731,000 in April 2020, all of which has been funded to date.

The Company recorded credits to research and development expense for costs related to the NICHD award of an immaterial amount the year ended December 31, 2021, and approximately $ 595,000 for the year ended December 31, 2020.

In August 2020, the Company received a notice of award of a grant from NICHD to support the development of DARE-PTB1.

The award in the amount of $ 300,000 was for what is referred to as the "Phase I" segment of the project outlined in the Company's grant application, which is ongoing.

Additional potential funding of up to approximately $ 2.0 million for the "Phase II" segment of the project outlined in the grant application is contingent upon satisfying specified requirements, including, assessment of the results of the Phase I segment, determination that the Phase I goals were achieved, and availability of funds.

There is no guarantee the Company will receive any Phase II award.

The Company recorded credits to research and development expense for costs related to the NIH award of approximately $ 131,000 for the year ended December 31, 2020.

The Company recorded credits to research and development expense for costs related to the NICHD award of approximately $ 65,000 for the year ended December 31, 2021.

At December 31, 2021, the Company recorded a receivable of approximately $ 9,600 for expenses incurred through such date that it believes are eligible for reimbursement under the grant.

Bill & Melinda Gates Foundation

The Company's wholly-owned subsidiary, Microchips, has a grant agreement with the Bill & Melinda Gates Foundation, or the Foundation, relating to the development of the pre-clinical stage contraceptive candidate, DARE-LARC1.

Expenses eligible for grant funding must be incurred, tracked and reported to the Foundation.

Microchips received grant funding payments of approximately $ 2.9 million in 2019 and $ 2.5 million in 2020.

At December 31, 2020, grant funding payments associated with research and development expenses for DARE-LARC1 not yet incurred totaled approximately $ 1.6 million and are recorded as deferred grant funding liability in the Company's consolidated balance sheet.

In September 2021, the Company received a notice of award of a grant from NICHD to support the development of DARE-LARC1.

The award in the amount of approximately $ 300,000 is to be used to explore device insertion and removal in nonclinical studies, which is to occur during the period of September 2021 through August 2022.

The Company recorded credits to research and development expense of approximately $ 7,400 for costs related to the NICHD award during the year ended December 31, 2021.

At December 31, 2021, the Company recorded a receivable of approximately $ 7,400 for expenses incurred through such date that it believes is eligible for reimbursement under the grant.

DARE-LARC1 Non-Dilutive Grant Funding

MBI Grant Agreement

The Company's wholly-owned subsidiary, MBI, was awarded $ 5.4 million to support the development of DARE-LARC1 under a grant agreement with the Bill & Melinda Gates Foundation, or the Foundation.

The funding period under this agreement ended June 30, 2021.

Expenses eligible for funding were incurred, tracked and reported to the Foundation.

MBI received payments under this agreement of approximately $ 2.5 million in 2020.

At December 31, 2021, all payments under this agreement associated with research and development expenses for DARE-LARC1 had been incurred and reported to the Foundation and no future funding will be received under this agreement.

2021 DARE-LARC1 Grant Agreement

In June 2021, the Company entered into an agreement with the Foundation, or the 2021 DARE-LARC1 Grant Agreement, under which the Company was awarded up to $ 48.95 million to support the development of DARE-LARC1.

The 2021 DARE-LARC1 Grant Agreement will support technology development and preclinical activities over the period of June 30, 2021 to November 1, 2026, to advance DARE-LARC1 in nonclinical proof of principle studies.

The Company received an initial payment of $ 11.45 million in July 2021.

Additional payments are contingent upon the DARE-LARC1 program’s achievement of specified development and reporting milestones.

At December 31, 2021, approximately $ 10.5 million of deferred grant funding liability under this agreement was recorded in the Company's consolidated balance sheet.

SUBSEQUENT EVENTS

Between January and March 2021, the Company sold an aggregate of 3,264,069 shares of common stock in at the market offerings through a sales agent and received aggregate gross proceeds of approximately $ 7.7 million and incurred sales agent commissions and fees of approximately $ 245,000 (see Note 9).

Between January and March 2021, the Company sold an aggregate of 2,400,000 shares of common stock to Lincoln Park under the Purchase Agreement and received aggregate net proceeds of approximately $ 3.9 million.

Exercise of February 2018 Warrants

In February 2021, warrants to purchase an aggregate of 52,500 shares of common stock were exercised at an exercise price of $ 0.96 per share resulting in gross proceeds to the Company of approximately $ 50,000 (see Note 9).

PPP Loan Forgiveness

In January 2021, the Company was notified that the principal balance of its PPP loan and all accrued interest was fully forgiven by the SBA.

The Company will record a gain contingency and debt forgiveness income with respect to such loan forgiveness in the first quarter of 2021.

Exclusive License Agreement with Organon to Commercialize XACIATO

On March 31, 2022, the Company entered into an exclusive license agreement with Organon pursuant to which Organon will obtain exclusive worldwide rights to develop, manufacture and commercialize XACIATO and other future intravaginal or urological products for human use formulated with clindamycin that rely on intellectual property controlled by the Company.

Under the agreement, the Company will receive a $ 10.0 million non-refundable and non-creditable payment following the effective date of the agreement and will be entitled to receive tiered double-digit royalties based on net sales and up to $ 182.5 million in milestone payments as follows:

$ 2.5 million following the first commercial sale of a licensed product in the United States;

and up to $ 180.0 million in tiered commercial sales milestones and regulatory milestones.

Royalty payments will be subject to customary reductions and offsets.

The royalty period for each licensed product will continue on a country-by-country basis from the first commercial sale of the licensed product in the country until the expiration of the later of (i) the date that no valid patent claim would be infringed in the absence of the license granted under the agreement by the sale of the licensed product in the country, (ii) 10 years after the end of the month in which the first commercial sale of the licensed product in the country occurred, and (iii) the expiration of regulatory market exclusivity for the licensed product in that country.

Under the agreement, the Company will be responsible for regulatory interactions and for providing product supply on an interim basis until Organon assumes such responsibilities.

Until such time, Organon will purchase all of its product requirements of XACIATO from the Company at a transfer price equal to the Company's manufacturing costs plus a single-digit percentage markup.

The effective date of the agreement will occur following the satisfaction of closing conditions that include receipt of all applicable approvals, or the expiration or termination of all applicable waiting periods, required under applicable antitrust laws, including the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended.

Unless terminated earlier, the agreement will expire on a product-by-product and country-by-country basis upon expiration of the applicable royalty period for each licensed product.

In addition to customary termination rights for both parties, following the first anniversary of the effective date of the agreement, Organon may terminate the agreement in its entirety or on a country-by-country basis at any time in Organon's sole discretion on 120 days' advance written notice.

The agreement includes customary representations and warranties, covenants and indemnification obligations of each party.

In addition, the terms of the agreement provide Organon exclusive worldwide rights of first negotiation for specified potential future products of the Company.

Leased Properties

On January 7, 2021, the Company exercised its option to extend the term of the lease for its corporate headquarters in San Diego, California for a year.

The extended term begins August 1, 2021 and expires July 31, 2022.

On January 25, 2021, the Company entered into an amendment extend the term of the lease for its office space in Lexington, Massachusetts for a year.

The extended term begins October 1, 2021 and expires September 30, 2022.

On February 4, 2022, the Company entered into an amendment to extend the term of the lease for its corporate headquarters in San Diego, California for two years .

The extended term begins August 1, 2022 and expires August 31, 2024.

On February 14, 2022, the Company entered into an amendment to extend the term of the lease for its office space in Lexington, Massachusetts for three years .

The extended term begins October 1, 2022 and expires December 31, 2025.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures