Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2018 | Nov. 09, 2018 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2018 | |
Document Fiscal Year Focus | 2,018 | |
Document Fiscal Period Focus | Q3 | |
Trading Symbol | DARE | |
Entity Registrant Name | Dare Bioscience, Inc. | |
Entity Central Index Key | 1,401,914 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock Shares Outstanding | 11,422,161 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Sep. 30, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and cash equivalents | $ 9,537,463 | $ 7,559,846 |
Other receivables | 80,278 | 284,206 |
Prepaid expenses | 549,949 | 311,571 |
Other current assets | 193,495 | |
Total current assets | 10,167,690 | 8,349,118 |
Property and equipment, net | 10,572 | |
Goodwill | 5,187,519 | |
Other non-current assets | 617,499 | 723,191 |
Total assets | 10,795,761 | 14,259,828 |
Current liabilities | ||
Accounts payable and accrued expenses | 1,202,912 | 966,653 |
Total current liabilities | 1,202,912 | 966,653 |
Deferred rent | 9,292 | 392 |
Total liabilities | 1,212,204 | 967,045 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity (deficit) | ||
Preferred stock, $0.01 par value, 5,000,000 shares authorized None issued and outstanding | ||
Common stock: $0.0001 par value, 120,000,000 shares authorized, 11,422,161 and 6,047,161 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively | 1,142 | 605 |
Accumulated other comprehensive loss | (78,032) | (18,080) |
Additional paid-in capital | 35,713,662 | 25,541,210 |
Accumulated deficit | (26,053,215) | (12,230,952) |
Total stockholders' equity | 9,583,557 | 13,292,783 |
Total liabilities and stockholders' equity | $ 10,795,761 | $ 14,259,828 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2018 | Dec. 31, 2017 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 120,000,000 | 120,000,000 |
Common stock, shares issued | 11,422,161 | 6,047,161 |
Common stock, shares outstanding | 11,422,161 | 6,047,161 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Operating expenses: | ||||
General and administrative | $ 1,175,049 | $ 1,052,628 | $ 3,635,413 | $ 1,729,338 |
Research and development expenses | 1,446,548 | 280,793 | 4,750,823 | 312,169 |
License expenses | 350,000 | |||
Impairment of goodwill | 5,187,519 | |||
Total operating expenses | 2,621,597 | 1,333,421 | 13,923,755 | 2,041,507 |
Loss from operations | (2,621,597) | (1,333,421) | (13,923,755) | (2,041,507) |
Other income (expense) | 47,122 | (296,262) | 101,492 | (330,233) |
Net loss | (2,574,475) | (1,629,683) | (13,822,263) | (2,371,740) |
Foreign currency translation adjustments | (18,721) | (9,774) | (59,952) | (9,774) |
Comprehensive loss | $ (2,593,196) | $ (1,639,457) | $ (13,882,215) | $ (2,381,514) |
Loss per common share - basic and diluted | $ (0.23) | $ (0.33) | $ (1.32) | $ (1.04) |
Weighted average number of common shares outstanding: | ||||
Basic and diluted | 11,422,161 | 4,986,226 | 10,499,982 | 2,283,673 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) | 9 Months Ended | |
Sep. 30, 2018 | Sep. 30, 2017 | |
Operating activities: | ||
Net loss | $ (13,822,263) | $ (2,371,740) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 1,263 | |
Stock-based compensation | 58,538 | 6,953 |
Non-cash interest | 316,804 | |
Acquired in-process research and development | 507,000 | |
Impairment of goodwill | 5,187,519 | |
Changes in operating assets and liabilities, net impact of acquisition: | ||
Other receivables | 203,928 | |
Prepaid expenses | (238,378) | (224,433) |
Other current assets | 193,495 | |
Other non-current assets and deferred charges | 105,692 | (2,800) |
Accounts payable and accrued expenses | 236,259 | 659,223 |
Interest payable | 36,776 | |
Deferred rent | 8,900 | 157 |
Net cash used in operating activities | (7,558,047) | (1,579,060) |
Investing activities: | ||
Cash acquired through merger | 9,918,440 | |
Purchases of property and equipment | (11,836) | |
Acquisition of Pear Tree and Hydra asset | (507,000) | |
Net cash provided by (used in) investing activities | (518,836) | 9,918,440 |
Financing activities: | ||
Net proceeds from issuance of common stock and warrants | 10,114,452 | |
Proceeds from issuance of convertible promissory notes | 155,000 | |
Net cash provided by financing activities | 10,114,452 | 155,000 |
Effect of exchange rate changes on cash and cash equivalents | (59,952) | (9,774) |
Net change in cash and cash equivalents | 1,977,617 | 8,484,606 |
Cash and cash equivalents, beginning of period | 7,559,846 | 44,614 |
Cash and cash equivalents, end of period | $ 9,537,463 | $ 8,529,220 |
Organization and Description of
Organization and Description of the Business | 9 Months Ended |
Sep. 30, 2018 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Organization and Description of the Business | 1. Daré Bioscience, Inc., is a clinical-stage biopharmaceutical company committed to the advancement of innovative products for women’s reproductive health. Daré Bioscience, Inc. and its wholly owned subsidiaries, Daré Bioscience Operations, Inc., Daré Bioscience Australia Pty LTD, and Pear Tree Pharmaceuticals, Inc., operate in one segment. In this report, the “Company” refers collectively to Daré Bioscience, Inc. 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 license or otherwise acquire the rights to differentiated reproductive health product candidates, some of which have existing clinical proof-of-concept data, and to take those candidates through advanced stages of clinical development or regulatory approval. The Company has assembled a portfolio of clinical-stage and preclinical-stage candidates addressing unmet needs in women’s reproductive health. The Company’s two clinical-stage assets—Ovaprene ® and Sildenafil Cream, 3.6%—were obtained through product license and development agreements. Ovaprene, was licensed in July of 2017 and was in February of 2018. In March of 2018, the Company entered into a collaboration and option agreement covering new injectable contraceptive product candidates; in April of 2018, the Company licensed the worldwide rights to a portfolio of preclinical intravaginal rings; in May of 2018, the Company acquired a company that owns the rights to a related to a novel target for non-hormonal contraceptives for both men and women. The Company’s primary operations have consisted of, and are expected to continue to consist of, product research and development and advancing its portfolio of product candidates through late-stage clinical development or regulatory approval. The Company has not generated any revenue related to its primary business purpose to date and 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. |
Liquidity
Liquidity | 9 Months Ended |
Sep. 30, 2018 | |
Liquidity [Abstract] | |
Liquidity | 2. The Company has a history of losses from operations and anticipates that it will continue to incur losses for at least the next several years. For the nine months ended September 30, 2018, the Company incurred a net loss of $13.8 million. At September 30, 2018, the Company had an accumulated deficit of approximately $26.1 million and had cash and cash equivalents of approximately $9.5 million. The Company also had negative cash flow from operations of approximately $7.6 million during the nine months ended September 30, 2018. During the first quarter of 2018, the Company received gross proceeds of approximately $11.3 million, resulting in net proceeds of approximately $10.1 million, from sales of its securities in registered offerings (see Note 7). During the third quarter, the Company received approximately $144,000 from a federal grant. The Company is focused primarily on the development and commercialization of innovative products in women’s reproductive health. T any of such that As of the date of current Although the Company has cash and cash equivalents of approximately $9.5 million at September 30, 2018, the Company will need to raise additional capital through 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 Company cannot be sure that capital will be available when needed or that, if available, it will be obtained on terms favorable to the Company or its stockholders. The interim consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 3. Summary of Significant Accounting Policies The Company’s significant accounting policies are described in Note 1 to the interim consolidated financial statements included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission, or SEC on March 28, 2018. Since the date of those financial statements, there have been no material changes to the Company’s significant accounting policies, except as described below. Basis of Presentation The accompanying interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying interim consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. Reverse Stock Split On July 20, 2017, the Company effected a of its common stock. Use of Estimates Preparing 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, goodwill impairment and purchase accounting. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results. Principles of Consolidation The interim consolidated financial statements of the Company are stated in U.S. dollars and are prepared using GAAP. These financial statements include the accounts of the Company and its wholly owned subsidiaries, Daré Bioscience Operations, Inc., Daré Bioscience Australia Pty LTD, and Pear Tree Pharmaceuticals, Inc. 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 in the interim consolidated balance sheets. All significant intercompany transactions and accounts have been eliminated in consolidation. Grant Funding The Company receives certain research and development funding through a grant issued by a division of the National Institutes of Health. 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 adopted this policy in 2018. During the three and nine months ended September 30, 2018, the Company recognized approximately $213,000 in the statement of operations as a reduction to research and development expense. Fair Value Measurements GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Cash and cash equivalents of $9.5 million and $7.6 million measured at fair value as of September 30, 2018 and December 31, 2017, respectively, are classified within Level 1 of the fair value hierarchy. Other receivables are financial assets with carrying values that approximate fair value due to the short-term nature of these assets. Accounts payable and accrued expenses and other liabilities are financial liabilities with carrying values that approximate fair value due to the short-term nature of these liabilities. Recent Pronouncements Not Yet Adopted In February 2016, FASB issued ASU 2016-02, Leases (Topic 842) Recently Adopted Accounting Standards In May 2014, FASB issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers In August 2016, FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments , which intended to add or clarify guidance on the classification of certain cash receipts and payments on the statement of cash flows. The new guidance addresses cash flows related to: debt prepayment or extinguishment costs, settlement of zero-coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies and bank-owned life insurance policies, distributions received from equity method investees, beneficial interest in securitization transactions, and the application of predominance principle to separately identifiable cash flows. The standard became effective on January 1, 2018. The Company’s adoption of this standard on January 1, 2018 did not have a material impact on the Company’s interim consolidated financial statements. In January 2017, FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business In January 2017, FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment (Topic 350) In May 2017, FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting In July 2017, FASB issued ASU 2017-11, Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480), Derivatives and Hedging (Topic 815): (I) Accounting for Certain Financial Instruments with Down Round Features, (II) Replacement for the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. |
Acquisitions
Acquisitions | 9 Months Ended |
Sep. 30, 2018 | |
Business Combinations [Abstract] | |
Acquisitions | 4. Acquisitions Cerulean/Private Dare Stock Purchase Transaction On July 19, 2017, the Company completed its business combination with Daré Bioscience Operations, Inc., a privately held Delaware corporation, or Private Daré, in accordance with the terms of the Stock Purchase Agreement dated as of March 19, 2017, or the Daré Stock Purchase Agreement, by and among the Company, Private Daré and the holders of capital stock and securities convertible into capital stock of Private Daré named therein, or the Private Daré Stockholders. Pursuant to the Daré Stock Purchase Agreement, each Private Daré Stockholder sold their shares of capital stock in Private Daré to the Company in exchange for newly issued shares of the Company’s common stock, and as a result, Private Daré became a wholly owned subsidiary of the Company and the Private Daré Stockholders became majority stockholders of the Company. In connection with the closing of that transaction, the Company changed its name from “Cerulean Pharma Inc.” to “Daré Bioscience, Inc.” In this report, that transaction is referred to as the Cerulean/Private Daré stock purchase transaction and “Cerulean” refers to Cerulean Pharma Inc. before that transaction closed. The Cerulean/Private Daré stock purchase transaction was accounted for as a reverse merger under the acquisition method of accounting whereby Private Daré was considered to have acquired Cerulean for financial reporting purposes because immediately upon completion of the transaction, Private Daré stockholders held a majority of the voting interest of the combined company. Pursuant to business combination accounting, the Company applied the acquisition method, which requires the assets acquired and liabilities assumed be recorded at fair value with limited exceptions. The excess of the purchase price over the assets acquired and liabilities assumed represents goodwill. The goodwill is primarily attributable to the cash and cash equivalents at closing of the transaction of approximately $9.9 million and the impact of the unamortized fair value of stock options granted by Cerulean that were outstanding immediately before the transaction closed of approximately $3.7 million. The unamortized fair value of such stock options relates to an option modification approved on March 19, 2017 that provided for an acceleration of vesting of such options upon a change in control event. Such modification became effective upon the closing of the Cerulean/Private Daré stock purchase transaction. Hence, the unamortized fair value of such stock options is deemed to be part of total purchase consideration and goodwill. Transaction costs associated with the Cerulean/Private Daré stock purchase transaction of $0.96 million are included in general and administrative expense. The total purchase price consideration of approximately $24.3 million represents the fair value of the shares of Cerulean stock issued in connection with the Cerulean/Private Daré stock purchase transaction and the unamortized fair value of the stock options described above, which was allocated as follows: Purchase Consideration (in thousands) Fair value of shares issued $ 20,625 Unamortized fair value of Cerulean options 3,654 Fair value of total consideration $ 24,279 Assets acquired and liabilities assumed Cash and cash equivalents $ 9,918 Prepaid expense and other current assets 1,915 Accounts payable (233 ) Total assets acquired and liabilities assumed 11,600 Goodwill $ 12,679 The final allocation of the purchase price depended on finalizing the valuation of the fair value of assets acquired and liabilities assumed. The Company retrospectively recorded purchase price adjustments at the acquisition date to increase current liabilities and current assets by $23,609 and $225,778, respectively, which reduced the original goodwill amount of $12.9 million by $202,169. The Company tests its goodwill for impairment at least annually as of December 31 and between annual tests if it becomes aware of an event or change in circumstance that would indicate the carrying value may be impaired. The Company tests goodwill for impairment at the entity level because it operates on the basis of a single reporting unit. A goodwill impairment is the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. When impaired, the carrying value of goodwill is written down to fair value. Any excess of the reporting unit goodwill carrying value over the fair value is recognized as impairment loss. The Company assessed goodwill at December 31, 2017. The Company determined there was an impairment and recognized an impairment charge of approximately $7.5 million in the consolidated statement of operations and comprehensive loss for the year ended December 31, 2017 and reduced the goodwill carrying value from approximately $12.7 million to $5.2 million on its consolidated balance sheet as of December 31, 2017. The Company assessed goodwill at March 31, 2018, determined there was an impairment and recognized an impairment charge of approximately $5.2 million in the interim consolidated statement of operations and comprehensive loss for the three months ended March 31, 2018. As of March 31, 2018, the goodwill carrying value on the Company’s consolidated balance sheet was written off in its entirety. Pear Tree Merger On April 30, 2018, the Company entered into an Agreement and Plan of Merger, the Merger Agreement, with Pear Tree Pharmaceuticals, Inc., or Pear Tree, Daré Merger Sub, Inc., a wholly-owned subsidiary of the Company, or Merger Sub, and two individuals in their respective capacities as Pear Tree stockholders’ representatives. The transactions contemplated by the Merger Agreement closed on May 16, 2018, and as a result, Pear Tree became the Company’s wholly owned subsidiary. The Company acquired Pear Tree to secure the rights to develop DARE-VVA1, a proprietary vaginal formulation of tamoxifen, as a potential treatment for vulvar and vaginal atrophy. The Company determined that the acquisition of Pear Tree should be accounted for as an asset acquisition instead of a business combination because substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets, and therefore, the asset is not considered a business. Transaction costs of approximately $452,000 associated with the merger are included in the Company’s research and development expense. In accordance with the terms of the Merger Agreement, because the Negative Consideration Amount (as defined below) exceeded the Positive Consideration Amount (as defined below), at the time of the closing of the merger, the excess amount (approximately $132,000) will be offset against future payments otherwise due under the Merger Agreement to certain former and continuing Pear Tree service providers and former holders of Pear Tree’s capital stock, or the Holders, including the potential $75,000 payment due on the one-year anniversary of the closing of the merger. Positive Consideration Amount means the sum of $75,000, and the cash and cash equivalents held by Pear Tree at closing, and Negative Consideration Amount means the sum of (i) certain Pear Tree indebtedness and transaction expenses, (ii) transaction expenses of the stockholders’ representatives, and (iii) amounts payable under Pear Tree’s management incentive plan. Under the Merger Agreement, 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. The Company must also make contingent payments to 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. |
Convertible Promissory Notes
Convertible Promissory Notes | 9 Months Ended |
Sep. 30, 2018 | |
Debt Disclosure [Abstract] | |
Convertible Promissory Notes | 5. Convertible Promissory Notes Prior to the Cerulean/Private Daré stock purchase transaction, Private Daré financed its operations through the sale of convertible promissory notes that entitled the holder to accrued interest at an annual rate of 8%. In the event of a preferred stock financing by Private Daré, all outstanding principal and unpaid interest under the convertible promissory notes would have converted into the shares of Private Daré’s preferred stock issued in such financing at the price per share paid by the purchasers of such shares and an additional number of shares equal to, depending on the time of purchase, 20% to 40% of the outstanding principal and unpaid interest, or the conversion benefit. Private Daré issued a convertible promissory note in the principal amount of $100,000 in February 2017 and issued additional convertible promissory notes in the aggregate principal amount of $55,000 between April 1, 2017 and June 6, 2017. In connection with the Cerulean/Private Daré stock purchase transaction, all outstanding convertible promissory notes were amended to provide that their principal amount plus accrued interest and taking into account their conversion benefit, would convert into shares of Private Daré common stock immediately prior to the closing of the Cerulean/Private Daré stock purchase transaction. The number of shares of Private Daré common stock issued upon conversion of the convertible promissory notes issued before March 31, 2017 was equal to (i) their outstanding principal amount plus accrued interest through March 31, 2017 multiplied by the respective conversion benefit, which ranged from 125% to 140%, divided by (ii) $0.18727. The number of shares of Private Daré common stock issued upon conversion of the convertible promissory notes issued after March 31, 2017 was equal to (i) 120% of their outstanding principal amount, divided by (ii) $0.38. In connection with the closing of the Cerulean/Private Daré stock purchase transaction, all the outstanding shares of Private Daré common stock, including the shares issued upon conversion of the above described convertible promissory notes, were exchanged for shares of the Company’s common stock at the exchange ratio specified in the Daré Stock Purchase Agreement. The Company recognized interest expense of $0 and $316,804 at September 30, 2018 and September 30, 2017, respectively, relating to the convertible promissory notes. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-based Compensation | 6. Stock-based Compensation The 2015 Employee, Director and Consultant Equity Incentive Plan Prior to the Cerulean/Private Daré stock purchase transaction, the 2015 Employee, Director and Consultant Equity Incentive Plan of Private Daré, or the 2015 Private Daré Plan, governed the issuance of equity awards to Private Daré employees, officers, non-employee directors and consultants. Options granted under the 2015 Private Daré Plan have terms of ten years from the date of grant unless earlier terminated and generally vest over a three-year period. Upon closing of the Cerulean/Private Daré stock purchase transaction, the Company assumed the 2015 Private Daré Plan and each outstanding option to acquire Private Daré stock that was not exercised prior to the closing. Options to purchase 50,000 shares of Private Daré stock were assumed. Such options were assumed on the same terms as were applicable to them under the 2015 Private Daré Plan and became an option to purchase such number of shares of the Company’s common stock equal to the number of Private Daré shares subject to such option multiplied by the exchange ratio specified in the Daré Stock Purchase Agreement, at a correspondingly adjusted exercise price. Based on the exchange ratio and after giving effect to the reverse stock split effected in connection with the closing of the Cerulean/Private Daré stock purchase transaction, such options were replaced with options to purchase 10,149 shares of the Company’s common stock, all of which were outstanding as of September 30, 2018. Private Daré issued 900,000 and 200,000 shares of fully vested restricted stock to non-employees under the 2015 Private Daré Plan during 2015 and 2016, respectively. In connection with the closing of the Cerulean/Private Daré stock purchase transaction, the Company assumed these shares and replaced them with 223,295 restricted shares of the Company’s common stock (after giving effect to the reverse stock split effected in connection with the closing of the Cerulean/Private Daré stock purchase transaction). No further awards may be granted under the 2015 Private Daré Plan following the closing of the Cerulean/Private Daré stock purchase transaction. 2014 Employee Stock Purchase Plan In March 2014, the Company’s board of directors adopted, and its stockholders approved the 2014 Employee Stock Purchase Plan, or the ESPP, which became effective in April 2014. The ESPP permits eligible employees to enroll in a six-month offering period whereby participants may purchase shares of the Company’s common stock, through payroll deductions, at a price equal to 85% of the closing price of the common stock on the first day of the offering period or on the last day of the offering period, whichever is lower. Purchase dates under the ESPP occur on or about June 30 and December 31 each year. The Company’s board of directors decided not to initiate a new offering period beginning January 1, 2017 and no offering period has been initiated since then. There was no stock-based compensation related to the ESPP for the nine months ended September 30, 2018 or September 30, 2017. Amended and Restated 2014 Stock Incentive Plan The Company maintains the Amended and Restated 2014 Plan, or the Amended 2014 Plan, which was approved by the Company’s stockholders on July 10, 2018. The Amended 2014 Plan was an amendment and restatement of the Company’s 2014 Stock Incentive Plan, or the 2014 Plan. The number of shares authorized for issuance under the Amended 2014 Plan is 2,046,885, which is the sum of (a) 1,509,463 shares of common stock plus (b) 537,422 shares of common stock subject to awards granted under the 2014 Plan. The number of authorized shares will increase annually on the first day of each fiscal year until, and including, the fiscal year ending December 31, 2024 by the least of (i) 2,000,000, (ii) 4% of the number of outstanding shares of common stock on such date, or (iii) an amount determined by the Company’s board of directors. In March 2017, the Company’s board of directors approved two modifications to outstanding stock options granted under the 2014 Plan to participants providing services to the Company as of that date. One modification extended the exercise period of such stock options to two years after such participant’s termination date, unless the exercise period absent such modification would be longer. The other modification provided for accelerated vesting of such stock options upon a change in control event. These modifications resulted in unamortized fair value expense of approximately $3.7 million and was recorded as part of the total consideration in the Cerulean/Private Daré stock purchase transaction (see Note 4). At September 30, 2018, 451,244 shares of common stock were reserved for future issuance under the Amended 2014 Plan, and options to purchase 1,605,790 shares of the Company’s common stock granted under the Amended 2014 Plan were outstanding. Summary of Stock Option Activity The table below summarizes stock option activity under the Amended 2014 Plan, and related information for the nine months ended September 30, 2018. The exercise price of all options granted during the nine months ended September 30, 2018 was equal to the market value of the Company’s common stock on the date of the grant. As of September 30, 2018, unamortized stock-based compensation expense of $1,089,491 will be amortized over a weighted average period of 3.6 years. Number of Shares Weighted Average Exercise Price Outstanding at December 31, 2017 (1) 539,896 $ 31.40 Granted 1,066,050 1.09 Exercised — — Cancelled/expired (156 ) 59.48 Outstanding at September 30, 2018 (unaudited) 1,605,790 $ 11.27 Exercisable at September 30, 2018 (unaudited) 535,031 $ 31.62 (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. Compensation Expense Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statement of operations is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Research and development $ 5,494 $ — $ 5,994 $ — General and administrative 34,497 6,947 52,544 6,953 Total $ 39,991 $ 6,947 $ 58,538 $ 6,953 The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of board services during the three and nine months ended September 30, 2018 are as follows: Three Months Ended Nine Months Ended September 30, 2018 September 30, 2018 Expected life in years 10.0 10.0 Risk-free interest rate 2.90% 2.90% Expected volatility 123% 123% Forfeiture rate 0.0% 0.0% Dividend yield 0.0% 0.0% Weighted-average fair value of options granted $ 1.03 $ 1.04 Restricted Stock After the Cerulean/Private Daré Stock Purchase Transaction The 3.14 million shares of common stock issued in connection with the Cerulean/Private Daré stock purchase transaction to the Private Daré stockholders were not registered with the SEC and may only be sold if registered under the Securities Act of 1933, as amended, or pursuant to an exemption from the registration requirements thereunder. The shares held by non-affiliates became eligible for sale under Rule 144 beginning . |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | 7. Stockholders’ Equity ATM Sales Agreement In January 2018, the Company entered into a common stock sales agreement under which the Company may sell up to an aggregate of $10 million in gross proceeds through the sale of shares of common stock from time to time in “at-the-market” equity offerings (as defined in Rule 415 promulgated under the Securities Act of 1933, as amended), including in sales made directly on the Nasdaq Capital Market, or Nasdaq, to or through a market maker or, subject to our prior approval, in negotiated transactions. The Company agreed to 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 the nine months ended September 30, 2018, the Company issued and sold 375,000 shares under the common stock sales agreement for gross proceeds of approximately $1.0 million and incurred offering expenses of approximately $336,000. All such shares were sold during January and February 2018. Underwritten Public Offering In February 2018, the Company closed an underwritten public offering of 5.0 million shares of its common stock and warrants to purchase up to 3.5 million shares of its common stock. Each share of common stock was sold with a warrant to purchase up to 0.70 of a share of the Company’s common stock. The Company granted the underwriter a 30-day overallotment option to purchase up to an additional 750,000 shares of common stock and/or warrants to purchase up to 525,000 shares of common stock. The underwriter exercised the option with respect to warrants to purchase 220,500 shares of common stock. The Company received gross proceeds of $10.3 million, including the proceeds from the sale of the warrants upon exercise of the underwriter’s overallotment option, and net proceeds of approximately $9.4 million. Common Stock Warrants The warrants issued in the February 2018 underwritten offering have an exercise price of $3.00 per share and are exercisable immediately and for five years from issuance. 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 adjusted downward if the Company issues or sells (or is deemed to issue or sell) securities at a price that is less than the exercise price in effect immediately prior to such issuance or sale (or deemed issuance or sale). In that case, the exercise price of the warrants will be adjusted to equal the price at which the new securities are issued or sold (or are deemed to have been issued or sold). In addition, subject to certain exceptions, if the Company issues, sells or enters into any agreement to issue or sell securities at a price which varies or may vary with the market price of the shares of the Company’s common stock, the warrant holders have the right to substitute such variable price for the exercise price of the warrant then in effect. The warrants are exercisable only for cash, unless a registration statement covering the shares issued upon exercise of the warrants is not effective, in which case the warrants may be exercised on a cashless basis. The Company has estimated the fair value of the warrants as of February 15, 2018 to be approximately $3.0 million which has been recorded in equity as of the grant date. The Company early adopted ASU 2017-11 and as a result has recorded the fair value of the warrants as equity (see Note 3). No warrants were exercised during the nine months ended September 30, 2018 or 2017. During the nine months ended September 30, 2018, warrants to purchase 170 shares of the Company’s common stock expired. As of September 30, 2018, the Company had these warrants outstanding: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,906 $ 120.40 December 1, 2021 3,737 $ 120.40 December 6, 2021 17,190 $ 60.50 January 8, 2020 6,500 $ 10.00 April 4, 2026 3,720,500 $ 3.00 February 15, 2023 3,750,833 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2018 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8. Commitments and Contingencies License and Research Agreements ADVA-Tec License Agreement In March 2017, the Company entered into a license agreement, or the ADVA-Tec Agreement, with ADVA-Tec, Inc., or ADVA-Tec, under which the Company was granted the exclusive right to develop and commercialize Ovaprene for human contraceptive use worldwide. ADVA-Tec and its affiliates own issued patents or patent applications covering Ovaprene and control proprietary trade secrets covering the manufacture of Ovaprene. As of the date of this report, this patent portfolio includes 12 issued patents worldwide and 8 patent applications, all of which are exclusively licensed to the Company for the human contraceptive use of Ovaprene under the terms of the ADVA-Tec Agreement. The license 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. The Company also has a right of first refusal to license these patents and patent applications for additional indications for Ovaprene. The following is a summary of certain terms of the ADVA-Tec Agreement: • Research and Development. ADVA-Tec will conduct certain research and development work as necessary to allow the Company to seek a Premarket Approval, or PMA, from the United States Food and Drug Administration, or the FDA, and will supply the Company with its requirements of Ovaprene for clinical and commercial use on commercially reasonable terms. The Company must use commercially reasonable efforts to develop and commercialize Ovaprene, and must meet certain minimum spending amounts per year, such amounts totaling $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. • Milestone Payments. The Company must make payments of up to $14.6 million in the aggregate to ADVA-Tec based on the achievement of specified development and regulatory milestones, which include the completion of a successful Postcoital Clinical Trial Study (as defined in the ADVA-Tec Agreement); approval by the FDA to commence the Phase 3 pivotal human clinical trial; successful completion of the Phase 3 pivotal human clinical trial; the FDA’s acceptance of the filing of a PMA for Ovaprene; the FDA’s approval of the PMA for Ovaprene; obtaining Conformité Européenne 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. The Company is also required to make up to $20 million in the aggregate in commercial milestone payments to ADVA-Tec upon reaching certain worldwide net sales milestones. Because these milestone payments depend upon the successful progress of the Company’s product development programs, the Company cannot estimate with certainty when these payments will occur, if ever. • Royalty Payments. After the commercial launch of Ovaprene, the Company is required to make royalty payments to ADVA-Tec based on aggregate annual net sales of Ovaprene in specified regions, which percentage royalty rate will vary between 1% and 10% and will increase based on various net sales thresholds. • Termination Rights. The ADVA-Tec Agreement includes customary termination rights for both parties and provides the Company the right to terminate with or without cause in whole or on a country-by-country basis upon 60 days prior written notice. ADVA-Tec may terminate the agreement if the Company fails to do any of the following: (i) satisfy the annual spending obligation described above, (ii) use commercially reasonable efforts to complete all necessary pre-clinical and clinical studies required to support and submit a PMA, (iii) conduct clinical trials as set forth in the development plan that is agreed by the Company and ADVA-Tec, and as may be modified by a joint research committee, where such failure is not caused by events outside of the Company’s reasonable control, or (iv) enroll a patient in the first non-significant risk medical device study or clinical trial as allowed by an institutional review board within six months of the production and release of Ovaprene, where non-enrollment is not caused by events outside of its reasonable control. In addition, ADVA-Tec may terminate the ADVA-Tec Agreement if the Company develops or commercializes any non-hormonal ring-based vaginal contraceptive device deemed competitive to Ovaprene or, in certain limited circumstances, if the Company fails to commercialize Ovaprene in certain designated countries within three years of the first commercial sale of Ovaprene. SST License and Collaboration Agreement In February 2018, the Company entered into a license and collaboration agreement, or the SST License Agreement, with Strategic Science & Technologies-D, LLC and Strategic Science & Technologies, LLC, referred to collectively as SST. Under the SST License Agreement, the Company was required to secure an investment of at least $10 million by March 31, 2018, which it did. The SST License Agreement provides the Company with 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 exists as of the effective date of the SST License 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 certain 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. • Joint Development Committee . The parties will collaborate through a joint development committee that will determine the strategic objectives for, and generally oversee, the development efforts of both parties under the SST License Agreement. • Development. The Company must use commercially reasonable efforts to develop the Licensed Products in the Field of Use in accordance with a development plan in the SST License Agreement, and to commercialize the Licensed Products in the Field of Use. The Company is responsible for all reasonable internal and external costs and expenses incurred by SST in its performance of the development activities it must perform under the SST License Agreement. • Royalty Payments. SST will be eligible to receive tiered royalties based on percentages of annual net sales of Licensed Products in the single digits to the mid double digits, subject to customary royalty reductions and offsets, and a percentage of sublicense revenue. • Milestone Payments. SST will be eligible to receive payments ranging from $0.5 million to $18.0 million on achieving certain clinical and regulatory milestones in the U.S. and worldwide, and an additional $10.0 million to $100 million upon achieving certain commercial milestones. If the Company enters into strategic development or distribution partnerships related to the Licensed Products, additional milestone payments would be due to SST. • License Term. The Company’s license received under the SST License Agreement 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. Upon expiration (but not termination) of the SST License Agreement in a particular country, the Company will have a fully paid-up license under the licensed intellectual property to develop and commercialize the applicable Licensed Products in the applicable country on a non-exclusive basis. • Termination. Each party has customary rights to terminate the SST License Agreement in the event of material uncured breach by the other party. In addition: (1) prior to receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including New Drug Application Approval, or NDA Approval, the Company may terminate the SST License Agreement without cause upon 90 days prior written notice to SST; (2) following receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA Approval, the Company may terminate the SST License Agreement without cause upon one 180 days prior written notice; and (3) SST may terminate the SST License Agreement with respect to the applicable Licensed Product(s) in the applicable country(ies) upon 30 days’ notice to the Company if the Company fails to use commercially reasonable efforts to perform development activities in substantial accordance with the development plan and does not cure such failure within 60 days of receipt of SST’s notice thereof. Orbis Development and Option Agreement In March 2018, the Company entered into an exclusive development and option agreement, or the Orbis Agreement, with Orbis Biosciences, or Orbis, for the development of long-acting injectable etonogestrel contraceptive with 6- and 12-month durations (ORB-204 and ORB-214, respectively). The Company agreed to pay Orbis $300,000 to conduct the first stage of development work, Stage 1, as follows: $150,000 upon signing the Orbis Agreement, $75,000 at the 50% completion point, not later than 6 months following the date the Orbis Agreement was signed, and $75,000 upon delivery by Orbis of the 6-month batch, not later than 11 months following the date the Orbis Agreement was signed. Upon Orbis successfully completing Stage 1 of the development program and achieving the predetermined target milestones for Stage 1, the Company will have 90 days to instruct Orbis whether to commence the second stage of development work, Stage 2. Should the Company execute its option to proceed to Stage 2, it will have to provide additional funding to Orbis 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 Orbis will continue to advance the program through formulation optimization with the goal of achieving sustained release over the target time period. The Orbis Agreement provides the Company with an option to enter into a license agreement for ORB-204 and ORB-214 should development efforts be successful. Juniper Pharmaceuticals - License Agreement In April 2018, the Company entered into an Exclusive License Agreement, or the Juniper License Agreement, with Juniper Pharmaceuticals, Inc., or Juniper, under which Juniper granted the Company (a) an exclusive, royalty-bearing worldwide license under certain patent rights, either owned by or exclusively licensed to Juniper, 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 Juniper 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 the Juniper License Agreement. The following is a summary of certain terms of the Juniper License Agreement: • Upfront Fee. The Company paid a $250,000 non-creditable upfront license fee to Juniper in connection with the execution of the Juniper License Agreement. • Annual Maintenance Fee . The Company will pay an annual license maintenance fee to Juniper on each anniversary of the date of the Juniper License 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 Juniper in the same calendar year but may not be carried forward to any other year. • Milestone Payments. The Company must make potential future development and sales milestone payments of up to $43.8 million (up to $13.5 million in clinical and regulatory milestones and up to $30.3 million in sales milestones) for each product or process covered by the licenses granted under the Juniper License Agreement. • Royalty Payments . During the royalty term, the Company will pay Juniper mid-single-digit to low double-digit royalties based on worldwide net sales of products and processes covered by the licenses granted under the Juniper Agreement. In lieu of such royalty payments, the Company will pay Juniper a low double-digit percentage of all sublicense income that the Company receives for the sublicense of rights under the Juniper License 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. • Efforts . 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 Juniper License Agreement. • Term . Unless earlier terminated, the term of the Juniper License Agreement will continue on a country-by-country basis until the later of (1) the expiration date of the last valid claim within such country, or (2) 10 years from the date of first commercial sale of a product or process in such country. Upon expiration (but not early termination) of the Juniper License Agreement, the licenses granted thereunder will convert automatically to fully-paid irrevocable licenses. Juniper may terminate the Juniper License Agreement (1) upon 30 days’ notice for the Company’s uncured breach of any payment obligation under the Juniper License 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 its other obligations under the Juniper License Agreement. The Company may terminate the Juniper License 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). If Juniper terminates the Juniper License Agreement for the reason described in clause (4) above or if the Company terminates the Juniper License Agreement, Juniper will have full access including the right to use and reference all product data generated during the term of the Juniper License Agreement that is owned by the Company. Pear Tree Acquisition The Company may be required to make certain royalty and milestone payments under the Merger Agreement (see Note 4). Operating Lease The Company entered into a facility lease agreement that commenced on July 1, 2018 for 3,169 square feet of office space for its corporate headquarters. The term of the lease is 37 months and terminates on July 31, 2021. The Company has the option to extend the term of the lease for one year. The gross monthly base rent is $8,873, which will increase approximately 4% per year, subject to certain future adjustments. The base rent was abated during the second month of the lease. Future minimum lease payments at September 30, 2018 total $315,727. The Company recognizes rent expense by the straight-line method over the lease term. As of September 30, 2018, deferred rent totaled $9,292. |
Grant Award
Grant Award | 9 Months Ended |
Sep. 30, 2018 | |
Grant Award [Abstract] | |
Grant Award | 9. Grant Award In April 2018, the Company received a Notice of Award for the first $224,665 of the anticipated $1.9 million in grant funding from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, a division of the National Institutes of Health. The award will be applied to clinical development efforts supporting Ovaprene. The balance of the award is contingent upon, among other matters, assessment of the results of the first phase of the research and availability of funds. The Company must incur and track expenses eligible for reimbursement under the award and submit a detailed accounting of such expenses to receive payment. As of September 30, 2018, the Company has received payments totaling approximately $144,000. The funding is 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. At September 30, 2018, the Company has recorded a receivable of approximately $69,000 for expenses believed to be eligible for reimbursement incurred through September 30, 2018. |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10. Net Loss Per Share The Company computes basic net loss per share using the weighted average number of common shares outstanding during the period. Diluted net income per share is based upon the weighted average number of common shares and potentially dilutive securities (common share equivalents) outstanding during the period. Common share equivalents outstanding, determined using the treasury stock method, are comprised of shares that may be issued under outstanding options and warrants to purchase shares of the Company’s common stock. Common share equivalents are excluded from the diluted net loss per share calculation if their effect is anti-dilutive. The following potentially dilutive outstanding securities were excluded from diluted net loss per common share for the period indicated because of their anti-dilutive effect: Three months ended Nine months ended September 30, September 30, 2018 2017 2018 2017 Stock options 1,605,790 545,640 1,605,790 545,640 Warrants 3,750,833 30,502 3,750,833 30,502 Total 5,356,623 576,142 5,356,623 576,142 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2018 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying interim consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP, as defined by the Financial Accounting Standards Board, or FASB, for interim financial information and the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In management’s opinion, the accompanying interim consolidated financial statements reflect all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the results of the interim periods presented. Interim financial results are not necessarily indicative of results anticipated for any other interim period or for the full year. The accompanying interim consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. |
Reverse Stock Split | Reverse Stock Split On July 20, 2017, the Company effected a of its common stock. |
Use of Estimates | Use of Estimates Preparing 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, goodwill impairment and purchase accounting. Actual results could differ from those estimates and could materially affect the reported amounts of assets, liabilities and future operating results. |
Principles of Consolidation | Principles of Consolidation The interim consolidated financial statements of the Company are stated in U.S. dollars and are prepared using GAAP. These financial statements include the accounts of the Company and its wholly owned subsidiaries, Daré Bioscience Operations, Inc., Daré Bioscience Australia Pty LTD, and Pear Tree Pharmaceuticals, Inc. 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 in the interim consolidated balance sheets. All significant intercompany transactions and accounts have been eliminated in consolidation. |
Grant Funding | Grant Funding The Company receives certain research and development funding through a grant issued by a division of the National Institutes of Health. 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 adopted this policy in 2018. During the three and nine months ended September 30, 2018, the Company recognized approximately $213,000 in the statement of operations as a reduction to research and development expense. |
Fair Value Measurements | Fair Value Measurements GAAP defines fair value as the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date, and also establishes a fair value hierarchy which requires an entity to maximize the use of observable inputs, where available. The three-level hierarchy of valuation techniques established to measure fair value is defined as follows: • Level 1: inputs are unadjusted quoted prices in active markets for identical assets or liabilities. • Level 2: inputs other than level 1 that are observable, either directly or indirectly, such as quoted prices in active markets for similar assets and liabilities, quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of assets or liabilities. • Level 3: unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. Cash and cash equivalents of $9.5 million and $7.6 million measured at fair value as of September 30, 2018 and December 31, 2017, respectively, are classified within Level 1 of the fair value hierarchy. Other receivables are financial assets with carrying values that approximate fair value due to the short-term nature of these assets. Accounts payable and accrued expenses and other liabilities are financial liabilities with carrying values that approximate fair value due to the short-term nature of these liabilities. |
Recent Pronouncements Not Yet Adopted | Recent Pronouncements Not Yet Adopted In February 2016, FASB issued ASU 2016-02, Leases (Topic 842) |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In May 2014, FASB issued Accounting Standards Update, or ASU, 2014-09, Revenue from Contracts with Customers In August 2016, FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments , which intended to add or clarify guidance on the classification of certain cash receipts and payments on the statement of cash flows. The new guidance addresses cash flows related to: debt prepayment or extinguishment costs, settlement of zero-coupon bonds, contingent consideration payments made after a business combination, proceeds from the settlement of insurance claims, proceeds from the settlement of corporate-owned life insurance policies and bank-owned life insurance policies, distributions received from equity method investees, beneficial interest in securitization transactions, and the application of predominance principle to separately identifiable cash flows. The standard became effective on January 1, 2018. The Company’s adoption of this standard on January 1, 2018 did not have a material impact on the Company’s interim consolidated financial statements. In January 2017, FASB issued ASU 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business In January 2017, FASB issued ASU 2017-04, Simplifying the Test for Goodwill Impairment (Topic 350) In May 2017, FASB issued ASU 2017-09, Compensation – Stock Compensation (Topic 718): Scope of Modification Accounting |
Acquisitions (Tables)
Acquisitions (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Business Combinations [Abstract] | |
Schedule of Purchase Price Consideration Allocation | The total purchase price consideration of approximately $24.3 million represents the fair value of the shares of Cerulean stock issued in connection with the Cerulean/Private Daré stock purchase transaction and the unamortized fair value of the stock options described above, which was allocated as follows: Purchase Consideration (in thousands) Fair value of shares issued $ 20,625 Unamortized fair value of Cerulean options 3,654 Fair value of total consideration $ 24,279 Assets acquired and liabilities assumed Cash and cash equivalents $ 9,918 Prepaid expense and other current assets 1,915 Accounts payable (233 ) Total assets acquired and liabilities assumed 11,600 Goodwill $ 12,679 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity for Amended 2014 Plan and Related Information | The table below summarizes stock option activity under the Amended 2014 Plan, and related information for the nine months ended September 30, 2018. Number of Shares Weighted Average Exercise Price Outstanding at December 31, 2017 (1) 539,896 $ 31.40 Granted 1,066,050 1.09 Exercised — — Cancelled/expired (156 ) 59.48 Outstanding at September 30, 2018 (unaudited) 1,605,790 $ 11.27 Exercisable at September 30, 2018 (unaudited) 535,031 $ 31.62 (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. |
Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors | Total stock-based compensation expense related to stock options granted to employees and directors recognized in the consolidated statement of operations is as follows: Three Months Ended Nine Months Ended September 30, September 30, 2018 2017 2018 2017 Research and development $ 5,494 $ — $ 5,994 $ — General and administrative 34,497 6,947 52,544 6,953 Total $ 39,991 $ 6,947 $ 58,538 $ 6,953 |
Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and Directors | The assumptions used in the Black-Scholes option-pricing model for stock options granted to employees and to directors in respect of board services during the three and nine months ended September 30, 2018 are as follows: Three Months Ended Nine Months Ended September 30, 2018 September 30, 2018 Expected life in years 10.0 10.0 Risk-free interest rate 2.90% 2.90% Expected volatility 123% 123% Forfeiture rate 0.0% 0.0% Dividend yield 0.0% 0.0% Weighted-average fair value of options granted $ 1.03 $ 1.04 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Equity [Abstract] | |
Schedule of Common Stock Warrants Outstanding | As of September 30, 2018, the Company had these warrants outstanding: Shares Underlying Outstanding Warrants Exercise Price Expiration Date 2,906 $ 120.40 December 1, 2021 3,737 $ 120.40 December 6, 2021 17,190 $ 60.50 January 8, 2020 6,500 $ 10.00 April 4, 2026 3,720,500 $ 3.00 February 15, 2023 3,750,833 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2018 | |
Earnings Per Share [Abstract] | |
Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share | The following potentially dilutive outstanding securities were excluded from diluted net loss per common share for the period indicated because of their anti-dilutive effect: Three months ended Nine months ended September 30, September 30, 2018 2017 2018 2017 Stock options 1,605,790 545,640 1,605,790 545,640 Warrants 3,750,833 30,502 3,750,833 30,502 Total 5,356,623 576,142 5,356,623 576,142 |
Organization and Description _2
Organization and Description of the Business - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2018SegmentClinicalStageAsset | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Number of operating segments | Segment | 1 |
Number of clinical stage assets assembled as portfolio | ClinicalStageAsset | 2 |
Liquidity - Additional Informat
Liquidity - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2018 | Mar. 31, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2017 | Dec. 31, 2016 | |
Liquidity [Abstract] | |||||||
Net loss | $ (2,574,475) | $ (1,629,683) | $ (13,822,263) | $ (2,371,740) | |||
Accumulated deficit | (26,053,215) | (26,053,215) | $ (12,230,952) | ||||
Cash and cash equivalents | 9,537,463 | $ 8,529,220 | 9,537,463 | 8,529,220 | $ 7,559,846 | $ 44,614 | |
Cash flow from operations | $ 7,558,047 | $ 1,579,060 | |||||
Gross proceeds on sale of shares of common stock | $ 11,300,000 | ||||||
Aggregate net proceeds on sales of shares of common stock | $ 10,100,000 | ||||||
Cash received from federal grant | $ 144,000 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Additional Information (Detail) | Jul. 20, 2017 | Sep. 30, 2018USD ($) | Sep. 30, 2018USD ($) | Dec. 31, 2017USD ($) |
Significant Accounting Policies [Line Items] | ||||
Reverse stock split | 1-for-10 | |||
Reverse stock split, conversion ratio | 0.1 | |||
Fair Value, Measurements, Recurring [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Cash and cash equivalents | $ 9,500,000 | $ 9,500,000 | $ 7,600,000 | |
Research and Development Expense [Member] | ||||
Significant Accounting Policies [Line Items] | ||||
Grant funding recognized during period | $ 213,000 | $ 213,000 |
Acquisitions - Additional Infor
Acquisitions - Additional Information (Detail) - USD ($) | May 16, 2018 | Apr. 30, 2018 | Jul. 19, 2017 | Mar. 31, 2018 | Sep. 30, 2018 | Dec. 31, 2017 |
Business Combination Reverse Merger [Line Items] | ||||||
Stock option modification approval date | Mar. 19, 2017 | |||||
Goodwill impairment charge | $ 5,200,000 | $ 5,187,519 | $ 7,500,000 | |||
Goodwill | $ 12,700,000 | $ 5,187,519 | ||||
Pear Tree Pharmaceuticals, Inc. [Member] | ||||||
Business Combination Reverse Merger [Line Items] | ||||||
Business combination completed date | May 16, 2018 | |||||
Merger Agreement entered date | Apr. 30, 2018 | |||||
Potential cash payment to acquire business | $ 75,000 | |||||
Consideration amount | $ 132,000 | |||||
Period of potential cash payment | 1 year | |||||
Research and Development Expense [Member] | Pear Tree Pharmaceuticals, Inc. [Member] | ||||||
Business Combination Reverse Merger [Line Items] | ||||||
Transaction costs | $ 452,000 | |||||
Cerulean/Private Dare Stock Purchase Transaction [Member] | ||||||
Business Combination Reverse Merger [Line Items] | ||||||
Cash and cash equivalents | 9,918,000 | |||||
Unamortized fair value of stock options | 3,654,000 | |||||
Total purchase price consideration | 24,279,000 | |||||
Purchase price adjustments increase in current liabilities | 23,609 | |||||
Purchase price adjustments increase in current assets | 225,778 | |||||
Original goodwill amount acquired | 12,900,000 | |||||
Reduced original goodwill | 202,169 | |||||
Goodwill | 12,679,000 | |||||
Cerulean/Private Dare Stock Purchase Transaction [Member] | General and Administrative Expense [Member] | ||||||
Business Combination Reverse Merger [Line Items] | ||||||
Transaction costs | $ 960,000 | |||||
Private Dare [Member] | ||||||
Business Combination Reverse Merger [Line Items] | ||||||
Business combination completed date | Jul. 19, 2017 | |||||
Stock purchase transaction completion date | Jul. 19, 2017 | |||||
Stock purchase agreement date | Mar. 19, 2017 |
Acquisitions - Schedule of Purc
Acquisitions - Schedule of Purchase Price Consideration Allocation (Detail) - USD ($) | Jul. 19, 2017 | Dec. 31, 2017 |
Assets acquired and liabilities assumed | ||
Goodwill | $ 12,700,000 | $ 5,187,519 |
Cerulean/Private Dare Stock Purchase Transaction [Member] | ||
Business Combination Reverse Merger [Line Items] | ||
Fair value of shares issued | 20,625,000 | |
Unamortized fair value of Cerulean options | 3,654,000 | |
Fair value of total consideration | 24,279,000 | |
Assets acquired and liabilities assumed | ||
Cash and cash equivalents | 9,918,000 | |
Prepaid expense and other current assets | 1,915,000 | |
Accounts payable | (233,000) | |
Total assets acquired and liabilities assumed | 11,600,000 | |
Goodwill | $ 12,679,000 |
Convertible Promissory Notes -
Convertible Promissory Notes - Additional Information - (Detail) - USD ($) | 1 Months Ended | 2 Months Ended | 3 Months Ended | 9 Months Ended | |
Feb. 28, 2017 | Jun. 06, 2017 | Mar. 31, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Debt Conversion [Line Items] | |||||
Convertible promissory notes issued | $ 155,000 | ||||
Private Dare [Member] | |||||
Debt Conversion [Line Items] | |||||
Note annual interest rate | 8.00% | ||||
Convertible promissory notes issued | $ 100,000 | $ 55,000 | |||
Convertible notes issued, per share | $ 0.18727 | $ 0.38 | |||
Conversion percentage | 120.00% | ||||
Private Dare [Member] | Convertible Promissory Notes [Member] | |||||
Debt Conversion [Line Items] | |||||
Interest expense recognized from convertible promissory notes | $ 0 | $ 316,804 | |||
Private Dare [Member] | Minimum [Member] | |||||
Debt Conversion [Line Items] | |||||
Percentage of conversion benefit on preferred stock financing | 20.00% | ||||
Percentage of conversion benefit | 125.00% | ||||
Private Dare [Member] | Maximum [Member] | |||||
Debt Conversion [Line Items] | |||||
Percentage of conversion benefit on preferred stock financing | 40.00% | ||||
Percentage of conversion benefit | 140.00% |
Stock based compensation - Addi
Stock based compensation - Additional Information (Detail) - USD ($) | Jul. 10, 2018 | Mar. 31, 2017 | Mar. 31, 2014 | Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2017 | Jul. 19, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock options outstanding | 1,605,790 | 1,605,790 | 539,896 | ||||||||
Common stock, shares outstanding | 11,422,161 | 11,422,161 | 6,047,161 | ||||||||
Stock options awards granted | 1,066,050 | ||||||||||
Unamortized stock-based compensation expense | $ 1,089,491 | $ 1,089,491 | |||||||||
Amortized weighted average period | 3 years 7 months 6 days | ||||||||||
Common stock, shares issued | 11,422,161 | 11,422,161 | 6,047,161 | ||||||||
Cerulean/Private Dare Stock Purchase Transaction [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Common stock, shares issued | 3,140,000 | 3,140,000 | |||||||||
Stock Options [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock-based compensation expense | $ 39,991 | $ 6,947 | $ 58,538 | $ 6,953 | |||||||
2015 Stock Incentive Plan [Member] | Private Dare [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock options awards granted | 0 | ||||||||||
2015 Stock Incentive Plan [Member] | Stock Options [Member] | Private Dare [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock options grant period | 10 years | ||||||||||
Stock options vesting period | 3 years | ||||||||||
Stock options outstanding | 10,149 | 10,149 | 50,000 | ||||||||
2015 Stock Incentive Plan [Member] | Restricted Stock [Member] | Private Dare [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares issued to non-employees | 200,000 | 900,000 | |||||||||
Common stock, shares outstanding | 223,295 | 223,295 | |||||||||
2014 Employee Stock Purchase Plan [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Offering period | 6 months | ||||||||||
Purchase price as percentage of stock price on offering period | 85.00% | ||||||||||
Stock-based compensation expense | $ 0 | $ 0 | |||||||||
Amended and Restated 2014 Plan [Member] | Stock Options [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Stock options outstanding | 2,000,000 | ||||||||||
Share-based compensation description | The number of shares authorized for issuance under the Amended 2014 Plan is 2,046,885, which is the sum of (a) 1,509,463 shares of common stock plus (b) 537,422 shares of common stock subject to awards granted under the 2014 Plan. The number of authorized shares will increase annually on the first day of each fiscal year until, and including, the fiscal year ending December 31, 2024 by the least of (i) 2,000,000, (ii) 4% of the number of outstanding shares of common stock on such date, or (iii) an amount determined by the Company’s board of directors. | ||||||||||
Options to purchase number of outstanding shares of common stock | 2,046,885 | 1,605,790 | 1,605,790 | ||||||||
Number of outstanding shares of common stock authorized | 1,509,463 | ||||||||||
Number of outstanding shares of common stock authorized subject to grant | 537,422 | ||||||||||
Annual percentage increase in outstanding number of common stock | 4.00% | ||||||||||
Exercise period for stock options after termination date | 2 years | ||||||||||
Unamortized fair value expense | $ 3,700,000 | ||||||||||
Common stock reserved for future issuance | 451,244 | 451,244 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity for Amended 2014 Plan and Related Information (Detail) | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Number of shares | |
Number of Shares, Outstanding Beginning | shares | 539,896 |
Number of Shares, Granted | shares | 1,066,050 |
Number of Shares, Cancelled/expired | shares | (156) |
Number of Shares, Outstanding Ending | shares | 1,605,790 |
Number of Shares, Exercisable | shares | 535,031 |
Weighted-Average Exercise Price | |
Weighted Average Exercise Price, Outstanding Beginning | $ / shares | $ 31.40 |
Weighted Average Exercise Price, Granted | $ / shares | 1.09 |
Weighted Average Exercise Price, Cancelled/expired | $ / shares | 59.48 |
Weighted Average Exercise Price, Outstanding Ending | $ / shares | 11.27 |
Weighted Average Exercise Price, Exercisable | $ / shares | $ 31.62 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Stock Option Activity for Amended 2014 Plan and Related Information (Detail) (Parenthetical) - shares | Sep. 30, 2018 | Dec. 31, 2017 | Jul. 19, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options outstanding | 1,605,790 | 539,896 | |
Private Dare [Member] | Stock Options [Member] | 2015 Stock Incentive Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options outstanding | 10,149 | 50,000 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Recognized Stock-Based Compensation Expense Related to Stock Options Granted to Employees and Directors (Details) - Stock Options [Member] - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 39,991 | $ 6,947 | $ 58,538 | $ 6,953 |
Research and Development [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 5,494 | 5,994 | ||
General and Administrative Expense [Member] | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 34,497 | $ 6,947 | $ 52,544 | $ 6,953 |
Stock-based Compensation - Su_4
Stock-based Compensation - Summary of Assumptions Used in Black-Scholes Option-Pricing Model for Stock Options Granted to Employees and Directors (Detail) - $ / shares | 3 Months Ended | 9 Months Ended |
Sep. 30, 2018 | Sep. 30, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Expected life in years | 10 years | 10 years |
Risk-free interest rate | 2.90% | 2.90% |
Expected volatility | 123.00% | 123.00% |
Forfeiture rate | 0.00% | 0.00% |
Dividend yield | 0.00% | 0.00% |
Weighted-average fair value of options granted | $ 1.03 | $ 1.04 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Feb. 28, 2018 | Jan. 31, 2018 | Mar. 31, 2018 | Sep. 30, 2018 | Sep. 30, 2017 | Feb. 15, 2018 | |
Stockholders Equity [Line Items] | ||||||
Gross proceeds on sale of shares of common stock | $ 11,300,000 | |||||
Common stock, shares issued and sold | 5,000,000 | |||||
Price per share | $ 0.70 | |||||
Class of warrant or right exercisable period | 5 years | |||||
Warrants exercised | 0 | 0 | ||||
Warrants to purchase common stock expired | 170 | |||||
Accounting Standards Update 2017-11 [Member] | ||||||
Stockholders Equity [Line Items] | ||||||
Estimated fair value of warrants, recorded in equity | $ 3,000,000 | |||||
Maximum [Member] | ||||||
Stockholders Equity [Line Items] | ||||||
Warrants to purchase common stock | 3,500,000 | |||||
ATM Sales Agreement [Member] | ||||||
Stockholders Equity [Line Items] | ||||||
Gross proceeds on sale of shares of common stock | $ 1,000,000 | |||||
Offering expenses incurred | $ 336,000 | |||||
Common stock, shares issued and sold | 375,000 | |||||
ATM Sales Agreement [Member] | Maximum [Member] | ||||||
Stockholders Equity [Line Items] | ||||||
Gross proceeds on sale of shares of common stock | $ 10,000,000 | |||||
Aggregate commission rate | 3.00% | |||||
Underwritten Offering [Member] | ||||||
Stockholders Equity [Line Items] | ||||||
Gross proceeds from offering of common stock and warrants | $ 10,300,000 | |||||
Underwriters overallotment option to purchase additional shares of common stock and warrants period | 30 days | |||||
Proceeds from offering of common stock and warrants, net of costs | $ 9,400,000 | |||||
Exercise Price | $ 3 | |||||
Underwritten Offering [Member] | Maximum [Member] | ||||||
Stockholders Equity [Line Items] | ||||||
Common stock, shares issued and sold | 220,500 | |||||
Warrants to purchase common stock | 525,000 | |||||
Underwriters option to purchase additional shares | 750,000 |
Stockholders' Equity - Schedule
Stockholders' Equity - Schedule of Common Stock Warrants Outstanding (Details) | 9 Months Ended |
Sep. 30, 2018$ / sharesshares | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 3,750,833 |
Warrants Expiring on December 1, 2021 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 2,906 |
Exercise Price | $ / shares | $ 120.40 |
Expiration Date | Dec. 1, 2021 |
Warrants Expiring on December 6, 2021 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 3,737 |
Exercise Price | $ / shares | $ 120.40 |
Expiration Date | Dec. 6, 2021 |
Warrants Expiring on January 8, 2020 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 17,190 |
Exercise Price | $ / shares | $ 60.50 |
Expiration Date | Jan. 8, 2020 |
Warrants Expiring on April 4, 2026 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 6,500 |
Exercise Price | $ / shares | $ 10 |
Expiration Date | Apr. 4, 2026 |
Warrants Expiring on February 15, 2023 [Member] | |
Class Of Warrant Or Right [Line Items] | |
Shares Underlying Outstanding Warrants | 3,720,500 |
Exercise Price | $ / shares | $ 3 |
Expiration Date | Feb. 15, 2023 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) | Jul. 01, 2018USD ($)ft² | Apr. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Feb. 28, 2018USD ($) | Mar. 31, 2017USD ($)Country | Sep. 30, 2018USD ($) | Dec. 31, 2017USD ($) |
Commitments And Contingencies [Line Items] | |||||||
Leased rent area | ft² | 3,169 | ||||||
Lease expiration date | 37 months | ||||||
Renewal term of lease | 1 year | ||||||
Gross monthly base rent | $ 8,873 | ||||||
Percentage of increase in annual base rent, each year | 4.00% | ||||||
Operating leases, future minimum lease payments | $ 315,727 | ||||||
Deferred rent, total | $ 9,292 | $ 392 | |||||
License and Collaboration Agreement [Member] | SST [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Secured investment funding requirement to be fulfilled, date | Mar. 31, 2018 | ||||||
Percentage of rights to inventions by employees under license agreement | 50.00% | ||||||
License agreement, expiration period | 10 years | ||||||
License agreement, termination description | Termination. Each party has customary rights to terminate the SST License Agreement in the event of material uncured breach by the other party. In addition: (1) prior to receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including New Drug Application Approval, or NDA Approval, the Company may terminate the SST License Agreement without cause upon 90 days prior written notice to SST; (2) following receipt of approval by a regulatory authority necessary for commercialization of a Licensed Product in the corresponding jurisdiction, including NDA Approval, the Company may terminate the SST License Agreement without cause upon one 180 days prior written notice; and (3) SST may terminate the SST License Agreement with respect to the applicable Licensed Product(s) in the applicable country(ies) upon 30 days’ notice to the Company if the Company fails to use commercially reasonable efforts to perform development activities in substantial accordance with the development plan and does not cure such failure within 60 days of receipt of SST’s notice thereof | ||||||
License agreement, termination period prior to receipt of approval | 90 days | ||||||
License agreement, termination period after receipt of approval | 180 days | ||||||
License agreement, termination period for applicable license products of applicable countries | 30 days | ||||||
License agreement, termination period due to performance failure | 60 days | ||||||
License and Collaboration Agreement [Member] | Minimum [Member] | SST [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Secured investment required for license agreement | $ 10,000,000 | ||||||
Milestone payments, contingent amount | 500,000 | ||||||
License and Collaboration Agreement [Member] | Minimum [Member] | Upon Achieving Certain Commercial Milestones [Member] | SST [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments, contingent amount | 10,000,000 | ||||||
License and Collaboration Agreement [Member] | Maximum [Member] | SST [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments, contingent amount | 18,000,000 | ||||||
License and Collaboration Agreement [Member] | Maximum [Member] | Upon Achieving Certain Commercial Milestones [Member] | SST [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments, contingent amount | $ 100,000,000 | ||||||
Development and Option Agreement [Member] | Orbis [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments | $ 300,000 | ||||||
Commencement period for stage two upon achievement of stage one | 90 days | ||||||
Development and Option Agreement [Member] | Upon Signing of Development and Option Agreement [Member] | Orbis [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments | $ 150,000 | ||||||
Development and Option Agreement [Member] | Upon Completion of Fifty Percent Development Not Later Than Six Months [Member] | Orbis [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments | 75,000 | ||||||
Development and Option Agreement [Member] | Upon Delivery of Six Month Batch Development Not Later Than Eleven Months [Member] | Orbis [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments | $ 75,000 | ||||||
Juniper Pharmaceuticals - License Agreement [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
License agreement, termination description | Unless earlier terminated, the term of the Juniper License Agreement will continue on a country-by-country basis until the later of (1) the expiration date of the last valid claim within such country, or (2) 10 years from the date of first commercial sale of a product or process in such country. Upon expiration (but not early termination) of the Juniper License Agreement, the licenses granted thereunder will convert automatically to fully-paid irrevocable licenses. Juniper may terminate the Juniper License Agreement (1) upon 30 days’ notice for the Company’s uncured breach of any payment obligation under the Juniper License 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 its other obligations under the Juniper License Agreement. The Company may terminate the Juniper License 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). If Juniper terminates the Juniper License Agreement for the reason described in clause (4) above or if the Company terminates the Juniper License Agreement, Juniper will have full access including the right to use and reference all product data generated during the term of the Juniper License Agreement that is owned by the Company. | ||||||
License agreement, termination period prior to receipt of approval | 90 days | ||||||
Upfront license fee paid | $ 250,000 | ||||||
Annual license maintenance fee payable in first year | 50,000 | ||||||
Annual license maintenance fee payable in second year | 50,000 | ||||||
Annual license maintenance fee payable thereafter | 100,000 | ||||||
Maximum potential milestone payments | $ 43,800,000 | ||||||
License agreement, royalty termination description | 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 | ||||||
License agreement, period of continuation from date of first commercial sale of product or process | 10 years | ||||||
License agreement, notice period of termination for breach of payment obligation | 30 days | ||||||
Period of dismissal of bankruptcy petition | 90 days | ||||||
License agreement, notice period of termination for breach of other obligation | 60 days | ||||||
License agreement, notice period of termination | 180 days | ||||||
ADVA Tec Agreement [Member] | License Agreement [Member] | Upon Reaching Certain Worldwide Net Sales Milestones [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments | $ 20,000,000 | ||||||
ADVA Tec Agreement [Member] | License Agreement [Member] | Ovaprene [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Minimum obligation to be paid in number of years | 3 years | ||||||
Prior written notice period for termination of agreement for both parties | 60 days | ||||||
Agreement termination on failing to enroll patient within months of production and release | 6 months | ||||||
Agreement termination period on failing to commercialize in certain designated countries | 3 years | ||||||
ADVA Tec Agreement [Member] | License Agreement [Member] | Minimum [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Number of designated European countries | Country | 3 | ||||||
Percentage of royalty rate | 1.00% | ||||||
ADVA Tec Agreement [Member] | License Agreement [Member] | Minimum [Member] | Ovaprene [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Minimum spending amounts per year | $ 5,000,000 | ||||||
ADVA Tec Agreement [Member] | License Agreement [Member] | Maximum [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Percentage of royalty rate | 10.00% | ||||||
ADVA Tec Agreement [Member] | License Agreement [Member] | Maximum [Member] | Upon Achievement of Specified Development and Regulatory Milestones [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Milestone payments | $ 14,600,000 | ||||||
Clinical and Regulatory Milestones [Member] | Juniper Pharmaceuticals - License Agreement [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Maximum potential milestone payments | $ 13,500,000 | ||||||
Sales Milestones [Member] | Juniper Pharmaceuticals - License Agreement [Member] | |||||||
Commitments And Contingencies [Line Items] | |||||||
Maximum potential milestone payments | $ 30,300,000 |
Grant Award - Additional Inform
Grant Award - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 9 Months Ended |
Apr. 30, 2018 | Sep. 30, 2018 | Sep. 30, 2018 | |
Grant Award [Line Items] | |||
Cash received from federal grant | $ 144,000 | ||
National Institutes of Health [Member] | Eunice Kennedy Shriver National Institute of Child Health and Human Development [Member] | |||
Grant Award [Line Items] | |||
Grants receivable | $ 1,900,000 | ||
Cash received from federal grant | $ 144,000 | ||
Reimbursement of grant expenses receivable | $ 69,000 | $ 69,000 | |
National Institutes of Health [Member] | First Phase of Research And Availability of Funds [Member] | Eunice Kennedy Shriver National Institute of Child Health and Human Development [Member] | Grant [Member] | |||
Grant Award [Line Items] | |||
Revenue from grant for notice of award | $ 224,665 |
Net Loss Per Share - Potential
Net Loss Per Share - Potential Dilutive Outstanding Securities Excluded From Diluted Net Loss Per Common Share (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2018 | Sep. 30, 2017 | Sep. 30, 2018 | Sep. 30, 2017 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding | 5,356,623 | 576,142 | 5,356,623 | 576,142 |
Stock Options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding | 1,605,790 | 545,640 | 1,605,790 | 545,640 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted-average shares outstanding | 3,750,833 | 30,502 | 3,750,833 | 30,502 |