Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2019 | Mar. 01, 2020 | Jun. 28, 2019 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2019 | ||
Document Fiscal Year Focus | 2019 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Acer Therapeutics Inc. | ||
Entity Central Index Key | 0001069308 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 21,551,439 | ||
Entity Common Stock, Shares Outstanding | 10,095,176 | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | ACER | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-33004 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 32-0426967 | ||
Entity Address, Address Line One | One Gateway Center | ||
Entity Address, Address Line Two | Ste. 351 | ||
Entity Address, Address Line Three | 300 Washington St. | ||
Entity Address, City or Town | Newton | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02458 | ||
City Area Code | 844 | ||
Local Phone Number | 902-6100 | ||
Document Annual Report | true | ||
Document Transition Report | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Current assets: | ||
Cash and cash equivalents | $ 12,077,640 | $ 41,671,284 |
Prepaid expenses and other current assets | 807,356 | 1,075,021 |
Total current assets | 12,884,996 | 42,746,305 |
Property and equipment, net | 193,974 | 130,867 |
Other assets: | ||
Goodwill | 7,647,267 | 7,647,267 |
In-process research and development | 118,600 | 118,600 |
Other non-current assets | 620,674 | 20,380 |
Total assets | 21,465,511 | 50,663,419 |
Current liabilities: | ||
Accounts payable | 561,090 | 1,033,829 |
Accrued expenses | 1,944,431 | 4,546,432 |
Other current liabilities | 263,392 | |
Total current liabilities | 2,768,913 | 5,580,261 |
Other non-current liabilities | 326,282 | |
Total liabilities | 3,095,195 | 5,580,261 |
Commitments and Contingencies (Note 6) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; authorized 10,000,000 shares; none issued and outstanding | ||
Common stock, $0.0001 par value; authorized 150,000,000 shares; 10,095,176 and 10,087,363 shares issued and outstanding at December 31, 2019 and 2018, respectively | 1,010 | 1,009 |
Additional paid-in capital | 94,619,818 | 91,914,692 |
Accumulated deficit | (76,250,512) | (46,832,543) |
Total stockholders’ equity | 18,370,316 | 45,083,158 |
Total liabilities and stockholders’ equity | $ 21,465,511 | $ 50,663,419 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2019 | Dec. 31, 2018 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 10,095,176 | 10,087,363 |
Common stock, shares outstanding | 10,095,176 | 10,087,363 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Operating expenses: | ||
Research and development | $ 13,851,018 | $ 12,452,424 |
General and administrative | 16,046,423 | 9,261,570 |
Total operating expenses | 29,897,441 | 21,713,994 |
Loss from operations | (29,897,441) | (21,713,994) |
Other income, net: | ||
Interest income | 471,267 | 412,553 |
Foreign currency transaction gain | 8,205 | 20,550 |
Total other income, net | 479,472 | 433,103 |
Net loss | $ (29,417,969) | $ (21,280,891) |
Net loss per share - basic and diluted | $ (2.91) | $ (2.49) |
Weighted average common shares outstanding - basic and diluted | 10,092,179 | 8,555,039 |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2017 | $ 22,335,537 | $ 74,974 | $ 47,812,215 | $ (25,551,652) |
Beginning balance, shares at Dec. 31, 2017 | 7,497,433 | |||
Reallocation for change in par value | $ (74,224) | 74,224 | ||
Issuance of common stock, net of issuance costs | 42,622,700 | $ 256 | 42,622,444 | |
Issuance of common stock, net of issuance costs, shares | 2,555,555 | |||
Issuance of common stock in connection with stock option exercises | 87,659 | $ 3 | 87,656 | |
Issuance of common stock in connection with stock option exercises, shares | 34,375 | |||
Stock-based compensation | 1,318,153 | 1,318,153 | ||
Net loss | (21,280,891) | (21,280,891) | ||
Ending balance at Dec. 31, 2018 | $ 45,083,158 | $ 1,009 | 91,914,692 | (46,832,543) |
Ending balance, shares at Dec. 31, 2018 | 10,087,363 | 10,087,363 | ||
Issuance of common stock in connection with stock option exercises | $ 92,272 | $ 1 | 92,271 | |
Issuance of common stock in connection with stock option exercises, shares | 7,813 | 7,813 | ||
Stock-based compensation | $ 2,612,855 | 2,612,855 | ||
Net loss | (29,417,969) | (29,417,969) | ||
Ending balance at Dec. 31, 2019 | $ 18,370,316 | $ 1,010 | $ 94,619,818 | $ (76,250,512) |
Ending balance, shares at Dec. 31, 2019 | 10,095,176 | 10,095,176 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | ||
Net loss | $ (29,417,969) | $ (21,280,891) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,612,855 | 1,318,153 |
Depreciation | 58,282 | 27,744 |
Loss on disposal of property and equipment | 57,578 | |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | 267,665 | (193,134) |
Accounts payable | (472,739) | 937,956 |
Accrued expenses | (2,602,001) | 2,609,101 |
Other noncurrent assets | (10,620) | (6,732) |
Net cash used in operating activities | (29,506,949) | (16,587,803) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (178,967) | (95,627) |
Net cash used in investing activities | (178,967) | (95,627) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 42,622,700 | |
Proceeds from exercise of stock options | 92,272 | 87,659 |
Net cash provided by financing activities | 92,272 | 42,710,359 |
Net (decrease) increase in cash and cash equivalents | (29,593,644) | 26,026,929 |
Cash and cash equivalents, beginning of the year | 41,671,284 | 15,644,355 |
Cash and cash equivalents, end of the year | $ 12,077,640 | $ 41,671,284 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 2019 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Operations and Basis of Presentation | 1. NATURE OF OPERATIONS AND BASIS OF PRESENTATION Business Acer Therapeutics Inc., a Delaware corporation (the “Company”), is a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. The Company’s pipeline includes three clinical-stage candidates: EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (“vEDS”) in patients with a confirmed type III collagen (COL3A1) mutation; ACER-001 (a taste-masked, immediate release formulation of sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (“UCD”) and Maple Syrup Urine Disease (“MSUD”); and osanetant for the treatment of induced Vasomotor Symptoms (“iVMS”) where Hormone Replacement Therapy (“HRT”) is likely contraindicated. The Company’s product candidates are believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation, and/or accelerated paths for development through specific programs and procedures established by the United States (“U.S.”) Food and Drug Administration (“FDA”). Since its inception, the Company has devoted substantially all of its efforts to business planning, research and development, recruiting management and technical staff, acquiring operating assets and raising capital. The Company has not generated any product revenue to date and may never generate any product revenue in the future. In June 2019, the Company received a Complete Response Letter from the FDA regarding its new drug application (“NDA”) for EDSIVO TM TM In March 2020, the Company received a response to its Formal Dispute Resolution Request from the Office of New Drugs of the FDA stating that it had denied the Company’s appeal of the Complete Response Letter in relation to the NDA for EDSIVO TM TM TM TM Merger and Reverse Stock Split On September 19, 2017, the Company (then a Texas corporation known as Opexa Therapeutics, Inc.) completed its business combination with Acer Therapeutics Inc., a Delaware corporation (“Private Acer”), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated as of June 30, 2017, by and among the Company, Opexa Merger Sub, Inc. (“Merger Sub”) and Private Acer (the “Merger Agreement”), pursuant to which Merger Sub merged with and into Private Acer, with Private Acer surviving as a wholly-owned subsidiary of the Company (the “Merger”). This transaction was approved by the Company’s stockholders at a special meeting of its stockholders on September 19, 2017. Also on September 19, 2017, in connection with, and prior to the completion of, the Merger, the Company effected a 1-for-10.355527 reverse stock split of its then outstanding common stock (the “Reverse Split”) and immediately following the Merger, the Company changed its name to “Acer Therapeutics Inc.” pursuant to amendments to its certificate of formation filed with the Texas Secretary of State on September 19, 2017. All share numbers in this report have been adjusted to reflect the Reverse Split. Following the completion of the Merger, the business conducted by the Company became primarily the business conducted by Private Acer. Delaware Reincorporation and Subsidiary Merger On May 15, 2018, the Company changed its state of incorporation from the State of Texas to the State of Delaware pursuant to a plan of conversion, dated May 15, 2018. As a result of this reincorporation, the par value of the Company’s preferred stock was changed to $0.0001 from no par value and the par value of the Company’s common stock was reduced to $0.0001 from $0.01. Immediately following the Reincorporation, the Company’s holding company structure was eliminated by merging wholly-owned subsidiary Private Acer with and into the Company (the “Subsidiary Merger”). The Company was the surviving corporation in connection with the Subsidiary Merger. Basis of Presentation The consolidated financial statements include Acer Therapeutics Inc. and, prior to the date of the Subsidiary Merger, its wholly-owned subsidiary, Private Acer. All intercompany balances and transactions have been eliminated in consolidation. Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the U.S., as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). Liquidity The Company had an accumulated deficit of $76.3 million and cash and cash equivalents of $12.1 million as of December 31, 2019. Net cash used in operating activities was $29.5 million and $16.6 million for the years ended December 31, 2019 and 2018, respectively. On November 9, 2018, the Company entered into a sales agreement with Roth Capital Partners, LLC, and on March 18, 2020, an amended and restated sales agreement (the “Agreement”) was entered into with JonesTrading Institutional Services LLC and Roth Capital Partners, LLC. The Agreement provides a facility for the offer and sale of shares of common stock from time to time having an aggregate offering price of up to $50 million depending upon market demand, in transactions deemed to be an at-the-market offering (the “ATM Offering”) . As of December 31, 2019, the Company had TM support for EDSIVO™ development and precommercial activities and the planned osanetant clinical trial Management expects to continue to finance operations through the issuance of additional equity or debt securities and/or through strategic collaborations. Any transactions which occur may contain covenants that restrict the ability of management to operate the business and any securities issued may have rights, preferences, or privileges senior to the Company’s common stock and may dilute the ownership of current stockholders of the Company. Going Concern The accompanying financial statements have been prepared in conformity with GAAP, which contemplate continuation of the Company as a going concern. The Company has not established a source of revenues and, as such, has been dependent on funding operations through the sale of equity securities. Since inception, the Company has experienced significant losses and incurred negative cash flows from operations. The Company expects to incur further losses over the next several years as it develops its business. The Company has spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including its planned product development efforts and potential precommercial activities. As of December 31, 2019, the Company had cash and cash equivalents of $12.1 million. The Company’s cash and cash equivalents available at December 31, 2019 are expected to fund operations through the end of 2020, excluding support for EDSIVO™ development and precommercial activities and the planned osanetant clinical trial The Company will need to raise additional capital to fund continued operations some time during 2020. The Company has no commitments for any additional financing and may not be successful in its efforts to raise additional funds or achieve profitable operations. Any amounts raised will be used for further development of the Company’s product candidates, precommercial activities, potential acquisitions of additional product candidates and for other working capital purposes. If the Company is unable to obtain additional capital (which is not assured at this time), its long-term business plan may not be accomplished, and the Company may be forced to cease, reduce, or delay operations. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. |
Significant Accounting Polices
Significant Accounting Polices | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Significant Accounting Polices | 2. SIGNIFICANT ACCOUNTING POLICIES A summary of the significant accounting policies followed by the Company in the preparation of the accompanying consolidated financial statements follows: Use of Estimates The Company’s accounting principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Estimates having relatively higher significance include stock-based compensation, contract manufacturing accruals, and income taxes. Actual results could differ from those estimates and changes in estimates may occur. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. The Company follows the provisions of ASC Topic 820, Fair Value Measurement, which establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The Company considers its investments in money market funds of $11.6 million and $41.7 million as of December 31, 2019 and 2018, respectively, included in cash and cash equivalents, to be Level 1, which are based on unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. The estimated fair value of the Company’s financial instruments, which include cash and cash equivalents, accounts payable, and accrued liabilities approximates their carrying value, based upon their short-term maturities or prevailing interest rates. Research and Development Expenses Costs incurred for research and development are expensed as incurred. Stock-Based Compensation The Company records stock-based payments at fair value. The measurement date for compensation expense related to awards is generally the date of the grant. The fair value of awards is recognized as an expense in the statement of operations over the requisite service period, which is generally the vesting period. The fair value of options is calculated using the Black-Scholes option pricing model. This option valuation model requires the use of assumptions including, among others, the volatility of stock price, the expected term of the option, and the risk-free interest rate. The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes option pricing model: 2019 2018 Risk-free interest rate 1.68% - 2.57% 2.27% - 2.98% Expected life (years) 6 6 Volatility 60% 60% Dividend rate 0% 0% Due to its limited operating history and a limited trading history of its common stock in relation to the life of its standard option grants, the Company estimates the volatility of its stock in consideration of a number of factors including the volatility of comparable public companies. The expected term of a stock option granted to employees and directors (including non-employee directors) is based on the average of the contractual term (generally 10 years) and the vesting period. For other non-employee options, the expected term is the contractual term. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The Company recognizes forfeitures related to employee stock-based awards as they occur. The risk-free rate for periods within the expected life of the option is based upon the U.S. Treasury yield curve in effect at the time of grant. Option awards are granted at an exercise price equal to the closing market price of the Company’s common stock on the Nasdaq Capital Market on the date of grant. In-process Research and Development In-process research and development (“IPRD”) represents the value of the three G-protein-coupled receptors (“GPCR”) targets (the “Targets”) from the GPCR Target pools of Anchor to which the Company obtained the rights in its March 20, 2015 acquisition of Anchor. IPRD was recorded at fair value and is an indefinite-lived intangible asset. The Company reviews IPRD annually to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining useful life of the asset. There were no triggering events or circumstances that would indicate IPRD was impaired as of December 31, 2019 or 2018. Goodwill Goodwill represents the excess of the purchase price (consideration paid plus net liabilities assumed) of an acquired business over the fair value of the underlying net tangible and intangible assets. The Company evaluates the recoverability of goodwill according to ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350), which it adopted in the fourth quarter of 2018, Foreign Currency Transaction Gain/(Loss) Gains and losses arising from transactions and revaluation of balances denominated in currencies other than U.S. dollars are recorded in foreign currency transaction gain/(loss) on the consolidated statements of operations. Income Taxes The Company is primarily subject to U.S. federal and Massachusetts state income taxes. The Company’s tax returns for years 2015 through present are open to tax examinations by U.S. federal and state tax authorities; however, carryforward attributes that were generated prior to January 1, 2015 remain subject to adjustment upon examination if they either have been utilized or will be utilized in a future period. For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. The tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure in the consolidated financial statements as of December 31, 2019 and 2018. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. As of December 31, 2019 and 2018, the Company had no accruals for interest or penalties related to income tax matters. Basic and Diluted Net Loss per Common Share Basic and diluted net loss per common share is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented, common stock equivalents, consisting of stock-based awards, were not included in the calculation of the diluted net loss per share because to do so would be anti-dilutive. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 3 . PROPERTY AND EQUIPMENT Property and equipment consisted of the following at December 31, 2019 and 2018: December 31, 2019 December 31, 2018 Computer hardware and software $ 60,749 $ 58,868 Leasehold improvements 60,535 7,648 Furniture and fixtures 145,487 96,013 Subtotal property and equipment, gross 266,771 162,529 Less accumulated depreciation (72,797 ) (31,662 ) Property and equipment, net $ 193,974 $ 130,867 Property and equipment are stated on the basis of historical cost less accumulated depreciation. Depreciation is provided using the straight-line method over the estimated useful lives of the assets. Major renewals and improvements are capitalized, while minor replacements, maintenance and repairs are charged to current operations. Impairment losses are recorded on long-lived assets used in operations when indicators of impairment are present and the undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amount. Computer hardware and software are depreciated over an estimated useful life of 3 years, leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the duration of the current lease arrangement, and furniture and fixtures are depreciated over an estimated useful life of 7 years. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2019 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Accrued Expenses | 4 . ACCRUED EXPENSES Accrued expenses consisted of the following at December 31, 2019 and 2018: December 31, 2019 December 31, 2018 Accrued contract manufacturing $ 655,207 $ 1,079,314 Accrued contract research and regulatory consulting 418,000 128,678 Accrued precommercial costs 252,125 85,000 Accrued payroll and payroll taxes 153,238 1,302,728 Accrued legal 152,340 111,543 Accrued accounting, audit, and tax fees 147,850 102,000 Accrued consulting 109,073 49,940 Accrued miscellaneous expenses 56,598 119,861 Accrued license fees — 1,567,368 Total accrued expenses $ 1,944,431 $ 4,546,432 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Leases | 5. On March 6, 2018, the Company entered into a lease agreement (the “Newton Lease”) commencing on October 1, 2018 for certain premises, which consist of 2,760 square feet of office space located in Newton, Massachusetts (the “Newton Premises”), to serve as its corporate headquarters. On March 5, 2019, the Company entered into a lease agreement to amend the Newton Lease and to lease an additional 1,600 square feet of office space, commencing on June 1, 2019, located in Newton, Massachusetts (the “Additional Newton Premises”) to serve as additional space for its corporate headquarters. The term of the leases for the Newton Premises and the Additional Newton Premises expires on May 31, 2022. In addition, the Company is required to share in certain taxes and operating expenses of the Newton Premises and the Additional Newton Premises. The Company entered into a triple net lease (the “Bend Lease”) effective April 1, 2018 for certain premises consisting of 2,288 square feet of office space located in Bend, Oregon (the “Bend Premises”) to serve as a satellite facility. On April 23, 2019, the Company entered into a lease agreement to amend the Bend Lease and to lease an additional 1,389 square feet of office space, commencing on May 1, 2019, located in Bend, Oregon (the “Additional Bend Premises”) to serve as additional space for its satellite facility. The term of the lease for the Bend Premises and the Additional Bend Premises expires on May 31, 2022 (the “Bend Term”). The Company has an option to extend the Bend Term for up to two additional periods of three years and a right of first refusal to lease an additional suite in the same building. The leases for the Newton Premises, the Additional Newton Premises, the Bend Premises, and the Additional Bend Premises are classified as operating leases. In the first quarter of 2019, the Company adopted ASU 2016-02 and recorded a non-cash transaction to recognize a right-of-use-asset of $0.4 million in other noncurrent assets, as well as a lease liability of $0.2 million in other current liabilities and $0.2 million in other non-current liabilities. Since the adoption of ASU 2016-02, the Company has recognized additional right-of-use-assets totaling $0.3 million as well as additional lease liabilities totaling $0.1 million in other current liabilities and $0.2 million in other non-current liabilities in conjunction with the commencement of the leases for the Additional Newton Premises and the Additional Bend Premises. The Company’s lease liability represents the net present value of future lease payments utilizing a discount rate of 8%, which corresponds to the Company’s incremental borrowing rate. As of December 31, 2019, the weighted average remaining lease term was 2.4 years. For the years ended December 31, 2019 and 2018, the Company recorded expense of $0.2 million and $0.1 million, respectively, related to the leases. During the year ended December 31, 2019, the Company made cash payments of $0.2 million for amounts included in the measurement of lease liabilities. The Company is therefore reporting a right-of-use asset of $0.6 million in Other non-current assets and lease liabilities totaling $0.6 million in Other current liabilities and Other non-current liabilities on its consolidated balance sheet as of December 31, 2019. The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of December 31, 2019: Undiscounted lease liabilities for years ending December 31,: 2020 $ 263,392 2021 273,158 2022 115,951 Total undiscounted lease liabilities 652,501 Less effects of discounting (62,827 ) Total lease liabilities as of December 31, 2019 $ 589,674 Reported as of December 31, 2019: Other current liabilities $ 263,392 Other non-current liabilities 326,282 Total lease liabilities $ 589,674 Future minimum lease payments at December 31, 2018 were as follows: Years Ending December 31: Minimum Lease Payments 2019 $ 151,579 2020 155,813 2021 93,204 Total $ 400,596 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2019 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6 . COMMITMENTS AND CONTINGENCIES License Agreements In April 2014, Private Acer obtained exclusive rights to intellectual property relating to ACER-001 and preclinical and clinical data, through a license agreement with Baylor College of Medicine (“BCM”). Under the terms of the agreement, as amended, the Company has worldwide exclusive rights to develop, manufacture, use, sell and import licensed products as defined in the agreement. The license agreement requires the Company to make certain upfront and annual payments to BCM, as well as reimburse certain legal costs, make payments upon achievement of defined milestones, and pay royalties in the low single-digit percent range on net sales of any developed product over the royalty term. In August 2016, Private Acer signed an agreement with Assistance Publique—Hôpitaux de Paris, Hôpital Européen Georges Pompidou (“AP-HP”) (via its Department of Clinical Research and Development) granting the Company the exclusive worldwide rights to access and use data from a randomized controlled clinical study of celiprolol. The Company used this pivotal clinical data to support an NDA regulatory filing for EDSIVO TM In September 2018, the Company entered into a License Agreement for Development and Exploitation with AP-HP to acquire the exclusive worldwide intellectual property rights to three European patent applications relating to certain uses of celiprolol including (i) the optimal dose of celiprolol in treating vEDS patients, (ii) the use of celiprolol during pregnancy and (iii) the use of celiprolol to treat kyphoscoliotic Ehlers-Danlos syndrome (type VI). Pursuant to the agreement, the Company will reimburse AP-HP for certain costs and will pay annual maintenance fee payments. Subject to a minimum royalty amount, the Company will also pay royalty payments on annual net sales of celiprolol during the royalty term in the low single digit percent range, depending upon whether there is a valid claim of a licensed patent. Under the agreement, the Company will control and pay the costs of ongoing patent prosecution and maintenance for the licensed applications. The Company may terminate the agreement in its sole discretion upon written notice to AP-HP, and AP-HP may terminate the agreement in the event the Company fails to make the required payments after notice and opportunity to cure. Additionally, the agreement will terminate if the Company terminates clinical development, marketing approval is withdrawn by the health or regulatory authorities in all countries, the Company ceases to do business or there is a procedure of winding-up by court decision against the Company. The Company subsequently filed three U.S. In December 2018, the Company entered into an exclusive license agreement with Sanofi granting the Company worldwide rights to osanetant, a clinical-stage, selective, non-peptide tachykinin NK3 receptor antagonist. The agreement required the Company to make a certain upfront payment to Sanofi, make payments upon achievement of defined development and sales milestones and pay royalties on net sales of osanetant over the royalty term. The Company plans to initially pursue development of osanetant as a potential treatment for iVMS where HRT is likely contraindicated. Litigation From time to time, the Company may become involved in litigation or proceedings relating to claims arising out of its operations. On September 27, 2017, Piper Sandler & Co. (“Piper”) filed a lawsuit against the Company, Piper Sandler & Co. v. Acer Therapeutics Inc., Index No. 656055/2017, in the Supreme Court of the State of New York, County of New York. The complaint alleges that the Company breached its obligations to Piper pursuant to an August 30, 2016 engagement letter between the parties and an April 28, 2017 addendum thereto by failing to pay Piper (i) a fee of $1.1 million in connection with the financing which closed on September 19, 2017 for aggregate consideration of approximately $15.7 million and (ii) $0.1 million in reimbursement for expenses incurred by Piper pursuant to the engagement letter. On November 10, 2017, the Company filed an answer and counterclaim in the lawsuit, denying Piper’s breach of contract allegation, asserting several defenses, and bringing several counterclaims, including claims for breach of contract and breach of the duty of good faith and fair dealing. Piper filed a reply to the counterclaims denying the essential allegations, and discovery has commenced. On February 22, 2019, Piper filed a motion for summary judgment. In response, the Company filed its opposition to Piper's motion on March 22, 2019. Piper subsequently filed its reply to the Company’s opposition on April 5, 2019. Piper's motion is currently pending before the Court and oral argument on the summary judgment motion was held on September 4, 2019. No ruling on the motion has yet been issued by the Court. The Company has not recorded a liability as of December 31, 2019 In addition, on July 1, 2019, plaintiff Tyler Sell filed a putative class action lawsuit, Sell v. Acer Therapeutics Inc., against the Company, Chris Schelling and Harry Palmin, in the U.S. U.S. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Stockholders' Equity | 7 . STOCKHOLDERS’ EQUITY Underwritten Public Offerings On August 3, 2018, the Company completed an underwritten public offering of 2,555,555 shares of common stock, including 333,333 shares sold pursuant to the underwriters’ full exercise of their option to purchase additional shares to cover over-allotments, at a public offering price of $18.00 per share. The Company received aggregate net proceeds of approximately $42.7 million, after deducting underwriting discounts, commissions and offering-related expenses of approximately $3.3 million. At-the-Market Facility On November 9, 2018, the Company entered into a sales agreement with Roth Capital Partners, LLC, and on March 18, 2020, the Company entered into an amended and restated sales agreement with JonesTrading Institutional Services LLC and Roth Capital Partners, LLC. The agreement provides a facility for the offer and sale of shares of common stock from time to time having an aggregate offering price of up to $50 million depending upon market demand, in transactions deemed to be an “at-the-market” offering (the “ATM Offering”). Any such sales would be effected pursuant to the Company’s registration statement on Form S-3 (File No. 333-228319), declared effective by the SEC on November 21, 2018. As of December 31, 2019, the Company has not sold any shares of common stock under the agreement. . 2018 Stock Incentive Plan The Company’s 2018 Stock Incentive Plan (the “2018 Plan”), adopted on May 14, 2018, provides for the grant of up to 500,000 shares of common stock as stock options, restricted stock, stock appreciation rights, restricted stock units, performance-based awards and cash-based awards that may be settled in cash, stock or other property to employees, executive officers, directors, and consultants. In addition to the 500,000 shares, the total number of shares reserved for issuance under the 2018 Plan also consists of the sum of the number of shares subject to outstanding awards under the Company’s 2010 Stock Incentive Plan, as amended and restated (the “2010 Plan”), and the 2013 Stock Incentive Plan, as amended (the “2013 Plan”), as of the effective date of the 2018 Plan that are subsequently forfeited or terminated for any reason prior to being exercised or settled, plus the number of shares subject to vesting restrictions under the 2010 Plan and the 2013 Plan on the effective date of the 2018 Plan that are subsequently forfeited, plus the number of shares reserved but not issued or subject to outstanding grants under the 2010 Plan and the 2013 Plan as of the effective date of the 2018 Plan, up to a maximum of 635,170 shares in aggregate. In addition, the number of shares authorized for issuance under the 2018 Plan is automatically increased (the “evergreen provision”) on the first day of each fiscal year beginning on January 1, 2019, and ending on (and including) January 1, 2028, in an amount equal to the lesser of (i) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (ii) another amount (including zero) determined by the Company’s Board of Directors. Any shares subject to awards granted under the 2018 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2018 Plan. Shares withheld to satisfy the grant, exercise price or tax withholding obligation related to an award will again become available for issuance under the 2018 Plan. On January 1, 2019, 403,495 additional shares were authorized according to the evergreen provision. At December 31, 2019, 162,004 shares of common stock remained available for the grant of future awards under the 2018 Plan. The 2018 Plan is administered by the Company’s Board of Directors, which may in turn delegate authority to administer the plan to a committee such as the Compensation Committee, referred to herein as the 2018 Plan administrator. Subject to the terms of the 2018 Plan, the 2018 Plan administrator will determine recipients, the number of shares or amount of cash subject to awards to be granted, whether an option is to be an incentive stock options or non-incentive stock options and the terms and conditions of the stock awards, including the period of their exercisability and vesting. Subject to the limitations set forth below, the 2018 Plan administrator will also determine the exercise price of options granted under the 2018 Plan. The 2018 Plan expressly provides that, without the approval of the stockholders, the 2018 Plan administrator does not have the authority to reduce the exercise price of any outstanding stock options or stock appreciation rights under the 2018 Plan (except in connection with certain corporate transactions, such as stock splits, certain dividends, recapitalizations, reorganizations, mergers, spin-offs and the like), or cancel any outstanding underwater stock options or stock appreciation rights in exchange for cash or new stock awards under the 2018 Plan. Option awards are generally granted with an exercise price equal to the fair value of the common stock at the date of grant and have contractual terms of 10 years. Stock options granted to executive officers and employees generally vest either 1) over a four-year period, with 25% vesting on the one-year anniversary of the grant date and the remaining 75% vesting quarterly over the remaining three years, assuming continued service, and with vesting acceleration in full immediately prior to a change in control, or 2) for certain stock options granted on September 18, 2019, 50% vest on each of January 1, 2021 and January 1, 2022, assuming continued service, and with vesting acceleration in full immediately prior to a change in control. Restricted stock units generally vest and are settled upon the first anniversary of the grant date. 2013 Stock Incentive Plan Private Acer’s 2013 Plan, which was assumed by the Company in connection with the Merger, provided for the issuance of up to 165,000 shares of common stock as incentive or non-qualified stock options and/or restricted common stock to employees, officers, directors, consultants and advisers. Option awards were generally granted with an exercise price equal to the fair value of the common stock at the date of grant and had contractual terms of 10 years. At December 31, 2019, all shares available under the 2013 Plan were subject to outstanding equity awards, and no new awards may be granted under the 2013 Plan. 2010 Stock Incentive Plan The Company’s 2010 Plan, as amended and restated, provided for the grant of up to 470,170 shares of common stock as incentive or non-qualified stock options, stock appreciation rights, restricted stock units and/or restricted common stock to employees, officers, directors, consultants and advisers. Option awards were generally granted with an exercise price equal to the fair value of the common stock at the date of grant and had contractual terms of 10 years. At December 31, 2019, all shares available under the 2010 Plan were subject to outstanding equity awards, and no new awards may be granted under the 2010 Plan. A summary of option activity under the 2018 Plan, 2013 Plan, and 2010 Plan for the year ended December 31, 2019 is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in millions) Options outstanding at December 31, 2018 781,725 $ 16.34 9.0 Granted 1,063,150 $ 13.84 Exercised (7,813 ) $ 11.81 $ 0.1 Cancelled/forfeited (523,587 ) $ 21.51 Options outstanding at December 31, 2019 1,313,475 $ 12.28 8.7 $ 0.4 Options exercisable at December 31, 2019 339,184 $ 11.79 7.4 $ 0.1 A summary of restricted stock unit activity under the 2018 Plan for the year ended December 31, 2019 is as follows: Number of Shares Weighted Average Grant Date Fair Value Per Share Aggregate Intrinsic Value (in millions) Non-vested outstanding at December 31, 2018 — — Granted 15,000 $ 23.60 Cancelled/forfeited (6,000 ) Non-vested outstanding at December 31, 2019 9,000 $ 23.60 $ 0.1 At December 31, 2019, there was approximately $5.6 million of unrecognized compensation expense related to the stock-based compensation arrangements granted under all plans. The average remaining vesting period for options was 2.2 years. The weighted average grant-date fair value of options granted during the years ended December 31, 2019 and 2018 was $8.03 and $12.73, respectively. The amount of stock-based compensation expense recorded to general and administrative expenses and to research and development expenses was approximately $1.6 million and $1.0 million, respectively, for the year ended December 31, 2019. The amount of stock-based compensation expense recorded to general and administrative expenses and to research and development expenses was approximately $0.6 million and $0.7 million, respectively, for the year ended December 31, 2018. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8 . INCOME TAXES There was no provision for income taxes for the years ended December 31, 2019 and 2018, due to the Company’s operating losses and a full valuation allowance on deferred tax assets. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2019 2018 Deferred tax assets: Net operating loss carry forwards $ 8,506,035 $ 3,604,179 Capitalized research and development costs 17,477,585 14,381,936 Accrued liabilities 133,933 232,899 Tax credit carryforwards 7,174,516 6,311,164 Stock-based compensation 935,508 394,918 Operating lease 141,777 — Total deferred tax assets 34,369,354 24,925,096 Valuation allowance (34,221,451 ) (24,922,829 ) Net deferred tax assets 147,903 2,267 Deferred tax liabilities: Operating lease right of use asset (141,777 ) — Other (6,126 ) (2,267 ) Total deferred tax liabilities (147,903 ) (2,267 ) $ — $ — A reconciliation of the U.S. federal statutory tax rate to the effective tax rate is as follows: December 31, 2019 2018 Federal statutory rate 21.0 % 21.0 % R&D and Orphan Drug credits 4.4 % 10.9 % State income tax, net of federal tax benefit 6.6 % 2.8 % Valuation allowance (31.6 %) (35.2 %) Share-based compensation (0.2 %) 0.0 % Other, net (0.2 %) 0.5 % Effective tax rate 0.0 % 0.0 % Management currently believes that it is more likely than not that the deferred tax assets relating to the loss carryforwards and other temporary differences will not be realized in the future. Through December 31, 2019, for income tax reporting purposes, the Company had U.S. federal and state net operating loss carryforwards of approximately $36.1 million and research and development credits and Orphan Drug credits of approximately $7.1 million that can be carried forward and offset against taxable income. For state purposes, the Company had state net operating loss carryforwards of approximately $1.1 million and research and development credits of approximately $0.1 million that can be carried forward and offset against taxable income. Federal net operating loss, research and development credits, and Orphan Drug credits generated prior to 2018 and Massachusetts net operating losses can be carried forward for 20 years and begin to expire in 2022. Federal net operating loss generated after 2017 can be carried forward indefinitely. Utilization of net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code of 1986, and similar state provisions. The annual limitations may result in the expiration of net operating losses before utilization. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 9 . NET LOSS PER SHARE Basic net loss per share is computed by dividing the net loss in each period by the weighted-average number of common shares outstanding during such period. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. For the periods presented, common stock equivalents, consisting of stock-based awards, were not included in the calculation of the diluted loss per share because to do so would be anti-dilutive. As of December 31, 2019 and 2018, the number of shares of common stock underlying potentially dilutive securities consist of: December 31, 2019 2018 Options to purchase common stock 1,313,475 781,725 Restricted stock units 9,000 — Total 1,322,475 781,725 |
Restructuring
Restructuring | 12 Months Ended |
Dec. 31, 2019 | |
Restructuring And Related Activities [Abstract] | |
Restructuring | 1 0 . RESTRUCTURING In June 2019, the Company received a Complete Response Letter from the FDA regarding its New Drug Application for EDSIVO TM TM |
Significant Accounting Polices
Significant Accounting Polices (Policies) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company had an accumulated deficit of $76.3 million and cash and cash equivalents of $12.1 million as of December 31, 2019. Net cash used in operating activities was $29.5 million and $16.6 million for the years ended December 31, 2019 and 2018, respectively. On November 9, 2018, the Company entered into a sales agreement with Roth Capital Partners, LLC, and on March 18, 2020, an amended and restated sales agreement (the “Agreement”) was entered into with JonesTrading Institutional Services LLC and Roth Capital Partners, LLC. The Agreement provides a facility for the offer and sale of shares of common stock from time to time having an aggregate offering price of up to $50 million depending upon market demand, in transactions deemed to be an at-the-market offering (the “ATM Offering”) . As of December 31, 2019, the Company had TM support for EDSIVO™ development and precommercial activities and the planned osanetant clinical trial Management expects to continue to finance operations through the issuance of additional equity or debt securities and/or through strategic collaborations. Any transactions which occur may contain covenants that restrict the ability of management to operate the business and any securities issued may have rights, preferences, or privileges senior to the Company’s common stock and may dilute the ownership of current stockholders of the Company. |
Going Concern | Going Concern The accompanying financial statements have been prepared in conformity with GAAP, which contemplate continuation of the Company as a going concern. The Company has not established a source of revenues and, as such, has been dependent on funding operations through the sale of equity securities. Since inception, the Company has experienced significant losses and incurred negative cash flows from operations. The Company expects to incur further losses over the next several years as it develops its business. The Company has spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including its planned product development efforts and potential precommercial activities. As of December 31, 2019, the Company had cash and cash equivalents of $12.1 million. The Company’s cash and cash equivalents available at December 31, 2019 are expected to fund operations through the end of 2020, excluding support for EDSIVO™ development and precommercial activities and the planned osanetant clinical trial The Company will need to raise additional capital to fund continued operations some time during 2020. The Company has no commitments for any additional financing and may not be successful in its efforts to raise additional funds or achieve profitable operations. Any amounts raised will be used for further development of the Company’s product candidates, precommercial activities, potential acquisitions of additional product candidates and for other working capital purposes. If the Company is unable to obtain additional capital (which is not assured at this time), its long-term business plan may not be accomplished, and the Company may be forced to cease, reduce, or delay operations. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. |
Use of Estimates | Use of Estimates The Company’s accounting principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. Estimates having relatively higher significance include stock-based compensation, contract manufacturing accruals, and income taxes. Actual results could differ from those estimates and changes in estimates may occur. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. The Company follows the provisions of ASC Topic 820, Fair Value Measurement, which establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The Company considers its investments in money market funds of $11.6 million and $41.7 million as of December 31, 2019 and 2018, respectively, included in cash and cash equivalents, to be Level 1, which are based on unadjusted quoted prices in active markets for identical assets or liabilities accessible to the reporting entity at the measurement date. The estimated fair value of the Company’s financial instruments, which include cash and cash equivalents, accounts payable, and accrued liabilities approximates their carrying value, based upon their short-term maturities or prevailing interest rates. |
Research and Development Expenses | Research and Development Expenses Costs incurred for research and development are expensed as incurred. |
Stock-Based Compensation | Stock-Based Compensation The Company records stock-based payments at fair value. The measurement date for compensation expense related to awards is generally the date of the grant. The fair value of awards is recognized as an expense in the statement of operations over the requisite service period, which is generally the vesting period. The fair value of options is calculated using the Black-Scholes option pricing model. This option valuation model requires the use of assumptions including, among others, the volatility of stock price, the expected term of the option, and the risk-free interest rate. The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes option pricing model: 2019 2018 Risk-free interest rate 1.68% - 2.57% 2.27% - 2.98% Expected life (years) 6 6 Volatility 60% 60% Dividend rate 0% 0% Due to its limited operating history and a limited trading history of its common stock in relation to the life of its standard option grants, the Company estimates the volatility of its stock in consideration of a number of factors including the volatility of comparable public companies. The expected term of a stock option granted to employees and directors (including non-employee directors) is based on the average of the contractual term (generally 10 years) and the vesting period. For other non-employee options, the expected term is the contractual term. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The Company recognizes forfeitures related to employee stock-based awards as they occur. The risk-free rate for periods within the expected life of the option is based upon the U.S. Treasury yield curve in effect at the time of grant. Option awards are granted at an exercise price equal to the closing market price of the Company’s common stock on the Nasdaq Capital Market on the date of grant. |
In-process Research and Development | In-process Research and Development In-process research and development (“IPRD”) represents the value of the three G-protein-coupled receptors (“GPCR”) targets (the “Targets”) from the GPCR Target pools of Anchor to which the Company obtained the rights in its March 20, 2015 acquisition of Anchor. IPRD was recorded at fair value and is an indefinite-lived intangible asset. The Company reviews IPRD annually to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining useful life of the asset. There were no triggering events or circumstances that would indicate IPRD was impaired as of December 31, 2019 or 2018. |
Goodwill | Goodwill Goodwill represents the excess of the purchase price (consideration paid plus net liabilities assumed) of an acquired business over the fair value of the underlying net tangible and intangible assets. The Company evaluates the recoverability of goodwill according to ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350), which it adopted in the fourth quarter of 2018, |
Foreign Currency Transactions Gain/(Loss) | Foreign Currency Transaction Gain/(Loss) Gains and losses arising from transactions and revaluation of balances denominated in currencies other than U.S. dollars are recorded in foreign currency transaction gain/(loss) on the consolidated statements of operations. |
Income Taxes | Income Taxes The Company is primarily subject to U.S. federal and Massachusetts state income taxes. The Company’s tax returns for years 2015 through present are open to tax examinations by U.S. federal and state tax authorities; however, carryforward attributes that were generated prior to January 1, 2015 remain subject to adjustment upon examination if they either have been utilized or will be utilized in a future period. For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. The tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure in the consolidated financial statements as of December 31, 2019 and 2018. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. As of December 31, 2019 and 2018, the Company had no accruals for interest or penalties related to income tax matters. |
Basic and Diluted Net Loss per Common Share | Basic and Diluted Net Loss per Common Share Basic and diluted net loss per common share is computed by dividing net loss in each period by the weighted average number of shares of common stock outstanding during such period. For the periods presented, common stock equivalents, consisting of stock-based awards, were not included in the calculation of the diluted net loss per share because to do so would be anti-dilutive. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) In June 2018, the FASB issued ASU No. 2018-07, Compensation—Stock Compensation (Topic 718) Improvements to Nonemployee Share-Based Payment Accounting |
Significant Accounting Police_2
Significant Accounting Polices (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounting Policies [Abstract] | |
Schedule of Estimate Fair Value of Stock Options Granted | The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes option pricing model: 2019 2018 Risk-free interest rate 1.68% - 2.57% 2.27% - 2.98% Expected life (years) 6 6 Volatility 60% 60% Dividend rate 0% 0% |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following at December 31, 2019 and 2018: December 31, 2019 December 31, 2018 Computer hardware and software $ 60,749 $ 58,868 Leasehold improvements 60,535 7,648 Furniture and fixtures 145,487 96,013 Subtotal property and equipment, gross 266,771 162,529 Less accumulated depreciation (72,797 ) (31,662 ) Property and equipment, net $ 193,974 $ 130,867 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following at December 31, 2019 and 2018: December 31, 2019 December 31, 2018 Accrued contract manufacturing $ 655,207 $ 1,079,314 Accrued contract research and regulatory consulting 418,000 128,678 Accrued precommercial costs 252,125 85,000 Accrued payroll and payroll taxes 153,238 1,302,728 Accrued legal 152,340 111,543 Accrued accounting, audit, and tax fees 147,850 102,000 Accrued consulting 109,073 49,940 Accrued miscellaneous expenses 56,598 119,861 Accrued license fees — 1,567,368 Total accrued expenses $ 1,944,431 $ 4,546,432 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Leases [Abstract] | |
Reconciliation of Undiscounted Lease Liabilities to Total Lease Liabilities | The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the consolidated balance sheet as of December 31, 2019: Undiscounted lease liabilities for years ending December 31,: 2020 $ 263,392 2021 273,158 2022 115,951 Total undiscounted lease liabilities 652,501 Less effects of discounting (62,827 ) Total lease liabilities as of December 31, 2019 $ 589,674 Reported as of December 31, 2019: Other current liabilities $ 263,392 Other non-current liabilities 326,282 Total lease liabilities $ 589,674 |
Future Minimum Lease Payments | Future minimum lease payments at December 31, 2018 were as follows: Years Ending December 31: Minimum Lease Payments 2019 $ 151,579 2020 155,813 2021 93,204 Total $ 400,596 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Equity [Abstract] | |
Summary of Option Activity under 2018 Plan, 2013 Plan and 2010 Plan | A summary of option activity under the 2018 Plan, 2013 Plan, and 2010 Plan for the year ended December 31, 2019 is as follows: Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in millions) Options outstanding at December 31, 2018 781,725 $ 16.34 9.0 Granted 1,063,150 $ 13.84 Exercised (7,813 ) $ 11.81 $ 0.1 Cancelled/forfeited (523,587 ) $ 21.51 Options outstanding at December 31, 2019 1,313,475 $ 12.28 8.7 $ 0.4 Options exercisable at December 31, 2019 339,184 $ 11.79 7.4 $ 0.1 |
Summary of Restricted Stock Unit Activity under 2018 Plan | A summary of restricted stock unit activity under the 2018 Plan for the year ended December 31, 2019 is as follows: Number of Shares Weighted Average Grant Date Fair Value Per Share Aggregate Intrinsic Value (in millions) Non-vested outstanding at December 31, 2018 — — Granted 15,000 $ 23.60 Cancelled/forfeited (6,000 ) Non-vested outstanding at December 31, 2019 9,000 $ 23.60 $ 0.1 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2019 2018 Deferred tax assets: Net operating loss carry forwards $ 8,506,035 $ 3,604,179 Capitalized research and development costs 17,477,585 14,381,936 Accrued liabilities 133,933 232,899 Tax credit carryforwards 7,174,516 6,311,164 Stock-based compensation 935,508 394,918 Operating lease 141,777 — Total deferred tax assets 34,369,354 24,925,096 Valuation allowance (34,221,451 ) (24,922,829 ) Net deferred tax assets 147,903 2,267 Deferred tax liabilities: Operating lease right of use asset (141,777 ) — Other (6,126 ) (2,267 ) Total deferred tax liabilities (147,903 ) (2,267 ) $ — $ — |
Schedule of Reconciliation of Effective Income Tax Rate | A reconciliation of the U.S. federal statutory tax rate to the effective tax rate is as follows: December 31, 2019 2018 Federal statutory rate 21.0 % 21.0 % R&D and Orphan Drug credits 4.4 % 10.9 % State income tax, net of federal tax benefit 6.6 % 2.8 % Valuation allowance (31.6 %) (35.2 %) Share-based compensation (0.2 %) 0.0 % Other, net (0.2 %) 0.5 % Effective tax rate 0.0 % 0.0 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2019 | |
Earnings Per Share [Abstract] | |
Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities | As of December 31, 2019 and 2018, the number of shares of common stock underlying potentially dilutive securities consist of: December 31, 2019 2018 Options to purchase common stock 1,313,475 781,725 Restricted stock units 9,000 — Total 1,322,475 781,725 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation - Additional Information (Details) | Mar. 18, 2020USD ($) | Sep. 19, 2017 | Jun. 30, 2019Employee | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | May 15, 2018$ / shares | May 14, 2018$ / shares |
Organization Consolidation and Presentation of Financial Statement [Line Items] | |||||||
Restructuring implemented date | Jun. 30, 2019 | ||||||
Corporate restructuring, reduction of full-time workforce percentage | 60.00% | ||||||
Corporate restructuring, reduction of full-time workforce employees | Employee | 48 | ||||||
Restructuring completion date | Dec. 31, 2019 | ||||||
Preferred stock, no par value | $ 0 | ||||||
Preferred stock, par value | $ 0.0001 | $ 0.0001 | |||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 0.01 | ||||
Accumulated deficit | $ | $ 76,250,512 | $ 46,832,543 | |||||
Cash and cash equivalents | $ | 12,077,640 | 41,671,284 | |||||
Net cash used in operating activities | $ | $ 29,506,949 | $ 16,587,803 | |||||
Common stock, shares issued | shares | 10,095,176 | 10,087,363 | |||||
At-the-Market Facility | |||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | |||||||
Common stock, shares issued | shares | 0 | ||||||
At-the-Market Facility | Subsequent Event | Maximum | |||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | |||||||
Aggregate offering price of common stock | $ | $ 50,000,000 | ||||||
Merger of Private Acer with opexa therapeutics incorporation and Opexa Merger Sub Incorporation | |||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | |||||||
Business combination date of completion | Sep. 19, 2017 | ||||||
Business combination date of agreement | Jun. 30, 2017 | ||||||
Reverse stock split ratio | 0.09656678989 | ||||||
Delaware Reincorporation and Subsidiary Merger | |||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | |||||||
Merger incorporation description | On May 15, 2018, the Company changed its state of incorporation from the State of Texas to the State of Delaware pursuant to a plan of conversion, dated May 15, 2018. As a result of this reincorporation, the par value of the Company’s preferred stock was changed to $0.0001 from no par value and the par value of the Company’s common stock was reduced to $0.0001 from $0.01. Immediately following the Reincorporation, the Company’s holding company structure was eliminated by merging wholly-owned subsidiary Private Acer with and into the Company (the “Subsidiary Merger”). The Company was the surviving corporation in connection with the Subsidiary Merger. | ||||||
Date of reincorporation | May 15, 2018 | ||||||
Preferred stock, par value | $ 0.0001 | ||||||
Common stock, par value | $ 0.0001 |
Significant Accounting Police_3
Significant Accounting Polices - Additional Information (Details) | 12 Months Ended | |||
Dec. 31, 2019USD ($)Segment | Dec. 31, 2018USD ($) | Mar. 31, 2019USD ($) | Jan. 01, 2019USD ($) | |
Schedule Of Significant Accounting Policies [Line Items] | ||||
Expected term of stock option granted to employees and directors, average contractual term and vesting period | 10 years | |||
Impaired of in-process research and development | $ 0 | $ 0 | ||
Goodwill impairment | 0 | |||
Uncertain tax positions, accruals | 0 | 0 | ||
Accruals for interest or penalties related to income tax matters | $ 0 | 0 | ||
Number of operating segment | Segment | 1 | |||
Operating lease liability | $ 589,674 | $ 400,000 | ||
Operating lease right of use asset | 600,000 | $ 400,000 | $ 400,000 | |
Cash and Cash Equivalents | ||||
Schedule Of Significant Accounting Policies [Line Items] | ||||
Investments in money market funds | $ 11,600,000 | $ 41,700,000 |
Significant Accounting Police_4
Significant Accounting Polices - Schedule of Estimate Fair Value of Stock Options Granted (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Accounting Policies [Abstract] | ||
Risk-free interest rate, minimum | 1.68% | 2.27% |
Risk-free interest rate, maximum | 2.57% | 2.98% |
Expected life (years) | 6 years | 6 years |
Volatility | 60.00% | 60.00% |
Dividend rate | 0.00% | 0.00% |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 266,771 | $ 162,529 |
Less accumulated depreciation | (72,797) | (31,662) |
Property and equipment, net | 193,974 | 130,867 |
Computer Hardware and Software | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 60,749 | 58,868 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 60,535 | 7,648 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 145,487 | $ 96,013 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2019 | |
Computer Hardware and Software | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture and Fixtures | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 7 years |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Accounts Payable And Accrued Liabilities Current [Abstract] | ||
Accrued contract manufacturing | $ 655,207 | $ 1,079,314 |
Accrued contract research and regulatory consulting | 418,000 | 128,678 |
Accrued precommercial costs | 252,125 | 85,000 |
Accrued payroll and payroll taxes | 153,238 | 1,302,728 |
Accrued legal | 152,340 | 111,543 |
Accrued accounting, audit, and tax fees | 147,850 | 102,000 |
Accrued consulting | 109,073 | 49,940 |
Accrued miscellaneous expenses | 56,598 | 119,861 |
Accrued license fees | 1,567,368 | |
Total accrued expenses | $ 1,944,431 | $ 4,546,432 |
Leases - Additional Information
Leases - Additional Information (Details) | 12 Months Ended | |||||||
Dec. 31, 2019USD ($)Term | Dec. 31, 2018USD ($) | Apr. 23, 2019ft² | Mar. 31, 2019USD ($) | Mar. 05, 2019ft² | Jan. 01, 2019USD ($) | Apr. 01, 2018ft² | Mar. 06, 2018ft² | |
Lessee Lease Description [Line Items] | ||||||||
Operating lease right of use asset | $ 600,000 | $ 400,000 | $ 400,000 | |||||
Operating lease liability, current | 263,392 | |||||||
Operating lease liability, non-current | $ 326,282 | |||||||
Operating lease discount rate | 8.00% | |||||||
Operating lease, weighted average remaining lease term | 2 years 4 months 24 days | |||||||
Operating lease, cash payment made | $ 200,000 | |||||||
Operating lease expense | $ 200,000 | $ 100,000 | ||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | |||||||
Operating lease liability | $ 589,674 | $ 400,000 | ||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilities | |||||||
ASU 2016-02 | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Operating lease right of use asset | $ 300,000 | |||||||
Operating lease liability, current | 100,000 | 200,000 | ||||||
Operating lease liability, non-current | $ 200,000 | $ 200,000 | ||||||
Newton Lease | Newton, Massachusetts | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement date | Mar. 6, 2018 | |||||||
Lease commencement date | Oct. 1, 2018 | |||||||
Square feet of office space leased | ft² | 2,760 | |||||||
Amended Newton Lease | Newton, Massachusetts | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement date | Mar. 5, 2019 | |||||||
Lease commencement date | Jun. 1, 2019 | |||||||
Square feet of office space leased | ft² | 1,600 | |||||||
Lease expiration date | May 31, 2022 | |||||||
Bend Lease | Oregon | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement date | Apr. 1, 2018 | |||||||
Square feet of office space leased | ft² | 2,288 | |||||||
Maximum additional periods of option to extend the bend term | Term | 2 | |||||||
Option to extend bend term for duration period | 3 years | |||||||
Amended Bend Lease | Oregon | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement date | Apr. 23, 2019 | |||||||
Lease commencement date | May 1, 2019 | |||||||
Square feet of office space leased | ft² | 1,389 | |||||||
Lease expiration date | May 31, 2022 |
Leases - Reconciliation of Undi
Leases - Reconciliation of Undiscounted Lease Liabilities to Total Lease Liabilities (Details) - USD ($) | Dec. 31, 2019 | Jan. 01, 2019 |
Undiscounted lease liabilities for years ending December 31,: | ||
2020 | $ 263,392 | |
2021 | 273,158 | |
2022 | 115,951 | |
Total undiscounted lease liabilities | 652,501 | |
Less effects of discounting | (62,827) | |
Total lease liabilities as of December 31, 2019 | 589,674 | $ 400,000 |
Operating lease liability, current | 263,392 | |
Operating lease liability, non-current | 326,282 | |
Total lease liabilities | $ 589,674 | $ 400,000 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) | Dec. 31, 2018USD ($) |
Leases [Abstract] | |
2019 | $ 151,579 |
2020 | 155,813 |
2021 | 93,204 |
Total | $ 400,596 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | Sep. 27, 2017USD ($) | Sep. 30, 2018Patent | Dec. 31, 2019 |
Pending Litigation | Piper Sandler & Co. | |||
Commitments And Contingencies [Line Items] | |||
Loss contingency payable fees | $ 1.1 | ||
Loss contingency closing date | Sep. 19, 2017 | ||
Financing aggregate consideration | $ 15.7 | ||
Reimbursement expenses | $ 0.1 | ||
Assistance Publique – Hôpitaux de Paris (“AP-HP”) | License Agreement | |||
Commitments And Contingencies [Line Items] | |||
Agreement entered date | 2018-09 | ||
Number of patent applications | Patent | 3 | ||
Assistance Publique – Hôpitaux de Paris (“AP-HP”) | Private Acer | License Agreement | |||
Commitments And Contingencies [Line Items] | |||
Agreement entered date | 2016-08 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Mar. 18, 2020 | Sep. 18, 2019 | Aug. 03, 2018 | May 14, 2018 | Sep. 19, 2017 | Dec. 31, 2019 | Dec. 31, 2018 | Jan. 01, 2019 |
Stockholders Equity [Line Items] | ||||||||
Stock issued during period, shares, new issues | 2,555,555 | |||||||
Public offering price per share | $ 18 | |||||||
Proceeds from issuance initial public offering, after deduction underwriting discounts, commissions | $ 42.7 | |||||||
Payments for Underwriting Expense | $ 3.3 | |||||||
Common stock, shares issued | 10,095,176 | 10,087,363 | ||||||
Number of share outstanding | 1,313,475 | 781,725 | ||||||
Awards granted under the plan | 1,063,150 | |||||||
Unrecognized compensation expense | $ 5.6 | |||||||
Share based compensation arrangement by share based payment award, Average remaining vesting period | 2 years 2 months 12 days | |||||||
Weighted average grant date fair value of options granted | $ 8.03 | $ 12.73 | ||||||
General and Administrative | ||||||||
Stockholders Equity [Line Items] | ||||||||
Stock based compensation expense | $ 1.6 | $ 0.6 | ||||||
Research and Development | ||||||||
Stockholders Equity [Line Items] | ||||||||
Stock based compensation expense | $ 1 | $ 0.7 | ||||||
2018 Stock Incentive Plan | ||||||||
Stockholders Equity [Line Items] | ||||||||
Number of common stock authorized for issuance | 500,000 | 403,495 | ||||||
Share-based compensation arrangement by share-based payment award, description | In addition, the number of shares authorized for issuance under the 2018 Plan is automatically increased (the “evergreen provision”) on the first day of each fiscal year beginning on January 1, 2019, and ending on (and including) January 1, 2028, in an amount equal to the lesser of (i) 4% of the outstanding shares of common stock on the last day of the immediately preceding fiscal year, or (ii) another amount (including zero) determined by the Company’s Board of Directors. Any shares subject to awards granted under the 2018 Plan that are forfeited or terminated before being exercised or settled, or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2018 Plan. Shares withheld to satisfy the grant, exercise price or tax withholding obligation related to an award will again become available for issuance under the 2018 Plan. On January 1, 2019, 403,495 additional shares were authorized according to the evergreen provision. At December 31, 2019, 162,004 shares of common stock remained available for the grant of future awards under the 2018 Plan. | |||||||
Share-based compensation arrangement by share-based payment award, expiration date | Jan. 1, 2028 | |||||||
Share-based compensation arrangement by share-based payment award, percentage of outstanding our common stock | 4.00% | |||||||
Available for the grant of future awards | 162,004 | |||||||
Options contractual term | 10 years | |||||||
2018 Stock Incentive Plan | Executive Officers and Employees | ||||||||
Stockholders Equity [Line Items] | ||||||||
Share-based compensation arrangement by share-based payment award, stock options vesting period | 4 years | |||||||
2018 Stock Incentive Plan | Executive Officers and Employees | One-year Anniversary of the Grant Date | ||||||||
Stockholders Equity [Line Items] | ||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage Share-based compensation arrangement by share-based payment award, Vesting percentage | 25.00% | |||||||
2018 Stock Incentive Plan | Executive Officers and Employees | Quarterly over Remaining Three Years | ||||||||
Stockholders Equity [Line Items] | ||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage Share-based compensation arrangement by share-based payment award, Vesting percentage | 75.00% | |||||||
2018 Stock Incentive Plan | Executive Officers and Employees | January 1, 2021 | ||||||||
Stockholders Equity [Line Items] | ||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage Share-based compensation arrangement by share-based payment award, Vesting percentage | 50.00% | |||||||
2018 Stock Incentive Plan | Executive Officers and Employees | January 1, 2022 | ||||||||
Stockholders Equity [Line Items] | ||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage Share-based compensation arrangement by share-based payment award, Vesting percentage | 50.00% | |||||||
2013 Stock Incentive Plan | ||||||||
Stockholders Equity [Line Items] | ||||||||
Number of common stock authorized for issuance | 165,000 | |||||||
Options contractual term | 10 years | |||||||
Awards granted under the plan | 0 | |||||||
2010 Stock Incentive Plan | ||||||||
Stockholders Equity [Line Items] | ||||||||
Number of common stock authorized for issuance | 470,170 | |||||||
Options contractual term | 10 years | |||||||
Awards granted under the plan | 0 | |||||||
Maximum | 2010 and 2013 Stock Incentive Plan | ||||||||
Stockholders Equity [Line Items] | ||||||||
Number of share outstanding | 635,170 | |||||||
Over-Allotment Option | ||||||||
Stockholders Equity [Line Items] | ||||||||
Stock issued during period, shares, new issues | 333,333 | |||||||
At-the-Market Facility | ||||||||
Stockholders Equity [Line Items] | ||||||||
Common stock, shares issued | 0 | |||||||
At-the-Market Facility | Subsequent Event | Maximum | ||||||||
Stockholders Equity [Line Items] | ||||||||
Aggregate offering price of common stock | $ 50 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Option Activity under 2018 Plan, 2013 Plan and 2010 Plan (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Options | ||
Number of Shares, Options outstanding at beginning of period | 781,725 | |
Number of Shares, Options Granted | 1,063,150 | |
Number of Shares, Options Exercised | (7,813) | |
Number of Shares, Options Cancelled/forfeited | (523,587) | |
Number of Shares, Options outstanding at end of period | 1,313,475 | 781,725 |
Number of Shares, Options exercisable at end of period | 339,184 | |
Weighted Average Exercise Price, Options | ||
Weighted Average Exercise Price, Options outstanding at beginning of period | $ 16.34 | |
Weighted Average Exercise Price, Options Granted | 13.84 | |
Weighted Average Exercise Price, Options Exercised | 11.81 | |
Weighted Average Exercise Price, Options Cancelled/forfeited | 21.51 | |
Weighted Average Exercise Price, Options outstanding at end of period | 12.28 | $ 16.34 |
Weighted Average Exercise Price, Options exercisable at end of period | $ 11.79 | |
Weighted Average Remaining Contract Term, Options | ||
Weighted Average Remaining Contractual Term, Options outstanding at beginning of period | 8 years 8 months 12 days | 9 years |
Weighted Average Remaining Contractual Term, Options exercisable at end of period | 7 years 4 months 24 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Options outstanding at end of period | $ 0.4 | |
Aggregate Intrinsic Value, Options exercisable at end of period | 0.1 | |
Aggregate Intrinsic Value, Options Exercised | $ 0.1 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Restricted Stock Unit Activity under 2018 Plan (Details) - Restricted Stock Units (RSUs) $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2019USD ($)$ / sharesshares | |
Restricted Stock Units | |
Number of Shares, Granted | 15,000 |
Number of Shares, Cancelled/forfeited | (6,000) |
Number of Shares, Non-Vested outstanding at end of period | 9,000 |
Weighted Average Grant Date Fair Value Per Share | |
Weighted Average Grant Date Fair Value Per Share, Granted | $ / shares | $ 23.60 |
Weighted Average Grant Date Fair Value Per Share, Non-Vested outstanding at end of the period | $ / shares | $ 23.60 |
Aggregate Intrinsic Value | |
Aggregate Intrinsic Value, Non-Vested outstanding at end of the period | $ | $ 0.1 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Line Items] | ||
Provision for income taxes | $ 0 | $ 0 |
Net operating loss carryforwards | 8,506,035 | $ 3,604,179 |
Research and development and orphan drug credits | $ 7,100,000 | |
Net operating loss carryforwards term | 20 years | |
Net operating loss carryforwards expiration beginning year | 2022 | |
U.S. Federal and State | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | $ 36,100,000 | |
State | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 1,100,000 | |
Research and development and orphan drug credits | $ 100,000 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2019 | Dec. 31, 2018 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 8,506,035 | $ 3,604,179 |
Capitalized research and development costs | 17,477,585 | 14,381,936 |
Accrued liabilities | 133,933 | 232,899 |
Tax credit carryforwards | 7,174,516 | 6,311,164 |
Stock-based compensation | 935,508 | 394,918 |
Operating lease | 141,777 | |
Total deferred tax assets | 34,369,354 | 24,925,096 |
Valuation allowance | (34,221,451) | (24,922,829) |
Net deferred tax assets | 147,903 | 2,267 |
Deferred tax liabilities: | ||
Operating lease right of use asset | (141,777) | |
Other | (6,126) | (2,267) |
Total deferred tax liabilities | $ (147,903) | $ (2,267) |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21.00% | 21.00% |
R&D and Orphan Drug credits | 4.40% | 10.90% |
State income tax, net of federal tax benefit | 6.60% | 2.80% |
Valuation allowance | (31.60%) | (35.20%) |
Share-based compensation | (0.20%) | 0.00% |
Other, net | (0.20%) | 0.50% |
Effective tax rate | 0.00% | 0.00% |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,322,475 | 781,725 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 9,000 | |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,313,475 | 781,725 |
Restructuring - Additional Info
Restructuring - Additional Information (Details) | 1 Months Ended | 3 Months Ended | |
Jun. 30, 2019Employee | Jun. 30, 2019USD ($) | Dec. 31, 2019USD ($) | |
Restructuring Cost And Reserve [Line Items] | |||
One-time severance-related charge | $ 1,500,000 | ||
Corporate restructuring, reduction of full-time workforce percentage | 60.00% | ||
Corporate restructuring, reduction of full-time workforce employees | Employee | 48 | ||
One Time Employee Severance | |||
Restructuring Cost And Reserve [Line Items] | |||
Remaining liability | $ 0 | ||
General and Administrative | |||
Restructuring Cost And Reserve [Line Items] | |||
One-time severance-related charge | 1,000,000 | ||
Research and Development | |||
Restructuring Cost And Reserve [Line Items] | |||
One-time severance-related charge | $ 500,000 |