Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2020 | May 01, 2020 | |
Cover [Abstract] | ||
Entity Registrant Name | Acer Therapeutics Inc. | |
Entity Central Index Key | 0001069308 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2020 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Trading Symbol | ACER | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 10,249,182 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2020 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-33004 | |
Entity Tax Identification Number | 32-0426967 | |
Entity Address, Address Line One | One Gateway Center | |
Entity Address, Address Line Two | Suite 351 | |
Entity Address, Address Line Three | 300 Washington Street | |
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 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 7,007,260 | $ 12,077,640 |
Prepaid expenses and other current assets | 624,520 | 807,356 |
Total current assets | 7,631,780 | 12,884,996 |
Property and equipment, net | 176,265 | 193,974 |
Other assets: | ||
Goodwill | 7,647,267 | 7,647,267 |
In-process research and development | 118,600 | 118,600 |
Other non-current assets | 566,466 | 620,674 |
Total assets | 16,140,378 | 21,465,511 |
Current liabilities: | ||
Accounts payable | 344,800 | 561,090 |
Accrued expenses | 1,171,164 | 1,944,431 |
Other current liabilities | 264,472 | 263,392 |
Total current liabilities | 1,780,436 | 2,768,913 |
Other non-current liabilities | 270,994 | 326,282 |
Total liabilities | 2,051,430 | 3,095,195 |
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; 10,101,034 and 10,095,176 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively | 1,011 | 1,010 |
Additional paid-in capital | 95,287,156 | 94,619,818 |
Accumulated deficit | (81,199,219) | (76,250,512) |
Total stockholders’ equity | 14,088,948 | 18,370,316 |
Total liabilities and stockholders’ equity | $ 16,140,378 | $ 21,465,511 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2020 | Dec. 31, 2019 |
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 | 10,101,034 | 10,095,176 |
Common stock, shares outstanding | 10,101,034 | 10,095,176 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Operating expenses: | ||
Research and development | $ 2,322,905 | $ 3,946,220 |
General and administrative | 2,648,551 | 4,230,698 |
Total operating expenses | 4,971,456 | 8,176,918 |
Loss from operations | (4,971,456) | (8,176,918) |
Other income, net: | ||
Interest income | 25,742 | 185,143 |
Foreign currency transaction (loss) gain | (2,993) | 23,070 |
Total other income, net | 22,749 | 208,213 |
Net loss | $ (4,948,707) | $ (7,968,705) |
Net loss per share - basic and diluted | $ (0.49) | $ (0.79) |
Weighted average common shares outstanding - basic and diluted | 10,097,107 | 10,087,363 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2018 | $ 45,083,158 | $ 1,009 | $ 91,914,692 | $ (46,832,543) |
Beginning balance, shares at Dec. 31, 2018 | 10,087,363 | |||
Stock-based compensation | 671,927 | 671,927 | ||
Net loss | (7,968,705) | (7,968,705) | ||
Ending balance at Mar. 31, 2019 | 37,786,380 | $ 1,009 | 92,586,619 | (54,801,248) |
Ending balance, shares at Mar. 31, 2019 | 10,087,363 | |||
Beginning balance at Dec. 31, 2019 | $ 18,370,316 | $ 1,010 | 94,619,818 | (76,250,512) |
Beginning balance, shares at Dec. 31, 2019 | 10,095,176 | 10,095,176 | ||
Issuance of common stock in connection with restricted stock vesting | $ 1 | $ 1 | ||
Issuance of common stock in connection with restricted stock vesting, shares | 5,858 | |||
Stock-based compensation | 667,338 | 667,338 | ||
Net loss | (4,948,707) | (4,948,707) | ||
Ending balance at Mar. 31, 2020 | $ 14,088,948 | $ 1,011 | $ 95,287,156 | $ (81,199,219) |
Ending balance, shares at Mar. 31, 2020 | 10,101,034 | 10,101,034 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (4,948,707) | $ (7,968,705) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 667,338 | 671,927 |
Depreciation | 17,709 | 9,548 |
Changes in operating assets and liabilities | ||
Prepaid expenses and other current assets | 182,837 | 296,283 |
Accounts payable | (216,290) | (972,662) |
Accrued expenses | (773,267) | (1,787,310) |
Net cash used in operating activities | (5,070,380) | (9,750,919) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (88,938) | |
Net cash used in investing activities | (88,938) | |
Net decrease in cash and cash equivalents | (5,070,380) | (9,839,857) |
Cash and cash equivalents, beginning of period | 12,077,640 | 41,671,284 |
Cash and cash equivalents, end of period | $ 7,007,260 | $ 31,831,427 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 3 Months Ended |
Mar. 31, 2020 | |
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 four clinical-stage candidates: emetine hydrochloride (“emetine”) for the treatment of patients with COVID-19; 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. Liquidity The Company had an accumulated deficit of $81.2 million and cash and cash equivalents of $7.0 million as of March 31, 2020. Net cash used in operating activities was $5.1 million and $9.8 million for the three months ended March 31, 2020 and 2019, 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 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 (“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 . TM 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 has an accumulated deficit of $81.2 million as of March 31, 2020 and 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 March 31, 2020, the Company had cash and cash equivalents of $7.0 million and current liabilities aggregating to $1.8 million. The Company’s cash and cash equivalents available at March 31, 2020 are expected to fund operations into the fourth quarter of 2020, excluding support for a planned emetine clinical trial and support for EDSIVO™ development and precommercial activities. The Company will need to raise additional capital in 2020 to fund continued operations. The Company may not be successful in its efforts to raise additional funds or achieve profitable operations. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations through and beyond the next 12 months, including cutting expenses where possible and raising additional capital through either private or public equity or debt financing as well as using its ATM facility and/or its $15.0 million equity line facility entered into on April 30, 2020, with Lincoln Park Capital Fund, LLC (“Lincoln Park”) (once sales can commence to Lincoln Park under the purchase agreement), which is subject to certain limitations and conditions. The Company has no commitments for any additional financing. Any amounts raised will be used for further development of its product candidates, precommercial activities, potential acquisitions of additional product candidates, and for other working capital purposes. If the Company is unable to obtain additional funding to support its current or proposed activities and operations, it may not be able to continue its operations as proposed, which may require it to suspend or terminate any ongoing development activities, modify its business plan, curtail various aspects of its operations, cease operations, or seek relief under applicable bankruptcy laws. In such event, the Company’s stockholders may lose a substantial portion or even all of their investment. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern for twelve months from the date these financial statements are available, or May 14, 2021. The accompanying unaudited condensed 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. Merger and Reincorporation 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, 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”). 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. Following the completion of the Merger, the business conducted by the Company became primarily the business conducted by Private Acer. For accounting and financial reporting purposes, Private Acer was considered to have acquired the Company in the 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. Immediately following the reincorporation, the holding company structure was eliminated by merging wholly-owned subsidiary Private Acer with and into the Company. The Company was the surviving corporation in connection with the subsidiary merger. Basis of Presentation The accompanying unaudited condensed financial statements are unaudited and have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Regulation S-X. The unaudited condensed financial statements have been prepared on the same basis as the audited annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial position, results of operations, stockholders’ equity and cash flows for the periods presented. The results of operations for the three months ended March 31, 2020 are not necessarily indicative of the results to be expected for the year ending December 31, 2020 or for any other future annual or interim period. The condensed balance sheet as of December 31, 2019, included herein, was derived from the audited financial statements as of that date but does not include all disclosures required by GAAP. These unaudited financial state 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 GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Significant Accounting Polices
Significant Accounting Polices | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Significant Accounting Polices | 2. SIGNIFICANT ACCOUNTING POLICIES The Company’s significant accounting policies are described in Note 2, “Significant Accounting Policies,” in its Annual Report on Form 10-K for the year ended December 31, 2019. 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 $6.5 million and $11.6 million as of March 31, 2020 and December 31, 2019, 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. 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 a respiratory illness caused by a novel coronavirus 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 condensed 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 during the three-month period ending March 31, 2020 and 2019 using the Black-Scholes option pricing model: 2020 2019 Risk-free interest rate 1.61% 2.44% – 2.57% Expected life (years) 6.25 6.25 Volatility 60% 60% Dividend rate 0% 0% 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 condensed financial statements and reported amounts of revenues and 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. Income Taxes The Company recorded no income tax expense or benefit during the three months ended March 31, 2020 and 2019, due to a full valuation allowance recognized against its net deferred tax assets. The Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted in the U.S. on March 27, 2020. The CARES Act included several income tax provisions such as net operating loss (“NOL”) carryback and carryforward benefits. There were also changes giving rise to increases in the 163(j) interest limitation and changes to the timing of qualified leasehold improvements depreciation deductions. These NOL and other benefit provisions have no impact on the Company’s financial statements for the period ended March 31, 2020. Management will continue to monitor future developments and interpretations for any further impacts. 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 loss per share because to do so would be anti-dilutive. |
Property and Equipment
Property and Equipment | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 3. PROPERTY AND EQUIPMENT Property and equipment consisted of the following at March 31, 2020 and December 31, 2019: March 31, 2020 December 31, 2019 Computer hardware and software $ 60,749 $ 60,749 Leasehold improvements 60,535 60,535 Furniture and fixtures 145,487 145,487 Subtotal property and equipment, gross 266,771 266,771 Less accumulated depreciation (90,506 ) (72,797 ) Property and equipment, net $ 176,265 $ 193,974 |
Accrued Expenses
Accrued Expenses | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Accrued Expenses | 4. ACCRUED EXPENSES Accrued expenses consisted of the following at March 31, 2020 and December 31, 2019: March 31, 2020 December 31, 2019 Accrued contract manufacturing $ 290,619 $ 655,207 Accrued contract research and regulatory consulting 270,250 418,000 Accrued payroll and payroll taxes 233,340 153,238 Accrued accounting, audit, and tax fees 70,850 147,850 Accrued miscellaneous expenses 68,834 56,598 Accrued license fees 61,156 — Accrued legal 153,500 152,340 Accrued consulting 22,615 109,073 Accrued pre-commercial costs — 252,125 Total accrued expenses $ 1,171,164 $ 1,944,431 |
Leases
Leases | 3 Months Ended |
Mar. 31, 2020 | |
Leases [Abstract] | |
Leases | 5. LEASES 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 additional office space, commencing on May 1, 2019, located in Bend, Oregon (the “Additional Bend Premises”). The term of the lease for the Bend Premises and the Additional Bend Premises expires on March 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 non-current 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 March 31, 2020, the weighted average remaining lease term was 2.2 years. For the three months ended March 31, 2020 and 2019, the Company recorded expense of $65 thousand and $37 thousand, respectively, related to the leases. During the three months ended March 31, 2020 and 2019, the Company made cash payments of $68 thousand and $28 thousand, respectively, for amounts included in the measurement of lease liabilities. The Company is therefore reporting a right-of-use asset of $0.5 million in Other non-current assets and lease liabilities totaling $0.5 million in Other current liabilities and Other non-current liabilities as of March 31, 2020. The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the unaudited condensed balance sheet as of March 31, 2020: Undiscounted lease liabilities for years ending December 31,: 2020 (remaining) $ 197,944 2021 273,158 2022 115,951 Total undiscounted lease liabilities $ 587,053 Less effects of discounting (51,587 ) Total lease liabilities as of March 31, 2020 $ 535,466 Reported as of March 31, 2020: Other current liabilities $ 264,472 Other non-current liabilities 270,994 Total lease liabilities $ 535,466 Future minimum lease payments at December 31, 2019 were as follows: Years Ending December 31: Minimum Lease Payments 2020 $ 263,392 2021 273,158 2022 115,951 Total $ 652,501 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2020 | |
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. patent applications on this subject matter in October 2018. 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. On March 26, 2020, the Court denied Piper’s motion in part, as to Piper’s claim and the Company’s counterclaim for damages, and granted in part, as to certain counterclaims by the Company. Discovery is ongoing in the case. The Company has not recorded a liability as of March 31, 2020 because a potential loss is not probable or reasonably estimable given the status of the proceedings. 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. District Court for the Southern District of New York. The complaint alleges that prior to the receipt of the Complete Response Letter from the FDA, the Company made material false and misleading statements or omissions which allegedly constitute securities fraud. On August 12, 2019, a stockholder’s derivative action, Gress v. Acer Therapeutics Inc., was filed in the U.S. District Court for the District of Delaware against the Company and certain of its officers and directors, asserting damages resulting from alleged breach of fiduciary duties, based on the same facts at issue in the Sell case. On March 17, 2020, a second stockholder’s derivative action, Giroux v. Acer Therapeutics Inc., was filed in the U.S. District Court for the District of Massachusetts against the Company and certain of its officers and directors, asserting damages resulting from alleged breach of fiduciary duties, based on the same facts at issue in the Sell and Gress cases. No activity has occurred in either suit thus far. With the selection of a lead plaintiff, the Sell case is now known as Skiadas v. Acer Therapeutics. A second amended complaint was filed by the plaintiff in the Skiadas class action lawsuit on February 28, 2020. On May 1, 2020, the Company filed a motion to dismiss the second amended complaint. The proceedings in the Gress and Giroux cases are stayed pending the outcome of the motion to dismiss in the class action. The Company has not recorded a liability as of March 31, 2020 because a potential loss is not probable or reasonably estimable given the preliminary nature of the proceedings. |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2020 | |
Equity [Abstract] | |
Stockholders' Equity | 7 . STOCKHOLDERS’ EQUITY 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” (“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 March 31, 2020, the Company has not sold any shares of common stock under the agreement. The Company has no obligation to sell any shares of common stock pursuant to the agreement and may at any time suspend sales pursuant to the agreement. Each party may terminate the agreement at any time without liability . 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. 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. At March 31, 2020, after the authorization on January 1, 2020 and 2019 of 403,807 and 403,495 additional shares, respectively, according to the evergreen provision, 507,953 shares of common stock remained available for the grant of future awards under the 2018 Plan. 2013 Stock Incentive Plan The Company’s 2013 Plan 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 March 31, 2020, 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 March 31, 2020, 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 three months ended March 31, 2020, is as follows: Year-to-Date Activity Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in millions) Options outstanding at December 31, 2019 1,313,475 $ 12.28 8.7 Granted 61,000 3.89 Options outstanding at March 31, 2020 1,374,475 11.91 8.5 $ — Options exercisable at March 31, 2020 447,477 $ 14.39 7.5 $ — A summary of restricted stock unit activity under the 2018 Plan for the three months ended March 31, 2020, is as follows: Year-to-Date Activity Number of Shares Weighted Average Grant Date Fair Value Per Share Aggregate Intrinsic Value (in millions) Non-vested outstanding at December 31, 2019 9,000 $ 23.60 Granted — — Vested/settled (5,858 ) Cancelled/forfeited (3,142 ) Non-vested outstanding at March 31, 2020 — — — At March 31, 2020, there was approximately $5.1 million of unrecognized compensation expense related to the stock-based compensation arrangements granted under all plans. The average remaining vesting period for options was 2.0 years. The weighted average grant date fair value of options granted during the three months ended March 31, 2020 was $2.22. The amount of stock-based compensation expense recorded to research and development expenses and to general and administrative expenses is detailed in table below: Three Months Ended March 31, 2020 2019 Stock-based compensation Research and development $ 262,457 $ 369,941 General and administrative 404,881 301,986 $ 667,338 $ 671,927 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 8 . 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 March 31, 2020 and 2019, the number of shares of common stock underlying potentially dilutive securities are comprised of: March 31, 2020 2019 Options to purchase common stock and unvested, unsettled restricted stock units 1,374,475 1,166,875 Total 1,374,475 1,166,875 |
Restructuring
Restructuring | 3 Months Ended |
Mar. 31, 2020 | |
Restructuring And Related Activities [Abstract] | |
Restructuring | 9. RESTRUCTURING In June 2019, the Company received a Complete Response Letter from the FDA regarding its NDA for EDSIVO TM TM |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2020 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. SUBSEQUENT EVENTS Common Stock Purchase Agreement On April 30, 2020, the Company entered into a purchase agreement and a registration rights agreement pursuant to which Lincoln Park has committed to purchase up to $15.0 million of the Company’s common stock. Under the terms and subject to the conditions of the purchase agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase up to $15.0 million of the Company’s common stock. Such sales of common stock by the Company, if any, will be subject to certain limitations, and may occur from time to time, at the Company’s sole discretion, over the 36-month period commencing on the date that a registration statement covering the resale of shares of common stock that have been and may be issued under the purchase agreement is declared effective by the SEC and a final prospectus in connection therewith is filed and the other conditions set forth in the purchase agreement are satisfied. The number of shares the Company may sell to Lincoln Park on any single business day in a regular purchase is 50,000, but that amount may be increased up to 100,000 shares, depending upon the market price of the Company’s common stock at the time of sale and subject to a maximum limit of $1.0 million per regular purchase. The purchase price per share for each such regular purchase will be based on prevailing market prices of the Company’s common stock immediately preceding the time of sale as computed under the purchase agreement. In addition to regular purchases, the Company may also direct Lincoln Park to purchase other amounts as accelerated purchases or as additional accelerated purchases if the closing sale price of the common stock exceeds certain threshold prices as set forth in the purchase agreement. Under applicable rules of the Nasdaq Capital Market, in no event may the Company issue or sell to Lincoln Park under the purchase agreement more than 19.99% of the shares of the Company’s common stock outstanding immediately prior to the execution of the purchase agreement, unless (i) the Company obtains stockholder approval to issue shares of common stock in excess of the Exchange Cap or (ii) the average price of all applicable sales of common stock to Lincoln Park under the purchase agreement equals or exceeds $2.135 per share plus an incremental amount, such that issuances and sales of the common stock to Lincoln Park under the purchase agreement would be exempt from the Exchange Cap limitation under applicable Nasdaq rules. Lincoln Park has no right to require the Company to sell any shares of common stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions. In all instances, the Company may not sell shares of its common stock to Lincoln Park under the purchase agreement if doing so would result in Lincoln Park beneficially owning more than 9.99% of its common stock. Actual sales of shares of common stock to Lincoln Park under the purchase agreement will depend on a variety of factors to be determined by the Company from time to time, including, among others, market conditions, the trading price of the common stock and determinations by the Company as to the appropriate sources of funding for the Company and its operations. The net proceeds under the purchase agreement to the Company will depend on the frequency and prices at which the Company sells shares of its stock to Lincoln Park. The Company issued 148,148 restricted shares of common stock to Lincoln Park as a commitment fee in connection with entering into the purchase agreement. Paycheck Protection Program (“PPP”) Loan On April 11, 2020, the Company was advised that its principal bank, JPMorgan Chase Bank, N.A., had approved a $0.6 million loan under the PPP pursuant to the CARES Act that was signed into law on March 27, 2020. As a U.S. small business, the Company has qualified for the PPP, which allows businesses and nonprofits with fewer than 500 employees to obtain loans of up to $10 million to incent companies to maintain their workers as they manage the business disruptions caused by the COVID-19 pandemic. The loan, evidenced by a promissory note to JPMorgan Chase Bank, N.A. as lender, has a term of two years, is unsecured, and is guaranteed by the Small Business Administration. The loan bears interest at a fixed rate of one percent per annum, with the first six months of interest and principal deferred. Some or all of the loan may be forgiven if at least 75 percent of the loan proceeds are used by the Company to cover payroll costs, including benefits, and if the Company maintains its employment and compensation within certain parameters during the eight-week period following the loan origination date and complies with other relevant conditions. As written in the CARES Act, the Company expects to utilize these funds to cover payroll costs for its 18 employees. |
Significant Accounting Polices
Significant Accounting Polices (Policies) | 3 Months Ended |
Mar. 31, 2020 | |
Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company had an accumulated deficit of $81.2 million and cash and cash equivalents of $7.0 million as of March 31, 2020. Net cash used in operating activities was $5.1 million and $9.8 million for the three months ended March 31, 2020 and 2019, 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 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 (“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 . TM 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 has an accumulated deficit of $81.2 million as of March 31, 2020 and 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 March 31, 2020, the Company had cash and cash equivalents of $7.0 million and current liabilities aggregating to $1.8 million. The Company’s cash and cash equivalents available at March 31, 2020 are expected to fund operations into the fourth quarter of 2020, excluding support for a planned emetine clinical trial and support for EDSIVO™ development and precommercial activities. The Company will need to raise additional capital in 2020 to fund continued operations. The Company may not be successful in its efforts to raise additional funds or achieve profitable operations. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations through and beyond the next 12 months, including cutting expenses where possible and raising additional capital through either private or public equity or debt financing as well as using its ATM facility and/or its $15.0 million equity line facility entered into on April 30, 2020, with Lincoln Park Capital Fund, LLC (“Lincoln Park”) (once sales can commence to Lincoln Park under the purchase agreement), which is subject to certain limitations and conditions. The Company has no commitments for any additional financing. Any amounts raised will be used for further development of its product candidates, precommercial activities, potential acquisitions of additional product candidates, and for other working capital purposes. If the Company is unable to obtain additional funding to support its current or proposed activities and operations, it may not be able to continue its operations as proposed, which may require it to suspend or terminate any ongoing development activities, modify its business plan, curtail various aspects of its operations, cease operations, or seek relief under applicable bankruptcy laws. In such event, the Company’s stockholders may lose a substantial portion or even all of their investment. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern for twelve months from the date these financial statements are available, or May 14, 2021. The accompanying unaudited condensed 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. |
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 $6.5 million and $11.6 million as of March 31, 2020 and December 31, 2019, 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. |
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 a respiratory illness caused by a novel coronavirus |
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 condensed 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 during the three-month period ending March 31, 2020 and 2019 using the Black-Scholes option pricing model: 2020 2019 Risk-free interest rate 1.61% 2.44% – 2.57% Expected life (years) 6.25 6.25 Volatility 60% 60% Dividend rate 0% 0% |
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 condensed financial statements and reported amounts of revenues and 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. |
Income Taxes | Income Taxes The Company recorded no income tax expense or benefit during the three months ended March 31, 2020 and 2019, due to a full valuation allowance recognized against its net deferred tax assets. The Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted in the U.S. on March 27, 2020. The CARES Act included several income tax provisions such as net operating loss (“NOL”) carryback and carryforward benefits. There were also changes giving rise to increases in the 163(j) interest limitation and changes to the timing of qualified leasehold improvements depreciation deductions. These NOL and other benefit provisions have no impact on the Company’s financial statements for the period ended March 31, 2020. Management will continue to monitor future developments and interpretations for any further impacts. |
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 loss per share because to do so would be anti-dilutive. |
Significant Accounting Police_2
Significant Accounting Polices (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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 during the three-month period ending March 31, 2020 and 2019 using the Black-Scholes option pricing model: 2020 2019 Risk-free interest rate 1.61% 2.44% – 2.57% Expected life (years) 6.25 6.25 Volatility 60% 60% Dividend rate 0% 0% |
Property and Equipment (Tables)
Property and Equipment (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following at March 31, 2020 and December 31, 2019: March 31, 2020 December 31, 2019 Computer hardware and software $ 60,749 $ 60,749 Leasehold improvements 60,535 60,535 Furniture and fixtures 145,487 145,487 Subtotal property and equipment, gross 266,771 266,771 Less accumulated depreciation (90,506 ) (72,797 ) Property and equipment, net $ 176,265 $ 193,974 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following at March 31, 2020 and December 31, 2019: March 31, 2020 December 31, 2019 Accrued contract manufacturing $ 290,619 $ 655,207 Accrued contract research and regulatory consulting 270,250 418,000 Accrued payroll and payroll taxes 233,340 153,238 Accrued accounting, audit, and tax fees 70,850 147,850 Accrued miscellaneous expenses 68,834 56,598 Accrued license fees 61,156 — Accrued legal 153,500 152,340 Accrued consulting 22,615 109,073 Accrued pre-commercial costs — 252,125 Total accrued expenses $ 1,171,164 $ 1,944,431 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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 unaudited condensed balance sheet as of March 31, 2020: Undiscounted lease liabilities for years ending December 31,: 2020 (remaining) $ 197,944 2021 273,158 2022 115,951 Total undiscounted lease liabilities $ 587,053 Less effects of discounting (51,587 ) Total lease liabilities as of March 31, 2020 $ 535,466 Reported as of March 31, 2020: Other current liabilities $ 264,472 Other non-current liabilities 270,994 Total lease liabilities $ 535,466 |
Future Minimum Lease Payments | Future minimum lease payments at December 31, 2019 were as follows: Years Ending December 31: Minimum Lease Payments 2020 $ 263,392 2021 273,158 2022 115,951 Total $ 652,501 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
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 three months ended March 31, 2020, is as follows: Year-to-Date Activity Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in millions) Options outstanding at December 31, 2019 1,313,475 $ 12.28 8.7 Granted 61,000 3.89 Options outstanding at March 31, 2020 1,374,475 11.91 8.5 $ — Options exercisable at March 31, 2020 447,477 $ 14.39 7.5 $ — |
Summary of Restricted Stock Unit Activity under 2018 Plan | A summary of restricted stock unit activity under the 2018 Plan for the three months ended March 31, 2020, is as follows: Year-to-Date Activity Number of Shares Weighted Average Grant Date Fair Value Per Share Aggregate Intrinsic Value (in millions) Non-vested outstanding at December 31, 2019 9,000 $ 23.60 Granted — — Vested/settled (5,858 ) Cancelled/forfeited (3,142 ) Non-vested outstanding at March 31, 2020 — — — |
Summary of Stock-Based Compensation Expense | The amount of stock-based compensation expense recorded to research and development expenses and to general and administrative expenses is detailed in table below: Three Months Ended March 31, 2020 2019 Stock-based compensation Research and development $ 262,457 $ 369,941 General and administrative 404,881 301,986 $ 667,338 $ 671,927 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2020 | |
Earnings Per Share [Abstract] | |
Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities | As of March 31, 2020 and 2019, the number of shares of common stock underlying potentially dilutive securities are comprised of: March 31, 2020 2019 Options to purchase common stock and unvested, unsettled restricted stock units 1,374,475 1,166,875 Total 1,374,475 1,166,875 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation - Additional Information (Details) - USD ($) | Apr. 30, 2020 | Mar. 18, 2020 | Sep. 19, 2017 | Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 |
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||
Accumulated deficit | $ 81,199,219 | $ 76,250,512 | ||||
Cash and cash equivalents | 7,007,260 | $ 12,077,640 | ||||
Net cash used in operating activities | $ 5,070,380 | $ 9,750,919 | ||||
Common stock, shares issued | 10,101,034 | 10,095,176 | ||||
Current liabilities | $ 1,780,436 | $ 2,768,913 | ||||
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 | |||||
Merger and Reincorporation | ||||||
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. Immediately following the reincorporation, the holding company structure was eliminated by merging wholly-owned subsidiary Private Acer with and into the Company. The Company was the surviving corporation in connection with the subsidiary merger. | |||||
Date of reincorporation | May 15, 2018 | |||||
Lincoln Park | Subsequent Event | ||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||
Purchase of common stock | $ 15,000,000 | |||||
Maximum | Lincoln Park | Subsequent Event | ||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||
Purchase of common stock | $ 15,000,000 | |||||
At-the-Market Facility | ||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||
Common stock, shares issued | 0 | |||||
At-the-Market Facility | Maximum | ||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||
Aggregate offering price of common stock | $ 50,000,000 |
Significant Accounting Police_3
Significant Accounting Polices - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2020 | Mar. 31, 2019 | Dec. 31, 2019 | |
Schedule Of Significant Accounting Policies [Line Items] | |||
Income tax expense (benefit) | $ 0 | $ 0 | |
Cash and Cash Equivalents | |||
Schedule Of Significant Accounting Policies [Line Items] | |||
Investments in money market funds | $ 6,500,000 | $ 11,600,000 |
Significant Accounting Police_4
Significant Accounting Polices - Schedule of Estimate Fair Value of Stock Options Granted (Details) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Accounting Policies [Abstract] | ||
Risk-free interest rate | 1.61% | |
Risk-free interest rate, minimum | 2.44% | |
Risk-free interest rate, maximum | 2.57% | |
Expected life (years) | 6 years 3 months | 6 years 3 months |
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 ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 266,771 | $ 266,771 |
Less accumulated depreciation | (90,506) | (72,797) |
Property and equipment, net | 176,265 | 193,974 |
Computer Hardware and Software | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 60,749 | 60,749 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 60,535 | 60,535 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 145,487 | $ 145,487 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Mar. 31, 2020 | Dec. 31, 2019 |
Accounts Payable And Accrued Liabilities Current [Abstract] | ||
Accrued contract manufacturing | $ 290,619 | $ 655,207 |
Accrued contract research and regulatory consulting | 270,250 | 418,000 |
Accrued payroll and payroll taxes | 233,340 | 153,238 |
Accrued accounting, audit, and tax fees | 70,850 | 147,850 |
Accrued miscellaneous expenses | 68,834 | 56,598 |
Accrued license fees | 61,156 | |
Accrued legal | 153,500 | 152,340 |
Accrued consulting | 22,615 | 109,073 |
Accrued pre-commercial costs | 252,125 | |
Total accrued expenses | $ 1,171,164 | $ 1,944,431 |
Leases - Additional Information
Leases - Additional Information (Details) | 3 Months Ended | ||||
Mar. 31, 2020USD ($)Term | Mar. 31, 2019USD ($) | Mar. 05, 2019ft² | Apr. 01, 2018ft² | Mar. 06, 2018ft² | |
Lessee Lease Description [Line Items] | |||||
Operating lease right of use asset | $ 500,000 | $ 400,000 | |||
Operating lease liability, current | 264,472 | ||||
Operating lease liability, non-current | $ 270,994 | ||||
Operating lease discount rate | 8.00% | ||||
Operating lease, weighted average remaining lease term | 2 years 2 months 12 days | ||||
Operating lease, cash payment made | $ 68,000 | 28,000 | |||
Operating lease expense | $ 65,000 | 37,000 | |||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherAssetsNoncurrent | ||||
Operating lease liability | $ 535,466 | ||||
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 | ||||
Lease expiration date | Mar. 31, 2022 |
Leases - Reconciliation of Undi
Leases - Reconciliation of Undiscounted Lease Liabilities to Total Lease Liabilities (Details) | Mar. 31, 2020USD ($) |
Undiscounted lease liabilities for years ending December 31,: | |
2020 (remaining) | $ 197,944 |
2021 | 273,158 |
2022 | 115,951 |
Total undiscounted lease liabilities | 587,053 |
Less effects of discounting | (51,587) |
Total lease liabilities as of March 31, 2020 | 535,466 |
Operating lease liability, current | 264,472 |
Operating lease liability, non-current | 270,994 |
Total lease liabilities | $ 535,466 |
Leases - Future Minimum Lease P
Leases - Future Minimum Lease Payments (Details) | Dec. 31, 2019USD ($) |
Leases [Abstract] | |
2020 | $ 263,392 |
2021 | 273,158 |
2022 | 115,951 |
Total | $ 652,501 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) $ in Millions | Sep. 27, 2017USD ($) | Sep. 30, 2018Patent | Mar. 31, 2020 |
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 | May 14, 2018 | Sep. 19, 2017 | Mar. 31, 2020 | Jan. 01, 2020 | Dec. 31, 2019 | Jan. 01, 2019 |
Stockholders Equity [Line Items] | ||||||||
Common stock, shares issued | 10,101,034 | 10,095,176 | ||||||
Number of share outstanding | 1,374,475 | 1,313,475 | ||||||
Awards granted under the plan | 61,000 | |||||||
Unrecognized compensation expense | $ 5.1 | |||||||
Share based compensation arrangement by share based payment award, Average remaining vesting period | 2 years | |||||||
Weighted average grant date fair value of options granted | $ 2.22 | |||||||
2018 Stock Incentive Plan | ||||||||
Stockholders Equity [Line Items] | ||||||||
Number of common stock authorized for issuance | 500,000 | 403,807 | 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. | |||||||
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% | |||||||
Options contractual term | 10 years | |||||||
Available for the grant of future awards | 507,953 | |||||||
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 | |||||||
At-the-Market Facility | ||||||||
Stockholders Equity [Line Items] | ||||||||
Common stock, shares issued | 0 | |||||||
At-the-Market Facility | 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) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2020 | Dec. 31, 2019 | |
Options | ||
Number of Shares, Options outstanding at beginning of period | 1,313,475 | |
Number of Shares, Options Granted | 61,000 | |
Number of Shares, Options outstanding at end of period | 1,374,475 | 1,313,475 |
Number of Shares, Options exercisable at end of period | 447,477 | |
Weighted Average Exercise Price, Options | ||
Weighted Average Exercise Price, Options outstanding at beginning of period | $ 12.28 | |
Weighted Average Exercise Price, Options Granted | 3.89 | |
Weighted Average Exercise Price, Options outstanding at end of period | 11.91 | $ 12.28 |
Weighted Average Exercise Price, Options exercisable at end of period | $ 14.39 | |
Weighted Average Remaining Contract Term, Options | ||
Weighted Average Remaining Contractual Term, Options outstanding at beginning of period | 8 years 6 months | 8 years 8 months 12 days |
Weighted Average Remaining Contractual Term, Options exercisable at end of period | 7 years 6 months |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Restricted Stock Unit Activity under 2018 Plan (Details) - Restricted Stock Units (RSUs) | 3 Months Ended |
Mar. 31, 2020$ / sharesshares | |
Restricted Stock Units | |
Number of Shares, Non-Vested outstanding at beginning of period | 9,000 |
Number of Shares, Vested/settled | (5,858) |
Number of Shares, Cancelled/forfeited | (3,142) |
Weighted Average Grant Date Fair Value Per Share | |
Weighted Average Grant Date Fair Value Per Share, Non-Vested outstanding at beginning of the period | $ / shares | $ 23.60 |
Stockholders' Equity - Summar_3
Stockholders' Equity - Summary of Stock-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Stockholders Equity [Line Items] | ||
Stock-based compensation | $ 667,338 | $ 671,927 |
Research and Development | ||
Stockholders Equity [Line Items] | ||
Stock-based compensation | 262,457 | 369,941 |
General and Administrative | ||
Stockholders Equity [Line Items] | ||
Stock-based compensation | $ 404,881 | $ 301,986 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2020 | Mar. 31, 2019 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,374,475 | 1,166,875 |
Options to purchase common stock and unvested, unsettled restricted stock units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,374,475 | 1,166,875 |
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 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event | Apr. 30, 2020USD ($)$ / sharesshares | Apr. 11, 2020USD ($)Employee |
Subsequent Event [Line Items] | ||
Expected employees payroll cost to be covered under CARES act fund utilization | Employee | 18 | |
Minimum percentage of loan proceeds used to cover payroll costs eligible for loan forgiven | 75.00% | |
PPP Loan | JPMorgan Chase Bank, N.A | ||
Subsequent Event [Line Items] | ||
CARES act of 2020 aid loan amount | $ 600,000 | |
Promissory Note | JPMorgan Chase Bank, N.A | ||
Subsequent Event [Line Items] | ||
Debt Instrument, Term | 2 years | |
Debt Instrument, fixed interest rate | 1.00% | |
Lincoln Park | ||
Subsequent Event [Line Items] | ||
Purchase of common stock | $ 15,000,000 | |
Maximum number of common stock shares may sell in single business day on regular purchases | shares | 50,000 | |
Market price of common stock at the time of sale and subject to maximum limit per regular purchase | $ 1,000,000 | |
Maximum percentage of outstanding shares can be sold under purchase agreement immediately prior to execution of agreement | 19.99% | |
Restricted common stock issued under purchase agreement | shares | 148,148 | |
Maximum | Lincoln Park | ||
Subsequent Event [Line Items] | ||
Purchase of common stock | $ 15,000,000 | |
Number of shares sell on single business day in regular purchases, amount increased | shares | 100,000 | |
Beneficially ownership percentage | 9.99% | |
Minimum [Member] | Lincoln Park | ||
Subsequent Event [Line Items] | ||
Minimum average price of shares issued under purchase agreement. | $ / shares | $ 2.135 |