Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2021 | Nov. 01, 2021 | |
Cover [Abstract] | ||
Entity Registrant Name | Acer Therapeutics Inc. | |
Entity Central Index Key | 0001069308 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2021 | |
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 | 14,310,244 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2021 | |
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, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 14,151,496 | $ 5,761,568 |
Prepaid expenses | 1,106,650 | 679,461 |
Other current assets | 9,323,586 | |
Total current assets | 24,581,732 | 6,441,029 |
Property and equipment, net | 113,314 | 130,081 |
Other assets: | ||
Goodwill | 7,647,267 | 7,647,267 |
Other non-current assets | 207,895 | 395,311 |
Total assets | 32,550,208 | 14,613,688 |
Current liabilities: | ||
Accounts payable | 1,089,061 | 1,672,109 |
Accrued expenses | 2,084,015 | 3,781,101 |
Deferred collaboration funding | 17,771,957 | |
Other current liabilities | 9,440,732 | 692,336 |
Total current liabilities | 30,385,765 | 6,145,546 |
Other non-current liabilities | 243,808 | |
Total liabilities | 30,385,765 | 6,389,354 |
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; 14,310,244 and 13,233,137 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 1,431 | 1,324 |
Additional paid-in capital | 112,252,323 | 107,358,971 |
Accumulated deficit | (110,089,311) | (99,135,961) |
Total stockholders’ equity | 2,164,443 | 8,224,334 |
Total liabilities and stockholders’ equity | $ 32,550,208 | $ 14,613,688 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
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 | 14,310,244 | 13,233,137 |
Common stock, shares outstanding | 14,310,244 | 13,233,137 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Income Statement [Abstract] | ||||
Revenue | $ 900,000 | |||
Operating expenses: | ||||
Research and development (in the three and nine months ended September 30, 2021, net of collaboration funding of $3,454,881 and $4,766,919, respectively) | $ 1,435,461 | $ 3,227,048 | 4,802,653 | $ 8,366,702 |
General and administrative (in the three and nine months ended September 30, 2021, net of collaboration funding of $958,590 and $1,561,124, respectively) | 1,843,360 | 2,661,989 | 7,626,009 | 8,263,677 |
Total operating expenses | 3,278,821 | 5,889,037 | 12,428,662 | 16,630,379 |
Loss from operations | (3,278,821) | (5,889,037) | (11,528,662) | (16,630,379) |
Other income (expense), net: | ||||
Interest and other (expense) income, net | (2,471) | (4,129) | 522,280 | 17,673 |
Foreign currency transaction gain (loss) | 8,284 | (35,092) | 53,032 | (35,059) |
Total other income (expense), net | 5,813 | (39,221) | 575,312 | (17,386) |
Net loss | $ (3,273,008) | $ (5,928,258) | $ (10,953,350) | $ (16,647,765) |
Net loss per share - basic and diluted | $ (0.23) | $ (0.51) | $ (0.77) | $ (1.56) |
Weighted average common shares outstanding - basic and diluted | 14,310,244 | 11,514,254 | 14,254,092 | 10,662,164 |
Condensed Statements of Opera_2
Condensed Statements of Operations (Parenthetical) - USD ($) | 3 Months Ended | 9 Months Ended |
Sep. 30, 2021 | Sep. 30, 2021 | |
Research and Development | ||
Collaboration funding amount | $ 3,454,881 | $ 4,766,919 |
General and Administrative | ||
Collaboration funding amount | $ 958,590 | $ 1,561,124 |
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, 2019 | $ 18,370,316 | $ 1,010 | $ 94,619,818 | $ (76,250,512) |
Beginning balance, shares at Dec. 31, 2019 | 10,095,176 | |||
Issuance of common stock in connection with restricted stock unit vesting | 1 | $ 1 | ||
Issuance of common stock in connection with restricted stock unit 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 | |||
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 | |||
Net loss | (16,647,765) | |||
Ending balance at Sep. 30, 2020 | 10,503,512 | $ 1,192 | 103,400,598 | (92,898,278) |
Ending balance, shares at Sep. 30, 2020 | 11,912,731 | |||
Beginning balance at Mar. 31, 2020 | 14,088,948 | $ 1,011 | 95,287,156 | (81,199,219) |
Beginning balance, shares at Mar. 31, 2020 | 10,101,034 | |||
Issuance of common stock through at-the-market facility; net of issuance costs | 1,941,095 | $ 36 | 1,941,059 | |
Issuance of common stock through at-the-market facility, net of issuance costs, shares | 363,549 | |||
Issuance of common stock for commitment fee | 355,555 | $ 15 | 355,540 | |
Issuance of common stock for commitment fee, shares | 148,148 | |||
Stock-based compensation | 603,574 | 603,574 | ||
Net loss | (5,770,801) | (5,770,801) | ||
Ending balance at Jun. 30, 2020 | 11,218,371 | $ 1,062 | 98,187,329 | (86,970,020) |
Ending balance, shares at Jun. 30, 2020 | 10,612,731 | |||
Issuance of common stock through at-the-market facility; net of issuance costs | 3,868,497 | $ 105 | 3,868,392 | |
Issuance of common stock through at-the-market facility, net of issuance costs, shares | 1,055,002 | |||
Issuance of common stock through private placement | 857,499 | $ 25 | 857,474 | |
Issuance of common stock through private placement, shares | 244,998 | |||
Stock-based compensation | 487,403 | 487,403 | ||
Net loss | (5,928,258) | (5,928,258) | ||
Ending balance at Sep. 30, 2020 | 10,503,512 | $ 1,192 | 103,400,598 | (92,898,278) |
Ending balance, shares at Sep. 30, 2020 | 11,912,731 | |||
Beginning balance at Dec. 31, 2020 | $ 8,224,334 | $ 1,324 | 107,358,971 | (99,135,961) |
Beginning balance, shares at Dec. 31, 2020 | 13,233,137 | 13,233,137 | ||
Issuance of common stock, net of issuance costs | $ 3,139,047 | $ 107 | 3,138,940 | |
Issuance of common stock, net of issuance costs, shares | 1,077,107 | |||
Stock-based compensation | 559,436 | 559,436 | ||
Net loss | (4,611,305) | (4,611,305) | ||
Ending balance at Mar. 31, 2021 | 7,311,512 | $ 1,431 | 111,057,347 | (103,747,266) |
Ending balance, shares at Mar. 31, 2021 | 14,310,244 | |||
Beginning balance at Dec. 31, 2020 | $ 8,224,334 | $ 1,324 | 107,358,971 | (99,135,961) |
Beginning balance, shares at Dec. 31, 2020 | 13,233,137 | 13,233,137 | ||
Net loss | $ (10,953,350) | |||
Ending balance at Sep. 30, 2021 | $ 2,164,443 | $ 1,431 | 112,252,323 | (110,089,311) |
Ending balance, shares at Sep. 30, 2021 | 14,310,244 | 14,310,244 | ||
Beginning balance at Mar. 31, 2021 | $ 7,311,512 | $ 1,431 | 111,057,347 | (103,747,266) |
Beginning balance, shares at Mar. 31, 2021 | 14,310,244 | |||
Stock-based compensation | 594,663 | 594,663 | ||
Net loss | (3,069,037) | (3,069,037) | ||
Ending balance at Jun. 30, 2021 | 4,837,138 | $ 1,431 | 111,652,010 | (106,816,303) |
Ending balance, shares at Jun. 30, 2021 | 14,310,244 | |||
Stock-based compensation | 600,313 | 600,313 | ||
Net loss | (3,273,008) | (3,273,008) | ||
Ending balance at Sep. 30, 2021 | $ 2,164,443 | $ 1,431 | $ 112,252,323 | $ (110,089,311) |
Ending balance, shares at Sep. 30, 2021 | 14,310,244 | 14,310,244 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (10,953,350) | $ (16,647,765) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Stock-based compensation | 1,754,412 | 1,758,315 |
Depreciation | 51,225 | 53,058 |
Gain on extinguishment of debt | (568,909) | |
Fair value of share issued for commitment fee | 355,555 | |
Non-cash interest expense | 2,297 | |
Changes in operating assets and liabilities | ||
Prepaid expenses | (427,189) | (61,018) |
Other current assets | (9,323,586) | 21,975 |
Accounts payable | (583,048) | 353,114 |
Accrued expenses | (1,697,086) | 1,009,217 |
Deferred collaboration funding | 13,771,957 | |
Other current liabilities | 9,260,913 | 7,719 |
Net cash provided by (used in) operating activities | 1,285,339 | (13,147,533) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (34,458) | (2,229) |
Net cash used in investing activities | (34,458) | (2,229) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 3,139,047 | 6,667,091 |
Proceeds from Paycheck Protection Program loan | 562,479 | |
Receipt of funds from secured loan | 4,000,000 | |
Net cash provided by financing activities | 7,139,047 | 7,229,570 |
Net increase (decrease) in cash and cash equivalents | 8,389,928 | (5,920,192) |
Cash and cash equivalents, beginning of period | 5,761,568 | 12,077,640 |
Cash and cash equivalents, end of period | 14,151,496 | $ 6,157,448 |
Non-cash financing activities: | ||
Extinguishment of debt | $ 568,909 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 9 Months Ended |
Sep. 30, 2021 | |
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 programs: ACER-001 (sodium phenylbutyrate) for the treatment of various inborn errors of metabolism, including urea cycle disorders (“UCDs”) and Maple Syrup Urine Disease (“MSUD”); ACER-801 (osanetant) for the treatment of induced vasomotor symptoms (“iVMS”); EDSIVO™ (celiprolol) for the treatment of vascular Ehlers-Danlos syndrome (“vEDS”) in patients with a confirmed type III collagen (COL3A1) mutation; and ACER-2820 (emetine), a host-directed therapy against a variety of infectious diseases, including COVID-19. The Company’s product candidates are believed to present comparatively de-risked programs, as evidenced by having one or more of the following: 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 generated revenue related to the collaboration and license agreement (the “Collaboration Agreement”) with Relief Therapeutics Holding AG (“Relief”) as described below but 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 $110.1 million and cash and cash equivalents of $14.2 million as of September 30, 2021. Net cash provided by operating activities was $1.3 million for the nine months ended September 30, 2021, as compared to net cash used in operating activities of $13.1 million for the nine months ended September 30, 2020. 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 $50.0 million depending upon market demand, in transactions deemed to be an at-the-market (“ATM”) offering. 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. During the three months ended September 30, 2021, the Company did not sell any shares through its ATM facility. During the nine months ended September 30, 2021, during multiple trading days, the Company sold an aggregate of 877,107 shares at an average gross sale price of $3.1692 per share, resulting in gross proceeds of $2.8 million. Proceeds during the nine months ended September 30, 2021, net of $0.2 million of fees and offering costs, were $2.6 million. On April 30, 2020, the Company entered into an equity line purchase agreement and registration rights agreement pursuant to which Lincoln Park Capital Fund, LLC (“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, with $12.1 million obligation remaining as of September 30, 2021. Such sales of common stock by the Company 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 June 8, 2020. 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. The Company issued 148,148 shares of common stock to Lincoln Park as a commitment fee in connection with entering into the purchase agreement. The $0.4 million fair value of the commitment fee shares was recorded to general and administrative expense along with other costs incurred in connection with entering into the purchase agreement. During the three months ended September 30, 2021, the Company did not sell any shares of common stock under its purchase agreement with Lincoln Park. On July 24, 2020, the Company entered into a securities purchase agreement for the sale and issuance of an aggregate of 244,998 shares of the Company’s common stock, for an aggregate purchase price of $0.9 million, in a private placement transaction (“Private Placement”) with certain directors, officers, and employees at a price per share of $3.50. The shares of common stock issued in the Private Placement constitute “restricted securities” under the federal securities laws and were subject to a minimum six-month holding period. On March 19, 2021, the Company entered into the Collaboration Agreement with Relief providing for the development and commercialization of ACER-001 for the treatment of various inborn errors of metabolism, including for the treatment of UCDs and MSUD. The Collaboration Agreement is the culmination of the option agreement (the “Option Agreement,” together the “Agreements”) previously entered into between the Company and Relief on January 25, 2021. Pursuant to the Agreements, the Company received from Relief an upfront non-refundable payment of $1.0 million and a reimbursement payment of $14.0 million. Under the terms of the Collaboration Agreement, Relief committed to pay the Company up to $20.0 million in U.S. development and commercial launch costs for the UCDs and MSUD indications (the “Development Payments”). During the three months ended June 30, 2021, the Company received from Relief the $10.0 million First Development Payment. The Company is contractually entitled to receive from Relief an additional $10.0 million Second Development Payment conditioned upon the FDA’s acceptance of a New Drug Application (“NDA”) for ACER-001 in a UCD for filing and review. This acceptance was received on October 4, 2021. On October 6, 2021, the Company entered into a Waiver and Agreement with Relief to amend the timing for the Second Development Payment. The Company received the first $5.0 million tranche of the Second Development Payment on October 12, 2021. The Company is contractually entitled to receive from Relief an additional $5.0 million second tranche of the Second Development Payment upon the earlier of January 14, 2022 or 15 business days following the Company’s written notice. Should that payment not occur, the Company’s development plans could be affected unless it were able to obtain other funds. There is no guarantee that ACER-001 will receive regulatory authority approval in any territory or become commercially available for the indications under investigation. The Company could also receive a total of $6.0 million in milestone payments based on the first European marketing approvals of ACER-001 for a UCD and MSUD. The terms of the Agreements are further described below in the Revenue Recognition section of Note 2, Significant Accounting Policies. The Company’s existing cash and cash equivalents available at September 30, 2021, plus the $10.0 million Second Development Payment in two tranches following the FDA’s acceptance for filing and review of an NDA for ACER-001 in a UCD per the Collaboration Agreement with Relief, are expected to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-801 and EDSIVO TM Management expects to continue to finance operations through the issuance of additional equity or debt securities, non-dilutive funding, 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 accounting principles generally accepted in the U.S. (“GAAP”), which contemplate continuation of the Company as a going concern. The Company has not established a source of commercial product revenues and, as such, has been dependent on funding operations through the sale of equity securities and through a collaboration agreement. Since inception, the Company has experienced significant losses and incurred negative cash flows from operations. The Company has an accumulated deficit of $110.1 million as of September 30, 2021 and expects to incur further losses for the foreseeable future 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 September 30, 2021, the Company had cash and cash equivalents of $14.2 million and current liabilities of $30.4 million, which include $17.8 million associated with deferred collaboration funding, as well as a $9.2 million liability related to the securities class action and stockholder derivative actions settlements and legal costs, for which the Company has also recorded a receivable from its insurance carriers. The Company’s cash and cash equivalents available at September 30, 2021, plus the $10.0 million Second Development Payment in two tranches following the FDA’s acceptance for filing and review of an NDA for ACER-001 in a UCD per the Collaboration Agreement with Relief, are expected to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-801 and EDSIVO TM The Company will need to raise additional capital to fund continued operations beyond mid-2022 because neither FDA approval of ACER-001 nor subsequent product revenues are assured. 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 beyond mid-2022, including raising additional capital through either private or public equity or debt financing or non-dilutive funding, as well as using its ATM facility and/or its remaining $12.1 million equity line facility entered into on April 30, 2020 with Lincoln Park, which is subject to certain limitations and conditions. The Company has no commitments for any additional financing, except for the agreement with Lincoln Park and the Collaboration Agreement with Relief. 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, curtai l 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. 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. See Note 9 to these unaudited condensed interim financial statements. Basis of Presentation The accompanying 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 and nine months ended September 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021 or for any other future annual or interim period. The condensed balance sheet as of December 31, 2020, 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 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 | 9 Months Ended |
Sep. 30, 2021 | |
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, 2020. Revenue Recognition and Accounting for Collaboration Agreements The Company’s revenues are generated from a single collaboration agreement which included the sale of a license of intellectual property. The Company analyzes its collaboration agreements to assess whether they are within the scope of ASC Topic 808, (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and the collaboration partner are within the scope of other accounting literature. If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, the Company accounts for those aspects of the arrangement within the scope of ASC Topic 606, Revenue from Contracts with Customers The Company determines the units of account within the collaborative arrangement utilizing the guidance in ASC 606 to determine which promised goods or services are distinct. In order for a promised good or service to be considered “distinct” under ASC 606, the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct), and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). For any units of account that fall within the scope of ASC 606, where the other party is a customer, the Company evaluates the separate performance obligation(s) under each contract, determines the transaction price, allocates the transaction price to each performance obligation considering the estimated stand-alone selling prices of the services and recognizes revenue upon the satisfaction of such obligations at a point in time or over time dependent on the satisfaction of one of the following criteria: (1) the customer simultaneously receives and consumes the economic benefits provided by the vendor’s performance; (2) the vendor creates or enhances an asset controlled by the customer; (3) the vendor’s performance does not create an asset for which the vendor has an alternative use; and (4) the vendor has an enforceable right to payment for performance completed to date. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property is recognized only when (or as) the later of the following events occurs: (i) the subsequent sale or usage occurs; or (ii) the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). On January 25, 2021, the Company entered into the Option Agreement with Relief pursuant to which the Company granted Relief an exclusive option (the “Exclusivity Option”) to pursue a potential collaboration and license arrangement with the Company for the development, regulatory approval and commercialization of ACER-001 for the treatment of various inborn errors of metabolism, including UCDs and MSUD. The Option Agreement provided a period of time up to June 30, 2021 for the parties to perform additional due diligence and to work toward negotiation and execution of a definitive agreement with respect to the potential collaboration for ACER‑001. In consideration for the grant of the Exclusivity Option, (i) the Company received from Relief an upfront nonrefundable payment of $1.0 million, (ii) Relief provided to the Company a 12-month secured loan in the principal amount of $4.0 million, as evidenced by a Promissory Note (the “Note”) issued by the Company to Relief, and (iii) the Company granted to Relief a security interest in all of its assets to secure performance of the Note, as evidenced by a Security Agreement (the “Security Agreement”). The Note was repayable in one lump sum within 12 months from issuance and bore interest at a rate equal to 6% per annum. If a definitive agreement with respect to the potential collaboration had not been executed by the parties on or before June 30, 2021, the Exclusivity Option would have terminated and the Note would have been repayable by the Company upon maturity. On March 19, 2021, the Company entered into the Collaboration Agreement with Relief providing for the development and commercialization of ACER-001 for the treatment of various inborn errors of metabolism, including for the treatment of UCDs and MSUD. The Company received the $10.0 million cash payment from Relief ($14.0 million “Reimbursement Payment,” but offset by repayment of the $4.0 million outstanding balance of the Note, plus interest earned through the date of the Collaboration Agreement, from Relief to the Company). Under the terms of the Collaboration Agreement, Relief committed to pay the Company up to an additional $20.0 million for U.S. development and commercial launch costs for the UCDs and MSUD indications (the “Development Payments”). During the three months ended June 30, 2021, the Company received from Relief the $10.0 million First Development Payment. The Company is contractually entitled to receive from Relief an additional $10.0 million Second Development Payment conditioned upon the FDA’s acceptance of an NDA for ACER-001 in a UCD for filing and review. This acceptance was received on October 4, 2021. On October 6, 2021, the Company entered into a Waiver and Agreement with Relief to amend the timing for the Second Development Payment. The Company received the first $5.0 million tranche of the Second Development Payment on October 12, 2021. The Company is contractually entitled to receive from Relief an additional $5.0 million second tranche of the Second Development Payment upon the earlier of January 14, 2022 or 15 business days following the Company’s written notice. Should that payment not occur, the Company’s development plans could be affected unless it were able to obtain other funds. There is no guarantee that ACER-001 will receive regulatory authority approval in any territory or become commercially available for the indications under investigation. Further, the Company retained development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan (“Acer Territory”). The companies will split net profits from the Acer Territory 60%:40% in favor of Relief. Relief licensed the rights for the rest of the world (“Relief Territory”), where the Company will receive from Relief a 15% royalty on all net sales received in Relief Territory. The Company could also receive a total of $6.0 million in milestone payments based on the first European (EU) marketing approvals for a UCD and MSUD. The Company assessed these agreements in accordance with the authoritative literature and concluded that they meet the definition of a collaborative arrangement per ASC 808. For certain parts of the collaborative arrangement, the Company concluded that Relief represented a customer while for other parts of the agreement Relief did not represent a customer. The units of account of the collaborative arrangement where Relief does not represent a customer are outside of the scope of ASC 606. The Company also determined that the development and commercialization services and Relief’s right to 60% profit in Acer Territory is within the scope of ASC 730, with regard to funded research and development arrangements. The Company concluded the promised goods and services contained in the Collaboration Agreement, represented two distinct units of account consisting of a license in Relief Territory, and a combined promise for the development and commercialization of ACER-001 in Acer Territory and the payment of 60% net profit from that territory (together, the “Services”). The stand-alone selling price was estimated for each distinct unit of account. The Company determined that the transaction price at the outset of the Collaboration Agreement is $25.0 million, including the Option Fee of $1.0 million, the Reimbursement Payment of $14.0 million, and the First Development Payment of $10.0 million. The Company concluded that consistent with the evaluation of variable consideration, using the most likely amount approach, the Second Development Payment as well as the milestone payments for EU marketing approvals, should be fully constrained until the contingency associated with each payment has been resolved and the Company’s NDA is accepted for review by the FDA, and Relief receives EU marketing approval, respectively. Since ASC 808 does not provide recognition and measurement guidance for collaborative arrangements, the Company applied the principles of ASC 606 for those units of account where Relief is a customer and ASC 730-20 for the funded research and development activities. The license revenue was recognized at the point where the Company determined control was transferred to the customer. The combined unit of account for the Services associated with the allocation of the initial transaction price will be recognized over the service period through the anticipated date of first commercial sale of the ACER-001 approved product in the U.S. The Company also determined that the Services associated with the allocation of the initial transaction price would be satisfied over time as measured using actual costs incurred by the Company toward the identified development and commercialization services agreed to between the parties up to the point of first commercial sale of the ACER-001 product. Research and development expense and general and administrative expense, as they relate to activities governed by the Collaboration Agreement, incurred in satisfying the Services unit-of-account will be recognized as contra-expense within their respective categories, consistent with the presentation guidance in ASC 730. The Company recognizes as receivable under the Collaboration Agreement consideration, which is deemed unconditional, or when only the passage of time is required before payment of that consideration is due. Amounts receivable under the Collaboration Agreement plus payments received from Relief, net of the amount recorded as revenue, are reported as deferred collaboration funding. At September 30, 2021, the amount of deferred collaboration funding associated with unsatisfied promises under the Collaboration Agreement amounted to $17.8 million. The Company expects to recognize this deferred collaboration funding as it incurs expenses associated with performing the Services up to the date of first commercial sale in Acer Territory and through the end of the effective date of the Collaboration Agreement. At September 30, 2021, deferred collaboration funding was composed of $25.0 million received from Relief, offset by $0.9 million recognized as license revenue and $4.8 million recorded as an offset to research and development expenses and $1.6 million recorded as an offset to general and administrative expenses during the nine months ended September 30, 2021. Cash and Cash Equivalents and Fair Value of Financial Instruments 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 $12.9 million and $5.3 million as of September 30, 2021 and December 31, 2020, 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 receivable, accounts payable, and loans payable recorded in other current liabilities and other non-current liabilities approximates their carrying value, based upon their short-term maturities or prevailing interest rates. The Company recognized a $4.0 million non-cash reduction in a secured loan from Relief during the nine months ended September 30, 2021, since the Reimbursement Payment from Relief was received net of the amount of principal and interest due in connection with the secured loan. 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 assessment or a quantitative impairment test to determine whether goodwill is impaired. The Company’s goodwill is allocated to a single reporting unit. If the Company were to determine based on a qualitative assessment that it was more likely than not that the fair value of the reporting unit was less than its carrying value, a quantitative impairment test would then be performed. The quantitative impairment test compares the fair value of the reporting unit with its carrying amount, including goodwill. If the estimated fair value of the reporting unit is less than its carrying amount, a goodwill impairment would be recognized for the difference. The COVID-19 pandemic involving a respiratory illness caused by a novel coronavirus affected the worldwide economy and triggered decline in the stock markets in 2020 . The Company considered potential triggering events related to COVID-19 and concluded that there was not a triggering event that would require the Company to perform further impairment analysis. 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 risk-free rate for periods within the expected life of the option is based on the U.S Treasury yield curve in effect at the time of the grant. 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 expected volatility of its stock in consideration of a number of factors including the volatility of comparable public companies. The Company recognizes forfeitures related to employee stock-based awards as they occur. The following assumptions were used to estimate the fair value of stock options granted during the nine months ended September 30, 2021 and 2020 using the Black-Scholes option pricing model: 2021 2020 Risk-free interest rate 0.37% -0.84% 0.36%-1.61% Expected life (years) 6.25 6.25 Expected volatility 92.4% 60.0% Dividend rate 0% 0% Research and Development Expenses Research and development costs are expensed as incurred and include compensation and related benefits, license fees and outside contracted research and manufacturing consultants. The Company sometimes makes nonrefundable advance payments for goods and services that will be used in future research and development activities. These payments are capitalized and recorded as an expense in the period that the goods are received or when the services are performed. From time to time, in connection with the Collaboration Agreement with Relief, the Company may recognize “contra-expense” for the research and development activities which were funded by this agreement. These contra-expense amounts will be disclosed parenthetically on the face of the financial statements. General and Administrative Expenses General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits, and stock-based compensation; precommercial costs; and professional fees for legal, business consulting, auditing, and tax services. We expect that general and administrative expenses will be substantial in the future. From time to time, in connection with the Collaboration Agreement with Relief, the Company may recognize “contra-expense” for the general and administrative activities which were funded by this agreement. These contra-expense amounts will be disclosed parenthetically on the face of the financial statements. Clinical Trial and Preclinical Study Expenses The Company makes estimates of prepaid and/or accrued expenses as of each balance sheet date in its financial statements based on certain facts and circumstances at that time. The accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred for services provided by contract research organizations (“CRO”), manufacturing organizations, and for other trial- and study-related activities. Payments under the Company’s agreements with external service providers depend on a number of factors such as site initiation, patient screening, enrollment, delivery of reports, and other events. In accruing for these activities, the Company obtains information from various sources and estimates the level of effort or expense allocated to each period. Adjustments to research and development expenses may be necessary in future periods as the Company’s estimates change. As these activities are generally material to the Company’s overall financial statements, subsequent changes in estimates may result in a material change in the Company’s accruals. No material changes in estimates were recognized in each of the three and nine months ended September 30, 2021 and 2020 . At September 30, 2021 , accounts payable and accrued expenses did no t include any costs associated with preclinical or clinical study expense. At December 31, 2020 , accounts payable and accrued expenses included $ million for costs associated with preclinical or clinical study expense . 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. From time to time, estimates having relatively higher significance include revenue recognition, determination of stand-alone selling price, stock-based compensation, contract manufacturing and clinical trial 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 and nine months ended September 30, 2021 and 2020, due to a full valuation allowance recognized against its net deferred tax assets. 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. 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. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. The Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted in the U.S. on March 27, 2020 . The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions, and technical corrections to tax depreciation methods for qualified improvement property. The Company is required to recognize the effects of tax law changes in the period of enactment. The enactment of the CARES Act did not result in material adjustments for the income tax provision for the three and nine months ended or to the Company’s assessment of the realizability of deferred tax assets as the carry back of net operating losses was used as a source of income. There were no other effects to the Company’s tax provision as a result of the CARES Act as of September 30, 2021. 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. Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options The Company early adopted ASU No. 2020-06 in the first quarter of 2021. There was no impact on the Company’s financial statements as a result of the adoption of this guidance. |
Property and Equipment
Property and Equipment | 9 Months Ended |
Sep. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 3. PROPERTY AND EQUIPMENT Property and equipment consisted of the following at September 30, 2021 and December 31, 2020: September 30, 2021 December 31, 2020 Computer hardware and software $ 93,361 $ 58,903 Leasehold improvements 60,535 60,535 Furniture and fixtures 145,487 145,487 Subtotal property and equipment, gross 299,383 264,925 Less accumulated depreciation (186,069 ) (134,844 ) Property and equipment, net $ 113,314 $ 130,081 |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2021 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Accrued Expenses | 4. ACCRUED EXPENSES Accrued expenses consisted of the following at September 30, 2021 and December 31, 2020: September 30, 2021 December 31, 2020 Accrued contract manufacturing $ 1,254,270 $ 1,479,771 Accrued payroll and payroll taxes 353,257 267,159 Accrued consulting 140,938 88,750 Accrued accounting, audit, and tax fees 120,218 181,200 Accrued license fees 87,984 240,041 Accrued legal 64,863 350,517 Accrued miscellaneous expenses 34,985 102,999 Accrued contract research and regulatory consulting 27,500 1,070,664 Total accrued expenses $ 2,084,015 $ 3,781,101 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
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 an amendment to the Newton Lease to add 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 an amendment to the Bend Lease to add an additional 1,389 square feet of 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 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 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% for each of the three and nine months ended September 30, 2021 and 2020, which corresponds to the Company’s incremental borrowing rate. As of September 30, 2021, the weighted average remaining lease term was 0.7 years. The Company recorded expense of $0.1 million related to the leases for each of the three months ended September 30, 2021 and 2020, and recorded expense of $0.2 million related to the leases for each of the nine months ended September 30, 2021 and 2020. The Company made cash payments for amounts included in the measurement of lease liabilities of $0.1 million and $0.2 million, respectively, during each of the three and nine months ended September 30, 2021 and 2020 . T he Company is r eporting a right-of-use asset of $0.2 million in Other non-current assets and lease liabilities totaling $0.2 million in Other current liabilities as of September 30, 2021 . The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the unaudited condensed balance sheet as of September 30, 2021: Undiscounted lease liabilities for years ending December 31,: 2021 (remaining) $ 69,571 2022 115,951 Total undiscounted lease liabilities 185,522 Less effects of discounting (8,627 ) Total lease liabilities as of September 30, 2021 $ 176,895 The Company’s lease liabilities are reported on the balance sheets as follows: September 30, 2021 December 31, 2020 Other current liabilities $ 176,895 $ 274,172 Other non-current liabilities — 90,139 Total lease liabilities $ 176,895 $ 364,311 |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 6 . COMMITMENTS AND CONTINGENCIES License Agreements In April 2014, the Company 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, the Company 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 ACER-801, 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 ACER-801 over the royalty term. The Company plans to initially pursue development of ACER-801 as a potential treatment for iVMS. On March 19, 2021, the Company entered into the Collaboration Agreement with Relief providing for the development and commercialization of ACER-001 for the treatment of various inborn errors of metabolism, including for the treatment of UCDs and MSUD. The Collaboration Agreement is the culmination of the Option Agreement previously entered into between the Company and Relief on January 25, 2021, which provided Relief with an exclusive period of time up to June 30, 2021 for the parties to enter into a mutually acceptable definitive agreement with respect to the potential collaboration and license arrangements. In consideration for the grant of the exclusivity option, (i) the Company received from Relief an upfront non-refundable payment of $ 1.0 million, (ii) Relief provided to the Company a 12-month secured loan in the principal amount of $ 4.0 million with interest at a rate equal to 6% per annum, as evidenced by a promissory note the Company issued to Relief, and (iii) the Company granted Relief a security interest in all of its assets to secure performance of the promissory note, as evidenced by a security agreement. Upon signing t he Collaboration Agreement, the Company received an approximately $ 10.0 million cash payment from Relief ( the $ 14.0 million (“Reimbursement Payment”) , offset by repayment of the $ 4.0 million outstanding balance of the prior loan, plus interest, from Relief to the Company). Under the terms of the Collaboration Agreement, Relief committed to pay the Company Development Payments of up to $ 20.0 million in U.S. development and commercial launch costs for the UCDs and MSUD indications . During the three months ended June 30, 2021, the Company received from Relief the $ 10.0 million First Development Payment . The Company is contractually entitled to receive from R elief an additional $ 10.0 million Second Development Payment condition ed up on the FDA ’s accept ance of a n NDA for ACER-001 in a UCD for filing and review. This acceptance was received on October 4 , 2021. On October 6 , 2021, the Company entered into a Waiver and Agreement with Relief to amend the timing for the Second Development Payment. The Company received the first $5.0 million tranche of the Second Development Payment on October 12, 2021. The Company is contractually entitled to receive from Relief an additional $ 5.0 million second tranche of the Second Development Payment upon the earlier of January 14, 2022 or 15 business days following the Company’s written notice. Should that payment not occur, the Company’s development plans could be affected unless it were able to obtain other funds. There is no guarantee that ACER-001 will receive regulatory authority approval in any territory or become commercially available for the indications under investigation. Further, the Company retained development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan. The companies will split net profits from the Company’s territories 60% :40% in favor of Relief. Relief licensed the rights for the rest of the world, where the Company will receive from Relief a 15% royalty on all net sale s received by Relief in Relief’s territories. The Company could also receive a total of $ 6.0 million in milestone payment s based on the first European marketing approvals of ACER-001 for a UCD and MSUD . In connection with cancellation of the $4.0 million promissory note executed by the Company in favor of Relief on January 25, 2021, Relief released its security interest in all of the Company’s assets. 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 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, had a term of two years, was unsecured, and was guaranteed by the Small Business Administration. The loan bore interest at a fixed rate of one percent per annum, with the first six months of interest and principal deferred. Some or all of a loan may be forgiven if at least 75% 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 period following the loan origination date and complies with other relevant conditions. On June 5, 2020, the Payroll Protection Flexibility Act of 2020 was signed into law, adjusting certain terms of the loans issued under the PPP, including extending the initial deferral period from six to up to ten months, reducing from 75% to 60% the portion of loan proceeds required to be used to cover payroll costs, and allowing borrowers to elect a 24-week rather than an eight-week period related to employment and compensation provisions. The Company accounted for the loan according to ASC 470. As of December 31, 2020, the Company reported the liability associated with the loan as $0.4 million in Other current liabilities and $0.2 million in Other non-current liabilities. The Company was advised by JPMorgan Chase Bank, N.A. that the principal and interest associated with its PPP loan were forgiven in full as of June 10, 2021. As a result, during the nine months ended September 30, 2021, the Company recognized a gain on extinguishment of debt of $0.6 million in Interest and other income (expense), net representing the principal and accrued interest for the PPP loan. Litigation From time to time, the Company may become involved in litigation or proceedings relating to claims arising out of its operations. Piper vs. Acer Therapeutics Inc. 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 $ million in connection with the financing which closed on September 19, 2017 for aggregate consideration of $ 15.7 million and (ii) $ 0.1 million in reimbursement for expenses incurred by Piper pursuant to the engagement letter. The parties have reached a mutually satisfactory resolution of this dispute and a stipulation of discontinuance with prejudice has been filed by the parties . The Company has not recorded a liability as of September 30, 2021 because a potential loss is not probable or reasonably estimable given the status of the proceedings. The Securities Class Action and Stockholder Derivative Actions On July 1, 2019, plaintiff Tyler Sell filed a putative class action lawsuit, Sell v. Acer Therapeutics Inc. et al. TM Skiadas v. Acer Therapeutics Inc. et al On August 12, 2019, a stockholder derivative action, Gress v. Aselage et al Skiadas Giroux v. Amello et al. Skiadas Gress King v. Schelling et al Skiadas Gress Giroux Diaz v. Amello et al. Gress Diaz In re Acer Therapeutics Inc. Derivative Litigation he parties reached an agreement to settle all of the derivative cases. At a hearing held on May 12, 2021 in the District Court of Massachusetts, the Court administering the matter, the settlement was approved. Payment of the settlement amount of $0.5 million, plus legal fees and costs in excess of the retention (deductible) amount, has been made by the Company’s insurance carriers. As of |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
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 $50.0 million depending upon market demand, in transactions deemed to be an “at-the-market” (“ATM”) offering. 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 Common Stock Purchase Agreement On April 30, 2020, the Company entered into an equity line 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, with $12.1 million obligation remaining as of September 30, 2021. Such sales of common stock by the Company 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 June 8, 2020. 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 $2.1668, such that issuances and sales of the common stock to Lincoln Park under the purchase agreement would be exempt from the issuance limitation under applicable Nasdaq rules. The Company determined that the right to sell additional shares represents a freestanding put option under ASC 815 Derivatives and Hedging, but has a fair value of zero, and therefore no additional accounting was required. 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 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 shares of common stock to Lincoln Park as a commitment fee in connection with entering into the purchase agreement. The $0.4 million fair value of the commitment fee shares was recorded to General and administrative expense along with other costs incurred in connection with entering into the purchase agreement. During the three months ended September 30, 2021, the Company did not sell any shares of common stock under its purchase agreement with Lincoln Park. During the nine months ended September 30, 2021, the Company sold 200,000 shares of common stock under its purchase agreement with Lincoln Park at a weighted average price of $2.47 per share, resulting in proceeds of $0.5 million. Private Placement On July 24, 2020, the Company entered into a securities purchase agreement for the sale and issuance of an aggregate of 244,998 shares of the Company’s common stock, for an aggregate purchase price of $0.9 million, in a Private Placement with certain directors, officers, and employees at a price per share of $3.50. The shares of common stock issued in the Private Placement constitute “restricted securities” under the federal securities laws and are subject to a minimum six-month holding period. 2018 Stock Incentive Plan The Company’s 2018 Stock Incentive Plan (the “2018 Plan”), adopted on May 14, 2018, originally provided 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. On January 1, 2021 and 2020 , 529,325 and 403,807 additional shares, respectively, were authorized according to the evergreen provision. 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 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 September 30, 2021, 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 September 30, 2021, all shares available under the 2010 Plan were subject to outstanding equity awards, and no new awards may be granted under the 2010 Plan. Stock Plan Activity A summary of option activity under the 2018 Plan, 2013 Plan, and 2010 Plan for the nine months ended September 30, 2021, is as follows: Year-to-Date Activity Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in thousands) Options outstanding at December 31, 2020 1,240,354 $ 11.16 7.8 Granted 687,500 $ 3.48 Cancelled/forfeited (18,879 ) $ 20.37 Options outstanding at September 30, 2021 1,908,975 $ 8.30 8.0 $ 12 Options exercisable at September 30, 2021 858,426 $ 11.70 6.9 $ 1 At September 30, 2021, there was $2.9 million of unrecognized compensation expense related to non-vested awards related to the stock-based compensation arrangements granted under all plans, which is expected to be recorded over a weighted average period of 2.4 years. The weighted average grant date fair value of options granted during the nine months ended September 30, 2021 was $ . 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 September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Stock-based compensation Research and development $ 183,805 $ 115,817 $ 528,385 $ 606,470 General and administrative 416,508 371,586 1,226,027 1,151,845 $ 600,313 $ 487,403 $ 1,754,412 $ 1,758,315 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021 and 2020, the number of shares of common stock underlying potentially dilutive securities are comprised of: September 30, 2021 2020 Options to purchase common stock 1,908,975 1,357,163 Total 1,908,975 1,357,163 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9 . SUBSEQUENT EVENTS On October 4, 2021, the FDA accepted for filing and review the Company’s NDA for ACER-001 for the treatment of patients with UCDs. The Company is contractually entitled to receive from Relief a $10.0 million Second Development Payment conditioned upon the FDA’s acceptance of an NDA for ACER-001 in a UCD for filing and review. On October 6, 2021, the Company and Relief entered into a Waiver and Agreement to amend the timing for the Second Development Payment. The Company received the first $5.0 million tranche of the Second Development Payment on October 12, 2021. Pursuant to the Waiver and Agreement, the Company is contractually entitled to receive from Relief an additional $5.0 million second tranche of the Second Development Payment upon the earlier of January 14, 2022 or 15 business days following the Company’s written notice. |
Significant Accounting Polices
Significant Accounting Polices (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company had an accumulated deficit of $110.1 million and cash and cash equivalents of $14.2 million as of September 30, 2021. Net cash provided by operating activities was $1.3 million for the nine months ended September 30, 2021, as compared to net cash used in operating activities of $13.1 million for the nine months ended September 30, 2020. 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 $50.0 million depending upon market demand, in transactions deemed to be an at-the-market (“ATM”) offering. 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. During the three months ended September 30, 2021, the Company did not sell any shares through its ATM facility. During the nine months ended September 30, 2021, during multiple trading days, the Company sold an aggregate of 877,107 shares at an average gross sale price of $3.1692 per share, resulting in gross proceeds of $2.8 million. Proceeds during the nine months ended September 30, 2021, net of $0.2 million of fees and offering costs, were $2.6 million. On April 30, 2020, the Company entered into an equity line purchase agreement and registration rights agreement pursuant to which Lincoln Park Capital Fund, LLC (“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, with $12.1 million obligation remaining as of September 30, 2021. Such sales of common stock by the Company 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 June 8, 2020. 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. The Company issued 148,148 shares of common stock to Lincoln Park as a commitment fee in connection with entering into the purchase agreement. The $0.4 million fair value of the commitment fee shares was recorded to general and administrative expense along with other costs incurred in connection with entering into the purchase agreement. During the three months ended September 30, 2021, the Company did not sell any shares of common stock under its purchase agreement with Lincoln Park. On July 24, 2020, the Company entered into a securities purchase agreement for the sale and issuance of an aggregate of 244,998 shares of the Company’s common stock, for an aggregate purchase price of $0.9 million, in a private placement transaction (“Private Placement”) with certain directors, officers, and employees at a price per share of $3.50. The shares of common stock issued in the Private Placement constitute “restricted securities” under the federal securities laws and were subject to a minimum six-month holding period. On March 19, 2021, the Company entered into the Collaboration Agreement with Relief providing for the development and commercialization of ACER-001 for the treatment of various inborn errors of metabolism, including for the treatment of UCDs and MSUD. The Collaboration Agreement is the culmination of the option agreement (the “Option Agreement,” together the “Agreements”) previously entered into between the Company and Relief on January 25, 2021. Pursuant to the Agreements, the Company received from Relief an upfront non-refundable payment of $1.0 million and a reimbursement payment of $14.0 million. Under the terms of the Collaboration Agreement, Relief committed to pay the Company up to $20.0 million in U.S. development and commercial launch costs for the UCDs and MSUD indications (the “Development Payments”). During the three months ended June 30, 2021, the Company received from Relief the $10.0 million First Development Payment. The Company is contractually entitled to receive from Relief an additional $10.0 million Second Development Payment conditioned upon the FDA’s acceptance of a New Drug Application (“NDA”) for ACER-001 in a UCD for filing and review. This acceptance was received on October 4, 2021. On October 6, 2021, the Company entered into a Waiver and Agreement with Relief to amend the timing for the Second Development Payment. The Company received the first $5.0 million tranche of the Second Development Payment on October 12, 2021. The Company is contractually entitled to receive from Relief an additional $5.0 million second tranche of the Second Development Payment upon the earlier of January 14, 2022 or 15 business days following the Company’s written notice. Should that payment not occur, the Company’s development plans could be affected unless it were able to obtain other funds. There is no guarantee that ACER-001 will receive regulatory authority approval in any territory or become commercially available for the indications under investigation. The Company could also receive a total of $6.0 million in milestone payments based on the first European marketing approvals of ACER-001 for a UCD and MSUD. The terms of the Agreements are further described below in the Revenue Recognition section of Note 2, Significant Accounting Policies. The Company’s existing cash and cash equivalents available at September 30, 2021, plus the $10.0 million Second Development Payment in two tranches following the FDA’s acceptance for filing and review of an NDA for ACER-001 in a UCD per the Collaboration Agreement with Relief, are expected to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-801 and EDSIVO TM Management expects to continue to finance operations through the issuance of additional equity or debt securities, non-dilutive funding, 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 accounting principles generally accepted in the U.S. (“GAAP”), which contemplate continuation of the Company as a going concern. The Company has not established a source of commercial product revenues and, as such, has been dependent on funding operations through the sale of equity securities and through a collaboration agreement. Since inception, the Company has experienced significant losses and incurred negative cash flows from operations. The Company has an accumulated deficit of $110.1 million as of September 30, 2021 and expects to incur further losses for the foreseeable future 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 September 30, 2021, the Company had cash and cash equivalents of $14.2 million and current liabilities of $30.4 million, which include $17.8 million associated with deferred collaboration funding, as well as a $9.2 million liability related to the securities class action and stockholder derivative actions settlements and legal costs, for which the Company has also recorded a receivable from its insurance carriers. The Company’s cash and cash equivalents available at September 30, 2021, plus the $10.0 million Second Development Payment in two tranches following the FDA’s acceptance for filing and review of an NDA for ACER-001 in a UCD per the Collaboration Agreement with Relief, are expected to fund its currently anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-801 and EDSIVO TM The Company will need to raise additional capital to fund continued operations beyond mid-2022 because neither FDA approval of ACER-001 nor subsequent product revenues are assured. 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 beyond mid-2022, including raising additional capital through either private or public equity or debt financing or non-dilutive funding, as well as using its ATM facility and/or its remaining $12.1 million equity line facility entered into on April 30, 2020 with Lincoln Park, which is subject to certain limitations and conditions. The Company has no commitments for any additional financing, except for the agreement with Lincoln Park and the Collaboration Agreement with Relief. 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, curtai l 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. 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. See Note 9 to these unaudited condensed interim financial statements. |
Revenue Recognition and Accounting for Collaboration Agreements | Revenue Recognition and Accounting for Collaboration Agreements The Company’s revenues are generated from a single collaboration agreement which included the sale of a license of intellectual property. The Company analyzes its collaboration agreements to assess whether they are within the scope of ASC Topic 808, (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards that are dependent on the commercial success of such activities. To the extent the arrangement is within the scope of ASC 808, the Company assesses whether aspects of the arrangement between the Company and the collaboration partner are within the scope of other accounting literature. If the Company concludes that some or all aspects of the arrangement represent a transaction with a customer, the Company accounts for those aspects of the arrangement within the scope of ASC Topic 606, Revenue from Contracts with Customers The Company determines the units of account within the collaborative arrangement utilizing the guidance in ASC 606 to determine which promised goods or services are distinct. In order for a promised good or service to be considered “distinct” under ASC 606, the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct), and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). For any units of account that fall within the scope of ASC 606, where the other party is a customer, the Company evaluates the separate performance obligation(s) under each contract, determines the transaction price, allocates the transaction price to each performance obligation considering the estimated stand-alone selling prices of the services and recognizes revenue upon the satisfaction of such obligations at a point in time or over time dependent on the satisfaction of one of the following criteria: (1) the customer simultaneously receives and consumes the economic benefits provided by the vendor’s performance; (2) the vendor creates or enhances an asset controlled by the customer; (3) the vendor’s performance does not create an asset for which the vendor has an alternative use; and (4) the vendor has an enforceable right to payment for performance completed to date. Variable consideration is included in the transaction price only to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. Revenue for a sales-based or usage-based royalty promised in exchange for a license of intellectual property is recognized only when (or as) the later of the following events occurs: (i) the subsequent sale or usage occurs; or (ii) the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). On January 25, 2021, the Company entered into the Option Agreement with Relief pursuant to which the Company granted Relief an exclusive option (the “Exclusivity Option”) to pursue a potential collaboration and license arrangement with the Company for the development, regulatory approval and commercialization of ACER-001 for the treatment of various inborn errors of metabolism, including UCDs and MSUD. The Option Agreement provided a period of time up to June 30, 2021 for the parties to perform additional due diligence and to work toward negotiation and execution of a definitive agreement with respect to the potential collaboration for ACER‑001. In consideration for the grant of the Exclusivity Option, (i) the Company received from Relief an upfront nonrefundable payment of $1.0 million, (ii) Relief provided to the Company a 12-month secured loan in the principal amount of $4.0 million, as evidenced by a Promissory Note (the “Note”) issued by the Company to Relief, and (iii) the Company granted to Relief a security interest in all of its assets to secure performance of the Note, as evidenced by a Security Agreement (the “Security Agreement”). The Note was repayable in one lump sum within 12 months from issuance and bore interest at a rate equal to 6% per annum. If a definitive agreement with respect to the potential collaboration had not been executed by the parties on or before June 30, 2021, the Exclusivity Option would have terminated and the Note would have been repayable by the Company upon maturity. On March 19, 2021, the Company entered into the Collaboration Agreement with Relief providing for the development and commercialization of ACER-001 for the treatment of various inborn errors of metabolism, including for the treatment of UCDs and MSUD. The Company received the $10.0 million cash payment from Relief ($14.0 million “Reimbursement Payment,” but offset by repayment of the $4.0 million outstanding balance of the Note, plus interest earned through the date of the Collaboration Agreement, from Relief to the Company). Under the terms of the Collaboration Agreement, Relief committed to pay the Company up to an additional $20.0 million for U.S. development and commercial launch costs for the UCDs and MSUD indications (the “Development Payments”). During the three months ended June 30, 2021, the Company received from Relief the $10.0 million First Development Payment. The Company is contractually entitled to receive from Relief an additional $10.0 million Second Development Payment conditioned upon the FDA’s acceptance of an NDA for ACER-001 in a UCD for filing and review. This acceptance was received on October 4, 2021. On October 6, 2021, the Company entered into a Waiver and Agreement with Relief to amend the timing for the Second Development Payment. The Company received the first $5.0 million tranche of the Second Development Payment on October 12, 2021. The Company is contractually entitled to receive from Relief an additional $5.0 million second tranche of the Second Development Payment upon the earlier of January 14, 2022 or 15 business days following the Company’s written notice. Should that payment not occur, the Company’s development plans could be affected unless it were able to obtain other funds. There is no guarantee that ACER-001 will receive regulatory authority approval in any territory or become commercially available for the indications under investigation. Further, the Company retained development and commercialization rights in the U.S., Canada, Brazil, Turkey and Japan (“Acer Territory”). The companies will split net profits from the Acer Territory 60%:40% in favor of Relief. Relief licensed the rights for the rest of the world (“Relief Territory”), where the Company will receive from Relief a 15% royalty on all net sales received in Relief Territory. The Company could also receive a total of $6.0 million in milestone payments based on the first European (EU) marketing approvals for a UCD and MSUD. The Company assessed these agreements in accordance with the authoritative literature and concluded that they meet the definition of a collaborative arrangement per ASC 808. For certain parts of the collaborative arrangement, the Company concluded that Relief represented a customer while for other parts of the agreement Relief did not represent a customer. The units of account of the collaborative arrangement where Relief does not represent a customer are outside of the scope of ASC 606. The Company also determined that the development and commercialization services and Relief’s right to 60% profit in Acer Territory is within the scope of ASC 730, with regard to funded research and development arrangements. The Company concluded the promised goods and services contained in the Collaboration Agreement, represented two distinct units of account consisting of a license in Relief Territory, and a combined promise for the development and commercialization of ACER-001 in Acer Territory and the payment of 60% net profit from that territory (together, the “Services”). The stand-alone selling price was estimated for each distinct unit of account. The Company determined that the transaction price at the outset of the Collaboration Agreement is $25.0 million, including the Option Fee of $1.0 million, the Reimbursement Payment of $14.0 million, and the First Development Payment of $10.0 million. The Company concluded that consistent with the evaluation of variable consideration, using the most likely amount approach, the Second Development Payment as well as the milestone payments for EU marketing approvals, should be fully constrained until the contingency associated with each payment has been resolved and the Company’s NDA is accepted for review by the FDA, and Relief receives EU marketing approval, respectively. Since ASC 808 does not provide recognition and measurement guidance for collaborative arrangements, the Company applied the principles of ASC 606 for those units of account where Relief is a customer and ASC 730-20 for the funded research and development activities. The license revenue was recognized at the point where the Company determined control was transferred to the customer. The combined unit of account for the Services associated with the allocation of the initial transaction price will be recognized over the service period through the anticipated date of first commercial sale of the ACER-001 approved product in the U.S. The Company also determined that the Services associated with the allocation of the initial transaction price would be satisfied over time as measured using actual costs incurred by the Company toward the identified development and commercialization services agreed to between the parties up to the point of first commercial sale of the ACER-001 product. Research and development expense and general and administrative expense, as they relate to activities governed by the Collaboration Agreement, incurred in satisfying the Services unit-of-account will be recognized as contra-expense within their respective categories, consistent with the presentation guidance in ASC 730. The Company recognizes as receivable under the Collaboration Agreement consideration, which is deemed unconditional, or when only the passage of time is required before payment of that consideration is due. Amounts receivable under the Collaboration Agreement plus payments received from Relief, net of the amount recorded as revenue, are reported as deferred collaboration funding. At September 30, 2021, the amount of deferred collaboration funding associated with unsatisfied promises under the Collaboration Agreement amounted to $17.8 million. The Company expects to recognize this deferred collaboration funding as it incurs expenses associated with performing the Services up to the date of first commercial sale in Acer Territory and through the end of the effective date of the Collaboration Agreement. At September 30, 2021, deferred collaboration funding was composed of $25.0 million received from Relief, offset by $0.9 million recognized as license revenue and $4.8 million recorded as an offset to research and development expenses and $1.6 million recorded as an offset to general and administrative expenses during the nine months ended September 30, 2021. |
Cash and Cash Equivalents and Fair Value of Financial Instruments | Cash and Cash Equivalents and Fair Value of Financial Instruments 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 $12.9 million and $5.3 million as of September 30, 2021 and December 31, 2020, 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 receivable, accounts payable, and loans payable recorded in other current liabilities and other non-current liabilities approximates their carrying value, based upon their short-term maturities or prevailing interest rates. The Company recognized a $4.0 million non-cash reduction in a secured loan from Relief during the nine months ended September 30, 2021, since the Reimbursement Payment from Relief was received net of the amount of principal and interest due in connection with the secured loan. |
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 assessment or a quantitative impairment test to determine whether goodwill is impaired. The Company’s goodwill is allocated to a single reporting unit. If the Company were to determine based on a qualitative assessment that it was more likely than not that the fair value of the reporting unit was less than its carrying value, a quantitative impairment test would then be performed. The quantitative impairment test compares the fair value of the reporting unit with its carrying amount, including goodwill. If the estimated fair value of the reporting unit is less than its carrying amount, a goodwill impairment would be recognized for the difference. The COVID-19 pandemic involving a respiratory illness caused by a novel coronavirus affected the worldwide economy and triggered decline in the stock markets in 2020 . The Company considered potential triggering events related to COVID-19 and concluded that there was not a triggering event that would require the Company to perform further impairment analysis. |
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 risk-free rate for periods within the expected life of the option is based on the U.S Treasury yield curve in effect at the time of the grant. 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 expected volatility of its stock in consideration of a number of factors including the volatility of comparable public companies. The Company recognizes forfeitures related to employee stock-based awards as they occur. The following assumptions were used to estimate the fair value of stock options granted during the nine months ended September 30, 2021 and 2020 using the Black-Scholes option pricing model: 2021 2020 Risk-free interest rate 0.37% -0.84% 0.36%-1.61% Expected life (years) 6.25 6.25 Expected volatility 92.4% 60.0% Dividend rate 0% 0% |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and include compensation and related benefits, license fees and outside contracted research and manufacturing consultants. The Company sometimes makes nonrefundable advance payments for goods and services that will be used in future research and development activities. These payments are capitalized and recorded as an expense in the period that the goods are received or when the services are performed. From time to time, in connection with the Collaboration Agreement with Relief, the Company may recognize “contra-expense” for the research and development activities which were funded by this agreement. These contra-expense amounts will be disclosed parenthetically on the face of the financial statements. |
General and Administrative Expenses | General and Administrative Expenses General and administrative expenses consist primarily of employee-related expenses, including salaries, benefits, and stock-based compensation; precommercial costs; and professional fees for legal, business consulting, auditing, and tax services. We expect that general and administrative expenses will be substantial in the future. From time to time, in connection with the Collaboration Agreement with Relief, the Company may recognize “contra-expense” for the general and administrative activities which were funded by this agreement. These contra-expense amounts will be disclosed parenthetically on the face of the financial statements. |
Clinical Trial and Preclinical Study Expenses | Clinical Trial and Preclinical Study Expenses The Company makes estimates of prepaid and/or accrued expenses as of each balance sheet date in its financial statements based on certain facts and circumstances at that time. The accrued expenses for preclinical studies and clinical trials are based on estimates of costs incurred for services provided by contract research organizations (“CRO”), manufacturing organizations, and for other trial- and study-related activities. Payments under the Company’s agreements with external service providers depend on a number of factors such as site initiation, patient screening, enrollment, delivery of reports, and other events. In accruing for these activities, the Company obtains information from various sources and estimates the level of effort or expense allocated to each period. Adjustments to research and development expenses may be necessary in future periods as the Company’s estimates change. As these activities are generally material to the Company’s overall financial statements, subsequent changes in estimates may result in a material change in the Company’s accruals. No material changes in estimates were recognized in each of the three and nine months ended September 30, 2021 and 2020 . At September 30, 2021 , accounts payable and accrued expenses did no t include any costs associated with preclinical or clinical study expense. At December 31, 2020 , accounts payable and accrued expenses included $ million for costs associated with preclinical or clinical study expense . |
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. From time to time, estimates having relatively higher significance include revenue recognition, determination of stand-alone selling price, stock-based compensation, contract manufacturing and clinical trial 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 and nine months ended September 30, 2021 and 2020, due to a full valuation allowance recognized against its net deferred tax assets. 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. 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. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. The Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”) was enacted in the U.S. on March 27, 2020 . The CARES Act, among other things, includes provisions relating to refundable payroll tax credits, deferment of employer side social security payments, net operating loss carryback periods, alternative minimum tax credit refunds, modifications to the net interest deduction limitations, increased limitations on qualified charitable contributions, and technical corrections to tax depreciation methods for qualified improvement property. The Company is required to recognize the effects of tax law changes in the period of enactment. The enactment of the CARES Act did not result in material adjustments for the income tax provision for the three and nine months ended or to the Company’s assessment of the realizability of deferred tax assets as the carry back of net operating losses was used as a source of income. There were no other effects to the Company’s tax provision as a result of the CARES Act as of September 30, 2021. |
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. |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options The Company early adopted ASU No. 2020-06 in the first quarter of 2021. There was no impact on the Company’s financial statements as a result of the adoption of this guidance. |
Significant Accounting Police_2
Significant Accounting Polices (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 nine months ended September 30, 2021 and 2020 using the Black-Scholes option pricing model: 2021 2020 Risk-free interest rate 0.37% -0.84% 0.36%-1.61% Expected life (years) 6.25 6.25 Expected volatility 92.4% 60.0% Dividend rate 0% 0% |
Property and Equipment (Tables)
Property and Equipment (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following at September 30, 2021 and December 31, 2020: September 30, 2021 December 31, 2020 Computer hardware and software $ 93,361 $ 58,903 Leasehold improvements 60,535 60,535 Furniture and fixtures 145,487 145,487 Subtotal property and equipment, gross 299,383 264,925 Less accumulated depreciation (186,069 ) (134,844 ) Property and equipment, net $ 113,314 $ 130,081 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following at September 30, 2021 and December 31, 2020: September 30, 2021 December 31, 2020 Accrued contract manufacturing $ 1,254,270 $ 1,479,771 Accrued payroll and payroll taxes 353,257 267,159 Accrued consulting 140,938 88,750 Accrued accounting, audit, and tax fees 120,218 181,200 Accrued license fees 87,984 240,041 Accrued legal 64,863 350,517 Accrued miscellaneous expenses 34,985 102,999 Accrued contract research and regulatory consulting 27,500 1,070,664 Total accrued expenses $ 2,084,015 $ 3,781,101 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 September 30, 2021: Undiscounted lease liabilities for years ending December 31,: 2021 (remaining) $ 69,571 2022 115,951 Total undiscounted lease liabilities 185,522 Less effects of discounting (8,627 ) Total lease liabilities as of September 30, 2021 $ 176,895 The Company’s lease liabilities are reported on the balance sheets as follows: September 30, 2021 December 31, 2020 Other current liabilities $ 176,895 $ 274,172 Other non-current liabilities — 90,139 Total lease liabilities $ 176,895 $ 364,311 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
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 nine months ended September 30, 2021, is as follows: Year-to-Date Activity Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in thousands) Options outstanding at December 31, 2020 1,240,354 $ 11.16 7.8 Granted 687,500 $ 3.48 Cancelled/forfeited (18,879 ) $ 20.37 Options outstanding at September 30, 2021 1,908,975 $ 8.30 8.0 $ 12 Options exercisable at September 30, 2021 858,426 $ 11.70 6.9 $ 1 |
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 September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Stock-based compensation Research and development $ 183,805 $ 115,817 $ 528,385 $ 606,470 General and administrative 416,508 371,586 1,226,027 1,151,845 $ 600,313 $ 487,403 $ 1,754,412 $ 1,758,315 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities | As of September 30, 2021 and 2020, the number of shares of common stock underlying potentially dilutive securities are comprised of: September 30, 2021 2020 Options to purchase common stock 1,908,975 1,357,163 Total 1,908,975 1,357,163 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation - Additional Information (Details) | Oct. 12, 2021USD ($) | Oct. 06, 2021USD ($) | Oct. 04, 2021USD ($)Tranche | Mar. 19, 2021USD ($) | Jan. 25, 2021USD ($) | Jul. 24, 2020USD ($)$ / sharesshares | Apr. 30, 2020USD ($)shares | Mar. 18, 2020USD ($) | Nov. 09, 2018USD ($) | Sep. 30, 2021USD ($)$ / sharesshares | Jun. 30, 2021USD ($) | Sep. 30, 2021USD ($)$ / sharesshares | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) |
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Accumulated deficit | $ 110,089,311 | $ 110,089,311 | $ 99,135,961 | |||||||||||
Cash and cash equivalents | 14,151,496 | 14,151,496 | 5,761,568 | |||||||||||
Net cash used in operating activities | 1,285,339 | $ (13,147,533) | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | 3,139,047 | $ 6,667,091 | ||||||||||||
Reimbursement payment | $ 14,000,000 | |||||||||||||
Development payments | 10,000,000 | |||||||||||||
Current liabilities | 30,385,765 | 30,385,765 | $ 6,145,546 | |||||||||||
Deferred collaboration funding | 17,771,957 | 17,771,957 | ||||||||||||
Liability related to securities class action and stockholder derivative actions settlements and legal costs | $ 9,200,000 | $ 9,200,000 | ||||||||||||
Lincoln Park | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Issuance of common stock | shares | 0 | 200,000 | ||||||||||||
Issuance of common stock, price per share | $ / shares | $ 2.47 | $ 2.47 | ||||||||||||
Proceeds from issuance of common stock gross | $ 500,000 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | 500,000 | |||||||||||||
Remaining obligation | $ 12,100,000 | $ 12,100,000 | ||||||||||||
Number of shares, company may sell on any single business day | shares | 50,000 | |||||||||||||
Maximum amount of Common stock at time of sale, per regular purchase | $ 1,000,000 | |||||||||||||
Issuance of common stock for commitment fee, shares | shares | 148,148 | |||||||||||||
Stock to be issued value on certain limitation and condition | $ 12,100,000 | |||||||||||||
Collaboration Agreement | Relief | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Upfront non-refundable payment received | $ 1,000,000 | |||||||||||||
Reimbursement payment | 14,000,000 | 14,000,000 | ||||||||||||
Guarantee for substantive review food and drug application | 0 | |||||||||||||
Milestone payment to be received | $ 6,000,000 | 6,000,000 | ||||||||||||
Collaboration Agreement | Relief | First Development Payment | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Development payments subject new drug application | $ 10,000,000 | |||||||||||||
Collaboration Agreement | Subsequent Event | Relief | Second Development Payment | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Potential proceeds from development payments subject to new drug application | $ 10,000,000 | |||||||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | |||||||||||||
Number of tranches in developments payments to be made | Tranche | 2 | |||||||||||||
Waiver and Agreement | Subsequent Event | Relief | Second Development Payment | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Potential proceeds from second tranche of development payments subject to new drug application | $ 5,000,000 | |||||||||||||
Second tranche of development payment, expiry date | Jan. 14, 2022 | |||||||||||||
Written notice period (in business days) for second tranche of development payment | 15 days | |||||||||||||
General and Administrative | Lincoln Park | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Fair value of the commitment fee shares, recorded to general and administrative expense along with other costs | 400,000 | |||||||||||||
Weighted Average | Lincoln Park | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Issuance of common stock, price per share | $ / shares | $ 2.47 | $ 2.47 | ||||||||||||
Maximum | Lincoln Park | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Shares value might be issued under agreement | $ 15,000,000 | |||||||||||||
Number of shares, company may sell on any single business day | shares | 100,000 | |||||||||||||
Maximum | Collaboration Agreement | Relief | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Development payments | $ 20,000,000 | |||||||||||||
At-the-Market Facility | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Issuance of common stock | shares | 0 | 877,107 | ||||||||||||
Proceeds from issuance of common stock gross | $ 2,800,000 | |||||||||||||
Common stock offering costs | 200,000 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,600,000 | |||||||||||||
At-the-Market Facility | Weighted Average | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Issuance of common stock, price per share | $ / shares | $ 3.1692 | $ 3.1692 | ||||||||||||
At-the-Market Facility | Maximum | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Aggregate offering price of common stock | $ 50,000,000 | $ 50,000,000 | ||||||||||||
Private Placement | Directors, Officers and Employees | ||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||
Issuance of common stock | shares | 244,998 | |||||||||||||
Issuance of common stock, price per share | $ / shares | $ 3.50 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 900,000 |
Significant Accounting Police_3
Significant Accounting Polices - Additional Information (Details) - USD ($) | Oct. 12, 2021 | Oct. 06, 2021 | Mar. 19, 2021 | Jan. 25, 2021 | Sep. 30, 2021 | Jun. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Oct. 04, 2021 | Dec. 31, 2020 |
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Upfront nonrefundable payment | $ 1,000,000 | ||||||||||
Loan in principal amount | $ 4,000,000 | ||||||||||
Issuance and bore interest rate | 6.00% | ||||||||||
Reimbursement payment | $ 14,000,000 | ||||||||||
Collaboration agreement amount | 25,000,000 | ||||||||||
Development payments | 10,000,000 | ||||||||||
Deferred collaboration funding | $ 17,771,957 | $ 17,771,957 | |||||||||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 | $ 0 | |||||||
Accounting Standard Update [Extensible List] | ASU No. 2020-06 | ||||||||||
Change in accounting principle, accounting standards update, adopted | true | true | |||||||||
Change in accounting principle, accounting standards update, adoption date | Mar. 31, 2021 | Mar. 31, 2021 | |||||||||
Change in accounting principle, accounting standards update, immaterial effect | true | true | |||||||||
Accounts Payable and Accrued Expenses | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Preclinical or clinical study expense | $ 0 | $ 0 | $ 1,800,000 | ||||||||
Cash and Cash Equivalents | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Investments in money market funds | 12,900,000 | 12,900,000 | $ 5,300,000 | ||||||||
Performance Obligations | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Deferred collaboration funding | 17,800,000 | 17,800,000 | |||||||||
Deferred collaboration funding, cash received | $ 25,000,000 | 25,000,000 | |||||||||
Revenue recognized | 900,000 | ||||||||||
Offset to research and development expenses | 4,800,000 | ||||||||||
Offset to general and administrative expenses | 1,600,000 | ||||||||||
Relief | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Non-cash reduction recognized in secured loan | $ 4,000,000 | ||||||||||
Collaboration Agreement | Relief | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Cash payment received | 10,000,000 | $ 10,000,000 | |||||||||
Reimbursement payment | 14,000,000 | 14,000,000 | |||||||||
Repayment of outstanding balance of prior loan and interest | 4,000,000 | $ 4,000,000 | |||||||||
Development and commercial launch costs | $ 20,000,000 | ||||||||||
Net profit split ratio based on territory | 60.00% | 60.00% | |||||||||
Percentage of royalty net sales received | 15.00% | ||||||||||
Milestone payment to be received | $ 6,000,000 | $ 6,000,000 | |||||||||
Percentage of development and commercialization services | 60.00% | ||||||||||
Percentage of payment net profit territory | 60.00% | ||||||||||
Upfront non-refundable payment received | $ 1,000,000 | ||||||||||
Collaboration Agreement | Relief | First Development Payment | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Cash payment received | $ 10,000,000 | ||||||||||
Collaboration Agreement | Relief | Second Development Payment | Subsequent Event | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Potential proceeds from development payments subject to new drug application | $ 10,000,000 | ||||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | ||||||||||
Waiver and Agreement | Relief | Second Development Payment | Subsequent Event | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Potential proceeds from second tranche of development payments subject to new drug application | $ 5,000,000 | ||||||||||
Second tranche of development payment, expiry date | Jan. 14, 2022 | ||||||||||
Written notice period (in business days) for second tranche of development payment | 15 days | ||||||||||
Collaboration And License Agreement | |||||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||||
Upfront non-refundable payment received | $ 1,000,000 |
Significant Accounting Police_4
Significant Accounting Polices - Schedule of Estimate Fair Value of Stock Options Granted (Details) | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Accounting Policies [Abstract] | ||
Risk-free interest rate, minimum | 0.37% | 0.36% |
Risk-free interest rate, maximum | 0.84% | 1.61% |
Expected life (years) | 6 years 3 months | 6 years 3 months |
Expected volatility | 92.40% | 60.00% |
Dividend rate | 0.00% | 0.00% |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 299,383 | $ 264,925 |
Less accumulated depreciation | (186,069) | (134,844) |
Property and equipment, net | 113,314 | 130,081 |
Computer Hardware and Software | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 93,361 | 58,903 |
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 ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Accounts Payable And Accrued Liabilities Current [Abstract] | ||
Accrued contract manufacturing | $ 1,254,270 | $ 1,479,771 |
Accrued payroll and payroll taxes | 353,257 | 267,159 |
Accrued consulting | 140,938 | 88,750 |
Accrued accounting, audit, and tax fees | 120,218 | 181,200 |
Accrued license fees | 87,984 | 240,041 |
Accrued legal | 64,863 | 350,517 |
Accrued miscellaneous expenses | 34,985 | 102,999 |
Accrued contract research and regulatory consulting | 27,500 | 1,070,664 |
Total accrued expenses | $ 2,084,015 | $ 3,781,101 |
Leases - Additional Information
Leases - Additional Information (Details) | 3 Months Ended | 9 Months Ended | ||||||||
Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($)Term | Sep. 30, 2020USD ($) | Dec. 31, 2020USD ($) | Apr. 23, 2019ft² | Mar. 31, 2019USD ($) | Mar. 05, 2019ft² | Apr. 01, 2018ft² | Mar. 06, 2018ft² | |
Lessee Lease Description [Line Items] | ||||||||||
Operating lease right of use asset | $ 200,000 | $ 200,000 | ||||||||
Operating lease liability, current | $ 176,895 | $ 176,895 | $ 274,172 | |||||||
Operating lease liability, non-current | 90,139 | |||||||||
Operating lease discount rate | 8.00% | 8.00% | 8.00% | 8.00% | ||||||
Operating lease, weighted average remaining lease term | 8 months 12 days | 8 months 12 days | ||||||||
Operating lease, cash payment made | $ 100,000 | $ 100,000 | $ 200,000 | $ 200,000 | ||||||
Operating lease expense | $ 100,000 | $ 100,000 | $ 200,000 | $ 200,000 | ||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | us-gaap:OtherAssets | us-gaap:OtherAssets | ||||||||
0.2 | $ 176,895 | $ 176,895 | $ 274,172 | |||||||
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Other current liabilities | Other current liabilities | Other current liabilities | |||||||
ASU 2016-02 | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating lease right of use asset | $ 300,000 | $ 300,000 | $ 400,000 | |||||||
Operating lease liability, current | 100,000 | 100,000 | 200,000 | |||||||
Operating lease liability, non-current | 200,000 | 200,000 | 200,000 | |||||||
0.2 | $ 100,000 | $ 100,000 | $ 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 ($) | Sep. 30, 2021 | Dec. 31, 2020 |
Undiscounted lease liabilities for years ending December 31,: | ||
2021 (remaining) | $ 69,571 | |
2022 | 115,951 | |
Total undiscounted lease liabilities | 185,522 | |
Less effects of discounting | (8,627) | |
Total lease liabilities as of September 30, 2021 | 176,895 | $ 364,311 |
Operating lease liability, current | $ 176,895 | $ 274,172 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible Enumeration] | Other current liabilities | Other current liabilities |
Operating lease liability, non-current | $ 90,139 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other non-current liabilities | Other non-current liabilities |
Total lease liabilities | $ 176,895 | $ 364,311 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Oct. 12, 2021USD ($) | Oct. 06, 2021USD ($) | Mar. 19, 2021USD ($) | Jan. 25, 2021USD ($) | Jan. 21, 2021USD ($) | Jun. 05, 2020 | Apr. 11, 2020USD ($) | Sep. 27, 2017USD ($) | Sep. 30, 2018Patent | Aug. 31, 2016 | Jun. 30, 2021USD ($) | Sep. 30, 2021USD ($) | Dec. 31, 2020USD ($) | Oct. 04, 2021USD ($) |
Commitments And Contingencies [Line Items] | ||||||||||||||
Reimbursement payment | $ 14,000,000 | |||||||||||||
Minimum percentage of loan proceeds used to cover payroll costs eligible for loan forgiven | 60.00% | 75.00% | ||||||||||||
Gain on extinguishment of debt | $ 568,909 | |||||||||||||
Other current assets | 9,323,586 | |||||||||||||
Pending Litigation | Piper Sandler & Co. | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Loss contingency payable fees | $ 1,100,000 | |||||||||||||
Loss contingency closing date | Sep. 19, 2017 | |||||||||||||
Financing aggregate consideration | $ 15,700,000 | |||||||||||||
Reimbursement expenses | $ 100,000 | |||||||||||||
Pending Litigation | The Securities Class Action | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Proposed settlement as a loss in accrued expenses | 8,400,000 | |||||||||||||
Pending Litigation | Stockholders Derivative Action | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Payment of settlement plus legal fees and costs in excess of retention (deductible) amount | $ 500,000 | |||||||||||||
Other current assets | $ 900,000 | |||||||||||||
PPP Loan | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Debt instrument, description | On June 5, 2020, the Payroll Protection Flexibility Act of 2020 was signed into law, adjusting certain terms of the loans issued under the PPP, including extending the initial deferral period from six to up to ten months, reducing from 75% to 60% the portion of loan proceeds required to be used to cover payroll costs, and allowing borrowers to elect a 24-week rather than an eight-week period related to employment and compensation provisions. | |||||||||||||
Gain on extinguishment of debt | $ 600,000 | |||||||||||||
PPP Loan | Other Current Liabilities | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
CARES act of 2020 aid loan amount | $ 400,000 | |||||||||||||
PPP Loan | Other Non-current Liabilities | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
CARES act of 2020 aid loan amount | $ 200,000 | |||||||||||||
PPP Loan | JPMorgan Chase Bank, N.A | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
CARES act of 2020 aid loan amount | $ 600,000 | |||||||||||||
Promissory Note | JPMorgan Chase Bank, N.A | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Debt instrument, term | 2 years | |||||||||||||
Debt instrument, interest rate | 1.00% | |||||||||||||
Assistance Publique - Hopitaux de Paris ("AP-HP") | License Agreement | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Agreement entered date | 2018-09 | |||||||||||||
Number of patent applications | Patent | 3 | |||||||||||||
Assistance Publique - Hopitaux de Paris ("AP-HP") | Private Acer | License Agreement | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Agreement entered date | 2016-08 | |||||||||||||
Relief | Collaboration Agreement | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Upfront non-refundable payment received | $ 1,000,000 | |||||||||||||
Cash payment received | 10,000,000 | 10,000,000 | ||||||||||||
Reimbursement payment | 14,000,000 | 14,000,000 | ||||||||||||
Repayment of outstanding balance of prior loan and interest | 4,000,000 | 4,000,000 | ||||||||||||
Development and commercial launch costs | $ 20,000,000 | |||||||||||||
Guarantee for substantive review food and drug application | $ 0 | |||||||||||||
Net profit split ratio based on territory | 60.00% | 60.00% | ||||||||||||
Percentage of royalty revenue received | 15.00% | |||||||||||||
Milestone payment to be received | $ 6,000,000 | $ 6,000,000 | ||||||||||||
Promissory note cancellation amount | 4,000,000 | |||||||||||||
Relief | Collaboration Agreement | First Development Payment | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Cash payment received | $ 10,000,000 | |||||||||||||
Development payments subject new drug application | $ 10,000,000 | |||||||||||||
Relief | Collaboration Agreement | Second Development Payment | Subsequent Event | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Potential proceeds from development payments subject to new drug application | $ 10,000,000 | |||||||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | |||||||||||||
Relief | Collaboration Agreement | Maximum | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Development and commercial launch costs | $ 20,000,000 | |||||||||||||
Relief | Collaboration Agreement | Secured Loan | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Debt instrument, term | 12 months | |||||||||||||
Debt instrument, principal amount | $ 4,000,000 | |||||||||||||
Debt instrument, interest rate | 6.00% | |||||||||||||
Relief | Waiver and Agreement | Second Development Payment | Subsequent Event | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Potential proceeds from second tranche of development payments subject to new drug application | $ 5,000,000 | |||||||||||||
Second tranche of development payment, expiry date | Jan. 14, 2022 | |||||||||||||
Written notice period (in business days) for second tranche of development payment | 15 days |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Details) - USD ($) | Jul. 24, 2020 | Apr. 30, 2020 | Mar. 18, 2020 | Sep. 18, 2019 | Nov. 09, 2018 | May 14, 2018 | Sep. 19, 2017 | Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Jan. 01, 2021 | Dec. 31, 2020 | Jan. 01, 2020 |
Stockholders Equity [Line Items] | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 3,139,047 | $ 6,667,091 | |||||||||||
Number of share outstanding | 1,908,975 | 1,908,975 | 1,240,354 | ||||||||||
Awards granted under the plan | 687,500 | ||||||||||||
Unrecognized compensation expense | $ 2,900,000 | $ 2,900,000 | |||||||||||
Share based compensation arrangement by share based payment award, Weighted average period | 2 years 4 months 24 days | ||||||||||||
Weighted average grant date fair value of options granted | $ 2.63 | ||||||||||||
2018 Stock Incentive Plan | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Number of common stock authorized for issuance | 500,000 | 529,325 | 403,807 | ||||||||||
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. On January 1, 2021 and 2020, 529,325 and 403,807 additional shares, respectively, were authorized according to the evergreen provision. 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 | 502,778 | 502,778 | |||||||||||
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 | ||||||||||||
Executive Officers and Employees | 2018 Stock Incentive Plan | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Share-based compensation arrangement by share-based payment award, stock options vesting period | 4 years | ||||||||||||
Executive Officers and Employees | 2018 Stock Incentive Plan | One-year Anniversary of the Grant Date | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 25.00% | ||||||||||||
Executive Officers and Employees | 2018 Stock Incentive Plan | Quarterly over Remaining Three Years | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 75.00% | ||||||||||||
Executive Officers and Employees | 2018 Stock Incentive Plan | January 1, 2021 | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 50.00% | ||||||||||||
Executive Officers and Employees | 2018 Stock Incentive Plan | January 1, 2022 | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 50.00% | ||||||||||||
Lincoln Park | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Issuance of common stock | 0 | 200,000 | |||||||||||
Issuance of common stock, price per share | $ 2.47 | $ 2.47 | |||||||||||
Proceeds from issuance of common stock gross | $ 500,000 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | 500,000 | ||||||||||||
Remaining obligation | $ 12,100,000 | $ 12,100,000 | |||||||||||
Number of shares, company may sell on any single business day | 50,000 | ||||||||||||
Maximum amount of Common stock at time of sale, per regular purchase | $ 1,000,000 | ||||||||||||
Maximum percentage of shares may be issued or sold based on outstanding shares immediately prior to execution of agreement | 19.99% | ||||||||||||
Issuance of common stock for commitment fee, shares | 148,148 | ||||||||||||
Lincoln Park | General and Administrative | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Fair value of the commitment fee shares, recorded to general and administrative expense along with other costs | $ 400,000 | ||||||||||||
Weighted Average | Lincoln Park | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Issuance of common stock, price per share | $ 2.47 | $ 2.47 | |||||||||||
Maximum | 2010 and 2013 Stock Incentive Plan | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Number of share outstanding | 635,170 | ||||||||||||
Maximum | Lincoln Park | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Shares value might be issued under agreement | $ 15,000,000 | ||||||||||||
Number of shares, company may sell on any single business day | 100,000 | ||||||||||||
Beneficially ownership percentage | 9.99% | ||||||||||||
Minimum | Lincoln Park | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Threshold price per share for issuance of shares under agreement | $ 2.1668 | ||||||||||||
At-the-Market Facility | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Issuance of common stock | 0 | 877,107 | |||||||||||
Proceeds from issuance of common stock gross | $ 2,800,000 | ||||||||||||
Common stock offering costs | 200,000 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 2,600,000 | ||||||||||||
At-the-Market Facility | Weighted Average | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Issuance of common stock, price per share | $ 3.1692 | $ 3.1692 | |||||||||||
At-the-Market Facility | Maximum | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Aggregate offering price of common stock | $ 50,000,000 | $ 50,000,000 | |||||||||||
Private Placement | Directors, Officers and Employees | |||||||||||||
Stockholders Equity [Line Items] | |||||||||||||
Issuance of common stock | 244,998 | ||||||||||||
Issuance of common stock, price per share | $ 3.50 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 900,000 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Option Activity under 2018 Plan, 2013 Plan and 2010 Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Options | ||
Number of Shares, Options outstanding at beginning of period | 1,240,354 | |
Number of Shares, Options Granted | 687,500 | |
Number of Shares, Cancelled/forfeited | (18,879) | |
Number of Shares, Options outstanding at end of period | 1,908,975 | 1,240,354 |
Number of Shares, Options exercisable at end of period | 858,426 | |
Weighted Average Exercise Price, Options | ||
Weighted Average Exercise Price, Options outstanding at beginning of period | $ 11.16 | |
Weighted Average Exercise Price, Options Granted | 3.48 | |
Weighted Average Exercise Price, Cancelled/forfeited | 20.37 | |
Weighted Average Exercise Price, Options outstanding at end of period | 8.30 | $ 11.16 |
Weighted Average Exercise Price, Options exercisable at end of period | $ 11.70 | |
Weighted Average Remaining Contract Term, Options | ||
Weighted Average Remaining Contractual Term, Options outstanding at beginning of period | 8 years | 7 years 9 months 18 days |
Weighted Average Remaining Contractual Term, Options exercisable at end of period | 6 years 10 months 24 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Options outstanding at end of period | $ 12 | |
Aggregate Intrinsic Value, Options exercisable at end of period | $ 1 |
Stockholders' Equity - Summar_2
Stockholders' Equity - Summary of Stock-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Stockholders Equity [Line Items] | ||||
Stock-based compensation | $ 600,313 | $ 487,403 | $ 1,754,412 | $ 1,758,315 |
Research and Development | ||||
Stockholders Equity [Line Items] | ||||
Stock-based compensation | 183,805 | 115,817 | 528,385 | 606,470 |
General and Administrative | ||||
Stockholders Equity [Line Items] | ||||
Stock-based compensation | $ 416,508 | $ 371,586 | $ 1,226,027 | $ 1,151,845 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,908,975 | 1,357,163 |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,908,975 | 1,357,163 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - Subsequent Event - Relief - Second Development Payment - USD ($) $ in Millions | Oct. 12, 2021 | Oct. 06, 2021 | Oct. 04, 2021 |
Collaboration Agreement | |||
Subsequent Event [Line Items] | |||
Potential proceeds from development payments subject to new drug application | $ 10 | ||
Proceeds from first tranche of development payments subject to new drug application | $ 5 | ||
Waiver and Agreement | |||
Subsequent Event [Line Items] | |||
Potential proceeds from second tranche of development payments subject to new drug application | $ 5 | ||
Second tranche of development payment, expiry date | Jan. 14, 2022 | ||
Written notice period (in business days) for second tranche of development payment | 15 days |