Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2021 | Jan. 15, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | ACER THERAPEUTICS INC. | ||
Entity Central Index Key | 0001069308 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 34,649,392 | ||
Entity Common Stock, Shares Outstanding | 14,310,244 | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Title of 12(b) Security | Common Stock, $0.0001 par value per share | ||
Trading Symbol | ACER | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-33004 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 32-0426967 | ||
Entity Address, Address Line One | One Gateway Center | ||
Entity Address, Address Line Two | Suite 351 | ||
Entity Address, Address Line Three | 300 Washington Street | ||
Entity Address, City or Town | Newton | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02458 | ||
City Area Code | 844 | ||
Local Phone Number | 902-6100 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Auditor Name | BDO USA, LLP | ||
Auditor Firm ID | 243 | ||
Auditor Location | Boston, MA |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 12,710,762 | $ 5,761,568 |
Collaboration receivable | 5,000,000 | |
Prepaid expenses | 1,094,229 | 510,635 |
Other current assets | 9,283,625 | 168,826 |
Total current assets | 28,088,616 | 6,441,029 |
Property and equipment, net | 114,112 | 130,081 |
Other assets: | ||
Goodwill | 7,647,267 | 7,647,267 |
Other non-current assets | 406,956 | 395,311 |
Total assets | 36,256,951 | 14,613,688 |
Current liabilities: | ||
Accounts payable | 1,405,734 | 1,672,109 |
Accrued expenses | 2,428,193 | 3,781,101 |
Deferred collaboration funding, current | 15,825,938 | |
Other current liabilities | 9,450,085 | 692,336 |
Total current liabilities | 29,109,950 | 6,145,546 |
Deferred collaboration funding, non-current | 8,661,109 | |
Other non-current liabilities | 209,497 | 243,808 |
Total liabilities | 37,980,556 | 6,389,354 |
Commitments and Contingencies (Note 6) | ||
Stockholders’ (deficit) 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 December 31, 2021 and 2020, respectively | 1,431 | 1,324 |
Additional paid-in capital | 112,784,918 | 107,358,971 |
Accumulated deficit | (114,509,954) | (99,135,961) |
Total stockholders’ (deficit) equity | (1,723,605) | 8,224,334 |
Total liabilities and stockholders’ (deficit) equity | $ 36,256,951 | $ 14,613,688 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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 |
Statements of Operations
Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Statement [Abstract] | ||
Revenue | $ 1,260,000 | $ 0 |
Operating expenses: | ||
Research and development (in the year ended December 31, 2021, net of collaboration funding of $6,055,295) | 6,508,055 | 11,847,902 |
General and administrative (in the year ended December 31, 2021, net of collaboration funding of $3,197,659) | 10,700,334 | 10,954,923 |
Total operating expenses | 17,208,389 | 22,802,825 |
Loss from operations | (15,948,389) | (22,802,825) |
Other income (expense), net: | ||
Interest and other income (expense), net | 519,639 | 13,578 |
Foreign currency transaction gain (loss) | 54,757 | (96,202) |
Total other income (expense), net | 574,396 | (82,624) |
Net loss | $ (15,373,993) | $ (22,885,449) |
Net loss per share - basic and diluted | $ (1.08) | $ (2.06) |
Weighted average common shares outstanding - basic and diluted | 14,268,245 | 11,121,039 |
Statements of Operations (Paren
Statements of Operations (Parenthetical) | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Research and Development | |
Collaboration funding amount | $ 6,055,295 |
General and Administrative | |
Collaboration funding amount | $ 3,197,659 |
Statements of Changes in Stockh
Statements of Changes in Stockholders' (Deficit) 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, net of issuance costs | 10,159,766 | $ 298 | 10,159,468 | |
Issuance of common stock, net of issuance costs, shares | 2,983,955 | |||
Issuance of common stock for commitment fee | 355,555 | $ 15 | 355,540 | |
Issuance of common stock for commitment fee, shares | 148,148 | |||
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 | 2,224,146 | 2,224,146 | ||
Net loss | (22,885,449) | (22,885,449) | ||
Ending balance at Dec. 31, 2020 | $ 8,224,334 | $ 1,324 | 107,358,971 | (99,135,961) |
Ending 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 | 2,287,007 | 2,287,007 | ||
Net loss | (15,373,993) | (15,373,993) | ||
Ending balance at Dec. 31, 2021 | $ (1,723,605) | $ 1,431 | $ 112,784,918 | $ (114,509,954) |
Ending balance, shares at Dec. 31, 2021 | 14,310,244 | 14,310,244 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (15,373,993) | $ (22,885,449) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 2,287,007 | 2,224,146 |
Depreciation | 70,913 | 70,814 |
Gain on extinguishment of debt | (568,909) | |
Fair value of shares issued for commitment fee | 355,555 | |
Loss on disposal of property and equipment | 3,981 | |
Non-cash interest expense | 3,674 | |
Impairment of in-process research and development | 118,600 | |
Changes in operating assets and liabilities | ||
Collaboration receivable | (5,000,000) | |
Prepaid expenses | (414,767) | 105,871 |
Other current assets | (9,265,745) | 22,024 |
Accounts payable | (266,375) | 1,111,019 |
Accrued expenses | (1,352,908) | 1,836,670 |
Deferred collaboration funding | 20,487,047 | |
Other current liabilities | 9,262,821 | 5,680 |
Net cash used in operating activities | (134,909) | (17,027,415) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (54,944) | (10,902) |
Net cash used in investing activities | (54,944) | (10,902) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 3,139,047 | 10,159,766 |
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 | 10,722,245 |
Net increase (decrease) in cash and cash equivalents | 6,949,194 | (6,316,072) |
Cash and cash equivalents, beginning of the year | 5,761,568 | 12,077,640 |
Cash and cash equivalents, end of the year | 12,710,762 | $ 5,761,568 |
Non-cash financing activities: | ||
Forgiveness of PPP loan | 568,909 | |
Non-cash repayment of secured loan | $ 4,000,000 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 12 Months Ended |
Dec. 31, 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 viruses, including cytomegalovirus, zika, dengue, ebola and COVID-19. Each of the Company’s product candidates is believed to present a comparatively de-risked profile, having one or more of a favorable safety profile, clinical proof-of-concept data, mechanistic differentiation, and/or accelerated pathways 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 $114.5 million and cash and cash equivalents of $12.7 million as of December 31, 2021. Net cash used in operating activities was $0.1 million and $17.0 million for the years ended December 31, 2021 and 2020, respectively. On November 9, 2018, the Company entered into a sales agreement with Roth Capital Partners, LLC, and on March 18, 2020, an amended and restated sales agreement was entered into with JonesTrading Institutional Services LLC and Roth Capital Partners, LLC. The agreement provides a facility for the offer and sale of shares of common stock from time to time having an aggregate offering price of up to $50.0 million depending upon market demand, in transactions deemed to be an at-the-market (“ATM”) offering From May 19, 2020 through December 31, 2020, during multiple trading days, the Company sold an aggregate of 1,838,957 shares of common stock at an average gross sale price of $3.9228 per share, for gross proceeds of $7.2 million. Gross proceeds, net of $0.3 million of fees and offering costs, resulted in net proceeds of $6.9 million. As of December 31, 2021, $40.0 million remained available under the Company’s ATM facility. 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 December 31, 2021. Such sales of common stock by the Company will be subject to certain limitations, and may 104 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 year ended December 31, 2020, the Company sold 900,000 shares of common stock under our purchase agreement with Lincoln Park at a weighted average gross sale price of $ 2.64 per share, resulting in gross proceeds of $ 2.4 million. Gross p roceeds, net of $ 0.2 million of offering costs, resulted in net proceeds of $ 2.2 million. During the year ended December 31, 2021 , the Company sold shares of common stock under its purchase agreement with Lincoln Park at a weighted average gross sale price of $ per share, resulting in proceeds of $ 0.5 million . 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 are subject to a minimum six-month holding period. 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”) the Company issued to Relief, and (iii) the Company granted 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 a 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 105 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 the Relief Territory. 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. 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 terms of the Agreements are further described below in the Revenue Recognition and Accounting for Collaboration Agreements section of Note 2, Significant Accounting Policies. The Company’s existing cash and cash equivalents available at December 31, 2021, plus the $5.0 million second tranche of the Second Development Payment received on January 14, 2022 per the Collaboration Agreement with Relief, will be sufficient to fund the Company’s anticipated operating and capital requirements into mid-2022, excluding support for 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 spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including its planned product development efforts and potential precommercial activities. As of December 31, 2021, the Company had cash and cash equivalents of $12.7 million and current liabilities of $29.1 million, which include $15.8 million associated with deferred collaboration funding (see Revenue Recognition and Accounting for Collaboration Agreements below in Note 2, Significant Accounting Policies), as well as a $9.3 million liability related to the securities class action and stockholder derivative actions settlements and legal costs, for which the Company has also recorded an asset of an equal amount representing the recovery from its insurance carriers. The Company’s cash and cash equivalents available at December 31, 2021, plus the $5.0 million second tranche of the Second Development Payment received on January 14, 2022 per the Collaboration Agreement with Relief, are expected to fund our anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-001 (MSUD), 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. T he Company may not be successful in its efforts to raise additional funds or achieve profitable operations. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations through and beyond the next 12 months, including 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. As of December 31, 2021, $40.0 million remained available under the Company’s ATM facility. (See At-the-Market Facility and Common Stock Purchase Agreement below in Note 7 Stockholders’ (Deficit) Equity.) If the Company is unable to obtain additional funding to support its current or proposed activities and operations, it may not be able to continue its operations as proposed, which may require it to suspend or terminate any ongoing development activities, modify its business plan, curtail various aspects of its operations, cease 106 operations, or seek relief under applicable bankruptcy laws. In such event, the Company’s stockholders may lose a substantial portion or even all of their investment. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the date these financial statements are available, or March 2, 2022. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. Basis of Presentation Any reference in these notes to applicable guidance is meant to refer to the authoritative accounting principles generally accepted in the U.S., as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Significant Accounting Polices
Significant Accounting Polices | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Significant Accounting Polices | 2. SIGNIFICANT ACCOUNTING POLICIES The preparation of these financial statements and related disclosures is in conformity with GAAP. A summary of the significant accounting policies followed by the Company in the preparation of the accompanying financial statements follows: Use of Estimates The Company’s accounting principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. From time to time, estimates having relatively higher significance include determination of stand-alone selling price and variable consideration estimates for purposes of revenue recognition, 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. 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, Collaborative Arrangements 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 107 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; and (3) the vendor’s performance does not create an asset for which the vendor has an alternative use and 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 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 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 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 a $10.0 million cash payment from Relief ($14.0 million “Reimbursement Payment,” 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), and Relief released its security interest in all of the Company’s assets. 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 was contractually entitled to receive from Relief an additional $10.0 million Second Development Payment conditioned upon 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 Second Development Payment in two $5.0 million tranches on each of October 12, 2021 and January 14, 2022. 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 the Relief Territory. The Company could also receive a total of $6.0 million in milestone payments based on the first 108 European (EU) marketing approvals for a UCD and MSUD. 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 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 Collaboration Agreement, the Company concluded that Relief represented a customer while for other parts of the Collaboration Agreement Relief did not represent a customer. The units of account of the Collaboration Agreement 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 the 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 the Relief Territory, and a combined promise for the development and commercialization of ACER-001 in the 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 utilizing an estimate of discounted cashflows associated with each. The Company determined that the transaction price at the outset of the Collaboration Agreement was $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 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 as 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 Topic 730, Research and Development The Company recognizes a receivable under the Collaboration Agreement when the consideration to be received 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 amounts recorded as license revenue and as offsets to research and development expenses and to general and administrative expenses, are reported as deferred collaboration funding. At December 31, 2021, the Company recognized as a receivable the $5.0 million second tranche of the Second Development Payment. At December 31, 2021, the amount of deferred collaboration funding associated with unsatisfied promises under the Collaboration Agreement amounted to $24.5 million. The Company has recorded $15.8 million as a current liability, which equates to the Company’s estimate of remaining spending under the Collaboration Agreement and which the Company estimates will be recognized within the next 12 months up to the point of the first commercial sale of ACER-001. The remaining balance of $8.8 million is recorded as a non-current liability and represents the estimated amount that would be taken against future net profit payments made to Relief should they occur. 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 the Acer Territory and through the end of the effective date of the Collaboration Agreement. At December 31, 2021, deferred collaboration funding was composed of $35.0 million received or receivable from Relief, offset by $1.3 million recognized as license revenue and $5.8 million recorded as an offset to research and development expenses and $3.4 million recorded as an offset to general and administrative expenses during the year ended December 31, 2021. 109 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. Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash deposits. Accounts at each institution are insured by the Federal deposit Insurance Corporation (“FDIC”) up to $250,000. At December 31, 2021 and 2020, the Company had $12.5 million and $5.5 million, respectively, in excess of the FDIC insured limit. 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 $12.2 million and $5.3 million as of December 31, 2021 and 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, collaboration receivable, and accounts payable 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 year ended December 31, 2021, since the Reimbursement Payment from Relief was received net of the amount of principal and interest due in connection with the secured loan. Research and Development Expenses Research and development costs are expensed as incurred and include compensation and related benefits, license fees, and third-party 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 that 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 the Collaboration Agreement. These contra-expense amounts are 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. The Company expects 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 the Collaboration Agreement. These contra-expense amounts are 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 Company’s 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 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 either of the years ended December 31, 2021 and 2020. Accounts payable and accrued expenses included $0.2 million and $1.8 million for costs associated with preclinical or clinical study expense at December 31, 2021 and 2020, respectively. 110 Stock-Based Compensation The Company records stock-based payments at fair value. The measurement date for compensation expense related to awards is generally the date of the grant. The fair value of awards is recognized as an expense in the statement of operations over the requisite service period, which is generally the vesting period. The fair value of options is calculated using the Black-Scholes option pricing model. For a limited number of option grants to non-employee contractors, the Company utilizes the simplified method to value these awards. This option valuation model requires the use of assumptions including, among others, the volatility of stock price, the expected term of the option, and the risk-free interest rate. The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes option pricing model: 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% Due to its limited operating history and a limited trading history of its common stock in relation to the life of its standard option grants, the Company estimates the volatility of its stock in consideration of a number of factors including the volatility of comparable public companies. The expected term of a stock option granted to employees and directors (including non-employee directors) is based on the average of the contractual term (generally ten years) and the vesting period. For other non-employee options, the expected term is the contractual term. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The Company recognizes forfeitures related to employee stock-based awards as they occur. The risk-free rate for periods within the expected life of the option is based upon the U.S. Treasury yield curve in effect at the time of grant. Option awards are granted at an exercise price equal to the closing market price of the Company’s common stock on the Nasdaq Capital Market on the date of grant. Goodwill Goodwill represents the excess of the purchase price (consideration paid plus net liabilities assumed) of an acquired business over the fair value of the underlying net tangible and intangible assets. The Company evaluates the recoverability of goodwill according to ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350) 111 In-process Research and Development In-process research and development (“IPRD”) represents the value of the three G-protein-coupled receptors (“GPCR”) targets (the “Targets”) from the GPCR Target pools of Anchor to which the Company obtained the rights in its March 20, 2015 acquisition of Anchor. IPRD was recorded at fair value and is an indefinite-lived intangible asset. The Company reviews IPRD at least annually to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining useful life of the asset. As part of our annual impairment analysis as of December 31, 2020, the Company evaluated the potential future cash flows of the IPRD asset, and it was determined that the fair value was at or near zero due to the limited time remaining for the asset to be developed before the expiration of its intellectual property exclusivity. As a result, the Company determined that IPRD was impaired as of December 31, 2020 and wrote off the value of the IPRD accordingly. The Company recorded the impairment charge of $0.1 million in research and development expense during the year ended December 31, 2020. Foreign Currency Transaction Gain/(Loss) Gains and losses arising from transactions and revaluation of balances denominated in currencies other than U.S. dollars are recorded in foreign currency transaction gain/(loss) on the statements of operations. Income Taxes The Company is primarily subject to U.S. federal and Massachusetts state income taxes. The Company’s tax returns for years 2015 through present are open to tax examinations by U.S. federal and state tax authorities; however, carryforward attributes that were generated prior to January 1, 2015 remain subject to adjustment upon examination if they either have been utilized or will be utilized in a future period. For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. The tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure in the financial statements as of December 31, 2021 and 2020. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. As of December 31, 2021 and 2020, the Company had no accruals for interest or penalties related to income tax matters. 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 year ended December 31, 2021 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 December 31, 2021. On April 11, 2020, the Company was approved for $0.6 million of loan proceeds under the PPP, as fully described in Note 6. A key feature of the PPP is that loan proceeds used by borrowers to pay certain expenses during the eight-week period following origination of the loan (the covered period) are eligible to be forgiven. Forgiveness is available to the extent proceeds are used to pay payroll, rent or mortgages, and utilities during the covered period. In addition, the CARES Act provides that any amounts forgiven 112 pursuant to this rule are not taxable (i.e., no cancellation of debt income for the borrower). The Company recognized approximately $ 0.6 million in PPP loan forgiveness during the second quarter of 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 net loss per share because to do so would be anti-dilutive. Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 3 . PROPERTY AND EQUIPMENT Property and equipment consisted of the following at December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Computer hardware and software $ 113,847 $ 58,903 Leasehold improvements 60,535 60,535 Furniture and fixtures 145,487 145,487 Subtotal property and equipment, gross 319,869 264,925 Less accumulated depreciation (205,757 ) (134,844 ) Property and equipment, net $ 114,112 $ 130,081 Property and equipment are stated on the basis of historical cost less accumulated depreciation. Depreciation is provided using the straight-line method over the estimated useful lives of the assets. Major renewals and improvements are capitalized, while minor replacements, maintenance and repairs are charged to current operations. Impairment losses are recorded on long-lived assets used in operations when indicators of impairment are present 113 and the undiscounted cash flows estimated to be generated by those assets are less than the assets’ carrying amount. Computer hardware and software are depreciated over an estimated useful life of 3 years , leasehold improvements are depreciated over the shorter of the estimated useful life of the asset or the duration of the current lease arrangement, and furniture and fixtures are depreciated over an estimated useful life of 7 years . |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Accrued Expenses | 4 . ACCRUED EXPENSES Accrued expenses consisted of the following at December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Accrued contract manufacturing $ 827,390 $ 1,479,771 Accrued payroll and payroll taxes 419,354 267,159 Accrued precommercial costs 395,923 — Accrued miscellaneous expenses 216,103 102,999 Accrued accounting, audit, and tax fees 167,630 181,200 Accrued legal 162,812 350,517 Accrued consulting 105,085 88,750 Accrued license fees 86,259 240,041 Accrued contract research and regulatory consulting 47,637 1,070,664 Total accrued expenses $ 2,428,193 $ 3,781,101 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | 5. On March 6, 2018, the Company entered into a lease agreement (the “Newton Lease”), commencing on October 1, 2018, for certain premises, which consist of 2,760 square feet of office space located in Newton, Massachusetts. On March 5, 2019, the Company entered into a modified lease agreement (the “Additional Newton Lease”) to lease an additional 1,600 square feet of office space, commencing on June 1, 2019, located in Newton, Massachusetts. The Newton Lease expires on May 31, 2022. On October 15, 2021, the Company entered into a lease amendment extending the Additional Newton Lease through December 31, 2022. Effective with the expiration of the Newton Lease and the extension of the Newton Additional Lease, the space leased by the Company in Newton will be reduced to 1,600 square feet as of June 1, 2022. The Company is required to share in certain taxes and operating expenses associated with the Newton Lease and the Additional Newton Lease. 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. On April 23, 2019, the Company entered into a modified lease agreement (the “Additional Bend Lease”) to lease an additional 1,389 square feet of office space, commencing on May 1, 2019, located in Bend, Oregon. On November 17, 2021, the Company entered into a lease agreement to extend the term of Bend Lease and the Additional Bend Lease to June 30, 2022 and to further extend the term either (1) until June 30, 2027 if FDA approval of ACER-001 is received in June 2022, or (2) until June 30, 2025 if FDA approval of ACER-001 is not received in June 2022. The leases for the Newton and Bend office space are classified as operating leases. The leases contain immaterial provisions for rent holidays and rent escalations over the term of the leases, which have been included in the Company’s right of use asset and lease liabilities. In the year ended December 31, 2021, the Company recorded a non-cash transaction to recognize an additional $0.4 million right of use asset and lease liability in conjunction with the modifications to the leases. The Company’s lease liability as of December 31, 2020 represents the net present value of future lease payments utilizing a discount rate of 8%. The Company’s lease liability as of December 31, 2021 represents the net present value of future lease payments utilizing discount rates of 8% to 10%, which correspond to the Company’s incremental borrowing rates as of the effective dates of the leases. As of December 31, 2021, the weighted average remaining lease term was 2.8 years. For each of the years ended December 31, 2021 and 2020, the Company recorded expense of $0.3 million related to the leases and made cash payments of $0.3 million for amounts included in the measurement of lease liabilities. The Company is therefore reporting a right-of-use asset 114 of $ million in Other non-current assets and lease liabilities totaling $ million in Other current liabilities and Other non-current liabilities as of December 31, 2021 . The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the balance sheet as of December 31, 2021. Undiscounted lease liabilities for years ending December 31, 2022 $ 190,064 2023 103,925 2024 107,290 2025 54,579 Total undiscounted lease liabilities $ 455,858 Less effects of discounting (62,021 ) Total lease liabilities as of December 31, 2021 $ 393,837 The Company’s lease liabilities are reported on the consolidated balance sheets as follows: December 31, 2021 2020 Other current liabilities $ 184,340 $ 274,172 Other non-current liabilities 209,497 90,139 Total lease liabilities $ 393,837 $ 364,311 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 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 for the treatment of inborn errors of BCAA metabolism, including MSUD, 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 115 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 the Collaboration Agreement, the Company received a $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), and Relief released its security interest in the Company’s assets. Under the terms of the Collaboration Agreement, Relief committed to pay the Company Development Payments of up to $20.0 million for U.S. development and commercial launch costs for the UCDs and MSUD indications. 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, is unsecured, and is 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 116 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 year ended December 31, 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. To the extent that the Company incurs legal cost associated with any potential loss contingency, those legal costs are expensed as incurred. 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. U.S. TM With the selection of a lead plaintiff, the case is now captioned Skiadas v. Acer Therapeutics Inc. et al . The Lead Plaintiff filed a Second Amended Complaint on February 28, 2020 and the Company moved to dismiss the Second Amended Complaint on May 1, 2020. On June 16, 2020, the Court granted in part and denied in part the Company’s motion to dismiss. The Company filed its answer to the Second Amended Complaint on August 7, 2020, and the Court held an initial conference on August 17, 2020. After obtaining leave from the Court to do so, the Lead Plaintiff filed his Third Amended Complaint on February 4, 2021. The parties reached an agreement in principle to settle this action for a payment of $8.4 million, which was approved by the Court on January 7, 2022. Payment of the settlement was made into escrow by the Company’s insurance carriers. As of December 31, 2021, the Company has recognized liabilities of $8.4 million for the proposed settlement and of $0.9 million for costs related to both the derivative and class action cases in other current liabilities and has also recognized an asset of an equal amount in other current assets representing the recovery from its insurance carriers of an equal amount. On August 12, 2019, a stockholder derivative action, Gress v. Aselage et al U.S. Skiadas On March 17, 2020, a second stockholder derivative action, Giroux v. Amello et al. , No. 1:20-cv-10537-GAO, was filed in the U.S. District Court for the District of Massachusetts against certain of the Company’s present and former officers and directors, asserting claims based on the same facts at issue in the Skiadas and Gress cases. On June 23, 2020, a third stockholder derivative action, King v. Schelling , et al ., No. 1:20-cv-04779-GHW, was filed in the U.S. District Court for the Southern District of New York against certain of the Company’s present and former officers and directors that arises from the same facts underlying the Skiadas , Gress , and Giroux cases. On July 6, 2020, a fourth stockholder derivative action, Diaz v. Amello et al. , No. 1:20-cv-00909-MN, was filed in the U.S. District Court for the District of Delaware. By Stipulation and Order dated August 7, 2020, the Gress and Diaz cases were consolidated under the caption In re Acer Therapeutics Inc. Derivative Litigation , Lead Case No. 1:19-cv-01505-MN. As disclosed previously, the 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. |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Stockholders' (Deficit) Equity | 7 . STOCKHOLDERS’ (DEFICIT) 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. 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 December 31, 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. 118 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. However, there can be no assurance that the Company will be able to receive the entire obligation amount from Lincoln Park because the purchase agreement contains limitations, restrictions, requirements, events of default and other provisions that could lim i t the Company’s ability to cause Lincoln Park to buy common stock from the Company. 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 year ended December 31, 2020, the Company sold 900,000 shares of common stock under its purchase agreement with Lincoln Park at a weighted average price of $2.64 per share, resulting in net proceeds of $2.2 million. During the year ended December 31, 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 119 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 ten years. Stock options granted to executive officers and employees generally vest either 1) over a four-year At December 31, 2021, 456,778 shares of common stock remained available for the grant of future awards under the 2018 Plan. 2013 Stock Incentive Plan The Company’s 2013 Plan provided for the issuance of up to 165,000 shares of common stock as incentive or non-qualified stock options and/or restricted common stock to employees, officers, directors, consultants and advisers. Option awards were generally granted with an exercise price equal to the fair value of the common stock at the date of grant and had contractual terms of ten years. At December 31, 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 ten years. At December 31, 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. 120 Stock Plan Activity A summary of option activity under the 2018 Plan, 2013 Plan, and 2010 Plan for the year ended December 31, 2021 is as follows: 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 733,500 $ 3.41 Cancelled/forfeited (18,879 ) $ 20.37 Options outstanding at December 31, 2021 1,954,975 $ 8.16 7.8 $ 2 Options exercisable at December 31, 2021 894,879 $ 11.94 6.6 $ — At December 31, 2021, there was $2.5 million of unrecognized compensation expense related to the stock-based compensation arrangements granted under all plans. The average remaining vesting period for options was 2.8 years. The weighted average grant-date fair value of options granted during the years ended December 31, 2021 and 2020 was $2.57 and $1.99, respectively. The fair value of shares vested during the years ended December 31, 2021 and 2020 were $2.0 million and $2.4 million, respectively. Years Ended December 31, 2021 2020 Stock-based compensation expense Research and development $ 696,283 $ 764,526 General and administrative 1,590,724 1,459,620 Total stock-based compensation expense $ 2,287,007 $ 2,224,146 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8 . INCOME TAXES 121 There was no provision for income taxes for the years ended December 31, 2021 and 2020 , due to the Company’s operating losses and a full valuation allowance on deferred tax assets. Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2021 2020 Deferred tax assets: Net operating loss carry forwards $ 12,059,019 $ 11,979,869 Capitalized research and development costs 18,865,707 18,650,538 Accrued liabilities 156,415 111,481 Tax credit carryforwards 8,730,816 7,755,146 Stock-based compensation 1,745,654 1,229,407 Deferred collaboration funding 3,312,415 — Operating lease 94,946 86,491 Total deferred tax assets 44,964,972 39,812,932 Valuation allowance (44,866,411 ) (39,726,441 ) Net deferred tax assets 98,561 86,491 Deferred tax liabilities: Operating lease right of use asset (94,945 ) (86,491 ) Unrealized foreign exchange gain (3,616 ) — Total deferred tax liabilities (98,561 ) (86,491 ) $ — $ — A reconciliation of the U.S. federal statutory tax rate to the effective tax rate is as follows: December 31, 2021 2020 Federal statutory rate 21.0 % 21.0 % R&D and Orphan Drug credits 6.4 % 2.5 % State income tax, net of federal tax benefit 5.4 % 1.5 % Valuation allowance (33.2 %) (24.3 %) Share-based compensation (0.3 %) (0.8 %) Other, net 0.7 % 0.1 % Effective tax rate 0.0 % 0.0 % Management currently believes that it is more likely than not that the deferred tax assets relating to the loss carryforwards and other temporary differences will not be realized in the future. Through December 31, 2021, for income tax reporting purposes, the Company had U.S. federal and state net operating loss carryforwards of $51.1 million and research and development credits and Orphan Drug credits of $8.7 million that can be carried forward and offset against taxable income. For state purposes, the Company had state net operating loss carryforwards of $1.7 million and research and development credits of $0.1 million that can be carried forward and offset against taxable income. Federal net operating loss, research and development credits, and Orphan Drug credits generated prior to 2018 and Massachusetts net operating losses can be carried forward for 20 years and begin to expire in 2022. Federal net operating loss generated after 2017 can be carried forward indefinitely. Utilization of net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code of 1986, and similar state provisions. The annual limitations may result in the expiration of net operating losses before utilization. There were no uncertain tax positions that require accrual or disclosure in the financial statements as of December 31, 2021 and 2020. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. As of December 31, 2021 and 2020, the Company had no accruals for interest or penalties related to income tax matters. 122 The 2017 merger of Opexa Therapeutics, Inc. and private Acer Therapeutics Inc. resulted in an ownership change for the Company. Additional ownership changes in the future could result in additional limitations on the Company’s net operating loss carryforwards and certain other tax attributes. Consequently, even if the Company achieves profitability, it may not be able to utilize a material portion of its net operating loss carryforwards and certain other tax attributes, which could increase its tax obligations and thus have a material adverse effect on its cash flow and results of operations. Under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, if a corporation undergoes an ‘‘ownership change,’’ the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes to offset its post-change income and taxes may be limited. In general, an ‘‘ownership change’’ generally occurs if there is a cumulative change in the Company’s ownership by ‘‘five-percent shareholders’’ that exceeds 50 percentage points over a rolling three-year period. Similar rules may apply under state tax laws. The Company experienced an ownership change on July 17, 2015 and August 3, 2018, and may experience ownership changes in the future as a result of this issuance or future transactions in the Company’s stock, some of which may be outside the Company’s control. As a result, if the Company earns net taxable income, the Company’s ability to use the Company’s pre-change net operating loss carryforwards, or other pre-change tax attributes, to offset U.S. federal and state taxable income and taxes may be subject to significant limitations. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 9 . NET LOSS PER SHARE Basic net loss per share is computed by dividing the net loss in each period by the weighted-average number of common shares outstanding during such period. Diluted net loss per share is computed similarly to basic net loss per share except that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential common shares had been issued and if the additional common shares were dilutive. For the periods presented, common stock equivalents, consisting of stock-based awards, were not included in the calculation of the diluted loss per share because to do so would be anti-dilutive. As of December 31, 2021 and 2020, the number of shares of common stock underlying potentially dilutive securities consist of: December 31, 2021 2020 Options to purchase common stock 1,954,975 1,240,354 Total 1,954,975 1,240,354 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events [Abstract] | |
Subsequent Events | 1 0 . SUBSEQUENT EVENTS Pursuant to the Waiver and Agreement, the Company received from Relief the $5.0 million second tranche of the Second Development Payment on January 14, 2022. Subsequent to the year ended December 31, 2021, the Company approved a discretionary bonus pool for employees for the year ended December 31, 2021 of up to $2.2 million that remains contingent on the completion of certain financing transactions, the completion of which cannot be ascertained or assured at the current time. |
Significant Accounting Polices
Significant Accounting Polices (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company had an accumulated deficit of $114.5 million and cash and cash equivalents of $12.7 million as of December 31, 2021. Net cash used in operating activities was $0.1 million and $17.0 million for the years ended December 31, 2021 and 2020, respectively. On November 9, 2018, the Company entered into a sales agreement with Roth Capital Partners, LLC, and on March 18, 2020, an amended and restated sales agreement was entered into with JonesTrading Institutional Services LLC and Roth Capital Partners, LLC. The agreement provides a facility for the offer and sale of shares of common stock from time to time having an aggregate offering price of up to $50.0 million depending upon market demand, in transactions deemed to be an at-the-market (“ATM”) offering From May 19, 2020 through December 31, 2020, during multiple trading days, the Company sold an aggregate of 1,838,957 shares of common stock at an average gross sale price of $3.9228 per share, for gross proceeds of $7.2 million. Gross proceeds, net of $0.3 million of fees and offering costs, resulted in net proceeds of $6.9 million. As of December 31, 2021, $40.0 million remained available under the Company’s ATM facility. 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 December 31, 2021. Such sales of common stock by the Company will be subject to certain limitations, and may 104 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 year ended December 31, 2020, the Company sold 900,000 shares of common stock under our purchase agreement with Lincoln Park at a weighted average gross sale price of $ 2.64 per share, resulting in gross proceeds of $ 2.4 million. Gross p roceeds, net of $ 0.2 million of offering costs, resulted in net proceeds of $ 2.2 million. During the year ended December 31, 2021 , the Company sold shares of common stock under its purchase agreement with Lincoln Park at a weighted average gross sale price of $ per share, resulting in proceeds of $ 0.5 million . 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 are subject to a minimum six-month holding period. 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”) the Company issued to Relief, and (iii) the Company granted 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 a 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 105 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 the Relief Territory. 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. 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 terms of the Agreements are further described below in the Revenue Recognition and Accounting for Collaboration Agreements section of Note 2, Significant Accounting Policies. The Company’s existing cash and cash equivalents available at December 31, 2021, plus the $5.0 million second tranche of the Second Development Payment received on January 14, 2022 per the Collaboration Agreement with Relief, will be sufficient to fund the Company’s anticipated operating and capital requirements into mid-2022, excluding support for 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 spent, and expects to continue to spend, a substantial amount of funds in connection with implementing its business strategy, including its planned product development efforts and potential precommercial activities. As of December 31, 2021, the Company had cash and cash equivalents of $12.7 million and current liabilities of $29.1 million, which include $15.8 million associated with deferred collaboration funding (see Revenue Recognition and Accounting for Collaboration Agreements below in Note 2, Significant Accounting Policies), as well as a $9.3 million liability related to the securities class action and stockholder derivative actions settlements and legal costs, for which the Company has also recorded an asset of an equal amount representing the recovery from its insurance carriers. The Company’s cash and cash equivalents available at December 31, 2021, plus the $5.0 million second tranche of the Second Development Payment received on January 14, 2022 per the Collaboration Agreement with Relief, are expected to fund our anticipated operating and capital requirements into mid-2022, excluding support for planned ACER-001 (MSUD), 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. T he Company may not be successful in its efforts to raise additional funds or achieve profitable operations. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations through and beyond the next 12 months, including 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. As of December 31, 2021, $40.0 million remained available under the Company’s ATM facility. (See At-the-Market Facility and Common Stock Purchase Agreement below in Note 7 Stockholders’ (Deficit) Equity.) If the Company is unable to obtain additional funding to support its current or proposed activities and operations, it may not be able to continue its operations as proposed, which may require it to suspend or terminate any ongoing development activities, modify its business plan, curtail various aspects of its operations, cease 106 operations, or seek relief under applicable bankruptcy laws. In such event, the Company’s stockholders may lose a substantial portion or even all of their investment. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the date these financial statements are available, or March 2, 2022. The accompanying financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. |
Use of Estimates | Use of Estimates The Company’s accounting principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the financial statements and reported amounts of expenses during the reporting period. From time to time, estimates having relatively higher significance include determination of stand-alone selling price and variable consideration estimates for purposes of revenue recognition, 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. |
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, Collaborative Arrangements 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 107 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; and (3) the vendor’s performance does not create an asset for which the vendor has an alternative use and 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 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 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 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 a $10.0 million cash payment from Relief ($14.0 million “Reimbursement Payment,” 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), and Relief released its security interest in all of the Company’s assets. 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 was contractually entitled to receive from Relief an additional $10.0 million Second Development Payment conditioned upon 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 Second Development Payment in two $5.0 million tranches on each of October 12, 2021 and January 14, 2022. 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 the Relief Territory. The Company could also receive a total of $6.0 million in milestone payments based on the first 108 European (EU) marketing approvals for a UCD and MSUD. 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 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 Collaboration Agreement, the Company concluded that Relief represented a customer while for other parts of the Collaboration Agreement Relief did not represent a customer. The units of account of the Collaboration Agreement 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 the 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 the Relief Territory, and a combined promise for the development and commercialization of ACER-001 in the 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 utilizing an estimate of discounted cashflows associated with each. The Company determined that the transaction price at the outset of the Collaboration Agreement was $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 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 as 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 Topic 730, Research and Development The Company recognizes a receivable under the Collaboration Agreement when the consideration to be received 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 amounts recorded as license revenue and as offsets to research and development expenses and to general and administrative expenses, are reported as deferred collaboration funding. At December 31, 2021, the Company recognized as a receivable the $5.0 million second tranche of the Second Development Payment. At December 31, 2021, the amount of deferred collaboration funding associated with unsatisfied promises under the Collaboration Agreement amounted to $24.5 million. The Company has recorded $15.8 million as a current liability, which equates to the Company’s estimate of remaining spending under the Collaboration Agreement and which the Company estimates will be recognized within the next 12 months up to the point of the first commercial sale of ACER-001. The remaining balance of $8.8 million is recorded as a non-current liability and represents the estimated amount that would be taken against future net profit payments made to Relief should they occur. 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 the Acer Territory and through the end of the effective date of the Collaboration Agreement. At December 31, 2021, deferred collaboration funding was composed of $35.0 million received or receivable from Relief, offset by $1.3 million recognized as license revenue and $5.8 million recorded as an offset to research and development expenses and $3.4 million recorded as an offset to general and administrative expenses during the year ended December 31, 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. Financial instruments that potentially subject the Company to concentration of credit risk consist principally of cash deposits. Accounts at each institution are insured by the Federal deposit Insurance Corporation (“FDIC”) up to $250,000. At December 31, 2021 and 2020, the Company had $12.5 million and $5.5 million, respectively, in excess of the FDIC insured limit. 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 $12.2 million and $5.3 million as of December 31, 2021 and 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, collaboration receivable, and accounts payable 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 year ended December 31, 2021, since the Reimbursement Payment from Relief was received net of the amount of principal and interest due in connection with the secured loan. |
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 third-party 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 that 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 the Collaboration Agreement. These contra-expense amounts are 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. The Company expects 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 the Collaboration Agreement. These contra-expense amounts are 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 Company’s 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 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 either of the years ended December 31, 2021 and 2020. Accounts payable and accrued expenses included $0.2 million and $1.8 million for costs associated with preclinical or clinical study expense at December 31, 2021 and 2020, respectively. |
Stock-Based Compensation | Stock-Based Compensation The Company records stock-based payments at fair value. The measurement date for compensation expense related to awards is generally the date of the grant. The fair value of awards is recognized as an expense in the statement of operations over the requisite service period, which is generally the vesting period. The fair value of options is calculated using the Black-Scholes option pricing model. For a limited number of option grants to non-employee contractors, the Company utilizes the simplified method to value these awards. This option valuation model requires the use of assumptions including, among others, the volatility of stock price, the expected term of the option, and the risk-free interest rate. The following assumptions were used to estimate the fair value of stock options granted using the Black-Scholes option pricing model: 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% Due to its limited operating history and a limited trading history of its common stock in relation to the life of its standard option grants, the Company estimates the volatility of its stock in consideration of a number of factors including the volatility of comparable public companies. The expected term of a stock option granted to employees and directors (including non-employee directors) is based on the average of the contractual term (generally ten years) and the vesting period. For other non-employee options, the expected term is the contractual term. The assumed dividend yield is based upon the Company’s expectation of not paying dividends in the foreseeable future. The Company recognizes forfeitures related to employee stock-based awards as they occur. The risk-free rate for periods within the expected life of the option is based upon the U.S. Treasury yield curve in effect at the time of grant. Option awards are granted at an exercise price equal to the closing market price of the Company’s common stock on the Nasdaq Capital Market on the date of grant. |
Goodwill | Goodwill Goodwill represents the excess of the purchase price (consideration paid plus net liabilities assumed) of an acquired business over the fair value of the underlying net tangible and intangible assets. The Company evaluates the recoverability of goodwill according to ASU No. 2017-04, Intangibles – Goodwill and Other (Topic 350) |
In-process Research and Development | In-process Research and Development In-process research and development (“IPRD”) represents the value of the three G-protein-coupled receptors (“GPCR”) targets (the “Targets”) from the GPCR Target pools of Anchor to which the Company obtained the rights in its March 20, 2015 acquisition of Anchor. IPRD was recorded at fair value and is an indefinite-lived intangible asset. The Company reviews IPRD at least annually to determine if any adverse conditions exist or a change in circumstances has occurred that would indicate impairment or a change in the remaining useful life of the asset. As part of our annual impairment analysis as of December 31, 2020, the Company evaluated the potential future cash flows of the IPRD asset, and it was determined that the fair value was at or near zero due to the limited time remaining for the asset to be developed before the expiration of its intellectual property exclusivity. As a result, the Company determined that IPRD was impaired as of December 31, 2020 and wrote off the value of the IPRD accordingly. The Company recorded the impairment charge of $0.1 million in research and development expense during the year ended December 31, 2020. |
Foreign Currency Transactions Gain/(Loss) | Foreign Currency Transaction Gain/(Loss) Gains and losses arising from transactions and revaluation of balances denominated in currencies other than U.S. dollars are recorded in foreign currency transaction gain/(loss) on the statements of operations. |
Income Taxes | Income Taxes The Company is primarily subject to U.S. federal and Massachusetts state income taxes. The Company’s tax returns for years 2015 through present are open to tax examinations by U.S. federal and state tax authorities; however, carryforward attributes that were generated prior to January 1, 2015 remain subject to adjustment upon examination if they either have been utilized or will be utilized in a future period. For federal and state income taxes, deferred tax assets and liabilities are recognized based upon temporary differences between the financial statement and the tax basis of assets and liabilities. Deferred income taxes are based upon prescribed rates and enacted laws applicable to periods in which differences are expected to reverse. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. The tax positions taken or expected to be taken in the course of preparing the Company’s tax returns are required to be evaluated to determine whether the tax positions are “more-likely-than-not” of being sustained by the applicable tax authority. Tax positions not deemed to meet a more-likely-than-not threshold would be recorded as a tax expense in the current year. There were no uncertain tax positions that require accrual or disclosure in the financial statements as of December 31, 2021 and 2020. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. As of December 31, 2021 and 2020, the Company had no accruals for interest or penalties related to income tax matters. 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 year ended December 31, 2021 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 December 31, 2021. On April 11, 2020, the Company was approved for $0.6 million of loan proceeds under the PPP, as fully described in Note 6. A key feature of the PPP is that loan proceeds used by borrowers to pay certain expenses during the eight-week period following origination of the loan (the covered period) are eligible to be forgiven. Forgiveness is available to the extent proceeds are used to pay payroll, rent or mortgages, and utilities during the covered period. In addition, the CARES Act provides that any amounts forgiven 112 pursuant to this rule are not taxable (i.e., no cancellation of debt income for the borrower). The Company recognized approximately $ 0.6 million in PPP loan forgiveness during the second quarter of 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 net loss per share because to do so would be anti-dilutive. |
Segment Information | Segment Information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and in assessing performance. The Company views its operations and manages its business in one operating segment, which is the business of a pharmaceutical company focused on the acquisition, development, and commercialization of therapies for serious rare and life-threatening diseases with significant unmet medical needs. |
Recently Adopted Accounting Pronouncements | Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity’s Own Equity (Subtopic 815-40) In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance |
Significant Accounting Police_2
Significant Accounting Polices (Tables) | 12 Months Ended |
Dec. 31, 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 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) | 12 Months Ended |
Dec. 31, 2021 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following at December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Computer hardware and software $ 113,847 $ 58,903 Leasehold improvements 60,535 60,535 Furniture and fixtures 145,487 145,487 Subtotal property and equipment, gross 319,869 264,925 Less accumulated depreciation (205,757 ) (134,844 ) Property and equipment, net $ 114,112 $ 130,081 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following at December 31, 2021 and 2020: December 31, 2021 December 31, 2020 Accrued contract manufacturing $ 827,390 $ 1,479,771 Accrued payroll and payroll taxes 419,354 267,159 Accrued precommercial costs 395,923 — Accrued miscellaneous expenses 216,103 102,999 Accrued accounting, audit, and tax fees 167,630 181,200 Accrued legal 162,812 350,517 Accrued consulting 105,085 88,750 Accrued license fees 86,259 240,041 Accrued contract research and regulatory consulting 47,637 1,070,664 Total accrued expenses $ 2,428,193 $ 3,781,101 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 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 balance sheet as of December 31, 2021. Undiscounted lease liabilities for years ending December 31, 2022 $ 190,064 2023 103,925 2024 107,290 2025 54,579 Total undiscounted lease liabilities $ 455,858 Less effects of discounting (62,021 ) Total lease liabilities as of December 31, 2021 $ 393,837 The Company’s lease liabilities are reported on the consolidated balance sheets as follows: December 31, 2021 2020 Other current liabilities $ 184,340 $ 274,172 Other non-current liabilities 209,497 90,139 Total lease liabilities $ 393,837 $ 364,311 |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity (Tables) | 12 Months Ended |
Dec. 31, 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 year ended December 31, 2021 is as follows: 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 733,500 $ 3.41 Cancelled/forfeited (18,879 ) $ 20.37 Options outstanding at December 31, 2021 1,954,975 $ 8.16 7.8 $ 2 Options exercisable at December 31, 2021 894,879 $ 11.94 6.6 $ — |
Summary of Stock-Based Compensation Expense | Years Ended December 31, 2021 2020 Stock-based compensation expense Research and development $ 696,283 $ 764,526 General and administrative 1,590,724 1,459,620 Total stock-based compensation expense $ 2,287,007 $ 2,224,146 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Deferred Tax Assets and Liabilities | Significant components of the Company’s deferred tax assets and liabilities are as follows: December 31, 2021 2020 Deferred tax assets: Net operating loss carry forwards $ 12,059,019 $ 11,979,869 Capitalized research and development costs 18,865,707 18,650,538 Accrued liabilities 156,415 111,481 Tax credit carryforwards 8,730,816 7,755,146 Stock-based compensation 1,745,654 1,229,407 Deferred collaboration funding 3,312,415 — Operating lease 94,946 86,491 Total deferred tax assets 44,964,972 39,812,932 Valuation allowance (44,866,411 ) (39,726,441 ) Net deferred tax assets 98,561 86,491 Deferred tax liabilities: Operating lease right of use asset (94,945 ) (86,491 ) Unrealized foreign exchange gain (3,616 ) — Total deferred tax liabilities (98,561 ) (86,491 ) $ — $ — |
Schedule of Reconciliation of Effective Income Tax Rate | A reconciliation of the U.S. federal statutory tax rate to the effective tax rate is as follows: December 31, 2021 2020 Federal statutory rate 21.0 % 21.0 % R&D and Orphan Drug credits 6.4 % 2.5 % State income tax, net of federal tax benefit 5.4 % 1.5 % Valuation allowance (33.2 %) (24.3 %) Share-based compensation (0.3 %) (0.8 %) Other, net 0.7 % 0.1 % Effective tax rate 0.0 % 0.0 % |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities | As of December 31, 2021 and 2020, the number of shares of common stock underlying potentially dilutive securities consist of: December 31, 2021 2020 Options to purchase common stock 1,954,975 1,240,354 Total 1,954,975 1,240,354 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation - Additional Information (Details) - USD ($) | Jan. 14, 2022 | Oct. 12, 2021 | Mar. 19, 2021 | Jan. 25, 2021 | Jul. 24, 2020 | Apr. 30, 2020 | Mar. 18, 2020 | Nov. 09, 2018 | Jun. 30, 2021 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Oct. 04, 2021 |
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Accumulated deficit | $ 99,135,961 | $ 114,509,954 | $ 99,135,961 | ||||||||||
Cash and cash equivalents | 5,761,568 | 12,710,762 | 5,761,568 | ||||||||||
Net cash used in operating activities | 134,909 | 17,027,415 | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | 3,139,047 | 10,159,766 | |||||||||||
Reimbursement payment | $ 14,000,000 | ||||||||||||
Development payments | 10,000,000 | ||||||||||||
Current liabilities | $ 6,145,546 | 29,109,950 | $ 6,145,546 | ||||||||||
Deferred collaboration funding, current | 15,825,938 | ||||||||||||
Liability related to securities class action and stockholder derivative actions settlements and legal costs | $ 9,300,000 | ||||||||||||
Lincoln Park | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Issuance of common stock, net of issuance costs, shares | 200,000 | 900,000 | |||||||||||
Issuance of common stock, price per share | $ 2.64 | $ 2.47 | $ 2.64 | ||||||||||
Proceeds from issuance of common stock gross | $ 500,000 | $ 2,400,000 | |||||||||||
Common stock offering costs | 2,200,000 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 200,000 | ||||||||||||
Remaining obligation | 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 | ||||||||||||
Issuance of common stock for commitment fee, shares | 148,148 | ||||||||||||
Fair value of the commitment fee shares, recorded to general and administrative expense along with other costs | $ 400,000 | ||||||||||||
Stock to be issued value on certain limitation and condition | 12,100,000 | ||||||||||||
Proposed Collaboration and License Agreement | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Upfront non-refundable payment received | 1,000,000 | ||||||||||||
Proposed Collaboration and License Agreement | Relief Therapeutics Holding AG | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Upfront non-refundable payment received | $ 1,000,000 | ||||||||||||
Proposed Collaboration and License Agreement | Secured Loan | Relief Therapeutics Holding AG | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Debt instrument, term | 12 months | ||||||||||||
Debt instrument, principal amount | $ 4,000,000 | ||||||||||||
Debt instrument, interest rate | 6.00% | ||||||||||||
Collaboration Agreement | Second Development Payment | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Deferred collaboration funding, current | $ 24,500,000 | ||||||||||||
Collaboration Agreement | Relief Therapeutics Holding AG | |||||||||||||
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 | |||||||||||
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 | ||||||||||||
Net profit split ratio based on territory | 60.00% | 60.00% | |||||||||||
Percentage of royalty net sales received | 15.00% | 15.00% | |||||||||||
Guarantee for substantive review food and drug application | $ 0 | ||||||||||||
Milestone payment to be received | $ 6,000,000 | $ 6,000,000 | |||||||||||
Collaboration Agreement | Relief Therapeutics Holding AG | First Development Payment | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Development payments subject new drug application | $ 10,000,000 | ||||||||||||
Collaboration Agreement | Relief Therapeutics Holding AG | 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 | ||||||||||||
Collaboration Agreement | Secured Loan | Relief Therapeutics Holding AG | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Debt instrument, term | 12 months | ||||||||||||
Debt instrument, principal amount | $ 4,000,000 | ||||||||||||
Debt instrument, interest rate | 6.00% | ||||||||||||
Waiver and Agreement | Relief Therapeutics Holding AG | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Proceeds from second tranche of development payments subject to new drug application | 5,000,000 | ||||||||||||
Waiver and Agreement | Relief Therapeutics Holding AG | Second Development Payment | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | 5,000,000 | |||||||||||
Proceeds from second tranche of development payments subject to new drug application | $ 5,000,000 | ||||||||||||
Waiver and Agreement | Relief Therapeutics Holding AG | Subsequent Event | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Second tranche of development payment, expiry date | Jan. 14, 2022 | ||||||||||||
Waiver and Agreement | Relief Therapeutics Holding AG | Subsequent Event | Second Development Payment | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
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 | ||||||||||||
Weighted Average | Lincoln Park | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Issuance of common stock, price per share | $ 2.64 | $ 2.47 | $ 2.64 | ||||||||||
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 | 100,000 | ||||||||||||
Maximum | Collaboration Agreement | Relief Therapeutics Holding AG | |||||||||||||
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, net of issuance costs, shares | 1,838,957 | 877,107 | |||||||||||
Proceeds from issuance of common stock gross | $ 7,200,000 | $ 2,800,000 | |||||||||||
Common stock offering costs | 300,000 | 200,000 | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 6,900,000 | 2,600,000 | |||||||||||
Remained available under facility | $ 40,000,000 | ||||||||||||
At-the-Market Facility | Weighted Average | |||||||||||||
Organization Consolidation And Presentation Of Financial Statement [Line Items] | |||||||||||||
Issuance of common stock, price per share | $ 3.9228 | $ 3.1692 | $ 3.9228 | ||||||||||
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, net of issuance costs, shares | 244,998 | ||||||||||||
Issuance of common stock, price per share | $ 3.50 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 900,000 |
Significant Accounting Police_3
Significant Accounting Polices - Additional Information (Details) | Jan. 14, 2022USD ($) | Oct. 12, 2021USD ($) | Mar. 19, 2021USD ($) | Jan. 25, 2021USD ($) | Apr. 11, 2020USD ($) | Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($)Segment | Dec. 31, 2020USD ($) | Oct. 04, 2021USD ($) |
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 | $ 15,825,938 | ||||||||
Cash in excess of FDIC insured limit | $ 12,500,000 | $ 5,500,000 | |||||||
Expected term of stock option granted to employees and directors, average contractual term and vesting period | 10 years | ||||||||
Impairment of in-process research and development | 118,600 | ||||||||
Uncertain tax positions, accruals | $ 0 | 0 | |||||||
Accruals for interest or penalties related to income tax matters | 0 | 0 | |||||||
Forgiveness of PPP loan | $ 568,909 | ||||||||
Number of operating segment | Segment | 1 | ||||||||
PPP Loan | JPMorgan Chase Bank, N.A | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
CARES act of 2020 aid loan amount | $ 600,000 | ||||||||
Forgiveness of PPP loan | $ 600,000 | ||||||||
In-process Research and Development | Research and Development | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Impairment of in-process research and development | 100,000 | ||||||||
Accounts Payable and Accrued Expenses | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Preclinical or clinical study expense | $ 200,000 | 1,800,000 | |||||||
Cash and Cash Equivalents | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Investments in money market funds | 12,200,000 | $ 5,300,000 | |||||||
Maximum | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Cash, FDIC insured amount | 250,000 | ||||||||
Relief | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Non-cash reduction recognized in secured loan | 4,000,000 | ||||||||
Collaboration Agreement | Second Development Payment | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Receivables recognized | 5,000,000 | ||||||||
Deferred collaboration funding | 24,500,000 | ||||||||
Deferred collaboration funding, current | 15,800,000 | ||||||||
Noncurrent liability | 8,800,000 | ||||||||
Deferred collaboration funding, cash received | 35,000,000 | ||||||||
Revenue recognized | 1,300,000 | ||||||||
Offset to research and development expenses | 5,800,000 | ||||||||
Offset to general and administrative expenses | $ 3,400,000 | ||||||||
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% | 15.00% | |||||||
Milestone payment to be received | $ 6,000,000 | $ 6,000,000 | |||||||
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 | ||||||||
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 | Maximum | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Development and commercial launch costs | 20,000,000 | ||||||||
Development payments | 20,000,000 | ||||||||
Collaboration Agreement | Relief | Second Development Payment | |||||||||
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 | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | $ 5,000,000 | |||||||
Proposed Collaboration and License Agreement | |||||||||
Schedule Of Significant Accounting Policies [Line Items] | |||||||||
Upfront non-refundable payment received | $ 1,000,000 | ||||||||
Proposed Collaboration and License Agreement | Relief | |||||||||
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) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 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 ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 319,869 | $ 264,925 |
Less accumulated depreciation | (205,757) | (134,844) |
Property and equipment, net | 114,112 | 130,081 |
Computer Hardware and Software | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 113,847 | 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 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Computer Hardware and Software | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture and Fixtures | |
Property Plant And Equipment [Line Items] | |
Estimated useful lives | 7 years |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Accounts Payable And Accrued Liabilities Current [Abstract] | ||
Accrued contract manufacturing | $ 827,390 | $ 1,479,771 |
Accrued payroll and payroll taxes | 419,354 | 267,159 |
Accrued precommercial costs | 395,923 | |
Accrued miscellaneous expenses | 216,103 | 102,999 |
Accrued accounting, audit, and tax fees | 167,630 | 181,200 |
Accrued legal | 162,812 | 350,517 |
Accrued consulting | 105,085 | 88,750 |
Accrued license fees | 86,259 | 240,041 |
Accrued contract research and regulatory consulting | 47,637 | 1,070,664 |
Total accrued expenses | $ 2,428,193 | $ 3,781,101 |
Leases - Additional Information
Leases - Additional Information (Details) | Nov. 17, 2021 | Oct. 15, 2021 | Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) | Apr. 23, 2019ft² | Mar. 05, 2019ft² | Apr. 01, 2018ft² | Mar. 06, 2018ft² |
Lessee Lease Description [Line Items] | ||||||||
Operating lease right of use asset | $ | $ 400,000 | |||||||
Operating lease liability | $ | $ 393,837 | $ 364,311 | ||||||
Operating lease discount rate | 10.00% | 8.00% | ||||||
Operating lease, weighted average remaining lease term | 2 years 9 months 18 days | |||||||
Operating lease, cash payment made | $ | $ 300,000 | $ 300,000 | ||||||
Operating lease expense | $ | $ 300,000 | $ 300,000 | ||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | us-gaap:OtherAssets | |||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | us-gaap:OtherLiabilities | |||||||
Newton Lease | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease expiration date | May 31, 2022 | |||||||
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 | 2,760 | |||||||
Additional Newton Lease | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease expiration date | Dec. 31, 2022 | |||||||
Additional 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 | 1,600 | |||||||
Amendment of Newton Lease | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease expiration date | Jun. 1, 2022 | |||||||
Reduced area of land | 1,600 | |||||||
Amendment of Newton Lease | Newton, Massachusetts | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement date | Oct. 15, 2021 | |||||||
Bend Lease | Oregon | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement date | Apr. 1, 2018 | |||||||
Square feet of office space leased | 2,288 | |||||||
Additional 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 | 1,389 | |||||||
Modified Bend Lease | ||||||||
Lessee Lease Description [Line Items] | ||||||||
Lease agreement date | Nov. 17, 2021 | |||||||
Lease expiration date | Jun. 30, 2022 | |||||||
Lease, existence of option to extend | true | |||||||
Lease, option to extend | On November 17, 2021, the Company entered into a lease agreement to extend the term of Bend Lease and the Additional Bend Lease to June 30, 2022 and to further extend the term either (1) until June 30, 2027 if FDA approval of ACER-001 is received in June 2022, or (2) until June 30, 2025 if FDA approval of ACER-001 is not received in June 2022 |
Leases - Reconciliation of Undi
Leases - Reconciliation of Undiscounted Lease Liabilities to Total Lease Liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Undiscounted lease liabilities for years ending December 31, | ||
2022 | $ 190,064 | |
2023 | 103,925 | |
2024 | 107,290 | |
2025 | 54,579 | |
Total undiscounted lease liabilities | 455,858 | |
Less effects of discounting | (62,021) | |
Total lease liabilities as of December 31, 2021 | 393,837 | $ 364,311 |
Operating lease liability, current | $ 184,340 | $ 274,172 |
Operating Lease Liability Current Statement Of Financial Position Extensible List | Other current liabilities | Other current liabilities |
Operating lease liability, non-current | $ 209,497 | $ 90,139 |
Operating Lease Liability Noncurrent Statement Of Financial Position Extensible List | Other non-current liabilities | Other non-current liabilities |
Total lease liabilities | $ 393,837 | $ 364,311 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | Jan. 14, 2022USD ($) | Oct. 12, 2021USD ($) | Mar. 19, 2021USD ($) | Jan. 25, 2021USD ($) | Jan. 21, 2021USD ($) | Jun. 05, 2020 | Apr. 11, 2020USD ($) | Sep. 30, 2018Patent | Aug. 31, 2016 | Jun. 30, 2021USD ($) | Dec. 31, 2021USD ($) | Oct. 04, 2021USD ($) | Dec. 31, 2020USD ($) |
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 liabilities | 9,450,085 | $ 692,336 | |||||||||||
Other current assets | 9,283,625 | $ 168,826 | |||||||||||
Pending Litigation | The Securities Class Action | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Proposed settlement as a loss in accrued expenses | 8,400,000 | ||||||||||||
Other current liabilities | 900,000 | ||||||||||||
Other current assets | $ 900,000 | ||||||||||||
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 | ||||||||||||
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 | 2016-08 | |||||||||||
Number of patent applications | Patent | 3 | ||||||||||||
Relief Therapeutics Holding AG | Collaboration Agreement | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Upfront non-refundable payment received | $ 1,000,000 | ||||||||||||
Cash payment received | 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 | ||||||||||||
Potential proceeds from development payments subject to new drug application | $ 10,000,000 | ||||||||||||
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 | |||||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | ||||||||||||
Relief Therapeutics Holding AG | Collaboration Agreement | First Development Payment | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Development payments subject new drug application | $ 10,000,000 | ||||||||||||
Relief Therapeutics Holding AG | Collaboration Agreement | Second Development Payment | |||||||||||||
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 Therapeutics Holding AG | Collaboration Agreement | Maximum | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Development and commercial launch costs | $ 20,000,000 | ||||||||||||
Relief Therapeutics Holding AG | 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 Therapeutics Holding AG | Waiver and Agreement | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Proceeds from second tranche of development payments subject to new drug application | 5,000,000 | ||||||||||||
Relief Therapeutics Holding AG | Waiver and Agreement | Second Development Payment | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | 5,000,000 | |||||||||||
Proceeds from second tranche of development payments subject to new drug application | $ 5,000,000 | ||||||||||||
Relief Therapeutics Holding AG | Waiver and Agreement | Subsequent Event | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
Second tranche of development payment, expiry date | Jan. 14, 2022 | ||||||||||||
Relief Therapeutics Holding AG | Waiver and Agreement | Subsequent Event | Second Development Payment | |||||||||||||
Commitments And Contingencies [Line Items] | |||||||||||||
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 |
Stockholders' (Deficit) Equit_2
Stockholders' (Deficit) 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 | Dec. 31, 2020 | Dec. 31, 2021 | Dec. 31, 2020 | Jan. 01, 2021 | Jan. 01, 2020 |
Stockholders Equity [Line Items] | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 3,139,047 | $ 10,159,766 | ||||||||||
Number of share outstanding | 1,240,354 | 1,954,975 | 1,240,354 | |||||||||
Awards granted under the plan | 733,500 | |||||||||||
Unrecognized compensation expense | $ 2,500,000 | |||||||||||
Share based compensation arrangement by share based payment award, Average remaining vesting period | 2 years 9 months 18 days | |||||||||||
Weighted average grant date fair value of options granted | $ 2.57 | $ 1.99 | ||||||||||
Fair value of options vested | $ 2,000,000 | $ 2,400,000 | ||||||||||
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% | |||||||||||
Available for the grant of future awards | 456,778 | |||||||||||
Options contractual term | 10 years | |||||||||||
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 Share-based compensation arrangement by share-based payment award, Vesting percentage | 25.00% | |||||||||||
Executive Officers and Employees | 2018 Stock Incentive Plan | One-year Anniversary of the Grant Date | Restricted Stock Units | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Awards granted under the plan | 0 | 0 | ||||||||||
Executive Officers and Employees | 2018 Stock Incentive Plan | One-year Anniversary of the Grant Date | Unvested Restricted Stock Units | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Awards granted under the plan | 0 | 0 | ||||||||||
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 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 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 Share-based compensation arrangement by share-based payment award, Vesting percentage | 50.00% | |||||||||||
Board of Directors | 2018 Stock Incentive Plan | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Share-based compensation arrangement by share-based payment award, stock options vesting period | 12 months | |||||||||||
Lincoln Park | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Issuance of common stock, net of issuance costs, shares | 200,000 | 900,000 | ||||||||||
Issuance of common stock, price per share | $ 2.64 | $ 2.47 | $ 2.64 | |||||||||
Proceeds from issuance of common stock gross | $ 500,000 | $ 2,400,000 | ||||||||||
Common stock offering costs | 2,200,000 | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | 200,000 | |||||||||||
Remaining obligation | 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 | |||||||||||
Fair value of the commitment fee shares, recorded to general and administrative expense along with other costs | $ 400,000 | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 500,000 | $ 2,200,000 | ||||||||||
Weighted Average | Lincoln Park | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Issuance of common stock, price per share | $ 2.64 | $ 2.47 | $ 2.64 | |||||||||
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, net of issuance costs, shares | 1,838,957 | 877,107 | ||||||||||
Proceeds from issuance of common stock gross | $ 7,200,000 | $ 2,800,000 | ||||||||||
Common stock offering costs | 300,000 | 200,000 | ||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 6,900,000 | 2,600,000 | ||||||||||
Amount remained available under facility | $ 40,000,000 | |||||||||||
At-the-Market Facility | Weighted Average | ||||||||||||
Stockholders Equity [Line Items] | ||||||||||||
Issuance of common stock, price per share | $ 3.9228 | $ 3.1692 | $ 3.9228 | |||||||||
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, net of issuance costs, shares | 244,998 | |||||||||||
Issuance of common stock, price per share | $ 3.50 | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 900,000 |
Stockholders' (Deficit) Equit_3
Stockholders' (Deficit) Equity - Summary of Option Activity under 2018 Plan, 2013 Plan and 2010 Plan (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Options | ||
Number of Shares, Options outstanding at beginning of period | 1,240,354 | |
Number of Shares, Options Granted | 733,500 | |
Number of Shares, Options Cancelled/forfeited | (18,879) | |
Number of Shares, Options outstanding at end of period | 1,954,975 | 1,240,354 |
Number of Shares, Options exercisable at end of period | 894,879 | |
Weighted Average Exercise Price, Options | ||
Weighted Average Exercise Price, Options outstanding at beginning of period | $ 11.16 | |
Weighted Average Exercise Price, Options Granted | 3.41 | |
Weighted Average Exercise Price, Options Cancelled/forfeited | 20.37 | |
Weighted Average Exercise Price, Options outstanding at end of period | 8.16 | $ 11.16 |
Weighted Average Exercise Price, Options exercisable at end of period | $ 11.94 | |
Weighted Average Remaining Contract Term, Options | ||
Weighted Average Remaining Contractual Term, Options outstanding at beginning of period | 7 years 9 months 18 days | 7 years 9 months 18 days |
Weighted Average Remaining Contractual Term, Options exercisable at end of period | 6 years 7 months 6 days | |
Aggregate Intrinsic Value | ||
Aggregate Intrinsic Value, Options outstanding at end of period | $ 2 |
Stockholders' (Deficit) Equit_4
Stockholders' (Deficit) Equity - Summary of Stock-Based Compensation Expense (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stockholders Equity [Line Items] | ||
Stock-based compensation expense | $ 2,287,007 | $ 2,224,146 |
Research and Development | ||
Stockholders Equity [Line Items] | ||
Stock-based compensation expense | 696,283 | 764,526 |
General and Administrative | ||
Stockholders Equity [Line Items] | ||
Stock-based compensation expense | $ 1,590,724 | $ 1,459,620 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Line Items] | ||
Provision for income taxes | $ 0 | $ 0 |
Net operating loss carryforwards | 12,059,019 | 11,979,869 |
Research and development and orphan drug credits | $ 8,700,000 | |
Net operating loss carryforwards term | 20 years | |
Net operating loss carryforwards expiration beginning year | 2022 | |
Uncertain tax positions, accruals | $ 0 | 0 |
Accruals for interest or penalties related to income tax matters | 0 | $ 0 |
U.S. Federal and State | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 51,100,000 | |
State | ||
Income Tax Disclosure [Line Items] | ||
Net operating loss carryforwards | 1,700,000 | |
Research and development and orphan drug credits | $ 100,000 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets and Liabilities (Details) - USD ($) | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carry forwards | $ 12,059,019 | $ 11,979,869 |
Capitalized research and development costs | 18,865,707 | 18,650,538 |
Accrued liabilities | 156,415 | 111,481 |
Tax credit carryforwards | 8,730,816 | 7,755,146 |
Stock-based compensation | 1,745,654 | 1,229,407 |
Deferred collaboration funding | 3,312,415 | |
Operating lease | 94,946 | 86,491 |
Total deferred tax assets | 44,964,972 | 39,812,932 |
Valuation allowance | (44,866,411) | (39,726,441) |
Net deferred tax assets | 98,561 | 86,491 |
Deferred tax liabilities: | ||
Operating lease right of use asset | (94,945) | (86,491) |
Unrealized foreign exchange gain | (3,616) | |
Total deferred tax liabilities | $ (98,561) | $ (86,491) |
Income Taxes - Schedule of Reco
Income Taxes - Schedule of Reconciliation of Effective Income Tax Rate (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21.00% | 21.00% |
R&D and Orphan Drug credits | 6.40% | 2.50% |
State income tax, net of federal tax benefit | 5.40% | 1.50% |
Valuation allowance | (33.20%) | (24.30%) |
Share-based compensation | (0.30%) | (0.80%) |
Other, net | 0.70% | 0.10% |
Effective tax rate | 0.00% | 0.00% |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,954,975 | 1,240,354 |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 1,954,975 | 1,240,354 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ in Millions | Jan. 14, 2022 | Oct. 12, 2021 | Jan. 01, 2022 |
Waiver and Agreement | Relief Therapeutics Holding AG | |||
Subsequent Event [Line Items] | |||
Proceeds from second tranche of development payments subject to new drug application | $ 5 | ||
Waiver and Agreement | Relief Therapeutics Holding AG | Second Development Payment | |||
Subsequent Event [Line Items] | |||
Proceeds from second tranche of development payments subject to new drug application | $ 5 | ||
Subsequent Event | Maximum | Bonus | |||
Subsequent Event [Line Items] | |||
Discretionary bonus pool for employees | $ 2.2 | ||
Subsequent Event | Waiver and Agreement | Relief Therapeutics Holding AG | Second Development Payment | |||
Subsequent Event [Line Items] | |||
Proceeds from second tranche of development payments subject to new drug application | $ 5 | ||
Second tranche of development payment date | Jan. 14, 2022 |