Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 01, 2022 | |
Cover [Abstract] | ||
Entity Registrant Name | Acer Therapeutics Inc. | |
Entity Central Index Key | 0001069308 | |
Document Type | 10-Q | |
Document Period End Date | Jun. 30, 2022 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Trading Symbol | ACER | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Common Stock, Shares Outstanding | 15,942,749 | |
Document Fiscal Period Focus | Q2 | |
Document Fiscal Year Focus | 2022 | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 001-33004 | |
Entity Tax Identification Number | 32-0426967 | |
Entity Address, Address Line One | One Gateway Center | |
Entity Address, Address Line Two | Suite 356 | |
Entity Address, Address Line Three | 300 Washington Street | |
Entity Address, City or Town | Newton | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02458 | |
City Area Code | 844 | |
Local Phone Number | 902-6100 | |
Entity Interactive Data Current | Yes | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Security Exchange Name | NASDAQ | |
Entity Incorporation, State or Country Code | DE | |
Document Quarterly Report | true | |
Document Transition Report | false |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 14,469,744 | $ 12,710,762 |
Collaboration receivable | 5,000,000 | |
Prepaid expenses | 666,318 | 1,094,229 |
Other current assets | 65,061 | 9,283,625 |
Total current assets | 15,201,123 | 28,088,616 |
Property and equipment, net | 101,582 | 114,112 |
Other assets: | ||
Goodwill | 7,647,267 | 7,647,267 |
Other non-current assets | 292,918 | 406,956 |
Total assets | 23,242,890 | 36,256,951 |
Current liabilities: | ||
Accounts payable | 3,491,991 | 1,405,734 |
Accrued expenses | 5,567,964 | 2,428,193 |
Deferred collaboration funding, current | 6,340,438 | 15,825,938 |
Other current liabilities | 185,265 | 9,450,085 |
Bridge loan payable, current, at fair value | 1,887,606 | |
Total current liabilities | 17,473,264 | 29,109,950 |
Deferred collaboration funding, non-current | 7,868,731 | 8,661,109 |
Bridge loan payable non-current, at fair value | 2,197,103 | |
Convertible note payable, at fair value | 4,321,200 | |
Other non-current liabilities | 166,134 | 209,497 |
Total liabilities | 32,026,432 | 37,980,556 |
Commitments and Contingencies (Note 8) | ||
Stockholders’ deficit: | ||
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; 15,672,791 and 14,310,244 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 1,567 | 1,431 |
Additional paid-in capital | 117,570,885 | 112,784,918 |
Accumulated deficit | (126,355,994) | (114,509,954) |
Total stockholders’ deficit | (8,783,542) | (1,723,605) |
Total liabilities and stockholders’ deficit | $ 23,242,890 | $ 36,256,951 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 15,672,791 | 14,310,244 |
Common stock, shares outstanding | 15,672,791 | 14,310,244 |
Condensed Statements of Operati
Condensed Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Income Statement [Abstract] | ||||
Revenue | $ 900,000 | |||
Operating expenses: | ||||
Research and development (net of collaboration funding of $1,648,631 and $1,025,935 in the three months ended June 30, 2022 and 2021, respectively, and of $4,648,002 and $1,312,038 in the six months ended June 30, 2022 and 2021, respectively) | $ 3,426,773 | $ 1,361,287 | $ 6,598,412 | 3,367,192 |
General and administrative (net of collaboration funding of $3,257,701 and $602,534 in the three months ended June 30, 2022 and 2021, respectively, and of $5,629,876 and $602,534 in the six months ended June 30, 2022 and 2021, respectively) | 3,638,073 | 2,268,508 | 7,513,674 | 5,782,649 |
Total operating expenses | 7,064,846 | 3,629,795 | 14,112,086 | 9,149,841 |
Loss from operations | (7,064,846) | (3,629,795) | (14,112,086) | (8,249,841) |
Other income (expense), net: | ||||
Costs of debt issuance | (200,129) | (1,368,194) | ||
Changes in fair value of debt instruments | 4,729,460 | 3,767,060 | ||
Interest and other income (expense) , net | (139,234) | 564,914 | (142,072) | 524,751 |
Foreign currency transaction gain (loss) | 7,713 | (4,156) | 9,252 | 44,748 |
Total other income (expense), net | 4,397,810 | 560,758 | 2,266,046 | 569,499 |
Net loss | $ (2,667,036) | $ (3,069,037) | $ (11,846,040) | $ (7,680,342) |
Net loss per share - basic | $ (0.17) | $ (0.21) | $ (0.80) | $ (0.54) |
Net loss per share - diluted | $ (0.64) | $ (0.21) | $ (0.54) | |
Weighted average common shares outstanding - basic | 15,273,707 | 14,310,244 | 14,794,637 | 14,225,551 |
Weighted average common shares outstanding - diluted | 14,310,244 | 14,310,244 | 14,225,551 |
Condensed Statements of Opera_2
Condensed Statements of Operations (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Research and Development | ||||
Collaboration funding amount | $ 1,648,631 | $ 1,025,935 | $ 4,648,002 | $ 1,312,038 |
General and Administrative | ||||
Collaboration funding amount | $ 3,257,701 | $ 602,534 | $ 5,629,876 | $ 602,534 |
Condensed Statements of Changes
Condensed Statements of Changes in Stockholders' (Deficit) Equity - USD ($) | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit |
Beginning balance at Dec. 31, 2020 | $ 8,224,334 | $ 1,324 | $ 107,358,971 | $ (99,135,961) |
Beginning balance, shares at Dec. 31, 2020 | 13,233,137 | |||
Issuance of common stock, net of issuance costs | 3,139,047 | $ 107 | 3,138,940 | |
Issuance of common stock, net of issuance costs, shares | 1,077,107 | |||
Stock-based compensation | 559,436 | 559,436 | ||
Net loss | (4,611,305) | (4,611,305) | ||
Ending balance at Mar. 31, 2021 | 7,311,512 | $ 1,431 | 111,057,347 | (103,747,266) |
Ending balance, shares at Mar. 31, 2021 | 14,310,244 | |||
Beginning balance at Dec. 31, 2020 | 8,224,334 | $ 1,324 | 107,358,971 | (99,135,961) |
Beginning balance, shares at Dec. 31, 2020 | 13,233,137 | |||
Net loss | (7,680,342) | |||
Ending balance at Jun. 30, 2021 | 4,837,138 | $ 1,431 | 111,652,010 | (106,816,303) |
Ending balance, shares at Jun. 30, 2021 | 14,310,244 | |||
Beginning balance at Mar. 31, 2021 | 7,311,512 | $ 1,431 | 111,057,347 | (103,747,266) |
Beginning balance, shares at Mar. 31, 2021 | 14,310,244 | |||
Stock-based compensation | 594,663 | 594,663 | ||
Net loss | (3,069,037) | (3,069,037) | ||
Ending balance at Jun. 30, 2021 | 4,837,138 | $ 1,431 | 111,652,010 | (106,816,303) |
Ending balance, shares at Jun. 30, 2021 | 14,310,244 | |||
Beginning balance at Dec. 31, 2021 | $ (1,723,605) | $ 1,431 | 112,784,918 | (114,509,954) |
Beginning balance, shares at Dec. 31, 2021 | 14,310,244 | 14,310,244 | ||
Stock-based compensation | $ 474,097 | 474,097 | ||
Proceeds allocated to SWK Warrant | 327,031 | 327,031 | ||
Net loss | (9,179,004) | (9,179,004) | ||
Ending balance at Mar. 31, 2022 | (10,101,481) | $ 1,431 | 113,586,046 | (123,688,958) |
Ending balance, shares at Mar. 31, 2022 | 14,310,244 | |||
Beginning balance at Dec. 31, 2021 | $ (1,723,605) | $ 1,431 | 112,784,918 | (114,509,954) |
Beginning balance, shares at Dec. 31, 2021 | 14,310,244 | 14,310,244 | ||
Net loss | $ (11,846,040) | |||
Ending balance at Jun. 30, 2022 | $ (8,783,542) | $ 1,567 | 117,570,885 | (126,355,994) |
Ending balance, shares at Jun. 30, 2022 | 15,672,791 | 15,672,791 | ||
Beginning balance at Mar. 31, 2022 | $ (10,101,481) | $ 1,431 | 113,586,046 | (123,688,958) |
Beginning balance, shares at Mar. 31, 2022 | 14,310,244 | |||
Issuance of common stock, net of issuance costs | $ 3,524,198 | $ 136 | 3,524,062 | |
Issuance of common stock, net of issuance costs, shares | 300,000 | 1,362,547 | ||
Stock-based compensation | $ 460,777 | 460,777 | ||
Net loss | (2,667,036) | (2,667,036) | ||
Ending balance at Jun. 30, 2022 | $ (8,783,542) | $ 1,567 | $ 117,570,885 | $ (126,355,994) |
Ending balance, shares at Jun. 30, 2022 | 15,672,791 | 15,672,791 |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (11,846,040) | $ (7,680,342) |
Adjustments to reconcile net loss to net cash (used in) provided by operating activities: | ||
Stock-based compensation | 934,874 | 1,154,099 |
Depreciation | 38,796 | 32,637 |
Non-cash changes in fair value of debt | (3,767,060) | |
Debt issuance costs recognized as expense | 1,368,194 | |
Gain on extinguishment of debt | (568,909) | |
Non-cash interest expense | 2,756 | |
Loss on disposal of property and equipment, net | 4,669 | |
Changes in operating assets and liabilities | ||
Collaboration receivable | 5,000,000 | |
Prepaid expenses | 427,911 | 251,338 |
Other current assets | 9,215,320 | (9,395,172) |
Accounts payable | 2,086,257 | 136,346 |
Accrued expenses | 3,139,771 | (2,281,814) |
Deferred collaboration funding | (10,277,878) | 18,191,292 |
Other current liabilities | (9,190,901) | 9,400,708 |
Net cash (used in) provided by operating activities | (12,866,087) | 9,242,939 |
Cash flows from investing activities: | ||
Purchase of property and equipment | (30,935) | (15,222) |
Net cash used in investing activities | (30,935) | (15,222) |
Cash flows from financing activities: | ||
Proceeds from issuance of common stock, net of issuance costs | 3,524,198 | 3,139,047 |
Receipt of funds from Relief secured loans | 4,000,000 | |
Proceeds from Bridge Loan, net of warrant allocation and lender fees | 6,013,148 | |
Proceeds from Secured Convertible Notes, net of lender fees | 5,516,556 | |
Proceeds allocated to SWK Warrant based on valuation | 327,031 | |
Payment of debt and convertible debt issuance costs | (724,929) | |
Net cash provided by financing activities | 14,656,004 | 7,139,047 |
Net increase in cash and cash equivalents | 1,758,982 | 16,366,764 |
Cash and cash equivalents, beginning of period | 12,710,762 | 5,761,568 |
Cash and cash equivalents, end of period | 14,469,744 | 22,128,332 |
Supplemental cash flow information: | ||
Cash paid for interest | $ 136,500 | |
Non-cash financing activities: | ||
Non-cash repayment of secured loan | 4,000,000 | |
Extinguishment of debt | $ 568,909 |
Nature of Operations and Basis
Nature of Operations and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
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 investigational 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 $126.4 million and cash and cash equivalents of $14.5 million as of June 30, 2022. Net cash used in operating activities was $12.9 million for the six months ended June 30, 2022. On November 9, 2018, the Company entered into a sales agreement with Roth Capital Partners, LLC, and on March 18, 2020, an amended and restated sales agreement was entered into with JonesTrading Institutional Services LLC and Roth Capital Partners, LLC. The agreement provides a facility for the offer and sale of shares of common stock from time to time having an aggregate offering price of up to $50.0 million depending upon market demand, in transactions deemed to be an at-the-market (“ATM”) offering. The Company has no obligation to sell any shares of common stock pursuant to the agreement and may at any time suspend sales pursuant to the agreement. Each party may terminate the agreement at any time without liability. During the three and six months ended June 30, 2022, the Company sold 1,062,547 shares of common stock through its ATM facility at a gross sale price of $3.0719 per share, for gross proceeds of $3.3 million. Proceeds, net of $0.2 million of fees and offering costs, were $3.1 million. As of June 30, 2022, $36.7 million remained available under the Company’s ATM facility, subject to various limitations. 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 $11.8 million obligation remaining as of June 30, 2022. 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. During the three and six months ended June 30, 2022, the Company sold 300,000 shares of common stock under its purchase agreement with Lincoln Park at a weighted average gross sale price of $1.25 per share, resulting in proceeds of $0.4 million. On January 25, 2021, the Company entered into an option agreement (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 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 (consisting of a $14.0 million “Reimbursement Payment” from Relief to the Company offset by payment of the $4.0 million outstanding balance of the Note plus interest earned through the date of the Collaboration Agreement) and Relief released its security interest in all of the Company’s assets pursuant to the Promissory Note. 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 a New Drug Application (“NDA”) for ACER-001 in a UCD for filing and review. This acceptance was received on October 4, 2021. On October 6, 2021, the Company entered into a Waiver and Agreement with Relief to amend the timing for the Second Development Payment. The Company received the 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 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 Collaboration Agreement and Option Agreement are further described below in the Revenue Recognition and Accounting for Collaboration Agreements section of Note 2, Significant Accounting Policies. On March 4, 2022, the Company entered into a Credit Agreement (the “SWK Credit Agreement”) with the lenders party thereto and SWK Funding LLC (“SWK”), as the agent, sole lead arranger and sole bookrunner, which provided for a senior secured term loan facility in an aggregate amount of $6.5 million in a single borrowing (the “Bridge Loan”). The Bridge Loan funding closed on March 14, 2022. The proceeds of the Bridge Loan were used to pay fees, costs and expenses related to the SWK Credit Agreement, the Secured Convertible Note Purchase Agreement (as defined and described below) and the Marathon Credit Agreement (as defined and described below) and for other working capital and general corporate purposes. The Bridge Loan bears interest at an annual rate of the sum of (i) 3-month LIBOR (or such other rate as may be agreed by the Company and SWK following the date on which 3-month LIBOR is no longer available), subject to a 1% floor, plus (ii) a margin of 11%, with such interest payable quarterly in arrears. In the event of default, the interest rate will increase by 3% per annum over the contract rate effective at the time of default but shall not be higher than the maximum rate permitted to be charged by applicable laws. The Company has the option to capitalize such interest commencing on the date on which the Bridge Loan was funded and continuing until November 15, 2022. Commencing on November 15, 2022, the principal amount of the Bridge Loan will amortize at a rate of $0.7 million, payable quarterly. The final maturity date of the Bridge Loan is (a) if full approval by FDA for marketing of ACER-001 (“ACER-001 Approval”) occurs on or before September 30, 2022, then the date which is 12 business days after ACER-001 Approval, or (b) if ACER-001 Approval does not occur on or before September 30, 2022, then March 4, 2024. The Company has the option to prepay the Bridge Loan in whole or in part. Upon the repayment of the Bridge Loan (whether voluntary or at scheduled maturity), the Company must pay an exit fee so that SWK receives an aggregate amount (inclusive of all principal, interest and origination and other fees paid to SWK under the SWK Credit Agreement on or prior to the prepayment date) equal to (a) 1.3 1.5 The Bridge Loan is secured by a first priority lien on all assets of the Company and any of its future subsidiaries pursuant to a Guarantee and Collateral Agreement entered into on March 4, 2022, between the Company and SWK, as agent (the “SWK Security Agreement”). The SWK Credit Agreement contains customary representations and warranties and affirmative and negative covenants. The Company paid to SWK $ 0.1 million in origination fees on the date on which the Bridge Loan was funded. In addition, the Company issued a warrant (the “SWK Warrant”) to purchase 150,000 shares of the Company’s common stock at an exercise price of $2.46 per share. SWK may exercise the SWK Warrant in accordance with the terms thereof for all or any part of such shares of common stock from the date on which the Bridge Loan was funded until and including March 4, 2029. On March 4, 2022, the Company also entered into a Secured Convertible Note Purchase Agreement with MAM Aardvark, LLC (“Marathon”) and Marathon Healthcare Finance Fund, L.P. (“Marathon Fund” and together with “Marathon” each a “Holder” and collectively the “Holders”) (the “Secured Convertible Note Purchase Agreement”) pursuant to which the Company issued and sold to the Holders secured convertible notes (the “Secured Convertible Notes”) in an aggregate amount of up to $6.0 million (the “Convertible Note Financing”). The Convertible Note Financing closed on March 14, 2022. The proceeds of the Convertible Note Financing are being used to pay fees, costs and expenses related to the SWK Credit Agreement, the Secured Convertible Note Purchase Agreement and the Marathon Credit Agreement and for other working capital and general corporate purposes. The Secured Convertible Notes bear interest at an annual rate of 6.5%, with such interest payable quarterly; provided, however, that until the first to occur of ACER-001 Approval and the repayment in full of the Bridge Loan, interest will not be payable in cash, but will accrue and be payable in cash upon the earlier of a) the repayment of all obligations under the Bridge Loan and termination of such Bridge Loan or b) within three business days of ACER-001 Approval. Subject to the restrictions set forth in an agreement among each of the Holders and SWK, as agent and lender, and any other intercreditor or subordination agreement entered into in connection with the Term Loan (defined below), each of the Holders has the right, during the 30-day periods beginning 12 months, 18 months and 24 months after the closing date of the Convertible Note Financing, to require the Company to redeem the Convertible Secured Note held by such Holder at a redemption price of the outstanding principal amount plus any accrued but unpaid interest. Each of the Holders also has the right to convert all or any portion of the outstanding principal amount plus any accrued but unpaid interest under the Convertible Secured Note held by such Holder into shares of common stock at a conversion price of $2.50 per share, subject to adjustment. Each Holder has certain rights with respect to the registration by the Company for resale of the shares of common stock issuable upon conversion of the Secured Convertible Note held by such Holder which are forth in the Secured Convertible Note Purchase Agreement. Any outstanding principal, together with all accrued and unpaid interest, will be payable on the earlier of the third anniversary of the date of issuance, or upon a change of control of the Company. Pursuant to the Secured Convertible Note Purchase Agreement, the Secured Convertible Notes are secured by a lien on collateral representing substantially all assets of the Company, although such security interest is subordinated to the Company’s obligations under the SWK Credit Agreement and may also be subordinated to the Company’s obligations under the Marathon Credit Agreement. On March 4, 2022, the Company also entered into a Credit Agreement (the “Marathon Credit Agreement”) with the lenders party thereto and Marathon, as the agent, sole lead arranger and sole bookrunner, which provides for a senior secured term loan facility in an aggregate amount of up to $42.5 million in a single borrowing (the “Term Loan”). The Term Loan will be available to be borrowed only following ACER-001 Approval and until December 31, 2022 (i.e., if ACER-001 Approval does not occur on or before December 31, 2022, then the Term Loan will not be available unless the Company is able to obtain an extension for the time period beyond December 31, 2022, to the actual PDUFA target action date), and funding of the Term Loan is also subject to the satisfaction of conditions as set forth in the Marathon Credit Agreement. Although the Company’s resubmitted NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs has been accepted for substantive review by FDA, the Prescription Drug User Fee Act (“PDUFA”) target action date is January 15, 2023. The Term Loan, if it becomes available, will be used to refinance certain other indebtedness of the Company (including the Bridge Loan), to pay fees, costs and expenses related to the Marathon Credit Agreement and for other working capital and general corporate purposes. Should the Term Loan become available, the Company will pay Marathon a commitment fee equal to 1.5% of the Term Loan amount. The Marathon Credit Agreement also includes an accordion feature pursuant to which the Company, Marathon and the lenders under the Marathon Credit Agreement may agree to increase the Term Loan commitments by up to an additional $50.0 million dollars for a total commitment of $92.5 million; provided, however, that any such increase is within the sole discretion of each party (i.e., the Company cannot unilaterally trigger such an increase). The Term Loan would bear interest at an annual rate of 13.5% and would be payable quarterly in arrears. The Company would have the option to capitalize up to 4% of such interest commencing on the date on which the Term Loan is funded (the “Term Loan Funding Date”) and continuing until the third anniversary of the Term Loan Funding Date. Commencing on the third anniversary of the Term Loan Funding Date, the principal outstanding amount of the Term Loan would amortize at a rate of 2.78%, payable monthly. The final maturity date of the Term Loan would be the earlier of six years after the Term Loan Funding Date or December 31, 2028. The Company would have the option to prepay the Term Loan in whole or in part at any time, subject to a prepayment fee equal to (a) if the prepayment is made prior to March 4, 2025, then the greater of 5% or the amount of interest that would have accrued from the date of prepayment until March 4, 2025, (b) if the prepayment is made on or after March 4, 2025, but prior to March 4, 2026, then 3%, (c) if the prepayment is made on or after March 4, 2026, but prior to March 4, 2027, then 2 %, or (d) if the prepayment is made on or after March 4, 2027, then 1 %. The Term Loan would be secured by a first priority lien on all assets of the Company and any of its future subsidiaries pursuant to a Guarantee and Collateral Agreement to be entered into on the Term Loan Funding Date between the Company and Marathon, as agent (the “Marathon Security Agreement”). The Marathon Credit Agreement contains customary representations and warranties and affirmative and negative covenants. The Company paid $0.2 million in commitment fees to Marathon in connection with obtaining the commitments in respect of the Term Loan and will pay $0.6 million in additional commitment fees to Marathon following ACER-001 Approval or any change of control of the Company or sale or transfer of the ACER-001 product. In connection with the Marathon Credit Agreement, on March 4, 2022, the Company, Marathon and the Marathon Fund also entered into a Synthetic Royalty Agreement (the “Royalty Agreement”) pursuant to which, in the event of the funding of the Term Loan, the Company will pay Marathon and the Marathon Fund, on a quarterly basis, 2% of certain aggregate commercial revenue from sales of ACER-001 during that quarter (i.e., 2% of the net sales and of the amount of certain other payments), subject to a cap on the aggregate amount of such payments of $15.0 million. Upon a change of control of the Company or the sale of the ACER-001 business to a third party, the Company would pay Marathon and the Marathon Fund the difference between $15.0 million and the aggregate amount of the payments previously made by the Company to Marathon and the Marathon Fund pursuant to the Royalty Agreement. The Company’s cash and cash equivalents available at June 30, 2022 are expected to be sufficient to fund its anticipated operating and capital requirements through the third quarter of 2022. 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, through a collaboration agreement, and through debt instruments. 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 June 30, 2022, the Company had cash and cash equivalents of $14.5 million and current liabilities of $17.5 million, which include $6.3 million associated with deferred collaboration funding (see Revenue Recognition and Accounting for Collaboration Agreements below in Note 2, Significant Accounting Policies). The Company’s cash and cash equivalents available at June 30, 2022 are expected to be sufficient to fund its anticipated operating and capital requirements through the third quarter of 2022. The Company will need to raise additional capital to fund continued operations beyond the third quarter of 2022 because neither FDA approval of ACER-001 nor subsequent product revenues are assured. The Company may not be successful in its efforts to raise additional funds or achieve profitable operations. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations beyond the third quarter of 2022, including raising additional capital through either private or public equity or debt financing or additional program collaborations or non-dilutive funding, as well as using its ATM facility which has $36.7 million available as of June 30, 2022 and/or its remaining $11.8 million available under the equity line facility entered into on April 30, 2020 with Lincoln Park. (See At-the-Market Facility and Common Stock Purchase Agreement below in Note 9.) Due to the SEC’s “baby shelf rules,” which prohibit companies with a public float of less than $75 million from issuing securities under a shelf registration statement in excess of one-third of such company’s public float in a 12-month period, the Company is currently only able to issue a limited number of shares under its ATM facility which aggregate to no more than one-third of its public float. Additionally, 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 limit the Company’s ability to cause Lincoln Park to buy common stock from the Company. As noted above, the Company also has available to it the $42.5 million Term Loan conditional upon the approval of ACER-001 by FDA; provided, however, that if ACER-001 Approval does not occur on or before December 31, 2022, then the Term Loan will not be available unless the Company is able to obtain an extension for the time period beyond December 31, 2022, to the actual PDUFA target action date. The PDUFA target action date for the Company’s resubmitted NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatments of patients with UCDs is January 15, 2023. The Company has no commitments for any additional financing, except for the agreement with Lincoln Park, and the Marathon Credit Agreement for the Term Loan. Any amounts raised will be used for further development of its product candidates, precommercial activities, and for other working capital purposes. If the Company is unable to obtain additional funding to support its current or proposed activities and operations, it may not be able to continue its operations as currently anticipated , which may require it to suspend or terminate any ongoing development activities, modify its business plan, curtai l various aspects of its operations, cease operations , or seek relief under applicable bankruptcy laws. In such event, the Company’s stockholders may lose a substantial portion or even all of their investment. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the date these financial statements are available, or August 15, 2023. The accompanying unaudited condensed financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. Basis of Presentation The accompanying condensed financial statements are unaudited and have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Regulation S-X. The unaudited condensed financial statements have been prepared on the same basis as the audited annual financial statements and reflect, in the opinion of management, all adjustments of a normal and recurring nature that are necessary for the fair presentation of the Company’s financial position, results of operations, stockholders’ (deficit) equity and cash flows for the periods presented. The results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results to be expected for the year ending December 31, 2022 or for any other future annual or interim period. The condensed balance sheet as of December 31, 2021, included herein, was derived from the audited financial statements as of that date but does not include all disclosures required by GAAP. These unaudited financial state Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the Financial Accounting Standards Board (“FASB”). |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 2. SIGNIFICANT ACCOUNTING POLICIES The Company’s significant accounting policies are described in Note 2, “Significant Accounting Policies,” in its Annual Report on Form 10-K for the year ended December 31, 2021. Use of Estimates The Company’s accounting principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the condensed financial statements and reported amounts of revenues and expenses during the reporting period. From time to time, estimates having relatively higher significance include determination of stand-alone selling price and variable consideration estimates for purposes of revenue recognition, deferred collaboration funding, stock-based compensation, inputs to fair value for debt, 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 ASC 606 or ASC 808, the Company consider s the guidance in other accounting literature as applicable or by analogy to account for such transaction. The Company determines the units of account within the collaborative arrangement utilizing the guidance in ASC 606 to determine which promised goods or services are distinct. In order for a promised good or service to be considered “distinct” under ASC 606, the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct), and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). For any units of account that fall within the scope of ASC 606, where the other party is a customer, the Company evaluates the separate performance obligation(s) under each contract, determines the transaction price, allocates the transaction price to each performance obligation considering the estimated stand-alone selling prices of the services and recognizes revenue upon the satisfaction of such obligations at a point in time or over time dependent on the satisfaction of one of the following criteria: (1) the customer simultaneously receives and consumes the economic benefits provided by the vendor’s performance; (2) the vendor creates or enhances an asset controlled by the customer; 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 (consisting of a $14.0 million “Reimbursement Payment” from Relief to the Company offset by repayment of the $4.0 million outstanding balance of the Note, plus interest earned through the date of the Collaboration Agreement), and Relief released its security interest in all of the Company’s assets pursuant to the Promissory Note. 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. 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 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 C ollaborati on Agree ment where Relief does not represent a customer are outside of the scope of ASC 606. The Company also determined that the development and commercial ization 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 expenses and general and administrative expenses, 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 June 30, 2022, the amount of deferred collaboration funding associated with unsatisfied promises under the Collaboration Agreement amounted to $14.2 million. The Company has recorded $6.3 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 $7.9 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 June 30, 2022, deferred collaboration funding was composed of $35.0 million received from Relief, offset by $1.3 million recognized as license revenue during the year ended December 31, 2021 and $10.7 million recorded as an offset to research and development expenses and $8.8 million recorded as an offset to general and administrative expenses subsequent to signing the Collaboration Agreement and through the date of this report. Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. 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 June 30, 2022 and December 31, 2021, the Company had $14.2 million and $12.5 million, respectively, in excess of the FDIC insured limit. Under the Bridge Loan, the Company was required to maintain a cash and cash equivalents balance of not less than $4.0 million as of 20 days following receipt of FDA’s Complete Response Letter in June 2022 with respect to the Company’s NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs and is then required to maintain a cash and cash equivalents balance of not less than $6.5 million as of 40 days following receipt of that Complete Response Letter for the remainder of the time that the Bridge Loan is outstanding. The minimum cash balance would be reduced to $2.0 million in the event of positive safety and efficacy data for ACER-801 from a Phase 2a trial. The Company recognized a $4.0 million non-cash reduction in a secured loan from Relief during the six months ended June 30, 2021, since the Reimbursement Payment from Relief was received net of the amount of principal and interest due in connection with the secured loan. Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurement ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following: • Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. • Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Financial instruments consist of cash equivalents, collaboration receivable, accounts payable, accrued expenses, and debt instruments. These financial instruments are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature, except for cash equivalents and debt instruments, which were marked to market at the end of each reporting period. See Note 7 for additional information on the fair value of the debt liabilities. The Company elected the fair value option for both its Bridge Loan and its Secured Convertible Notes dated March 14, 2022 (see Note 7). The Company adjusts both the Bridge Loan and the Secured Convertible Notes to fair value through the change in fair value of debt in the accompanying unaudited condensed statements of operations. Subsequent unrealized gains and losses on items for which the fair value option is elected are reported in the accompanying unaudited condensed statement of operations. Debt Convertible notes are regarded as compound instruments, consisting of a liability component and an equity component. The Company determined that it is eligible for the fair value option election in connection with the Bridge Loan and the Secured Convertible Notes. Each instrument met the definition of a “recognized financial liability” which is an acceptable financial instrument eligible for the fair value option under ASC 825-10-15-4 and do not meet the definition of any of the financial instruments found within ASC 825-10-15-5 that are not eligible for the fair value option 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 (“CROs”), manufacturing organizations, and for other trial- and study-related activities. Payments under the Company’s agreements with external service providers depend on a number of factors such as site initiation, patient screening, enrollment, delivery of reports, and other events. In accruing for these activities, the Company obtains information from various sources and estimates the level of effort or expense allocated to each period. Adjustments to research and development expenses may be necessary in future periods as the Company’s estimates change. As these activities are generally material to the Company’s 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 three or six months ended June 30, 2022 or 2021. Accounts payable and accrued expenses include costs associated with preclinical or clinical studies of $0.3 million and $0.2 million at June 30, 2022 and December 31, 2021, respectively. Stock-Based Compensation The Company records stock-based payments at fair value. The measurement date for compensation expense related to awards is generally the date of the grant. The fair value of awards is recognized as an expense in the condensed statements 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. A limited number of option grants are periodically made to non-employee contractors, and 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 during the six months ended June 30, 2022 and 2021 using the Black-Scholes option pricing model: 2022 2021 Risk-free interest rate 1.18%-1.83% 0.37%- 0.62% Expected life (years) 6.25 6.25 Expected volatility 113.0% - 115.0% 92.4% 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 Company’s available stock price history and the stock price 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’s goodwill is allocated to the Company’s single reporting unit. The Company evaluates the recoverability of goodwill according to ASC Topic 350, Intangibles – Goodwill and Other the Company were to determine based on a qualitative assessment that it was more likely than not that the fair value of the reporting unit was less than its carrying value, a quantitative impairment test would then be performed. The quantitative impairment test compares the fair value of the reporting unit with its carrying amount, including goodwill. If the estimated fair value of the reporting unit is less than its carrying amount, a goodwill impairment would be recognized for the difference. The Company performed a qualitative analysis of goodwill as of June 21 , 2022 as it considered the Complete Response Letter received from FDA in June 2022 with respect to the Company’s NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs to be a triggering event requiring it to perform that analysis. Management concluded that it was more likely than not that the fair value of the reporting unit was greater than its carrying amount at June 30, 2022 . 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. The Company recorded no income tax expense or benefit during the three or six months ended June 30, 2022 and 2021, due to a full valuation allowance recognized against its net deferred tax assets. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. Utilization of net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code of 1986, and similar state provisions. The annual limitations may result in the expiration of net operating losses before utilization. The 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 June 30, 2022 and 2021. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. As of June 30, 2022 and 2021, 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 three or six months ended or to the Company’s assessment of the realizability of deferred tax assets as the carry back of net operating losses was used as a source of income. There were no other effects to the Company’s tax provision as a result of the CARES Act as of June 30, 2022. Basic and Diluted Net Loss per Common Share Basic and diluted net loss per common share is computed using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, warrants, and the impact of unvested restricted stock. Basic and diluted shares outstanding are the same for each period presented as all common stock equivalents, including potential shares from convertible debt and warrants, would be antidilutive due to the net losses incurred. The Company applied the two-class method to calculate basic and diluted net loss per share attributable to common stockholders as its warrants to purchase common stock are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. However, the two-class method does not impact the net loss per share of common stock as the Company has been in a net loss position and the warrant holders do not participate in losses. Diluted net income per share is computed using the more dilutive of (a) the two-class method or (b) the if-converted method o r treasury stock method, as applicable, to the potentially dilutive instruments. Recently Adopted 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) The Company early adopted ASU No. 2020-06 in the first quarter of 2021. See Note 6 regarding the Secured Convertible Notes which were recognized in the first quarter of 2022 consistent with the adoption of this guidance. In May 2021, the FASB issued ASU No. 2021-04 , Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force), which clarifies and reduces diversity in issuers’ accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The Company adopted ASU No. 2021-04 in the first quarter of 2022. There was no impact on the Company’s financial statements or disclosures as a result of the adoption of this guidance. 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 | 6 Months Ended |
Jun. 30, 2022 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 3. PROPERTY AND EQUIPMENT Property and equipment consisted of the following at June 30, 2022 and December 31, 2021: June 30, 2022 December 31, 2021 Computer hardware and software $ 144,782 $ 113,847 Leasehold improvements 52,887 60,535 Furniture and fixtures 106,698 145,487 Subtotal property and equipment, gross 304,367 319,869 Less accumulated depreciation (202,785 ) (205,757 ) Property and equipment, net $ 101,582 $ 114,112 |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2022 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Accrued Expenses | 4. ACCRUED EXPENSES Accrued expenses consisted of the following at June 30, 2022 and December 31, 2021: June 30, 2022 December 31, 2021 Accrued payroll and payroll taxes $ 2,539,643 $ 419,354 Accrued precommercial costs 1,120,435 395,923 Accrued contract manufacturing 935,710 827,390 Accrued accounting, audit, and tax fees 278,950 167,630 Accrued contract research and regulatory consulting 236,356 47,637 Accrued legal 212,291 162,812 Accrued consulting 103,855 105,085 Accrued license fees 78,015 86,259 Accrued miscellaneous expenses 62,709 216,103 Total accrued expenses $ 5,567,964 $ 2,428,193 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Leases | 5. LEASES On March 6, 2018, the Company entered into a lease agreement (the “Newton Lease”), commencing on October 1, 2018, for certain premises which consist of 2,760 square feet of office space located in Newton, Massachusetts. 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 was 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 the 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 was received in June 2022, or (2) until June 30, 2025 if FDA approval of ACER-001 was not received in June 2022. As FDA approval of ACER-001 was not received in June 2022, the Company entered into a lease amendment in June 2022 such that the renewal term for this office space was extended until June 30, 2025. 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 June 30, 2022 and 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 June 30, 2022, the weighted average remaining lease term was 2.7 years. The Company recorded expense of $0.1 million related to the leases for each of the three and six months ended June 30, 2022 and 2021. The Company made cash payments for amounts included in the measurement of lease liabilities of $0.1 million, during each of the three and six months ended June 30, 2022 and 2021. The Company reported a right-of-use asset of $0.3 million in Other non-current assets and lease liabilities totaling $0.3 million in Other current liabilities and Other non-current liabilities as of June 30, 2022. The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the unaudited condensed balance sheet as of June 30, 2022: Undiscounted lease liabilities for years ending December 31: 2022 (remaining) $ 60,317 2023 103,925 2024 107,290 2025 54,579 Total undiscounted lease liabilities 326,111 Less effects of discounting (49,556 ) Total lease liabilities as of June 30, 2022 $ 276,555 The Company’s lease liabilities are reported on the unaudited condensed balance sheets as follows: June 30, 2022 December 31, 2021 Other current liabilities $ 110,421 $ 184,340 Other non-current liabilities 166,134 209,497 Total lease liabilities $ 276,555 $ 393,837 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | 6. DEBT SWK Credit Agreement On March 4, 2022, the Company entered into the SWK Credit Agreement with the lenders party thereto and SWK, as the agent, sole lead arranger and sole bookrunner, which provides for a senior secured term loan facility in an aggregate amount of $6.5 million in a single borrowing (the “Bridge Loan”). The Bridge Loan closed on March 14, 2022, after consummation of the Convertible Note Financing (as defined and described below) as well as the satisfaction of other closing conditions as set forth in the SWK Credit Agreement. The proceeds of the Bridge Loan are being used to pay fees, costs and expenses related to the SWK Credit Agreement, the Secured Convertible Note Purchase Agreement (as defined and described below) and the Marathon Credit Agreement (as defined and described below) and for other working capital and general corporate purposes. The Bridge Loan bears interest at an annual rate of the sum of (i) 1.3 times 1.5 times The Bridge Loan is secured by a first priority lien on all assets of the Company and any of its future subsidiaries pursuant to the SWK Security Agreement. The SWK Credit Agreement contains customary representations and warranties and affirmative and negative covenants. The Company paid to SWK $0.1 million in origination fees on the date on which the Bridge Loan was funded. The Bridge Loan contains certain provisions which could accelerate the maturity date of the outstanding loan should the Company be out of compliance with any of the stated covenants. At June 30, 2022, the Company did not deem probable any events that would give rise to such an acceleration. The Company classified the principal amortization payments of $1.9 million due within twelve months from the date of this report as current in the unaudited condensed balance sheet as of June 30, 2022. In addition, the Company issued the SWK Warrant to purchase 150,000 shares of the Company’s common stock at an exercise price of $2.46 per share. SWK may exercise the SWK Warrant in accordance with the terms thereof for all or any part of such shares of common stock from the date on which the Bridge Loan was funded until and including March 4, 2029. The Company recognized the fair value of the SWK Warrant for $0.3 million as additional paid in capital as of the date of the closing of the transaction. The Company evaluated its compliance with all covenants with respect to the SWK Credit Agreement and concluded that it was in compliance as of June 30, 2022. Secured Convertible Notes On March 4, 2022, the Company also entered into the Secured Convertible Note Purchase Agreement with MAM Aardvark, LLC (“Marathon”) and Marathon Healthcare Finance Fund, L.P. (“Marathon Fund” and together with “Marathon” each a “Holder” and collectively the “Holders”) pursuant to which the Company issued and sold to the Holders the Secured Convertible Notes in an aggregate amount of $6.0 million (the “Convertible Note Financing”). The Convertible Note Financing closed on March 14, 2022 after satisfaction of closing conditions as set forth in the Secured Convertible Note Purchase Agreement. The proceeds of the Convertible Note Financing are being used to pay fees, costs and expenses related to the SWK Credit Agreement, the Secured Convertible Note Purchase Agreement and the Marathon Credit Agreement and for other working capital and general corporate purposes. The Secured Convertible Notes bear interest at an annual rate of 6.5%, with such interest payable quarterly; provided, however, that until the first to occur of ACER-001 Approval and the repayment in full of the Bridge Loan, interest will not be payable in cash, but will accrue and be payable in cash upon the earlier of a) the repayment of all obligations under the Bridge Loan and termination of such Bridge Loan or b) within three business days of ACER-001 Approval. Subject to the restrictions set forth in an agreement among each of the Holders and SWK, as agent and lender, and any other intercreditor or subordination agreement entered into in connection with the Term Loan (defined below), each of the Holders has the right, during the 30-day periods beginning 12 months, 18 months and 24 months after the closing date of the Convertible Note Financing, to require the Company to redeem the Convertible Secured Note held by such Holder at a redemption price of the outstanding principal amount plus any accrued but unpaid interest. In the event of default, interest on the Secured Convertible Notes will increase to the lower of 11.5 % per annum or the highest rate permitted by law. Each of the Holders also has the right to convert all or any portion of the outstanding principal amount plus any accrued but unpaid interest under the Convertible Secured Note held by such Holder into shares of c ommon s tock at a conversion price of $ 2.50 per share , subject to adjustment . Each Holder has certain rights with respect to the registration by the Company for resale of the shares of c ommon s tock issuable upon conversion of the Secured Convertible Note held by such Holder which are forth in the Secured Convertible Note Purchase Agreement. Any outstanding principal, together with all accrued and unpaid interest, will be payable on the earlier of the third anniversary of the date of issuance, or upon a change of control of the Company. Pursuant to the Secured Convertible Note Purchase Agreement, the Secured Convertible Notes are secured by a lien on collateral representing substantially all assets of the Company, although such security interest is subordinated to the Company’s obligations under the SWK Credit Agreement and may also be subordinated to the Company’s obligations under the Marathon Credit Agreement. The Company evaluated its compliance with all covenants with respect to the Secured Convertible Note Purchase Agreement and concluded that it was in compliance as of June 30, 2022. Marathon Credit Agreement On March 4, 2022, the Company also entered into the Marathon Credit Agreement with the lenders party thereto and Marathon, as the agent, sole lead arranger and sole bookrunner, which provides for a senior secured term loan facility in an aggregate amount of up to $42.5 million in a single borrowing (the “Term Loan”). The Term Loan will be available to be borrowed only following ACER-001 Approval and until December 31, 2022 (i.e., if ACER-001 Approval does not occur on or before December 31, 2022, then the Term Loan will not be available unless the Company is able to obtain an extension for the time period beyond December 31, 2022, to the actual PDUFA target action date), and funding of the Term Loan is also subject to the satisfaction of conditions as set forth in the Marathon Credit Agreement. Although the Company’s resubmitted NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs has been accepted for substantive review by FDA, the PDUFA target action date is January 15, 2023. The Term Loan, if it becomes available, will be used to refinance certain other indebtedness of the Company (including the Bridge Loan), to pay fees, costs and expenses related to the Marathon Credit Agreement and for other working capital and general corporate purposes. Should the Term Loan become available, the Company will pay Marathon a commitment fee equal to 1.5% of the term loan amount. The Marathon Credit Agreement also includes an accordion feature pursuant to which the Company, Marathon and the lenders under the Marathon Credit Agreement may agree to increase the Term Loan commitments by up to an additional $50.0 million dollars for a total commitment of $92.5 million; provided, however, that any such increase is within the sole discretion of each party (i.e., the Company cannot unilaterally trigger such an increase). The Term Loan would bear interest at an annual rate of 13.5% and would be payable quarterly in arrears. The Company would have the option to capitalize up to 4% of such interest commencing on the Term Loan Funding Date and continuing until the third anniversary of the Term Loan Funding Date. Commencing on the third anniversary of the Term Loan Funding Date, the principal outstanding amount of the Term Loan would amortize at a rate of 2.78%, payable monthly. The final maturity date of the Term Loan would be the earlier of six years after the Term Loan Funding Date or December 31, 2028. The Company would have the option to prepay the Term Loan in whole or in part at any time, subject to a prepayment fee equal to (a) if the prepayment is made prior to March 4, 2025, then the greater of 5% or the amount of interest that would have accrued from the date of prepayment until March 4, 2025, (b) if the prepayment is made on or after March 4, 2025, but prior to March 4, 2026, then 3%, (c) if the prepayment is made on or after March 4, 2026, but prior to March 4, 2027, then 2%, or (d) if the prepayment is made on or after March 4, 2027, then 1%. The Term Loan would be secured by a first priority lien on all assets of the Company and any of its future subsidiaries pursuant to a Guarantee and Collateral Agreement to be entered into on the Term Loan Funding Date between the Company and Marathon, as agent (the “Marathon Security Agreement”). The Marathon Credit Agreement contains customary representations and warranties and affirmative and negative covenants. The Company paid $0.2 million in commitment fees to Marathon in connection with obtaining the commitments in respect of the Term Loan and will pay $0.6 million in additional commitment fees to Marathon following ACER-001 Approval or any change of control of the Company or sale or transfer of the ACER-001 product. In connection with the Marathon Credit Agreement, on March 4, 2022, the Company, Marathon and the Marathon Fund also entered into the Royalty Agreement pursuant to which, in the event of the funding of the Term Loan, the Company will pay Marathon and the Marathon Fund, on a quarterly basis, 2% of certain aggregate commercial revenue from sales of ACER-001 during that quarter (i.e., 2% of the net sales and of the amount of certain other payments), subject to a cap on the aggregate amount of such payments of $ 15.0 million. Upon a change of control of the Company or the sale of the ACER-001 business to a third party, the Company would pay Marathon and the Marathon Fund the difference between $ 15.0 million and the aggregate amount of the payments previously made by the Company to Marathon and the Marathon Fund pursuant to the Royalty Agreement. As of June 30, 2022, the Company had not triggered the conditions in order to draw on the Term Loan, and as such had not triggered the associated Royalty Agreement. T he Company engaged an exclusive financial advisor with respect to the financings contemplated by the SWK Credit Agreement, the Secured Convertible Note Purchase Agreement and the Marathon Credit Agreement. In connection with the funding of the Bridge Loan and the Convertible Note Financing, the Company paid its financial advisor a fee of $0.5 million for its services. In connection with a funding of the Term Loan, the Company expects to pay the same financial advisor an additional fee of approximately $0.7 million for its services. The Company is eligible to elect the fair value option under ASC 815 and bypass analysis of potential embedded derivatives and further analysis of bifurcation of any such financial instruments and has elected such option. The Company recognized the SWK Warrant at fair value as of the date of the close of the transaction and recorded it in equity. The Bridge Loan and Secured Convertible Notes met the definition of a “recognized financial liability” which is an acceptable financial instrument eligible for the fair value option under ASC 825-10-15-4 and do not meet the definition of any of the financial instruments found within ASC 825-10-15-5 that are not eligible for the fair value option. Therefore, both the Bridge Loan and Secured Convertible Notes are recorded at their fair value upon issuance and subsequently re-measured at each reporting period until their maturity, prepayment or conversion. Additionally, all issuance costs incurred in connection with a debt instrument that is measured at fair value pursuant to the election of the fair value option are expensed during the period the debt is acquired. The Bridge Loan was recorded at fair value of $6.2 million after allocating the fair value of the SWK Warrant of $0.3 million. The Company incurred $1.2 million of debt issuance costs, which were expensed as incurred due to the election of the fair value option and were included in interest expense in the accompanying unaudited condensed statement of operations for the six months ended June 30, 2022. Debt issuance costs were comprised of $0.5 million that related to the costs and expense paid directly to SWK and the Holders, $0.7 million of costs and expenses paid to the Company’s financial advisor, and other legal and accounting costs. The fee of $0.2 million paid in connection with obtaining the commitments in respect of the Term Loan was paid to Marathon through gross proceeds received from the Secured Convertible Notes. The Company recorded this fee as expense during the three months ended June 30, 2022. |
Fair Value Measurements
Fair Value Measurements | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. In instances where the determination of the fair value measurement is based on inputs from different levels of the fair value hierarchy, the level in the fair value hierarchy within which the entire fair value measurement falls is based on the lowest level input that is significant to the fair value measurement in its entirety. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires judgment and considers factors specific to the asset or liability. The financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. At each reporting period, the Company reviews the assets and liabilities that are subject to ASC 815-40. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or no price transparency are classified as Level 3. The valuation methodologies used for the Company’s financial instruments measured on a recurring basis at fair value, including the general classification of such instruments pursuant to the valuation hierarchy, is set forth in the tables below. The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of June 30, 2022. As of June 30, 2022 Fair Value Measurements As of June 30, 2022 Carrying Amount Fair Value Level 1 Level 2 Level 3 Assets: Money Market Funds in Cash Equivalents $ 13,969,744 $ 13,969,744 $ 13,969,744 $ — $ — Liabilities: Debt: Secured Convertible Notes $ 4,321,200 $ 4,321,200 $ — $ — $ 4,321,200 Bridge Loan $ 4,084,709 $ 4,084,709 $ — $ — $ 4,084,709 $ 8,405,909 $ 8,405,909 $ — $ — $ 8,405,909 A lattice-based model was used to estimate the fair value of the Secured Convertible Notes at June 30, 2022. The lattice model utilizes a “decision tree,” whereby future movement in the Company’s common stock price is estimated based on a volatility factor. The Company classified the fair value of the Secured Convertible Notes as a Level 3 measurement due to the lack of observable market data. The lattice model requires the development and use of assumptions, including the Company’s stock price volatility returns, an appropriate risk-free interest rate, default intensity rate, and expected recovery rate given default. The Company updated its estimate of fair value of the Bridge Loan based on the probability-weighted net present value of future cash flows at June 30, 2022 The significant unobservable inputs used in calculating the fair value of the Secured Convertible Notes and Bridge Loan represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. Any significant changes in the inputs described herein may result in significantly higher or lower fair value measurements. During the three and six months ended June 30, 2022, the Company recognized a reduction in the fair value of the Bridge Loan of $2.1 million, through non-operating income in the statement of operations. During the three and six months ended June 30, 2022, the Company recognized a reduction in the fair value of the Secured Convertible Notes of $2.7 million and $1.7 million, respectively, through non-operating income in the statement of operations. December 31, 2021 Loan Received Payments Accretion/ Interest Accrued Adjustment to Fair Value Mark to Market June 30, 2022 Secured Convertible Notes $ — $ 6,000,000 $ — $ — $ (1,678,800 ) $ 4,321,200 Bridge Loan $ — $ 6,172,969 $ — $ — $ (2,088,260 ) $ 4,084,709 $ — $ 12,172,969 $ — $ — $ (3,767,060 ) $ 8,405,909 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2022 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 8 . 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 branched-chain amino acid 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 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 . Collaboration Agreement 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” from Relief to the Company, offset by repayment of the $4.0 million outstanding balance of the prior loan, plus interest), and Relief released its security interest in the Company’s assets pursuant to the Promissory Note. Under the terms of the Collaboration Agreement, Relief committed to pay the Company Development Payments of up to an additional $20.0 million for U.S. development and commercial launch costs for the UCDs and MSUD indications. During the three months ended June 30, 2021, the Company received from Relief the $10.0 million First Development Payment. The Company 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 European (EU) 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. Paycheck Protection Program (“PPP”) Loan On April 11, 2020, the Company was advised that its principal bank, JPMorgan Chase Bank, N.A., had approved a $0.6 million loan under the PPP pursuant to the CARES Act that was signed into law on March 27, 2020. As a U.S. small business, the Company qualified for the PPP, which allows businesses and nonprofits with fewer than 500 employees to obtain loans of up to $10 million to incent companies to maintain their workers as they manage the business disruptions caused by the COVID-19 pandemic. The loan, evidenced by a promissory note to JPMorgan Chase Bank, N.A. as lender, had a term of two years, was unsecured, and was guaranteed by the Small Business Administration. The loan bore interest at a fixed rate of one percent per annum, with the first six months of interest and principal deferred. Some or all of a loan may be forgiven if at least 75% of the loan proceeds are used by the Company to cover payroll costs, including benefits, and if the Company maintains its employment and compensation within certain parameters during the period following the loan origination date and complies with other relevant conditions. On June 5, 2020, the Payroll Protection Flexibility Act of 2020 was signed into law, adjusting certain terms of the loans issued under the PPP, including extending the initial deferral period from six to up to ten months, reducing from 75% to 60% the portion of loan proceeds required to be used to cover payroll costs, and allowing borrowers to elect a 24-week rather than an eight-week period related to employment and compensation provisions. The Company accounted for the loan according to ASC 470. 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. 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 costs 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. TM Skiadas v. Acer Therapeutics Inc. et al On August 12, 2019, a stockholder derivative action, Gress v. Aselage et al Skiadas Giroux v. Amello et al. Skiadas Gress King v. Schelling et al Skiadas Gress Giroux Diaz v. Amello et al. Gress Diaz In re Acer Therapeutics Inc. Derivative Litigation he parties reached an agreement to settle all of the derivative cases. At a hearing held on May 12, 2021 in the District Court of Massachusetts, the Court administering the matter, the settlement was approved. Payment of the settlement amount of $0.5 million, plus legal fees and costs in excess of the retention (deductible) amount, has been made by the Company’s insurance carriers. Commitments Under Clinical Trial Agreements The Company has entered into agreements with two CROs in connection with the conduct of two separate clinical trials for ACER-801 and EDSIVO TM |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity | 6 Months Ended |
Jun. 30, 2022 | |
Equity [Abstract] | |
Stockholders' (Deficit) Equity | 9 . 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. The Company has no obligation to sell any shares of common stock pursuant to the agreement and may at any time suspend sales pursuant to the agreement. Each party may terminate the agreement at any time without liability The Company will need to keep current its shelf registration statement and the offering prospectus relating to the ATM facility, in addition to providing certain periodic deliverables under the sales agreement, in order to use such facility. Due to the SEC’s “baby shelf rules,” which prohibit companies with a public float of less than $75 million from issuing securities under a shelf registration statement in excess of one-third of such company’s public float in a 12-month period, the Company is currently only able to issue a limited number of shares which aggregate to not more than one-third of the Company’s public float. During the three and six months ended June 30, 2022, the Company sold 1,062,547 shares of common stock through its ATM facility at a gross sale price of $3.0719 per share, for gross proceeds of $3.3 million. Proceeds, net of $0.2 million of fees and offering costs, were $3.1 million. As of June 30, 2022, $36.7 million remained available under the Company’s ATM facility. 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 $11.8 million obligation remaining as of June 30, 2022. 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. 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. 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. 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 limit 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 expenses along with other costs incurred in connection with entering into the purchase agreement. During the three and six months ended June 30, 2022, the Company sold 300,000 shares of common stock under its purchase agreement with Lincoln Park at a weighted average gross sale price of $1.25 per share, resulting in proceeds of $0.4 million. During the three months ended June 30, 2021, the Company did not sell any shares of common stock under its purchase agreement with Lincoln Park. During the six months ended June 30, 2021, the Company sold 200,000 shares of common stock under the purchase agreement with Lincoln Park at a weighted average price of $2.47 per share, resulting in proceeds of $0.5 million. 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, 2022 and 2021, 572,410 and 529,325 additional shares, respectively, were authorized according to the evergreen provision. On February18, 2022, the Company’s Board of Directors amended and restated the 2018 Plan to add a provision permitting the grant of inducement awards under Nasdaq Marketplace Rule 5635(c)(4) to eligible recipients and initially reserved 200,000 shares of the Company’s common stock for issuance pursuant to inducement awards granted under the 2018 Plan. Any shares subject to awards granted under the 2018 Plan that are forfeited or terminated before being exercised or settled or are not delivered to the participant because such award is settled in cash, will again become available for issuance under the 2018 Plan. Shares withheld to satisfy the grant, exercise price or tax withholding obligation related to an award will again become available for issuance under the 2018 Plan. The 2018 Plan is administered by the Company’s Board of Directors, which may in turn delegate authority to administer the plan to a committee such as the Compensation Committee, referred to herein as the 2018 Plan administrator. Subject to the terms of the 2018 Plan, the 2018 Plan administrator will determine recipients, the number of shares or amount of cash subject to awards to be granted, whether an option is to be an incentive stock options or non-incentive stock options and the terms and conditions of the stock awards, including the period of their exercisability and vesting. Subject to the limitations set forth below, the 2018 Plan administrator will also determine the exercise price of options granted under the 2018 Plan. The 2018 Plan expressly provides that, without the approval of the stockholders, the 2018 Plan administrator does not have the authority to reduce the exercise price of any outstanding stock options or stock appreciation rights under the 2018 Plan (except in connection with certain corporate transactions, such as stock splits, certain dividends, recapitalizations, reorganizations, mergers, spin-offs and the like), or cancel any outstanding underwater stock options or stock appreciation rights in exchange for cash or new stock awards under the 2018 Plan. Option awards are generally granted with an exercise price equal to the fair value of the common stock at the date of grant and have contractual terms of ten years. Stock options granted to executive officers and employees generally vest either 1) over a four-year At June 30, 2022, 333,376 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 June 30, 2022, 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 June 30, 2022, all shares available under the 2010 Plan were subject to outstanding equity awards, and no new awards may be granted under the 2010 Plan. Stock Plan Activity A summary of option activity under the 2018 Plan, 2013 Plan, and 2010 Plan for the six months ended June 30, 2022, is as follows: Year-to-Date Activity Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in Millions) Options outstanding at December 31, 2021 1,954,975 $ 8.16 7.8 Granted 958,000 $ 2.33 Cancelled/forfeited (62,188 ) $ 4.12 Options outstanding at June 30, 2022 2,850,787 $ 6.29 8.0 $ — Options exercisable at June 30, 2022 1,322,180 $ 9.80 6.6 $ — At June 30, 2022, there was $3.3 million of unrecognized compensation expense related to the stock-based compensation arrangements granted under all plans. The average remaining vesting period for options was 3.0 years. The weighted average grant date fair value of options granted during the three and six months ended June 30, 2022 was $1.97 and $1.99, respectively. The weighted average grant date fair value of options granted during the three and six months ended June 30, 2021was $2.18 and $2.83, respectively. The fair value of shares vested during the three and six months ending June 30, 2022 was $0.4 million and $1.5 million, respectively. The fair value of shares vested during the three and six months ending June 30, 2021 was $0.3 million and $1.2 million, respectively. The amount of stock-based compensation expense recorded to research and development expenses and to general and administrative expenses is detailed in table below: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Stock-based compensation Research and development $ 158,880 $ 176,534 $ 299,320 $ 344,580 General and administrative 301,897 418,129 635,554 809,519 Total stock-based compensation expense $ 460,777 $ 594,663 $ 934,874 $ 1,154,099 Warrants issued to SWK Six Months Ended June 30, 2022 2021 Number Weighted Average Exercise Price Number Weighted Average Exercise Price Granted during the period 150,000 $ 2.46 — $ — Outstanding at end of the period 150,000 $ 2.46 — $ — Exercisable at end of the period 150,000 $ 2.46 Weighted average remaining life 6.8 years — |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 10 . 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 and the SWK Warrant, were not included in the calculation of the diluted loss per share because to do so would be anti-dilutive. The SWK Warrant price is subject to a proportionate adjustment in the event of a stock dividend or stock split. The Company concluded that they should be deemed participating securities. However, as the Company is currently operating in a net loss position as of the second quarter of 2022 and has not declared any dividends, such inclusion of the participating securities related to the SWK Warrant (as common stock equivalents) would be anti-dilutive and thus would be excluded from the calculation of net loss per share. As of June 30, 2022, the Company excluded from its net loss per share calculations 2.4 million shares related to the Secured Convertible Notes under the “if-converted” method, since even after adjusting for discrete items related to the Secured Convertible Notes for interest and adjustment of fair value, the Company has a net loss during the period and to include these shares would be anti-dilutive. As of June 30, 2022 and 2021, the number of shares of common stock underlying potentially dilutive securities consist of: June 30, 2022 2021 Options to purchase common stock 2,850,787 1,751,475 SWK Warrant 150,000 — Total 3,000,787 1,751,475 |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | 1 1 . SUBSEQUENT EVENTS Subsequent to June 30, 2022, the Company sold an aggregate of 133,206 shares of common stock under its ATM facility at an average gross sale price of $1.51 per share, resulting in gross and net proceeds of $0.2 million. Subsequent to June 30, 2022, the Company sold 275,000 shares of common stock under its purchase agreement with Lincoln Park at an average gross sale price of $1.38 per share, resulting in gross proceeds of $0.4 million. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Liquidity | Liquidity The Company had an accumulated deficit of $126.4 million and cash and cash equivalents of $14.5 million as of June 30, 2022. Net cash used in operating activities was $12.9 million for the six months ended June 30, 2022. On November 9, 2018, the Company entered into a sales agreement with Roth Capital Partners, LLC, and on March 18, 2020, an amended and restated sales agreement was entered into with JonesTrading Institutional Services LLC and Roth Capital Partners, LLC. The agreement provides a facility for the offer and sale of shares of common stock from time to time having an aggregate offering price of up to $50.0 million depending upon market demand, in transactions deemed to be an at-the-market (“ATM”) offering. The Company has no obligation to sell any shares of common stock pursuant to the agreement and may at any time suspend sales pursuant to the agreement. Each party may terminate the agreement at any time without liability. During the three and six months ended June 30, 2022, the Company sold 1,062,547 shares of common stock through its ATM facility at a gross sale price of $3.0719 per share, for gross proceeds of $3.3 million. Proceeds, net of $0.2 million of fees and offering costs, were $3.1 million. As of June 30, 2022, $36.7 million remained available under the Company’s ATM facility, subject to various limitations. 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 $11.8 million obligation remaining as of June 30, 2022. 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. During the three and six months ended June 30, 2022, the Company sold 300,000 shares of common stock under its purchase agreement with Lincoln Park at a weighted average gross sale price of $1.25 per share, resulting in proceeds of $0.4 million. On January 25, 2021, the Company entered into an option agreement (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 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 (consisting of a $14.0 million “Reimbursement Payment” from Relief to the Company offset by payment of the $4.0 million outstanding balance of the Note plus interest earned through the date of the Collaboration Agreement) and Relief released its security interest in all of the Company’s assets pursuant to the Promissory Note. 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 a New Drug Application (“NDA”) for ACER-001 in a UCD for filing and review. This acceptance was received on October 4, 2021. On October 6, 2021, the Company entered into a Waiver and Agreement with Relief to amend the timing for the Second Development Payment. The Company received the 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 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 Collaboration Agreement and Option Agreement are further described below in the Revenue Recognition and Accounting for Collaboration Agreements section of Note 2, Significant Accounting Policies. On March 4, 2022, the Company entered into a Credit Agreement (the “SWK Credit Agreement”) with the lenders party thereto and SWK Funding LLC (“SWK”), as the agent, sole lead arranger and sole bookrunner, which provided for a senior secured term loan facility in an aggregate amount of $6.5 million in a single borrowing (the “Bridge Loan”). The Bridge Loan funding closed on March 14, 2022. The proceeds of the Bridge Loan were used to pay fees, costs and expenses related to the SWK Credit Agreement, the Secured Convertible Note Purchase Agreement (as defined and described below) and the Marathon Credit Agreement (as defined and described below) and for other working capital and general corporate purposes. The Bridge Loan bears interest at an annual rate of the sum of (i) 3-month LIBOR (or such other rate as may be agreed by the Company and SWK following the date on which 3-month LIBOR is no longer available), subject to a 1% floor, plus (ii) a margin of 11%, with such interest payable quarterly in arrears. In the event of default, the interest rate will increase by 3% per annum over the contract rate effective at the time of default but shall not be higher than the maximum rate permitted to be charged by applicable laws. The Company has the option to capitalize such interest commencing on the date on which the Bridge Loan was funded and continuing until November 15, 2022. Commencing on November 15, 2022, the principal amount of the Bridge Loan will amortize at a rate of $0.7 million, payable quarterly. The final maturity date of the Bridge Loan is (a) if full approval by FDA for marketing of ACER-001 (“ACER-001 Approval”) occurs on or before September 30, 2022, then the date which is 12 business days after ACER-001 Approval, or (b) if ACER-001 Approval does not occur on or before September 30, 2022, then March 4, 2024. The Company has the option to prepay the Bridge Loan in whole or in part. Upon the repayment of the Bridge Loan (whether voluntary or at scheduled maturity), the Company must pay an exit fee so that SWK receives an aggregate amount (inclusive of all principal, interest and origination and other fees paid to SWK under the SWK Credit Agreement on or prior to the prepayment date) equal to (a) 1.3 1.5 The Bridge Loan is secured by a first priority lien on all assets of the Company and any of its future subsidiaries pursuant to a Guarantee and Collateral Agreement entered into on March 4, 2022, between the Company and SWK, as agent (the “SWK Security Agreement”). The SWK Credit Agreement contains customary representations and warranties and affirmative and negative covenants. The Company paid to SWK $ 0.1 million in origination fees on the date on which the Bridge Loan was funded. In addition, the Company issued a warrant (the “SWK Warrant”) to purchase 150,000 shares of the Company’s common stock at an exercise price of $2.46 per share. SWK may exercise the SWK Warrant in accordance with the terms thereof for all or any part of such shares of common stock from the date on which the Bridge Loan was funded until and including March 4, 2029. On March 4, 2022, the Company also entered into a Secured Convertible Note Purchase Agreement with MAM Aardvark, LLC (“Marathon”) and Marathon Healthcare Finance Fund, L.P. (“Marathon Fund” and together with “Marathon” each a “Holder” and collectively the “Holders”) (the “Secured Convertible Note Purchase Agreement”) pursuant to which the Company issued and sold to the Holders secured convertible notes (the “Secured Convertible Notes”) in an aggregate amount of up to $6.0 million (the “Convertible Note Financing”). The Convertible Note Financing closed on March 14, 2022. The proceeds of the Convertible Note Financing are being used to pay fees, costs and expenses related to the SWK Credit Agreement, the Secured Convertible Note Purchase Agreement and the Marathon Credit Agreement and for other working capital and general corporate purposes. The Secured Convertible Notes bear interest at an annual rate of 6.5%, with such interest payable quarterly; provided, however, that until the first to occur of ACER-001 Approval and the repayment in full of the Bridge Loan, interest will not be payable in cash, but will accrue and be payable in cash upon the earlier of a) the repayment of all obligations under the Bridge Loan and termination of such Bridge Loan or b) within three business days of ACER-001 Approval. Subject to the restrictions set forth in an agreement among each of the Holders and SWK, as agent and lender, and any other intercreditor or subordination agreement entered into in connection with the Term Loan (defined below), each of the Holders has the right, during the 30-day periods beginning 12 months, 18 months and 24 months after the closing date of the Convertible Note Financing, to require the Company to redeem the Convertible Secured Note held by such Holder at a redemption price of the outstanding principal amount plus any accrued but unpaid interest. Each of the Holders also has the right to convert all or any portion of the outstanding principal amount plus any accrued but unpaid interest under the Convertible Secured Note held by such Holder into shares of common stock at a conversion price of $2.50 per share, subject to adjustment. Each Holder has certain rights with respect to the registration by the Company for resale of the shares of common stock issuable upon conversion of the Secured Convertible Note held by such Holder which are forth in the Secured Convertible Note Purchase Agreement. Any outstanding principal, together with all accrued and unpaid interest, will be payable on the earlier of the third anniversary of the date of issuance, or upon a change of control of the Company. Pursuant to the Secured Convertible Note Purchase Agreement, the Secured Convertible Notes are secured by a lien on collateral representing substantially all assets of the Company, although such security interest is subordinated to the Company’s obligations under the SWK Credit Agreement and may also be subordinated to the Company’s obligations under the Marathon Credit Agreement. On March 4, 2022, the Company also entered into a Credit Agreement (the “Marathon Credit Agreement”) with the lenders party thereto and Marathon, as the agent, sole lead arranger and sole bookrunner, which provides for a senior secured term loan facility in an aggregate amount of up to $42.5 million in a single borrowing (the “Term Loan”). The Term Loan will be available to be borrowed only following ACER-001 Approval and until December 31, 2022 (i.e., if ACER-001 Approval does not occur on or before December 31, 2022, then the Term Loan will not be available unless the Company is able to obtain an extension for the time period beyond December 31, 2022, to the actual PDUFA target action date), and funding of the Term Loan is also subject to the satisfaction of conditions as set forth in the Marathon Credit Agreement. Although the Company’s resubmitted NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs has been accepted for substantive review by FDA, the Prescription Drug User Fee Act (“PDUFA”) target action date is January 15, 2023. The Term Loan, if it becomes available, will be used to refinance certain other indebtedness of the Company (including the Bridge Loan), to pay fees, costs and expenses related to the Marathon Credit Agreement and for other working capital and general corporate purposes. Should the Term Loan become available, the Company will pay Marathon a commitment fee equal to 1.5% of the Term Loan amount. The Marathon Credit Agreement also includes an accordion feature pursuant to which the Company, Marathon and the lenders under the Marathon Credit Agreement may agree to increase the Term Loan commitments by up to an additional $50.0 million dollars for a total commitment of $92.5 million; provided, however, that any such increase is within the sole discretion of each party (i.e., the Company cannot unilaterally trigger such an increase). The Term Loan would bear interest at an annual rate of 13.5% and would be payable quarterly in arrears. The Company would have the option to capitalize up to 4% of such interest commencing on the date on which the Term Loan is funded (the “Term Loan Funding Date”) and continuing until the third anniversary of the Term Loan Funding Date. Commencing on the third anniversary of the Term Loan Funding Date, the principal outstanding amount of the Term Loan would amortize at a rate of 2.78%, payable monthly. The final maturity date of the Term Loan would be the earlier of six years after the Term Loan Funding Date or December 31, 2028. The Company would have the option to prepay the Term Loan in whole or in part at any time, subject to a prepayment fee equal to (a) if the prepayment is made prior to March 4, 2025, then the greater of 5% or the amount of interest that would have accrued from the date of prepayment until March 4, 2025, (b) if the prepayment is made on or after March 4, 2025, but prior to March 4, 2026, then 3%, (c) if the prepayment is made on or after March 4, 2026, but prior to March 4, 2027, then 2 %, or (d) if the prepayment is made on or after March 4, 2027, then 1 %. The Term Loan would be secured by a first priority lien on all assets of the Company and any of its future subsidiaries pursuant to a Guarantee and Collateral Agreement to be entered into on the Term Loan Funding Date between the Company and Marathon, as agent (the “Marathon Security Agreement”). The Marathon Credit Agreement contains customary representations and warranties and affirmative and negative covenants. The Company paid $0.2 million in commitment fees to Marathon in connection with obtaining the commitments in respect of the Term Loan and will pay $0.6 million in additional commitment fees to Marathon following ACER-001 Approval or any change of control of the Company or sale or transfer of the ACER-001 product. In connection with the Marathon Credit Agreement, on March 4, 2022, the Company, Marathon and the Marathon Fund also entered into a Synthetic Royalty Agreement (the “Royalty Agreement”) pursuant to which, in the event of the funding of the Term Loan, the Company will pay Marathon and the Marathon Fund, on a quarterly basis, 2% of certain aggregate commercial revenue from sales of ACER-001 during that quarter (i.e., 2% of the net sales and of the amount of certain other payments), subject to a cap on the aggregate amount of such payments of $15.0 million. Upon a change of control of the Company or the sale of the ACER-001 business to a third party, the Company would pay Marathon and the Marathon Fund the difference between $15.0 million and the aggregate amount of the payments previously made by the Company to Marathon and the Marathon Fund pursuant to the Royalty Agreement. The Company’s cash and cash equivalents available at June 30, 2022 are expected to be sufficient to fund its anticipated operating and capital requirements through the third quarter of 2022. 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, through a collaboration agreement, and through debt instruments. 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 June 30, 2022, the Company had cash and cash equivalents of $14.5 million and current liabilities of $17.5 million, which include $6.3 million associated with deferred collaboration funding (see Revenue Recognition and Accounting for Collaboration Agreements below in Note 2, Significant Accounting Policies). The Company’s cash and cash equivalents available at June 30, 2022 are expected to be sufficient to fund its anticipated operating and capital requirements through the third quarter of 2022. The Company will need to raise additional capital to fund continued operations beyond the third quarter of 2022 because neither FDA approval of ACER-001 nor subsequent product revenues are assured. The Company may not be successful in its efforts to raise additional funds or achieve profitable operations. The Company continues to explore potential opportunities and alternatives to obtain the additional resources that will be necessary to support its ongoing operations beyond the third quarter of 2022, including raising additional capital through either private or public equity or debt financing or additional program collaborations or non-dilutive funding, as well as using its ATM facility which has $36.7 million available as of June 30, 2022 and/or its remaining $11.8 million available under the equity line facility entered into on April 30, 2020 with Lincoln Park. (See At-the-Market Facility and Common Stock Purchase Agreement below in Note 9.) Due to the SEC’s “baby shelf rules,” which prohibit companies with a public float of less than $75 million from issuing securities under a shelf registration statement in excess of one-third of such company’s public float in a 12-month period, the Company is currently only able to issue a limited number of shares under its ATM facility which aggregate to no more than one-third of its public float. Additionally, 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 limit the Company’s ability to cause Lincoln Park to buy common stock from the Company. As noted above, the Company also has available to it the $42.5 million Term Loan conditional upon the approval of ACER-001 by FDA; provided, however, that if ACER-001 Approval does not occur on or before December 31, 2022, then the Term Loan will not be available unless the Company is able to obtain an extension for the time period beyond December 31, 2022, to the actual PDUFA target action date. The PDUFA target action date for the Company’s resubmitted NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatments of patients with UCDs is January 15, 2023. The Company has no commitments for any additional financing, except for the agreement with Lincoln Park, and the Marathon Credit Agreement for the Term Loan. Any amounts raised will be used for further development of its product candidates, precommercial activities, and for other working capital purposes. If the Company is unable to obtain additional funding to support its current or proposed activities and operations, it may not be able to continue its operations as currently anticipated , which may require it to suspend or terminate any ongoing development activities, modify its business plan, curtai l various aspects of its operations, cease operations , or seek relief under applicable bankruptcy laws. In such event, the Company’s stockholders may lose a substantial portion or even all of their investment. These factors individually and collectively raise substantial doubt about the Company’s ability to continue as a going concern for at least 12 months from the date these financial statements are available, or August 15, 2023. The accompanying unaudited condensed financial statements do not include any adjustments or classifications that may result from the possible inability of the Company to continue as a going concern. |
Use of Estimates | Use of Estimates The Company’s accounting principles require management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of assets and liabilities at the date of the condensed financial statements and reported amounts of revenues and expenses during the reporting period. From time to time, estimates having relatively higher significance include determination of stand-alone selling price and variable consideration estimates for purposes of revenue recognition, deferred collaboration funding, stock-based compensation, inputs to fair value for debt, 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 ASC 606 or ASC 808, the Company consider s the guidance in other accounting literature as applicable or by analogy to account for such transaction. The Company determines the units of account within the collaborative arrangement utilizing the guidance in ASC 606 to determine which promised goods or services are distinct. In order for a promised good or service to be considered “distinct” under ASC 606, the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer (i.e., the good or service is capable of being distinct), and the entity’s promise to transfer the good or service to the customer is separately identifiable from other promises in the contract (i.e., the promise to transfer the good or service is distinct within the context of the contract). For any units of account that fall within the scope of ASC 606, where the other party is a customer, the Company evaluates the separate performance obligation(s) under each contract, determines the transaction price, allocates the transaction price to each performance obligation considering the estimated stand-alone selling prices of the services and recognizes revenue upon the satisfaction of such obligations at a point in time or over time dependent on the satisfaction of one of the following criteria: (1) the customer simultaneously receives and consumes the economic benefits provided by the vendor’s performance; (2) the vendor creates or enhances an asset controlled by the customer; 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 (consisting of a $14.0 million “Reimbursement Payment” from Relief to the Company offset by repayment of the $4.0 million outstanding balance of the Note, plus interest earned through the date of the Collaboration Agreement), and Relief released its security interest in all of the Company’s assets pursuant to the Promissory Note. 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. 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 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 C ollaborati on Agree ment where Relief does not represent a customer are outside of the scope of ASC 606. The Company also determined that the development and commercial ization 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 expenses and general and administrative expenses, 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 June 30, 2022, the amount of deferred collaboration funding associated with unsatisfied promises under the Collaboration Agreement amounted to $14.2 million. The Company has recorded $6.3 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 $7.9 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 June 30, 2022, deferred collaboration funding was composed of $35.0 million received from Relief, offset by $1.3 million recognized as license revenue during the year ended December 31, 2021 and $10.7 million recorded as an offset to research and development expenses and $8.8 million recorded as an offset to general and administrative expenses subsequent to signing the Collaboration Agreement and through the date of this report. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with maturities of three months or less at the date of purchase to be cash equivalents. 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 June 30, 2022 and December 31, 2021, the Company had $14.2 million and $12.5 million, respectively, in excess of the FDIC insured limit. Under the Bridge Loan, the Company was required to maintain a cash and cash equivalents balance of not less than $4.0 million as of 20 days following receipt of FDA’s Complete Response Letter in June 2022 with respect to the Company’s NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs and is then required to maintain a cash and cash equivalents balance of not less than $6.5 million as of 40 days following receipt of that Complete Response Letter for the remainder of the time that the Bridge Loan is outstanding. The minimum cash balance would be reduced to $2.0 million in the event of positive safety and efficacy data for ACER-801 from a Phase 2a trial. The Company recognized a $4.0 million non-cash reduction in a secured loan from Relief during the six months ended June 30, 2021, since the Reimbursement Payment from Relief was received net of the amount of principal and interest due in connection with the secured loan. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurement ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following: • Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. • Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Financial instruments consist of cash equivalents, collaboration receivable, accounts payable, accrued expenses, and debt instruments. These financial instruments are stated at their respective historical carrying amounts, which approximate fair value due to their short-term nature, except for cash equivalents and debt instruments, which were marked to market at the end of each reporting period. See Note 7 for additional information on the fair value of the debt liabilities. The Company elected the fair value option for both its Bridge Loan and its Secured Convertible Notes dated March 14, 2022 (see Note 7). The Company adjusts both the Bridge Loan and the Secured Convertible Notes to fair value through the change in fair value of debt in the accompanying unaudited condensed statements of operations. Subsequent unrealized gains and losses on items for which the fair value option is elected are reported in the accompanying unaudited condensed statement of operations. |
Debt | Debt Convertible notes are regarded as compound instruments, consisting of a liability component and an equity component. The Company determined that it is eligible for the fair value option election in connection with the Bridge Loan and the Secured Convertible Notes. Each instrument met the definition of a “recognized financial liability” which is an acceptable financial instrument eligible for the fair value option under ASC 825-10-15-4 and do not meet the definition of any of the financial instruments found within ASC 825-10-15-5 that are not eligible for the fair value option |
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 (“CROs”), manufacturing organizations, and for other trial- and study-related activities. Payments under the Company’s agreements with external service providers depend on a number of factors such as site initiation, patient screening, enrollment, delivery of reports, and other events. In accruing for these activities, the Company obtains information from various sources and estimates the level of effort or expense allocated to each period. Adjustments to research and development expenses may be necessary in future periods as the Company’s estimates change. As these activities are generally material to the Company’s 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 three or six months ended June 30, 2022 or 2021. Accounts payable and accrued expenses include costs associated with preclinical or clinical studies of $0.3 million and $0.2 million at June 30, 2022 and December 31, 2021, 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 condensed statements 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. A limited number of option grants are periodically made to non-employee contractors, and 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 during the six months ended June 30, 2022 and 2021 using the Black-Scholes option pricing model: 2022 2021 Risk-free interest rate 1.18%-1.83% 0.37%- 0.62% Expected life (years) 6.25 6.25 Expected volatility 113.0% - 115.0% 92.4% 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 Company’s available stock price history and the stock price 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’s goodwill is allocated to the Company’s single reporting unit. The Company evaluates the recoverability of goodwill according to ASC Topic 350, Intangibles – Goodwill and Other the Company were to determine based on a qualitative assessment that it was more likely than not that the fair value of the reporting unit was less than its carrying value, a quantitative impairment test would then be performed. The quantitative impairment test compares the fair value of the reporting unit with its carrying amount, including goodwill. If the estimated fair value of the reporting unit is less than its carrying amount, a goodwill impairment would be recognized for the difference. The Company performed a qualitative analysis of goodwill as of June 21 , 2022 as it considered the Complete Response Letter received from FDA in June 2022 with respect to the Company’s NDA in respect of ACER-001 (sodium phenylbutyrate) for oral suspension for the treatment of patients with UCDs to be a triggering event requiring it to perform that analysis. Management concluded that it was more likely than not that the fair value of the reporting unit was greater than its carrying amount at June 30, 2022 . |
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. The Company recorded no income tax expense or benefit during the three or six months ended June 30, 2022 and 2021, due to a full valuation allowance recognized against its net deferred tax assets. A valuation allowance is recorded when it is more likely than not that some portion or all of the deferred tax assets will not be realized. Accordingly, the Company provides a valuation allowance, if necessary, to reduce deferred tax assets to amounts that are realizable. Utilization of net operating losses may be subject to substantial annual limitations due to the “change in ownership” provisions of the Internal Revenue Code of 1986, and similar state provisions. The annual limitations may result in the expiration of net operating losses before utilization. The 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 June 30, 2022 and 2021. The Company’s policy is to recognize interest and penalties related to income tax, if any, in income tax expense. As of June 30, 2022 and 2021, 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 three or six months ended or to the Company’s assessment of the realizability of deferred tax assets as the carry back of net operating losses was used as a source of income. There were no other effects to the Company’s tax provision as a result of the CARES Act as of June 30, 2022. |
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 using the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed using the sum of the weighted average number of common shares outstanding during the period and, if dilutive, the weighted average number of potential shares of common stock, including the assumed exercise of stock options, warrants, and the impact of unvested restricted stock. Basic and diluted shares outstanding are the same for each period presented as all common stock equivalents, including potential shares from convertible debt and warrants, would be antidilutive due to the net losses incurred. The Company applied the two-class method to calculate basic and diluted net loss per share attributable to common stockholders as its warrants to purchase common stock are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to common stockholders. However, the two-class method does not impact the net loss per share of common stock as the Company has been in a net loss position and the warrant holders do not participate in losses. Diluted net income per share is computed using the more dilutive of (a) the two-class method or (b) the if-converted method o r treasury stock method, as applicable, to the potentially dilutive instruments. |
Recently Adopted Accounting Pronouncements | Recently Adopted 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) The Company early adopted ASU No. 2020-06 in the first quarter of 2021. See Note 6 regarding the Secured Convertible Notes which were recognized in the first quarter of 2022 consistent with the adoption of this guidance. In May 2021, the FASB issued ASU No. 2021-04 , Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (a consensus of the FASB Emerging Issues Task Force), which clarifies and reduces diversity in issuers’ accounting for modifications or exchanges of freestanding equity-classified written call options that remain equity classified after modification or exchange. The Company adopted ASU No. 2021-04 in the first quarter of 2022. There was no impact on the Company’s financial statements or disclosures as a result of the adoption of this guidance. In November 2021, the FASB issued ASU No. 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Estimate Fair Value of Stock Options Granted | The following assumptions were used to estimate the fair value of stock options granted during the six months ended June 30, 2022 and 2021 using the Black-Scholes option pricing model: 2022 2021 Risk-free interest rate 1.18%-1.83% 0.37%- 0.62% Expected life (years) 6.25 6.25 Expected volatility 113.0% - 115.0% 92.4% Dividend rate 0% 0% |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Property Plant And Equipment [Abstract] | |
Schedule of Property and Equipment | Property and equipment consisted of the following at June 30, 2022 and December 31, 2021: June 30, 2022 December 31, 2021 Computer hardware and software $ 144,782 $ 113,847 Leasehold improvements 52,887 60,535 Furniture and fixtures 106,698 145,487 Subtotal property and equipment, gross 304,367 319,869 Less accumulated depreciation (202,785 ) (205,757 ) Property and equipment, net $ 101,582 $ 114,112 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accounts Payable And Accrued Liabilities Current [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following at June 30, 2022 and December 31, 2021: June 30, 2022 December 31, 2021 Accrued payroll and payroll taxes $ 2,539,643 $ 419,354 Accrued precommercial costs 1,120,435 395,923 Accrued contract manufacturing 935,710 827,390 Accrued accounting, audit, and tax fees 278,950 167,630 Accrued contract research and regulatory consulting 236,356 47,637 Accrued legal 212,291 162,812 Accrued consulting 103,855 105,085 Accrued license fees 78,015 86,259 Accrued miscellaneous expenses 62,709 216,103 Total accrued expenses $ 5,567,964 $ 2,428,193 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Leases [Abstract] | |
Reconciliation of Undiscounted Lease Liabilities to Total Lease Liabilities | The following table reconciles the undiscounted lease liabilities to the total lease liabilities recognized on the unaudited condensed balance sheet as of June 30, 2022: Undiscounted lease liabilities for years ending December 31: 2022 (remaining) $ 60,317 2023 103,925 2024 107,290 2025 54,579 Total undiscounted lease liabilities 326,111 Less effects of discounting (49,556 ) Total lease liabilities as of June 30, 2022 $ 276,555 The Company’s lease liabilities are reported on the unaudited condensed balance sheets as follows: June 30, 2022 December 31, 2021 Other current liabilities $ 110,421 $ 184,340 Other non-current liabilities 166,134 209,497 Total lease liabilities $ 276,555 $ 393,837 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value | The following table presents the Company’s assets and liabilities that are measured and recognized at fair value on a recurring basis classified under the appropriate level of the fair value hierarchy as of June 30, 2022. As of June 30, 2022 Fair Value Measurements As of June 30, 2022 Carrying Amount Fair Value Level 1 Level 2 Level 3 Assets: Money Market Funds in Cash Equivalents $ 13,969,744 $ 13,969,744 $ 13,969,744 $ — $ — Liabilities: Debt: Secured Convertible Notes $ 4,321,200 $ 4,321,200 $ — $ — $ 4,321,200 Bridge Loan $ 4,084,709 $ 4,084,709 $ — $ — $ 4,084,709 $ 8,405,909 $ 8,405,909 $ — $ — $ 8,405,909 |
Schedule of Change in Fair Value | The significant unobservable inputs used in calculating the fair value of the Secured Convertible Notes and Bridge Loan represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. Any significant changes in the inputs described herein may result in significantly higher or lower fair value measurements. During the three and six months ended June 30, 2022, the Company recognized a reduction in the fair value of the Bridge Loan of $2.1 million, through non-operating income in the statement of operations. During the three and six months ended June 30, 2022, the Company recognized a reduction in the fair value of the Secured Convertible Notes of $2.7 million and $1.7 million, respectively, through non-operating income in the statement of operations. December 31, 2021 Loan Received Payments Accretion/ Interest Accrued Adjustment to Fair Value Mark to Market June 30, 2022 Secured Convertible Notes $ — $ 6,000,000 $ — $ — $ (1,678,800 ) $ 4,321,200 Bridge Loan $ — $ 6,172,969 $ — $ — $ (2,088,260 ) $ 4,084,709 $ — $ 12,172,969 $ — $ — $ (3,767,060 ) $ 8,405,909 |
Stockholders' (Deficit) Equity
Stockholders' (Deficit) Equity (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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 six months ended June 30, 2022, is as follows: Year-to-Date Activity Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value (in Millions) Options outstanding at December 31, 2021 1,954,975 $ 8.16 7.8 Granted 958,000 $ 2.33 Cancelled/forfeited (62,188 ) $ 4.12 Options outstanding at June 30, 2022 2,850,787 $ 6.29 8.0 $ — Options exercisable at June 30, 2022 1,322,180 $ 9.80 6.6 $ — |
Summary of Stock-Based Compensation Expense | The fair value of shares vested during the three and six months ending June 30, 2022 was $0.4 million and $1.5 million, respectively. The fair value of shares vested during the three and six months ending June 30, 2021 was $0.3 million and $1.2 million, respectively. The amount of stock-based compensation expense recorded to research and development expenses and to general and administrative expenses is detailed in table below: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Stock-based compensation Research and development $ 158,880 $ 176,534 $ 299,320 $ 344,580 General and administrative 301,897 418,129 635,554 809,519 Total stock-based compensation expense $ 460,777 $ 594,663 $ 934,874 $ 1,154,099 |
Summary of Warrants Issued | Six Months Ended June 30, 2022 2021 Number Weighted Average Exercise Price Number Weighted Average Exercise Price Granted during the period 150,000 $ 2.46 — $ — Outstanding at end of the period 150,000 $ 2.46 — $ — Exercisable at end of the period 150,000 $ 2.46 Weighted average remaining life 6.8 years — |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities | As of June 30, 2022 and 2021, the number of shares of common stock underlying potentially dilutive securities consist of: June 30, 2022 2021 Options to purchase common stock 2,850,787 1,751,475 SWK Warrant 150,000 — Total 3,000,787 1,751,475 |
Nature of Operations and Basi_2
Nature of Operations and Basis of Presentation - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||||||||||||
Mar. 14, 2022 | Mar. 04, 2022 | Jan. 14, 2022 | Oct. 12, 2021 | Mar. 19, 2021 | Jan. 25, 2021 | Apr. 30, 2020 | Mar. 18, 2020 | Nov. 09, 2018 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Mar. 31, 2022 | Dec. 31, 2021 | Oct. 04, 2021 | |
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Accumulated deficit | $ 126,355,994 | $ 126,355,994 | $ 114,509,954 | |||||||||||||
Cash and cash equivalents | $ 14,469,744 | 14,469,744 | 12,710,762 | |||||||||||||
Net cash used in operating activities | (12,866,087) | $ 9,242,939 | ||||||||||||||
Issuance of common stock, net of issuance costs, shares | 300,000 | |||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 400,000 | 3,524,198 | $ 3,139,047 | |||||||||||||
Reimbursement payment | $ 14,000,000 | |||||||||||||||
Development payments | 10,000,000 | |||||||||||||||
Current liabilities | 17,473,264 | 17,473,264 | $ 29,109,950 | |||||||||||||
Deferred collaboration funding | 6,300,000 | 6,300,000 | ||||||||||||||
Event of Positive Safety | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Cash and cash equivalents | 2,000,000 | 2,000,000 | ||||||||||||||
Lincoln Park | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Remained available under facility | $ 11,800,000 | $ 11,800,000 | ||||||||||||||
Issuance of common stock, net of issuance costs, shares | 300,000 | 0 | 300,000 | 200,000 | ||||||||||||
Issuance of common stock, price per share | $ 1.25 | $ 1.25 | ||||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 400,000 | $ 500,000 | ||||||||||||||
Proceeds from issuance of common stock gross | $ 400,000 | 400,000 | ||||||||||||||
Remaining obligation | 11,800,000 | 11,800,000 | ||||||||||||||
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 | |||||||||||||||
Stock to be issued value on certain limitation and condition | 11,800,000 | |||||||||||||||
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% | |||||||||||||||
Collaboration Agreement | Second Development Payment | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Deferred collaboration funding | 14,200,000 | 14,200,000 | ||||||||||||||
Collaboration Agreement | Relief Therapeutics Holding AG | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Upfront non-refundable payment received | $ 1,000,000 | |||||||||||||||
Cash payment received | 10,000,000 | $ 10,000,000 | ||||||||||||||
Repayment of outstanding balance of prior loan and interest | 4,000,000 | 4,000,000 | ||||||||||||||
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% | 60% | ||||||||||||||
Net profit split ratio | 60%:40% | |||||||||||||||
Percentage of royalty net sales received | 15% | 15% | ||||||||||||||
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 | $ 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% | |||||||||||||||
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 | |||||||||||||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Debt instrument, principal amount | $ 6,500,000 | |||||||||||||||
Debt instrument, interest rate, increase | 3% | |||||||||||||||
Minimum cash balance required by the loan covenants | 4,000,000 | 4,000,000 | ||||||||||||||
Origination fees | $ 100,000 | |||||||||||||||
Warrant issued to purchase common stock | 150,000 | |||||||||||||||
Warrant, exercise price | $ 2.46 | |||||||||||||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | Event of Positive Safety | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Cash and cash equivalents | $ 2,000,000 | $ 2,000,000 | ||||||||||||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | If ACER-001 Approval does not Occur on or Before September 30, 2022 | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Debt instrument, maturity date | Mar. 04, 2024 | |||||||||||||||
Debt instrument repayment percentage on outstanding principal amount | 150% | |||||||||||||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | If ACER-001 Approval Occur on or Before September 30, 2022 | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Debt instrument repayment percentage on outstanding principal amount | 130% | |||||||||||||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | Remainder of the Time Till Bridge Loan is Outstanding | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Minimum cash balance required by the loan covenants | $ 6,500,000 | |||||||||||||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | LIBOR | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Debt instrument, interest rate | 1% | |||||||||||||||
Debt instrument, description of variable rate basis | 3-month LIBOR | |||||||||||||||
Debt instrument, periodic payment, principal | $ 700,000 | |||||||||||||||
Debt instrument, frequency of periodic payment | quarterly | |||||||||||||||
Debt instrument, basis spread on variable rate | 11% | |||||||||||||||
Loan repayment commencing date | Nov. 15, 2022 | |||||||||||||||
Secured Convertible Note Purchase Agreement | Secured Convertible Notes | MAM Aardvark, LLC and Marathon Healthcare Finance Fund, L.P. | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Debt instrument, principal amount | $ 6,000,000 | |||||||||||||||
Debt instrument, interest rate | 6.50% | |||||||||||||||
Debt instrument, frequency of periodic payment | quarterly | |||||||||||||||
Debt instrument, interest rate, increase | 11.50% | |||||||||||||||
Conversion price | $ 2.50 | |||||||||||||||
Marathon Credit Agreement | Term Loan | Lender Party and Marathon | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Debt instrument, principal amount | $ 42,500,000 | |||||||||||||||
Debt instrument, interest rate | 13.50% | |||||||||||||||
Debt instrument, frequency of periodic payment | quarterly | |||||||||||||||
Debt instrument, maturity date | Dec. 31, 2028 | |||||||||||||||
Percentage of commitment fee | 1.50% | |||||||||||||||
Line of credit facility, maximum borrowing capacity | $ 92,500,000 | |||||||||||||||
Line of credit facility, additional borrowing capacity | $ 50,000,000 | |||||||||||||||
Percentage of option to capitalize | 4% | |||||||||||||||
Debt instrument amortization percentage | 2.78% | |||||||||||||||
Debt instrument, maturity date, description | The final maturity date of the Term Loan would be the earlier of six years after the Term Loan Funding Date or December 31, 2028. | |||||||||||||||
Percentage of prepayment, prior to March 4, 2025 | 5% | |||||||||||||||
Percentage of prepayment, on or after March 4, 2025, but prior to March 4, 2026 | 3% | |||||||||||||||
Percentage of prepayment, on or after March 4, 2026, but prior to March 4, 2027 | 2% | |||||||||||||||
Percentage of prepayment, on or after March 4, 2027 | 1% | |||||||||||||||
Payment for commitment fees | $ 200,000 | |||||||||||||||
Payment for additional commitment fees | $ 600,000 | |||||||||||||||
Percentage of aggregate revenue as royalty payments | 2% | |||||||||||||||
Royalty payments on aggregate revenue cap amount | $ 15,000,000 | |||||||||||||||
Weighted Average | Lincoln Park | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Issuance of common stock, price per share | $ 1.25 | $ 2.47 | $ 1.25 | $ 2.47 | ||||||||||||
Minimum [Member] | SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Number of days required for cash balance | 20 days | |||||||||||||||
Minimum [Member] | SWK Credit Agreement | Bridge Loan | Lenders Party and SWK Funding LLC | Remainder of the Time Till Bridge Loan is Outstanding | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Number of days required for cash balance | 40 days | |||||||||||||||
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] | ||||||||||||||||
Remained available under facility | $ 36,700,000 | $ 36,700,000 | ||||||||||||||
Common stock offering costs | $ 200,000 | $ 200,000 | $ 200,000 | |||||||||||||
Issuance of common stock, net of issuance costs, shares | 1,062,547 | 1,062,547 | 877,107 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 3,100,000 | $ 3,100,000 | $ 2,600,000 | |||||||||||||
Proceeds from issuance of common stock gross | $ 3,300,000 | $ 3,300,000 | $ 2,800,000 | |||||||||||||
At-the-Market Facility | Weighted Average | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Issuance of common stock, price per share | $ 3.0719 | $ 3.1692 | $ 3.0719 | $ 3.1692 | ||||||||||||
At-the-Market Facility | Maximum | ||||||||||||||||
Organization Consolidation and Presentation of Financial Statement [Line Items] | ||||||||||||||||
Aggregate offering price of common stock | $ 50,000,000 | $ 50,000,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Jan. 14, 2022 | Oct. 12, 2021 | Mar. 19, 2021 | Jan. 25, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Oct. 04, 2021 | |
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% | |||||||||
Reimbursement payment | $ 14,000,000 | |||||||||
Collaboration agreement amount | 25,000,000 | |||||||||
Development payments | 10,000,000 | |||||||||
Deferred collaboration funding | $ 6,300,000 | $ 6,300,000 | ||||||||
Deferred collaboration funding, current | 6,340,438 | 6,340,438 | $ 15,825,938 | |||||||
Cash in excess of FDIC insured limit | 14,200,000 | 14,200,000 | 12,500,000 | |||||||
Cash and cash equivalents | 14,469,744 | 14,469,744 | 12,710,762 | |||||||
Preclinical or clinical study expense included in accounts payable and accrued expenses. | 300,000 | 300,000 | 200,000 | |||||||
Income tax expense (benefit) | 0 | $ 0 | 0 | $ 0 | ||||||
Uncertain tax positions, accruals | 0 | 0 | 0 | 0 | ||||||
Accruals for interest or penalties related to income tax matters | $ 0 | 0 | $ 0 | 0 | ||||||
ASU No. 2020-06 | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Change in accounting principle, accounting standards update, adopted | true | true | ||||||||
Change in accounting principle, accounting standards update, adoption date | Mar. 31, 2021 | Mar. 31, 2021 | ||||||||
ASU No. 2021-10 | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Change in accounting principle, accounting standards update, adopted | true | true | ||||||||
Change in accounting principle, accounting standards update, adoption date | Dec. 31, 2021 | Dec. 31, 2021 | ||||||||
Change in accounting principle, accounting standards update, immaterial effect | true | true | ||||||||
ASU No. 2021-04 | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Change in accounting principle, accounting standards update, adopted | true | true | ||||||||
Change in accounting principle, accounting standards update, adoption date | Mar. 31, 2022 | Mar. 31, 2022 | ||||||||
Change in accounting principle, accounting standards update, immaterial effect | true | true | ||||||||
Event of Positive Safety | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Cash and cash equivalents | $ 2,000,000 | $ 2,000,000 | ||||||||
Maximum | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Cash, FDIC insured amount | 250,000 | 250,000 | ||||||||
Bridge Loan | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Minimum cash balance required by the loan covenants | 4,000,000 | 4,000,000 | ||||||||
Bridge Loan | Remainder of the Time Till Bridge Loan is Outstanding | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Minimum cash balance required by the loan covenants | 6,500,000 | $ 6,500,000 | ||||||||
Bridge Loan | Minimum [Member] | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Number of days required for cash balance | 20 days | |||||||||
Bridge Loan | Minimum [Member] | Remainder of the Time Till Bridge Loan is Outstanding | ||||||||||
Schedule Of Significant Accounting Policies [Line Items] | ||||||||||
Number of days required for cash balance | 40 days | |||||||||
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] | ||||||||||
Deferred collaboration funding | 14,200,000 | $ 14,200,000 | ||||||||
Deferred collaboration funding, current | 6,300,000 | 6,300,000 | ||||||||
Noncurrent liability | 7,900,000 | 7,900,000 | ||||||||
Deferred collaboration funding, cash received | $ 35,000,000 | 35,000,000 | ||||||||
Revenue recognized | $ 1,300,000 | |||||||||
Offset to research and development expenses | 10,700,000 | |||||||||
Offset to general and administrative expenses | $ 8,800,000 | |||||||||
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% | 60% | ||||||||
Percentage of royalty net sales received | 15% | 15% | ||||||||
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% | |||||||||
Percentage of payment net profit territory | 60% | |||||||||
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 Polici_5
Significant Accounting Policies - Schedule of Estimate Fair Value of Stock Options Granted (Details) | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Schedule Of Significant Accounting Policies [Line Items] | ||
Risk-free interest rate, minimum | 1.18% | 0.37% |
Risk-free interest rate, maximum | 1.83% | 0.62% |
Expected life (years) | 6 years 3 months | 6 years 3 months |
Expected volatility | 92.40% | |
Dividend rate | 0% | 0% |
Minimum [Member] | ||
Schedule Of Significant Accounting Policies [Line Items] | ||
Expected volatility | 113% | |
Maximum | ||
Schedule Of Significant Accounting Policies [Line Items] | ||
Expected volatility | 115% |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 304,367 | $ 319,869 |
Less accumulated depreciation | (202,785) | (205,757) |
Property and equipment, net | 101,582 | 114,112 |
Computer Hardware and Software | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 144,782 | 113,847 |
Leasehold Improvements | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | 52,887 | 60,535 |
Furniture and Fixtures | ||
Property Plant And Equipment [Line Items] | ||
Subtotal property and equipment, gross | $ 106,698 | $ 145,487 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Accounts Payable And Accrued Liabilities Current [Abstract] | ||
Accrued payroll and payroll taxes | $ 2,539,643 | $ 419,354 |
Accrued precommercial costs | 1,120,435 | 395,923 |
Accrued contract manufacturing | 935,710 | 827,390 |
Accrued accounting, audit, and tax fees | 278,950 | 167,630 |
Accrued contract research and regulatory consulting | 236,356 | 47,637 |
Accrued legal | 212,291 | 162,812 |
Accrued consulting | 103,855 | 105,085 |
Accrued license fees | 78,015 | 86,259 |
Accrued miscellaneous expenses | 62,709 | 216,103 |
Total accrued expenses | $ 5,567,964 | $ 2,428,193 |
Leases - Additional Information
Leases - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||
Nov. 17, 2021 | Oct. 15, 2021 | Jun. 30, 2022 USD ($) ft² | Jun. 30, 2022 USD ($) ft² | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) ft² | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Apr. 23, 2019 ft² | Mar. 05, 2019 ft² | Apr. 01, 2018 ft² | Mar. 06, 2018 ft² | |
Lessee Lease Description [Line Items] | ||||||||||||
Operating lease right of use asset | $ | $ 300,000 | $ 300,000 | $ 300,000 | $ 400,000 | ||||||||
Operating lease liability | $ | $ 276,555 | $ 276,555 | $ 276,555 | $ 393,837 | ||||||||
Operating lease discount rate | 8% | 8% | 8% | 10% | ||||||||
Operating lease, weighted average remaining lease term | 2 years 8 months 12 days | 2 years 8 months 12 days | 2 years 8 months 12 days | |||||||||
Operating lease, cash payment made | $ | $ 100,000 | $ 100,000 | $ 100,000 | $ 100,000 | ||||||||
Operating lease expense | $ | $ 100,000 | $ 100,000 | $ 100,000 | $ 100,000 | ||||||||
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible Enumeration] | Other non-current assets | Other non-current assets | Other non-current assets | |||||||||
Operating Lease, Liability, Statement of Financial Position [Extensible Enumeration] | us-gaap:OtherLiabilities | us-gaap:OtherLiabilities | 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. 06, 2018 | |||||||||||
Lease commencement date | Oct. 01, 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. 05, 2019 | |||||||||||
Lease commencement date | Jun. 01, 2019 | |||||||||||
Square feet of office space leased | 1,600 | |||||||||||
Amendment of Newton Lease | ||||||||||||
Lessee Lease Description [Line Items] | ||||||||||||
Reduced area of land | 1,600 | 1,600 | 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. 01, 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 01, 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 | Jun. 30, 2025 | ||||||||||
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 the 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 was received in June 2022, or (2) until June 30, 2025 if FDA approval of ACER-001 was not received in June 2022 |
Leases - Reconciliation of Undi
Leases - Reconciliation of Undiscounted Lease Liabilities to Total Lease Liabilities (Details) - USD ($) | Jun. 30, 2022 | Dec. 31, 2021 |
Undiscounted lease liabilities for years ending December 31: | ||
2022 (remaining) | $ 60,317 | |
2023 | 103,925 | |
2024 | 107,290 | |
2025 | 54,579 | |
Total undiscounted lease liabilities | 326,111 | |
Less effects of discounting | (49,556) | |
Total lease liabilities as of June 30, 2022 | 276,555 | $ 393,837 |
Other current liabilities | $ 110,421 | $ 184,340 |
Operating Lease Liability Current Statement Of Financial Position Extensible List | Other current liabilities | Other current liabilities |
Other non-current liabilities | $ 166,134 | $ 209,497 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible Enumeration] | Other non-current liabilities | Other non-current liabilities |
Total lease liabilities | $ 276,555 | $ 393,837 |
Debt - Additional Information (
Debt - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Mar. 14, 2022 | Mar. 04, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2022 | Dec. 31, 2021 | |
Debt Instrument [Line Items] | ||||||
Cash and cash equivalents | $ 14,469,744 | $ 14,469,744 | $ 12,710,762 | |||
Proceeds allocated to SWK Warrant | $ 327,031 | |||||
Debt issuance costs incurred | 1,200,000 | |||||
SWK Warrant | ||||||
Debt Instrument [Line Items] | ||||||
Fair value of warrant | 300,000 | 300,000 | ||||
Bridge Loan | ||||||
Debt Instrument [Line Items] | ||||||
Fair value of loan | 6,200,000 | 6,200,000 | ||||
Event of Positive Safety | ||||||
Debt Instrument [Line Items] | ||||||
Cash and cash equivalents | 2,000,000 | 2,000,000 | ||||
Financial Advisor | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance costs incurred | 700,000 | |||||
SWK and Holders | ||||||
Debt Instrument [Line Items] | ||||||
Debt issuance costs incurred | 500,000 | |||||
Bridge Loan | Non-Operating Income | ||||||
Debt Instrument [Line Items] | ||||||
Reduction in the fair value of debt | (2,100,000) | (2,100,000) | ||||
Secured Convertible Notes | Non-Operating Income | ||||||
Debt Instrument [Line Items] | ||||||
Reduction in the fair value of debt | (2,700,000) | (1,700,000) | ||||
Term Loan | Financial Advisor | ||||||
Debt Instrument [Line Items] | ||||||
Payment for funding fee for services | 700,000 | |||||
Bridge Loan and Convertible Note Financing | Financial Advisor | ||||||
Debt Instrument [Line Items] | ||||||
Payment for funding fee for services | 500,000 | |||||
SWK Credit Agreement | Lenders Party and SWK | Event of Positive Safety | ||||||
Debt Instrument [Line Items] | ||||||
Cash and cash equivalents | $ 2,000,000 | 2,000,000 | ||||
SWK Credit Agreement | Bridge Loan | ||||||
Debt Instrument [Line Items] | ||||||
Principal amortization payments | $ 1,900,000 | |||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, principal amount | $ 6,500,000 | |||||
Debt instrument, interest rate | 12% | 12% | ||||
Debt instrument, interest rate, increase | 3% | |||||
Debt instrument, maturity date, description | The final maturity date of the Bridge Loan is (a) if full approval by FDA for marketing of the Company’s product known as ACER-001 (sodium phenylbutyrate) (“ACER-001 Approval”) occurs on or before September 30, 2022, then the date which is 12 business days after ACER-001 Approval, or (b) if ACER-001 Approval does not occur on or before September 30, 2022, then March 4, 2024. | |||||
Minimum cash balance required by the loan covenants | $ 4,000,000 | $ 4,000,000 | ||||
Origination fees | $ 100,000 | |||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK | SWK Warrant | ||||||
Debt Instrument [Line Items] | ||||||
Warrant issued to purchase common stock | 150,000 | |||||
Warrant, exercise price | $ 2.46 | |||||
Proceeds allocated to SWK Warrant | $ 300,000 | |||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK | Minimum [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Number of days required for cash balance | 20 days | |||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK | If ACER-001 Approval does not Occur on or Before September 30, 2022 | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, maturity date | Mar. 04, 2024 | |||||
Debt instrument repayment percentage on outstanding principal plus any and all paid-in-kind interest amount | 150% | |||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK | If ACER-001 Approval Occur on or Before September 30, 2022 | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument repayment percentage on outstanding principal plus any and all paid-in-kind interest amount | 130% | |||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK | Remainder of the Time Till Bridge Loan is Outstanding | ||||||
Debt Instrument [Line Items] | ||||||
Minimum cash balance required by the loan covenants | $ 6,500,000 | $ 6,500,000 | ||||
SWK Credit Agreement | Bridge Loan | Lenders Party and SWK | LIBOR | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, description of variable rate basis | 3-month LIBOR | |||||
Debt instrument, interest rate | 1% | |||||
Debt instrument, basis spread on variable rate | 11% | |||||
Debt instrument, periodic payment, principal | $ 700,000 | |||||
Debt instrument, frequency of periodic payment | quarterly | |||||
Loan repayment commencing date | Nov. 15, 2022 | |||||
Secured Convertible Note Purchase Agreement | Secured Convertible Notes | MAM Aardvark, LLC and Marathon Healthcare Finance Fund, L.P. | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, principal amount | $ 6,000,000 | |||||
Debt instrument, interest rate | 6.50% | |||||
Debt instrument, interest rate, increase | 11.50% | |||||
Debt instrument, frequency of periodic payment | quarterly | |||||
Conversion price | $ 2.50 | |||||
Marathon Credit Agreement | Term Loan | Lender Party and Marathon | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, principal amount | $ 42,500,000 | |||||
Debt instrument, interest rate | 13.50% | |||||
Debt instrument, frequency of periodic payment | quarterly | |||||
Debt instrument, maturity date, description | The final maturity date of the Term Loan would be the earlier of six years after the Term Loan Funding Date or December 31, 2028. | |||||
Debt instrument, maturity date | Dec. 31, 2028 | |||||
Commitment fee percentage on term loan amount | 1.50% | |||||
Line of credit facility, maximum borrowing capacity | $ 92,500,000 | |||||
Line of credit facility, additional borrowing capacity | $ 50,000,000 | |||||
Percentage of option to capitalize | 4% | |||||
Debt instrument amortization percentage | 2.78% | |||||
Percentage of prepayment, prior to March 4, 2025 | 5% | |||||
Percentage of prepayment, on or after March 4, 2025, but prior to March 4, 2026 | 3% | |||||
Percentage of prepayment, on or after March 4, 2026, but prior to March 4, 2027 | 2% | |||||
Percentage of prepayment, on or after March 4, 2027 | 1% | |||||
Payment for commitment fees | $ 200,000 | |||||
Payment for additional commitment fees | $ 600,000 | |||||
Percentage of aggregate revenue as royalty payments | 2% | |||||
Royalty payments on aggregate revenue cap amount | $ 15,000,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value (Details) - Recurring | Jun. 30, 2022 USD ($) |
Carrying Amount | |
Debt: | |
Liabilities, fair value | $ 8,405,909 |
Carrying Amount | Money Market Funds in Cash Equivalents | |
Assets: | |
Assets, fair value | 13,969,744 |
Fair Value | |
Debt: | |
Liabilities, fair value | 8,405,909 |
Fair Value | Money Market Funds in Cash Equivalents | |
Assets: | |
Assets, fair value | 13,969,744 |
Level 1 | Money Market Funds in Cash Equivalents | |
Assets: | |
Assets, fair value | 13,969,744 |
Level 3 | |
Debt: | |
Liabilities, fair value | 8,405,909 |
Secured Convertible Notes | Carrying Amount | |
Debt: | |
Liabilities, fair value | 4,321,200 |
Secured Convertible Notes | Fair Value | |
Debt: | |
Liabilities, fair value | 4,321,200 |
Secured Convertible Notes | Level 3 | |
Debt: | |
Liabilities, fair value | 4,321,200 |
Bridge Loan | Carrying Amount | |
Debt: | |
Liabilities, fair value | 4,084,709 |
Bridge Loan | Fair Value | |
Debt: | |
Liabilities, fair value | 4,084,709 |
Bridge Loan | Level 3 | |
Debt: | |
Liabilities, fair value | $ 4,084,709 |
Fair Value Measurements - Addit
Fair Value Measurements - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Changes in fair value | $ (3,767,060) | |
Bridge Loan | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Changes in fair value | $ (2,100,000) | (2,088,260) |
Secured Convertible Notes | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Changes in fair value | $ (2,700,000) | $ (1,678,800) |
Fair Value Measurements - Sch_2
Fair Value Measurements - Schedule of Change in Fair Value (Details) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Loan Received | $ 12,172,969 | |
Adjustment to Fair Value Mark to Market | (3,767,060) | |
Ending Balance | $ 8,405,909 | 8,405,909 |
Secured Convertible Notes | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Loan Received | 6,000,000 | |
Adjustment to Fair Value Mark to Market | (2,700,000) | (1,678,800) |
Ending Balance | 4,321,200 | 4,321,200 |
Bridge Loan | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Loan Received | 6,172,969 | |
Adjustment to Fair Value Mark to Market | (2,100,000) | (2,088,260) |
Ending Balance | $ 4,084,709 | $ 4,084,709 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||||
Jan. 14, 2022 USD ($) | Oct. 12, 2021 USD ($) | Mar. 19, 2021 USD ($) | Jan. 25, 2021 USD ($) | Jan. 21, 2021 USD ($) | Jun. 05, 2020 | Apr. 11, 2020 USD ($) | Sep. 30, 2018 Patent | Aug. 31, 2016 | Jun. 30, 2021 USD ($) | Jun. 30, 2022 USD ($) | Jun. 30, 2021 USD ($) | Dec. 31, 2021 USD ($) | Oct. 04, 2021 USD ($) | |
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% | 75% | ||||||||||||
Other current liabilities | $ 185,265 | $ 9,450,085 | ||||||||||||
Other current assets | 65,061 | $ 9,283,625 | ||||||||||||
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 | 100,000 | |||||||||||||
Other current assets | $ 100,000 | |||||||||||||
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. | |||||||||||||
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% | |||||||||||||
Assistance Publique - Hopitaux de Paris ("AP-HP") | License Agreement | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Agreement entered date | 2018-09 | |||||||||||||
Number of patent applications | Patent | 3 | |||||||||||||
Assistance Publique - Hopitaux de Paris ("AP-HP") | Private Acer | License Agreement | ||||||||||||||
Commitments And Contingencies [Line Items] | ||||||||||||||
Agreement entered date | 2016-08 | |||||||||||||
Relief 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% | 60% | ||||||||||||
Percentage of royalty revenue received | 15% | |||||||||||||
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 | $ 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% | |||||||||||||
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 second tranche of development payments subject to new drug application | 5,000,000 | |||||||||||||
Proceeds from first tranche of development payments subject to new drug application | $ 5,000,000 | $ 5,000,000 |
Stockholders' (Deficit) Equit_2
Stockholders' (Deficit) Equity - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||||||
Apr. 30, 2020 | Mar. 18, 2020 | Sep. 18, 2019 | Nov. 09, 2018 | May 14, 2018 | Sep. 19, 2017 | Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | Feb. 18, 2022 | Jan. 01, 2022 | Jan. 01, 2021 | |
Stockholders Equity [Line Items] | ||||||||||||||
Issuance of common stock, net of issuance costs, shares | 300,000 | |||||||||||||
Proceeds from issuance of common stock, net of issuance costs | $ 400,000 | $ 3,524,198 | $ 3,139,047 | |||||||||||
Number of share outstanding | 2,850,787 | 2,850,787 | 1,954,975 | |||||||||||
Awards granted under the plan | 958,000 | |||||||||||||
Unrecognized compensation expense | $ 3,300,000 | $ 3,300,000 | ||||||||||||
Share based compensation arrangement by share based payment award, Weighted average period | 3 years | |||||||||||||
Weighted average grant date fair value of options granted | $ 1.97 | $ 2.18 | $ 1.99 | $ 2.83 | ||||||||||
Fair value of options vested | $ 400,000 | $ 300,000 | $ 1,500,000 | $ 1,200,000 | ||||||||||
2018 Stock Incentive Plan | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Number of common stock authorized for issuance | 500,000 | 572,410 | 529,325 | |||||||||||
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, 2022 and 2021, 572,410 and 529,325 additional shares, respectively, were authorized according to the evergreen provision. On February18, 2022, the Company’s Board of Directors amended and restated the 2018 Plan to add a provision permitting the grant of inducement awards under Nasdaq Marketplace Rule 5635(c)(4) to eligible recipients and initially reserved 200,000 shares of the Company’s common stock for issuance pursuant to inducement awards granted under the 2018 Plan. 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. 01, 2028 | |||||||||||||
Share-based compensation arrangement by share-based payment award, percentage of outstanding our common stock | 4% | |||||||||||||
Grant of inducement awards and reserved, shares | 200,000 | |||||||||||||
Options contractual term | 10 years | |||||||||||||
Available for the grant of future awards | 333,376 | 333,376 | ||||||||||||
2018 Stock Incentive Plan | Executive Officers and Employees | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, stock options vesting period | 4 years | |||||||||||||
2018 Stock Incentive Plan | Executive Officers and Employees | One-year Anniversary of the Grant Date | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 25% | |||||||||||||
Awards granted under the plan | 0 | 0 | 0 | |||||||||||
2018 Stock Incentive Plan | Executive Officers and Employees | Quarterly over Remaining Three Years | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 75% | |||||||||||||
2018 Stock Incentive Plan | Executive Officers and Employees | January 1, 2021 | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 50% | |||||||||||||
2018 Stock Incentive Plan | Executive Officers and Employees | January 1, 2022 | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, Vesting percentage | 50% | |||||||||||||
2018 Stock Incentive Plan | Board of Directors | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Share-based compensation arrangement by share-based payment award, stock options vesting period | 12 months | |||||||||||||
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 | |||||||||||||
Lincoln Park | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Issuance of common stock, net of issuance costs, shares | 300,000 | 0 | 300,000 | 200,000 | ||||||||||
Issuance of common stock, price per share | $ 1.25 | $ 1.25 | ||||||||||||
Proceeds from issuance of common stock gross | $ 400,000 | $ 400,000 | ||||||||||||
Proceeds from issuance of common stock, net of issuance costs | 400,000 | $ 500,000 | ||||||||||||
Remaining obligation | $ 11,800,000 | $ 11,800,000 | ||||||||||||
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 incurred | $ 400,000 | |||||||||||||
Weighted Average | Lincoln Park | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Issuance of common stock, price per share | $ 1.25 | $ 2.47 | $ 1.25 | $ 2.47 | ||||||||||
Maximum | 2010 and 2013 Stock Incentive Plan | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Number of share outstanding | 635,170 | |||||||||||||
Maximum | Lincoln Park | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Shares value might be issued under agreement | $ 15,000,000 | |||||||||||||
Number of shares, company may sell on any single business day | 100,000 | |||||||||||||
Beneficially ownership percentage | 9.99% | |||||||||||||
Minimum [Member] | 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 | 1,062,547 | 1,062,547 | 877,107 | |||||||||||
Proceeds from issuance of common stock gross | $ 3,300,000 | $ 3,300,000 | $ 2,800,000 | |||||||||||
Common stock offering costs | 200,000 | 200,000 | 200,000 | |||||||||||
Proceeds from issuance of common stock, net of issuance costs | 3,100,000 | 3,100,000 | $ 2,600,000 | |||||||||||
Amount remained available under facility | $ 36,700,000 | $ 36,700,000 | ||||||||||||
At-the-Market Facility | Weighted Average | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Issuance of common stock, price per share | $ 3.0719 | $ 3.1692 | $ 3.0719 | $ 3.1692 | ||||||||||
At-the-Market Facility | Maximum | ||||||||||||||
Stockholders Equity [Line Items] | ||||||||||||||
Aggregate offering price of common stock | $ 50,000,000 | $ 50,000,000 |
Stockholders' (Deficit) Equit_3
Stockholders' (Deficit) Equity - Summary of Option Activity under 2018 Plan, 2013 Plan and 2010 Plan (Details) - $ / shares | 6 Months Ended | 12 Months Ended |
Jun. 30, 2022 | Dec. 31, 2021 | |
Options | ||
Number of Shares, Options outstanding at beginning of period | 1,954,975 | |
Awards granted under the plan | 958,000 | |
Number of Shares, Options Cancelled/forfeited | (62,188) | |
Number of Shares, Options outstanding at end of period | 2,850,787 | 1,954,975 |
Number of Shares, Options exercisable at end of period | 1,322,180 | |
Weighted Average Exercise Price, Options | ||
Weighted Average Exercise Price, Options outstanding at beginning of period | $ 8.16 | |
Weighted Average Exercise Price, Options Granted | 2.33 | |
Weighted Average Exercise Price, Options Cancelled/forfeited | 4.12 | |
Weighted Average Exercise Price, Options outstanding at end of period | 6.29 | $ 8.16 |
Weighted Average Exercise Price, Options exercisable at end of period | $ 9.80 | |
Weighted Average Remaining Contract Term, Options | ||
Weighted Average Remaining Contractual Term, Options outstanding at beginning of period | 8 years | 7 years 9 months 18 days |
Weighted Average Remaining Contractual Term, Options exercisable at end of period | 6 years 7 months 6 days |
Stockholders' (Deficit) Equit_4
Stockholders' (Deficit) Equity - Summary of Stock-Based Compensation Expense (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stockholders Equity [Line Items] | ||||
Stock-based compensation expense | $ 460,777 | $ 594,663 | $ 934,874 | $ 1,154,099 |
Research and Development | ||||
Stockholders Equity [Line Items] | ||||
Stock-based compensation expense | 158,880 | 176,534 | 299,320 | 344,580 |
General and Administrative | ||||
Stockholders Equity [Line Items] | ||||
Stock-based compensation expense | $ 301,897 | $ 418,129 | $ 635,554 | $ 809,519 |
Stockholders' (Deficit) Equit_5
Stockholders' (Deficit) Equity - Summary of Warrant Issued (Details) - Warrants Issued to SWK | 6 Months Ended |
Jun. 30, 2022 $ / shares shares | |
Stockholders Equity [Line Items] | |
Number of shares, Granted during the period | shares | 150,000 |
Number of shares,Outstanding at end of the period | shares | 150,000 |
Number of shares, Exercisable at end of the period | shares | 150,000 |
Weighted average remaining life | 6 years 9 months 18 days |
Weighted Average Exercise Price, Granted | $ / shares | $ 2.46 |
Weighted Average Exercise Price, Outstanding at end of the period | $ / shares | 2.46 |
Weighted Average Exercise Price, Exercisable at end of the period | $ / shares | $ 2.46 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities excluded from computation of net loss per share | 3,000,787 | 1,751,475 |
Senior Convertible Notes | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities excluded from computation of net loss per share | 2,400,000 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Number of Shares of Common Stock Underlying Potentially Dilutive Securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 3,000,787 | 1,751,475 |
Options to purchase common stock | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 2,850,787 | 1,751,475 |
SWK Warrant | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Common stock dilutive securities | 150,000 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |
Aug. 15, 2022 | Jun. 30, 2022 | Jun. 30, 2022 | Jun. 30, 2021 | |
Subsequent Event [Line Items] | ||||
Issuance of common stock, net of issuance costs, shares | 300,000 | |||
Proceeds from issuance of common stock, net of issuance costs | $ 400,000 | $ 3,524,198 | $ 3,139,047 | |
Subsequent Event | Lincoln Park | ||||
Subsequent Event [Line Items] | ||||
Issuance of common stock, net of issuance costs, shares | 275,000 | |||
Issuance of common stock, price per share | $ 1.38 | |||
Proceeds from issuance of common stock gross | $ 400,000 | |||
At-the-Market Facility | ||||
Subsequent Event [Line Items] | ||||
Issuance of common stock, net of issuance costs, shares | 1,062,547 | 1,062,547 | 877,107 | |
Proceeds from issuance of common stock gross | $ 3,300,000 | $ 3,300,000 | $ 2,800,000 | |
Proceeds from issuance of common stock, net of issuance costs | $ 3,100,000 | $ 3,100,000 | $ 2,600,000 | |
At-the-Market Facility | Subsequent Event | ||||
Subsequent Event [Line Items] | ||||
Issuance of common stock, net of issuance costs, shares | 133,206 | |||
Issuance of common stock, price per share | $ 1.51 | |||
Proceeds from issuance of common stock gross | $ 200,000 | |||
Proceeds from issuance of common stock, net of issuance costs | $ 200,000 |