Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2023 | Mar. 01, 2024 | Jun. 30, 2023 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2023 | ||
Document Fiscal Year Focus | 2023 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Evoke Pharma, Inc. | ||
Entity Central Index Key | 0001403708 | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Public Float | $ 5.3 | ||
Entity Common Stock, Shares Outstanding | 8,477,801 | ||
Entity Shell Company | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | false | ||
Document Financial Statement Error Correction [Flag] | false | ||
Title of 12(b) Security | Common Stock, par value $0.0001 per share | ||
Trading Symbol | EVOK | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-36075 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 20-8447886 | ||
Entity Address, Address Line One | 420 Stevens Avenue | ||
Entity Address, Address Line Two | Suite 230 | ||
Entity Address, City or Town | Solana Beach | ||
Entity Address, State or Province | CA | ||
Entity Address, Postal Zip Code | 92075 | ||
City Area Code | 858 | ||
Local Phone Number | 345-1494 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive proxy statement to be filed with the Securities and Exchange Commission pursuant to Regulation 14A in connection with the registrant’s 2024 Annual Meeting of Stockholders, which will be filed subsequent to the date hereof, are incorporated by reference into Part III of this Form 10-K. Such proxy statement will be filed with the Securities and Exchange Commission not later than 120 days following the end of the registrant’s fiscal year ended December 31, 2023. | ||
Auditor Firm ID | 243 | ||
Auditor Name | BDO USA, P.C. | ||
Auditor Location | San Diego, California |
Balance Sheets
Balance Sheets - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Current Assets: | ||
Cash and cash equivalents | $ 4,739,426 | $ 9,843,699 |
Accounts receivable | 673,071 | 624,832 |
Prepaid expenses | 885,040 | 952,954 |
Inventory | 481,840 | 289,378 |
Other current assets | 47,532 | 11,551 |
Total current assets | 6,826,909 | 11,722,414 |
Deferred offering costs | 241,637 | |
Operating lease right-of-use asset | 129,074 | |
Total assets | 7,068,546 | 11,851,488 |
Current Liabilities: | ||
Accounts payable and accrued expenses | 1,711,778 | 934,312 |
Accrued compensation | 1,324,010 | 591,158 |
Operating lease liability | 129,074 | |
Total current liabilities | 3,035,788 | 1,654,544 |
Long-term Liabilities: | ||
Note payable | 5,000,000 | 5,000,000 |
Accrued interest payable | 1,612,295 | 1,112,295 |
Total long-term liabilities | 6,612,295 | 6,112,295 |
Total liabilities | 9,648,083 | 7,766,839 |
Commitments and contingencies (Note 3) | ||
Stockholders' equity (deficit): | ||
Preferred stock, $0.0001 par value; authorized shares - 5,000,000 at December 31, 2023 and 2023; issued and outstanding shares - 0 at December 31, 2023 and 2022 respectively | ||
Common stock, $0.0001 par value; authorized shares - 50,000,000 at December 31, 2023 and 2022; issued and outstanding shares - 3,343,070 at December 31, 2023 and 2022, respectively | 334 | 334 |
Additional paid-in capital | 120,859,567 | 119,731,458 |
Accumulated deficit | (123,439,438) | (115,647,143) |
Total stockholders' equity (deficit) | (2,579,537) | 4,084,649 |
Total liabilities and stockholders' equity (deficit) | $ 7,068,546 | $ 11,851,488 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 50,000,000 | 50,000,000 |
Common stock, shares issued | 3,343,070 | 3,343,070 |
Common stock, shares outstanding | 3,343,070 | 3,343,070 |
Statements of Operations
Statements of Operations - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Statement [Abstract] | ||
Net product sales | $ 5,180,630 | $ 2,508,645 |
Operating expenses: | ||
Cost of goods sold | $ 201,879 | $ 370,394 |
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember |
Research and development | $ 181,907 | $ 300,789 |
Selling, general and administrative | 12,227,735 | 9,623,599 |
Total operating expenses | 12,611,521 | 10,294,782 |
Loss from operations | (7,430,891) | (7,786,137) |
Other income (expense): | ||
Interest income | 138,596 | 62,007 |
Interest expense | (500,000) | (500,000) |
Total other income (expense) | (361,404) | (437,993) |
Net loss | $ (7,792,295) | $ (8,224,130) |
Net loss per share of common stock, basic | $ (2.33) | $ (2.62) |
Net loss per share of common stock, diluted | $ (2.33) | $ (2.62) |
Weighted-average shares used to compute basic net loss per share | 3,343,070 | 3,143,626 |
Weighted-average shares used to compute diluted net loss per share | 3,343,070 | 3,143,626 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity (Deficit) - USD ($) | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] |
Beginning Balance at Dec. 31, 2021 | $ 3,555,094 | $ 272 | $ 110,977,835 | $ (107,423,013) |
Beginning Balance, Shares at Dec. 31, 2021 | 2,721,373 | |||
Stock-based compensation expense | 1,458,709 | 1,458,709 | ||
Issuance of common stock from ATM offering, net of costs | 7,294,976 | $ 62 | 7,294,914 | |
Issuance of common stock from ATM offering, net of costs, Shares | 621,697 | |||
Net loss | (8,224,130) | (8,224,130) | ||
Ending Balance at Dec. 31, 2022 | $ 4,084,649 | $ 334 | 119,731,458 | (115,647,143) |
Ending Balance, Shares at Dec. 31, 2022 | 3,343,070 | 3,343,070 | ||
Stock-based compensation expense | $ 1,128,109 | 1,128,109 | ||
Net loss | (7,792,295) | (7,792,295) | ||
Ending Balance at Dec. 31, 2023 | $ (2,579,537) | $ 334 | $ 120,859,567 | $ (123,439,438) |
Ending Balance, Shares at Dec. 31, 2023 | 3,343,070 | 3,343,070 |
Statements of Stockholders' E_2
Statements of Stockholders' Equity (Deficit) (Parenthetical) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Stock Issuance Cost | $ 148,993 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating activities | ||
Net loss | $ (7,792,295) | $ (8,224,130) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Non-cash lease expense | 129,074 | 37,025 |
Stock-based compensation expense | 1,128,109 | 1,458,709 |
Change in operating assets and liabilities: | ||
Accounts receivable | (48,239) | (329,639) |
Prepaid expenses and other assets | 31,932 | (29,208) |
Inventory | (192,462) | (103,843) |
Accounts payable and accrued expenses | 655,126 | 60,284 |
Accrued compensation | 732,852 | 71,840 |
Accrued interest payable | 500,000 | 500,000 |
Operating lease liabilities | (129,074) | (37,025) |
Net cash used in operating activities | (4,984,977) | (6,595,987) |
Financing activities | ||
Proceeds from issuance of common stock from ATM | 7,443,969 | |
Payment of ATM offering costs | (148,993) | |
Cash paid for offering costs | (119,296) | |
Net cash (used)/provided by financing activities | (119,296) | 7,294,976 |
Net (decrease)/ increase in cash and cash equivalents | (5,104,273) | 698,989 |
Cash and cash equivalents at beginning of period | 9,843,699 | 9,144,710 |
Cash and cash equivalents at end of period | 4,739,426 | 9,843,699 |
Non-cash financing activities | ||
Public offering costs included in accounts payable and accrued expenses | $ 122,340 | |
Operating lease right-of-use asset obtained in exchange for operating lease liabilities | $ 153,671 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Pay vs Performance Disclosure | ||
Net Income (Loss) | $ (7,792,295) | $ (8,224,130) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b5-1 Arrangement Modified | false |
Non-Rule 10b5-1 Arrangement Modified | false |
Organization and Basis of Prese
Organization and Basis of Presentation | 12 Months Ended |
Dec. 31, 2023 | |
Organization And Basis Of Presentation [Abstract] | |
Organization and Basis of Presentation | 1. Organization and Basis of Presentation Evoke Pharma, Inc. (the “Company”) was incorporated under the laws of the state of Delaware in January 2007 . The Company is a specialty pharmaceutical company focused primarily on the development of drugs to treat gastroenterological disorders and disease. Since its inception, the Company has devoted its efforts to developing its sole product, Gimoti (metoclopramide) nasal spray, the first and only nasally-administered product indicated for the relief of symptoms in adults with acute and recurrent diabetic gastroparesis. On June 19, 2020, the Company received approval from the U.S. Food and Drug Administration (“FDA”) for its 505(b)(2) New Drug Application (“NDA”) for Gimoti. The Company launched U.S. commercial sales of Gimoti in October 2020 through its commercial partner Eversana Life Science Services, LLC (“Eversana”). The Company’s activities are subject to the significant risks and uncertainties associated with any specialty pharmaceutical company that has launched its first commercial product, including market acceptance of the product and the potential need to obtain additional funding for its operations. Going Concern The financial statements have been prepared assuming the Company will continue as a going concern, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations since inception and expects to continue to incur net losses for the foreseeable future until such time, if ever, that it can generate significant revenues from the sale of Gimoti. The Company ended 2023 with approximately $ 4.7 million in cash and cash equivalents, plus the estimated net proceeds of approximately $ 6.1 million from the offering we completed in February 2024 as described in the subsequent event note. The Company anticipates that it will continue to incur losses from operations due to commercialization activities, including manufacturing Gimoti, conducting the post-marketing commitment single-dose pharmacokinetics (“PK”) clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, and for other general and administrative costs to support the Company’s operations. Additionally, if Eversana were to terminate the Commercial Services and Loan Agreement as described in Note 7, the principal and interest on the Loan, $ 6.6 million as of December 31, 2023, becomes due in 90 days. As a result, the Company believes that there is substantial doubt about its ability to continue as a going concern for one year after the date these financial statements are issued. The financial statements do not include any adjustments that may result from the outcome of this uncertainty. The Company’s net losses may fluctuate significantly from quarter to quarter and year to year. The Company anticipates that it will be required to raise additional funds through debt, equity or other forms of financing, such as potential collaboration arrangements, to fund future operations and continue as a going concern. There can be no assurance that additional financing will be available when needed or on acceptable terms. If the Company is not able to secure adequate additional funding, the Company may be forced to make reductions in spending, extend payment terms with suppliers, and/or suspend or curtail commercialization activities. Any of these actions could materially harm the Company’s business, results of operations, financial condition and future prospects. There can be no assurance that the Company will be able to successfully commercialize Gimoti. Because the Company’s business is entirely dependent on the success of Gimoti, if the Company is unable to secure additional financing, successfully commercialize Gimoti or identify and execute on strategic alternatives for Gimoti or the Company, the Company will be required to curtail all of its activities and may be required to liquidate, dissolve or otherwise wind down its operations. Notice of Delisting and Reverse Stock Split On December 29, 2021, the Company received a letter from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for our common stock had closed below the minimum $ 1.00 per share requirement for continued listing on the Nasdaq Capital Market. In accordance with Nasdaq listing rules, the Company was provided an initial period of 180 calendar days, or until June 27, 2022, to regain compliance. The letter stated that Nasdaq will provide written notification that the Company has achieved compliance with its rules if at any time before June 27, 2022 the bid price of the Company’s common stock closes at $ 1.00 per share or more for a minimum of ten consecutive business days. The Nasdaq letter had no immediate effect on the listing or trading of the Company’s common stock and the common stock continued to trade on The Nasdaq Capital Market. On April 27, 2022, the Company’s stockholders granted the board of directors the authority to effect a reverse stock split of the Company’s outstanding common stock. On May 23, 2022 the Company effected a 1-for-12 reverse stock split of the shares of the Company’s common stock (the “Reverse Stock Split”). The par value and the authorized shares of the common stock were not adjusted as a result of the Reverse Stock Split. All of the Company’s issued and outstanding common stock, warrants to purchase common stock, and options to purchase common stock have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented. On June 7, 2022, the Company received notice from Nasdaq stating that the closing price of the Company’s common stock had been at $ 1.00 per share or greater for the prior ten consecutive business days and that the Company had regained compliance with the minimum $ 1.00 per share requirement. On May 24, 2023, the Company received a written notice from Nasdaq indicating that, based on the Company's stockholders’ equity of $ 2.1 million as of March 31, 2023, as reported in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, the Company was not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1) (the “Minimum Stockholders’ Equity Requirement”). As required by Nasdaq, the Company submitted its plan to regain compliance with the Minimum Stockholders’ Equity Requirement and Nasdaq granted the Company an extension until November 20, 2023 to regain compliance. Following notice on November 21, 2023 from Nasdaq that the Company had not met the Minimum Stockholders’ Equity Requirement, the Company requested a hearing before the Nasdaq Hearings Panel (the “Hearings Panel”) and on December 9, 2023, Nasdaq notified the Company that the hearing was scheduled for February 15, 2024. On February 15, 2024, the Company had the hearing before the Hearings Panel. There can be no assurance that the Hearings Panel will grant our request for continued listing or that we will be able to evidence compliance prior to the expiration of any extension that may be granted by the Hearings Panel. As of the date of this Annual Report, the Hearings Panel has not issued a ruling. On February 21, 2024, the Company received a letter from Nasdaq indicating that, for the last thirty consecutive business days, the bid price for the Company's common stock had closed below the minimum $ 1.00 per share requirement for continued listing on the Nasdaq Capital Market. In accordance with Nasdaq listing rules, the Company was provided an initial period of 180 calendar days, or until August 19, 2024, to regain compliance. The letter states that Nasdaq will provide written notification that the Company has achieved compliance with its rules if at any time before August 19, 2024, the bid price of the Company's common stock closes at $ 1.00 per share or more for a minimum of ten consecutive business days. The Nasdaq letter had no immediate effect on the listing or trading of the Company's common stock and the common stock continued to trade on The Nasdaq Capital Market. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker ("CODM") in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment operating in the United States. Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking and savings accounts. The Company's cash equivalents are classified as Level 1 inputs within the fair value hierarchy. Fair Value of Financial Instruments The carrying amounts of all financial instruments, including accounts receivable and accounts payable and accrued expenses, are considered to be representative of their respective fair values because of the short-term nature of those instruments. The carrying value of other short-term and long-term borrowings approximates fair value based upon interest rates the Company believes it can currently obtain for similar debt, which is a Level 2 input within the fair value hierarchy. Concentrations of Risk Financial instruments that potentially subject the Company to significant credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in a federally insured financial institution in excess of federally insured limits. The Company has established guidelines designed to maintain safety and liquidity, has not experienced any losses in such accounts and believes the exposure to significant risk to the cash balance is minimal. The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory activities. If the CROs and consultants are unable to continue their support, this could adversely affect the Company’s operations. In addition, the Company relies on third-party manufacturers for the production of Gimoti. If the third-party manufacturers are unable to continue manufacturing Gimoti, or if the Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet any development needs or commercial supply demand for Gimoti, and the development and/or commercialization of Gimoti could be materially and adversely affected. The Company also relies on a dedicated third-party sales team to sell Gimoti. If such third-party organization is unable to continue serving as a dedicated sales team, the commercialization of Gimoti could be materially and adversely affected. Accounts Receivable and Allowance for Credit Losses Accounts receivable are recorded net of allowance for credit losses. The Company evaluates the collectability of accounts receivable based on a combination of factors, including specific circumstances that may impair a customer's ability to pay and historical payment patterns. The allowance for credit losses was zero at December 31, 2023 and December 31, 2022, and no bad debt expense was recorded for the years ended December 31, 2023 and December 31, 2022. Inventory The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its commercial manufacturing. The Company has agreements with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, and with Thermo Fisher Scientific Inc., through its subsidiary Patheon UK Limited, for the manufacturing of Gimoti. The Company currently utilizes third-party consultants, which it engages on an as-needed, hourly basis, to manage the manufacturing contractors. Subsequent to FDA approval, the Company began manufacturing Gimoti for commercialization and began capitalizing inventory at that time. The Company’s inventory consisted of approximately $ 361,000 and $ 239,000 of raw materials at December 31, 2023 and December 31, 2022, respectively, and approximately $ 121,000 and $ 50,000 of finished goods inventory at December 31, 2023 and December 31, 2022, respectively. Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. The Company’s raw materials inventory is held at its third-party suppliers and its work-in-process and finished goods inventory is held at its manufacturer and at Eversana. The Company records such inventory as consigned inventory. Deferred Offering Costs Deferred offering costs represent legal, accounting and other direct costs related to the public offering that was completed in February 2024. All deferred offering costs were reclassified to additional paid-in capital in February 2024. The Company recorded approximately $ 242,000 and zero deferred offering costs as a non-current asset in the accompanying balance sheets as of December 31, 2023 and 2022, respectively. Revenue Recognition The Company’s ability to generate revenue and become profitable depends on its ability to successfully commercialize Gimoti, which was launched in the United States in October 2020 through the Company’s commercial partner Eversana. If the Company or Eversana fail to successfully grow and maintain sales of Gimoti, the Company may never generate significant revenues and its results of operations and financial position will be adversely affected. In accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers , the Company recognizes revenue when a customer obtains control of promised goods in an amount that reflects the consideration the Company expects to receive in exchange for the goods provided. Customer control is determined upon the customer’s physical receipt of the product. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with the customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when (or as) it satisfies a performance obligation. At contract inception, the Company assesses the goods promised within each contract and determines those that are performance obligations and assesses whether each promised good is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the customer obtains control of the product. Product revenues are recorded net of sales-related adjustments, wherever applicable, including patient support programs, rebates, and other sales related discounts. The Company uses judgment to estimate variable consideration. The Company is subject to rebates under Medicaid and Medicare programs. The rebates for these programs are determined based on statutory provisions. The Company estimates Medicaid and Medicare rebates based on the expected number of claims and related cost associated with the customer transaction. Medicaid and Medicare rebates of $ 46,000 were recorded as accounts payable and accrued expenses on the balance sheet as of December 31, 2023, and $ 13,000 was recorded as a reduction to Accounts Receivable as of December 31, 2022. Co-payment assistance is recorded as an offset to gross revenue at the time revenue from the product sale is recognized based on expected and actual program participation. Co-pay liabilities are estimated using prescribing data available from customers. The Company's analysis also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not occur in a future period. If actual results in the future vary from estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $ 66,000 at each of December 31, 2023 and December 31, 2022, are classified as accounts payable and accrued expenses in the balance sheets. Stock-Based Compensation Stock-based compensation expense for stock option grants and employee stock purchases under the Company’s Employee Stock Purchase Plan (the “ESPP”) is recorded at the estimated fair value of the award as of the grant date and is recognized as expense on a straight-line basis over the employee’s requisite service period, except awards with a performance condition. Awards with a performance condition commence vesting when the satisfaction of the performance condition is probable. The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized. The Company grants stock options to purchase common stock to employees and members of the board of directors with exercise prices equal to the Company’s closing market price on the date the stock options are granted. The risk-free interest rate assumption was based on the yield of an applicable rate for U.S. Treasury instruments with maturities similar to those of the expected term of the award being valued. The weighted average expected term of options and employee stock purchases was calculated using the simplified method as prescribed by accounting guidance for stock-based compensation. Expected volatility was calculated based on historical volatility of the Company's common stock. The assumed dividend yield was based on the Company never paying cash dividends and having no expectation of paying cash dividends in the foreseeable future. The Company accounts for forfeitures as the forfeitures occur. Research and Development Expenses Research and development costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense, costs paid to third-party contractors for product development activities and drug product materials, and technology acquisition milestones. The Company will expense the clinical, regulatory and manufacturing costs related to the post-marketing commitment to conduct a single dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, as well as other costs that may occur for any additional clinical trials the Company may pursue to expand the indication of Gimoti. Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes . Under ASC 740, deferred tax assets and liabilities reflect the future tax consequences of the differences between the financial reporting and tax basis of assets and liabilities using current enacted tax rates. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company’s policy related to accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attributed criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common stock outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock and common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of warrants to purchase common stock and options to purchase common stock under the Company’s equity incentive plan. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive for the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Common stock options 624,232 491,851 Total excluded securities 624,232 491,851 Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, (“FASB”) issued ASU 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments , which amended the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for-sale debt securities. This update was effective for annual periods beginning after December 15, 2022. The adoption of this new standard did not have a material impact on the Company's financial statements. Recently Issued Accounting Pronouncements — Not Yet Adopte d In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures (“Topic 280”), which modifies the disclosure and presentation requirements of reportable segments. The amendments in the update require the disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit and loss. The amendments also require disclosure of all other segment items by reportable segment and a description of its composition. Additionally, the amendments require disclosure of the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. Lastly, the amendment requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. This update is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes. In December 2023, the FASB issued ASU No. 2023-09 ("ASU 2023-09"), “Improvements to Income Tax Disclosures.” ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024 and for private businesses for annual periods beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its financial statement disclosures. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 3. Commitments and Contingencies Leases In December 2016, the Company entered into an operating lease for office space in Solana Beach, California. The lease commenced on January 1, 2017 , was extend ed in September 2018, December 2019, December 2020, February 2022, and August 2022 and expired on October 31, 2023 . The Company recognized an operating lease ROU asset and liability based on the present value of the future minimum lease payments over the lease term at the commencement date, using the Company’s assumed incremental borrowing rate, and then amortizes the ROU assets over the lease term. The Company applies a discount rate to the minimum lease payments within the lease agreement to determine the value of right-of-use assets and lease liabilities. The Company noted that the implicit rate in the lease was not determinable and calculated its incremental borrowing rate of 10 % upon execution of the lease. In October 2023, the Company entered into a 12-month lease agreement for office space in Solana Beach, effective November 1, 2023 , that expires on October 31, 2024 . Leases with an initial term of 12 months or less are not recorded on the balance sheet and operating lease expense for these leases are recognized on a straight-line basis over the lease term as general and administrative expense within the accompanying financial statements. The operating lease expense of $ 154,000 and $ 150,000 is included in the general and administrative expense for the years ended December 31, 2023 and 2022, respectively. The cash paid for the operating leases was $ 146,000 and $ 39,000 for the years ended December 31, 2023 and 2022, respectively. As of December 31, 2023, the Company has future minimum lease payments under its existing facility lease of approximately $ 63,000 payable in 2024. The remaining lease term was 0.83 years as of December 31, 2023 and December 31, 2022, respectively. |
Technology Acquisition Agreemen
Technology Acquisition Agreement | 12 Months Ended |
Dec. 31, 2023 | |
Technology Acquisition Agreement [Abstract] | |
Technology Acquisition Agreement | 4. Technology Acquisition Agreement In June 2007, the Company acquired all worldwide rights, data, patents and other related assets associated with Gimoti from Questcor Pharmaceuticals, Inc. (“Questcor”) pursuant to an asset purchase agreement. The Company paid Questcor $ 650,000 in the form of an upfront payment and $ 500,000 in May 2014 as a milestone payment based upon the initiation of the first patient dosing in the Company’s Phase 3 clinical trial for Gimoti . In August 2014, Mallinckrodt, plc (“Mallinckrodt”) acquired Questcor. As a result of that acquisition, Questcor transferred its rights included in the asset purchase agreement with the Company to Mallinckrodt. In addition to the payments previously made to Questcor, the Company may also be required to make additional milestone payments totaling up to $ 52 million. In March 2018, the Company and Mallinckrodt amended the asset purchase agreement to defer development and approval milestone payments, such that, rather than paying two milestone payments based on FDA acceptance for review of the NDA and final product marketing approval, the Company would be required to make a single $ 5 million payment on the one-year anniversary after the Company receives FDA approval to market Gimoti. At the time of the Gimoti NDA approval, the Company recorded the $ 5 million payable owed to Mallinckrodt, along with a $ 5 million research and development expense. The $ 5 million milestone payment was paid in July 2021. The remaining $ 47 million in milestone payments depended on Gimoti’s commercial success. The Company was required to pay Mallinckrodt a low single digit royalty percentage on net sales of Gimoti . As of December 31, 2023, the Company has paid Mallinckrodt approximately $ 134,000 in royalties on net sales of Gimoti. The Company’s obligation to pay such royalties and milestones terminated due to the expiration of the last patent right covering Gimoti transferred under the asset purchase agreement. |
Preferred Stock, Common Stock a
Preferred Stock, Common Stock and Stockholders' Equity | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Preferred Stock, Common Stock and Stockholders' Equity | 5. Preferred Stock, Common Stock and Stockholders’ Equity Preferred Stock Under the Company’s amended and restated certificate of incorporation, the Company is authorized to issue 5,000,000 shares of preferred stock with a $ 0.0001 par value. No shares of preferred stock were outstanding as of December 31, 2023 or 2022. Common Stock As of December 31, 2023, there were 3,343,070 shares of common stock outstanding. Each share of common stock is entitled to one vote. The holders of the common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors of the Company. To date, no dividends have been declared. At the Market Equity Offering Program In December 2020, the Company filed a shelf registration statement with the SEC on Form S-3 (the “shelf registration statement”) which was declared effective by the SEC on January 6, 2021. In December 2020, the Company also entered into an At Market Issuance Sales Agreement (the “ATM Sales Agreement”), with B. Riley FBR, Inc. (“FBR”) and H.C. Wainwright & Co. (together with FBR, the “Sales Agents”), pursuant to which the Company was able to sell from time to time, at its option, up to an aggregate of $ 30 million worth of shares of the Company’s common stock through the Sales Agents. No shares were sold during the year ended December 31, 2023. During the year ended December 31, 2022, the Company sold 621,697 shares of common stock at a weighted-average price per share of $ 11.97 pursuant to the ATM Sales Agreement and received proceeds of approximately $ 7.3 million, net of commissions and fees. The shelf registration statement, including the prospectus related to the ATM Sales Agreement, expired on January 6, 2024. Warrants The Company has issued warrants to purchase common stock to banks that have previously loaned funds to the Company, as well as to representatives of the underwriters of the Company’s public offerings and certain of their affiliates. During 2023, there were no outstanding warrants to purchase shares of common stock. During 2022, no warrants were exercised and warrants to purchase 139,972 shares of common stock expired. Equity Incentive Award Plans In August 2013, the Company adopted the 2013 Equity Incentive Award Plan (the “2013 Plan”). Under the 2013 Plan, the Company may grant stock options, stock appreciation rights, restricted stock, restricted stock units and other awards to individuals who are then employees, officers, non-employee directors or consultants of the Company. Since its adoption, the Company’s stockholders have amended and restated the 2013 Plan. As of May 2023, the Company’s stockholders increased the number of shares of common stock authorized for issuance under the 2013 Plan to an aggregate of 1,194,717 shares and extended the term of the 2013 Plan to March 2033 . In addition, the number of shares available for issuance is annually increased on the first day of each fiscal year by that number of shares equal to the least of (a) six percent of the outstanding shares of common stock on the last day of the immediately preceding calendar year, and (b) such other amount determined by the Company’s board of directors. Notwithstanding the foregoing, the number of shares of common stock that may be issued or transferred pursuant to incentive stock options under the Restated Plan may not exceed an aggregate of 50,000,000 shares. As a result of the annual increases since the 2013 Plan originated, and the increase of stock options reserved under the restatements of the 2013 Plan approved by the Company’s stockholders through May 2023, the Company has increased the number shares reserved for issuance under the 2013 Plan by 1,352,800 shares. As of December 31, 2023, 547,838 options remain available for future grant under the 2013 Plan. On January 1, 2024, the Company further increased the number of shares reserved for issuance under the 2013 Plan by 200,584 shares, making 748,422 options available for future grant under the 2013 Plan. Options granted under the 2013 Plan have ten-year terms from the date of grant and generally vest over a one to four year period. The Company granted options to purchase 153,750 and 78,247 shares of common stock in 2023 and 2022, respectively. The exercise price of all options granted during the years ended December 31, 2023 and 2022 was equal to the market value per share of the Company’s common stock on the date of grant. A summary of the Company’s stock option activity under the 2013 Plan is as follows: Shares Weighted Weighted Aggregate Value Outstanding at December 31, 2022 491,851 $ 19.11 7.22 Granted 153,750 $ 3.07 9.23 Expired ( 21,369 ) $ 45.78 - Outstanding at December 31, 2023 624,232 $ 14.25 7.05 - Vested and expected to vest at December 31, 2023 624,232 $ 14.25 7.05 - Exercisable at December 31, 2023 418,591 $ 14.64 6.23 - The aggregate intrinsic values of outstanding options are calculated as the difference between the exercise price of the underlying options and the closing price of our common stock of $ 1.05 at December 31, 2023. The weighted average grant date fair value per share of employee stock options granted during the years ended December 31, 2023 and 2022, was $ 2.42 and $ 4.86 , respectively. Employee Stock Purchase Plan In June 2013, the Company’s board of directors adopted the ESPP, and the Company’s stockholders approved the ESPP on August 29, 2013 . The ESPP became effective on the day prior to the effectiveness of the IPO. The ESPP permits participants to purchase the Company’s common stock at 85 % of the fair market value through payroll deductions of up to 20 % of their eligible compensation. A total of 2,500 shares of common stock were initially reserved for issuance under the ESPP. In addition, the number of shares of common stock available for issuance under the ESPP has been annually increased on the first day of each fiscal year during the term of the ESPP by an amount equal to the lesser of: (i) 2,500 shares; (ii) one percent of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. In May 2017, the Company’s stockholders approved an amendment and restatement of the Company’s ESPP to increase the number of shares of common stock reserved under the ESPP by 8,333 shares (to an aggregate of 20,833 shares), to increase the annual evergreen provision from 2,500 shares to 8,333 shares, and to extend the term of the ESPP into 2027 . In May 2023, the Company’s stockholders approved an amendment and restatement of the Company’s ESPP to increase the number of shares of common stock reserved under the ESPP by 100,000 shares (to an aggregate of 170,833 shares), and to increase the annual evergreen provision by the lesser of (a) one percent of the outstanding shares of common stock on the last day of the immediately preceding calendar year, or (b) such other amount determined by the Company’s board of directors, and to extend the term of the ESPP into 2033 . The Company has increased the number shares reserved for issuance under the ESPP by 168,333 shares since the inception of the ESPP. As of December 31, 2023, 145,381 shares remain available for future issuance under the ESPP. On January 1, 2024, the Company further increased the number of shares reserved for future issuance under the ESPP by 33,430 shares, making 178,811 shares available for future issuance under the ESPP after that increase. No shares of common stock were issued through the ESPP during 2023 and 2022. Stock-Based Compensation Stock-based compensation expense includes charges related to employee stock purchases under the ESPP and stock option grants. The Company measures stock-based compensation expense based on the grant date fair value of any awards granted to its employees. Such expense is recognized over the period of time that employees provide service and earn rights to the awards. The estimated fair value of each stock option award granted was determined on the date of grant using the Black Scholes option-pricing valuation model with the following assumptions for option grants during the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Risk free interest rate 1.34 %- 3.39 % 1.67 %- 3.55 % Expected option term 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility of common stock 99.34 %- 103.64 % 97.04 %- 113.23 % Expected dividend yield 0.0 % 0.0 % The Company recognized stock-based compensation expense to employees and directors in its research and development and its general and administrative functions during the years ended December 31, 2023 and 2022 as follows: Year Ended December 31, 2023 2022 Research and development $ 2,840 $ 11,278 Selling, general and administrative 1,125,269 1,447,431 Total stock-based compensation expense $ 1,128,109 $ 1,458,709 As of December 31, 2023, there was approximately $ 1.1 million of unrecognized compensation costs related to outstanding employee and board of director options, which are expected to be recognized over a weighted-average period of 0.75 years. Common Stock Reserved for Future Issuance Common stock reserved for future issuance consists of the following: December 31, 2023 2022 Stock options issued and outstanding 624,232 491,851 Authorized for future option grants 547,838 146,497 Authorized for employee stock purchase plan 145,381 37,048 Total common stock reserved for future issuance 1,317,451 675,396 |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | 6. Employee Benefit Plan The Company has established a defined contribution 401(k) plan (the “Plan”) for all employees who are at least 21 years of age. Employees are eligible to participate in the Plan beginning on the date of employment. Under the terms of the Plan, employees may make voluntary contributions as a percentage of compensation. The Company’s contributions to the Plan are discretionary, and no contributions have been made by the Company to date. For the years ended December 31, 2023 and 2022, the Company adopted Safe Harbor 401(k) provisions. A contribution of $ 3,000 was required to be made to the accounts of employees for the year ended December 31, 2023 in order to maintain the Plan’s compliance with Internal Revenue Service regulations. No contributions were made during 2022. |
Commercial Services and Loan Ag
Commercial Services and Loan Agreements with Eversana | 12 Months Ended |
Dec. 31, 2023 | |
Commercial Services And Loan Agreements [Abstract] | |
Commercial Services and Loan Agreements with Eversana | 7. Commercial Services and Loan Agreements with Eversana On January 21, 2020, the Company entered into a commercial services agreement (as amended, the “Eversana Agreement”) with Eversana for the commercialization of Gimoti. Pursuant to the Eversana Agreement, Eversana commercializes and distributes Gimoti in the United States. Eversana also manages the marketing of Gimoti to targeted health care providers, as well as the sales and distribution of Gimoti in the United States. Under the terms of the Eversana Agreement, the Company maintains ownership of the Gimoti NDA, as well as legal, regulatory, and manufacturing responsibilities for Gimoti. Eversana will utilize its internal sales organization, along with other commercial functions, for market access, marketing, distribution and other related patient support services. The Company will record sales for Gimoti and retain more than 80 % of net product profits once both parties’ costs are reimbursed. For the years ended December 31, 2023 and 2022, approximately $ 4.4 million and $ 2.0 million of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. As of December 31, 2023, unreimbursed commercialization costs to Eversana were approximately $ 63.5 million. Such costs will generally be payable only as net product profits are recognized. Eversana will receive reimbursement of its commercialization costs pursuant to an agreed upon budget and a percentage of product profits in the mid-to-high teens. Net product profits are the net sales (as defined in the Eversana Agreement) of Gimoti, less (i) reimbursed commercialization costs, (ii) manufacturing and administrative costs set at a fixed percentage of net sales, and (iii) third party royalties. During the term of the Eversana Agreement, Eversana agreed to not market, promote, or sell a competing product in the United States. On February 1, 2022, the Eversana Agreement was amended to extend the term from June 19, 2025 (five years from the date the Food & Drug Administration approved the Gimoti new drug application) to December 31, 2026 , unless terminated earlier pursuant to its terms. This amendment also increased the percentage of net product profit retained by the Company and increased the proportion of costs that are reimbursed to Eversana to the extent Eversana has accumulated unreimbursed costs . Upon expiration or termination of the agreement, the Company will retain all profits from product sales and assume all corresponding commercialization responsibilities. Within 30 days after each of the first three annual anniversaries of commercial launch, either party may terminate the agreement if net sales of Gimoti do not meet certain annual thresholds. Either party may terminate the agreement: for the material breach of the other party, subject to a 60-day cure period; in the event an insolvency, petition of the other party is pending for more than 60 days; upon 30 days written notice to the other party if Gimoti is subject to a safety recall; the other party is in breach of certain regulatory compliance representations under the agreement; if the Company discontinues the development or production of Gimoti; if the net profit is negative for any two consecutive calendar quarters beginning with the first full calendar quarter 24 months following commercial launch; if the cumulative net product profits fail to reach certain thresholds in the first three years following launch; or if there is a change in applicable laws that makes operation of the services as contemplated under the agreement illegal or commercially impractical. Either party may also terminate the Eversana Agreement upon a change of control of the Company’s ownership. As of December 31, 2023, either party has the right to exercise the Net Profit Quarterly Termination Right, which it may do for a 60-day period following the end of the quarter. Each party will continue to have the option to exercise this termination right for the 60-day period following the end of future quarters so long as the net profit under the agreement remains negative for consecutive quarters. In the event that the Company initiates such termination, the Company shall pay to Eversana a one-time payment equal to all of Eversana’s unreimbursed cost plus a portion of Eversana’s commercialization costs incurred in the 12 months prior to termination. Such payment amount would be reduced by the amount of previously reimbursed commercialization costs and profit split paid for the related prior twelve-month period and any revenue which occurred prior to the termination yet to be collected. If Eversana terminates the agreement due to an uncured material breach by the Company, or if the Company terminates the Eversana Agreement in certain circumstances, i ncluding pursuant to the Net Profit Quarterly Termination Right, the Company has agreed to reimburse Eversana for its unreimbursed commercialization costs for the prior twelve-month period and certain other costs. In addition, Eversana may terminate the Eversana Agreement if the Company withdraws Gimoti from the market for more than 90 days. In connection with the Eversana Agreement, the Company and Eversana have entered into the Eversana Credit Facility, pursuant to which Eversana has agreed to provide a revolving Credit Facility of up to $ 5 million to the Company upon FDA approval of the Gimoti NDA under certain customary conditions. The Eversana Credit Facility terminates on December 31, 2026, unless terminated earlier pursuant to its terms. The Eversana Credit Facility is secured by all of the Company’s personal property other than the Company’s intellectual property. Under the terms of the Eversana Credit Facility, the Company cannot grant an interest in the Company’s intellectual property to any other person. Each loan under the Eversana Credit Facility will bear interest at an annual rate equal to 10.0 %, with such interest due at the end of the loan term. In 2020 the Company borrowed $ 5 million under the Eversana Credit Facility. The Company may prepay any amounts borrowed under the Eversana Credit Facility at any time without penalty or premium. The maturity date of all amounts, including interest, borrowed under the Eversana Credit Facility will be 90 days after the expiration or earlier termination of the Eversana Agreement. The Eversana Credit Facility also includes events of default, the occurrence and continuation of which provide Eversana with the right to exercise remedies against the Company and the collateral securing the loans under the Eversana Credit Facility, including the Company’s cash. These events of default include, among other things, the Company’s failure to pay any amounts due under the Eversana Credit Facility, an uncured material breach of the representations, warranties and other obligations under the Eversana Credit Facility, the occurrence of insolvency events and the occurrence of a change in control. On November 3, 2022, the Company and Eversana entered into Amendment No. 2 (the "Amendment") to the Eversana Agreement. The Amendment provides that the preexisting rights of both parties to terminate the commercial services agreement within 30 days of the first three annual anniversaries of commercial launch, if net sales of Gimoti did not meet certain annual thresholds, would be modified solely for 2022 such that either party can terminate by written notice to the other party by November 30, 2022. Neither party terminated the Agreement under this Amendment. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 8. Income Taxes The Company accounts for uncertain tax positions in accordance with ASC Topic 740, Income Taxes . The application of income tax law and regulations is inherently complex. Interpretations and guidance surrounding income tax laws and regulations change over time. As such, changes in the Company’s subjective assumptions and judgments can materially affect amounts recognized in its financial statements. The Company’s policy is to recognize interest and/or penalties related to income tax matters in income tax expense. The Company had no accrual for interest and penalties on the balance sheet at December 31, 2023. The Company has an uncertain tax position (“UTP”) of approximately $ 2.0 million related to California net operating losses at December 31, 2023. The Company is subject to taxation in the United States and state jurisdictions, and the Company’s tax years beginning 2007 to date are subject to examination by taxing authorities. Deferred income taxes result from temporary differences between the tax basis of assets and liabilities and their reported amounts in the financial statements that will result in taxable or deductible amounts in future years. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in years in which those temporary differences are expected to be recovered or settled. As changes in tax laws or rates are enacted, deferred tax assets and liabilities are adjusted through income tax expense. A reconciliation of the federal statutory income tax rate and the effective income tax rate is as follows for the years ended December 31, 2023 and 2022: December 31, 2023 2022 (%) (%) Federal statutory rate 21 21 Change in valuation allowance ( 3 ) - State income taxes, net of federal benefit 1 2 Removal of net operating losses and other credits ( 16 ) ( 24 ) Impact of state tax rate change ( 1 ) 1 Stock compensation and other permanent items ( 2 ) - Effective income tax rate - - Pursuant to Internal Revenue Code of 1986 (“IRC”) Sections 382 and 383, annual use of the Company’s net operating loss and research and development credit carryforwards may be limited in the event a cumulative change in ownership of more than 50 % occurs within a three-year period. The Company has not completed an IRC Section 382/383 analysis regarding the limitation of net operating loss and research and development credit carryforwards. Until this analysis has been completed, the Company has excluded the deferred tax assets for net operating losses of approximately $ 25.8 million and a research and development credit of approximately $ 3.6 million generated through December 31, 2023 from its deferred tax asset. When this analysis is finalized, the Company plans to update its unrecognized tax benefits accordingly. The Company does not expect this analysis to be completed within the next twelve months and, as a result, the Company does not expect that the unrecognized tax benefits will change within twelve months of this reporting date. Due to the existence of the valuation allowance, future changes in the Company’s unrecognized tax benefits will not impact the Company’s effective tax rate. Significant components of the Company’s deferred tax assets are as follows: December 31, 2023 2022 Deferred tax assets : Stock compensation expense $ 1,839,000 $ 1,825,000 Capitalized R&D 161,000 125,000 Lease liability - 29,000 Accruals and other 294,000 136,000 Total deferred tax assets 2,294,000 2,115,000 Deferred tax liabilities : Right of use asset - ( 29,000 ) Total deferred tax liabilities - ( 29,000 ) Less valuation allowance ( 2,294,000 ) ( 2,086,000 ) Net deferred tax assets (liabilities) $ - $ - The deferred tax assets and valuation allowance as of December 31, 2023 increased by $ 208,000 . The Company carries a full valuation allowance against these deferred tax assets, therefore, the adjustments had no effect on the balance sheets, statements of operations and cash flows for the periods presented. At December 31, 2023, the Company has federal and state net operating loss carryforwards of approximately $ 105.8 million and $ 53.6 million, respectively. The federal and state loss carryforwards begin to expire in 2027 and 2028 , respectively, unless previously utilized. The portion of federal net operating losses created after 2017 of approximately $ 43.9 million do not expire and will carry forward indefinitely. At December 31, 2023, the Company also has federal and California research tax credit carryforwards of approximately $ 2.4 million and $ 1.5 million, respectively. The federal research credit carryforwards will begin expiring in 2027 unless previously utilized. The California research credit will carry forward indefinitely. Pursuant to U.S. tax legislation enacted in December 2017, tax losses generated in calendar year 2018 and beyond do not expire, but may only offset 80 % of the Company’s taxable income. This change may require us to pay federal income taxes in future years despite generating a loss for federal income tax purposes in prior years. There were no changes to unrecognized tax benefits in 2023 and 2022. As such, the balance of unrecognized tax benefits (excluding interest and penalties) was approximately $ 2.0 million at December 31, 2023 and 2022. The Company will recognize interest and penalties related to unrecognized tax benefits as income tax expense when incurred. To date, since no benefit has been taken related to the UTP, there has been no interest and penalties recognized. Due to the full valuation allowance that the Company has on the deferred tax assets, there are no unrecognized tax benefits that would impact the effective tax rate, if recognized. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | 9. Subsequent Events On February 13, 2024, the Company sold 5,134,731 common stock units (the “Common Stock Units”), at a public offering price of $ 0.68 per Common Stock Unit and, to certain investors, 5,894,680 pre-funded warrant units (the “PFW Units”), at a public offering price of $ 0.6799 per PFW Unit. Each Common Stock Unit consists of (i) one share of common stock, (ii) a Series A Warrant to purchase one share of common stock (the “Series A Warrant”), (iii) a Series B Warrant to purchase one share of common stock (the “Series B Warrant”), and (iv) a Series C Warrant to purchase one share of common stock (the “Series C Warrant”). Each PFW Unit consists of (i) a pre-funded warrant to purchase one share of common stock, (ii) a Series A Warrant, (iii) a Series B Warrant, and (iv) a Series C Warrant. After deducting underwriting discounts and commissions and offering expenses paid by the Company, the net proceeds to the Company from this offering are estimated to be approximately $ 6.1 million. The Pre-Funded Warrants have an exercise price of $ 0.0001 per share. The Series A Warrants, Series B Warrants and the Series C Warrants have an exercise price of $ 0.68 per share. The Pre-Funded Warrants, Series A Warrants and Series B Warrants are exercisable immediately. The Series C Warrants are subject to a vesting schedule and may only be exercised to the extent and in proportion to a holder of the Series C Warrants exercising its corresponding Series B Warrants. The Series A Warrants will expire on February 13, 2029 , which is five years from the date of issuance. The Series B Warrants will expire on November 13, 2024 , which is nine months from the date of issuance. The Series C Warrants will also expire on November 13, 2024 , provided that to the extent and in proportion to a holder of the Series C Warrants exercising its corresponding Series B Warrants included in the applicable unit, such Series C Warrant will expire on February 13, 2029 . |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Use of Estimates | Use of Estimates The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates. |
Segment Reporting | Segment Reporting Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker ("CODM") in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one operating segment operating in the United States. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less from the date of purchase to be cash equivalents. Cash and cash equivalents include cash in readily available checking and savings accounts. The Company's cash equivalents are classified as Level 1 inputs within the fair value hierarchy. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of all financial instruments, including accounts receivable and accounts payable and accrued expenses, are considered to be representative of their respective fair values because of the short-term nature of those instruments. The carrying value of other short-term and long-term borrowings approximates fair value based upon interest rates the Company believes it can currently obtain for similar debt, which is a Level 2 input within the fair value hierarchy. |
Concentrations of Risk | Concentrations of Risk Financial instruments that potentially subject the Company to significant credit risk consist primarily of cash and cash equivalents. The Company maintains deposits in a federally insured financial institution in excess of federally insured limits. The Company has established guidelines designed to maintain safety and liquidity, has not experienced any losses in such accounts and believes the exposure to significant risk to the cash balance is minimal. The Company relies on contract research organizations (“CROs”) and consultants to assist with ongoing regulatory activities. If the CROs and consultants are unable to continue their support, this could adversely affect the Company’s operations. In addition, the Company relies on third-party manufacturers for the production of Gimoti. If the third-party manufacturers are unable to continue manufacturing Gimoti, or if the Company loses one of its sole source suppliers used in its manufacturing processes, the Company may not be able to meet any development needs or commercial supply demand for Gimoti, and the development and/or commercialization of Gimoti could be materially and adversely affected. The Company also relies on a dedicated third-party sales team to sell Gimoti. If such third-party organization is unable to continue serving as a dedicated sales team, the commercialization of Gimoti could be materially and adversely affected. |
Accounts Receivable and Allowance for Credit Losses | Accounts Receivable and Allowance for Credit Losses Accounts receivable are recorded net of allowance for credit losses. The Company evaluates the collectability of accounts receivable based on a combination of factors, including specific circumstances that may impair a customer's ability to pay and historical payment patterns. The allowance for credit losses was zero at December 31, 2023 and December 31, 2022, and no bad debt expense was recorded for the years ended December 31, 2023 and December 31, 2022. |
Inventory | Inventory The Company does not own or operate manufacturing facilities for the production of Gimoti, nor does it plan to develop its own manufacturing operations in the foreseeable future. The Company depends on third-party contract manufacturers for all of its required raw materials, drug substance and finished product for its commercial manufacturing. The Company has agreements with Cosma S.p.A. to supply metoclopramide for the manufacture of Gimoti, and with Thermo Fisher Scientific Inc., through its subsidiary Patheon UK Limited, for the manufacturing of Gimoti. The Company currently utilizes third-party consultants, which it engages on an as-needed, hourly basis, to manage the manufacturing contractors. Subsequent to FDA approval, the Company began manufacturing Gimoti for commercialization and began capitalizing inventory at that time. The Company’s inventory consisted of approximately $ 361,000 and $ 239,000 of raw materials at December 31, 2023 and December 31, 2022, respectively, and approximately $ 121,000 and $ 50,000 of finished goods inventory at December 31, 2023 and December 31, 2022, respectively. Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. The Company’s raw materials inventory is held at its third-party suppliers and its work-in-process and finished goods inventory is held at its manufacturer and at Eversana. The Company records such inventory as consigned inventory. |
Deferred Offering Costs | Deferred Offering Costs Deferred offering costs represent legal, accounting and other direct costs related to the public offering that was completed in February 2024. All deferred offering costs were reclassified to additional paid-in capital in February 2024. The Company recorded approximately $ 242,000 and zero deferred offering costs as a non-current asset in the accompanying balance sheets as of December 31, 2023 and 2022, respectively. |
Revenue Recognition | Revenue Recognition The Company’s ability to generate revenue and become profitable depends on its ability to successfully commercialize Gimoti, which was launched in the United States in October 2020 through the Company’s commercial partner Eversana. If the Company or Eversana fail to successfully grow and maintain sales of Gimoti, the Company may never generate significant revenues and its results of operations and financial position will be adversely affected. In accordance with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers , the Company recognizes revenue when a customer obtains control of promised goods in an amount that reflects the consideration the Company expects to receive in exchange for the goods provided. Customer control is determined upon the customer’s physical receipt of the product. To determine revenue recognition for arrangements within the scope of ASC 606, the Company performs the following five steps: identify the contracts with the customer; identify the performance obligations in the contract; determine the transaction price; allocate the transaction price to the performance obligations in the contract; and recognize revenue when (or as) it satisfies a performance obligation. At contract inception, the Company assesses the goods promised within each contract and determines those that are performance obligations and assesses whether each promised good is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when the customer obtains control of the product. Product revenues are recorded net of sales-related adjustments, wherever applicable, including patient support programs, rebates, and other sales related discounts. The Company uses judgment to estimate variable consideration. The Company is subject to rebates under Medicaid and Medicare programs. The rebates for these programs are determined based on statutory provisions. The Company estimates Medicaid and Medicare rebates based on the expected number of claims and related cost associated with the customer transaction. Medicaid and Medicare rebates of $ 46,000 were recorded as accounts payable and accrued expenses on the balance sheet as of December 31, 2023, and $ 13,000 was recorded as a reduction to Accounts Receivable as of December 31, 2022. Co-payment assistance is recorded as an offset to gross revenue at the time revenue from the product sale is recognized based on expected and actual program participation. Co-pay liabilities are estimated using prescribing data available from customers. The Company's analysis also contemplated application of the constraint in accordance with the guidance, under which it determined a significant reversal of revenue would not occur in a future period. If actual results in the future vary from estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $ 66,000 at each of December 31, 2023 and December 31, 2022, are classified as accounts payable and accrued expenses in the balance sheets. |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense for stock option grants and employee stock purchases under the Company’s Employee Stock Purchase Plan (the “ESPP”) is recorded at the estimated fair value of the award as of the grant date and is recognized as expense on a straight-line basis over the employee’s requisite service period, except awards with a performance condition. Awards with a performance condition commence vesting when the satisfaction of the performance condition is probable. The estimation of stock option and ESPP fair value requires management to make estimates and judgments about, among other things, employee exercise behavior, forfeiture rates and volatility of the Company’s common stock. The judgments directly affect the amount of compensation expense that will be recognized. The Company grants stock options to purchase common stock to employees and members of the board of directors with exercise prices equal to the Company’s closing market price on the date the stock options are granted. The risk-free interest rate assumption was based on the yield of an applicable rate for U.S. Treasury instruments with maturities similar to those of the expected term of the award being valued. The weighted average expected term of options and employee stock purchases was calculated using the simplified method as prescribed by accounting guidance for stock-based compensation. Expected volatility was calculated based on historical volatility of the Company's common stock. The assumed dividend yield was based on the Company never paying cash dividends and having no expectation of paying cash dividends in the foreseeable future. The Company accounts for forfeitures as the forfeitures occur. |
Research and Development Expenses | Research and Development Expenses Research and development costs are expensed as incurred and primarily include compensation and related benefits, stock-based compensation expense, costs paid to third-party contractors for product development activities and drug product materials, and technology acquisition milestones. The Company will expense the clinical, regulatory and manufacturing costs related to the post-marketing commitment to conduct a single dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti, as well as other costs that may occur for any additional clinical trials the Company may pursue to expand the indication of Gimoti. |
Income Taxes | Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes . Under ASC 740, deferred tax assets and liabilities reflect the future tax consequences of the differences between the financial reporting and tax basis of assets and liabilities using current enacted tax rates. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company’s policy related to accounting for uncertainty in income taxes prescribes a recognition threshold and measurement attributed criteria for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common stock outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is calculated by dividing the net loss by the weighted-average number of common stock and common stock equivalents outstanding for the period determined using the treasury-stock method. Dilutive common stock equivalents are comprised of warrants to purchase common stock and options to purchase common stock under the Company’s equity incentive plan. The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive for the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Common stock options 624,232 491,851 Total excluded securities 624,232 491,851 |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements In June 2016, the Financial Accounting Standards Board, (“FASB”) issued ASU 2016-13, Financial Instruments – Credit Losses: Measurement of Credit Losses on Financial Instruments , which amended the impairment model by requiring entities to use a forward-looking approach based on expected losses to estimate credit losses on certain types of financial instruments, including trade receivables and available-for-sale debt securities. This update was effective for annual periods beginning after December 15, 2022. The adoption of this new standard did not have a material impact on the Company's financial statements. Recently Issued Accounting Pronouncements — Not Yet Adopte d In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280) Improvements to Reportable Segment Disclosures (“Topic 280”), which modifies the disclosure and presentation requirements of reportable segments. The amendments in the update require the disclosure of significant segment expenses that are regularly provided to the CODM and included within each reported measure of segment profit and loss. The amendments also require disclosure of all other segment items by reportable segment and a description of its composition. Additionally, the amendments require disclosure of the title and position of the CODM and an explanation of how the CODM uses the reported measure(s) of segment profit or loss in assessing segment performance and deciding how to allocate resources. Lastly, the amendment requires that a public entity that has a single reportable segment provide all the disclosures required by ASU 2023-07 and all existing segment disclosures in Topic 280. This update is effective for annual periods beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Early adoption is permitted. The Company is currently evaluating the impact that this guidance will have on the presentation of its financial statements and accompanying notes. In December 2023, the FASB issued ASU No. 2023-09 ("ASU 2023-09"), “Improvements to Income Tax Disclosures.” ASU 2023-09 requires disaggregated information about a reporting entity’s effective tax rate reconciliation as well as information on income taxes paid. ASU 2023-09 is effective for public entities with annual periods beginning after December 15, 2024 and for private businesses for annual periods beginning after December 15, 2025, with early adoption permitted. The Company is currently evaluating the impact of this guidance on its financial statement disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share | The following table sets forth the outstanding potentially dilutive securities that have been excluded from the calculation of diluted net loss per share because to do so would be anti-dilutive for the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Common stock options 624,232 491,851 Total excluded securities 624,232 491,851 |
Preferred Stock, Common Stock_2
Preferred Stock, Common Stock and Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Equity [Abstract] | |
Summary of Stock Option Activity | A summary of the Company’s stock option activity under the 2013 Plan is as follows: Shares Weighted Weighted Aggregate Value Outstanding at December 31, 2022 491,851 $ 19.11 7.22 Granted 153,750 $ 3.07 9.23 Expired ( 21,369 ) $ 45.78 - Outstanding at December 31, 2023 624,232 $ 14.25 7.05 - Vested and expected to vest at December 31, 2023 624,232 $ 14.25 7.05 - Exercisable at December 31, 2023 418,591 $ 14.64 6.23 - |
Summary of Estimated Fair Value of Stock Option Award | The estimated fair value of each stock option award granted was determined on the date of grant using the Black Scholes option-pricing valuation model with the following assumptions for option grants during the years ended December 31, 2023 and 2022: Year Ended December 31, 2023 2022 Risk free interest rate 1.34 %- 3.39 % 1.67 %- 3.55 % Expected option term 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility of common stock 99.34 %- 103.64 % 97.04 %- 113.23 % Expected dividend yield 0.0 % 0.0 % |
Summary of Recognized Stock-Based Compensation Expense | The Company recognized stock-based compensation expense to employees and directors in its research and development and its general and administrative functions during the years ended December 31, 2023 and 2022 as follows: Year Ended December 31, 2023 2022 Research and development $ 2,840 $ 11,278 Selling, general and administrative 1,125,269 1,447,431 Total stock-based compensation expense $ 1,128,109 $ 1,458,709 |
Summary of Common Stock Reserved for Future Issuance | Common stock reserved for future issuance consists of the following: December 31, 2023 2022 Stock options issued and outstanding 624,232 491,851 Authorized for future option grants 547,838 146,497 Authorized for employee stock purchase plan 145,381 37,048 Total common stock reserved for future issuance 1,317,451 675,396 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Federal Statutory Income Tax Rate and Effective Income Tax Rate | A reconciliation of the federal statutory income tax rate and the effective income tax rate is as follows for the years ended December 31, 2023 and 2022: December 31, 2023 2022 (%) (%) Federal statutory rate 21 21 Change in valuation allowance ( 3 ) - State income taxes, net of federal benefit 1 2 Removal of net operating losses and other credits ( 16 ) ( 24 ) Impact of state tax rate change ( 1 ) 1 Stock compensation and other permanent items ( 2 ) - Effective income tax rate - - |
Summary of Significant Components of Deferred Tax Assets | Significant components of the Company’s deferred tax assets are as follows: December 31, 2023 2022 Deferred tax assets : Stock compensation expense $ 1,839,000 $ 1,825,000 Capitalized R&D 161,000 125,000 Lease liability - 29,000 Accruals and other 294,000 136,000 Total deferred tax assets 2,294,000 2,115,000 Deferred tax liabilities : Right of use asset - ( 29,000 ) Total deferred tax liabilities - ( 29,000 ) Less valuation allowance ( 2,294,000 ) ( 2,086,000 ) Net deferred tax assets (liabilities) $ - $ - |
Organization and Basis of Pre_2
Organization and Basis of Presentation - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||||||||
Feb. 13, 2024 | May 23, 2022 | Dec. 31, 2023 | Aug. 19, 2024 | Feb. 21, 2024 | Mar. 31, 2023 | Dec. 31, 2022 | Jun. 26, 2022 | Jun. 07, 2022 | Dec. 31, 2021 | Dec. 29, 2021 | |
Organization And Basis Of Presentation [Line Items] | |||||||||||
Month and year of incorporation | 2007-01 | ||||||||||
Cash and cash equivalents | $ 4,739,426 | $ 9,843,699 | |||||||||
Common stock, par value | $ 0.0001 | $ 0.0001 | $ 1 | $ 1 | |||||||
Stockholders' equity | $ (2,579,537) | $ 2,100,000 | $ 4,084,649 | $ 3,555,094 | |||||||
Reverse stock split description | 1-for-12 reverse stock split | ||||||||||
Eversana Agreement [Member] | |||||||||||
Organization And Basis Of Presentation [Line Items] | |||||||||||
Principal and interest on the loan | $ 6,600,000 | ||||||||||
Principal and interest on loan due period | 90 days | ||||||||||
Minimum [Member] | |||||||||||
Organization And Basis Of Presentation [Line Items] | |||||||||||
Common stock, par value | $ 1 | $ 1 | |||||||||
Subsequent Event [Member] | |||||||||||
Organization And Basis Of Presentation [Line Items] | |||||||||||
Proceeds from issuance of common stock net of underwriting discounts and commissions and offering expenses | $ 6,100,000 | ||||||||||
Subsequent Event [Member] | Minimum [Member] | |||||||||||
Organization And Basis Of Presentation [Line Items] | |||||||||||
Common stock, par value | $ 1 | ||||||||||
Forecast [Member] | |||||||||||
Organization And Basis Of Presentation [Line Items] | |||||||||||
Common stock, par value | $ 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | |
Dec. 31, 2023 USD ($) Segment | Dec. 31, 2022 USD ($) | |
Significant Accounting Policies [Line Items] | ||
Number of operating segment | Segment | 1 | |
Allowance for doubtful accounts receivable | $ 0 | $ 0 |
Bad debt expense | 0 | 0 |
Inventory raw materials | 361,000 | 239,000 |
Inventory finished goods | 121,000 | 50,000 |
Deferred offering costs | 241,637 | |
Non-current Assets [Member] | ||
Significant Accounting Policies [Line Items] | ||
Deferred offering costs | 242,000 | 0 |
Accounts Payable and Accrued Expenses [Member] | ||
Significant Accounting Policies [Line Items] | ||
Medicaid and Medicare rebates | 46,000 | |
Liabilities for co-pay assistance | $ 66,000 | 66,000 |
Accounts Receivable [Member] | ||
Significant Accounting Policies [Line Items] | ||
Medicaid and Medicare rebates | $ 13,000 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 624,232 | 491,851 |
Common stock options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the calculation of diluted net loss per share | 624,232 | 491,851 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||
Lease commencement date | Nov. 01, 2023 | Jan. 01, 2017 | |
Lessee operating lease existence of option to extend | true | ||
Lease expiry date | Oct. 31, 2024 | Oct. 31, 2023 | |
Operating lease incremental borrowing rate | 10% | ||
Lease agreement term | 12 months | ||
Cash paid for the operating leass | $ 146,000 | $ 39,000 | |
Remaining lease term | 9 months 29 days | 9 months 29 days | |
Future minimum facility lease payments due in 2024 | $ 63,000 | ||
General and administrative expense [Member] | |||
New Accounting Pronouncements Or Change In Accounting Principle [Line Items] | |||
Operating lease expense | 154,000 | $ 150,000 | |
Rent expense | $ 154,000 | $ 150,000 |
Technology Acquisition Agreem_2
Technology Acquisition Agreement - Additional Information (Detail) | 1 Months Ended | 12 Months Ended | ||||
Jul. 31, 2021 USD ($) | May 31, 2014 USD ($) | Jun. 30, 2007 USD ($) | Dec. 31, 2023 USD ($) Milestone | Dec. 31, 2020 USD ($) | Jun. 30, 2021 USD ($) | |
Technology Acquisition Agreement [Line Items] | ||||||
Payment expensed as in-process research and development | $ 650,000 | |||||
Mallinckrodt Plc [Member] | ||||||
Technology Acquisition Agreement [Line Items] | ||||||
Milestone payments contingent amount | $ 5,000,000 | |||||
Number of milestone payments | Milestone | 1 | |||||
Mallinckrodt Plc [Member] | Gimoti [Member] | ||||||
Technology Acquisition Agreement [Line Items] | ||||||
Milestone payment | $ 5,000,000 | |||||
Amount payable to Mallinckro dt | $ 5,000,000 | |||||
Research and development expense payable | $ 5,000,000 | |||||
Mallinckrodt Plc [Member] | Rights and Patents Acquired from Questcor Pharmaceuticals Inc [Member] | Maximum [Member] | ||||||
Technology Acquisition Agreement [Line Items] | ||||||
Milestone payments contingent amount | $ 52,000,000 | |||||
Development Target One [Member] | Rights and Patents Acquired from Questcor Pharmaceuticals Inc [Member] | ||||||
Technology Acquisition Agreement [Line Items] | ||||||
Milestone payment | $ 500,000 | |||||
Development targets description | upon the initiation of the first patient dosing in the Company’s Phase 3 clinical trial for Gimoti | |||||
Development Target Four [Member] | Mallinckrodt Plc [Member] | Patented Technology [Member] | ||||||
Technology Acquisition Agreement [Line Items] | ||||||
Development targets description | depended on Gimoti’s commercial success. The Company was required to pay Mallinckrodt a low single digit royalty percentage on net sales of Gimoti | |||||
Milestone payments contingent amount | $ 47,000,000 | |||||
Royalties on net sales | $ 134,000 |
Preferred Stock, Common Stock_3
Preferred Stock, Common Stock and Stockholders' Equity - Preferred Stock - Additional Information (Detail) - $ / shares | Dec. 31, 2023 | Dec. 31, 2022 |
Equity [Abstract] | ||
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares outstanding | 0 | 0 |
Preferred Stock, Common Stock_4
Preferred Stock, Common Stock and Stockholders' Equity - Common Stock - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Sale Of Common Stock [Line Items] | ||
Shareholders voting power description | Each share of common stock is entitled to one vote. The holders of the common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors of the Company. | |
Dividends declared on common stock | $ 0 | |
Common stock, shares issued | 3,343,070 | 3,343,070 |
ATM Sales Agreement [Member] | ||
Sale Of Common Stock [Line Items] | ||
Common stock, shares issued | 0 | 621,697 |
Preferred Stock, Common Stock_5
Preferred Stock, Common Stock and Stockholders' Equity - At the Market Equity Offering Program - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2020 | Dec. 31, 2023 | |
Sale Of Common Stock [Line Items] | |||
Common stock, shares issued | 3,343,070 | 3,343,070 | |
ATM Sales Agreement [Member] | |||
Sale Of Common Stock [Line Items] | |||
Common stock, shares issued | 621,697 | 0 | |
Common stock , weighted average price per share | $ 11.97 | ||
Proceeds from issuance of common stock, net | $ 7.3 | ||
ATM Sales Agreement [Member] | Maximum [Member] | |||
Sale Of Common Stock [Line Items] | |||
Potential proceeds from issuance of common stock, net | $ 30 |
Preferred Stock, Common Stock_6
Preferred Stock, Common Stock and Stockholders' Equity - Warrants - Additional Information (Detail) - shares | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | ||
Warrants to purchase shares of common stock expired | 139,972 | |
Issuance of common stock from warrant exercise | 0 | |
Warrants outstanding to purchase common stock | 0 |
Preferred Stock, Common Stock_7
Preferred Stock, Common Stock and Stockholders' Equity - Equity Incentive Award Plans - Additional Information (Detail) - $ / shares | 1 Months Ended | 12 Months Ended | ||
Jan. 01, 2024 | May 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | |
Sale Of Stock [Line Items] | ||||
Aggregate number of shares of common stock reserved under the plan | 1,194,717 | 1,317,451 | 675,396 | |
Award plan expiration month and year | 2033-03 | |||
Options available for future grant | 547,838 | 146,497 | ||
Options granted, weighted average term | 10 years | |||
Number of stock options granted | 153,750 | 78,247 | ||
Intrinsic value, common stock price | $ 1.05 | |||
Weighted Average Grant Date Fair Value Per Share, Granted | $ 2.42 | $ 4.86 | ||
Minimum [Member] | ||||
Sale Of Stock [Line Items] | ||||
Options granted, vesting period | 1 year | |||
Maximum [Member] | ||||
Sale Of Stock [Line Items] | ||||
Options granted, vesting period | 4 years | |||
Amended and Restated Equity Incentive Plan 2013 [Member] | ||||
Sale Of Stock [Line Items] | ||||
Aggregate number of shares of common stock reserved under the plan | 50,000,000 | |||
Shares available for issuance, description | In addition, the number of shares available for issuance is annually increased on the first day of each fiscal year by that number of shares equal to the least of (a) six percent of the outstanding shares of common stock on the last day of the immediately preceding calendar year, and (b) such other amount determined by the Company’s board of directors. Notwithstanding the foregoing, the number of shares of common stock that may be issued or transferred pursuant to incentive stock options under the Restated Plan may not exceed an aggregate of 50,000,000 shares. | |||
Amended and Restated Equity Incentive Plan 2013 [Member] | Annual Increase in Shares [Member] | ||||
Sale Of Stock [Line Items] | ||||
Reserve percentage for issuance of shares | 6% | |||
2013 Equity Incentive Award Plan [Member] | ||||
Sale Of Stock [Line Items] | ||||
Increase in the number of shares of common stock reserved under the plan | 1,352,800 | |||
Options available for future grant | 547,838 | |||
Number of stock options granted | 153,750 | |||
2013 Equity Incentive Award Plan [Member] | Subsequent Event [Member] | ||||
Sale Of Stock [Line Items] | ||||
Increase in the number of shares of common stock reserved under the plan | 200,584 | |||
Options available for future grant | 748,422 |
Preferred Stock, Common Stock_8
Preferred Stock, Common Stock and Stockholders' Equity - Summary of Stock Option Activity (Detail) - $ / shares | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Options, Outstanding beginning balance | 491,851 | |
Options, Granted | 153,750 | 78,247 |
Options, Outstanding ending balance | 624,232 | 491,851 |
2013 Equity Incentive Award Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||
Options, Outstanding beginning balance | 491,851 | |
Options, Granted | 153,750 | |
Options, Expired | (21,369) | |
Options, Outstanding ending balance | 624,232 | 491,851 |
Options, Vested and expected to vest at December 31, 2023 | 624,232 | |
Options, Exercisable at December 31, 2023 | 418,591 | |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Exercise Price [Roll Forward] | ||
Weighted Average Exercise Price, Outstanding beginning balance | $ 19.11 | |
Weighted Average Exercise Price, Granted | 3.07 | |
Weighted Average Exercise Price, Expired | 45.78 | |
Weighted Average Exercise Price, Outstanding ending balance | 14.25 | $ 19.11 |
Weighted Average Exercise Price, Vested and expected to vest at December 31, 2023 | 14.25 | |
Weighted Average Exercise Price, Exercisable at December 31, 2023 | $ 14.64 | |
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding Weighted Average Remaining Contractual Term [Abstract] | ||
Weighted Average Remaining Contractual Term (Years), Outstanding | 7 years 18 days | 7 years 2 months 19 days |
Weighted Average Remaining Contractual Term (Years), Granted | 9 years 2 months 23 days | |
Weighted Average Remaining Contractual Term (Years), Vested and expected to vest at December 31, 2023 | 7 years 18 days | |
Weighted Average Remaining Contractual Term (Years), Exercisable at December 31, 2023 | 6 years 2 months 23 days |
Preferred Stock, Common Stock_9
Preferred Stock, Common Stock and Stockholders' Equity - Employee Stock Purchase Plan and Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 12 Months Ended | 127 Months Ended | |||||
Jan. 01, 2024 | May 31, 2023 | May 31, 2017 | Jun. 30, 2013 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2023 | Apr. 30, 2017 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Unrecognized compensation costs | $ 1.1 | $ 1.1 | ||||||
Weighted average period | 9 months | |||||||
Aggregate number of shares of common stock reserved under the plan | 1,194,717 | 1,317,451 | 675,396 | 1,317,451 | ||||
Shares of common stock available for future issuance under ESPP | 145,381 | 37,048 | 145,381 | |||||
Stock issued during period, shares, period increase | 168,333 | |||||||
Issuance of common stock under employee stock purchase plan | 0 | 0 | ||||||
Amended and Restated ESPP [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Aggregate number of shares of common stock reserved under the plan | 170,833 | 20,833 | ||||||
Number of shares increased annually to common stock shares reserved for issuance | 100,000 | 8,333 | 2,500 | |||||
Award plan expiration year | 2033 | 2027 | ||||||
Employee stock purchase plan [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Purchase price of common stock as percentage of fair market value | 85% | |||||||
Percentage of deduction of eligible compensation | 20% | |||||||
Aggregate number of shares of common stock reserved under the plan | 2,500 | |||||||
Shares available for issuance, description | In addition, the number of shares of common stock available for issuance under the ESPP has been annually increased on the first day of each fiscal year during the term of the ESPP by an amount equal to the lesser of: (i) 2,500 shares; (ii) one percent of the outstanding shares of common stock as of the last day of the immediately preceding fiscal year; or (iii) such other amount as the Company’s board of directors may determine. | |||||||
Reserve percentage for issuance of shares | 1% | |||||||
ESPP approval date | Aug. 29, 2013 | |||||||
Subsequent Event [Member] | Employee stock purchase plan [Member] | ||||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||||
Aggregate number of shares of common stock reserved under the plan | 178,811 | |||||||
Stock issued during period, shares, period increase | 33,430 |
Preferred Stock, Common Stoc_10
Preferred Stock, Common Stock and Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail) - Common stock options [Member] | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk free interest rate | 1.34% | 1.67% |
Expected option term | 5 years 6 months | 5 years 6 months |
Expected volatility of common stock | 99.34% | 97.04% |
Maximum [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Risk free interest rate | 3.39% | 3.55% |
Expected option term | 6 years | 6 years |
Expected volatility of common stock | 103.64% | 113.23% |
Preferred Stock, Common Stoc_11
Preferred Stock, Common Stock and Stockholders' Equity - Summary of Recognized Stock-Based Compensation Expense (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 1,128,109 | $ 1,458,709 |
Research and development [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 2,840 | 11,278 |
Selling, general and administrative [Member] | ||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 1,125,269 | $ 1,447,431 |
Preferred Stock, Common Stoc_12
Preferred Stock, Common Stock and Stockholders' Equity - Summary of Common Stock Reserved for Future Issuance (Detail) - shares | Dec. 31, 2023 | May 31, 2023 | Dec. 31, 2022 |
Share-Based Payment Arrangement [Abstract] | |||
Stock options issued and outstanding | 624,232 | 491,851 | |
Authorized for future option grants | 547,838 | 146,497 | |
Authorized for employee stock purchase plan | 145,381 | 37,048 | |
Total common stock reserved for future issuance | 1,317,451 | 1,194,717 | 675,396 |
Employee Benefit Plan - Additio
Employee Benefit Plan - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Postemployment Benefits [Abstract] | ||
Eligible age for employees for participating in the plan | 21 years | |
Company's contributions to employee benefit plan | $ 3,000 | $ 0 |
Commercial Services and Loan _2
Commercial Services and Loan Agreements with Eversana - Additional Information (Detail) - USD ($) | 12 Months Ended | ||||
Feb. 01, 2022 | Jan. 21, 2020 | Dec. 31, 2023 | Dec. 31, 2022 | Jan. 31, 2020 | |
Commercial Services And Loan Agreements [Line Items] | |||||
Selling, general and administrative | $ 12,227,735 | $ 9,623,599 | |||
Eversana Agreement [Member] | |||||
Commercial Services And Loan Agreements [Line Items] | |||||
Unreimbursed commercialization cost | $ 63,500,000 | ||||
Agreement term | On February 1, 2022, the Eversana Agreement was amended to extend the term from June 19, 2025 (five years from the date the Food & Drug Administration approved the Gimoti new drug application) to December 31, 2026, unless terminated earlier pursuant to its terms. | ||||
Agreement expiration date | Dec. 31, 2026 | ||||
Selling, general and administrative | $ 4,400,000 | $ 2,000,000 | |||
Eversana Agreement [Member] | Revolving Credit Facility [Member] | |||||
Commercial Services And Loan Agreements [Line Items] | |||||
Line of credit | $ 5,000,000 | ||||
Line of credit facility, Interest rate | 10% | ||||
Borrowings | $ 5,000,000 | ||||
Eversana Agreement [Member] | Gimoti [Member] | Minimum [Member] | |||||
Commercial Services And Loan Agreements [Line Items] | |||||
Percentage of Product Profits | 80% |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Operating Loss Carryforwards [Line Items] | ||
Accrual on interest and penalties related to income taxes | $ 0 | |
Uncertain tax position | 2,000,000 | $ 2,000,000 |
Removal of net operating losses from deferred tax assets | $ 25,800,000 | |
Cumulative change in ownership for limitation of use of net operating loss and research and development credit carryforwards | 50% | |
Period of cumulative change of ownership | 3 years | |
Removal of research and development credit from deferred tax assets | $ 3,600,000 | |
Deferred tax asset, Valuation allowance increase | $ 208,000 | |
Percentage of taxable income offset by tax losses | 80% | |
Changes to unrecognized tax benefits | $ 0 | $ 0 |
Unrecognized tax benefits that would affect company's effective tax rate, if recognized | $ 0 | |
Earliest Tax Year [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax years subject to examination by taxing authorities | 2007 | |
State [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Uncertain tax position | $ 2,000,000 | |
Net operating loss carry forwards | $ 53,600,000 | |
Expiry date of carry forwards | Dec. 31, 2028 | |
State [Member] | Research Tax Credit Carryforward [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carry forwards | $ 1,500,000 | |
Federal [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Net operating loss carry forwards | $ 105,800,000 | |
Expiry date of carry forwards | Dec. 31, 2027 | |
Net operating loss carryforwards, not subject to expiration | $ 43,900,000 | |
Federal [Member] | Research Tax Credit Carryforward [Member] | ||
Operating Loss Carryforwards [Line Items] | ||
Tax credit carry forwards | $ 2,400,000 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Federal Statutory Income Tax Rate and Effective Income Tax Rate (Detail) | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory rate | 21% | 21% |
Change in valuation allowance | (3.00%) | |
State income taxes, net of federal benefit | 1% | 2% |
Removal of net operating losses and other credits | (16.00%) | (24.00%) |
Impact of state tax rate change | (1.00%) | 1% |
Stock compensation and other permanent items | (2.00%) |
Income Taxes - Summary of Signi
Income Taxes - Summary of Significant Components of Deferred Tax Assets (Detail) - USD ($) | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Stock compensation expense | $ 1,839,000 | $ 1,825,000 |
Capitalized R&D- 174 | 161,000 | 125,000 |
Lease liability | 29,000 | |
Accruals and other | 294,000 | 136,000 |
Total deferred tax assets | 2,294,000 | 2,115,000 |
Deferred tax liabilities: | ||
Right of use asset | (29,000) | |
Total deferred tax liabilities | (29,000) | |
Less valuation allowance | $ (2,294,000) | $ (2,086,000) |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 13, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Subsequent Event [Line Items] | |||
Common stock, sold | 3,343,070 | 3,343,070 | |
Pre-funded warrant units | 0 | ||
Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Common stock, sold | 5,134,731 | ||
Shares issued, price per share | $ 0.68 | ||
Number of shares issuable per warrant | 1 | ||
Proceeds from issuance of common stock net of underwriting discounts and commissions and offering expenses | $ 6.1 | ||
Subsequent Event [Member] | PFW Units [Member] | |||
Subsequent Event [Line Items] | |||
Pre-funded warrant units | 5,894,680 | ||
Shares issued, price per share | $ 0.6799 | ||
Exercise price per warrant | 0.0001 | ||
Subsequent Event [Member] | Series A Warrants [Member] | |||
Subsequent Event [Line Items] | |||
Exercise price per warrant | $ 0.68 | ||
Number of shares issuable per warrant | 1 | ||
Warrants maturity date | Feb. 13, 2029 | ||
Warrants expiration term | 5 years | ||
Subsequent Event [Member] | Series B Warrants [Member] | |||
Subsequent Event [Line Items] | |||
Exercise price per warrant | $ 0.68 | ||
Number of shares issuable per warrant | 1 | ||
Warrants maturity date | Nov. 13, 2024 | ||
Warrants expiration term | 9 months | ||
Subsequent Event [Member] | Series C Warrants [Member] | |||
Subsequent Event [Line Items] | |||
Exercise price per warrant | $ 0.68 | ||
Number of shares issuable per warrant | 1 | ||
Warrants maturity date | Nov. 13, 2024 | ||
Warrants conditional maturity date | Feb. 13, 2029 |