0000950170-23-061578 | 10-Q | XBRL Viewer

Commitments and Contingencies

9 Months Ended

Sep. 30, 2023

Commitments and Contingencies Disclosure [Abstract]

3. Commitments and Contingencies

Leases

The Company’s operating lease for office space in Solana Beach, California had an expiration date of October 31, 2023, subject to the landlord’s option to cancel upon 30 days written notice. In October 2023, the Company entered into a 12-month lease agreement for an office space located on a different floor of the same building, effective November 1, 2023. Future minimum lease payments under the new lease are approximately $76,000 over the lease term.

As of September 30, 2023, the Company has future minimum lease payments under its existing facility lease of $13,371 payable in 2023. The remaining lease term is 0.08 years and the discount rate used was 10% as of September 30, 2023.

Short-term and operating lease expense are recognized on a straight-line basis over the lease term as general and administrative expense within the accompanying condensed financial statements. The following table summarizes lease expense for the three and nine months ended September 30, 2023 and 2022:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Operating lease expense	$	39,164	$	37,281	$	114,767	$	111,843
Cash paid for operating lease	$	40,112	$	37,281	$	120,335	$	111,843

Legal Proceedings

On February 25, 2022, the Company received a letter notifying us that Teva submitted to the U.S. Food and Drug Administration, or FDA, an abbreviated new drug application, or ANDA, for a generic version of Gimoti (metoclopramide hydrochloride) nasal spray eq. 15 mg base/spray that contains Paragraph IV certifications with respect to two of our patents covering Gimoti, U.S. Patent Nos. 8,334,281, expiration date May 16, 2030; and 11,020,361, expiration date December 22, 2029. These patents are listed in FDA’s list of Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book, for Gimoti. The certifications allege these patents are invalid or will not be infringed by the manufacture, use or sale of Teva’s metoclopramide hydrochloride nasal spray eq. 15 mg base/spray. In April 2022, the Company initiated litigation in the United States District Court for the District of New Jersey (Civil Action No. 1:22-cv-02019), alleging that Teva infringes the patents covering Gimoti. After the Company initiated litigation, Teva converted to a Paragraph III certification, which prevents the FDA from approving Teva’s ANDA until after the latest expiring patent expires in 2030. Consequently, the litigation against Teva was dismissed in January 2023.

Stockholders' Equity

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

Stockholders' Equity

5. Stockholders’ Equity

At the Market Equity Offering Program

In December 2020, the Company filed a new shelf registration statement with the SEC on Form S-3, or the replacement shelf registration statement. The replacement shelf registration statement replaced the registration statement on Form S-3 the Company originally filed with the SEC in November 2017, which registration statement expired in December 2020. The replacement shelf registration was declared effective by the SEC on January 6, 2021. In December 2020, the Company also entered into a new At Market Issuance Sales Agreement (the “ATM Sales Agreement”), with FBR and H.C. Wainwright & Co. (together with FBR, the “Sales Agents”), pursuant to which the Company may 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. The ATM Sales Agreement provides, among other things, that sales under the ATM Sales Agreement will be made pursuant to the registration statement, including the base prospectus filed as part of such registration statement. During the nine months ended September 30, 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. No shares were sold pursuant to the ATM Sales Agreement in the three and nine months ended September 30, 2023.

Future sales under the ATM Sales Agreement will depend on a variety of factors including, but not limited to, market conditions, the trading price of the Company’s common stock and the Company’s capital needs. There can be no assurance that the Sales Agents will be successful in consummating future sales based on prevailing market conditions or in the quantities or at the prices that the Company deems appropriate.

In addition, the Company will not be able to make future sales of common stock pursuant to the ATM Sales Agreement unless certain conditions are met, which include the accuracy of representations and warranties made to the Sales Agents under the ATM Sales Agreement. Furthermore, each of the Sales Agents is permitted to terminate the ATM Sales Agreement with respect to itself in its sole discretion upon ten days’ notice, or at any time in certain circumstances, including the occurrence of an event that would be reasonably likely to have a material adverse effect on the Company’s assets, business, operations, earnings, properties, condition (financial or otherwise), prospects, stockholders’ equity or results of operations. The Company has no obligation to sell the shares available for sale pursuant to the ATM Sales Agreement.

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 the nine months ended September 30, 2022, warrants to purchase 139,972 shares of common stock expired. At September 30, 2023, and December 31, 2022, there were no warrants outstanding.

Stock-Based Compensation

Stock-based compensation expense includes charges related to 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.

During the nine months ended September 30, 2023 and 2022, the Company granted stock options to purchase 153,750 and 78,247 shares of the Company’s common stock, respectively. 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 nine months ended September 30, 2023 and 2022:


	Nine Months Ended September 30,
Common Stock Options	2023	2022
Risk free interest rate	1.34%- 3.39%	1.67% - 3.55%
Expected term	5.5 - 6.0 years	5.5 - 6.02 years
Expected volatility of common stock	99.34%- 103.64%	97.04% - 113.23%
Expected dividend yield	0.00%	0.00%

The Company recognized stock-based compensation expense to employees and directors in its research and development and its selling, general and administrative functions during the three and nine months ended September 30, 2023 and 2022 as follows:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Research and development	$	-	$	1,897	$	2,841	$	7,505
Selling, general and administrative		281,758		353,855		843,629		1,096,232
Total stock-based compensation expense	$	281,758	$	355,752	$	846,470	$	1,103,737

As of September 30, 2023, there was approximately $1.3 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 0.83 years.

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The accompanying condensed balance sheet as of December 31, 2022, which has been derived from audited financial statements, and the unaudited interim condensed financial statements, have been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”) and follow the requirements of the U.S. Securities and Exchange Commission (“SEC”) for interim reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by GAAP can be condensed or omitted. In management’s opinion, the unaudited interim financial statements have been prepared on the same basis as the audited financial statements and include all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position and its results of operations and its cash flows for the periods presented. These statements do not include all disclosures required by GAAP and should be read in conjunction with the Company’s financial statements and accompanying notes for the year ended December 31, 2022, which are contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 21, 2023. The results for interim periods are not necessarily indicative of the results expected for the full fiscal year or any other interim period.

Use of Estimates

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.

Contract Research Organizations and Consultants

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.

Cash and Cash Equivalents

The Company deposits its cash with reputable financial institutions that are insured by the Federal Deposit Insurance Corporation ("FDIC"). This cash is held in checking, cash sweep, and money market accounts. At times, deposits held may exceed the amount of insurance provided by the FDIC. The Company maintains an insured cash sweep account in which cash from its main operating checking account is invested overnight in highly liquid, short-term investments. The Company considers all highly liquid investments with a maturity date of 90 days or less at the date of purchase to be cash equivalents. The Company has not experienced any losses in its cash and cash equivalents and management believes the Company is not exposed to significant credit risk with respect to such accounts.

Accounts Receivable

Accounts receivable are recorded net of allowance for doubtful accounts. The allowance for doubtful accounts was zero at September 30, 2023 and December 31, 2022 and no bad debt expense was recorded for the three and nine months ended September 30, 2023 and 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.

The Company’s inventory consisted of approximately $361,000 and $239,000 of raw materials at September 30, 2023 and December 31, 2022, and approximately $144,000 and $50,000 of finished goods inventory at September 30, 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.

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 judgement 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 $13,000 were recorded as a reduction to Accounts Receivable as of December 31, 2022, and $44,000 were recorded as accounts payable and accrued expenses on the balance sheet as of September 30, 2023.

Product sales are recorded at the transaction price, which may include variable considerations for co-payment assistance to commercially insured patients meeting certain eligibility requirements, as well as to uninsured patients. 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. Actual amounts of consideration ultimately received may materially differ from the Company’s estimates. 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 $82,000 and $66,000 at September 30, 2023 and December 31, 2022, respectively, 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 upon the Company’s historical volatility. 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, and costs paid to third-party contractors for product development activities and drug product materials. 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.

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 stock 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 three and nine months ended September 30, 2023 and 2022:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Common stock options		639,601		491,851		639,601		491,851
Total excluded securities		639,601		491,851		639,601		491,851

Recent 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 amends 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 is effective for annual periods beginning after December 15, 2022, and interim periods within those periods, and early adoption is permitted. The Company's adoption of this accounting standard on January 1, 2023 did not have a material impact on the Company's financial statements and related disclosures.

Condensed Statements of Stockholders' Equity (Deficit) (Parenthetical) - USD ($)	3 Months Ended
	Jun. 30, 2022	Mar. 31, 2022
Statement of Stockholders' Equity [Abstract]
Stock Issuance Cost	$ 145,445	$ 3,548

Technology Acquisition Agreement	9 Months Ended
Sep. 30, 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 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 Company was also required to pay Mallinckrodt a low single digit royalty percentage 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.

Technology Acquisition Agreement

9 Months Ended

Sep. 30, 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 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 Company was also required to pay Mallinckrodt a low single digit royalty percentage 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.

Commercial Services and Loan Agreements with Eversana	9 Months Ended
Sep. 30, 2023
Commercial Services And Loan Agreements [Abstract]
Commercial Services and Loan Agreements with Eversana	6. 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 three months ended September 30, 2023 and 2022, approximately $1.3 million and $672,000 of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. For the nine months ended September 30, 2023 and 2022, approximately $3.0 million and $1.4 million of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. As of September 30, 2023, unreimbursed commercialization costs to Eversana were approximately $60.4 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. In addition, 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: o Gimoti is subject to a safety recall; o the other party is in breach of certain regulatory compliance representations under the agreement; o if the Company discontinues the development or production of Gimoti; o if the net profit is negative for any two consecutive calendar quarters beginning with the first full calendar quarter 24 months following commercial launch (the “Net Profit Quarterly Termination Right”); o if the cumulative net product profits fail to reach certain thresholds in the first three years following launch; o if there is a change in applicable laws that makes operation of the services as contemplated under the agreement illegal or commercially impractical; or o upon a change of control of the Company’s ownership. As of September 30, 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, including 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. 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. In connection with the Eversana Agreement, the Company and Eversana 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.

Commercial Services and Loan Agreements with Eversana

9 Months Ended

Sep. 30, 2023

Commercial Services And Loan Agreements [Abstract]

Commercial Services and Loan Agreements with Eversana

6. 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 three months ended September 30, 2023 and 2022, approximately $1.3 million and $672,000 of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. For the nine months ended September 30, 2023 and 2022, approximately $3.0 million and $1.4 million of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. As of September 30, 2023, unreimbursed commercialization costs to Eversana were approximately $60.4 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.

In addition, 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 (the “Net Profit Quarterly Termination Right”);

if the cumulative net product profits fail to reach certain thresholds in the first three years following launch;

if there is a change in applicable laws that makes operation of the services as contemplated under the agreement illegal or commercially impractical; or

upon a change of control of the Company’s ownership.

As of September 30, 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, including 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.

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.

In connection with the Eversana Agreement, the Company and Eversana 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.

Condensed Balance Sheets (Parenthetical) (Unaudited) - $ / shares	Sep. 30, 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

Condensed Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Operating activities
Net loss	$ (1,693,907)	$ (2,013,864)	$ (5,804,894)	$ (6,420,909)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	281,758	355,752	846,470	1,103,737
Non-cash lease expense			115,704	12,428
Change in operating assets and liabilities:
Accounts receivable, net			(609,072)	(379,777)
Prepaid expenses, inventory and other assets			613,009	888,976
Accounts payable and other accrued expenses			463,130	146,662
Accrued compensation			238,511	197,676
Accrued interest expense			373,973	373,973
Operating lease liabilities			(115,704)	(12,428)
Net cash used in operating activities			(3,878,873)	(4,089,662)
Financing activities
Proceeds from issuance of common stock from ATM				7,443,969
Payment of common stock offering costs from ATM				(148,993)
Net cash provided by financing activities				7,294,976
Net (decrease)/increase in cash and cash equivalents			(3,878,873)	3,205,314
Cash and cash equivalents at beginning of period			9,843,699	9,144,710
Cash and cash equivalents at end of period	$ 5,964,826	$ 12,350,024	$ 5,964,826	12,350,024
Supplemental disclosure of non-cash investing and financing activities
Operating lease right-of-use assets obtained in exchange for operating lease liabilities				$ 153,671

Commitments and Contingencies (Tables)

9 Months Ended

Sep. 30, 2023

Commitments and Contingencies Disclosure [Abstract]

Summary of Lease Expense

The following table summarizes lease expense for the three and nine months ended September 30, 2023 and 2022:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Operating lease expense	$	39,164	$	37,281	$	114,767	$	111,843
Cash paid for operating lease	$	40,112	$	37,281	$	120,335	$	111,843

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2023	Nov. 03, 2023
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Sep. 30, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Trading Symbol	EVOK
Entity Registrant Name	EVOKE PHARMA, INC.
Entity Central Index Key	0001403708
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Current Fiscal Year End Date	--12-31
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Title of 12(b) Security	Common Stock, par value $0.0001 per share
Security Exchange Name	NASDAQ
Entity File Number	001-36075
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
Entity Incorporation, State or Country Code	DE
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		3,343,070
Document Quarterly Report	true
Document Transition Report	false

Technology Acquisition Agreement - Additional Information (Detail)	1 Months Ended			9 Months Ended
	Jul. 31, 2021 USD ($)	May 31, 2014 USD ($)	Jun. 30, 2007 USD ($)	Sep. 30, 2023 USD ($) Milestone	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
Gimoti [Member] \| Mallinckrodt Plc [Member]
Technology Acquisition Agreement [Line Items]
Milestone payment	$ 5,000,000
Research and development expense payable				$ 5,000,000
Amount payable to Mallinckrodt					$ 5,000,000
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.

Stockholders' Equity (Tables)

9 Months Ended

Sep. 30, 2023

Equity [Abstract]

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 nine months ended September 30, 2023 and 2022:


	Nine Months Ended September 30,
Common Stock Options	2023	2022
Risk free interest rate	1.34%- 3.39%	1.67% - 3.55%
Expected term	5.5 - 6.0 years	5.5 - 6.02 years
Expected volatility of common stock	99.34%- 103.64%	97.04% - 113.23%
Expected dividend yield	0.00%	0.00%

Summary of Recognized Stock-Based Compensation Expense


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Research and development	$	-	$	1,897	$	2,841	$	7,505
Selling, general and administrative		281,758		353,855		843,629		1,096,232
Total stock-based compensation expense	$	281,758	$	355,752	$	846,470	$	1,103,737

Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Significant Accounting Policies [Line Items]
Allowance for doubtful accounts receivable	$ 0		$ 0		$ 0
Bad debt expense	0	$ 0	0	$ 0
Inventory raw materials	361,000		361,000		239,000
Inventory finished goods	144,000		144,000		50,000
Accounts Receivable [Member]
Significant Accounting Policies [Line Items]
Medicaid and Medicare rebates					13,000
Accounts Payable and Accrued Expenses [Member]
Significant Accounting Policies [Line Items]
Medicaid and Medicare rebates			44,000
Liabilities for co-pay assistance	$ 82,000		$ 82,000		$ 66,000

Stockholders' Equity - Warrants - Additional Information (Detail) - shares	9 Months Ended
	Sep. 30, 2023	Dec. 31, 2022
Share-Based Payment Arrangement [Abstract]
Warrants to purchase shares of common stock expired	139,972
Warrants outstanding to purchase common stock	0	0

Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail) - Common stock options [Member]	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected dividend yield	0.00%	0.00%
Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk free interest rate	1.34%	1.67%
Expected 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 term	6 years	6 years 7 days
Expected volatility of common stock	103.64%	113.23%

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Summary of Significant Accounting Policies (Tables)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Common stock options		639,601		491,851		639,601		491,851
Total excluded securities		639,601		491,851		639,601		491,851

Organization and Basis of Presentation

9 Months Ended

Sep. 30, 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 and commercialization 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. As of September 30, 2023, the Company had approximately $6.0 million in cash and cash equivalents. 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. 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, the Company will be required to curtail all of its activities and may be required to liquidate, dissolve or otherwise wind down its operations.

Reverse Stock Split

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.

Nasdaq Compliance

On May 24, 2023, the Company received a written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC (“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”), which requires listed companies to maintain stockholders’ equity of at least $2.5

million. As required by Nasdaq, the Company submitted its plan to regain compliance with the Minimum Stockholders’ Equity Requirement on July 7, 2023.

On July 19, 2023, Nasdaq granted the Company an extension until November 20, 2023 to regain compliance. Under the terms of the extension, the Company must provide to the Nasdaq staff a publicly available report that evidences such compliance and otherwise comply with conditions included in the extension notice. If the Company fails to evidence compliance upon filing the Company’s Annual Report on Form 10-K for the year ended December 31, 2023 with the Securities and Exchange Commission and Nasdaq, the Company may be subject to delisting from the Nasdaq Capital Market. In the event the Company does not satisfy the terms of the extension, the Nasdaq staff will provide written notification to the Company that its securities will be delisted. At that time, the Company may appeal the Nasdaq staff’s determination to a Hearings Panel.

Condensed Balance Sheets (Unaudited) - USD ($)	Sep. 30, 2023	Dec. 31, 2022
Current Assets:
Cash and cash equivalents	$ 5,964,826	$ 9,843,699
Accounts receivable, net	1,233,904	624,832
Prepaid expenses	37,855	952,954
Inventory, net	504,925	289,378
Other current assets	98,094	11,551
Total current assets	7,839,604	11,722,414
Operating lease right-of-use asset	13,370	129,074
Total assets	7,852,974	11,851,488
Current Liabilities:
Accounts payable and accrued expenses	1,397,442	934,312
Accrued compensation	829,669	591,158
Operating lease liability	13,370	129,074
Total current liabilities	2,240,481	1,654,544
Long-term Liabilities:
Note payable	5,000,000	5,000,000
Accrued interest payable	1,486,268	1,112,295
Total long-term liabilities	6,486,268	6,112,295
Total liabilities	8,726,749	7,766,839
Commitments and contingencies (Note 3)
Stockholders' equity (deficit):
Preferred stock, $0.0001 par value; authorized shares - 5,000,000 at September 30, 2023 and December 31, 2022; none issued and outstanding at both September 30, 2023 and December 31, 2022
Common stock, $0.0001 par value; authorized shares - 50,000,000 at September 30, 2023 and December 31, 2022; issued and outstanding shares - 3,343,070 at September 30, 2023 and December 31, 2022, respectively	334	334
Additional paid-in capital	120,577,928	119,731,458
Accumulated deficit	(121,452,037)	(115,647,143)
Total stockholders' equity (deficit)	(873,775)	4,084,649
Total liabilities and stockholders' equity (deficit)	$ 7,852,974	$ 11,851,488

Commitments and Contingencies - Additional Information (Detail)	9 Months Ended
	Sep. 30, 2023 USD ($)
Operating Leased Assets [Line Items]
Lease expiry date	Oct. 31, 2023
Future minimum facility lease payments due in 2022	$ 13,371
Remaining lease term	29 days
Office lease discount rate	10.00%

Condensed Statements of Stockholders' Equity (Deficit) (Unaudited) - 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	381,061		381,061
Issuance of common stock, from ATM offering, net of costs, Shares		21,783
Issuance of common stock, from ATM offering, net of costs	171,521	$ 2	171,519
Net loss	(2,173,665)			(2,173,665)
Ending Balance at Mar. 31, 2022	1,934,011	$ 274	111,530,415	(109,596,678)
Ending Balance, Shares at Mar. 31, 2022		2,743,156
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
Net loss	(6,420,909)
Ending Balance at Sep. 30, 2022	5,532,898	$ 334	119,376,486	(113,843,922)
Ending Balance, Shares at Sep. 30, 2022		3,343,070
Beginning Balance at Mar. 31, 2022	1,934,011	$ 274	111,530,415	(109,596,678)
Beginning Balance, Shares at Mar. 31, 2022		2,743,156
Stock-based compensation expense	366,924		366,924
Issuance of common stock, from ATM offering, net of costs, Shares		599,914
Issuance of common stock, from ATM offering, net of costs	7,123,455	$ 60	7,123,395
Net loss	(2,233,380)			(2,233,380)
Ending Balance at Jun. 30, 2022	7,191,010	$ 334	119,020,734	(111,830,058)
Ending Balance, Shares at Jun. 30, 2022		3,343,070
Stock-based compensation expense	355,752		355,752
Net loss	(2,013,864)			(2,013,864)
Ending Balance at Sep. 30, 2022	5,532,898	$ 334	119,376,486	(113,843,922)
Ending Balance, Shares at Sep. 30, 2022		3,343,070
Beginning Balance at Dec. 31, 2022	$ 4,084,649	$ 334	119,731,458	(115,647,143)
Beginning Balance, Shares at Dec. 31, 2022	3,343,070	3,343,070
Stock-based compensation expense	$ 284,572		284,572
Net loss	(2,243,070)			(2,243,070)
Ending Balance at Mar. 31, 2023	2,126,151	$ 334	120,016,030	(117,890,213)
Ending Balance, Shares at Mar. 31, 2023		3,343,070
Beginning Balance at Dec. 31, 2022	$ 4,084,649	$ 334	119,731,458	(115,647,143)
Beginning Balance, Shares at Dec. 31, 2022	3,343,070	3,343,070
Net loss	$ (5,804,894)
Ending Balance at Sep. 30, 2023	$ (873,775)	$ 334	120,577,928	(121,452,037)
Ending Balance, Shares at Sep. 30, 2023	3,343,070	3,343,070
Beginning Balance at Mar. 31, 2023	$ 2,126,151	$ 334	120,016,030	(117,890,213)
Beginning Balance, Shares at Mar. 31, 2023		3,343,070
Stock-based compensation expense	280,140		280,140
Net loss	(1,867,917)			(1,867,917)
Ending Balance at Jun. 30, 2023	538,374	$ 334	120,296,170	(119,758,130)
Ending Balance, Shares at Jun. 30, 2023		3,343,070
Stock-based compensation expense	281,758		281,758
Net loss	(1,693,907)			(1,693,907)
Ending Balance at Sep. 30, 2023	$ (873,775)	$ 334	$ 120,577,928	$ (121,452,037)
Ending Balance, Shares at Sep. 30, 2023	3,343,070	3,343,070

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
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-Name Accounting Standards Codification
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- Definition

Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest.

+ References

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+ Details

Summary of Significant Accounting Policies - Summary of Outstanding Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share (Detail) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 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	639,601	491,851	639,601	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	639,601	491,851	639,601	491,851

Commitments and Contingencies - Summary of Lease Expense (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Operating Leased Assets [Line Items]
Cash paid for operating lese	$ 40,112	$ 37,281	$ 120,335	$ 111,843
General and Administrative Expense [Member]
Operating Leased Assets [Line Items]
Operating lease expense	$ 39,164	$ 37,281	$ 114,767	$ 111,843

Commercial Services and Loan Agreements with Eversana - Additional Information (Detail) - USD ($)			3 Months Ended		9 Months Ended
	Feb. 01, 2022	Jan. 21, 2020	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Jan. 31, 2020
Commercial Services And Loan Agreements [Line Items]
Selling, general and administrative			$ 3,131,389	$ 2,614,488	$ 8,745,407	$ 7,334,738
Eversana Agreement [Member]
Commercial Services And Loan Agreements [Line Items]
Unreimbursed commercialization cost			60,400,000		$ 60,400,000
Agreement expiration date	Dec. 31, 2026
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.
Selling, general and administrative			$ 1,300,000	$ 672,000	$ 3,000,000	$ 1,400,000
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		10.00%
Borrowings							$ 5,000,000
Eversana Agreement [Member] \| Gimoti [Member] \| Minimum [Member]
Commercial Services And Loan Agreements [Line Items]
Percentage Of Product Profits		80.00%

Organization and Basis of Presentation - Additional Information (Detail) - USD ($)			9 Months Ended
	May 24, 2023	May 23, 2022	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Dec. 31, 2022	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Dec. 31, 2021
Organization And Basis Of Presentation [Line Items]
Month and year of incorporation			2007-01
Cash and cash equivalents			$ 5,964,826			$ 9,843,699
Reverse stock split description		1-for-12 reverse stock split
Minimum market value of listed securities	$ 2,500,000
Stockholders' equity			$ (873,775)	$ 538,374	$ 2,126,151	$ 4,084,649	$ 5,532,898	$ 7,191,010	$ 1,934,011	$ 3,555,094

- Definition

Amount of equity (deficit) attributable to parent. Excludes temporary equity and equity attributable to noncontrolling interest.

+ References

+ Details

Stockholders' Equity - Summary of Recognized Stock-Based Compensation Expense (Detail) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	$ 281,758	$ 355,752	$ 846,470	$ 1,103,737
Research and development [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense		1,897	2,841	7,505
Selling, general and administrative [Member]
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items]
Stock-based compensation expense	$ 281,758	$ 353,855	$ 843,629	$ 1,096,232

Stockholders' Equity - Stock-Based Compensation - Additional Information (Detail) $ in Millions	9 Months Ended
	Sep. 30, 2023 USD ($)
Share-Based Payment Arrangement [Abstract]
Unrecognized compensation costs	$ 1.3
Weighted average period	9 months 29 days

Stockholders' Equity - Common Stock - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2020	Dec. 31, 2022
Sale Of Common Stock [Line Items]
Common stock, shares issued	3,343,070			3,343,070
Options Granted [Member]
Sale Of Common Stock [Line Items]
Number of stock options granted	153,750	78,247
ATM Sales Agreement [Member]
Sale Of Common Stock [Line Items]
Common stock, shares issued	0	621,697
Proceeds from issuance of common stock		$ 7.3
Common stock , weighted average price per share		$ 11.97
ATM Sales Agreement [Member] \| Maximum [Member]
Sale Of Common Stock [Line Items]
Potential proceeds from issuance of common stock, net			$ 30.0

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Income Statement [Abstract]
Net product sales	$ 1,562,860	$ 832,100	$ 3,504,636	$ 1,712,275
Operating expenses:
Cost of goods sold	$ 34,908	$ 89,775	$ 142,855	$ 180,310
Cost, Product and Service [Extensible List]	us-gaap:ProductMember	us-gaap:ProductMember	us-gaap:ProductMember	us-gaap:ProductMember
Research and development		$ 40,388	$ 159,347	$ 273,582
Selling, general and administrative	$ 3,131,389	2,614,488	8,745,407	7,334,738
Total operating expenses	3,166,297	2,744,651	9,047,609	7,788,630
Loss from operations	(1,603,437)	(1,912,551)	(5,542,973)	(6,076,355)
Other income (expense):
Interest income	35,558	24,714	112,052	29,419
Interest expense	(126,028)	(126,027)	(373,973)	(373,973)
Total other (expense)	(90,470)	(101,313)	(261,921)	(344,554)
Net loss	$ (1,693,907)	$ (2,013,864)	$ (5,804,894)	$ (6,420,909)
Net loss per share of common stock, basic	$ (0.51)	$ (0.60)	$ (1.74)	$ (2.09)
Net loss per share of common stock, diluted	$ (0.51)	$ (0.60)	$ (1.74)	$ (2.09)
Weighted-average shares used to compute basic net loss per share	3,343,070	3,343,070	3,343,070	3,077,145
Weighted-average shares used to compute diluted net loss per share	3,343,070	3,343,070	3,343,070	3,077,145

Summary of Significant Accounting Policies (Policies)

9 Months Ended

Sep. 30, 2023

Accounting Policies [Abstract]

Use of Estimates

Contract Research Organizations and Consultants

Cash and Cash Equivalents

Accounts Receivable

Inventory

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.

Revenue Recognition

Stock-Based Compensation

Research and Development Expenses

Net Loss Per Share


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023		2022		2023		2022
Common stock options		639,601		491,851		639,601		491,851
Total excluded securities		639,601		491,851		639,601		491,851

Recent Accounting Pronouncements