10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2025

OR

☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission File Number 001-36075

EVOKE PHARMA, INC.

(Exact name of registrant as specified in its charter)

Delaware	20-8447886
(State or other jurisdiction of incorporation)	(IRS Employer Identification No.)
420 Stevens Avenue, Suite 230, Solana Beach, CA	92075
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: (858) 345-1494

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading symbol	Name of each exchange on which registered
Common Stock, par value $0.0001 per share	EVOK	The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

Large accelerated filer	☐	Accelerated filer	☐
Non-accelerated filer	☒	Smaller reporting company	☒
Emerging growth company	☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of May 1, 2025, the registrant had 1,492,858 shares of common stock outstanding.

Evoke pharma, inc.

Form 10-Q

TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION	1
Item 1. Financial Statements	1
Condensed Balance Sheets as of March 31, 2025 (Unaudited) and December 31, 2024	1
Condensed Statements of Operations for the three months ended March 31, 2025 and 2024 (Unaudited)	2
Condensed Statements of Stockholders’ Equity for the three months ended March 31, 2025 and 2024 (Unaudited)	3
Condensed Statements of Cash Flows for the three months ended March 31, 2025 and 2024 (Unaudited)	4
Notes to Condensed Financial Statements (Unaudited)	5
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	16
Item 3. Quantitative and Qualitative Disclosures about Market Risk	22
Item 4. Controls and Procedures	22
PART II. OTHER INFORMATION	24
Item 1. Legal Proceedings	24
Item 1A. Risk Factors	24
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	24
Item 3. Defaults Upon Senior Securities	24
Item 4. Mine Safety Disclosures	24
Item 5. Other Information	24
Item 6. Exhibits	25
SIGNATURES	27

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

Evoke Pharma, Inc.

Condensed Balance Sheets

	March 31,			December 31,
	2025			2024
	(Unaudited)
Assets
Current assets:
Cash and cash equivalents	$	12,624,090		$	13,596,600
Accounts receivable, net of allowance for credit losses of $0		2,511,490			2,420,373
Prepaid expenses		523,910			731,945
Inventories		532,145			445,081
Other current assets		39,240			43,898
Total current assets		16,230,875			17,237,897
Operating lease right-of-use asset		138,758			154,184
Deferred offering costs		—			120,614
Other long-term assets		6,312			6,312
Total assets	$	16,375,945		$	17,519,007
Liabilities and stockholdersʼ equity
Current liabilities:
Accounts payable and accrued expenses	$	2,781,203		$	2,341,191
Accrued compensation		371,732			865,650
Operating lease liability		61,625			59,533
Note payable		5,000,000			5,000,000
Accrued interest payable		2,236,953			2,113,665
Total current liabilities		10,451,513			10,380,039
Operating lease liability, net of current portion		83,217			100,958
Total liabilities		10,534,730			10,480,997
Commitments and contingencies
Stockholdersʼ equity:
Preferred stock, $0.0001 par value; authorized shares — 5,000,000    as of March 31, 2025 and December 31, 2024; issued and    outstanding shares — zero as of March 31, 2025 and December 31, 2024		—			—
Common stock, $0.0001 par value; authorized shares — 100,000,000 and    50,000,000 as of March 31, 2025 and December 31, 2024, respectively;    issued and outstanding shares — 1,492,858 and 1,486,009 as of    March 31, 2025 and December 31, 2024, respectively		149			149
Additional paid-in capital		135,938,876			135,829,493
Accumulated deficit		(130,097,810	)		(128,791,632	)
Total stockholdersʼ equity		5,841,215			7,038,010
Total liabilities and stockholdersʼ equity	$	16,375,945		$	17,519,007

See accompanying notes to these unaudited condensed financial statements.

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Evoke Pharma, Inc.

Condensed Statements of Operations

(Unaudited)

	Three Months Ended March 31,
	2025			2024
Net product sales	$	3,080,158		$	1,735,490
Operating expenses:
Cost of goods sold		41,613			92,529
Research and development		42,783			4,645
Selling, general and administrative		4,297,505			3,139,536
Total operating expenses		4,381,901			3,236,710
Loss from operations		(1,301,743	)		(1,501,220	)
Other income (expense):
Interest income		118,853			46,058
Interest expense		(123,288	)		(124,658	)
Total other expense		(4,435	)		(78,600	)
Net loss	$	(1,306,178	)	$	(1,579,820	)
Net loss per share of common stock, basic and diluted	$	(0.51	)	$	(2.09	)
Weighted-average shares used to compute basic and diluted      net loss per share		2,548,684			756,808

See accompanying notes to these unaudited condensed financial statements.

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Evoke Pharma, Inc.

Condensed Statements of Stockholders’ Equity (Deficit)

(Unaudited)

					Additional					Total
	Common Stock				Paid-In		Accumulated			Stockholdersʼ
	Shares		Amount		Capital		Deficit			Equity
Balance as of January 1, 2025		1,486,009	$	149	$	135,829,493	$	(128,791,632	)	$	7,038,010
Stock-based compensation expense		—		—		84,384		—			84,384
Issuance of common stock pursuant to the ESPP		6,849		—		24,999		—			24,999
Net loss		—		—		—		(1,306,178	)		(1,306,178	)
Balance as of March 31, 2025		1,492,858	$	149	$	135,938,876	$	(130,097,810	)	$	5,841,215

					Additional					Total
	Common Stock				Paid-In		Accumulated			Stockholdersʼ
	Shares		Amount		Capital		Deficit			(Deficit) Equity
Balance as of January 1, 2024		278,558	$	28	$	120,859,873	$	(123,439,438	)	$	(2,579,537	)
Stock-based compensation expense		—		—		254,029		—			254,029
Issuance of common stock, Pre-Funded Warrants, Series      A Warrants, Series B Warrants, and Series C Warrants,      net of issuance costs		427,886		43		6,172,580		—			6,172,623
Amendment and issuance of common stock and Pre-Funded Warrants from the March 2024 Amendment of Series B Warrants and Series C Warrants, net of issuance costs		9,967		1		1,229,873		—			1,229,874
Net loss		—		—		—		(1,579,820	)		(1,579,820	)
Balance as of March 31, 2024		716,411	$	72	$	128,516,355	$	(125,019,258	)	$	3,497,169

See accompanying notes to these unaudited condensed financial statements.

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Evoke Pharma, Inc.

Condensed Statements of Cash Flows

(Unaudited)

	Three Months Ended March 31,
	2025			2024
Operating activities
Net loss	$	(1,306,178	)	$	(1,579,820	)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense		84,384			254,029
Non-cash interest expense		123,288			124,658
Non-cash operating lease expense		19,147			—
Change in operating assets and liabilities:
Accounts receivable		(91,117	)		(778,833	)
Prepaid expenses and other assets		333,307			222,045
Inventories		(87,064	)		(106,936	)
Accounts payable and accrued expenses		440,012			343,596
Accrued compensation		(493,918	)		(1,058,129	)
Operating lease liabilities		(19,370	)		—
Net cash used in operating activities		(997,509	)		(2,579,390	)
Financing activities
Proceeds from February 2024 Offering		—			6,718,211
Payment of February 2024 Offering costs		—			(426,292	)
Proceeds from March 2024 Warrant Amendment		—			1,250,800
Proceeds from the issuance of common stock pursuant to the ESPP		24,999			—
Net cash provided by financing activities		24,999			7,542,719
Net (decrease) increase in cash and cash equivalents		(972,510	)		4,963,329
Cash and cash equivalents at beginning of period		13,596,600			4,739,426
Cash and cash equivalents at end of period	$	12,624,090		$	9,702,755
Supplemental disclosure of non-cash investing and financing activities
Offering costs in accounts payable and accrued expenses	$	—		$	20,926

See accompanying notes to these unaudited condensed financial statements.

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Evoke Pharma, Inc.

Notes to Condensed Financial Statements

(Unaudited)

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. 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 March 31, 2025 the Company had approximately $12.6 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. Both the Company and Eversana may terminate the commercial services and loan agreement (as described in Note 5. Commercial Services and Loan Agreements with Eversana), pursuant to the Net Profit Quarterly Termination Right (NPQTR) (as defined in Note 5); however, the Company has no intent to terminate the Eversana Agreement. There can be no assurance that Eversana will not exercise its right pursuant to the NPQTR. Should Eversana exercise its right under the NPQTR, the Loan Agreement, as described in Note 5, would also be terminated and the Company would be responsible for repaying the principal and accrued interest on the loan, which was $7.2 million as of March 31, 2025, within 90 days of the effective date of the termination. In addition, the Company would need to establish a commercial infrastructure in order to continue distributing Gimoti. The timing and costs associated with this are not clear, but the Company believes they would be substantial. As a result, management believes that there is substantial doubt about the Company’s 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. 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.

Reverse Stock Split

On May 22, 2024, 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 July 31, 2024, the Company filed an amendment (the “Amendment”) to its amended and restated certificate of incorporation to effectuate a reverse stock split of the Company’s common stock. Pursuant to the Amendment, at the effective time of 12:01 a.m. Eastern Time on August 1, 2024, each twelve (12) shares of the Company’s common stock issued and outstanding was combined into one (1) validly issued, fully paid and non-assessable share of common stock (the “Reverse Stock Split”). The par value and the authorized shares of the Company's common stock were not adjusted as

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a result of the Reverse Stock Split. All issued and outstanding common stock, warrants to purchase common stock, options to purchase common stock, per-share data and related information have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.

2. Summary of Significant Accounting Policies

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the condensed financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. These financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2025. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2024, has been derived from the audited financial statements at that date.

Risks and Uncertainties

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the 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. On an ongoing basis, the Company evaluates its estimates, including those related to the valuation of share-based awards, the fair value of warrants and the assessment of its ability to fund its operations for at least the next 12 months from the date of issuance of these condensed financial statements. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that management believes to be reasonable under the circumstances. Estimates are assessed each reporting period and updated to reflect current information. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

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. The Company's cash and 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 the note payable approximates fair value since the debt is due on demand as of March 31, 2025 and the carrying value is the settlement value, which is a Level 2 input within the fair value hierarchy.

Accounts Receivable and Allowance for Credit Losses

Accounts receivable are recorded net of allowance for credit losses, if any. The Company evaluates its estimate of expected credit losses based on a combination of factors, including historical experience, assessment of specific customer-related risks, review of outstanding invoices, forecasts about the future, and various other assumptions and estimates. The allowance for credit losses was zero as of both March 31, 2025 and December 31, 2024 and no provision for credit losses was recorded for the three months ended March 31, 2025 and 2024.

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Inventories

The Company's inventories consisted of the following as of March 31, 2025 and December 31, 2024:

	March 31,		December 31,
	2025		2024
Raw materials	$	157,070	$	257,467
Finished goods		375,075		187,614
Total inventories	$	532,145	$	445,081

Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. The Company’s raw materials inventories are held at its third-party suppliers and its finished goods inventories are held by Eversana. The Company records such inventories as consigned inventories.

Deferred Offering Costs

Deferred offering costs represent legal, accounting, and other direct costs related to future equity financings and are recognized as a non-current asset on the condensed balance sheets. After consummation of the equity financing, the offering costs are recognized as a reduction of proceeds and reclassified to additional paid-in capital on the condensed balance sheet. Should a planned equity financing be abandoned, terminated, or significantly delayed, the deferred offering costs are immediately written off as an administrative expense. As of December 31, 2024, the Company had deferred offering costs of $0.1 million related to the filing of a shelf registration statement in August 2024, which were written off during the first quarter of 2025.

Warrants

The Company accounts for warrants as equity-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For warrants that meet all criteria for equity classification, the warrants are required to be recorded as additional paid-in capital in the condensed balance sheets at the time of issuance. Equity-classified warrants are measured at their estimated fair value on the issuance date using either the Black-Scholes option pricing model or a Monte-Carlo simulation model based on the applicable assumptions, which include the exercise price of the warrants, the Company's stock price and volatility, the expected warrant term, the risk-free interest rate, the expected dividends, and if applicable, the vesting behavior.

Revenue Recognition

At the inception of a collaboration arrangement, the Company first assesses whether the contractual arrangement is within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether the arrangement involves a joint operating activity and involves two (or more) parties that are both active participants in the activity and exposed to significant risks and rewards dependent on the commercial success of such activity. Then the Company determines whether the collaboration arrangement in its entirety represents a contract with a customer as defined by ASC 606, Revenue from Contracts with Customers (“ASC 606”). If only a portion of the collaboration arrangement is potentially with a customer, the Company applies the distinct good or service unit-of-account guidance in ASC 606 to determine whether there is a unit of account that should be accounted for under ASC 606.

The Company has entered into a collaborative arrangement with Eversana for the commercialization and distribution of Gimoti in the United States. Under this arrangement, Eversana is responsible for market access, marketing, distribution, and patient support services, while the Company retains ownership of Gimoti and all legal, regulatory, and manufacturing responsibilities. The Company records sales for Gimoti. The Company reimburses Eversana for its commercialization costs pursuant to an agreed upon budget and a percentage of product profits, if any, which are recorded within selling, general and administrative expenses in the statement of operations. The Company has determined that the underlying patient is the customer and the Company is the principal in its relationship with Eversana based on the indicators of control occurring prior to product transfer to the customer, including risks related to inventory and responsibility for product fulfillment. Payment terms are net 30 from invoice date.

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In accordance with ASC 606, 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 allocated to the respective performance obligation when the customer obtains control of the product.

Product revenues are recognized net of any applicable variable consideration. The Company uses judgment to estimate variable consideration including (i) Medicaid and Medicare program rebates, (ii) sales related adjustments, wherever applicable, including patient support programs, rebates, and other sales related discounts and (iii) co-pay assistance. The Medicaid and Medicare program rebates are determined based on statutory provisions and are estimated based on the expected number of claims and related cost associated with the customer transaction. Medicaid and Medicare rebates of $0.2 million were recorded as accounts payables and accrued expenses in the condensed balance sheets as of both March 31, 2025 and December 31, 2024.

Co-pay 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 assistance liabilities are estimated using prescribing data available from customers. The Company's analysis also contemplates application of the constraint in accordance with the guidance, under which it determines 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 could affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $0.3 million and $0.1 million as of March 31, 2025 and December 31, 2024, respectively, are classified as accounts payable and accrued expenses in the condensed balance sheets.

The Company does not allow product returns. The Company may replace damaged product upon shipment, but such amounts have been immaterial. Cash receipts from sales come directly from the Company’s commercial partner, Eversana, and are typically received in 30 to 60 days after month-end.

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. Warrants to purchase shares of the Company’s common stock are included in the calculation of basic net loss per common share if the exercise price of the warrants represents de minimis consideration and is non-substantive in relation to the price paid for the warrant, and if the warrants are immediately exercisable with no further vesting conditions or contingencies associated with them. The 1,060,316 shares of the Company's common stock underlying the Pre-Funded Warrants, Modified Series A Warrants and Modified Series C Warrants described in Note 4, Stockholders’ Equity, are included in the weighted average outstanding common stock in the calculation of basic and diluted net loss per share due to their nominal exercise price. The Company considers Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants do not have a contractual obligation to share in the Company’s losses. As such, losses are attributed entirely to common stockholders and for periods in which the Company has reported a net loss, diluted loss per common share is the same as basic loss per common share. 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.

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:

	Three Months Ended March 31,
	2025		2024
Warrants to purchase common stock		792,731		2,641,907
Common stock options		269,930		51,983
Total excluded securities		1,062,661		2,693,890

Recent Accounting Pronouncements – Not Yet Adopted

From time to time, new accounting pronouncements are issued by the FASB or other standards setting bodies that are adopted as of the specified effective date. The Company believes the impact of recently issued standards, other than those noted below, and any issued but not yet effective standards will not have a material impact on our financial statements upon adoption.

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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.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40) (ASU 2024-03). The amendments in this update require disclosure, in the notes to the financial statements, of specific expense categories present within expense captions presented on the face of the income statement within continuing operations of public business entities. The amendments in this update are effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any and all prior periods presented in the financial statements. The impact of adoption this ASU on the Company’s disclosures is currently being evaluated.

In January 2025, the FASB issued ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. The amendment in this update clarifies the effective date of ASU 2024-03, which is that public business entities are required to adopt the guidance in annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The impact of adoption of this ASU on the Company’s disclosures is currently being evaluated.

3. Commitments and Contingencies

Leases

In December 2016, the Company entered into an operating lease for office space in Solana Beach, California (the “Initial Lease”). The Initial Lease commenced on January 1, 2017, and as amended, expired on October 31, 2023.

Upon expiration of the Initial Lease, the Company entered into an operating lease for a new office space in Solana Beach, California commencing on November 1, 2023 and expiring on October 31, 2024 (the “Short-Term Lease”). The Short-Term Lease qualified as a short-term lease under ASC 842 and was not recorded on the balance sheet. Operating lease expense for the Short-Term Lease was recognized on a straight-line basis over the lease term as general administrative expense within the statement of operations.

Upon expiration of the Short-Term Lease, the Company entered into an amendment for the same office space in Solana Beach commencing on November 1, 2024 and expiring on March 31, 2027 (the “Current Lease”). As the Current Lease agreement did not include an implicit rate, the Company estimated the incremental borrowing rate of 10% utilized to discount future minimum lease payments based on information available at lease commencement. Operating lease expense for the Current Lease is recognized on a straight-line basis over the lease term. The Company recognized a right-of-use asset obtained in exchange for new lease obligations of $0.2 million upon commencement of the Current Lease. The new lease liability obligation is recorded in operating lease liability and operating lease liability, net of current portion in the balance sheets. As of March 31, 2025, the remaining lease term was 2.0 years.

The following table summarizes supplemental lease information:

	Three Months Ended March 31,
	2025		2024
Lease costs(1)	$	20,107	$	18,936
Cash paid for leases	$	19,370	$	18,936

(1)Lease costs and cash paid for leases includes $20,331 and $18,936 of short-term lease expense for the three months ended March 31, 2025 and 2024, respectively. Variable lease costs included in general and administrative expense for three months ended March 31, 2025 and 2024 were immaterial.

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Future lease payments as of March 31, 2025 were as follows:

Years Ending December 31,
2025 (Remainder)	$	58,500
2026		80,207
2027		20,551
Total future lease payments		159,258
Less: imputed interest		(14,416	)
Total lease liability	$	144,842

4. Stockholders’ Equity

Equity Transactions

February 2024 Offering

In February 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Craig-Hallum Capital Group LLC and Laidlaw & Company (UK) Ltd. (collectively, the “Underwriters”), relating to the issuance and sale of 427,886 common stock units (the “Common Stock Units”) at a public offering price of $8.16 per Common Stock Unit and, to certain investors, 491,221 pre-funded warrant units (the “PFW Units”) at a public offering price of $8.1588 per PFW Unit (the “February 2024 Offering”). Each Common Stock Unit consisted 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 consisted of (i) a pre-funded warrant to purchase one share of common stock (the “Pre-Funded Warrants”), (ii) a Series A Warrant, (iii) a Series B Warrant, and (iv) a Series C Warrant. The Company also issued warrants to the Underwriters to purchase up to 45,955 shares of common stock, equal to 5% of the securities sold in the February 2024 Offering (the “Representatives’ Warrants”). The Series A Warrants are fully exercisable and are recognized as a freestanding financial instruments. In accordance with the terms and provisions of the Series C Warrants, the Series C Warrants were not exercisable, in part or in whole, at any time unless the Series B Warrants had been exercised. If Series B Warrants were not exercised before November 13, 2024, the corresponding Series C Warrants were no longer deemed outstanding and could not be exercised. Furthermore, the Series B Warrants and Series C Warrants could not be transferred by the holder without the consent of the Company, and, therefore the Series B Warrants and Series C Warrants were accounted for as a single unit of account.

Net cash proceeds from the February 2024 Offering was $6.2 million after deducting underwriter and offering expenses. The Pre-Funded Warrants, Series A Warrants, Series B Warrants, and Series C Warrants are equity classified and were recognized as additional paid-in capital in the balance sheets. The Representatives’ Warrants were accounted for under ASC 718, Compensation — Stock Compensation, and were recognized as an equity issuance cost at their grant date fair value within additional paid-in capital in the balance sheets.

August 2024 Shelf Registration Statement

On August 29, 2024, the Company filed a universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”), covering the offering of up to $50.0 million of common stock, preferred stock, debt securities, warrants, and/or units, subject to the “Baby Shelf Limitation” which limits the amount that the Company can offer and sell to up to one-third of its public float during any 12-month period so long as our public float remains below $75.0 million. The Shelf Registration Statement was declared effective by the SEC on September 6, 2024.

As of March 31, 2025, there have been no shares of common stock, preferred stock, debt securities, warrants, and/or units issued under the Shelf Registration Statement.

At The Market Equity Offering

The Company had previously entered into a Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to approximately $1.9 million through Wainwright (the “ATM Offering”). The Shelf Registration Statement included a prospectus covering the offering, issuance and sale of up to approximately $1.9 million of the Company’s common stock from time to time through the ATM Offering (the “ATM Prospectus”). In November 2024, the Company filed a prospectus supplement to amend and supplement the ATM Prospectus to update the amount of shares it is eligible to sell under the “Baby Shelf Limitation” to $3.1 million under the Sales Agreement.

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The Company did not issue any shares of common stock pursuant to the ATM Offering during the three months ended March 31, 2025.

Warrant Amendments

In each of March, June and September 2024, the Company entered into substantially similar amendments with certain holders of its Series B Warrants and Series C Warrants (individually, the “March 2024 Warrant Amendment,” “June 2024 Warrant Amendment,” and the “September 2024 Warrant Amendment,” respectively and collectively, the “Warrant Amendments”). Pursuant to the Warrant Amendments, to the extent a holder exercised its Series B Warrants prior to the exercise deadlines set forth in the respective Warrant Amendment (the “Amendment Exercise Deadline”), the holder’s corresponding Series C Warrants vested and became exercisable for the lesser of (i) three times the number of Series B Warrants exercised by the Holder and (ii) the total number of Series C Warrants outstanding to the holder. Following each Amendment Exercise Deadline, if the holder exercised any remaining Series B Warrants, the remaining Series C Warrants, if any, vested and became exercisable on a one-for-one basis as to the same number of Series B Warrants exercised.

The Warrant Amendments allowed a holder to elect to receive Pre-Funded Warrants upon exercise of Series B Warrants and Series C Warrants in lieu of shares of the Company’s common stock, at a purchase price of $8.1588 per warrant exercised and an exercise price of $0.0012 per Pre-Funded Warrant.

Net cash proceeds from the March Warrant Amendment, the June Warrant Amendment, and the September 2024 Warrant Amendment were $1.2 million, $0.3 million and $0.4 million, respectively, after deducting underwriter commissions and offering expenses. The Warrant Amendments were entered into to encourage the exercise of Series B Warrants in order to obtain capital to meet the Minimum Stockholders’ Equity Requirement as more fully discussed in Note 1. Organization and Basis of Presentation. The Warrant Amendments neither changed the number of shares of common stock underlying each series of warrants nor its equity classification. The incremental change in fair value from the Warrant Amendments was accounted for as equity issuance costs and recognized within additional paid-in capital in the balance sheets.

September 2024 Exercise Price Warrant Amendment

In September 2024, the Company also entered into an amendment with certain holders of its Series A Warrants, Series B Warrants and Series C Warrants (the “September 2024 Exercise Price Warrant Amendment”). Pursuant to the September 2024 Exercise Price Warrant Amendment, such holders who agreed to pay a non-refundable up-front payment of $3.99 per Series A Warrant or Series C Warrant prior to September 30, 2024 deadline (as defined in the September 2024 Exercise Price Amendment) had the exercise price reduced for each of the Series A Warrants and Series C Warrants from $8.16 to $0.01 (such Series A Warrants and Series C Warrants modified to have a reduced exercise price referred to as the “Modified Series A Warrants” and “Modified Series C Warrants”). To the extent such holder did not elect to modify all outstanding Series A Warrants and Series C Warrants, the remaining Series A Warrants and Series C Warrants held by each holder retained an exercise price of $8.16 per Series A Warrant or Series C Warrant.

Net cash proceeds from the September 2024 Exercise Price Warrant Amendment were $2.5 million after deducting underwriter and offering expenses. The September 2024 Exercise Price Warrant Amendment was entered to encourage the modification of Series A Warrants and Series C Warrants in order to obtain capital to meet the Minimum Stockholders’ Equity Requirement. The September 2024 Exercise Price Warrant Amendment neither changed the number of shares of Common Stock underlying each series of warrants nor its equity classification. The incremental change in fair value from the September 2024 Exercise Price Warrant Amendment was an equity issuance cost and was recognized within additional paid-in capital in the balance sheets.

In connection with the September 2024 Exercise Price Warrant Amendment, the Company entered into a letter agreement, dated September 27, 2024 (the “Letter Agreement”), with certain affiliates of Nantahala Capital Management, LLC (collectively, “Nantahala”), pursuant to which, subject to certain limitations, the Company provided Nantahala the right to appoint (or cause to be nominated) (i) one member of the Company’s board of directors (the “Board”) and one member of each Board committee so long as Nantahala, together with its affiliates, beneficially owns at least 5.0% of the Company’s outstanding shares of common stock and (ii) two members of the Board so long as Nantahala, together with its affiliates, beneficially owns at least 15.0% of the Company’s outstanding shares of common stock, subject to certain exceptions.

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Warrants

Each of the outstanding warrants is convertible on a one-for-one basis into the Company’s common stock and are fully exercisable as of March 31, 2025. The following table is a summary of the Company’s warrants outstanding as of March 31, 2025:

	Number of
	Warrants Outstanding		Exercise Price		Initial Exercise Date	Expiration Date
Pre-Funded Warrants		528,609	$	0.0012	February 13, 2024	Until Exercised in Full
Series A Warrants		354,022	$	8.16	February 13, 2024	February 13, 2029
Modified Series A Warrants(1)		281,080	$	0.01	February 13, 2024	February 13, 2029
Series C Warrants		392,754	$	8.16	February 13, 2024	February 13, 2029
Modified Series C Warrants(1)		250,627	$	0.01	February 13, 2024	February 13, 2029
Representativesʼ Warrants		45,955	$	13.47	August 13, 2024	February 13, 2029
Total warrants		1,853,047

__________________

(1)The Modified Series A Warrants and Modified Series C Warrants represent Series A Warrants and Series C Warrants, respectively, modified under the September 2024 Exercise Price Warrant Amendment.

Stock-Based Compensation

Stock Options

In January 2025, the number of shares of common stock available for issuance under the 2013 Equity Incentive Award Plan (the “2013 Plan”) was increased by 89,161 shares as a result of the automatic increase provision in the 2013 Plan. 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 three months ended March 31, 2025, the Company granted stock options to purchase 143,915 shares of the Company’s common stock. During the three months ended March 31, 2024, no options were granted.

The following assumptions were used in estimating the grant date fair value of options issued during the three months ended March 31, 2025:

Risk free interest rate	4.38-4.39%
Expected option term (in years)	5.8 - 6.0
Volatility of common stock	99% - 107.3%
Expected dividend yield	0.0%

Employee Stock Purchase Plan

Stock-based compensation expense also includes charges related to common stock issued under the Amended and Restated 2013 Employee Stock Purchase Plan (the “ESPP”). The Company allows eligible employees to purchase shares of the Company’s common stock through payroll deductions at a price equal to 85% of the lesser of the fair market value of the Company’s common stock on the first trading day of the offering period or on the applicable purchase date. The offering period is determined by the compensation committee and may be up to 27 months long. Current offering periods commence on each of September 1 and March 1 during the term. Purchase dates will be set for the last trading day in each six-month period and will occur on each of August 31 and February 28 (unless such days are not trading days). In January 2025, the number of shares of common stock available for issuance under the ESPP was increased by 14,860 shares as a result of the automatic increase provision in the ESPP. During the third quarter of 2024, an offering period was initiated. During the three months ended March 31, 2025, there were 6,849 shares of common stock issued pursuant to the Company’s ESPP, for gross proceeds of approximately $25,000.

During the three months ended March 31, 2024, no employees participated in the ESPP plan and as such, no ESPP awards were valued using the Black-Scholes option pricing-model. The estimated fair value of each ESPP award granted was determined on

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the date of purchase using the Black-Scholes option-pricing valuation model with the following assumptions for the three months ended March 31, 2025,:

Risk free interest rate	4.3%
Expected option term (in years)	0.5
Volatility of common stock	91.5%
Expected dividend yield	0.0%

The Company recognized stock-based compensation expense as follows:

	Three Months Ended March 31,
	2025		2024
Research and development	$	4,373	$	1,215
Selling, general and administrative		80,011		252,814
Total stock-based compensation expense	$	84,384	$	254,029

	Three Months Ended March 31,
	2025		2024
Stock options	$	77,638	$	254,029
ESPP		6,746		—
Total stock-based compensation expense	$	84,384	$	254,029

As of March 31, 2025, there was approximately $0.9 million of unrecognized compensation costs related to outstanding options, which are expected to be recognized over a weighted-average period of 2.8 years.

As of March 31, 2025, there was approximately $18,000 of unrecognized compensation costs related to the ESPP, which are expected to be recognized over a weighted-average period of 0.4 years.

5. 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 utilizes its internal sales organization, along with other commercial functions, for market access, marketing, distribution and other related patient support services. The Company records sales for Gimoti and retain more than 80% of net product profits once both parties’ costs are reimbursed. For the three months ended March 31, 2025 and 2024, approximately $2.6 million and $1.5 million of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. As of March 31, 2025, unreimbursed commercialization costs to Eversana were approximately $77.5 million. Such costs will generally be payable only as net product profits are recognized or upon certain termination events. Eversana receives 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 (the “Eversana Amendment”). The Eversana 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 Eversana Agreement; if the

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Company discontinues the development or production of Gimoti; if the net profit is negative for any two consecutive calendar quarters (the “Net Profit Quarterly Termination Right”) beginning with the measurement date of June 30, 2023; 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.

The Company's net profits were negative for the two preceding calendar quarters as of March 31, 2025, and therefore, Eversana or the Company could have exercised the Net Profit Quarterly Termination Right (“NPQTR”) during the 60-day period after quarter-end. Since the note payable and accrued interest payable could be accelerated by Eversana by terminating the Eversana Agreement as of March 31, 2025, those payments were recorded as current liabilities as of March 31, 2025. Each party continues to have the option to exercise the NPQTR for the 60-day period following the end of future quarters so long as the net profit under the Eversana Agreement remains negative for consecutive quarters.

In the event 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 NPQTR, 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. If Eversana terminates the Eversana Agreement for convenience, the Company is under no obligation to reimburse Eversana for unreimbursed commercialization costs.

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 $5.0 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 $5.0 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.

6. Segment Information

Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer, in deciding how to allocate resources and assess performance. The Company’s CODM evaluates the Company’s financial information including budget-versus-actual results and cash projections on an aggregate basis when assessing performance for allocating financial and personnel resources. The Company is not organized by market and is managed and operated as one business.

The Company identifies its operating segments based on its business activities. The Company operates within a single operating segment being the development and commercialization of pharmaceutical products. The development and commercialization of pharmaceutical products segment generates revenues in the United States. The Company’s administrative functions including finance, business development and procurement, support the development and commercialization of pharmaceutical products segment. The Company operates primarily in one geographic area, being the United States. The CODM allocates resources (inclusive of both capital and personnel) based upon the Company’s net loss, which is utilized to monitor budget-to-actual variances on a monthly basis.

The accounting policies of the development and commercialization of pharmaceutical products segment are the same as those described in Note 2. Summary of Significant Accounting Policies. All Company assets are in the United States. The measure of segment assets is reported on the balance sheets as total assets. The Company does not have intra-entity sales or transfers.

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The Company has no transactions denominated in foreign currencies nor any tangible or intangible property for which is recognizes depreciation or amortization and depreciating assets are not part of the CODMs evaluation or decision-making process.

The following table summarizes the Company’s financial data for its development and commercialization of pharmaceutical products segment:

	Three Months Ended March 31,
	2025			2024
Net product sales	$	3,080,158		$	1,735,490
Less:
Cost of goods sold		(41,613	)		(92,529	)
Eversana profit sharing		(2,618,135	)		(1,475,261	)
Employee expenses		(638,099	)		(696,801	)
Professional fees		(704,629	)		(503,717	)
Stock-based compensation		(84,384	)		(254,029	)
Sales and marketing expenses		(188,668	)		(163,797	)
Other operating expenses(1)		(106,373	)		(50,576	)
Interest income		118,853			46,058
Interest expense (non-cash)		(123,288	)		(124,658	)
Total segment costs loss and net loss	$	(1,306,178	)	$	(1,579,820	)

________________

(1) Includes ongoing product development costs, occupancy costs (including rent and utilities), administrative costs, travel and business taxes.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis should be read in conjunction with our financial statements and accompanying notes included in this Quarterly Report on Form 10-Q and the financial statements and accompanying notes thereto for the fiscal year ended December 31, 2024 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, both of which are contained in our Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on March 13, 2025. Past operating results are not necessarily indicative of results that may occur in future periods.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. All statements other than statements of historical facts contained in this Quarterly Report on Form 10-Q, including statements regarding our future results of operations and financial position, business strategy, commercial activities to be conducted by Eversana Life Science Services, LLC, or Eversana, the pricing and reimbursement for Gimoti®™ (metoclopramide) nasal spray, future prescribing trends for Gimoti, future regulatory developments, research and development costs, the timing and likelihood of commercial success, the potential to develop future product candidates, plans and objectives of management for future operations, continued compliance with Nasdaq listing requirements and future results of current and anticipated products, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statement. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other similar expressions. Although we believe the expectations reflected in these forward-looking statements are reasonable, such statements are inherently subject to risk and we can give no assurances that our expectations will prove to be correct. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. You should read this Quarterly Report on Form 10-Q completely. As a result of many factors, including without limitation those set forth under “Risk Factors” under Item 1A of Part II below, and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements. Except as required by applicable law, we undertake no obligation to update these forward-looking statements to reflect events or circumstances after the date of this report or to reflect actual outcomes. For all forward-looking statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.

We use our registered trademark, EVOKE PHARMA, and other trademarks, including GIMOTI, in this Quarterly Report on Form 10-Q. This Quarterly Report on Form 10-Q also includes trademarks, tradenames and service marks that are the property of other organizations. Solely for convenience, trademarks and tradenames referred to in this Quarterly Report on Form 10-Q appear without the ® and ™ symbols, but those references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or that the applicable owner will not assert its rights, to these trademarks and tradenames.

Unless the context requires otherwise, references in this Quarterly Report on Form 10-Q to “Evoke,” “we,” “us” and “our” refer to Evoke Pharma, Inc.

Overview

We are a specialty pharmaceutical company focused primarily on the development and commercialization of drugs to treat gastrointestinal, or GI, disorders and diseases. Since our inception, we have devoted our efforts to developing our 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. In June 2020, we received approval from the U.S. Food and Drug Administration, or FDA, for our 505(b)(2) New Drug Application, or NDA, for Gimoti. We launched commercial sales of Gimoti in the United States in October 2020 through our commercial partner Eversana.

Diabetic gastroparesis is a GI disorder affecting millions of patients worldwide, in which food in an individual’s stomach takes too long to empty resulting in a variety of serious GI symptoms and systemic metabolic complications. The gastric delay caused by gastroparesis can compromise absorption of orally administered medications. In May 2023, we reported results from a study conducted by Eversana which showed diabetic gastroparesis patients taking Gimoti had significantly fewer physician office visits, emergency department visits, and inpatient hospitalizations compared to patients taking oral metoclopramide. This overall lower health resource utilization reduced patient and payor costs by approximately $15,000 during a six-month time period for patients taking Gimoti compared to patients taking oral metoclopramide.

In January 2020, we entered into a commercial services agreement with Eversana, or the Eversana Agreement, for the commercialization of Gimoti. Pursuant to the Eversana Agreement, Eversana commercializes and distributes Gimoti in the United

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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. Eversana also provided a $5 million revolving credit facility, or the Eversana Credit Facility, that became available upon FDA approval of the Gimoti NDA. In 2020, we borrowed $5 million under the Eversana Credit Facility, which expires on December 31, 2026, unless terminated earlier pursuant to its terms.

We have primarily funded our operations through the sale of our convertible preferred stock prior to our initial public offering in September 2013, borrowings from loans, and the sale of shares of our common stock, warrants, and pre-funded warrants in public offerings. We launched commercial sales of Gimoti in late October 2020 with Eversana and, to date, have generated modest sales.

We have incurred losses in each year since our inception. These operating losses resulted from expenses incurred in connection with advancing Gimoti through development activities, pre-commercial and commercialization activities, and other general and administrative costs associated with our operations. We expect to continue to incur operating losses until revenues from sales of Gimoti exceed our expenses, if ever. We may never become profitable, or if we do, we may not be able to sustain profitability on a recurring basis.

As of March 31, 2025, we had cash and cash equivalents of approximately $12.6 million. Current cash on hand is intended to fund commercialization activities for Gimoti, including manufacturing Gimoti, conducting the post-marketing commitment single-dose pharmacokinetics, or PK, clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti and any additional development activities should we seek additional indications, protecting our intellectual property portfolio and for other general and administrative costs to support our operations. We believe, based on our current operating plan, excluding any potential early repayment of the Eversana Credit Facility, that our existing cash and cash equivalents as of March 31, 2025, as well as cash flows from future net sales of Gimoti, will be sufficient to fund our operations into the second quarter of 2026. However, should Eversana terminate the Eversana Agreement under the NPQTR (as defined in Note 1. Organization and Basis of Presentation to our financial statements), repayment of the Eversana Credit Facility, in addition to our other ongoing obligations, would raise substantial doubt about our ability to continue as a going concern. As such, we have concluded there is substantial doubt about our ability to continue as a going concern as our existing cash on hand as of March 31, 2025, is not sufficient to fund our operations 12 months from the issuance of this Quarterly Report on Form 10-Q. This period could be further shortened if future net sales of Gimoti are less than expected or if there are any significant increases in planned spending on commercialization activities, including for marketing and manufacturing of Gimoti, and our selling, general and administrative costs to support operations, including as a result of any termination of the Eversana Agreement. We anticipate that we will be required to raise additional funds in order to continue as a going concern. Because our business is entirely dependent on the success of Gimoti, if we are unable to secure additional financing or identify and execute on other development or strategic alternatives for Gimoti or our company, we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in a complete loss of your investment in our securities.

Nasdaq Listing and Reverse Stock Split

On May 24, 2023, we received a written notice from Nasdaq indicating that, based on our stockholders’ equity of $2.1 million as of March 31, 2023, as reported in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, we were not in compliance with the minimum stockholders’ equity requirement for continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(b)(1) (“Minimum Stockholders’ Equity Requirement”). As required by Nasdaq, we submitted our plan to regain compliance with the Minimum Stockholders’ Equity Requirement and, following a hearing before the Nasdaq Hearings Panel (the “Panel”), and several quarters in which we demonstrated continued compliance with the Minimum Stockholders’ Equity Requirements, we were notified on June 4, 2024, that the Panel determined that we had regained compliance with the Minimum Stockholders’ Equity Requirement. Pursuant to Nasdaq Listing Rule 5815(d)(4)(A), we will be subject to a discretionary panel monitor through June 4, 2025. If, within that one-year monitoring period, we fail to maintain compliance with any Nasdaq continued listing requirement, the Listing Qualifications Staff (the “Staff”) of Nasdaq will issue a Delist Determination Letter, and we will have an opportunity to request a new hearing with the initial Panel or a newly convened Hearings Panel if the initial Panel is unavailable. Notwithstanding Nasdaq Listing Rule 5810(c)(2), we will not be permitted to provide the Staff with a plan of compliance with respect to any deficiency that arises during the one-year monitoring period, and the Staff will not be permitted to grant additional time for us to regain compliance with respect to any deficiency.

On February 21, 2024, we 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 under Nasdaq Listing Rule 5550(a)(2) (the “Minimum Bid Price Requirement”).

In May 2024, our stockholders granted our board of directors the authority to effect a reverse stock split of our outstanding common stock. In order to regain compliance with the Minimum Bid Price Requirement by August 19, 2024, on July 31, 2024, we filed an amendment (the “Amendment”) to our amended and restated certificate of incorporation to effectuate a reverse stock split of our common stock. Pursuant to the Amendment, at the effective time of 12:01 a.m. Eastern Time on August 1, 2024, each twelve (12) shares of our common stock issued and outstanding was combined into one (1) validly issued, fully paid and non-assessable share of common stock (the “Reverse Stock Split”). The par value and the authorized shares of our common stock were not adjusted as a result

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of the Reverse Stock Split. All of our issued and outstanding common stock, warrants to purchase common stock, options to purchase common stock, per-share data and related information have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.

On August 15, 2024, we received a letter from Nasdaq stating we had regained compliance with the Minimum Bid Price Requirement and the minimum bid price matter was closed.

Financial Operations Overview

Revenue Recognition

Our ability to generate revenue and become profitable depends on our ability to successfully commercialize Gimoti, which we launched in the United States through prescription in October 2020 through our commercial partner Eversana. If we or Eversana fail to successfully grow sales of Gimoti, we may never generate significant revenues and our results of operations and financial position will be adversely affected.

In accordance with Accounting Standards Codification, or ASC, 606, Revenue from Contracts with Customers, we recognize revenue when a customer obtains control of promised goods in an amount that reflects the consideration we expect 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, we perform 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, we assess the goods promised within each contract and determine those that are performance obligations and assess whether each promised good is distinct. We then recognize 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. We use judgment to estimate variable consideration. We are subject to rebates under Medicaid and Medicare programs. The rebates for these programs are determined based on statutory provisions. We estimate Medicaid and Medicare rebates based on the expected number of claims and related cost associated with the customer transaction.

We also make estimates about 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 differ from our estimates. If actual results in the future vary from estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Liabilities for Medicare and Medicaid rebates, as well as co-pay assistance, are classified as accounts payable and accrued expenses in the balance sheets.

Sales of Gimoti Metrics

Gimoti prescriptions, prescribers, and other revenue metrics continue to increase. Net product sales during the quarter ended March 31, 2025 were approximately $3.1 million which is a $1.3 million increase compared to net product sales for the quarter ended March 31, 2024. ASPN Pharmacy, or ASPN, serves as the non-dispensing pharmacy hub for Gimoti. ASPN offers a seamless path for processing and filling prescriptions, helps patients understand coverage and identify available savings opportunities, and facilitates communications between providers and payors. ASPN improves the proportion of prescriptions covered by insurance payors through increased patient communication and electronic automation of processes and speed of communication. We added several new dispensing pharmacies to our pharmacy platform during the year ended December 31, 2024, which has allowed for better insurance coverages by mitigating geographic and pharmacy benefit manager restrictions to filling prescriptions, and plan to continue this expansion throughout 2025. Adding dispensing pharmacies has also added redundancy and capacity to fill prescriptions and reduced reliance on having a single dispensing pharmacy partner. ASPN continues to process inbound prescriptions at a pace that is showing improved patient capture and conversion to reimbursed fills by insurers, and reduced reliance on savings programs.

There were approximately 1,793 new inbound prescriptions into the ASPN reimbursement center during the quarter ended March 31, 2025, which is a 25% increase compared to the quarter ended March 31, 2024. Patients who have an opportunity to refill the product (that is, patients who have completed their first fill and have additional refills on their prescription) received a refill approximately 70% of the time. We believe some patients choose not to refill their prescriptions due to remission of symptoms. Cumulatively, new prescribers increased 9.6% during the quarter ended March 31, 2025.

The ASPN team accesses the Medicare and Medicaid systems to facilitate product reimbursement submissions for patients seeking treatment. For the three months ended March 31, 2025, these government programs made up approximately 31% of the filled prescriptions for Gimoti. From the commercial launch of Gimoti through March 31, 2025, the majority of patients have been between

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the ages of 31 and 65 years old. The vast majority of patients are female and were being treated by a gastroenterologist or a nurse practitioner or physician assistant on their staff.

Key Opinion Leaders, or KOLs, have presented data regarding the safety profile for Gimoti and we expect KOLs will present additional data in the future. Data presented at the May 2024 Digestive Disease Week indicated a far lower incidence of tardive dyskinesia, or TD, than previously published. This retrospective data was generated from a U.S. based database covering over 270 million patient lives. The outcome showed a 0.12% incidence of TD for gastroparesis patients taking any form of metoclopramide for any diagnosis.

At the May 2023 Digestive Disease Week conference, a head-to-head (oral v. nasal metoclopramide), real world evidence data in 514 patients was presented. Compared to patients in the oral metoclopramide cohort, patients taking Gimoti experienced fewer visits to a physician’s office and emergency room (60% reduction), and had fewer inpatient admissions (68% reduction) compared to oral metoclopramide. To our knowledge, this study is the first such head-to-head data ever to be presented regarding the product and a clear support for improved outcomes for patients using Gimoti. This data was further validated in October 2023 at the American College of Gastroenterology conference, when the related cost data was presented at a plenary session showing a $15,000 savings for those patients taking Gimoti compared to oral metoclopramide over the six-month period following initiation of therapy. In October 2024 during the American College of Gastroenterology meeting, additional data related to the comparative study between Gimoti and oral metoclopramide showed a similar benefit for persons also taking GLP-1 treatments. This continues to be an area of interest for gastroenterologists who are more frequently seeing patients with delayed gastric emptying accompanying GLP-1 following initiation of therapy. These data have recently been provided to our commercialization field force to inform physicians and payers of the potential benefits seen in these real-world trials.

Research and Development Expenses

We expense all research and development expenses as they are incurred. Research and development expenses primarily include:

•clinical and regulatory-related costs;

•expenses incurred under agreements with contract research organizations, or CROs;

•manufacturing and stability testing costs and related supplies and materials used in clinical trials; and

•employee-related expenses, including salaries, benefits, travel and stock-based compensation expense.

All of our research and development expenses to date have been incurred in connection with the development of Gimoti. Since FDA approval of Gimoti in June 2020, research and development costs have decreased and shifted to commercialization and selling costs. We are waiting for feedback from the FDA related to the design of an FDA post-marketing commitment single-dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti to accommodate patients that may require further dosage adjustments. We are unable to estimate with any certainty the costs we will incur related to this trial, or the regulatory review of such lower dosage of Gimoti, though such costs may be significant and will substantially increase research and development expenses once this trial is initiated. We may also incur additional costs to the extent we pursue additional clinical trials to expand the indication of Gimoti. Clinical development timelines, the probability of success and development costs can differ materially from expectations.

The costs of clinical trials may vary significantly over the life of a project owing to, but not limited to, the following:

•per subject trial costs;

•the number of sites included in the trials;

•the length of time required to enroll eligible subjects;

•the number of subjects that participate in the trials;

•the number of doses that subjects receive;

•the cost of comparative agents used in trials;

•the drop-out or discontinuation rates of subjects;

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•potential additional safety monitoring or other studies requested by regulatory agencies; and

•the duration of patient follow-up.

Selling, General and Administrative Expenses

Selling, general and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation. Other selling, general and administrative expenses include professional fees for accounting, tax, patent costs, legal services, insurance, facility costs and costs associated with being a publicly-traded company, including fees associated with investor relations and directors’ and officers’ liability insurance premiums. We expect that selling, general and administrative expenses will increase in the future as we continue to progress with the commercialization of Gimoti and we reimburse Eversana from the net profits attained from the sales of Gimoti.

Other Developments

The United States has enacted, and continues to consider, a range of trade-related measures, including tariffs, export controls, and other policies. These actions, as well as retaliatory tariffs imposed by other countries on U.S. exports, have led to significant volatility and uncertainty in global markets. Although we are actively monitoring the tariff developments and analyzing the potential impacts, we currently do not expect them to have a material impact on our business or results of operations.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our condensed financial statements, which we have prepared in accordance with generally accepted accounting principles in the United States, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed financial statements, as well as the reported expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ materially from these estimates under different assumptions or conditions.

There have been no new or significant changes to our critical accounting policies and estimates discussed in Management’s Discussion and Analysis of Financial Condition and Results of Operations included in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 13, 2025.

Results of Operations

Comparison of Three Months Ended March 31, 2025 and 2024

The following table summarizes the results of our operations:

	Three Months Ended March 31,
	2025		2024		$ Change			% Change
Net product sales	$	3,080,158	$	1,735,490	$	1,344,668			77	%
Cost of goods sold	$	41,613	$	92,529	$	(50,916	)		-55	%
Research and development expenses	$	42,783	$	4,645	$	38,138			821	%
Selling, general and administrative expenses	$	4,297,505	$	3,139,536	$	1,157,969			37	%

Net Product Sales. Net product sales for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 increased by approximately $1.3 million. The increase in product sales during 2025 is due to the increased conversion rate due to the expanded pharmacy network, a greater number of physicians within larger gastroenterology teams prescribing Gimoti after first-physician adoption and patients re-filling prescriptions at a higher rate.

Cost of Goods Sold. Cost of goods sold for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 decreased by approximately $51,000. The decrease in costs of goods sold during 2025 is primarily due to timing of stability testing on commercial product batches which was partially offset by an overall increase in sales and related costs

Research and Development Expenses. Research and development expenses for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 increased by approximately $38,000 due to miscellaneous product development costs.

Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 increased by approximately $1.2 million primarily due to an increase of $1.2 million in marketing and Eversana profit sharing amounts as a direct result of an increase in net product sales, and increase of

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$0.2 million in professional fees primarily as a result of expensing the deferred offering costs associated with the filing of a shelf registration statement in August 2024 and a $0.1 million increase in product liability insurance and other costs associated with being a public company. These increases were partially offset by a decrease of $0.3 million in wages, taxes and employee insurance, including a $0.2 million decrease in stock-based compensation expense.

Liquidity and Capital Resources

Since our inception in 2007, we have funded our operations primarily from the sale of equity securities and borrowings under loan and security agreements.

In connection with the Eversana Agreement, we entered into the Eversana Credit Facility, pursuant to which Eversana agreed to provide a revolving credit facility of up to $5.0 million to us upon FDA approval of the Gimoti NDA, as well as certain other 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 our personal property other than our intellectual property. Under the terms of the Eversana Credit Facility, we cannot grant an interest in our 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, we borrowed $5.0 million from the Eversana Credit Facility.

As of March 31, 2025, we had approximately $12.6 million in cash and cash equivalents. We anticipate that we will continue to incur losses from operations due to commercialization activities, including manufacturing Gimoti, conducting the post-marketing commitment single-dose 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 our operations. Both we and Eversana may terminate the commercial services agreement (as described in Note 5. Commercial Services and Loan Agreements with Eversana), pursuant to the NPQTR (as defined in Note 5); however, we have no intent to terminate the Eversana Agreement. There can be no assurance that Eversana will not exercise its right pursuant to the NPQTR. Should Eversana exercise its right under the NPQTR, the Loan Agreement (as described in Note 5) would also be terminated and we would be responsible for repaying the principal and accrued interest on the loan, which was $7.2 million as of March 31, 2025, within 90 days of the effective date of the termination. In addition, we would need to establish a commercial infrastructure in order to continue distributing Gimoti. The timing and costs associated with this are not clear, but we believe they would be substantial. As a result, management 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. This would materially and adversely affect our near-term liquidity needs and cash runway. We anticipate we will be required to raise additional funds in order to continue as a going concern. Because our business is entirely dependent on the success of Gimoti, if we are unable to secure additional financing or identify and execute on other development or strategic alternatives for Gimoti or our company, we will be required to curtail all of our activities and may be required to liquidate, dissolve or otherwise wind down our operations. Any of these events could result in a complete loss of your investment in our securities.

There is no assurance that other financing will be available when needed to allow us to continue as a going concern. The perception that we may not be able to continue as a going concern may cause others to choose not to deal with us due to concerns about our ability to meet our contractual obligations.

Sources and Uses of Our Cash

The following table summarizes our cash flows:

	Three Months Ended March 31,
	2025			2024			$ Change
Net cash used in operating activities	$	(997,509	)	$	(2,579,390	)	$	1,581,881
Net cash provided by financing activities	$	24,999		$	7,542,719		$	(7,517,720	)
Net (decrease) increase in cash and cash equivalents	$	(972,510	)	$	4,963,329		$	(5,935,839	)

Operating Activities. The primary use of our cash has been to fund our clinical research, prepare our NDA, manufacture Gimoti, commercial sales of Gimoti, and other general operations. The cash used in operating activities during the three months ended March 31, 2025 and 2024 was primarily related to commercialization activities for Gimoti and other general operational activities. We expect that cash used in operating activities during the remainder of 2025 will be in-line with cash used during similar periods in 2024 because growing sales are expected to offset commercialization activities, including manufacturing Gimoti, and the planned post-marketing commitment to conduct a single-dose PK clinical trial of Gimoti to characterize dose proportionality of a lower dose strength of Gimoti.

Financing Activities. During the three months ended March 31, 2025, cash provided by financing activities was $24,999 due to the issuance of 6,849 shares of common stock pursuant to our employee stock purchase plan. No shares were issued during the three months ended March 31, 2024. During three months ended March 31, 2024, cash provided by financing activities was $7.5 million

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primarily due to the sale of 437,853 shares of common stock at $8.16 per share and 642,626 Pre-Funded Warrants at $8.1588 per share.

Capital Resource Requirements

On October 16, 2024, we entered into the Seventh Amendment to our existing office lease agreement. The Seventh Amendment extends the term of the lease from October 31, 2024 to March 31, 2027. The Seventh Amendment provides for an initial monthly base rent of approximately $6,500, with stated escalation clauses each November first through the lease term. We are also responsible for common area maintenance costs associated with the leased space.

The amount and timing of our future funding requirements will depend on many factors, including but not limited to:

•the costs of commercialization activities, including costs associated with commercial manufacturing;

•the commercial success of Gimoti, including competition with well-established products approved earlier by FDA, including oral and intravenous forms of metoclopramide, the same active ingredient in the nasal spray for Gimoti;

•our ability to manufacture sufficient quantities of Gimoti to meet demand, including whether our contract manufacturers, suppliers, and/or consultants are able to meet appropriate timelines;

•the progress and costs of 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 and the costs of any additional clinical trials we may pursue to expand the indication of Gimoti;

•our ability to obtain, maintain and enforce our patents and other intellectual property rights, and the costs incurred to do so;

•the terms and timing of any collaborative, licensing, co-promotion or other arrangements that we may establish; and

•costs associated with any other product candidates that we may develop, in-license or acquire.

We expect to continue to incur expenses as we:

•continue the commercial activities for Gimoti;

•manufacture Gimoti;

•conduct the post-marketing commitment single-dose PK clinical trial of Gimoti and any additional development activities should we seek additional indications;

•maintain, expand and protect our intellectual property portfolio; and

•continue to fund the accounting, legal, insurance and other costs associated with being a public company.

Item 3. Quantitative and Qualitative Disclosure about Market Risk

As a smaller reporting company, we are not required to provide the information required by this Item.

Item 4. Controls and Procedures

Conclusions Regarding the Effectiveness of Disclosure Controls and Procedures

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our Exchange Act reports is recorded, processed, summarized and reported within the timelines specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can only provide reasonable assurance of achieving the desired control objectives, and in reaching a reasonable level of assurance, management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures. In addition, the design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, control may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a cost-effective control system, misstatements due to error or fraud may occur and not be detected.

As required by SEC Rule 13a-15(b), as of March 31, 2025, we carried out an evaluation, under the supervision and with the

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participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures, as of the end of the period covered by this report. Based on the foregoing, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective at the reasonable assurance level as of March 31, 2025.

Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) of the Exchange Act during the quarter ended March 31, 2025, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

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PART II. OTHER INFORMATION

Item 1. Legal Proceedings

None.

Item 1A. Risk Factors

There have been no material changes to the risk factors included in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 filed with the SEC on March 13, 2025 other than the following:

Changes to United States tariff and import/export regulations may have a negative effect on us.

The United States has enacted, and continues to consider, a range of trade-related measures, including tariffs, export controls, and other policies. The President of the United States has directed agencies to reassess key aspects of U.S. trade policy, and there has been ongoing debate and uncertainty surrounding potential changes to trade agreements, tariff structures, and foreign investment regulations. Shifts in trade policy—whether through legislation, executive action, or international negotiation—could alter the global trade landscape and affect supply chains, pricing, and demand for goods and services. These developments, or the perception that such changes may occur, have and could continue to have a material adverse effect on global economic conditions, contribute to volatility in financial markets, and disrupt international trade, including trade between the United States and its key partners. We currently depend on third-party contract manufacturers for starting materials, the final drug substance and nasal spray delivery device for Gimoti, including Cosma located in Italy as the sole-source supplier of metoclopramide, and Thermo Fisher Scientific Inc. located in France, as the sole manufacturer of Gimoti. As a result of these tariff and trade developments, we could experience a negative impact to our costs for Gimoti from our third-party manufacturers, or may experience supply chain disruptions. Any of these factors could adversely affect our business, financial condition and results of operations.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

None.

Item 3. Defaults Upon Senior Securities

None.

Item 4. Mine Safety Disclosures

Not applicable.

Item 5. Other Information

During the three months ended March 31, 2025, none of our officers or directors adopted, modified or terminated any contract, instruction or written plan for the purchase or sale of our securities that was intended to satisfy the affirmative defense conditions of Rule 10b5-1(c) or any non Rule 10b5-1 trading arrangement.

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Item 6. Exhibits

Index to Exhibits

Exhibit Number	Description of Exhibit	Form	File Number	Date of Filing	Exhibit Number	Filed Herewith
3.1	Amended and Restated Certificate of Incorporation of the Company	8-K	001-36075	9/30/2013	3.1
3.2	Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Company	8-K	001-36075	5/20/2022	3.1
3.3	Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Company	10-Q	001-36075	8/13/2024	3.3
3.4	Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Company	8-K	001-36075	8/1/2024	3.1
3.5	Amended and Restated Bylaws of the Company	8-K	001-36075	9/30/2013	3.2
4.1	Form of Pre-Funded Warrant	S-1/A	333-275443	12/15/2023	4.2
4.2	Form of Series A Warrant	S-1/A	333-275443	1/11/2024	4.3
4.3	Form of Series B Warrant	S-1/A	333-275443	1/11/2024	4.4
4.4	Form of Series C Warrant	S-1/A	333-275443	1/11/2024	4.5
4.5	Form of Representative Warrant	S-1/A	333-275443	2/14/2024	4.1
4.6	Form of Warrant Amendment	8-K	001-36075	3/25/2024	4.1
4.7	Form of Warrant Amendment	8-K	001-36075	6/20/2024	4.1
4.8	Form of Exercise Price Warrant Amendment	8-K	001-36075	9/27/2024	4.1
4.9	Form of Series C Vesting Warrant Amendment	8-K	001-36075	9/27/2024	4.2
10.1	Amended and Restated Non-Employee Director Compensation Policy					X
31.1	Certification of Principal Executive Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934					X
31.2	Certification of Principal Financial Officer pursuant to Rules 13a-14 and 15d-14 promulgated under the Securities Exchange Act of 1934					X
32.1*	Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002					X
32.2*	Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002					X
101.INS	Inline XBRL Instance Document – the instance document does not appear in the Interactive Data					X

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Exhibit Number	Description of Exhibit	Form	File Number	Date of Filing	Exhibit Number	Filed Herewith
	File because its XBRL tags are embedded within the inline XBRL document
104	Cover Page Interactive Data File (formatted as inline XBRL and contained in Exhibit 101)					X

* This certification is being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934 and are not to be incorporated by reference into any filing of Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

	Evoke Pharma, Inc.
Date: May 13, 2025	By:	/s/ Matthew J. D'Onofrio
		Matthew J. D’Onofrio Chief Executive Officer (Principal Executive Officer)

	Evoke Pharma, Inc.
Date: May 13, 2025	By:	/s/ Mark Kowieski
		Mark Kowieski Chief Financial Officer (Principal Financial and Accounting Officer)

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EX-10.1

Explanatory Note: This policy has been updated to reflect the one-for-twelve reverse stock split effected on August 1, 2024.

EVOKE PHARMA, INC.

Non-Employee DIRECTOR COMPENSATION POLICY

(As Amended and Restated Effective February 8, 2023)

Non-employee members of the board of directors (the “Board”) of Evoke Pharma, Inc. (the “Company”) shall be eligible to receive cash and equity compensation commencing on the Effective Date, as set forth in this Non-Employee Director Compensation Policy (this “Policy”). The cash and equity compensation described in this Policy shall be paid or be made, as applicable, automatically and without further action of the Board, to each member of the Board who is not an employee of the Company or any parent or subsidiary of the Company (each, a “Non-Employee Director”) who may be eligible to receive such cash or equity compensation, unless such Non-Employee Director declines the receipt of such cash or equity compensation by written notice to the Company. This Policy shall remain in effect until it is revised or rescinded by further action of the Board. The terms and conditions of this Policy shall supersede any prior cash or equity compensation arrangements between the Company and its Non-Employee Directors. This amended and restated Policy will be effective as of February 8, 2023 (the “Effective Date”).

1. Cash Compensation.

(a) Annual Retainers. Each Non-Employee Director shall be eligible to receive an annual retainer of $45,000 for service on the Board. In addition, a Non-Employee Director shall receive the following additional annual retainers, as applicable:

(i) Chairperson of the Board. A Non-Employee Director serving as Chairperson of the Board shall receive an additional annual retainer of $20,000 for such service.

(ii) Chairperson of the Audit Committee. A Non-Employee Director serving as Chairperson of the Audit Committee shall receive an additional annual retainer of $15,000 for such service.

(iii) Member of the Audit Committee. A Non-Employee Director serving as a member of the Audit Committee (other than the Chairperson) shall receive an additional annual retainer of $5,750 for such service.

(iv) Chairperson of the Compensation Committee. A Non-Employee Director serving as Chairperson of the Compensation Committee shall receive an additional annual retainer of $8,000 for such service.

(v) Member of the Compensation Committee. A Non-Employee Director serving as a member of the Compensation Committee (other than the Chairperson) shall receive an additional annual retainer of $4,000 for such service.

(vi) Chairperson of the Nominating and Corporate Governance Committee. A Non-Employee Director serving as Chairperson of the Nominating and Corporate Governance Committee shall receive an additional annual retainer of $5,500 for such service.

|US-DOCS\141406269.3||

(vii) Member of the Nominating and Corporate Governance Committee. A Non-Employee Director serving as a member of the Nominating and Corporate Governance Committee (other than the Chairperson) shall receive an additional annual retainer of $2,750 for such service.

(b) Payment of Retainers. The annual retainers described in Section 1(a) shall be earned on a quarterly basis based on a calendar quarter and shall be paid by the Company in arrears not later than the fifth business day following the end of each calendar quarter. In the event a Non-Employee Director does not serve as a Non-Employee Director, or in the applicable positions described in Section 1(a), for an entire calendar quarter, the retainer paid to such Non-Employee Director shall be prorated for the portion of such calendar quarter actually served as a Non-Employee Director, or in such positions, as applicable.

2. Equity Compensation. Non-Employee Directors shall be granted the equity awards described below. The awards described below shall be granted under and shall be subject to the terms and provisions of the 2013 Equity Incentive Award Plan (the “Equity Plan”) and shall be granted subject to the execution and delivery of award agreements, including attached exhibits, in substantially the same forms previously approved by the Board, setting forth the vesting schedule applicable to such awards and such other terms as may be required by the Equity Plan. All applicable terms of the Equity Plan apply to this Policy as if fully set forth herein, and all grants of awards hereunder are subject in all respects to the terms of the Equity Plan. For the avoidance of doubt, the share numbers in this Section 2 shall be subject to adjustment as provided in the Equity Plan.

(a) Initial Awards. A person who is initially elected or appointed to the Board following the Effective Date, and who is a Non-Employee Director at the time of such initial election or appointment, shall be eligible to receive a stock option to purchase 5,833 shares of the Company’s common stock on the date of such initial election or appointment. The awards described in this Section 2(a) shall be referred to as “Initial Awards.” No Non-Employee Director shall be granted more than one Initial Award.

(b) Subsequent Awards.

(i)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will continue to serve as a Non-Employee Director immediately following such annual meeting, shall be automatically granted an option to purchase 1,000 shares of the Company’s common stock on the date of each such annual meeting.

(ii)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will serve as Chairman of the Board immediately following such annual meeting, shall be automatically granted an additional option to purchase 291 shares of the Company’s common stock on the date of each such annual meeting.

(iii)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will serve as Chairperson of the Audit Committee immediately following such annual meeting, shall be automatically granted an additional option to purchase 250 shares of the Company’s common stock on the date of each such annual meeting.

(iv)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will serve as Chairperson of the Compensation Committee immediately following such annual meeting, shall be

2

|US-DOCS\141406269.3||

automatically granted an additional option to purchase 187 shares of the Company’s common stock on the date of each such annual meeting.

(v)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will serve as Chairperson of the Nominating and Corporate Governance Committee immediately following such annual meeting, shall be automatically granted an additional option to purchase 125 shares of the Company’s common stock on the date of each such annual meeting.

(vi)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will serve as a member of the Audit Committee immediately following such annual meeting, shall be automatically granted an additional option to purchase 125 shares of the Company’s common stock on the date of each such annual meeting.

(vii)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will serve as a member of the Compensation Committee immediately following such annual meeting, shall be automatically granted an additional option to purchase 93 shares of the Company’s common stock on the date of each such annual meeting.

(viii)A Non-Employee Director who is (A) serving on the Board as of the date of any annual meeting of the Company’s stockholders after the Effective Date and (B) will serve as a member of the Nominating and Corporate Governance Committee immediately following such annual meeting, shall be automatically granted an additional option to purchase 62 shares of the Company’s common stock on the date of each such annual meeting.

The awards described in this Section 2(b) shall be referred to as “Subsequent Awards.” For the avoidance of doubt, a Non-Employee Director elected for the first time to the Board at an annual meeting of the Company’s stockholders shall only receive an Initial Award in connection with such election, and shall not receive any Subsequent Award on the date of such meeting as well.

(c) Termination of Employment of Employee Directors. Members of the Board who are employees of the Company or any parent or subsidiary of the Company who subsequently terminate their employment with the Company and any parent or subsidiary of the Company and remain on the Board will not receive an Initial Award pursuant to Section 2(a) above, but to the extent that they are otherwise eligible, will be eligible to receive, after termination from employment with the Company and any parent or subsidiary of the Company, Subsequent Awards as described in Section 2(b) above.

(d) Terms of Awards Granted to Non-Employee Directors.

(i) Purchase Price. The per share exercise price of each option granted to a Non-Employee Director shall equal 100% of the Fair Market Value (as defined in the Equity Plan) of a share of common stock on the date the option is granted.

(ii) Vesting. Each Initial Award shall vest and become exercisable in three equal annual installments over the three year period following the date of grant, subject to the Non-Employee Director continuing in service on the Board through each such vesting date. Each Subsequent Award shall vest and/or become exercisable on the one-year anniversary of the date of grant, subject to the Non-Employee Director continuing in service on the Board through each such vesting date. All of a

3

|US-DOCS\141406269.3||

Non-Employee Director’s Initial Awards and Subsequent Awards shall vest in full upon the occurrence of a Change in Control (as defined in the Equity Plan).

(iii) Term. The term of each stock option granted to a Non-Employee Director shall be ten years from the date the option is granted. Upon a Non-Employee Director’s termination of membership on the Board for any reason, his or her stock options granted under this Policy shall remain exercisable for twelve months following his or her termination of membership on the Board (or such longer period as the Board may determine in its discretion on or after the date of grant of such stock options).

4

|US-DOCS\141406269.3||

EX-31.1

Exhibit 31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Matthew J. D’Onofrio, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Evoke Pharma, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 13, 2025	/s/ Matthew J. D’Onofrio
	Matthew J. D’Onofrio
	Chief Executive Officer
	(Principal Executive Officer)

EX-31.2

Exhibit 31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

PURSUANT TO SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

I, Mark A. Kowieski, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Evoke Pharma, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

4. I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

a. designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

b. designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

c. evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

d. disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

a. all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

b. any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: May 13, 2025	/s/ Mark Kowieski
	Mark Kowieski
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

EX-32.1

Exhibit 32.1

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of Evoke Pharma, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Matthew J. D’Onofrio, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 13, 2025	/s/ Matthew J. D’Onofrio
	Matthew J. D’Onofrio
	Chief Executive Officer
	(Principal Executive Officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

EX-32.2

Exhibit 32.2

CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

In connection with the quarterly report of Evoke Pharma, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2025, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Mark A. Kowieski, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:

(1) The Report fully complies with the requirements of Section 13(a) or 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and

(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date: May 13, 2025	/s/ Mark Kowieski
	Mark Kowieski
	Chief Financial Officer
	(Principal Financial and Accounting Officer)

The foregoing certification is being furnished solely to accompany the Report pursuant to 18 U.S.C. § 1350, and is not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the Company, whether made before or after the date hereof, regardless of any general incorporation language in such filing. A signed original of this written statement required by Section 906 has been provided to the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.

XML

Document and Entity Information - shares	3 Months Ended
	Mar. 31, 2025	May 01, 2025
Cover [Abstract]
Document Type	10-Q
Amendment Flag	false
Document Period End Date	Mar. 31, 2025
Document Fiscal Year Focus	2025
Document Fiscal Period Focus	Q1
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		1,492,858
Document Quarterly Report	true
Document Transition Report	false

XML

Condensed Balance Sheets (Unaudited) - USD ($)	Mar. 31, 2025	Dec. 31, 2024
Current assets:
Cash and cash equivalents	$ 12,624,090	$ 13,596,600
Accounts receivable, net of allowance for credit losses of $0	2,511,490	2,420,373
Prepaid expenses	523,910	731,945
Inventories	532,145	445,081
Other current assets	39,240	43,898
Total current assets	16,230,875	17,237,897
Operating lease right-of-use asset	138,758	154,184
Deferred offering costs		120,614
Other long-term assets	6,312	6,312
Total assets	16,375,945	17,519,007
Current liabilities:
Accounts payable and accrued expenses	2,781,203	2,341,191
Accrued compensation	371,732	865,650
Operating lease liability	61,625	59,533
Note payable	5,000,000	5,000,000
Accrued interest payable	2,236,953	2,113,665
Total current liabilities	10,451,513	10,380,039
Operating lease liability, net of current portion	83,217	100,958
Total liabilities	10,534,730	10,480,997
Commitments and contingencies
Stockholders' equity:
Preferred stock, $0.0001 par value; authorized shares - 5,000,000 as of March 31, 2025 and December 31, 2024; issued and outstanding shares - zero as of March 31, 2025 and December 31, 2024	0	0
Common stock, $0.0001 par value; authorized shares - 100,000,000 and 50,000,000as of March 31, 2025 and December 31, 2024, respectively; issued and outstanding shares - 1,492,858 and 1,486,009 as of March 31, 2025 and December 31, 2024, respectively	149	149
Additional paid-in capital	135,938,876	135,829,493
Accumulated deficit	(130,097,810)	(128,791,632)
Total stockholders' equity	5,841,215	7,038,010
Total liabilities and stockholders' equity	$ 16,375,945	$ 17,519,007

XML

Condensed Balance Sheets (Parenthetical) (Unaudited) - USD ($)	Mar. 31, 2025	Dec. 31, 2024
Statement Of Financial Position [Abstract]
Allowance for credit losses	$ 0	$ 0
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	100,000,000	50,000,000
Common stock, shares issued	1,492,858	1,486,009
Common stock, shares outstanding	1,492,858	1,486,009

XML

Condensed Statements of Operations (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Income Statement [Abstract]
Net product sales	$ 3,080,158	$ 1,735,490
Operating expenses:
Cost of goods sold	$ 41,613	$ 92,529
Cost, Product and Service [Extensible List]	us-gaap:ProductMember	us-gaap:ProductMember
Research and development	$ 42,783	$ 4,645
Selling, general and administrative	4,297,505	3,139,536
Total operating expenses	4,381,901	3,236,710
Loss from operations	(1,301,743)	(1,501,220)
Other income (expense):
Interest income	118,853	46,058
Interest expense	(123,288)	(124,658)
Total other expense	(4,435)	(78,600)
Net loss	$ (1,306,178)	$ (1,579,820)
Net loss per share of common stock, basic	$ (0.51)	$ (2.09)
Net loss per share of common stock, diluted	$ (0.51)	$ (2.09)
Weighted-average shares used to compute basic net loss per share	2,548,684	756,808
Weighted-average shares used to compute diluted net loss per share	2,548,684	756,808

XML

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, 2023	$ (2,579,537)	$ 28	$ 120,859,873	$ (123,439,438)
Beginning Balance, Shares at Dec. 31, 2023		278,558
Stock-based compensation expense	254,029		254,029
Issuance of common stock, Pre-Funded Warrants, Series A Warrants, Series B Warrants, and Series C Warrants, net of issuance costs	6,172,623	$ 43	6,172,580
Issuance of common stock, Pre-Funded Warrants, Series A Warrants, Series B Warrants, and Series C Warrants, net of issuance costs, shares		427,886
Amendment and issuance of common stock and Pre-Funded Warrants from the March 2024 Amendment of Series B Warrants and Series C Warrants, net of issuance costs	1,229,874	$ 1	1,229,873
Amendment and issuance of common stock and Pre-Funded Warrants from the March 2024 Amendment of Series B Warrants and Series C Warrants, net of issuance costs, shares		9,967
Net loss	(1,579,820)			(1,579,820)
Ending Balance at Mar. 31, 2024	3,497,169	$ 72	128,516,355	(125,019,258)
Ending Balance, Shares at Mar. 31, 2024		716,411
Beginning Balance at Dec. 31, 2024	$ 7,038,010	$ 149	135,829,493	(128,791,632)
Beginning Balance, Shares at Dec. 31, 2024	1,486,009	1,486,009
Stock-based compensation expense	$ 84,384		84,384
Issuance of common stock pursuant to the ESPP	24,999		24,999
Issuance of common stock pursuant to the ESPP, Shares		6,849
Net loss	(1,306,178)			(1,306,178)
Ending Balance at Mar. 31, 2025	$ 5,841,215	$ 149	$ 135,938,876	$ (130,097,810)
Ending Balance, Shares at Mar. 31, 2025	1,492,858	1,492,858

XML

Condensed Statements of Cash Flows (Unaudited) - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Operating activities
Net loss	$ (1,306,178)	$ (1,579,820)
Adjustments to reconcile net loss to net cash used in operating activities:
Stock-based compensation expense	84,384	254,029
Non-cash interest expense	123,288	124,658
Non-cash operating lease expense	19,147
Change in operating assets and liabilities:
Accounts receivable	(91,117)	(778,833)
Prepaid expenses and other assets	333,307	222,045
Inventories	(87,064)	(106,936)
Accounts payable and accrued expenses	440,012	343,596
Accrued compensation	(493,918)	(1,058,129)
Operating lease liabilities	(19,370)
Net cash used in operating activities	(997,509)	(2,579,390)
Financing activities
Proceeds from the issuance of common stock pursuant to the ESPP	24,999
Net cash provided by financing activities	24,999	7,542,719
Net (decrease) increase in cash and cash equivalents	(972,510)	4,963,329
Cash and cash equivalents at beginning of period	13,596,600	4,739,426
Cash and cash equivalents at end of period	$ 12,624,090	9,702,755
Supplemental disclosure of non-cash investing and financing activities
Offering costs in accounts payable and accrued expenses		20,926
February 2024 Offering [Member]
Financing activities
Proceeds from Issuance Initial Public Offering		6,718,211
Payment of Offering costs		(426,292)
March 2024 Warrant [Member]
Financing activities
Proceeds from Warrant Amendment, net of issuance costs		$ 1,250,800

XML

Pay vs Performance Disclosure - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024	Jun. 30, 2023
Pay vs Performance Disclosure
Net Income (Loss)	$ (1,306,178)	$ (1,579,820)	$ (1,579,820)

XML

Insider Trading Arrangements	3 Months Ended
	Mar. 31, 2025
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

XML

Organization and Basis of Presentation

3 Months Ended

Mar. 31, 2025

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. 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 March 31, 2025 the Company had approximately $12.6 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. Both the Company and Eversana may terminate the commercial services and loan agreement (as described in Note 5. Commercial Services and Loan Agreements with Eversana), pursuant to the Net Profit Quarterly Termination Right (NPQTR) (as defined in Note 5); however, the Company has no intent to terminate the Eversana Agreement. There can be no assurance that Eversana will not exercise its right pursuant to the NPQTR. Should Eversana exercise its right under the NPQTR, the Loan Agreement, as described in Note 5, would also be terminated and the Company would be responsible for repaying the principal and accrued interest on the loan, which was $7.2 million as of March 31, 2025, within 90 days of the effective date of the termination. In addition, the Company would need to establish a commercial infrastructure in order to continue distributing Gimoti. The timing and costs associated with this are not clear, but the Company believes they would be substantial. As a result, management believes that there is substantial doubt about the Company’s 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. 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.

Reverse Stock Split

On May 22, 2024, 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 July 31, 2024, the Company filed an amendment (the “Amendment”) to its amended and restated certificate of incorporation to effectuate a reverse stock split of the Company’s common stock. Pursuant to the Amendment, at the effective time of 12:01 a.m. Eastern Time on August 1, 2024, each twelve (12) shares of the Company’s common stock issued and outstanding was combined into one (1) validly issued, fully paid and non-assessable share of common stock (the “Reverse Stock Split”). The par value and the authorized shares of the Company's common stock were not adjusted as

a result of the Reverse Stock Split. All issued and outstanding common stock, warrants to purchase common stock, options to purchase common stock, per-share data and related information have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.

XML

Summary of Significant Accounting Policies

3 Months Ended

Mar. 31, 2025

Accounting Policies [Abstract]

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”) for interim financial information and with the instructions of the Securities and Exchange Commission (“SEC”) on Form 10-Q and Rule 8-03 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the condensed financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of the Company’s financial position and of the results of operations and cash flows for the periods presented. These financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2024 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 13, 2025. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or for the full year. The balance sheet at December 31, 2024, has been derived from the audited financial statements at that date.

Risks and Uncertainties

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the 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. On an ongoing basis, the Company evaluates its estimates, including those related to the valuation of share-based awards, the fair value of warrants and the assessment of its ability to fund its operations for at least the next 12 months from the date of issuance of these condensed financial statements. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that management believes to be reasonable under the circumstances. Estimates are assessed each reporting period and updated to reflect current information. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

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. The Company's cash and 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 the note payable approximates fair value since the debt is due on demand as of March 31, 2025 and the carrying value is the settlement value, which is a Level 2 input within the fair value hierarchy.

Accounts Receivable and Allowance for Credit Losses

Accounts receivable are recorded net of allowance for credit losses, if any. The Company evaluates its estimate of expected credit losses based on a combination of factors, including historical experience, assessment of specific customer-related risks, review of outstanding invoices, forecasts about the future, and various other assumptions and estimates. The allowance for credit losses was zero as of both March 31, 2025 and December 31, 2024 and no provision for credit losses was recorded for the three months ended March 31, 2025 and 2024.

Inventories

The Company's inventories consisted of the following as of March 31, 2025 and December 31, 2024:

	March 31,		December 31,
	2025		2024
Raw materials	$	157,070	$	257,467
Finished goods		375,075		187,614
Total inventories	$	532,145	$	445,081

Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. The Company’s raw materials inventories are held at its third-party suppliers and its finished goods inventories are held by Eversana. The Company records such inventories as consigned inventories.

Deferred Offering Costs

Deferred offering costs represent legal, accounting, and other direct costs related to future equity financings and are recognized as a non-current asset on the condensed balance sheets. After consummation of the equity financing, the offering costs are recognized as a reduction of proceeds and reclassified to additional paid-in capital on the condensed balance sheet. Should a planned equity financing be abandoned, terminated, or significantly delayed, the deferred offering costs are immediately written off as an administrative expense. As of December 31, 2024, the Company had deferred offering costs of $0.1 million related to the filing of a shelf registration statement in August 2024, which were written off during the first quarter of 2025.

Warrants

The Company accounts for warrants as equity-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For warrants that meet all criteria for equity classification, the warrants are required to be recorded as additional paid-in capital in the condensed balance sheets at the time of issuance. Equity-classified warrants are measured at their estimated fair value on the issuance date using either the Black-Scholes option pricing model or a Monte-Carlo simulation model based on the applicable assumptions, which include the exercise price of the warrants, the Company's stock price and volatility, the expected warrant term, the risk-free interest rate, the expected dividends, and if applicable, the vesting behavior.

Revenue Recognition

At the inception of a collaboration arrangement, the Company first assesses whether the contractual arrangement is within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether the arrangement involves a joint operating activity and involves two (or more) parties that are both active participants in the activity and exposed to significant risks and rewards dependent on the commercial success of such activity. Then the Company determines whether the collaboration arrangement in its entirety represents a contract with a customer as defined by ASC 606, Revenue from Contracts with Customers (“ASC 606”). If only a portion of the collaboration arrangement is potentially with a customer, the Company applies the distinct good or service unit-of-account guidance in ASC 606 to determine whether there is a unit of account that should be accounted for under ASC 606.

The Company has entered into a collaborative arrangement with Eversana for the commercialization and distribution of Gimoti in the United States. Under this arrangement, Eversana is responsible for market access, marketing, distribution, and patient support services, while the Company retains ownership of Gimoti and all legal, regulatory, and manufacturing responsibilities. The Company records sales for Gimoti. The Company reimburses Eversana for its commercialization costs pursuant to an agreed upon budget and a percentage of product profits, if any, which are recorded within selling, general and administrative expenses in the statement of operations. The Company has determined that the underlying patient is the customer and the Company is the principal in its relationship with Eversana based on the indicators of control occurring prior to product transfer to the customer, including risks related to inventory and responsibility for product fulfillment. Payment terms are net 30 from invoice date.

In accordance with ASC 606, 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 allocated to the respective performance obligation when the customer obtains control of the product.

Product revenues are recognized net of any applicable variable consideration. The Company uses judgment to estimate variable consideration including (i) Medicaid and Medicare program rebates, (ii) sales related adjustments, wherever applicable, including patient support programs, rebates, and other sales related discounts and (iii) co-pay assistance. The Medicaid and Medicare program rebates are determined based on statutory provisions and are estimated based on the expected number of claims and related cost associated with the customer transaction. Medicaid and Medicare rebates of $0.2 million were recorded as accounts payables and accrued expenses in the condensed balance sheets as of both March 31, 2025 and December 31, 2024.

Co-pay 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 assistance liabilities are estimated using prescribing data available from customers. The Company's analysis also contemplates application of the constraint in accordance with the guidance, under which it determines 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 could affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $0.3 million and $0.1 million as of March 31, 2025 and December 31, 2024, respectively, are classified as accounts payable and accrued expenses in the condensed balance sheets.

The Company does not allow product returns. The Company may replace damaged product upon shipment, but such amounts have been immaterial. Cash receipts from sales come directly from the Company’s commercial partner, Eversana, and are typically received in 30 to 60 days after month-end.

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. Warrants to purchase shares of the Company’s common stock are included in the calculation of basic net loss per common share if the exercise price of the warrants represents de minimis consideration and is non-substantive in relation to the price paid for the warrant, and if the warrants are immediately exercisable with no further vesting conditions or contingencies associated with them. The 1,060,316 shares of the Company's common stock underlying the Pre-Funded Warrants, Modified Series A Warrants and Modified Series C Warrants described in Note 4, Stockholders’ Equity, are included in the weighted average outstanding common stock in the calculation of basic and diluted net loss per share due to their nominal exercise price. The Company considers Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants do not have a contractual obligation to share in the Company’s losses. As such, losses are attributed entirely to common stockholders and for periods in which the Company has reported a net loss, diluted loss per common share is the same as basic loss per common share. 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.

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:

	Three Months Ended March 31,
	2025		2024
Warrants to purchase common stock		792,731		2,641,907
Common stock options		269,930		51,983
Total excluded securities		1,062,661		2,693,890

Recent Accounting Pronouncements – Not Yet Adopted

From time to time, new accounting pronouncements are issued by the FASB or other standards setting bodies that are adopted as of the specified effective date. The Company believes the impact of recently issued standards, other than those noted below, and any issued but not yet effective standards will not have a material impact on our financial statements upon adoption.

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.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40) (ASU 2024-03). The amendments in this update require disclosure, in the notes to the financial statements, of specific expense categories present within expense captions presented on the face of the income statement within continuing operations of public business entities. The amendments in this update are effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any and all prior periods presented in the financial statements. The impact of adoption this ASU on the Company’s disclosures is currently being evaluated.

In January 2025, the FASB issued ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. The amendment in this update clarifies the effective date of ASU 2024-03, which is that public business entities are required to adopt the guidance in annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The impact of adoption of this ASU on the Company’s disclosures is currently being evaluated.

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Commitments and Contingencies

3 Months Ended

Mar. 31, 2025

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 “Initial Lease”). The Initial Lease commenced on January 1, 2017, and as amended, expired on October 31, 2023.

Upon expiration of the Initial Lease, the Company entered into an operating lease for a new office space in Solana Beach, California commencing on November 1, 2023 and expiring on October 31, 2024 (the “Short-Term Lease”). The Short-Term Lease qualified as a short-term lease under ASC 842 and was not recorded on the balance sheet. Operating lease expense for the Short-Term Lease was recognized on a straight-line basis over the lease term as general administrative expense within the statement of operations.

Upon expiration of the Short-Term Lease, the Company entered into an amendment for the same office space in Solana Beach commencing on November 1, 2024 and expiring on March 31, 2027 (the “Current Lease”). As the Current Lease agreement did not include an implicit rate, the Company estimated the incremental borrowing rate of 10% utilized to discount future minimum lease payments based on information available at lease commencement. Operating lease expense for the Current Lease is recognized on a straight-line basis over the lease term. The Company recognized a right-of-use asset obtained in exchange for new lease obligations of $0.2 million upon commencement of the Current Lease. The new lease liability obligation is recorded in operating lease liability and operating lease liability, net of current portion in the balance sheets. As of March 31, 2025, the remaining lease term was 2.0 years.

The following table summarizes supplemental lease information:

	Three Months Ended March 31,
	2025		2024
Lease costs(1)	$	20,107	$	18,936
Cash paid for leases	$	19,370	$	18,936

(1)Lease costs and cash paid for leases includes $20,331 and $18,936 of short-term lease expense for the three months ended March 31, 2025 and 2024, respectively. Variable lease costs included in general and administrative expense for three months ended March 31, 2025 and 2024 were immaterial.

Future lease payments as of March 31, 2025 were as follows:

Years Ending December 31,
2025 (Remainder)	$	58,500
2026		80,207
2027		20,551
Total future lease payments		159,258
Less: imputed interest		(14,416	)
Total lease liability	$	144,842

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Stockholders' Equity

3 Months Ended

Mar. 31, 2025

Equity [Abstract]

Stockholders' Equity

4. Stockholders’ Equity

Equity Transactions

February 2024 Offering

In February 2024, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with Craig-Hallum Capital Group LLC and Laidlaw & Company (UK) Ltd. (collectively, the “Underwriters”), relating to the issuance and sale of 427,886 common stock units (the “Common Stock Units”) at a public offering price of $8.16 per Common Stock Unit and, to certain investors, 491,221 pre-funded warrant units (the “PFW Units”) at a public offering price of $8.1588 per PFW Unit (the “February 2024 Offering”). Each Common Stock Unit consisted 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 consisted of (i) a pre-funded warrant to purchase one share of common stock (the “Pre-Funded Warrants”), (ii) a Series A Warrant, (iii) a Series B Warrant, and (iv) a Series C Warrant. The Company also issued warrants to the Underwriters to purchase up to 45,955 shares of common stock, equal to 5% of the securities sold in the February 2024 Offering (the “Representatives’ Warrants”). The Series A Warrants are fully exercisable and are recognized as a freestanding financial instruments. In accordance with the terms and provisions of the Series C Warrants, the Series C Warrants were not exercisable, in part or in whole, at any time unless the Series B Warrants had been exercised. If Series B Warrants were not exercised before November 13, 2024, the corresponding Series C Warrants were no longer deemed outstanding and could not be exercised. Furthermore, the Series B Warrants and Series C Warrants could not be transferred by the holder without the consent of the Company, and, therefore the Series B Warrants and Series C Warrants were accounted for as a single unit of account.

Net cash proceeds from the February 2024 Offering was $6.2 million after deducting underwriter and offering expenses. The Pre-Funded Warrants, Series A Warrants, Series B Warrants, and Series C Warrants are equity classified and were recognized as additional paid-in capital in the balance sheets. The Representatives’ Warrants were accounted for under ASC 718, Compensation — Stock Compensation, and were recognized as an equity issuance cost at their grant date fair value within additional paid-in capital in the balance sheets.

August 2024 Shelf Registration Statement

On August 29, 2024, the Company filed a universal shelf registration statement on Form S-3 (the “Shelf Registration Statement”), covering the offering of up to $50.0 million of common stock, preferred stock, debt securities, warrants, and/or units, subject to the “Baby Shelf Limitation” which limits the amount that the Company can offer and sell to up to one-third of its public float during any 12-month period so long as our public float remains below $75.0 million. The Shelf Registration Statement was declared effective by the SEC on September 6, 2024.

As of March 31, 2025, there have been no shares of common stock, preferred stock, debt securities, warrants, and/or units issued under the Shelf Registration Statement.

At The Market Equity Offering

The Company had previously entered into a Sales Agreement (the “Sales Agreement”) with H.C. Wainwright & Co., LLC (“Wainwright”), under which the Company may, from time to time, sell shares of its common stock having an aggregate offering price of up to approximately $1.9 million through Wainwright (the “ATM Offering”). The Shelf Registration Statement included a prospectus covering the offering, issuance and sale of up to approximately $1.9 million of the Company’s common stock from time to time through the ATM Offering (the “ATM Prospectus”). In November 2024, the Company filed a prospectus supplement to amend and supplement the ATM Prospectus to update the amount of shares it is eligible to sell under the “Baby Shelf Limitation” to $3.1 million under the Sales Agreement.

The Company did not issue any shares of common stock pursuant to the ATM Offering during the three months ended March 31, 2025.

Warrant Amendments

In each of March, June and September 2024, the Company entered into substantially similar amendments with certain holders of its Series B Warrants and Series C Warrants (individually, the “March 2024 Warrant Amendment,” “June 2024 Warrant Amendment,” and the “September 2024 Warrant Amendment,” respectively and collectively, the “Warrant Amendments”). Pursuant to the Warrant Amendments, to the extent a holder exercised its Series B Warrants prior to the exercise deadlines set forth in the respective Warrant Amendment (the “Amendment Exercise Deadline”), the holder’s corresponding Series C Warrants vested and became exercisable for the lesser of (i) three times the number of Series B Warrants exercised by the Holder and (ii) the total number of Series C Warrants outstanding to the holder. Following each Amendment Exercise Deadline, if the holder exercised any remaining Series B Warrants, the remaining Series C Warrants, if any, vested and became exercisable on a one-for-one basis as to the same number of Series B Warrants exercised.

The Warrant Amendments allowed a holder to elect to receive Pre-Funded Warrants upon exercise of Series B Warrants and Series C Warrants in lieu of shares of the Company’s common stock, at a purchase price of $8.1588 per warrant exercised and an exercise price of $0.0012 per Pre-Funded Warrant.

Net cash proceeds from the March Warrant Amendment, the June Warrant Amendment, and the September 2024 Warrant Amendment were $1.2 million, $0.3 million and $0.4 million, respectively, after deducting underwriter commissions and offering expenses. The Warrant Amendments were entered into to encourage the exercise of Series B Warrants in order to obtain capital to meet the Minimum Stockholders’ Equity Requirement as more fully discussed in Note 1. Organization and Basis of Presentation. The Warrant Amendments neither changed the number of shares of common stock underlying each series of warrants nor its equity classification. The incremental change in fair value from the Warrant Amendments was accounted for as equity issuance costs and recognized within additional paid-in capital in the balance sheets.

September 2024 Exercise Price Warrant Amendment

In September 2024, the Company also entered into an amendment with certain holders of its Series A Warrants, Series B Warrants and Series C Warrants (the “September 2024 Exercise Price Warrant Amendment”). Pursuant to the September 2024 Exercise Price Warrant Amendment, such holders who agreed to pay a non-refundable up-front payment of $3.99 per Series A Warrant or Series C Warrant prior to September 30, 2024 deadline (as defined in the September 2024 Exercise Price Amendment) had the exercise price reduced for each of the Series A Warrants and Series C Warrants from $8.16 to $0.01 (such Series A Warrants and Series C Warrants modified to have a reduced exercise price referred to as the “Modified Series A Warrants” and “Modified Series C Warrants”). To the extent such holder did not elect to modify all outstanding Series A Warrants and Series C Warrants, the remaining Series A Warrants and Series C Warrants held by each holder retained an exercise price of $8.16 per Series A Warrant or Series C Warrant.

Net cash proceeds from the September 2024 Exercise Price Warrant Amendment were $2.5 million after deducting underwriter and offering expenses. The September 2024 Exercise Price Warrant Amendment was entered to encourage the modification of Series A Warrants and Series C Warrants in order to obtain capital to meet the Minimum Stockholders’ Equity Requirement. The September 2024 Exercise Price Warrant Amendment neither changed the number of shares of Common Stock underlying each series of warrants nor its equity classification. The incremental change in fair value from the September 2024 Exercise Price Warrant Amendment was an equity issuance cost and was recognized within additional paid-in capital in the balance sheets.

In connection with the September 2024 Exercise Price Warrant Amendment, the Company entered into a letter agreement, dated September 27, 2024 (the “Letter Agreement”), with certain affiliates of Nantahala Capital Management, LLC (collectively, “Nantahala”), pursuant to which, subject to certain limitations, the Company provided Nantahala the right to appoint (or cause to be nominated) (i) one member of the Company’s board of directors (the “Board”) and one member of each Board committee so long as Nantahala, together with its affiliates, beneficially owns at least 5.0% of the Company’s outstanding shares of common stock and (ii) two members of the Board so long as Nantahala, together with its affiliates, beneficially owns at least 15.0% of the Company’s outstanding shares of common stock, subject to certain exceptions.

Warrants

Each of the outstanding warrants is convertible on a one-for-one basis into the Company’s common stock and are fully exercisable as of March 31, 2025. The following table is a summary of the Company’s warrants outstanding as of March 31, 2025:

	Number of
	Warrants Outstanding		Exercise Price		Initial Exercise Date	Expiration Date
Pre-Funded Warrants		528,609	$	0.0012	February 13, 2024	Until Exercised in Full
Series A Warrants		354,022	$	8.16	February 13, 2024	February 13, 2029
Modified Series A Warrants(1)		281,080	$	0.01	February 13, 2024	February 13, 2029
Series C Warrants		392,754	$	8.16	February 13, 2024	February 13, 2029
Modified Series C Warrants(1)		250,627	$	0.01	February 13, 2024	February 13, 2029
Representativesʼ Warrants		45,955	$	13.47	August 13, 2024	February 13, 2029
Total warrants		1,853,047

__________________

(1)The Modified Series A Warrants and Modified Series C Warrants represent Series A Warrants and Series C Warrants, respectively, modified under the September 2024 Exercise Price Warrant Amendment.

Stock-Based Compensation

Stock Options

In January 2025, the number of shares of common stock available for issuance under the 2013 Equity Incentive Award Plan (the “2013 Plan”) was increased by 89,161 shares as a result of the automatic increase provision in the 2013 Plan. 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 three months ended March 31, 2025, the Company granted stock options to purchase 143,915 shares of the Company’s common stock. During the three months ended March 31, 2024, no options were granted.

The following assumptions were used in estimating the grant date fair value of options issued during the three months ended March 31, 2025:

Risk free interest rate	4.38-4.39%
Expected option term (in years)	5.8 - 6.0
Volatility of common stock	99% - 107.3%
Expected dividend yield	0.0%

Employee Stock Purchase Plan

Stock-based compensation expense also includes charges related to common stock issued under the Amended and Restated 2013 Employee Stock Purchase Plan (the “ESPP”). The Company allows eligible employees to purchase shares of the Company’s common stock through payroll deductions at a price equal to 85% of the lesser of the fair market value of the Company’s common stock on the first trading day of the offering period or on the applicable purchase date. The offering period is determined by the compensation committee and may be up to 27 months long. Current offering periods commence on each of September 1 and March 1 during the term. Purchase dates will be set for the last trading day in each six-month period and will occur on each of August 31 and February 28 (unless such days are not trading days). In January 2025, the number of shares of common stock available for issuance under the ESPP was increased by 14,860 shares as a result of the automatic increase provision in the ESPP. During the third quarter of 2024, an offering period was initiated. During the three months ended March 31, 2025, there were 6,849 shares of common stock issued pursuant to the Company’s ESPP, for gross proceeds of approximately $25,000.

During the three months ended March 31, 2024, no employees participated in the ESPP plan and as such, no ESPP awards were valued using the Black-Scholes option pricing-model. The estimated fair value of each ESPP award granted was determined on

the date of purchase using the Black-Scholes option-pricing valuation model with the following assumptions for the three months ended March 31, 2025,:

Risk free interest rate	4.3%
Expected option term (in years)	0.5
Volatility of common stock	91.5%
Expected dividend yield	0.0%

The Company recognized stock-based compensation expense as follows:

	Three Months Ended March 31,
	2025		2024
Research and development	$	4,373	$	1,215
Selling, general and administrative		80,011		252,814
Total stock-based compensation expense	$	84,384	$	254,029

	Three Months Ended March 31,
	2025		2024
Stock options	$	77,638	$	254,029
ESPP		6,746		—
Total stock-based compensation expense	$	84,384	$	254,029

As of March 31, 2025, there was approximately $0.9 million of unrecognized compensation costs related to outstanding options, which are expected to be recognized over a weighted-average period of 2.8 years.

As of March 31, 2025, there was approximately $18,000 of unrecognized compensation costs related to the ESPP, which are expected to be recognized over a weighted-average period of 0.4 years.

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Commercial Services and Loan Agreements with Eversana

3 Months Ended

Mar. 31, 2025

Commercial Services And Loan Agreements [Abstract]

Commercial Services and Loan Agreements with Eversana

5. 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 utilizes its internal sales organization, along with other commercial functions, for market access, marketing, distribution and other related patient support services. The Company records sales for Gimoti and retain more than 80% of net product profits once both parties’ costs are reimbursed. For the three months ended March 31, 2025 and 2024, approximately $2.6 million and $1.5 million of Eversana profit sharing costs were included as selling, general and administrative costs, respectively. As of March 31, 2025, unreimbursed commercialization costs to Eversana were approximately $77.5 million. Such costs will generally be payable only as net product profits are recognized or upon certain termination events. Eversana receives 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 (the “Eversana Amendment”). The Eversana 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 Eversana Agreement; if the

Company discontinues the development or production of Gimoti; if the net profit is negative for any two consecutive calendar quarters (the “Net Profit Quarterly Termination Right”) beginning with the measurement date of June 30, 2023; 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.

The Company's net profits were negative for the two preceding calendar quarters as of March 31, 2025, and therefore, Eversana or the Company could have exercised the Net Profit Quarterly Termination Right (“NPQTR”) during the 60-day period after quarter-end. Since the note payable and accrued interest payable could be accelerated by Eversana by terminating the Eversana Agreement as of March 31, 2025, those payments were recorded as current liabilities as of March 31, 2025. Each party continues to have the option to exercise the NPQTR for the 60-day period following the end of future quarters so long as the net profit under the Eversana Agreement remains negative for consecutive quarters.

In the event 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 NPQTR, 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. If Eversana terminates the Eversana Agreement for convenience, the Company is under no obligation to reimburse Eversana for unreimbursed commercialization costs.

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 $5.0 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 $5.0 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.

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Segment Information

3 Months Ended

Mar. 31, 2025

Segment Reporting [Abstract]

Segment Information

6. Segment Information

Operating segments are defined as components of an enterprise for which separate financial information is regularly evaluated by the chief operating decision maker (“CODM”), which is the Company’s Chief Executive Officer, in deciding how to allocate resources and assess performance. The Company’s CODM evaluates the Company’s financial information including budget-versus-actual results and cash projections on an aggregate basis when assessing performance for allocating financial and personnel resources. The Company is not organized by market and is managed and operated as one business.

The Company identifies its operating segments based on its business activities. The Company operates within a single operating segment being the development and commercialization of pharmaceutical products. The development and commercialization of pharmaceutical products segment generates revenues in the United States. The Company’s administrative functions including finance, business development and procurement, support the development and commercialization of pharmaceutical products segment. The Company operates primarily in one geographic area, being the United States. The CODM allocates resources (inclusive of both capital and personnel) based upon the Company’s net loss, which is utilized to monitor budget-to-actual variances on a monthly basis.

The accounting policies of the development and commercialization of pharmaceutical products segment are the same as those described in Note 2. Summary of Significant Accounting Policies. All Company assets are in the United States. The measure of segment assets is reported on the balance sheets as total assets. The Company does not have intra-entity sales or transfers.

The Company has no transactions denominated in foreign currencies nor any tangible or intangible property for which is recognizes depreciation or amortization and depreciating assets are not part of the CODMs evaluation or decision-making process.

The following table summarizes the Company’s financial data for its development and commercialization of pharmaceutical products segment:

	Three Months Ended March 31,
	2025			2024
Net product sales	$	3,080,158		$	1,735,490
Less:
Cost of goods sold		(41,613	)		(92,529	)
Eversana profit sharing		(2,618,135	)		(1,475,261	)
Employee expenses		(638,099	)		(696,801	)
Professional fees		(704,629	)		(503,717	)
Stock-based compensation		(84,384	)		(254,029	)
Sales and marketing expenses		(188,668	)		(163,797	)
Other operating expenses(1)		(106,373	)		(50,576	)
Interest income		118,853			46,058
Interest expense (non-cash)		(123,288	)		(124,658	)
Total segment costs loss and net loss	$	(1,306,178	)	$	(1,579,820	)

________________

(1) Includes ongoing product development costs, occupancy costs (including rent and utilities), administrative costs, travel and business taxes.

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Summary of Significant Accounting Policies (Policies)

3 Months Ended

Mar. 31, 2025

Accounting Policies [Abstract]

Risks and Uncertainties

Risks and Uncertainties

Use of Estimates

Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the 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. On an ongoing basis, the Company evaluates its estimates, including those related to the valuation of share-based awards, the fair value of warrants and the assessment of its ability to fund its operations for at least the next 12 months from the date of issuance of these condensed financial statements. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that management believes to be reasonable under the circumstances. Estimates are assessed each reporting period and updated to reflect current information. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.

Cash and Cash Equivalents

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. The Company's cash and 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 the note payable approximates fair value since the debt is due on demand as of March 31, 2025 and the carrying value is the settlement value, which is a Level 2 input within the fair value hierarchy.

Accounts Receivable and Allowance for Credit Losses

Accounts Receivable and Allowance for Credit Losses

Accounts receivable are recorded net of allowance for credit losses, if any. The Company evaluates its estimate of expected credit losses based on a combination of factors, including historical experience, assessment of specific customer-related risks, review of outstanding invoices, forecasts about the future, and various other assumptions and estimates. The allowance for credit losses was zero as of both March 31, 2025 and December 31, 2024 and no provision for credit losses was recorded for the three months ended March 31, 2025 and 2024.

Inventories

Inventories

The Company's inventories consisted of the following as of March 31, 2025 and December 31, 2024:

	March 31,		December 31,
	2025		2024
Raw materials	$	157,070	$	257,467
Finished goods		375,075		187,614
Total inventories	$	532,145	$	445,081

Inventories are stated at the lower of cost (first-in first-out basis) or net realizable value. The Company’s raw materials inventories are held at its third-party suppliers and its finished goods inventories are held by Eversana. The Company records such inventories as consigned inventories.

Deferred Offering Costs

Deferred Offering Costs

Deferred offering costs represent legal, accounting, and other direct costs related to future equity financings and are recognized as a non-current asset on the condensed balance sheets. After consummation of the equity financing, the offering costs are recognized as a reduction of proceeds and reclassified to additional paid-in capital on the condensed balance sheet. Should a planned equity financing be abandoned, terminated, or significantly delayed, the deferred offering costs are immediately written off as an administrative expense. As of December 31, 2024, the Company had deferred offering costs of $0.1 million related to the filing of a shelf registration statement in August 2024, which were written off during the first quarter of 2025.

Warrants

Warrants

The Company accounts for warrants as equity-classified instruments based on an assessment of the warrant’s specific terms and applicable authoritative guidance in Accounting Standards Codification (“ASC”) 480, Distinguishing Liabilities from Equity (“ASC 480”) and ASC 815, Derivatives and Hedging (“ASC 815”). The assessment considers whether the warrants are freestanding financial instruments pursuant to ASC 480, meet the definition of a liability pursuant to ASC 480, and whether the warrants meet all of the requirements for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own common stock and whether the warrant holders could potentially require “net cash settlement” in a circumstance outside of the Company’s control, among other conditions for equity classification. This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.

For warrants that meet all criteria for equity classification, the warrants are required to be recorded as additional paid-in capital in the condensed balance sheets at the time of issuance. Equity-classified warrants are measured at their estimated fair value on the issuance date using either the Black-Scholes option pricing model or a Monte-Carlo simulation model based on the applicable assumptions, which include the exercise price of the warrants, the Company's stock price and volatility, the expected warrant term, the risk-free interest rate, the expected dividends, and if applicable, the vesting behavior.

Revenue Recognition

Revenue Recognition

At the inception of a collaboration arrangement, the Company first assesses whether the contractual arrangement is within the scope of ASC 808, Collaborative Arrangements (“ASC 808”) to determine whether the arrangement involves a joint operating activity and involves two (or more) parties that are both active participants in the activity and exposed to significant risks and rewards dependent on the commercial success of such activity. Then the Company determines whether the collaboration arrangement in its entirety represents a contract with a customer as defined by ASC 606, Revenue from Contracts with Customers (“ASC 606”). If only a portion of the collaboration arrangement is potentially with a customer, the Company applies the distinct good or service unit-of-account guidance in ASC 606 to determine whether there is a unit of account that should be accounted for under ASC 606.

The Company has entered into a collaborative arrangement with Eversana for the commercialization and distribution of Gimoti in the United States. Under this arrangement, Eversana is responsible for market access, marketing, distribution, and patient support services, while the Company retains ownership of Gimoti and all legal, regulatory, and manufacturing responsibilities. The Company records sales for Gimoti. The Company reimburses Eversana for its commercialization costs pursuant to an agreed upon budget and a percentage of product profits, if any, which are recorded within selling, general and administrative expenses in the statement of operations. The Company has determined that the underlying patient is the customer and the Company is the principal in its relationship with Eversana based on the indicators of control occurring prior to product transfer to the customer, including risks related to inventory and responsibility for product fulfillment. Payment terms are net 30 from invoice date.

In accordance with ASC 606, 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 allocated to the respective performance obligation when the customer obtains control of the product.

Product revenues are recognized net of any applicable variable consideration. The Company uses judgment to estimate variable consideration including (i) Medicaid and Medicare program rebates, (ii) sales related adjustments, wherever applicable, including patient support programs, rebates, and other sales related discounts and (iii) co-pay assistance. The Medicaid and Medicare program rebates are determined based on statutory provisions and are estimated based on the expected number of claims and related cost associated with the customer transaction. Medicaid and Medicare rebates of $0.2 million were recorded as accounts payables and accrued expenses in the condensed balance sheets as of both March 31, 2025 and December 31, 2024.

Co-pay 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 assistance liabilities are estimated using prescribing data available from customers. The Company's analysis also contemplates application of the constraint in accordance with the guidance, under which it determines 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 could affect net product revenue and earnings in the period such variances become known. Liabilities for co-pay assistance of approximately $0.3 million and $0.1 million as of March 31, 2025 and December 31, 2024, respectively, are classified as accounts payable and accrued expenses in the condensed balance sheets.

The Company does not allow product returns. The Company may replace damaged product upon shipment, but such amounts have been immaterial. Cash receipts from sales come directly from the Company’s commercial partner, Eversana, and are typically received in 30 to 60 days after month-end.

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. Warrants to purchase shares of the Company’s common stock are included in the calculation of basic net loss per common share if the exercise price of the warrants represents de minimis consideration and is non-substantive in relation to the price paid for the warrant, and if the warrants are immediately exercisable with no further vesting conditions or contingencies associated with them. The 1,060,316 shares of the Company's common stock underlying the Pre-Funded Warrants, Modified Series A Warrants and Modified Series C Warrants described in Note 4, Stockholders’ Equity, are included in the weighted average outstanding common stock in the calculation of basic and diluted net loss per share due to their nominal exercise price. The Company considers Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants to be participating securities, because holders of such instruments participate in the event a dividend is paid on common stock. The holders of the Series A Warrants, Series B Warrants, Series C Warrants, and Representatives’ Warrants do not have a contractual obligation to share in the Company’s losses. As such, losses are attributed entirely to common stockholders and for periods in which the Company has reported a net loss, diluted loss per common share is the same as basic loss per common share. 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.

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:

	Three Months Ended March 31,
	2025		2024
Warrants to purchase common stock		792,731		2,641,907
Common stock options		269,930		51,983
Total excluded securities		1,062,661		2,693,890

Recent Accounting Pronouncements

Recent Accounting Pronouncements – Not Yet Adopted

From time to time, new accounting pronouncements are issued by the FASB or other standards setting bodies that are adopted as of the specified effective date. The Company believes the impact of recently issued standards, other than those noted below, and any issued but not yet effective standards will not have a material impact on our financial statements upon adoption.

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.

In November 2024, the FASB issued ASU No. 2024-03, Income Statement-Reporting Comprehensive Income-Expense Disaggregation Disclosures (Subtopic 220-40) (ASU 2024-03). The amendments in this update require disclosure, in the notes to the financial statements, of specific expense categories present within expense captions presented on the face of the income statement within continuing operations of public business entities. The amendments in this update are effective for annual periods beginning after December 15, 2026 and interim periods beginning after December 15, 2027. Early adoption is permitted. The amendments should be applied either prospectively to financial statements issued for reporting periods after the effective date of this ASU or retrospectively to any and all prior periods presented in the financial statements. The impact of adoption this ASU on the Company’s disclosures is currently being evaluated.

In January 2025, the FASB issued ASU No. 2025-01, Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Clarifying the Effective Date. The amendment in this update clarifies the effective date of ASU 2024-03, which is that public business entities are required to adopt the guidance in annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. The impact of adoption of this ASU on the Company’s disclosures is currently being evaluated.

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Summary of Significant Accounting Policies (Tables)

3 Months Ended

Mar. 31, 2025

Accounting Policies [Abstract]

Schedule of Inventories

The Company's inventories consisted of the following as of March 31, 2025 and December 31, 2024:

	March 31,		December 31,
	2025		2024
Raw materials	$	157,070	$	257,467
Finished goods		375,075		187,614
Total inventories	$	532,145	$	445,081

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:

	Three Months Ended March 31,
	2025		2024
Warrants to purchase common stock		792,731		2,641,907
Common stock options		269,930		51,983
Total excluded securities		1,062,661		2,693,890

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Commitments and Contingencies (Tables)

3 Months Ended

Mar. 31, 2025

Commitments And Contingencies Disclosure [Abstract]

Summary of Supplemental Lease Information

The following table summarizes supplemental lease information:

	Three Months Ended March 31,
	2025		2024
Lease costs(1)	$	20,107	$	18,936
Cash paid for leases	$	19,370	$	18,936

(1)Lease costs and cash paid for leases includes $20,331 and $18,936 of short-term lease expense for the three months ended March 31, 2025 and 2024, respectively. Variable lease costs included in general and administrative expense for three months ended March 31, 2025 and 2024 were immaterial.

Summary of Future Lease Payments

Future lease payments as of March 31, 2025 were as follows:

Years Ending December 31,
2025 (Remainder)	$	58,500
2026		80,207
2027		20,551
Total future lease payments		159,258
Less: imputed interest		(14,416	)
Total lease liability	$	144,842

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Stockholders' Equity (Tables)

3 Months Ended

Mar. 31, 2025

Share Based Compensation Arrangement By Share Based Payment Award [Line Items]

Summary of the Company's Warrants Outstanding

The following table is a summary of the Company’s warrants outstanding as of March 31, 2025:

	Number of
	Warrants Outstanding		Exercise Price		Initial Exercise Date	Expiration Date
Pre-Funded Warrants		528,609	$	0.0012	February 13, 2024	Until Exercised in Full
Series A Warrants		354,022	$	8.16	February 13, 2024	February 13, 2029
Modified Series A Warrants(1)		281,080	$	0.01	February 13, 2024	February 13, 2029
Series C Warrants		392,754	$	8.16	February 13, 2024	February 13, 2029
Modified Series C Warrants(1)		250,627	$	0.01	February 13, 2024	February 13, 2029
Representativesʼ Warrants		45,955	$	13.47	August 13, 2024	February 13, 2029
Total warrants		1,853,047

__________________

(1)The Modified Series A Warrants and Modified Series C Warrants represent Series A Warrants and Series C Warrants, respectively, modified under the September 2024 Exercise Price Warrant Amendment.

Summary of Estimated Fair Value of Stock Option Award

The following assumptions were used in estimating the grant date fair value of options issued during the three months ended March 31, 2025:

Risk free interest rate	4.38-4.39%
Expected option term (in years)	5.8 - 6.0
Volatility of common stock	99% - 107.3%
Expected dividend yield	0.0%

Summary of Recognized Stock-Based Compensation Expense

The Company recognized stock-based compensation expense as follows:

	Three Months Ended March 31,
	2025		2024
Research and development	$	4,373	$	1,215
Selling, general and administrative		80,011		252,814
Total stock-based compensation expense	$	84,384	$	254,029

	Three Months Ended March 31,
	2025		2024
Stock options	$	77,638	$	254,029
ESPP		6,746		—
Total stock-based compensation expense	$	84,384	$	254,029

ESPP [Member]

Share Based Compensation Arrangement By Share Based Payment Award [Line Items]

Summary of Estimated Fair Value of Stock Option Award

The estimated fair value of each ESPP award granted was determined on

the date of purchase using the Black-Scholes option-pricing valuation model with the following assumptions for the three months ended March 31, 2025,:

Risk free interest rate	4.3%
Expected option term (in years)	0.5
Volatility of common stock	91.5%
Expected dividend yield	0.0%

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Segment Information (Tables)

3 Months Ended

Mar. 31, 2025

Segment Reporting [Abstract]

Summary of Company's Financial Data for Development and Commercialization of Pharmaceutical Products Segment

The following table summarizes the Company’s financial data for its development and commercialization of pharmaceutical products segment:

	Three Months Ended March 31,
	2025			2024
Net product sales	$	3,080,158		$	1,735,490
Less:
Cost of goods sold		(41,613	)		(92,529	)
Eversana profit sharing		(2,618,135	)		(1,475,261	)
Employee expenses		(638,099	)		(696,801	)
Professional fees		(704,629	)		(503,717	)
Stock-based compensation		(84,384	)		(254,029	)
Sales and marketing expenses		(188,668	)		(163,797	)
Other operating expenses(1)		(106,373	)		(50,576	)
Interest income		118,853			46,058
Interest expense (non-cash)		(123,288	)		(124,658	)
Total segment costs loss and net loss	$	(1,306,178	)	$	(1,579,820	)

________________

(1) Includes ongoing product development costs, occupancy costs (including rent and utilities), administrative costs, travel and business taxes.

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Organization and Basis of Presentation - Additional Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2025	Dec. 31, 2024	Mar. 31, 2024	Dec. 31, 2023
Organization And Basis Of Presentation [Line Items]
Month and year of incorporation	2007-01
Cash and cash equivalents	$ 12,624,090	$ 13,596,600
Stockholders' equity	$ 5,841,215	$ 7,038,010	$ 3,497,169	$ (2,579,537)
Common stock, par value	$ 0.0001	$ 0.0001
Reverse stock split description	On May 22, 2024, 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 July 31, 2024, the Company filed an amendment (the “Amendment”) to its amended and restated certificate of incorporation to effectuate a reverse stock split of the Company’s common stock. Pursuant to the Amendment, at the effective time of 12:01 a.m. Eastern Time on August 1, 2024, each twelve (12) shares of the Company’s common stock issued and outstanding was combined into one (1) validly issued, fully paid and non-assessable share of common stock (the “Reverse Stock Split”). The par value and the authorized shares of the Company's common stock were not adjusted as a result of the Reverse Stock Split. All issued and outstanding common stock, warrants to purchase common stock, options to purchase common stock, per-share data and related information have been retroactively adjusted to reflect the Reverse Stock Split for all periods presented.
Eversana Agreement [Member]
Organization And Basis Of Presentation [Line Items]
Principal and interest on the loan	$ 7,200,000
Principal and interest on loan due period	90 days

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Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($)	3 Months Ended		12 Months Ended
	Mar. 31, 2025	Mar. 31, 2024	Dec. 31, 2024
Significant Accounting Policies [Line Items]
Allowance for doubtful accounts receivable	$ 0		$ 0
Provision for credit losses	0	$ 0
Deferred offering costs			120,614
Public Offering [Member]
Significant Accounting Policies [Line Items]
Deferred offering costs			100,000
Accounts Payable and Accrued Expenses [Member]
Significant Accounting Policies [Line Items]
Liabilities for co-pay assistance	300,000		100,000
Accounts Payables [Member]
Significant Accounting Policies [Line Items]
Medicaid and Medicare rebates	$ 200,000		$ 200,000
Pre-Funded Warrants, Modified Series A Warrants and Modified Series C Warrants [Member]
Significant Accounting Policies [Line Items]
Shares of common stock underlying pre-funded warrants	1,060,316

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Summary of Significant Accounting Policies - Schedule of Inventories (Details) - USD ($)	Mar. 31, 2025	Dec. 31, 2024
Organization, Consolidation and Presentation of Financial Statements [Abstract]
Raw materials	$ 157,070	$ 257,467
Finished goods	375,075	187,614
Total inventories	$ 532,145	$ 445,081

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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
	Mar. 31, 2025	Mar. 31, 2024
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items]
Anti-dilutive securities excluded from the calculation of diluted net loss per share	1,062,661	2,693,890
Warrants to purchase common stock [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	792,731	2,641,907
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	269,930	51,983

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Commitments and Contingencies - Additional Information (Detail) $ in Millions	3 Months Ended
	Mar. 31, 2025 USD ($)
New Accounting Pronouncements Or Change In Accounting Principle [Line Items]
Operating lease incremental borrowing rate	10.00%
Lease agreement term	2 years
Initial Lease [Member]
New Accounting Pronouncements Or Change In Accounting Principle [Line Items]
Lease commencement date	Jan. 01, 2017
Lease expiry date	Oct. 31, 2023
Short Term Lease [Member]
New Accounting Pronouncements Or Change In Accounting Principle [Line Items]
Lease commencement date	Nov. 01, 2023
Lease expiry date	Oct. 31, 2024
Current Lease [Member]
New Accounting Pronouncements Or Change In Accounting Principle [Line Items]
Lease commencement date	Nov. 01, 2024
Lease expiry date	Mar. 31, 2027
Right-of-use asset obtained in exchange	$ 0.2

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Commitments and Contingencies - Summary of Supplemental Lease Information (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Lease, Cost [Abstract]
Lease costs	$ 20,107	$ 18,936
Cash paid for leases	$ 19,370	$ 18,936

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Commitments and Contingencies - Summary of Supplemental Lease Information (Parenthetical) (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Lease, Cost [Abstract]
Short-term lease expense	$ 20,331	$ 18,936

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Commitments and Contingencies - Summary of Future Lease Payments (Detail)	Mar. 31, 2025 USD ($)
Lessee, Operating Lease, Liability, to be Paid, Fiscal Year Maturity [Abstract]
2025 (Remainder)	$ 58,500
2026	80,207
2027	20,551
Total future lease payments	159,258
Less: imputed interest	(14,416)
Total lease liability	$ 144,842

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Stockholders' Equity - February 2024 Offering - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	Feb. 29, 2024	Mar. 31, 2025	Dec. 31, 2024
Sale Of Common Stock [Line Items]
Warrants issued and outstanding		1,853,047
Common stock, shares issued		1,492,858	1,486,009
Pre-Funded Warrants [Member]
Sale Of Common Stock [Line Items]
Warrants issued and outstanding		528,609
Series A Warrants [Member]
Sale Of Common Stock [Line Items]
Warrants issued and outstanding		354,022
Series C Warrants [Member]
Sale Of Common Stock [Line Items]
Warrants issued and outstanding		392,754
February 2024 Offering [Member]
Sale Of Common Stock [Line Items]
Shares issued, price per share	$ 8.16
Warrants to the underwriters purchase	45,955
Common stock, shares issued	427,886
Number of shares issuable per warrant	1
Percentage Of Securities Sold	5.00%
Proceeds from issuance of common stock net of underwriter and offering expenses	$ 6.2
February 2024 Offering [Member] | Pre-Funded Warrants [Member]
Sale Of Common Stock [Line Items]
Shares issued, price per share	$ 8.1588
Warrants issued and outstanding	491,221
February 2024 Offering [Member] | Series A Warrants [Member]
Sale Of Common Stock [Line Items]
Number of shares issuable per warrant	1
February 2024 Offering [Member] | Series C Warrants [Member]
Sale Of Common Stock [Line Items]
Number of shares issuable per warrant	1

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Stockholders' Equity - August 2024 Shelf Registration Statement (Additional Information) (Detail) - USD ($)		1 Months Ended	3 Months Ended
	Aug. 29, 2024	Nov. 30, 2024	Mar. 31, 2025	Dec. 31, 2024
Sale Of Common Stock [Line Items]
Common stock, shares issued			1,492,858	1,486,009
August 2024 Shelf Registration Statement [Member]
Sale Of Common Stock [Line Items]
Shares offering description			Company can offer and sell to up to one-third of its public float during any 12-month period so long as our public float remains below $75.0 million
Common stock, preferred stock, debt securities, warrants, issued			0
August 2024 Shelf Registration Statement [Member] | Maximum [Member]
Sale Of Common Stock [Line Items]
Proceeds from offering of equity	$ 50,000,000
Remaining public float amount	$ 75,000,000
ATM Sales Agreement [Member]
Sale Of Common Stock [Line Items]
Proceeds from Issuance of Common Stock		$ 3,100,000
Common stock, shares issued			0
ATM Sales Agreement [Member] | H.C. Wainwright & Co., LLC [Member] | Maximum [Member]
Sale Of Common Stock [Line Items]
Proceeds from Issuance of Common Stock			$ 1,900,000

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Stockholders' Equity - Warrant Amendments - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions	1 Months Ended
	Sep. 30, 2024	Jun. 30, 2024	Mar. 31, 2024	Mar. 31, 2025
Class of Warrant or Right [Line Items]
Number of warrants outstanding				1,853,047
Warrant Amendments [Member]
Class of Warrant or Right [Line Items]
Proceeds from issuance of warrant amendments net of underwriter commissions and offering expenses	$ 0.4	$ 0.3	$ 1.2
Pre-Funded Warrants [Member]
Class of Warrant or Right [Line Items]
Exercise Price				$ 0.0012
Number of warrants outstanding				528,609
Pre-Funded Warrants [Member] | Warrant Amendments [Member]
Class of Warrant or Right [Line Items]
Exercise Price				$ 0.0012
Purchase price				$ 8.1588

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Stockholders' Equity - September 2024 Exercise Price Warrant Amendment - Additional Information (Detail) - USD ($)	1 Months Ended
	Sep. 30, 2024	Mar. 31, 2025
September 2024 Exercise Price Warrant Amendment [Member]
Class of Warrant or Right [Line Items]
Proceeds from issuance of warrant amendments net of underwriter and offering expenses	$ 2,500,000
September 2024 Exercise Price Warrant Amendment [Member] | Member One [Member]
Class of Warrant or Right [Line Items]
Percentage of outstanding shares of common stock	5.00%
September 2024 Exercise Price Warrant Amendment [Member] | Member Two [Member]
Class of Warrant or Right [Line Items]
Percentage of outstanding shares of common stock	15.00%
Series A Warrants [Member]
Class of Warrant or Right [Line Items]
Exercise Price		$ 8.16
Series A Warrants [Member] | September 2024 Exercise Price Warrant Amendment [Member]
Class of Warrant or Right [Line Items]
Non-refundable up-front payment	$ 3.99
Series A Warrants [Member] | Maximum [Member] | September 2024 Exercise Price Warrant Amendment [Member]
Class of Warrant or Right [Line Items]
Exercise Price	$ 0.01
Series A Warrants [Member] | Minimum [Member] | September 2024 Exercise Price Warrant Amendment [Member]
Class of Warrant or Right [Line Items]
Exercise Price	8.16
Exercise price of non-modified warrants	$ 8.16
Series C Warrants [Member]
Class of Warrant or Right [Line Items]
Exercise Price		$ 8.16
Series C Warrants [Member] | September 2024 Exercise Price Warrant Amendment [Member]
Class of Warrant or Right [Line Items]
Non-refundable up-front payment	$ 3.99
Series C Warrants [Member] | Maximum [Member] | September 2024 Exercise Price Warrant Amendment [Member]
Class of Warrant or Right [Line Items]
Exercise Price	$ 0.01
Series C Warrants [Member] | Minimum [Member] | September 2024 Exercise Price Warrant Amendment [Member]
Class of Warrant or Right [Line Items]
Exercise Price	8.16
Exercise price of non-modified warrants	$ 8.16

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Stockholders' Equity - Summary of the Company's Warrants Outstanding (Details)	3 Months Ended
	Mar. 31, 2025 $ / shares shares
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding	1,853,047
Pre-Funded Warrants [Member]
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding	528,609
Exercise Price | $ / shares	$ 0.0012
Initial Exercise Date	Feb. 13, 2024
Series A Warrants [Member]
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding	354,022
Exercise Price | $ / shares	$ 8.16
Initial Exercise Date	Feb. 13, 2024
Expiration Date	Feb. 13, 2029
Modified Series A Warrants [Member]
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding	281,080
Exercise Price | $ / shares	$ 0.01
Initial Exercise Date	Feb. 13, 2024
Expiration Date	Feb. 13, 2029
Series C Warrants [Member]
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding	392,754
Exercise Price | $ / shares	$ 8.16
Initial Exercise Date	Feb. 13, 2024
Expiration Date	Feb. 13, 2029
Modified Series C Warrants [Member]
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding	250,627
Exercise Price | $ / shares	$ 0.01
Initial Exercise Date	Feb. 13, 2024
Expiration Date	Feb. 13, 2029
Representative Warrants [Member]
Class of Warrant or Right [Line Items]
Number of Warrants Outstanding	45,955
Exercise Price | $ / shares	$ 13.47
Initial Exercise Date	Aug. 13, 2024
Expiration Date	Feb. 13, 2029

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Stockholders' Equity - Stock-Based Compensation - Additional Information (Detail) - USD ($)	1 Months Ended		3 Months Ended
	Jan. 31, 2025	Jan. 31, 2024	Mar. 31, 2025	Mar. 31, 2024
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted average period			2 years 9 months 18 days
Unrecognized compensation costs			$ 900,000
Proceeds from the issuance of common stock pursuant to the ESPP			$ 24,999
Employee Stock Option
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Number of stock options granted			143,915	0
Amended and Restated ESPP [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Weighted average period			4 months 24 days
Unrecognized compensation costs			$ 18,000,000,000
Purchase price of common stock as percentage of fair market value			85.00%
Increase in number of shares of common stock available for issuance		14,860
Issuance of common stock under employee stock purchase plan			6,849
Proceeds from the issuance of common stock pursuant to the ESPP			$ 25,000
2013 Equity Incentive Award Plan [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Increase in the number of shares of common stock reserved under the plan	89,161

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Stockholders' Equity - Summary of Estimated Fair Value of Stock Option Award (Detail)	3 Months Ended
	Mar. 31, 2025
Common stock options [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk free interest rate	4.38%
Expected dividend yield	0.00%
Common stock options [Member] | Minimum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected option term	5 years 9 months 18 days
Volatility of common stock	99.00%
Common stock options [Member] | Maximum [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Expected option term	6 years
Volatility of common stock	107.30%
ESPP [Member]
Share Based Compensation Arrangement By Share Based Payment Award [Line Items]
Risk free interest rate	4.30%
Expected option term	6 months
Volatility of common stock	91.50%
Expected dividend yield	0.00%

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Stockholders' Equity - Summary of Recognized Stock-Based Compensation Expense (Detail) - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 84,384	$ 254,029
Stock Options [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	77,638	254,029
ESPP [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	6,746
Research and development [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	4,373	1,215
Selling, general and administrative [Member]
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items]
Stock-based compensation expense	$ 80,011	$ 252,814

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Commercial Services and Loan Agreements with Eversana - Additional Information (Detail) - USD ($)			3 Months Ended
	Feb. 01, 2022	Jan. 21, 2020	Mar. 31, 2025	Mar. 31, 2024	Jan. 31, 2020
Commercial Services And Loan Agreements [Line Items]
Selling, general and administrative			$ 4,297,505	$ 3,139,536
Eversana Agreement [Member]
Commercial Services And Loan Agreements [Line Items]
Unreimbursed commercialization cost			$ 77,500,000
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 (the “Eversana Amendment”).
Selling, general and administrative			$ 2,600,000	$ 1,500,000
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%

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Segment Information - Additional Information (Details)

3 Months Ended

Mar. 31, 2025

Segment

Segment Reporting [Abstract]

Number of operating segment

1

Segment Reporting, Policy [Policy Text Block]

The accounting policies of the development and commercialization of pharmaceutical products segment are the same as those described in Note 2. Summary of Significant Accounting Policies. All Company assets are in the United States. The measure of segment assets is reported on the balance sheets as total assets. The Company does not have intra-entity sales or transfers.

Segment Reporting, CODM, Individual Title and Position or Group Name [Extensible Enumeration]

srt:ChiefExecutiveOfficerMember

Segment Reporting, CODM, Profit (Loss) Measure, How Used, Description

The Company’s CODM evaluates the Company’s financial information including budget-versus-actual results and cash projections on an aggregate basis when assessing performance for allocating financial and personnel resources. The Company is not organized by market and is managed and operated as one business.

Segment Reporting, Recasting, Previously Reported Information, Description

The Company identifies its operating segments based on its business activities. The Company operates within a single operating segment being the development and commercialization of pharmaceutical products. The development and commercialization of pharmaceutical products segment generates revenues in the United States. The Company’s administrative functions including finance, business development and procurement, support the development and commercialization of pharmaceutical products segment. The Company operates primarily in one geographic area, being the United States. The CODM allocates resources (inclusive of both capital and personnel) based upon the Company’s net loss, which is utilized to monitor budget-to-actual variances on a monthly basis.

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Segment Information - Summary of Company's Financial Data for Development and Commercialization of Pharmaceutical Products Segment (Details) - USD ($)	3 Months Ended
	Mar. 31, 2025	Mar. 31, 2024
Segment Reporting Information [Line Items]
Net product sales	$ 3,080,158	$ 1,735,490
Cost of goods sold	41,613	92,529
Eversana profit sharing	4,297,505	3,139,536
Interest income	118,853	46,058
Interest expense (non-cash)	123,288	124,658
Pharmaceutical Products [Member]
Segment Reporting Information [Line Items]
Net product sales	3,080,158	1,735,490
Cost of goods sold	(41,613)	(92,529)
Eversana profit sharing	(2,618,135)	(1,475,261)
Employee expenses	(638,099)	(696,801)
Professional fees	(704,629)	(503,717)
Stock-based compensation	(84,384)	(254,029)
Sales and marketing expenses	(188,668)	(163,797)
Other operating expenses	(106,373)	(50,576)
Interest income	118,853	46,058
Interest expense (non-cash)	(123,288)	(124,658)
Total segment costs loss and net loss	$ (1,306,178)	$ (1,579,820)