08/14/2025 | Press release | Distributed by Public on 08/14/2025 05:01
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
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 June 30, 2025, we had cash and cash equivalents of approximately $12.1 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 June 30, 2025, as well as cash flows from future net sales of Gimoti, will be sufficient to fund our operations into the third quarter of 2026. However, should Eversana terminate the Eversana Agreement under the NPQTR (as defined in Note 1. Organization and Basis of Presentationto 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 June 30, 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 were subject to a discretionary panel monitor through June 4, 2025. On June 20, 2025, we received a letter from Nasdaq indicating that we had regained compliance with the Minimum Stockholder's Equity Requirements and were no longer under a panel monitor.
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 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.
Recent Developments
One Big Beautiful Bill Act
On July 4, 2025, President Trump signed into law the legislation commonly referred to as the One Big Beautiful Bill Act ("OBBBA"). The OBBBA includes various provisions, such as the permanent extension of certain expiring provisions of the Tax Cuts and Jobs Act, modifications to the international tax framework and the restoration of favorable tax treatment for certain business provisions. The OBBBA has multiple effective dates, with certain provisions effective in 2025 and others implemented through 2027. We are currently assessing its impact on our consolidated financial statements and will recognize the income tax effects in the consolidated financial statements beginning in the period in which the OBBBA was signed into law.
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 June 30, 2025 were approximately $3.7 million which is a $0.7 million increase compared to net product sales for the quarter ended March 31, 2025. 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 continue to add new dispensing pharmacies to the ASPN platform, 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 any one of our dispensing pharmacy partners. 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 1,960 new inbound prescriptions into the ASPN reimbursement center during the quarter ended June 30, 2025, which is a 9.3% increase compared to the quarter ended March 31, 2025. 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 9.0% during the quarter ended June 30, 2025.
The ASPN team conducts benefit verification and facilitates the prior authorization process across all payer types for patients prescribed Gimoti. For the six months ended June 30, 2025, these government programs made up approximately 30% of the filled prescriptions for Gimoti. From the commercial launch of Gimoti through June 30, 2025, the majority of patients have been between 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:
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:
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 June 30, 2025 and 2024
The following table summarizes the results of our operations:
|
Three Months Ended June 30, |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Net product sales |
$ |
3,752,142 |
$ |
2,551,366 |
$ |
1,200,776 |
47 |
% |
||||||||
|
Cost of goods sold |
$ |
167,679 |
$ |
41,478 |
$ |
126,201 |
304 |
% |
||||||||
|
Research and development expenses |
$ |
8,413 |
$ |
- |
$ |
8,413 |
100 |
% |
||||||||
|
Selling, general and administrative expenses |
$ |
5,134,902 |
$ |
3,733,450 |
$ |
1,401,452 |
38 |
% |
||||||||
Net Product Sales. Net product sales for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 increased by approximately $1.2 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 June 30, 2025 compared to the three months ended June 30, 2024 increased by approximately $126,000. The increase in costs of goods sold during 2025 is primarily due to timing of stability testing on commercial product batches.
Research and Development Expenses. Research and development expenses for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 increased by approximately $8,000 due to miscellaneous product development costs.
Selling, General and Administrative Expenses. Selling, general and administrative expenses for the three months ended June 30, 2025 compared to the three months ended June 30, 2024 increased by approximately $1.4 million primarily due to an increase of $1.0 million in marketing and Eversana profit sharing amounts as a direct result of an increase in net product sales, an increase of 0.3
million in professional fees and a $0.1 million increase in product liability insurance and other costs associated with being a public company.
Comparison of Six Months Ended June 30, 2025 and 2024
The following table summarizes the results of our operations:
|
Six Months Ended June 30, |
||||||||||||||||
|
2025 |
2024 |
$ Change |
% Change |
|||||||||||||
|
Net product sales |
$ |
6,832,300 |
$ |
4,286,856 |
$ |
2,545,444 |
59 |
% |
||||||||
|
Cost of goods sold |
$ |
209,292 |
$ |
134,007 |
$ |
75,285 |
56 |
% |
||||||||
|
Research and development expenses |
$ |
51,196 |
$ |
4,645 |
$ |
46,551 |
1002 |
% |
||||||||
|
Selling, general and administrative expenses |
$ |
9,432,407 |
$ |
6,872,986 |
$ |
2,559,421 |
37 |
% |
||||||||
Net Product Sales. Net product sales for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $2.5 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 six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $0.1 million. The increase in costs of goods sold during 2025 is primarily due to timing of stability testing on commercial product batches.
Research and Development Expenses. Research and development expenses for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $47,000 due to miscellaneous product development costs.
Selling, General and Administrative Expenses. Selling, general and administrative expenses for the six months ended June 30, 2025 compared to the six months ended June 30, 2024 increased by approximately $2.6 million primarily due to an increase of $2.2 million in marketing and Eversana profit sharing amounts as a direct result of an increase in net product sales, an increase of $ 0.4 million in professional fees and a $0.2 million increase in product liability insurance and other costs associated with being a public company. These increases were partially offset by 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 June 30, 2025, we had approximately $12.1 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 $7.4 million as of June 30, 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:
|
Six Months Ended June 30, |
||||||||||||
|
2025 |
2024 |
$ Change |
||||||||||
|
Net cash used in operating activities |
$ |
(1,562,527 |
) |
$ |
(3,400,005 |
) |
$ |
1,837,478 |
||||
|
Net cash provided by financing activities |
$ |
24,999 |
$ |
7,838,415 |
$ |
(7,813,416 |
) |
|||||
|
Net (decrease) increase in cash and cash equivalents |
$ |
(1,537,528 |
) |
$ |
4,438,410 |
$ |
(5,975,938 |
) |
||||
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 six months ended June 30, 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.
Financing Activities. During the six months ended June 30, 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 six months ended June 30, 2024. During six months ended June 30, 2024, cash provided by financing activities was $7.8 million primarily due to the sale of 437,853 shares of common stock at $8.16 per share and 683,475 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:
We expect to continue to incur expenses as we: