[10-Q] Evofem Biosciences, Inc. Quarterly Earnings Report
Evofem Biosciences (EVFM) filed its Q3 2025 10‑Q, showing modest revenue and ongoing financial pressure. Net product sales were $4.952 million for the quarter and $10.622 million year‑to‑date. Q3 operating income was $0.951 million, aided by a $1.933 million gain from a change in accounting estimates on a contingent royalty liability, but other expenses led to a net loss of $1.569 million for Q3 and $2.397 million for the first nine months.
Liquidity remains tight: cash, cash equivalents and restricted cash were $840 thousand at period end. Total assets were $13.807 million versus total liabilities of $83.976 million, resulting in a stockholders’ deficit of $75.066 million. Management disclosed substantial doubt about the company’s ability to continue as a going concern and outlined plans to pursue product revenues, milestones from ex‑U.S. licensing, restructuring of payables, and additional financing. The company’s common stock moved from OTCQB to OTCPK on April 23, 2025, and to OTCID on July 1, 2025. Common shares outstanding were 123,956,354 as of September 30, 2025, and 126,685,925 as of November 12, 2025.
- None.
- Going concern warning due to limited liquidity and large deficits
- Listing downgrades: moved from OTCQB to OTCPK, then to OTCID in 2025
Insights
Going‑concern doubt and OTC tier moves highlight elevated risk.
Evofem posted Q3 net product sales of
The balance sheet shows
Trading moved from OTCQB to OTCPK on
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For
the quarterly period ended
or
| TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
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File Number:
(Exact name of registrant as specified in its charter)
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telephone number, including area code:
N/A
(Former name or former address, if changed since last report.)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| None |
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.
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).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, 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 ☐ |
| 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
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The number of shares of the registrant’s Common Stock, $
Table of Contents
| Page | ||
| FORWARD-LOOKING STATEMENTS | 1 | |
| PART I. | FINANCIAL INFORMATION | |
| Item 1. | Financial Statements (Unaudited) | 3 |
| Condensed Consolidated Balance Sheets | 3 | |
| Condensed Consolidated Statements of Operations | 4 | |
| Condensed Consolidated Statements of Comprehensive Operations | 5 | |
| Condensed Consolidated Statements of Convertible and Redeemable Preferred Stock and Stockholders’ Deficit | 6 | |
| Condensed Consolidated Statements of Cash Flows | 7 | |
| Notes to Unaudited Condensed Consolidated Financial Statements | 8 | |
| Item 2. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 34 |
| Item 3. | Quantitative and Qualitative Disclosures About Market Risk | 43 |
| Item 4. | Controls and Procedures | 43 |
| PART II. | OTHER INFORMATION | |
| Item 1. | Legal Proceedings | 45 |
| Item 1A. | Risk Factors | 45 |
| Item 2. | Unregistered Sales of Equity Securities and Use of Proceeds | 45 |
| Item 3. | Defaults Upon Senior Securities | 45 |
| Item 4. | Mine Safety Disclosures | 45 |
| Item 5. | Other Information | 45 |
| Item 6. | Exhibits | 45 |
| Signatures | 46 | |
FORWARD-LOOKING STATEMENTS
This quarterly report on Form 10-Q (Quarterly Report), contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” All statements, other than statements of historical facts, contained in this Quarterly Report, including statements regarding our strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. Words such as, but not limited to, “anticipate,” “aim,” “believe,” “contemplate,” “continue,” “could,” “design,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “seek,” “should,” “suggest,” “strategy,” “target,” “will,” “would,” and similar expressions or phrases, or the negative of those expressions or phrases, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
These forward-looking statements include, among other things, statements about:
| ● | our ability to continue as a going concern; |
| ● | risks and uncertainties related to changes in government operations, including a federal government shutdown, which could delay our ability to offer registered securities, FDA reviews, disrupt supply chains, or affect healthcare reimbursement decisions; |
| ● | the Notice of Default and cancellation of Forbearance Agreement received by Future Pak, LLC and any potential legal action(s) against the Company, including that its assets that could be taken and potential negative outcome(s) thereof; |
| ● | our ability to successfully commercialize SOLOSEC® (secnidazole) 2g oral granules (SOLOSEC); |
| ● | our ability to remediate the material weaknesses in our internal controls and procedures identified by management; |
| ● | our ability to obtain necessary approvals of any corporate action(s) needing stockholder, FINRA, Nasdaq, or other approvals; |
| ● | our ability to file Annual and Quarterly Reports on a timely basis; |
| ● | our ability to raise additional capital to fund our operations if and as needed; |
| ● | our ability to achieve and sustain profitability; |
| ● | our estimates regarding our future performance including, without limitation, any estimates of potential future revenues; |
| ● | estimates regarding market size; |
| ● | our estimates regarding expenses, revenues, financial performance, and capital requirements, including the length of time our capital resources will sustain our operations; |
| ● | our ability to comply with the provisions and requirements of our debt arrangements, to avoid future defaults pursuant to our debt arrangements, and to pay amounts owed, including any amounts that may be accelerated, pursuant to our debt arrangements; |
| ● | estimates regarding health care providers’ (HCPs’) recommendations of PHEXX® (formerly known as PHEXXI) (lactic acid, citric acid, and potassium bitartrate) vaginal gel (PHEXX) to patients; |
| ● | estimates regarding HCPs’ recommendations of SOLOSEC to patients suffering from the sexual health infections for which it is indicated; |
| ● | the rate and degree of market acceptance of our products; |
| ● | our ability to successfully commercialize and distribute our products and continue to develop our sales and marketing capabilities, particularly after any product rebrand; |
| ● | changing the name of our hormone-free birth control product from PHEXXI to PHEXX; |
| ● | our estimates regarding the effectiveness of our marketing campaigns; |
| ● | our strategic plans for our business, including the commercialization of our products; |
| 1 |
| Table of Contents |
| ● | the potential for changes to current regulatory mandates requiring health insurance plans to cover U.S. Food and Drug Administration (FDA) cleared or approved contraceptive products without cost sharing; |
| ● | our ability to obtain or maintain third-party payer coverage and adequate reimbursement, and our reliance on the willingness of patients to pay out-of-pocket for our products absent full or partial third-party payer reimbursement; |
| ● | the potential substantial negative impact on contraception access and STI treatment, especially for low-income and uninsured women after the passage of the One Big Beautiful Bill Act; |
| ● | our ability to protect and defend our intellectual property position and our reliance on third party licensors; |
| ● | our ability to obtain additional patent protection for our products; |
| ● | our dependence on third parties for the manufacture of our products; |
| ● | our ability to expand our organization to accommodate potential growth; and |
| ● | our ability to retain and attract key personnel. |
Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements are based on our projections of the future that are subject to known and unknown risks and uncertainties and other factors that may cause our actual results, level of activity, performance or achievements expressed or implied by these forward-looking statements, to differ. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. All forward-looking statements are qualified in their entirety by this cautionary statement. Forward-looking statements should be regarded solely as our current plans, estimates and beliefs. You should read this Quarterly Report and the documents that we have filed as exhibits to this Quarterly Report and incorporated by reference herein completely and with the understanding that our actual results may be materially different from the plans, intentions and expectations disclosed in the forward-looking statements we make. Moreover, we operate in a very competitive and rapidly changing environment and new risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. The forward-looking statements contained in this Quarterly Report are made as of the date of this Quarterly Report, and we do not assume any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
This Quarterly Report contains estimates and other statistical data made by independent parties and by the Company relating to market size and growth and other data about its industry. This data involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such estimates.
Unless the context requires otherwise, references in this Quarterly Report to “Evofem,” “Company,” “we,” “us” and “our” refer to Evofem Biosciences, Inc. and its subsidiaries.
This Quarterly Report includes our trademarks, trade names and service marks, including “EVOFEM®”, “PHEXX®”, “FEMIDENCE™”, and “SOLOSEC®”, which are protected under applicable intellectual property laws and are the property of Evofem Biosciences, Inc. or its subsidiaries. Solely for convenience, trademarks, trade names and service marks referred to in this Quarterly Report may appear without the ®, ™ or SM symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the right of the applicable licensor to these trademarks, trade names and service marks. We do not intend our use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply a relationship with, or endorsement or sponsorship of us by, these other parties.
| 2 |
| Table of Contents |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except par value and share data)
| September 30, 2025 | December 31, 2024 | |||||||
| As of | ||||||||
| September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | - | $ | - | ||||
| Restricted cash | ||||||||
| Trade accounts receivable, net | ||||||||
| Inventories | ||||||||
| Prepaid and other current assets | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Operating lease right-of-use assets | ||||||||
| Intangible asset, net (Note 7) | ||||||||
| Other noncurrent assets | ||||||||
| Total assets | $ | $ | ||||||
| Liabilities, convertible and redeemable preferred stock and stockholders’ deficit | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Notes - carried at fair value (Note 4) | ||||||||
| Notes - carried at fair value - Related Party (Note 4) | - | |||||||
| Convertible notes, net - Adjuvant - Related Party (Note 4) | ||||||||
| Convertible notes | ||||||||
| Short term debt | ||||||||
| Accrued expenses | ||||||||
| Accrued compensation | ||||||||
| Operating lease liabilities – current | ||||||||
| Derivative liabilities | ||||||||
| Contingent liabilities - current (Note 7) | ||||||||
| Other current liabilities | ||||||||
| Total current liabilities | ||||||||
| Operating lease liabilities - noncurrent | ||||||||
| Contingent liabilities - noncurrent (Note 7) | ||||||||
| Total liabilities | ||||||||
| Commitments and contingencies (Note 7) | - | |||||||
| Convertible and redeemable preferred stock, $ | ||||||||
| Series E-1, F-1 and G-1 convertible and redeemable preferred stock, | ||||||||
| Convertible and redeemable preferred stock | ||||||||
| Stockholders’ deficit: | ||||||||
| Preferred stock, $ | - | - | ||||||
| Common Stock, $ | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated other comprehensive loss | ( | ) | ( | ) | ||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ deficit | ( | ) | ( | ) | ||||
| Total liabilities, convertible and redeemable preferred stock and stockholders’ deficit | $ | $ | ||||||
See accompanying notes to the condensed consolidated financial statements (unaudited).
| 3 |
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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share data)
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Product sales, net | $ | $ | $ | $ | ||||||||||||
| Operating Expenses: | ||||||||||||||||
| Cost of goods sold | ||||||||||||||||
| Gain on change in accounting estimates on contingent royalty liability (Note 7) | ( | ) | - | ( | ) | - | ||||||||||
| Amortization of intangible asset | ||||||||||||||||
| Research and development, net | ( | ) | ||||||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Income (loss) from operations | ( | ) | ( | ) | ||||||||||||
| Other income (expense): | ||||||||||||||||
| Interest income | ||||||||||||||||
| Other expense, net | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Loss on issuance of financial instruments | - | - | - | ( | ) | |||||||||||
| Gain (loss) on debt extinguishment, net | - | ( | ) | - | ||||||||||||
| Change in fair value of financial instruments | ( | ) | ( | ) | ||||||||||||
| Total other income (expense), net | ( | ) | ( | ) | ||||||||||||
| Loss before income tax benefit (expense) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income tax benefit (expense) | ( | ) | - | |||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
Convertible and redeemable preferred stock deemed dividends | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss attributable to common stockholders | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted-average shares used to compute net loss per share attributable to common shareholders, basic and diluted | ||||||||||||||||
See accompanying notes to condensed consolidated financial statements (unaudited).
| 4 |
| Table of Contents |
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS
(Unaudited)
(In thousands)
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Other comprehensive income (loss): | ||||||||||||||||
| Change in fair value of financial instruments attributed to credit risk change (Note 4) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Reclassification adjustment related to debt extinguishment | - | - | ||||||||||||||
| Comprehensive loss | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
See accompanying notes to condensed consolidated financial statements (unaudited).
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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE AND REDEEMABLE PREFERRED STOCK AND STOCKHOLDERS’ DEFICIT
(Unaudited)
(In thousands, except share data)
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Income (Loss) | Deficit | Deficit | ||||||||||||||||||||||||||||||||||||||||
Series E-1 Convertible and Redeemable Preferred Stock | Series F-1 Convertible and Redeemable Preferred Stock |
Series G1 Convertible and Redeemable Preferred Stock | Common Stock | Additional Paid-in | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Income (Loss) | Deficit | Deficit | ||||||||||||||||||||||||||||||||||||||
| Balance as of December 31, 2024 | $ | $ | - | - | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||
| Change in fair value of financial instruments attributed to credit risk change (Note 4) | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||
| Series E-1 Shares dividends | - | - | - | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
| Net income | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||
| Balance as of March 31, 2025 | $ | $ | - | - | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||
| Issuance of Common Stock upon noncash exercise of purchase rights | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||
| Issuance of Aditxt Notes – Related Party (Note 4) | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||
| Change in fair value of financial instruments attributed to credit risk change (Note 4) | - | - | - | - | - | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||
| Series E-1 Shares dividends | - | - | - | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||
| Balance as of June 30, 2025 | $ | $ | - | - | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||||||||||||||||||||||||||||||||
| Issuance of Common Stock upon noncash exercise of purchase rights | - | - | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||
| Issuance of Series G-1 convertible and redeemable preferred stock upon conversion of convertible notes (Note 8) | - | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||
Stock-based compensation | - | - | - | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||
| Change in fair value of financial instruments attributed to credit risk change (Note 4) | - | - | - | - | - | - | - | - | - | ( | ) | - | ( | ) | |||||||||||||||||||||||||||||||||||
| Series E-1 and G-1 Shares dividends | - | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - |
- | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||
| Balance as of September 30, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Income (Loss) | Deficit | Deficit | |||||||||||||||||||||||||||||||
| Series E-1 Convertible and Redeemable Preferred Stock | Series F-1 Convertible and Redeemable Preferred Stock | Common Stock | Additional Paid-in | Accumulated Other Comprehensive | Accumulated | Total Stockholders’ | ||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Capital | Income (Loss) | Deficit | Deficit | |||||||||||||||||||||||||||||||
| Balance as of December 31, 2023 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Issuance of Common Stock upon exercise of warrants | - | - | - | - | - | - | - | |||||||||||||||||||||||||||||||||
| Issuance of Common Stock upon noncash exercise of purchase rights | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||
| Issuance of Common Stock upon conversion of notes | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Change in fair value of financial instruments attributed to credit risk change (Note 4) | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Series E-1 Shares dividends | - | - | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Balance as of March 31, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Issuance of Common Stock upon noncash exercise of purchase rights | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||
| Issuance of Common Stock upon conversion of notes | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Change in fair value of financial instruments attributed to credit risk change (Note 4) | - | - | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||
| Series E-1 Shares dividends | - | - | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Balance as of June 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Issuance of Common Stock upon noncash exercise of purchase rights | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||
| Stock-based compensation | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Extinguishment of Baker Notes (Note 4) | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Change in fair value of financial instruments attributed to credit risk change (Note 4) | - | - | - | - | - | - | - | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||
| Series E-1 Shares dividends | - | - | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||||
| Issuance of Series F-1 Shares to Aditxt (Related Party) | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||
| Allocation of reinstatement proceeds (Related Party) | - | - | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Net income (loss) | - | - | - | - | - | - | - | - | ( | ) | ( | ) | ||||||||||||||||||||||||||||
| Balance as of September 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||
See accompanying notes to condensed consolidated financial statements (unaudited).
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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
| 2025 | 2024 | |||||||
| Nine months ended September 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows from operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities: | ||||||||
| Loss on issuance of financial instruments | - | |||||||
| Gain on debt extinguishment | - | ( | ) | |||||
Gain on change in accounting estimates on contingent royalty liability | ( | ) | - | |||||
| Change in fair value of financial instruments | ( | ) | ||||||
| Inventory write-down for excess & obsolescence | - | |||||||
| Loss on contingent liability | ||||||||
| Stock-based compensation | ||||||||
| Depreciation | ||||||||
| Amortization of intangible asset | ||||||||
| Noncash interest expense | ||||||||
| Noncash right-of-use amortization | ||||||||
| Net loss on disposal or impairment of property and equipment | ||||||||
| Gain on accounts payable and accrued expenses settlements | ( | ) | - | |||||
| Changes in operating assets and liabilities: | ||||||||
| Trade accounts receivable | ||||||||
| Inventories | ( | ) | ||||||
| Prepaid and other assets | ||||||||
| Accounts payable | ( | ) | ( | ) | ||||
| Accrued expenses and other liabilities | ||||||||
| Accrued compensation | ||||||||
| Contingent liabilities | ( | ) | - | |||||
| Operating lease liabilities | ( | ) | ( | ) | ||||
| Net cash, cash equivalents and restricted cash used in operating activities | ( | ) | ( | ) | ||||
| Cash flows from investing activities: | ||||||||
| Payments related to asset acquisition | ( | ) | ( | ) | ||||
| Purchases of property and equipment | ( | ) | ( | ) | ||||
| Net cash, cash equivalents and restricted cash used in investing activities | ( | ) | ( | ) | ||||
| Cash flows from financing activities: | ||||||||
| Proceeds from issuance of Aditxt Notes – Related Party | - | |||||||
| Borrowings under short-term debt and Notes – carried at fair value | ||||||||
| Proceeds from reinstatement of Merger Agreement – Related Party | - | |||||||
| Proceeds from issuance of preferred stock – Related Party | - | |||||||
| Payments under short term debt and Notes – carried at fair value | ( | ) | ( | ) | ||||
| Net cash, cash equivalents and restricted cash provided by financing activities | ||||||||
| Net change in cash, cash equivalents and restricted cash | ||||||||
| Cash, cash equivalents and restricted cash, beginning of period | ||||||||
| Cash, cash equivalents and restricted cash, end of period | $ | $ | ||||||
| Supplemental disclosure of noncash investing and financing activities: | ||||||||
| Net increase/(decrease) in contingent liabilities | $ | ( | ) | $ | ||||
| Exchange of convertible notes to Series G-1 convertible and redeemable preferred stock | - | |||||||
| Addition to ROU asset and lease liability due to new leases | ||||||||
| Purchases of property and equipment included in accounts payable and accrued expenses | ||||||||
| Series E-1 and G-1 Shares deemed dividends | ||||||||
| Issuance of Common Stock upon exercise of purchase rights | ||||||||
| Issuance of Common Stock upon conversion of notes | - | |||||||
| Issuance of Common Stock upon exercise of warrants | - | |||||||
| Allocation of reinstatement proceeds – Related Party | - | |||||||
| Acquisition related amounts included in accounts payable and accrued expenses | - | |||||||
See accompanying notes to condensed consolidated financial statements (unaudited).
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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. Description of Business and Basis of Presentation
Description of Business
Evofem is a San Diego-based commercial-stage biopharmaceutical company committed to commercializing innovative products to address unmet needs in women’s sexual and reproductive health.
The Company’s first commercial product, PHEXX®, was approved by the FDA on May 22, 2020, for the prevention of pregnancy and launched in the U.S. in September 2020. PHEXX is the first and only non-hormonal prescription contraceptive vaginal gel. Women use it when they have sex, applying PHEXX 0-60 minutes prior to intercourse. Because PHEXX is hormone-free and non-systemic, it is not associated with side effects of hormonal contraceptive methods, which include depression, weight gain, headaches, loss of libido, mood swings and irritability. Taking hormones may not be right for some women, especially those with certain medical conditions including clotting disorders, hormone-sensitive cancers, diabetes, or a BMI over 30, as well as women who are breast feeding, and / or who smoke. Per National Center for Health Statistics (NCHS)-published data, more than 23.3 million women in the U.S. do not want to get pregnant and will not use a hormonal contraceptive.
The Company acquired global rights to SOLOSEC® on July 14, 2024 and relaunched the brand in November 2024. SOLOSEC is an FDA-approved single-dose oral antimicrobial agent that provides a complete course of therapy for the treatment of two common sexual health infections – bacterial vaginosis (BV) and trichomoniasis. This acquisition aligns with and advances the Company’s mission to commercialize innovative and differentiated products for women’s sexual and reproductive health.
Outside the U.S., the Company’s strategy is to commercialize its products in global markets through commercial partnerships and/or license agreements.
| ● | The Company licensed commercial rights to PHEXX and SOLOSEC in the Middle East and North Africa (MENA) to Pharma 1 Drug Store, LLC, an emerging Emirati health care company (Pharma 1), in July 2024 and May 2025, respectively. Pharma 1 filed for regulatory approval of PHEXX in the United Arab Emirates (UAE) in June 2025 and of SOLOSEC in the UAE in September 2025. | |
| ● | PHEXX was approved in Nigeria on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control. | |
| ● | PHEXX has also been submitted for approval in Mexico, Ethiopia and Ghana. |
Basis of Presentation and Principles of Consolidation
The Company prepared the unaudited interim condensed consolidated financial statements included in this Quarterly Report in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information and the rules and regulations of the Securities and Exchange Commission (SEC) related to quarterly reports on Form 10-Q.
The Company’s financial statements are presented on a consolidated basis, which include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements do not include all information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s consolidated financial statements and notes thereto for the year ended December 31, 2024 included in its Annual Report on Form 10-K as filed with the SEC on March 24, 2025 as amended on March 28, 2025 (the 2024 Audited Financial Statements).
The unaudited interim condensed consolidated financial statements included in this report have been prepared on the same basis as the Company’s audited consolidated financial statements and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations, cash flows, and statements of convertible and redeemable preferred stock and stockholders’ deficit for the periods presented. The results for the three and nine months ended September 30, 2025 are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2024 was derived from the 2024 Audited Financial Statements.
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Risks, Uncertainties and Going Concern
Any disruptions in the commercialization of PHEXX or SOLOSEC and/or the products’ supply chains could have a material adverse effect on the Company’s business, results of operations and financial condition.
The condensed consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities in the normal course of business and does not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.
The Company’s principal operations are related to the commercialization
of PHEXX and, since July 2024, SOLOSEC. Additional activities have included raising capital, identifying alternative manufacturing to
lower PHEXX cost of goods sold (COGS), seeking ex-U.S. licensing partners to add non-dilutive capital to the balance sheet and geographically
diversify the revenue stream, seeking product in-licensing/acquisition opportunities to expand and diversify the U.S. revenue stream,
and establishing and maintaining a corporate infrastructure to support commercial products. The Company has incurred operating losses
and negative cash flows from operating activities since inception. As of September 30, 2025, the Company had a working capital deficit
of $
On
January 6, 2025, the Company received a written notice from the OTC Markets notifying the Company that, because the closing bid price
for the Company’s Common Stock was below $
On
April 22, 2025, the Company received a written notice from the OTC Markets that it did not regain compliance with the Minimum Bid Price
Requirement during the specified period, and as such, its Common Stock was removed from OTCQB and began trading on the OTC Pink Current
(OTCPK) at market open on April 23, 2025. OTC Markets concurrently notified the Company that if the closing bid price for the Company’s
Common Stock is $
The Company’s Common Stock was moved to and began trading on the Over-the-Counter Integrated Disclosure (OTCID), the new basic reporting market tier launched by the OTC Markets Group, at market open on July 1, 2025.
Management’s plans to meet its cash flow needs in the next 12 months include generating recurring product revenue from PHEXX and SOLOSEC, earning milestone payments by achieving certain regulatory milestone under the License and Supply Agreement with Pharma 1 for SOLOSEC, restructuring its current payables, and obtaining additional funding through non-dilutive or dilutive financings, collaborations or partnerships with other companies, including license agreements for PHEXX and/or SOLOSEC in the U.S. or foreign markets, or through other potential business combinations.
The Company anticipates it will continue to incur net losses for the foreseeable future. According to management estimates, liquidity resources as of September 30, 2025, were not sufficient to maintain the Company’s cash flow needs for the twelve months from the date of issuance of these unaudited interim condensed consolidated financial statements.
If the Company is not able to obtain the required funding through a significant increase in revenue, equity or debt financings, license agreements for PHEXX and/or SOLOSEC, or other means, or is unable to obtain funding on terms favorable to the Company, or if there is another event of default affecting the notes payable, there will be a material adverse effect on commercialization operations and the Company’s ability to execute its strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make further reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend or curtail planned operations, or cease operations entirely. Any of these could materially and adversely affect the Company’s liquidity, financial condition and business prospects, and the Company would not be able to continue as a going concern. The Company has concluded that these circumstances and the uncertainties associated with the Company’s ability to obtain additional equity or debt financing on terms that are favorable to the Company, or at all, and otherwise succeed in its future operations raise substantial doubt about the Company’s ability to continue as a going concern.
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2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of interim condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the interim condensed consolidated financial statements and the notes thereto.
Significant estimates affecting amounts reported or disclosed in the interim condensed consolidated financial statements include, but are not limited to: the assumptions used in measuring the revenue gross-to-net variable consideration items; the allowance for expected credit losses estimate; the assumptions used in estimating the fair value of convertible notes, preferred stock, warrants and purchase rights issued; the assumptions used in the valuation of inventory, intangible asset, and contingent liabilities; the useful lives and recoverability of long-lived assets; the assumptions used to estimate the amount due under the contingent Rush Royalty liability; and the valuation of deferred tax assets. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. The estimates are the basis for making judgments about the carrying values of assets, liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.
Segment Reporting
Operating
segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation
by the chief operating decision-maker (CODM), the Chief Executive Officer of the Company, in making decisions regarding resource allocation
and assessing performance. The Company views its operations and manages its business in
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking, time deposit and investment accounts are maintained in federally insured financial institutions and are subject to federally insured limits or limits set by Securities Investor Protection Corporation. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the condensed consolidated balance sheets.
The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances on amounts in excess of federally insured limits due to the financial position of the depository institutions in which these deposits are held.
The Company is also subject to credit risk related to its trade accounts receivable from product sales. Its customers are located in the U.S. and, expected to begin in the fourth quarter of 2025, in the UAE, and consist of wholesale distributors, retail pharmacies, mail-order specialty pharmacies and, in the UAE, its licensee Pharma 1. The Company extends credit to its customers in the normal course of business after evaluating their overall financial condition and evaluates the collectability of its accounts receivable by periodically reviewing the age of the receivables, the financial condition of its customers, and its past collection experience. As of September 30, 2025 and December 31, 2024, based on the evaluation of these factors, the Company did not record an allowance for expected credit losses.
In the U.S., products are distributed primarily through three major distributors and mail-order pharmacies, which receive service fees calculated as a percentage of the gross sales and a fee-per-unit shipped, respectively. These entities are not obligated to purchase any set number of units; they distribute products on demand as orders are received.
For the three and nine months ended September 30, 2025, the Company’s
three largest customers combined made up approximately
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Significant Accounting Policies
There have been no changes to the significant accounting policies that were described in Note 2 – Summary of Significant Accounting Policies of the 2024 Audited Financial Statements in the Company’s Annual Report.
Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents consist of readily available cash in checking accounts and money market funds. Restricted cash consists of cash held in monthly time deposit accounts and letters of credit as described in Note 7- Commitments and Contingencies.
Net Loss Per Share
Basic
net loss per share attributable to Common Stockholders is calculated by dividing the net loss by the weighted-average number of
common shares outstanding during the period, without consideration for potentially dilutive securities. The net loss available to
Common Stockholders is adjusted for amounts in accumulated deficit related to the deemed dividends triggered for certain financial
instruments. Such adjustment was $
Schedule of Potentially Dilutive Securities Excluded from Calculation of Diluted Net Loss Per Share
| 2025 | 2024 | |||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Options to purchase Common Stock | ||||||||
| Warrants to purchase Common Stock | ||||||||
| Purchase rights to purchase Common Stock | ||||||||
| Convertible debt | ||||||||
| Series E-1 Shares | ||||||||
| Series F-1 Shares | ||||||||
| Series G-1 Shares | - | |||||||
| Total(1) | ||||||||
| (1) |
Recently Adopted Accounting Pronouncements
No significant new standards were adopted during the nine months ended September 30, 2025.
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Recently Issued Accounting Pronouncements — Not Yet Adopted
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standards setting bodies that are adopted as of the specified effective date.
In October 2023, the FASB issued Accounting Standards Update (ASU) 2023-06, Disclosure Improvements: Codification Amendments in Response to the SEC’s Disclosure Update and Simplification Initiative, designed to clarify or improve disclosure and presentation requirements on a variety of topics and align the requirements in the FASB Accounting Standards Codification (ASC) with the SEC regulations. This guidance is effective for the Company no later than June 30, 2027. The Company is still evaluating the impact of ASU 2023-06.
In December 2023, the FASB issued ASU 2023-09, Income Taxes: Improvements to Income Tax Disclosures, addressing income tax disclosures, requiring entities to annually disclose specific categories in the rate reconciliation and provide additional information for certain reconciling items and categories. ASU 2023-09 will be effective for the Company beginning with the annual filing for the period ending December 31, 2025 and early adoption is allowed. The Company is still evaluating the impact of ASU 2023-09.
In November 2024, the FASB issued ASU 2024-03, Disaggregation of Income Statement Expenses, which primarily requires disaggregation of specific expense categories in disclosures within the footnotes on an annual and interim basis. ASU 2024-03 is effective for the Company’s annual period ending December 31, 2027 and interim periods thereafter. Early adoption is permitted. In January 2025, the FASB issued ASU 2025-01 to clarify the effective date of ASU 2024-03. The Company is still evaluating the impacts of ASU 2024-03 and ASU 2025-01.
In November 2024, the FASB issued ASU 2024-04, Debt - Debt with Conversion and Other Options (Subtopic 470-20): Induced Conversions of Convertible Debt Instruments, designed to clarify the requirements for accounting for the settlement of a debt as an induced conversion versus as an extinguishment. This guidance is effective for the Company no later than January 1, 2026. The Company is still evaluating the impact of ASU 2024-04.
In July 2025, the FASB issued ASU 2025-05, Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets, to provide a practical expedient related to the estimation of expected credit losses for current accounts receivable and current contract assets that arise from transactions accounted for under ASC 606. This guidance is effective for the Company no later than January 1, 2026. The Company is still evaluating the impact of ASU 2025-05.
The Company does not believe the impact of any other recently issued standards and any issued but not yet effective standards will have a material impact on its condensed consolidated financial statements upon adoption.
3. Revenue
The Company recognizes revenue from the sale of PHEXX and SOLOSEC in accordance with ASC 606, Revenue from Contracts with Customers (ASC 606). The provisions of ASC 606 require the following steps to determine revenue recognition: (1) identify the contract(s) with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when (or as) the entity satisfies a performance obligation.
In
accordance with ASC 606, the Company recognizes revenue when its performance obligation is satisfied by transferring control of the product
to a customer. Any payments received before the Company satisfies its performance obligations are considered deferred revenue until the
obligations are satisfied. In accordance with the Company’s contracts with customers, control of the product is transferred upon
the conveyance of title, which occurs when the product is sold to and received by a customer. The Company’s customers are primarily
located in the U.S., and expected to begin in the fourth quarter of 2025, in the UAE, and consist of wholesale distributors, retail pharmacies,
and mail-order specialty pharmacies. Payment terms typically range from
The amount of revenue recognized by the Company is equal to the amount of consideration that is expected to be received from the sale of product to its customers. Revenue is only recognized when the performance obligation is satisfied. To determine whether a significant reversal will occur in future periods, the Company assesses both the likelihood and magnitude of any such potential reversal of revenue.
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Our products are sold to domestic customers at the Wholesale Acquisition Cost (WAC), or in some cases at a discount to WAC. However, the Company records product revenue net of reserves for applicable variable consideration. These types of variable consideration reduce revenue and include the following:
| ● | Distribution services fees | |
| ● | Prompt pay and other discounts | |
| ● | Product returns | |
| ● | Chargebacks | |
| ● | Rebates | |
| ● | Patient support programs, including our co-pay programs |
An estimate for variable consideration is made with each sale and is recorded in conjunction with the revenue being recognized. To calculate the variable consideration, the Company uses the expected value method and the estimated amounts are recorded as a reduction to accounts receivable or as a current liability based on the nature of the allowance and the terms of the related arrangements. An estimated amount of variable consideration may differ from the actual amount. At each balance sheet date, these provisions are analyzed and adjustments are made if necessary. Any adjustments made to these provisions would also affect net product revenue and earnings.
In accordance with ASC 606, the Company must make significant judgments to determine the estimate for certain variable consideration. For example, the Company must estimate the percentage of end-users that will obtain the product through public insurance such as Medicaid or through private commercial insurance. To determine these estimates, the Company relies on historical sales data showing the amount of various end-user consumer types, inventory reports from the wholesale distributors and mail-order specialty pharmacy, and other relevant data reports.
The specific considerations that the Company uses in estimating these amounts related to variable consideration are as follows:
Distribution services fees – The Company pays distribution service fees to its wholesale distributors and mail-order specialty pharmacies. These fees are a contractually fixed percentage of WAC and are calculated at the time of sale based on the purchase amount. The Company considers these fees to be separate from the customer’s purchase of the product and, therefore, they are recorded in other current liabilities on the condensed consolidated balance sheets.
Prompt pay and other discounts – The Company incentivizes its customers to pay their invoices on time through prompt pay discounts. These discounts are an industry standard practice, and the Company offers a prompt pay discount to each wholesale distributor and retail pharmacy customers. The specific prompt pay terms vary by customer and are contractually fixed. Prompt pay discounts are typically taken by the Company’s customers, so an estimate of the discount is recorded at the time of sale based on the purchase amount. Prompt pay discount estimates are recorded as contra trade accounts receivable on the condensed consolidated balance sheets.
The Company may also give other discounts to its customers to incentivize purchases and promote customer loyalty. The terms of such discounts may vary by customer. These discounts reduce gross product revenue at the time the revenue is recognized.
Product returns – Domestic customers have the right to return product that is within six months or less of the labeled expiration date or that is past the expiration date by no more than twelve months. PHEXX has a shelf life of 48 months. SOLOSEC has a shelf life of 60 months. The Company uses historical sales and return data to estimate future product returns. Product return estimates are recorded as other current liabilities on the condensed consolidated balance sheets.
Chargebacks – Certain government entities and covered entities (e.g., Veterans Administration, 340B covered entities, group purchasing organizations) are able to purchase products at a price discounted below WAC. The difference between the government or covered entity purchase price and the wholesale distributor purchase price of WAC will be charged back to the Company. The Company estimates the amount of each chargeback channel based on the expected number of claims in each channel and related chargeback that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Estimated chargebacks are recorded as contra trade accounts receivable on the condensed consolidated balance sheets.
Rebates – The Company is subject to mandatory discount obligations under the Medicaid and Tricare programs. The rebate amounts for these programs are determined by statutory requirements or contractual arrangements. Rebates are owed after the product has been dispensed to an end user and the Company has been invoiced. Rebates for Medicaid and Tricare are invoiced in arrears. The Company also has a commercial rebate program whereby certain customers receive a rebate as contractually arranged. The Company estimates the amount of rebates based on the expected number of claims and related cost that is associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Rebate estimates are recorded as other current liabilities on the condensed consolidated balance sheets.
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Patient support programs – The Company voluntarily offers a co-pay program to provide financial assistance to patients meeting certain eligibility requirements. The Company estimates the amount of financial assistance for these programs based on the expected number of claims and related cost associated with the revenue being recognized for product that remains in the distribution channel at the end of each reporting period. Patient support program estimates are recorded as other current liabilities on the condensed consolidated balance sheets.
The variable consideration discussed above was recorded in the condensed
consolidated balance sheets and consisted of $
4. Debt
Baker Notes (temporarily owned by Aditxt from December 11, 2023 through February 26, 2024 and owned by Future Pak, LLC since July 23, 2024)
On April 23, 2020, the Company entered into a Securities Purchase and Security
Agreement (the Baker Bros. SPA) with certain affiliates of Baker Bros. Advisors LP, as purchasers (the Baker Purchasers), and Baker Bros.
Advisors LP, as designated agent, pursuant to which the Company agreed to issue and sell to the Baker Purchasers (i) convertible senior
secured promissory notes (the Baker Notes) in an aggregate principal amount of up to $
The Baker Notes have a five-year
The
Baker Notes were callable by the Company on
On November 20, 2021, the Company entered into the first amendment to the
Baker Bros. Purchase Agreement (the First Baker Amendment), in which each Baker Purchaser had the right to convert all or any portion
of the Baker Notes into Common Stock at a conversion price equal to the lesser of (a) $
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The
First Baker Amendment extended, effective upon the Company’s achievement of the Financing Threshold, the affirmative covenant to
achieve $
On March 21, 2022, the Company entered into the second amendment to the
Baker Bros. Purchase Agreement (the Second Baker Amendment), which granted each Baker Purchaser the right to convert all or any portion
of the Baker Notes into Common Stock at a conversion price equal to the lesser of (a) $
On
September 15, 2022, the Company entered into the third amendment to the Baker Bros. Purchase Agreement (the Third Baker Amendment), pursuant
to which the conversion price was amended to $
On
December 19, 2022, the Company entered into the First Amendment to the Forbearance Agreement (the Amendment) effective as of December
15, 2022 to amend certain provisions of the Forbearance Agreement dated September 15, 2022. The Amendment revised the Forbearance Agreement
to (i) amend the Fifth Recital Clause to clarify that the Purchasers consent to any additional indebtedness pari passu, but not
senior to that of the Purchasers, in an amount not to exceed $
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On
March 7, 2023, Baker Bros. Advisors, LP (the Designated Agent) provided a Notice of Event of Default and Reservation of Rights (the Notice
of Default) relating to the Baker Bros. Purchase Agreement. The Notice of Default claimed that the Company failed to maintain the “Required
Reserve Amount” as required by the Third Baker Amendment. The Designated Agent, at the direction of the Baker Purchasers, accelerated
repayment of the outstanding balance payable. As a result, approximately $
On September 8, 2023, the Company entered into the Fourth Amendment to the Baker Bros. Purchase Agreement (the Fourth Baker Amendment) with the Baker Purchasers. The Fourth Amendment amends certain provisions within the Baker Bros. Purchase Agreement including:
| (i) | the rescission of the Notice of Default delivered to the Company on March 7, 2023 and waiver of the Events of Default named therein; | |
| (ii) | the waiver of any and all other Events of Default existing as of the Fourth Amendment date; | |
| (iii) | the removal of the conversion feature into shares of Company Common Stock, including the removal of any requirement to reserve shares of Common Stock for conversion of the Baker Notes as well as any registration rights related thereto; | |
| (iv) | the clarification that for the sole purpose of enabling ex-U.S. license agreements for such assets, any Patents, Trademarks or Copyrights acquired after the Effective Date shall be excluded from the definition of Collateral; and, | |
| (v) | the removal of the requirement
for the Company to achieve $ |
The
outstanding balance of the Baker Notes will continue to accrue interest at
The
Company paid the required $
Schedule of Cash payments Determined based Upon the Quarterly Global Net Revenue
| Quarterly global net revenue | Quarterly cash payment | |
| ≤ $5.0 million | ||
| >$5.0 million and ≤ $7.0 million | ||
| Greater than $7.0 million |
The quarterly cash payments became payable beginning in the fourth quarter of 2023 and have been timely paid since.
Regardless
of the percentage paid, the quarterly cash payment amounts, along with the $
The Fourth Amendment also granted the Company the ability to repurchase the principal amount and accrued and unpaid interest of the Baker Notes for up to a five-year period for the one-time Repurchase Price designated below:
Schedule of Repurchase Price Reduction
| Date of Notes’ Repurchase | Repurchase Price | |
| On or prior to September 8, 2024 | $ | |
| September 9, 2024-September 8, 2025 | $ | |
| September 9, 2025-September 8, 2026 | $ | |
| September 9, 2026-September 8, 2027 | $ | |
| September 9, 2027-September 8, 2028 | $ |
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The Company evaluated whether any of the Embedded Features required bifurcation as a separate component. The Company elected the fair value option (FVO) under ASC 825, Financial Instruments (ASC 825), as the Baker Notes are qualified financial instruments and are, in whole, classified as liabilities. Under the FVO, the Company recognized the debt instrument at fair value, inclusive of the Embedded Features, with changes in fair value related to changes in the Company’s credit risk being recognized as a component of accumulated other comprehensive loss in the condensed consolidated balance sheets. All other changes in fair value were recognized in the condensed consolidated statements of operations.
As part of the consideration for the Merger, on December 11, 2023, the Baker Purchasers signed an agreement to assign the Baker Notes to Aditxt (the December Assignment Agreement). Upon execution of the December Assignment Agreement, Aditxt assumed all terms under the Baker Notes, with Aditxt becoming the new senior secured debtholder of the Company, governed by the requirements under the Fourth Baker Amendment. The Baker Notes were re-assigned back to the Baker Purchasers on February 26, 2024 (the February Assignment Agreement).
Due
to the execution of the February Assignment Agreement, the Company reviewed the Baker Notes in accordance with ASC 470. The Baker Notes,
having been effectively terminated, were extinguished on February 26, 2024, resulting in removing the fair value of the old Baker Notes
of $
On
July 23, 2024, the Company consented to the transfer of ownership of the Baker Notes from Baker Brothers Life Sciences, 667, L.P., and
Baker Bros. Advisors, LP, each a Delaware limited partnership (collectively, Baker) to Future Pak, LLC (the Assignee) (the July 2024
Assignment). The terms of the Baker Notes were not changed in connection with the assignment from Baker to the Assignee. Due to the July
2024 Assignment, the Company reviewed the Baker Notes in accordance with ASC 470. The Baker Notes, having been effectively terminated,
were extinguished on July 23, 2024, resulting in removing the fair value of the old Baker Notes of $
The
Company did not repurchase the Baker Notes prior to September 8, 2025. As of September 30, 2025, the Baker Notes are recorded at
fair value in the condensed consolidated balance sheet as short-term Notes – carried at fair value with a total fair value of
$
On September 27, 2024, the Assignee, as agent for the Purchasers (in such capacity, the Designated Agent), provided a Notice of Event of Default and Reservation of Rights (the September 2024 Notice of Default) relating to the Securities Purchase and Security Agreement dated April 23, 2020, as amended, by and among the Company, Designated Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers). The September 2024 Notice of Default claims that by entering into arrangements to pay certain existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Baker Bros. SPA.
According to the Notice of Default, the Designated Agent has accelerated repayment of the outstanding principal balance owed by the Company under the Securities Purchase Agreement. If all Purchasers exercise the Section 5.7 Option (as defined below), the repurchase price would be equal to the total outstanding balance, including principal and accrued interest. Pursuant to Section 5.7(b) of the Baker Bros. SPA, upon the occurrence of an Event of Default, each Purchaser may elect, at its option, to require the Company to repurchase the Note held by such Purchaser (or any portion thereof) at a repurchase price equal to two times the sum of the outstanding principal balance and all accrued and unpaid interest thereon, due within three business days after such Purchaser delivers a notice of such election (the Section 5.7 Option).
On October 27, 2024, the Designated Agent sent an amended and supplemental notice to the Initial Notice of Default (the Amended Notice of Default) which added new claims of default based on the Company’s payment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services; allegedly triggering an Event of Default under Section 9.1(e) of the Baker Bros. Purchase Agreement, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the Baker Bros. SPA thereby provided notice to the Company that the Forbearance Agreement was terminated as of October 27, 2024.
On
November 8, 2024, the Designated Agent sent an amended and supplemental notice to
The Events of Defaults have not been waived or cured. The Company strongly disagrees with the Designated Agent’s claim that an Event of Default has occurred. The Company intends to vigorously contest any attempt by the Designated Agent and the Purchasers to exercise their default rights and remedies under the Baker Bros. SPA.
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Adjuvant Notes
On
October 14, 2020, the Company entered into a Securities Purchase Agreement (the Adjuvant Purchase Agreement) with Adjuvant Global
Health Technology Fund, L.P., and Adjuvant Global Health Technology Fund DE, L.P. (together, the Adjuvant Purchasers or Adjuvant), pursuant to
which the Company sold unsecured convertible promissory notes (the Adjuvant Notes) in aggregate principal amount of $
The
Adjuvant Notes have a five-year
Interest expense for the Adjuvant Notes consists of the following, and is included in convertible notes, net – Adjuvant on the condensed consolidated balance sheets as of September 30, 2025 and December 31, 2024 and in other expense, net on the condensed consolidated statements of operations for the three and nine months ended September 30, 2025 and 2024 (in thousands):
Schedule of Interest Expense
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Coupon interest | $ | $ | $ | $ | ||||||||||||
| Amortization of issuance costs | - | - | - | |||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
The
Adjuvant Notes are convertible, subject to customary
On April 4, 2022, the Company entered into the first amendment to the Adjuvant
Purchase Agreement (the Adjuvant Amendment). The Adjuvant Amendment extended the affirmative covenant to achieve $
The Adjuvant Notes contain various customary affirmative and negative covenants agreed to by the Company. On September 12, 2022, the Company was in default of the Adjuvant Notes due to the default with the Baker Notes under the cross-default provision. On September 15, 2022, the Company entered into a Forbearance Agreement (the Adjuvant Forbearance Agreement) with the Adjuvant Purchasers, pursuant to which the Adjuvant Purchasers agreed to forbear from exercising any of their rights and remedies during the Forbearance Period as defined in therein, but solely with respect to the specified events of default provided under the Adjuvant Forbearance Agreement.
Also
on September 15, 2022, the Company entered into the second amendment to the Adjuvant Purchase Agreement (the Second Adjuvant Amendment),
pursuant to which the conversion price per share was reduced to $
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The
Adjuvant Notes are accounted for in accordance with authoritative guidance for convertible debt instruments and are classified as current
liabilities in the condensed consolidated balance sheets. The aggregate proceeds of $
The Company was in default of the Adjuvant Notes as of September 30, 2023, due to the failure to meet the cumulative net sales requirement. However, Adjuvant forbore such default in October 2023 and therefore the Company is no longer in default.
As
of September 30, 2025, the Adjuvant Notes are recorded in the condensed consolidated balance sheet as convertible notes, net –
Adjuvant with a total balance of $
On
April 10, 2025, Aditxt, the Company and Adjuvant entered into a Call Option Agreement wherein Adjuvant granted to Aditxt, a call option to purchase, at the sole discretion
of Aditxt, all of the convertible Adjuvant Notes and Rights to receive Common Stock (the Securities) held by Adjuvant for an aggregate
purchase price of $
As
described in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit, on
August 22, 2025, the Company entered into an Exchange Agreement with Adjuvant providing for the exchange of a portion of the
Adjuvant Notes due in the aggregate original principal and accrued interest amount of approximately $
On October 13, 2025 the Company and the Adjuvant Purchasers entered into a third amendment to the Adjuvant Purchase Agreement (the Adjuvant Third Amendment).
The Adjuvant Third Amendment amends certain provisions including updating the date that the Adjuvant Notes will be payable in full to the earlier of (a) six months after the October 13, 2025, (b) at the election of Adjuvant, the date of a consummation of a Change of Control (as defined in the Adjuvant Purchase Agreement), and (c) the date of any acceleration of the Adjuvant Notes in accordance with Section 8 (the Maturity Date, as per the Adjuvant Purchase Agreement). The Adjuvant Notes may not be prepaid prior to the date that is six months after October 13, 2025 without prior written consent of Adjuvant.
Term Notes
Original SSNs and Exchanged SSNs
The
Company entered into eight Securities Purchase Agreements (SPAs) between December 2022 and September 2023 with certain investors;
each of the agreements was materially similar. Pursuant to each SPA, the Company agreed to sell in a registered direct offering (i)
unsecured
On December 1, 2023, the Company entered into restructuring agreements with the holders of the Original SSNs, pursuant to which the Company and each holder agreed to, among other things, to (i) change the governing law and jurisdiction of the Notes from New York to Delaware and (ii) reissue the Notes (the Exchanged SSNs) under Section 3(a)(9) exemption of the Securities Act of 1993, as amended (the Restructuring Agreements). The maturity date of the Exchanged SSNs is December 1, 2026. No new consideration was paid and, other than the maturity date, no other terms of the Original SSNs were changed in conjunction with the Restructuring Agreements.
Assuming
the applicable conversion price per share, the Exchanged SSNs could be converted into
The
Exchanged SSNs’ interest rates are subject to increase to
The Company evaluated the Original SSNs in accordance with ASC 480 and determined that the Original SSNs were all liability instruments at issuance. The applicable Original SSNs were then evaluated in accordance with the requirements of ASC 825 and the Company concluded that they were not precluded from electing the fair value option for the applicable Original SSNs.
Pursuant to the Restructuring Agreement, the Company evaluated the Exchanged SSNs under ASC 470 – Debt (ASC 470), and concluded that the exchange represented a non-substantial modification of the Original SSNs. Accordingly, the Company accounted for the Exchanged SSNs as a modification of the Original SSNs rather than as an extinguishment which would require derecognizing the fair value of Original SSNs and related accumulated other comprehensive loss and replacing them with the fair Exchanged SSNs.
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The Company also evaluated the warrants in accordance with ASC 480 and ASC 815 and as of both September 30, 2025 and December 31, 2024, the warrants are recorded in equity.
On
December 21, 2023, warrants to purchase up to
As
described in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit, on
August 22, 2025, the Company entered into Exchange Agreements with certain SSN holders providing for the exchange of a portion of
the SSNs due in the aggregate original principal and accrued interest amount of approximately $
Aditxt Notes and Warrants
On
April 8, 2025, the Company entered into a securities purchase agreement (the Aditxt April SPA) with Aditxt providing for the sale and
issuance of senior subordinated convertible notes due in the aggregate original principal amount of $
On
June 26, 2025, the Company entered into a securities purchase agreement (the Aditxt June SPA) with Aditxt providing for the sale and
issuance of senior subordinated convertible notes due in the aggregate original principal amount of $
In
both the Aditxt April Offering and the Aditxt June Offering, Aditxt paid approximately $
The Company evaluated the Aditxt April Notes and Aditxt June Notes in accordance with ASC 480 and determined that the notes were all liability instruments at issuance. The notes were then evaluated in accordance with the requirements of ASC 825 and the Company concluded that they were not precluded from electing the fair value option for the applicable Aditxt Notes.
The Company also evaluated the Aditxt April Warrants and the Aditxt June Warrants in accordance with ASC 480 and ASC 815 and as of September 30, 2025 the warrants are recorded in equity.
Summary of SSNs and Warrants at Issuance (December 2022 to September 2023 and April to June 2025):
Schedule of SSNs and Warrants
| Principal At Issuance | Net Proceeds Before Issuance | |||||||||||||||||||||
| Notes | (in Thousands) | costs (in Thousands) | Common Warrants | Preferred Shares | Original Maturity Date | Current Maturity Date |
||||||||||||||||
| December 2022 Notes(4) | $ | $ | (4) | |||||||||||||||||||
| February 2023 Notes(1)(4) | - | (4) | ||||||||||||||||||||
| March 2023 Notes(4) | - | (4) | ||||||||||||||||||||
| March 2023 Notes(2)(4) | - | (4) | ||||||||||||||||||||
| April 2023 Notes(4) | - | (4) | ||||||||||||||||||||
| July 2023 Notes(4) | - | (4) | ||||||||||||||||||||
| August 2023 Notes(4) | - | (4) | ||||||||||||||||||||
| September 2023 Notes(3)(4) | - | (4) | ||||||||||||||||||||
| Aditxt April Note | - | |||||||||||||||||||||
| Aditxt June Note | - | |||||||||||||||||||||
| Total Offerings | $ | $ | ||||||||||||||||||||
| (1) | |
| (2) | |
| (3) | |
| (4) |
Short-term Debt
Insurance Premium Finance Agreement
In
June 2024, the Company entered into an insurance premium finance agreement with First Insurance Funding (FIF) to finance a portion of
the year’s D&O and general insurance policies. The total amount financed was $
In
June 2025, the Company entered into an insurance premium finance agreement with First Insurance Funding (FIF) to finance a portion of
its current policy year’s Directors and Officers (D&O) and general insurance policies. The total amount financed was $
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5. Balance Sheet Details
Inventories
Inventories consist of the following (in thousands):
Schedule of Inventories
| September 30, 2025 | December 31, 2024 | |||||||
| Raw materials | $ | $ | ||||||
| Work in process | ||||||||
| Finished goods | ||||||||
| Total | $ | $ | ||||||
Prepaid and Other Current Assets
Prepaid and other current assets consist of the following (in thousands):
Schedule of Prepaid and Other Current Assets
| September 30, 2025 | December 31, 2024 | |||||||
| Insurance | $ | $ | ||||||
| Prescription Drug User Fee Act (PDUFA) fees | - | |||||||
| Outside service retainers | ||||||||
| Short-term deposits | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
Property and Equipment, Net
Property and equipment, net, consists of the following (in thousands):
Schedule of Property and Equipment Net
| Useful Life | September 30, 2025 | December 31, 2024 | ||||||||||
| Research equipment | $ | $ | ||||||||||
| Computer equipment and software | ||||||||||||
| Construction in-process | - | |||||||||||
| Property and equipment, gross | ||||||||||||
| Less: accumulated depreciation | ( | ) | ( | ) | ||||||||
| Total, net | $ | $ | ||||||||||
Depreciation expense for property and equipment was immaterial in each of the three and nine months ended September 30, 2025 and 2024, respectively.
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Intangible Asset, Net
Intangible asset, net, acquired in July 2024, consists of the following (in thousands):
Schedule of Intangible Assets, Net
| Useful Life | September 30, 2025 | December 31, 2024 | ||||||||
| Intellectual property | $ | $ | ||||||||
| Less: accumulated amortization | ( | ) | ( | ) | ||||||
| Total, net | $ | $ | ||||||||
The
intangible asset relates entirely to the asset acquired with the SOLOSEC asset acquisition and, as described further in Note
7 – Commitments and Contingencies, the useful life is based on the SOLOSEC IP patent expiration. Amortization expense was
$
Accrued Expenses
Accrued expenses consist of the following (in thousands):
Schedule of Accrued Expenses
| September 30, 2025 | December 31, 2024 | |||||||
| Clinical trial related costs | $ | - | $ | |||||
| Accrued royalty | ||||||||
| Accrued compensation for non-employee directors | ||||||||
| Other | ||||||||
| Total | $ | $ | ||||||
6. Fair Value of Financial Instruments
Fair Value of Financial Liabilities
The following tables summarize the Company’s debt instruments as of September 30, 2025 and December 31, 2024, respectively (in thousands):
Schedule of Fair Value of Financial Liabilities
| Principal | Accrued | Net Carrying | Fair Value | |||||||||||||||||
| As of September 30, 2025 | Amount | Interest | Amount | Amount | Leveling | |||||||||||||||
| Baker Notes(1)(2) | $ | $ | - | $ | $ | Level 3 | ||||||||||||||
| Adjuvant Notes(3) | N/A | N/A | ||||||||||||||||||
| December 2022 Notes(1) (4) | - | Level 3 | ||||||||||||||||||
| February 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| March 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| April 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| July 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| August 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| September 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| Aditxt Notes(1) | - | Level 3 | ||||||||||||||||||
| Totals | $ | $ | $ | $ | N/A | |||||||||||||||
| Principal | Accrued | Net Carrying | Fair Value | |||||||||||||||||
| As of December 31, 2024 | Amount | Interest | Amount | Amount | Leveling | |||||||||||||||
| Baker Notes(1)(2) | $ | $ | - | $ | $ | Level 3 | ||||||||||||||
| Adjuvant Notes(3) | N/A | N/A | ||||||||||||||||||
| December 2022 Notes(1) (4) | - | Level 3 | ||||||||||||||||||
| February 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| March 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| April 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| July 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| August 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| September 2023 Notes (1) (4) | - | Level 3 | ||||||||||||||||||
| Totals | $ | $ | $ | $ | N/A | |||||||||||||||
| (1) |
| (2) |
| (3) | |
| (4) |
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The following tables summarize the Company’s derivative liabilities as of September 30, 2025 and December 31, 2024 as discussed in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit (in thousands):
Schedule of Fair Value of Derivative Liabilities
| Fair Value | ||||||||||||
| September 30, 2025 | December 31, 2024 | Leveling | ||||||||||
| Purchase rights | $ | $ | Level 3 | |||||||||
| Total derivative liabilities | $ | $ | ||||||||||
Change in Fair Value of Level 3 Financial Liabilities
The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes, SSNs, and Aditxt Notes measured at fair value on a recurring basis for the three and nine months ended September 30, 2025 (in thousands):
Schedule of Change in Fair Value of Level 3 Financial Liabilities
Baker Notes (Assigned to Future Pak; Note 4) | Total SSNs and Aditxt Notes | Total | ||||||||||
| Balance at June 30, 2025 | $ | $ | $ | |||||||||
| Balance at issuance | ||||||||||||
| Extinguishment/conversion | - | ( | ) | ( | ) | |||||||
| Payments | ( | ) | - | ( | ) | |||||||
| Change in fair value presented in the condensed consolidated statements of operations | - | |||||||||||
| Change in fair value presented in the condensed consolidated statements of comprehensive operations | - | |||||||||||
| Exercises | ||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | |||||||||
Baker Notes (Assigned to Future Pak; Note 4) | Total SSNs and Aditxt Notes | Total | ||||||||||
| Balance at December 31, 2024 | $ | $ | $ | |||||||||
| Balance at issuance | - | |||||||||||
| Extinguishment/conversion | - | ( | ) | ( | ) | |||||||
| Payments | ( | ) | - | ( | ) | |||||||
| Change in fair value presented in the condensed consolidated statements of operations | - | |||||||||||
| Change in fair value presented in the condensed consolidated statements of comprehensive operations | ||||||||||||
| Balance at September 30, 2025 | $ | $ | $ | |||||||||
The following table summarizes the changes in Level 3 financial liabilities related to Baker Notes and SSNs measured at fair value on a recurring basis for the three and nine months ended September 30, 2024 (in thousands):
| Baker Notes (Assigned to Future Pak; Note 4) | Total SSNs (Note 4) | Total | ||||||||||
| Balance at June 30, 2024 | $ | $ | $ | |||||||||
| Balance at issuance | - | |||||||||||
| Extinguishment/conversion | ( | ) | - | ( | ) | |||||||
| Payments | ( | ) | - | ( | ) | |||||||
| Change in fair value presented in the condensed consolidated statements of comprehensive operations | ( | ) | ||||||||||
| Balance at September 30, 2024 | $ | $ | $ | |||||||||
Baker Notes (Assigned to Note 4) | Total SSNs (Note 4) | Total | ||||||||||
| Balance at December 31, 2023 | $ | $ | $ | |||||||||
| Balance at issuance | - | |||||||||||
| Extinguishment/conversion | ( | ) | ( | ) | ( | ) | ||||||
| Payments | ( | ) | - | ( | ) | |||||||
| Change in fair value presented in the condensed consolidated statements of comprehensive operations | ( | ) | ||||||||||
| Balance at September 30, 2024 | $ | $ | $ | |||||||||
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The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three and nine months ended September 30, 2025 (in thousands):
| Purchase Rights | Derivative Liabilities Total | |||||||
| Balance at June 30, 2025 | $ | $ | ||||||
| Exercises | - | - | ||||||
| Change in fair value presented in the condensed consolidated statements of operations | ||||||||
| Balance at September 30, 2025 | $ | $ | ||||||
| Purchase Rights | Derivative Liabilities Total | |||||||
| Balance at December 31, 2024 | $ | $ | ||||||
| Exercises | ( | ) | ( | ) | ||||
| Change in fair value presented in the condensed consolidated statements of operations | ( | ) | ( | ) | ||||
| Balance at September 30, 2025 | $ | $ | ||||||
The following table summarizes the changes in Level 3 financial liabilities related to derivative liabilities measured at fair value on a recurring basis for the three and nine months ended September 30, 2024 (in thousands):
| Purchase Rights | Derivative Liabilities Total | |||||||
| Balance at June 30, 2024 | $ | $ | ||||||
| Exercises | ( | ) | ( | ) | ||||
| Change in fair value presented in the condensed consolidated statements of operations | ( | ) | ( | ) | ||||
| Balance at September 30, 2024 | $ | $ | ||||||
| Purchase Rights | Derivative Liabilities Total | |||||||
| Balance at December 31, 2023 | $ | $ | ||||||
| Beginning balance | $ | $ | ||||||
| Balance at issuance | ||||||||
| Exercises | ( | ) | ( | ) | ||||
| Change in fair value presented in the condensed consolidated statements of operations | ( | ) | ( | ) | ||||
| Balance at September 30, 2024 | $ | $ | ||||||
| Ending balance | $ | $ | ||||||
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Valuation Methodology
Baker Notes
The
fair value of the Baker Notes is determined using a Monte Carlo simulation-based model and is subject to uncertainty due to the assumptions
used in the model. The fair value of the Baker Notes is sensitive to these estimated inputs made by management that are used in the calculation.
The Monte Carlo simulation takes into account several embedded features and factors and management inputs, including the exercise of
the repurchase rights, the Company’s future revenues, meeting certain debt covenants, the maturity term of the note and dissolution.
For the dissolution scenario, the cost approach, an adjusted net asset value method was used to determine the net recoverable value of
the Company, including an estimate of the fair value of the Company’s intellectual property. The estimated fair value of the Company’s
intellectual property was valued using a relief from royalty method which required management to make significant estimates and assumptions
related to forecasts of future revenue, and the selection of the royalty (
Exchanged SSNs and Aditxt Notes
The fair value of the Exchanged SSNs and Aditxt Notes issued, as described in Note 4 – Debt, were determined by estimating the fair value of the Market Value of Invested Capital (MVIC) of the Company on a going-concern basis. This was estimated using a form of the market approach where comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. An option-pricing model (OPM) was then applied to value the Exchanged SSNs by allocating the estimated MVIC through the Company’s capital structure including the more senior notes payoff in a hypothetical exit event. Under the OPM, each debt or equity class is modeled as a call option with a distinct claim on the total value of the Company. The option’s exercise price is based on the Company’s total value available for each participating security holder. By constructing a series of options in which the exercise price is set at incremental levels of value, which correspond to the value necessary for each level of equity to participate, we determined the incremental option value of each series. When multiplied by the percentage of ownership of each equity class participating, the result is the incremental value allocated to each class under that series.
Purchase Rights
The Adjuvant Purchase Rights and the May Note Purchase Rights (collectively Purchase Rights) are recorded as derivative liabilities in the condensed consolidated balance sheets. The Purchase Rights are valued using an OPM, like a Black-Scholes model, with changes in the fair value being recorded in the condensed consolidated statements of operations. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price and the expected term the Purchase Rights will be held prior to exercise and a risk-free interest rate.
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Warrants
Warrants are classified as equity and the Company re-evaluates the classification of its warrants at the close of each reporting period to determine their proper balance sheet classification. The warrants are valued using an OPM based on the applicable assumptions, which include the exercise price of the warrants, time to expiration, expected volatility of our peer group, risk-free interest rate, and expected dividends. The assumptions used in the OPM are considered level 3 assumptions and include, but are not limited to, the market value of invested capital, the cumulative equity value of the Company as a proxy for the exercise price, the expected term the warrants will be held prior to exercise, a risk-free interest rate, and probability of change of control event. Additionally, because the warrants are re-priced under certain provisions in the agreements, at each re-pricing event the Company must value the warrants using a Black-Scholes model immediately prior to and immediately following the re-pricing event. The incremental fair value is recorded as an increase to accumulated deficit and additional paid-in capital, in accordance with ASC 470.
SOLOSEC Asset Acquisition Intangible Asset and Contingent Liabilities
The
total consideration for the SOLOSEC asset acquisition included an up-front payment (paid at closing), sales-based payments to be paid
over the next
The fair value of the total consideration, including cash paid and future sales-based payments, is determined using a Monte Carlo simulation model, which assumes the Company’s revenue follows a geometric Brownian motion. Using specific revenue factors, including expected growth, risk adjustments, and revenue volatility, future revenues were simulated through the Earnout Term to assess whether sales-based payments would be triggered in each relevant period, as stipulated by the SOLOSEC Asset Purchase Agreement. The average output of the Monte Carlo simulations for each period provides the expected payment value, which is then discounted to its present value to derive the fair value of future sales-based payments and recorded as contingent liabilities. The discount rate is a market index rate based on the Company’s credit risk.
The fair value of the SOLOSEC contingent liabilities is subject to uncertainty due to the assumptions made by management that are used in the Monte Carlo simulation-based model. These factors include the estimated future SOLOSEC net revenue, the risk-neutral revenue calculation and simulation assumptions, payment timing, and the discount rate.
The fair value of the SOLOSEC contingent liabilities will be updated at each reporting period using the methodology described above. Any changes to the fair value will be recorded as an adjustment to the carrying value of both the contingent liabilities and the SOLOSEC IP intangible asset as per ASC 323, Investments – Equity Method and Joint Ventures (ASC 323). Periodic intangible amortization will also be prospectively updated based on the new fair value of the SOLOSEC IP.
7. Commitments and Contingencies
SOLOSEC
The Company reviewed the SOLOSEC acquisition in accordance with ASC 805, Business Combinations (ASC 805), including applying the screen test. In accordance with ASC 805, the Company engaged a third-party valuation specialist to estimate the fair value for the SOLOSEC IP as well as for the total consideration. Per the valuation, the fair value of the SOLOSEC IP exceeded 90% of the total consideration, which indicates that the screen test failed. Further, the Company did not acquire any substantive processes, which indicates that the acquisition is an asset acquisition rather than a business combination. The Company recorded the fair value of the future sales-based payments as contingent liabilities in accordance with ASC 450, Contingencies (ASC 450) and the fair value of the total consideration plus the transaction costs as an intangible asset in accordance with ASC 350, Intangibles (ASC 350).
Per
the Transition Services Agreement (TSA) entered into in conjunction with the SOLOSEC asset acquisition, the Company is committed to
purchasing finished goods inventory from the seller through a transition period ending in November 2026 at a pre-defined unit price.
The total expected commitment is approximately $
The Company is also obligated to pay a quarterly royalty, in amounts equal
to a certain percentage of the SOLOSEC net revenue, beginning July 14, 2024. There are
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Fleet Lease
In
December 2019, the Company and Enterprise FM Trust (the Lessor) entered into a Master Equity Lease Agreement whereby the Company leases
vehicles to be delivered by the Lessor from time to time with various monthly costs depending on whether the vehicles are delivered for
a term of
The
Company determined that the leased vehicles are accounted for as operating leases under ASC 842, Leases (ASC 842). In May and
June 2024, the Company extended the lease term by an additional
In the second and third quarter of 2025, the Company replaced the leased vehicles; the vehicles have a lease term of 24 months. In conjunction with the new leases, the Company assessed the incremental borrowing rate and also determined that the leased vehicles should be accounted for as operating leases under ASC 842.
Supplemental Financial Statement Information
Schedule of Lease Cost
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||||
| Lease Cost (in thousands) | Classification | 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Operating lease expense | Research and development | $ | $ | - | $ | $ | ||||||||||||
| Operating lease expense | Selling and marketing | |||||||||||||||||
| Operating lease expense | General and administrative | |||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||||
Schedule of Lease Term and Discount Rate
| Lease Term and Discount Rate | September 30, 2025 | December 31, 2024 | ||||||
| Weighted Average Remaining Lease Term (in years) | ||||||||
| Weighted Average Discount Rate | % | % | ||||||
Schedule of Operating Lease Maturities
| Maturity of Operating Lease Liabilities (in thousands) | September 30, 2025 | |||
| Remainder of 2025 (3 months) | $ | |||
| Year ending December 31, 2026 | ||||
| Year ending December 31, 2027 | ||||
| Total lease payments | ||||
| Less imputed interest | ( | ) | ||
| Total | $ | |||
Schedule of Supplement Cash Outflows in Operating Leases
| Nine Months Ended September 30, | ||||||||
| Other information (in thousands) | 2025 | 2024 | ||||||
| Operating cash outflows in operating leases | $ | $ | ||||||
| Non-cash addition to ROU assets and lease liabilities due to new leases | $ | $ | ||||||
Other Contractual Commitments
In
November 2019, the Company entered into a supply and manufacturing agreement with a third-party to manufacture PHEXX, with potential
to manufacture other product candidates, in accordance with all applicable current good manufacturing practice regulations. There were
$
Related Party Transactions
Windtree
On March 20, 2025, Windtree Therapeutics, Inc. (Windtree) and the Company entered into a License and Supply Agreement, as amended on March 28, 2025 (collectively, the Windtree License and Supply Agreement), wherein Windtree agreed to become a manufacturer and supplier of PHEXX. The Company expects to significantly reduce its COGS once the Company begins selling PHEXX manufactured under the Windtree License and Supply Agreement. The Company will not have any financial obligations until submitting a binding forecast six months prior to the scheduled manufacturing date. Because Saundra Pelletier, the Company’s CEO, is also on the board of Windtree, the Company evaluated the relationship between the entities and determined that Windtree is a related party of the Company. Due to the related party nature of the entities, the Company will add additional disclosures around any transactions that occur between the companies under the Windtree License and Supply Agreement once they begin; as of the date of this Quarterly Report, no transactions have been started.
Aditxt
Aditxt was considered a related party of the Company during the three and nine months ended September 30, 2025 because Saundra Pelletier, the Company’s Chief Executive Officer, served as a member of Aditxt’s Board of Directors from June 9, 2025 until September 23, 2025. Ms. Pelletier’s term expired on that date.
Merger
On
July 14, 2024, the Company entered into an Amended and Restated Agreement and Plan of Merger (the “A&R Merger
Agreement”) with Aditxt, Inc. (“Aditxt”), pursuant to which Aditxt was expected to acquire the Company in an
all-stock transaction. The A&R Merger Agreement was amended several times, including the Sixth Amendment to the A&R Merger
Agreement, entered into on August 26, 2025 (the Sixth Amendment). The Sixth Amendment was entered into to
On October 20, 2025, the Company terminated the A&R Merger Agreement after the proposed merger was not approved by the Company’s stockholders. No termination fee or other cash consideration was paid by either party, and no further obligations remain under the agreement.
Notes
As
discussed in Note 4 – Debt, on April 8, 2025 and June 26, 2025, the Company entered into two securities purchase
agreements with Aditxt (the Aditxt April Note and the Aditxt June Note). Under these agreements the Company
issued senior subordinated convertible notes in the aggregate original principal amount of $
Adjuvant
Because Adjuvant has significant voting power due to its increased beneficial ownership limitation, the Company evaluated the relationship between the entities and determined that Adjuvant is a related party of the Company. Except for the exchange from the Adjuvant Notes to Series G-1 Shares during the third quarter of 2025 as described in Note 8 – Convertible and Redeemable Preferred Stock and Stockholders’ Deficit, and the Adjuvant Third Amendment as described and defined in Note 10 – Subsequent Events, there was no other transaction occurred between two entities in 2025.
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Contingencies
From time to time the Company may be involved in various lawsuits, legal proceedings, or claims that arise in the ordinary course of business. As of September 30, 2025, there were no other claims or actions pending against the Company which management believes have a probable, or a reasonably possible, probability of an unfavorable outcome other than the TherapeuticsMD, Inc. (TherapeuticsMD) dispute as described below.
During
the nine months ended September 30, 2025, the Company settled a portion of its trade payables with numerous vendors, which resulted in
a $
On
December 14, 2020, a trademark dispute captioned TherapeuticsMD, Inc. v Evofem Biosciences, Inc., was filed in the U.S. District Court
for the Southern District of Florida against the Company, alleging trademark infringement of certain trademarks owned by TherapeuticsMD
under federal and state law (Case No. 9:20-cv-82296). On July 18, 2022, the Company settled the lawsuit with TherapeuticsMD, with certain
requirements which were required to be performed by July 2024 (the Settlement Timeline), including changing the name of PHEXX. The Company
failed to meet the terms of the settlement agreement by the Settlement Timeline. As a result, the Company is currently working with TherapeuticsMD
on resolution of this issue. In September 2024, the Company filed an application for a new name, which was approved by the FDA in April
2025. The Company is advancing its re-branding plans and timeline. In accordance with ASC 450, the Company has accrued the present value
of the probable settlement amounts remaining payable over the next several years, which was $
As of September 30, 2025, the Company has received multiple letters from purported Company stockholders demanding that the Company’s board of directors take action on behalf of the Company to remedy allegations regarding the Company’s disclosures to shareholders with respect to various alleged omissions of material information in both its preliminary proxy statement filed September 23, 2024 and definitive proxy statement filed September 8, 2025 relating to the A&R Merger Agreement, as amended, and demands made under Section 220 of the DGCL for books and records related to the transaction and disclosures in the proxy statement. The Company believes all such demands are without merit. Furthermore, on October 20, 2025, the Company terminated the A&R Merger Agreement after the Merger was not approved by the required number of shareholders at the Special Meeting as further discussed in Note 10 – Subsequent Events. The Company continues to work with each of the firms representing the stockholders to resolve.
On
September 27, 2024, Future Pak, LLC, as agent for the Purchasers (in such capacity, the Designated Agent) provided a Notice of Event
of Default and Reservation of Rights (the Notice of Default) relating to the Baker Bros. SPA, as amended, by and among the Company, Designated
Agent, as certain guarantors and the purchasers (each a Purchaser and collectively Purchasers). The Notice of Default claims that by
entering into arrangements to repay certain existing obligations, including obligations owed to the U.S. Department of Health and Human
Services, an Event of Default has occurred under Section 9.1(e) of the Baker Bros. SPA.
On October 27, 2024, the Designated Agent sent an amended and supplemented notice to the Notice of Default which adds additional claims of default based on the Company’s current repayment agreements of existing obligations, including obligations owed to the U.S. Department of Health and Human Services, an Event of Default has occurred under Section 9.1(e) of the Securities Purchase and Security Agreement dated April 23, 2020, as amended. Furthermore, the Amended Notice stated that, because the events of default described in the Amended Notice of Default are not the certain prior events of default listed in the Forbearance Agreement (the Specified Defaults), the Designated Agent and the holders of the senior secured promissory notes described in the Baker Bros. SPA thereby provided notice to the Company that the Forbearance Agreement is terminated as of October 27, 2024. The Company strongly disagrees with the Designated Agent’s claim that any Event of Default has occurred.
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On
November 8, 2024, the Designated Agent sent an amended and supplemented notice to
Intellectual Property Rights
In
2014, the Company entered into an amended and restated license agreement (the Rush License Agreement) with Rush University Medical
Center (Rush University), pursuant to which Rush University granted the Company an exclusive, worldwide license of a patent and
certain know-how related to its vaginal pH modulator technology (US6706276, the Rush Patent). Pursuant to the Rush License
Agreement, until the expiration of the Rush Patent, the Company was obligated to pay Rush University an earned royalty during the
patent term, calculated as a mid-single digit percentage of PHEXX net sales (the Rush Royalty). In September 2020, the Company
entered into the first amendment to the Rush License Agreement, pursuant to which the Company agreed to pay a minimum annual royalty
amount of $
The Rush Patent would expire on March 6, 2021 (the Original Expiration Date) if no PTE was obtained. Rush University filed an application for PTE in July 2020, which would extend the expiration date of the Rush Patent to March 6, 2026 if granted. Multiple Orders Granting Interim Extension (OGIEs) were received from the U.S. Patent and Trademark Office (USPTO) while the PTE was under evaluation. The last OGIE expired on March 6, 2025.
Because
the USPTO had granted multiple OGIEs to Rush University, between the date of the original PTE application (July 2020) and the final
OGIE expiration (March 2025), the Company determined it was probable that the PTE extending the expiration to March 6, 2026 would
be granted. Therefore, the Company accrued a total of $
During
the first quarter of 2025, the Company’s legal counsel ascertained that no further OGIEs were granted after March 6, 2025 and the
PTE had also still not been granted. As a result, the Company discontinued accruing the Rush Royalty since, based on the new information,
the Company deemed it remote that the PTE would ultimately be granted. Amounts previously accrued under the rush License Agreement were still being assessed at that time and as such, no
adjustments were made. No royalty costs were recorded for the three and nine months ended
September 30, 2025. For the three and nine months ended September 30, 2024, $
Furthermore, in August 2025 the
FDA confirmed that the relevant active ingredient covered by the Rush Patent had previously been used in other FDA-approved products and,
as such, no PTE should be granted, the Company and its legal counsel determined that the Rush Patent expired on the Original Expiration
Date and as such it is no longer probable that the Company will be required to pay any expenses related to the Rush Royalty accrued after
that date. The Company reversed the outstanding accrued Rush Royalty contingent liability of $
If the Company determines
to pursue a refund of the estimated royalties paid but not earned per its current analysis, it could potentially receive a refund of $
Our vaginal pH modulator (PHEXX) remains protected in the U.S. by four Orange Book patents which are solely-owned by Evofem.
8. Convertible and Redeemable Preferred Stock and Stockholders’ Deficit
Warrants
In
April and June 2020, pursuant to the Baker Bros. Purchase Agreement, as discussed in Note 4 – Debt, the Company issued warrants
to purchase up to
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In May 2022, the Company completed an underwritten public offering (the
May 2022 Public Offering) which included the issuance of common warrants to purchase
In
June 2022, as required by the Second Baker Amendment, the Company issued the June 2022 Baker Warrants to purchase up to
In
February, March, April, July, August, and September 2023, pursuant to the SSNs as discussed in Note 4 – Debt, the Company issued
warrants to purchase up to
On
December 21, 2023, warrants to purchase up to
As
of September 30, 2025, warrants to purchase up to
Schedule of Warrants
| Type of Warrants | Underlying Common Stock to be Purchased | Exercise Price | Issue Date | Exercise Period | ||||||||||
| Common Warrants | $ | April 11, 2019 | ||||||||||||
| Common Warrants | $ | June 10, 2019 | ||||||||||||
| Common Warrants | $ | January 13, 2022 | ||||||||||||
| Common Warrants | $ | March 1, 2022 | ||||||||||||
| Common Warrants | $ | May 4, 2022 | ||||||||||||
| Common Warrants | $ | May 24, 2022 | ||||||||||||
| Common Warrants | $ | June 28, 2022 | ||||||||||||
| Common Warrants | $ | December 21, 2022 | ||||||||||||
| Common Warrants | $ | February 17, 2023 | ||||||||||||
| Common Warrants | $ | March 20, 2023 | ||||||||||||
| Common Warrants | $ | April 5, 2023 | ||||||||||||
| Common Warrants | $ | July 3, 2023 | ||||||||||||
| Common Warrants | $ | August 4, 2023 | ||||||||||||
| Common Warrants | $ | September 27, 2023 | ||||||||||||
| Common Warrants | $ | April 8, 2025 | ||||||||||||
| Common Warrants | $ | June 26, 2025 | ||||||||||||
| Prefunded Common Warrants | $ | September 27, 2023 | ||||||||||||
| Total | ||||||||||||||
Preferred Stock
Effective
December 15, 2021, the Company amended and restated its certificate of incorporation, under which the Company is currently authorized
to issue up to
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Convertible and Redeemable Preferred Stock
On
August 7, 2023, the Company filed a Certificate of Designation of Series E-1 Convertible Preferred Stock (E-1 Certificate of Designation),
par value $
On
August 7, 2023, certain investors party to the December 2022 Notes and the February 2023 Notes exchanged $
On
December 11, 2023, the Company filed a Certificate of Designation of Series F-1 Convertible Preferred Stock (F-1 Certificate of Designation),
par value $
On
December 21, 2023, the Company issued a total of
During
the second half of 2024, as part of the funding requirement by Aditxt pursuant to the A&R Merger Agreement, the Company issued a
total of
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On
August 22, 2025, the Company filed a Certificate of Designations creating the Series G-1 Preferred Stock (G-1 Certificate of Designations),
par value $
The fair value of the G-1 Shares issued was determined by estimating the fair value of the MVIC of the Company on a going-concern basis. This was estimated using a form of the market approach where comparable market revenue multiples were selected and applied to the Company’s forward revenue forecast to ultimately derive a MVIC indication. An OPM was then applied to value the G-1 Shares by allocating the estimated MVIC through the Company’s capital structure including the more senior notes payoff in a hypothetical exit event. Under the OPM, each debt or equity class is modeled as a call option with a distinct claim on the total value of the Company. The option’s exercise price is based on the Company’s total value available for each participating security holder. By constructing a series of options in which the exercise price is set at incremental levels of value, which correspond to the value necessary for each level of equity to participate, we determined the incremental option value of each series. When multiplied by the percentage of ownership of each equity class participating, the result is the incremental value allocated to each class under that series.
Common Stock
Effective
September 14, 2023, the Company further amended its amended and restated certificate of incorporation to increase the number of authorized
shares of Common Stock to
Purchase Rights
On
September 15, 2022, the Company entered into certain exchange agreements with the Adjuvant Purchasers and the May 2022 Notes Purchasers
to exchange, upon request, the Purchase Rights for an aggregate of
In
connection with the SSNs issuances, during the three and nine months ended September 30, 2024, the Company increased the number of
outstanding Purchase Rights by
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Common Stock Reserved for Future Issuance
Common Stock reserved for future issuance is as follows in common equivalent shares as of September 30, 2025:
Summary of Common Stock Reserved for Future Issuance
| Common Stock issuable upon the exercise of stock options outstanding | ||||
| Common Stock issuable upon the exercise of Common Stock warrants | ||||
| Common Stock available for future issuance under the 2019 ESPP | ||||
| Common Stock available for future issuance under the Amended Inducement Plan | ||||
| Common Stock reserved for the exercise of purchase rights | ||||
| Common Stock reserved for the conversion of convertible notes | ||||
| Common Stock reserved for the conversion of series E-1 preferred stock | ||||
| Total Common Stock reserved for future issuance(1) |
| (1) |
9. Stock-based Compensation
Equity Incentive Plans
Schedule of Stock-based Compensation Expense Related to Stock Options
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Research and development | $ | - | $ | $ | $ | |||||||||||
| Selling and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Total | $ | $ | $ | $ | ||||||||||||
Stock Options
As of September 30, 2025, unrecognized stock-based compensation expense
for employee stock options was approximately $
10. Subsequent Events
Termination of Aditxt Merger
On October 20, 2025, the Company held a Special Meeting of Stockholders. After the Company’s stockholders did not approve the transactions contemplated by the A&R Merger Agreement, the Company delivered a notice of termination to Aditxt notifying it that the Company was exercising its right to terminate the A&R Merger Agreement effective October 20, 2025. The termination was in accordance with (i) Section 8.1(b)(ii), which allows either party to terminate the A&R Merger Agreement if the Merger shall not have been consummated on or before 5:00 p.m. Eastern Time, on September 30, 2025, and (ii) as per Section 8.1(b)(iv), which allows either party to terminate the A&R Merger Agreement if the Company Shareholder Approval shall not have been obtained at a duly held Company Shareholders Meeting at which a vote was taken on the approval of the Agreement and the Transactions, including the Merger.
As a result of the termination of the A&R Merger Agreement, all other ancillary agreements related to the A&R Merger Agreement, with the exception of the obligations under the Non-Disclosure Agreement, entered into by and between the Company and Aditxt, as of October 23, 2023, terminated concurrently with the termination of the A&R Merger Agreement. No consideration was paid in connection with the termination.
Adjuvant Third Amendment
On October 13, 2025 the Company and the Adjuvant Purchasers entered into the Adjuvant Third Amendment, which amends certain provisions within the Adjuvant Purchase Agreement including updating the date that the Notes will be payable in full to the earlier of (a) six months after the October 13, 2025, (b) at the election of Adjuvant, the date of a consummation of a Change of Control (as defined in the Adjuvant Purchase Agreement), and (c) the date of any acceleration of the Adjuvant Notes in accordance with Section 8 (the Maturity Date, as per the Adjuvant Purchase Agreement). The Adjuvant Notes may not be prepaid prior to the date that is six months after October 13, 2025 without prior written consent of Adjuvant.
2025 Equity Incentive Plan
On October 3, 2025, our board
of directors approved, and recommended our stockholders to approve at our annual meeting to be held on November 26, 2025, the 2025 Equity
Incentive Plan (the “2025 Plan”), with a maximum of
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The terms “we,” “us,” “our,” “Evofem” or the “Company” refer collectively to Evofem Biosciences, Inc. and its wholly-owned subsidiaries, unless otherwise stated. All information presented in this quarterly report on Form 10-Q (Quarterly Report) is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years.
You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this Quarterly Report. Some of the information contained in this discussion and analysis is set forth elsewhere in this Quarterly Report, including information with respect to our plans and strategy for our business and related financing, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report, our actual results could differ materially from the results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.
Overview
We are a San Diego-based commercial-stage biopharmaceutical company with a strong focus on innovation in women’s health. We currently commercialize two FDA-approved products: PHEXX® (lactic acid, citric acid and potassium bitartrate) vaginal gel and SOLOSEC® (secnidazole) 2 g oral granules.
Approved by the FDA on May 22, 2020, PHEXX is the first and only non-hormonal prescription contraceptive gel. It is locally acting, with no systemic activity, and used on-demand by women only when they have sex. Because PHEXX is a non-hormonal contraceptive, it is not associated with side effects of exogenous hormone use, which include depression, weight gain, headaches, loss of libido, mood swings and irritability. Taking hormones may not be right for some women, especially those with certain medical conditions, including clotting disorders hormone-sensitive cancer, diabetes, or a BMI over 30, or those who are breast feeding or who smoke. Per the National Center for Health Statistics (NCHS), more than 23.3 million women in the U.S. will not use a hormonal contraceptive.
Evofem has delivered PHEXX net sales growth in each consecutive year since it was launched in September 2020. Key growth drivers for 2025 include social media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like Ozempic, Mounjaro and Zepbound for weight loss. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Per the United States Prescribing Information (USPI), prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times.
In July 2024 we acquired global rights to SOLOSEC. This FDA-approved single-dose oral antimicrobial agent provides a complete course of therapy for the treatment of two common sexual health infections – bacterial vaginosis (BV) and trichomoniasis. The SOLOSEC acquisition aligns with and advances our mission to improve access to innovative and differentiated options that impact women’s daily lives. We expect commercialization of SOLOSEC will benefit from our commercial infrastructure and strong physician relationships.
We intend to expand the global reach of our products and further increase our global potential through ex-U.S. partnerships or licensing agreements for PHEXX and SOLOSEC.
We licensed exclusive commercial rights for PHEXX in MENA to Pharma 1 Drug Store, an emerging Emirati health care company. Under the License and Supply Agreement dated on July 17, 2024, as amended on May 3, 2025, the licensed territory includes the UAE, Kuwait, Saudi Arabia, Qatar, Oman, and Jordan, with potential to expand into 15 other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell PHEXX, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply product to Pharma 1 at cost-plus. Pharma 1 filed for regulatory approval of PHEXX in the UAE in June 2025.
The Company also licensed commercial rights to SOLOSEC in MENA to Pharma 1 on May 19, 2025. Under this agreement, the licensed territory includes the UAE, Kuwait, Saudi Arabia, Qatar, Oman, and Jordan, with potential to expand into 15 other countries in the region. Pharma 1 is responsible for obtaining and maintaining any regulatory approvals required to market and sell SOLOSEC, and will handle all aspects of distribution, sales and marketing, pharmacovigilance and all other commercial functions in these countries. Evofem will supply product to Pharma 1 at a specified cost per unit. Pharma 1 filed for regulatory approval of SOLOSEC in the UAE in September 2025.
Additionally, PHEXX was approved in Nigeria on October 6, 2022, as Femidence™ by the National Agency for Food and Drug Administration and Control. PHEXX has also been submitted for approval in Mexico, Ethiopia and Ghana.
We halted clinical development of our investigational product candidates in October 2022 to focus resources on growing domestic sales of PHEXX for the prevention of pregnancy.
In the second quarter of 2025, enrollment commenced in an investigator-led randomized, open-label, parallel Phase 4 clinical trial to evaluate the efficacy and cost-effectiveness of secnidazole (SOLOSEC® 2 g, one dose administered one time) versus metronidazole (Flagyl® 500 mg, administered twice daily for seven days) for the treatment of trichomoniasis in men and women. Study investigators hypothesize that, in the current clinical trial, the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi-dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. This trial is funded directly by the National Institutes of Health (NIH).
In an investigator-led clinical study of SOLOSEC in 24 women with recurrent bacterial vaginosis (BV), once-weekly dosing with demonstrated efficacy matching or potentially surpassing outcomes of current CDC-recommended suppressive treatments. These promising results underscore SOLOSEC’s potential to redefine the standard of care for recurrent BV – offering a simpler treatment option for long-term symptom control. The study was presented at the 2025 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting.
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PHEXX as a Contraceptive; Commercial Strategies
In September 2020, we commercially launched PHEXX in the United States. Our sales force promotes PHEXX directly to obstetrician/gynecologists and their affiliated health professionals, who collectively write the majority of prescriptions for contraceptive products. Our sales force comprises approximately 16 regional sales representatives, two business directors and a Senior Vice President of Commercial Operations. Additionally, we offer women direct access to PHEXX via a telehealth platform. Using this platform, women can directly meet with an HCP to determine their eligibility for a PHEXX prescription and, if eligible, have the prescription written by the HCP, then filled and mailed directly to them by a third-party pharmacy.
Our comprehensive commercial strategy for PHEXX includes marketing and product awareness campaigns targeting HCPs and women of reproductive potential in the U.S., including the approximately 23.3 million women who are not using hormonal contraception and the approximately 20.0 million women who are using a prescription contraceptive, some of whom, particularly oral birth control pill users, may be ready to move to an FDA-approved, non-invasive, non-systemic hormone-free contraceptive, as well as certain identified target HCP segments. In addition to marketing and product awareness campaigns, our commercial strategy includes payer outreach and execution of our consumer digital and media strategy.
Key growth drivers for 2025 include social media campaigns, participation in strategic medical conferences, and initiatives to expand use of PHEXX in women who take oral birth control pills in conjunction with GLP-1 prescription medications like Ozempic, Mounjaro and Zepbound for weight loss. These drugs may make oral birth control pills less effective at certain points in the dosing schedule. Per the USPI, prescribers are instructed to “advise patients using oral contraceptives to switch to a non-oral contraceptive method or add a barrier method” to prevent unintended pregnancy during these times.
We continue working to increase the number of lives covered and to gain a preferred formulary position for PHEXX.
Previous contracting efforts have validated our access strategy. With PHEXX approval rates consistently above 80%, the Company has shifted from broad payer contracting to strengthening pharmacy partnerships. In 2025, we expanded our network in two of our highest-volume markets — California and the Northeast — by adding new partners in California and a regional distributor with more than 90 pharmacies in the Northeast. These targeted partnerships represent low-hanging fruit in high-demand areas, improving patient access while supporting more cost-effective and scalable pull-through.
Since the second quarter of 2022, we have been under contract with one of the largest pharmacy benefit managers (PBMs) in the nation, which added PHEXX to its formulary with no restrictions for most women covered by the plan. The agreement was retroactive and took effect January 1, 2022 and is representative of approximately 46 million lives.
An additional 13.7 million lives are covered under our December 2020 contract award from the U.S. Department of Veterans Affairs.
We also participate in government programs, including the 340B and the Medicaid Drug Rebate Program. As a result of our participation in the Medicaid National Drug Rebate Program, the U.S. Medicaid population gained access to PHEXX on January 1, 2021. As of May 2025, Medicaid provides health coverage to approximately 70.5 million members; nearly two-thirds of adult women enrolled in Medicaid are in their reproductive years (19-44). Additionally, we began participating in a 340B Group Purchasing Organization (GPO) that serves safety-net clinics throughout the U.S. in June 2024. This GPO has over 6,500 members, which expands our reach among safety-net providers.
As of July 2025, approximately 86% of commercial and Medicaid PHEXX prescriptions are being approved by payers.
PHEXX is classified in the databases and pricing compendia of Medi-Span and First Databank, two major drug information databases that payers can consult for pricing and product information, as the first and only “Vaginal pH Modulator.”
Effective as of January 1, 2023, most insurers and PBMs must provide coverage, with no out-of-pocket costs (e.g., $0 copay) to the subscriber or dependent, for FDA-approved contraceptive products, like PHEXX, prescribed by healthcare providers.
To comply with these federal guidelines, payers are increasingly covering PHEXX by:
| – | Adding PHEXX to formulary (commercial insurers) or preferred drug list (Medicaid) | |
| – | Removing the requirement for a Prior Authorization letter from the HCP (commercial insurers) | |
| – | Moving PHEXX to $0 copay (commercial insurers) |
In 2022, Evofem developed and introduced a new contraceptive educational chart for patients and HCPs that details high-level information about birth control methods currently available to women in the U.S., including the vaginal pH modulator. This new contraceptive educational tool has been extremely well received and has had a positive impact with HCPs and patients alike.
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SOLOSEC
In July 2024, we expanded our commercial portfolio by acquiring global rights to SOLOSEC® (secnidazole) 2 g oral granules, a single-dose oral antimicrobial agent that provides a complete course of therapy with just one dose for the treatment of two common sexual health infections. SOLOSEC is FDA-approved for the treatment of:
| 1) | Bacterial vaginosis (BV), a common vaginal infection, in females 12 years of age and older, and | |
| 2) | Trichomonas vaginalis, a common sexually transmitted infection (STI), in people 12 years of age and older. |
SOLOSEC has the same call point as PHEXX, enabling us to leverage our commercial infrastructure and strong physician relationships. We re-launched the brand in November 2024.
Bacterial Vaginosis
Bacterial vaginosis (BV) affects an estimated 21 million women in the U.S., approximately 29% of the U.S. population, making it the most common vaginal condition in women ages 15-44. It results from an overgrowth of bacteria, which upsets the balance of the natural vaginal microbiome and can lead to symptoms including odor and discharge. Of interest, BV raises the pH of the vagina, making it a more friendly environment for trichomoniasis and other STIs; approximately 20% of BV patients also have trichomoniasis.
If left untreated, BV can have serious health consequences. Untreated or improperly treated BV is associated with increased risk of infection with STIs like HPV, herpes, trichomoniasis, chlamydia, gonorrhea, and HIV, as well as transmission of STIs to a partner. Additional risks include developing pelvic inflammatory disease (PID), which can threaten a woman’s fertility, and complications with gynecological surgery.
Research has shown that as many as 50% of patients with BV do not adhere to a full course of metronidazole treatment (500mg BID x 7d) 14 doses. 58% of women who do not complete therapy will have a recurrence within one year. Noncompliance to a multiple-day metronidazole regimen is a contributing factor to persistent BV.
In clinical trials, SOLOSEC demonstrated clinically and statistically significant efficacy in the treatment of BV with just one dose; 68% of patients treated with SOLOSEC did not require any additional treatment for BV. Guidelines from the American College of Obstetricians and Gynecologists (ACOG) in 2020 and the U.S. Centers for Disease Control (CDC) in 2021 each include single dose SOLOSEC for the treatment of BV.
In May 2025, an investigator-led clinical trial entitled ‘Once Weekly Secnidazole Granules for the Treatment of Recurrent Bacterial Vaginosis’ was presented at the 2025 ACOG Annual Clinical and Scientific Meeting; the abstract was subsequently published in Obstetrics & Gynecology. In this focused clinical study of 24 women with recurrent BV, once-weekly dosing with SOLOSEC demonstrated efficacy matching or potentially surpassing outcomes of current CDC-recommended suppressive treatments. These promising results underscore SOLOSEC’s potential to redefine the standard of care for recurrent BV by offering a simpler treatment option for long-term symptom control.
Trichomoniasis
Trichomoniasis (Trich) is the most common non-viral STI in the world. It is caused by a parasite called Trichomonas vaginalis and affects both women and men. All sexual partners of an infected person must be treated to prevent reinfection with the parasite. In 2018, there were an estimated 6.9 million new T. vaginalis infections in the U.S. According to the CDC, the U.S. prevalence of T. vaginalis is 2.1% among females and 0.5% among males, with the highest rates among Black females (9.6%) and Black males (3.6%). A study of STD clinic attendees in Birmingham, Alabama, identified a prevalence of 27% among women and 9.8% among men. Approximately 70% of women with trichomoniasis are also infected with the bacteria that cause BV.
In clinical trials, a single dose of SOLOSEC demonstrated a cure rate of 92.2% for Trich in women, while reported cure rates in males range from 91.7%-100%.
SOLOSEC’s one-and-done dosing and the resulting high level of compliance is believed to be a significant differentiator. Non-compliance to a multi-day metronidazole regimen is a contributing factor to persistent Trich or BV; and ACOG and the CDC no longer recommend single dose metronidazole to treat Trich in women.
A Phase 4 investigator-led randomized, open-label, parallel arm clinical trial is underway to evaluate the efficacy and cost-effectiveness of secnidazole (SOLOSEC 2 g, one dose administered one time) versus metronidazole (Flagyl® 500 mg, administered twice daily for seven days) for the treatment of trichomoniasis in men and women. Study investigators hypothesize that, in the current clinical trial, the rate of repeat infections with T. vaginalis will be 1.75 lower in the SOLOSEC arm versus the multi- dose oral metronidazole arm and that single-dose SOLOSEC will have higher initial cost but will be more cost effective compared to multi-dose metronidazole, largely due to lower breakthrough rates of infection. This trial is funded by the National Institutes of Health (NIH).
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Recent Developments
Aditxt Merger Termination
On July 12, 2024, the Company entered into an Agreement and Plan of Merger, as amended, (the A&R Merger Agreement) with Aditxt, Inc., a Delaware corporation (Aditxt), and Adifem, Inc., a Delaware corporation and wholly-owned Subsidiary of Aditxt (Merger Sub), pursuant to which, and on the terms and subject to the conditions thereof, Merger Sub will merge with and into the Company, with the Company surviving as a wholly owned subsidiary of Aditxt (the Merger).
On October 20, 2025, the Company held a Special Meeting of Stockholders. After the Company’s stockholders did not approve a proposal to approve the transactions contemplated by the A&R Merger Agreement, the Company delivered a notice of termination to Aditxt notifying it that the Company was exercising its right to terminate the A&R Merger Agreement effective October 20, 2025. The termination was in accordance with (i) Section 8.1(b)(ii), which allows either party to terminate the A&R Merger Agreement if the Merger shall not have been consummated on or before 5:00 p.m. Eastern Time, on September 30, 2025, and (ii) as per Section 8.1(b)(iv), which allows either party to terminate the A&R Merger Agreement if the Company Shareholder Approval shall not have been obtained at a duly held Company Shareholders Meeting at which a vote was taken on the approval of the Agreement and the Transactions, including the Merger.
As a result of the termination of the A&R Merger Agreement, all other ancillary agreements related to the A&R Merger Agreement, with the exception of the obligations under the Non-Disclosure Agreement, entered into by and between the Company and Aditxt, as of October 23, 2023, terminated concurrently with the termination of the A&R Merger Agreement. No consideration was paid in connection with the termination.
We are now pursuing a new path, including aiming to re-list our stock on the Nasdaq Capital Market or a comparable national market and complete a fundraising round to provide critical capital for sales and marketing initiatives designed to catalyze our net sales growth over the next 18-24 months.
Adjuvant Amendment
On October 13, 2025, we entered into a Third Amendment to our Securities Purchase Agreement with Adjuvant Global Health Technology Fund, which extended the maturity and payment terms of the Adjuvant Notes. See Note 10 — Subsequent Events.
2025 Equity Incentive Plan
On October 3, 2025, our Board approved the 2025 Equity Incentive Plan authorizing up to 50 million shares, subject to stockholder approval at the 2025 Annual Meeting. No awards have been granted under the plan to date.
Financial Operations Overview
Net Product Sales
Our revenue recognition is based on unit shipments from our third-party logistics warehouse to our customers, which consist of wholesale distributors, retail pharmacies, telehealth companies, and a mail-order specialty pharmacy. We have recognized net product sales in the U.S. since the commercial launch of PHEXX in September 2020; SOLOSEC net product sales were added to our revenue beginning in July 2024. Gross revenues, as discussed in Note 3 - Revenue, are adjusted for variable consideration, including our patient support programs.
Operating Expenses
Cost of Goods Sold
Inventory costs include all purchased materials, direct labor, and manufacturing overhead. In addition, in prior years we accrued quarterly royalty amounts that would have been due pursuant to our license agreement with Rush University had their application for PTE been granted. The royalty expense accrued were amounts equal to a single-digit percentage of the gross amounts we receive on a quarterly basis, less certain deductions incurred in the quarter based on a sliding scale. Due to the patent expiration, no royalty costs were recorded for the three and nine months ended September 30, 2025, while $0.2 million and $0.6 million were recorded for the three and nine months ended September 30, 2024 and were included in the costs of goods sold in the condensed consolidated statements of operations. As described in Note 7 – Commitments and Contingencies, no further royalties are due to Rush University now that the patent has expired and the amounts that had been previously accrued but were unpaid as of December 31, 2024 were reversed in the current period, which had a favorable impact on the total operating expenses during the three months ended September 30, 2025 of approximately $1.9 million that is not expected to be repeated in further periods. Due to the materiality and the one-time nature of the reversal, the amount was included in the gain on change in accounting estimates on contingent royalty liability in the condensed consolidated statements of operations.
We are obligated to pay quarterly royalties under the SOLOSEC Asset Purchase Agreement dated July 14, 2024; this royalty is based on a percentage of SOLOSEC net sales, adjusted for co-pay program costs. There are no minimum quarterly or annual royalty amounts. Such royalty costs were immaterial and approximately $0.1 million for the three and nine months ended September 30, 2025, respectively.
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Research and Development Expenses
Our research and development expenses primarily consist of costs associated with ongoing improvements related to our products. These expenses include:
| ● | continuous improvements of manufacturing and analytical efficiency; | |
| ● | ongoing product characterization and process optimization; | |
| ● | alternative raw material evaluation to secure an uninterrupted supply chain and reduce cost of goods sold; | |
| ● | employee-related expenses, including salaries, benefits, travel and noncash stock-based compensation expense; and | |
| ● | facilities, depreciation, and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, and research and other supplies. |
We expense internal and third-party research and development expenses as incurred. We do not anticipate significant investment in clinical development for the foreseeable future.
Selling and Marketing Expenses
Our selling and marketing expenses consist primarily of PHEXX and SOLOSEC commercialization costs, the PHEXX telehealth platform, training, salaries, benefits, travel, noncash stock-based compensation expense, PDUFA fees, and other related costs for our employees and consultants.
General and Administrative Expenses
Our general and administrative expenses consist primarily of salaries, benefits, travel, business development expenses, investor and public relations expenses, noncash stock-based compensation, and other related costs for our employees and consultants performing executive, administrative, finance, legal and human resource functions. Other general and administrative expenses include facility-related costs not otherwise included in research and development or selling and marketing, and professional fees for accounting, auditing, tax and legal fees, and other costs associated with obtaining and maintaining our patent portfolio.
Other Income (Expense)
Other income (expense) consists primarily of interest expense and the fair value adjustments of financial instruments issued in various capital raise transactions, including loss on issuance of financial instruments, quarterly change in fair value adjustments, and gains or losses on debt extinguishment. The change in fair value of financial instruments was recognized as a result of mark-to-market adjustments for those financial instruments.
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Results of Operations
Three Months Ended September 30, 2025 Compared to Three Months Ended September 30, 2024 (in thousands):
Net Product Sales
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Product sales, net | $ | 4,952 | $ | 4,496 | $ | 456 | 10 | % | ||||||||
The increase in product sales, net, primarily reflects a full quarter of SOLOSEC in the current year period as well as the increased PHEXX WAC that took effect January 1, 2025.
Cost of Goods Sold
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Cost of goods sold | $ | 905 | $ | 869 | $ | 36 | 4 | % | ||||||||
The immaterial increase in cost of goods sold was in line with the increased product sales, net, partially offset by the lack of accrual for the Rush Royalty contingent liability in the current year.
Gain on Change in Accounting Estimates on Contingent Royalty Liability
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
Gain on change in accounting estimates on contingent royalty liability | $ | (1,933 | ) | $ | - | $ | (1,933 | ) | (100 | )% | ||||||
The $1.9 million gain on change in accounting estimates on contingent royalty liability was due to the reversal of previously accrued but unpaid amounts related to the Rush Royalty as a result of the additional information obtained during the three months ended September 30, 2025, including clarification by the FDA that no PTE should be granted. See Note 7 – Commitments and Contingencies for more information regarding this reversal.
Amortization of Intangible Asset
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Amortization of intangible asset | $ | 80 | $ | 301 | $ | (221 | ) | (73 | )% | |||||||
The decrease in amortization of intangible asset was primarily due to the decrease in the intangible value due to the prior quarterly valuation of the SOLOSEC contingent liability.
Research and Development Expenses
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Research and development, net | $ | 470 | $ | 332 | $ | 138 | 42 | % | ||||||||
The increase in research and development expenses was primarily due to a $0.1 million increase in personnel costs.
Selling and Marketing Expenses
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Selling and marketing | $ | 2,391 | $ | 2,382 | $ | 9 | 0 | % | ||||||||
The immaterial increase in selling and marketing expenses reflects a $0.1 million increase in personnel costs, partially offset by a decrease in business development and outside services expenses.
General and Administrative Expenses
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| General and administrative | $ | 2,088 | $ | 3,052 | $ | (964 | ) | (32 | )% | |||||||
The decrease in general and administrative expenses was primarily due to an approximately $0.8 million decrease in professional services costs and a reduction of approximately $0.2 million in personnel costs.
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Total Other Income (Expense), Net
| Three Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Total other income (expense), net | $ | (2,524 | ) | $ | 67 | $ | (2,591 | ) | (3,867 | )% | ||||||
Total other expense, net, for the three months ended September 30, 2025 primarily included $0.7 million of interest expense related primarily to the Adjuvant Note and a loss of $1.8 million related to the change in fair value of financial instruments including adjustments related to the purchase rights of $1.1 million and those related to the Baker Notes of $0.7 million. Historically the changes in fair value related to the Baker Notes have been recorded in the condensed consolidated statements of comprehensive operations as the changes were determined to be related to changes in the Company’s credit risk. However, in the three months ended September 30, 2025, the primary driver for the increase in the fair value of the Baker Notes is related to the Company not retiring the notes by September 8, 2025, which caused the total amount legally payable to repurchase the notes to increase by approximately $2.8 million.
Total other income, net, for the three months ended September 30, 2024 primarily included a $0.8 million gain on the change in fair value of financial instruments, partially offset by $0.6 million in interest expense related to the Adjuvant Note and loss on the debt extinguishment of $0.1 million.
Nine Months Ended September 30, 2025 Compared to Nine Months Ended September 30, 2024 (in thousands):
Net Product Sales
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Product sales, net | $ | 10,622 | $ | 12,259 | $ | (1,637 | ) | (13 | )% | |||||||
The decrease in product sales, net, was primarily due to lower PHEXX sales volume, partially offset by the addition of SOLOSEC in the current year and the increased PHEXX WAC that took effect January 1, 2025.
Cost of Goods Sold
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Cost of goods sold | $ | 2,025 | $ | 2,322 | $ | (297 | ) | (13 | )% | |||||||
The decrease in cost of goods sold in the current year was due primarily to the lower product sales, net as well as the lack of expense related to the Rush Royalty liability in the current year, which was an expense in the prior year.
Gain on Change in Accounting Estimates on Contingent Royalty Liability
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
Gain on change in accounting estimates on contingent royalty liability | $ | (1,933 | ) | $ | - | $ | (1,933 | ) | (100 | )% | ||||||
The gain on change in accounting estimates on contingent royalty liability was due to the reversal of previously accrued but unpaid amounts related to the Rush Royalty as a result of the additional information obtained during the three months ended September 30, 2025, including clarification by the FDA that no PTE should be granted. See Note 7 – Commitments and Contingencies for more information regarding this reversal.
Amortization of Intangible Asset
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Amortization of intangible asset | $ | 410 | $ | 301 | $ | 109 | 36 | % | ||||||||
The increase in amortization of intangible asset was primarily due to the timing of the SOLOSEC acquisition. Because the acquisition closed in July 2024, the prior year amortization was therefore only for a partial portion of the nine-month period while the current year is for the entire nine-month period.
Research and Development Expenses
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Research and development, net | $ | (3,819 | ) | $ | 1,196 | $ | (5,015 | ) | (419 | )% | ||||||
The decrease in research and development expenses was primarily due to the negotiation of a portion of the Company’s trade payables and accrued liabilities, which resulted in a $5.6 million reduction in research and development expenses in the current period. The decrease was partially offset by an increase of $0.7 million in facilities and outside services costs.
Selling and Marketing Expenses
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Selling and marketing | $ | 7,616 | $ | 6,970 | $ | 646 | 9 | % | ||||||||
The increase in selling and marketing expenses was primarily due to a $0.3 million increase related to the PDUFA fee for SOLOSEC as well as an increase in facilities and outside services costs of $0.3 million.
General and Administrative Expenses
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| General and administrative | $ | 6,296 | $ | 8,143 | $ | (1,847 | ) | (23 | )% | |||||||
The decrease in general and administrative expenses was primarily due to a $1.0 million decrease in professional services, a $0.4 million decrease in personnel costs, and a $0.4 million reduction in facilities costs.
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Total Other Income (Expense), Net
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Total other income (expense), net | $ | (2,421 | ) | $ | 850 | $ | (3,271 | ) | (385 | )% | ||||||
Total other expense, net, for the nine months ended September 30, 2025 primarily included a $1.9 million interest expense related to the Adjuvant Note and a loss on the change in fair value of financial instruments of $0.5 million, including a gain related to the purchase rights of $0.2 million and a loss related to the Baker Notes of $0.7 million. Historically the changes in fair value related to the Baker Notes have been recorded in the condensed consolidated statements of comprehensive operations as the changes were determined to be related to changes in the Company’s credit risk. However, in the three months ended September 30, 2025, the primary driver for the increase in the fair value of the Baker Notes is related to the Company not retiring the notes by September 8, 2025, which caused the total amount legally payable to repurchase the notes to increase by approximately $2.8 million.
Total other income, net, for the nine months ended September 30, 2024 primarily included a $4.9 million gain on the change in fair value of financial instruments and a gain of $1.0 million related to the Baker Notes extinguishment. The gains were partially offset by a $3.3 million loss on the issuance of financial instruments related to the anti-dilution adjustment for the purchase rights and $1.7 million of interest expense related to the Adjuvant Note.
Liquidity and Capital Resources
Overview
As of September 30, 2025, we had a working capital deficit of $70.3 million and an accumulated deficit of $900.2 million. We have financed our operations to date primarily through the issuance of preferred stock, Common Stock, warrants and convertible and term notes; cash received from private placement transactions; and, to a lesser extent, product sales. As of September 30, 2025, we had approximately $0.8 million in cash and cash equivalents, all of which is restricted cash available for use as prescribed in the Adjuvant Notes (as defined in Note 4 - Debt). Our cash and cash equivalents include amounts held in checking accounts. Management believes that the Company’s cash and cash equivalents as of September 30, 2025 are insufficient to fund operations for at least the next 12 months from the date on which this Quarterly Report on Form 10-Q is filed with the SEC.
We have incurred losses and negative cash flows from operating activities since inception. In 2024, we focused on further improving and increasing PHEXX access, acquired global rights to SOLOSEC, and delivered our fourth consecutive year of PHEXX net sales growth. In 2025, we continue to focus on top-line growth while maintaining a lean operating structure. We will continue to explore opportunities for organic growth, entry into new markets including those covered by our license and supply agreements with Pharma 1, and potential expansion of our product offerings beyond PHEXX and SOLOSEC.
As of September 30, 2025, the Company’s significant commitments include the Baker Notes, Adjuvant Notes, SSNs, and Aditxt Notes as described in Note 4 - Debt and fleet leases, SOLOSEC contingent liability, and the potential settlement amount with TherapeuticsMD as described in Note 7 - Commitments and Contingencies. The purpose of these commitments is to further the commercialization of PHEXX and SOLOSEC. Management’s plans to meet the Company’s cash flow needs in the next 12 months include generating revenue from the sale of PHEXX and SOLOSEC, further restructuring of the Company’s current payables, and obtaining additional funding through means such as the issuance of its capital stock, non-dilutive or dilutive financings, or through collaborations or partnerships with other companies, including license agreements for PHEXX and/or SOLOSEC in the U.S. or foreign markets, or other potential business combinations.
If the Company is not able to obtain the required funding through a significant increase in revenue, equity or debt financings, license agreements for our products in the U.S. or foreign markets, or other means, or is unable to obtain funding on terms favorable to the Company, there will be a material adverse effect on commercialization and development operations and the Company’s ability to execute its strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make further reductions in spending, including spending in connection with its commercialization activities, extend payment terms with suppliers, liquidate assets where possible at a potentially lower amount than as recorded in the condensed consolidated financial statements, suspend, or curtail planned operations, or cease operations entirely. Any of these could materially and adversely affect the Company’s liquidity, financial condition and business prospects, and the Company would not be able to continue as a going concern. The Company has concluded that these circumstances and the uncertainties associated with the Company’s ability to obtain additional equity or debt financing on terms that are favorable to the Company, or at all, and otherwise succeed in its future operations raise substantial doubt about the Company’s ability to continue as a going concern.
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If we are unable to continue as a going concern, we may have to liquidate our assets and, in doing so, we may receive less than the value at which those assets are carried on our condensed consolidated financial statements. Any of these developments would materially and adversely affect the price of our stock and the value of an investment in our stock. As a result, our condensed consolidated financial statements include explanatory disclosures expressing substantial doubt about our ability to continue as a going concern.
The opinion of our independent registered public accounting firm on our audited consolidated financial statements as of and for the years ended December 31, 2024 and 2023 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. Future reports on our consolidated financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Our unaudited condensed consolidated financial statements as of September 30, 2025 and December 31, 2024 and for the three and nine months ended September 30, 2025 and 2024 included in this Quarterly Report do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue our operations.
The Company expects future equity-based compensation expense to increase following stockholder approval of the 2025 Equity Incentive Plan, which authorizes up to 50 million additional shares.
Potential Impact of Federal Government Shutdown
Certain functions of the U.S. federal government, including the Food and Drug Administration (FDA) and other agencies that regulate or reimburse our products, may be limited or delayed in the event of a government shutdown. A prolonged shutdown could delay FDA reviews or other regulatory interactions, temporarily slow processing of payor or government program reimbursements, or defer implementation of new coverage or public-health initiatives. At this time, management does not expect any material adverse impact on our ongoing commercial operations, but we continue to monitor the situation.
Summary Statement of Cash Flows
The following table sets forth a summary of the net cash flow activity for each of the periods set forth below (in thousands):
| Nine Months Ended September 30, | 2025 vs. 2024 | |||||||||||||||
| 2025 | 2024 | $ Change | % Change | |||||||||||||
| Net cash, cash equivalents and restricted cash used in operating activities | $ | (2,023 | ) | $ | (1,477 | ) | $ | (546 | ) | (37 | )% | |||||
| Net cash, cash equivalents and restricted cash used in investing activities | (59 | ) | (523 | ) | 464 | 89 | % | |||||||||
| Net cash, cash equivalents and restricted cash provided by in financing activities | 2,181 | 2,142 | 39 | 2 | % | |||||||||||
| Net change in cash, cash equivalents and restricted cash | $ | 99 | $ | 142 | $ | (43 | ) | (30 | )% | |||||||
Cash Flows from Operating Activities. During the nine months ended September 30, 2025, the primary use of cash, cash equivalents and restricted cash in operating activities was driven by net loss of $2.4 million plus net adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities of $4.4 million. The increase in cash used in operating activities was also driven by the payment of trade payables of $1.4 million, contingent liabilities of $0.5 million, and the purchase of inventory of $0.3 million. The use of cash, cash equivalents, and restricted cash in operating activities was partially offset by the collection of $5.4 million of accounts receivable and increases in accrued expenses and other liabilities of $1.0 million and prepaid expenses of $0.5 million.
During the nine months ended September 30, 2024, the primary use of cash, cash equivalents and restricted cash in operating activities was driven by net loss of $5.8 million offset by net adjustments to reconcile net loss to net cash, cash equivalents, and restricted cash used in operating activities of $1.0 million. The cash used in operating activities was also driven by the payment of trade payables of $0.2 million, partially offset by the collection of $0.3 million of accounts receivable, $0.2 million fewer inventory purchases, and increases in accrued expenses and other liabilities of $2.2 million, accrued compensation of $0.6 million, and prepaid expenses of $0.2 million.
Cash Flows from Investing Activities. During the nine months ended September 30, 2025, the primary use of cash, cash equivalents and restricted cash was the payment of legal and accounting fees related to the acquisition of SOLOSEC which had previously been recorded as accounts payable. During the nine months ended September 30, 2024, the primary use of cash, cash equivalents and restricted cash was the acquisition of the SOLOSEC asset.
Cash Flows from Financing Activities. During the nine months ended September 30, 2025, the primary source of cash, cash equivalents and restricted cash was related to the Aditxt Notes and the financing agreement with First Insurance Funding for total net proceeds to the Company of approximately $2.8 million, partially offset by the payment of short-term debt and quarterly cash payments due under the Fourth Baker Amendment of $0.6 million. During the nine months ended September 30, 2024, the primary source of cash, cash equivalents, and restricted cash was from the $1.0 million received from Aditxt in order to reinstate the Merger Agreement as described above as well as the $1.3 million in Series F-1 Preferred Stock purchased by Aditxt, and the finance agreement with First Insurance Funding for $0.4 million. These inflows were partially offset by $0.5 million of payments under the Baker Notes and short-term debt.
Operating and Capital Expenditure Requirements
Our specific future operating and capital expense requirements are difficult to forecast. However, we can anticipate the general types of expenses and areas in which they might occur. In 2025, while we expect to maintain a lean operating structure at approximately the same level as 2024; should resources become available we may increase marketing spend to drive further sales growth.
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Contractual Obligations and Commitments
Operating Leases
Operating lease right-of-use assets and lease liabilities were $0.2 million and $0.1 million on September 30, 2025 and December 31, 2024, respectively. See Note 7- Commitments and Contingencies for more detailed discussions on leases and financial statements information under ASC 842, Leases.
Other Contractual Commitments
As described in Note 7 - Commitments and Contingencies, in November 2019, the Company entered into a supply and manufacturing agreement with a third-party to manufacture PHEXX, with potential to manufacture other product candidates, in accordance with all applicable current good manufacturing practice regulations. There were $0.3 million and $1.1 million in purchases under the supply and manufacturing agreement for the three and nine months ended September 30, 2025, respectively, and $0.8 million and $1.0 million in such purchases during the three and nine months ended September 30, 2024.
As described in Note 7 - Commitments and Contingencies, the Company also has commitments related to the SOLOSEC asset acquisition, including a commitment to purchase inventory from the seller through November 2026 at a pre-defined unit price. The Company is further obligated to pay contingent liabilities and quarterly royalties based on SOLOSEC net revenue over the Earnout Term as described in Note 7 - Commitments and Contingencies.
Intellectual Property Rights
As described in Note 7 - Commitments and Contingencies, royalty costs estimated to be payable to Rush University pursuant to the Rush License Agreement were $0.2 million and $0.6 million for the three and nine months ended September 30, 2024. No such amounts were incurred for the three and nine months ended September 30, 2025 due to the expiration of the Rush patent. As of December 31, 2024, approximately $1.9 million were included in accrued expenses in the condensed consolidated balance sheets and no such accrual existed at September 30, 2025 due to the gain on change in accounting estimates on contingent royalty liability recorded during the nine months ended September 30, 2025.
Other Matters
Recently Issued Accounting Pronouncements
For information with respect to recent accounting pronouncements, see Note 2 - Summary of Significant Accounting Policies to our condensed consolidated financial statements appearing in Part I, Item 1 of this Quarterly Report.
Critical Accounting Policies
There have not been any material changes to the critical accounting policies disclosed in our Form 10-K for the year ended December 31, 2024.
Item 3. Quantitative and Qualitative Disclosures about Market Risk
Not applicable.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Disclosure controls and procedures are controls and other procedures of a company that are designed to ensure that information required to be disclosed by the company in the reports that it files or submits under the Securities Exchange Act of 1934, as amended (the Exchange Act) is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure.
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As described in our Annual Report on Form 10-K for the year ended December 31, 2024, we identified material weaknesses in our internal control over financial reporting. As a result of these material weaknesses, our Chief Executive Officer (CEO) and Chief Financial Officer (CFO) have concluded that our disclosure controls and procedures are not effective to provide reasonable assurance that information required to be disclosed in the reports we file and submit under the Securities and Exchange Act is recorded, processed, summarized, and reported as and when required.
Notwithstanding the conclusion by our CEO and CFO that our Disclosure Controls as of September 30, 2025 were not effective, and notwithstanding the material weaknesses in our internal control over financial reporting described more fully under Item 9A in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, management believes that the condensed consolidated financial statements and related financial information included in this Quarterly Report on Form 10-Q fairly present in all material respects our financial condition, results of operations and cash flows as of the date presented, and for the periods ended on such dates, in conformity with accounting principles generally accepted in the United States of America (U.S. GAAP).
Remediation Activities:
Management continues to evaluate the material weaknesses discussed above and is implementing its remediation plan. However, assurance as to when the remediation efforts will be complete cannot be provided and the material weaknesses cannot be considered remedied until the applicable controls have operated for a sufficient period of time and management has concluded, through testing, that these controls are operating effectively. Management cannot assure readers that the measures that have been taken to date, and are continuing to be implemented, will be sufficient to remediate the material weaknesses identified or to avoid potential future material weaknesses.
Changes in Internal Control over Financial Reporting
Except for ongoing remediation activities described in the preceding paragraph, there were no changes in our internal control over financial reporting that occurred during our latest fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Inherent Limitations of Internal Controls
Management recognizes that a control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or error, if any, have been detected. These inherent limitations include the realities that judgments in decision making can be faulty, and that breakdowns can occur because of a simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the controls. The design of any system of controls 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, controls 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.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Refer to Note 7 - Commitments and Contingencies to the unaudited condensed consolidated financial statements in this Form 10-Q for any required disclosure.
Item 1A. Risk Factors
There have not been any material changes to the risk factors disclosed in our Form 10-K for the year ended December 31, 2024, as filed with the SEC on March 24, 2025 and amended on March 28, 2025.
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
| (a) | None. |
| (b) | None. |
| (c) | Rule 10b5-1 Trading Plans |
During
the three months ended September 30, 2025, none of our directors or officers entered into,
Item 6. Exhibits
The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index.
EXHIBIT INDEX
| Exhibit | Filed | Incorporated by Reference | ||||||||
| No. | Exhibit Title | Herewith | Form | File No. | Date Filed | |||||
| 2.1 | Amended and Restated Plan of Merger, by and between the Company, Aditxt, Inc. and Adifem, Inc. | 8-K | 001-36754 | 7/18/2024 | ||||||
| 2.2 | First Amendment to the Amended and Restated Agreement and Plan of Merger, by and between the Company, Aditxt, Inc., and Adifem, Inc., dated August 16, 2024 | 8-K | 001-36754 | 8/20/2024 | ||||||
| 2.3 | Second Amendment to the Amended and Restated Agreement and Plan of Merger, by and between the Company, Aditxt, Inc., and Adifem, Inc., dated September 6, 2024 | 8-K | 001-36754 | 9/6/2024 | ||||||
| 2.4 | Third Amendment to the Amended and Restated Agreement and Plan of Merger, by and among the Company, Aditxt, Inc. and Adifem, Inc., dated October 2, 2024 | 8-K | 001-36754 | 10/3/2024 | ||||||
| 2.5 | Fourth Amendment to the Amended and Restated Agreement and Plan of Merger, by and among the Company, Aditxt, Inc. and Adifem, Inc., dated November 19, 2024 | 8-K | 001-36754 | 11/25/2024 | ||||||
| 2.6 | Fifth Amendment to the Amended and Restated Agreement and Plan of Merger by and among the Company, Aditxt, Inc. and Adifem, Inc., dated March 22, 2025 | 10-K | 001-36754 | 3/24/2025 | ||||||
| 2.7 | Sixth Amendment to the Amended and Restated Merger Agreement, dated August 26, 2025 | 8-K | 001-36754 | 8/26/2025 | ||||||
| 3.1 | Certificate of Designations of the Series G-1 Preferred Stock | 8-K | 001-36754 | 8/26/2025 | ||||||
| 10.1 | License and Supply Agreement dated March 20, 2025 | 8-K | 001-36754 | 3/26/2025 | ||||||
| 10.2 | Amendment No. 1 to License and Supply Agreement dated March 20, 2025 | 8-K | 001-36754 | 4/3/2025 | ||||||
| 10.3 | Form of Securities Purchase Agreement | 8-K | 001-36754 | 7/2/2025 | ||||||
| 10.4 | Form of Senior Subordinated Convertible Note | 8-K | 001-36754 | 7/2/2025 | ||||||
| 10.5 | Form of Warrant | 8-K | 001-36754 | 7/2/2025 | ||||||
| 10.6 | Form of Call Option Agreement | 8-K | 001-36754 | 4/14/2025 | ||||||
| 10.7 | First Amendment to Development and Supply Agreement dated May 3, 2025 | 8-K | 001-36754 | 5/8/2025 | ||||||
| 10.8 | License Agreement by and between the Company and Pharma 1 Drug Store, L.L.C | 8-K | 001-36754 | 5/22/2025 | ||||||
| 10.9 | Form of Exchange Agreement | 8-K | 001-36754 | 8/26/2025 | ||||||
| 10.10 | Third Amendment to Securities Purchase Agreement dated as of October 13, 2025 | 8-K | 001-36754 | 10/17/2025 | ||||||
| 31.1 | * | Certification of Principal Executive Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | |||||||
| 31.2 | * | Certification of Principal Financial Officer Pursuant to Rules 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | X | |||||||
| 32.1 | * | Certification of Principal Executive Officer and 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 | X | |||||||
| 101.SCH | † | Inline XBRL Taxonomy Extension Schema Document | X | |||||||
| 101.CAL | † | Inline XBRL Taxonomy Extension Calculation Linkbase Document | X | |||||||
| 101.DEF | † | Inline XBRL Definition Linkbase Document | X | |||||||
| 101.LAB | † | Inline XBRL Taxonomy Extension Labels Linkbase Document | X | |||||||
| 101.PRE | † | Inline XBRL Taxonomy Extension Presentation Linkbase Document | X | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | X | ||||||||
| * | Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and are 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 registrant, whether made before or after the date hereof, regardless of any general incorporation by reference language in such filing. |
| † | The financial information of Evofem Biosciences, Inc. Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 filed on November 13, 2025 formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets, (ii) Parenthetical Data to the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Operations, (iv) the Condensed Consolidated Statements of Convertible and Redeemable Preferred Stock and Stockholders’ Deficit, (v) the Condensed Consolidated Statements of Cash Flows, and (vi) Notes to Unaudited Condensed Consolidated Financial Statements, is furnished electronically herewith. |
| ^^ | Certain exhibits and schedules have been omitted pursuant to Item 601(a)(5) of Regulation S-K. The Company hereby undertakes to furnish supplementally a copy of any omitted exhibit or schedule upon request by the SEC. |
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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 hereunto duly authorized.
| EVOFEM BIOSCIENCES, INC. | ||
| Date: November 13, 2025 | By: | /s/ Ivy Zhang |
| Ivy Zhang | ||
Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer) | ||
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FAQ
What were EVFM’s Q3 2025 net product sales?
Did EVFM report a profit or loss in Q3 2025?
What is EVFM’s liquidity position as of September 30, 2025?
What does EVFM’s balance sheet look like?
Did management raise going‑concern doubts?
Where does EVFM’s stock trade now?
How many common shares were outstanding?
