INVO Fertility, Inc 10-Q for FY2025 Q3
INVO Fertility, Inc. (IVF)
About this 10-Q
INVO Fertility, Inc filed this 10-Q on November 17, 2025, covering the quarter ended September 30, 2025 (FY2025 Q3).
Headline figures
Quarter ended September 30, 2025, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $1.76M
- up 22.6% from $1.43M a year earlier
- Net loss
- $2.64M
- compared with a net loss of $1.63M a year earlier
- Diluted EPS
- -$0.77
- compared with -$15.11 a year earlier
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
For
the quarterly period ended
OR
For the transition period from ________________ to ________________
Commission
File Number:
(Exact Name of Registrant as Specified in its Charter)
(State or other jurisdiction of incorporation or organization) |
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| (Address of principal executive offices) | (Zip Code) |
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||
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, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
| Large accelerated filer ☐ | Accelerated filer ☐ | |||
| Smaller
reporting company |
Emerging
growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No
As of November 17, 2025, the Registrant had shares of common stock outstanding.
INVO FERTILITY, INC. FORM 10-Q
FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025
TABLE OF CONTENTS
| 2 |
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND INDUSTRY DATA
This Quarterly Report on Form 10-Q contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). These statements may be identified by such forward-looking terminology as “may,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology. Our forward-looking statements are based on a series of expectations, assumptions, estimates, and projections about our company, are not guarantees of future results or performance, and involve substantial risks and uncertainty. We may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. Actual results or events could differ materially from the plans, intentions, and expectations disclosed in these forward-looking statements. Our business and our forward-looking statements involve substantial known and unknown risks and uncertainties, including the risks and uncertainties inherent in our statements regarding the following:
| ● | our business strategies; |
| ● | the timing of regulatory submissions; |
| ● | our ability to obtain and maintain regulatory approval of our existing product candidates and any other product candidates we may develop, and the labeling under any approval we may obtain; |
| ● | risks relating to the timing and costs of clinical trials and the timing and costs of other expenses; |
| ● | risks related to market acceptance of products; |
| ● | the ultimate impact of a health epidemic on our business, our clinical trials, our research programs, healthcare systems or the global economy as a whole; |
| ● | intellectual property risks; |
| ● | risks associated with our reliance on third-party organizations; |
| ● | our competitive position; |
| ● | our industry environment; |
| ● | our anticipated financial and operating results, including anticipated sources of revenues; |
| ● | assumptions regarding the size of the available market, benefits of our products, product pricing and timing of product launches; |
| ● | management’s expectation with respect to future acquisitions; |
| ● | statements regarding our goals, intentions, plans, and expectations, including the introduction of new products and markets; and |
| ● | our cash needs and financing plans. |
All of our forward-looking statements are as of the date of this Quarterly Report on Form 10-Q only. In each case, actual results may differ materially from such forward-looking information. We can give no assurance that such expectations or forward-looking statements will prove to be correct. An occurrence of, or any material adverse change in, one or more of the risk factors or risks and uncertainties referred to in this Quarterly Report on Form 10-Q or included in our other public disclosures or our other periodic reports or other documents or filings filed with or furnished to the U.S. Securities and Exchange Commission (the “SEC”) could materially and adversely affect our business, prospects, financial condition and results of operations. Except as required by law, we do not undertake or plan to update or revise any such forward-looking statements to reflect actual results, changes in plans, assumptions, estimates, or projections or other circumstances affecting such forward-looking statements occurring after the date of this Quarterly Report on Form 10-Q, even if such results, changes, or circumstances make it clear that any forward-looking information will not be realized. Any public statements or disclosures by us following this Quarterly Report on Form 10-Q that modify or impact any of the forward-looking statements contained in this Quarterly Report on Form 10-Q will be deemed to modify or supersede such statements in this Quarterly Report on Form 10-Q.
This Quarterly Report on Form 10-Q may include market data and certain industry data and forecasts, which we may obtain from internal company surveys, market research, consultant surveys, publicly available information, reports of governmental agencies, and industry publications, articles, and surveys. Industry surveys, publications, consultant surveys, and forecasts generally state that the information contained therein has been obtained from sources believed to be reliable, but the accuracy and completeness of such information is not guaranteed. While we believe that such studies and publications are reliable, we have not independently verified market and industry data from third-party sources.
| 3 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
INVO FERTILITY, INC.
CONSOLIDATED BALANCE SHEETS
| September 30, | December 31, | |||||||
| 2025 | 2024 | |||||||
(unaudited) | ||||||||
| ASSETS | ||||||||
| Current assets | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable | ||||||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ||||||||
| Current assets held for sale | ||||||||
| Total current assets | ||||||||
| Property and equipment, net | ||||||||
| Lease right of use | ||||||||
| Intangible assets, net | ||||||||
| Goodwill | ||||||||
| Equity investments | ||||||||
| Investment in NAYA | ||||||||
Note receivable | ||||||||
| Noncurrent assets held for sale | ||||||||
| Total assets | $ | $ | ||||||
| LIABILITIES, MEZZANINE EQUITY, AND STOCKHOLDERS’ EQUITY | ||||||||
| Current liabilities | ||||||||
| Accounts payable and accrued liabilities | $ | $ | ||||||
| Accrued compensation | ||||||||
| Convertible notes payable – current portion, net | ||||||||
| Convertible notes payable – related parties, net | ||||||||
| Convertible notes payable | ||||||||
| Deferred revenue | ||||||||
| Lease liability, current portion | ||||||||
| Additional payments for acquisition, current portion | ||||||||
| Other current liabilities | ||||||||
| Current liabilities held for sale | ||||||||
| Total current liabilities | ||||||||
| Notes payable, net of current portion | ||||||||
| Lease liability, net of current portion | ||||||||
| Additional payments for acquisition, net of current portion | ||||||||
| Total liabilities | ||||||||
| Mezzanine equity | ||||||||
| Series C-2 Preferred Stock $ par value; shares authorized; and issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | ||||||||
| Stockholders’ equity | ||||||||
| Series C-1 Preferred Stock, $ par value; and shares authorized; and issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | ||||||||
| Series C-2 Preferred Stock $ par value; shares authorized; and issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | ||||||||
| Preferred stock value | ||||||||
| Common Stock, $ par value; shares authorized; and issued and outstanding as of September 30, 2025 and December 31, 2024, respectively | ||||||||
| Additional paid-in capital | ||||||||
| Accumulated deficit | ( | ) | ( | ) | ||||
| Total stockholders’ equity | ||||||||
| Total liabilities, mezzanine equity, and stockholders’ equity | $ | $ | ||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 4 |
INVO FERTILITY, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue: | ||||||||||||||||
| Clinic revenue | $ | $ | $ | $ | ||||||||||||
| Product revenue | ||||||||||||||||
| Total revenue | ||||||||||||||||
| Operating expenses | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Selling, general and administrative expenses | ||||||||||||||||
| Research and development expenses | ||||||||||||||||
| Impairment loss | ||||||||||||||||
| (Gain) loss on disposal of fixed assets | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Total operating expenses | ||||||||||||||||
| Loss from operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Other income (expense): | ||||||||||||||||
| Gain (loss) from equity method joint ventures | ( | ) | ( | ) | ||||||||||||
| Gain on lease termination | ||||||||||||||||
| Loss on debt extinguishment | ( | ) | ( | ) | ( | ) | ||||||||||
| Gain on settlement (Note 17) | ||||||||||||||||
| Interest expense | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Total other income (expense) | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net loss from continuing operations before income taxes | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Income taxes | ||||||||||||||||
| Net loss from continuing operations | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Discontinued operations (Note 3) | ||||||||||||||||
| Loss on disposal of NTI | ( | ) | ||||||||||||||
| Loss on discontinued operations of NTI | ( | ) | ||||||||||||||
| Net loss | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Loss from continuing operations per share | ||||||||||||||||
| Basic | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Loss from discontinued operations per common share | ||||||||||||||||
| Basic | $ | $ | $ | ( | ) | $ | ||||||||||
| Diluted | $ | $ | $ | ( | ) | $ | ||||||||||
| Loss per common share: | ||||||||||||||||
| Basic | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Diluted | $ | ( | ) | $ | ( | ) | $ | ( | ) | $ | ( | ) | ||||
| Weighted average number of common shares outstanding: | ||||||||||||||||
| Basic | ||||||||||||||||
| Diluted | ||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 5 |
INVO FERTILITY, INC.
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(UNAUDITED)
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||
| Stockholders’ Equity | Mezzanine Equity | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Series A Preferred Stock | Series B Preferred Stock | Series C-1 Preferred Stock | Additional Paid-in | Accumulated | Series C-2 Preferred Stock | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | Shares | Amount | ||||||||||||||||||||||||||||||||||||||||
| Balances, December 31, 2023 | $ | $ | $ | $ | $ | $ | ( | ) | $ | $ | ||||||||||||||||||||||||||||||||||||||||||
| Common stock issued to directors and employees | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued for services | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Preferred stock issued | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock options issued to directors and employees as compensation | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss | - | - | - | - | ( | ) | ( | ) | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Balances, March 31, 2024 | $ | $ | $ | $ | $ | $ | ( | ) | $ | $ | ||||||||||||||||||||||||||||||||||||||||||
| Common stock issued to directors and employees | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued to service providers | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Preferred stock issued | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock issued for cash | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Warrants issued with notes payable | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Convertible note modification/extinguishment | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Warrants issued | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Debt conversion | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Warrant exercise | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock options issued to directors and employees | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Deemed dividend | - | - | - | - | ( | ) | - | - | ||||||||||||||||||||||||||||||||||||||||||||
| Net loss attributable to INVO Fertility, Inc | - | - | - | - | ( | ) | ( | ) | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Balance, June 30, 2024 | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Common stock issued to service providers | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Preferred stock issued | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock options issued to directors and employees | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Net loss attributable to INVO Fertility, Inc | - | - | - | - | ( | ) | ( | ) | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Balance, September 30, 2024 | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||
| Balances, December 31, 2024 | $ | $ | $ | $ | $ | $ | ( | ) | $ | $ | ||||||||||||||||||||||||||||||||||||||||||
| Common stock issued, net of fees and expenses | $ | - | $ | - | $ | - | $ | $ | $ | $ | - | $ | - | |||||||||||||||||||||||||||||||||||||||
| Preferred stock redemption | - | - | - | - | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||
| Warrant exercise - cashless | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Warrant exercise - prefunded | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Stock options issued to directors and employees as compensation | - | - | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||
| Accrued dividend on preferred stock | - | - | - | - | ( | ) | ( | ) | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Rounding for reverse split | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | ( | ) | ( | ) | - | - | ||||||||||||||||||||||||||||||||||||||||||
| Balances, March 31 2025 | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||||||||||||||
| Stockholders’ Equity | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Stock | Series A Preferred Stock | Series B Preferred Stock | Series C-1 Preferred Stock | Series C-2 Preferred Stock | Additional Paid-In | Accumulated | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||||||||||||||
| Balances, March 31 2025 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||
| Reclassification of Series C-2 Preferred stock from mezzanine equity | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| Stock issued to service providers | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Debt conversion | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Warrant exercise - cashless | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Warrant exercise - prefunded | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| Warrant exercise | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| C-1 to C-2 exchange | - | - | - | ( | ) | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Divesture of NAYA | - | - | - | ( | ) | ( | ) | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||
| Preferred stock issued | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| Dividends on preferred stock | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Stock options issued to directors and employees as compensation | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Balances, June 30, 2025 | $ | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||
| Balance | $ | $ | $ | $ | $ | ( | ) | $ | ||||||||||||||||||||||||||||||||||||||||||||
| Stock issued to service providers | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Debt conversion | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||
| Warrant exercise | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| C-2 to common stock exchange | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||
| Proceeds from the sale of preferred stock | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| Dividends on preferred stock | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||
| Stock options issued to directors and employees as compensation | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||
| Post stock split rounding | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||
| Net loss | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Balances, September 30, 2025 | $ | $ | $ | $ | $ | $ | ( | ) | $ | |||||||||||||||||||||||||||||||||||||||||||
| Balance | $ | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 6 |
INVO FERTILITY, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
| 2025 | 2024 | |||||||
| For the Nine Months Ended | ||||||||
| September 30, | ||||||||
| 2025 | 2024 | |||||||
| Cash flows used in operating activities: | ||||||||
| Net loss | $ | ( | ) | $ | ( | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Stock compensation issued for services | ||||||||
| Stock compensation issued to directors and employees | ||||||||
| Fair value of stock options issued to employees | ||||||||
| Non-cash compensation for services | ||||||||
| Amortization of discount on notes payable | ||||||||
| Loss (gain) from equity method investment | ( | ) | ||||||
| Loss from debt extinguishment | ||||||||
| Impairment loss | ||||||||
| Loss from disposal of assets | ||||||||
| Loss on disposition | ||||||||
| Gain on settlement | ( | ) | ||||||
| Gain on lease termination | ( | ) | ||||||
| Depreciation and amortization | ||||||||
| Changes in assets and liabilities: | ||||||||
| Accounts receivable | ( | ) | ( | ) | ||||
| Inventory | ||||||||
| Prepaid expenses and other current assets | ( | ) | ( | ) | ||||
| Accounts payable and accrued expenses | ( | ) | ||||||
| Accrued compensation | ( | ) | ||||||
| Deferred revenue | ||||||||
| Other current liabilities | ( | ) | ||||||
| Leasehold liability | ||||||||
| Accrued interest | ||||||||
| Net cash used in operating activities | ( | ) | ( | ) | ||||
| Cash used in investing activities: | ||||||||
| Payments to acquire property, plant, and equipment | ( | ) | ( | ) | ||||
| Proceeds from sale of fixed assets | ||||||||
| Divesture of NAYA | ( | ) | ||||||
| Net cash used in investing activities | ( | ) | ( | ) | ||||
| Cash from financing activities: | ||||||||
| Proceeds from the sale of notes payable | ||||||||
| Proceeds from the sale of common stock, net of offering costs | ||||||||
| Proceeds from sale of preferred stock | ||||||||
| Proceeds from warrant exercise | ||||||||
| Preferred stock redemption | ( | ) | ||||||
| Principal payments on notes payable | ( | ) | ( | ) | ||||
| Net cash provided by financing activities | ||||||||
| Increase (decrease) in cash and cash equivalents | ( | ) | ||||||
| Cash and cash equivalents at beginning of period | ||||||||
| Cash and cash equivalents at end of period | $ | $ | ||||||
| Supplemental disclosure of cash flow information: | ||||||||
| Cash paid during the period for: | ||||||||
| Interest | $ | $ | ||||||
| Noncash activities: | ||||||||
| Preferred stock redemption adjustment | ||||||||
| Restated debenture, interest conversion | ||||||||
| Common and preferred stock issued upon conversion notes payable and accrued interest | ||||||||
| C-2 to common stock exchange | ||||||||
| Preferred stock exchange | ||||||||
| Fair value of warrants issued with debt | ||||||||
| Dividend on preferred stock | ||||||||
| Deemed dividend | ||||||||
| Common stock issued for accounts payable | ||||||||
The accompanying notes are an integral part of these consolidated financial statements.
| 7 |
INVO FERTILITY, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
September 30, 2025
(UNAUDITED)
Note 1 – Summary of Significant Accounting Policies
Description of Business
INVO Fertility, Inc., (“INVO” or the “Company”) is a healthcare services and technology company focused on the fertility marketplace and dedicated to expanding access to assisted reproductive technology (“ART”) care for patients in need. The Company’s principal commercialization strategy is focused on building, acquiring and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by its INVOcell medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. As of the date of this filing, the Company has two operational INVO Centers and one IVF clinic in the United States. The Company also continues to engage in the sale and distribution of its INVOcell technology solution into third-party owned and operated fertility clinics. The Company’s proprietary technology, INVOcell, is a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first IVC technique for the incubation of oocytes and sperm during fertilization and early embryo development. The Company intends to seek out additional, innovative fertility-focused technologies, to license or acquire in order to utilize within its operating clinics. In addition, the Company owns 19.9% of NAYA Therapeutics, Inc. (“NTI”), a clinical-stage oncology and autoimmune technology business, after divesting the remaining 80.1% in the second quarter of 2025 to focus exclusively on the fertility marketplace.
Basis of Presentation
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and applicable rules and regulations of the U.S. Securities and Exchange Commission (“SEC”) for the fair presentation of the Company’s financial statements for the periods presented. The Company’s fiscal year-end is December 31.
The Company’s accompanying consolidated financial statements are unaudited. The unaudited interim consolidated financial statements have been prepared on the same basis as the audited annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for the fair statement of the Company’s financial position as of September 30, 2025, the results of its operations for the three and nine months ended September 30, 2025 and 2024, the statements of changes in stockholders’ equity for the three and nine months ended September 30, 2025 and 2024, and its cash flows for the nine months ended September 30, 2025 and 2024. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2025, and 2024 are also unaudited. The results for the three and nine months ended September 30, 2025, are not necessarily indicative of results to be expected for the year ending December 31, 2025, any other interim periods, or any future year or period. These interim financial statements should be read in conjunction with the audited financial statements as of and for the year ended December 31, 2024, and notes thereto, which are included in the Company’s Annual Report on Form 10-K filed with the SEC on April 30, 2025.
The accompanying consolidated financial statements present on a consolidated basis the accounts of the Company and its wholly owned subsidiaries and controlled affiliates. The Company presents noncontrolling interest within the equity section of its consolidated balance sheets and the amount of consolidated net income (loss) that is attributable to the Company in its consolidated statement of operations. All significant intercompany accounts and transactions have been eliminated in consolidation.
The Company uses the equity method of accounting when it owns an interest in an entity whereby it can exert significant influence over but cannot control the entity’s operations.
The Company considers events or transactions that have occurred after the consolidated balance sheet date of September 30, 2025, but prior to the filing of the consolidated financial statements with the SEC in this Quarterly Report on Form 10-Q, to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure, as applicable. Subsequent events have been evaluated through the date of the filing of this Quarterly Report on Form 10-Q.
Business Segments
The
Company operates in
Business Acquisitions
The Company accounts for all business acquisitions at fair value and expenses acquisition costs as they are incurred. Any identifiable assets acquired and liabilities assumed are recognized and measured at their respective fair values on the acquisition date. If information about facts and circumstances existing as of the acquisition date is incomplete at the end of the reporting period in which a business acquisition occurs, the Company will report provisional amounts for the items for which the accounting is incomplete. The measurement period ends once the Company receives sufficient information to finalize the fair values; however, the period will not exceed one year from the acquisition date. Any adjustments to provisional amounts that are identified during the measurement period are recognized in the reporting period in which the adjustment amounts are determined.
Discontinued Operations
The Company accounted for the divesture of its NAYA Therapeutics (“NTI”) subsidiary in accordance with Accounting Standards Codification (“ASC”) 205 Discontinued Operations (“ASC 205”). ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale, has operations and cash flows that can be clearly distinguished from the rest of the entity, and represents a strategic shift that has (or will have) a major effect on the reporting entity’s financial results must be reported as discontinued operations. As of June 30, 2025 the divesture of NTI met the held-for-sale criteria as defined in ASC 205.
In the period a component of an entity is classified as a discontinued operation, the results of operations for the periods presented are reclassified into separate line items in the unaudited condensed consolidated statements of operations and the assets and liabilities of the discontinued operation are also reclassified into separate line items on the related condensed consolidated balance sheets. Prior period amounts are also adjusted to reflect discontinued operations presentation. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted.
Variable Interest Entities
The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the Company’s VIEs.
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Equity Method Investments
Investments in unconsolidated affiliates, over which the Company exerts significant influence but does not control or otherwise consolidate, are accounted for using the equity method. Equity method investments are initially recorded at cost. These investments are included in equity investments in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating performance of the investees and records reductions in carrying values when necessary.
Use of Estimates
In preparing financial statements in conformity with generally accepted accounting principles, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and revenues and expenses during the reported period. Actual results could differ from those estimates.
Cash and Cash Equivalents
For financial statement presentation purposes, the Company considers time deposits, certificates of deposit, and all highly liquid investments with original maturities of three months or less to be cash and cash equivalents. At times, cash and cash equivalents balances exceed amounts insured by the Federal Deposit Insurance Corporation.
Inventory
Inventories consist of raw materials, work in process and finished goods and are stated at the lower of cost or net realizable value, using the first-in, first-out method as a cost flow method.
Property and Equipment
The
Company records property and equipment at cost. Property and equipment are depreciated using the straight-line method over the estimated
economic lives of the assets, which are from
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Long- Lived Assets
Long-lived assets and certain identifiable assets related to those assets are periodically reviewed for impairment whenever circumstances and situations change such that there is an indication that the carrying amounts may not be recoverable. If the non-discounted future cash flows of the asset are less than their carrying amount, their carrying amounts are reduced to fair value and an impairment loss recognized.
Fair Value of Financial Instruments
ASC 825-10-50, “Disclosures about Fair Value of Financial Instruments,” requires disclosure of the fair value of certain financial instruments. The carrying value of cash and cash equivalents, accounts payable and borrowings, as reflected in the balance sheets, approximate fair value because of the short-term maturity of these instruments.
ASC 820-10, “Fair Value Measurements” provides a framework for measuring fair value under GAAP. ASC 820-10 defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820-10 requires that valuation techniques maximize the use of observable inputs and minimize the use of unobservable inputs.
Derivatives
The Company reviews the conversion features of all liability and equity instruments based on the requirements of ASC 815, “Derivatives and Hedging” to determine if the conversion feature represents an embedded derivative. The Company determined there were no derivatives, embedded or otherwise, as of September 30, 2025.
Income Taxes
The Company is subject to income taxes in the United States and its domestic tax liabilities are subject to the allocation of expenses in multiple state jurisdictions. The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The recoverability of deferred tax assets is evaluated by assessing the adequacy of future expected taxable income from all sources, including taxable income in prior carryback years, reversal of taxable temporary differences, forecasted operating earnings, and available tax planning strategies. To the extent the Company does not consider it more-likely-than-not that a deferred tax asset will be recovered, a valuation allowance is established. The Company's policy is to treat tax-related interest and penalties as income tax expense.
Concentration of Credit Risk
Cash includes amounts deposited in financial institutions in excess of insurable Federal Deposit Insurance Corporation (“FDIC”) limits. As of September 30, 2025, the Company had cash balances in excess of FDIC limits.
Revenue Recognition
The Company recognizes revenue on arrangements in accordance with ASC 606, Revenue from Contracts with Customers (“ASC 606”). The core principle of ASC 606 is to recognize revenues when promised goods or services are transferred to customers in an amount that reflects the consideration to which an entity expects to be entitled for those goods or services ASC 606 requires companies to assess their contracts to determine the timing and amount of revenue to recognize under the new revenue standard. The model has a five-step approach:
| 1. | Identify the contract with the customer. |
| 2. | Identify the performance obligations in the contract. |
| 3. | Determine the total transaction price. |
| 4. | Allocate the total transaction price to each performance obligation in the contract. |
| 5. | Recognize as revenue when (or as) each performance obligation is satisfied. |
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Revenue generated from the sale of INVOcell is typically recognized at the time the product is shipped, at which time the title passes to the customer, and there are no further performance obligations.
Revenue generated from clinical and lab services related at the Company’s fertility clinics is typically recognized at the time the service is performed.
The Company’s Therapeutics segment did not generate revenue. This segment was divested during the second quarter of 2025.
The Company accounts for stock-based compensation under the provisions of Accounting Standards Codification (“ASC”) subtopic 718-10, Compensation (“ASC 718-10”). This statement requires the Company to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost is recognized over the period in which the employee is required to provide service or based on performance goals in exchange for the award, which is usually the vesting period.
Basic loss per share is computed by dividing net loss by the weighted-average number of common shares outstanding. Diluted earnings per share are computed similarly to basic earnings per share except that the denominator is increased to include potentially dilutive securities. The Company’s diluted loss per share is the same as the basic loss per share for the nine months ended September 30, 2025, and 2024, as the inclusion of any potential shares would have had an anti-dilutive effect due to the Company generating a loss.
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Net loss (numerator) | $ | ( | ) | ( | ) | ( | ) | ( | ) | |||||||
| Basic and diluted weighted-average number of common shares outstanding (denominator) | ||||||||||||||||
| Basic and diluted net loss per common share | ) | ) | ) | ) | ||||||||||||
Schedule of Antidilutive Securities Excluded from Computation of Earnings Per Share
| 2025 | 2024 | |||||||
| As of September 30, | ||||||||
| 2025 | 2024 | |||||||
| Options | ||||||||
| Convertible notes and interest | ||||||||
| Preferred stock | ||||||||
| Warrants and unit purchase options | ||||||||
| Total | ||||||||
Recently Adopted Accounting Pronouncements
In December 2023, the FASB issued ASU 2023-09, Improvements to Income Tax Disclosures. The ASU requires greater disaggregation of information about a reporting entity’s effective tax rate reconciliation and information on income taxes paid. The ASU applies to all entities subject to income taxes and is intended to help investors better understand an entity’s exposure to potential changes in jurisdictional tax legislation and assess income tax information that affects cash flow forecasts and capital allocation decisions. The ASU is effective for annual periods beginning after December 15, 2024, with early adoption permitted. The adoption of this ASU on January 1, 2025, had no material impact on the Company’s financial statements.
Accounting Pronouncements Not Yet Adopted
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvement to Income Tax Disclosures, amending income tax disclosure requirements for the effective tax rate reconciliation and income taxes paid. The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024 and are applied prospectively. Early adoption and retrospective application of the amendments are permitted. The Company is currently evaluating the impact of the adoption of ASU 2023-09.
In November 2024, the FASB issued ASU 2024-03 Income Statement – Reporting Comprehensive Income – Expense Disaggregation Disclosures (Subtopic 220-40). The ASU aims to improve financial reporting by requiring that public business entities disclose additional information about specific expense categories in the notes to financial statements at interim and annual reporting periods. In January 2025, the ASU was subsequently amended by ASU 2025-01 to clarify the effective date by which all public business entities are required to adopt the guidance in annual reporting periods beginning after December 15, 2026, and interim periods within annual reporting periods beginning after December 15, 2027. Early adoption of ASU 2024-03 is permitted. The Company is currently evaluating the impact of this guidance on its financial statements.
The FASB and other entities issued new or modifications to, or interpretations of, existing accounting guidance during 2025. Management has carefully considered the new pronouncements that altered generally accepted accounting principles and does not believe that any other new or modified principles will have a material impact on the Company’s reported financial position or operations in the near term.
Note 2 – Liquidity
Historically,
the Company has funded its cash and liquidity needs primarily through revenue collection and debt and equity financings. For the nine
months ended September 30, 2025, and 2024, the Company incurred a net loss of approximately $
As
of September 30, 2025, we had approximately $
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The
Company has been dependent on raising capital from debt and equity financings to meet its needs for cash used in operating and investing
activities. During the first nine months of 2025, we received $
These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date the accompanying financial statements are issued. If the Company is unable to raise additional funding to meet its working capital needs in the future, it will be forced to delay or reduce the scope of its growth and acquisition plans and/or limit or cease its operations. If the Company cannot continue as a going concern, its stockholders would likely lose most or all of their investment in the Company. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Note 3 – Business Combinations
NAYA Therapeutics
On October 11, 2024 (the “Effective Time”), the Company, a wholly owned subsidiary (“Merger Sub”), and NTI entered into an Amended and Restated Agreement and Plan of Merger (the “A&R Merger Agreement”) and consummated the transactions contemplated thereby (the “Merger”). Upon the terms and subject to the conditions set forth in the A&R Merger Agreement, Merger Sub merged with and into NTI, with NTI continuing as the surviving corporation and a wholly owned subsidiary of the Company.
At the Effective Time and as a result of the consummation of the Merger:
● Each share of Class A common stock, par value $ per share, and Class B common stock, par value $ per share, of NTI (“NTI common stock”) outstanding immediately prior to the Effective Time, other than certain excluded shares held by NTI as treasury stock or owned by the Company or Merger Sub, automatically converted into the right to receive shares of the Company’s common stock and shares of the Company’s newly-designated Series C-1 Convertible Preferred Stock (the “Series C-1 Preferred”). See “Note 12 – Stockholders’ Equity” for additional information on the Series C-1 Preferred.
●
Certain outstanding debt obligations of NTI, including a portion of an amended and restated senior secured convertible debenture issued
to Five Narrow Lane LP (“FNL”), with a combined principal balance of $
●
The remaining balance of the amended and restated senior secured convertible debenture issued to FNL in the amount of $
The allocation of the purchase price is as follows:
Schedule of Allocation of Purchase Price
| Consideration given: | ||||
| Common Stock | $ | |||
| NAYA Acquisition Pre-funded Warrants | ||||
| Series C-1 Preferred | ||||
| Series C-2 Preferred | ||||
| Convertible Debenture | ||||
| Business acquisition cost | ||||
| Assets and liabilities acquired: | ||||
| Cash | ||||
| Other current assets | ||||
| Tradename | ||||
| In process R&D | ||||
| Goodwill | ||||
| AP & accrued liabilities | ( | ) | ||
| Debt | ( | ) | ||
| Total assets and liabilities acquired | $ |
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On
June 2, 2025, the Company divested a majority stake in NTI. The Company elected to redeem all outstanding shares of Series C-1 Preferred
at a redemption price of shares of Class A Common Stock of NTI for each share of C-1 Preferred being redeemed. Immediately,
prior to the redemption, the Company was the holder of shares of Class A Common Stock of NTI, representing all outstanding
common shares of NTI. The Company retained shares of Series A Preferred Stock of NTI, which represents 19.9% of the outstanding
common stock on an as-if converted basis. In addition, on May 28, 2025, NTI issued a secured convertible promissory note (“NTI
Note Receivable”) in the principal amount of $
The
Company recognized a loss of $
Schedule of Allocation of Purchase Price
| Consideration received: | ||||
| Series C-1 Preferred | ||||
| NTI Note Receivable | ||||
| NTI Series A Preferred | ||||
| Business acquisition cost | $ | |||
| Assets and liabilities divested: | ||||
| Cash | ||||
| Other current assets | ||||
| Tradename | ||||
| In process R&D | ||||
| Goodwill | ||||
| AP & accrued liabilities | ( | ) | ||
| Debt | ( | ) | ||
| Net assets | $ | |||
| Loss on disposition | $ |
The Company’s consolidated financial statements for the nine months ended September 30, 2025, include NTI’s results of operations through June 2, 2025. The Company’s consolidated financial statements reflect the purchase accounting adjustments in accordance with ASC 805 “Business Combinations”, whereby the purchase price was allocated to the assets acquired and liabilities assumed based upon their estimated fair values on the acquisition date as well as deconsolidation adjustments in accordance with ASC 810 “Consolidation”, whereby the loss upon disposition was recognized.
The carrying amounts of major classes of assets and liabilities held for sale are as follows:
Schedule of Assets and Liabilities Held for Sale
| December 31, 2024 | ||||
| ASSETS | ||||
| Cash | ||||
| Prepaid expenses and other current assets | ||||
| Intangible assets, net | ||||
| Goodwill | ||||
| Total assets held for sale | $ | |||
| LIABILITIES | ||||
| Accounts payable and accrued liabilities | ||||
| Notes payable, net | ||||
| Total liabilities held for sale | $ | |||
The major classes of line items constituting loss from discontinued operations are as follows:
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| For the Three Months Ended | For the Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Selling, general and administrative expenses | ||||||||||||||||
| Research and development expenses | ||||||||||||||||
| Impairment loss | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Interest expense | ||||||||||||||||
| Loss on discontinued operations | $ | $ | $ | $ | ||||||||||||
There were no depreciation, amortization, capital expenditures, or significant operating and investing noncash items related to the discontinued operations
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Note 4 – Variable Interest Entities
Consolidated VIEs
Bloom INVO, LLC
On June 28, 2021, INVO Centers LLC (“INVO CTR”) entered into a limited liability company agreement (the “Bloom Agreement”) with Bloom Fertility, LLC (“Bloom”) to establish a joint venture entity, formed as “Bloom INVO LLC” (the “Georgia JV”), for the purposes of commercializing INVOcell, and the related IVC procedure, through the establishment of an INVO Center in the Atlanta, Georgia metropolitan area (the “Atlanta Clinic”).
In
consideration for the Company’s commitment to contribute up to $
The responsibilities of Bloom include providing all medical services required for the operation of the Atlanta Clinic. The responsibilities of INVO CTR include providing certain funding to the Georgia JV, lab services quality management, and providing access to and being the exclusive provider of the INVOcell to the Georgia JV. INVO CTR also performs all required, industry specific compliance and accreditation functions, and product documentation for product registration.
The
Bloom Agreement provides Bloom with a “profits interest” in the Georgia JV and, in connection with such profits interest,
states that profits and losses be allocated to its members based on a hypothetical liquidation of the Georgia JV. In such a scenario,
liquidation proceeds would be distributed in the following order: (a) to INVO CTR until the difference between its capital contributions
and distributions equals $
The Atlanta Clinic opened to patients on September 7, 2021.
The
Company determined the Georgia JV is a VIE, and that the Company is its primary beneficiary because the Company has an obligation to
absorb losses that are potentially significant and the Company controls the majority of the activities that impact the Georgia JV’s
economic performance, specifically control of the INVOcell and lab services quality management. As a result, the Company consolidated
the Georgia JV’s results with its own. As of September 30, 2025, the Company invested $
Unconsolidated VIEs
HRCFG INVO, LLC
On
March 10, 2021, INVO CTR entered into a limited liability company agreement with HRCFG, LLC (“HRCFG”) to establish a joint
venture, formed as HRCFG INVO, LLC (the “Alabama JV”), for the purpose of commercializing INVOcell, and the related IVC procedure,
through the establishment of an INVO Center in Birmingham, Alabama (the “Birmingham Clinic”). The Company also provides certain
funding to the Alabama JV. INVO CTR and HRCFG party owns
The Birmingham clinic opened to patients on August 9, 2021.
The
Company determined the Alabama JV is a VIE, and that there is no primary beneficiary. As a result, the Company uses the equity method
to account for its interest in the Alabama JV. As of September 30, 2025, the Company invested $
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The following table summarizes our investments in unconsolidated VIEs:
Schedule of Investments in Unconsolidated Variable Interest Entities
| Carrying Value as of | ||||||||||||||
| Location | Percentage Ownership | September 30, 2025 | December 31, 2024 | |||||||||||
| HRCFG INVO, LLC | Alabama, United States | % | $ | |||||||||||
| Total investment in unconsolidated VIEs | $ | |||||||||||||
Earnings from investments in unconsolidated VIEs were as follows:
Schedule of Earnings from Investments in Unconsolidated Variable Interest Entities
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| HRCFG INVO, LLC | $ | $ | ( | ) | $ | $ | ( | ) | ||||||||
| Total earnings (loss) from unconsolidated VIEs | ( | ) | ( | ) | ||||||||||||
The following tables summarize the combined unaudited financial information of our unconsolidated VIEs:
Schedule of Financial Information of Investments in Unconsolidated Variable Interest Entities
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Statements of operations: | ||||||||||||||||
| Operating revenue | $ | $ | $ | $ | ||||||||||||
| Operating expenses | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
| Net profit (loss) | ( | ( | ||||||||||||||
September 30, 2025 | December 31, 2024 | |||||||
| Balance sheets: | ||||||||
| Current assets | $ | |||||||
| Long-term assets | ||||||||
| Current liabilities | ( | ) | ( | ) | ||||
| Net assets | $ | |||||||
Note 5 – Agreements and Transactions with VIE’s
The Company sells INVOcells to its consolidated and unconsolidated VIEs and anticipates continuing to do so in the ordinary course of business. All intercompany transactions with consolidated entities are eliminated in the Company’s consolidated financial statements. Pursuant to ASC 323-10-35-8, the Company eliminates any sales to an unconsolidated VIE for INVOcell inventory that the VIE still has remaining on the books at period end.
The following table summarizes the Company’s transactions with VIEs:
Summary of Transaction with Variable Interest Entities
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Bloom INVO, LLC | ||||||||||||||||
| INVOcell revenue | $ | $ | $ | $ | ||||||||||||
| Unconsolidated VIEs | ||||||||||||||||
| INVOcell revenue | $ | $ | $ | $ | ||||||||||||
The Company had balances with VIEs as follows:
Summary of Balances with Variable Interest Entities
September 30, 2025 | December 31, 2024 | |||||||
| Bloom INVO, LLC | ||||||||
| Accounts receivable | $ | |||||||
| Notes payable | ||||||||
| Unconsolidated VIEs | ||||||||
| Accounts receivable | $ | |||||||
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Note 6 – Inventory
Components of inventory are as follows:
Schedule of Inventory
September 30, 2025 | December 31, 2024 | |||||||
| Raw materials | $ | $ | ||||||
| Finished goods | ||||||||
| Total inventory | $ | $ | ||||||
Note 7 – Property and Equipment
The estimated useful lives and accumulated depreciation for equipment are as follows as of September 30, 2025, and December 31, 2024:
Schedule of Estimated Useful Lives of Property and Equipment
Estimated Useful Life | ||||
| Manufacturing equipment | ||||
| Medical equipment | ||||
| Office equipment |
Schedule of Property and Equipment
September 30, 2025 | December 31, 2024 | |||||||
| Manufacturing equipment | $ | $ | ||||||
| Medical equipment | ||||||||
| Office equipment | ||||||||
| Leasehold improvements | ||||||||
| Property, plant and equipment, gross | ||||||||
| Less: accumulated depreciation | ( | ) | ( | ) | ||||
| Total equipment, net | $ | $ | ||||||
During
the nine months ended September 30, 2025, and 2024, the Company recorded depreciation expense of $
For
the nine months ended September 30, 2025, and 2024, the Company recognized a loss on disposal of fixed assets of $
Note 8 – Intangible Assets and Goodwill
Components of intangible assets are as follows:
Schedule of Finite-Lived Intangible Assets
September 30, 2025 | December 31, 2024 | |||||||
| Tradename | $ | $ | ||||||
| Noncompetition agreement | ||||||||
| Goodwill | ||||||||
| Less: accumulated amortization | ( | ) | ( | ) | ||||
| Total intangible assets | $ | $ | ||||||
As
part of the Wisconsin Fertility Institute (“WFI”) acquisition, that closed on August 10, 2023, the Company acquired a tradename
valued at $
As
part of the NTI acquisition, that closed on October 11, 2024, the Company acquired a tradename valued at $
During
the nine months ended September 30, 2025, and 2024, the Company recorded amortization expenses related to intangible assets of $
Goodwill
has an indefinite useful life and is therefore not amortized. The Company performed an impairment analysis as of March 31, 2025, and
determined the goodwill of NTI was impaired by $
The
Company determined an impairment analysis was needed for the NTI goodwill due to an overall decline in the Company’s stock price
as of March 31, 2025. The Company engaged an independent third-party valuation specialist to complete the impairment analysis. The valuation
specialist used a discounted cash flow method to determine the fair value of NTI was less than the carrying value and therefore goodwill
was impaired by $
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Note 9 – Leases
The Company has various operating lease agreements in place for its office and joint ventures. Per FASB’s ASU 2016-02, Leases Topic 842 (“ASU 2016-02”), effective January 1, 2019, the Company is required to report a right-of-use (“ROU”) asset and corresponding liability to report the present value of the total lease payments, with appropriate interest calculation. The Company utilizes the incremental borrowing rate for each lease by developing a synthetic credit rating for the Company as of the commencement date of each lease, adjusting the synthetic credit rating to reflect the collateralized nature of the incremental borrowing rate, the Company’s borrowing rate under other debt facilities, and the market spread between secured and unsecured borrowings, and based on the adjusted synthetic rating and the various terms of the leases, selected the incremental borrowing rate based on the commencement date, duration of the lease, and a corresponding weight-adjusted corporate yield curve. Lease renewal options included in any lease are considered in the lease term if it is reasonably certain the Company will exercise the option to renew. The Company’s operating lease agreements do not contain any material restrictive covenants.
As of September 30, 2025, the Company’s lease components included in the consolidated balance sheet were as follows:
Schedule of Lease Components
| Lease component | Balance sheet classification | September 30, 2025 | December 31, 2024 | |||||||
| Assets | ||||||||||
| ROU assets – operating lease | Other assets | $ | $ | |||||||
| Total ROU assets | $ | $ | ||||||||
| Liabilities | ||||||||||
| Current operating lease liability | Current liabilities | $ | $ | |||||||
| Long-term operating lease liability | Other liabilities | |||||||||
| Total lease liabilities | $ | $ | ||||||||
Future minimum lease payments as of September 30, 2025, were as follows:
Schedule of Future Minimum Lease Payments
| 2025 | ||||
| 2026 | ||||
| 2027 | ||||
| 2028 | ||||
| 2029 and beyond | ||||
| Total future minimum lease payments | $ | |||
| Less: Interest | ( | ) | ||
| Total operating lease liabilities | $ |
For
the nine months ended September 30, 2025 and 2024, the weighted average remaining lease term for operating leases was
For
the nine months ended September 30, 2025, and 2024, the Company recognized a gain on lease termination of $ and $
| 17 |
Note 10 – Notes Payable
Notes payables consisted of the following:
Schedule of Notes Payable
September 30, 2025 | December 31, 2024 | |||||||
| Related party demand notes with a | $ | $ | ||||||
| Related party convertible notes with a | ||||||||
| Convertible notes payable. | ||||||||
| Convertible note payable. | ||||||||
| Cash advance agreement | ||||||||
| Note payable. | ||||||||
| Convertible debenture payable. | ||||||||
| Note payable. | ||||||||
| Other debt | ||||||||
| Long term debt gross | ||||||||
| Less debt discount and financing costs | ( | ) | ( | ) | ||||
| Total, net of discount | ||||||||
| Less current portion | ||||||||
| Long-term portion of notes payable | $ | $ | ||||||
Related Party Notes
In
the fourth quarter of 2022, the Company received $
In
consideration for subscribing to the JAG Note for $
On
August 13, 2025, the Company and JAG entered into a letter agreement (the “JAG August Letter”)
In
the fourth quarter of 2022, the Company received $
The financing fees for all demand notes were recorded as a debt discount and, as of September 30, 2025, the Company had fully amortized the discount.
For
the nine months ended September 30, 2025, the Company incurred $
| 18 |
Standard Merchant Cash Advance
On
September 25, 2024, the Company entered into a Standard Merchant Cash Advance Agreement (the “Sept 24 Cash Advance Agreement”)
with Cedar under which Cedar purchased $
The
financing fees were recorded as a debt discount. For the nine months ended September 30, 2025, the Company amortized $
Revenue Loan and Security Agreement
On
September 29, 2023, the Company, Steven Shum, as a Key Person, and the Company’s wholly-owned subsidiaries Bio X Cell, Inc, INVO
CTR, Wood Violet Fertility LLC (“Wood Violet”), FLOW and Orange Blossom Fertility LLC as guarantors (the “Guarantors”),
entered into a Revenue Loan and Security Agreement (the “Loan Agreement”) with Decathlon Alpha V LP (the “Lender”)
under which the Lender advanced a gross amount of $
The
financing fees for the RSLA Loan were recorded as a debt discount. For the nine months ended September 30, 2025, the Company amortized
$
On
September 24, 2024, the Company, the Lender, Steven Shum and the Guarantors entered into an amendment to the Loan Agreement, pursuant
to which the Lender approved the Sept 24 Cash Advance Agreement and the Company agreed to increase the “Minimum Interest”
(as defined in the Loan Agreement) by 0.15x effective as of December 1, 2024, if the Company did not receive equity investment of at
least $
On
August 13, 2025, the Company, the Lender, Steven Shum and the Guarantors entered into a third amendment to the Loan Agreement, pursuant
to which (i) the Lender consented to the change of the Company’s name to INVO Fertility, Inc., (ii) the Lender waived the event
of default that would result from the entry of judgment pursuant to the Term Sheet with Dr. Pritts and the Pritts Trust, (iii) the parties
agreed to an adjusted repayment schedule whereby the monthly payment under the Loan Agreement increased by $
Future Receipts Agreement
On
February 26, 2024, the Company finalized an Agreement for the Purchase and Sale of Future Receipts (the “Future Receipts Agreement”)
with a buyer (the “Buyer”) under which the Buyer purchased $
The financing fees were recorded as a debt discount. The debt discount was fully amortized as of August 2024.
FirstFire Convertible Note
On
April 5, 2024, the Company entered into a purchase agreement with FirstFire Global Opportunities Fund, LLC (“FirstFire”),
pursuant to which FirstFire agreed to purchase, and the Company agreed to issue and sell, (i) a promissory note with an aggregate principal
amount of $
The
FirstFire Note carried an interest rate of twelve percent (
The
financing fees for the FirstFire Note were recorded as a debt discount. For the nine months ended September 30, 2025, the Company
amortized $
On
October 14, 2024, $
| 19 |
7.0% Senior Secured Convertible Debenture
In
connection with the NTI Merger, on October 11, 2024, the Company issued the Convertible Debenture to FNL in an exchange of an outstanding
note of NTI held by FNL. The Convertible Debenture carried an interest rate of seven percent (
Conversion.
At any time after the Company’s stockholders approve the issuance of any Company common stock upon conversion of the Convertible
Debenture, the holder of the Convertible Debenture would be entitled to convert any portion of the outstanding and unpaid principal amount
and accrued interest into shares of Company common stock. The initial conversion price of the Convertible Debenture was $
Prepayment. The Company could not prepay the Convertible Debenture without the prior written consent of FNL.
Monthly Redemption. Commencing March 14, 2025, and on the 14th of each month thereafter until the Maturity Date, the Company could redeem $, plus accrued but unpaid interest and other fees, of the principal amount of the Convertible Debenture.
Mandatory
Redemption. While any portion of the Convertible Debenture was outstanding, if the Company received gross proceeds of more than
$ from any equity or debt financings (other than a public offering as described herein), the Company would, at the option of
the holder, apply one-third (1/3) of such gross proceeds to the redemption of the principal amount of the Convertible Debenture, except
that if such equity or debt financing was a public offering of the Company’s securities pursuant to a registration statement on
Form S-1, the Company would, at the option of the holder, apply one hundred percent (100%) of such gross proceeds, not to exceed $
The
Convertible Debenture contained events representations, warranties, covenants, and events of default that were customary for similar
transactions. Upon an event of default, the Convertible Debenture became immediately due and payable, and the Borrower was subject to
a default rate of interest of
In
November 2024, the Company received an additional $
Amended and Restated Debenture (May 2025)
On
May 23, 2025, the Company agreed to exchange the Convertible Debenture for an amended and restated debenture (the “Amended and
Restated Debenture”). The Amended and Restated Debenture carries an interest rate of seven percent (
Following
the Company’s stockholders approval of the issuance of any Company common stock upon conversion of the Amended and Restated Debenture
on June 25, 2025, the holder of the Amended and Restated Debenture became entitled to convert any portion of the outstanding and unpaid
principal amount and accrued interest into shares of Company common stock at an initial conversion price of $
The Company may not prepay the Amended and Restated Debenture without the prior written consent of FNL.
Commencing
August 15, 2025, and on the 15th of each month thereafter until the maturity date, the Company will be required to redeem
$
While
any portion of the Amended and Restated Debenture is outstanding, if the Company receives gross proceeds of more than $
The Amended and Restated Debenture contains events representations, warranties, covenants, and events of default that are customary for similar transactions. Upon an event of default, the Amended and Restated Debenture becomes immediately due and payable, and the Company is subject to a default rate of interest of 15% per annum and a default sum as stipulated.
On
June 30, 2025, the Company entered into an inducement letter agreement (the “AIR Exercise and Reload Agreement”) with FNL,
pursuant to which FNL agreed to exercise its Additional Investment Right to acquire shares of C-2 Preferred, with an aggregate
stated value of $
| 20 |
Amended and Restated Debenture (August 2025)
On
August 21, 2025, the Company and FNL entered into an agreement (the “Amendment and Exchange Agreement”) pursuant to which
the parties agreed to exchange the Amended and Restated Debenture in exchange for a Second Amended and Restated Debenture to (i) decrease
the outstanding principal amount of the Second Amended and Restated Debenture to $
In
consideration of the foregoing amendments, the Company and FNL agreed to reduce the outstanding principal amount of the Second Amended
and Restated Debenture by $
Extinguishment of the Amended and Restated Debenture (September 2025)
On
September 29, 2025, the Company and FNL entered into an exchange agreement pursuant to which FNL agreed to exchange the Second Amended
and Restated Debenture held by FNL for receipt of shares of Series C-2 Preferred with an aggregated stated value of $
For
the nine months ended September 30, 2025, the Company incurred $
Note 11 – Related Party Transactions
In
the fourth quarter of 2022, the Company issued a series of demand promissory notes in the aggregate principal amount of $
In
consideration for subscribing to the JAG Note for $
On
August 13, 2025, the Company and JAG entered into a letter agreement
| 21 |
In
the fourth quarter of 2022, the Company issued demand promissory notes in the aggregate principal amount of $
For
the nine months ended September 30, 2025, the Company incurred $
As
of September 30, 2025, the Company owed accrued compensation of $
Note 12 – Stockholders’ Equity
Reverse Stock Split (March 2025)
On
February 24, 2025, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio
of 1-for-12 and also approved a proportionate decrease in its authorized common stock to shares from .
Reverse Stock Split (July 2025)
On
June 30, 2025, the Company’s board of directors approved a reverse stock split of the Company’s common stock at a ratio of
1-for-3 and also approved a proportionate decrease in its authorized common stock to shares from .
Increase in Authorized Common Stock
On July 23, 2025, the stockholders of the Company approved an amendment to the Company’s Amended and Restated Articles of Incorporation to increase its number of authorized shares of common stock from to . On July 23, 2025, the Company filed a Certificate of Amendment to its Articles of Incorporation to increase its authorized shares of common stock from shares to shares.
Series C-1 Preferred Stock
On October 14, 2024, the Company filed with the Nevada Secretary of State a Certificate of Designation (the “Series C-1 Certificate of Designation”) of Series C-1 Convertible Preferred Stock (the “Series C-1 Preferred”) which sets forth the rights, preferences, and privileges of the Series C-1 Preferred. shares of Series C-1 Preferred with a stated value of $ per share were authorized under the Series C-1 Certificate of Designation.
Each
share of Series C-1 Preferred had a stated value of $, which was convertible into shares of the Company’s common stock
at a conversion price equal to $
| 22 |
Commencing
on the ninety-first (91st) day after the first issuance of any Series C-1 Preferred, the holders of Series C-1 Preferred became entitled
to receive dividends on the stated value at the rate of two percent (
The Series C-1 Preferred ranked senior to the Company’s common stock and junior to the Series C-2 Preferred (as defined below). Subject to the rights of the holders of any senior securities, in the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company, each holder of Series C-1 Preferred was entitled to receive its pro rata portion of an aggregate payment equal to the amount as would be paid on the Company’s common stock issuable upon conversion of the Series C-1 Preferred, determined on an as-converted basis, without regard to any beneficial ownership limitation.
Other than those rights provided by law, the Series C-1 Preferred had no voting rights. Prior to the filing of the certificate of amendment to the Series C-1 Certificate of Designation (described below), the Series C-1 Preferred were not redeemable.
On May 28, 2025, the Company filed with the Nevada Secretary of State a certificate of amendment to the Series C-1 Certificate of Designation pursuant to which, the Company was entitled to redeem the Series C-1 Preferred, at the Company’s option, at any time or from time to time upon not less than 2 calendar days written notice to the holders prior to the date fixed for redemption thereof, at a redemption price of shares of Class A Common Stock of NTI for each share of Series C-1 Preferred being redeemed.
On May 28, 2025, the Company gave notice to the holders of the Series C-1 Preferred that the Company elected to redeem, and would redeem, on May 31, 2025, all of the issued and outstanding shares of its Series C-1 Preferred (including any accrued but unpaid dividends) at a redemption price of shares of Class A Common Stock of NTI for each share of C-1 Preferred being redeemed. The redemption became effective on the following business day, June 2, 2025.
Series C-2 Preferred Stock
On October 14, 2024, the Company filed with the Nevada Secretary of State a Certificate of Designation (the “Series C-2 Certificate of Designation”) of Series C-2 Convertible Preferred Stock (the “Series C-2 Preferred”) which sets forth the rights, preferences, and privileges of the Series C-2 Preferred. shares of Series C-2 Preferred with a stated value of $ per share were authorized under the Series C-2 Certificate of Designation.
Each
share of Series C-2 Preferred has a stated value of $, which, along with any additional amounts accrued thereon pursuant to the
terms of the Series C-2 Certificate of Designation (collectively, the “Conversion Amount”) is convertible into shares of
the Company’s common stock at a an initial conversion price equal to $
Commencing
on the ninety-first (91st) day after the first issuance of any Series C-2 Preferred, the holders of Series C-2 Preferred were entitled
to receive dividends on the stated value at the rate of ten percent (
The
Series C-2 Preferred ranks senior to the Company’s common stock and to the Series C-1 Preferred. Subject to the rights of the holders
of any senior securities, in the event of any voluntary or involuntary liquidation, dissolution, or winding up, or sale of the Company,
each holder of Series C-2 Preferred shall be entitled to receive its pro rata portion of an aggregate payment equal to the greater of
(a)
Other than those rights provided by law, the Series C-2 Preferred has no voting rights. The Series C-2 Preferred was only redeemable upon a “Bankruptcy Triggering Event” or a “Change of Control” that may have occurred after May 9, 2025. Due to the Series C-2 Preferred being redeemable under these triggering events it was classified as mezzanine equity until it was amended on June 27, 2025, to remove the triggering event redemption (as noted below). The Series C-2 Preferred is now classified as permanent equity due to these changes.
On May 23, 2025, the Company filed with the Nevada Secretary of State the Certificate of Amendment to the Series C-2 Certificate of Designation pursuant to which, among other things, holders of Series C-2 Preferred are entitled to receive dividends payable in Series C-2 Preferred, subject to meeting certain conditions (the “Equity Conditions”).
In addition, upon issuance of AIR Preferred Shares (as defined below), the conversion price of the Series C-2 Preferred shall be deemed to be the lowest of (i) the conversion price as in effect on the date that the Holder exercises its Additional Investment Right (as defined above), and (ii) the greater of (x) the Floor Price (as defined in the Certificate of Amendment to the Series C-2 Certificate of Designations) and (y) 85% of the arithmetic average of the three (3) lowest VWAPs during the ten (10) trading days prior to the date of the exercise of the Additional Investment Right.
On June 27, 2025, the Company filed with the Nevada Secretary of State a Certificate of Amendment to Certificate of Designation of the Series C-2 Non-Voting Convertible Preferred Stock of the Company (the “2nd Certificate of Amendment”), which amends and restates the rights, preferences, and privileges of the Series C-2 Preferred. Twenty thousand () shares of Series C-2 Preferred with a stated value of $ per share were authorized under the 2nd Certificate of Amendment.
The 2nd Certificate of Amendment removed the “Bankruptcy Triggering Event” and “Change of Control” redemption rights.
| 23 |
Additional Investment Right
Effective
as of May 23, 2025, the Company and FNL entered into an agreement to amend that certain Securities Purchase Agreement, dated as of January
3, 2024, between FNL and NTI (the “Securities Purchase Agreement”) to provide that, for so long as the Amended and Restated
Debenture or shares of Series C-2 Preferred are outstanding, FNL shall have the right (the “Additional Investment Right”),
exercisable at any time and from time to time, beginning on or after May 23, 2025, to purchase up to $ of aggregate stated
value of additional shares of Series C-2 Preferred (the “AIR Preferred Shares”), provided that any Additional Investment
Right may only be exercised in a minimum amount of $
On
June 26, 2025, FNL exercised its Additional Investment Right to acquire shares of Series C-2 Preferred, with an aggregate stated
value of $, for $
On
June 30, 2025, the Company and FNL entered to an Amendment to Securities Purchase Agreement (the “Amendment”) to allow FNL
to elect, under the Additional Investment Right, to purchase the AIR Preferred Shares for cash (an “AIR Purchase”) or to
exchange the AIR Preferred Shares for all or a portion of the Amended and Restated Debenture, with the aggregate stated value of such
AIR Preferred Shares received in such exchange equal to the principal amount of the Amended and Restated Debenture so exchanged, plus
any accrued and unpaid interest thereon (an “AIR Exchange”). Any Additional Investment Right may only be exercised in a minimum
amount of $
On
June 30, 2025, the Company entered into an inducement letter agreement (the “AIR Exercise and Reload Agreement”) with FNL,
pursuant to which FNL agreed to exercise its Additional Investment Right to acquire shares of Series C-2 Preferred, with an aggregate
stated value of $
During
the third quarter of 2025 FNL exercised its Additional Investment Right to acquire
shares of Series C-2 Preferred, with an aggregate stated value of $,
for $
On
August 21, 2025, the Company and FNL agreed to reduce the outstanding principal amount of the Second Amended and Restated Debenture by
$
On
September 29, 2025, the Company and FNL entered into an exchange agreement pursuant to which FNL agreed to exchange the Second Amended
and Restated Debenture held by FNL for receipt of shares of Series C-2 Preferred with an aggregated stated value of $
Jan 2025 Public Offering
On
January 14, 2025, the Company, consummated a public offering (the “Jan 2025 Offering”) of units, each consisting
of either one share of common stock, or one pre-funded warrant to purchase one share of common stock (“Jan 2025 PFW”) in
lieu thereof, and one warrant to purchase one share of common stock at an offering price of $ per unit. The warrants are exercisable
from and after the date of their issuance and expire on the five-year anniversary of such date, at an exercise price of $
| 24 |
Also
in connection with the Jan 2025 Offering, on January 13, 2025, the Company entered into a placement agency agreement with Maxim Group
LLC (the “Placement Agent”), pursuant to which
The
Company received net proceeds of $
In
connection with the Jan 2025 Offering, the Company entered into a Preferred Stock Redemption Agreement with a holder of the Company’s
Series C-2 Convertible Preferred Stock pursuant to which the Company agreed to purchase and acquire from the holder shares of C-2
Preferred Stock for $
Nine months ended September 30, 2025
In January 2025, the Company issued shares of common stock pursuant to the Jan 2025 Offering. The securities issued were offered pursuant to the Company’s registration statement on Form S-1, initially filed by the Company with the SEC under the Securities Act on December 17, 2024, and declared effective on January 13, 2025.
In
January 2025, the Company issued
During the first nine months of 2025, the Company issued shares of common stock upon the exercise of the January 2025 PFWs. These shares were issued pursuant to the Company’s registration statement on Form S-1, as amended (File No. 333-283872) initially filed by the Company with the SEC on December 17, 2024, and declared effective on January 13, 2025.
In May 2025, the Company issued shares of common stock upon the exercise of the FNL warrants.
In May 2025, the Company issued shares of common stock to consultants in consideration of services rendered. The shares were issued under the Company’s 2019 Stock Incentive Plan (the “2019 Plan”).
In
May 2025, the Company issued
In
June 2025, the Company issued shares of common stock upon conversion of $
In
July 2025, the Company issued shares of common stock upon conversion of $
In
August and September 2025, the Company issued shares of common stock upon conversion of $
During the third quarter of 2025, the Company issued shares of common stock upon the conversion of shares of Series C-2 Preferred.
Equity Incentive Plans
In October 2019, the Company adopted the 2019 Plan. Under the 2019 Plan, the Company’s board of directors is authorized to grant stock options to purchase common stock, restricted stock units, and restricted shares of common stock to its employees, directors, and consultants. The 2019 Plan initially provided for the issuance of shares. In January 2024, the number of available shares increased by shares, bringing the total shares available under the 2019 Plan to . On June 25, 2025, stockholders approved a third amendment and restatement of the Company’s 2019 Stock Incentive Plan to increase the number of shares of common stock available for issuance thereunder to a total amount of .
Options granted under the 2019 Plan generally have a life of to years and exercise prices equal to or greater than the fair market value of the common stock as determined by the Company’s board of directors. Vesting for employees typically occurs over a three-year period. For the nine months ended September 30, 2025, the Company incurred $ in expense related to the vesting of options.
| 25 |
Schedule of Stock Options Activity
Number of Shares | Weighted Average Exercise Price | Aggregate Intrinsic Value | ||||||||||
| Outstanding as of December 31, 2024 | $ | $ | ||||||||||
| Granted | ||||||||||||
| Exercised | ||||||||||||
| Canceled | ( | ) | ||||||||||
| Balance as of September 30, 2025 | $ | $ | ||||||||||
| Exercisable as of September 30, 2025 | $ | $ | ||||||||||
Schedule of Share-Based Payment Award, Stock Options, Valuation Assumptions
Nine months ended March 31, | ||||||||
| 2025 | 2024 | |||||||
| Risk-free interest rate range | % | % | ||||||
| Expected life of option-years | - | |||||||
| Expected stock price volatility | % | % | ||||||
| Expected dividend yield | % | % | ||||||
The risk-free interest rate is based on U.S. Treasury interest rates, the terms of which are consistent with the expected life of the stock options. Expected volatility is based upon the average historical volatility of the common stock over the period commensurate with the expected term of the related instrument. The expected life and estimated post-employment termination behavior is based upon historical experience of homogeneous groups, executives and non-executives, within the Company. The Company does not currently pay dividends on its common stock, nor does it expect to do so in the foreseeable future.
Total Intrinsic Value of Options Exercised | Total Fair Value of Vested | |||||||
| Year ended December 31, 2024 | $ | $ | ||||||
| Nine months ended September 30, 2025 | $ | $ | ||||||
For the nine months ended September 30, 2025, the weighted average grant date fair value of options granted was $ per share. The Company estimates the fair value of options at the grant date using the Black-Scholes model. For all stock options granted through September 30, 2025, the weighted average remaining service period is year.
Restricted Stock and Restricted Stock Units
In the nine months ended September 30, 2025, the Company did not grant any restricted stock units or shares of restricted stock to employees, directors, or consultants under the 2019 Plan. Restricted stock issued to employees, directors, and consultants generally vest either at grant or vest over a period of one year from the date of grant.
Note 14 – Unit Purchase Options and Warrants
The following table sets forth the activity of unit purchase options:
Schedule of Unit Purchase Option Activity
Number of Unit Purchase Options | Weighted Average Exercise Price | Aggregate Intrinsic Value | ||||||||||
| Outstanding as of December 31, 2024 | $ | $ | $ | |||||||||
| Granted | ||||||||||||
| Exercised | ||||||||||||
| Canceled | ||||||||||||
| Balance as of September 30, 2025 | $ | $ | $ | |||||||||
The following table sets forth the activity of warrants:
Schedule of Warrants Activity
Number of Warrants | Weighted Average Exercise Price | Aggregate Intrinsic Value | ||||||||||
| Outstanding as of December 31, 2024 | $ | $ | ||||||||||
| Granted | ||||||||||||
| Exercised | ( | ) | ||||||||||
| Canceled | ||||||||||||
| Balance as of September 30, 2025 | $ | $ | ||||||||||
| 26 |
Jan 2025 Offering Warrants
On
January 14, 2025, the Company, consummated the Jan 2025 Offering, consisting of units at an offering price of $ per unit.
The warrants are exercisable from and after the date of their issuance and expire on the five-year anniversary of such date, at an exercise
price of $
Also
in connection with the Jan 2025 Offering, on January 13, 2025, the Company entered into a placement agency agreement with the Placement
Agent, pursuant to which (i) the Placement Agent agreed to act as lead placement agent on a “best efforts” basis in connection
with the Jan 2025 Offering, and (ii) the Company agreed to pay the Placement Agent an aggregate fee equal to 6.5% of the gross proceeds
raised in the Jan 2025 Offering (or 5.0% in the case of certain investors) and the Jan 2025 Placement Agent Warrants to purchase up to
Warrant Inducement
On
April 30, 2025, the Company entered into an inducement letter agreement (the “Inducement Letter Agreement”) with an institutional
investor and existing holder (the “Holder”) of certain existing warrants (the “Existing Warrants”) to purchase
up to shares of the Company’s common stock (the “Common Stock”). The Existing Warrants were originally issued
on January 14, 2025, with an exercise price of $
The issuance of the shares of Common Stock upon exercise of the Existing Warrants was registered pursuant to a registration statement on Form S-1 (File No. 333-283872), which was declared effective by the SEC on January 13, 2025.
Pursuant
to the Inducement Letter Agreement, the Holder agreed to exercise the Existing Warrants for cash at the exercise price of $
On
May 1, 2025, the Company issued shares upon the exercise of the Existing Warrants. On May 5, 2025, the Company issued an additional
shares of common stock upon the exercise of additional Existing Warrants. The aggregate gross proceeds to the Company from the
exercise of the Existing Warrants was approximately $
Note 15 – Segment Reporting
The Company’s Chief Operating Decision Maker (“CODM”) as defined under GAAP is the Company’s chief executive officer.
The Company defines its segments on the basis of the way in
which internally reported financial information is regularly reviewed by the CODM to analyze financial performance, make decisions, and
allocate resources. The CODM assesses the performance of its reportable segments and decides how to allocate resources based on the revenue
and the loss from operations. The Company has analyzed its operations per ASC 280 and identified three operating segments: Clinic Services,
INVOcell Device, and Therapeutics. The
The Clinics Services operating segment consists of financial information for WFI and the Atlanta Clinic. The INVOcell Device operating segment consists of financial information relating to the Company’s manufacture and sales of the INVOcell. The Therapeutics segment consists of financial information relating to the Company’s recently acquired subsidiary, NTI. The Company divested 80.1% of NTI during the second quarter of 2025 and as such the Therapeutics segment consults of the results of NTI through June 2, 2025.
The tables below provide information about the Company’s segments and include a reconciliation to income before taxes:
Schedule of Company’s Segments Including a Reconciliation to Income Before Taxes
| Nine months ended September 30, 2025 | Fertility Clinic Services | INVOcell Device | Therapeutics | Total | ||||||||||||
| Revenue from external customers | ||||||||||||||||
| Intersegment revenues | ||||||||||||||||
| Total revenue | ||||||||||||||||
| Reconciliation of revenue | ||||||||||||||||
| Elimination of intersegment revenue | ( | ) | ||||||||||||||
| Total consolidated revenue | ||||||||||||||||
| Less: | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Research and development | ||||||||||||||||
| Impairment loss | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Segment profit (loss) | ( | ) | ( | ) | ( | ) | ||||||||||
| Reconciliation of net loss | ||||||||||||||||
| Other income (loss) | ( | ) | ||||||||||||||
| Interest expense | ( | ) | ||||||||||||||
| Loss on disposition | ( | ) | ( | ) | ||||||||||||
| Unallocated amounts: | ||||||||||||||||
| Other corporate expenses | ( | ) | ||||||||||||||
| Loss before taxes | ( | ) | ||||||||||||||
| Assets | ||||||||||||||||
| 27 |
| Nine months ended September 30, 2024 | Fertility Clinic Services | INVOcell Device | Therapeutics | Total | ||||||||||||
| Revenue from external customers | ||||||||||||||||
| Intersegment revenues | ||||||||||||||||
| Total revenue | ||||||||||||||||
| Reconciliation of revenue | ||||||||||||||||
| Elimination of intersegment revenue | ( | ) | ||||||||||||||
| Total consolidated revenue | ||||||||||||||||
| Less: | ||||||||||||||||
| Cost of revenue | ||||||||||||||||
| Sales and marketing | ||||||||||||||||
| General and administrative | ||||||||||||||||
| Depreciation and amortization | ||||||||||||||||
| Segment profit (loss) | ||||||||||||||||
| Reconciliation of net loss | ||||||||||||||||
| Other income (loss) | ||||||||||||||||
| Interest expense | ( | ) | ||||||||||||||
| Unallocated amounts: | ||||||||||||||||
| Other corporate expenses | ( | ) | ||||||||||||||
| Loss before taxes | ( | ) | ||||||||||||||
| Assets | ||||||||||||||||
No
single customer comprised
Note 16 – Income Taxes
The Company uses the asset and liability method to account for income taxes. Under this method, deferred income tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. If a carryforward exists, the Company decides as to whether the carryforward will be utilized in the future. Currently, a valuation allowance is established for all deferred tax assets and carryforwards as their recoverability is deemed to be uncertain. If the Company’s expectations for future operating results at the federal or at the state jurisdiction level vary from actual results due to changes in healthcare regulations, general economic conditions, or other factors, it may need to adjust the valuation allowance, for all or a portion of the Company’s deferred tax assets. The Company’s income tax expense in future periods will be reduced or increased to the extent of offsetting decreases or increases, respectively, in the Company’s valuation allowance in the period when the change in circumstances occurs. These changes could have a significant impact on the Company’s future earnings.
The Company’s policy is to recognize interest and penalties related to the underpayment of income taxes as a component of the provision for income taxes.
On July 4, 2025, the One Big Beautiful Bill Act (“OBBA”) was enacted into law. The OBBA contains several key tax law changes, including extensions and modifications of the Tax Cuts and Jobs Act. In accordance with ASC 740, Income Taxes, the Company is required to recognize the effect of the tax law changes in the period of enactment. The Company is in the process of assessing the impacts from the tax law changes in the OBBA but does not expect a material impact to the Company’s Consolidated Financial Statements.
Income
tax expense was $ for the nine months ended September 30, 2025, compared to $
Note 17 – Commitments and Contingencies
Insurance
The Company’s insurance coverage is carried with third-party insurers and includes (i) general liability insurance covering third-party exposures, (ii) statutory workers’ compensation insurance, (iii) excess liability insurance above the established primary limits for general liability and automobile liability insurance, (iv) property insurance, which covers the replacement value of real and personal property and includes business interruption, and (v) insurance covering our directors and officers for acts related to our business activities. All coverage is subject to certain limits and deductibles, the terms and conditions of which are common for companies with similar types of operations.
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Legal Matters
As of September 30, 2025, the Company was not subject to any material legal proceedings; however, it could be subject to legal proceedings and claims from time to time in the ordinary course of its business, or legal proceedings it considered immaterial may in the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources.
WFI Settlement
In
June 2024, Wood Violet, pursuant to its rights under the WFI acquisition transaction documents (the “WFI Documents”), transferred
ownership of Wisconsin Fertility and Reproductive Surgery Associates, S.C. (“WFRSA”) from Dr. Elizabeth Pritts MD (“Dr.
Pritts”) to a new medical doctor. Upon completion of such transfer, WFRSA terminated Dr. Pritts’ employment. Since then,
various disputes among the parties have arisen under the WFI Documents, including, without limitation, Wood Violet’s non-payment
of the second installment of the purchase consideration of $
On May 7, 2025, Dr. Pritts and the Pritts Trust filed a complaint in the Circuit Court of the State of Wisconsin, Dane County, against the Company and its subsidiaries INVO CTR, WFRSA, and Wood Violet. Dr. Pritts and the Pritts Trust have asserted causes of action arising out of the WFI Documents for breach of contract, breach of the implied covenant of good faith and fair dealing, tortious interference with contract (or, in the alternative, veil piercing), and unjust enrichment.
On
May 14, 2025, the Company, Dr. Pritts, the Pritts Trust, and certain of their respective affiliates entered into a binding term sheet
(the “Term Sheet”) to settle all disputes between the parties pursuant to the terms set forth in the Term Sheet (the “Terms”).
The parties agreed to cooperate in good faith to prepare and enter into a final settlement agreement (the “Settlement Agreement”)
based on the terms set forth in the Term Sheet; provided, however, that unless and until the Settlement Agreement is executed, the Terms
are binding on the parties. Under the Terms, Wood Violet agreed to pay Dr. Pritts $
The
Company recognized a gain on settlement of $
Note 18 – Subsequent Events
Additional AIR Investments
On
October 6, 2025, the Holder exercised its right to an additional acquire shares of Series C-2 Preferred, with an aggregate stated
value of $
On
October 16, 2025, the Holder exercised its right to an additional acquire
shares of Series C-2 Preferred, with an aggregate stated value of $
Common Stock Issuances
Since September 30, 2025, the Company issued shares of common stock upon conversion of shares of Series C-2 Preferred.
JAG Amendment
On
November 13, 2025, the Company and JAG entered into a letter agreement pursuant to which (i) the maturity date of the JAG Notes was extended
until December 31, 2025, if the Company pays $
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
You should read the following discussion and analysis of our financial condition and results of operations together with our financial statements and the related notes appearing elsewhere in this Quarterly Report on Form 10-Q. In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those discussed below. Factors that could cause or contribute to such differences include, but are not limited to, those identified below, and those discussed in the section titled “Risk Factors” included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024 as may be amended, supplemented, or superseded from time to time by other reports we file with the SEC. All amounts in this report are in U.S. dollars, unless otherwise noted.
Throughout this Quarterly Report on Form 10-Q, references to “we,” “our,” “us,” the “Company,” “INVO,” or “INVO Fertility, Inc.” refer to INVO Fertility, Inc.
Overview
We are a healthcare services and technology company focused on the fertility marketplace and dedicated to expanding access to assisted reproductive technology (“ART”) care for patients in need. Our principal commercial strategy is focused on building, acquiring and operating fertility clinics, including “INVO Centers” dedicated primarily to offering the intravaginal culture (“IVC”) procedure enabled by our INVOcell® medical device (“INVOcell”) and US-based, profitable in vitro fertilization (“IVF”) clinics. We have two operational INVO Centers and one IVF clinic in the United States. We also continue to engage in the sale and distribution of our INVOcell technology solution into third-party owned and operated fertility clinics. We also intend to seek out additional, innovative fertility-focused technologies, to license or acquire in order to utilize within our clinics.
In October 2024, we acquired a 100% interest in Naya Therapeutics, Inc. (“NAYA Therapeutics” or “NTI”), a clinical-stage oncology and autoimmune technology company. In May 2025, we divested an 80.1% ownership interest in NTI, returning to an exclusive focus on the fertility marketplace, and changing our name and ticker symbol to “INVO Fertility, Inc.” and “IVF”, respectively.
Fertility Clinics
On August 10, 2023, we consummated the first acquisition of an existing IVF clinic, the Wisconsin Fertility Institute (“WFI”). As an established and profitable clinic, the closing of the WFI acquisition more than tripled our annual revenue and became a major part of our clinic-based operations. The acquisition accelerated our transformation from a medical device company to a healthcare services company and immediately added scale and a significant source of positive cash flow to our operations. The acquisition of profitable IVF clinics complements our efforts to build new INVO Centers, and we expect to continue this strategy to accelerate overall growth.
On March 10 and June 28, 2021, we established joint ventures to open INVO Centers in Birmingham, Alabama, and Atlanta, Georgia, respectively. We established these clinics to increase use of the INVOcell, to accelerate the growth and awareness of the IVC procedure and to expand the availability of statistical data supporting its use. These clinics also enabled us to expand our revenue per fertility cycle from hundreds of dollars (from the sale of each INVOcell device) to thousands of dollars, and to significantly advance our path to profitability. We believe a dedicated INVO Centers requires less investment than a traditional IVF clinic and are operationally efficient, making them ideal for underserved secondary markets. We plan on opening additional, wholly owned INVO Centers in the coming years.
INVOcell Device
Our proprietary technology, INVOcell®, is an innovative medical device that allows fertilization and early embryo development to take place in vivo within the woman’s body. This treatment solution is the world’s first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development and provides patients with a natural, intimate, and affordable experience. As reflected in available data, we believe the IVC procedure can deliver comparable results at a lower cost than traditional IVF and is a significantly more effective treatment than intrauterine insemination (“IUI”).
Unlike IVF, where the oocytes and sperm develop into embryos in an expensive laboratory incubator, the INVOcell allows fertilization and early embryo development to take place in the woman’s body. The IVC procedure can provide many benefits, including the following:
| ● | May reduce lab procedures, helping clinics and doctors to increase patient capacity, lower costs and offer an affordable advanced fertility treatment option; | |
| ● | Provide a natural, stable incubation environment; | |
| ● | Offer a more personal, intimate experience in creating a baby; and | |
| ● | Reduce the risk of errors and wrong embryo transfers. |
In both current utilization of the INVOcell, and in clinical studies, the IVC procedure has demonstrated equivalent pregnancy success and live birth rates as IVF.
While INVOcell remains part of our efforts, our commercial and corporate development strategy within the fertility market has expanded to focus more broadly on providing ART services through our emphasis on operating clinics. However, we will continue to provide INVOcell as well as seek out additional, innovative technologies, we can utilize to benefit patients and enhance our clinic operations.
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NAYA Therapeutics
On October 11, 2024, we acquired NAYA Therapeutics with the intent to expand our business activities beyond fertility and to create a healthcare portfolio company initially focused on a commercial-stage fertility business combined with a unique clinical-stage oncology and autoimmune technology business.
In April 2025, not having received sufficient shareholder support for key elements of the NAYA Therapeutics transaction at a shareholder meeting scheduled for March 10, 2025 (further detail available below under Recent Developments – 2024 Annual Meeting), upon advice of counsel and of our proxy solicitation firm, as well as general feedback from stakeholders, we elected to re-focus exclusively on our fertility business. As such, we changed our name to “INVO Fertility, Inc.” and our ticker symbol to “IVF”, and, on June 2, 2025, we divested a majority of our holdings in NAYA Therapeutics.
We remain enthusiastic about its prospects and will retain a minority stake in NAYA Therapeutics, which we hope to monetize in the future through value appreciation that could be generated from the clinical development of its bifunctional antibodies. We retain this minority stake in NTI as an asset on our balance sheet.
NAYA Therapeutics is advancing a portfolio of highly-competitive clinical candidates including NY-303, a first-in-class GPC3 x NKp46 bifunctional antibody for the treatment of hepatocellular carcinoma (HCC) with a unique mode of action targeting non-responders to the current immunotherapy standard of care (approximately 70% of the current treatable market) cleared to enroll patients in a Phase 1/2a monotherapy trial in 2025, NY-500, an AI-Optimized bifunctional antibody aiming to be the first PD1 x VEGF therapeutic to market in HCC, and NY-338, a CD38 x NKp46 bifunctional antibody for the treatment of multiple myeloma with a differentiated safety and efficacy profile.
Operations
Our critical management and leadership functions are carried out by our management team. In the Fertility Clinic segment, each clinic is separately staffed with the people necessary to manage daily activities, while most administrative tasks are centralized and handled by the INVO corporate staff. With respect to the INVOcell Device segment, we have contracted out the manufacturing, assembly, packaging, and labeling to a medical manufacturing company, sterilization of the device to a sterilization specialist, and storage and shipping to a third part logistics company.
Wisconsin Fertility Institute
On August 10, 2023, we consummated the first acquisition of an existing IVF clinic, WFI. As an established and profitable clinic, WFI has a full staff, including a reproductive endocrinology and infertility medical doctor (“REI”), an OBGYN trained to provide fertility treatment and full complement of medical, laboratory and administration staff. In June 2024, we replaced WFI’s REI with an REI that had previously worked at the clinic and was well acquainted with its staff and procedures. WFI’s staff manages most day-to-day activities, which, except for medical matters, is overseen by our VP operations. Upon closing the acquisition, our corporate staff assumed finance, accounting, human resources and other overhead responsibilities.
Alabama JV
On March 10, 2021, our wholly owned subsidiary, INVO Centers, LLC (“INVO CTR”) formed a joint venture with HRCFG, LLC (“HRCFG”) to establish an INVO Center in Birmingham, Alabama. The name of the joint venture is HRCFG INVO, LLC (the “Alabama JV”). The responsibilities of HRCFG’s principals include providing clinical practice expertise, performing recruitment functions, providing all necessary training, and providing day-to-day management of the INVO Center. Our responsibilities include providing funding to the Alabama JV and being the exclusive provider of the INVOcell. We also perform all required, industry-specific compliance and accreditation functions, and product documentation for product registration. The Birmingham INVO Center opened to patients on August 9, 2021.
Georgia JV Agreement
On June 28, 2021, INVO CTR formed a joint venture with Bloom Fertility, LLC (“Bloom”) to establish an INVO Center in Atlanta, Georgia. The name of the joint venture is Bloom INVO LLC (the “Georgia JV”). The responsibilities of Bloom include providing all medical services required for the operation of the INVO Center. Our responsibilities include providing funding to the Georgia JV, lab services, quality management, and being the exclusive provider of the INVOcell. We also perform all required, industry specific compliance and accreditation functions, and product documentation for product registration. The Atlanta INVO Center opened to patients on September 7, 2021.
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INVOcell
To date, we have completed a series of important steps in the successful development and manufacturing of the INVOcell:
| ● | Manufacturing: We are ISO 13485:2016 certified and manage all aspects of production and manufacturing with qualified suppliers. Our key suppliers, which include NextPhase Medical Devices, R.E.C. Manufacturing Corporation, and Casco Bay Molding, have been steadfast partners since our company first began and can provide us with virtually an unlimited capability to support our growth objectives, with all manufacturing performed in the New England region of the U.S. |
| ● | Raw Materials: All raw materials utilized for the INVOcell are medical grade and commonly used in medical devices (e.g., medical grade silicone, medical grade plastic). Our principal molded component suppliers, Casco Bay Molding and R.E.C. Manufacturing Corporation, are well-established companies in the molding industry and are either ISO 13485 or ISO 9001 certified. The molded components are supplied to our contract manufacturer for assembly and packaging of the INVOcell system. The contract manufacturer is ISO 13485 certified, and U.S. Food & Drug Administration (“FDA”) registered. |
| ● | US Marketing Clearance: The safety and efficacy of the INVOcell have been demonstrated and cleared for marketing and use by the FDA in November 2015. |
| ● | Clinical: In June 2023, we received FDA 510(k) clearance to expand the labeling on the INVOcell device and its indication for use to provide for a 5-day incubation period. The data supporting the expanded 5-day incubation clearance demonstrated improved patient outcomes. |
Market Opportunity
Fertility Clinics and INVOcell Device
The global ART marketplace is a large and growing, multi-billion-dollar industry across the world as increased infertility rates, greater patient awareness and improving financial incentives, such as insurance and governmental assistance, continue to drive demand. According to the European Society for Human Reproduction 2024 ART Fact Sheet, one in six couples worldwide experience fertility challenges. Additionally, the worldwide market remains vastly underserved as a high percentage of patients in need of care continue to go untreated each year for many reasons, but key among them are capacity constraints and cost barriers. There have been large increases in the use of IVF, with current estimates of approximately 4 million ART cycles performed globally each year, producing around 1 million babies. Regrettably, this only amounts to less than 5% of the infertile couples worldwide being treated and less than 2% of such couples having a child though IVF. The industry remains capacity constrained which creates challenges in providing access to care for the volume of patients in need. A survey by “Resolve: The National Infertility Association,” indicates the two main reasons couples do not use IVF is cost and geographical availability (and/or capacity).
In the United States, infertility affects an estimated 10%-15% of the couples of childbearing-age, according to the American Society of Reproductive Medicine (2017). According to the Centers for Disease Control (“CDC”), there are approximately 6.7 million women with impaired fertility. Based on 2022 data from the CDC’s National ART Surveillance System, approximately 435,000 IVF cycles were performed across ~500 IVF centers, leaving the U.S. with a large, underserved patient population, similar to most markets around the world.
Our corporate development strategy is aimed at taking advantage of the fertility market’s imbalance between supply and demand. We have identified a number of locations in the United States with attractive demographics and fertility service levels that would be ideal for the opening of new INVO Centers. Similarly, we have identified several profitable US-based IVF practices suitable for acquisition.
Competitive Advantages
INVOcell Device and INVO Centers
Over the past several years, the principal focus of our commercial efforts has shifted from the distribution of our INVOcell device to the provision of fertility clinic services through our INVO Centers and IVF clinic acquisition, with acquisitions of existing operations a near-term focus. For the most part, our activities have been focused on secondary markets where there is a greater imbalance between the need for ART treatment and the number of cycles available. Combined with our ability to offer a wider range of advanced fertility care, including IVC, IVF and IUI, at multiple price points, our clinics have the opportunity for differentiation from our competitors. As with our INVOcell technology, we continuously look for new solutions that can create greater efficiency and effectiveness in the provision of fertility cycles and support our efforts to democratize fertility care.
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While a smaller part of our current business, we continue to believe that our INVOcell device, and the IVC procedure it enables, can play a key role in making advanced fertility care more affordable and accessible. We continue to engage with third-party clinics that share our same vision and that use our one-of-a-kind INVOcell device.
Unlike IVF, where the oocytes and sperm develop into embryos in a laboratory incubator, the INVOcell allows fertilization and early embryo development to take place in the woman’s body. We believe that the IVC procedure can provide the following benefits:
| ● | May reduce lab procedures, helping clinics and doctors to increase patient capacity, lower costs and offer a more affordable advanced fertility treatment option; | |
| ● | A natural and stable incubation environment; | |
| ● | A more personal, intimate experience in creating a baby; and | |
| ● | A reduced risk of errors and wrong embryo transfers. |
In both current utilization of the INVOcell, and in clinical studies, the IVC procedure has demonstrated equivalent pregnancy success and live birth rates as IVF and generally may be offered at a significant discount to IVF cycles.
We will also continue seek out additional, innovative technologies, that we can utilize to further benefit patients and enhance our clinic operations.
Sales and Marketing
Fertility Clinics
Our two INVO Centers and WFI clinic employ various strategies to build awareness for their services and/or to maintain and grow patient flow and fertility cycle volume. The principal source of patient flow comes through OBGYN referrals and patient word of mouth. Our clinical staff maintain relationships with the local OBGYN community and organize virtual and in person events to showcase our centers’ services, fertility treatment effectiveness statistics and quality of our clinical personnel. We also conduct regular social and other media campaigns to attract new patients and to build awareness.
At the corporate level, we seek to build general awareness for our clinical activities and IVC procedure results with a view to drive patients to our centers and to grow demand for our INVOcell device. These efforts also support our ongoing work to open new INVO Centers and to acquire additional IVF clinics.
The acquisition of existing IVF clinics requires less sales and marketing effort compared to opening new INVO Centers, as they have established patient flows that can be built upon. When entering a new market with an INVO Center, we leverage the experience developed in establishing our Alabama and Georgia joint ventures. We employ strategies to secure patient flow levels that can enable new INVO Centers to become profitable and contribute economically to our overall business as soon as possible. Primarily, our INVO Centers seek to employ local, reputable physicians with strong ties to the OBGYN community.
INVOcell Device
Historically, our approach to marketing INVOcell was focused on identifying partners within targeted geographic regions that we believe could best support our efforts to expand access to advanced fertility treatment using the INVOcell and IVC procedure for the large number of underserved infertile people around the world. Those efforts resulted in the execution of a series of distribution agreements with partners across the globe. More recently, as we shifted our focus to opening INVO Centers and acquiring IVF clinics, which activities have been centered in the US, and as a result of the limited traction experienced in international markets, proactive marketing efforts for the INVOcell have been limited to the United States. In our domestic market, we distribute the INVOcell directly to a number of third-party IVF clinics and we remain open to pursuing foreign markets that present a realistic opportunity for incremental revenue on a profitable basis.
Recent Developments
Increase in Authorized Common Stock
On July 23, 2025, our stockholders approved an amendment to our Amended and Restated Articles of Incorporation to increase our number of authorized shares of common stock from 1,388,888 to 50,000,000. On July 23, 2025, we filed a Certificate of Amendment to its Articles of Incorporation to increase our authorized shares of common stock from 1,388,888 shares to 50,000,000 shares.
Reverse Stock Split (July 2025)
On June 30, 2025, our board of directors approved a reverse stock split of our common stock at a ratio of 1-for-3 and also approved a proportionate decrease in its authorized common stock to 4,166,667 shares from 1,388,888. On July 18, 2025, we filed a certificate of change (with an effective date of July 21, 2025) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 1-for-3 reverse stock split of its outstanding common stock. On July 11, 2025, we received notice from Nasdaq that the reverse split would take effect at the open of business on July 21, 2025, and the reverse stock split took effect on that date. All share information included in this Form 10-Q has been reflected as if the reverse stock split occurred as of the earliest period presented.
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NTI Divesture
On June 2, 2025, we divested a majority stake in NTI. We elected to redeem all outstanding shares of Series C-1 Preferred at a redemption price of 113.855837742504 shares of Class A Common Stock of NTI for each share of C-1 Preferred being redeemed. Immediately, prior to the redemption, we were the holder of 3,227,813 shares of Class A Common Stock of NTI, representing all outstanding common shares of NTI. We retained 6,300 shares of Series A Preferred Stock of NTI, which represents 19.9% of the outstanding common stock on an as-if converted basis. In addition, on May 28, 2025, NTI issued a secured convertible promissory note in the principal amount of $4,803,175 to us.
Additional Investment Right
Effective as of May 23, 2025, INVO and FNL entered into an agreement to amend that certain Securities Purchase Agreement, dated as of January 3, 2024, between FNL and NTI (the “Securities Purchase Agreement”) to provide that, for so long as the Amended and Restated Debenture or shares of Series C-2 Preferred are outstanding, FNL shall have the right (the “Additional Investment Right”), exercisable at any time and from time to time, beginning on or after May 23, 2025, to purchase up to $10,000,000 of aggregate stated value of additional shares of Series C-2 Preferred (the “AIR Preferred Shares”), provided that any Additional Investment Right may only be exercised in a minimum amount of $500,000 of AIR Preferred Shares. The AIR Preferred Shares shall have the same terms as the Series C-2 Preferred then outstanding, provided that, upon issuance of AIR Preferred Shares, the conversion price in the AIR Preferred Shares and Series C-2 Preferred shall be deemed to be the lowest of (i) the conversion price as in effect on the date that the Holder exercises such Additional Investment Right, and (ii) the greater of (x) the Floor Price (as defined in the Certificate of Amendment to the Series C-2 Certificate of Designation) and (y) 85% of the arithmetic average of the three (3) lowest VWAPs during the ten (10) trading days prior to the date FNL Purchaser exercises its Additional Investment Right. In consideration of the foregoing, we agreed to issue an additional 1,029 shares of Series C-2 Preferred to FNL.
On June 26, 2025, FNL exercised its Additional Investment Right to acquire 500 shares of Series C-2 Preferred, with an aggregate stated value of $500,000, for $500,000 in cash. As a result of the exercise, the conversion price on the right to additionally acquire Series C-2 Preferred adjusted to $2.85.
On June 30, 2025, INVO and FNL entered to an Amendment to Securities Purchase Agreement (the “Amendment”) to allow FNL to elect, under the Additional Investment Right, to purchase the AIR Preferred Shares for cash (an “AIR Purchase”) or to exchange the AIR Preferred Shares for all or a portion of the Amended and Restated Debenture, with the aggregate stated value of such AIR Preferred Shares received in such exchange equal to the principal amount of the Amended and Restated Debenture so exchanged, plus any accrued and unpaid interest thereon (an “AIR Exchange”). Any Additional Investment Right may only be exercised in a minimum amount of $200,000 of AIR Preferred Shares.
On June 30, 2025, we entered into an inducement letter agreement (the “AIR Exercise and Reload Agreement”) with FNL, pursuant to which FNL agreed to exercise its Additional Investment Right to acquire 1,800 shares of Series C-2 Preferred, with an aggregate stated value of $1,800,000, in exchange for $1,800,000 in principal amount, plus accrued and unpaid interest thereon of the Amended and Restated Debenture. Pursuant to the AIR Exercise and Reload Agreement, FNL agreed to exercise its Additional Investment Right in consideration for our agreement to issue 630 shares of new unregistered Series C-2 Preferred to FNL.
During the third quarter of 2025 FNL exercised its Additional Investment Right to acquire 1,650 shares of Series C-2 Preferred, with an aggregate stated value of $1,650,000, for $1,650,000 in cash. As a result of these exercises, the conversion price on the right to additionally acquire Series C-2 Preferred adjusted to $.7141. The Series C-2 Preferred issued pursuant to these exercises were sold and issued, and the shares of common stock issuable thereunder will be sold and issued, without registration under the Securities Act, in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder as transactions not involving a public offering.
On August 21, 2025, INVO and FNL agreed to reduce the outstanding principal amount of the Second Amended and Restated Debenture by $1,300,000 in exchange for receipt of shares of our Series C-2 Preferred pursuant to an additional investment right previously granted to FNL with aggregated stated value of $1,300,000. In consideration thereof, we agreed to issue 325 shares of additional C-2 Preferred to FNL.
On September 29, 2025, INVO and FNL entered into an exchange agreement pursuant to which FNL agreed to exchange the Second Amended and Restated Debenture held by FNL for receipt of shares of Series C-2 Preferred with an aggregated stated value of $1,334,000. In consideration thereof, we agreed to issue 467 additional shares of Series C-2 Preferred to FNL.
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Series C-2 Preferred Amendments
On May 23, 2025, we filed with the Nevada Secretary of State the Certificate of Amendment to the Series C-2 Certificate of Designation pursuant to which, among other things, holders of Series C-2 Preferred are be entitled to receive dividends payable in Series C-2 Preferred, subject to meeting certain conditions (the “Equity Conditions”).
In addition, upon issuance of AIR Preferred Shares (as defined below), the conversion price of the Series C-2 Preferred shall be deemed to be the lowest of (i) the conversion price as in effect on the date that the Holder exercises its Additional Investment Right (as defined above), and (ii) the greater of (x) the Floor Price (as defined in the Certificate of Amendment to the Series C-2 Certificate of Designations) and (y) 85% of the arithmetic average of the three (3) lowest VWAPs during the ten (10) trading days prior to the date of the exercise of the Additional Investment Right.
On June 27, 2025, we filed with the Nevada Secretary of State a Certificate of Amendment to Certificate of Designation of the Series C-2 Non-Voting Convertible Preferred Stock of INVO (the “2nd Certificate of Amendment”), which amends and restates the rights, preferences, and privileges of the Series C-2 Preferred. Twenty thousand (20,000) shares of Series C-2 Preferred with a stated value of $1,000.00 per share were authorized under the 2nd Certificate of Amendment.
The 2nd Certificate of Amendment removed the “Bankruptcy Triggering Event” and “Change of Control” redemption rights.
Series C-1 Preferred Amendment
On May 28, 2025, we filed with the Nevada Secretary of State a certificate of amendment to the Series C-1 Certificate of Designation pursuant to which, we are entitled to redeem at our option at any time or from time to time upon not less than 2 calendar days written notice to the holders prior to the date fixed for redemption thereof, at a redemption price of 113.855837742504 shares of Class A Common Stock of NTI for each share of Series C-1 Preferred being redeemed.
FNL Amendment and Exchange Agreements
Effective as of May 23, 2025, INVO and FNL entered into an agreement (the “FNL Amendment and Exchange Agreement”) pursuant to which the parties agreed concurrently to (a) exchange outstanding shares of Series C-1 Preferred held by FNL for shares of Series C-2 Preferred, (b) amend the Series C-2 Certificate of Designation pursuant to a certificate of amendment (the “Certificate of Amendment to the Series C-2 Certificate of Designation”), (c) exchange a 7.0% Senior Secured Convertible Debenture in the principal balance of $3,934,146 due December 11, 2025 issued to FNL (the “Debenture”) for an Amended and Restated Senior Secured Convertible Debenture Due February 11, 2026 (the “Amended and Restated Debenture”) and (d), amend that certain Securities Purchase Agreement, dated as of January 3, 2024, between FNL and NTI (the “Securities Purchase Agreement”) to provide that, for so long as the Amended and Restated Debenture or shares of Series C-2 Preferred are outstanding, FNL shall have the right (the “Additional Investment Right”), exercisable at any time and from time to time, beginning on or after May 23, 2025, to purchase up to $10,000,000 of aggregate stated value of additional shares of Series C-2 Preferred (the “AIR Preferred Shares”), provided that any Additional Investment Right may only be exercised in a minimum amount of $500,000 of AIR Preferred Shares. The AIR Preferred Shares shall have the same terms as the Series C-2 Preferred then outstanding, provided that, upon issuance of AIR Preferred Shares, the conversion price in the AIR Preferred Shares and Series C-2 Preferred shall be deemed to be the lowest of (i) the conversion price as in effect on the date that the Holder exercises such Additional Investment Right, and (ii) the greater of (x) the Floor Price (as defined in the Certificate of Amendment to the Series C-2 Certificate of Designation) and (y) 85% of the arithmetic average of the three (3) lowest VWAPs during the ten (10) trading days prior to the date FNL Purchaser exercises its Additional Investment Right. In consideration of the foregoing, we agreed to issue an additional 1,029 shares of Series C-2 Preferred to FNL.
On August 21, 2025, INVO and FNL entered into an agreement (the “Amendment and Exchange Agreement”) pursuant to which the parties agreed to exchange the Amended and Restated Debenture in exchange for a Second Amended and Restated Debenture to (i) decrease the outstanding principal amount of the Second Amended and Restated Debenture to $1,751,343.75, (ii) remove provisions related to Monthly Redemption Amounts, as defined in the Second Amended and Restated Debenture, and (iii) make other changes mutually agreed to between the parties.
In consideration of the foregoing amendments, INVO and FNL agreed to reduce the outstanding principal amount of the Second Amended and Restated Debenture by $1,300,000 in exchange for receipt of shares of our Series C-2 Preferred pursuant to an additional investment right previously granted to FNL with aggregated stated value of $1,300,000. In consideration thereof, we agreed to issue 325 shares of additional C-2 Preferred to FNL.
On September 29, 2025, INVO and FNL entered into an exchange agreement pursuant to which FNL agreed to exchange the Second Amended and Restated Debenture held by FNL for receipt of shares of Series C-2 Preferred with an aggregated stated value of $1,334,000. In consideration thereof, we agreed to issue 467 additional shares of Series C-2 Preferred to FNL. As a result, the Second Amended and Restated Debenture has been paid in full and fully extinguished.
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Pritts Litigation and Binding Settlement Term Sheet
On May 7, 2025, Dr. Elizabeth Pritts (“Dr. Pritts”) and the Elizabeth Pritts Revocable Living Trust (the “Pritts Trust”) filed a complaint in the Circuit Court of the State of Wisconsin, Dane County, against us and our subsidiaries INVO CTR, Wisconsin Fertility and Reproductive Surgery Associates, S.C., and Wood Violet Fertility LLC (“Wood Violet”). Dr. Pritts and the Pritts Trust have asserted causes of action arising out of the WFI acquisition documents (the “WFI Documents”) for breach of contract, breach of the implied covenant of good faith and fair dealing, tortious interference with contract (or, in the alternative, veil piercing), and unjust enrichment.
On May 14, 2025, INVO, Dr. Pritts, the Pritts Trust, and certain of their respective affiliates entered into binding term sheet (the “Term Sheet”) to settle all disputes between the parties pursuant to the terms set forth in the Term Sheet (the “Terms”). The parties agreed to cooperate in good faith to prepare and enter into a final settlement agreement (the “Settlement Agreement”) based on the terms set forth in the Term Sheet; provided, however, that unless and until the Settlement Agreement is executed, the Terms are binding on the parties. Under the Terms, Wood Violet agreed to pay Dr. Pritts $5,000,000 in full and final settlement and satisfaction of all obligations to Dr. Pritts and her affiliates under the WFI Documents, of which $525,000 was paid concurrently with the execution of the Term Sheet, and the remainder of which is payable as follows: $475,000 due June 30, 2025, $750,000 due September 30, 2025, $750,000 due December 31, 2025, $1,000,000 due March 31, 2026, $2,000,000 due June 30, 2026, and $500,000 due December 31, 2026. INVO shall provide Wood Violet with use of 25% of all gross funding proceeds above $2,000,000 raised within any six-month period to accelerate the payment of scheduled settlement payments in chronological order. The parties will enter into a consent judgment to resolve the complaint that would come into effect upon any breach of the Settlement Agreement. The parties agreed to settle all disputes, including those related to employment, acquisition, tax, and related matters, the termination of all employment, consulting, and similar agreements with Dr Pritts, and other customary terms, including, without limitation, indemnification and release of claims. On September 30, 2025 we executed the Settlement Agreement.
Warrant Inducement
On April 30, 2025, we entered into an inducement letter agreement (the “Inducement Letter Agreement”) with an institutional investor and existing holder (the “Holder”) of certain existing warrants (the “Existing Warrants”) to purchase up to 155,280 shares of our common stock. The Existing Warrants were originally issued on January 14, 2025, with an exercise price of $25.20 per share.
The issuance of the shares of common stock upon exercise of the Existing Warrants is registered pursuant to a registration statement on Form S-3 (File No. 333-283872), which was declared effective by the Securities and Exchange Commission (the “SEC”) on January 14, 2025.
Pursuant to the Inducement Letter Agreement, the Holder agreed to exercise the Existing Warrants for cash at the exercise price of $4.83 per share in consideration for our agreement to issue new unregistered warrants to purchase up to an aggregate of 232,920 shares of common stock at an exercise price of $4.83 per share (the “New Warrant”). The New Warrants will be exercisable upon receipt of such approval as may be required by the applicable rules and regulations of the Nasdaq Capital Market (or any successor entity) from the stockholders of INVO with respect to issuance of all of the New Warrants and the shares of common stock upon the exercise thereof (Stockholder Approval, and such date, the “Stockholder Approval Date”) and have a term of five years from the Stockholder Approval Date.
The aggregate gross proceeds to us from the exercise of the Existing Warrants was approximately $750,000, before deducting offering expenses payable by us.
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Name Change
On April 14, 2025, we changed our corporate name to INVO Fertility, Inc., pursuant to an Amendment to Articles of Incorporation filed with the Nevada Secretary of State on April 14, 2025 (the “Name Change”). Pursuant to Nevada law, a stockholder vote was not necessary to effectuate the Name Change.
On April 28, 2025, our common stock ceased trading under the ticker symbol “NAYA” and began trading under our new ticker symbol, “IVF”, on the Nasdaq Capital Market.
Reverse Stock Split (March 2025)
On February 24, 2025, our board of directors approved a reverse stock split of our common stock at a ratio of 1-for-12 and also approved a proportionate decrease in its authorized common stock to 12,500,000 shares from 4,166,667. On March 18, 2025, we filed a certificate of change (with an effective date of March 18, 2025) with the Nevada Secretary of State pursuant to Nevada Revised Statutes 78.209 to effectuate a 1-for-12 reverse stock split of its outstanding common stock. On March 17, 2025, we received notice from Nasdaq that the reverse split would take effect at the open of business on March 18, 2025, and the reverse stock split took effect on that date. All share information included in this Form 10-Q has been reflected as if the reverse stock split occurred as of the earliest period presented.
2024 Annual Meeting
On February 11, 2025, we filed a definitive proxy statement (the “February Proxy”) in connection with our annual meeting of stockholders (the “2024 ASM”). The 2024 ASM was scheduled for March 10, 2025, at 12 pm Eastern Time, and had a record date of January 24, 2025.
The February Proxy included standard proposals (the “Standard Proposals”) for stockholders (i) to elect five new directors (the “New Board Slate”) to our board of directors (the “Board”) and (i) to ratify the appointment of M&K CPAS, PLLC as our independent registered public accounting firm for the fiscal year ended December 31, 2024. The Standard Proposals customarily would have been voted on at a stockholder meeting in calendar year 2024. We opted to delay holding our 2024 annual stockholder meeting until 2025 to hold a single meeting that would cover both the Standard Proposals and a number of special proposals (the “Special Proposals”) requesting that the stockholders approve (i) the issuance, in accordance with Nasdaq Listing Rule 5635(a), of Common Stock, upon conversion of our outstanding Series C-1 and C-2 Non-Voting Convertible Preferred Stock, upon conversion of an outstanding 7.0% Senior Secured Convertible Debenture in the principal balance of $3,934,146 due December 11, 2025 (the “Debenture”), and upon settlement of restricted stock units and exercise of stock options issued in exchange for restricted stock units and stock options that were previously granted to certain directors, employees, and consultants of the NAYA Therapeutics, (ii) an amendment to our Second Amended and Restated 2019 Stock Incentive Plan to increase the number of shares of Common Stock available for issuance thereunder to an amount of 8,200,000 (pre-reverse split), equal to approximately 15% of the total of the total issued and outstanding stock, including shares issued upon conversion of our Series C-1 and C-2 Non-Voting Convertible Preferred Stock, and (iii) an amendment to our Amended and Restated Articles of Incorporation to increase the number of authorized shares of Common Stock from 50,000,000 to 100,000,000 after a reverse split of our Common Stock approved by the Board at a ratio ranging from any whole number between 1-for-2 and 1-for-20, as determined by the Board in its discretion, subject to the Board’s authority to abandon such reverse stock split.
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While Standard Proposals received sufficient votes for approval, several Special Proposals did not garner the necessary votes required for approval. Upon advice of counsel and our proxy solicitation firm, the Board approved the postponement of the 2024 ASM to April 9, 2025, the fixing of a new record date on March 10, 2025, and the filing of a new definitive proxy statement (the “March Proxy”).
As a result of this postponement and of the new record date, all votes cast by stockholders with respect to the proposals included in the February Proxy became null and void. The March Proxy was delivered with a new proxy card pursuant to which stockholders were asked to vote again on the Standard Proposals.
The 2024 ASM was held solely to cover the Standard Proposals and to regain compliance under Nasdaq Rules 5620(a) and 5801(s)(2)(G) that require companies listed on Nasdaq to hold an annual meeting of stockholders within twelve months of the fiscal year’s end (the “ASM Rule”). Pursuant to the previously disclosed notice received from the staff (the “Staff”) of The Nasdaq Stock Market LLC, we had until February 25, 2025, to submit a plan to regain compliance under the ASM Rule. We submitted a plan to the Staff in a timely fashion and, on February 28, 2025, the Staff notified us that we were granted an extension until June 30, 2025, to regain compliance with the ASM Rule. On April 15, 2025, the Staff notified us that we were in compliance with the ASM Rule and the matter is now closed.
The Standard Proposals in the March Proxy included (a) the re-election of existing directors to the Board (as would have been submitted for approval had the 2024 ASM been held in calendar year 2024, and in lieu of the New Board Slate included in the February Proxy), and (b) ratification of M&K CPAs LLC as our independent registered public accounting firm for the fiscal year ending December 31, 2024.
At the 2024 ASM, the stockholders approved the Standard Proposals in the March Proxy.
Public Offering
On January 14, 2025, we consummated a public offering (the “January 2025 Offering”) of 378,199 units (“Units”), each consisting of either one share of Common Stock, or one pre-funded warrant to purchase one share of Common Stock (the “January 2025 PFWs”) in lieu thereof, and one warrant to purchase one share of Common Stock at an offering price of $25.20 per Unit (the “January 2025 Warrants”). The January 2025 Warrants are exercisable from and after the date of their issuance and expire on the five-year anniversary of such date, at an exercise price of $25.20 per share of Common Stock. Each January 2025 PFW is immediately exercisable at an exercise price of $0.0036 per share and may be exercised at any time until all of the January 2025 PFWs are exercised in full. In connection with the January 2025 Offering, we entered into a securities purchase agreement (the “January 2025 SPA”) with certain institutional investors who purchased Units in this January 2025 Offering.
The securities issued in the January 2025 Offering were offered pursuant to our registration statement on Form S-1, as amended (File No. 333-283872) (the “January 2025 S-1”), initially filed by us with the SEC under the Securities Act of 1933, as amended (the “Securities Act”), on December 17, 2024 and declared effective on January 13, 2025.
We closed the January 2025 Offering on January 14, 2015, raising gross proceeds of approximately $9.5 million before deducting placement agent fees and other offering expenses payable.
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The stated intention for net proceed utilization included (i) up to $2,500,000 to fund the second installment of the purchase price for the WFI; (ii) $4,000,000 to redeem 4,000 shares of our Series C-2 preferred stock with a stated value of $4,000,000; (iii) up to $1,950,000 towards outstanding debt obligations that were payable prior to or upon completion of the January 2025 Offering and that we did not otherwise restructure or refinance, and (iv) the balance for clinical trials, product development, marketing, strengthening the corporate management team, working capital, and general corporate purposes.
Also in connection with the January 2025 Offering, on January 13, 2025, we entered into a placement agency agreement (the “January 2025 PAA”) with Maxim Group LLC (“Maxim”), pursuant to which (i) Maxim agreed to act as lead placement agent on a “best efforts” basis in connection with the January 2025 Offering, and (ii) we agreed to pay Maxim an aggregate fee equal to 6.5% of the gross proceeds raised in the January 2025 Offering (or 5.0% in the case of certain investors) and warrants to purchase up to 62,197 shares of Common Stock at an exercise price of $10.50 per share (the “Maxim January 2025 Warrants”). The Maxim January 2025 Warrants are exercisable at any time after the six-month anniversary of the closing date, from time to time, in whole or in part, until five (5) years from the commencement of sales of the securities in the January 2025 Offering. Additionally, we reimbursed Maxim for certain expenses and legal fees up to $90,000.
The January 2025 PAA and the January 2025 SPA contain customary representations, warranties and agreements made by us, customary conditions to closing, indemnification obligations by us, Maxim or the investors, as the case may be and other obligations of the parties.
Pursuant to the terms of the January 2025 SPAs and January 2025 PAA, we agreed that for a period of up to ninety (90) days from the closing of the January 2025 Offering, that neither we nor any subsidiary may (i) issue, enter into any agreement to issue or announce the issuance or proposed issuance of any shares of Common Stock or Common Stock equivalents or (ii) file any registration statement or prospectus, or any amendment or supplement thereto, in each case, subject to certain exceptions. We also agreed not to effect or enter into an agreement to effect any issuance of Common Stock or Common Stock equivalents involving a Variable Rate Transaction, as defined in the January 2025 SPA, for a period of up to twelve (12) months following the closing of the January 2025 Offering, subject to certain exceptions.
On January 14, 2025, we entered into a warrant agency agreement (the “January 2025 WAA”), with Transfer Online, Inc. appointing Transfer Online, Inc. as warrant agent for the January 2025 Warrants.
In connection with the January 2025 Offering, on January 13, 2025, we entered into a Class C-2 Preferred Stock Redemption Agreement (the “FNL C-2 Redemption Agreement”) with Five Narrow Lane, LP (“FNL”), pursuant to which we agreed to purchase and acquire from FNL 4,000 shares of our Series C-2 Convertible Preferred Stock (the “C-2 Preferred Stock”) for $4,000,000. Accrued dividends, plus any other accrued payments under the Certificate of Designations for the C-2 Preferred Stock, remain outstanding.
Results of Operations
During the first nine months of 2025, our fertility revenue increased approximately 9% compared to last year. Looking ahead, we expect our fertility operations to expand further, both through organic growth of our existing clinics and through the acquisition of additional, profitable IVF clinics similar to our Wisconsin clinic, which we acquired in 2023 and now serves as a solid foundation for our operations. Our active pursuit of additional acquisitions is aimed at accelerating our growth and driving our overall business to cash flow break even and beyond to profitability.
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Although we anticipate our clinic operations will dominate our commercial efforts and revenue, we also will continue to work on growing INVOcell, both within our own clinics as well as to third party fertility clinics. We also intend to seek out additional, innovative technologies that we can utilize to benefit patients and enhance our clinic operations.
From a macro perspective, we believe we will benefit from the ongoing growth in the ART market, which continues to experience positive trends, including (1) an under-served patient population, (2) increasing infertility rates around the world, (3) growing awareness and education of fertility treatment options, (4) a growing acceptance of fertility treatment, (5) improvements in procedure techniques and hence improvements in pregnancy success rates, and (6) generally improving insurance (private and public) reimbursement trends.
As previously described, we completed the acquisition of NAYA Therapeutics in October of 2024. The original goal behind this transaction was to expand our business activities beyond fertility and to create a healthcare portfolio company initially focused on a commercial-stage fertility business combined with a unique clinical-stage oncology and autoimmune technology business.
In April 2025, not having received sufficient shareholder support for key elements of the NAYA Therapeutics transaction at a shareholder meeting scheduled for March 10, 2025 (further detail available above under Recent Developments – 2024 Annual Meeting), upon advice of counsel and of our proxy solicitation firm, as well as general feedback from stakeholders, we elected to re-focus exclusively on our fertility business. As such, we changed our name and ticker symbol to “INVO Fertility, Inc.” and “IVF”, respectively, and, in May 2025, divested a majority interest in NAYA Therapeutics.
We remain enthusiastic about NTI’s prospects and will retain a minority stake, which we hope to monetize in the future through value appreciation that could be generated from the clinical development of its bifunctional antibodies.
We believe that our renewed focus on our core fertility operations best serves our growth objectives.
Comparison of the Three Months Ended September 30, 2025, and 2024
Revenue
Revenue for the three months ended September 30, 2025, was approximately $1.7 million, compared to approximately $1.4 million for the three months ended September 30, 2024. The increase of approximately 23% was primarily related to year over year organic growth in both the Wisconsin Clinic and the Atlanta Clinic.
Cost of Revenue
Cost of revenue for the three months ended September 30, 2025, was approximately $1.1 million, compared to approximately $1.0 million for the three months ended September 30, 2024. The increase in cost of revenue was primarily related to increased labor costs in the Wisconsin clinic.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses for the three months ended September 30, 2025, were approximately $2.1 million, compared to approximately $1.5 million for the three months ended September 30, 2024. The increase of approximately $0.6 million was primarily related to increased legal and accounting costs. Non-cash, stock-based compensation expense was $0.01 million in the period, compared to $0.2 million for the same period in the prior year.
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Loss from debt extinguishment
Loss from debt extinguishment for the three months ended September 30, 2025, was approximately $0.9 million, compared to nil for the three months ended September 30, 2024. This debt extinguishment expense is primarily related to the Amended and Restated Debenture.
Interest Expense and Financing Fees
Interest expense and financing fees were approximately $0.1 million for the three months ended September 30, 2025, compared to approximately $0.3 million for the three months ended September 30, 2024. The decrease in interest expense and financing fees was primarily related to a decrease in debt.
Comparison of the Nine Months Ended September 30, 2025, and 2024
Revenue
Revenue for the nine months ended September 30, 2025, was approximately $5.2 million, compared to approximately $4.8 million for the nine months ended September 30, 2024. The increase of approximately 8% was primarily related to year over year organic growth in both the Wisconsin Clinic and the Atlanta Clinic.
Cost of Revenue
Cost of revenue for the nine months ended September 30, 2025, was approximately $3.3 million, compared to approximately $2.7 million for the nine months ended September 30, 2024. The increase in cost of revenue was primarily related to increased labor costs in the Wisconsin clinic.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses for the nine months ended September 30, 2025, were approximately $5.9 million, compared to approximately $5.6 million for the nine months ended September 30, 2024. The increase of approximately $0.3 million was primarily related to increased legal and accounting costs. Non-cash, stock-based compensation expense was $0.7 million in the period, compared to $1.6 million for the same period in the prior year.
Impairment Loss
Impairment loss for the nine months ended September 30, 2025, was approximately $1.4 million compared to nil for the nine months ended September 30, 2024. The increase of approximately $1.4 million is noncash and is related to an impairment on the Wisconsin clinic’s noncompetition agreement related to the agreement to release Dr. Pritts from her noncompetition commitment under the Settlement Agreement.
Loss from debt extinguishment
Loss from debt extinguishment for the nine months ended September 30, 2025, was approximately $1.6 million, compared to $0.04 million for the nine months ended September 30, 2024. This debt extinguishment expense is primarily related to the Amended and Restated Debenture.
Gain on settlement
Gain on settlement for the nine months ended September 30, 2025, was approximately $0.7 million, compared to nil for the nine months ended September 30, 2024. This gain is due to the Settlement Agreement with Dr. Pritts.
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Interest Expense and Financing Fees
Interest expense and financing fees were approximately $0.7 million for the nine months ended September 30, 2025, compared to approximately $0.8 million for the nine months ended September 30, 2024. The decrease in interest expense and financing fees was primarily related to a decrease in debt.
Loss on Discontinued Operations
Loss on discontinued operations was approximately $18.0 million for the nine months ended September 30 ,2025, compared to nil for the nine months ended September 30 ,2024. The loss consists of approximately $16.5 million from the loss from operations of NTI, including a goodwill impairment of approximately $14.6 million and approximately $1.5 million from the loss on disposal of NTI.
Liquidity and Capital Resources
For the nine months ended September 30, 2025, and 2024, we had net losses of approximately $25.3 million and $5.5 million, respectively, and an accumulated deficit of approximately $93.1 million as of September 30, 2025. Approximately $19.6 million of the net loss was related to non-cash expenses for the nine months ended September 30, 2025, compared to $3.2 million for the nine months ended September 30, 2024. We had negative working capital of approximately $3.3 million as of September 30, 2025, compared to negative working capital of approximately $5.6 million as of December 31, 2024. As of September 30, 2025, we had stockholder’s equity of approximately $5.8 million compared to stockholder’s equity of approximately $12.7 million as of December 31, 2024.
We have been dependent on raising capital from debt and equity financings to meet our needs for cash required to fund our operating expenses and investing activities. During the first nine months of 2025, we received $2.2 million for the sale of our preferred stock, $1.0 million from the exercise of warrants, and $8.7 million in net proceeds for a public offering, which was partially used to redeem $4 million of preferred stock and repay approximately $1.2 million in debt. During the first nine months of 2024, we received net proceeds of approximately $1.6 million for the sale of our preferred stock, $0.9 million from the exercise of warrants, $0.7 million in proceeds from the sale of notes payable, and $0.2 million in net proceeds for the sale of our common stock. Until we can generate positive cash from operations, we will need to raise additional funding to meet our liquidity needs and to execute our business strategy. As in the past, we will seek debt and/or equity financing, which may not be available on reasonable terms, if at all.
Although our audited consolidated financial statements for the year ended December 31, 2024 were prepared under the assumption that we would continue operations as a going concern, the report of our independent registered public accounting firm that accompanies our consolidated financial statements for the year ended December 31, 2024 contains a going concern qualification in which such firm expressed substantial doubt about our ability to continue as a going concern, based on the consolidated financial statements at that time. Specifically, as noted above, we have incurred significant operating losses and we expect to continue to incur significant expenses and operating losses as we continue to acquire existing IVF clinics, develop the commercialization of our INVOcell solution and proceed with clinical trials of our newly acquired therapeutics. Prior losses and expected future losses have had, and will continue to have, an adverse effect on our financial condition. If we cannot continue as a going concern, our stockholders would likely lose most or all of their investment in us.
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Cash Flows
The following table shows a summary of our cash flows for the nine months ended September 30, 2025 and 2024:
| 2025 | 2024 | |||||||
| Cash (used in) provided by: | ||||||||
| Operating activities | (7,039,692 | ) | (2,357,021 | ) | ||||
| Investing activities | (38,158 | ) | (29,239 | ) | ||||
| Financing activities | 6,692,345 | 2,625,427 | ||||||
Cash Flows from Operating Activities
As of September 30, 2025, we had approximately $0.4 million in cash, compared to approximately $0.5 million as of September 30, 2024. Net cash used in operating activities for the first nine months of 2025 was approximately $7.0 million, compared to approximately $2.4 million for the same period in 2024. The increase in net cash used in operating activities was primarily due to the increase in net loss related to the consolidation of NTI.
Cash Flows from Investing Activities
During the nine months ended September 30, 2025, cash used in investing activities of $38 thousand was primarily related to the purchase of equipment for WFI. During the nine months ended September 30, 2024, cash used in investing activities of $30 thousand was primarily related to the purchase of equipment for WFI.
Cash Flows from Financing Activities
During the nine months ended September 30, 2025, cash provided by financing activities of approximately $6.7 million was primarily related to approximately $8.7 million of net proceeds from a public offering and $2.2 million in proceeds from the sale of preferred stock, which was partially offset by a $4 million redemption of the C-2 Preferred Stock, approximately $1.2 million of debt repayment, and warrant exercises. During the nine months ended September 30, 2024, cash provided by financing activities of approximately $2.6 million was primarily related to the sale of preferred stock, warrant exercises, and notes payable.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition presented in this section is based upon our audited consolidated financial statements, which have been prepared in accordance with generally accepted accounting principles in the United States. During the preparation of the financial statements, we are required to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate, based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, our results, which allows us to form a basis for making judgments on the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates based on variance with our assumptions and conditions. A summary of significant accounting policies is included below. Management believes that the application of these policies on a consistent basis enables us to provide useful and reliable financial information about our operating results and financial condition.
See Note 1 of the Notes to Consolidated Financial Statements included in Item 1 of this Quarterly Report on Form 10-Q for a summary of significant accounting policies and the effect on our financial statements.
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Business Acquisitions
The Company accounts for all business acquisitions at fair value and expenses acquisition costs as they are incurred. Any identifiable assets acquired and liabilities assumed are recognized and measured at their respective fair values on the acquisition date. If information about facts and circumstances existing as of the acquisition date is incomplete at the end of the reporting period in which a business acquisition occurs, the Company will report provisional amounts for the items for which the accounting is incomplete. The measurement period ends once the Company receives sufficient information to finalize the fair values; however, the period will not exceed one year from the acquisition date. Any adjustments to provisional amounts that are identified during the measurement period are recognized in the reporting period in which the adjustment amounts are determined.
Discontinued Operations
The Company accounted for the divesture of its NAYA Therapeutics (“NTI”) subsidiary in accordance with ASC 205 Discontinued Operations (“ASC 205”). ASC 205 requires that a component of an entity that has been disposed of or is classified as held for sale, has operations and cash flows that can be clearly distinguished from the rest of the entity, and represents a strategic shift that has (or will have) a major effect on the reporting entity’s financial results must be reported as discontinued operations. The divesture of NTI met the held-for-sale criteria as defined in ASC 205.
In the period a component of an entity is classified as a discontinued operation, the results of operations for the periods presented are reclassified into separate line items in the unaudited condensed consolidated statements of operations and the assets and liabilities of the discontinued operation are also reclassified into separate line items on the related condensed consolidated balance sheets. Prior period amounts are also adjusted to reflect discontinued operations presentation. All amounts included in the notes to the unaudited condensed consolidated financial statements relate to continuing operations unless otherwise noted.
Variable Interest Entities
The Company’s consolidated financial statements include the accounts of the Company, its wholly owned subsidiaries, and variable interest entities (“VIE”), where the Company is the primary beneficiary under the provisions of ASC 810, Consolidation (“ASC 810”). A VIE must be consolidated by its primary beneficiary when, along with its affiliates and agents, the primary beneficiary has both: (i) the power to direct the activities that most significantly impact the VIE’s economic performance; and (ii) the obligation to absorb losses or the right to receive the benefits of the VIE that could potentially be significant to the VIE. The Company reconsiders whether an entity is still a VIE only upon certain triggering events and continually assesses its consolidated VIEs to determine if it continues to be the primary beneficiary. See “Note 3 – Variable Interest Entities” for additional information on the Company’s VIEs.
Equity Method Investments
Investments in unconsolidated affiliates, over which the Company exerts significant influence but does not control or otherwise consolidate, are accounted for using the equity method. Equity method investments are initially recorded at cost. These investments are included in investment in joint ventures in the accompanying consolidated balance sheets. The Company’s share of the profits and losses from these investments is reported in loss from equity method joint venture in the accompanying consolidated statements of operations. The Company monitors its investments for other-than-temporary impairment by considering factors such as current economic and market conditions and the operating performance of the investees and records reductions in carrying values when necessary.
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Recently Issued Accounting Standards Not Yet Effective or Adopted
Management does not believe that any recently issued, but not yet effective accounting pronouncements, if adopted, would have a material impact on the accompanying condensed consolidated financial statements.
Item 3. Quantitative and Qualitative Disclosures about Market Risks
We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and are not required to provide the information required under this item.
Item 4. Controls and Procedures
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act), that are designed to be effective in providing reasonable assurance that information required to be disclosed in our reports under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to our management to allow timely decisions regarding required disclosure.
Our chief executive officer and chief financial officer previously concluded that our disclosure controls and procedures were not effective as of December 31, 2023, due solely to the events that led to the restatements of our financial statements for the periods ending June 30, 2021, through June 30, 2024. Our management determined a material weakness in our internal control over financial reporting existed due to the accounting treatment of our right-of-use asset and corresponding lease liability for our operating leases on our balance sheet. Management’s review was insufficient to identify an error in the incremental borrowing rate that led to our restatement of our financial statements for the periods.
Our management, including the chief executive officer and chief financial officer, has since carried out an evaluation of the effectiveness of the Company’s disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act, as amended, as of the end of the period covered by this report. These disclosure controls and procedures are designed to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and (ii) accumulated and communicated to our management, including our principal executive and principal financial officers, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure. Based on this evaluation, our chief executive officer and chief financial officer have concluded that our disclosure controls and procedures were not effective as of September 30, 2025, due to the material weaknesses described below.
Changes in Internal Control over Financial Reporting
There were no changes to our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II. OTHER INFORMATION
Item 1. Legal Proceedings
We are not currently subject to any material legal proceedings other than as described below; however, we could be subject to legal proceedings and claims from time to time in the ordinary course of our business, or legal proceedings we considered immaterial may in the future become material. Regardless of the outcome, litigation can, among other things, be time consuming and expensive to resolve, and can divert management resources.
Elizabeth Pritts and the Elizabeth Pritts Revocable Living Trust
On May 7, 2025, Dr. Elizabeth Pritts (“Dr. Pritts”) and the Elizabeth Pritts Revocable Living Trust (the “Pritts Trust”) filed a complaint in the Circuit Court of the State of Wisconsin, Dane County, against the Company and its subsidiaries INVO Centers LLC, Wisconsin Fertility and Reproductive Surgery Associates, S.C., and Wood Violet Fertility LLC (“Wood Violet”). Dr. Pritts and the Pritts Trust have asserted causes of action arising out of alleged breach of contract under the acquisition documents (the “WFI Documents”) for the Company’s acquisition of Wisconsin Fertility Institute (“WFI”), breach of the implied covenant of good faith and fair dealing, tortious interference with contract (or, in the alternative, veil piercing), and unjust enrichment.
On May 14, 2025, the Company, Dr. Pritts, the Pritts Trust, and certain of their respective affiliates entered into binding term sheet (the “Term Sheet”) to settle all disputes between the parties pursuant to the terms set forth in the Term Sheet (the “Terms”). The parties agreed to cooperate in good faith to prepare and enter into a final settlement agreement (the “Settlement Agreement”) based on the terms set forth in the Term Sheet; provided, however, that unless and until the Settlement Agreement is executed, the Terms are binding on the parties. Under the Terms, Wood Violet agreed to pay Dr. Pritts $5,000,000 in full and final settlement and satisfaction of all obligations to Dr. Pritts and her affiliates under the WFI Documents, of which $525,000 was paid concurrently with the execution of the Term Sheet, and the remainder of which is payable as follows: $475,000 due June 30, 2025, $750,000 due September 30, 2025, $750,000 due December 31, 2025, $1,000,000 due March 31, 2026, $2,000,000 due June 30, 2026, and $500,000 due December 31, 2026. The Company shall provide Wood Violet with use of 25% of all gross funding proceeds above $2,000,000 raised within any six-month period to accelerate the payment of scheduled settlement payments in chronological order. The parties will enter into a consent judgment to resolve the complaint that would come into effect upon any breach of the Settlement Agreement. The parties agreed to settle all disputes, including those related to employment, acquisition, tax, and related matters, the termination of all employment, consulting, and similar agreements with Dr Pritts, and (8) other customary terms, including, without limitation, indemnification and release of claims. On September 30, 2025 the Company executed the Settlement Agreement.
Item 1A. Risk Factors
Smaller reporting companies are not required to provide the information required by this item.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
On August 28, 2025, an institutional investor and existing holder exercised its right to acquire 200 shares of Series C-2 Preferred, with an aggregate stated value of $200,000, for $200,000 in cash. As a result of the exercise, the conversion price on the right to additionally acquire Series C-2 Preferred adjusted to $0.8892 per share. The Series C-2 Preferred issued pursuant to this exercise were sold and issued, and the shares of common stock issuable thereunder will be sold and issued, without registration under the Securities Act, in reliance on the exemptions provided by Section 4(a)(2) of the Securities Act and/or Rule 506 promulgated thereunder as transactions not involving a public offering.
During the third quarter of 2025, we issued an aggregate of 685,000 shares of our common stock upon conversion of $739,961 in principal amount due under an amended and restated 7.0% debenture (the “Amended and Restated Debenture”). The shares were issued without registration under the Securities Act, in reliance on the exemption provided by Section 3(a)(9) of the Securities Act.
During the third quarter of 2025, we issued an aggregate of 3,885,775 shares of our common stock upon conversion of 6,565 shares of Series C-2 Preferred. The shares were issued without registration under the Securities Act, in reliance on the exemption provided by Section 3(a)(9) of the Securities Act.
Since September 30, 2025, we issued 6,584,097 shares of our common stock upon conversion of 5,535 shares of Series C-2 Preferred. The shares were issued without registration under the Securities Act, in reliance on the exemption provided by Section 3(a)(9) of the Securities Act.
Item 3. Defaults Upon Senior Securities
None.
Item 4. Mine Safety Disclosures
Not applicable
Item 5. Other Information
| (a) | None. |
| (b) | None. |
| (c) | Insider Adoption or Termination of Trading Arrangements |
During
the fiscal quarter ended September 30, 2025, none of our directors or officers informed us of the
| 46 |
Item 6. Exhibits
| * Filed herewith. | ||
| ** Furnished herewith. |
| 47 |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized on November 17, 2025.
| INVO Fertility, Inc. | ||
| Date: November 17, 2025 | By: | /s/ Steven Shum |
| Steven Shum, Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| Date: November 17, 2025 | By: | /s/ Andrea Goren |
| Andrea Goren, Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||
| 48 |
Exhibit 10.1
November 13, 2025
James Goren
JAG Multi Investments LLC
c/o Bredefeld & Assoc. PC
125 Maple Avenue, Suite C
Chester, New Jersey 07930
| RE: | Demand Notes and Warrants |
Dear James
Reference is made to those certain demand notes dated October 21, October 28, November 10, December 13, December 29, 2022, and July 10, 2023 (the “Demand Notes”) issued by INVO Fertility, Inc. (f/k/a INVO Bioscience, Inc.; “INVO”) to JAG Multi Investments LLC (“JAG”). Under the Demand Notes, JAG loaned INVO a total of $600,000. All capitalized terms used herein that are not defined shall have the meaning assigned to those terms in the Demand Notes.
In a letter dated August 13, 2025 (the “August Letter”), INVO and JAG agreed to certain terms including an automatic extension of the maturity date of the Demand Notes to December 31, 2025, should INVO have paid $100,000 to JAG before September 30, 2025. To date, INVO has not made such payment.
By signing below, INVO and JAG agree to the following:
| 1. | Should INVO pay $100,000 to JAG before November 31, 2025, the maturity date of the Demand Notes will be extended automatically to December 31, 2025; |
| 2. | The exercise price on the warrant issued by INVO to JAG and dated August 13, 2025 will be reduced from $2 per share to $0.75 per share; and |
| 3. | The remaining terms of the August Letter will remain unchanged. |
| invofertility.com |
| JAG Demand Note |
| Page 2 of 2 |
| Sincerely, | AGREED AND ACCEPTED BY | |
| INVO BIOSCIENCE INC. | JAG MULTI INVESTMENTS LLC | |
| Steve Shum, CEO | James Goren, Managing Member |
| invofertility.com |
Exhibit 31.1
Certification of Principal Executive Officer of INVO Fertility, Inc.
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Steven Shum, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of INVO Fertility, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the unaudited condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| INVO Fertility, Inc. | ||
| Date: November 17, 2025 | By: | /s/ Steven Shum |
| Steven Shum | ||
| (Principal Executive Officer) | ||
Exhibit 31.2
Certification of Principal Financial Officer of INVO Fertility, Inc.
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Andrea Goren, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of INVO Fertility, Inc.; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the unaudited condensed consolidated financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have: |
| a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; | |
| b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; | |
| c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and | |
| d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and | |
| b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| INVO Fertility, Inc. | ||
| Date: November 17, 2025 | By: | /s/ Andrea Goren |
| Andrea Goren | ||
Chief Financial Officer (Principal Financial and Accounting Officer) | ||
Exhibit 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
In connection with the Quarterly Report on Form 10-Q of INVO Fertility, Inc. (the “Company”) for the period ended September 30, 2025 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), the undersigned, Steven Shum, Chief Executive Officer of the Company, and Andrea Goren, Chief Financial Officer of the Company, each hereby certifies, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| INVO Fertility, Inc. | ||
| Date: November 17, 2025 | By: | /s/ Steven Shum |
| Steven Shum | ||
| Chief Executive Officer | ||
| (Principal Executive Officer) | ||
| INVO Fertility, Inc. | ||
| Date: November 17, 2025 | By: | /s/ Andrea Goren |
| Andrea Goren | ||
| Chief Financial Officer | ||
| (Principal Financial and Accounting Officer) | ||