INVO Fertility, Inc 10-K for FY2024

INVO Fertility, Inc. (IVF)

10-K 2025-04-30 For: 2024-12-31

Added on April 08, 2026

About this 10-K

INVO Fertility, Inc filed this 10-K on April 30, 2025, covering the fiscal year ended December 31, 2024 (FY2024).

Headline figures

Fiscal year ended December 31, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $6.53M; up 116.3% from $3.02M a year earlier
Net loss: $9.1M; compared with a net loss of $8.03M a year earlier
Diluted EPS: -$30.19; compared with -$67.37 a year earlier

Search and read filings like this one from Claude or ChatGPT with the SEC filings MCP server →

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common Stock, $0.0001 par value per share		IVF		The Nasdaq Stock Market LLC

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

		Page
Part I

Item 1.	Business	4
Item 1A.	Risk Factors	16
Item 1B.	Unresolved Staff Comments	70
Item 1C.	Cybersecurity	70
Item 2.	Properties	71
Item 3.	Legal Proceedings	71
Item 4.	Mine Safety Disclosures	71

Part II

Item 5.	Market for Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	72
Item 6.	[Reserved]	72
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	72
Item 7A.	Quantitative and Qualitative Disclosure About Market Risk	86
Item 8.	Financial Statements and Supplementary Data	87
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	88
Item 9A.	Controls and Procedures	88
Item 9B.	Other Information	88
Item 9C.	Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.	88

Part III

Item 10.	Directors, Executive Officers and Corporate Governance	89
Item 11.	Executive and Director Compensation	92
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	100
Item 13.	Certain Relationships and Related Transactions, and Director Independence	101
Item 14.	Principal Accountant Fees and Services	102

Part IV

Item 15.	Exhibits, Financial Statement Schedules	103

SIGNATURES		111

	●	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.

●	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 has 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.

☒	Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

	For the fiscal year ended December 31, 2024

☐	Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

	For the transition period from to

	●	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.

●	the payment or receipt of anything of value in exchange for referrals of business (e.g. Anti-Kickback Statute (42 U.S.C. § 1320a-7b) (the “AKS”); Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a) (the “CMPL”); Ala. Code § 22-1-11(c));
●	the presenting of a false or fraudulent claim for payment by a government healthcare program, such as Medicare or Medicaid (e.g. False Claims Act (31 U.S.C. §§ 3729 – 3733); Georgia State False Medicaid Claims Act (Ga. Code Ann. §§ 49-4-168 – 49-4-168.6)); and
●	the referral by certain ordering licensed healthcare providers of certain healthcare items and services that are payable by a government healthcare program to an entity in which the healthcare provider or his or her immediate family member has an investment or other financial relationship (e.g. Section 1877 of the Social Security Act (42 U.S.C. § 1395nn), commonly referred to as the “Stark Law”; Georgia Patient Self-Referral Act of 1993 (Ga. Code Ann. §§ 43-1B-1 – 43-1B-8)).

●	Registration Nos. 6146631 and 3757982 for INVOCELL
●	Registration No. 4009827 for INVO
●	Registration No. 4009828 for INVO BIOSCIENCE

	●	The federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) (the “AKS”), a criminal statute, makes it illegal for any person or entity to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay any remuneration that is in exchange for or to induce the referral of business, including the purchase, order, lease of any good, facility, item, or service for which payment may be made under a federal healthcare program, such as Medicare or Medicaid. The term “remuneration” has been broadly interpreted to include anything of value. The Civil Monetary Penalties Law (42 U.S.C. § 1320a-7a) (the “CMPL”) also contains a provision that prohibits the payment of anything of value in return for referrals and provides for the imposition of civil penalties.
	●	Federal false claims and false statement laws, including the federal civil False Claims Act (31 U.S.C. §§ 3729 – 3733), prohibits, among other things, any person or entity from knowingly presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid, claims for items or services that are false or fraudulent.
	●	Section 1877 of the Social Security Act (42 U.S.C. § 1395nn), commonly referred to as the “Stark Law, prohibits referrals by ordering by a physician of “designated health services,” which include durable medical equipment and supplies as well as inpatient and outpatient hospital services, that are payable, in whole or in part, by Medicare or Medicaid, to an entity in which the physician or the physician’s immediate family member has an investment interest or other financial relationship, subject to several exceptions. Financial relationships that are implicated by the Stark Law can include arrangements ranging from marketing arrangements and consulting agreements to medical director agreements with physicians who order our products. The Stark Law also prohibits billing for services rendered pursuant to a prohibited referral. Several states have enacted laws similar to the Stark Law. These state laws may cover all (not just Medicare and Medicaid) patients. Many federal healthcare reform proposals in the past few years have attempted to expand the Stark Law to cover all patients as well. If we violate the Stark Law, our financial results and operations could be adversely affected. Penalties for violations include denial of payment for the services, significant civil monetary penalties, and exclusion from the Medicare and Medicaid programs;

	●	suspension or termination of our participation in federal healthcare programs;

	●	criminal or civil liability, fines, damages or monetary penalties for violations of healthcare fraud and abuse laws, including the federal False Claims Act, CMPL, and AKS;

	●	repayment of amounts received in violation of law or applicable payment program requirements, and related monetary penalties;

	●	mandated changes to our practices or procedures that materially increase operating expenses;

	●	imposition of corporate integrity agreements that could subject us to ongoing audits and reporting requirements as well as increased scrutiny of our business practices;

	●	termination of various relationships or contracts related to our business; and

	●	harm to our reputation which could negatively affect our business relationships, decrease our ability to attract or retain patients and physicians, decrease access to new business opportunities and impact our ability to obtain financing, among other things.

	●	political and economic instability;

	●	export controls;

	●	changes in international legal and regulatory requirements;

	●	United States and foreign government policy changes affecting the product marketability; and

	●	changes in tax laws, duties and tariffs.

	●	have significant discretion in determining the efforts and resources that they will apply;

	●	may not perform their obligations as expected;

	●	may dispute the amounts of payments owed;

	●	may fail to comply with applicable legal and regulatory requirements regarding the distribution or marketing of our INVOcell product;

	●	may not properly maintain or defend their or our relevant intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation and liability;

	●	may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability;

	●	could become involved in a business combination or cessation that could cause them to deemphasize or terminate the development or commercialization of our INVOcell product; and

	●	may seek to terminate our joint venture, which could require us to raise additional capital and to develop new joint venture relationships.

	●	disagreement with the design or conduct of any of our future clinical trials;

	●	failure to demonstrate to the satisfaction of regulatory agencies that our product candidates are safe and effective, or have a positive benefit/risk profile for our proposed indication;

	●	failure of future clinical trials to meet the level of statistical significance required for approval;

	●	disagreement with our interpretation of data from preclinical studies or future clinical trials;

	●	the insufficiency of data collected from future clinical trials of our product candidates to support the submission and filing of a BLA or equivalent foreign submission or to obtain regulatory approval;

	●	failure to obtain approval of our therapeutics manufacturing processes or facilities of third-party manufacturers with whom we contract for clinical and commercial supplies or our own therapeutics manufacturing facility; or

	●	changes in the approval policies or regulations that render our preclinical and clinical data insufficient for approval.

	●	physicians, hospitals, cancer treatment centers and patients considering our product candidates as a safe and effective treatment;

	●	the cost, efficacy, safety profile, convenience, ease of administration and other potential advantages compared to alternative treatments and therapies;

	●	the willingness of patients to pay out-of-pocket in the absence of coverage and adequate reimbursement by third-party payors and government authorities;

	●	product labeling or product insert requirements of the FDA or other comparable foreign regulatory authorities and any limitations or warning contained in the labeling approved by the FDA or comparable foreign regulatory authorities;

	●	the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies;

	●	the strength of our relationships with patient communities;

	●	the availability of third-party coverage and adequate reimbursement;

	●	the prevalence and severity of any side effects;

	●	the timing of market introduction of our product candidates as well as competitive products;

	●	relative convenience and ease of administration, including as compared to alternative treatments and competitive therapies; and

	●	the effectiveness of our sales and marketing efforts.

	●	manufacturing our product candidate to our specifications and in a timely manner to support our future clinical trials, and, if approved, commercialization;

	●	sourcing clinical and, if approved, commercial supplies for the raw materials used to manufacture our product candidates;

	●	enrolling sufficient numbers of patients in future clinical trials;

	●	understanding and addressing variability in demand for manufacturing and our impact on capacity utilization of available infrastructure and costs;

	●	submitting applications for and obtaining regulatory approval, as the FDA and other regulatory authorities including comparable foreign authorities have limited experience with commercial development of immunotherapies for cancer and viral associated infectious diseases; and

	●	establishing sales and marketing capabilities, as well as developing a manufacturing process and distribution network to support the commercialization of any approved products.

	●	delays in reaching a consensus with regulatory authorities on the design, location or implementation of our clinical trials;

	●	delays or setbacks in patient enrollment;

	●	clinical trials of our product candidates may produce negative or inconclusive results;

	●	the number of patients required for clinical trials for our product candidates may be larger than it anticipates, enrollment in these clinical trials may be slower than it anticipate or may be lower than it anticipates due to challenges in recruiting and enrolling suitable patients that meet the study criteria, participants may drop out of these clinical trials at a higher rate than we anticipate or the duration of these clinical trials may be longer than it anticipates;

	●	imposition of a clinical hold by regulatory authorities as a result of, among other reasons, a serious adverse event, a failure in the chemistry manufacturing and controls requirements, or a failed inspection of our clinical trial operations, trial sites or manufacturing facilities;

	●	occurrence of serious adverse events associated with the product candidate that are viewed to outweigh its potential benefits; and

	●	need to conduct additional clinical trials or abandon product development programs.

	●	the severity and incidence of the disease under investigation;

	●	the design of the trial and the complexity for patients and clinical sites;

	●	the general health condition of the patient and their immune broadly;

	●	the risk that patients’ general health conditions do not allow the conduct of study/screening procedures (such as leukapheresis), the manufacture of therapeutic product or application of the appropriate standard-of-care treatment or application of the Stupp regimen;

	●	the ability to consistently manufacture FLEX-NK™ engager product candidates in sufficient quantities at sufficient activity and/or transduction efficiency to provide a suitable therapeutic dose of FLEX-NK cell engager antibodies;

	●	competing clinical trials for similar therapies, other new therapeutics, new combination treatments, new medicinal products;

	●	clinicians’ and patients’ perceptions as to the potential advantages and side effects of the product candidate being studied in relation to other available therapies, including any new drugs or treatments that may be approved or become standard of care for the indications we are investigating;

	●	the ability to obtain and maintain patient consents due to various reasons;

	●	the risk that enrolled subjects will drop out, develop complications or die before completion of the trial;

	●	the ability to develop and provide appropriate screening, product characterization and release assays;

	●	patients failing to complete a clinical trial or returning for post-treatment follow-up;

	●	our ability to manufacture the requisite materials for a patient and clinical trial; and

	●	inability of clinical sites to enroll patients as health care capacities are required to cope with natural disasters, epidemics or other health system emergencies.

	●	the methodology used may not be successful in identifying potential product candidates;

	●	competitors may develop alternatives that render any product candidates it develops obsolete;

	●	any product candidates it develops may be covered by third parties’ patents or other exclusive rights;

	●	a product candidate may demonstrate harmful side effects or other characteristics that indicate it is unlikely to be effective or otherwise does not meet applicable regulatory criteria;

	●	a product candidate may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and

	●	a product candidate may not be accepted as safe and effective by physicians, patients, the medical community or third-party payors.

●	decreased demand for our product candidates;

●	injury to our reputation;

●	withdrawal of clinical trial participants;

●	initiation of investigations by regulators;

●	costs to defend the related litigation;

●	a diversion of management’s time and our resources;

●	substantial monetary awards to trial participants or patients;

●	product recalls, withdrawals or labeling, marketing or promotional restrictions;

●	loss of revenue;

●	exhaustion of any available insurance and our capital resources; and

●	the inability to commercialize any product candidate.

	●	conducting clinical development and obtaining required regulatory approvals for product candidates; and

	●	commercializing any resulting products.

	●	shifts our priorities and resources away from our collaborations due to a change in business strategies, or a merger, acquisition, sale or downsizing of our company or business unit;

	●	ceases development in therapeutic areas which are the subject of our collaboration;

	●	fails to select a product candidate for advancement into preclinical development, clinical development, or subsequent clinical development into a marketed product;

	●	changes the success criteria for a particular product candidate, thereby delaying or ceasing development of such product candidate;

	●	significantly delays the initiation or conduct of certain activities which could delay our receipt of milestone payments tied to such activities, thereby impacting our ability to fund our own activities;

	●	develops a product candidate that competes, either directly or indirectly, with our product candidates;

	●	does not obtain the requisite regulatory approval of a product candidate;

	●	does not successfully commercialize a product candidate;

	●	encounters regulatory, resource or quality issues and are unable to meet demand requirements;

	●	exercises its rights under the agreement to terminate the collaboration, or otherwise withdraws support for, or otherwise impairs development under the collaboration;

	●	disagrees on the research, development or commercialization of a product candidate resulting in a delay in milestones, royalty payments or termination of such product candidate; and

	●	uses our proprietary information or intellectual property in such a way as to jeopardize our rights in such property.

	●	inability to meet our product specifications and quality requirements consistently;

	●	delay or inability to procure or expand sufficient manufacturing capacity;

	●	issues related to scale-up of manufacturing;

	●	costs and validation of new equipment and facilities required for scale-up;

	●	our third-party manufacturers may not be able to execute our manufacturing procedures and other logistical support requirements appropriately;

	●	our third-party manufacturers may fail to comply with cGMP requirements and other inspections by the FDA or other comparable foreign regulatory authorities;

	●	our inability to negotiate manufacturing agreements with third parties under commercially reasonable terms, if at all;

	●	breach, termination or nonrenewal of manufacturing agreements with third parties in a manner or at a time that is costly or damaging to us;

	●	reliance on single sources for reagents and components;

	●	lack of qualified backup suppliers for those components that are currently purchased from a sole or single-source supplier;

	●	our third-party manufacturers may not devote sufficient resources to our antibody product candidates;

	●	we may not own, or may have to share, the intellectual property rights to any improvements made by our third-party manufacturers in the manufacturing process for our antibody product candidates;

	●	operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier; and

	●	carrier disruptions or increased costs that are beyond our control.

	●	the degree of government involvement;

	●	the level of development;

	●	the growth rate;

	●	the control of foreign exchange;

	●	access to financing; and

	●	the allocation of resources.

	●	the scope of rights granted under the license agreement and other interpretation-related issues;

	●	the extent to which our technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;

	●	the sublicensing of patents and other rights under our collaborative development relationships;

	●	our diligence obligations under the license agreement and what activities satisfy those diligence obligations;

	●	the inventorship and ownership of inventions and know-how resulting from the joint creation or use of intellectual property by us, our licensors, and our partners; and

	●	the priority of invention of patented technology.

	●	others may be able to make molecules that are similar to our product candidates but that are not covered by the claims of any patents, should they issue, that we own or license;

	●	We or our licensors might not have been the first to make the inventions covered by the issued patents or pending patent applications that we own or license;

	●	We or our licensors might not have been the first to file patent applications covering certain of our inventions;

	●	others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our intellectual property rights;

	●	it is possible that our pending patent applications will not lead to issued patents;

	●	issued patents that we own or license may not provide us with any competitive advantages or may be held invalid or unenforceable as a result of legal challenges;

	●	Our competitors might conduct research and development activities in the United States and other countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where we do not have patent rights, and then use the information learned from such activities to develop competitive drugs for sale in our major commercial markets;

	●	We may not develop additional proprietary technologies that are patentable; and

	●	the patents of others may have an adverse effect on our business.

●	a limited availability of market quotations for our common stock;

●	a decreased ability to issue additional securities or obtain additional financing in the future;

●	reduced liquidity for our stockholders;

●	potential loss of confidence by customers, collaboration partners and employees; and

●	loss of institutional investor interest.