As filed with the U.S. Securities and Exchange Commission on December 17, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INVO FERTILITY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Commission Nevada 001-39701 20-4036208 (I.R.S. Employer Identification Number) 5582 Broadcast Court Sarasota, Florida, 34240 (978) 878 ...

Revenue Performance - Revenue for Q3 2025 was $1,757,094, representing a 23% increase compared to $1,433,151 in Q3 2024[5] - Consolidated clinic revenue increased by 21% to $1,722,223 from $1,418,011 year-over-year[5] - Total revenue from all clinics, including consolidated and equity method clinics, was $1,995,007, an 18% increase from $1,686,093[5] Financial Losses - The net loss for Q3 2025 was $(2.6) million, compared to $(1.6) million in Q3 2024[5] - Adjusted EBITDA for Q3 2025 was $(947,568), slightly worse than $(945,949) in the prior year[5] Growth and Strategy - The company achieved 23% organic growth driven by increased patient flow and enhanced marketing efforts[5] - INVOcell device revenue grew by 130% year-over-year due to expanded training support and improved pricing[5] - The company is pursuing an acquisition strategy with a growing pipeline of interested fertility clinics[5] Market and Operational Developments - Recent policy updates allow employers to offer standalone infertility benefit packages, expanding access to IVF coverage[5] - The company is focused on improving operational efficiencies, including a partnership with Heidi Health for an AI-powered scribe platform[5]

Revenue and Growth - Total revenue for the three months ended September 30, 2025, was $1,757,094, an increase of 22.6% compared to $1,433,151 for the same period in 2024[14] - Clinic revenue for the nine months ended September 30, 2025, reached $5,175,870, up from $4,763,131 in 2024, reflecting an increase of 8.7%[14] - For the nine months ended September 30, 2025, total consolidated revenue was $5,257,933, an increase from $4,846,034 for the same period in 2024, representing an increase of approximately 8.5%[189][190] - The Clinic Services segment generated revenue of $5,175,870, while the INVOcell Device segment contributed $82,063, with no revenue from the Therapeutics segment[189] Expenses and Losses - Total operating expenses for the three months ended September 30, 2025, were $3,392,578, compared to $2,733,553 in 2024, representing a 24.2% increase[14] - The net loss from continuing operations for the three months ended September 30, 2025, was $2,644,625, compared to a loss of $1,630,662 in 2024, indicating a deterioration in performance[14] - The net loss for the nine months ended September 30, 2025, was $25,333,069, compared to a net loss of $5,472,345 for the same period in 2024[22] - The Company reported a loss before taxes of $25,333,069 for the nine months ended September 30, 2025, compared to a loss of $5,441,250 for the same period in 2024[189][190] Cash and Assets - Cash and cash equivalents as of September 30, 2025, were $355,891, down from $619,520 as of December 31, 2024, a decrease of 42.5%[12] - Total assets decreased to $18,832,198 as of September 30, 2025, from $46,449,182 as of December 31, 2024, a decline of 59.5%[12] - As of September 30, 2025, the Company had total assets of $7,831,342 in the Fertility Clinic segment and $34,671 in the INVOcell segment[189] Liabilities and Equity - Total liabilities as of September 30, 2025, were $12,983,476, down from $26,244,709 as of December 31, 2024, a reduction of 50.6%[12] - As of March 31, 2025, total stockholders' equity is $3,335,365, with accumulated deficit of $(84,873,449)[18] - The Company has substantial doubt about its ability to continue as a going concern for at least one year from the date the financial statements are issued[62] Impairment and Losses - The company reported an impairment loss of $1,397,353 for the nine months ended September 30, 2025[14] - The company reported an impairment loss of $16,042,422 during the nine months ended September 30, 2025[22] - The Company recognized a gain on settlement of $714,500 related to the Settlement Agreement with Dr. Pritts, alongside an impairment loss of $1,397,353[201] Operational Developments - The company has two operational INVO Centers and one IVF clinic in the United States, focusing on expanding access to assisted reproductive technology[25] - The company divested 80.1% of NAYA Therapeutics, Inc. in the second quarter of 2025 to concentrate exclusively on the fertility marketplace[25] - The Company plans to grow the Wisconsin Fertility Institute and pursue the acquisition of additional U.S.-based, profitable IVF clinics over the next 12 months[61] Financing and Stock Activity - The Company raised $2.2 million from the sale of preferred stock, $1.0 million from the exercise of warrants, and $8.7 million in net proceeds from a public offering during the first nine months of 2025[61] - The Company raised net proceeds of $8,747,880 from the January 2025 Offering, which included 378,199 units at an offering price of $25.20 per unit[164] - A reverse stock split at a ratio of 1-for-12 was approved on February 24, 2025, and took effect on March 18, 2025, reducing authorized common stock to 12,500,000 shares[136] Future Outlook - The company anticipates future growth through the introduction of new products and market expansion strategies[10] - Management highlighted the importance of regulatory approvals and market acceptance for future product candidates[10] - The company intends to seek additional innovative fertility-focused technologies to license or acquire for its operating clinics[25]

As filed with the U.S. Securities and Exchange Commission on October 14, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INVO FERTILITY, INC. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Commission Nevada 001-39701 20-4036208 (I.R.S. Employer Identification Number) 5582 Broadcast Court Sarasota, Florida, 34240 (978) 878- ...

Financial Performance - Revenue for Q2 2025 was $1,863,654, a 1% increase from $1,836,597 in Q2 2024, marking a new quarterly record for the Company[5] - Consolidated clinic revenue increased by 1% to $1,832,094 compared to $1,807,921 in the previous year[5] - Net loss from continuing operations was $(3.2) million, compared to $(2.2) million in Q2 2024[5] - Adjusted EBITDA for Q2 2025 was $(587,230), compared to $(509,623) in Q2 2024[5] - Total revenue from all clinics, including consolidated and equity method clinics, was $2,188,893, a 2% increase from $2,141,229[5] Operational Developments - The Company launched telehealth capabilities at its Wisconsin clinic to enhance patient access to fertility care[5] - A new patent for a modified version of the INVOcell device was allowed, extending intellectual property protection through 2040[5] - The Wisconsin Fertility Institute was recognized on Newsweek's List of America's Best Fertility Clinics for 2025[5] - The Company completed the divestiture of NAYA Therapeutics, allowing a focus on fertility operations[6] - Management emphasized a commitment to maintaining an efficient operating structure while pursuing complementary revenue-generating opportunities[7]

Revenue Performance - Total revenue for Q2 2025 was $1.86 million, a slight increase from $1.84 million in Q2 2024, representing a growth of 0.6%[15] - Clinic revenue reached $1.83 million in Q2 2025, compared to $1.81 million in Q2 2024, indicating a growth of 1.4%[15] - Product revenue decreased to $31,560 in Q2 2025 from $28,676 in Q2 2024, reflecting a decline of 10.5%[15] - Total consolidated revenue for the six months ended June 30, 2025, was $3,500,839, an increase from $3,412,883 in the same period of 2024, representing a growth of approximately 2.6%[171] - Revenue from external customers in the Fertility Clinic Services segment was $3,453,647 for the six months ended June 30, 2025, compared to $3,345,120 in 2024, indicating a year-over-year increase of about 3.3%[171] Operating Expenses and Losses - Total operating expenses increased to $4.85 million in Q2 2025 from $3.69 million in Q2 2024, marking a rise of 31.5%[15] - The net loss for Q2 2025 was $5.28 million, compared to a net loss of $2.25 million in Q2 2024, indicating a significant increase in losses[15] - The company reported a total segment loss of $(17,554,365) for the six months ended June 30, 2025, compared to a profit of $626,867 in the same period of 2024, reflecting a significant decline in profitability[171] - The cost of revenue for the six months ended June 30, 2025, was $2,178,420, up from $1,738,974 in 2024, marking an increase of approximately 25.3%[171] - The company reported a net loss of $17,403,586 for the year ending March 31, 2025[19] Cash and Assets - Cash and cash equivalents as of June 30, 2025, were $549,181, down from $619,520 as of December 31, 2024, a decrease of 11.3%[13] - Total current assets increased to $1.40 billion as of June 30, 2025, compared to $1.32 billion as of December 31, 2024, an increase of 6.1%[13] - As of June 30, 2025, the Company had total assets of $8,679,223, a decrease from $11,328,414 as of June 30, 2024[171] Liabilities and Equity - Total liabilities decreased to $16.69 billion as of June 30, 2025, from $26.24 billion as of December 31, 2024, a reduction of 36.5%[13] - The accumulated deficit increased to $90.20 million as of June 30, 2025, compared to $67.16 million as of December 31, 2024, reflecting a rise of 34.3%[13] - The total stockholders' equity as of June 30, 2025, was $2,631,473, with an accumulated deficit of $90,203,241[19] Stock and Financing Activities - The company raised $8,747,902 from the sale of common stock, net of offering costs, in 2025, compared to $165,131 in 2024[21] - The company issued 72,545 shares of common stock, net of fees and expenses, totaling $8,747,902[19] - The company approved a reverse stock split at a ratio of 1-for-12 on March 18, 2025, and a subsequent reverse stock split at a ratio of 1-for-3 on July 21, 2025[123][124] - On July 23, 2025, the stockholders approved an increase in the number of authorized shares of common stock from 1,388,888 to 50,000,000[125] Impairment and Other Charges - The company reported an impairment loss of $16,042,422 in 2025, which was not present in 2024[21] - The Company recognized an impairment of $1,397,353 on the noncompetition agreement related to the WFI acquisition[79] Divestitures and Strategic Changes - The divestiture of NAYA Therapeutics, which represented a strategic shift, was completed in the second quarter of 2025[24] - The company divested its Therapeutics segment during the second quarter of 2025, which did not generate revenue[50] - The Company divested 80.1% of its subsidiary NTI during the second quarter of 2025, impacting the Therapeutics segment's financial results[170] Joint Ventures and Investments - As of June 30, 2025, the Georgia JV recorded net losses of $32,000 and $47,000 for the six months ended June 30, 2025, and 2024, respectively[69] - The Alabama JV recorded a net loss of $10,000 for the six months ended June 30, 2025, compared to a net income of $36,000 for the same period in 2024[71] - The Company invested $0.9 million in the Georgia JV and $1.1 million in the Alabama JV as of June 30, 2025[69][71] Future Outlook and Plans - The company intends to seek additional innovative fertility-focused technologies for licensing or acquisition to enhance its service offerings[24] - The company plans to grow the Wisconsin Fertility Institute and pursue the acquisition of additional U.S.-based, profitable IVF clinics over the next 12 months[54]

Company Overview - NAYA Biosciences is developing a competitive bifunctional antibody pipeline, targeting multiple clinical milestones between 2025 and 2027[3, 6, 8] - The company utilizes a validated hub & spoke model for acquiring, developing, and partnering high-potential assets[7, 115, 125] Therapeutic Portfolio & Target Indications - The company's therapeutic portfolio includes candidates targeting hepatocellular carcinoma (HCC), multiple myeloma, prostate cancer, and autoimmune diseases[8, 10, 126] - NY-303 (GPC3 x NKp46) is being developed as a second-line monotherapy in HCC for patients not responding to first-line checkpoint inhibitors, with Phase I/IIa clinical trials planned to start in H1 2025 and data expected by H1 2026[10, 69, 79, 120] - NY-500 (PD1 x VEGF) is an AI-optimized bifunctional antibody being developed as a monotherapy for first-line HCC, with clinical data expected in 2026[10, 40, 80, 120] - NY-338 (CD38 x NKp46) is a bifunctional antibody with potential differentiation from Darzalex and T-cell engagers in multiple myeloma and autoimmune diseases[10, 91, 92, 93, 120] - NY-600 (PSMA x NKp46) is a bifunctional antibody targeting metastatic castration-resistant prostate cancer (mCRPC), with potential differentiation from T-cell engagers, antibody-drug conjugates, and radioimmunotherapeutics[10, 120] Market Opportunity & Competitive Landscape - The market for PD(L)1 antibodies is forecasted to reach $58 billion in 2025, with Keytruda generating $272 billion in sales in 2024[81] - Glypican 3 (GPC3) is expressed on 80% of HCC cells and 30-50% of other solid tumors, making it a promising target[43] - The multiple myeloma market is projected to grow from $23 billion in 2023 to $33 billion in 2030, with Darzalex sales expected to increase from $97 billion to $147 billion during the same period[91]

Revenue Growth - INVO Fertility reported record revenue of $6.5 million for 2024, representing a 116% increase compared to 2023[4] - Consolidated clinic revenue increased by 125% to $6.45 million in 2024, compared to $2.86 million in 2023[5] - Revenue from all clinics, including consolidated and equity method clinics, was $7.73 million, a 78% increase from $4.35 million in 2023[5] Financial Performance - Adjusted EBITDA for the fourth quarter of 2024 improved to $(450,908), compared to $(1.0) million in the prior year[5] - The net loss for 2024 increased to $(9.1) million, up from $(8.0) million in 2023, primarily due to the addition of NAYA Therapeutics and related merger costs[5] - Adjusted EBITDA for the fertility business was $(2.23) million for the year, compared to $(4.90) million in the previous year[14] Strategic Expansion - The company plans to expand its fertility operations into additional markets, leveraging existing centers in Wisconsin, Georgia, and Alabama[4] - INVO Fertility is divesting a majority stake in NAYA TX to refocus on its core fertility operations[6] - The company aims to capitalize on favorable market trends and policy developments that emphasize the importance of fertility care[4] Market Trends - The global fertility services market is projected to grow, driven by rising infertility rates and increasing acceptance of assisted reproductive technologies[7]

Financial Performance - Total revenue for the three months ended March 31, 2025, was $1,637,185, representing an increase of 3.9% compared to $1,576,286 for the same period in 2024[17] - Clinic revenue increased to $1,621,553, up from $1,537,199, reflecting a growth of 5.5% year-over-year[17] - The net loss for the quarter was $17,403,586, compared to a net loss of $1,596,513 in the same quarter of 2024, indicating a substantial decline in profitability[17] - Basic and diluted net loss per common share was $(12.53) for the three months ended March 31, 2025, compared to $(7.55) for the same period in 2024[17] - For the three months ended March 31, 2025, the net loss was $17,403,586 compared to a net loss of $1,596,513 for the same period in 2024[22] - The company reported a basic net loss per common share of $12.53 for Q1 2025, compared to $7.55 for Q1 2024[17] Operating Expenses - Operating expenses surged to $18,744,597, a significant increase from $3,084,323 in the prior year, primarily due to an impairment loss of $14,645,069[17] - The company reported an impairment loss of $14,645,069 during the period[22] - Research and development expenses increased significantly to $265,663 from $4,880, highlighting a focus on innovation[17] Assets and Liabilities - Total current assets increased to $1,569,122 as of March 31, 2025, from $1,318,331 as of December 31, 2024, marking a growth of 19%[14] - Total liabilities decreased to $24,429,823 as of March 31, 2025, down from $26,244,709 as of December 31, 2024, reflecting a reduction of approximately 6.9%[14] - Stockholders' equity decreased to $3,335,365 from $12,747,473, indicating a decline of about 73.8%[14] Cash Flow - Cash used in operating activities for the three months ended March 31, 2025, was $3,545,534, significantly higher than $260,557 in the prior year[22] - Cash and cash equivalents increased to $840,407 from $741,396, indicating improved liquidity[14] - Cash and cash equivalents at the end of the period increased to $840,407 from $475,125 year-over-year[22] - Cash paid for interest during the period was $169,042, compared to $50,804 in the prior year[22] Strategic Initiatives - The company anticipates future growth driven by new product introductions and market expansion strategies[12] - The company is in the process of divesting a majority stake in NAYA Therapeutics, Inc. to concentrate on the fertility marketplace[25] - The company plans to grow the Wisconsin Fertility Institute and pursue the acquisition of additional U.S.-based, profitable IVF clinics over the next 12 months[52] - The company is focused on expanding access to assisted reproductive technology (ART) care[25] - The proprietary INVOcell technology allows fertilization and early embryo development to occur in vivo within the woman's body[25] Investments and Acquisitions - The Company completed the acquisition of NAYA Therapeutics on October 11, 2024, with a total consideration of approximately $29.6 million allocated to various assets and liabilities acquired[54][58] - The acquisition included the conversion of NTI's outstanding debt obligations into shares of the Company's common stock and newly-designated preferred stock[56] - The Company executed a reverse stock split of 1-for-12 on March 18, 2025, resulting in 4,166,667 shares of authorized common stock[117][118] Legal and Compliance - The company is subject to potential legal proceedings, although none were material as of March 31, 2025[155] - A legal settlement was reached with Dr. Pritts, where the company agreed to pay $5,000,000, with scheduled payments including $475,000 due June 30, 2025, and $2,000,000 due June 30, 2026[173] - The company regained compliance with Nasdaq's Timely Filing Rule after filing its Annual Report on Form 10-K on April 30, 2025[161] Future Outlook - The company anticipates future acquisitions and the introduction of new products as part of its growth strategy[12] - The company has expressed substantial doubt about its ability to continue as a going concern due to significant operating losses and expected future losses[53]

Financial Health - The company has accumulated a net loss of $67.2 million from January 5, 2007, through December 31, 2024, raising doubts about its ability to continue as a going concern [109]. - The company is required to make additional annual payments of approximately $2.5 million for a total of $7.5 million through 2026 following the acquisition of Wisconsin Fertility Institute [118]. - The company has incurred substantial indebtedness, including secured obligations, which may affect its ability to service its debt in the future [110]. - The company does not expect its current cash position to be sufficient to fund operations and service debt obligations for the next 12 months [111]. - The company may need to raise additional funding, which may not be available on acceptable terms, potentially forcing it to limit or terminate operations [113]. Regulatory and Compliance Risks - The company is subject to significant domestic and international governmental regulations that could adversely affect its business operations [124]. - The company is subject to HIPAA regulations, and failure to comply could materially harm its business, including penalties ranging from $100 to $50,000 per violation, with an annual cap of $1,500,000 for identical violations [134]. - Compliance with FDA regulations is critical, and failure to do so could result in severe enforcement actions and impact business operations [168]. - The regulatory approval process for the company's product candidates is complex and may result in delays or unexpected costs, impacting the ability to generate revenue [182]. - Regulatory approval processes for medical devices are expensive and uncertain, potentially delaying product commercialization [162]. - The regulatory landscape for the company's placental-derived cell product candidates is new and may involve more stringent regulations than traditional products [183]. - Regulatory compliance is critical, as failure to maintain it could result in sanctions, including refusal to approve new drug applications [281]. Operational Challenges - The company may face challenges in integrating and managing the operations of Wisconsin Fertility Institute, which could impact expected benefits from the acquisition [116]. - The company faces risks related to cybersecurity breaches, which could disrupt operations and result in financial and reputational damage [148]. - The company may experience challenges due to consolidation among healthcare facilities, which could limit its market access and pricing power [141]. - The company is exposed to risks associated with global operations, including currency fluctuations and compliance with various laws and regulations [121]. - The company faces potential liability risks associated with medical devices, which could lead to costly legal challenges [157]. - The company may face challenges in maintaining product quality standards, which could affect customer demand and revenue [159]. - The company is dependent on third-party manufacturers for production, and any disruptions could adversely affect its business [261]. Market and Competitive Landscape - The fertility business operates in a highly competitive environment, with significant risks of market share loss due to new entrants and technological advancements [152]. - Economic downturns could adversely affect the company's financial performance, potentially leading to decreased sales and profitability [145]. - The company faces significant competition from larger pharmaceutical and biotechnology companies, which may have more resources and experience in clinical trials and regulatory approvals [236][239]. - The potential for biosimilars to enter the market could significantly impact the company's business if they are priced lower than its products [206]. Product Development and Clinical Trials - The success of the company's therapeutics business relies on the timely completion of clinical trials and obtaining regulatory approvals, which are subject to various risks [184]. - The company anticipates seeking initial regulatory approvals in the United States and the European Union, but has not yet obtained any approvals for its product candidates [185]. - Clinical trials for product candidates are lengthy and expensive, with uncertain outcomes that may delay or prevent marketing approval [215]. - The design of clinical trials can significantly impact approval outcomes, and flaws may not be apparent until late in the process [209]. - The company may not be able to consistently manufacture its product candidates in sufficient quantities or quality, impacting clinical trial outcomes [227]. - The inclusion of patients with significant comorbidities in clinical trials may lead to adverse events that are unrelated to the product candidates, complicating the development process [241]. Intellectual Property and Strategic Partnerships - The company relies on a combination of patents, trade secret protection, and confidentiality agreements to protect its proprietary technologies and product candidates [294]. - The company is party to several intellectual property license agreements, which impose various obligations, including milestone payments and royalties [301]. - The company depends on intellectual property licensed from third parties, and failure to comply with license agreements could result in the loss of significant rights [306]. - Disputes may arise regarding intellectual property subject to licensing agreements, which could impact the company's ability to commercialize its product candidates [307].