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]

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].

Company Overview - INVO Fertility, Inc. is a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition, and operation of fertility clinics [1][4] - The company will begin trading under the new Nasdaq ticker symbol "IVF" on April 28, 2025, reflecting its concentration on the fertility care market [1][3] Strategic Focus - The company has made a strategic decision to separate its fertility and oncology businesses into distinct operations [2] - CEO Steve Shum emphasized the focus on building, acquiring, and operating fertility clinics in the U.S. and on innovative reproductive services and technologies [3] Product and Services - INVO Fertility's principal commercial strategy includes the operation of "INVO Centers" that primarily offer the intravaginal culture (IVC) procedure enabled by the INVOcell medical device [4] - The INVOcell device allows fertilization and early embryo development to occur in vivo within the woman's body, providing a more natural and affordable experience compared to traditional ART treatments [4] - The IVC procedure is believed to deliver comparable results at a fraction of the cost of traditional IVF and is more effective than intrauterine insemination (IUI) [4]

Core Viewpoint - INVO Fertility, Inc. has announced a strategic separation of its fertility and oncology operations to maximize shareholder value, returning to a focus on the fertility marketplace and the distribution of its FDA-cleared INVOcell device [1][4][5] Group 1: Company Name Change and Structure - The company has been renamed to "INVO Fertility, Inc." effective April 14, 2025, with a new Nasdaq ticker symbol "IVF" to be implemented soon [2] - The separation will allow INVO Fertility to concentrate on building, acquiring, and operating fertility clinics, as well as distributing the INVOcell device [3][4] Group 2: Business Focus and Operations - INVO Fertility will leverage its existing operations in Wisconsin, Alabama, and Georgia to expand its network of fertility centers across the U.S. [5] - The company currently operates two INVO Centers and one IVF clinic, focusing on assisted reproductive technology (ART) care [6] Group 3: NAYA Therapeutics - NAYA Therapeutics will operate as a private company focusing on the clinical development of bifunctional antibodies, with the company retaining a minority stake to benefit from potential value appreciation [4][7] - NAYA Therapeutics has a portfolio that includes several bifunctional antibodies targeting various cancers, with clinical trials expected to commence in the near future [7]