Core Viewpoint - INVO Fertility, Inc. has received a notice of allowance for a new patent on a modified version of its proprietary INVOcell device, extending intellectual property protection through 2040, which reflects feedback from embryologists to simplify the device's use [1][2][5] Company Overview - INVO Fertility is a healthcare company focused on the fertility sector, dedicated to expanding assisted reproductive technology (ART) care [6] - The company operates two INVO Centers and one IVF clinic in the United States, and engages in the sale and distribution of the INVOcell technology to third-party fertility clinics [6] Product Details - The INVOcell device is the world's first FDA-cleared intravaginal culture (IVC) system, allowing fertilization and early embryo development to occur within a woman's body, providing a more natural alternative to traditional IVF [3][4] - The device was originally granted FDA clearance in 2015 and received an update in 2023 to extend the incubation period from 3 days to 5 days [4] - The modified design of the INVOcell device was based on embryologists' feedback, transitioning from a dual-chamber to a singular main chamber [4] Market Position - The INVOcell procedure offers comparable pregnancy rates to traditional IVF while providing a more patient-centered and affordable experience [5][6] - The company believes that the IVC procedure can deliver similar results at a lower cost compared to traditional IVF and is more effective than intrauterine insemination (IUI) [6]

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]

Core Viewpoint - INVO Fertility, Inc. is expanding its telehealth capabilities at the Wisconsin Fertility Institute to enhance access to fertility care for prospective parents, particularly in underserved areas [1][5]. Group 1: Telehealth Expansion - The telehealth platform allows patients to connect with fertility specialists from home, providing personalized assessments and treatment planning through secure virtual consultations [3][4]. - This initiative aims to break down geographic barriers, making expert fertility care more accessible and convenient for individuals and couples [4][5]. Group 2: Service Reach and Accessibility - The expansion is expected to significantly broaden the reach of Wisconsin Fertility Institute, especially for those in rural areas facing challenges in accessing specialized fertility care [5]. - The integration of telehealth with in-clinic procedures is designed to help families navigate the complexities of fertility treatment with greater confidence and ease [5]. Group 3: Company Overview - INVO Fertility focuses on expanding assisted reproductive technology (ART) care through the establishment and operation of fertility clinics, including the innovative INVOcell medical device [7]. - The company operates two INVO Centers and one IVF clinic in the U.S., and continues to distribute its INVOcell technology to third-party clinics [7].

Core Insights - INVO Fertility, Inc. has announced that its Wisconsin Fertility Institute clinic has been recognized as one of America's Best Fertility Clinics for 2025 by Newsweek [1][2] - The ranking was developed in partnership with Statista and evaluated clinics based on criteria set by the CDC [2][5] - The CEO of INVO Fertility expressed pride in the recognition, attributing it to the dedication of the team in providing high-quality fertility care [2] Company Overview - INVO Fertility is focused on expanding access to assisted reproductive technology (ART) through the establishment, acquisition, and operation of fertility clinics [3] - The company operates two INVO Centers and one IVF clinic in the United States, and is engaged in the sale and distribution of its proprietary INVOcell technology [3] - The INVOcell device allows fertilization and early embryo development to occur in vivo, offering a more natural and affordable alternative to traditional IVF [3] Evaluation Criteria - The evaluation for the Best Fertility Clinics included quality metrics from ART, a nationwide survey of medical professionals, accreditation data from recognized bodies, and patient satisfaction based on Google reviews [5]

Financial Performance - INVO Fertility reported record revenue of $6.5 million for 2024, representing a 116% increase compared to $3.0 million in 2023[4] - Consolidated clinic revenue increased by 125% to $6.45 million in 2024, up from $2.86 million in 2023[5] - Revenue from all clinics, including consolidated and equity method clinics, rose by 78% to $7.73 million in 2024, compared to $4.35 million in 2023[5] - Adjusted EBITDA for the fourth quarter of 2024 improved to $(450,908), a significant enhancement from $(1.0) million in the prior year[5] - Adjusted EBITDA for the fertility business was $(450,908) for Q4 2024, compared to $(1,020,499) in Q4 2023[14] Loss and Costs - The net loss for 2024 increased to $(9.1) million, compared to $(8.0) million in 2023, primarily due to the addition of NAYA Therapeutics and related merger costs[5] Market Expansion - The company is actively pursuing expansion into additional markets, leveraging the success of its existing fertility centers in Wisconsin, Georgia, and Alabama[4] - The company aims to expand access to fertility care in response to declining U.S. fertility rates and rising public demand for solutions[4] Strategic Divestment - INVO Fertility plans to divest a majority stake in NAYA TX to refocus on its core fertility operations, with the final separation subject to necessary approvals[6] Market Trends - The global fertility services market is projected to grow, driven by rising infertility rates and increasing acceptance of assisted reproductive technologies (ART)[7]

Revenue and Growth - 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] - For the three months ended March 31, 2025, total consolidated revenue was $1,637,185, with external customer revenue from Clinic Services at $1,621,553[149] Expenses and Losses - 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 net loss for the first quarter of 2025 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] - Approximately $14.8 million of the net loss for the three months ended March 31, 2025, was related to non-cash expenses, compared to $1.0 million for the same period in 2024[51] Cash Flow and Assets - Cash used in operating activities for the three months ended March 31, 2025, was $3,545,534, compared to $260,557 for the same period in 2024, reflecting a substantial increase in cash outflows[22] - Cash and cash equivalents increased to $840,407 as of March 31, 2025, compared to $741,396 at the end of 2024, showing a growth of 13.3%[14] - Total current assets increased to $1,569,122 as of March 31, 2025, compared to $1,318,331 at the end of 2024, marking a growth of 19%[14] Liabilities and Equity - Total liabilities decreased to $24,429,823 as of March 31, 2025, down from $26,244,709 at the end of 2024, reflecting a reduction of approximately 6.9%[14] - The company’s total stockholders' equity as of March 31, 2025, was $3,335,365, compared to a deficit of $84,873,449[22] - Stockholders' equity decreased to $3,335,365 from $12,747,473, reflecting a decline of 73.8%[14] Investments and Acquisitions - The company has plans for future acquisitions and product introductions, although specific details were not disclosed in the report[12] - The company is in the process of divesting a majority stake in NAYA Therapeutics, Inc. to focus exclusively on the fertility marketplace[25] - 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] Operational Highlights - 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 proprietary INVOcell technology allows fertilization and early embryo development to occur in vivo, representing a significant advancement in assisted reproductive technology[25] - The Company has identified three operating segments: Clinic Services, INVOcell Device, and Therapeutics[148] 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 million, with scheduled payments including $475,000 due June 30, 2025, and $2 million due June 30, 2026[173] - The company regained compliance with Nasdaq's Timely Filing Rule on May 8, 2025, after filing its Annual Report on Form 10-K[161] Future Outlook - 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] - The Company will need to raise additional funding to meet its liquidity needs and execute its business strategy until it can generate positive cash from operations[52] - The company anticipates future acquisitions and the introduction of new products as part of its growth strategy[12]

Financial Health and Obligations - 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]. - The capital markets have been unpredictable for unprofitable companies, making it difficult for the company to secure financing on attractive terms [114]. 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 risks associated with healthcare fraud, waste, and abuse laws, which could impact its financial results and operations [126]. - The company is subject to HIPAA regulations, and failure to comply could materially harm its business, including penalties for breaches of protected health information [132]. - Compliance with FDA regulations is critical, as failure to obtain necessary clearances could delay product commercialization and impact revenue [162][164]. - The EU's new MDR regulations may increase costs and complexity in obtaining necessary approvals for medical devices, affecting market entry timelines [173][174]. - Regulatory compliance is critical, as failure to maintain it could result in sanctions, including refusal to approve new drug applications [281]. Market and Competitive Landscape - Economic downturns could negatively affect the company's sales and profitability, particularly in the fertility treatment market [145]. - The fertility business faces significant competition, with new ART services potentially rendering existing technologies obsolete, impacting market share and growth rates [152]. - The company may experience challenges due to consolidation among healthcare facilities, potentially limiting its market access [141]. - 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]. 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 relies on key personnel, and the loss of executive management could adversely affect its operations and revenues [135]. - The company requires additional qualified personnel to expand its fertility business, which may be challenging to attract and retain [161]. - The management team has limited experience in managing fertility clinics, which could affect operational success [156]. - The company faces risks related to cybersecurity breaches, which could disrupt operations and lead to financial and reputational damage [148]. Product Development and Clinical Trials - The acquisition of NAYA Therapeutics presents risks due to its limited operating history and lack of approved products for commercial sale [115]. - The success of the company's therapeutics business relies on the timely completion of clinical trials and obtaining regulatory approvals, which are uncertain [184]. - 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]. - Clinical trials are lengthy and expensive, with uncertain outcomes that may delay or prevent marketing approval [215]. - 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]. - The company may not be able to manufacture its product candidates in sufficient quantities or quality, impacting clinical trial outcomes [227]. 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 patent prosecution process is expensive and time-consuming, and the company may not be able to file all necessary patent applications at a reasonable cost [296]. - The company is party to several intellectual property license agreements, which impose various obligations, including milestone payments and royalties [301]. - NAYA Therapeutics depends on intellectual property licensed from third parties, and failure to comply with license agreements could result in significant rights loss [306]. - The company has the right to bring actions against third parties for infringing on the patents it has exclusively licensed, subject to specified conditions [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, which is part of its broader strategy to enhance its focus on fertility services [2][3] - CEO Steve Shum emphasized the company's commitment to building, acquiring, and operating fertility clinics in the U.S., as well as its focus 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 its proprietary INVOcell medical device [4] - The IVC procedure is designed to provide a more natural, intimate, and affordable experience compared to traditional assisted reproductive technology (ART) treatments, potentially delivering comparable results at a lower cost [4]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $1,433,151, representing an increase of 47% compared to $974,894 for the same period in 2023[17]. - Clinic revenue for the nine months ended September 30, 2024, reached $4,763,131, up from $1,499,636 in the same period last year, indicating a growth of 217%[17]. - The company reported a net loss of $1,630,662 for the three months ended September 30, 2024, compared to a net loss of $1,248,440 for the same period in 2023, representing a 31% increase in losses[17]. - Operating expenses for the three months ended September 30, 2024, totaled $2,733,553, a 47% increase from $1,861,184 in the same period last year[17]. - Net loss for the nine months ended September 30, 2024, was $5,472,345, an improvement from a net loss of $6,039,830 for the same period in 2023, representing a decrease of approximately 9.4%[25]. - Basic net loss per common share for the three months ended September 30, 2024, was $(0.42), compared to $(0.70) for the same period in 2023[17]. Assets and Liabilities - Total current assets increased to $1,957,481 as of September 30, 2024, compared to $1,259,775 at the end of 2023, reflecting a growth of 55%[15]. - Cash balance increased to $471,591 as of September 30, 2024, compared to $232,424 at the end of 2023, marking a growth of 103%[15]. - Total liabilities decreased slightly to $17,042,805 as of September 30, 2024, from $17,613,091 at the end of 2023[15]. - The company’s accumulated deficit increased to $(63,541,125) as of September 30, 2024, compared to $(57,818,145) at the end of 2023[15]. - Total stockholders' equity (deficit) was $(23,316) as of September 30, 2024, down from $892,825 at the end of 2023[15]. Stock and Financing Activities - The company raised $1,587,500 from the sale of common stock, net of fees, during the quarter ending June 30, 2023[20]. - The total common stock issued increased to 2,492,531 shares by December 31, 2023, with additional paid-in capital at $52,710,721[20]. - The Company raised $1.6 million from the sale of preferred stock and $0.9 million from the exercise of warrants during the first nine months of 2024[61]. - The Company completed the acquisition of the Wisconsin Fertility Institute for a total purchase price of $10 million, with $2.15 million paid in cash at closing[63]. - The Company entered into a Revenue Loan and Security Agreement for $1,500,000 with a maturity date of June 29, 2028, incurring $169,042 in interest for the nine months ended September 30, 2024[121][122]. Operational Highlights - The company plans to continue expanding its market presence and product offerings in the upcoming quarters[20]. - The Company expects to continue incurring significant expenses and operating losses as it ramps up commercialization of INVOcell and develops new INVO Centers[62]. - The Company anticipates continuing sales of INVOcells to its consolidated and unconsolidated VIEs in the ordinary course of business[82]. Joint Ventures and Acquisitions - The Georgia joint venture recorded net losses of $0.1 million for both the nine months ended September 30, 2024, and 2023[73]. - The Mexico joint venture was impaired by approximately $0.09 million in 2023 due to operational uncertainties, and as of September 30, 2024, the Company's investment in this JV was $0[79]. - The Company plans to grow the Wisconsin Fertility Institute and pursue additional IVF clinic acquisitions over the next 12 months[61]. Tax and Legal Matters - Income tax expense for the three months ended September 30, 2024, was $29,259, compared to $1,886 for the same period in 2023, representing a significant increase[206]. - The annual forecasted effective income tax rate for 2024 is 0%, with a year-to-date effective income tax rate of 0% for the nine months ended September 30, 2024[206]. - The Company is currently not subject to any material legal proceedings, but may face claims in the ordinary course of business[209]. Stock Options and Compensation - The Company has issued stock options to directors and employees as compensation, totaling 69,035 shares[21]. - The Company incurred $209,371 in expenses related to the vesting of options for the nine months ended September 30, 2024[183]. - The total fair value of options vested was $209,371, with no options granted during this period[187]. Depreciation and Amortization - The Company reported depreciation and amortization expenses of $687,793 for the nine months ended September 30, 2024, compared to $59,296 in the same period of 2023, reflecting a substantial increase[25]. - The Company recorded depreciation expenses of $26,120 for the three months ended September 30, 2024, compared to $20,504 for the same period in 2023, an increase of 27.5%[85]. - The Company recorded amortization expenses related to intangible assets of $204,375 for the three months ended September 30, 2024, compared to $0 for the same period in 2023[88]. Merger and Corporate Governance - The Company entered into a Merger Agreement with Legacy NAYA on October 22, 2023, which was amended on October 25, 2023[210]. - As a result of the Merger, each share of Legacy NAYA common stock will be converted into the right to receive 7.33333 shares of the Company's newly designated Class B common stock[212]. - Following the Merger, Dr. Daniel Teper will be named chairman and CEO of the Company, with a board of directors comprising at least nine members[213].

Core Viewpoint - INVO Biosciences has merged with NAYA Biosciences and changed its corporate name to NAYA Biosciences Inc., with trading under the new symbol "NAYA" starting on October 22, 2024 [1][2] Group 1: Company Overview - The merger aims to expand the company's portfolio in fertility, oncology, and autoimmune diseases while continuing to operate its revenue-generating fertility business [1] - The new corporate strategy combines profitable revenues from the fertility business with innovative therapeutics, optimizing risk-return for investors [2] Group 2: Operational Strategy - The company will utilize a hub-and-spoke model to share resources and talent, which is expected to accelerate the development of its subsidiaries [2]