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]

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 shortly [2]. - The separation will allow INVO Fertility to concentrate on establishing, acquiring, and operating fertility clinics, as well as distributing the INVOcell device [3][4]. Group 2: Business Focus and Strategy - INVO Fertility aims to leverage its existing operations in Wisconsin, Alabama, and Georgia to expand its network of fertility centers across the U.S., capitalizing on a growing market opportunity [5]. - The company plans to divest a majority stake in its subsidiary, NAYA Therapeutics, while retaining a minority position to benefit from potential value appreciation in its bifunctional antibodies [4][5]. Group 3: NAYA Therapeutics Overview - NAYA Therapeutics will operate as a private company focused on the clinical development of bifunctional antibodies, with several promising candidates in its pipeline targeting oncology [7]. - The company’s lead candidate, NY-303, is set to enter a Phase I/IIa trial in H2 2025, targeting a significant portion of the current treatable market for hepatocellular carcinoma (HCC) [7].

Core Viewpoint - NAYA Biosciences, Inc. will implement a 1-for-12 reverse stock split to comply with Nasdaq's minimum bid price requirement, effective March 18, 2025 [1][3]. Company Overview - NAYA Biosciences is focused on developing breakthrough treatments in oncology, autoimmune diseases, and women's health, and is a leading provider of IVF and IVC fertility treatments [1][4]. - The company utilizes a hub & spoke model to optimize the acquisition, development, and partnering of assets, aiming for efficient returns on investment [4]. Reverse Stock Split Details - The reverse stock split will convert every 12 shares of common stock into 1 share, rounding up any fractional shares [2]. - Post-split, the company will have approximately 666,057 shares issued and outstanding, with authorized shares adjusted to 4,166,666 [2]. Compliance and Market Position - The primary goal of the reverse stock split is to meet Nasdaq's $1.00 per share minimum bid price requirement for continued listing, although success is not guaranteed [3]. - NAYA's current portfolio includes innovative therapies targeting significant market needs, such as hepatocellular carcinoma and multiple myeloma [5].

Core Viewpoint - NAYA Biosciences supports the U.S. President's executive order aimed at reducing IVF costs and expanding access to fertility services, which is expected to significantly lower out-of-pocket expenses for families dealing with infertility [1][3]. Company Overview - NAYA Biosciences is a life science portfolio company focused on breakthrough treatments in oncology, autoimmune diseases, and women's health, with a particular emphasis on fertility services [7]. - The company operates fertility-focused clinics through its subsidiary INVO Centers, LLC, and currently has two operational INVO Centers in the U.S. along with a conventional IVF clinic [5]. Fertility Treatment Innovations - NAYA's INVOcell device is the first FDA-cleared in vivo Intravaginal Culture (IVC) system in the U.S., offering a more natural and economical fertility treatment compared to conventional IVF methods [6]. - The INVOcell procedure utilizes the woman's vagina as an incubator for embryo development, which is believed to provide a safer and more effective treatment option [6]. Industry Context - The high cost of IVF and lack of comprehensive insurance coverage for fertility services in most states create significant financial barriers for individuals and couples struggling with infertility [2]. - Currently, fewer than 20 states mandate some level of fertility coverage, leaving millions without insurance assistance, highlighting the importance of the administration's actions to address these cost concerns [3]. Commitment to Accessibility - NAYA is committed to advocating for policies that support individuals and families seeking fertility treatments, aiming to ensure that every hopeful parent has the opportunity to build a family [4].

Core Insights - NAYA Biosciences is enhancing its focus on oncology and autoimmune diseases by nominating five new board candidates with extensive biotechnology experience [1] Group 1: New Board Members - Laurent Audoly, PhD, cofounder and CEO of PriveBio, has a strong background in R&D and has played a pivotal role in eight drug approvals [2] - Melissa Fensterstock, MPhil, MBA, has experience in translating academic innovations to commercial scale and has held executive positions at prestigious universities [3] - Prakash Raman, PhD, CEO of InduPro, Inc., has significant experience in business development and licensing in the biotechnology sector [4] - Daniel Teper, PharmD, MBA, founder and president of NAYA, has held various senior management positions in leading pharmaceutical companies [5] - Alexandra Urman, MPH, has a background in clinical cancer research and healthcare innovation, currently serving as CEO of Aomics [6] Group 2: Company Overview - NAYA Biosciences is dedicated to developing breakthrough treatments in oncology, autoimmune diseases, and women's health [7] - The company employs a hub & spoke model to optimize the acquisition, development, and partnering of assets, aiming for efficient returns on investment [8] - NAYA's portfolio includes innovative therapies such as NY-303 for hepatocellular carcinoma, NY-338 for multiple myeloma and autoimmune diseases, NY-500 for solid tumors, and NY-600 for metastatic castration-resistant prostate cancer [9]

Core Viewpoint - NAYA Biosciences has announced a public offering of 13,615,171 units at a price of $0.70 per unit, aiming to raise approximately $9.5 million for various corporate purposes [1][3]. Group 1: Offering Details - The public offering consists of units that include one share of common stock (or pre-funded warrant) and one warrant to purchase one share of common stock, with an exercise price of $0.70 per share [1]. - The offering is expected to close on or about January 14, 2025, pending customary closing conditions [1]. - Maxim Group LLC is the lead placement agent, with Brookline Capital Markets acting as co-placement agent [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for multiple purposes, including funding an installment towards the purchase of the Wisconsin Fertility Institute, redeeming 4,000 shares of Series C-2 preferred stock valued at $4 million, and addressing outstanding debt obligations [3]. - Additional funds will be allocated for clinical trials, product development, marketing, strengthening the corporate management team, working capital, general corporate purposes, and potential acquisitions [3]. Group 3: Company Overview - NAYA Biosciences is focused on developing breakthrough treatments in oncology, autoimmune diseases, and women's health, utilizing a hub & spoke model for efficient asset acquisition and development [6]. - The company's portfolio includes several bifunctional antibodies targeting various cancers, such as NY-303 for hepatocellular carcinoma and NY-600 for metastatic Castration Resistant Prostate Cancer [7].