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]

Revenue Performance - Revenue for Q2 2024 was $1,836,597, representing a 481% increase compared to $315,902 in Q2 2023 and a 17% sequential increase from Q1 2024[1] - Clinic revenue surged 611% to $1,807,921 from $254,364, with all reported clinic revenue coming from the INVO Center in Atlanta and the fertility clinic in Middleton[1] - Total revenue from all clinics, including those under the equity method, was $2,141,229, a 201% increase from $712,433[1] Operating Expenses and Profitability - Total operating expenses increased to $3.7 million, up $1.3 million from $2.4 million, primarily due to a one-time non-cash expense of $1.0 million[1] - Adjusted EBITDA improved by $1.1 million to $(0.5) million compared to $(1.6) million in the prior year[1] - The net loss for Q2 2024 was $(2.2) million, consistent with the net loss of $(2.2) million in Q2 2023[1] - INVO's fertility centers are collectively profitable and experiencing sequential revenue growth[2] - The company aims to achieve breakeven with current operations through careful management of corporate expenses[2] Strategic Initiatives - The company plans to resume acquisition and new INVO Center activities in 2025 to accelerate profitability[2] - INVO entered into a definitive merger agreement with NAYA Biosciences for an all-stock transaction, with discussions ongoing for further extensions[2]

Revenue Growth - Total revenue for the second quarter of 2024 was $1,836,597, a significant increase from $315,902 in the same period of 2023, representing a growth of approximately 480%[9] - Clinic revenue reached $1,807,921 in Q2 2024, compared to $254,364 in Q2 2023, marking an increase of about 608%[9] - The company reported a net loss of approximately $3.8 million for the six months ended June 30, 2024, compared to a net loss of $4.8 million for the same period in 2023, indicating a 21% improvement in losses year-over-year[36] - The basic and diluted net loss per common share for the three months ended June 30, 2024, was $(0.62), a significant improvement from $(3.06) for the same period in 2023[33] Financial Position - Total current assets increased to $2,396,063 as of June 30, 2024, up from $1,259,775 at the end of 2023, reflecting a growth of approximately 90%[7] - Cash reserves increased significantly to $942,934 as of June 30, 2024, compared to $232,424 at the end of 2023, representing a growth of approximately 304%[7] - Total liabilities decreased to $16,668,243 as of June 30, 2024, down from $19,994,962 at the end of 2023, a reduction of about 16%[7] - The accumulated deficit as of June 30, 2024, was $(61,910,463), up from $(57,818,145) at the end of 2023, indicating an increase in losses[8] Operating Expenses - Operating expenses for Q2 2024 totaled $3,739,510, compared to $2,381,879 in Q2 2023, indicating an increase of about 57%[9] - Cash used in operating activities decreased to $1,716,214 for the six months ended June 30, 2024, compared to $2,792,860 in the prior year, indicating a 38.6% reduction[12] - Approximately $2.6 million of the net loss for the six months ended June 30, 2024, was related to noncash expenses, compared to $1.4 million for the same period in 2023[36] Shareholder Equity - The weighted average number of common shares outstanding increased to 3,609,812 in Q2 2024, compared to 732,255 in Q2 2023[9] - The total balances as of June 30, 2024, showed an increase in common shares to 3,864,072, with an accumulated deficit of $61,910,463[11] - The company has no current plans to pay dividends on its common stock in the foreseeable future[121] Acquisitions and Joint Ventures - INVO Bioscience completed its first IVF clinic acquisition in August 2023, expanding its operational footprint in the fertility care market[13] - The acquisition of the Wisconsin Fertility Institute was completed for a total purchase price of $10 million, with $2.15 million paid in cash at closing[40] - The company has invested $0.9 million in the Georgia joint venture (Bloom INVO, LLC) and recorded net losses of $47,000 for the six months ended June 30, 2024[47] - The Alabama joint venture (HRCFG INVO, LLC) recorded a net income of $36,000 for the six months ended June 30, 2024, with the Company recognizing a gain of $18,000 from equity method investments[49] Market Strategy - The company aims to pursue additional acquisitions of established and profitable fertility clinics to accelerate growth[155] - The company has identified over 50 suitable locations in the U.S. for new INVO Centers to address the supply-demand imbalance in the fertility market[161] - The company has entered into exclusive distribution agreements in various international markets, including Mexico and Malaysia, with minimum annual purchase requirements[168] Technology and Operations - The proprietary INVOcell technology allows fertilization and early embryo development to occur in vivo, providing a more natural and cost-effective alternative to traditional IVF[156] - INVOcell has received FDA 510(k) clearance for a 5-day incubation period, demonstrating improved patient outcomes[158] - The IVC procedure is offered at INVO Centers for $4,500 to $7,000 per cycle, significantly lower than the average IVF cost of $11,000 to $15,000[163] Financing Activities - The company raised approximately $3 million from the RD Offering and March Warrant Placement, with potential additional proceeds of $3.5 million if the March Warrant is fully exercised[105] - The Company entered into a Revenue Loan and Security Agreement for $1,500,000 with a maturity date of June 29, 2028, with interest varying based on repayment timing[79] - The Company incurred $108,513 in interest related to the RSLA Loan for the six months ended June 30, 2024[80] Merger and Future Plans - The company plans to merge with NAYA Biosciences, with each share of NAYA common stock converting into approximately 7.33333 shares of the company's newly designated common stock[179] - The completion of the merger is contingent upon the sale of 5,000,000 shares of Series A Preferred Stock at $5.00 per share to support fertility business activities[182] - The merger agreement completion is subject to several conditions, including the aggregate liabilities not exceeding $5,000,000[183]

Financial Results Announcement - INVO Bioscience, Inc. announced financial results for the period ended March 31, 2024[4]. - The press release detailing the financial results was issued on May 15, 2024[4]. Company Information - The company is listed on The Nasdaq Stock Market under the trading symbol INVO[2]. - The report does not indicate whether the company is an emerging growth company[3]. Regulatory Compliance - The financial results are not deemed "filed" under the Securities Exchange Act of 1934[5]. - The report includes an interactive data file embedded within the Inline XBRL document[6].

Financial Performance - Total revenue for Q1 2024 was $1,576,286, a significant increase of 353% compared to $348,025 in Q1 2023[17] - Clinic revenue reached $1,537,199 in Q1 2024, up from $297,381 in Q1 2023, representing a growth of 417%[17] - The net loss for Q1 2024 was $1,596,513, a reduction from a net loss of $2,550,879 in Q1 2023, indicating an improvement of approximately 37%[17] - The company reported a basic net loss per share of $0.42 for Q1 2024, compared to a loss of $4.10 per share in Q1 2023[17] - The net loss for the three months ended March 31, 2024, was $1,596,513, a decrease from a net loss of $2,550,879 in the same period of 2023, representing a 37.5% improvement[50] - The basic and diluted net loss per common share improved to $(0.42) for Q1 2024 from $(4.10) in Q1 2023[50] Assets and Liabilities - Total current assets increased to $1,724,946 as of March 31, 2024, compared to $1,259,775 as of December 31, 2023, reflecting a growth of 37%[15] - Total liabilities decreased to $18,307,610 as of March 31, 2024, down from $19,994,962 as of December 31, 2023, a reduction of about 8%[15] - Cash and cash equivalents rose to $475,125 as of March 31, 2024, compared to $232,424 as of December 31, 2023, an increase of 104%[15] - The total stockholders' equity as of March 31, 2024, was $10,155, a decrease from $892,825 as of December 31, 2023[15] Cash Flow and Operating Activities - Net cash used in operating activities decreased to $(260,557) in Q1 2024 from $(1,148,461) in Q1 2023, indicating improved cash flow management[50] - Cash and cash equivalents at the end of the period were $475,125, down from $2,188,245 at the end of Q1 2023[50] - The company had cash paid for interest amounting to $50,804 during the period, compared to no interest paid in the same period of the previous year[50] Research and Development - Research and development expenses significantly decreased to $4,880 in Q1 2024 from $73,520 in Q1 2023, a decline of approximately 93%[17] Acquisitions and Joint Ventures - The company completed its first IVF clinic acquisition in August 2023 and currently operates two INVO Centers in the United States[24] - The Company acquired the Wisconsin Fertility Institute for a total purchase price of $10 million, with $2.15 million paid in cash at closing and the remainder in installments[55] - The Georgia joint venture (Bloom INVO, LLC) recorded net losses of $50,000 for the three months ended March 31, 2024, compared to a net loss of $32,000 for the same period in 2023[65] - The Alabama joint venture (HRCFG INVO, LLC) reported a net income of $0.2 thousand for the three months ended March 31, 2024, recovering from a net loss of $37,000 in the same period of 2023[67] - The Company recognized a total impairment of approximately $0.09 million for its investment in the Mexico joint venture due to operational uncertainties[70] Financing Activities - The company raised $500,000 from the sale of preferred stock during the financing activities in Q1 2024[50] - During the first three months of 2024, the Company raised $0.5 million from preferred stock sales and $0.2 million from note sales, indicating ongoing reliance on capital raising[53] - The Company entered into a Standard Merchant Cash Advance Agreement with Cedar Advance LLC, resulting in a net cash receipt of $356,250 after a gross purchase price of $375,000 for receivables of $543,750[99] - The Company secured a Revenue Loan and Security Agreement for a gross amount of $1,500,000, with a maturity date of June 29, 2028, and varying interest based on repayment timing[102] Stock and Shareholder Matters - The Company approved a reverse stock split at a ratio of 1-for-20, reducing authorized common stock from 125,000,000 to 6,250,000 shares[109] - Shareholders approved an increase in authorized common stock from 6,250,000 to 50,000,000 shares on October 13, 2023[110] - The Company filed a Certificate of Designation for Series A Preferred Stock, authorizing 1,000,000 shares with a stated value of $5.00 per share, convertible at $2.20 per share[111][112] - The Company entered into a share exchange agreement with Cytovia Therapeutics for the acquisition of 1,200,000 shares of Series B Preferred Stock in exchange for 163,637 shares of NAYA's common stock[125][126] - The Company entered into an equity purchase agreement allowing the purchase of up to $10.0 million of common stock in multiple tranches[127] Legal and Compliance - The Company received a notice from Nasdaq indicating non-compliance with the Equity Rule, requiring a minimum stockholders' equity of $2,500,000, as it reported stockholders' equity of $892,825[211] - The Company is subject to various covenants that restrict its ability to declare dividends, make certain investments, or enter into transactions with affiliates, prioritizing the repayment of the FirstFire Note[193] Future Outlook - The Company expects to continue incurring significant operating losses as it ramps up commercialization efforts and develops new INVO Centers[54] - The completion of the merger is subject to several conditions, including a private offering of at least $5,000,000 in gross proceeds and the Company's liabilities not exceeding $5,000,000[174]

Invo Bioscience (NASDAQ:INVO) stock is rocketing higher on Wednesday alongside its earnings report for the fourth quarter of 2023.The healthcare services fertility company reported a net loss of $2 million during the quarter. That’s an improvement over its net loss of $2.8 million from the same period of the year prior.Revenue reported by Invo Bioscience comes in at $1.38 million for Q4 2023. That’s a massive 397% increase over its Q4 2022 revenue of $278,142.Invo Bioscience CEO Steve Shum said the followin ...

☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 or For the transition period from to | --- | --- | --- | --- | --- | |---------------------------------------------------------|---------------------------------------|---------------------|------------------|------------------------------------| | Nevada | 001-39701 | | | 20-4036208 | | (State or other jurisdiction of incorporation | (Commission | | | (IRS Employee | | or organization) | File No.) | | | Identification No ...