MIDDLETON, Wis. and SARASOTA, Fla., June 16, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics and related businesses and technologies, today announced that its Wisconsin Fertility Institute clinic has been included on Newsweek’s list of America’s Best Fertility Clinics for 2025. The America’s Best Fertility ...

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].

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]