INVO BioScience(INVO)

Search documents
INVO BioScience(INVO) - 2025 Q2 - Quarterly Results
2025-08-15 18:03
Exhibit 99.1 INVO Fertility Announces Second Quarter 2025 Financial Results SARASOTA, Fla., August 14, 2025 — INVO Fertility, Inc. (Nasdaq: IVF) ("INVO Fertility" or the "Company"), a healthcare services 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 second quarter 2025 financial results. Q2 2025 Financial Highlights (all metrics compared to Q2 2024 unless o ...
INVO Fertility Announces Second Quarter 2025 Financial Results
GlobeNewswire News Room· 2025-08-14 21:34
SARASOTA, Fla., Aug. 14, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: IVF) (“INVO Fertility” or the “Company”), a healthcare services 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 second quarter 2025 financial results. Q2 2025 Financial Highlights (all metrics compared to Q2 2024 unless otherwise noted) Revenue was $1,863,654, an increase of 1% co ...
INVO BioScience(INVO) - 2025 Q2 - Quarterly Report
2025-08-14 21:28
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________________ to ________________ Commission File Number: 001-39701 INVO Fertility, Inc. (Exact Name of Registrant as Specified in its Charter) Nevada 20-4036208 (Stat ...
INVO Fertility Enhances INVOcell Technology with Expanded Awareness, Training, and Improved Pricing
GlobeNewswire News Room· 2025-07-09 13:00
Core Insights - INVO Fertility, Inc. is enhancing its fertility services through expanded clinical and embryology training support and improved pricing for its INVOcell technology, aiming to provide patient-centered care while expanding clinic operations [1][3][4] Company Overview - INVO Fertility focuses on the fertility market, operating two INVO Centers and one IVF clinic in the U.S., and aims to build, acquire, and operate more fertility clinics [6] - The company offers the INVOcell, the first FDA-cleared intravaginal culture system, which allows fertilization and early embryo development to occur within a woman's body, providing a more natural alternative to traditional IVF [2][6] Product and Technology - INVOcell delivers comparable pregnancy rates to conventional IVF while offering a more intimate and affordable experience for patients [2][8] - The company has secured a notice of allowance for a new patent from the U.S. Patent and Trademark Office, reinforcing its position as a technology innovator [4] Training and Support - INVO Fertility provides hands-on training and clinical support for embryologists and physicians to integrate the INVOcell solution into their practices [3] - The company is launching targeted educational campaigns to raise awareness of patient success rates with INVOcell, which are similar to those of conventional IVF [3] Market Positioning - INVOcell is positioned as an inclusive option for diverse family structures, including same-sex couples and single parents, and offers a streamlined lab workflow for clinics [8]
INVO Fertility Receives Notice of Allowance for Modified INVOcell Device Patent
GlobeNewswire News Room· 2025-06-25 13:00
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]
NAYA Biosciences (INVO) Earnings Call Presentation
2025-06-23 11:45
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]
INVO Fertility Expands Telehealth Capabilities at Its Wisconsin Fertility Institute
GlobeNewswire News Room· 2025-06-18 13:00
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].
INVO Fertility's Wisconsin Clinic Recognized on Newsweek's List of America's Best Fertility Clinics for 2025
GlobeNewswire News Room· 2025-06-16 13:00
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]
INVO BioScience(INVO) - 2025 Q1 - Quarterly Results
2025-05-21 01:05
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]
INVO BioScience(INVO) - 2025 Q1 - Quarterly Report
2025-05-20 20:05
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]