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Globe and Mail
30-04-2025
- Business
- Globe and Mail
INVO Fertility Announces 2024 Financial Results with 116% Annual Revenue Growth and Further Improvements in Adjusted EBITDA
SARASOTA, Fla., April 30, 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, today announced fourth quarter and full year 2024 financial results. Q4 2024 Financial Highlights (all metrics compared to Q4 2023 unless otherwise noted) Revenue was $1,685,966, an increase of 22% compared to $1,381,754. Consolidated clinic revenue from the Company's INVO Center in Atlanta, Georgia, and fertility clinic in Madison, Wisconsin increased 24% to $1,687,300, compared to $1,362,938. Revenue from all clinics, including both consolidated and equity method clinics, was $2,034,332, an increase of 24% compared to $1,634,912. Net loss increased to $(3.6) million compared to $(2.0) million as a result of the addition of NAYA Therapeutics during the period and the corresponding merger costs. Adjusted EBITDA (see table included) was $(450,908) compared to $(1.0) million in the prior year. Adjusted EBITDA does not include the loss from NAYA Therapeutics, Inc. ('NAYA TX') or corresponding merger related costs, which, as recently announced, the Company is in the process of divesting a majority stake in. 2024 Financial Highlights (all metrics compared to 2023 unless otherwise noted) Revenue was $6,532,000, an increase of 116% compared to $3,020,575. Consolidated clinic revenue increased 125% to $6,450,431, compared to $2,862,574. Revenue from all clinics was $7,731,177, including both consolidated and equity method clinics, an increase of 78% compared to $4,346,933. Net loss increased to $(9.1) million compared to $(8.0) million as a result of the addition of NAYA Therapeutics and corresponding merger costs. Adjusted EBITDA (see table included) was $(2.2) compared to $(4.9) million. Management Commentary 'We achieved record revenue during 2024 of $6.5 million, an increase of 116% compared to 2023, thanks to the hard work of our fertility teams at our clinics across the U.S.,' commented Steve Shum, CEO of INVO Fertility. 'Importantly, we have dramatically streamlined and improved our fertility-based operating structure to move the Company towards positive cash flow. In fact, Adjusted EBITDA for the fourth quarter of 2024 was the best quarterly period in the Company's recent history showing an improvement of approximately $570,000 from the comparable period of a year ago.' 'Following our announcement to divest a majority stake in NAYA TX, we have refocused our efforts towards being a fertility company to continue capitalizing on the favorable market trends and recent policy developments that underscore the importance of fertility care. Leveraging the success of our existing three operating fertility centers in Wisconsin, Georgia and Alabama, we are actively pursuing expansion into additional markets. Our planned expansion comes at a pivotal moment given the further declines in the U.S. fertility rate and rising public demand for solutions which are aligned with our objective to expand access to care for patients in need.' Return to Focus on Fertility Operations On April 14, 2025, the Company announced its decision to divest a majority stake in NAYA TX. The retained minority position is expected to provide value upside for the Company, assuming the successful clinical development of NAYA TX's bifunctional antibodies. The revised corporate structure is intended to enable both businesses to focus on their respective opportunities and operations, with the existing management team and board of directors set to lead the INVO Fertility, Inc. public company moving forward. NAYA TX will return to being a privately held biotechnology company led by its management team and board. The final separation is subject to completing definitive transaction documents and key closing conditions, including receipt of necessary approvals. The global fertility services market is projected to grow driven by rising infertility rates, delayed parenthood, and increasing acceptance of assisted reproductive technologies (ART). In the U.S., the Centers for Disease Control and Prevention reported a 50% increase in ART-conceived births from 2012 to 2021, with ART now accounting for 2.3% of all births. Use of Non-GAAP Measure Included in this press release is a reconciliation of Adjusted EBITDA, which does not include the loss from NAYA TX or corresponding merger related costs. Additional financial tables are included in the Company's 10-K, which can be found on the Company's website at or at Adjusted EBITDA is a non-GAAP measure. This measure is not intended to be a substitute for those financial measures reported in accordance with GAAP. Adjusted EBITDA has been included because management believes that, when considered together with the GAAP figures, it provides meaningful information related to our operating performance and liquidity and can enhance an overall understanding of financial results and trends. Adjusted EBITDA may be calculated by us differently than other companies that disclose measures with the same or similar terms. See our attached financials for a reconciliation of this non-GAAP measure to the nearest GAAP measure. About INVO Fertility We are a healthcare services fertility company dedicated to expanding assisted reproductive technology ('ART') care to patients in need. Our principal commercial strategy is focused on building, acquiring and operating fertility clinics, including 'INVO Centers' dedicated primarily to offering the intravaginal culture ('IVC') procedure enabled by our INVOcell® medical device ('INVOcell') and US-based, profitable in vitro fertilization ('IVF') clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of our INVOcell technology solution into third-party owned and operated fertility clinics. The INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more natural, intimate, and affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly more effective treatment than intrauterine insemination ('IUI'). For more information, please visit Safe Harbor Statement This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events, or otherwise. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO 978-878-9505 sshum@ Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 INVO@ INVO FERTILITY, INC. CONSOLIDATED STATEMENTS OF OPERATIONS For the Three Months Ended December 31, For the Year Ended December 31, 2024 2023 2024 2023 Revenue: Clinic revenue $ 1,687,300 $ 1,362,938 $ 6,450,431 $ 2,862,574 Product revenue (1,334) 18,816 81,569 158,001 Total revenue 1,685,966 1,381,754 6,532,000 3,020,575 Operating expenses: Cost of revenue 957,419 886,750 3,657,766 1,934,437 Selling, general and administrative 3,476,101 1,855,967 9,078,804 7,486,454 Research and development 484,780 5,907 489,660 165,945 Loss on disposal of fixed assets - - 511,663 - Depreciation and amortization 231,810 141,598 919,603 200,894 Total operating expenses 5,150,110 2,890,222 14,657,496 9,787,730 Loss from operations (3,464,144) (1,508,468) (8,125,496) (6,767,155) Other income (expense): Gain (loss) from equity method investment 18,467 (28,160) 9,045 (60,270) Impairment from equity method joint ventures - (89,794) - (89,794) Gain on lease termination - - 94,551 - Loss from debt extinguishment - (163,278) (40,491) (163,278) Interest expense (231,824) (182,043) (1,056,360) (925,909) Foreign currency exchange loss - (4) - (420) Total other income (expense) (213,357) (463,279) (993,255) (1,239,671) Loss before income taxes (3,677,501) (1,971,747) (9,118,751) (8,006,826) Income taxes (54,008) 23,035 (22,913) 27,786 Net loss attributable to INVO Fertility, Inc. $ (3,623,493) $ (1,994,782) (9,095,838) $ (8,034,612) Common stock warrants deemed dividends - - (250,635 ) - Net loss attributable to common shareholders (3,623,493) (1,994,782) (9,346,473) (8,034,612) Net loss per common share: Basic $ (9.04) $ (9.65) $ (30.19) $ (67.37) Diluted $ (9.04) $ (9.65) $ (30.19) $ (67.37) Weighted average number of common shares outstanding: Basic 401,011 206,761 309,539 119,264 Diluted 401,011 206,761 309,539 119,264 INVO FERTILITY, INC. ADJUSTED EBITDA Three Months Ended Year Ended December 31 December 31 2024 2023 2024 2023 Net loss attributable to INVO Fertility, Inc. $ (3,623,493) $ (1,994,782) $ (9,095,838) $ (8,034,612) Interest expense 145,200 74,174 434,077 205,781 Amortization of debt discount 86,624 107,869 622,283 720,128 Tax expense (benefit) (54,008) 23,035 (22,913) 27,786 Stock-based compensation 36,010 34,727 1,246,918 344,386 Stock option expense 133,357 144,804 342,728 1,049,109 Non cash compensation for services 45,000 45,000 180,000 180,000 Reserve on other assets receivable 498,592 - 498,592 - Foreign currency exchange loss - 4 - 420 Loss on disposal of fixed assets - - 511,663 - Gain on lease termination - - (94,551) - Loss from debt extinguishment - 163,278 40,491 163,278 Impairment on equity method JV - 89,794 89,794 Depreciation and amortization 231,810 141,598 919,603 200,894 Adjusted EBITDA $ (2,500,908) $ (1,170,499) $ (4,416,947) $ (5,053,036) NAYA Therapeutics loss $ 1,519,000 $ - $ 1,519,000 $ - Merger-related costs $ 531,000 $ 150,000 $ 671,000 $ 150,000
Globe and Mail
24-04-2025
- Business
- Globe and Mail
INVO Fertility Confirms New Nasdaq Trading Symbol of 'IVF'
SARASOTA, Fla., April 24, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc. (Nasdaq: NAYA), formerly known as NAYA Biosciences, Inc., a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition and operation of fertility clinics, today confirmed it will begin trading under the new symbol 'IVF' at the market open on April 28, 2025. The CUSIP number for the Company's common stock will remain unchanged. The symbol change follows the Company's announcement on April 14, 2025, regarding the strategic decision to separate its fertility and oncology businesses into distinct operations. 'Our new Nasdaq ticker symbol of 'IVF' reflects our go-forward business concentration on the fertility care market,' commented Steve Shum, CEO of INVO Fertility. 'This change underscores our strategic focus on building, acquiring and operating fertility clinics in the United States and our focus on innovative reproductive services and technologies. As reinforced by the U.S. President's recent executive order to reduce the cost of IVF and expand access to fertility services, we look forward to refocusing and scaling our mission of helping people build the families of which they dream.' About INVO Fertility We are a healthcare services fertility company dedicated to expanding assisted reproductive technology ('ART') care to patients in need. Our principal commercial strategy is focused on building, acquiring and operating fertility clinics, including 'INVO Centers' dedicated primarily to offering the intravaginal culture ('IVC') procedure enabled by its INVOcell® medical device ('INVOcell') and US-based, profitable in vitro fertilization ('IVF') clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of our INVOcell technology solution into third-party owned and operated fertility clinics. The INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more natural, intimate, and affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly more effective treatment than intrauterine insemination ('IUI'). For more information, please visit Safe Harbor Statement This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise. For more information, please contact: INVO Fertility Steve Shum, CEO 978-878-9505 sshum@ Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700
Yahoo
14-04-2025
- Business
- Yahoo
NAYA Biosciences Announces Strategic Decision to Separate Fertility and Oncology Businesses into Distinct Operations – Company Renamed 'INVO Fertility, Inc.'
SARASOTA, Fla., April 14, 2025 (GLOBE NEWSWIRE) -- INVO Fertility, Inc., formerly known as NAYA Biosciences, Inc. (the 'Company') (Nasdaq: NAYA), a healthcare services fertility company focused on expanding access to advanced treatment through the establishment, acquisition, and operation of fertility clinics, today announced its decision to separate its fertility and oncology operations. This strategic decision to separate its two principal focus areas is expected to enable both businesses to maximize shareholder value. In connection with the planned separation, the Company has been renamed to 'INVO Fertility, Inc.' effective Monday, April 14, 2025, and its Nasdaq ticker symbol will be changed to 'IVF' as soon as practicable. The Company will provide additional information on the expected date for the new symbol to go effective. With this separation, the Company returns to its previous, exclusive focus on the fertility marketplace – the establishment, acquisition and operation of new fertility clinics and the distribution of the Company's FDA-cleared INVOcell device. The Company plans to divest a majority stake in its wholly owned subsidiary, NAYA Therapeutics Inc. ('NAYA TX'). Through the retention of a minority position, the Company seeks to benefit from the potential value appreciation that could be generated from the clinical development of NAYA TX's bifunctional antibodies. This revised corporate structure aims to enable both businesses to focus on their respective opportunities and operations, with the existing management team and board of directors set to lead the Company. NAYA TX will return to being a privately held biotechnology company led by its management team and board. The final separation is subject to completing definitive transaction documents and key closing conditions, including receipt of necessary approvals. 'Moving forward, we will leverage our existing, revenue-generating fertility operations with operating centers in Wisconsin, Alabama, and Georgia, to acquire and build new centers across the U.S.,' stated Steve Shum, CEO of INVO Fertility. 'We believe the fertility market opportunity remains large and growing, as confirmed by the U.S. President's recent executive order aimed at reducing the cost of IVF and expanding access to fertility services.' 'We remain enthusiastic about NAYA TX's assets and their significant potential upside, which we hope to monetize in the future through value appreciation in the minority stake we plan to retain. At the same time, the return of the two businesses to independent entities is expected to enable a more focused effort with dedicated teams. We believe the respective shareholders for each business agree and support this revised structure and approach.' The Company previously filed an extension for the filing of its Annual Report on Form 10-K for the year ended December 31, 2024. The Company is in the process of completing its financial statements and other disclosures for the fiscal year ended December 31, 2024. About INVO Fertility, Inc. We are a healthcare services fertility company dedicated to expanding assisted reproductive technology ('ART') care to patients in need. Our principal commercial strategy is focused on building, acquiring and operating fertility clinics, including 'INVO Centers' dedicated primarily to offering the intravaginal culture ('IVC') procedure enabled by our INVOcell® medical device ('INVOcell') and US-based, profitable in vitro fertilization ('IVF') clinics. We have two operational INVO Centers in the United States and one IVF clinic. We also continue to engage in the sale and distribution of our INVOcell technology solution into third-party owned and operated fertility clinics. The INVOcell is a proprietary and revolutionary medical device, and the first to allow fertilization and early embryo development to take place in vivo within the woman's body. The IVC procedure provides patients with a more natural, intimate, and affordable experience in comparison to other ART treatments. We believe the IVC procedure can deliver comparable results at a fraction of the cost of traditional IVF and is a significantly more effective treatment than intrauterine insemination ('IUI'). For more information, please visit About NAYA Therapeutics, Inc. NAYA Therapeutics is a clinical-stage biopharmaceutical company dedicated to advancing oncology outcomes through the development of next-generation bifunctional antibodies. Its portfolio currently includes NY-303, a GPC3 x NKp46 bifunctional antibody for the treatment of HCC with a unique mechanism of action targeting non-responders to the current immunotherapy standard of care (70-85% of the current treatable market), cleared to enroll patients in a Phase I/IIa monotherapy trial in H2 2025, NY-500, an AI-optimized PD-1 x VEGF bifunctional antibody aiming to be the first PD-1 x VEGF to market in HCC, with translational clinical and preclinical data in 2025 and Phase I/II in HCC to be initiated in early 2026, and NY-338, a CD38 x NKp46 bifunctional antibody for the treatment of multiple myeloma with a unique mechanism of action enhancing safety & efficacy and a differentiated profile to daratumumab and T-Cell engagers, aiming to enroll patients in its Phase I/II clinical trials in early 2026. For more information, please visit Safe Harbor Statement This release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as "anticipate," "if," "believe," "plan," "estimate," "expect," "intend," "may," "could," "should," "will," and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise. For more information, please contact: INVO Fertility, Inc. Steve Shum, CEO 978-878-9505sshum@ NAYA Therapeutics, Inc. Lyn Falconio, Chief Communications Officer917-575-1844lyn@ Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 INVO@ in to access your portfolio
Yahoo
25-02-2025
- Health
- Yahoo
NAYA Biosciences Supports Recent Executive Order Aimed at Improving Access to Fertility Treatment
NAYA Sees Potential Positive Impact to Its Existing Fertility Operations and FDA-Cleared INVOcell Technology SARASOTA, Fla. and MIAMI, Feb. 25, 2025 (GLOBE NEWSWIRE) -- NAYA Biosciences, Inc. ('NAYA') (NASDAQ: NAYA), a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and women's health, and a leading provider of in vitro fertilization (IVF) and in vivo Intravaginal Culture ('IVC') fertility treatments, proudly supports the U.S. President's recent executive order aimed at reducing the cost of IVF and expanding access to fertility services. The order directs the Domestic Policy Council to develop policy recommendations within 90 days to protect IVF access and significantly lower out-of-pocket expenses and health plan costs for families dealing with infertility. For many individuals and couples struggling with infertility, the high cost of IVF often makes treatment financially out of reach. The lack of comprehensive insurance coverage for fertility services in most states further compounds this challenge, forcing many patients to take on significant debt or forego treatment altogether. 'Infertility is a challenging medical condition, and no one should have to choose between financial stability and starting a family,' said Steve Shum, CEO of NAYA Biosciences. 'President Trump's executive order is a critical step in the right direction, and we stand ready to support efforts that make fertility treatments more accessible and affordable for all. In addition to our existing fertility clinic operations, we also believe our FDA-cleared INVOcell device and the IVC treatment process is uniquely positioned to offer an efficient, effective, and more affordable treatment solution, which is aligned with the administration's efforts to reduce costs.' Currently, fewer than 20 states mandate some level of fertility coverage, leaving millions without insurance assistance. By addressing cost concerns, the administration's action has the potential to bring hope to those who have faced heartbreaking obstacles on their journey to parenthood. 'As a trusted partner in fertility care with centers in Wisconsin, Alabama, and Georgia, NAYA remains committed to providing high-quality, patient-centered treatment and advocating for policies that support individuals and families seeking to conceive. We look forward to working alongside policymakers, medical professionals, and advocacy groups to ensure that every hopeful parent has the opportunity to experience the joy of building a family,' Shum concluded. About NAYA Women's HealthNAYA Women's Health is currently focused within the fertility marketplace. Our commercial strategy includes operating fertility-focused clinics providing treatment to patients via INVO Centers, LLC, our wholly owned subsidiary. We currently have two operational INVO Centers in the United States along with a conventional IVF clinic. Naya Women's Health also includes the INVOcell medical device. The INVOcell is the first in vivo Intravaginal Culture ('IVC') system granted FDA clearance in the United States. We believe this novel device and procedure provides a more natural, safe, effective and economical fertility treatment for patients. Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women's vagina as an incubator to support a more natural fertilization and embryo development environment, and infertility treatment. We currently sell and distribute INVOcell into existing independently owned and operated fertility clinics as well as within our own INVO Center clinics. About NAYA BiosciencesNAYA Biosciences (NASDAQ: NAYA) is a life science portfolio company dedicated to bringing breakthrough treatments to patients in oncology, autoimmune diseases, and women's health. Our proven hub & spoke model harnesses the shared resources of a parent company and agility of lean strategic franchises, enabling efficient acquisition, development, and partnering of assets and allowing for optimized return on investment by combining scalable, profitable commercial revenues with the upside of innovative clinical-stage therapeutics. NAYA's expanding portfolio of assets currently includes NY-303, a GPC3 x NKp46 bifunctional antibody for the treatment of hepatocellular carcinoma (HCC) with a unique mode of action targeting non-responders to the current immunotherapy standard of care (approximately 70% of the current treatable market) cleared to enroll patients in a Phase 1/2a monotherapy trial in 2025, NY-338, a CD38 x NKp46 bifunctional antibody for the treatment of multiple myeloma and autoimmune diseases with a differentiated safety and efficacy profile, NY-500, a PD-1 x VEGF bifunctional antibody for the treatment of HCC and other solid tumors, and NY-600 a PSMA x NKp46 bifunctional antibody for the treatment of metastatic Castration Resistant Prostate Cancer (mCRPC). Safe Harbor StatementThis release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The Company invokes the protections of the Private Securities Litigation Reform Act of 1995. All statements regarding our expected future financial position, results of operations, cash flows, financing plans, business strategies, products and services, competitive positions, growth opportunities, plans and objectives of management for future operations, as well as statements that include words such as 'anticipate,' 'if,' 'believe,' 'plan,' 'estimate,' 'expect,' 'intend,' 'may,' 'could,' 'should,' 'will,' and other similar expressions are forward-looking statements. All forward-looking statements involve risks, uncertainties, and contingencies, many of which are beyond our control, which may cause actual results, performance, or achievements to differ materially from anticipated results, performance, or achievements. Factors that may cause actual results to differ materially from those in the forward-looking statements include those set forth in our filings at We are under no obligation to (and expressly disclaim any such obligation to) update or alter our forward-looking statements, whether as a result of new information, future events or otherwise. NAYA Investor & Media ContactAnna Baran-DjokovicSVP, Investor Relations+1-305-615-9162anna@ in to access your portfolio
