NAYA Biosciences Announces Strategic Decision to Separate Fertility and Oncology Businesses into Distinct Operations – Company Renamed 'INVO Fertility, Inc.'
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 www.invobio.com.
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 www.nayatx.com.
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 www.sec.gov. 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@invobio.com
NAYA Therapeutics, Inc. Lyn Falconio, Chief Communications Officer917-575-1844lyn@nayatx.com
Investor Contact Lytham Partners, LLC Robert Blum 602-889-9700 INVO@lythampartners.comSign in to access your portfolio
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