NAYA Biosciences Announces Strategic Decision to Separate Fertility and Oncology Businesses into Distinct Operations – Company Renamed “INVO Fertility, Inc.”
NAYA Biosciences has announced a strategic separation of its fertility and oncology businesses, with the public company being renamed to INVO Fertility, Inc. The company's Nasdaq ticker will change from NAYA to IVF. The restructuring involves:
1. The public company (INVO Fertility) will focus on:
- Operating and expanding fertility clinics
- Distributing FDA-cleared INVOcell device
- Managing existing revenue-generating centers in Wisconsin, Alabama, and Georgia
2. The oncology division will become a private entity named NAYA Therapeutics, focusing on bifunctional antibodies development. INVO Fertility will retain a minority stake in NAYA Therapeutics to benefit from potential value appreciation.
The separation, effective April 14, 2025, aims to maximize shareholder value and enable focused operations for both entities. The transaction remains subject to definitive documents and necessary approvals. The company has filed an extension for its 2024 Annual Report.
NAYA Biosciences ha annunciato una separazione strategica delle sue attività nei settori della fertilità e dell'oncologia, con la società pubblica che cambierà nome in INVO Fertility, Inc. Il ticker Nasdaq passerà da NAYA a IVF. La ristrutturazione prevede:
1. La società pubblica (INVO Fertility) si concentrerà su:
- La gestione e l'espansione delle cliniche per la fertilità
- La distribuzione del dispositivo INVOcell approvato dalla FDA
- La gestione dei centri attivi che generano ricavi in Wisconsin, Alabama e Georgia
2. La divisione oncologica diventerà un'entità privata chiamata NAYA Therapeutics, focalizzata sullo sviluppo di anticorpi bifunzionali. INVO Fertility manterrà una partecipazione minoritaria in NAYA Therapeutics per beneficiare di un’eventuale rivalutazione del valore.
La separazione, efficace dal 14 aprile 2025, mira a massimizzare il valore per gli azionisti e a consentire operazioni più mirate per entrambe le entità. L’operazione è soggetta alla firma di documenti definitivi e alle necessarie approvazioni. La società ha richiesto una proroga per la presentazione del suo Rapporto Annuale 2024.
NAYA Biosciences ha anunciado una separación estratégica de sus negocios de fertilidad y oncología, con la empresa pública que cambiará su nombre a INVO Fertility, Inc. El símbolo en Nasdaq cambiará de NAYA a IVF. La reestructuración incluye:
1. La empresa pública (INVO Fertility) se enfocará en:
- Operar y expandir clínicas de fertilidad
- Distribuir el dispositivo INVOcell aprobado por la FDA
- Gestionar los centros generadores de ingresos existentes en Wisconsin, Alabama y Georgia
2. La división de oncología se convertirá en una entidad privada llamada NAYA Therapeutics, centrada en el desarrollo de anticuerpos bifuncionales. INVO Fertility mantendrá una participación minoritaria en NAYA Therapeutics para beneficiarse de una posible apreciación del valor.
La separación, efectiva a partir del 14 de abril de 2025, busca maximizar el valor para los accionistas y permitir operaciones enfocadas para ambas entidades. La transacción está sujeta a documentos definitivos y aprobaciones necesarias. La empresa ha solicitado una extensión para su Informe Anual 2024.
NAYA Biosciences는 생식 및 종양 사업부의 전략적 분리를 발표했으며, 상장 회사는 INVO Fertility, Inc.로 사명을 변경할 예정입니다. 나스닥 티커는 NAYA에서 IVF로 변경됩니다. 구조조정 내용은 다음과 같습니다:
1. 상장 회사(INVO Fertility)는 다음에 집중합니다:
- 생식 클리닉 운영 및 확장
- FDA 승인 INVOcell 기기 유통
- 위스콘신, 앨라배마, 조지아에 위치한 기존 수익 창출 센터 관리
2. 종양학 부문은 NAYA Therapeutics라는 비상장 회사로 전환되며, 이중기능 항체 개발에 집중합니다. INVO Fertility는 NAYA Therapeutics의 소수 지분을 보유하여 잠재적 가치 상승에 따른 이익을 누릴 예정입니다.
이 분리는 2025년 4월 14일부터 시행되며, 주주 가치를 극대화하고 두 회사가 각각 집중된 운영을 할 수 있도록 하는 것이 목적입니다. 거래는 최종 문서 및 필요한 승인에 따라 진행됩니다. 회사는 2024년 연례 보고서 제출 기한 연장을 신청했습니다.
NAYA Biosciences a annoncé une séparation stratégique de ses activités dans la fertilité et l'oncologie, la société cotée étant renommée INVO Fertility, Inc. Le symbole Nasdaq passera de NAYA à IVF. La restructuration comprend :
1. La société cotée (INVO Fertility) se concentrera sur :
- L’exploitation et l’expansion des cliniques de fertilité
- La distribution du dispositif INVOcell approuvé par la FDA
- La gestion des centres générateurs de revenus existants dans le Wisconsin, l’Alabama et la Géorgie
2. La division oncologie deviendra une entité privée nommée NAYA Therapeutics, axée sur le développement d’anticorps bifonctionnels. INVO Fertility conservera une participation minoritaire dans NAYA Therapeutics afin de bénéficier d’une éventuelle valorisation.
La séparation, effective à partir du 14 avril 2025, vise à maximiser la valeur pour les actionnaires et à permettre des opérations ciblées pour les deux entités. La transaction reste soumise à la finalisation des documents et aux approbations nécessaires. La société a demandé une extension pour son rapport annuel 2024.
NAYA Biosciences hat eine strategische Trennung seiner Geschäftsbereiche Fertilität und Onkologie angekündigt, wobei das börsennotierte Unternehmen in INVO Fertility, Inc. umbenannt wird. Das Nasdaq-Tickersymbol ändert sich von NAYA zu IVF. Die Umstrukturierung umfasst:
1. Das börsennotierte Unternehmen (INVO Fertility) wird sich konzentrieren auf:
- Den Betrieb und Ausbau von Fruchtbarkeitskliniken
- Den Vertrieb des von der FDA zugelassenen INVOcell-Geräts
- Die Verwaltung bestehender umsatzgenerierender Zentren in Wisconsin, Alabama und Georgia
2. Die Onkologie-Sparte wird zu einer privaten Gesellschaft namens NAYA Therapeutics, die sich auf die Entwicklung bifunktionaler Antikörper spezialisiert. INVO Fertility behält eine Minderheitsbeteiligung an NAYA Therapeutics, um von einem möglichen Wertzuwachs zu profitieren.
Die Trennung, die am 14. April 2025 wirksam wird, zielt darauf ab, den Aktionärswert zu maximieren und beiden Einheiten fokussierte Geschäftsabläufe zu ermöglichen. Die Transaktion steht unter dem Vorbehalt endgültiger Dokumente und erforderlicher Genehmigungen. Das Unternehmen hat eine Fristverlängerung für seinen Jahresbericht 2024 beantragt.
- Strategic separation allows focused operations and potential maximization of shareholder value
- Company maintains revenue-generating operations in three states
- Retains minority stake in oncology business for potential future value appreciation
- Alignment with U.S. President's executive order on reducing IVF costs and expanding fertility services access
- Delayed filing of 2024 Annual Report
- Transaction completion subject to approvals and conditions
- Majority stake divestment in oncology business reduces exposure to that sector
Insights
This strategic separation of NAYA Biosciences into two distinct businesses represents a significant corporate restructuring that aims to enhance operational focus. The company will become INVO Fertility, Inc. with a new Nasdaq ticker IVF, concentrating on its fertility clinic business while divesting a majority stake in its oncology division.
The fertility business already generates revenue through operations in Wisconsin, Alabama, and Georgia, providing a stable foundation as the company pursues its expansion strategy. Management's decision to retain a minority position in NAYA Therapeutics demonstrates a balanced approach – maintaining exposure to potential upside from the oncology pipeline without the full R&D cost burden.
This move aligns with favorable regulatory trends, as referenced by the U.S. President's executive order on reducing IVF costs and expanding access to fertility services. However, investors should note potential execution risks inherent in any major restructuring. The delayed filing of the company's Annual Report raises questions about financial complexities related to this transition.
The separation could ultimately benefit both businesses by allowing dedicated management teams to pursue focused strategies. For INVO Fertility, this means leveraging its FDA-cleared INVOcell device alongside a clinic acquisition/operation model – a clearer value proposition than the previous hybrid structure. The transaction remains subject to approvals and closing conditions, indicating additional steps before completion.
Public company to operate under new name and concentrate on building, acquiring and operating fertility clinics and the distribution of FDA-cleared INVOcell device
Private company to operate as NAYA Therapeutics and focus on clinical development of bifunctional antibodies
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 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
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
978-878-9505
sshum@invobio.com
NAYA Therapeutics, Inc.
Lyn Falconio, Chief Communications Officer
917-575-1844
lyn@nayatx.com
Investor Contact
Lytham Partners, LLC
Robert Blum
602-889-9700
INVO@lythampartners.com
FAQ
What are the key changes in NAYA's business restructuring announced on April 14, 2025?
How many fertility centers does NAYA (soon to be INVO Fertility) currently operate?
What will happen to NAYA's stock symbol after the restructuring?
Will NAYA maintain any stake in the oncology business after separation?
