NAYA Biosciences To Acquire Clinical Stage Gene Therapy Program for Leber's Hereditary Optic Neuropathy (LHON)

• NAYA to accelerate Phase II clinical development and Early Patient Access after initial safety demonstrated in 28-patient clinical trial
• Program developed by Florida Biotechnologies, Inc. & the University of Miami’s Bascom Palmer Eye Institute
• NAYA continuing to implement acquisition roll-up of clinical and commercial assets in oncology, regenerative medicine, and fertility
• NAYA expects to close its previously announced merger with INVO Bioscience (NASDAQ: INVO) in the first quarter of 2024 following the recent filing of S-4 and joint draft proxy statements

AVENTURA, Fla. and SARASOTA, Fla., Jan. 23, 2024 (GLOBE NEWSWIRE) -- NAYA Biosciences Inc. ("NAYA"), a company which has recently signed a definitive merger agreement with INVO Bioscience to establish an expanded, publicly-traded life science company dedicated to increasing patient access to breakthrough treatments in oncology, regenerative medicine, and fertility, today announced that it has entered into a binding letter of intent to acquire Florida Biotechnologies, Inc. a gene therapy company focusing on the treatment of mitochondrial diseases.

“We are delighted to contribute to the emergence of a strong biotech ecosystem leveraging Florida’s academic medical excellence,” commented Florida Biotechnologies cofounder Dr. Peter Kash. “The NAYA leadership team brings an agile entrepreneurial platform, broad development and commercialization experience, and access to public capital, which will unlock the potential of our promising AAV gene therapy platform for mitochondrial genetic diseases. As it expands its clinical pipeline to additional regenerative medicine as well as oncology and fertility programs, NAYA is poised to build a world-class Miami-based biopharmaceutical company.”

“We are impressed by the initial safety and efficacy of the AAV gene therapy developed by Florida Biotechnologies and the University of Miami for the treatment of LHON, a rare and debilitating genetic disease with no currently approved therapeutic regimen,” commented NAYA Chairman & CEO Dr. Daniel Teper. “NAYA is committed to accelerating clinical development and Early Patient Access to this breakthrough therapy, which has the potential to achieve curative results in patients with progressive vision loss and blindness.”

The therapy’s strong intellectual property is focused on the modification to traditional AAV gene therapy, in which a mitochondrial targeting sequence is added to the capsid, which allows for localization to the mitochondria. The modification can be used on AAV2-AAV9 and provided via different routes of administration. The first-generation product has been evaluated in a phase I trial and a second-generation product with improved mitochondrial targeting has demonstrated curative results without any serious adverse events noted in preclinical studies for LHON. The program has received over $6 million in grant funding to date and qualifies for Regenerative Medicine Advanced Therapy (RMAT) designation and multiple priority FDA review vouchers. The combination of multiple orphan indications, multiple routes of administration, and multiple AAV serotypes applicable supports a broad gene therapy platform for mitochondrial orphan diseases. 

NAYA entered into a binding Term Sheet with Florida Biotechnologies Inc. to acquire all of the outstanding capital stock of Florida Biotechnologies for $20,000,000 in shares of NAYA post-merger with INVO, or 4,000,000 shares, each worth $5.00 (the "Florida Biotechnologies Transaction"). Florida Biotechnologies is eligible for an additional $5,000,000, or 1,000,000 shares each worth $5.00, upon achievement of certain milestones. The Florida Biotechnologies Transaction is contingent on the closing of the INVO Merger and sufficient financing to further develop the gene therapy programs from Florida Biotechnologies.

In conjunction with this transaction, Dr. Peter Kash will join NAYA’s board of directors as Vice Chairman. Dr. Kash has over 36 years of leadership experience in the biotech industry. He is currently the cofounder and Vice Chairman of TargImmune Therapeutics (Switzerland) and cofounder and Managing Director of Camelot BioCapital. He was formerly a cofounder and partner and Chairman of Two River Group and President of Riverbank Capital Securities, specializing in helping create and finance several biotech companies including Kite Pharma, Edgemont Pharmaceuticals, and Intercept Pharmaceuticals. He has cofounded more than a dozen biotech companies and coraised in excess of $2 billion in private/public financing, helping creating more than $20 billion in peak aggregate market value. Dr. Kash has worked on Wall Street for 30 years including at Shearson Lehman Hutton and Paramount Capital. At Paramount he cofounded and helped finance PolaRx Biopharmaceuticals, developing the first cancer drug from China, Trisenox approved by the FDA. The portfolio companies have received a total of 6 FDA approvals to date.

About NAYA Biosciences

NAYA Biosciences is building a group of agile, disruptive, high-growth companies dedicated to bringing breakthrough therapies to patients at accelerated speed through an agile shared platform, backed by access to capital and public markets and driven by experienced, entrepreneurial leadership.

NAYA Oncology aims to achieve clinical proof-of-concept for its two bispecific antibodies acquired from Cytovia Therapeutics, with the goal of advancing towards breakthrough outcomes for Hepatocellular Carcinoma and Multiple Myeloma patients. Clinical trials are expected to start in 2024.

NAYA Regenerative Medicine is building a cell and gene therapy clinical pipeline, starting with the acquisition of an AAV gene therapy platform for mitochondrial diseases from Florida Biotechnologies and the University of Miami.

NAYA Fertility aims to increase accessibility to advanced fertility care through a growing network of INVO-owned and affiliated clinics and the commercialization of INVO's unique FDA-cleared INVOcell® device.

For more information, please visit www.nayabiosciences.com.

About INVO Bioscience

We are a healthcare services fertility company dedicated to expanding the assisted reproductive technology ("ART") marketplace by making fertility care accessible and inclusive to people around the world. Our commercialization strategy is focused on the opening of dedicated "INVO Centers" offering the INVOcell® and IVC procedure (with three centers in North America now operational), the acquisition of US-based, profitable in vitro fertilization ("IVF") clinics and the sale and distribution of our technology solution into existing fertility clinics. Our proprietary technology, INVOcell®, is a revolutionary medical device that allows fertilization and early embryo development to take place in vivo within the woman's body. This treatment solution is the world's first intravaginal culture technique for the incubation of oocytes and sperm during fertilization and early embryo development. This technique, designated as "IVC", provides patients a more natural, intimate, and more 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's Proposed Merger with INVO Bioscience

NAYA Biosciences and INVO Bioscience have announced a definitive merger agreement to establish an expanded publicly-traded life science company. Under the terms of the October 23rd merger agreement, pending approval of the transaction by INVO's, Cytovia Therapeutic Holdings Inc.’s, and NAYA's stockholders and subject to key closing conditions, INVO will acquire 100% of the outstanding equity interests in NAYA by means of a reverse triangular merger of a wholly owned subsidiary of INVO with and into NAYA, with NAYA surviving as a wholly owned subsidiary of INVO (the "Merger"). In connection with the Merger, INVO will issue to the stockholders of NAYA newly issued common stock, representing, following such issuance, more than eighty percent (80%) of its issued and outstanding common stock, effectively resulting in a change of control.

Among key closing conditions, INVO must obtain shareholder approval along with certain approvals from existing warrant holders, a private sale of INVO’s preferred stock at a price of $5.00 per share, in a private offering resulting in amount equal to at least $2,000,000 of gross proceeds to INVO in the aggregate, plus an additional amount as may be required prior to closing of the Merger to be determined in good faith by the parties to adequately support INVO’s fertility business activities per an agreed forecast of INVO, as well as for a period of twelve (12) months post-closing including a catch-up on INVO’s past due accrued payables still outstanding, and a private offering by the combined company at a target price of $5.00, representing a premium to INVO's last offering of $2.85 per share. The merger target valuation is $12,373,780 for INVO and $90,750,000 for NAYA, based on a target stock price of $5.00 per share. Subject to the Interim PIPE, immediately following the closing of the Merger (but prior to the private offering), the equity holders of NAYA are expected to own approximately 88% of the issued and outstanding common stock of the combined company while the equity holders of INVO are expected to own approximately 12% of the issued and outstanding common stock of the combined company.

The Merger has been unanimously approved by the board of directors of each company and is expected to close in the first quarter (Q1) of 2024.

Glaser Weil Fink Howard Jordan & Shapiro LLP is serving as legal counsel to INVO. Pearl Cohen Zedek Latzer Baratz LLP is serving as legal counsel to NAYA.

Additional Information about the Proposed Merger and Where to Find It 

INVO will furnish to the U.S. Securities and Exchange Commission (the "SEC") a Current Report on Form 8-K regarding the Merger, which will include the Merger Agreement as an exhibit thereto. Shareholders and others wishing to obtain additional information regarding the Merger Agreement and the Merger are urged to review these documents, which will be available at the SEC's website (https://www.sec.gov).

In connection with the Merger, INVO and NAYA will file relevant materials with the SEC, including a registration statement on Form S-4 filed by INVO that will include a proxy statement of INVO that also constitutes a prospectus of INVO. A definitive proxy statement/prospectus will be distributed to stockholders of NAYA. This communication is not a substitute for the registration statement, proxy statement, or prospectus or any other document that INVO or NAYA (as applicable) may file with the SEC in connection with the proposed Merger. Before making any voting or investment decision, investors and security holders of INVO and NAYA are urged to read carefully and in their entirety the registration statement, the proxy statement/prospectus, and any other materials filed with or furnished to the SEC when they become available, as well as any amendments or supplements to these documents, as they contain or will contain important information about INVO, NAYA, the Merger Agreement, the Merger, and related matters. In addition to receiving the proxy statement/prospectus by mail, shareholders also will be able to obtain the full registration statement and the proxy statement/prospectus and the exhibits thereto, as well as other filings containing information about INVO, the Merger Agreement, the Merger, and related matters, without charge, from the SEC's website (http://www.sec.gov), or at the SEC's public reference room at 100 F Street, NE, Room 1580, Washington, D.C. 20549. The information included on, or accessible through, INVO's or NAYA's website is not incorporated by reference to this communication.

INVO, NAYA and certain of their directors, executive officers, and other members of management and employees may, under SEC rules, be deemed to be "participants" in the solicitation of proxies from INVO's shareholders with respect to the Merger. Information about the directors and executive officers of INVO will be set forth in the proxy statement/prospectus and in its Form 10-K for the year ended December 31, 2022, which was filed with the SEC on April 17, 2023. Information about the directors and executive officers of NAYA will be set forth in the joint proxy statement/prospectus. 

This announcement is not a solicitation of a proxy, an offer to purchase, or a solicitation of an offer to sell any securities and it is not a substitute for the Schedule 14A, the registration statement on S-4, the proxy statement/prospectus, or other filings that may be made with the SEC in connection with the Merger Agreement and the Merger.

No Offer or Solicitation

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor a solicitation of any vote or approval with respect to the proposed transaction or otherwise. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended, and otherwise in accordance with applicable law.

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.

CONTACT

NAYA Biosciences:
Anna Baran-Djokovic
305-615-9162
[email protected]

INVO Bioscience:
Steve Shum
978-878-9505
[email protected] 

INVO Investor Contact:
Robert Blum (Lytham Partners, LLC)
602-889-9700
[email protected]