Core Viewpoint - INVO Fertility, Inc. has announced a strategic separation of its fertility and oncology operations to maximize shareholder value, returning to a focus on the fertility marketplace and the distribution of its FDA-cleared INVOcell device [1][4][5]. Group 1: Company Name Change and Structure - The company has been renamed to "INVO Fertility, Inc." effective April 14, 2025, with a new Nasdaq ticker symbol "IVF" to be implemented shortly [2]. - The separation will allow INVO Fertility to concentrate on establishing, acquiring, and operating fertility clinics, as well as distributing the INVOcell device [3][4]. Group 2: Business Focus and Strategy - INVO Fertility aims to leverage its existing operations in Wisconsin, Alabama, and Georgia to expand its network of fertility centers across the U.S., capitalizing on a growing market opportunity [5]. - The company plans to divest a majority stake in its subsidiary, NAYA Therapeutics, while retaining a minority position to benefit from potential value appreciation in its bifunctional antibodies [4][5]. Group 3: NAYA Therapeutics Overview - NAYA Therapeutics will operate as a private company focused on the clinical development of bifunctional antibodies, with several promising candidates in its pipeline targeting oncology [7]. - The company’s lead candidate, NY-303, is set to enter a Phase I/IIa trial in H2 2025, targeting a significant portion of the current treatable market for hepatocellular carcinoma (HCC) [7].

Core Viewpoint - NAYA Biosciences, Inc. will implement a 1-for-12 reverse stock split to comply with Nasdaq's minimum bid price requirement, effective March 18, 2025 [1][3]. Company Overview - NAYA Biosciences is focused on developing breakthrough treatments in oncology, autoimmune diseases, and women's health, and is a leading provider of IVF and IVC fertility treatments [1][4]. - The company utilizes a hub & spoke model to optimize the acquisition, development, and partnering of assets, aiming for efficient returns on investment [4]. Reverse Stock Split Details - The reverse stock split will convert every 12 shares of common stock into 1 share, rounding up any fractional shares [2]. - Post-split, the company will have approximately 666,057 shares issued and outstanding, with authorized shares adjusted to 4,166,666 [2]. Compliance and Market Position - The primary goal of the reverse stock split is to meet Nasdaq's $1.00 per share minimum bid price requirement for continued listing, although success is not guaranteed [3]. - NAYA's current portfolio includes innovative therapies targeting significant market needs, such as hepatocellular carcinoma and multiple myeloma [5].

Core Viewpoint - NAYA Biosciences supports the U.S. President's executive order aimed at reducing IVF costs and expanding access to fertility services, which is expected to significantly lower out-of-pocket expenses for families dealing with infertility [1][3]. Company Overview - NAYA Biosciences is a life science portfolio company focused on breakthrough treatments in oncology, autoimmune diseases, and women's health, with a particular emphasis on fertility services [7]. - The company operates fertility-focused clinics through its subsidiary INVO Centers, LLC, and currently has two operational INVO Centers in the U.S. along with a conventional IVF clinic [5]. Fertility Treatment Innovations - NAYA's INVOcell device is the first FDA-cleared in vivo Intravaginal Culture (IVC) system in the U.S., offering a more natural and economical fertility treatment compared to conventional IVF methods [6]. - The INVOcell procedure utilizes the woman's vagina as an incubator for embryo development, which is believed to provide a safer and more effective treatment option [6]. Industry Context - The high cost of IVF and lack of comprehensive insurance coverage for fertility services in most states create significant financial barriers for individuals and couples struggling with infertility [2]. - Currently, fewer than 20 states mandate some level of fertility coverage, leaving millions without insurance assistance, highlighting the importance of the administration's actions to address these cost concerns [3]. Commitment to Accessibility - NAYA is committed to advocating for policies that support individuals and families seeking fertility treatments, aiming to ensure that every hopeful parent has the opportunity to build a family [4].

Core Insights - NAYA Biosciences is enhancing its focus on oncology and autoimmune diseases by nominating five new board candidates with extensive biotechnology experience [1] Group 1: New Board Members - Laurent Audoly, PhD, cofounder and CEO of PriveBio, has a strong background in R&D and has played a pivotal role in eight drug approvals [2] - Melissa Fensterstock, MPhil, MBA, has experience in translating academic innovations to commercial scale and has held executive positions at prestigious universities [3] - Prakash Raman, PhD, CEO of InduPro, Inc., has significant experience in business development and licensing in the biotechnology sector [4] - Daniel Teper, PharmD, MBA, founder and president of NAYA, has held various senior management positions in leading pharmaceutical companies [5] - Alexandra Urman, MPH, has a background in clinical cancer research and healthcare innovation, currently serving as CEO of Aomics [6] Group 2: Company Overview - NAYA Biosciences is dedicated to developing breakthrough treatments in oncology, autoimmune diseases, and women's health [7] - The company employs a hub & spoke model to optimize the acquisition, development, and partnering of assets, aiming for efficient returns on investment [8] - NAYA's portfolio includes innovative therapies such as NY-303 for hepatocellular carcinoma, NY-338 for multiple myeloma and autoimmune diseases, NY-500 for solid tumors, and NY-600 for metastatic castration-resistant prostate cancer [9]

Core Viewpoint - NAYA Biosciences has announced a public offering of 13,615,171 units at a price of $0.70 per unit, aiming to raise approximately $9.5 million for various corporate purposes [1][3]. Group 1: Offering Details - The public offering consists of units that include one share of common stock (or pre-funded warrant) and one warrant to purchase one share of common stock, with an exercise price of $0.70 per share [1]. - The offering is expected to close on or about January 14, 2025, pending customary closing conditions [1]. - Maxim Group LLC is the lead placement agent, with Brookline Capital Markets acting as co-placement agent [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for multiple purposes, including funding an installment towards the purchase of the Wisconsin Fertility Institute, redeeming 4,000 shares of Series C-2 preferred stock valued at $4 million, and addressing outstanding debt obligations [3]. - Additional funds will be allocated for clinical trials, product development, marketing, strengthening the corporate management team, working capital, general corporate purposes, and potential acquisitions [3]. Group 3: Company Overview - NAYA Biosciences is focused on developing breakthrough treatments in oncology, autoimmune diseases, and women's health, utilizing a hub & spoke model for efficient asset acquisition and development [6]. - The company's portfolio includes several bifunctional antibodies targeting various cancers, such as NY-303 for hepatocellular carcinoma and NY-600 for metastatic Castration Resistant Prostate Cancer [7].

Core Viewpoint - NAYA Biosciences has announced a public offering of 13,615,171 units at a price of $0.70 per unit, aiming to raise approximately $9.5 million for various corporate purposes including acquisitions and clinical trials [1][3]. Group 1: Offering Details - The public offering consists of units that include one share of common stock (or pre-funded warrant) and one warrant to purchase one share of common stock, with an exercise price of $0.70 per share [1]. - The offering is expected to close on or about January 14, 2025, pending customary closing conditions [1]. - Maxim Group LLC is the lead placement agent, with Brookline Capital Markets acting as co-placement agent [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used for multiple purposes, including funding an installment towards the purchase of the Wisconsin Fertility Institute, redeeming 4,000 shares of Series C-2 preferred stock valued at $4 million, and addressing outstanding debt obligations [3]. - Additional funds will support clinical trials, product development, marketing, strengthening the corporate management team, working capital, general corporate purposes, and potential acquisitions of complementary businesses or technologies [3]. Group 3: Company Overview - NAYA Biosciences is focused on developing breakthrough treatments in oncology, autoimmune diseases, and women's health, utilizing a hub & spoke model for efficient asset management [6]. - The company's portfolio includes innovative therapies such as NY-303 for hepatocellular carcinoma, NY-338 for multiple myeloma, NY-500 for solid tumors, and NY-600 for metastatic castration-resistant prostate cancer [7].

Core Insights - NAYA Biosciences is expanding its bifunctional antibody pipeline to include a novel PD-1 x VEGF tetravalent bifunctional antibody for treating hepatocellular carcinoma (HCC) and other solid tumors [1][4] Company Overview - NAYA Biosciences is a life science portfolio company focused on breakthrough treatments in oncology, autoimmune diseases, and women's health [5] - The company utilizes a hub & spoke model to efficiently acquire, develop, and partner assets, optimizing return on investment through scalable and profitable commercial revenues [5] Product Development - The new PD-1 x VEGF antibody, named NY-500, is designed to synergistically target PD-1 and VEGF, potentially improving T-cell infiltration and immune response in tumors [4] - NAYA is also developing NY-303, a GPC3-targeting bifunctional antibody, currently in a phase 1/2 clinical trial for HCC patients who do not respond to existing therapies [3][6] - NY-500 is expected to enter monotherapy phase 1/2a clinical trials in early 2026 [4][7] Market Potential - The PD-(L)1 market is projected to exceed $50 billion in 2025, indicating significant growth opportunities for NAYA's therapeutic candidates [4]

Core Insights - NAYA Biosciences is expanding its bifunctional antibody pipeline with a novel PD-1 x VEGF tetravalent bifunctional antibody, NY-500, targeting hepatocellular carcinoma (HCC) and other solid tumors, aiming to initiate clinical trials in early 2026 [1][4] Company Overview - NAYA Biosciences is a life science portfolio company focused on breakthrough treatments in oncology, autoimmune diseases, and women's health, utilizing a hub & spoke model for efficient asset development and partnering [5] Product Pipeline - The company is leveraging its proprietary FLEX antibody platform and collaborating with MabSilico to optimize the design of new therapeutic candidates [2] - NY-500 is designed to synergistically target PD-1 and VEGF, enhancing T-cell infiltration and immune response while disrupting tumor vasculature, with recent data showing its potential superiority over existing therapies [4] - NAYA is also developing NY-303, a GPC3-targeting bifunctional antibody, currently in a phase 1/2 clinical trial for HCC patients who do not respond to PD-1 +/- VEGF therapy, with data indicating its ability to reverse resistance to immunotherapy [3][6] Market Potential - The PD(L)1 market is projected to exceed $50 billion in 2025, indicating significant growth opportunities for NAYA's innovative therapies [4]

Financial Performance - Total revenue for the three months ended September 30, 2024, was $1,433,151, a 47% increase from $974,894 in the same period of 2023[17] - Clinic revenue for the nine months ended September 30, 2024, reached $4,763,131, compared to $1,499,636 for the same period in 2023, indicating a significant growth[17] - The net loss for the three months ended September 30, 2024, was $1,630,662, compared to a net loss of $1,248,440 for the same period in 2023[17] - Basic net loss per common share for the three months ended September 30, 2024, was $(0.42), compared to $(0.70) for the same period in 2023[17] - Net loss for the nine months ended September 30, 2024, was $5,472,345, an improvement from a net loss of $6,039,830 for the same period in 2023, representing a reduction of approximately 9.3%[25] - The company reported a net loss of $2,245,170 for the quarter ending June 30, 2024[21] - For the three months ended September 30, 2024, the company reported a net loss of $1,630,662 compared to a net loss of $1,248,440 for the same period in 2023, representing an increase in loss of approximately 30.6%[57] Assets and Liabilities - Total current assets increased to $1,957,481 as of September 30, 2024, up from $1,259,775 at the end of 2023, reflecting a 55% growth[15] - Total liabilities decreased slightly to $17,042,805 as of September 30, 2024, from $17,613,091 at the end of 2023[15] - Cash balance increased to $471,591 as of September 30, 2024, from $232,424 at the end of 2023, representing a 103% increase[15] - Total stockholders' equity (deficit) decreased to $(23,316) as of September 30, 2024, from $892,825 at the end of 2023[15] - Cash and cash equivalents at the end of the period were $471,591, down from $1,055,544 at the end of the previous period[25] - The company has an accumulated deficit of approximately $63.5 million as of September 30, 2024[59] Operating Expenses - Operating expenses for the three months ended September 30, 2024, totaled $2,733,553, up from $1,861,184 in the same period of 2023[17] - Net cash used in operating activities decreased to $2,357,021 for the nine months ended September 30, 2024, compared to $4,040,171 for the same period in 2023, indicating a 41.5% improvement[25] - Total stock compensation issued for services increased to $1,210,755 for the nine months ended September 30, 2024, compared to $255,424 for the same period in 2023[25] Capital Structure and Financing - The company raised $1,587,500 from the sale of common stock, net of fees and expenses, during the second quarter of 2023[20] - The company raised $1.6 million from the sale of preferred stock and $0.9 million from the exercise of warrants during the first nine months of 2024[61] - The Company entered into a Standard Merchant Cash Advance Agreement on July 20, 2023, with a gross purchase price of $543,750, which was reduced to $465,000 after repayment[116] - The Company secured a $1,500,000 Revenue Loan with a maturity date of June 29, 2028, and incurred $169,042 in interest related to this loan for the nine months ended September 30, 2024[121][122] - The Company has been dependent on raising capital from debt and equity financings to meet its cash needs, which may not be available on reasonable terms in the future[61] Stock and Equity Transactions - The total common stock issued increased to 2,492,531 shares by December 31, 2023, with additional paid-in capital at $52,710,721[20] - The Company approved a reverse stock split at a ratio of 1-for-20 on June 28, 2023, reducing authorized common stock from 125 million to 6.25 million shares[134] - On October 13, 2023, stockholders approved an increase in authorized common stock from 6.25 million shares to 50 million shares[135] - The Company authorized 1 million shares of Series A Preferred Stock with a stated value of $5.00 per share, convertible at a fixed price of $2.20 per share[136][137] - The Company completed a share exchange with Cytovia for 1.2 million shares of Series B Preferred Stock in exchange for 163,637 shares of Legacy NAYA's common stock[155] Joint Ventures and Acquisitions - The company completed the acquisition of the Wisconsin Fertility Institute for a total purchase price of $10 million, with $2.5 million paid at closing and the remaining payments structured over three installments[63] - The Georgia joint venture (Bloom INVO, LLC) recorded net losses of $0.1 million for both the nine months ended September 30, 2024, and 2023[73] - The Mexico joint venture ceased operations, and the company recognized an impairment of approximately $0.09 million for the investment in 2023[79] Tax and Legal Matters - The Company has established a valuation allowance for all deferred tax assets due to uncertainty in their recoverability[205] - The Company is not currently subject to any material legal proceedings, but may face claims in the ordinary course of business[209] - The annual forecasted effective income tax rate for 2024 is projected to be 0%[206] - Income tax expense for Q3 2024 was $29,259, compared to $1,886 in Q3 2023, representing a significant increase[206] Company Operations - The company operates in one segment, focusing on life sciences and innovative clinical-stage therapeutics[33] - NAYA Biosciences, Inc. is dedicated to developing breakthrough treatments in oncology, autoimmune diseases, and fertility[27]