CISH

CHICAGO, Dec. 27, 2023 /PRNewswire/ -- The Skin of Color Society (SOCS), the global leader in skin of color dermatology, reports that 2023 was a year of exceptional progress in support of its mission to change the landscape for people of color through research, education, mentorship and advocacy. Several signature SOCS programs and newer initiatives that took place this year made uniquely important contributions to the field, as follows. Continue Reading SOCS Presidents united, pictured from left: Drs. Andrew F. Alexis (current SOCS President) with Past Presidents through the years: Drs. Rebat Halder, Valerie M. Harvey, Valerie D. Callender, Founder Susan C. Taylor, Amy McMichael, Lynn McKinley-Grant, Seemal R. Desai and President-Elect Victoria Barbosa. 2023 Highlights December 2023: The SOCS Meeting the Challenge Summit: Population Descriptors in Dermatology Research Studies—Continuing in its commitment to increase diversity in dermatology research studies and clinical trials, SOCS presented its second Meeting the Challenge Summit in December 2023, this time focusing on population descriptors that best describe various populations under study. As the second in a series, the Summit convened an esteemed, diverse group of 116 stakeholders, including skin of color dermatology leaders, researchers, clinicians, regulators, dermatologists-in-training, industry representatives, geneticists, dermatology journal editors, and an anthropologist. Co-chaired by Valerie M. Harvey, MD, MPH, FAAD and Valerie D. Callender, MD, FAAD, the 2023 Summit further advanced the broader work of the SOCS Diversity in Dermatology Clinical Trials Task Force, which introduced the inaugural Meeting the Challenge Summit in 2022—a groundbreaking gathering that led to the development of the nation's first Diversity in Clinical Trials Mentorship Program, presented in 2023 in collaboration with the National Medical Association. In addition, this SOCS Task Force is in the process of developing a comprehensive, evidence-based review of the use and misuse of the current scales used to measure skin tones. The 2023 Meeting the Challenge Summit was made possible with thanks to the support of the following sponsors: Johnson & Johnson Health Care Systems, Inc. and L'Oréal Research & Innovation (Champion Level); Bristol Myers Squibb, Eli Lilly, Inc., and Incyte Corporation (Ally Level), and AbbVie, Arcutis Biotherapeutics, Google Health, and Sanofi-Regeneron (Partner Level). The 3rd SOCS Meeting the Challenge Summit will take place in 2025. October 2023: My Best Winter Skin Campaign— On October 24, 2023, SOCS launched a new national health awareness day known as My Best Winter Skin Day, (MBWS), kicking off an annual seasonal campaign built around public education, volunteerism and giving. While raising awareness about winter skin— a common skin condition that affects people of all ages, skin types and tones in the colder months of the year— funds raised through this public educational campaign go to the SOCS Foundation to help support innovative research and mentorship in skin of color dermatology. The world's first MBWS Day rolled out with two successful community outreach events held in Chicago, IL and Washington, D.C., led by teams of SOCS members, dermatology residents and medical students from Northwestern University and Howard University respectively. Participating SOCS volunteers shared educational tips for managing winter skin that were developed by members of the SOCS Patient Education Committee, and distributed free moisturizers generously donated by MBWS campaign sponsors, La Roche-Posay and CeraVe. Campaign support was also provided by Restore Hair. Since the MBWS Day events, a total of 36 SOCS members in 18 U.S. states and Washington, D.C. have volunteered to conduct additional outreach events in their communities and on local college campuses, resulting in the distribution of 5,000 educational tips and donated moisturizers to the public. Hundreds of medical school students, Resident and Fellow members have participated in this inaugural outreach to date. Plans are underway for an expanded MBWS campaign in 2024. August 2023: Dermatology Foundation and SOCS Partner to Deliver Impactful Opportunity to Advance Health Equity in Dermatology—For the first time, the Dermatology Foundation (DF) and SOCS have partnered to deliver new DEI research support for 2024, with a one-million-dollar grant generously provided by Sanofi-Regeneron. The Sanofi-Regeneron Diversity, Equity and Inclusion Mid-Career Award was developed especially for the exceptional mid-career investigator with an established trajectory of excellence in basic, clinical or translational science and will expand the understanding of dermatological issues impacting underrepresented or underserved groups in medicine. This substantial award adds a critical piece to the pathways of investigators working to address healthcare disparities. Supported research projects are expected to yield novel results that will provide urgently needed preliminary data and will serve as a springboard for obtaining larger research grants. Administered and promoted by the DF/SOCS Collaborative, this unique award leverages the DF's experience and infrastructure in award development and management, along with the SOCS's expertise in DEI and deep reach into the community of DEI investigators. Applications are closed for the 2024 Award cycle. Recipients will be announced in March 2024. July 2023: The first-ever SOCS Scientific Session at the World Congress of Dermatology (WCD)–SOCS was pleased to present its first WCD Scientific Session at the 25th World Congress of Dermatology in Singapore. Organized by the International League of Dermatological Societies, of which SOCS is a proud member, the WCD is one of the largest dermatology meetings in the world. Featuring expert presentations on inflammatory disorders, cultural beauty around the world, lichen planopilaris in South Africa, facial pigmentation and less-known facets of cutaneous tuberculosis, the SOCS Scientific Session was co-chaired by Drs. Victoria Barbosa and Ginette A. Okoye, under the leadership of SOCS President Dr. Andrew Alexis. This well-attended program was made possible by an educational grant from Pfizer. June 2023: The SOCS Educational Video Series—In its continuing dedication to physician, patient and public education, SOCS released an innovative educational video series in June 2023, consisting of the "MelanatED" series of eight short-form videos and ten longer-form SOCS Identity videos. Covering pertinent, high-interest topics ranging from cultural competency, inflammatory diseases, hair loss, and sunscreen in skin of color to patient safety, dermatologic differences in darker skin, the importance of early detection, how to find "Dr. Right" and much more, this enlightening collection addresses many issues of importance to patients of color and the physicians who care for them. Drawn from the 6th Annual SOCS Media Day initiative, held in March 2023, these insightful videos feature nationally and globally recognized SOCS leaders, including: Drs. Susan C. Taylor, Andrew F. Alexis, Valerie M. Harvey, Candrice R. Heath, Janiene Luke, Corey L. Hartman, Shawn Kwatra, and Nkem Ugonabo. This initiative was made possible thanks to the support of: Johnson & Johnson Health Care Systems, Inc., Procter & Gamble, Senté, Bristol Myers Squibb, Arcutis Biotherapeutics and Dove. The 7th Annual SOCS Media Day, "Changes, Challenges and Choices in Skin of Color: What SOCS Experts Say in an Era of Opportunity and Promise," will lead to a new series of educational videos, featuring SOCS leaders who will share their insights on a range of timely and relevant topics of importance to patients of color. March 2023: The 19th Annual SOCS Scientific Symposium—Held in March 2023, the 19th Annual SOCS Scientific Symposium, "Where Science, Innovation and Inclusion Meet," showcased the latest skin of color dermatology research and insights from emerging researchers and leading experts from around the US and the world. A record 179 scientific abstracts were submitted, with 128 poster abstracts and five oral abstract presentations accepted for inclusion in the program. Experienced by an international audience of 511 attendees, the Symposium featured 16 invited speakers, including a keynote address, who shared their insights through presentations, moderated panels and oral abstracts, along with an expansive range of iPosters on display for viewing. This informative program was co-chaired by Victoria Barbosa, MD, MPH, MBA, FAAD and Ginette A. Okoye, MD, FAAD. The 19th Annual SOCS Scientific Symposium was supported by AbbVie, Arcutis, AVITA Medical, Beiersdorf, Bristol Myers Squibb, Dermavant Sciences, Eli Lilly, Evolus, Incyte Johnson & Johnson Health Care Systems, Inc., OrthoDermotologics, Sanofi-Regeneron, Sente, Strata Skin Sciences, UCB, and Unilever/Dove/Vaseline. The 20th Annual SOCS Scientific Symposium, "Pathways to Equity: Advancing Advocacy, Research, and Clinical Excellence," will take place on Thursday, March 7, 2024, at the Marriott Marquis in San Diego. The upcoming Symposium is co-chaired by Nada Elbuluk, MD, MSc, FAAD and Chere Lucas Anthony, MD, FAAD. 2023 By the Numbers: SOCS Signature Programs and Activities Membership is growing globally, with 505 new SOCS members added from 30 countries. 11 SOCS Observership Grants awarded, supported by EltaMD, L'Oréal and many SOCS members who have made voluntary contributions through the SOCS Foundation. 5 SOCS Research Grants awarded, supported by Bristol Myers Squibb, L'Oréal and Pfizer. 3 SOCS Career Development Grants awarded, supported by Bristol Myers Squibb and Pfizer. 2 SOCS Early Career Innovations Awards given, supported by SOCS member Dhaval Bhanusali, MD, FAAD. 8 Travel Grants to the SOCS Meeting the Challenge Summit awarded to Dermatology Residents, supported by Summit sponsorships. 128 SOCS Mentee applications for the SOCS Mentorship program received 48 SOCS Mentor-Mentee pairings in the SOCS Mentorship program were facilitated, thanks to individual donations made to the SOCS Foundation. A total of 150 SOCS members and dermatology colleagues participated in SOCS Networking & Educational Symposia held in Chicago, Boston, New York, San Antonio, Philadelphia and San Francisco during 2023. These events were supported by Pfizer. "As we usher in our 20th Anniversary milestone in 2024, we're deeply grateful to so many SOCS leaders, members, supporters and collaborators who have helped make 2023 an extraordinary year of remarkable progress," comments SOCS President Andrew F. Alexis, MD, MPH, FAAD. About the Skin of Color Society The Skin of Color Society (SOCS) is an international professional dermatologic organization dedicated to achieving health equity and excellence in patient care through research, education, mentorship and advocacy. SOCS is committed to increasing diversity and inclusion in dermatology to advance patient care. Established in 2004 by Susan C. Taylor, MD, SOCS includes members from more than 30 countries around the world. Learn more: . SOURCE Skin of Color Society

ONK Therapeutics and NAYA Biosciences to assess proof-of-concept and establish activity and feasibility of the combination of ONK’s optimally engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK™ bispecific antibodies for the treatment of cancerPartnership may be expanded to joint clinical development following successful completion of the initial researchCombination therapy expected to improve response rate and address significant unmet medical need in hepatocellular carcinoma (HCC) GALWAY, Ireland and SAN DIEGO and AVENTURA, Fla. and SARASOTA, Fla., Dec. 06, 2023 (GLOBE NEWSWIRE) -- ONK Therapeutics (“ONK”), an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf natural killer (NK) cell therapies, and NAYA Biosciences Inc. ("NAYA"), a company dedicated to increasing patient access to breakthrough treatments in fertility, oncology, and regenerative medicine, today announced that they have entered into a research partnership to evaluate combination therapy consisting of ONK’s optimally-engineered natural killer (NK) cell therapies and NAYA’s FLEX-NK™ bispecific antibodies. Specifically, the partnership will explore the combination of ONK’s ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy with NAYA’s GPC3-targeted NY-303 FLEX-NK™ bispecific antibody. “We are impressed with the data ONK has generated using its differentiated editing of NK cells, which may further enhance the efficacy of our FLEX-NK™ bispecific antibodies,” commented NAYA’s CEO Dr. Daniel Teper. “The future development of this combination therapy alongside our monotherapy clinical trials will help expand patient options and narrow the gap towards improving the long-term survival of patients with hepatocellular carcinoma.” ONK’s CEO Chris Nowers added, “The opportunity to partner with NAYA to evaluate the activity of our optimally gene-edited, non-CAR directed, allogeneic NK cell therapies in combination with its exciting FLEX-NK™ bispecific antibodies offers an opportunity to further improve response rates and durability of NK cell therapy. We believe this therapeutic combination represents a broadly applicable and versatile approach to treat patients with cancer and autoimmune diseases, where additional treatment options are needed.” ONK and NAYA plan to assess several combination therapies in preclinical cancer models in 2024 prior to subsequently exploring initiating clinical trials. The companies’ R&D teams will collaboratively evaluate ONK’s optimally gene-edited NK cell therapy, ONKT105, with NAYA’s NY-303 bispecific antibody before selecting the best candidates for potential clinical development. Both companies will share the costs of manufacturing and preclinical assessments. ONK Therapeutics employs an innovative gene editing strategy to engineer NK cell therapies that are fit for purpose and optimally engineered, depending on the indication and intent for use alone (CAR NK), or in combination with targeting monoclonal antibody or NK cell engager therapies. All of ONK’s allogeneic NK cell therapy products candidates include the foundational CISH KO gene edit, to allow for enhanced metabolic properties and improved in vivo persistence. ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells. Additional gene edits, such as the KO of immunosuppressive checkpoints such as TGFβR2, as well as gene knock-ins (KIs), such as sIL-15, are included to further armor the NK cell therapies for maximal activity within the tumor microenvironment. NAYA’s FLEX-NK bispecific antibodies are built on a proprietary tetravalent, multifunctional format with flexible linker, facilitating simultaneous binding to different antigens on one or multiple cells. They redirect and trigger the killing activity of Natural Killer (NK) cells towards their tumor targets using NKp46 activating receptors. NKp46 mediates NK-cell lysis in both autologous and allogeneic cells and shows sustained expression on NK cells in the tumor microenvironment. NY-303 targets GPC3 for the treatment of HCC and other solid tumors and has demonstrated enhanced tumor growth inhibition when combined with NK cells in data presented at leading conferences including the American Association for Cancer Research (AACR) and the Society for Immunotherapy of Cancer (SITC). About ONK Therapeutics – www.onktherapeutics.com ONK Therapeutics is an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf, natural killer (NK) cell therapies. With a growing pre-clinical pipeline targeting both hematological malignancies and solid tumors, ONK is advancing multiple cell therapy candidates towards the clinic, including its two lead programs, ONKT105, a highly functional, multi gene edited NK cell therapy for use either alone or in combination with monoclonal antibodies or NK cell engagers, and ONKT102, an optimized affinity CD38 CAR-NK product, intended for the treatment of patients with relapsed/refractory multiple myeloma. Read about the pipeline here. The company’s optimally engineered NK cell therapy platform utilizes a suite of proprietary gene edits and cell modification strategies to optimize NK cell metabolic health, persistence and anti-tumor effect of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. These include CISH knockout (KO); the expression of high affinity, membrane bound, TNF-related apoptosis-inducing ligand variants (TRAILv) targeting DR5 or DR4; and the deletion of inhibitory receptors, including extracellular proteins for example CD96, and Siglec-7. Read about the platform here. Follow us on Twitter and LinkedIn. About NAYA Biosciences NAYA Biosciences is building a group of agile, disruptive, high-growth companies dedicated to increasing patient access to life-transforming treatments in oncology, fertility, and regenerative medicine. NAYA's capabilities in biology, cell and gene therapy, and artificial intelligence (AI) provide a synergistic platform for the accelerated clinical development and commercialization of these breakthrough treatments. 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 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. NAYA Regenerative Medicine is evaluating the acquisition of clinic-stage assets aiming to restore biological function in patients with damaged tissues and organs. On October 22, 2023, NAYA and INVO announced a merger agreement, which is expected to close in Q1 2024. For additional details, see Inline XBRL Viewer (sec.gov). For more information, please visit www.nayabiosciences.com. Media enquiries ONK Therapeutics – International:Sue Charles (Charles Consultants)+44 7968 726585 sue@charles-consultants.com ONK Therapeutics – Ireland:Ray Gordon (Gordon MRM)+353 87 2417373 ray@gordonmrm.ie NAYA Biosciences:Anna Baran-Djokovic305-615-9162anna@nayabiosciences.com INVO Bioscience:Steve Shum978-878-9505sshum@invobio.com; INVO Investor Contact:Robert Blum (Lytham Partners, LLC)602-889-9700INVO@lythampartners.com

NAYA Biosciences and ONK Therapeutics to assess proof-of-concept and establish activity and feasibility of the combination of NAYA's FLEX-NK™ bispecific antibodies and ONK's optimally engineered natural killer (NK) cells for the treatment of cancer Partnership may be expanded to joint clinical development following successful completion of the initial research Combination therapy expected to improve response rate and address significant unmet medical need in hepatocellular carcinoma (HCC) NAYA expects to close its previously announced merger with INVO Bioscience (NASDAQ: INVO) in the first quarter of 2024 AVENTURA, Fla. and SARASOTA, Fla. and GALWAY, Ireland and SAN DIEGO, Dec. 6, 2023 /PRNewswire/ -- 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 fertility, oncology, and regenerative medicine, and ONK Therapeutics ("ONK"), an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf natural killer (NK) cell therapies, today announced that they have entered into a research partnership to evaluate combination therapy consisting of NAYA's FLEX-NK™ bispecific antibodies and ONK's optimally engineered natural killer (NK) cells. Specifically, the partnership will explore the combination of NAYA's GPC3-targeted NY-303 FLEX-NK™ bispecific antibody with ONK's ONKT105, CISH + TGFβR2 double knock-out (KO), sIL-15 knock-in (KI) allogeneic NK cell therapy. "We are impressed with the data ONK has generated using its differentiated editing of NK cells, which may further enhance the efficacy of our FLEX-NK™ bispecific antibodies," commented NAYA's CEO Dr. Daniel Teper. "The future development of this combination therapy alongside our monotherapy clinical trials will help expand patient options and narrow the gap towards improving the long-term survival of patients with hepatocellular carcinoma." ONK's CEO Chris Nowers added, "The opportunity to partner with NAYA to evaluate the activity of our optimally gene-edited, non-CAR directed, allogeneic NK cell therapies in combination with its exciting FLEX-NK™ bispecific antibodies offers an opportunity to further improve response rates and durability of NK cell therapy. We believe this therapeutic combination represents a broadly applicable and versatile approach to treat patients with cancer and autoimmune diseases, where additional treatment options are needed." NAYA and ONK plan to assess several combination therapies in preclinical cancer models in 2024 prior to subsequently exploring initiating clinical trials. The companies' R&D teams will collaboratively evaluate ONK's optimally gene-edited NK cell therapy, ONKT105, with NAYA's NY-303 bispecific antibody before selecting the best candidate for potential clinical development. Both companies will share the costs of manufacturing and preclinical assessments. NAYA's FLEX-NK™ bispecific antibodies are built on a proprietary tetravalent, multifunctional format with flexible linker, facilitating simultaneous binding to different antigens on one or multiple cells. They redirect and trigger the killing activity of Natural Killer (NK) cells towards their tumor targets using NKP46 activating receptors. NKp46 mediates NK-cell lysis in both autologous and allogeneic cells and shows sustained expression on NK cells in the tumor microenvironment. NY-303 targets GPC3 for the treatment of HCC and other solid tumors and has demonstrated enhanced tumor growth inhibition when combined with NK cells in data presented at leading conferences including the American Association for Cancer Research (AACR) and the Society for Immunotherapy of Cancer (SITC). ONK Therapeutics employs an innovative gene editing strategy to engineer NK cell therapies that are fit for purpose and optimally engineered, depending on the indication and intent for use alone (CAR NK), or in combination with targeting monoclonal antibody or NK cell engager therapies. All of ONK's allogeneic NK cell therapy products candidates include the foundational CISH KO gene edit, to allow for enhanced metabolic properties and improved in vivo persistence. ONK has exclusive, worldwide rights to KO of CISH in NK cells, regardless of the source of the NK cells. Additional gene edits, such as the KO of immunosuppressive checkpoints such as TGFβR2, as well as gene knock-ins (KIs), such as sIL-15, are included to further armor the NK cell therapies for maximal activity within the tumor microenvironment. About ONK Therapeutics – ONK Therapeutics is an innovative cell therapy company dedicated to developing the next generation of optimally engineered off-the-shelf, natural killer (NK) cell therapies. With a growing pre-clinical pipeline targeting both hematological malignancies and solid tumors, ONK is advancing multiple cell therapy candidates towards the clinic, including its two lead programs, ONKT105, a highly functional, multi gene edited NK cell therapy for use either alone or in combination with monoclonal antibodies or NK cell engagers, and ONKT102, an optimized affinity CD38 CAR-NK product, intended for the treatment of patients with relapsed/refractory multiple myeloma. Read about the pipeline here. The company's optimally engineered NK cell therapy platform utilizes a suite of proprietary gene edits and cell modification strategies to optimize NK cell metabolic health, persistence, and anti-tumor effect of NK cells, while reducing the potential for their exhaustion in the tumor microenvironment. These include CISH knockout (KO); the expression of high affinity, membrane bound, TNF-related apoptosis-inducing ligand variants (TRAILv) targeting DR5 or DR4; and the deletion of inhibitory receptors, including extracellular proteins for example CD96, and Siglec-7. Read about the platform here. Follow us on Twitter and LinkedIn. About NAYA Biosciences NAYA Biosciences is building a group of agile, disruptive, high-growth companies dedicated to increasing patient access to life-transforming treatments in oncology, fertility, and regenerative medicine. NAYA's capabilities in biology, cell and gene therapy, and artificial intelligence (AI) provide a synergistic platform for the accelerated clinical development and commercialization of these breakthrough treatments. 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 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. NAYA Regenerative Medicine is evaluating the acquisition of clinic-stage assets aiming to restore biological function in patients with damaged tissues and organs. For more information, please visit . 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, 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, an estimated $5 million or more (at NAYA's discretion) in interim private financing in INVO at a premium to INVO's market price at time of financing ("Interim PIPE"), 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 ( ). In connection with the Merger, INVO and NAYA will 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 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 ( ), 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 . 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. Company Codes: NASDAQ-NMS:INVO, ISIN:US44984F1049