Tribe Public. Thank you for all for joining, and for all that will join today. Again, Tribe Public is an organization that is connecting interested investors across the world to learn about the companies that they care about. We do that through the wishlist process, where at the website, Tribe Public, T-R-I-B-E public.com, 24/7, 365, people can enter names of companies that they want to meet, and if we get enough interest, either for a webinar, as in this case, or an in-person meeting, typically over a beautiful luncheon in a city in the U.S., specifically, we'll try to get those CEOs out to provide a corporate sponsored event where you can learn directly from them.
Today's situation is where we have an event that you joined, where we have a speaker, a CEO, Dr. Teper, who's the Founder, Chairman, and CEO of a company called NAYA Biosciences. Dr. Teper has over 30 years leadership experience as a biopharma entrepreneur, corporate executive, and management consultant that included leadership positions at Novartis, GSK, and Sanofi. NAYA Biosciences is building a group of agile, disruptive, high-growth companies dedicated to increasing patients' access to life-transforming treatments in oncology, fertility, and regenerative medicine. NAYA's capabilities in biology, cell, and gene therapy and artificial intelligence provide a synergistic platform for the accelerated clinical development and commercialization of these breakthrough treatments. Pretty exciting company. Very excited to speak with Dr. Teper, who that I've known for a number of years, and I'm excited about his current venture.
Just note that we also run an investment advisor called Vista Partners, a registered investment advisor in California. Website is vistapglobal.com, and that we are shareholders of NAYA Biosciences and INVO Biosciences. Thank you, for, again, for attending, and we're gonna do this in a question format. We've got a number of questions that have been submitted today, and we're gonna, you know, go directly through that, try to be very relatively short and sweet, around the 30-minute mark. Then we'll have this published at the Tribe Public YouTube channel, sometime later today, if all goes as planned.
One other thing we should note, that recently, on October 23rd, INVO Bioscience, NASDAQ symbol INVO, a publicly held healthcare services company focused on expanding access to advanced fertility treatment worldwide, and NAYA Biosciences jointly announced that they have entered into a definitive agreement for INVO to acquire NAYA Biosciences in an all-stock transaction. Again, thank you. Dr. Teper, thanks for joining us today. We are excited to have this chance to ask a few questions of you and for us to learn more about NAYA and your venture moving forward here, and, thanks for taking the time. Let's just go straight into it. You are remaining the chairman of Cytovia. What is the relationship between Cytovia and NAYA?
Well, John, it's always a pleasure to talk with you. Cytovia is a company that we started in late 2019, you know, focusing on natural killer cells. D eveloped, you know, two platforms, one of gene-edited cell therapy and the other one of multi-specific antibodies. So we raised over $70 million in Cytovia as a private company. We've advanced the platforms and some of the products, including two products ready to go into clinical development. We made the decision last summer to reposition Cytovia as a drug discovery and early development company, and to go beyond natural killer cells. So the leadership of Cytovia will continue to grow the company based on the existing IP and know-how.
Cytovia has sold to NAYA Biosciences two products, which are bispecific antibodies going into the clinic, as I said, for a substantial consideration, primarily in equity, but also in cash. So that will give the resources to Cytovia to continue and expand. I will remain the chairman of Cytovia to guide them strategically, and I will take, you know, the role of CEO of NAYA Biosciences, which is an independent company, where Cytovia is a significant but non-controlling shareholder.
Well, thank you. The next question is, as you're adopting a business model for NAYA, similar to that of Roivant, symbol on that one is ROIV, and it has gotten much acclaim as it's been able to build great value and wealth for its shareholders. Does this address the challenges faced by biotech and volatile financial markets, or how do you see this, and why are you going down with this model?
Sure. I mean, every company has, you know, their own corporate culture and strategy, but the business model of Roivant and other, you know, similar companies, I think it's quite attractive in the current environment. The, you know, medical technology is advancing and is extremely fast pace, which, you know, means that the life cycle of products is very fast, is very, very, very short. And, you know, products that seem to be like, you know, first in class, by the time they get into phase III, you know, often are not the lead product anymore. So it requires to be extremely agile.
Also, pharma companies are increasingly selective, so they have many products on the shelf that are attractive to smaller companies, and others and ourselves are interested in acquiring those products. That's also the case of, you know, smaller biopharma companies that don't have the resources to advance their pipeline. So we are focused on potentially very high growth opportunities that are undervalued and can be acquired at favorable terms. We focus on, you know, disruptive opportunities. And clearly, whether it's, you know, oncology or regenerative medicine, there's a lot of disruption with cell and gene therapy and other technologies. And as far as, you know, fertility, which we'll talk in a few minutes, we'll talk more about it.
You know, fertility is a very high growth opportunity and, you know, there's a lot of demand that exceeds, you know, what's available today.
Got it. I think just last week, if I'm not mistaken, I think on the same day that you announced your. the combination of the merger with INVO, Roche announced that they had acquired Telavant, which is OrbiMed co-subsidiary for $7.1 billion. So obviously another stake that they've made, a successful move that they've made, and hopefully, you know, we'll see the same thing out of NAYA, as you-
John, this is an asset that they acquired, I think in the last couple years. You know, this is the business model that we may have for NAYA Oncology, where we have, you know, milestones, clinical milestones in the next two years. One of the options for NAYA Oncology will be to partner or divest one or both of the assets to a larger pharma company for phase II, III development.
Got it. I guess taking a step back and moving towards the merger with INVO. Next question, it says, Were you interested in the NASDAQ listing only, or did you see growth potential in the INVO business that exists today?
John, I think that initially we were interested in the NASDAQ listing, but very quickly we assessed the fertility opportunity, and we now are looking at the fertility business as being, you know, one of our primary focus going forward. I mean, again, if you're looking at supply versus demand in in vitro fertilization and in a new approach that INVO is pioneering, which is intravaginal, the intravaginal approach to fertilization. You've seen a growth of 78% since 2015 in the number of assisted reproductive technology cycles, that's those are CDC numbers. That's just in the U.S. The numbers are significantly larger, you know, worldwide.
You know, some people are suggesting that the demand just in the U.S. may be up to 1.5 million, you know, cycles. There's too few clinics and too few physicians to answer that demand. So there's a great opportunity for the companies in that field, and there's a great opportunity for INVO and for NAYA Biosciences.
I would agree. Following up with the, there's quite a number of questions around the part of the announcement that you made during the merger. It says there's an estimated $5 million or more in interim private financing INVO and a private operating by a combined company at a target price of $5. Can you, can you speak to that and the valuations?
Sure. I mean, you know, INVO is a great company. It's undervalued, and it has had, you know, some challenges in maintaining its listing. So we want to deal with it proactively and, you know, make sure that we maintain the NASDAQ listing. So that's why we've, you know, volunteered to invest $5 million in INVO in the very short term, even before the transaction closed. You know, as you said, we announced a definitive agreement on October twenty-third. This requires clearance by shareholders, of course, but also by the Securities and Exchange Commission. That typically takes two to three months, so we anticipate a closing in January, February timeframe.
We wanna make sure that the Nasdaq listing is maintained, and that we have enough time to not only get SEC clearance, but capitalize NAYA Biosciences to be successful in years to come.
Great. Thank you, Daniel. The next question is: What are your objectives for the oncology business? What milestones, and again, to follow up, what milestones should we expect over the next 12-24 months?
So NAYA has acquired two bispecific antibodies from Cytovia, which you can see here. You know, there's NY-303, which is for targets GPC3 for the treatment of hepatocellular carcinoma. This is a disease with 800,000 patients, you know, worldwide. The current standard of care, which is checkpoint inhibitors plus Avastin, is only a 28% response rate and less than seven months survival. So there's a great opportunity. We have very strong data that was presented at major oncology, you know, conferences. And our mechanism of action actually is very appropriate to the patients that are not responding to the Tecentriq Avastin, you know, standard of care. So we see there an opportunity that's probably north of $10 billion with NY-303 and other, you know, similar products.
We also see an opportunity to partner this product after, you know, phase I, II results, which we anticipate in 2025, and we've already have interest from major pharma company. Similarly, NY-338, which targets CD38. CD38 is the target of the monoclonal antibody Darzalex from Johnson & Johnson, which has reached $8 billion in worldwide sales in 2022. There are a number of patients that do not respond to this product, and bispecific antibodies, a position that next generation, best-in-class therapy for multiple myeloma. Again, the preclinical data is, you know, very strong and is supporting phase I, II clinical development, and there's interest from big pharma companies. We have support from some of the top clinical opinion leaders that you can see on the slide.
You know, Dr. Llovet from Mount Sinai for HCC, and Dr. Landgren, used to be at Memorial Sloan Kettering, is now at University of Miami, are some of the top opinion leaders in the world on those diseases.
Fantastic. Thank you. The next question is getting to your acquisition strategy. I guess, could you speak to that and beyond the current businesses that you have in play here?
So, you know, we're listing NAYA Regenerative Medicine, and we're not talking about in a specific, you know, program. We actually have two potential acquisitions, which we expect would take place post the closing of the merger with INVO, and they're in the field of regenerative medicine, and specifically, you know, they're clinical stage, they're cell and gene therapy, and they're aiming to restore biological function in, you know, patients with damaged tissues and organs. I mean, you can see in this picture, you know, the eye of an older patient, and so without disclosing too much, I can share that we have great interest in ophthalmology, where there's a substantial need for curative treatments, particularly for older patients.
That's great. Thank you. The next question is interesting, sort of look forward. What will you consider a success for NAYA in the next few years?
So, you know, maybe I would like to, you know, come back to fertility and to the growth, the growth opportunities. We see significant growth ahead for the, the fertility business. INVOcell is a, is a great, you know, product. You know, it is different from IVF, in, in that, the, the fertilization is happening in the, in, in the woman's body. So it keeps the woman at the center of the reproductive process. It's a significantly improved patient experience. It's also lower costs. It's between a third and half of the price of IVF. It's, it's been cleared recently by the FDA as having similar success rates, to IVF. So we see it as a great product, and, and you've seen the numbers of, of cycles.
So based on the number of cycles, you know, just the product INVO cell has potentials of, you know, for tens of millions of dollars in revenues in the US and more in internationally, maybe more than $100 million, just in the US. But beyond the product, you know, INVO has adopted the strategy, which we believe is very smart, of opening new INVO fertility centers, as well as acquiring existing fertility clinic. You know, INVO acquired last summer the Wisconsin Fertility Institute. This is a $5.4 million revenue clinic with EBITDA of $1.9 million.
There are up to 100 independent clinics in the U.S. which are interested in consolidation, and we intend to participate in this consolidation, along with some other, you know, very successful companies in the space, like US Fertility, CCRM or Kindbody. We also see great potential in the expansion of employer benefits and insurance coverage. You know, right now, you know, fertility is essentially a cash procedure, and there's less than 30% of the couples that are benefiting from either partial coverage from their employer or their insurance. Clearly, the INVOcell, you know, product, which is at least as good as the IVF, and significantly less expensive, you know, product and procedure, is very appropriate to expand the coverage.
And last but not least, and we've learned, you know, in recent weeks that the international market is actually very similar to the U.S. So, the expansion to Europe, Latin America, and Asia is definitely something that we're looking at. Maybe not as a first step. I think the first step in 2024 is it will be to consolidate the INVO Center to, you know, refine the INVO Center signature clinic model, and then to further expand internationally in 2025 and beyond. If we go back to the other businesses is, I talked about the potential acquisitions and cell and gene therapy for ophthalmology, you know, this is progressing.
Regarding oncology, we have two first-in-class products going into the clinic in 2024, with data in late 2024 and 2025, which will create opportunities for partnership with pharma, you know, companies. If you benchmark the partnership for similar products, they tend to be in the worth of $100 million in upfront payments and significantly more in future milestones and royalties. So we're looking at NAYA Biosciences as being strongly capitalized at the closing of the merger in January, February 2024, and having the resources to create value in 2024, 2025, through revenues, through profitable revenue generation and scaling, as well as partnership with other companies.
Thank you. Thank you, Daniel. Since we're getting right at the top of the hour here, wanted to thank everyone that came in to the webinar today. And ask you, Daniel, is there any parting sort of comments or thoughts that you'd like to leave with us? And please note that this video will be at the Tribe Public YouTube channel later today. And then we already have had expressed interest, and we have a planned event for November 9th, here in San Francisco, where Dr. Teper will be speaking to a group in the financial district around 1:00 P.M.
If anyone is on here that's interested, just ping me and I'll see if we can get you a seat there at this luncheon and CEO presentation event we'll have next week. Daniel, is there anything else you'd like to add here to close out?
Sure. I mean, I would say that, you know, in a very volatile health financial markets and including for healthcare and biotech, we believe that you need to be creative and agile, and that, you know, we and a few others have a business model that, you know, mitigates the risk because we have a combination of, you know, scalable, profitable revenues and you know, disruptive technologies and products that can lead to significant transactions in the next couple years. So, you know, we think that, you know, the business model is right for the current times. It, it's right, you know, for investors, you know, right now, it's not a binary business model.
But I think you can notice that beyond finances, we do deeply care about health and patients, and everything that we do has the potential to be, you know, game-changing for patients and their families. It's clearly the ability to have children for an increasing number of families is, you know, game changing for their life and, you know, women having babies later in life, often because of their careers. You know, this is a very important mission and we want to contribute to that.
So I think the combination in fertility, the combination of our experience in the medical field with our marketing and commercial experience and our experience with capital markets, can make the difference and make, you know, INVO as part of the NAYA Biosciences group, extremely successful. At the same time, you know, the oncology and regenerative medicine are addressing life situations. You know, as we talked about liver cancer, multiple myeloma, we're talking about, you know, eye disease and in older patients. So it's really an impact situation, and we're passionate about it. So which I would say is, you know, most important when you're considering, you know, investing in a company, is to know that, you know, impact on health and patient lives and their family is coming, you know, before, you know, financial return.
Financial return is a consequence of success. It doesn't precede bringing value to patients.
Thanks again, Dr. Teper, for joining us today and giving some insight into your plans at NAYA Biosciences and beyond. And again, remind everyone this video will be up if you'd like to view it. It'll be at the Tribe Public YouTube channel very soon. And do continue to express to the wish list if you'd like to see Dr. Teper in your city as we move forward, and/or back on a webinar later on as he advances his business plan. So again, thank you all for joining. Have a great and happy Halloween, and I wish you all well. Thanks a lot.
Thank you, John.