Hello, and welcome to Virtual Investor Conferences. On behalf of OTC Markets, we are very pleased you've joined us for our hybrid global markets forum. The next presentation is from Phio Pharmaceuticals. Please note you may submit questions for the presenter at any time. You can also view a company's availability for one-on-one meetings by clicking Book a Meeting. At this point, I am very pleased to welcome Robert Bitterman, President and Chief Executive Officer of Phio Pharmaceuticals, which trades on NASDAQ under the symbol PHIO. Welcome back, Robert. Thank you very much. Good morning, everybody, and thank you for tuning in to the Phio story today. Phio is an immuno-oncology company that is specializing in the treatment of certain types of skin cancers. In fact, our goal is to change the treatment paradigm in terms of how certain skin cancer is treated. We do this through enhancing our body's immune cell function and enable it to basically improve and kill solid tumors in the body. We do this through our technology of delivering RNA platform. It is called INTASYL. INTASYL is a short interfering RNA that has the ability to make our immune cells more effective in killing cancer cells. With a quick look at our forward-looking statements, let me introduce you to the disease called cutaneous squamous cell carcinoma and the opportunity that presents itself with this. The incidence of solid tumors in the human body is significant. There are over 7 million of them. In that, 25% of all solid tumors across all organs represent cutaneous squamous cell carcinoma. It represents about 1.8 million incidents overall annually, and it is a very complicated disease, but one that needs to be carefully addressed. One of the reasons is that it is increasing due to aging population. It is also known to be caused by excessive UV exposure and the weakened immunity of a body after patients get older, as this typically affects patients who are beyond 60 years of age and above. It is a recurring condition, and it is also progressive. If you get one, you are going to get another, and if left untreated, it can lead to death. In fact, what many people don't understand is that the mortality rate for cutaneous squamous cell carcinoma is almost double that of melanoma. The current treatment paradigm is surgical intervention. That is standard of care. But surgical intervention does have its complications that are associated with location, with the size of the tumor, and with the patient's overall health. Patients that have certain comorbidities, like a particular disease state, such as diabetes, or patients who have interactions with certain types of drugs, immune status, patients who might be affected by drugs that are immunosuppressive, such as inhaled steroids or products that basically are blood thinners that can cause excessive bleeding. All of those can ultimately lead to an outcome which is less than desirable, to promote faster healing and recovery time, to minimize disfigurement, which can come in the form of hypopigmentation or even scarring. Actually, to eliminate the functionality of certain digits on the body. Also, to decrease the need for reconstructive surgery and maybe even to reduce the surgical frequency as well. The opportunity in the neoadjuvant market for cutaneous squamous cell carcinoma rests with those lesions which are considered high risk. These are lesions that typically are in excess of 2 cm in dimension and also are in high-risk areas of the body, such as the head or the neck, the feet, the hand, and the pretibial, which is the lower leg. There is about 1.1 million of those incidences of the 1.8 million total. We believe that the opportunity, the addressable market, if you will, for this, in terms of a neoadjuvant treatment, could range somewhere between $2 billion-$3 billion. Our enthusiasm for this is really based on the results of the conclusion of our first phase I-B clinical trial. This took place over the course of a couple of years and concluded earlier in 2006. What I would like to point out here is that in the administration of four injections of drug over three weeks, and this was done over five escalating cohorts of the drug concentration. In the final cohort, we had an 85% response rate, and by that I mean there were seven patients in that cohort. Six of them responded. Four of those six had 100% pathologic clearance of the cancer in the tissue. One had greater than 90%, and one other had greater than 50%. Across all cohorts, the overall response rate was 65%. What this has done is it has actually led us to what will be our dose selection for the next phase II-B study, which will be coming up shortly. The other factor that was important in this, across those five escalating doses, which increased the dose 20-fold over that duration, there were no immune or dose-limiting toxicities in any of the patients. There was also no recurrence seen at the end of day 13. What this means is that we do have a very favorable safety and tolerability profile, which makes this a very attractive drug for moving forward into the next study with the FDA. A couple of other factors that make this particular concentration, or this particular therapy and treatment interesting is that it can be administered directly in the physician's office. With that, it avoids the logistics of systemic infusion centers, which are often used for monoclonal antibodies for the same purpose. It also minimizes the post-surgical recovery because we are successfully shrinking, if not eliminating the tumor before surgery. As a matter of convenience for the physician, the drug is refrigeration stable for two years, and it also has the ability to accommodate flexible dosing because not all lesions are the same size, and they require a different amount of drug. There are a number of patient factors and physician factors relative to convenience. There are also some interesting economic factors associated with the therapy as well, because visits to the physician by the patient drive physician practice economics. Doctors get paid for the number of patients that they see and the number of procedures that they perform. Also, unlike certain other types of therapies, there is no capital outlay required by the physician for this. Radiation therapy, for example, is a significant investment in capital, and it is also a very space-consuming piece of equipment. This is very simple. The injection basically takes one to two minutes, and the physician is finished, and the patient can be done. The other factor, and I think that is important to note in this too, is that in the production of the product, our active pharmaceutical ingredient, which is referred to as drug substance, is manufactured in a facility in the United States, as well as our finished drug product, that which is actually injected into the patient. That is also produced in the United States. This eliminates any of the risks associated with variability in tariffs that periodically come up in our economy. With that as a background on the disease and where we believe the opportunity rests, I would like to talk to you about the mechanism of action when it comes to this particular technology called INTASYL. Essentially, INTASYL is a technology designed to selectively block or turn off a signal from a designated gene. Our body's DNA is continuously giving instructions to RNA to do and perform certain things, basically upregulating proteins, downregulating proteins. In the process, when we are dealing with cutaneous squamous cell carcinoma, the presence of a certain protein created by a particular gene will cause our immune cells to become inert, to become ineffective. What we do is we have the ability to selectively identify that one gene that produces that particular protein, it is called PD-1, and turn off that signal so that the production of protein ceases, not permanently, just temporarily. As that happens, the body's immune cells suddenly reawaken, reactivate, and go after and attacking the foreign invader, which is the tumor. This makes our immune cells much more effective in killing the cancer cells. I would like to show you just a really brief illustration here, and if you bear with me and follow this from the upper left-hand corner of the graph or the picture. There you see the injection of the drug into the beige tumor. The drug is specifically programmed precisely to go into the T cell where the PD-1 protein is being produced. It basically turns it off in a matter of hours, and after that happens, the T cell awakens. It goes after and attacks the tumor cell, which you see at the lower center of the page. Not the tumor, but the tumor cell. Then once the T cell is reawakened, it also creates a dissemination of something called interferon gamma. This is a cytokine which does two things. This further attacks other tumor tissue, and at the same time, it attracts more and various kinds of T cells that become very effective in also killing the tumors. So that is really the picture and the mechanism of how this works. What does it look like? Well, we will not spend too much time on this, but technically, if you are a scientist, you can recognize this as an asymmetric duplex consisting of synthetic fragments of RNA. This configuration really has three very important characteristics. One which I basically already touched upon, which is exceptional gene targeting. The second is the ability to deliver the drug across that cell membrane. You saw the drug being injected in the prior slide. It gets it through there intact through endocytosis, and it can go to any cellular tissue, but is programmed to basically shut down that particular PD-1 protein. The drug also has a stability factor that allows it to do its job without basically losing its stability in the process. This is basis for why it works, and it's also the basis for a very broad patent portfolio. 54 patents have been issued, extending out to 2044, and the patents cover not only the core technology, but we patented sequences in the genes to shut down. We've developed compounds from the material, and also we've established methods of use. We've also, in the future, patented combinations of our technology with monoclonal antibodies as well. It's a very broad and extensive patent portfolio. I think the real question now becomes, what makes this so special in attacking the various tumors? The real answer to this is it attacks this problem at its source. It goes right into the tumor and shuts down the culprit, which is the PD-1 protein, before it migrates to the tumor cell surface. By doing this locally in the tumor, it reduces the risk of various toxicities and complications. Some of you are familiar with monoclonal antibodies. They're systemically infused throughout the entire body. When that happens, there is a number of different autoimmune side effects of a serious nature which can occur and create other complications for the patient. These are essentially mitigated with the use of INTASYL because it's only going directly to the tumor. It shuts it off at the source, just like you might be turning off a faucet if you have a leaky faucet. You just turn it off and the leak stops. Therefore, the PD-1 never actually gets to the surface of the tumor because its issue with shutting the T cells down. Today, we actually have two programs that are in our internal development. I've just described to you the PH-762, which silences the PD-1, and that has completed the phase I-B clinical trial. We're in the process now of preparing the protocol and the package for the phase II-B trial, which will start sometime in the first quarter of next year. We also have one other silencing INTASYL product, which shuts down a different gene, BRD4. We won't have time to get into that one today, but BRD4 is a gene which actually affects a number of different types of cancers as well. This is pre-IND. It's close to being IND ready, and we will ultimately start to move forward on that program once we get the PD-1 silencer, that being PH-762, actually in the phase II-B clinic. But it doesn't stop there because our scientists have also, over time, have been able to silence and patent the silencing of a number of other genes as well. These include factors that impact solid tumors. They impact hematologic cancers. Even they affect different types of infectious diseases. These activities are certainly well beyond the bandwidth of our particular organization today, but they can be of very much interest to other companies who are interested in these particular gene silencing processes to address other types of cancers that may be of interest. We look to identify strategic partners for these people or these genes with the hope of getting non-dilutive financing and consideration for the access to these types of materials as well. At this point, I'd like to talk to you a little bit about some specifics with regard to the Phio profile. From the standpoint of metrics, currently we have a cash runway that takes us into the second half of next year. With that, there's also ATM capacity of $6.3 million. We also have exercisable common stock warrants of a vanilla variety. They're a fixed conversion price at $2.05. There's no other entanglements associated with. They're just straight warrants. We have 12 million common shares outstanding and about 13 million fixed warrants associated with that potential cash value. We have no debt. We have research that's covered by H.C. Wainwright. Our organization is essentially virtual. We have seven full-time employees, and we have a handful of contracted subject matter experts who work with us on a part-time basis. These are individuals that we have worked with in our prior companies for a number of years, and they're very effective at helping us to move along the process. We use them when we need them, and when we don't, they don't carry us in overhead. Essentially, the message here is that with a very lean infrastructure, our funding is being directed essentially to the development programs as well as to continuing to enhance our patent portfolio. I'd like to talk to you about next steps. At this point, the most important thing really is to complete the clinical design for the next study, which we're in the process of doing now, and expect to have that clinical study in place before the end of the first quarter of next year. We're continuing to answer questions from FDA on an extensive briefing package that we submitted to them about a month ago. Additionally, I'm happy to announce that we have completed commercial scale production of our active pharmaceutical ingredient. That was an extensive 16-month exercise that included the collective work and efforts of scientists and chemists over multi-steps in a process to bring us to a robust CMC package for this active ingredient, which makes this now viable and acceptable for any types of registration studies or commercialization. That was a major accomplishment that happened about a couple of weeks ago. With that completed, that material is being shipped to our drug product manufacturer, which will start to make clinical supplies that will support the study in the first quarter next year. Also this year, we also did a longer-term nonclinical toxicology study. The treatment phase is completed. That's also important to support future clinical trials if the client trial is going to extend beyond four weeks. Here is the senior leadership team with our CFO, our head of regulatory corporate affairs, and our vice president of program management as well as strategic planning. This brings us to my conclusion, which is having now established safety and efficacy in a phase I-B trial with some rather not surprising but promising results in that first study. Given the size of the target market that we are addressing, the competitive landscape, the extensive intellectual property that I showed you, and the lean management structure, we think really that we are very strategically positioned right now to create value for you, the shareholder. In the process of continuing to make our immune cells more effective in killing tumor cells, we think that clearly, the best days of this company are lying ahead of it in very short order. With that, I would like to conclude and be open to answering any of the questions that you might have. I will turn this over to the moderator, who will basically feed the questions, and I will respond to them. Thank you for your attention thus far. Thank you, Bob. The first question from the audience is, "For those of us newer to Phio, what would you say is the most encouraging takeaway from those 22 patients in the phase I-B trial? I think that there are two things that really are important to come in tandem with each other. Obviously, everyone gets very excited about efficacy results when you are looking at response rates in the range of 85%. When you are looking at efficacy being defined as complete and total pathologic clearance, that is great. But in reality, if you do not have safety that goes along with that, it is problematic. In our case, we are very fortunate in the way that the study turned out that we could not find a toxic dose, even though we increased it 20-fold. Those are the two most important things I think that drive the future of this program, efficacy and safety. But they have to be looked at in combination. Both are important. Thank you, Bob. The next question is, "Your deck puts the addressable market at $2.2 billion- $3.3 billion. What is the strongest initial opportunity for Phio? Well, the opportunity rests in being complementary as a neoadjuvant to derm surgery. In that, as I mentioned, derm surgery is effective. Many of the surgeries are referred to as Mohs surgery. With high-risk lesions, they create complications, as I described, due to comorbidities, the size of the lesion, the placement of the lesion. Most dermatologists realize that. While they do not want a substitute for their derm surgery, they are looking for a complement, one that can basically, in effect, make their job less stressful, easier, so as to minimize less than desirable outcomes after the surgical procedure takes place. So our opportunity, realistically, is to make sure that the dermatologists understand the opportunity that we are bringing to them, not to replace what they are doing, but to complement them. We have found in discussions, and we have had many discussions in the last several months as we have done qualitative research with these physicians, we have learned that they actually view this as an excellent advancement. It will not be too long before there will be some published data going out, which I cannot give you the specifics on, but I know it is happening because we have been working with the authors that will speak to this fact. That is really the opportunity. Then the question will be, how many of these doctors are going to use this in combination with therapy? I have given you what I think is the addressable market. We are at this point not ready to actually throw out a market share in that addressable market. You can do the arithmetic and basically make your own judgments on that. I think it is a bit premature to get into those numbers yet, but the numbers would be very large any way you cut it, whether it is a modest share or a big share. Thank you, Bob. Next question. You have projected funding into the second half of 2027. Which milestones could that runway support? There's a few of them. The biggest would probably be the actual commencement of the clinical trial, in the first quarter. There are others as well that become major milestones in the process. Selection of a CRO to go forward with that. There can be the recognition of several publications in quality journals that will lend further credibility to the technology. There's also other activities associated with the overall drug development process. For example, the conclusion of the successful commercial scale CMC activity for the active pharmaceutical ingredient. So those are a handful. There's probably a few others that will come along in the process. I would cite those for starters as triggers or catalysts to move the ball forward. And of course, if we have the good fortune to connect with a potential licensing partner, certainly I'm sure that that would be a major catalyst as well. Thank you, Bob. The next question is, an 85% pathological response in the highest dose cohort is encouraging. What stood out most to you and your team about the clinical study results? Well, what stood out? If I could rephrase the question a little, what fascinated us in the study, just to give you a perspective of the breadth of this, we were talking about different tumors at different parts of the body. I think there were seven different body locations where the tumors were found. They were of different sizes, ranging anywhere from 1 cm to about 2.9 cm. And there were five different doses and concentrations of drug. When you start to analyze all those variables, which actually the FDA wants us to do. Some people had questioned why did it take so long to ultimately get to where we are? Start to figure the permutations of 22 patients, five doses, seven different types of placements on the body, and you start to look at all the analysis and comparisons. I think the one thing that was interesting and consistent is that there was a modest dose response. The safety features didn't matter whether it was a low dose or a high dose. That was a pleasant surprise to us. But that across the board, there did seem to be a good response. We also followed up with at least one of the physicians who commented to me that the patients that he had treated felt that they were really excited to be a part of what they considered to be groundbreaking or cutting-edge technology and participating in the process. To which I can say, off the record, that the physician said that none of the patients I've seen have had a recurrence either. Overall, I think this was a challenge because this was the first time this drug had been put in man in the United States, and these patients were subjected to at least 24 different blood draws over the course of four injections over three weeks, and then a follow-up resection at week five. But what we've learned from this, and I think this is important, as we examine the results of the study very carefully, cohort by cohort, time frame by time frame in terms of week by week, that we've now learned how we can design the next trial more effectively, and hopefully, we're going to get better results out of the next trial based on what we've learned in the first one. Thank you, Bob. Next question. How can Dr. Plott's dermatology and FDA advisory experience help you advance PH-762? He's been around for many, many years. He actually was my medical director in a former company back in like 1997. So I've known him on and off for decades now. But his experience in practice, in his own practice, in corporate world, both private and public, he's been very helpful in actually giving us some guidance and a perspective on how to design this next trial, which we've basically captured a lot of his advice and incorporated that into the next study. Thank you, Bob. One last question. What makes INTASYL's self-delivering chemistry difficult for competitors to replicate? Well, for starters, there's 54 patents that are floating around, so I'm sure that somebody could reverse engineer it, but they're going to have a difficult time doing that legally. The sequencing of the nucleotides or the fragments of RNA, it's a complicated process. Even if they can do that, they're going to have to be able to figure out how to manufacture the drug product, or I'm sorry, the drug substance, which is something that took us 16 months with the best of minds from both an engineering and a chemistry perspective, to compile and put together to satisfy all of the requirements that are needed to basically create a robust package for FDA. I think that's really the hard part, because most people who look at pharma companies, they don't understand that sometimes actually executing the clinical trial is a lot easier than basically ticking and tying and wrapping up the CMC section at a point where the precision and the validation is just such a critically important part of it, and it doesn't get a lot of visibility. It's likened to a lineman on a football team that's doing the blocking, and the running back gets all the credit. If it wasn't for the lineman, the running back could never get out of the backfield. I think that's something that people who are looking at investing in companies should understand, that that's an important part of the successful part of development in a drug. If you're just looking at clinical results, that's only half the story. Thank you, Bob. Now I'm going to turn this back to you for concluding remarks. Thank you. I would like to thank everybody for their attention. It is great to be able to address this group again. I would leave you with a couple of thoughts. The last couple of days, I have been down in sunny Florida, and this is really a haven for skin cancers. I would suggest that it is in your best interest, everyone, especially as you start to move up in years, to get a skin check from a dermatologist to make sure that if there is something that is suspicious that you see somewhere on your skin, don't ignore it, because some of these things can take off rather quickly. If you get it early, you are fine. If you let it go, you are going to have a lot of problems. I will just leave you with that piece of advice for your own sake. You owe it to yourself to get a skin check from a derm and stay healthy. With that, I will say thank you very much.