Pressure Biosciences

Good afternoon, ladies and gentlemen, and welcome to the Pressure Biosciences first quarter 2022 financial review and business update. At this time, all participants have been placed on a listen-only mode. If you have any questions or comments during the presentation, you may press star 1 on your phone to enter the question queue at any time. It is now my pleasure to turn the floor over to your host, Richard Schumacher, President and CEO of Pressure Biosciences. Sir, the floor is yours.

Thank you, Matthew, and welcome everybody to our First quarter of 2022, financial review and business update. Before we begin, as always, I'd like to read the following cautionary statement. The following remarks may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the company. to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among others, those detailed from time to time in the company's filings with the Securities and Exchange Commission. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in our expectations or any change in events, conditions, or circumstances on which such statements are based. So for today, for the first time in a while, I will not have a colleague with me. I'll be handling this myself, usually either John Hollister, who's our director of marketing and sales and does many other things. In addition to that, or Jeff Peterson, our board chairman, or both would join me on this call. But this call isn't on the day we expected it on several weeks ago. So neither was available today, so I'll be handling it just myself. For today's meeting, we're going to start with a brief discussion of the 2022 first quarter results, and I'll highlight some of the accomplishments thus far in 2022, followed by a general business update. Afterwards, I will certainly be pleased to take any and all questions. So on the financial review, in terms of the highlights of Q1 2022 versus Q1 2021, Total revenue for the quarter was $480,000, and these are all rounded, by the way, to the nearest hundredth, except, of course, the earnings per share at the end. The total revenue for Q1 2022 was $480,000 compared to $560,000 for Q1 last year, which is a decrease of 14%. Instrument sales were $246,000 compared to $319,000 for Q1, a decrease of 23%. I do apologize that Some people received the press release that had a mistake in it. It had the numbers slightly higher, but the actual decrease was about the same. So it wasn't material. It was 19% in the first one, 23% now. So instrument sales, again, were $246,000 compared to $319,000 for Q1 2021, which is a decrease of 23%. Consumable sales for Q1 were $40,000 compared to $102,000. For Q1 2021, that decrease was 61%. A lot of that, of course, had come from the fact that the previous year, the major pandemic year in 2020, we had very poor results and very especially poor in instrument sales and consumables because our customers are mainly in the lab and they were not in the lab during that year. So we had a catch up, a bit of a catch up, especially on consumables. in the first quarter of last year. The Barifold and UST services in Q1 were at 15,000 compared to 6,100. I'm looking forward to talking about that number in a few quarters from now. As we all know, we are starting to push Barifold, but most importantly, we started an early access program for UST services, and so that's a number that we anticipate will be quite different in several quarters from now and then quarters to come after that. The new PBI AgriChem subsidiary had initial sales in Q1 of 83,300 with no sales in Q1 of last year. So, although that number is a decent number, it's not anything close to what we had expected to have. So, we are disappointed that it's only $83,000 and still expect that that number to be significantly larger in quarters to come. The operating loss for the first quarter of 2022 was a million 86 compared to a million 75. So basically the same between the two quarters and the basic and diluted net loss per share was 48 cents for the first quarter this year versus a dollar 45 for last year. We of course have more shares outstanding, which brings that number down. So in terms of some of the operational technical highlights, We'll start with the most recent and go back, and we're going to talk about the highlights during the first quarter, but also over the last two months, April and half of May. So on May 4th, we announced the first nanomotions manufacturing agreement, which came underneath under the new UST Early Access Program. That Early Access Program was announced on April 27th. Those press releases are available, of course, on our website and in a lot of other places. And we can talk about those programs in a few minutes, but we're very excited that we were able to develop this program and very quickly sign up our first customer. And as we said in today's press release, we're in discussions with actually more than four others, but I just wanted to make sure that I put in there the number that we're actually in you know, really distinct discussions. And there's four companies that we've started talking to or have been talking to for quite some time that are interested in the early access program. There are many other potential customers that we have talked to and that we are getting back to, but we have a limited number of companies that we could actually bring into the early access program. So we want to make sure that we're bringing in those that make the most sense for us as a company as well as for them. So there's one that is signed up, and there's four others that we are in discussions with that are in deep discussions, and there are many others that we've had some discussions with. So again, it makes us very excited about what we think is going to happen to this company, especially because of the ultra-shear technology, nano-emulsion processing. capability. So on April 5th, we reported last year's fiscal year results, which were quite strong. The second best year we've ever had and had a lot of good news that we talked about on April 5th and at the conference call that followed. March 17th, we thought it was important to get out to all of our stakeholders, including, of course, all of our shareholders. our key 2022 goals. There were four in particular that we highlighted. The commercialization of the ultra-shear technology platform first and foremost was there. We expect a major revenue increase in the second half of 2022, probably at this point looking at mostly the fourth quarter, but it's going to be coming from the early access program that we've just talked about. We've clearly improved our financial position over the last couple of years. We still have a lot of debt. We actually have more debt than we had several years ago, but there is good debt and there's not good debt. And we had a lot of not so good debt on the balance sheet several years ago. We have debt on the balance sheet now, but for the most part, it's all good debt. It's from True investors, it's from people that are going to work with us. I've mentioned before, I'll mention again, that in talking to the individuals that hold these notes, about $20 million in notes, about 85 to 90% of the notes, the holders have said they would convert at the 250 price when we do our up list. So I ask when I talk to people, I point that out all the time that, yes, there's a lot of debt on the balance sheet, but that debt is with about 35 to 40 different lenders and one major lender and some somewhat major and then a lot of other lenders that are in the 50 to $250,000 range. And we've spoken with them all. We keep in touch with them all. And the vast majority, the vast majority, 85% to 90% of the notes, the investors have said they would convert on an up list. So that would mean that would leave very little to pay off or to work off somehow, which put us in a great position to find a good bank that understands that the vast majority of any money that might be raised prior to or during an up list depending on what we decide, would not have to go to payoff debt because the vast majority would convert. And we expect an up list to a national market. We need to do it at the right time. We're thinking that right time could be between now and the end of the year or now and the beginning of next year. But we certainly see ourselves as a listed company on a national exchange sometime over the next, you know, three to 12 months, hopefully sooner than later. So, on February 28th, we announced that and also around the same time Ohio State announced that there was the first successful commissioning of our production scale Barrow Shear USD Max system. This is the very largest of our three systems. To remind everybody, we have a benchtop system that we call the mini. And this is mainly for formulations. It can be used for by groups that have small amounts that need to be processed. but for the most part, the mini is there for formulations. If one is developing a product, and that product is going to have an active ingredient in oil, and you need to nano-emulsify that, I think there's one thing that there's not much in this world that you get a lot of consensus on, a lot of agreement on, but one thing that I hear out there a lot is that everybody basically understands and agrees that that the best way to present a product that has oil and water mixture and emulsion, that oil contains an active ingredient. It can be a pharmaceutical, a nutraceutical. It can be cosmetic. It could be agrochemical. It can be industrial. That the best way to do that hands down is to convert that oil and water into a nano emulsion. Almost all emulsions out there now are much larger than nano. Some people call them macro. Some people call them micro. There isn't even a lot of agreement on what nano means. Is it 300 nanometers or smaller? Is it 200 or smaller or 100 or smaller? 100 or smaller means it's smaller than a bacteria, than a bacterium. We believe that a true nano is under 100 nanometers. And so when we say we can get a very stable, long-term stable, highly water-soluble, and therefore expected to be highly bioavailable nanoemulsion, we're talking about emulsions where the oil droplets are below 100 nanometers. Our system can let us go to just about where we want it to go to. We can essentially dial it in. by knowing how many times it gets passed through our system in this very powerful patented valve that our guys have developed. And this system can reduce it to 500 nanometers, to 300, to 100. And knowing what it is and having done a trial and error on it, we can probably come within a reasonable amount of saying, okay, we're going to get to 200 nanometers or 100 or 80 or 50. I will remind everybody that smaller is not always better. I've had too many phone calls by, well, how low can you go? You get to a level of diminishing returns where you as a producer are spending a lot of time and money getting from some number, maybe 100 or 80 or 120 or 50 down to 20. Can we do that? Yes. We believe in most cases we can do that. Is it necessary? In most cases, it probably is not necessary. It's probably necessary to get down close to 100, but the difference between an 80 and a 40 nanometer may not be worth the extra cost and time and money to get there at all. You don't get much benefit from that. But that can be determined by the customer and the product that they're using. So we... installed our largest machine. So I just talked about the mini. We have a K45, which is the middle of the road, which we think will be the workhorse. And then we have a very large machine, the one that we installed in Ohio State. This is the one that could scale way up there and could be used by someone that perhaps wanted to put in, you know, enhance a soft drink or something and put it in millions and millions and tens or hundreds of millions of bottles in a year. So our max system is for very large amounts. Our K45 is probably the workhorse for will fit for most. And then the mini will help some smaller manufacturers that insist on doing it in-house, but they don't need a larger system. But it's mainly meant for formulation. One size doesn't fit all. You can't just say because I'm going to put CBD into this soft drink or I'm going to put astaxanthin into this cookie or whatever it's going to be that you come up with one formulation and you use it for all. That's not going to work. We have developed a very high expertise in formulation. There's a lot of things that come in that get involved when you're formulating. We've developed that. We were not formulators several years ago, but now we are. We have a great group in our formulation lab. And this instrument, the MINI, is the one that can be used because it doesn't require a lot of material up front. And you can generate, you know, milliliters of some, enough to test, enough to know that you need to go higher, lower, change the pH, add different materials to it in different concentrations, but not have to use very large amounts in that. So, the MINI has a great use down the road. The K45 will be the workhorse and the MAX. when we introduce someone to the MAX and they take the MAX and they're going to do a very large amount of nano emulsification. So very happy that our partners, Ohio State University, they have a College of Food and Environmental Science and Agriculture. They are experts in using high pressure. Dr. Bala, who's a full professor in the college there at Ohio State, is a colleague of Dr. Ting who runs our engineering. They both are pioneers along with the U.S. Army in bringing high pressure into the food and beverage industry. I'm talking 25, 30 years ago when this idea first was hatched by the Army, and they sought the experts, and two of the experts were Dr. Bala, who happened to be at Ohio State, and Dr. Ting, who was at a company called Flow. And they worked with the Army, and they developed the first process of high pressure that was being used to – to treat food and make it safer and not lose the nutritious value of the food because heat, anything that's thermal can cause a major problem with anything that contains proteins like food. So you try to keep away from heat and pressure can do many of the things that heat can do, but you can control the heat, keep it minimal, and once you take the pressure off, it's off when you take the heat off of something, it still is hot and it takes a while. It might take two minutes or it might take 20 minutes to get it back to equilibrium. So pressure has a lot of advantages. Two of the experts in that field, Dr. Bala and Dr. Ting, are with us. Dr. Ting's full-time employee is one of the, I'd call him a co-founder. He was one of the first hires I made, along with Dr. Lazaroff, who's our chief science officer, and Dr. Lawrence, who's now retired. living the life of retired scientists but but still consults for us the three of them all came in in the year of 2006 and these guys are experts in in proteomics and experts in high pressure and as I said at this point the high pressure market is I last I saw was about estimated we have 14 or 15 billion dollars in in just high pressure. This is not ultra-shear technology. This is not adding shearing to high pressure. This is high pressure alone, which is a wonderful technology, but it has limitations. This is a $14 or $15 billion market worldwide. And the ultra-shear technology, we think, can do some things that I believe, personally, that a lot of users of high-pressure processing, HPP, would love to have but they can't get it because they don't have shearing as part of the process. So we're bringing a whole new process to bear here where we've combined high pressure, now well accepted by the government and by the food and beverage industry, by many people. We've combined it with very high intense shearing and we're making one plus one sometimes equal 20. So we announced that on February 28th at Ohio state, we, we saw a video the other yesterday, uh, they're going to be presenting at a meeting coming up, a food technology meeting coming up. Uh, they're going to be talking about data they've been generating with, with ultra sheer using the UST max system that was installed there in January and announced in February. They've been generating some incredible data. We're very happy with it. This is part of the deal we got when we took a million dollars from the U S department of agriculture. and got a piece of that and Ohio State got the other piece to develop UltraShear is that we need to generate certain data and present it at meetings like the International Food Technology meeting. And so very, very happy that we are a partner with Ohio State. We actually formed a consortium where we and they are together and at some point in the near future, perhaps in the coming weeks, Ohio State is going to be inviting food and beverage companies from all over the world to start coming in and visiting and to see UST and maybe even try UST for themselves. January 27th is when we actually installed the Bereshear instrument at Ohio State. It was installed in their world-acclaimed Advanced Food Processing Technology Pilot Plant. They have a 40 or 50,000 square foot facility where companies from all over the world come in and bring the next generation of equipment. We're in that now, and we're looking forward to the opening and the invite to some amazing companies to come in and take a look. So those were the major advantages. I do want to highlights of the year so far. I do want to go back to the early access program. And after that, we'll open it up for questions. The early access program came about because we had several companies who were chomping at the bit to try to get access to ultra-shear technology to use it. We've had a number of companies come to us multiple applications certainly CBD is is one of the major applications it's it's extremely well known that that CBD as it is now and put into into food into beverages into other into gauze and and and and creams and things if it's not a nano emulsion The bioavailability, the ability of the body to use the CBD inside that oil is very low. CDC, not the CDC, the World Health Organization published three or four years ago, they estimated only six percent of CBD was actually used. The rest of it was excreted. Remember, we as human beings and our pets, everybody is taking CBD, for instance, in this case. We're water-based and when we ingest something with oil, our body wants to excrete the oil pretty quickly. If there's an active ingredient in the oil, the body is trying to extract out of that oil the active ingredient while the body is trying to extract out of the body the oil. So there's a battle going on there. And if you have globs of oil with active ingredient, you're not going to get very much of that active ingredient. However, If you break that oil into billions of nano-sized droplets of oil and spread the active ingredient among all of these billions of tiny nano-sized droplets, these droplets are so small that a light will go through and doesn't get blocked, so they become clear. That's a good sign of a nano-emulsion. It comes from cloudy to clear. And another sign is that stability. We're up to over two years of stability. We've shown people our receipts. CBD product, and this CBD product has been stable for over two years, and it looks exactly like what it looked like two years ago. So it's amazing. We've done some testing on the size of the oil droplets. They've remained very consistently around 40 to 50 nanometers in this case, and so we're very, very happy and excited about The data generated so far on CBD, we're generating also generating data on astaxanthin, which is considered by many to be the world's most potent antioxidant. We've generated data on that. We've generated data on other active ingredients on prednisone as a pharmaceutical and retinol as a compound that's used in the cosmetics area. And we've had terrific results across the board. So with the push from several companies saying, can't we get an early access? Can't you do it sort of like a beta? And you can learn from it and we can learn from it. We decided just a month ago, not even a month ago, that we would. And we've signed one contract. We're talking to four others. I believe that we will sign additional contracts in the coming weeks and months and that these will generate revenue substantial revenue in the fourth quarter and for next year, 2023. So, Matthew, I'm going to open it up now for any questions, if there are any, from our guests. Certainly.

Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We do ask that while posing your question, please pick up your handset, if you're listening on speakerphone, to provide optimum sound quality. Once again, if you have any questions or comments, please press star 1 on your phone. Please hold while you poll for questions. Your first question is coming from George Markleson. Your line is live. Hey, Rick.