Randy Hubbell, Armis Biopharma - Decreasing Quantity and Severity of Inflections | LSI USA '24

Randy Hubbell  0:01  
Randy. Okay, hello everyone. I'm Randy Hubble. I am the executive advisor to the board of directors for armas biopharma. I'm going to tell you about the company just a little bit about myself. I recently took Carmel therapeutics public after a seven year journey from a research company I spent out of Carnegie Mellon, and in 2023 we went public. Before that, I had a chief commercial operating job with cardiba Medical that was acquired by humanetics 500 million. And then 13 years at J and J in three, three bigger roles of heading up their BioSurgery business and from the marketing perspective. And then the pain franchise, and I was the launch leader for cipher, the first drug eluting stent. So what we're addressing here with armas is the challenge associated with antimicrobial resistance. This is a very well documented global challenge. There's superbugs out there and pathogens that are not being able to be killed and cured with the standard methods, whether that's in the hospital setting or in personal settings and viruses and so forth. There is not a lot of technology out there that's being developed, and armas believes we have a unique capability to address these so we're a private company that is has six cleared or approved products with three near term in the pipeline. The core technology is called variox. Variox is a combination of parasitic acid and hydrogen peroxide. The company has over 14 patents and the ability to put these in different formulations for different markets. You can see up here we have the dental and clinical services, wound care, veterinarian, just as an example, the armregard product is just been launched. Mike Voss here, Mike waved everybody is our Chief Commercial Officer. He worked with me at J and J, and just been here two months, and has already signed up a partnership for armaguard. I'm gonna talk a little bit more about that. The The other big activity we have going on is we are doing a development project for the United States Military Department of Defense for decontamination using the same variox technology, chemical warfare, biologic warfare. You wipe it off and it keeps the soldier alive. So the this technology has been around in under research and development. Mike and I came in to commercialize it, so they've got these approvals, but they've never commercialized. And so this is an inflection point for the company, but it has been validated in many areas, over 40 independent tests, including animal studies, including two GLP studies with the Department of Defense, a third one's being done today. That's what the $20 million contract's about. The mechanism of action. This is a very simplistic view, but essentially what it does is it breaches that cell wall. It kills everything in it, but it doesn't create a toxic environment. So it's an extremely safe product, highly effective and extremely safe. If you're going to use it on your oral appliance, it better be safe, right? So this is not meant to go into detail about it, but if you break it up into bacteria, viruses, fungi, biologic warfare, chemical warfare, you'll see a lot of bad stuff on there, C diff, Anthrax, fentanyl, nerve agents, MRSA. These are all pathogens that are very bad and very hard to manage. And we have evidence and efficacy, evidence demonstrating the capability to kill all that. So it's a log kill of six. As an example, when you use Clorox or Lysol on your kitchen counter, that's a log kill of three. And it doesn't include all of these pathogens. This includes everything with a log kill of six, highly, highly, highly effective. So the chemical warfare opportunity is the variox decon. Variox decon is under development. Think of it like a pouch a soldier would have in their uniform. You rip it open, you bring out a sheet, and you wipe yourself down, if you can look on this previous slide, bottom right here, you can see that in the testing with sulfur mustard gas and nerve agents, dramatic over 85 to 90% reduction in the amount of chemicals that's going to save the patient, that's going to save the soldier. So what we're doing now is we have a submission that we're getting ready to send to the FDA, and we have kind of like a fast track, because it's related to the military for variox decon on skin. So this is skin decontamination, what the military currently uses there is a product called rsdl. It's a legacy product. It's incumbent and it's essentially a grease that. That this soldier would rub on himself. So you can just imagine how difficult that is to apply, and then how difficult that is to get off. So tremendous benefit on ease of use, and that's our goal is to be the supplier to the militaries around the world for this technology. But in addition to that, the second animal study that we did, that the government did on our technology, comparing it to rsdl, we had a 2x benefit over what they did. So we got efficacy benefit, ease of use benefit, and the third big benefit is we're currently studying decontamination of wounds. So battlefield wound, right now, there is no solution. Rsdl won't work on a battlefield wound. We're testing variox technology in a GLP $20 million contract with the DoD now to test it in wounds. If it's successful in wounds, we'll expand the label from skin to skin and wounds, and that will then be, I would say, a transformational technology. It will be truly differentiated from what they're using. We also have a non dilutive grant with the NIH, and we have applied for other grants. So Mike and I are learning a lot about the military process, the DoD process. We're at a TLR six, okay, on a scale of one to nine, which basically means we need to start thinking about scaling up, because the government doesn't want to support innovation that can't be scaled up, and so we're applying for manufacturing grants as well. So we still have a hope that we'll have additional non dilutive funding coming our way. So where are we as a company? So we have armregard, which is for dental so that that technology. Think about retainers, Sleep Apnea devices, anything that goes in your mouth, dentures, mouth guards. If you have kids playing sports and they don't like their mouth guard because it's all nasty and smelly, spray it on, wait three minutes, rinse it off, bright and clean and no odor. So it's going to drive compliance, and that's a big deal. So that's armaguard. The Arma cleanse is the topical cleaner we're coming out with a much more powerful one called Arma cleanse Pro. And then we have armavet. This is for horses, dogs, cats. That is has hot, hot spots, rashes, cut sores. It cures that. So that that is available. Today, we're selling that, and then the varicent variance into wound care, wash. Okay, so the both for lavage as well as we're going to expand the label to include negative pressure wound therapy. So all these products are ready to go. Mike is putting a plan in place to launch them. The one that's furthest along is armaguard. We signed an agreement with vivos. Vivos is a publicly traded company that recently got a approval from the FDA for a sleep apnea appliance that goes into mouth. They want to make sure that appliance stays clean, so they have included us on their store to the dentist and the orthodontics to be able to buy it and then resell it to the patients. And they're also going to include us in their kits when they ship it out. Mike's looking at other partnerships. This is the first one he's been able to get in the two months that he's been here. We do so we're going to do the GLP study and register the bariacy con. We'll launch it with skin, and hopefully launch it with skin and wound as with an expanded label. I'm on board here because I enjoy exits, and I want to try to drive this company to an exit, either through just the technology we have our roll up strategy, like we did at Carmel in three or four years or so. So historically, no commercialization with this company. A lot of money was spent over the number of years, perfecting the technology, getting them clear, getting the technology cleared. They've done that successfully. I'm here to do MNA, to maybe do a roll up strategy to out license in license, and then take it to an exit right now, what we have available is a three and a half million dollars remaining on the convertible debt, and then I'm targeting 2025 for a Series C preferred equity round, where all the debt would then convert to equity. And in use that money, use of proceeds, is really to take what Mike does in 2024 and turbocharge it and really put the money behind the sales and marketing. Randd, we're not going to be spending a lot of money. We got grants for that, and so it's really going to be driving commercial. Thank you very much. Thank.