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Business as Usual: CytoAgents

Business as Usual

Get a front row seat today at noon with CytoAgents CEO Teresa Whalen as she discusses the company's clinical trials for GP1681 -- Treatment of COVID-19 Cytokine Storm. As the CEO of CytoAgents, Teresa leads a team of world-renowned clinical drug development experts and scientific advisory board members who are at the forefront of groundbreaking solutions to combat persistent and potentially deadly strains of Influenza, COVID19 and other viruses. CytoAgents is a clinical stage biotechnology company focused on the development of innovative pharmaceutical products for the treatment of COVID-19, Influenza and other viral infectious diseases. Using a novel, host-directed approach, CytoAgents targets the underlying cause of life-threatening symptoms associated with COVID-19, Influenza and Cytokine Releasing Syndrome by modulating the natural immune response to the disease. Discover how CytoAgents is committed to developing first-in-class, best-in-class products that meet a major medical need now and into the future.



So good afternoon, everyone. This is Audrey Russo thrilled to be here. I never know what day it is anymore. But Jonathan keeps me straight. I'm joined here by Jonathan kersting, Vice President of all things, media and marketing at the tech Council. And today's Thursday, right, Johnson.

Yes, all day long.

All day long. Okay, so we're pretty excited about today's guest, we're going to do a little bit of a deep dive on a topic that's probably near and dear to many of us. But we're gonna let Teresa Whalen sort of lead the way. I want to give thanks to Huntington bank, they have been amazing partners right from the onset. And they also are amazing partners, to businesses in the community, whether it's pandemic or not, you can count on them to be helpful. But leadership is heavily involved in the region's civic issues. And we are thrilled to partner with them. So we're on our date for 142. I think these guys are trying to keep track 142 businesses, usually with the intent of making sure that we're keeping the tech community connected, and making sure that everything that's happening in the community that we can continue to be connected. And that includes business development, to be cognizant about companies, and to understand where the gaps are, and also all the things that sort of set the table for the world that we're living in. Right now. Today is no different. We have muted your microphones just to be considerate, and we also have opportunities for chat. Jonathan is going to be paying attention to that so that we can have an opportunity to ask some questions of our guests. And with that note, I am very thrilled to just jump in and introduce Teresa Whalen. She is now the CEO of a Pittsburgh based company called psycho agents. And what we're going to do is just say, hey, Teresa, how are you? And who is Teresa a little bit about your journey that led you up to what you're doing today. So thank you for taking the time. I know you're very busy.

Thank you for having me. It's um, pleasure to be here. A little bit about myself. I am a pharmacist by background graduated right here from the University of Pittsburgh School of Pharmacy. And I spent some partially on my career. I did practice as a hospital pharmacists, but spent the vast majority in industry spanning multiple sectors across healthcare 10 years at Siemens medical and healthcare information. I spent some time at a robotics company. I developed and patented algorithm for this specially med medicine industry. And this is I'm also an investor in the next act fun and blue tree. And so this is really this is my second CEO position and I came to it through my contacts at Blue tree. So Katherine mod recruited me about two years ago to take oversight agents and here we are

left was it always called Seidel agents will come on.

Previously, it was called Gemma's pharma. And so blue tree was one of the majority shareholders in Gemma's and that's how we became aware of that and acquired the assets of this company and recapitalize the new for company and build brand new team.

So Katherine mock, just in full disclosure, she's a member of our board. And she's the founder of blue tree Angel. She's very active, excuse me, in the angel community, and she, as well uses her civic muscle to make sure that the innovation economy really thrives. So you're lucky and on both fronts as an investor, as a friend. He's an incredible supporter. Yeah.

Yeah. She's an incredible supporter of the company. She also sits on our board as blue tree as a lead investor.

So wait, so but here's the thing, let's just sort of backpedal a little bit. You know, you said you were pharmacists, you're an investor, you're an entrepreneur. You're an active angel investor. And now you're at the helm of another company. So how so how did you go like pharmacists, and sometimes entrepreneurs don't necessarily align into what you're doing right now. So what is it about you that didn't fit into any of these molds?

Yeah, I probably should have gone in medical school. I save I I knew I wanted to pursue you know, not that there's anything wrong with being a pharmacist. I love being a pharmacist. That Foundation has served me so well. But I think what I learned at Pitt, and that's carried me through my life is that you never stop learning. And they always said to us, we're here to teach you to think, and have problem solve. And I think that is really what's at the core of my spirit is looking at problems and coming up with solutions. And I like to be stimulated with new problems. So I've taken a lot of chances and then entering into new endeavors.

That's great. That's, that's really great. So talk talk about psycho agents now sort of talk about the evolution talk about the work you're doing. Let's do a little bit of a deep dive.

Sure. And I signed away just the website.

What's the website, psycho ages,

www dot seido. See why to big federal agents comm and sign up agents is a clinical stage biotech company, developing a drug to radically change how we treat a condition known as cytokine, storm. And cytokine storm is becoming more and more common, I think, given what's going on with COVID. What cytokine storm is, is it's an overreaction of your immune system, it causes overwhelming inflammation, and respiratory distress. And specifically in COVID, it is shown to be what's causing patients to progress from mild to severe illness, it's what's causing patients to go into the ICU require ventilation, it's an overwhelming respiratory distress response, that's causing more harm than the virus itself. So that's our initial focus. But there are many causes of cytokine storm. So our mission is to develop a long lasting treatment for many causes of cytokine, storm COVID and being the most urgently needed, but and we're going to address that first and then expand our pipeline.

So it's so interesting that most people have never heard of cytokine storm until COVID. So it's almost like, I don't want to say like you're at the right place at the right time. And now it's a common vocabulary. But I, even myself, I'd never heard of that. So what other conditions sort of align to that cytokine storm?

Well, the company was initially focused on influenza, which is still an incredible public health problem. So we know there's a strong cytokine, storm and influenza and that is what enabled us because of how we've mapped our science to be able to pivot to COVID-19. But we also know that conditions like vaping induced lung damage, we are working with two ln, which is a leading Academic Center for this type of research. And they are getting ready to publish a paper that shows that vaping induced cytokine storm is the strongest cytokine storm they've ever seen in their research. And it causes far greater damage than cigarette smoking. So we're working on that in parallel. And then there's things such as car T cell therapy, which is very big in oncology, in the treatment of cancers. And car T cell, the whole point of car C's cell therapy is to rev up your immune system to fight the cancer. But sometimes that becomes a bit of a runaway train. And you need to calm that storm down a bit. So that you know and then there's many others. rheumatoid arthritis, traumatic brain injury. There's there's many others.

So So this word storm, this is a this is a common word that's used in turn because we're throwing it around.

Yeah, I would say on the physician, the medical community would refer to it as cytokine release syndrome. That's the accurate medical term. But, you know, in the, in the, in lay language, it's, it's well referred to now as cytokine storm.

Well, so So talk about the, the vaping what what, when you say vaping you're talking about cigarettes, vaping marijuana vaping What are just all

vaping I have, generally speaking tends to deposit things more deeply in our lungs. And it, you know, in certain cases will cause this overwhelming response.

Wow. So it's, it's exciting times for you, I would imagine, are you feeling like this is more exciting than normal as you got into this? Or do you feel like this is just an alignment with what the hypothesis was in terms of the creation of the company?

Well, it certainly is an alignment with the hypothesis of the company. We knew from the beginning, we had this potential, what COVID, in the emergency circumstances has allowed us to do is accelerate to proof of concept. So we have the opportunity under an emergency situation, and under FDA guide guidance, that we can do a little bit more in parallel. So we can accelerate to proof of concept. And our goal would be to fast track to widespread treatment availability towards the end of next year.

So with all these opportunities, and all this focus, what's the configuration of your team right now?

Mm hmm. So we balance capital efficiency, with domain expertise. So we have four employees, and key employees, myself, our Chief Science Officer Jody crago, who's a PhD, out of the University of Pittsburgh, she was there for 20 years in the vaccine research center. And then we have our chief medical officer, Todd llorens, and who's a physician, and he is in California. He is a world renowned expert in drug development, has experienced running global trials with hundreds of sites and thousands of patients bringing the drugs to the market. So, you know, I was able to recruit the these really high caliber team members because they believe in the science, they looked at the science and said, Every clinician looks at the science and says, Wow, this has promise, and we want to be a part of this. So those are our employees. But then we have key consultant consultants. And we have an arrangement with a key consulting firm out in California that helps us manage regulatory toxicology, statisticians, all the domain expertise is required for drug development. And we don't have to hire them, we have the luxury of tremendous bench strength, and we just plug and play them when we need them. That's really

that's incredible.

We really tried to funnel every dollar to our r&d, and limit our spend on overhead.

Wow, that's great. It's really great. So that means maybe someone like myself could get into this business, right?

It's sure.

You bought orchestrated sort of a strategy. I'm just joking, you have an impeccable background that lines up to this. But I really like hearing about that, because you're really strategizing and not necessarily doing all the operating. And there's a lot to navigate. There's a lot to navigate. There's a lot so. So there's much work going on right now. Right. In terms of vaccine development. We've seen some hiatuses recently may have learned a vaccine trials that are going on here in Pittsburgh, but long after, you know, the vaccine is released. Can you talk about the role of therapeutics, just in terms of COVID?

Yeah, we see. And I think there's consensus that the ultimate solution is going to be a combination approach. vaccines and testing are key for prevention and tracing. But then there's the category, there's going to be an ongoing need for treatment. And there's essentially two broad categories of treatment types. One is the antiviral treatment type. And then the other is the drugs, the immunotherapy drugs that deal with the cytokine storm. We have data that shows that we make antivirals, better. So we our data showed that when given alone, there's 60% survival, but when you combine it with an antiviral in the influenza case, a Tamiflu in the COVID case, perhaps remdesivir, that we would actually make those drugs work better. So ideally, for the patient, the antiviral is going to reduce the viral load, and then we're going to plug in an immunoassay therapy to ensure that the immune system's not overreacting. And so we we play in the immunotherapy space. And then within that space, there's, um, there are a lot of biologicals that you hear about, if you ever hear aisle six reducers, a big one, that's in the news a lot. A lot of those are biologics. And while they may work, they have pretty significant side effect profiles. They're extremely expensive, they require refrigeration, the manufacturing is complicated. And so where our differentiation comes in is that we know that we can calm cytokine, storm, our safety profiles better. We are, it's an oral drug, it's a small molecule drug, it does not require refrigeration, and it has shelf stability for over three years. So we see it importantly, as a stockpiling candidate.

And so are you seeing the changes in terms of treatment over these last seven months?

Yes, yes. So I mean, we are learning in real time. Right? And, and, you know, as the trials get bigger, it becomes we our confidence and the safety of what's been tested, and the fact that it's working is statistically real. So we're learning in real time, and it does ebb and flow. What seems promising? Does it, you know, continue to be promising do side effects pop up. I mean, it's very normal to see stoppages and trials, we saw one in the AstraZeneca trial, they've restarted, we're set, we saw two this week, they that's part of the process, you just have to do some root cause analysis, and then you determine whether or not you move forward. So.

So before we jump to a couple of the questions in there, so with the announcement of this phase one launch, right, you'll be one of the first, we actually will be the first is that correct that on safety? But can you walk us through the various phases? I think that's really important for people to understand and what, what you seek to accomplish at each of these phases, because it is, it's complex, it's timely, and it's hard to rush through.

Yes. So to put in person why this is such an important milestone for seido agents is to put it into context to get to get authorization to move into phase one human trial. Tip, for every 50,000 drugs that are discovered in the lab, only five may get to where we're at. And, and so and then what happens from here, when you've been cleared to go into a phase one clinical trial, every phase builds on itself. So phase one, is typically 20 to 100 patients requiring months, and they're healthy volunteers. And we study side effects the safety of the drug, and what would be the ideal dose to take into your phase two trial. And then about 70% of drugs and phase one get cleared to go into phase two. And in phase two, you're talking about hundreds of patients, months to two years to a to complete, depending on the indication. And you expand what you look at from a safety standpoint, but you also begin to study does the drug work? Yeah, do you study efficacy of the drug,

and then

30% of the drugs clear phase two, and go into phase three. And that typically takes thousands of patients on you. And your safety, you expand, you become more statistically sound that the drug works the way you think it works. And again, about 30%. And that could take years as well, depending on the indication. And then 30% of those move on to the new drug application and commercialization. But along the way, there are opportunities to fast track. FDA has always had a fast track track and you see it largely in areas of tremendous need. And that's been the traditional use of the fast track. So oncology is used a lot infectious disease uses it a lot. But then what's unprecedented really is in COVID-19, they've enacted the emergency you thought us emergency use authorization pathway which again allows us to Get to widespread treatment availability more quickly, but it's still done in a very safe, scientifically sound way.

Okay, so I'm going to just ask one question that I'm asked Jonathan to take up these other questions. And he's going back real quickly on the cytokine. Storm, if you look back at 1918, in the flu, yeah, in that I mean, it, you know, it everything that was going on there in the lives that were lost, they were young people, they were they mostly young people. And was it a result of the storm that we lost so many people in 1918?

Well, in a typical flu season, the mortality curve is a you. And so it's mostly the very young and the very elderly. But every once in a while, and generally speaking, in a pandemic, you the curve becomes more of a W, where you have young young people, middle aged people, and older people that have spikes in mortality. And that's what's beginning to emerge in this pandemic. And, you know, influence the pandemic, also of 1918 also had more than what was more significant, and that was the second wave, which is starting to be discussed now. On second way was actually more deadly than the initial outbreak,

or really, in the Spanish flu. It was okay. In 1918. Okay, so you think we're approaching that as well?

I don't know. Um, you know, again, we're learning in real time. COVID-19 is a different virus family than influenza is it's a Coronavirus. You know, so we have less experience with it. And again,

I wish I could predict the future. But

I thought I had you at my disposal. And I wanted to.

So, let Jonathan, there's a couple of questions in here that I would like asked of you. So let Jonathan just read them quickly, and then we can get

to you. Two great questions here, Theresa, and thanks for being with us here today. First question, um, has COVID-19 diverted resources or attention that may have been directed towards your work regarding influenza? Or is what you may be learning ethical with regards to other viral infectious diseases as well?

Yeah, it's, it's very applicable. So we're not sacrificing one for the other, we've just reprioritized and sequence them differently. But the COVID program is relevant to our influenza and other infectious disease programs.

Interesting. And then from a dirt camp here basically wants to know, does your work also explored the nutritional approach in combination with the pharmacology?

We're focused on our drug development. Um, you know, we have to hone in on that ourselves. But, um, you know, I don't know that this is what was meant by the question, but we do is study food effect on the drug. And we do know that you know, what the food effect is on our drug. But from a nutritional standpoint, itself? Strictly speaking, that's a bit out of the scope of what we're doing.

Okay, great. So how can I mean, we're very proud. Obviously, we're proud of you. We're proud of this work. Right here. Can you talk about what it takes to fund this kind of work in this initiative and you know, other in the various sources of investments and grants that are powering you?

Yeah, so we take a multi pronged approach where we certainly pursue any non dilutive grant opportunity that we find. And we have an incredible grant writing consulting firm that does everything on contingency.

I know we

were awarded a $1.6 million dollar grant in May, and were able to apply for a supplement of equal value. And as well, we've submitted a $3 million grant that was scored even better by the NIH for COVID related work. So we're really excited about that. And then we're pursuing with NIH, also our vaping and our sepsis models. So that's the non dilutive. workstream, if you will, we have been incredibly successful with the angel community. Typically, even to run a phase one trial you have to go to venture and drug development. But we have secured enough funding that we are conducting our phase one trial through the investment of the angel community. And that allows us to really position the company in a way that is ideal for a series a round. So we're going to be able to de risk the safety, and increase the value and raise our series A as a face to ready company. And we're starting that process as we speak. We want to keep the momentum going, we need to secure this fundraising. And we need to do it by early next year to keep our phase two trials on track. So we're actively working with the investor community and looking for people who, you know, are have an interest in drug development, understand the risk profile, but understand there's tremendous upside, and that our company has already demonstrated that we've reduced the investment risk, and we have far exceeded the typical value that you would see in a series A,

I think it's really remarkable in all my years being in Pittsburgh, that's really remarkable. And so any local foundation support, have we have you had any support from the foundations or any in helping you?

Yeah, um, this summer, as part of their pandemic response, the rk Mellon Foundation invested $250,000 into the company. So that was incredibly meaningful to us and helped get us over the finish line to funding that phase one trial.

That's great. So if people are interested in investing, can they reach out to you?

Absolutely. Yeah.

I mean, because your model is very, very different than what we've seen. So this whole thought this whole verbiage that you're talking about de risking and doing some of the earliest stage is really fantastic. And it is actually pivotal and different in terms of what we've seen. So my hat's off to you, Jim being so creative and intentional, Are you hiring?

Well, before we leave that point, I do want to end

it any in order to keep the momentum going, yes. If anybody out there wants to invest as an individual that please feel free to contact me. But additionally, if anybody in the audience has connections to the VC world, and could provide an introduction, that would be also extremely meaningful.

We have time for one last question, Audrey.

What's Yes.

So the next key hire? Is that what you wanted me to

another question for you here.

When he says Pittsburgh is seen over the years, the number of organizations that show promise and draws interest from larger organizations, causing them to leave Pittsburgh for bigger biotech pharma markets. Two questions here, is the long term plan and acquisition for you guys, or do you foresee Pittsburgh being the long term home foresight of agents,

I'm typically to run phase three trials, you do need strategic pharma backing, because again, those are trials of thousands of patients. So we certainly do see an acquisition, but it may take the form of a variety of structures. You know, we could be we could license the COVID-19. Drug week, while we still pursue other indications, or we could be acquired in its entirety. It's really, we we aren't there yet. But our expectation is as soon as we establish proof of concept in our COVID-19 phase two trial by the end of next year, that that will lead us to fast track, widespread availability, and that will attract a strategic investor.

Okay, so I cut you off and you you circled back. So the last question is, Are you hiring? And is there anything that you would like to ask us? Is the tech community to be supportive of your work?

Um, yeah, our next key hire is going to be a VP of business development to really hone in on the likely strategic investor who establishing and further developing the relationship that we have in the pharma, Big Pharma world. But we do you need to start expanding on those relationships. So that when we do show proof of concept, we're ready and they're in there behind us.

Okay, well, we are cheering for you. We are, I can tell you that we are very, very excited. These are difficult problems. And these are life threatening problems when they're, they're happening, hampering our economic performance as well as as on the way we live and work. And so hats off to you for being here and being an entrepreneur, as well as a scientist. And taking a risk as well as understanding the de risking components that make the investment in your company and your work even more attractive. So we go to cyto agents. That's how you can find her. And as you can tell, she's pretty busy. And I just can't thank you enough for taking the time with us today. And

opportunity. Thank you so much.

Absolutely. And Jonathan, who's on board for wrapping up the week. Our friends at neighborhood allies are stopping by tomorrow going to talk about 2020 healthy neighborhood awards, which we're doing a full podcast series on some amazing, amazing winners this year, people just doing great work in their neighborhoods, feeding kids to stem stuff to helping people build some wealth. Great stuff. Can't wait to talk more about tomorrow.

That's great. Thank you, Teresa. Thank you, everyone. Joining us today, Stay safe, and we'll see you tomorrow.

Okay, great. Thank you.

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