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spk27: And welcome to the VaxArt fiscal year 2020 corporate update conference call and webinar. At this time, all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. David Holmes of LifeSci Advisors. Please go ahead, sir.
spk28: Thank you, Hector. Good afternoon and welcome to the Vaxar Corporate Update conference call. With me today are Andre Florio, Vaxar's Chief Executive Officer, and Sean Tucker, Accompanying Scientific Officer. During the course of the conference call, we will be making forward-looking statements regarding the future events, and the future performance of the company. These forward-looking statements may be accompanied by such words as should.
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spk28: believe, could, potential, will, expected, plan, and other words in terms of similar meeting. Examples of such statements include, but are not limited to, statements relating to our ability to develop and commercialize our product candidates and clinical results and trial data, our expectations with respect to the important advantages we believe our oral vaccine platform can offer over injectable alternatives, expectations regarding our ability to develop effective vaccines against new and emerging variant strains, the expected role of mucosal immunity in blocking transmission of COVID-19, and our expectations with respect to the effectiveness of our product candidates, including our potential role in mitigating the impact of COVID-19. All of these statements are based on the beliefs and expectations of management as of today. These statements involve certain assumptions of risks and uncertainties and could cause actual results to differ materially. We assume no obligation to revise or update forward-looking statements, whether as a result of new information, future events, or otherwise. Investors should read carefully the risks and uncertainties described within the Safe Harbor section of our website, as well as the risk factors included in the company's most recent quarterly and annual filings, with the U.S. Securities and Exchange Commission. Following Vaxar's prepared remarks, there will be a question and answer session, and a replay will be posted on the investor section of the company's website. At this time, I would like to turn the call over to Andre Florio. Andre, please go ahead.
spk02: Thank you, David. Good afternoon, everyone, and thank you for joining us. I'm excited to provide an update on our clinical programs and outline some of our priorities for the coming year. We started last year with a peer-reviewed publication in the Lancet ID, featuring results from a Phase II clinical trial of our pandemic flu vaccine, a trial that was sponsored by BARDA. In this flu challenge study, we showed that our oral tablet vaccine protected against flu, as well as the leading injectable flu vaccine, Fluzone. Importantly, our oral tablet flu vaccine produced much lower levels of serum-neutralizing antibodies than flusone, less than one-tenth as much, but was just as protective. This is a very important finding. In the context of COVID-19, serum-neutralizing antibodies are seen as a key metric for injectable COVID-19 vaccines. So it is very important to recognize that for our oral tablet vaccine, Serum-neutralizing antibodies are not an appropriate proxy for efficacy. The protection of our oral vaccine in the flu challenge study was driven in part by B cells that recognize HA of IgA class, as opposed to HAI titers for the injectable flu vaccine. These results provide important evidence that our vaccine is working through a different mechanism of action than injectable vaccines. In fact, our oral vaccine generated a broader adaptive immune response, including mucosal T cells and local IgA to effectively protect from influenza. Early last year, at the beginning of the COVID-19 pandemic, our team had the foresight to design a vaccine that incorporates both the spike S and nucleocapsid N viral protein. This approach was based on our expectation that coronavirus was likely to mutate and spawn new S-mutant variants. The N-protein is more conserved, less prone to mutations, and also a great target for potent T-cell responses. This and recent studies suggest that targeting the N-protein may induce broader protection from the new variants of SARS-CoV-2. Therefore, we are very excited about moving towards Phase 2 with a COVID-19 vaccine candidate that could be transformational, an oral tablet that works through a very different mechanism and which could prove to be a very valuable globally in the fight against coronavirus. We believe our COVID-19 vaccine constructs have several important advantages. One, the triggering of mucosal immunity, the first line of defense against airborne pathogens such as coronavirus. Two, the e-tablet. And three, the simplicity and lower cost of distribution of a room temperature stable pill. Recently, we have seen the emergence of new SARS-CoV-2 strains, against which some of the leading injectable vaccines offer reduced protection. At the same time, it has become clear that mass vaccinations by needle take a long time. and that new strains may emerge faster than we can vaccinate people. Therefore, a better solution is needed, given that COVID-19 may be a challenge for years to come. Our strategy for tackling this global challenge is to employ a multivalent portfolio approach, looking to improve on many aspects of the first-generation injectable vaccines, including convenience and speed of administration, breadth and depth of protection, and ease and cost of distribution. This involves advancing our S and N vaccine candidate into Phase II, while in parallel developing S-only vaccine constructs. We believe that with our COVID-19 vaccine portfolio, VaSTART will have multiple taskforwards, depending on geography. In the developed world, annual boosting of those previously vaccinated or infected with the potential of conferring cross variant protection. In the developing world, de novo vaccinations with a much more practical solution than cold chain dependent injectables. Based on the fundamental underpinnings of our oral delivery platform, we have also restarted our Norovirus program. As a quick reminder, the United States sees approximately 20 million Norovirus cases every year. Health economic impact is felt mainly by children under the age of five, as well as elderly over the age of 65. Recently published health economic data from the American Journal of Preventive Medicine puts the cost at over $10 billion annually.
spk00: Hey, Brad, what if you could see into the future? That'd be pretty incredible. Well, with Nationwide's personalized long-term care assessment tool, financial professionals can estimate their clients' future long-term care costs and help them plan for it. That's one less thing to worry about. Right? Yeah. Exactly. Totally.
spk11: Ladies and gentlemen, welcome to the final game of round number one. Quavo versus Roddy Ritchie. Roddy Ritchie! The winner will move on to the semifinals, one step closer to the $250,000 prize. There have been 30 games in crew league history.
spk09: This was the highest scoring. The bank is open! Two-pointer! Two-pointer!
spk22: We back. Bando Boys in here. You know what's going on. Yeah, from the north, man. You feel me? We from that way. You know what I'm saying? We need that two-figure, too.
spk24: What's happening? This Quavo Huncho. I'm from the north side. I'm the captain of the Bando Boys. So I got some northern dogs. I hear all the dogs, they all ready to kill. I played basketball in middle school. Didn't do it in high school. Played football in high school, baseball in high school. AAU and all that, yeah. Shit, we got the best crew in the city of Atlanta, so let's come and put it on the line about this money.
spk13: We finna put these boys in the band, though, and we finna board the windows. My name Real. I'm from the North. And, you know, I'm like the orchestrator, you know what I'm saying? I'm like the president, the general manager, you feel me? Yeah, man, my friends always got my back, you know what I'm saying? They got my back like a fall, you know what I'm saying? They got my back every time, you feel me?
spk12: Evan Ravenel, they call me Raph. Tampa, Florida, rolling with the Bando boys. Played collegially at The Ohio State University. Played professionally a little bit overseas. I'm going into my 10th year. If I need to go inside, I go inside. If I need to step outside, I need to step outside. So I got to get a little foul, got to get a little physical, I'll be a little physical. Whatever, take the win, get the job done. That's what I do. I play for them guys, you know, they do their thing. I grew up with the guys on this team, playing ball all the time, things like that. And we recently linked up, things like that. So it's cool, dog.
spk24: I got my boy Toosie with me. He coming to play with me, so.
spk21: My name's Toosie. I'm playing for the Bando boys. How do you know the playbook? That's my cousin. So now I'm just lying. Every time I say somebody's my cousin, y'all look at me like that. I'm telling y'all, my dad was out here tweeting. I came to talk to NLE Chopper because I don't like him. Talk to me about what happened last year. Well, you know, it was a lot of .
spk31: Pull up. Toosie's a midget. Pull up.
spk11: That is Zach Andrews. LeBron's stunt double for Space Jam. Crazy.
spk21: You get . and that Lee Chopper with from Space Jam and all these other , and it's like, I came with my cousins, and I'm just gonna be hunting. He suck. I do want to apologize, because I told the people he eat grass, so we didn't marry the same person. I just eat burgers, and he eat grass. And he didn't like that, so I do want to apologize for that, because that was a low blow. But other than that, he suck. What you know about Roddy and his basketball ability?
spk24: I don't know nothing, but he can make a hook, though. He hard.
spk21: What's the name of that team? The City Stars. The what?
spk13: The City Stars. Ain't never heard of them. Oh, they flew from L.A.? Yes, they did. That's tough, bro. Just because they flew here, they got to leave with something. We can put a stamp on that and let them know they came to Atlanta. Took an L and went back to L.A., you feel me? Let's talk.
spk25: City stars on the map. Let's go. Speak for yourself. Y'all know who I am. If you don't, go look me up. We at the crew league on the team, captain for the city stars, you know. Flyers, niggas, confident. I've been playing sports since I was little, you know what I'm saying, but I was too short. So I just, you know, I kicked it with all the hoopers and shit like that. West, west, my a**. No, west, my a**. Man, we here, man, you know what I'm saying? They know who they is, you know what I'm saying? And I just wanna see my boy, you know what I'm saying? That's it. Man! Come on, man. Man, bro, I don't wanna do a lot of talking. I don't like doing interviews. You know what I'm saying? You know I got a good coach, you know what I'm saying? Jimmy, you know what I'm saying? Jack, one of the best coaches out of L.A.
spk08: I'm Coach Jimmy. I'm from the city of Englewood. I coach for the City Stars. I first started by coaching with Baron Davis, my friend.
spk25: He do my AAU team. We done partnered up, you know what I'm saying? We repping for the City Stars. He been doing it before I got involved, but he the reason why I'm here. My moms and my pops, they went to school with him, and he put them together, so he the reason why I'm sitting here.
spk08: Got everything you need. I'm with the Coscos and handpicked this right here. I got everybody over here. I got a big man, which is Big Shell Dawg.
spk36: It's your boy, Big Shell, straight out of Compton, repping City Stars. If you're from the city, if you're from LA, you know about the City Stars. So I'm Big Dawg. I'm the dog of the court, I'm what you gotta go through. You can take shots outside the perimeter all you want, but anything in the paint or anything like that, that's all me.
spk08: You gonna do all the little good screens, you gonna hit the midi, you gonna pump fake, you hit that little jump hook on you. You got A.J. Buckets, he craftin'. You give him a step, it's flight school.
spk20: It's your boy AJ, straight out of Englewood, representing City Stars, baby. Give me the ball and move out the way. Roddy, of course, I done seen him around town at a derby, hooping, coaching the kids, doing his thing. I mean, shit, big fan, of course, like bangers, of course. I'm banging it in the car on the way to go get buckets.
spk37: I got weapons, man. My name is Chase Jeter. I'm from Las Vegas, Nevada, and I'm playing for the City Stars today. I played basketball since I was a young man. I played high school at Bishop Norman, college my first two years at Duke University. I stepped away from the game of basketball for a year. I had to find myself outside of it, so I became a yoga teacher. As long as you're breathing, you're doing yoga, brother. You know what I'm saying? You just got to sometimes be conscious of your breath. That's all we got to do. Sometimes I don't even know if people know that they're breathing. I was playing in the Drew League. Coach Jimbo, I call him Jimbo Slice. That's love right there. He approached me in the parking lot. I was just walking to my car getting ready to tread on home, and he came up to me. So it's a blessing from God.
spk08: Let's go out and be ourselves and let's win this game. Defense first. Rebound the ball. Steal the ball. Help each other. Double everything. I don't care. That's it, man. I trust y'all. You know what I mean? Let's give it to Danny.
spk13: Intensity. That's what we call it. Intensity. That's the word of the day. You feel me? F*** that phone. Intensity. You feel me? We're going to play aggressive off the muscle. You know what I'm saying? Yes, sir. City Star.
spk17: City Star for life, baby.
spk13: Here we go.
spk17: Here we go. Here we go.
spk08: One, two, three.
spk17: City Star for life. Let's get in here, man.
spk15: Look at this splash. All right, T, y'all know what we're doing. And we're going to bando on three. One, two, three. Bando!
spk11: Ladies and gentlemen, welcome back into Crew League Season 4. It's the league where artists and their crews battle it out for $250,000. The final game of round number one here at OTE Arena in Atlanta, Georgia. My name is Buster Sher. We got Funny Marco.
spk10: Y'all remember me from the last episode. Why you keep introducing me and I'm the same person? We the same people that's been on the last episode. People are watching this for the first time.
spk19: You know we're separated episode by episode, right?
spk11: I'm not going to argue with nobody with a bond, Nicole. We got Team City Stars led by Roddy Ricch and the Team Bando Boys led by Quavo. And they've got another very special guest who was a co-host of ours. Toosie will also be playing on the team. Four on four to 21. Ones and twos here at OTE Arena in Atlanta, Georgia for $250,000.
spk35: You are brought to you by the Crew League featuring Waka Flocker.
spk11: How do you guys feel about Quavo's game individually? Quavo Hooper, man. He's an athlete.
spk19: I look at him as an athlete. He decent. He decent.
spk14: Yo, we live in Atlanta with decent. your life, Bing Bong, all that good you heard. First up, Team City Stars. We got my boy, number eight, Danny. Next up, number 23, Chosen One. Number 24, Yase. Number 15, Dawn Love. Number 32, Shells. Number 11, Sidney Dean. Number 3, Roy. 21, Deion Wright. And last but not least, give it up for the captain, Roddy Rich.
spk24: Yeah. Get it. Tell them to clap their hands.
spk14: Next up, from Atlanta, we got Team Bendo Boys. Number 15, TJ. Number 24, Miguel. He ain't commentating right now. He's playing ball. Tusi. Number 21, JB. Number 8, DC. Number 34, Rav. Next up, Humphrey. Number 32, Spoon. Number one, Rel. Money. And last but not least, the captain of the Bando Boys, Quavo.
spk15: Bando Boys in the building. Let's go. Team Bobby Boucher, we do not play.
spk11: What are your guys' predictions after seeing these starting lineups? I'm not going to lie, man.
spk19: I have to see the first couple of minutes. There's no huge size discrepancy? If Roddy Ricch is amazing at basketball, I'm going to lose my mind.
spk15: We got to watch 23. We got to watch 23. Yeah, don't worry about me. Don't worry about me. He said we talking about him.
spk07: Roddy Ricch catches the ball, bro. One and double team. He's not going to make a smart basketball play. He's going to throw a pass, play zone on the back side, steal that bitch, let's go lay the ball up, bro.
spk08: Every single time. Hey, y'all know I like all that static, bro. I like what he's talking about, all right? We always the underdogs. That's what City Stars is about. We always the underdogs. We're going to show them who we are, all right? I don't know what they're talking about. I don't understand them, but we good.
spk24: If he's checking you, go get all of them. All right. You feel me? It depends. They might play hip. You going to take Quavo? You going to take Quavo?
spk11: And we have tip-off. I got 23.
spk17: I got 23. Match up. Match up. Match up.
spk11: Pass was a little hot inside from Rel to Quavo.
spk22: I couldn't see it. It hit the net.
spk11: I thought Quavo really run like an athlete.
spk22: I don't need him doing those stupid positions like that, bro.
spk11: Rel and Quavo playing the guard positions. Quavo guarding Roddy. Passing inside.
spk36: Oh, yeah. I like this matchup.
spk11: Backing down. No good. Rebound.
spk15: Rebound. Rebound. Rebound.
spk11: Rebound. Fight for it.
spk15: Fight for it.
spk11: A lot of energy early here.
spk17: I thought this was the cruelly. You were calling the foul where everybody playing strong to go get the ball. Match up, match up. Screen, Roddy, screen. Come on, slow it down.
spk11: Cuevo. Try to get the steal inside. Good pass to Rel. Rel back to Cuevo. Cuevo to chase Jeter. Close out, close out.
spk35: Shot.
spk15: No good. Y'all playing real sloppy, bro. I know, I know, I know. Don't go dust them, dust them. Let's go.
spk19: I wanted to say Rodney Rich.
spk11: Watch the road. Down low. No good. Offensive board. Oh, that's not a foul, bro.
spk35: That was all ball. That was all ball. You might be right, but we're not doing all that. Man, come on.
spk16: Yo, watch the hole, man. Downhill. Downhill. All day. All day. Money ball. He gonna get money. Let's go, Brando. Let's go. I like that.
spk11: Bucket.
spk16: He gonna get money. You're too little.
spk11: Deion Wright just got the bucket. The same one that was guarding LeBron just a few weeks ago in the Drew League.
spk18: Y'all know where I'll be at in the summertime? Y'all know where the f*** I'll be at in the summertime? You sorry as f***?
spk11: Doing all that . It's getting chippy. Roddy Cuevo guarding him. Roddy. Oh, Roddy. Putting some moves, lost it. Going back the other way. Cuevo for two. No good.
spk16: Don't worry about it. Yeah, don't worry about it. They only get six of them.
spk11: Bando boys have yet to score. Who is that? Oh. That was Chase Jeter, who played at Arizona. Back him up, big man. Back him up, big man. That's a very big man. Chase Jeter with the rebound. There you go. Go push. Push it. Corner. I was down below. Now we call it. Jeter, another one. Chase Jeter's built for the crew league. Bando Boy's got to get a bucket on the board. St. Hilaire, guarded on the perimeter. Rip, rip, rip, rip, rip. Stolen. Back the other way. Good. The chosen one with the bucket. They play a trade game basketball.
spk15: We don't ran y'all background. Uh-oh, uh-oh, uh-oh, uh-oh. Come on, Rod. Yeah, get deep, get deep. Yeah, there you go.
spk19: Four to one. Tootsie, get in, get in. Quavo has just came out the game. He's subbing out. What are you doing? We got to sub him out.
spk16: Go, go, go.
spk19: He's out. Roddy's out. Tootsie, though, is in.
spk16: Let's go, Tootsie. Uh-oh. Let's go, Tootsie. Let's go.
spk11: And one. City stars tack on another bucket. Hey, North. Quavo's squad is six fouls, so one more would put them in the bonus. That's good. That's good. I'm just a LA at heart, man. Deion Wright. This isn't looking good for the Bando boys. Quavo back in the game for the Bando boys. What the hell was that? That's seven fouls. That means Roddy Rich is going to shoot. You think Rod is going to hit this? Yeah. You think Roddy hits it? Yeah, Roddy is not missing nothing. Roddy Rich for the one-point free throw. Good! Yeah! It's an eight-to-one game. Should there be a mercy rule? I just, I mean, Quavo got to turn it on. Take him.
spk17: Here it is. Money, money, money. Up top.
spk11: Chosen one.
spk17: No.
spk08: No. No, bro. That was a pump-faking punch. No, no, no. He didn't do that. His first step was this way. He didn't even go that way. Hey, they playing just like that. Come on, bro.
spk15: Hey, I didn't drop. I didn't even change my foot.
spk11: Your people came off.
spk15: No way. He playing.
spk11: You want to bet?
spk15: What do you want to bet?
spk11: Why he ain't got out the game yet? What he eating? Bando boys back the other way. Opposite side. Two attempts. No good. Man, you talking about everything, bro.
spk35: What's up?
spk11: Roddy lost by Quavo. Height advantage.
spk10: That was a cool-up block. That was a cool-up block.
spk11: Hold on, hold on, hold on. Right. Back up top. Two-point touchdown.
spk16: What the f*** is that?
spk11: All air on that one.
spk16: Yeah, he didn't give a f***. Derek St.
spk11: Hilaire. Look at that. That'll add some momentum. Oh, he fought. Keep it real. He fought. Eight to two. Roddy Ricch. to Sheldon Allen. Sheldon Allen, no good. Oh, these old dudes, bro. He's scared. Oh, hard foul from Sheldon Allen. One more foul, and Quavo will be shooting free throws. Quavo. Good! Thank you, Quay! Thank you, Quay! Y'all tighten up! City Stars heading the other way. What the ? What the ? Two-point attempt, no good. Sheldon Allen with the rebound. Back out! What the ?
spk26: Look at that. How the is they throwing backboard shots like this?
spk17: We need two more points. Let's go!
spk26: Every bucket count.
spk17: Yo, front of post, Rowdy. There it is. Another one, Quavo. Quavo. Another one.
spk11: Get in buckets now. He going to abuse that boy. That makes it 9-4, plus the foul, which means they're in the bonus. Quavo is shooting free throws. Welcome to the crew league, everybody. Yeah, welcome to the bonus life. Oh, okay. Let's go. Hey, Quay, get that money, Quay. With Quavo shooting the free throws, it's going to be a different game. The chosen one. Chase Jeter setting a screen for him. Uh-oh, uh-oh. Chosen one to Jeter. Foul. That's four, that's four.
spk35: You can just watch how far you go out there. All right, perfect.
spk20: It don't matter if you miss or make it. Like I said, we're going to win the game.
spk15: Come on, help us. Hey, hey, what you just told him? There's more space jam juice back there.
spk11: Roddy at the line, does he make it? Nine to five, Chase Jeter to inbound, the retained possession.
spk16: Two point attempt.
spk11: Good. And that will send us to the half. That was Roy Clark. You knocked that down, baby.
spk17: I knew you was going to be ready. You told me you was. It's all good. It's all good. Hey, we good.
spk14: We good. We here. Halftime. Roddy, Rich, 11, Quavo, 5. Roddy, what you feel about that first quarter?
spk25: Shit was a cool quarter. We came together as a team. I feel like make more free throws and shit like that. But, you know, besides that, we played a good first half. You know what I'm saying?
spk14: Quavo, this is your hometown. You favorite. What's your thoughts right now?
spk24: We got to a little slow start. We're going to pick it up. We just now warming up. We down, what, six? We're walking down in a minute. What's the predictions for the second half?
spk14: You already know. What's the final score prediction?
spk25: You already know.
spk14: They got five. You going to keep them at five?
spk25: You already know.
spk14: Quavo, what's the final score prediction? We on top. Let's get it. We got to walk it down. They winning right now. There you go. Halftime. Bing bong. Told him. 11-5.
spk11: They've got to get themselves back in the bonus and attack the paint.
spk19: They know the game plan, though. They know the game plan. Quavo going to come out like a man possessed.
spk11: Oh, no, man. Cuervo's going to come out like Prime Jordan. Prime Jordan.
spk17: We got never more points, y'all. Let's get the out of here.
spk08: Hey, you, man. No more points. No more points, man. I see what you need. Every money you got, he going for it, bro. He's going to do it. Stop it. He's doing mid-range. Pull that bitch out. Go again. Get our money, y'all. Fuck it.
spk09: You can't stop me, bro.
spk17: Hey, who going in?
spk09: Who going in?
spk22: Who going in? Defense on three. Defense on three. One, two, three.
spk09: Defense. Six stars on three. One, two, three. Six stars. Yes, sir.
spk19: We're getting ready to kick off the second half, guys. All fouls have started back at zero. And the score is Quavo 5, Roddy Rich, and his squad 11. Uh-oh.
spk11: Quavo, he's coming in. Got knocked down. Watch out. Ain't nobody going to hit Quavo up. Roddy deflected out of bounds. Nice one.
spk15: He played dodgeball.
spk11: Back the other way. Here we go. Can they get a bucket? Yes.
spk16: Bucket.
spk11: Corner, corner, corner, rock corner. Chosen one. Whoa, through the legs. Stack up those fouls.
spk17: That's that space jam juice shit, man.
spk16: Hey, spread out. Uh-oh, uh-oh. Money ball. Roy Clark, good for two.
spk11: The bank is open. That'll extend their lead 13-6. It's 13, yeah. I'm about to say give it to them.
spk16: Yes, sirs.
spk11: Look at that rebound. That was Roy Clark with the rebound.
spk17: This time it's about to get serious.
spk10: Ronnie Rich is hurt. Fuck, Ronnie Rich's leg, he limping. Is he? Ronnie Rich is limping. He limping. He is.
spk25: He's called time. I got a Charlie horse. I got a Charlie horse in my leg. Back of my leg. Fuck.
spk24: Y'all doing good. Y'all doing good. Y'all doing good. Y'all doing good.
spk11: Did you see what happened to Roddy? No. How did he injure himself? Roddy is out. Quavo is out. 13-6. Bando boys trying to make something happen. 13-7 now. Don't talk. Don't talk. Don't talk. Get him out of here. Get him out of here. Roy Clark. Clark, no good.
spk10: Over through it, bro, when you trying to up a layup. TJ. Hey, Roy. Hey, Roy. Nice!
spk11: Two-pointer.
spk19: Kendrick Perkins with the two-pointer. Guys, we have a new co-host. Welcome, welcome.
spk32: What's up, y'all?
spk19: How are you feeling today?
spk32: Oh, you know. I'm chilling, I'm chilling.
spk11: Bando boys trying to inch back in.
spk32: Let's go. Slow down.
spk11: I say LA got it.
spk32: Slow down.
spk11: Two-point attempt on the other end. No good. That'll help them. Look at that rebound. Roy Clark. Dang it.
spk35: What? He flopped. He flopped. What are you talking? Flop. You fucking threw yourself, dog. You're not doing that.
spk11: Tack on another foul there. Inching the City Stars closer to that seven foul. Come on, Rob.
spk16: Oh, that's all. Derek St.
spk11: Hilaire. Let's go. 14-11 game. Three-point game. Park inside. Back to right. That was a real play right there. 15-11.
spk19: Oh, Kendrick Jerkins with the jumper. Wow.
spk11: Another one right there. Look at that.
spk17: Stay locked in. Stay locked in.
spk11: Two-point attempt on the other hand. Good. Yeah, Quavo's not happy about that one. Bando boys trying to keep their crew lead hopes alive.
spk33: Two-pointer.
spk11: Good. Calling that a one-pointer on that shot. If you were Quavo's team captain, what would you be telling your team? I'll put it in 2C.
spk32: I don't think I would go with 2C. Why? Because you feel like he's up? Roy Clark.
spk11: Oh, yes. Got some space. Got him. Help, Deion, help, Deion, help. Your man ain't here yet. Derek St. Hilaire. He's definitely going to pull up on him. Hilaire. Good shot. 18-14. It's just a four-point game. Anything is possible. How did he get on the court with LeBron?
spk16: Good block, boy. Let's go.
spk11: Back the other way, St. Hilaire. Slow it down. Wow. That's good, D. A lot of pushing and shoving. Hand it off. Back to St. Hilaire. St. Hilaire for two. Goal! This is about to get interesting. 18-16. Right. Trial. Massive bucket, which puts them within 1-2 of winning the game. Go back, go back. Yeah, Tate! Yeah, Tate! Iso, double team coming now. Go, go, go! Now called on the play. 19-16, a two wins it for the City Stars, led by Roddy Rich.
spk35: Yeah, Chase! Yeah, Chase! Yeah, Chase! Go to the rack. We in the bonus. Go to the rack. We won't go. Get it out. Tough bucket.
spk11: Took it all the way down to make it 19-17. The game could be decided here. Oh, that's an open. Yep. Thank you. Offensive foul on Chase Jeter. They're in the bonus. Quavo's shooting free throws.
spk16: We got seven. We cannot foul.
spk11: Quavo. Good. 19-18. Don't ever count Atlanta out. Hey, keep driving. It's win by two. This is an important bucket.
spk18: Very important bucket here.
spk11: Derek St. Hilaire guarded by Jeter who has five fouls. What did I say? What did I say? Bando boys leading by one. Be low. Solid, solid. I know you're trying to get that steal.
spk15: Just be solid. Roy, go get it, Roy. Go get it, Roy. Shake, shake. Chosen one.
spk11: File him, file him. Deion Wright. the bucket. Guys, they can still win on a two.
spk14: He's about to hack the hell out of you. This is it.
spk11: The Bando boys can win on a two. The one. It's not over. It is not over. What are they doing? Get back on defense. Somebody threw shoes on the court. That's a tag, man.
spk17: That's a tag. Yeah, they threw a shoe on the court.
spk11: Man, Shugate, I don't even know where to start. It was all a blur to us. St. Hilaire gets the ball in the corner. He hits it. They all storm the court in the corner. They're celebrating. They think they won. One of the rules is a team must win by two points, so the game can't end 21 to 20. Half the team is down in the corner celebrating, and Roddy Rich's squad is going the other way.
spk13: Well, I just knew it wasn't over. I didn't even see the shoes. I just saw everybody running on the court. Nah, don't say this don't count now. And then his shoes in the court, I'm like, ah, like.
spk11: So somebody, I don't know if it was because they were celebrating the victory or because they were trying to stop the game, threw shoes on the court.
spk31: We didn't win by two, so we kept playing his shoes on the court, technically foul.
spk21: No, no, no, no, no, no, it wasn't me. It wasn't me. It wasn't me. It wasn't me. I didn't do that. I didn't do that. I wish I thought about that, but it wasn't me, though. So who threw the shoes? Ask Bow Wow who threw the shoes. Bow Wow? Yeah, ask Bow Wow. No, like Mike, though. He know who threw the shoes. I don't know why.
spk16: They're hiding on my side of the court anyway.
spk11: I don't know how they got them off their feet that fast, but shoes were thrown on the court. Was it intentional knowing Roddy Ricch is not the greatest free throw shooter in the world? I don't know. He threw the shoes on the court.
spk30: That's not...
spk15: It is a technical foul.
spk11: Roddy Rich shoots a free throw and ball out on the side. So the official is that there was a technical foul. Shoes were thrown on the court. Roddy Rich will shoot a free throw and retain possession. Down by one here in the final game of round one. Roddy Rich at the line. Down by one. Big shot. The free throw is... No good. Deion Wright in the game. Chosen one in the game. Chase Jeter also in the game for the City Stars. Inside to Jeter, Jeter, bucket, and the foul. Your man is Jeter. A two-pointer would win it. Chosen one. Chosen one inside. Slammed it. Okay. Bando boys back the other way. They've got to score, otherwise the city stars will have a shot to win. Hey, that's how you do that shit, baby. Quavo will have to hit a free throw. Chase Jeter officially fouled out with six fouls. Come on, Quavo. You know what to do, baby. Come on, bro. Give us one.
spk13: Come on.
spk11: Come on, Quavo. Quavo. This game just keeps on going. Uh-oh. Mismatch. Chosen one. He said clear out. He said clear out. He said clear out. Chosen one inside has the lane slamming him. 23-22. All right, let's see. Hey! Oh! No, he's back. He's back. They've got to get a bucket here. Up and under. Goal! St. Clair! St. Clair! Derek St. Clair with the bucket. Roy Clark. Wow! Another.
spk33: Back. 24-23. St. Clair with the ball.
spk11: He just goes. That man is possessed. A one-point lead on the two. St. Clair is possessed. St. Hilaire, St. Hilaire.
spk19: Come on, man.
spk11: Chose one with the ball. Let's go. 25-24.
spk19: 25-25 with the dunk from Roy Clark.
spk11: Two-pointer would win it. St. Hilaire got to give it to him. He's got the ball. If he puts it up and he makes it, they win it. Move on to the Crew League semifinals. Inside the arc now for two. Almost had it. No good. Back the other way. City stars, that's Roy Clark. Roy Clark inside the arc. Up top. Made it. Able to get the friendly roll on that one. St. Hilaire. They got to get a bucket. Back him down. Outside. Two. No good. If the city stars get it, they win. Chosen one. Inside, lost it. But Wright got it. Foul on the shot. Bring those, Rodney! Also, if Rodney make this, it's over?
spk10: Rodney makes this. They move on to the semifinals. Rodney for game. That's Rodney for game right now. See, he been missing all of them. He got it. Here we go. Roddy Ricch from the line for the game.
spk11: Oh, my God. Oh, my goodness. The show goes on. Yo, Roddy Ricch shoots free throws like Shaq. Deion Wright will take it back the other way. Annie Bucket wins it once again. Game point. Chosen one. Chosen one, right setting a screen. Chosen one, lost it. Block. St. Hilaire, inside, out. Two pointer.
spk14: Oh, my goodness. Get your wrist. Let's go, man. Oh, wow.
spk11: You got a strong crossover. Sidney Dean looking for a shot. Blocked. And once again, any shot wins it. Say hello for the game.
spk35: Back the other way.
spk11: The chosen one.
spk35: We just needed one. We just needed one. That was bad. Uh-oh.
spk11: Oh, oh, oh. He traveled no call. Up top. Two for the game. They're good. That was really poor decision making on that two. Inside the right foul.
spk10: Roddy Ricch will shoot another free throw. I'm tired of free throws, man. Y'all, I'm right here. I'm just so up right now because my heart is pounding and I really want this dog. Thank you.
spk31: Let's go, man. You gonna make a free throw? Basketball. You been doing this how long? How long you been doing this? Let's go. Bye.
spk11: Roddy! Roddy! Roddy! Roddy Rich to put them up by one. Season four, round one.
spk37: Be conscious of your breath. That's all we gotta do.
spk11: Goal! He hit that. It's not over till it's over. Any basket wins. Deion Wright with the ball. Right.
spk16: Looking for a shot.
spk11: Spinning.
spk16: He nervous. He is.
spk11: He's not taking a shot. Show me something, jerk. Taking his time. No shot clock. Makes sense. Right. Up top. Floater. Game is over. bucket. That was Don Liv with the game winning shot. And without any further ado, we are on to the semifinals of season four.
spk26: I love y'all, man. Y'all did y'all thing. I swear to God. I swear to God y'all did y'all thing, though.
spk10: Hey. Hey. You went crazy on him.
spk18: What you got? What you got for him? What you got for him? Big ball. You fucking tough, man. This ain't talking ball, baby. I love this hoop. I don't give a shit where I'm at in America, bro. Drew League, TBT, I love this shit.
spk11: There have been 30 games in Crew League history. This was the highest scoring. That was an insane game.
spk19: That was a great game, man. Crazy. One of the best games I've seen in Crew League ever. Shout out to Team Quavo. I thought the Bando boys were going to pull it out.
spk11: It was a great game. We were down. What was it? It was like 7-1 at the start?
spk33: 8-1. Yeah. 8-1. They made it a good game. They made it a good game.
spk25: Yo, we're here with Roddy Ricch. How you feel taking that W? City stars, the right time, you know what I'm saying? We did what we were supposed to do. Tried to make that end free throw, you know what I'm saying? Got to work on my free throws. But, you know, I caught a little cramp, a little tired, like that. I came from the studio 5 o'clock in the morning. You know how I do. I don't stop that. That's the real money, you know what I'm saying? I got a Laker ring, you know, you calling me Shaquille O'Neal, like that. Really from the West, representing the West, you know what I'm saying? I appreciate everybody for letting us be here and shit like that, but you know what I'm saying? My man.
spk03: We out. Do you think you the best hooper in the culture? Can anybody see you? We'll see you.
spk24: I think I don't retire, though, man.
spk03: You retire? You took care of everybody?
spk24: I'm done, bro.
spk03: He took care of everybody? Quavo ain't never took no L? I don't be there for every.
spk24: Man, I took week. I ain't even gonna lie. We just took one, man. Matter of fact, he hung up here too. Matter of fact, he hung up here too.
spk03: I got hurt.
spk24: Let me tell you, I got hurt. Celebrity game, George. Ever since I got hurt, man, I ain't. You down with it?
spk07: I rolled my ankle, man.
spk24: What was the L, though? I rolled my anger. We took a look. Oh, yeah, that's it.
spk07: Oh, okay. It ain't like, you know, we was trying to, because he's Quavo, we was trying to give him, no, Quavo can play.
spk26: And Roddy Brick can play, too. Roddy Brick threw up a lot of them. Yeah, Roddy Brick, he threw up a lot of them.
spk07: Well, yeah, Quavo can play.
spk34: So, you know, it wasn't like we was trying to tell Quavo to do something that he couldn't do. Everybody locked in, too, man. There was a lot of selflessness going on on the sideline. We started off, you know, having a little trouble, but we all locked in.
spk26: Warriors, these warriors. We're warriors. We wear our L's like W's, man. We ain't even really lose. Warriors right here, man.
spk08: Before we came out, before they introduced us, they was behind us talking stuff. Oh, we don't know you. They was all big and they saw us. You know, we didn't say nothing.
spk38: It wasn't even supposed to be a game. We came out. It was A1 at a point.
spk20: Know that we're not losing. We a team that came all the way from L.A. Like, well, we got the furthest to travel. Go home and talk about a loss. Ain't no way.
spk08: Ain't no way.
spk20: Ain't no way.
spk08: You know, all I heard was them talking that stuff about my kids, you know? So, let me go. Let me spread this out. Let's see if they feet can work like ours. Come out here and guard us. You say that was the hottest game in crew league history?
spk36: Yes, sir. We broke one record. There it is.
spk08: We're trying to leave a little boo-boo stain up here. We're trying to leave a little boo-boo stain up here.
spk11: It's game time, semi-final action to determine the championship contender.
spk09: What you get, guys? What I'm trying to get, guys?
spk11: Roddy Ricch, 21 Savage, City Stars versus Watergate.
spk31: Welcome to L.A. Talk that up.
spk11: Wavy Navy Elite versus the Brick Squad. Waka Flocka, Babyface Ray.
spk07: Babyface Ray is not coming out the game.
spk17: Shut the f*** up.
spk07: Our whole team goal is to make Babyface Ray throw up.
spk17: Did you read him?
spk02: Based on this data and internal estimates, we believe there is an annual $10 billion plus opportunity for a norovirus vaccine in the U.S. alone. We are currently in the clinic with this norovirus vaccine, administering booster doses to a few patients who participated in our earlier norovirus phase one bivalent study. The data we generate here should give us an indication of the duration of protection provided by our vaccine, as well as the magnitude of response that is generated by the booster. In addition, this year we have two additional studies planned. The first will evaluate our norovirus vaccine in people over the age of 65, and the second will be a challenge study that will provide us with efficacy data in this disease model. I'll conclude by reminding everyone that to date, we have those nearly 500 subjects with vaccines based on our oral platform across 13 clinical trials targeting seven different viruses. And now, to provide some additional scientific background, I would like to pass the microphone to Sean to discuss our COVID-19 oral tablet vaccine phase one results. Sean?
spk40: Thanks, Andre. As this was a phase one study, the primary objective was to determine the safety of VXA CoV-2-1, our oral COVID-19 vaccine delivered by tablet. Overall, the vaccine appeared to be well tolerated. 60% of subjects reported no symptoms in the seven days post-vaccination, and among those 40% who did experience symptoms, the majority had only mild symptoms. These resolved without the need for medical treatment. No subjects discontinued the study due to a solicited adverse event, and to date, there have been no serious adverse events reported. The secondary objective of this study was to determine immunogenicity of the vaccine. Overall, immune responses against SARS-CoV-2 were observed in approximately 85% of subjects. We are very encouraged by the substantial T cell responses we saw as a result of the tablet vaccine, and I'm delighted to say that these results are the best we've ever seen in a human study. The cytotoxic T cell responses at day eight had a high percentage of cells that made gamma interferon, TNF alpha, and OCD107A in response to stimulation with the S protein, with substantial increases compared to the first day of the study. Potent T-cell responses may offer protection against severe COVID-19 illness across multiple variants. B-cell plasma blasts, which are the immune cells involved in antibody production, also increased in subjects post-immunization. There was also upregulation of the mucosal homing receptor and surface IgA on those B-cells in a dose-dependent manner. While no neutralizing antibodies responses were observed in the serum of subjects, Preliminary analysis showed that the increases in IgA responses to the S protein, receptor binding domain, and or the N protein could be found in the majority of subjects. IgA, as a reminder, is a class of antibody that plays a crucial role in mucosal immunity, the first line of defense against respiratory pathogens. These IgA antibodies, specific IgA antibodies, were detected in several different compartments, including nasal and saliva samples. Given the dose-dependent manner in which the B cells of interest were activated, future studies of this candidate will focus on dose ranging and boosting to increase the mucosal responses to SARS-CoV-2. In 2019, we anticipate starting several studies, which were highlighted by Andre before. For COVID-19, we are going to perform a Phase II study, Part A, immunogenicity and dose ranging, Part B, efficacy, and a boosting study, previously vaccinated and infected subjects. For norovirus, we are currently in a Phase 1B trial for booster vaccinations at 12 months or longer post-first dose, and we are planning dose-ranging Phase 1 study in the elderly 65 years of age and older, as well as performing a norovirus challenge study. We look forward to advancing multiple studies throughout the year and delivering both clinical data and publications to support a proprietary oral vaccine platform technology. We expect these data throughout the year to provide the medical community and investors with a great opportunity for this novel and groundbreaking approach. With that, I will now ask the operator to open up for questions.
spk27: Thank you. At this time, we'll be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please, while we poll for questions. Your first question comes from the line of Mayank Mamtani with B. Riley Securities. Please proceed with your question.
spk06: Thanks, Tim, for taking my questions, and I appreciate the update. So maybe just picking on the last topic that, Tom, you talked about around the study design, can you give us a little more color on, you know, the number of patients, the timelines, and maybe also in context of the recent FDA guidance document that came out last week, how do you sort of accommodate for, you know, the focus there being on utilizing antibodies?
spk23: I get pretty steamed when big money special interests get their way at our expense. That's why we're fighting back. We stood up to big pharma, and now we're cutting prescription drug prices to lower your costs because I'll take on any fight to make things better for all Marylanders.
spk40: Hello, sorry. Can you hear me now? So, yeah, let me answer.
spk06: Thank you.
spk40: Yeah, sorry. Yeah, let me answer that question. So the first thought, of course, is part A is a dose-ranging study where there's going to be three different dose levels and priming and boosting at all three levels. The ends are 16, but there's also it's broken out into elderly and young people to sort of get a good mix. And that guidance will basically be able to provide us insights into how to go forward with an efficacy study and do and take the proper dose and dosing regimen into a Phase II efficacy study, which we plan to run outside the U.S. and placebo-controlled trial. And I believe the ends for that study were approximately a total end of about 900, and obviously, You know, with the recent guidance that has come out with the FDA in terms of using potentially surrogates, we have to reevaluate that. And certainly, you know, from this candidate, the VXA-CoV-2-1, if it's a T-cell approach, we wouldn't be able to use a surrogate from the standpoint of getting, proving essentially efficacy. We would still have to do a efficacy study and prove that the vaccine can prevent something such as severe illness and hospitalization.
spk02: And this is Andre. I just wanted to add to that that our conversations with regulators indicated that they are fully aware that our vaccine is a mucosal vaccine, and they indicated flexibility in working with us to find a path to approval. So we don't expect the same kind of metrics and proxies that are being developed for vaccines to apply to us necessarily.
spk06: Actually, that brings me to the second question that I had around, you know, yes, your T cell response is, you know, comparably superior to what we have seen from others. And, you know, the recent Nature paper from Sterling, and there's a lot of, you know, literature coming out highlighting the importance of IgA also. Maybe, you know, T cell comparison has sort of started to come out against other peers, but can you comment on how your IGA responses are looking like, you know, relative to other more like more of the intramuscular vaccines? Do you have any thoughts on that?
spk40: So just, you know, as a highlight, I would say that our IGA responses in terms of we've compared, you know, in different indications head to head, our, you know, mucosal approach definitely produces much more mucosal IgA than an intermuscular approach. I mean, that's pretty clear. I mean, and in this study, we have not, of course, done a head-to-head comparison between our approach versus an injected vaccine. But I would say that, you know, as far as I know, we're the first vaccine company to report getting mucosal IgA of significance. So as far as I know. That's where we're at.
spk06: Okay. And my final question was, on norovirus, do you have any plans to do pediatrics, since that is also a big part of, you know, the population that gets exposed to it? And also, what does that mean as a read-through? Because pediatric and COVID is also a very big need.
spk40: Yeah, I think right now that, oh, sorry, go ahead.
spk02: No, you take it, Sean.
spk40: So, yes, we will be moving into the pediatric space on norovirus. I would expect this to happen in a number of years rather than this year. So, I don't think it will really overlap. Well, we hope it won't overlap with COVID too much. The key thing for us is that while right now all of our vaccines are delivered in tablets, which are really easy to swallow for someone who's 12 and older. It becomes, it's not, you know, a format that will allow a small infant to basically take it up for a child. And so we're developing other formulations to allow it to essentially be swallowed in a sort of a slurry with a buffer. So we're working on that. But we will be moving into the pediatric space on norovirus.
spk06: Okay, understood. And just last question then, do you expect coronavirus vaccine to be a single boost or a prime boost with one month or you just don't know, you have to run the study, you're not sure yet?
spk40: Well, obviously, you know, the answer is different with people that have been priorly infected or people that have been priorly immunized than it would be with people that are naive. We are doing this dose ranging study, of course, with people that are naive so we can understand more about the kinetics. But you might expect that, you know, for a lot of the Western, you know, world countries, you know, a lot of people will already be immunized, you know, within a year. And we'll probably look at this in terms of a one-dose sort of regiment on a boot.
spk06: Got it. Thanks so much for giving that question.
spk02: And Maya, just to elaborate a little bit on that, I think what we want to do is to develop a portfolio approach that can accommodate different needs in different geographies and also keep pace with the evolution of the virus. So whereas last year the challenge was to develop any vaccine against one strain, I think the challenge is now becoming developing vaccines that can offer a broad protection against various variants that are present now as well as future ones. So that's where we think that vaccines that target S and N, perhaps in combination with vaccines that only target S for various strains, may play a role.
spk06: Yeah, that makes a lot of sense. Thanks, Andrew, for that additional question.
spk27: As a reminder, if you'd like to ask a question, please press star 1 on your telephone keypad. As a reminder, if you'd like to ask a question, please press star 1 on your telephone keypad. One moment please while we poll for questions. Your next question comes from the line of Vernon Bernardino with HC Wainwright. Please proceed with your question.
spk29: Thank you. Hi, guys, Andre and Sean. Thanks for the additional details as far as the update on the programs with the COVID vaccine are concerned. So I may have basically asked all my questions, but one thing that perhaps we haven't talked about in a while is wondering if you could provide updates, and that is, is there anything going on with your collaboration with Johnson & Johnson? Thank you.
spk02: So that collaboration is still ongoing. And as you can appreciate, both us and J&J have been extremely focused and busy with our respective COVID-19 programs. And once there is something to announce as far as the next steps with our food programs, we'll make some public announcements.
spk29: Have you had any discussion with them as far as collaborating on the oral tablet COVID vaccine development?
spk02: Nothing of substance that would have to, you know, announce publicly for them.
spk29: Okay. And when again, may we see results from the ongoing COVID vaccine trial?
spk02: So the only thing we said is that we're looking to start phase two trial in Q2, and as we get closer to that, we'll elaborate on timelines following that.
spk29: Okay. Thank you. Look forward to the next progress report.
spk02: Thank you so much.
spk27: Your next question comes from the line of Shubendu Senroy with Brookline. Please proceed with your question.
spk04: Hi, I'm Shubendu on behalf of Kumar from Brookline. I really appreciate the business update. Thank you. I had a couple of questions. One was, so far Q2, in terms of enrollment of patients for the COVID vaccine study, do you see any challenges, especially for older patients now that we have few vaccines out there? Do you see that could be a problem, I think?
spk02: Hi, this is Andre. Thank you for your question. Look, it's hard to predict the future, but we think that given the attractiveness of an oral COVID-19 vaccine, given the relatively small number of patients that we would need for the dose-arranging study, And given that we still expect a significant share of the US population to not have been vaccinated, at this point, we don't see enrollment as being a significant issue, but we'll update as necessary as we progress. Got it. Thank you. And I would add that I think conducting a placebo-controlled trial in the U.S. and, broadly speaking, developed world may be a challenge because it's placebo control and they are large. But in the dose-ranging study, you know, all of the subjects are going to be on active drugs so that, you know, minimizes the challenge.
spk04: Right, right. And in terms of the product needed for phase two, you think you would have enough supply for that?
spk28: Yes.
spk04: Okay. I had a couple of questions for the COVID results. And could you please comment on how long is the CD8T response is expected to last? I mean, you have a really good response, CD8T cell response, but then do we have any idea of how long it is going to last?
spk40: Yes, this is Sean, by the way, of course. Hi, Sean. Yeah, we expect the CD8 responses to last a long time, and the reason why we think so is because when people have been infected with SARS, the original SARS, you can find T-cell responses 17 years later and cross-reactive against SARS-CoV-2. So we do expect that one of the advantages of a T-cell response is that they are long-lasting. We know that the magnitudes of the responses we looked at prime are pretty high, and we know that the convalescent people from SARS-CoV-2 get about a 0.2%, you know, gamma interferon response. So our expectation is that our responses will stay and be maintained, and we'll be able to find those cells, and we'll have more guidance probably later on that. But, yeah, our expectations at T-cells are going to be very long-lasting.
spk04: Right. And so in the same breath, you expect the overall protection against illness and infection by the vaccine to expect long as well?
spk40: So yeah, so I would say, you know, if you're talking about protection based on a sort of a T cell response, we do expect it to be long lasting. A T cell response is not going to prevent by itself, will not provide sterilizing protection, but would protect against severe infection and hospitalizations. And that's what we expect to last for, you know, quite some time. And again, if we can boost the NFV, mucosal responses are really robust. We also potentially can actually block infection.
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spk04: Thank you for taking my questions.
spk27: No problem. Your next question is a follow-up from Vernon Bernardino with HC Wainwright. Please proceed with your question.
spk29: Hi, Andrea and Sean. Thanks for taking my follow-up question. Given the challenges of perhaps conducting an optimal investigational COVID vaccine study in the United States, as well as many countries in the Western world where there has already been a rollout of the authorized vaccines, Have you considered perhaps trying to do a study with the oral tablet vaccine just in Brazil, for example, because obviously that is a variant of concern and one in which there has been very low vaccine efficacy demonstrated by all the vaccines so far that have completed phase three or in phase three?
spk02: So Vernon, thank you for your question. I'll answer first and then I'll let Sean add anything if he wants to. So from the get-go, a month ago, we said that our intention was to conduct larger phase two studies, placebo control, looking for efficacy outside of the US. So that remains the plan. However, At this point, as we said in the opening remarks, we see the world kind of diverging in terms of need. So in the developed world, there is a lot of interest for, one, cross-variant protection and then boosting, periodic boosting, whether it's annual or so on. So one of the studies that we are looking to do in the developed world is to boost those that have been previously infected or vaccinated. and then to do the novel vaccinations as you suggested in developing countries such as Brazil, India, and so on. Shyam, I don't know if you want to add anything.
spk40: Vernon, your question is spot on. Our intention is to open up regulatory paths in Latin America, South Africa, and potentially India to basically be able to address as you suggested, the strains that are emerging that are not necessarily covered by the vaccines very well. And again, with this product that drives, you know, a cross-reactive T cell response, that would be a pretty good way to find and look for efficacy.
spk29: Perfect. Yeah, I just asked because it seems like it'd be the easiest study to do of all, especially if you're going to go to a boost strategy eventually anyway.
spk40: It's a very good question and strategy.
spk29: All right. Thank you. Look forward to the continued progress as I said. Thank you.
spk27: Your next question is a follow-up from Mayank Mamthani with B Reilly Securities. Please proceed with your question.
spk06: Just on the topic of strategy, I thought I'd ask you this question. What about doing a challenge study? Have you guys opened any conversations with certain countries that have shown some willingness to at least be open-minded to it? And then my other higher level question was, how do you sort of see the broader landscape of vaccines that are looking at either oral modality or going after N-protein? What sort of, you know, you see broadly among your peers?
spk02: So let me take the first question. Sorry, could you please repeat the first question?
spk06: Just potential of doing a challenge study, like something similar to what you did in flu.
spk02: I was thinking about your second question while forgetting the first one. So we've had concrete discussions in some regions where they are open to doing challenge studies, but we feel like it's going to take some time for those to actually become reality. But, of course, we'd be very interested in doing that. in whatever region where regulators are open to doing that. And as far as your second question, I'll let Sean elaborate. We are not aware of any mucosal or oral vaccines that are, you know, relatively advanced or in the clinic. So we don't think too much about that competitively. Sean, I don't know if you have anything else to add.
spk40: Yeah, just on the oral side of things, I'd say that we've been in this business of the oral tablet for a long time, and there's definitely a lot of learning to do to get it to work and We think our technology is very important for that. In terms of, you know, again, nothing has been reported. I think we're the first mucosal vaccine to report data, as far as I know. And if competitors come out and report data, that's great. In terms of an N response as well, I mean, I think there's only a few other companies that are looking at N, and so far they haven't reported data. So I can't really comment on, you know, what they've shown yet.
spk06: Understood. And actually a follow-up that I just got was on the publication cadence from phase one data, like how are you thinking about, you know, that, Sean, just kind of putting this in a peer review journal. And also, I know you've, you know, considered working with universities like Stanford where, you know, thinking about this as a, kind of approach to a protein-based vaccine or an mRNA vaccine, or even looking at studies where you can maybe in a prospective way look at, you know, your data and compare it, be it T cell, be it IgA, to, you know, some of these other approaches in the more real-world setting. Like, when can we see some of that, you know, more sort of perspective and more, you know, direct comparison that we can, you know, in a proper study, proper controlled study?
spk40: Yeah, I mean, again, I don't think we can provide guidance on timing for these things, but we certainly will write up results for the phase one study. You know, there's definitely some things that we'd like to, you know, finish and, you know, detail out before we actually go and write the manuscript. And you did mention something, yeah, we do have lots of friends in the academic world, and there's ways for us to basically sort of look at our T cell responses in a sort of more, what I should say, head-to-head manner by collaborating with some of the sharing samples, for example, and everything else. Some of those things will just take a while to get in place, the agreements, but I do expect that we will get data coming out in Q2. without providing exact guidance at this point. But that would be a reasonable expectation is that, you know, we'll have a lot more to talk about, you know, in next quarter.
spk05: Sounds great. Looking forward to that. Thanks for taking the follow-up.
spk27: Ladies and gentlemen, we have reached the end of the question and answer session. And I would like to turn the call back to Mr. Andre Floriu, CEO, for closing remarks.
spk02: I want to thank everybody that attended this conference. And we're looking forward to progressing all of our programs and to updating you soon. Thank you so much.
spk27: This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.
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