Biotech Investing: Biotech Mid 2026 Catalysts To Watch

In this episode, as the biotech earnings season continues, John Gagliano and Sheff Sheffield explore the resilience of the biotech market, the impact of FDA policies, and the significance of conferences like AACR and ASCO. They highlight the potential of smaller companies and the evolving regulatory environment, particularly in the psychedelic space. 
In this episode:
🔹 White House Medical Executive Order on Psychedelics
🔹 OTLK on Federal Dispute Resolution (FDR) meeting with the FDA after One Pivotal Trial effects
🔹 Sheff's Watchlist for the middle of 2026.

Executive Order: https://www.whitehouse.gov/presidential-actions/2026/04/accelerating-medical-treatments-for-serious-mental-illness/

Outlook Press Release: https://www.biopharmcatalyst.com/company/OTLK/news/320085

🧭 Track upcoming catalysts: https://www.biopharmcatalyst.com/calendars/fda-calendar
🎧 Listen to more episodes: https://www.biopharmcatalyst.com/podcast
📈 See Sheff’s Watchlist: https://www.biopharmcatalyst.com/sheffs-trades

📲 Follow BioPharmCatalyst: https://x.com/BPharmCatalyst
📲 Follow Sheff: https://x.com/SheffStation

Disclaimer: BioPharmCatalyst is not a registered investment advisory firm and the views on this podcast are not to intended to be financial advice. The stocks discussed in this podcast may be held in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

Transcript

SPEAKER_00 0:02

Today's episode is brought to you by Scientist.com, the life science industry's leading RD orchestration platform. Scientist.com gives researchers instant access to thousands of pre-vetted suppliers, saving time, reducing costs, and accelerating innovation.

SPEAKER_01 0:32

Hi, I'm John Galliano, Senior Director of Biofarm Catalyst.

SPEAKER_02 0:36

Hello, I'm Chef, known as Chef Stakeon, a 20-year vet in trading biotech stocks. And this is Biotech Bulls and Breakthroughs.

SPEAKER_01 0:46

Biofarm Catalyst is not a registered investment advisory firm, and the views on this podcast are not intended to be financial advice. Guests on this podcast may hold the stocks discussed in personal or other investment accounts. This content is for informational purposes only and should not be considered investment advice. Always do your own research before making any investment decisions.

Introduction and Market Overview

SPEAKER_01 1:34

We're really excited to uh have Chef back on for our monthly episode. Um, as per usual, there is you know a ton of things to be discussing within the biotech markets. Chef, welcome back. Um thank you always for joining us. Um absolutely. Um I guess just kind of to start, you know, XBI at what, like $136, something like that. Um almost, you know, it's like about I guess that's gonna be what, like a 60-ish percent increase over the course of the last year or so. Um obviously things being going very, very strongly within the biotech markets. Um, you know, and that was something that that we had discussed about how how strong things were and continued to be. So any thoughts on that, on you know, on on how the overall markets are doing?

SPEAKER_02 2:26

I just think that um, you know, with the XBI and the IBB bouncing around, um, we're seeing that um healthcare

Biotech Market Resilience

SPEAKER_02 2:34

is is a staple industry. And I think biotech is showing the same. It's just showing a lot of resilience. Um, there aren't a lot of days where there's significantly um down days in terms of the XBI and the IBB, and if there are, um they seem to come back rather uh uh relatively quickly. I also think the kind of the firming and the cementing of FDA policies and you know what's occurring in terms of um Padufa approvals, um, you know, more direction with how companies can get uh their their products accelerated to the market a lot sooner has really helped out with with the uh investor confidence there.

SPEAKER_01 3:14

Yeah, absolutely. Absolutely. I I I couldn't agree more. And it's it's nice to see it coming into fruition. And, you know, because one thing to talk about it and say, oh, we think that theoretically this is what's supposed to happen, but it's nice to actually see it in the numbers, and um, that's something that that we're obviously seeing. Um another obviously big topic right now, uh, for those of you who most of you, I'm sure, are aware on the call, but uh we've got AACR

AACR Conference Insights

SPEAKER_01 3:39

going on right now, um, really big conference, one of the big conferences that we track at Biofarm Catalyst, um, along with some of the other major ones, JP Morgan, Asco, Esmo, um Ash, or some of the other ones that that we tend to, you know, have some pretty big catalysts for. Chef, you, you know, you mentioned prior to uh when we started this recording that that you were there over the weekend. Um and for those of you who don't know, Chef you know spent 25, 30 years um within the pharma space in oncology, uh, and you know, has a lot of connections still, a lot of old friends, I guess, in that in that area. Um, and you know, are you um, you know, did did you have any takeaways just from what you've seen out of AACR so far?

SPEAKER_02 4:22

Um, you know, the the takeaways are that I think AACR is a really good setup event for ASCO. And the reason I say that is because a lot of um you're not seeing a lot of plenary sessions with a lot of big news. You're seeing a lot of abstracts and um oral poster presentations that are setting up um for a lot of these um the a lot of these breakthrough information that the kids shared at ASCO. So as we as we start to see some of these smaller companies evolve, um we'll see abstracts presented, and then shortly after they'll say they're going to have an oral presentation at ASCO or something like that. I've seen a lot of smaller companies do that. Um and speaking of um you know smaller companies, you know, I I'd seen one at AACR Um Calady um therapeutics out of San Diego, and one of the gentlemen who who used to work with Pfizer, uh Dr. Mace Rothenberg, um, he used to be the chair of NSABP, which is a um it's a uh you know cooperative group that works with uh putting together clinical trials for colorectal cancer. So um, and that was 20, 25 years ago when we were just starting to get targeted therapy for colorectal cancer when we had a Reno T can and Oxaliplatin. So what you know, seeing him, you know, 20 plus years later and and really seeing how he is, you know, evolving and toward in terms of moving with smaller companies and getting them uh set up and scheduled to to present at ASCO lends to what I'm sharing in terms of um how a lot of AACR really shows the potential for these smaller companies and mid-sized companies. But the big players, the big players don't really play there. Like you're not gonna see Pfizer, you're not gonna see Novartis, you're not gonna see the big pharma at AACR. They they're all getting set up for ASCO.

SPEAKER_01 6:14

Yeah, absolutely. Um, and that that that's uh obviously another another big one that we'll be um that we'll be keeping our a close eye on and and have uh a dashboard on Biofarm Catalyst for as well. So um that's really cool though, um, that you were at least even able to get there for for a couple days this weekend. Um I guess just just changing gears real quick. One of the um there was somebody who commented on our video the last time that had a an interest in the psychedelic

Psychedelic Space Developments

SPEAKER_01 6:48

space. Um and this is something that we have definitely touched on in the past. Um, and I know Chef, you specifically touched on. Um, I mean, you want to kind of bring everyone up to speed on on what's going on within that space, um, just in terms of you know, some of the regulatory changes that have occurred recently and anything that is of interest for investors in that, in that space.

SPEAKER_02 7:13

Absolutely. That's I mean, that that's a great segue because um, you know, on Saturday, the 18th, uh, you know, there was a there's an executive order signed to accelerate access to psychedelic medicine for patients suffering from serious mental illnesses. So, you know, this order really directs the FDA to provide commissioners' national priority vouchers to appropriate psychedelic drugs with breakthrough designation that meet the criteria for the program. And that that um commissioner's national priority voucher streamlines the FDA review process to as little as one to two months. So, you know, it it's you know, the order directs the attorney general to initiate review of relevant products on the completion of phase three studies to enable rescheduling on FDA approval, streamlining this commercialization process. So, what does this mean for investors? What this means is yesterday we saw a significant uptick in psychedelic plays. And so this could potentially apply to compass pathways, which is ticker symbols CMPS, um, you know, uh for their comp 360. There's also Definium Therapeutics, which is uh David Frank Tom X-ray, which they have DT120, both of which those products have breakthrough designation that are on track to complete phase three clinical studies in 2026. Um, and in particular, Comp360, which is the Compass Pathways product, um, has been reported to have been initially under consideration for this commissioner's national priority voucher, um, but it was previously rejected. So, this obviously, with that being previously rejected, and then this initiative that just moved forward, it puts it back into play again. So, I mean, basically, this this you know represents a confirmation that there's institutional support seen amongst uh health and human services, FDA leadership that's extending to the highest level of government. And so with a catalyst-rich 2026 and like multiple programs completing clinical development over the next 20, 12 months, there's going to be, you know, current regulatory environment is highly favorable to each of these therapies to reach approval. So, you know, some of the companies I talked about, you know, Definium, DFTX. Um, you're on compass right now. Uh there's DFTX, there's uh uh ATAI, which, you know, um is launching a pivotal program for uh BPL003 in the second quarter of 2026. And um that's an intranasal um uh psychedelic therapy um that that they have moving forward. Um and then you know I talked about C MPS and then DFTX, but there's there's many others. Uh PBM. Um PBM had a uh that's Sise biomedical and very thin trader. Um that stock spiked um to you know 14 bucks yesterday. Um and uh going into the weekend, I think it was four or five. So it's still holding steady at at near 10. Obviously, the the uh XBI and the IBB were down today. But um the reason I bring that up is just going to what you were saying is that um a lot of the valuation on these companies have been lowered um over the past year because there hasn't been that support um from health and human services and FDA for psychedelic drugs. But again, as I mentioned, as of December, or excuse me, as of the 18th um of April, that that all changed. So I think we're gonna start seeing more movement. We're gonna start seeing um um, you know, uh expediency in terms of these products. And so it's it's it's another space that's being developed within the biotech space. So um I think it just creates excitement and adds uh more volatility and uh productivity to the to the sector.

SPEAKER_01 11:06

Yeah, it's almost like you know, there's there's a lot on the regulatory front in general, it just within biotech. But then when you take something like psychedelics, right, which is clearly, you know, uh something that has been has has evolved much more recently, right? It almost kind of doubles down on that to your point. Like if you don't have that support from a regulatory standpoint, it really can impede any progress. So anything that occurs in that space, i.e. something like that occurred, like that what occurred on the the 18th is is huge, right? Um it's almost kind of like it it requires it in order to uh in order to foster the growth within that kind of niche arena in biotech.

SPEAKER_02 11:51

Absolutely. And like you talked about, um, without that support, you don't have big pharma getting behind and pushing with with the dollars that they that they can uh push with. Um, because they're not going to touch anything that they don't see being a growth opportunity. A lot of the mid-cap and small cap that are getting bought up right now have um designated spaces that have that we've seen grow. GLP1 being an example, you know, pretty much being something that was just talked about a few years ago to all of a sudden, you know, you have several products on the market and you're seeing, you know, Will Covey and and uh you know all these products that are that are being have been accelerated in terms of their you usage in the past six to six months to 12 months. So it's it's been pretty remarkable.

SPEAKER_01 12:39

Yeah, absolutely. Um that's really cool. Um I'm glad that uh we were able to touch on that. Um and for anyone listening, um, as we always say, you know, we do look at the comments. If anyone has any areas that they want us to to discuss or look into, we're happy to do it. So um thanks so much for touching on that, chef. But let's let's dive into the uh the current watch list and see, you know, sort of what's changed since last month, what is new and upcoming. And yeah, if you want to just kind of walk us through what your what your plays are currently, what you're what you're thinking about in the next couple months. Absolutely. If you find the information that Chef is presenting on this podcast useful and would like to gain more insights into his trading strategy for individual tickers, you can donate to this charity, the Northwest Association for Blind Athletes, and all individuals donating $300 or more get full access to his VIP private X account. Founded in 2007, the Northwest Association for Blind Athletes is a national leader dedicated to improving the quality of life for children, youth, and adults through participation in sports and physical activity in communities across Washington, Oregon, Idaho, and Montana. NWABA's programs focus on helping people who are blind build confidence, gain self-esteem, develop friendships, and reach their greatest potential. You can donate by clicking on the link at the bottom of our podcast page, www.biofarmcatalyst.com/slash podcast, or via the link in the YouTube video description.

SPEAKER_02 14:10

Um one of the small caps that I think is very interesting,

Outlook Therapeutics FDR meeting FDA

SPEAKER_02 14:14

and it points to the fact of the way the new FDA in terms of you know, of the one study, um, one designated thorough study that shows statistical significance in terms of efficacy and tolerability gets approval, that this is really affecting the smaller companies that have had to go through the two-study process in the past and have not pushed through. Um I and the reason I bring that up is because of Outlook Therapeutics, ticker symbol OTLK. Now, as everyone recalls, they um had a complete response on December 30th, and it was a third complete response. Now, they had been in, they had been in contact with the FDA several times um regarding this um third complete response, and they believed that they had aligned with the FDA on what the FDA had asked for. They had done two studies. They had done the NOS II and the NORS 8. Um, the first study, the NORS II, showed statistical significance in terms of efficacy and tolerability. But at that time, which was three years ago, the FDA wanted to see two clinical studies that looked at um, you know, in the ophthalmic space with uh macular degeneration. And so um the second study um didn't meet the statistical significance. And when the FDA, even though Outlook thought that they were aligned, when the FDA looked at them in December, they said, um, you're not approvable. We don't have conclusive evidence that your product works, even though they had um done two studies and then had done a follow-up study to that. So uh fast forward, obviously, to the February changes where um Dr. Macquarie and Prasad um within the FDA went to this one clinical study that you can get approval through one study. And then all of a sudden, it became a game changer. So now you had Outlook, which just held a type A meeting with the FDA in March. And after the FDA meeting in March, they decided that they were going to elevate that. And they ended up having um a meeting that was much higher in terms of um, you know, the dialogue. It was a um federal, it was a uh dispute resolution meeting. Basically, what that what occurred there is that um on Monday is that they met with the FDA um, and it was one person who's a decider, it's an ombudsman to the FDA who reviewed all of the material. There was no new material submitted. The reason this is important is because Outlook is going to try to say, and they have a lot of ground to stand on, that they have already demonstrated statistical significance in one study, which is the Norse II. So they put out a press release today in the morning that stated that they appreciated the constructive dialogue that they had with the FDA through that FDR uh federal dispute resolution process. And they believe that that meeting was an important step in advancing the regulatory strategy, and they look forward to receiving feedback from the FDA in May, which usually is within a month of the meeting. So if you look at today being the 21st, that can we can expect resolution from a letter and minute meeting minutes by May 21st. Why is this important for investors? Because this could be the first situation in terms of clinical studies where the one study is actually challenged through the FDA because Outlook has already done the studies and they feel they're being penalized. And so now with that rule in place, do they have enough justification to stand on the one study? Many people aren't sure, but this meeting definitely, even in the language of the meeting, sensed that there's going to be um, there's going to be productive movement moving forward. So I'll end with this on this outlook.

SPEAKER_01 18:15

Yeah, that's that's real it that is really interesting and very timely. Isn't it what we talked about the la in the on the last episode? For anyone who didn't check out our last episode, we dove a little bit into the the one pivotal trial and how the FDA is kind of changing its tune and that's allowing for particularly some of the excuse me, some of these smaller players to be able to um, you know, get things approved that maybe they they wouldn't have been able to get approved in the past, right? There's a lot less roadblocks. And so uh it's great to have like a a prime example of that right here. And if if if there's some success with this, right, then there's the the chance that this is going to kind of have a snowball effect.

SPEAKER_02 18:53

Absolutely. And and the one thing that there was there's one neg the only negative outcome that could have occurred, which did not occur according to the language in the press release today, is if they just denied them. But obviously that would not occur because of the wealth of data that Outlook has, as well as the fact that it's approved in Europe. And as everyone, as if people don't know that this this product is BevacyMab, which you know, Genentech owns and um the patent, there's patent expiration that's occurred, but it was these first targeted therapy for colorectal cancer. Um so obviously it's it's a neovascularization product that works within um the ophthalmic space. And so it had been used as a generic for many years, and now they want to get it on the market as an actual um approved product. And so that's where they're at right now. So I encourage um investors to look at that. There's uh again, a formal decision is expected in May in terms of either they'll get approval or they will get a adcom potentially, or the FDA will ask them in the current study form they have to produce the information that they were looking for in the type A meeting or um a potentially small study moving forward. But I think there will be success. And I think the the amount of success will depend upon, you know, um the clarification in the letter, and obviously that's going to drive the stock price. Um that's Outlook Therapeutic. Um look for that in May. Um they've got, I did want to mention they've got three months left of cash. So they've got about 13 million. They had done an offering in March. Um there's about 75 million shares in the float, um, 84 million shares outstanding, and they have a market cap of about 27 million. So um you can imagine the market cap if they get um Vemicysimab um through the FDA hurdles here shortly. So uh on to the

Sheff's Watchlist and Outlook

SPEAKER_02 20:54

next one is Mankind. And Mankind has a uh Padofa date of uh May 29th. That ticker symbol is M, Mary, Nancy, Kid, David. Um and so they've got, you know, the again, that Padoofah is May 29th. Um they have 126 million in cash, so they have 47 months of cash. Um and you know, this is uh to my understanding, this is their first time through the FDA with this um with this FURO6 ReadyFlow auto injector, which um SCP-111. And um so, you know, again, oftentimes when dealing with, you know, with with drugs that have gone through the PADUFA process for the first time. And actually, that will be there, there's two decisions. The first one is May 29th, as I mentioned. That's a Fresa. That's for that's for their inhale one product. That's May 29th. The one, the FURO6 Ready Flow Auto Injector, is July 26th. So they've got two regulatory decisions. I think those are those are pretty meaty catalysts, you know, with you have again, as I mentioned, the one on the 29th is about a month from here from now. Um, and then uh, you know, Fuorix is in July. But they they give for good um catalysts um in terms of appreciation of stock. And I will go as I, you know, I'm just gonna mention Outlook. Um, we talked about that on the last conference call, and that was about, you know, 18, 19 cents. And that one ran to as high as 40 cents this morning, um, which is a hundred percent gain um before they came out with that news today. Um, and of course, you had a sell-off. So I think um that could happen with mankind. They definitely have a lot of cash. Um, they've already got two approved products with Afresa and Tavasso being approved. So um just one to keep in mind as well for a Pedufidate. The other one is uh another one is Sing. Singulate, it's ticker symbol C-I-N-G. It's um singulate. And they're a company that that focuses on the treatment of neurobiological and central nervous system disorders out of Kansas City. And they've they've got um um a PADUFA date for May 31st for regulatory decision for their CTX 1301, which is um from their fixed dose pediatric study, um, antibiotic. And so you, you know, they're they've got 16 months of cash. Um, they've got um 18 million in cash. They have a really slow cash burn of about 1 million um a month. And so, you know, all that to say um they've run quite significantly. They've run, uh if you look at the if you look at the chart back in April, they had ran to as high as 12, and then they did an offering um in mid-March, and then it pulled the stock down to about five. Um, and it's really pulled back here over here in the last week or so. But it's starting to, it's starting to gain traction again, um, hovering near six. I think the reason why the volatility, and I've I've been, you know, watching the the chart here, is that they have a small um share count. You know, they have 12 million shares outstanding. They've got 9.6 million shares um that are tradable. And so um I think with this one coming up here uh at the end of May on the 31st, you know, we've got, you know, we've got about 28 to 30 trading days that are um gonna allow for some for some movement hires. So, you know, if you like trading, and this is a biotech that you know offers that with the with the volatility and the small share structure that they do have. Next one is uh, which is my favorite and I've owned um you know uh for quite a while, um, is uh unisive ticker symbol UNCY. And UNCY is is you know followed by a lot of analysts. Um and a lot of analysts, I'm I mean specifically um Piper Jaffrey um follows them. It's their top pick for 2026. Guggenheim, it's their top pick for 2026. And uh health um HC Wainwright, it's their top pick for 2026. Um and to put that in perspective, I was reading an article from Piper Jaffrey, and they talked about um their allanthium carbonate is de-risk for potential approval and hyperphospotemia in chronic kidney disease patients on dialysis, with their PADUFA date being set at June 29th. And they assign a 95% um approval, um, which is the highest that they've had um on any product that I'm aware of. Most of the time, these analysts set a 75% at the highest because oftentimes um PADUFA decisions can result in 50-50. But I had mentioned before um in prior calls that you know, when a CRL, when a complete response letter was given to um unisive last year, it had nothing to do with their efficacy or the safety or tolerability of their clinical studies. Their clinical studies were absolutely clean, and they had developed this profile through a 505B pathway. And um the thing that they had, there was one uh deficiency that was related to a third-party vendor. And so when the FDA set with Unisive, um, Unisiv made sure that the FDA knew that they were there was nothing that unisive could do in terms of this. So unisiv said, look, we have two drug manufacturers. We have the one that had the deficiency, or we have a brand new one that we can work with. And the FDA told Unisive they need to just continue working with the one that had the deficiency because they could get their drug quicker to the market using them because the FDA had already worked with them. So they discovered what that deficiency was. They're going to uh they they've done an inspection. And so basically, you know, it's sending the paperwork in, signing it, and saying, hey, you know, we passed inspection and all is good. Um, but the reason that's important is because the market is absolutely huge here. And um, you know, they're going to get Tadappa pricing at the first of the year in 2027 if they get approved. And um, you know, that's just allows Tadappa pretty much, it's a way to have access to their drugs. So um lanthium carbonate being used three times a day instead of a lot of these other um phosphatemia agents that are eight or nine times a day. So all that to say, their Padufa date is June 29th. There's a lot of institutional money that's invested in this. And um I just think this is a cornerstone play. Um, whether you play it for a run-up or you play it to hold through, um, I think it it offers um a lot of appreciation here moving forward. That's unisive UNCY. Well, let's look at VTGN. That's one I also own, Vistagen. Vistagen, when we talked about this on the last conference, um, was around 50 cents. Now Vistagen has 40 million in cash. Um, they only have a market cap of 23 million. So think about that. 23 million, almost 24 million, 23.7 million market cap. They've got 40 million in cash. So they've got seven months of cash, got five months of burn, and um they are are pretty much they've got 39 million shares outstanding. They've got 27 million shares at the float. I see this being a more volatile one moving forward as well. We talked about um singular or CING, but this VI VTGN also offers that volatility that offers appreciation in return as well. What do they have moving forward? They've they are um another company similar to Outlook Therapeutics, but they're not looking for Padufa. What happened was they had one study that um their Palisade study that that um was positive, and their Palisade II. Now they're, you know, obviously with the FDA wanting two studies. Um back when they conducted this, they wanted two studies, so they did the Palisade IV. Um they failed in Palisade III. Okay, so they they have one successful study, one failed study. The FDA said you need two positive studies. So of course they did the Palisade IV. They had already completed Palisade IV when the FDA said, hey, guess what? You only need one study. So Palisade IV, which is going to read out at the end of June, would be a bonus study for them. It would clearly show that they had two studies that showed statistical significance in terms of efficacy and tolerability. But if Palisade IV does not measure out and fails at their primary endpoint, then Vistagen is gonna go back to the FDA before moving forward with their new drug application. And they're gonna say, look, based on your clinical, based on what you talked about about one study being approved to get approval, we've already shown success in a prior study. So it's gonna be a similar situation with Outlook. They're just gonna be later on in the docket with June. So um I think right now uh people are seeing if they, you know, are are investing and they're gonna see if they get approved here um shortly. Um not approved, but if their if their study, their second study is successful. And if it's not, then um, you know, the company has you know ways to move forward with the FDA. But it's a solid catalyst um for them. And uh obviously there it's in um it's a uh it's a depression uh product because that the company um works in the area to treat anxiety, depression, and all other CNS um uh disorders. So um they've got that, and then they've also got um a product for uh hot flashes that they're going to um um submit an IND for. So they're submitting that IND in late May, and they should be hearing acceptance in June. So you've got the the phase three study at the end of June, and then you've got um, you know, I and D acceptance. So there's a lot that's gonna be going on for this small company with 24 million market cap, but um, you know, 40 million in cash. So I I like Vistagen because of the because of the opportunities uh there. Um next one is is guts, ticker symbol G UTS. G UTS is is fractal health. Fractal health, last time we we were on this call and we were talking um this uh about this this stock, the stock was at uh 46 cents. Um it's up to 58 cents. And what you're saying, why is it up to 58 cents? Well, uh two things. One, uh because um the company has a lot of cash and they've got catalysts moving forward. They've got 55 million in cash, so they've got about eight months um cash left because they're burning about 7 million a month. Um, they've got about 158 million shares outstanding, about 117 million in the float, and they've got a $92 million market cap. What's important about this company, though, is that um they've got they they've got um uh the the reveal study that's going to be at the end of June. And that's an open label study. Um their open label study that they did in December was a six-month window, and they were successful in that study. And this reveal is going to be the open label study in June. And then the Revita, which is their double-blind placebo-controlled study, is going to be in the fourth quarter. All those studies together are going to allow them to put together a de novo application. And if those aren't aware, on the last call, I talked about one of the catalysts being them moving from a pre-marketing authorization, um, a PMA, which is has a much more stringent process of getting approved. The company moved to a de novo. So they submitted, they talked to the FDA and said, how can we move to a de novo where the efficacy parameters and guidelines aren't as stringent like they are with the PMA. They're less stringent with the de novo, where you just have to show tolerability and safety, wherein the efficacy is a bonus, but if you're de novo, it's tolerability and safety that matters. And this is clearly shown tolerability and safety over every study that they've done to date. So um, so you've got that, and then you've got um um their their Revita product, which um is going to go, you know, there's they're gonna get feedback from the FDA on that product um uh in June as well. So you've got you've got several different things. You've got two catalysts that are big coming up in June with the reveal study, not the remain, because that's the fourth quarter study, the reveal at the end of June, and then um, you know, a CTA with their device, which is the Revita device, which lowers um which lowers weight. Um so a lot of stuff going on. So um it pulled back a little today. It's run over the past few days from the mid-50s to you know 57, 58. And um, you know, we'll we'll see what happens moving forward. Um there's a Padufa in two days, uh GRCE. Ticker symbol, GRCE. That's Grace Therapeutics. Um so Grace has 16 million in cash. They're burning about 740,000 a month. So they've got 22 months of cash uh because they have a slow burn. Um that's another volatile one that that um has shown some some solid movement here. Um if you look at the chart, it's it's actually been pretty impressive. It's gone from the 350 range in January to well over five in the mid part of April. Um it was about 530, 540. And it's pulled back since then down to 350. And I think the reason it's pulled back is investors um it pulled back to 350 and then it's shot up again. But um, you know, many would ask, would you be an investor in it now? Um I wouldn't. And the reason I wouldn't, it's it's very close to approval. It doesn't mean it won't get approved. It could, it could very well get approved. But my philosophy over the years in in trading these Padofas is if the company hasn't been denied or smacked down once by the FDA, then um that's very rare. Most of the time, as in de novos, 15Ks, anything that you put before the FDA, oftentimes they have questions. And so it with padoofas, sometimes those questions come in the form of a CRL. And there's a lot of companies that are stumped that say, you told us everything was fine, only to find out that that isn't the case when it comes time to the Padofa day. So there's there's very few companies that get through unscathed the first time, but then there are those that do. But um, I don't want to take a chance with Grace, and this is Grace, their, it's their first, um, it's their first dance um to the FDA. And so again, they've got an April 23rd PADUFA Um and you know, seeking approval for GTX 104, which is in the treatment of patients with aneurysmal subarachnoid hemorrhage. So it's it's very specific. And then they they did a comprehensive data package that was supported by positive results from their phase three strive-on safety trial of this GTX 104. So, you know, I don't know what it's going to do over the next few days, but um, you know, I think after today is is if you're trading it tomorrow, I think you might be safe. The the FDA has been on time with their decisions most of the time. And I've seen lately is if it's if it veers toward the end of the day, it can get dicey because it's either approved in the market in the after hours, which if you're looking at a thin trading stock, um, and people see that it's gonna the bottom's gonna fall out, or they will give a decision and then they'll halt this, halt the stock. So you can't trade it until the next morning. And guess what? Smart money is always gonna get out before the retail investor. That's just the way it works. So um, so that's G R C E and that is going to be again on um on uh April 23rd. So uh let's look at Goss, ticker symbol G-O-S-S. Now, Gauss is a company that focuses on areas like immunology, inflammation, and oncology diseases. Um they're looking at one right now uh for PAH, which is um peripheral arterial hypertension. Um and so they've got um they've got serolutinib, and um it's it's also called ProSera, but they have got um a meeting with the FDA in June because they had data that came out that um their phase three data that that um failed in terms of meeting their primary endpoint. So the the Goss has plans um to meet with the FDA via type C meeting where they're gonna um that's gonna occur in June. So they're they're the goal for them is to discuss the data and potential regulatory path forward after this phase three um failed trial in the with in terms of primary endpoint. So um that could be a catalyst into that meeting. Um I do definitely think it will be if they um PR what the date of the meeting is. Um that would be helpful for investors. But if you're looking to trade around this, then know that June is the is the key date that, you know, is probably a good idea to trade around it. Um the the good thing about these decisions, uh these um meetings with the FDA is um oftentimes what I see is the company will continue to move higher into a meeting, even if they know the date or even if they don't. And they only they only trend down once the meeting has been completed that you typically in the the company has sent out a press release, and then the FDA has 30 days um or sooner to get meeting minutes to them. Um that can be a catalyst or or not. Today with Outlook, you saw Outlook um have that press release, and they um said, hey, we have an end of, we just had our meeting with the FDA, we've got 30 days, and it was at 40 cents and then it pulled back to 30 cents, and then I think that kind of sets for that time to move up. We could see that same thing happen with Gossamer bio. Um and again, they've got, you know, they've got about four and a half months, 4.8 months. They they burn a lot of cash. They've got 77 million in cash, but but they're burning about 16 million a month, which which you know means they've got five months left. So um they'll have plenty through this June decision. I think, you know, if you're looking for a longer time frame, they're they're gonna need at some point to raise, probably in October, uh excuse me, in August or September. So that's gossamer. Let's look at uh TCRX. That's T-scan therapeutics. And um they've got data coming up. They're gonna have data that they're gonna present at ASCO. And they've they're um, you know, they're gonna share early clinical data on patients treated in their cohort C and their ALOA study in the second quarter. Um that's one of the um clinical studies in the, or excuse me, one of their catalysts. They're gonna launch a pivotal trial for their TSC 101 in the second quarter. Um and again, I like I mentioned, they're gonna share uh data treated of patients treating cohort C in the ALOA study, and that's gonna be an ASCO. So um that we do we definitely know that. Um and then they're gonna initiate a phase one study, um, you know, that TSC 102 A01, TSC 102 A03 in the second half of 2026. Now they've got um and they've guided uh on March 4th, um, when they came out with their earnings, they have 152 million in cash um to provide a runway into the second half of 2027. So this is a small cap stock with a lot of money. So um I think we we saw it run over the past, we saw it run on Monday, big time. Um, but over the past few days, it's really run from the 115, 120 range. It ran to as high as 150 yesterday and it pulled back to 127 today. So um, you know, it's one to watch. It's it's definitely an ascope play, as as I mentioned, a lot of these plays are. And the the one I'm gonna talk about next is an ascopla, and that's uh ticker symbol um I Mary Mary Paul. And this is IMUTEP. IMUTEP has they completed a single ascending dose study portion of their IMP 761 study. It was well tolerated across all dose levels. Um and they were gonna present more in intensive data um and phase one results at um not ASCO, but ULAR, the ULAR conference, and they're gonna have a plenary session at ULAR. The thing I like about this is they give you a specific date. That date is going to be June 4th. Um so they have a June 4th presentation for IMP 761. And um, I just I think at 60 cents, it's it's a pretty solid catalyst trader. You know, so you get in, you trade up to around June, and you see what the stock can do. Uh of course, gets to 90 cents, looking at 50% gain, gets to $1.20, 100% gain. So um it's just for those traders that like to get in um and really see what biotech has, this is one um, you know, where they can do that. They've got 152 million in cash. Um 52 week low is 29 cents. Um they're they're 50. 52-week high is is 350. Um they've got about 140 million shares in the float, 147 million outstanding. So they can move. They can definitely move. And I think having a catalyst date like this is gonna allow them to move because they have a specific date. A lot of companies don't have specific dates. So that's that's really helpful. Let's look at um Mary, Dollar, Apple, Indigo, MDAI. MDAI filed um their de novo 510 application in June of 2025. And you typically they nine to ten, excuse me, every nine to nine to twelve months is usually the time frame that the FDA takes with the de novo before approval. So the company just had their earnings in March, um, the latter March, and they the the CEO basically said they're expecting approval of their AI burn device, their artificial intelligence burn device, um uh for the treatment of burns. Um and this device is able to detect burns and help heal burns through AI technology. It's it's pretty amazing. This company has has garnered over $100 million from federal grants. They just got $30 million in April. So they're definitely well funded. Um, you know, they've got um right now they've got $12 million in cash that's not tied to um, you know, grants um from from the from the federal government. But um, you know, they have a low cash burn. They've got 14 and a half months of cash. They've got a $57 million market cap. Their 52-week high is $320, um, $52 week low is $1.13. Um, they've got 22 million shares in the float, 31 million outstanding. And this is going to happen. It's just a matter of when the FDA is going to, you know, um give them approval. Um it's hard to say what the stock's gonna do. I mean, over the past two to three weeks, the stock's gone from, you know, um actually a couple weeks, it's gone from, you know, $1.20 range. You look at this chart. I mean, it's gone from $1.20 in, you know, a week and a half, two weeks ago, to over $2, which, you know, is a 70% gain. It's pulled back to about 181. But I think anytime you start talking artificial intelligence and you start talking, you know, a device that can, you know, um help burn victims um recover and re-rehabilitate, it's pretty substantial and pretty significant, uh, especially in terms of the biotech industry. Um, so I think we'll see more of that moving forward, but that this is one you need to watch. So um I like this one, MDAI, and I do own it. Um look at PYPD. So um this is PolyPid. Um, they've had a successful phase three study. Um they have a product that that is used in in surgical patients um that you know have cancer, um, colorectal cancer. And so um they developed this polymer lipid encapsulation matrix. It's called the Plex platform to address these unmet um clinical needs or medical needs. So um they have stated since February and March that they, upon receiving, upon getting uh submitting their NDA shortly after, which should be any day now, shortly after that, they're gonna announce a partner because they want to have a partner in place to sell this um device. Um and so I I think it's going to be um you know beneficial for the company. Um, and it's gonna be benefit more beneficial for investors because I think I don't know what what is gonna happen to their market price, their their market cap, but their market cap is is relatively low. It's only 87 million. They've got 10 million shares in the float, um, 19 million, um, outstanding. And so I think the main thing to know is the NDA submission and the partnership, which they're saying is gonna be a big medical company that's gonna be able to really push this through in terms of uh their support once they get approved. So let's look at ACHV. ACHV, I've got about 10 minutes. I'm gonna uh push through these. ACHV, they've got a uh June 20th presentation, or excuse me, Padufa date in smoking cessation. Um cystasnycline is their um drug that they have. Um in the Padufa, as I mentioned, is um June 20th. Um they about a month and a half ago ran into some issues in manufacturing. Um there's some deficiencies in one of the manufacturing facilities. So um unless those are cleaned up by the time the FDA uh gives them their approval, they're gonna get a CRL. Um it could be a it could be a minor one too. It could be a it could be um a you know a two-month you know turnaround, but who knows? Um but I think we're gonna start to see more activity in the stock, you know, over the next month, um, because that's a huge market. And so um I think that's gonna give them an opportunity to to do some things and investors who decide to invest in it. So that's ACHV achieve. Um look at Connect Bio, CNTB, so Charlie Nancy Tomboy. They've got data uh from their uh Redamicabart, their Seabreeze stat asthma clinical study, it's phase two study, top line data in H1, uh the first half 2026. But the company on their site um stated that um they have June data. So before it said H1, now it's June, specifically June data. So um they're gonna have June data. Um, and I think that helps out investors a lot because it's not so um, it's not just a H, you know, first half, and we're not just trying to figure out when when that is going to be. So uh a stock that you can trade around that date. I don't know when in June. They just said they're gonna have June data, and then they're going to have September data as well. So those are two month, month time frame dates that that we have. Um not the specific date, but I I think that that's what they've that's the best they've got so far, and that's pretty good, especially when you're dealing with biotech stocks. Um let's look at IVVD, Indian Victor, Victor David. They're $1.60. They've got a phase three study. They're they're they have a long COVID program, and so that that data is gonna read out mid-year. It's their uh VYD 2311, it's their declaration study. And that's gonna be um, I say mid-year, but it's Q3, their top line data. They're $1.60 right now. They've got $207 million in cash. Um, they burn about $5 million a month, so they have 40 months of cash. So that's that's a good position. And they have a uh a deep pipeline, so they're not a one-trick pony. Um they've got ADG20, they've got Pimgarda, um, they've got several other um products as well. So um that's one I'm watching. I I don't own that, but I'm I'm definitely watching um Envivide. PMN. TMN has um that's Paul Mary Nancy. That was a stock I I was talking about back in October when it was 35 cents. They did this big reverse split. Stock ended up at six bucks from 35 cents, and then it ran um two to three months ago. It ran as high as almost $30. It's pulled back significantly since then. But they have an ongoing phase 1B trial that's gonna have a readout in mid-year, probably June or July. Uh it's a hundred patient placebo-controlled study that's designed to provide definitive data that could allow the direct progression of a pivotal phase three study. And that trial focuses on a comprehensive panel of biomarkers, especially PTAU 17, which has been shown to correlate directly with clinical outcomes and serves as a key indicator of target engagement. So significant data catalysts are approaching, and they're gonna have this interim biomarker data expected in mid-2026 and final top-line results by year in 2026. So, you know, management's already stated there's they've had strong business development interests from large pharma companies due to their, due to their um PMN 310's unique mechanism and promising safety data. So, you know, I think that's one to watch. It's again, they've they've got 170 million in cash. They've got 5 million in the float. So it's a very low float stock. Um and, you know, I think if there was a more of a time frame on when data was coming out, traders would be more apt to trade around it because it is one of the more um expensive plays um in terms of biotech. If you're looking at um smaller cap and not necessarily mid-cap and large cap in the smaller cap space, it's bigger. So um that's that. And then uh OSTX. And I like OSTX a lot. That's one that I own. And um OSTX is is awesome because and I say awesome because I love what they're what you know what they're working for. They're you know, the number one killer of dogs in the world is car accidents. Number two killer of dogs in the world is osteosarcoma. And they're working, they've got a drug that they're working with. It's the OS2 HER2, where they're trying to get approval, accelerated approval for osteosarcoma in animals and people. Um, they have had meeting with the FDA um this year. Um, they're gonna have four meetings this summer um with different agencies. So the FDA in the US, they're gonna have meeting with European agency, and um the in so they have the US, the EU, the UK, and they're all working towards regulatory steps to um get accelerated approval by um clearly by the end of the year. Initially it was a September, but then what happened was there's this technical situation with the FDA where um because their meeting with the FDA got pushed from March 30th, and usually there's a six-month period with accelerated approval, they would have had to have had the meeting by March 30th to be under the accelerated approval six months to get approved by September 30th, which would have been able to grant them the priority voucher, which you get a priority review voucher, you can sell it for 150, 200 million. So, what made that change? Well, the FDA um changed and they put in section 6604, which is an extension of technical clarification. And so what it does is um it makes two principal statutory changes. First, it replaces the prior sunset provision, you know, with this with a new deadline of September 30th that the FDA is willing to work through. So the FDA can continue to award vouchers for qualifying approvals until that date. So um this the status doesn't oppose a separate deadline for obtaining a rare pediatric disease designation, but it gives them flexibility for sponsors who develop timelines that extend several years. So in the case of osteosarcoma, they're willing to be flexible. And so I think the company is looking at potentially um early October, late October, you know, to get um accelerated approval for this OST HER2 product in in dogs uh for osteosarcoma. So um, and then the you know, just uh another technical thing. The second is that this amendment clarifies that the prior to review voucher user fee is due upon submission. But the FDA is, I believe the FDA helped them with their submission, um, the FDA um uh fee. So I think, you know, the company is on the right path right now. I think they they remove the biggest overhang in terms of cash because um initially they had a one month of cash and then they did a private offering. They have eight million dollars in cash now, which gives them seven months um uh, you know, seven months of uh of burn. Um and so by the time they're out of cash, it'll be October, and hopefully by then they have their accelerated approval uh voucher um where they'll be able to sell it for 150 or 200 million. Uh the market cap right now is 54 million. They've got 39 million shares outstanding, 36 million in the float. So um, I like this company a lot, and I I think OSTX should be valued a lot higher than where it's at right now at 138. Um I've got a few more um to go over real quick. Um ACRS, $4.20. They've got top line data in a phase one B study. Uh in it's ACRS. Um and so, you know, that that study, it's it's a positive, it's um they've got a bi-specific antibody, um, which is AT1052, and they're expecting these top line results in the second quarter. And so that's that's one that has um a clinical catalyst. I think it's gonna be really strong. Um the one I'm looking at and I own shares in is is HCWB, which is um HCW Biologics. So HCWB. They've got um you know about six months of cash. HCWB. And the reason I like this one is because um they've got data in the first half, phase one data, um for they've they've it's it's in a it's in a dose escalation study that's designed to treat up to 30 patients. And it's in what I love about this is that it's a dose, it's a phase one study in alopecia ariata. Now, if you if you recall, yesterday nectar came out with data in alopecia areata, um, and that stock went from $85 to about $104 a share. So it's a it's you know, it's significant because, you know, what they're gonna do and look for in this study is the primary objectives are evaluate the safety where this HCW 930 9302 drug is injected under the skin subcutaneously, and it's they're gonna determine the recommended dose level to advance the later phase clinical studies. So their preliminary human data readout is expected in the first half. Last time they had a data readout, the stock was extremely low at 40 cents, and they said in their press release we have positive data. Stock traded almost 50 plus million shares and surged to $1.35, $1.40. So it was up almost 200% or a little over 200%. So um I think that can happen with this one. And I really like the fact that it's a low float. Um, they have 6 million shares in the float, 7 million um outstanding. Um, and it's just it's a it's it's a low float play that offers a lot of volatility, especially if in this multi-center dose escalation study, it's positive, which I think it will be. Most of those studies are typically positive because they don't have um they don't have um hard measures in terms of um efficacy that a lot of these later stage uh phase two and phase three studies have to show. And um the final one I want to look look at for everyone is NXRP. NXRP is one of these psychedelic plays that was up significantly yesterday. It's it's run over the past week or so from $1.70 to about $320, and it's NXRP. And that's called NRX Pharma. And they had a type C meeting that provided a clear NDA pathway for their NRX 100, which is supported by real-world evidence and a broader proposed indication, which significantly derised the program. So on February 17th, they said they had an in-person type C meeting with the FDA for the Division of Psychiatry Products and the Center for Drug Evaluation, or CEDAR, during which oral guidance outlined a path for filing an NDA and getting full approval of NRX-100, which is a preservative-free ketamine formulation based on the existing controlled clinical founder, Jonathan Javit, who helped develop this. Um, but what the FDA highlighted is that the FDA required no additional non-clinical studies or bridging studies for a review of their NRX-100 NDA. And importantly, they told them that they can pursue a broader indication and the treatment-resistant depression in the context of suicidality, um, rather than limiting the label to acute suicidality. So they plan to provide additional details following the receipt of that meeting, which they've got already. And, you know, I think this outcome significantly reduces the uncertainty with their um second quarter NDA submission. And then they've got a Padofa date of July 29th. So this is significant, I think. Um and I think we've seen the volatility in this play. We saw it as high as $3 yesterday, a pulled back today. But NRXP is one that that has the July 29th Padofa date. So it's definitely one to watch, one to look at, and um, you know, one to continue to continue to evaluate as a trader, especially as some of these other we get through these other catalysts, these, you know, these catalysts that we've talked about. Um, but um there's a lot going on, and that's it from here in terms of catalysts in the second quarter and early third quarter.

SPEAKER_01 1:03:27

Thanks so much, Jeff. That was uh great as always. We obviously went through a ton of information. Um and again, really appreciate you walking through walking us through all of that. Obviously, as usual, there um, you know, there's just so much to go through. So um, but it's it's a very exciting time. Like it, like you mentioned, 2026 is just a big year for a lot of these catalysts, and um, you know, it they're clearly operating in a lot of different arenas, right? Um, a lot of different, a lot of different indications, a lot of different um uh therapeutic areas. Um, so I think no matter kind of what area you're focused on, there's gonna be something for you. Um and it should be really interesting to see how some of these Padufas play out, how some of that uh that um the pivotal, the one pivotal trial stuff from the FDA plays out as we move forward. So uh again, really appreciate the time. Um for everyone on the call. Um as always, you know, listen to this episode a couple times, um, take notes, feel free to ask us any questions um that you have on any of these. Um and if there's any other areas that you want us to cover, please, please comment in in our comment section. Um, and as always, just you know, like and subscribe to our channel if you if you um you know like like this content and want to see more. But really appreciate the time, chef. Thanks so much, and um we will uh we will see everyone uh next month for another episode.

SPEAKER_02 1:04:51

Absolutely. Thank you so much, John, and and take care, everyone. Thank you for watching and listening as well. Bye now. Have a good one, guys.