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Tough Calls

I did not make very many changes to my portfolio last week. Yet it felt like a busy week because I did so much thinking about it.

It was a good week for thinking. Our family finally succumbed to COVID. My daughters had it during the week. My wife has it this weekend. I think I had it last week as well, I was ridiculously tired and headache-y, had weird neck and shoulder stiffness, had a worrisome (at the time) tingly feeling down my arms for a couple days, but I never tested positive, never had fever, never had a runny nose. So I don’t know.

Market-wise, there are so many things going on right now in so many directions. It is really tricky.

Let’s start with what we know. Biotech is going up. Finally. The question I am starting to ask is when do I sell some of these names? I think its a real balancing act.

On the one hand, I need to reduce my positions and take at least some profits. I have to, regardless of what my suspicions are about where we are going (I kinda think biotech goes higher). But I have to because I just don’t know. No one knows. Biotechs could flip and go back down for any number of reasons.

But at the same time, I did not go through that miserable biotech winter just to sell out for a 20% gain. Many of these stocks are up a lot from the lows. But they are still a double away from where they began the year and in many cases a triple or more away from the high. Its the same business. Just a different market. And markets change.

So like I said, its a balance. I have to trim in places. Sell down a little when a stock really takes off. But I can’t bring myself to a wholesale liquidation, even though the gains this last week have been significant.

I did add one new biotech position this week. Cidara Therapeutics. Its a decent story with a story in a story so here it goes.

Cidara’s lead program is Rezafungin, which is an anti-fungal that treats Candidemia and invasive Candiasis.

These are usually hospital acquired infections. The patients get very sick and many of them die. There is an existing treatment, but its old and, with a mortality of 35%, it doesn’t work that well.

Rezafungin finished a Phase 3 trial with results published in December. They were good results. Good enough to file an NDA (new drug application) with the FDA, which they expect to happen shortly.

I don’t really remember who told me about Cidara. It was back in December and I do remember it was someone telling it to me via a Twitter DM. But that DM isn’t there any more so whoever it was must have left Twitter.

Anyway, at the time I passed because Cidara didn’t have a lot of cash, they weren’t a negative enterprise value (I was all about having more cash than market cap back then if you remember) and I didn’t really know how they were going to get the money to commercialize Rezafungin, which seemed like a hurdle.

Flash forward to last week and I saw they did a Research and Development day. I went through their presentation, not really thinking much of it, when I saw this slide:

And that is like, Oh, well that’s interesting.

One thing I didn’t mention is that Rezafungin is already partnered for ROW ex-US and Japan. They had a partnership with a firm called mundipharma, which is where they got the cash to get this far:

So now Cidara is thinking that they will partner the rest of it. I listened to the Research Day call and they said they have had a lot of incoming interest in a partnership since the Ph3 results. Interesting. They say they think they will have something in place by the time they file the NDA. Interesting. They also say they will be filing the NDA shortly. Interesting.

But nothing here is a sure thing. I could get totally screwed on this by some sort of crummy financing that comes with the partnership. In fact, this is just what happened to me with another stock – Precision Biosciences – a few weeks ago.

Let me digress this story into another story that illustrates the caveat.

So I hold this other little biotech, Precision Biosciences. It’s kind of a crappy company. They do something like CRISPR but its probably not as good, the clinical results are promising but at the same time not promising, they do the same CAR-T stuff Caribou does and have the same problem with durability. And up until very recently the stock has been a complete disaster.

The stock was down at like a buck-20 a few weeks ago. It was finally trading less than cash. I was tempted, but I also didn’t know how they were going to make it as a going concern given the cash burn and the low cash levels. It seemed like they just might go bankrupt.

Then I saw this tweet.

That’s quoting the CEO pic.twitter.com/jLQ8qZSqR2

— Michael Klugmann (@MKlugmann) June 13, 2022

So I was like, oh, that’s interesting. And I bought DTIL.

About 8 days later DTIL announces a partnership with Novartis. For sickle cell, because every gene editing company needs a sickle cell program. But whatevs, its cash, $75 million, and that will keep them afloat and put another program in their pocket and all those shorts betting the company is going to go bankrupt are going to have to cover.

The market realizes this and the stock SOARS in after hours. I mean SOARS! It goes from $1.30 to $3. I’m rich! (well, not really because I don’t own that much, but nevertheless, its a win).

But then, BUT THEN – half an hour later – half an hour – they announce a bought deal financing. AT $1.39!!!!!

What a mess. The stock comes right back down. It trades at $1.50-ish the next day, a far cry from $3. I still hold my shares and they are doing pretty well because of the biotech resurgence, but still, it was a total gong-show.

So back to Cidara. Its kinda the same situation. You have a cash strapped company that just hinted they may come up with a deal that gives them some cash. If they get that cash, the market will flip from ‘this company ain’t going to make it’ to ‘this company can live to fight another day’.

But like DTIL, Cidara also could decide to completely screw over their shareholders in the process.

Neverthless I took a small position in Cidara on Friday. Small because of all of the above reasons and also small because I don’t really understand the molecules they are pivoting too. Its something called their Cloudbreak platform, they are going after oncology, its a big switch. I need to dig into that to make sure there is actually something there.

So that’s biotech. Oh, and Eiger had news of sort. Something is happening. We don’t know what. But at least we have a date to work with.

Onto SaaS. I did lighten up a bit on the SaaS stocks I bought (OKTA, AYX, DDOG, CRWD and ZM, which I added more recently). They have had a nice move but I’m not sure how long it will last. They have a few headwinds.

First, interest rates aren’t exactly heading straight down and in many ways these stocks are little, micro interest rate bets. Rates go down, future earnings go up and the stocks with them.

I don’t know what to make of rates. On the one hand I get that a lot of this inflation should be transitory and the market is probably finally caring about it just at the time it should stop caring about it.

On the other hand, I’m not sure. And when I’m not sure, I don’t have to be long the stocks that express that idea.

Second, I can’t help but shake the feeling that this is a little like telecom in 2000. Back then, there were all these telecom companies that were booming and then all of a sudden they weren’t booming. It stopped on a dime largely because they were all booming on the backs of one another. Everybody was buying from everyone else.

I have a feeling some of that has been going on with SaaS. And I really wonder if some of this “secular growth” is going to turn out to be less secular then we thought because of it. So I don’t want to be too long and I may sell the rest this week before earnings start to hit.

Finally oil and gas. I spent the first couple days last week frustrated that my oil stocks kept going down. So I kept buying them. Then I spent the last two days of the week selling what I bought as they came right back up again.

I made the case for owning some oil stocks in my last post. I tweeted that I thought it was getting a little silly on Wednesday.

Crescent Point had a nice pop the next day after they increased their dividend. So that’s great. But, I don’t want to be too long oil stocks here.

There is still this whole recession thing that seems quite plausible. And then there is Biden’s visit to Saudi Arabia. A good point was made on one of the Gulf Intelligence podcasts last week. I can’t remember which guest, but they pointed out that Biden would only be going to Saudi Arabia if he already has some sort of deal in the works. It would be too embarrassing otherwise.

I thought that made sense. I’m not sure exactly what Saudi Arabia can do, but they may be able to at least put on a show by making it look like they increasing production.

See the thing with Saudi Arabia is that they ALWAYS increase exports in the fall once their own domestic consumption (for air conditioning) begins to slow down. So that, and some releases from their strategic reserve and what-not could make for a big announcement and fan fare that makes it look like they are coming to the rescue. That makes me a bit nervous being too long oil here. I’ll keep my positions reasonably small.

Last, last thing. I put back on some of my index shorts again. I’m not unhedged any more. The market is well off the bottom now. It could verily easily keep going up. But I’m not really getting paid for heroics so I thought I’d feel better knowing that I’m not making a strictly one way bet.

The Gong-show we call the Russell Rebalancing

I think that the most frustrating weeks in the market are the one’s where you actually get quite a bit right, but you don’t do particularly well because of it.

That is what happened to me this last week.

This was by far one of the most difficult weeks of the year for me. I have no problem with being wrong. I’m wrong A LOT. I can correct it when I’m wrong. Reevaluate, change course. But when I’m right and it doesn’t matter, that is when it is SUPREMELY frustrating. I must have said the words ‘how the hell am I not going up?’ about two dozen times this week.

As I wrote in my last post, I was finding it hard to be bearish at the end of the last week. Sentiment was awful. Everyone was acting like the world was falling apart and all I saw was some tightening and a continuation of the momentum collapse. As such, I had covered most of my shorts. While no one was calling for a rally, that is how I positioned myself.

And we got it! Exactly as I thought.

But here’s the problem. My portfolio is hardly any better off now than then. My wife’s account, where I’m a little more conservative and take smaller long positions, was actually down a bit on the week!

THAT is frustrating. It is one thing to be wrong. But it is another to be right and still be wrong.

So what happened?

Well first, there was one thing I wasn’t right about. Gold stocks. No surprise there. They kept going down. And so I lost money there and have already reduced these positions somewhat.

But my foray into gold stocks was not completely without merit. I was prescient enough to have a revelation on Tuesday. I’ve written a couple of times about how gold and SaaS move with one another with some correlation because both like low real rates. It is not a perfect correlation and other factors impact it, but there is a kernel of truth to it.

This occurred to me on Tuesday, as it also occurred to me that if we were actually going to rally, these bombed out names should do well, so I bought SaaS. I took positions in DDOG, OKTA, CRWD, SNOW and AYX. I have since sold CRWD after it took off 15% the next 3 days.

Imagine if I hadn’t. How much would I have been DOWN on the week?

This is a trade for now. I’m not really convinced this is the bottom for these stocks. I’ve been reading about A. layoffs and hiring freezes around Silicon Valley and B. declining digital ad spend. These two things make SaaS treacherous because of knock-on effects. For example – are companies going to need more JIRA licenses (that is Atlassian) if they aren’t hiring? How about Datadog – this is infrastructure monitoring where pricing is per host – are we going to see as many hosts signed up (hosts are servers or applications that need to be monitored) if companies are cutting back on spend and trying to get profitable?

So buyer beware I think. This is a trade, a bear market trade, and one I don’t want to overstay my welcome on.

Let’s see, what else. Well there was the Canadian dollar, which always works against me on an up week like this, but that is expected. And I also had a couple of single stock hiccups. Rada Electronics got acquired and the stock tanked. CRISPR Therapeutics tanked on their Innovation Day (and I made it worse by selling into the tank, buying back, selling again – indecision is killing me right now).

And then I had this damn Russell rebalancing. I HATE the Russell rebalancing. The number of times I’ve gotten hosed by the Russell rebalancing is too many to count.

Consider BCB Bancorp. This is a stock that is lucky to trade 10,000 shares in a day. You can put a bid out there and it will sit for days without getting filled. Yet on Friday BCBP traded almost 2 million shares and the stock tanked to $16.50 on a day when the market was up 100 points and the KRE (the banking index) was showing a big white candle. There was no news. I am positive it was all Russell funds selling an illiquid stock to balance out their holdings with the new index make-up.

Well at least BCB Bancorp didn’t drop 30% in the last 5 minutes of trading. That happened to Corvus Pharmaceuticals and a number of other biotechs (IFRX was the worst I saw – it went from $1.30 to 78c in the last 5 minutes).

With Corvus, because my luck is complete garbage right now, I actually started a tiny position early Friday (I mean, come on!). I talked about Corvus a while back. It is far from the perfect investment but everything has a price. It is trading under cash, has a stock position in Angel Pharmaceuticals worth $30 million, they have an anti CD-73 molecule that I think could see a partner at some point, and there is enough cash there that I don’t think a crazy dilutive raise is imminent. And most important, it has a chart that is perking up nicely.

I should say had a chart. On Friday at 1:55 Corvus completely fell out of bed as Russell rebalancing sellers sold indiscriminately. The stock went from $1.10 to 80c in maybe 2 minutes.

Look, I don’t like to add to losing positions. It is a rule I try to stick by. That goes doubly for losing positions I just initiated that day. But with Corvus, I think the frustration of the week got to me. I was fortunate (unfortunate?) to get an email alert right away saying Corvus had hit a 52-week low. Then I did a quick check to see if news had come out (it hadn’t), and I suspected this was Russell shenanigans. I knew Corvus had no data pending and I knew there was plenty of cash on handso the chance of a highly dilutive offering seemed unlikely. So I just said screw it, if you are going to give me this stock at 80c I am going to buy whatever you give me.

And that is how I became the largest shareholder of Corvus Pharmaceuticals.

LOL, I’m JOKING, JOKING, kidding, kidding. I couldn’t resist the set-up.

But I did buy some more Corvus, its a 2% position for me now, which is larger than the 0.5% position I had intended to hold earlier in the day. I am hoping to be able to reduce it back down to a more reasonable level this coming week, now that the rebalancing is over and hopefully some sanity returns.

There was one other instance Friday where Russell rebalancing gave me an opportunity that I could not pass up. I tweeted about this one.

As you know, I own Bioceres – BIOX. Its an ag tech name, they genetically engineer seeds, they engineer better fertilizer, better adjuvants. I think it is a very interesting little company that the market overlooks because its in Argentina and trades by appointment.

BIOX has a merger agreement with another company Marrone Bio. I own some Marrone Bio as well because it trades at a discount to the merger value and over the next month or two that should close.

I don’t believe there is any reason to think this merger doesn’t close. It seems to be progressing as expected. Marrone Bio has traded at about a 5-6% discount to its implied merger value for the last while, which is pretty typical stuff.

But on Friday that all went to hell. BIOX went up about 30c to $13 while Marrone Bio went down as much as 7%. Marrone Bio did it on 10 million shares traded, a ridiculously high amount.

Usually any trade with Russell rebalancing comes with the nagging uncertainty of – what if this isn’t because of the Russell? What if the timing is coincidence, what if the stock is going down just because its going down?

Well with Marrone Bio you actually had a benchmark of where the stock should trade. BIOX at $13 means fair value for Marrone Bio, given a 0.088 share exchange, is $1.144. So when Marrone Bio is trading at 97c, that is getting to be quite the discount.

As you might expect I added to my Marrone Bio position.

So those are my Russell rebalancing stories. On none of these stories was I up on the week. I lost money on BCB Bancorp, on Corvus, and on Marrone Bio. I also had a couple other biotechs that had been up with the market on Friday give up all their gains in the last 2-3 minutes of trading. Fun times.

Final topic of conservation – oil. Going into this week I had no intention of buying back any of my oil stocks. I thought I was done for good. I had sold them all back in May, then I fooled around buying them back a couple weeks ago as I was sucked in by FOMO against my own better judgement only to quickly sell them again for what I thought was for good.

But then this week the oil stocks went down, and down some more and down some more. By the end of Thursday Obsidian Energy and Crescent Point were back to levels of mid-February. Pipestone was all the way back to where it was last November!

The only reason that these stocks should be that far down is if you think this is a redux of 2008. And there is a cohort of guys on Twitter calling this 2008. But I do not think this is 2008. I think this is more like a 2001-2002 Triple Waterfall. It is going to take time, it is not going to flush out the excesses in a single swoop, it will continue to ebb and flow until all hope is gone. And this isn’t an oil triple waterfall. its a SaaS/momentum Triple waterfall.

Given that premise, I’m of the mind that this was a little over done for the oil stocks. So I bought back all 3 of the above names. And I bought back PBF Energy as well.

Just to illustrate my thinking here. Crescent Point at its low of $8.50 was, by my calculations, trading at 3x FCF on $100 Canadian dollar oil. That is getting kind of crazy I think.

A few years ago I wrote this post where I talked about Texas Instruments and compared it to what I thought with the oil stocks.

Texas Instruments trades at a 4.8% free cash flow yield, so basically 21x free cash flow.   They don’t get the valuation because their business is growing at leaps and bounds.  In fact, revenue is expected to decline from $15.8 billion to $14.7 billion in 2019.   Even looking longer-term, revenue was close to $14 billion back in 2010, which means growth since that time has been minimal.  At best this looks like a 5% growth business over the long-run.

But Texas Instruments gets a reasonably strong valuation because the company has been very good at returning cash to shareholders.  In particular, Texas Instruments is excellent at repurchasing stock.

I realize that the comparison is far from perfect.  Oil is not technology.  But see my point. The Canadian oil producers have transitioned to a business model that emphasizes free cash flow.  Now they are beginning to return that free cash back to shareholders by buying up their shares.

That kind of sums up my thoughts here again. Crescent Point has a $150 million buyback for the first half of 2022. I betcha that is going to be higher in the second half. Remember that Texas Instruments had a flat to declining revenue business but a great performing stock for years. This was because the company buoyed its stock price by repurchasing shares and investors and traders made this a virtuous circle because they saw the shares were supported.

That is what I expected back in 2019 with the oil stocks and it is what I still expect today. Now that we have the excesses knocked out and all the Fintwit oil bulls back on their heels, I think it is worth taking a position on these stocks again.

Is the Hard Thing the Right Thing?

The reason for the title is that I found it very hard to write this update. Not because I don’t know what to say. I know exactly what I am thinking. But because it is one of those times where I am very conscious that I am not inline with what I’m hearing from most and so very conscious that I am wrong.

Through this whole downturn in the stock market I have been cautious and hedged. Apart from some individual stock episodes (I’m looking at you Caribou Biosciences), I have mostly avoided having my portfolio whacked by this bear.

But with the market now in the 3,600’s, I’m finding it hard to be as bearish as I was at the beginning of the year.

This week I took off a lot of my hedges. I’m less hedged right now than I’ve been in quite some time. It is difficult to write that.

I’ve done it with an extreme skittishness that illustrates how nervous this market is making me and everyone else. I take some off, I get nervous about doing so, I sell some longs to reduce exposure overall and make the nerves subside, then that doesn’t feel right so I buy some of the longs back.

It’s a messy process. It is like searching in the dark for a comfortable chair. I don’t know what it will feel like until I get there but when I sit down on a hard rock, I know it right away that isn’t it.

Thus my portfolio has had a lot of turnover in the last couple weeks. There are a few stocks where it is embarrassing how many times I’ve bought and sold them, as my inner struggle with what I really think waffles back and forth.

The worst has been PBF Energy. I bought it a few weeks ago and did very well. When it got close to $40 I knew it was way overbought and I sold. But then it started to come down and I was torn between A. thinking oil had to come down, B. oil not coming down, C. PBF being on a parabolic move up that usually doesn’t end well, D. PBF still being incredibly cheap if it can over earn on current refining margins for any decent length of time, E. wondering if the government is going to step in and screw the refiners, F. wondering if I should buy the dip now that the news is out that the government is going to screw the refiners and G. wondering if nothing PBF specific even mattered if the market was going to tank.

Its been a rollercoaster. I’ve bought and sold PBF Energy 6 times in the last week, which is ridiculous. It hasn’t been a good trade – with my indecision I’ve lost about half the gains I made on my original purchase. But I don’t own PBF any more. I think I’m done with it now.

In fact, the reason I’m finally okay with being done with PBF is the same reason I’m feeling a little more positive. We saw oil crack on Friday. We saw rates crack on Friday. That is not necessarily a bad thing.

Of course, both could be spun negatively, and they are – ‘oh look, now oil and rates are saying a recession is coming’. Honestly, if the market wasn’t where it was, I’d probably be inclined to make the same take.

But it would not going to take much to flip the boat to a more positive narrative. Extreme pessimism breeds a new positive narrative.

There certainly is a lot of pessimism to go around.

Bank of America’s Bull/Bear indicator has hit the ground:

The equity Put/Call ratio is at a level we have only had twice.

The bears are loud on Twitter. Some of the bears I follow, many of whom have a tendency to not be right that often, are tweeting stuff about how they are as short as they can be.

Now I know, I know, the counterargument is that you always have extreme sentiment right before the crash.

But quite honestly, I’m kinda wondering if that isn’t what just happened.

I wrote back in May that my assumption is that this is a Triple Waterfall type bear market. And that this means it will take time.

To me, the important takeaway from this is that what we are experiencing now is not about some one day “crash” that flushes away excess, cures the system of its malaise, and allows us to buy TDOC, SE and PTON again with reckless abandon. If this is a Triple Waterfall, which I think it could very well be, we will not be let off so easy. This will be drawn out for a few years more (I don’t know if I agree with the decades he describes) until the last of hope of the past belief has been vanquished.

This is still what I’m thinking now. I don’t think we are going to have a big 1987 type crash but I also don’t think this is going to be over any time soon.

Absent a big crash though, everyone is so bearish and the market has already come down so much, it seems like a decent time for a counter trend rally.

I don’t believe this enough to be really long here. I am actually less long than usual. The difference is on the short side, where I have taken off a lot of my index shorts and reduced individual name shorts to the one’s that are really crappy.

You have to remember, sentiment can change quickly. Just go back to that May post I linked to. My other main topic of conversation in that post was CRSP and how I couldn’t believe how cheap it had gotten, how negative everyone was on it, and yet it was well on its way to having its first approved drug in a few months.

Fast forward to and a month and a bit later and CRSP is 50% higher. Things change.

On the long-side, what did I do this week?

I bought back a bunch of my gold stocks. Speaking of negative sentiment, the gold miners bullish index is plumbing the depths again, which, if you can take the ridicule and a few more days of pain, is usually an indicator that miners are going to go up again.

I also held tight my biotechs. I am very, very cautiously optimistic that they are bottoming. CRSP is the leader here and you’d never know how bad this week was if you just looked at its chart:

Even ARK Genomics fund held its own during the last 4 days of the week amid the market carnage, including a big volume day Friday.

As for me, I have taken it on the chin in a few names.

I had a big miss with Caribou, which I should probably write about because I made a stupid mistake there. I knew the Caribou data was not going to be great. Everyone knew it. Yet I kind of just forgot to sell the stock. It was a total oversight and a costly one.

And Eiger has not panned out so far. I’m sticking with it. The stock is down because at the Jefferies conference they said they would not be submitting their EUA to the FDA for Lambda until after June 30th. This after they had said they would submit it by June 30th previously.

This isn’t great and the market reacted as such. You could read into it negatively if you’d like. I’m still optimistic though, because:

A. The same day that they announced the delay, Eiger announced a new credit facility to replace the old one and on better terms. Plus the lender took $5 million of stock at $6.60, or above the price at the time. This lender is almost assuredly aware of all the details of what is going on with the FDA and the EUA, so why lend this money out and take equity if it was bad news?

B. This whole EUA process is a bit suspect. If you listen carefully to what was said at the Jefferies conference, Eiger said they were submitting data the FDA had requested, including analysis of how Lambda performed with each variant of COVID. Wait, what? The EUA is the data submission. You didn’t hear about VERU (another COVID treatment play which I don’t really think much of) submitting data ahead of their EUA or having the FDA request data (and believe me, with those guys you would). But here we have EIGR is submitting data in advance of the EUA? And the FDA is requesting that data in advance of the EUA? What is really going on here?

C. That variant analysis was illuminating. It shows that Lambda worked way better with Omicron than it did with Delta or Gamma.

This is interesting because with just about every other treatment it has been the opposite. Omicron is escaping what worked previously. It also starts to make sense why the one earlier trial of Lambda, back in 2020, had kind of lackluster results. But with Omicron, Lambda appears to be extremely helpful

D. We had evidence out that paxlovid isn’t all its cracked up to be. Pfizer had data from their second study out, the one where they had mysteriously removed vaccinated patients half way through. Well, we know why.

E. Covid is over and not over. Yes, it seems past for most of us. We are getting on with regular life. But a couple things here. First, if you follow epidemiologists closely, they are a little worried how COVID keeps evolving. There was a paper out just this week about how the virus is sitting in people with long-COVID for 12 months or more, and all that time it is adapting. Another recent paper is suggesting that the most recent Omicron variant has figured out how to be more virulent against people that were infected with the first COVID variants – its kind of like having inverse immunity. There is all kinds of stuff going on under the surface. Hopefully none of it amounts to anything. But as a government, I think you’d still be crazy to not try to be prepared for it, have a war chest of therapeutics at the ready, just in case one of these new mutations goes off the tracks. Lambda really looks well positioned to fit into that box.

What’s not Working

Those of you that have read this blog for a while will know that my posts mostly focus on the stocks that aren’t working.

If a stock is working, I rarely write about it. If a stock works off the get-go, I may not even mention it all.

Why is that?

It’s no fun writing about what’s going up. This is a private blog with a handful of readers so its not like I’m getting some sort of chest beating bravado by talking about a winner. I’m certainly not trying to procure subscribers. When I reread something I wrote about something that has gone up, I usually cringe.

It is far more interesting to talk about what isn’t working. And that is, in fact, where I spend my time.

Again, if a stock is working I may not re-visit it for months. This is sometimes to my detriment as I have found that I can lose the thesis: in other words something changes even though the price doesn’t and I don’t realize it until its too late.

But there is only so much time in the day and it is better to spend it on what worries you the most.

What has worried me for the past couple months is biotech in general. But now that is right-siding for the most part. My worry now has become more dialed in. To a specific biotech. Eiger.

I already went through the story of what is going on with EIGR a few posts ago. I’m not going to rehash that.

But we are in June now, 3 weeks from July, and there is still no EUA and no real update for that matter.

A friend asked me whether I was concerned. In particular he asked me about this tweet:

Here was my response.

Yeah it is related to what I was saying.  But its more nuanced than his tweet. I had to talk to some folks to understand this, but I think I have it straight now:

So EIGR owns peg-interferon lambda.  It is not an approved product.  If you want to do a trial using an unapproved product, like peg-interferon lambda, you have to get EIGR’s permission.  This is different than if a drug is already approved for an indication.  If it is approved, then you can just buy it and use it in the trial – the company doesn’t have a say.

In this case for whatever reason the TOGETHER doctors went to EIGR and asked for permission.  EIGR said okay.  Some agreement was reached.

But this isn’t EIGR’s trial.  They don’t have anything to do with the trial itself, the data collection or the primary data analysis.  They aren’t a sponsor.  That is all on the TOGETHER doctors.

Yet while the TOGETHER doctors are responsible, at some point there is a data transfer to EIGR.  We know this because on the Q1 CC EIGR said they would be the ones publishing a manuscript and they would be the one’s publishing the data.  They are also the one’s doing the secondary analysis, so the more detailed breakdowns and such.

Unidentified Participant [6]

 So also, I have one — just a clarify question to do the — this TOGETHER data will need to be published? Or do you need to just complete the analysis to submit to the Agency?

 David Cory, Eiger BioPharmaceuticals, Inc. – President & CEO [7]

 Ingrid?

 Ingrid Choong, Eiger BioPharmaceuticals, Inc. – SVP, Clinical Development [8]

 Thanks. Yes. So our plan is to complete the secondary analysis and submit all of it in totality to the FDA. Concurrent with that, we will submit a manuscript that will include all of the data as well.

When Boulware talks about how slow EIGR is, I don’t think he is understanding the above situation.  One day before that tweet EIGR had their Q1 CC.  On that CC EIGR said they were still waiting for the full dataset from the Together doctors.  In fact, there is a tweet in that same thread below from one of the doctors confirming they have not finished the data set yet.

Its actually kind of interesting IMO since I love to think there are conspiracies.  A bunch of guys on stocktwits are screaming that EIGR is too slow. Yes, its true, EIGR is slow in general.  But in this case we don’t actually know. We don’t know when they got the data or for that matter even if they have the data right now (hopefully they have it by now though).   I’m more than a little skeptical of some of the motives of these folks that are using this as a tool to bash EIGR management. But I’m always skeptical.

I was worried about how long the process was taking as well, but from another angle.  I was worried the doctors hadn’t published anything yet.

I’m not as worried now.  My misunderstanding was thinking that the TOGETHER doctors could publish something before the EUA came out.  I had looked at the fluvoxamine arm of the TOGETHER trial and saw that it was about 2 months from last data collection to paper.  We are way past that with lambda – its probably at 90 days or so.  That had me worried.

But I’m not worried as much now because I think when EIGR signed an agreement with the TOGETHER doctors, they had the doctors agree to hand-off the process to EIGR at some point.  So we won’t see anything come out until EIGR comes out with their EUA.

The real gotcha here IMO is the incentive misalignment.  Think about it from the TOGETHER doctor side.   They had to do this trial, compile the data, do all the primary analysis, but now they have to hand it off to someone else to do the fun stuff, write the paper, take the credit.  I’m sure they’ll get their names on it but they aren’t in control of the process.

I suspect that is contributing to the time its taking.  Its probably lower on their priority list than it was for fluvoxamine, where they got to write the paper, make the conclusions, present it at conferences.

I think my takeaway is that yes, its taking longer than I would have expected. And that may be saying something but it may not. Bottomline is that EIGR said end of June for a reason, and until it gets passed that date you have to assume its inline with their expectations.

There are other things to worry about with EIGR and COVID as well. One is whether the FDA is going to approve this. I’ve been talking with another Twitter contributor that has recently taken an interest in EIGR. His big worry is that the FDA won’t approve this regardless, because they will protect Pfizer profits.

I’m not sure what to say about this. There are certainly a number of biotech investors that think Novovax got hosed for this reason. That there are now myocarditis issues with the Novovax vaccine that the FDA just leaked are laughable to many given that the FDA approved Moderna, which had similar issues.

I spent some time looking at the Novovax data and I can see both sides. That is to say: I’m not convinced that the FDA isn’t in the pockets of Pfizer, and if that is the case it certainly could work against Eiger. Its a risk I think.

There is also the matter of a recent study from Israel which does show efficacy of Pfizers paxlovid in a largely vaccinated population:

Once you delve in to the study, it is kind of a good/bad story with a whole bunch of uncertainty. It does show very good efficacy against hospitalizations in 65+ (about the same as Lambda did overall in TOGETHER) but it doesn’t show any efficacy in younger people. That is interesting because in the US right now, as it was described by one biotech commentator, they are giving paxlovid out like candy.

Even the 65+ cohort, results are a bit less positive if you dig deeper in the study (or the twitter thread!). In particular when you separate those that have been exposed versus those that have not.

You can see that even in the 65+ population, there is a big difference between the benefit of paxlovid in the prior immunity vs no prior immunity groups. If I understand absolute benefit correctly (and I might not) it is saying that for every 100 people that take paxlovid, you get 0.7 less hospitalizations from the prior immunity cohort, which doesn’t seem like that much benefit to me.

Absolute benefit also has issues. There are lots of papers that talk about them. Not the least of which is that it really depends on the baseline. And the Israeli trial is tricky there too. The cohort not taking paxlovid is massive – 42,000 people. The cohort taking paxlovid is much smaller – 2,504 people. Is this apples to apples?

Anyway I could go on and on. There is other things too but I’m not sure enough about them to write them up. Bottom-line, I don’t think this study is a negative for EIGR.

What is going to really matter for EIGR is how the lambda detailed data plays out. We know that the TOGETHER trial study showed lambda 3-day data is comparable to what we are seeing from paxlovid here and that included everyone, over 65, under 65, prior immunity or not. What we don’t know yet is how all that data breaks down on the lambda side. Is it just way better in the 65+ without prior exposure group like paxlovid? Or is its benefit more general? And what is the population comparison? Are these unhealthier people, or more healthy? We just don’t know any of that yet.

So where do I stand after considering all these (and some other) issues? Probably about the same place I did a month ago. I don’t see any evidence that the FDA will rescind the EUA process any time soon. There is too much worry about a fall wave with a new variant. I’m a little worried about the motives of FDA but not enough to sell. I’m not too worried about the Paxlovid competition – it isn’t really any better and it has lots of other issues, like the rebound effect that has been reported and all the drug interactions that make it hard to take for some people, but I’m also aware that until we have detailed data from lambda, we just don’t know enough to compare.

Lambda’s big positive is that it is a molecule that is in our body right now, and is used by our immune system to protect it against viruses coming in. In fact in people that don’t get COVID that bad, its probably lambda that contributes to that. It has been tested extensively already – its not an unknown like other drugs with worries about poorly understood side-effects.

Meawhile EIGR stock has been on a roller coaster. There isn’t a lot of volume but there are a bunch of big blocks that happen, which is unusual for EIGR and I don’t know what to make of it. Price wise it is back to pretty much where it was when I talked last time. $250 MC, $100 EV. It doesn’t take much in the way of lambda sales to generate that much cash.

But we’ll see. This is a gamble as are all biotechs. There are all kinds of possible unknown unknowns that could be gotcha’s. The downside is the EUA doesn’t happen, its probably a $3-4 stock again. I don’t think it goes any lower just because COVID is still a bit of a sideshow here to the HDV, which are going to report out in Q4. So I think if it sells off too much you will see new buyers that want a cheap ticket on those results. At any rate, it is sure to be an interesting summer.