Reasons For Intellia Therapeutics Stock Plunge Are Flimsy, But Don't Buck Mr. Market

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Intellia Therapeutics fell 20.5% the day after it reported Phase 2 test results for a promising treatment.You’d think, from the reaction, that the news was bad.Actually, it was quite the opposite… the...

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It’s caused by what is essentially a genetic typo. Check out my 8/3/24 NTLA report. There, I describe gene editing by making analogies to text editing. For HAE, the typo occurs in a gene known as kallikrein B1 . I’m now going to skip some biological details in the interest of clarity. KLKB1 tells the liver how to create stuff that leads to blood clotting. This is good. It limits blood loss after an injury. But we can live without KLKB1. Built-in redundancies can step in and do what’s needed to induce necessary blood clotting. T","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"NTLA":"Intellia Therapeutics Inc","LU1861559042.SGD":"日兴方舟颠覆性创新基金B SGD","BK4535":"淡马锡持仓","BK4585":"ETF&股票定投概念","BK4556":"基因编辑","BK4139":"生物科技","BK4588":"碎股","LU1861558580.USD":"日兴方舟颠覆性创新基金B"},"translate_title":"Intellia Therapeutics股价暴跌的原因很站不住脚，但不要违背市场先生的意愿","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"NTLA":0.9},"content_text":"Intellia Therapeutics fell 20.5% the day after it reported Phase 2 test results for a promising treatment.You’d think, from the reaction, that the news was bad.Actually, it was quite the opposite… the results were good, and the treatment is advancing to Phase 3.Naturally, reasons for the selloff were given, but I find them very flimsy.It’s tempting to bottom fish here, but I don’t recommend that until we get another (upside) catalyst.   kiankhoon/iStock via Getty Images  I get it. Biotech is risky. Drug discovery, getting approvals, new competitive drugs… So many things can go wrong. And for investors, developments can be harder to predict than for most stocks. True some such firms are less risky than others. Established players like Amgen (AMGN), Gilead Sciences (GILD) or AbbVie (ABBV) have diverse portfolios of drugs. And they’re making money selling them. Others like Neurocrine Biosciences (NBIX) are also making money. But their portfolios are much less established. And then, there are many clinical stage companies. I call them R&D shops. They have little or no revenues. They burn cash. They live by the grace of the capital markets. They often need to borrow more or issue more stock. Or they can get cash contributions from bigger companies that hope to partner with their discoveries. Intellia Therapeutics (NASDAQ:NTLA) is one of the latter. I wrote about it on 8/3/24. I said “Hold.” I’m intrigued by what it, and Crispr Therapeutics (CRSP), are doing in gene editing. A guy I used to work for insisted that this is the future of medicine. I looked at it. And I agree. CRSP does its work ex vivo, outside the patient’s body. NTLA is taking the next step. It’s developing in vivo (inside the body) editing therapies. Neither NTLA nor CRSP have meaningful financials yet. Not being anchored by numbers, stocks like these are apt to be volatile. They’re especially prone to big moves either way based on news. And often, such news will relate to results of drug trials. On October 24, 2024, NTLA share plunged 20.5%. That was how the Street reacted to a testing announcement. It was for a drug known as NTLA-2002. That, unfortunate as it was, seems in line with what can happen to shares of Biotech R&D shops. But here, I believe, the big move should have been upward. Let’s start our exploration of this bizarre situation with some background… What NTLA-2002 is About It’s designed to treat hereditary angioedema (HAE), severe swelling. It’s caused by what is essentially a genetic typo. Check out my 8/3/24 NTLA report. There, I describe gene editing by making analogies to text editing. For HAE, the typo occurs in a gene known as kallikrein B1 (KLKB1). I’m now going to skip some biological details in the interest of clarity. KLKB1 tells the liver how to create stuff that leads to blood clotting. This is good. It limits blood loss after an injury. But we can live without KLKB1. Built-in redundancies can step in and do what’s needed to induce necessary blood clotting. This is especially good because… KLKB1 also makes bradykinin. This makes blood vessels too permeable. Blood therefore leaks out. And that causes swelling, or inflammation. We all experience swelling from time to time. But HAE sufferers have a defective KLKB1 gene. It produces too much bradykinin. That reduces something called the C1-Inhibitor. When the C1-Inhibitor is in short supply, or functions improperly, swelling can dramatically increase.  Common symptoms of HAE include swelling attacks that can occur anywhere in the body. Many people report feeling this swelling in the face, throat, abdomen, hands, genitals, and feet. HAE attacks can be painful and sometimes make it difficult to perform everyday tasks. An attack affecting the airway can become life-threatening because of the risk of suffocation.  That’s what HAE is. Here’s the NTLA’s estimate of the market opportunity for the cure on which it’s working. NTLA IR NTLA-2002 aims to knock out the KLKB1 gene that starts the process leading to HAE. On October 24th, Intellia Announced the Successful Completion of its NTLA-2002 Phase 2 Study Clinical Trials Arena headlined its story of the announcement as follows: “Intellia reports positive data from Phase II study of NTLA- 2002 for HAE.” Biospace.com led with this headline: “Intellia’s CRISPR Gene Editor Cuts Hereditary Angioedema Attacks by 81% in Phase II Study.” The New England Journal of Medicine is much more academic. So, the title of the paper it published was suitably bland: CRISPR-Cas9 In Vivo Gene Editing of KLKB1 for Hereditary Angioedema. But its substance elaborated on what the other two web sites reported. And the Journal piece concluded… None of the patients who received NTLA-2002 had serious adverse events, and treatment with the drug elicited a dose-dependent reduction in the total plasma kallikrein level. After the receipt of NTLA-2002 therapy, patients had a decreased number of angio-edema attacks per month. These results support the continued investigation of NTLA-2002 as a new therapy for the treatment of hereditary angioedema. (Emphasis supplied.) Intellia details the results on its web site. You can get it here. You can also get a transcript of the conference call it held to discuss this with analysts. Here are the highlights.  During the 16-week observation period, 25mg doses of NTLA-2002 reduced HAE attack rates by 75%. Over that same time span, 50mg doses cut the attack rate by 77%. During those 16-week periods, weeks 5 through 16 attack rate reductions were a bit stronger: 80% with 25mg and 81% with 50mg. During the 16-week observation periods, (A) nobody in the placebo group experienced any reduction in HAE attacks; (B) 4 out of 10 patients getting 25mg were completely free from attacks; and (C) 8 out of 11 patients getting 50mg were completely attack free. The patents weren’t harmed… In physician lingo, NTLA-2002 was “well tolerated.”  The differing outcomes among the 25mg, 50mg and placebo groups suggests NTLA-2002 is helping patients. This drives it home further: Patients receiving the 50mg dose also showed a greater reduction in kallikrein protein levels, with an 86% mean reduction from baseline at week 16, as opposed to a 55% reduction in the 25mg group. Remember that kallikrein is the instigator. It launches the chain of biological events that leads to HAE. If we conquer kallikrein, we conquer HAE! Because of all this, Intellia is now moving NTLA-2002 into Phase 3 trials. It is doing so only with the 50mg dose. In my 8/3/24 NTLA report, I outlined the drug approval process and discussed the testing phases. About 77% of drugs that get tested fail before they reach Phase 3. That means NTLA-2002 is closing in on the finish line. It’s still got a tough path ahead. Only 25%-30% of the drugs entering Phase 3 succeed here. But passing Phase 2 is a major milestone. And for an R&D shop such as Intellia, it’s as good an item of news as an investor can reasonably expect. But Wall Street Defied Reason and Trashed NTLA Shares Here’s the Seeking Alpha News headline: “Intellia slips after mid-state data for CRISPR-based hereditary angioedema therapy.” (CRISPR refers to the gene-editing technique.) “Slips” turned out to have been an understandable understatement. The article was posted early in the day. At the time, NTLA stock was down about 9% in pre-market trading. We now know that the trading-day decline finished at 20.5%. An Investing.com story that came out later in the day headlined: “Intellia Therapeutics stock plunges after phase 2 results from NTLA2002 study.” The BioPharma Dive story was titled: “Intellia data spark debate about CRISPR drug’s potential.” Sparking debate about NTLA-2002’s potential? Did you see anything in the above section that might cause you to debate NTLA-2002’s potential? I didn’t. All the sources to which I linked above were on point with the bullet points I supplied. And you can check for yourself to see that I’m not missing anything. You’ll find more sources if you google “ntla-2002 phase 2” or something like that. But stocks don’t drop 20% or so in a day just for the heck of it. If we don’t see a reason the first time we look, we should go further until we discover… Why Investors Did as They Did… and Sold Analysts at Baird received a lot of media mention on the 24th. They reacted to the Phase 2 test results by cutting their NTLA price target from $24 to $18. According to Investing.com… The firm noted that although the therapy provides clear benefits, the reduction in attacks may not be sufficient to overcome the perceived risks of in vivo gene editing, especially in a competitive market. In isolation, that’s a reasonable ground for caution. But it isn’t isolated. Any questions raised by the safety of in vivo gene editing and competition were present all along. The analysts there should already have factored that into the analysis that led to the $24 target price. Nothing disclosed on October 24th had anything to do with the reasons they gave for slashing their target price. Meanwhile, BioPharma Dive wrote: Intellia still needs to prove its treatment can work in the Phase 3 trial. And the company will have to make the case to doctors that it’s worth taking a bet on a one-time, gene-editing therapy rather than the pills or injections that patients have come to depend on to control symptoms. Competitors in the field are also continuing to come up with new options on the more traditional path. Of course, Intellia needs to prove its treatment in Phase 3! Every new treatment must do likewise. That NTLA-2002 is entering Phase 3 is good news. As noted above, 77% of proposed new treatments fail before getting there. And of course, there’s competition. HAE sufferers aren’t being left to suffer. They’re already getting preventive therapy. Intellia’s aim is to offer something dramatically better. Doctor Paula Busse, of Mount Sinai, said as follows on the Intellia analyst call:  [T]his is a treatment that we've been all kind of waiting for colleagues as well as patients. So really, it's a onetime treatment. It can reduce, you don't need to have additional treatment, the free from breakthrough attacks. Really, this is something we've been waiting for. And I've had patients like asking me, when is this going to happen? So it's always you know, just wonderful to tell them that this is in the pipeline. **** [S]ome of the therapeutics we have, yes, patients can be attack free. However, they do have a huge burden to - for treatment. Patients either inject once every 3 to 4 days or once a month. So it's a huge and it's not without pain at the injection site. So again, you may be attack-free with some alternative therapies, but there's a - remains a huge burden of treatment. So patients can have one treatment and the attack-free, that's amazing. It's really, again, like I said before, it's a game changer in the treatment of HAE.  C.E.O. John Leonard added: What we found in our research, talking to patients and physicians is uniformly a desire for patients to be normal if that's possible. What does normal mean? It means not having attacks, not taking therapy and importantly, not living one's life with the fear that an attack is right around the corner, initiated by some exposure or having to have your access to insurance be determining what job you take or don't take. We've seen that up and down in all the work that we've done. So nobody is denying the existence of competition. The October 24th news suggests Intellia has a great chance of beating rivals. That’s good news. Morningstar (whose reports you can likely access for free through your on-line broker), had an interesting reaction: [W]e have pushed back our estimate for when the therapy could reach the market to 2028 from 2026 due to the ongoing clinical study. I’m not sure what to make of that. Review my 8/3/24 narration of the approval path for new treatments. This was never going to be a quick process. There’s always much to do after Phase 2. I didn’t see anything that should have prompted anyone to say Intellia’s prospects should be pushed back two years from what they seemed to have been on October 23rd. The only thing from October 24th that could legitimately have thrown anyone for a loop was the result from Phase 1. In the first phase, the percentage reduction of HAE attacks was higher… in the low 90s. Analysts were concerned that the percent reduction seemed to have fallen to the high 70s in Phase 2. That generated a lot of discussion in the Question-and-Answer portion of the analyst call. In sum, the Phase 1 and 2 tests had different protocols. Phase 2 was the classic double-blind study. Some participants received NTLA-2002. Others got placebos (fake treatments that have no therapeutic characteristics.) Phase 1 was different. Everybody knew they were getting NTLA-2002. The placebo effect is well known. It’s where medical science acknowledges that mind-over-body can be a real thing. Often, people who are being treated for something expect to get better. Then lo and behold, they wind up reporting improvement... even if the treatment was fake. That’s the power of expectation, mind over body. Had placebo recipients in any phase 2 test reported improvement statistically comparable to those who got the real treatment, that would have been an epic failure. Phase 3 won’t happen. And the company would go back to the drawing board. This did not happen for NTLA-2002. It passed Phase 2. In NTLA-2002’s Phase 1, where everybody knew they were getting a real treatment, almost everybody reported improvement. The question, though, is whether everybody who reported improvement really had any HAE attacks early on. There is no biological marker for the condition. Patient reporting is the only way to diagnose. Doctors routinely advise HAE sufferers to be vigilant about reporting. They tell patients to seek immediate treatment for any kind of swelling. Delay can pose risks. That often leads to over-reporting. So, knowing they were getting an HAE treatment and that their progress would be monitored, recipients were likely to report many instances that looked casually like HAE but really weren’t. In Phase 2, nobody knew what they were getting. That removed the incentive to overreport symptoms. Does Phase 1 make you confident in the efficacy of the treatment being studied? Probably not. That’s why Phase 1 is just a warm-up. It’s why so much more has to happen before anything is allowed to enter the marketplace. This is why none of the medical professionals were bothered by Phase 2 seeing a lower success rate than Phase 1. They knew Phase 1 success rates were likely inflated by false reporting. For them, it was all in a day’s work. But for equity analysts, who have different sensibilities relating to different professions, that was an “oh darn…” moment. I’m older and probably have more experience as a patient. (Age brings more than just senior discounts!) So, I completely understand what the medical pros were saying. I’ve been there. I don’t know the demographic profile of the analysts who were on the call. But based on my experience in the profession and their reactions to differences between phase 1 and 2 results, I’m guessing they skewed younger (than me). Risks NTLA is an R&D shop, a clinical-stage biotech. That says everything you need to know about risk. There’s a lot. There always was for this sort of thing. And there always will be. What to do About NTLA Stock As discussed above, I see no valid reason for the stock to have been worth 20.5% less at the close of trading on 10/24 than it was 24 hours earlier. The only issue even worthy of discussion was the difference between the Phases 1 and 2 results. Other reasons offered strike me as contrivances. For whatever reason, people decided to sell after the Phase 2 results came out. And since the results were good, sellers reached for whatever reason they could. I know that sounds cynical. But I’m stuck. I’ve been analyzing stocks since December 1, 1979. (In case you lost count, Jimmy Carter was still President.) And frankly, this is the single least rationally explainable selling wave I’ve ever seen. Again, and I can’t stress this enough… I understand not wanting to be in NTLA. It’s very high risk. But for investors who owned it, or analysts who supported it on October 23rd, nothing changed on October 24th. Let’s finish with a look at the price chart. StockCharts.com The idea of bottom fishing after an irrational price decline sounds appealing. But folklore warns investors to refrain from trying to catch so-called falling knives. In reality, though, hardy souls can make good money doing this. (Of course, that assumes they do their homework on the situation rather than acting reflexively.) Those I know who argue against falling knives are chartists who don’t really study companies. I do. But I also care about what the mass of others is doing. (The stock market is based on supply and demand. So, we can’t ignore “them.”) Looking at the above NTLA chart, we see that momentum has been weak for a while. The downtrending 10-day exponential moving average (EMA) has been living a lot below the also downtrending 50-day EMA. I could tolerate that if I saw reason to expect change. So, I look to Chaikin Money Flow (CMF) and the Chaikin Oscillator (CO). Both measure which party to trades is more motivated. CMF does it for institutional investors. CO does it for the market in general. Both indicators are meaningfully bearish. Hence motivated sellers are offering shares to apathetic-at-best buyers. That’s a heck of a headwind against any potential stock rise. That said, I can easily envision a new trading range near the current level. That would be at least until we get another catalyst. As I’ve said before, my investment stance depends mainly on whether I think a stock will be better than, in line with, or worse than market. Here’s how I apply that to the Seeking Alpha rating system:  “Strong Buy” means I see the stock as being better than the market and I’m bullish about the direction of the market. “Buy” means I see the stock as being better than the market but am not confident about the market’s near-term direction. “Hold” means I see the stock as moving in line with the market. “Sell” means I see the stock as being worse than the market but am not confident about the market’s near-term direction. “Strong Sell” means I see the stock as being worse than the market and I’m bearish about the direction of the market.   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