Enanta Pharmaceuticals Inc (ENTA) Cotización

Well enrollment times can certainly slip right now the company is guiding to complete enrollment this RSV season so six months is about right for data

Another news today - Enanta Pharmaceuticals had its target price reduced by equities researchers at HC Wainwright from $27.00 to $18.00 in a report issued on Tuesday,Benzinga reports. The brokerage presently has a "buy" rating on the biotechnology company's stock. HC Wainwright's target price would indicate a potential upside of 195.08% from the stock's current price.

so hopefully they will complete enrollment in Q1

Is 6 months reasonable, or is that too optimistic?

doing both, bidding common @ $5.99( got odd lots today), offering Puts @ 1.40( started higher, but MM undercut so lowered)... will continue after Xmas, Enjoy :)

HR adult data for RSV programme in six months

It looks like RSV season is picking up. Hospitalizations nearly doubled in the 75+ age cohort from the week ending 11/30 to 12/7, from 2.2 per 100k to 4.2 per 100k. This season is lagging last year by about a month, and may not be quite as severe but still too early to tell, but definitely seems more severe than in the two years preceding covid, so hopefully they will complete enrollment in Q1

https://www.cdc.gov/rsv/php/surveillance/rsv-net.html

All possible short term bad news should now be priced in, and tax selling done soon, market should start focus on potential partnerships, buyout anytime, plus HR adult data for RSV programme in six months. The risk reward here is insane.

AI's "thought process" which appears relevant to conflict of interest:

A "conflict of interest" refers to a legal situation where a court decision is reversed on appeal because a lawyer or judge involved in the original case had a conflict of interest that could have unfairly influenced the outcome, potentially impacting the fairness of the proceedings and causing a miscarriage of justice.

Key points about conflict of interest overturn cases:

What constitutes a conflict:
This could include situations where a lawyer represents multiple clients with opposing interests, has a personal relationship with someone involved in the case, or has a financial stake in the outcome.

How to raise a conflict of interest claim:
A party in a case can typically raise a conflict of interest claim by filing a motion to disqualify the lawyer or judge involved, arguing that the conflict could compromise their ability to act impartially.

Factors considered by courts:
When deciding if a conflict of interest is significant enough to overturn a decision, courts will consider the nature of the conflict, whether it was disclosed, and whether it could have affected the outcome of the case. {Might be that ENANTA did NOT know that her husband had corporate dealings with PFIZER. In today's world - anything is possible.}

Example scenarios:
A lawyer representing both the plaintiff and defendant in a lawsuit:
If a lawyer is representing both parties in a case, they might be unable to effectively advocate for each client's interests, leading to a potential conflict of interest.
A judge with a personal relationship with a party in a case:
If a judge has a close personal relationship with someone involved in a case, their impartiality could be questioned, potentially warranting a recusal.
A lawyer with a financial interest in the outcome of a case:
If a lawyer stands to gain financially from a specific decision in a case, this could create a conflict of interest.

Tempted to sell puts as well.
But too greedy and don’t want to miss the upside, thinking we should at least get back to net cash value in next few months

And the crazy thing is that’s a double from here

I know they are burning cash but still…

It’s not a dying company here

alert, been slowing building position in ENTA from sales of Rvnc... also selling naked Apr. 5's to bring in maybe $1.50+ ( if exercised in April., lower's cost to $3.5-4ish) ...have a great Christmas, next year promising with Enta :)

Recused

Why didn't they have her recused? Seems obvious conflict

FWIW - Conflict of interest might favor ENTA's appeal - one hand feeds the other B.S.

Denise Casper, the Judge in ENTA's infringement suit is married to Marc N. Casper who currently serves as president and chief executive officer of Thermo Fisher Scientific.

Thermo Fisher Scientific & Pfizer Partner to Expand Localized Access to Next Generation Sequencing-Based Testing for Cancer Patients in International Markets
Tuesday, May 09, 2023
https://www.pfizer.com/news/press-release/press-release-detail/thermo-fisher-scientific-pfizer-partner-expand-localized

Was wondering why the weakness after hours last night. Thanks

I guess no Xmas gift yet

Just released -

Enanta Pharmaceuticals to Appeal Ruling Related to ‘953 Patent Infringement Lawsuit

"We are disappointed with the Court’s ruling. We believe strongly in the merits of our case, and, through the appeal process, we will continue to defend our inventions from unlawful infringement."

https://finance.yahoo.com/news/enanta-pharmaceuticals-appeal-ruling-related-120000266.html

Monday, December 23, 2024
394 order Order Mon 12/23 4:12 PM
Judge Denise J. Casper: ELECTRONIC ORDER entered. In light of the Court's Memorandum and Order entered today, D.393 , the Court is prepared to enter judgment in favor of Defendant Pfizer Inc. ("Pfizer") on the only count in Plaintiff Enanta Pharmaceuticals, Inc.'s complaint (for infringement of the '953 patent), D.1 ; and in favor of Pfizer on its Counterclaim II (declaration of invalidity for the '953 patent), D.22 at 12. Pfizer's proposed order, D.269 -1, is silent as to the only other remaining claim, its Counterclaim I (declaration of non-infringement of the '953 patent). If, in light of the rulings today, Pfizer is not pressing Counterclaim I and the parties seek to have the Court enter judgment as to Enanta's claim and Pfizer's Counterclaim II resolved in today's Memorandum and Order, the parties shall confer and file a joint statement to that effect by January 10, 2025. (Cook, Savannah)

393 order Memorandum & Order Mon 12/23 4:07 PM
Judge Denise J. Casper: ORDER entered. MEMORANDUM AND ORDER - the Court ALLOWS Pfizer's motion for summary judgment as to invalidity, D.269 , and DENIES Enanta's motion for summary judgment as to infringement as moot, D.266 . In light of these rulings, the Court DENIES the parties' respective motions to exclude expert testimony, D.264 ,265 ,267 ,268 , as moot. (Cook, Savannah)

https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Even under these negative circumstances, I agree with Dew's POSITIVE statements on X - $ENTA is oversold. Break-up cash value—including NPV of retained Mavyret royalties—is ~$20/sh.

good buy at 6.20... all the best

sounds good. Merry chirstmas

For Big Pharma (who don’t generally have a liquidity issue), all-cash buyouts are more efficient than all-stock or stock+cash deals insofar as they eliminate the time premium of stock options held by employees of the acquired company. If the acquired company has a lot of outstanding options in its capital structure, this can be a material consideration.

Big pharma acquisitions are almost always 100% cash

Unless they have lots of other ideas that they are working on. Otherwise, it’s more along the lines of:

The experimental research project you managed while going it alone that worked out means that you are completely under our control now. We bought you out. We fully expect that the founders will take the money to the bank then move on, or they, and all the employees, will just become another cog in our very large machine.

If you enjoyed the perks of being the CEO, that time is over. Everyone in the executive suite can buy a really fancy car, vacation home, and then some, but you don’t know how to manage the nuts and bolts of producing a drug in bulk quantities under sterile conditions, nor how to package, sell, and distribute it. Thank you for your initial insight, but you’d be bored to tears with the minutia from here on in.

Plus, if you were clever, your employees will at most get a severance pay, if that. If you can, get them to sign away any vacation time they are due. No pensions. No stock options. Nothing that will be a debit on the balance sheet should someone be looking to buy you out. If you are a certain kind of person, you will brag about this to your employees and rub it in their face.

A run up to high teen next year, then a buyout come in at about 200 percent premium

Let’s go

By "large M&A" PFE means deals of $10B+.

Buying ENTA would represent a rounding error for PFE's finances.

That would mean smaller acquisitions are actually on the cards. Will take cash or shares, just thought shares would be more tax efficient for us ;)

And PFE is trading cheap.

It’s Xmas time, we can all dream.

By "large M&A" PFE means deals of $10B+.

PFE announced 2025 forecast and " no large M&A's are planned for next year".

Two shares of PFE for 1 share of ENTA would do the trick. Big pharma acquisitions are almost always 100% cash, unless the company being acquired is also a Big Pharma.

ED-235 is probably more valuable to PFE than anyone else. Then, RSV and the patent lawsuit settlement could all bring significant value to Pfizer. As well, PFE is under pressure to replenish its drug pipeline, ENTA's intellectual property and immunology program could provide crucial support in this area. Two shares of PFE for 1 share of ENTA would do the trick.

It just makes so much sense. Hopefully, it actually happens.

Yeah, the Covid drug pivot really killed this company last couple years

covid itself hurt the RSV program - there was no RSV to speak of in the 2020-2021 season, and a very atypical spike much earlier seasonally than expected that was severe but very short in 2021-2022 that seemed to catch them off guard. So that cost the RSV program 2 years
As for the covid drug, after seeing ensitrelvir succeed in the prevention setting where paxlovid failed which could create a new regulatory path, and reviewing PFE's second gen data I think ENTA's program is mostly dead, but not completely dead.
PFE’s second gen sars cov 2 PI showed a virologic response, but did not show any resolution in symptoms in standard risk patients https://academic.oup.com/cid/advance-article/doi/10.1093/cid/ciae529/7863440?login=false, while EDP DID show a reduction in total symptom scores https://www.enanta.com/wp-content/uploads/2024/04/P0423_ECCMID_2024_SPRINT_Poster_FINAL.pdf
I know 235 is collecting dust, but hey it seems to have some oomph on symptoms that PFE's drug is lacking, and PFE is trying to run a PBO controlled phase 3 in high risk patients with hospitalization as an endpoint which seems awfully challenging to me with paxlovid available for those at high risk. The study listing has not been updated for a while now fwiw, so who knows if it started recruiting last week as planned https://clinicaltrials.gov/study/NCT06679140?term=PF-07817883&rank=8

The rub on 235 was virology, but if you compare the data closely PFE showed a virologic response but they also restricted enrollment to those with more than 4 log virus at baseline and ended up with 5 log baseline VL vs ENTA at 4 log. Remember enta did show a modest virologic response in those with 5 log or more at baseline.

Potentially a lot higher. But probably will take some times -

1) favorable term on settlement - any time.
2) partnerships - any time, but likely 6 months
3) buyout - any time.
4) successful HR result - 6 months

EV dropped from 1.5 billions all the way to -ve 100mm+. I think the market does not only think RSV is a failed program, it also assume ENTA is a failed company with incompetent management. Sentiment can change in a heart beat though.

Yeah, the Covid drug pivot really killed this company last couple years.

This tax loss season seems rather extreme, the volume has been 4x last year.

Some funds are bailing big time. RSV data isn’t bad

Not really

Lots of swing-and-misses with this company.

good to see ENTA going higher...and it will go much higher ..

Yes… that makes sense. My point… ENTA stock went from $13 to $6 from 24 Oct till today and set new lows. Why more sold than bought during this two month period is debatable. In my mind, tax loss selling was the primary reason for the price decline, not a rethink of the probability of success. Thanks.

The stock hasn’t seen 20 dollars in 1.5 years. The latest sell off may be tax loss but we are nowhere in the ballpark of where it should trade with reasonable odds of success in RSV
The bullish analysts are modeling in 40-50 percent chance of success and 20-25 price targets
Tax loss gets you from 9 to 6, not from 26 to 6

The market clearly thinks the RSV drug is going to fail. I’m not so sure. I think it is more related to end of year tax selling and traders jumping on the bearish trend.

tax loss harvesting season...it will be alright...come January 2025

I had to make that decision. Should I sell now to generate a tax loss for 2024? I decide that the stock price had dropped too much too quickly so bought at $6.20 instead of selling. I figured the rebound would occur well before the wash period was over, and consequently, it would cost me more than the tax loss to restore my shares.

tax loss harvesting season...it will be alright...come January 2025

Thank you dewophile for your most insightful, positive analysis.

FWIW - On the sane note - I was told to "watch the ENTA news". This could mean anything, but IMHO this sounds quite$$POSITIVE! (Don't ask - don't tell )

The market clearly thinks the RSV drug is going to fail. The bear case is basically that other drugs with positive challenge data failed when tested in real world scenarios, including Zeli in standard risk adults. The only one that nominally succeeded - ziresovir, Ark bio's fusion inhibitor - had a benefit in hospitalized peds patients but the clinical significance remains unclear. The company touts the benefits of a replication inhibitor, but lumicitabine a nuke polymerase inhibitor and replication inhibitor which was halted, failed to show a benefit in the enrolled patients before the halt. In adult patients GILD's fusion inhibitor failed in the transplant setting. The recent peds data, while definitely positive on virology, has some overhang on clinical endpoints. "Top notch" data would have shown a trend on some clinical endpoints other than the evolving resolve-p tool they are working to validate. So that is the backdrop.
The bull case as I see it, with a focus on adult HR patients now that that is the next big readout is as follows:
1. lumicitabine, the only other replication inhibitor with data AFAIK, failed in peds and adults, but in peds where there is published data showing a lack of virologic benefit suggests it is inferior to zeli which clearly had a virologic effect in peds
2. GILD's fusion inhibitor failed in transplant patients, with lack of both virologic or clinical effects, but we know in the few enrolled transplant paitents zeli had a dramatic effect on virology (numbers admittedly very small), and it suffers from all the drawbacks of fusion inhibitors including high levels of drug resistance
3. The paitents in the failed standard risk adult study for zeli were clearly already improving at enrollment as the total symptom score AUC in the trial for PBO was very low at 62.5. As a basis of comparison TSS was 256 in the same paitent population in the challenge study because you can capture symptoms before peak. The duration of illness in the challenge study was only 5.45 days, so otherwise healthy adults clear illness in under a week on average even when you get a very early diagnosis in a controlled setting
4. The data in older high risk adults suggests that duration of illness is more like 15-16 days on average, and a significant proportion are hospitalized. For example in this trial 16% of older adults with comorbidities were hospitalized (https://www.nejm.org/doi/10.1056/NEJMoa043951?url_ver=Z39.88-2003). In the GSK vaccine trial 2 patients were hospitalized out of 47 cases of RSV LRTI, but there were alot of adults enrolled between ages 60-75 without comorbidities, while the zeli HR trial limits the number of patients 65-75 to enrich for much older patients (over 75) and / or those with comorbidities. So you have to think 5% to low double digit percent patients end up hospitalized, so there is a chance the zeli trial, while clearly not powered on hospitalization, can show a trend if say 5-6 of the 90 placebo patients end up hosptialized versus 2-3 of the 90 patients in the tx arm. It is worth noting that PFE was planning on a large 2715 patient adult HR phase 3 for sisunatovir with hospitallization as the primary endpoint before they ran into difficult with the program (including DDIs) and had to scrap the study
5. Ziresovir, ark's Fusiion inh, showed no virologic effect on day 2 and a minimal .4 log difference day 3 while Zeli was closer to a log day 3 in peds so clear suggestion zeli acts faster and is more active overall (1.4 vs .6 log at day 5) than ark bio, which was able to tease out a clinical effect in peds using their symptom tool
6. JNJ's fusion inhibitor similarly showed very modest antiviral effects in peds compared with zeli https://link.springer.com/article/10.1007/s40272-024-00625-x

But more than anything the much longer duration of illness in the literature in the high risk adult population suggests a much greater window to see an effect on symptoms, and Zeli clearly appears active, giving me a fairly high confidence in the upcoming adult HR readout. I would give it 70% chance of a positive readout of at least a 1 day improvement in duration of symptoms, and a 30% chance of very good efficacy with a 2 day improvement or more in symptoms and / or a trend in hospitalization.

Well, in this game one soon learns that the race is not a sprint. At least that’s my experience. We are all puzzled by the price drop since 24 October. We could debate the drop ad infinitum. I don’t understand it, and probably never will. GLTA

>> I’m calling a bottom here @$5.86.

Hope you are right! Good luck!

Where does one get updates on the lawsuit? You are correct dewophile; ENTA is on a slow news cycle. Alas it’s a relatively small biotech, but good things come to those that are patient (I guess). Using hindsight ENTA would have been a good stock to trade… sell in late October, buy back in late December. But when I sell a stock, the stock usually goes up (lol). I’m calling a bottom here @$5.86.

That’s why it is so frustrating and it often feels like I am missing something big.

The RSV program, top notch data and likely first and best in class, with significant market opportunity. Market couldn’t care less. Just not sure why.

you do realize that less than 10% of drugs that enter the clinic make it to market
enta has had two drugs approved, and a handful that were stopped for one reason or another, but their track record in the aggregate is above the curve
abbvie just bought a preclinical immunology company for 200M, a private company got 125M for a *discovery* stat6 program even though they are 1-2 years behind the market leader last year. neither company has even had a drug enter the clinic yet
so if you want to try and put a price on enta's preclinical immunology assets you can start there

We do not know that the ASK-1 program "failed" because it was just sort of dropped. I suppose it could be considered a program which failed to mature. I wish I knew more about why it was dropped. We were seeing all of the specificity and precision maps, then the program disappeared from the pipeline and was not mentioned thereafter.

If I knew more about why the ASK-1 program was dropped, then I would have more information upon which to judge the likelihood of success in the KIT and STAT 6 programs.

I would say that Enanta has suffered some business development setbacks. They announce molecules they feel are best in class, but then are unable to put them on a launch pad.

If it is not a business development problem, then it could be a chemistry problem, but when programs are dropped I don't think we learn enough about why they are dropped so there is a difficulty in whether to know if there is a business development problem or a chemistry problem.

well RSV cases are on the rise, with over 20% positivity in several states including two where ENTA has multiple sites enrolling (FL and TX)
so my hope is we get to that data quickly
older adults w comorbidities have a significant hospitalization rate so we might see a trend there, but the duration of illness that I have seen in the literature is about double that of healthy adults, so a clear window in which we can see a drug effect - unlike the healthy adults that had declining symptoms already at enrollment

Short interest is close to 20 percent of the float. Pretty high for a name that is trading at half of cash value. It’s rare.

The fireworks will be awesome if they get a nice deal sooner than expected ;)

Still hope PFE would just buy us out, make so much sense for them.

Wake up and see a few hundred percent up move would be wild experience and a nice gift.

The KIT program could follow the path of the (failed) ASK-1 program. Each program deserves to be considered on its own merits. Failure in NASH does not presage failure of a different compound in a different indication, such as EPS-1421 in CSU.

Regarding the ASK-1/NASH program, it’s worth noting that manifold biotech and Big Pharma companies failed to thread the efficacy/safety needle in this indication. Only one company (MDGL) has been successful to date, AFAIK.

any good news... I don't care

Any good news but I do care! 🤣

A holiday gift would be nice
but I do think the odds of good news in the adult trial is better than even what the bullish analysts are estimating, so part of me also doesn't want the company to give up too much now - although of course you can build in a milestone predicated on the HR results too
good luck