Enanta Pharmaceuticals Inc (ENTA) News

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

The KIT program could follow the path of the ASK-1 program.

Yeah, waiting mode.

I guess buyout, partnership or settlement news could in theory come in any time

But probably not during holiday seasons.

I wouldn’t mind if good news comes though. Would be a nice holiday gift for us all.

Partnership would help

yeah it is a pretty slow news cycle for enanta. the judge can render a decision on the summary judgment motions any time I guess, and the company can update enrollment for the adult HR study but otherwise not much, so this one will require patience. shionogi also will have their rsv challenge data out soon supposedly, and the fda will make a decision on ensitrelir at some point which could resurrect the prospects for 235 I guess

any good news... I don't care

what kind of news you are thinking?

I am expecting some kind of a good news from our CEO...pretty sure...it's coming ...in the next couple of weeks...my average cost is 1.39...slightly over 6k bet...hoping to make...some vacation money here.

Excellent timing. I thought 8-9 would be the bottom of this downtrend move.. How wrong

well 45 out of 48 call options ....5 dollar strike...were me adding today....I am highly optimistic that ..Christmas gift is coming my way


Good luck!

well 45 out of 48 call options ....5 dollar strike...were me adding today....I am highly optimistic that ..Christmas gift is coming my way

Volume remains very high - total volume since Nov 22 is about 10mm, public float is 15.44mm, so almost 70% of the float was traded.

Some big holders were selling, for whatever reasons. That on top of tax loss selling and the current bio-tech sentiment really is killing the stock. Sucks.

Don't worry, the current share price would mean nothing soon. More likely than not, the stock will trade a lot higher after the current liquidation sales is done. So instead of 6x, a a 2x to 3x would do.

Even if you cut the cash and royalty substantially given it is a declining asset, you can easily get to a sum of parts valuation over 30 dollars, which is likely what the company will demand in any buyout. I'm just not sure a pharma is willing to pay 6x premium right now, and I just don't know if the company is at all desperate to sell for much less of a discount to what they perceive as fair value

It's intriguing that if a buyout were to occur, the value to any buyer would easily surpass $20, factoring in JUST the cash and royalty value. Meanwhile, the stock is trading in the $5 range.

adding some call options...January expiration...I am so happy I didn't add 10 dollar calls...as I had found some other stock more attractive...but now...5 dollar January calls looks yummy...I just want to double my money...triple or more is more than welcome

I doubled my position in past Couple weeks

Amazed by the fact that there are so many shares up for sales in 6s range. Especially given the actual public float size of ENTA

I've bought 3 times in the last week-10 days, including this morning. Maybe about 15% total increase. Now comes the period of waiting.

FWIW, I increased my shares of ENTA by 20% this morning at $6.15 and bought a bit more VKTX.

my understanding is that about 40% of pediatric patients get antivirals for flu. Lower than ideal because of the risk for complications in the young, but still a sizeable chunk. Mind you this is without much marketing (tamiflu is generic)

The market seems to overlook ENTA's assets… What is the board’s thoughts on the impact of the Covid pandemic and an underlying mistrust and subsequent underutilization of antiviral medications. Ex. Some physicians hesitate in prescribing anti-virals for flu in pediatric patients due to misunderstandings and /,or lack of confidence in their effectiveness. Does the successful pursuit of an unmet medical need
guarantee a higher enterprise value?

Waiting to see the adult RSV data makes sense. Strong results could secure substantial upfront funding, while poor data could allow ENTA to shift focus to more promising areas.

As noted, a well-funded immunology company should command a higher valuation than ENTA's current trading price.

The market seems to overlook ENTA's assets anyway —RSV, the lawsuit, and remaining royalties—treating them more like liabilities.

Me too. They probably want to see the adult HR data and if Shionogi has comparable challenge data from their L inhibitor before finalizing any plan

Anxious to see how ENTA management moves forward given (2) leading molecules for RSV.

I don't think any potential partner feels any urgency just to get in on FDA meetings, but they could partner hoping to get more favorable terms if they think the drugs have a good chance of success. After the adult HR data the cost could go up if the data are good (and I think they will be)