Enanta Pharmaceuticals Inc (ENTA) Quote

Volume heavy again. Seems some funds liquidating recently after the run up

Hopefully done soon

I bought all I wanted higher

Sigh

New QT study posted for zelicapavir (938)

https://clinicaltrials.gov/study/NCT06601192?term=Edp-938&page=1&rank=2

It looks like a brokered trade to move volume without unduly affecting share price

Company update soon… The company will provide its next update with the release of the EDP-323 challenge study results, expected in late third quarter of 2024.

Weird indeed. The couple reports I read didnt give much odd for enta to win the case. Why would a law firm make it a showcase?

I guess any exposure is good exposure?

Flo, I too noticed the large Market on Close trade. I do not fully understand the logic on these trades. Perhaps others will opine.

lol, pretty sure we will get there at least one more time.

This management team delivers

Weird to highlight a case that is still pending. You would think they would only bring attention to cases with a favorable outcome.

Huge volume in after-market with one trade (no change) -

TIME. PRICE. #SHARES
16:00:06.............$11.3...................426,561

Foley Hoag Recognized as 2024 Law360 "Regional Powerhouse" in Massachusetts
September 19, 2024

Law360 again recognized Foley Hoag LLP as a “Regional Powerhouse” in Massachusetts. The law firms on Law360’s list of 2024 Regional Powerhouses are driving some of the biggest deals and most high-profile courtroom battles, delivering top-tier regional expertise for clients and making a lasting impact on the law at the state and local level.

The Regional Powerhouses Series honors leading law firms in various states based on their exceptional achievements. In Massachusetts, Law360 recognized only three firms, including Foley Hoag. Law360 noted, “With some of the state's household-name clients under its belt and a former Massachusetts attorney general on its roster, Foley Hoag LLP is one of the state's premier law firms in a number of growing sectors.”

The recognition reflects the complex legal work performed for clients by Foley Hoag across cutting-edge industries, including life sciences, technology, energy and cannabis, and the results achieved. Law360 specifically highlighted the firm’s representations of:
Enanta Pharmaceuticals in a patent litigation involving Pfizer's antiviral COVID treatment Paxlovid.

https://www.foleyhoag.com/news-and-insights/news/2024/september/foley-hoag-recognized-as-2024-law360-regional-powerhouse-in-massachusetts/

The "proof is in the pudding". Let's hope Hoag representation will be positive for ENTA.

Again, representing the Plaintiff, Enanta:
https://foleyhoag.com/people/fiacco-barbara/

🤗 See ya at $18 alert!

I am probably the one who needed more analysis

Either way, it’s cheap enough for me to get in just in case, some settlement , buyout or partnership news hit the wire.

I think my downside is protected nicely by cash and royalty value at this level

alert… ENTA was within pennies of yesterday’s low on 14 Aug and 6 Sep and we didn’t move straight to $18. I agree technical analysis is a tool, but as a predictor it often fails. Perhaps I need more analytical skills 🙃.

The last two times ENTA reached this level, it managed to bounce all the way back to 17 18

Will be interesting to see what happen in new couple months

references for ark bio peds data
(and apologies for typos in the post I am responding to I was mobile and dictating)

phase 2 data set from Ark bio's fusion inhibitor (N=80, 73 completed trial, N=49 for randomized part of trial with 3 dose levels tested so overall N in the go forward dose for phase 3 quite small so data will have a lot of noise):
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10368966/

PR on the phase 3 data with N=300 and change:

https://arkbiosciences.com/en_2022n/112

Ziresovir also showed a significant anti-viral effect: the active treatment group showed 77% greater reduction in viral load reduction on day 5 compared with placebo (p=0.006)

note that 1 log reduction is 90% reduction, 2 log 99%, 3 log 99.9% etc. so this is c/w what ENTA has said was a .6 log reduction in their phase 3 on virology (The full results are surely available if someone wants to dig them up but google just spit out the company PR)

Again the best benchmark there is for the upcoming peds phase 2 data as far as I know

Thanks dewophile…

Hard to say because there is a paucity of data in this setting amd it’s a small trial that is not powered on synptoms and other clinical endpoints. If they get a log delta and trend on any clinical endpoints that’s good. Less than half a log not good. The ark bio chinese trial had .6 log and got on clonical endponts in phase 3 but only had robust effects in the youngest age groups IIRC. those of the rough benchmarks I have in my head but the arc biodata is a different mechanism of action also and otherwise there’s really nothing else to go on as a frame of reference as far as I know

Understand… What's the definition of ‘meh data’? I can guess but rather hear from u…

the ‘planning for success’ comment caught my attention also

To be clear I think this kind of a line is typically meaningless, but it just so happens management probably has seen some of the data from the peds phase 2 and this is new language for them. I am reading tea leaves here. You can make an argument that negative data and scrapping the RSV program will cause the stock to rise since there is negative value right now on the program. Spending money on a phase 3 with meh data is the real bear case actually if you ask me

Dr. Tara Kieffer, Enanta’s Chief Product Strategy Officer, is very intelligent and well-spoken. Re: Today’s Cantor call.


Thanks for the heads up. I will listen tonight.

Yes, the ‘planning for success’ comment caught my attention also. One can tell Tara is talented in her work and in communicating her thoughts. She has a deliberate speaking style and she chooses words to allow a broad audience to understand her message. Also Cantor’s rep asked excellent questions in a thoughtful manner.

I listened and agree she is a good speaker. The story remains the same. The only thing worth emphasizing is that the cash runway factors in a phase 3 for the lead RSV drug and also phase 1 for the Kit inhibitor. She also mentioned they are "planning for success" for the peds trial with some "early start up activities" which of course doesn't mean the phase 2 data will be positive, but at this point the company probably has seen at least the antiviral data from the trial since it completed enrolling 6+ weeks ago

Dr. Tara Kieffer, Enanta’s Chief Product Strategy Officer, is very intelligent and well-spoken. Re: Today’s Cantor call.

What are the risks you see?

Key one is they keep spending the cash without any success.

What else?

The cash is real, royalty sale is real and then the pipeline result so far looks real

You would think this is at least a mid 20 dollars stock

Yes, ENTA is in a better financial position but there is uncertainty. Their Covid drug, EDP-235 sits on the shelf and EDP-514, their HepB drug is also sitting on the shelf. For EDP-235, ENTA won't move forward without a partner.

For EDP-514, ENTA needs to find another drug to combine with a nucleoside, either in house or for a more rapid developmental pathway, partner with another company which has a promising HepB drug.

For RSV, a strong result in the challenge trial of EDP-323 would provide a backup for EDP-938 in case the latter fails in the Peds and or high risk adult group. There might also be a combo trial of 323 and 938 if the latter doesn't show stellar results.

ENTA has yet to select a candidate for their Kit inhibitor program.

The lawsuit against PFE remains a wildcard.

ENTA is a decent chunk of my biotech portfolio and my position is down ~40%, by far the worst of my holdings. The revenue stream from HepC stabilizes ENTA but I am under no illusions. ENTA has signifcant risk but the upside can be large. Good luck to us both!

Well I am trying to learn from rvnc experience, with rvnc there were lots of uncertainties on sales projection

But here.

The cash is real, royalty sale is real and then the pipeline result so far looks real

You would think this is at least a mid 20 dollars stock

alert… understand what you can and leave the rest.

thanks guys, very helpful. Just hard to understand how this name would be selling at this level, especially with a pipeline that seems to have quite a bit of potential.

The "challenge" study (designated as phase-2a) provides sufficient information about dosage and pharmacokinetics that a second phase-2a trial (in "real world" patients) is generally not needed. The trial that ENTA would not have run with the benefit of hindsight is the phase-2b in standard-risk adults.

So dosage range/s would have been determined in phase 1. Only 1 phase 2 trial with possible 1/2 ranges ?



For other viral ind this phase 2a 2b design works?

With the benefit of hindsight, ENTA would not have conducted any RSV trial in a standard-risk adult population.

Thank you! Not that it matters now, but how should they have designed that trial?

Just to be clear—A "challenge" study in healthy subjects is an FDA requirement, but the phase-2b trial of EDP-938 in standard-risk adults was ENTA's own decision. With the benefit of hindsight, ENTA now knows that testing an RSV treatment in a standard-risk adult population is unlikely to show a meaningful benefit versus placebo.

Apologies if this is redundant, but I wanted to ensure that there was no confusion on this point.

Yes regulators require it (and it does have value to see antiviral effect in humans and some dose ranging too)

Right of passage? Are you saying they had to do that study with that design?

From the webcast I thought it sounded a bit like they were disappointed they took that approach, but at least they had a valid reason for the results?

Excellent post dewophile…

It's a challenge study where healthy volunteers are inoculated with virus and randomized to drug vs placebo. You should expect good results it is a very potent molecule. I would say the baseline expectation is the EDP-938 data:

https://www.nejm.org/doi/full/10.1056/NEJMoa2108903

I don't think it is a market moving event because in this setting you start drug as soon as infection sets in, whereas in the real world you at best can get drug on board 2 days post symptoms. EDP-938 failed in standard risk even with good challenge study results in healthy adults because the placebo arm was already getting better by the first dose. It is a right of passage though to move into a real world setting

And read this study… EDP-938, a Respiratory Syncytial Virus Inhibitor, in a Human Virus Challenge in the NEJM.
One needs to compare apples to apples.
Both studies are Challenge Studies, where healthy individuals are inoculated with the virus and symptoms, viral loads and safety are analyzed before and after dosage with the virus inhibitor. The primary end point was the area under the curve (AUC) for the RSV viral load, as measured by reverse-transcriptase–quantitative polymerase-chain-reaction assay. The key secondary end point was the AUC for the total symptom score. Low AUC is better than high AUC.

You should listen to the Wainwright call… and draw your own conclusions.

Thanks, so it would make sense to buy after 323 then?

This trial is on healthy patients. Don’t expect good results.

How significant is the upcoming 323 data?

What’s the expectation?

They would release the result anytime now, would it move the stock much either way?

The Baird call… let’s just say I have a lot to learn about Enanta and its pipeline. Agree the RSVpeds trial appears to be of high importance. The speakers were knowledgeable; my take from the call… Enanta has been successful in bringing a major drug candidate to market. The balance sheet is solid. Management has extensive experience and superior credentials.

I think #1 risk is real

But the the CEO is old, don’t think he would like to bet his farm on this

Thank you - VIn, Randy & dewophile plus others who might comment.

As you advice indicates - I plan on being patient or becoming a (mental) patient.

Sir Flo

After making a major hit in COLL, I decided to throw it all into ENTA (Las Vegas style) – possibly my last (age) roundup!

Flo, kudos on your big score in COLL. However, I don't think letting it ride by placing it on ENTA is wise. Better to spread it around on a few stocks. Good luck to you on ENTA. That will help me to as I now own more ENTA share than I ever have but feel less confident than you as it represents some ~10% of my biotech portfolio.

The balance sheet along with a few chances at a big jump in share price are attractive to me. I wish I felt a bit better about the chances of any or all of the future binary events.

Randy

you know I am bullish but i will present the bear case
1. they will burn money so the floor of 20 will go down with time
2. other RSV drugs with positive challenge data have failed in real world setting, including 938 in low risk people
3. the largest market is in peds, and there is a very effective antibody therapy for passive immunity (and a maternal vaccine) which cuts into the market opportunity
4. the lawsuit is a crapshoot and may favor PFE actually since the molecule predates the pandemic
5. they are starting to ramp up spending in immunology and the lead candidate/ indication is behind 2 other competitors already

1. I personally think they will exercise discipline
2. their RSV candidate has a different MOA as a replication inhibitor, has shown a hint of real world efficacy in the terminated stem cell trial
3. the peds market will remain large because passive immunity wanes and these kids will eventually have a first RSV infection that is often severe. The adult market could end up being sizeable as well and vaccine uptake is low and there are always breakthrough infections still
4. crapshoot could go their way too
5. again financial discipline, the opportunity is huge so room for more than one player

After making a major hit in COLL, I decided to throw it all into ENTA (Las Vegas style) – possibly my last (age) roundup!

Not sure I have done my correct homework/research on this one. Two years prior I did purchase ENTA at 42 & sold at 38. From there it went to the 60’s. Now --

I’ve heard Dew’s take (which I respect) that it’s worth a minimum of 20 which includes NO clinical trials in the equation. Plus, I’m quite optimistic in a trial settlement with PFE.

Therefore, fellow investors, what is your rationale for investing in ENTA?

Also do you know of symptoms other than mucus that will have to improve?

Clinical endpoints will be related to lower respiratory tract disease (pneumonia) , then other endpoints like oxygen needs, ventilation, hospitalization, etc. mucus won’t be an endpoint