Enanta Pharmaceuticals Inc (ENTA) News

What would be the drawback of pushing for a combo trial? How likely the combo would be worse than single trial given the 938 and 323 have different mechanics?

Also how is the current status of ENTA RSV programme compared to ReVirals a year or two ago?

I think back then ENTA didn’t have the infants data?

You think PFE would be interested to partner with Enta on RSV for competitive reason?

Ok but I would think there isn’t that much to say until 938 data are out. If the 938 data are robust there may not be much of a need to progress 323 although the company has alluded to possible combination for the rare difficult / severe case. The other relevant data to know before making a decision on 323 is the challenge study results from Shionogi which is also not due until Q4. If the company is compelled to move both drugs forward (for competitive reasons as much as anything) I hope they partner the assets.

In the 3% royalty scenario, would the 3% be applied to future sales as well?

Re: Paxlovid settlement estimate

Let's estimate what ENTA would be due from PFE if ENTA prevailed in a trial. Including PFE's guidance for 2024, PFE will have sold about $12B of Paxlovid in the US market from product inception (Dec 2021) to 12/31/24. Let's apply a 3% royalty rate, which is pretty conservative for a patent-infringement case. Then the cumulative royalties due to ENTA would be (0.03)($12B) = $360M, plus interest.

(If the court found PFE to be guilty of willfull infringement, it could award ENTA treble damages, or about $1B plus interest. However, few patent-infringement suits result in treble damages, so this outcome is a longshot.)

If a win at trial would result in an award to ENTA of $360M plus interest, a settlement of $150M to ENTA (the estimate you cited from a sell-side analyst) seems like a lower bound. A settlement of $200-250M is more likely, IMO.

alert, you ask questions which are impossible to answer. Suggest you wait till after the chickens are hatched, before counting ‘em. Best wishes.

Paxlovid patent lawsuit

Any estimate on what a settlement would look like if it happens?

iIRC, rbc estimates about 5 bucks per share or about 150mm, is that low?

I dunno… as dewophile messaged earlier, a disappointing 323 trial may actually cause the stock to move higher, given a possible reduction in p3 trial costs going forward

Hope they can conclude this chapter sooner rather than later, especially if it’s a moon shoot, they are spending quite a bit of SG&A on this.

I guess can be very rewarding if they do see a good chance on getting a settlement or favourable ruling on this.

Market cap is 230mm, a 200mm settlement payment will double the shares

And I think we can potentially see a much larger sum, only PFE and ENTA know better

I would think a positive challenge study results would at least help convince the market that the RSV pipeline is not a negative asset.

ENTA committed to having a CC for the EDP-323 "challenge" study results. This info is in the 8/5/24 PR announcing the FY3Q24 results (#msg-174869263).

I have no clue if there will be a call along with the challenge study results, but I do want to remind you that several drugs have had positive challenge study results and failed real world trials, so again I just don't think the Q3 release is market moving

There are motions in front of the judge to dismiss the case or settle the matter without trial, but if the case proceeds to trial enanta has said the timing should be around year end

When will we get an update on the patent case?

Is it going to full trial soon? Or it will be ruled without trial?

I guess both sides will appeal unless they have a settlement

Ie this will drag on for a while, correct?

We were told end of 3rd quarter, so on or before 30 September. Since they are going to have a call, I expect to hear an announcement of the call this week. ENTA, it’s time to go UP!

So we have 4 business days left in Sept... do you guys think we will see the data by end of Sept or will be slip to early Oct?

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?