Enanta Pharmaceuticals Inc (ENTA)

[alertmeipp]

FWIW - I tried similar prompts for RVNC in incognito mode (i.e. free mode which means data is stale).

It gives me $40-50 per share valuation based on Daxxify projected sale of ~1 billion per year after ramp up. Then, I told GPT that company was sold for $6.66. It then proceed to explain why it would happen, one of those guesses is failed marketing and sales campaign LOL.

[floblu14]

Repeat - At approximately 11:06+ of the 2024 Cantor Global Healthcare Conference (9.17.2024), Tara Kieffer states (with confidence) - ,,,,"we are already planning for success..engaging in some early start-up activities for a Phase 3 study" That's the affirmation I hear that success is on the horizon for RSVPEDS-EDP-938.

Additionally - Tara states - "we would not wait for the Adult study....if PEDS data is supportive, we'd move quickly....to the Phase 3 study"

https://wsw.com/webcast/cantor22/enta/2074968
_______________________________________________________
One of the major culprits in the current downtrend -

Assenagon Asset Management S.A. cut its position in Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA by 66.3% in the third quarter, according to the company in its most recent 13F filing with the Securities & Exchange Commission. The firm owned 143,806 shares of the biotechnology company's stock after selling 282,755 shares during the quarter. Assenagon Asset Management S.A. owned approximately 0.68% of Enanta Pharmaceuticals worth $1,490,000 at the end of the most recent quarter.

All it takes is ONE:
https://www.marketbeat.com/instant-alerts/nasdaq-enta-sec-filing-2024-11-02/

[dewophile]

It sounds like an analyst report so it may have access to some??
ChatGPT never gives the same answer twice. That is one of the distinguishing features of an AI vs search engine

[go seek]

Yes, quite bullish… furthermore, a major win on the patent case could outstrip this estimate. I see positive news from PEDS and the patent litigation as likely…

[alertmeipp]

Kind of scary. It probably “read” up from this board and other similar sources. I wondered if it has memories on our prior (gpt and me) so i asked my friend to try it.

Pretty similar result, although in his case, no patent suit was mentioned and then, it assigned a negative 100 to 200mm to it as gpt “thinks” if the patent got invalidated thru the case, it will damage ENTA IP value.

Also i noticed now it seems to read some financial info from SEC filings which is would be really handy

[dewophile]

I am one of those that thinks they have the data. Study completed aug 19 so how long does it take to scrub the data and lock the database? I honestly don't really know but it is a small study 96 patients so I am going with an estimate of 2-4 weeks, which is why I feel they probably had the data during the last cc Sept 26th.
I would guess data is released w earnings if they decide to have an earnings call (they may not ), or they wait until the last possible moment like the challenge study data which was I think the last day or two of Q3. Waiting gives them a better idea of what is going on w patent, with adult HR enrollment, timing of FDA interactions if data is positive for when they might be ready to move into phase 3, etc.

[dewophile]

I can see > $50 if the right news hit ;)

Apparently ChatGPT feels the same way!

[dewophile]

not far off from my bull case either. impressive
The only thing that is off IMO is the covid asset. They have had over a year to find a partner, so I don't think it is worth 100-200M.

[alertmeipp]

I am surprised chatGPT can write such an analytical piece without much prompting. It's too bullish even for my taste but not far off from my bull case. Thoughts?


Investment Thesis for Enanta Pharmaceuticals (ENTA) Buyout Potential

Valuation Estimate
Based on Enanta's promising assets and ongoing litigation with Pfizer (PFE), a buyout could realistically value Enanta between $1.3 billion and $1.5 billion. This valuation is based on the following key elements:

RSV Program: Positive results from Enanta’s RSVPEDs study for pediatric RSV treatment, valued at approximately $400-500 million due to high demand and limited competition in the RSV market.

COVID-19 Drug: Enanta’s Phase 2 COVID-19 treatment candidate, which could add $100-200 million if it shows competitive efficacy.

Royalties and Cash Position: Enanta’s reliable royalty income from its Hepatitis C treatment with AbbVie and its cash reserves (~$272 million) add stability and are valued at $150-200 million plus $272 million in direct cash.

Pipeline and Potential: Additional pipeline assets in immunology and antiviral research could add $100-150 million.

Patent Litigation with Pfizer: Enanta’s lawsuit against Pfizer for alleged patent infringement on Pfizer’s COVID-19 drug could add $200-400 million in potential settlement value or royalties, particularly if Enanta’s case is strong.

Per Share Value
With around 21 million shares outstanding, the per-share buyout value is estimated between $61.90 and $71.43.

Probability of Buyout

High Likelihood (50-60%) if Pfizer views the litigation as a significant risk and finds strategic value in Enanta’s RSV program and COVID-19 treatment.
Moderate Likelihood (30-40%) if Pfizer perceives manageable litigation risk or prefers licensing over acquisition.
In summary, a buyout would likely be priced at $1.3-$1.5 billion (or $61.90-$71.43 per share), with a 50-60% probability if litigation risk and strategic alignment favor acquisition.

[go seek]

ENTA earnings on or about 25 Nov…
Some think mgt has the PEDS data now. Any thoughts on when the PEDS data will be released?

[alertmeipp]

>> I see no reason to sell at these levels ahead of the news

Same here. I can see very significant upside if the upcoming news are positive. On the flip side, if the news were negative, current assets should limit the significant downside.

I can see > $50 if the right news hit ;)

[dewophile]

The decline on low volume could be one seller trying to get out of a position. But a sharp down day in an up market could also be a leak who knows.
I continue to think the price could actually go up if they cut the RSV program altogether so I see no reason to sell at these levels ahead of the news

[alertmeipp]

volume 35k shares so far

lack of interest is an understatement

i picked up some shares

[alertmeipp]

Hope so too. But whether it ends or not, I will still holding and wait for the critical news to hit.

[go seek]

It appears that the selling is about to end 🎃

[dewophile]

I don’t think so because once you are sick enough to seek medical attention the infection has set in long enough to spur immunity.
If you were to use it for post exposure prophylaxis then perhaps it could take more exposures to build up immunity (which is never long lasting anyway like chicken pox which is why we can all get seasonal RSV much like the flu)
By the way all peds patients with flu have blanket recommendation for antiviral. I would a successful RSV antiviral would get the same blanket recommendation because by definition all infants/young children w RSV are high risk (like flu)

[go seek]

Could it be argued that using a RSV therapeutic in PEDS impedes immunity development?

[dewophile]

US sales are what is relevant for the patent
bears will say 0% of many billion is still zero

[dewophile]

it should be mildly bullish but the company still likely won't develop this without a partner, the details of the ensitrelvir data are not yet public they are saving it for a scientific presentation, and the regulatory pathway in this indication has yet to be hammered out. But yes there now does seem to be potential for a new path to market which you would think is a positive for resurrecting some discussion with partners on 235. There could be a delayed reaction who knows there was nothing on the news wires when I first posted the info, but this is enta we are talking about so it is always hard to explain away the day to day trading

[alertmeipp]

imagine if they pay even couple percent royalty as part of the settlement

[LongRun8]

Paxlovid revenues are now the following: 
2021 - $76 million*
2022 - $18.933 billion
2023 - $1.279 billion
2024 - $4.951 billion (expect $5.5 billion total by year end)
*Note million, not billion

So total Paxlovid revenues would be $25.788 billion since inception (assuming they hit the $5.5 billion predicted for 2024).

[alertmeipp]

5.5 billions addressable market and now phase 3 pathway (at least with additional clarity)

somehow, no one cares ENTA has 235

[DewDiligence]

PFE just_raised 2024 Paxlovid guidance_to $5.5B—up $2.0B from_the_prior_guidance given three months ago:

#msg-175303891

[alertmeipp]

yeah, i hear you. still feel the market is way too bearish on handicapping the outcome for RSV.

the patent suit and covid drug, i can understand. those two do look like crapshoot ;)

but not sure why the market is so ready to write off RSV so soon.

[alertmeipp]

this should be bullish? 235 is phase 3 ready as well. i assume enta would be in dialogue with FDA for its pathway?

now that PFE sees that there is a potential competition coming, maybe that would incentivize them to pick up 235? or it’s a little too late to be a potential 3rd entry

we can all hope

[dewophile]

Actually, same thing for 235, COVID isn’t dead, just not in news daily anymore. COVID drug still take in billions of sales, why can’t ENTA get a partnership for it?

This news just came out today. It could provide a new path to market for covid antivirals

https://www.shionogi.com/global/en/news/2024/10/20241029.html

[dewophile]

The cash and royalty should but a floor, but if RSV fails they are going to have to make the decision to shut things down and become a well capitalized preclinical immunology company. That means layoffs and some difficult decisions, but at that point the market should recalibrate and give them a valuation commensurate w peers.

[alertmeipp]

ENTA is cheaper than cheap now as the market is paying investors couple hundreds millions for the option values for successful RSV and Covid patent settlement.

the rsv data could be bad and patent lawsuit might get tossed

but the cash and royalty value is there

and these two assets alone worth more than 16

the upside would be crazy good if one of those option hits

[go seek]

Today ENTA is the same price as on
21 June when ENTA started a nice run to $16.

[dewophile]

Edp-938 may get on the market as they enter phase 3. That may make enrollment tricky
I expect them to have comparable challenge data as enanta. Due this quarter

[DewDiligence]

Shionogi is a pretty big company. Its market cap is about $12B.

[go seek]

Shionogi appears to have solid positions on multiple fronts, a strong competitor.

[dewophile]

Shionogi is targeting 2030 time frame for launch of their RSV L inhibitor per presentation materials released today in conjunction w earnings (slide 33):

https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2024/%EF%BC%92q/E_FY2024_2Q_final.pdf

[dewophile]

sure
and it could be they are running this QTc study in preparation for an adult HR phase 3
But if the peds data is bad, then there could be negative read through for the adult study so I would think they slow play the QTc and wait for the adult data to roll in. Here they are doubling down to increase recruitment into the study faster. I don't think they do that with bad peds data in hand
JMHO

[go seek]

I expect there could be a scenario where ENTA moves forward to p3 in only the adult HR population. Your knowledge on this subject is far superior to mine. Thanks for sharing.

[dewophile]

I don't think a QTc trial in infants is something that is done but correct me if I am wrong
In general companies do the trial prior to phase 3 for operational reasons - it makes the conduct of the phase 3 easier (and cheaper)
My guess is the adult QTc will be sufficient for a peds phase 3

[go seek]

I don't know why they would spend money on this trial… They are different populations and Dr. Kieffer mentioned that a negative result in PEDS would not necessarily kill the HR effort. Regards.

[dewophile]

The QTc trial was just updated late last week to add a second site to recruit
I don't know why they would spend money on this trial if they didn't have positive data in hand for EDP-938 in peds


https://clinicaltrials.gov/study/NCT06601192?term=enanta&aggFilters=status:rec&rank=2&tab=history&a=1&b=2#version-content-panel

[dewophile]

ENTA does have the most promising RSV portfolio today, but after high profile busts by JNJ (alios) and PFE (reviral) the goal posts have moved IMO to where now success in a challenge trial is just not enough - you need to show proof of concept in a real world setting to get interest.
Regulators have made developing covid drugs extremely difficult. Let's see what happens with ensitrelvir - if the FDA shows some flexibility that could resurrect ENTA's program, but I wouldn't hold my breath.
In the meantime THRD has double the market cap of ENTA having in licensed their kit inhibitor program and they have about the same amount of money as ENTA (a bit less but their burn is also less). They are at least a year ahead but still there is a disconnect there if you ask me.

[alertmeipp]

dewophile and DewDiligence - to a layman like me, ENTAs RSV program seems to be more advanced and promising than others, so any particular reasons they haven’t been able to secure a nice partnership or buyout for RSV?

PFEs spent 500mm for an inferior (now bursted) program, ENTAs program should worth at least that?

Actually, same thing for 235, COVID isn’t dead, just not in news daily anymore. COVID drug still take in billions of sales, why can’t ENTA get a partnership for it?

Is there some weakness in their deal making strategy?

The insider owns significant shares, do they get too greedy because of that?

[go seek]

Thank you for sharing dewophile… I will study this information. I keep learning; I am impressed with Enanta’s management team. Drs. Luly and Keiffer work well together.
I am also fascinated with how the patent lawsuit is unfolding and how the parties duel over language and definitions. Seems like both sides have won small victories to date.

[dewophile]

Sure
Here is a sampling:

1. Ziresovir (fusion inhibitor) difference in VL vs placebo of .6 log on day 5 and they also hit on the primary clinical endpoint of brochiolitis score. This was in hospitalized infants.

https://www.nejm.org/doi/full/10.1056/NEJMoa2313551

2. ALX-0171 also targeting the fusion protein given as a nebulized / inhaled product which hit on virology in hospitalized infants - cleared virus about twice as fast as placebo but missed on clinical endpoints.

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(20)30320-9/abstract

3. Lumicitabine which is a polymerase inhibitor like ENTA’s second drug (although it is a nuke acting at the active site versus EDP-323). This missed on both virology and clinical endpoints.

https://pmc.ncbi.nlm.nih.gov/articles/PMC10355467/#pone.0288271.ref015

This is not exhaustive but covers a nice range of outcomes. The company has emphasized the advantage of a replication inhibitor versus fusion inhibitors w the latter only able to inhibit vital entry and not already infected cells. Enta feels this is important because in the real world unlike challenge studies infection has set in longer before dosing so being able to target already infected cells could be that much more important in a real world setting.
Lumicitabine is the only non fusion inhibitor I’m aware of with phase 2 data in real world settings including the pediatric setting. It had good challenge data (almost identical to 938 in fact ), has high barrier to resistance, replication inhibitor so also goes after cells that are infected. So that’s the hardest one to explain away IMO. While the study I linked to was sizable the single dose cohorts never got to therapeutic levels and the second study was halted and only 4 patients got study drug w 3 in the highest dose cohort. So that leaves the MAD cohort and only 13 evaluable patients were dosed at the high dose cohort. So this miss could easily be due to lack of power. The drug also has to be converted into the active triphosphate while EDP-938 and 323 don’t. (323 while also a polymerase inhibitor inhibits the L at an inactive site ). This makes modeling difficult amd in peds in particular in addition to using challenge data the company also had to incorporate a non human primate model to check levels of conversion into the active form in lungs (infants especially hospitalized have largely progressed from upper to lower respiratory tract infection. From the discussion in the linked paper.

“The pediatric PK model was coupled with a semi-mechanistic pediatric lung model from monkeys, which estimated the formation of the pulmonary ALS-008112 and NTP at a given plasma exposure.”

So while blood levels in these 13 patients were at least as high or higher than the adults in the challenge study you don’t know if the active drug levels in infant lungs were at therapeutic level. Edp-938 has no need for conversion to be active so easier to model effective doses from pk/pd models in adults.

Two other points of potential differentiation. Lumicitabine (like many other nukes) had neutropenia as a side effect. Not exactly great when you have a population fighting an infection. Also we don’t know when in the course of infection the 13 evaluable patients first got study drug , but the median time to dosing in the entire trial was 4 days. Enta will presumable have a larger data set with the 96 patients enrolled so they can look at data in patients who got as little as 3 days (and up to 5). There are examples of other antivirals for respiratory infection like tamiflu that only showed efficacy when given within 3 days of symptom onset. So the 13 could be down to a handful that got it within 3 days which leaves you even more underpowered to show a difference w placebo

Longer post than I intended sorry

[go seek]

Info on RSV in infants and young children…

https://www.cdc.gov/rsv/infants-young-children/index.html

[go seek]

To your knowledge, has any other company researched a RSV therapeutic for PEDS?
Seems like this arena is a bit of a ‘Black Hole’. Thx.

[go seek]

To me it’s just information and, in my mind, I question how accurate such information really is // Fact: ENTA rose (10%) from 30 Sep-15 October.

[vinmantoo]

Short interest increased 15% to 3.4M shares
as of 15 Oct vs 30 Sep., the highest short interest for 2024 to date.

ENTA stock price rose from just under $10 to over $12 in a short time frame on no news so it isn't surprising, at least to me

[go seek]

Short interest increased 15% to 3.4M shares
as of 15 Oct vs 30 Sep., the highest short interest for 2024 to date.

[alertmeipp]

Yes they are ready to become an immunology company risk reward higher but much hotter area w higher valuation even for early stage companies

So true, couple quarters from now, ENTA could be very different, especially if they have good data. Interesting time.

[dewophile]

Delayed reaction jinx we still blame you ;)
Yes they are ready to become an immunology company risk reward higher but much hotter area w higher valuation even for early stage companies

[go seek]

Jinx? Not. ENTA went up the day after my post. ;) On another note, Jay Luly announced on the Baird Global call that Enanta will be announcing another immunology candidate before year end.