Enanta Pharmaceuticals Inc (ENTA)

[alertmeipp]

Dripping down to 60 percent of net cash level

Irrational just irrational

[vinmantoo]

Estimates based on that price (made by dewophile) means about $8 billion in Paxlovid sales in 2024. That should be a positive for ENTA and its negotiations into getting a partner for EDP-235.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173052487

[biocqr]

Pfizer to more than double price of its COVID antiviral once drug moves to commercial market

https://www.financialjuice.com/News/7707571/-Pfizer-to-more-than-double-price-of-its-COVID-antiviral-once-drug-moves-to-commercial-market.aspx

Pfizer Inc. will charge $1,390 for a five-day course of its Paxlovid COVID-19 antiviral when the drug moves to the commercial market later this year. That’s more than double the amount the company charged the U.S. government during the pandemic.

The government paid about $529 per course when it was making Paxlovid available to patients free of cost. The news of the price increase was first reported by the Wall Street Journal.

[DC15]

What would impress me. European, Canadian, Central and South American governments telling their citizens that if they test positive for RSV, then they must receive treatment with EDP-938 because the burden on the health care system due to RSV is too great. That would impress me, and there is a precedent for it. Touche, Touche, Touche!

[DC15]

DeVincenzo and Wilkinson published together with respect to the viral challenge model so not a huge surprise that he is a panelist. Fergie has served as an advisor/consultant with Enanta for some time so not really additive in terms of broadly recognized support. Maybe, maybe new data will be released, but really, a last minute announcement for this event, come on man!

[DC15]

That's what Jay said! That's what she said too!

[Jake2234]

Stay tuned

[biotech_researcher]

Dew, I recall a robust pipeline at Enanta BEFORE Covid. What happened to those programs? Seems like there were 3 or 4…

[Jake2234]

True!

[dewophile]

I've never paid attention to job openings for pharma so no informed opinion here
On the one hand lack of hiring (and indeed cutting costs per some posts) suggests no imminent cash coming in via partnership, but it could suggest interest via a buyout
enta is not exactly cash starved so at a minimum it suggests management realizes that the value if the clinical programs don't pan out is in the cash and remaining royalty, which even accounting for 2-3 quarters of burn is well above present prices

[DC15]

It seems like ENTA is due for some insider buying activity, but since there has been a lull in this activity it makes me think that there is real partnership activity.

[DC15]

"for partnership" Jake, you should have put "for partnership" in quotes.

[Jake2234]

What DD and other fail to recognize is repeated years of failures in the clinic with HBV and NASH programs. Investors have apparently lost all trust. The attempt to market these dead programs as for partnership is a complete joke!

[alertmeipp]

PFE should just buy ENTA out, remove the patent risk, gain potential better drug for covid and potentially expand their RSV lead

[vinmantoo]

Mouton,

I know it was from a retrospective study not from a trial. It is the best metric we have right now. The death rate was 2.4%-3.4% in the two untreated groups.

As Dew pointed out, EDP-235 would have to show non-inferiority. PFE clearly thinks newer and better drugs than Paxlovid are needed.

[DewDiligence]

…my gut tells me that the trial would have to be very large to show a stat sig difference for 235 v. Paxlovid.

ENTA would not try to show statsig-superior efficacy to Paxlovid, but rather non-inferior efficacy to Paxlovid without Paxlovid’s DDI issues.

[mouton29]

You're citing results from a retrospective observational study based on data that's a year or more old. Not exactly out of date, but we are two boosters beyond that and lots more infections as well. And different strains. So who knows that the current death rate is.

In any event, if you believe the Jama study, what trial is Enanta going to run? 235 v. Paxlovid in high risk 65 and over? In that population, per the article:

Among patients aged 65 years or older, the cumulative incidence of death at 90 days was 0.25% (95% CI, 0.17%-0.37%) for the treated and 2.42% (95% CI, 1.15%-2.67%) for the untreated (eFigure 3A and eTable 4 in Supplement 1).

[Note the 3.46% death rate you cite is from untreated in the Molnupiraviv arm].

There's no data on the efficacy of 235 v. death in high risk patients (or any patients for that matter), and I'm not capable of running power computations, but my gut tells me that the trial would have to be very large to show a stat sig difference for 235 v. Paxlovid.

Perhaps it would be easier to attack Paxlovid's weak point, which is, limited evidence, if any, that Paxlovid reduces symptoms. Whereas 235 has some evidence of that. That could be a trial in a much larger population and presumably easier and cheaper to enroll.

[vinmantoo]

I think RBCs point is with vaccine, less harmful covid variant and natural immunity, hospitalization rate is lower than before, thus it’s harder than before to show stats significance on the same endpoint. (Reduce hospitalization rate)

I understand their point and appreciate your raising it. However, I am saying it is wrong. Both the hospitalization rate and death rate are high enough in high risk groups to provide a path forward for regulatory approval.

A recent study (2022-2023), which was brought to my attention by dewophile showed that the death rate in the high risk group was 1.4% in people not treated with either Paxlovid or Molnupiravir, and most were vaccinated. For people over 65, the death rate was 3.46%. These data were for a period of 90 days after infection with Covid.

https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2809779

So for 235, the regulatory pathway isn’t clear for them. That’s probably one of the reason 235 get discounted by the market even it seems to be superior drug

I sure seems that way.

Hope ENTA can work out the details with FDA and update the market soon

Obviously, so do I. Good luck to us both. We need it.

[alertmeipp]

Is it normal for a pharm to have zero opening position? I got that they are in waiting mode for their programs but many companies would still list opening positions just to build up resume database for future positions

[alertmeipp]

I think RBCs point is with vaccine, less harmful covid variant and natural immunity, hospitalization rate is lower than before, thus it’s harder than before to show stats significance on the same endpoint. (Reduce hospitalization rate)


So for 235, the regulatory pathway isn’t clear for them.

That’s probably one of the reason 235 get discounted by the market even it seems to be superior drug

Hope ENTA can work out the details with FDA and update the market soon

[vinmantoo]

From RBC: "the U.S. regulatory path currently emphasizes demonstration of outcomes benefits (hospitalization, mortality, etc.) and this would be difficult to show in the current environment, barring a major mutation."

ENTA would only have to show non-inferiority to Paxlovid in high risk groups for hospitalization and or death. It isn't clear to me why a drug that reduces symptoms in a regular risk group cannot be approved. A major new mutation could make vaccines less effective and increase the need for new anti-Covid drugs.

[alertmeipp]

PFE expects Paxlovid 2023 sales to be around 8b, So I would think 325 is viable and worth more than zero. But the concern seems to be its regulatory pathway?

From RBC: "the U.S. regulatory path currently emphasizes demonstration of outcomes benefits (hospitalization, mortality, etc.) and this would be difficult to show in the current environment, barring a major mutation."

[DewDiligence]

ENTA soared on expectations for the COVID program, but lately investors have (unduly, IMO) downgraded everything related to COVID as though the virus will just disappear.

Meanwhile, ENTA’s RSV program has taken longer than originally anticipated to develop, due to a low incidence of RSV infections during the pandemic, which has slowed patient enrollment in ENTA’s RSV trials.

See #msg-172945060 for related info on valuation.

[biotech_researcher]

Trying to understand this stock that I had a position in in 2020. At the time, it had a very promising pipeline.

This was $74 in Nov 21, and now it sits below $10. Can someone please express their opinion on what went wrong? It can’t be just a depression in biotech.
Thanks

[JK2016]

Not to my knowledge.

[DewDiligence]

Are any clinical programs being discontinued, to your knowledge? You didn't reply to my post in #msg-172923766.

[alertmeipp]

Make sense, they are mainly in waiting mode, pending patent lawsuit result and potential partnership deal

Not sure how can Enta trade this low with so much option values plus cash

[JK2016]

My post did not consider the posted positions, only those let go from existing roles. A total of 21 across almost all areas, mostly science roles , a few G&A.

[DC15]

Lots of speculation. I did notice that Jay did not participate in the last chat, but instead allowed his study to take it solo. I accept that as a natural progression of responsibilities and I recall seeing it previously with Ada shortly before she left.

I do not have enough information on this to know what is accurate. For the time being I trust that JK2016 is correct or that he made a mistake and his trusted source was the job postings on the Enanta site being removed. Could be that they were filled. I was concerned about the stated jump to a non virology initiative, but I cannot see hyping it and then abandoning it especially as the study did mention it in the most recent chat. Observing.

[dewophile]

while a buyout could happen at any time, I feel like the for sale sign will be up next year if RSV trial(s) fail* and no progress w the covid PI. At that point the company would be wise to shut things down, and the value is the cash + royalty stream + the lawsuit as a wildcard. In this scenario you want to maximize the cash on hand, and I think the value would be at least 18 dollars a share if this worst case comes to pass. The chairman of the board is Bruce carter and this is basically what he did with ZGEN when their recombinant thrombin inhibitor was struggling
JMO
* This assumes they get readouts for the phase 2 RSV trials. I think they will I have heard of several RSV cases now in the NYC area and one infant I know hospitalized already and it is just the beginning of traditional RSV season
DD - I also know several people who got the RSV vaccine all got the GSK FWIW

[radford]

Just a guess on my part but I think the headcount reduction may not be from layoffs but from the elimination of open positions. Enanta had around 20 open positions on the careers section of their website that were recently removed. If you consider approved positions that are not yet filled to be headcount, then cutting these openings could be construed as a 15% reduction in the workforce.

[DewDiligence]

Where are the layoffs coming from? ENTA does not have a lot of corporate bloat.

If your info is accurate, I presume that the early-stage research in undisclosed non-viral disease (see slide #5 at https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4 ) will get the axe.

[DewDiligence]

I don’t consider VERU's drug a competitor; VERU's phase-3 trial is restricted to hospitalized patients with ARDS, which is not the market ENTA is seeking to address:

https://finance.yahoo.com/news/veru-reaches-agreement-fda-phase-123000795.html

[ASPRV]

Is there anyone who knows about sabizabulin of Veru well enough? They restart their phase 3 again on Q4.23. Which looks so potent as far as I've seen.
Their mechanism of act is different so it could be whole different market, though.
I wonder if it could be ENTA's potential threat.

[JK2016]

A reliable source.

[ASPRV]

Me too! I would like to know where u find it out, if you do not mind, sir.

[DewDiligence]

The poster in question may be an ENTA employee or family member of an employee.

[DC15]

That might save 3.5M per year. I try to have confidence in Enanta's hiring process and not believe that they would hire any less than the best. Let's see what happens, perhaps the poster made a mistake.

[rwwine]

“Is this typical of pre-acquisition activities?”

My thinking is more inline with cutting costs to extend their cash while they continue to execute on the business plan. I don’t envision a buyout. JMHO

[DewDiligence]

Source? TIA

[DC15]

I cannot find additional information on this, but I did notice several weeks ago that most of the open positions had been removed from the company's website. Can you direct me to the source for this statement of trimming the headcount.

Is this typical of pre-acquisition activities?

[JK2016]

ENTA trims ~15% of headcount.

[JK2016]

Correct. Only had 9 enrolled over the last 3 years.

[vinmantoo]

ENTA halts enrollment/trial for RSV transplant patients

ENTA stated there were too few patients to recruit.

[JK2016]

ENTA halts enrollment/trial for RSV transplant patients

[DewDiligence]

ENTA updated corporate slide set (9/12/23):

https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4

Differences between the 9/12/23 corporate slide set and the 8/7/23 version are relatively minor. (In the bullet points below, I’ve omitted mention of slides that were merely re-sequenced with no changes to the content.)

• New slide 7 has additional info about the unmet medical need for an RSV treatment.

• Regarding the EDP-938 phase-2 clinical trials, new slides 14-15 replace old slides 13-15. ENTA discontinued the RSVTx trial in immunocompromised transplant patients because there weren’t enough transplant recipients infected with RSV to enroll the trial. (The RSVPEDs [pediatric] and RSVHR [high-risk adult] trials are continuing without change.)

• Old slide 30, which showed the performance of the placebo arms in various COVID trials, has been deleted.

• New slides 25 and 26 (which had no counterparts in the old slide set) show graphs of the EDP-235 SPRINT trial’s Total Symptom Score for all 14 prespecified symptoms among all ITT patients (slide 25) and patients treated within three days of symptom onset (slide 26). These two new slides supersede old slide 26, which showed Total Symptom Score for a post-hoc subset of 6 of the 14 prespecified symptoms.

• New slide 27 has the same content as old slide 27, a graph of the time to symptom improvement for a subset of 6 symptoms, but the header has been corrected to fix a clerical error in the old slide.

[willyw]

I was drawn into investing thru HCV.
Gilead paid 11 billion for a fabulous asset and generated a lot of income.
The only *problem* (some thought) it was a cure, and in time the treatment numbers dropped.

Covid on the other hand spins off variants that evade current vaccines.
Thus Covid may have a longer run than initially expected and repeat customers.

W/ regards to HCV, Enanta had little leverage and didn't get a large share in HCV profits.
It may be that this recent Covid surge- if there is continued negotiation w/ a potential partner- this surge may be a benefit.
Maybe Enanta won't accept a first low ball offer.
(that's a reason I wondered if they pulled the preclinical candidate from their slides)
No announced agreement doesn't equal failure- it may mean a better offer coming.
Rising Covid hospitalizations are probably also be getting investor's attention.

Not only has the share price come up the volume is encouraging too.

[vinmantoo]

Pavlovid weekly prescriptions have increased fourfold from their 2Q23 nadir, according to PFE’s CCO on today’s MS webcast. Weekly prescriptions are now running at about 60% of the peak 2023 level reached in January.

I wonder if the surge of Covid will finally end the precipitous downward spiral of ENTA stock price. It is up $0.75 this morning but this could be a head fake. I sure hope it is real and the start of a nice rise.

[dewophile]

we are on the same page wrt enta/luly etc
Even if the likelihood is very small, I was just speculating that perhaps one possibility for amending the pipeline in a rather peculiar way is to lower the likelihood of government scrutiny if PFE were in fact in discussions w ENTA about an acquisition. I am probably overthinking it anyway bc it would be a small transaction that almost never results in antitrust concerns, and we are talking about a super early program, which I have never seen anyone have to divest regardless of the size of the transaction.

[willyw]

why would ENTA drop a super early stage (covid) program...?

IDK. It seems to me that they could have left it or removed it and it ultimately means little. It could be a signal that it failed closer scrutiny without calling attention to it, It could mean it's a signal that they are not spending blindly and are prudently controlling their burn rate. IF they no longer have it on a slide it's not to say they couldn't keep working on that prospect and others. Ultimately I think they are just directing attention away from this for now.
It troubled me a little that the presentation the 9th of Sept was primarily RSV. But they can't talk about any potential partnerships. IF there's nothing concrete from regulators they are best not talking about that either.
One thing I DO like about Enanta and Luly is that they seem to not hype their products or over promise as some other companies do
My guess is that money is tight and the shortest path to raising share price is in completing RSV data.

Per the Pfizer link, I think that it underlines the thesis that new and better Covid drugs are needed- despite what some may think, and that there are pathways to future approvals.

Somewhat off topic- when I think of the value of a best in class Covid compound I would think that a compound that is somewhat more near approval (EDP-235 could start phase 3 if partnered) would be potential worth billions more than a preclinical, phase 1 or entering phase 2 compound. The efficacy has been proven and asset de-risked. There may be further labels to be investigated.
Even more off topic would be what would a patent settlement be worth to Pfizer? Well, that could also be worth billions.
And yet if Pfizer settled with Enanta- Enta could use the cash to further co-fund development of EDP-235 - not good for Pfizer.
So in a sense, wouldn't it make cash sense for Pfizer to try to acquire Enanta?

Even more off topic- 17% of my ENTA holdings are green since Sept 6.
I've either caught a falling knife or a dead cat on it's first bounce. : )