Enanta Pharmaceuticals Inc (ENTA)

[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. : )

[DewDiligence]

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.

https://event.webcasts.com/viewer/event.jsp?ei=1630426&tp_key=a1d42d6790

[dewophile]

Yes if PFE were making overtures to ENTA bc they dropped their RSV-N, they want the lawsuit to go away, etc (I mean it makes strategic sense), it might be easier to not raise any scrutiny if you are also getting the only 2 PLpro projects in the wings
mind you I have never heard of FTC action for super early stage projects, or for small buyouts like this would be , but could covid be different? TBH I doubt it, but it crossed my mind bc it really doesn't make sense to announce the project earlier this year and suddenly remove it from the pipeline chart so it jsut got me thinking that is all

[vinmantoo]

dewophile,

I agree with you. ENTA could just keep the product listed in development without spending any appreciable amount of money on it.

At the risk of sounding like a self serving conspiracy theorist I was just thinking it may be a bad look to let someone corner the covid market

I am not sure what kind of conspiracy theory you're talking about. Are you suggesting a ENTA is making a decision to appease PFE? If so what would be the reason? Are you suggesting/fantasizing it would be part of a deal to end the lawsuit over Paxlovid or a partnership/buyout deal? All I know is it doesn't seem to make sense, at least to me.

[dewophile]

At the risk of sounding like a self serving conspiracy theorist I was just thinking it may be a bad look to let someone corner the covid market

[DewDiligence]

What is your (possibly) far-fetched theory? TIA

[dewophile]

They can pause the program and still keep it listed on their slide deck, if anything to project they still have more in the tank as the street is writing them off
I have another theory but it may be far fetched

[DewDiligence]

why would ENTA drop a super early stage program in which no one is expecting to hear much for a long time from their slide deck?

It makes sense (IMO) to pause the PLPro program pending regulatory clarity on EDP-235. It should be a simple matter to resume discovery work on PLPro if ENTA opts to do so.

[dewophile]

why would ENTA drop a super early stage program in which no one is expecting to hear much for a long time from their slide deck?
If they want to signal to the market that they are further extending their cash runway dropping an early preclinical program isn't exactly going to move the needle
FYI PFE happens to be working on a PlPRO (https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-clear-creek-bio-collaborate-research-program).

[vinmantoo]

The Wells Fargo chat yesterday was valuable and informative......, well, if you knew nothing about ENTA.

The questions asked were mostly about RSV.

[vinmantoo]

Not a triple witching event this time and I am all ears for possible reasons.

S&P rebalancing is the likely culprit as ENTA was dropped from the S&P small cap 600 index.

[DC15]

Not a triple witching event this time and I am all ears for possible reasons.

[ASPRV]

Could Shionogi make their Xocova by Viiv Healthcare's HIV mechanism?

[biocqr]

Thanks.
Regardless of what happens with Covid, RSV Hep B/C etc.it appears a favorable settlement could propel the stock price 2X-4X from here.

[DewDiligence]

Re: PLPro program

There was no announcement, but ENTA removed the PLPro program from the pipeline chart on slide 5 of the latest slide set (https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4 ).

The PLPro program was only in the discovery phase—not yet in preclinical development—and ENTA had not even selected a lead candidate for the program. I.e., very little money has been spent to date on this program. It should be a simple matter for ENTA to reinstate the PLPro program if developments with EDP-235 warrant such an action.

[DewDiligence]

The Biktarvy patent settlement you cited can be considered a lower bound for the economics of a potential settlement of ENTA’s patent suit against PFE with respect to Paxlovid, IMO.

Regarding the merits of the two cases, I don’t have an educated opinion on how they compare.

[DewDiligence]

As an infused drug, GILD’s Veklury addresses a distinct market from Paxlovid and other oral antivirals.

[vinmantoo]

It's on hold pending developments for EDP-235.

I didn't see any announcement but just noticed is isn't listed as pre-clinical on the ENTA website.

[biocqr]

Dew...how similar are ENTA's claims against PFE compared to GSK/ViiV's patent suit against Gilead's Biktarvy?

How likely or unlikely is the possibility that an ENTA/PFE settlement would be more or less than Gileads settlement?

Paxlovid's sales to date are substantially higher than Gilead's Biktarvy at the settlement date...are they not?

https://viivhealthcare.com/hiv-news-and-media/news/press-releases/2022/january/gsk-announces-settlement-between-viiv-healthcare-and-gilead-sciences/

Under the terms of the global settlement and licensing agreement, Gilead will make an upfront payment of $1.25 billion to ViiV Healthcare which is expected in the first quarter of 2022. In addition, Gilead will also pay a 3% royalty on all future US sales of Biktarvy ($6.09 billion in 2020) and in respect of the bictegravir component of any other future bictegravir-containing products sold in the US. These royalties will be payable by Gilead to ViiV Healthcare from 1 February 2022 until the expiry of ViiV Healthcare’s U.S. Patent No. 8,129,385 on 5 October 2027. Gilead’s obligation to pay royalties does not extend into any period of regulatory paediatric exclusivity, if awarded. Regulatory paediatric exclusivity would extend the period of exclusivity after the expiry of the ‘385 patent by six months from 5 October 2027 to 5 April 2028.

[ASPRV]

Is there anyone who has an insight with Veklury of Gilead? I've just noticed its' revenue is higher than Paxlovid and Lagevrio. and it's got the FDA approval for liver patients on 24th, August.
But Enanta didn't even mention Veklury in their presentation which compares the drug efficacy.
Thank you in advance.

https://www.gilead.com/news-and-press/press-room/press-releases/2023/8/fda-approves-veklury-remdesivir-to-treat-covid19-in-people-with-mild-to-severe-hepatic-impairment-with-no-dose-adjustment

[ASPRV]

Thank you for the update. I'm looking forward to seeing the result of this. I think this is an important issue with Enanta. Do you have any insight on this kind of case?
Is there any reference case you know? I wonder if Enanta won over Pfizer, what percentage of the Paxlovid's previous revenue could we get? Additionally, are you expecting Paxlovid to suspend sales after Enanta win?

[DewDiligence]

It's on hold pending developments for EDP-235.

[DC15]

PLpro inhibitor? Did Enanta drop their PLpro inhibitor program? Can anyone offer any insight? Thank you in advance.

[vinmantoo]

Moreover, a settlement could occur before this goes to trial.

I was thinking the same thing.

[DewDiligence]

That timeline doesn't seem so long to me.

Same here. Moreover, a settlement could occur before this goes to trial.

[vinmantoo]

Pfizer - Enanta Patent Case Looks like a very long timeline.

Thanks for the update. That timeline doesn't seem so long to me.

[DC15]

Pfizer - Enanta Patent Case Looks like a very long timeline.

The following was posted yesterday at https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc

Judge Denise J. Casper: ELECTRONIC ORDER entered granting122 Joint MOTION for Extension of Time - Joint Motion to Modify Schedule. Deadline for substantial completion of document discovery by September 15, 2023. Close of fact discovery by November 17, 2023. Deadline for initial expert reports on issues as to which party bears the burden of proof by January 12, 2024. Deadline for rebuttal expert reports as to which party does not bear the burden of proof by March 1, 2024. Deadline for completion of expert depositions by April 12, 2024. Deadline for summary judgment motions and Daubert motions May 10, 2024. Deadline to file oppositions to summary judgment motions and oppositions to Daubert motions March 31, 2024. Deadline to file replies in support of summary judgment motions and replies in support of Daubert motions June 14, 2024. Status Conference set for 12/4/2023 02:45 PM in Courtroom 11 Related [+] before Judge Denise J. Casper. (Currie, Haley)

[rwwine]

Done!! Incredibly curious what if anything will be shared update wise on the 235 project. Cheers to all for a wonderful Labor Day weekend. Off to northern Wisconsin & the UP of Michigan for a few days of fishing, kayaking, campfires and a few nice bottles of wine with friends. Peace….

[vinmantoo]

rwwine,

Ha, ha, you just beat me to it. Why don't you post that on the Biotech Values site too?

Hopefully, they will be talking about developments in partnerships for EDP-235.

[rwwine]

Enanta Pharmaceuticals to Participate in Investor Conferences in September

August 31, 2023, 7:00 AM EDT
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced that members of management will participate in four investor conferences being webcast in September and provide a business update:

Wells Fargo Securities Healthcare Conference: Fireside Chat at 2:15 p.m. ET on September 7, 2023

H.C. Wainwright 25th Annual Global Investment Conference: Presentation at 4:30 p.m. ET on September 12, 2023

Baird Global Healthcare Conference: Fireside Chat at 1:25 p.m. ET on September 13, 2023

2023 Cantor Global Healthcare Conference: Fireside Chat at 8:45 a.m. ET on September 26, 2023

A live webcast of each event will be accessible by visiting the “Events and Presentations” section on the “Investors” page of Enanta’s website at www.enanta.com. A replay of the webcasts will be available following the presentation and will be archived for at least 30 days.
About Enanta Pharmaceuticals, Inc.
Enanta is using its robust, chemistry-driven approach and drug discovery capabilities to become a leader in the discovery and development of small molecule drugs for the treatment of viral infections. Enanta’s research and development programs include clinical candidates for the following disease targets: respiratory syncytial virus (RSV), SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also conducting research on a single agent targeting both RSV and human metapneumovirus (hMPV).

Glecaprevir, a protease inhibitor discovered by Enanta, is part of one of the leading treatment regimens for curing chronic hepatitis c virus infection and is sold by AbbVie in numerous countries under the tradenames MAVYRET® (U.S.) and MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit www.enanta.com for more information.

View source version on businesswire.com: https://www.businesswire.com/news/home/20230831535787/en/

Contacts
Media and Investors?Jennifer Viera?617-744-3848?[e-mail]

[ASPRV]

Thank you. Is the reason you think it won't get approval at least not for a long time because Xocova is teratogenic like the thalidomide(Contergan) case? Good thing we talked this time :)

[vinmantoo]

Shinogi's drug Ensitrelvir (Xocova) won't be getting approval in the US, at least not for a long time. The other drug is in phase 3 but no data is around yet and didn't meet primary endpoints in their 2021 phase 2 which had 1/3 of high risk patients yet you assume that will be approved next year.

https://www.fiercebiotech.com/biotech/atea-and-roche-s-covid-19-antiviral-flunks-phase-2-prompting-switch-will-delay-pivotal-data

I see you are another poster who has only made a small number of posts, all on the ENTA board. Nothing suspicious about that. /s

[ASPRV]

When Xocova and Atea's Sunrise comes out in U.S. market on 2024 or 2025. It will probably be before EDP-235's roll out.

Would it be weird thinking like one of each could substitute Paxlovid? Then EDP-235 wouldn't get as much market space to penetrate?

IMO, it is ritonavir that the most serious issue of Paxlovid. And both of them don't have ritonavir as far as I've seen.

Plus, EDP-514 has higher EC50 than Aligos drug, which means it has a less effective result as I understood. What do you think we could expect from this HBV treatment's result?

[vinmantoo]

That is why I mentioned it because the annual flu vaccine is still required. It is not clear if the two are being treated differently because the disease risk is different, or if it is because the vaccine risk is different.

Thanks. Hard to know the reasoning behind the difference.

[DewDiligence]

Many of_those points apply_to_the RSV program too:

With vaccine approvals for RSV for infants and seniors, and now at the time of pregnancy (congrats Pfizer), the final missing piece of this problem is an effective therapeutic. I had a good conversation with Jay Luly about this a couple of weeks ago. https://t.co/E1VY6gSpzK

— Brad Loncar (@bradloncar) August 21, 2023

[willyw]

I continue to have faith in Enanta for a few reasons;

1) While it has not been tested extensively EDP-235 still looks to be superior to Paxlovid and appears to be the best in class protease inhibitor.
2) Other larger pharmas continue development in the space and COVID is not going away. A best in class drug should have a good profitable run.
3) As in the past, new variants continue to arrive, have potential for evading vaccines which cannot keep pace with the continuous COVID adaptations.
4) Issues (opportunities) with long COVID, rebound, prophylaxis are still needing a solution.
5) Per my earlier post a large number of Americans are vaccine hesitant. The government is no longer supplying free pandemic vaccinations and so we will see reduced compliance and higher and more serious outcomes than are necessary.
-You do not need a "delta" variant to require the need for an improved antiviral; just new variants and lower compliance coupled with vaccines which are imperfectly suited to newer variants.

Obviously, all of this is my humble opinion, and the above pertain ONLY to COVID.
They only address the present need for an improved PI.

6) If Enanta has a good follow on COVID candidate that can be effective and has a different MOA it could possibly have two profitable COVID drugs and a longer deeper pipeline.

[DC15]

That is why I mentioned it because the annual flu vaccine is still required. It is not clear if the two are being treated differently because the disease risk is different, or if it is because the vaccine risk is different.

[vinmantoo]

What about the flu vaccine at Michigan? You suggested the requirements for the Covid vaccine was being treated differently than those for influenza vaccines, Berkeley treats them the same.

[DC15]

Michigan Medicine has updated its COVID-19 vaccination policy, no longer requiring the vaccine or an approved exemption as a condition of employment. ... The change aligns with the policies at other health systems and comes in advance of the upcoming release of an updated COVID-19 vaccine.

The message does not say anything about requiring the updated vaccine when it is available.

[vinmantoo]

Do you know that universities and their hospitals across America are not requiring any COVID vaccine or boosters for their employees, but they do continue to require yearly flu vaccines?

Not sure where you are getting your information but at Berkeley, both vaccines have similar requirements. You must get both unless you sign an opt/decline form.

[DC15]

Do you know that universities and their hospitals across America are not requiring any COVID vaccine or boosters for their employees, but they do continue to require yearly flu vaccines?

It is difficult to say that the change in policy is due to employee pushback.

[DewDiligence]

I arrived at this poll from a Yahoo article entitled; "A third of adults believe COVID-19 vaccines caused thousands of sudden deaths: Poll"

After reading the comments sections of various WSJ articles about COVID, I find the poll results you posted believable. This phenomenon is a serious problem for society, but is perversely bullish for ENTA.

[willyw]

This poll seems small but legit.
I also think it somewhat describes the current landscape of vaccines but particularly Covid.
So far as Enanta it suggests that Covid might last longer and have deeper consequences (for those unvaccinated).
https://www.kff.org/coronavirus-covid-19/poll-finding/kff-health-misinformation-tracking-poll-pilot/
There is an important link on methodology at the article's bottom.
Also that there WILL be those may be RSV vaccine resistant to vaccination.

I arrived at this poll from a Yahoo article entitled; "A third of adults believe COVID-19 vaccines caused thousands of sudden deaths: Poll"
https://www.yahoo.com/news/third-adults-believe-covid-19-090000023.html

(RE; Covid) " 65% of respondents heard or read the false claim; "The COVID-19 vaccines have caused thousands of sudden deaths in otherwise healthy people."
Percent who say the false claim is definitely or probably true: 34%
Percent who have both heard or read the false claim and say it is definitely or probably true: 29%"

I'm actually hesitant to post this since it has a Alice in Wonderland surreal quality to it.
But it explains a lot IMHO, if true.

[DewDiligence]

ENTA’s pro forma cash @6/30/23=$221.2M—treating_ENTA’s_deferred-royalty_obligations_as debt (as is done under GAAP [#msg-172603887]—but see note at bottom of this post). The $212.2M figure consists of:

• $380.3M of net current assets on the 6/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023039754/enta-20230630.htm#consolidated_balance_sheets );

• $5.9M of marketable securities on the 6/30/23 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year) (ibid); and

• ($165.0M) deferred long-term liabilities relating to the Omers royalty agreement. ($36.7M of liabilities relating to the Omers agreement are booked as current liabilities and hence are included in the $380.3M figure in the first bulleted item.)

Note: Excluding the “debt” associated with the Omers royalty agreement, ENTA’s pro forma net cash at 6/30/23 was $422.9M ($221.2M + $165.0M + $36.7M).

[DewDiligence]

ENTA’s fully-diluted share count @6/30/23=26.09M—a decrease of 0.07M since 3/31/23.

The 26.09M figure above consists of: 21.06 basic shares on the 6/30/23 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023039754/enta-20230630.htm#consolidated_balance_sheets ); and 5.03M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, p.10).

[vinmantoo]

COVID BA.2.86 strain is worrying some experts:

Covid isn't going away any time soon.

[DewDiligence]

COVID BA.2.86 strain is worrying some experts:

https://finance.yahoo.com/news/explainer-eris-ba-2-86-120000468.html

…the trajectory of BA.2.86 "doesn't look good right now," given the speed at which new cases are being identified, said Dr. Eric Topol, a genomics expert and director of the Scripps Research Translational Institute in La Jolla, California. Its many mutations make BA.2.86 "radically different in its structure" compared to earlier variants, Topol said. …Wider spread of BA.2.86 would likely cause more illness and death in vulnerable populations, Topol said.

[vinmantoo]

Agree. I wasn’t meaning it’s a $3 stock this year or next but at some point unless a deal is struck. On the positive side there is also the patent litigation with PFE that could yield positive results as well.

Looks like we are on the same page.

[vinmantoo]

I read it and you are wrong. They have the $200 million cash and they aren’t paying anything out of their pockets. It is coming out of future revenues. It is an accounting mechanism. Are you really saying they got the money but can’t use it for anything? That makes no sense.