Enanta Pharmaceuticals Inc (ENTA) Options

I’ll take that too!

I am hoping for a buyout next couple quarters ;) no funding issues ever.

I agree w DD on this one. I still think ENTA could get 120-150M if they wanted to monetize the remaining royalty stream today even though sales have been slowing. It would be nicer to get a cash injection from the patent suit and or partnering RSV though

Re: Reason for updated cash-runway guidance I thought it could be realization of decreased MAVYRET sales going forward. The outlook for ENTA’s royalty revenue is a small part of the picture, IMO. ABBV’s quarterly Mavyret sales are rather lumpy due to bolus orders by ex-US governments and US agencies such as state departments of correction. Although Mavyret’s sales are clearly in a downward trajectory, the trend line of the descent is gradual.

A ramp-up in R&D for the reasons posited by ‘dewophile’ is by far the bigger factor in the new guidance, IMO.

ENTA updated corporate slides (11/25/24)

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

The latest version of ENTA’s corporate slide set has new info on ENTA’s dual-pronged immunology program in slides 21-33:

• Slides 21-23 provide an overview of the program and the size of the addressable markets.

• Slides 25-29 describe the KIT program, which now has a lead compound called EPS-1421.

• Slides 30-33 have brand new info on the STAT6 (“oral Dupixent”) program that was announced in today’s press release.

Before reading your post, I thought it could be realization of decreased MAVYRET sales going forward.

I sure hope so. The revised cash runway is significant, so one can only speculate that one reason is resizing of a peds phase 3, or possibly including an adult phase 3 into new guidance. Otherwise what could it be? spend on the patent case going to trial? some acceleration in immunology - but that doesn't seem to be the case based on what they guided for the kit inhibitor so..

December: Outstanding RSVPEDS Results! 🎁 Merry Christmas shareholders!

It is designed to hit the same targets as dupixent so a massive opportunity which is why they got such a lucrative deal including up front despite being so early stage. It's the only competitor I could find, but there could be others in stealth mode. ENTA again will be at least a year behind or more, but given the size and scope of indications, and the fact someone can stumble or even be suboptimal in terms of dosing (we know ENTA is almost always able to get a QD drug and these are for chronic indications were dosing matters), this has the potential to be significant - but super early obviously
Here is ENTA's updated slide deck which includes this new program:

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

Interesting - Sanofi is paying Recludix Pharma $125 million and offering up more than $1.2 billion in biobucks for a pact taking aim at multiple immunological and inflammatory indications.... another partnership potential yet for $ENTA :)

Re stat6 inhibition slide deck (from competing company)

“Previously deemed undruggable”

https://recludixpharma.com/wp-content/uploads/2024/09/Recludix_Corp-Pres_September-2024.pdf

Re new immunology program

There is an SNY partnered program now in the preclinical IND-enabling stage. There could be others too

https://recludixpharma.com/recludix-pharma-enters-into-a-strategic-collaboration-with-sanofi-to-advance-novel-oral-stat6-inhibitor-in-multiple-immunological-and-inflammatory-indications/

So cash runway somewhat shorter than last quarter otherwise not much here good or bad as far as I can tell.
I’m hoping the shorter cash runway is because they realize a phase 3 in RSV will be a bit larger than originally anticipated (implying good enough data to move the program forward but perhaps need to increase power based on the phase 2 data that they surely must have by now )

ENTA reports FY4Q24* financials—RSVPEDs data due in December::

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-41

FY4Q24 highlights

• 9/30/24 cash = $248.2M, a decrease of $24.4M from the cash balance at 6/30/24.

• FY4Q24 royalty revenue was $14.6M, -18% QoQ [$18.0] and –23% YoY. Note: 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).

• FY2Q24 R&D expenses were $30.8M, consistent ENTA’s prior FY2024 guidance of $125-145M.

• FY1Q24 SG&A expenses were $13.7M, consistent with ENTA’s FY2024 guidance of $50-60M. Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.


Liquidity guidance

• ENTA stated that its cash and expected royalty revenue are sufficient to fund operations “into FY2027,” which starts on 10/1/26. This is a change from the prior guidance that liquidity was sufficient to fund operations through 6/30/27 (end of FY3Q27). ENTA did not give operating-expense guidance for the next fiscal year, as it historically has done when reporting FY fourth-quarter results.

*ENTA’s fiscal year ends on September 30.

Enanta Pharmaceuticals Reports Financial Results for its Fiscal Fourth Quarter and Year-Ended September 30, 2024
Nov 25, 2024

On Track to Report Topline Results for RSVPEDs, a Phase 2 Study of Zelicapavir in Infants and Children Infected with Respiratory Syncytial Virus (RSV), in December
Announced Positive Topline Results for EDP-323 in a Phase 2a Human Challenge Study of Healthy Adults Infected with RSV
Expands Immunology Portfolio with the Introduction of a New Discovery Program Focused on STAT6 Inhibition and the Nomination of EPS-1421, a Potent and Selective KIT Inhibitor Development Candidate
Operations Supported by Cash and Marketable Securities Totaling $248.2 Million at September 30, 2024, as well as Continuing Retained Royalties

Read more:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-41

🙏Thank you dewophile.

Thanks for sharing your knowledge here. And to be fair, his term was clinical benefits not necessarily mean meeting primary endpoint in the study.

Yes. Odd indeed, although iirc, they later found 935 failed the meet primary because healthy patients usually recovered themselves after day 2 anyways so adminstering them the drug after 48 hrs wasn’t useful … or something to that effect

if now even PED and high risk, which would have weaker immune, also failed to show clinical benefits, that would put the whole RSV program in doubt as one can easily imply 235 will run into same issue as well - Which would make his answer even more odd and somewhat foolish.

I linked to a prior post where I sort of answered that
I would guess divincenzo would say something along the lines of:

1. zeli failed in rsvp bc VL were already dropping by the time tx was initiated and all patients were already on the mend by the time drug was started
2. fusion inhibitors (except ziresovir) failed because they can't target the large number of already infected cells when you start treatment later during the course if infection versus challenge study patients
3. lumicitabine was underpowered because they had to halt the study due to safety

These are mostly things the company has already said by the way, but it is far from a slam dunk that zeli will succeed where others have failed

Dewophile, let’s suppose Dr. DeVincenzo was pushed back by a response similar to what you just provided here. What would be his retort, if any? Regards…

Apparently, a positive / safe RSVPEDs trial will be a milestone event.

re peds data for some other antivirals including lumicitabine

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=175293176

The odd thing is that there were several failures in this space of drugs that clearly have good antiviral activity. The analyst just didn’t push back. I’m fact zelicapavir itself failed in the standard risk RSVP study. The most notable failure was Lumicitabine which JNJ picked up from Alios which had challenge data on par with zelicapavir , was a replication inhibitor too (Nuke targeting polymerase), and failed to show an effect in their peds study. The drug was terminated for safety but there is a paper summarizing the clinical data among those that did get enrolled.

(I’m going to put the question back to you…)

Yes.. if he had seen the data then and the data was not good, he absolulely wouldn't say that... as then the answer for that question would now be Zelicapavir...

2B isn’t entirely impossible. Solid RSV data and a nice patent settlement would bring us there.

Some dated info on Dr. John P DeVincenzo:
(I’m going to put the question back to you…)

https://www.businesswire.com/news/home/20210105005335/en/Enanta-Pharmaceuticals-Announces-the-Appointment-of-John-P.-DeVincenzo-M.D.-as-Vice-President-of-Translational-Virology

Extended hours volume 926K

Drug development is hard eom

and would be rewarding I guess.. otherwise, why we are here :)

Nice to see 895,546 block trade done after hours.Will see if the non-sense dumping continues into next week.

Earning should be out next Monday.
Based on an event alert from my brokerage.

Drug development is hard eom

8B, I thought Enanta would be an 8B dollar company by now. I can accept that I was wrong, but I would like to know what others understood that I did not. All of those big targets, antibiotic resistant bacteria, NASH, PBC, HCV, HBV, RSV, development of unique assays; I was really enthusiastic. Now I just want it to be a 2B company. At least I did not go for the RVNC thing, I know a lot of people made money here and there as long as they got in and out at the right moments.

I am thankful that I could learn from this experience without any catastrophic outcomes.

That would be tragic!!
…blue has 3 fda approved drugs*, and c-ste blew thru billion$ over last decade (not unusual to burn but seriously), barely any revenue generated considering one of the indications (sickle cell) has a ~$3mm price tag!! Now company begging shareholders to approve 1:15/20 clock back so they can continue to pay themselves handsomely…smh

*57 patient starts completed to date in 2024 (35 ZYNTEGLO, 17 LYFGENIA, 5 SKYSONA).

$50/sh—>EV of ~$900M, which is actually quite modest. The arithmetic is in #msg-174935596 and #msg-174935610.

I was responsible for a portion of that :- )

>> at best an offer north of 50 dollars which is what really good RSV data would probably garner. Good luck

That’s exactly why i am holding on.

Dont want to wake up one day to see i missed out the buyout, and downside is very limited with the cash cushion. So its like a free call opton on RSV.

Obviously, the market doesnt see what we see.

Volume picked up to 237K today, the most since 8 October.

So the opportunity cost to buy now is much lower than a year ago.

yes you don't need to keep money sunk while waiting a year for trials to read out etc. There should be visibility on the lawsuit and even the adult study in 6 months or so, so no matter what all the cards are turned over soon. My thinking is at worst you have a well funded early stage immunology company, at best an offer north of 50 dollars which is what really good RSV data would probably garner. Good luck

Fair point, just now many unknowns are going to be known next few months. So the opportunity cost to buy now is much lower than a year ago.

yeah I agree but it went down to low 8s last year when there was more cash in the bank so it is not like we haven't seen this script before
I added 10K yesterday at 9.1 average, and 6k so far today at 8.8 fwiw

Never seen a company with such a promising program and yet selling way before current asset values.

Whoever dumping the shares day in and out arent doing it because of fundamentals. Imo

Added again, that’s it for me.
It is ridiculously cheap but already over allocated by fair bit.

Ready for partnership or buyout announcement now LOL.

And pls if the RSV is bad, just be very bad so they will just stop the program and focus on immunology.

Still will have significant upside but less so if that happens.

Good luck everyone

RSV season

Looks like Florida and Georgia are in full swing for RSV now. Texas also has a high rate of test positivity. Hopefully the adult HR study will complete enrollment soon.

https://www.cdc.gov/nrevss/php/dashboard/index.html

As a reminder the only adult HR data w zelicapavir is the terminated transplant study. very small N, but the effect on VL was stark with a -7 log decrease in the treatment arm versus -2 log in the placebo arm. On the clinical side 1 our of 4 on placebo developed lower respiratory tract infection versus 0 out of 5 on treatment.

https://clinicaltrials.gov/study/NCT04633187?term=edp-938&aggFilters=status:ter&rank=1&tab=results

For sure a fund or funds are selling out while we dont have enough buyers to step out


Got some more today. Dont see much risk buying here but i thought the same and loaded up at 11s

Painful

Looks like Clubber Lang made the right call for what is ahead for ENTA shareholders.

Yes back to pretty much all time low

Painful

Unbelievable. Down from 13 to 9 last month or so. Only news during the same period was the great challenge data. Feel like a repeat of year end last year indeed

Yes it can take time to get all the data together but this is a small 90 patient study with viral load as primary endpoint I would assume they have at least that top like data for some time. I would think a few weeks not months to scrub data and unlock database but perhaps someone more knowledgeable can chime in

While on vacation here in Maryland, noticed that ENTA has a new patent regarding prevention of coronavirus viruses. Might be the rationale for pre-market up-trades. Please check Enanta patents as of November 19.

Isnt it normal to tak at least 2 to 3 months to do data analysis etc before doing a presentation?

So they might be just not ready yet?

My dream case is a buyout so maybe they are just busy negotiating a deal so no CC and no data presentation yet