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ENTA did not give an estimated time for that.
Update on HBV development plan: #msg-166884086.
On yesterday’s CC Jay Luly was asked if ENTA would consider monetizing the Mavyret royalty stream. He replied that now would not be a good time to do such a deal insofar as Mavyret sales can be expected to rise as the COVID pandemic fades and new-patient starts return to pre-pandemic levels.
I’m not sure I agree with Luly. Why not let a third party gamble on when—and whether—Mavyret sales will rebound to pre-pandemic levels?
Moreover, the royalty stream will be worth less if real (adjusted for inflation) interest rates rise.
ENTA FY4Q21* financials—royalty_revenue=$23.6M—9/30/21_cash=$352.4M—(down from $372.5M at 6/30/21):
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Fourth-Quarter-and-Year-Ended-September-30-2021-with-Webcast-and-Conference-Call-Today-at-430-p.m.-ET/default.aspx
ENTA issued new FY2022* guidance for gross operating expenses (including non-cash components such as stock-based compensation): $150-170M for R&D (down from $174.1M actual in FY2021); and $35-41M for G&A (up from $32.5M actual in FY2021).
How ENTA’s Mavyret royalty is calculated
ENTA’s royalty rate on Mavyret sales from ABBV is tiered, as shown in the table in #msg-142808661. The royalty rate is applied to the 50% Glecaprevir component of Mavyret (a 2-drug combination). The royalty tiers reset at the start of each calendar year (like tax brackets), so ENTA’s royalty rate is highest in the fourth calendar quarter (ENTA’s fiscal* Q1) and is lowest during the first calendar quarter (ENTA’s fiscal* Q2).
During calendar 3Q21 (ENTA’s FY4Q21*), ABBV sold $426M of Mavyret (#msg-166561274), biting that HCV new-patient starts were still below pre-pandemic levels. ABBV has issued calendar-2021 guidance for Mavyret sales of $1.7B, implying 4Q21 Mavyret sales roughly equal to the 3Q21 amount.
*ENTA’s fiscal year ends on September 30.
According to Barron's ENTA's float is 20.21M shares.
Todays volume was 397,000 or 1.9% of the float.
That's 1.8X the 20 day avg volume.
I wouldn't call that a stampede towards the exit.
Blame the 18% drop on the market makers who milked the bad news for all it's worth.
Over reaction today?
Yes.
But first is still first.
A functional cure (even a 50% cure) and being first would have it's benefits.
I'm not up on who else has an effective agent for the surface antigen, but such an agent and EDP-514 could achieve a functional cure ...or..... it might prove/suggest what else is missing for a functional HBV cure.
RE: your post on "pretty modest"; the volume isn't that compelling. I held, although I thought the drop could easily be in the 10% range.
I'm not saying either party can or should.
I'm just wondering what the next move will be and thinking of options- while not knowing what Enanta has in development- or their competitors.
But JNJ-3939 is an injected drug. ENTA's distinction has been pursuing an all-oral functional cure. If ENTA drops the all-oral requirement, there are many competitors in the HBV arena.
Looks like I was wrong about, “pretty modest.”
Definitely a bummer. I was really hoping ENTA would be able to have two-thirds of a possible functional cure for HBV. It is still early on and if they have other options in the pipeline they could hopefully get it going more quickly given this recent discontinuation. The safety issue must have been very obvious, consistent, and/or severe given the quick hook they gave it. Hopefully it isn't a class effect if they have another RNA destabilizer in the pipeline.
ENTA hasn't disclosed whether there is a backup RNA-destabilizer in the pipeline, but I think it's pretty likely there is. The question, of course, is whether the safety problem seen with EDP-721 is compound-specific or class-specific.
The hit to the share price ought to be pretty modest inasmuch as EDP-721 was only in phase-1.
I assume ENTA will take a hit in stock price tomorrow. Do you think they have another destabilized in process or will this approach be a dead end. I assume the upcoming conference call will provide some information
ENTA new corporate slide set—updated for discontinuation of EDP-721 (HBV RNA destabilizer)—also new slide #19 with in vitro data on COVID protease inhibitor EDP-235:
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/11/Enanta-Corporate-Presentation-Final-11-18-21.pdf
Note: The new slide #19 is different from #19 in the previous version of the slide set, which also coincidentally had new data on EDP-235.
Re: ENTA EDP-721
Discontinuing a compound is always a letdown, but it’s much better to find a safety problem in phase-1 than later on.
ENTA will need to find a second oral compound to complement EDP-514 (the lead HBV compound), which could either be another RNA destabilizer or a compound with a different MoA. The company’s drug-discovery engine is up to the task, IMO.
Enta terminates edp-721 on safety issues…..
First off, I am unaware of any study where HBV viral DNA and RNA were reduced so completely in such a high percentage of trial participants. It's proper to note this is a tiny group and so obviously it needs to be verified in larger studies.
I theorized it like this; if 28 days of monotherapy could virtually eradicate HBV RNA and DNA, that with a nuc you could have the potential for viral eradication - if it weren't for the pesky surface antigen that EDP-721 (Oral Hepatitis B Virus RNA Destabilizer) was designed to attack. "HBV RNA was undetectable at Day 28 in 11 patients in the three EDP-514 cohorts as compared to none in placebo." That's including the 200mg arm that is probably not quite sufficient dosing. That's impressive.
I think I would say that as small as these cohorts were they validate Enanta's approach, their prowess with anti-virals and that success with EDP-514 may foreshadow similar success with EDP-721.
ENTA reports final data from two phase-1b studies of EDP-514 (including 800mg cohorts):
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Final-Data-from-its-Phase-1b-Studies-of-EDP-514-a-Novel-Hepatitis-B-Virus-Core-Inhibitor/default.aspx
In the nuke-suppressed phase-1b trial, HBV DNA at baseline is either very low or undetectable in all patients, but HBV RNA is detectable in some patients. However, in the 800mg cohort, 5 of the 6 patients happened to have very low or undetectable HBV RNA at baseline, making the HBV RNA change from baseline to day-28 a meaningless calculation.
In the viremic phase-1b trial, there was a nice dose response in the reduction of HBV DNA from baseline to day-28: -2.9 logs in the 200mg arm; -3.3logs in the 400mg arm; and -3.5 logs in the 800mg arm.
All told, the 400mg dose looks like it provides sufficient pressure on the virus, and it is the most likely dose for ENTA to advance into phase-2, IMO.
I still plan to post the AASLD poster presentations on both phase-1b studies when I obtain them from IR.
I'll post the two poster presentations when I get them from IR. As far as I know, only registered AASLD attendees can access the posters on their own.
That's great!
I wonder if the abstracts will be updated and where they will be visible? Or since it is a teleconference whether they can be viewed?
Thanks, Dew!
The actual poster presentations, which will be available tomorrow, should have the 800mg data. I'm getting copies of them from IR.
Thanks Dew and Willyw. I guess I am not crazy, well at least for for thinking the 800mg dose data would be out soon.
Really, their corporate slides had the same data more or less.
They did win an award for one abstract.
https://aasldpubs.onlinelibrary.wiley.com/doi/epdf/10.1002/hep.32188 (page 505) abstracts 822 and 823
AASLD presidential poster of distinction
I held back a post where I wrote what I thought it all meant, but felt like you know enough to correctly interpret the data.
My main point hinged on in the 6 each who got active EDP-514 in the 200 and 400 mg cohorts- 8 of the 12 had viral RNA clearance- which to me means 2/6 probably cleared in the 200mg cohort and that the 800mg arm may be less important.
If the 800mg arm had equal results to the 400mg those who experienced clearance of viral RNA in 28 days would be
2 (200mg) +6 (400mg) +6 (800mg)=14/18.
Now that the abstracts are out, the data was pretty much already out there- maybe Enanta will provide more commentary.
The 800mg (highest dose) data from both phase-1b trials of EDP-514 (nuke-supressed and viremic) should be in ENTA's two poster presentations this weekend at AASLD (https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Announces-Data-Presentations-at-AASLDs-The-Liver-Meeting-2021/default.aspx ).
I contacted IR to find out how to access these presentations. I'll post again when I get an answer.
The trading liquidity is very low, so ENTA has oversized swings from day to day (and hour to hour). Regardless, the good news is that ENTA is no longer considered a mere royalty play in HCV.
Sold some $46 shares today. Love the prospects but not the time to get greedy in this market.
The stock was in the $40’s a few months ago. I’m okay with $80’s…..
Easy come, easy go as ENTA is about back to where it was before the PFE COVID pill data was announced.
To which I would add- the PFE protease inhibitor also is prescribed w/ (ritonavir) RTV q12h (not terrible, but sub-optimal).
The Enanta compound could be more efficacious, fewer drug interactions, fewer pills fewer times per day.
Once (ha; and IF) approved it may be hard to beat.
And anti-virals will likely play a key part in ending the pandemic.
They will reduce viral shedding, reduce recovery time, probably reduce longer term inflammation damage. They will help make it safer to reopen hospitals, schools and work -thereby getting the economy back closer to normal.
So the value of a great covid anti-viral cannot be overstated.
One other thing that could change all results is (as J. Luly has said) getting the antiviral to patients sooner will likely improve the response success.
Quote:Pfizer to Seek U.S. Nod for Covid Pill After Strong Results
By Robert Langreth
November 5, 2021, 6:45 AM EDT Updated on November 5, 2021, 6:53 AM EDT
Drug reduced Covid hospitalizations by 89% in clinical trial
Covid pill race is heating up with Merck awaiting approval
Jbog, provided this Bloomberg article on the Biotech values web site. https://www.bloomberg.com/news/articles/2021-11-05/pfizer-to-seek-u-s-nod-for-covid-pill-after-strong-results?sref=XLA0GJqR
Two relevant passages from that from that link follow
Quote:
The drug, Paxlovid, binds to an enzyme called a protease to stop the virus from replicating itself. Some drugs for HIV work in a similar way.
The viral protease is the same target ENTA is attacking with EDP-235, which validates that approach.Quote:
The Pfizer drug works to block a crucial enzyme that the Covid-19 virus needs to replicate. It is taken twice a day for five days and used in combination with a second medicine called ritonavir that helps the Pfizer compound stay in the bloodstream longer.
So it is a twice a day combination oral drug whereas EDP-235 is a single oral drug and expected to be a once a day treatment regimen. The PFE drug will be a really nice advance but there is still plenty of room for EDP-235, well assuming it does well in trials.
DewDiligence corrected my dosing regimen comment for the PFE drug as it will required 6 pills a day.
You can see a comparison of the ENTA's drug vs the PFE drug for in vitro cell line data form the ENTA corporate presentation. See slide #19. The first column is ENTA's drug, EDP-235. The second column is the PFE drug. ENTA's drug looks a lot better, but keep in mind ENTA is behind as EDP-235 is slated to begin human trials in the beginning of next year.
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/10/v2/Enanta-Corporate-Presentation-Final-10.19.21.pdf
Roth Capital analyst Zegbeh Jallah keeps a Buy rating on Enanta Pharmaceuticals (ENTA) with a $107 price target after the company data for EDP-235, its oral protease inhibitor of SARS-CoV2. While Merck's (MRK) oral antiviral drug molnupiravir is expected to receive Emergency Use Authorization, EDP-235, specifically developed for SARS-CoV2, is "naturally more potent and could offer a lower pill burden" than the eight daily pills required for molnupiravir, Jallah tells investors in a research note. The analyst says EDP-235 has nanomolar potency against SARS-CoV2 and its variants, ranging from IC50 2.0 - 5.8 nM. She looks forward to EDP-235 entering the clinic in 2022.
Read more at:
https://thefly.com/n.php?id=3389716
ENTA EDP-235 vs competition—for those too lazy to scroll through the slides :- )
$ENTA $AVIR $PFE $MRK $GILD https://t.co/Wax5QGU8NK pic.twitter.com/gNYZITkISK
— M (@bio_clouseau) October 19, 2021
ENTA—New corporate slides—(with EDP-235/COVID update):
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/10/v2/Enanta-Corporate-Presentation-Final-10.19.21.pdf
The new info on EDP-235 is on slide #19.
New_preclinical_data_for EDP-235—the SaRS-CoV2 protease_inhibitor:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Presents-New-Data-for-EDP-235-its-Lead-Oral-Protease-Inhibitor-Designed-for-the-Treatment-of-COVID-19-at-the-ISIRVWHO-Virtual-Conference-2021/default.aspx
They have Aegis underwriting them with 23 mil in financing , and a protease inhibitor finishing mice trails , pretty sure they are going to be a competitor.
SBFM is essentially insolvent—here’s the 6/30/21 balance sheet:
https://www.sec.gov/ix?doc=/Archives/edgar/data/1402328/000168316821003345/sbfm_i10q-20210630.htm#a_003
Not a serious competitor to ENTA, IMO.
Has anyone heard of sunshine Biopharma ? Ticker SBFM. Great website to browse through. They have Aegis underwriting them to try and get to Nasdaq . COVID/ antiviral pill , Cancer cure and mRNA .
Good point about market cap and share price.
And in contrast to Merck look at Moderna
Moderna's market cap in 2018 - $5b --- 2019 - $6.5b ---2020 - $41. b
and 2021 - $137b
Moderna was tiny (but still 4X ENTA's market cap) and increases to it's market cap caused large elevations in share price; the past years share price range was $65.49 - $497.49.
SO.... if Enanta's Hep B asset alone does well the company will see huge increases in share price.
One would think that the covid asset would also raise it dramatically as well.
And I think other investors are seeing it the same way; hence the recent rise in share price.
I also agree w/ you on the Nash being shelved. The money is far better spent elsewhere.
I am pretty certain Enanta's Hep B franchise will get a lot of attention leading up to and culminating at AASLD mid November.
Congrats! I started adding in March, then share price dropped again which was a bonus. I closed another position in order to add.
Then the Hep B data came out, then covid- which seemed to validate my feelings.
Much of Enanta's pipeline will come into greater focus next year. So like you I rather wished it would stay down a bit longer.
At issue with covid- there are still huge numbers who aren't or won't get vaccinated AND data is showing the need for boosters, increasing proof that immunity isn't forever, etc.
So the need for an antiviral/theraputic is great.
What I am seeing is that the Pfizer PI has some issues (twice daily w/ R boosting), and the Merck is also not free of risk-regardless of the recent positive buzz. Do I think ENTA can create a superior PI to Pfizer's? Yes.
The ATI/Roche compound looks good/interesting and they say their nuke will be resistant to mutation vrs a PI, but we are looking at a 5-7 day treatment- so resistance may not be an issue. It may be more possible/likely to create a successful PI than a nuke but we will see.
IF the Hep B data gets digested and holds in trials the Jeffrie's 95 dollar target will be low.
I cannot imagine Enanta's market cap w/ a successful drug(s) in HBV, Covid and RSV; well over $95, I'd wager.
Finally got into this yesterday. Good timing.
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