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The difference is timing is so small I consider it insignificant.
It was ALGS' lead HBV candidate, which is why the stock was down >50% yesterday.
This is yesterday's ALGS PR:
https://finance.yahoo.com/news/aligos-halting-further-development-stops-130000126.html
*Correction* “Hep B asset”
(ENTA)-ALGS drops Hep B program.
from: @OxAnalyst on Twitter
$ALGS dropping STOPS hep B asset* due to lack of efficacy (no meaningful HBsAg reduction)
— . (@CrocsAnalyst) January 6, 2022
one of two clinical candidates in their pipeline pic.twitter.com/IqC5poNCwM
ENTA 2022 newsflow:
https://www.enanta.com/investors/news-releases/press-release/2022/Enanta-Pharmaceuticals-to-Provide-Updates-on-its-Research-and-Development-Programs-and-Outlook-for-2022-at-the-40th-Annual-J.P.-Morgan-Healthcare-Conference/default.aspx
• EDP-235 phase-1 starting Feb 2022. (EDP-235 is a SARS-CoV-2 protease inhibitor.)
• Phase-2 ‘RSVP’ data for EDP-938 in 2Q22.
• EDP-323 (RSV L-protein inhibitor) phase-1 starting 2H22.
CEO, Jay Luly is a 6.5% shareholder:
https://www.sec.gov/Archives/edgar/data/0001177648/000119312521361165/d273825dsc13da.htm
I'd like to think that this is a bottom.
I've been waiting and today I bought a bit more.
It appears that I wasn't alone.
Anyway, the day ended with a hammer on good volume.
Covid isn't going away.
ENTA will benefit by PFE's success with their PI. IMHO
Protease inhibitors as a therapeutic treatment for covid will soon be validated. People will see patient success, prescription numbers/$$$ and realize that theraputics will help recovery and transition from pandemic to endemic.
I understand people not wanting to buy until EDP-235 enters clinic, but that could be in the near future and Luly has mentioned phase 2/3 in 2022.
I would think a partner in covid would bolster share price dramatically. Would it be reasonable to compare it to the AVIR/Roche collaboration?
It's an aside- but Luly has mentioned a few times that EDP-235 shows potency against other coronaviruses.
At some point if successful that may also have some non-covid value attributed and some follow on compounds.
Even by ENTA's standards, day-to-day and intra-day share-price volatility have been crazy high lately.
It's harder to add now than when ENTA was half this price- but I've added small amounts recently.
The days volume (w/ after hours added) was over 500K! I hadn't checked since the AM- not bad for a stock that could only muster 1300 shares the first 20 minutes. Talk about thinly traded. : )
ENTA presentations the next 2 days -Dec 1 and 2.
Not only does Molnupiravir improve outcomes for the covid infected- it even improves the placebo arm!!! : )
Thanks Dew. I've not heard that one. ~ It's awesome!
(AVIR take note!!)
Re: Observed fall-off in Molnupiravir efficacy
From #msg-166912284 (posted last week):
Something is better than nothing after all.
And there is money to be made by merely being first.
Remdesivir has probably sold over 2 billion now.
AVIR is up some more- about 5%. Hope springs eternal. : )
MRK's Molnupiravir is being evaluated by an FDA adcomm today:
AVIR’s COVID antiviral has already failed:
#msg-166797909
#msg-166425975
Investing in a thinly traded stock is confounding.
This morning Merck is down for a few reasons
Moderna is down due to concerns about vaccine effectiveness against the new variant.
Pfizer is up (IMHO) due to faith in it's vaccines (relatively) but perhaps more so due to faith in it's covid antiviral (a PI)
Who else is up? AVIR at 8.06 this moment up 3%+ presumably an on hopes of it's Covid antiviral will work 225K shares traded.
And then there's ENTA which sat forever at -1.44 cents and 5800 shares traded.
My take on it is people aren't buying or selling their ENTA.
They are holding for news, waiting for catalysts.
Due to the new variant no one really knows where to put their $$$.
I held.
Generally speaking I think we are seeing the strength of vaccines being tested and the importance of antivirals growing.
In general, Merck's antiviral has lost some credibility, AVIR's will probably be worse. Pfizer's looks best at the moment- one reason it is up- while Moderna is down.
(Enanta's covid antiviral - a PI- looks promising but no human data- and that's months away)
AS I was typing ENTA has RALLIED to -.51 (minus) cents and 82 hundred shares. and AVIR hit 4%+
So much of investing is merely waiting.
More on the same topic (ENTA's HBV program):
https://twitter.com/DewDiligence/status/1463579276842881034
ENTA’s fully-diluted share count @9/30/21=24.4M—an increase of 0.3M since 6/30/21 (#msg-165355921).
The 24.4M figure above consists of: 20.2M basic shares on the 9/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017021004895/enta-20210930.htm page F-4 ); and 4.2M options outstanding at 9/30/21 (whether or not exercisable) (ibid, p.64).
ENTA’s pro forma cash @9/30/21=$391.3M—a decrease of $16.9M since 6/30/21 (#msg-165355929).
The $391.3M figure above consists of: $282.8M of net current assets on the 9/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017021004895/enta-20210930.htm page F-4); and $108.4M of marketable securities on the 9/30/21 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
Note: Among the current assets is a $37.3M tax-refund receivable from the IRS, pursuant to a provision of the 2020 Cares Act that permits businesses to carry losses backward to offset previously paid US federal income taxes. This provision of the Cares Act has now expired, so ENTA will have no future tax refunds of this nature.
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.
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