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PRDS terminates COVID antiviral program—one fewer competitor for ENTA:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171603861
40? Now 38. Look out below
Surprised we hover around $40 with news out in May. Any insights as to why? Thought there would be a build to news at least.
Update—ENTA will not have any SVB losses:
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171426798
ENTA’s worst-case SVB exposure is ~$12M:
Based on the 8-K filing in the post I’m replying to—and the reasonable assumption that ENTA’s current balance sheet is essentially unchanged from its 12/31/22 balance sheet—the worst-case scenario is SVB exposure of 0.05 x $241M, or about $12M.
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023002134/enta-20221231.htm#consolidated_balance_sheets
ENTA Reg-FD disclosure re SVB Bank:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023007317/enta-20230310.htm
The HCV-eradication program in_Biden’s_budget allocates $11B over_five_years.
Biden’s proposed budget includes program to eradicate HCV, using Louisiana’s plan as a template:
https://endpts.com/francis-collins-readies-a-biden-push-to-eliminate-hepatitis-c-nationwide
ENTA to present on March 14 and March15 at the International Conference on antiviral research. Abstract 21 is the EDP-235 data in ferrets showing the blocking transmission to others in close quarters, which we had seen. Abstract 523 says EDP-235 has the potential to mitigate viral rebound in Covid 19 patients. I don't recall hearing this before so it may be new data form the phase I trial.
https://finance.yahoo.com/news/enanta-pharmaceuticals-present-data-edp-135100715.html
PFE’s $8B guidance for 2023 Paxlovid sales is artificially low compared to the $22B sales in 2022 because US government supplies procured during 2022 won’t be exhausted until late 2Q23 or 3Q23.
I.e., a considerable proportion of Paxlovid courses used during 2023 will be from stock that was booked in 2022 and contributed to 2022’s reported sales.
Any thoughts or concerns regarding Pfizers Paxlovid guidance for 2023 at $8 billion compared to $22 for 2022 and how that might/will impact EDP-235?
ENTA’s EV at the current share price ($52.99)=~$1.1B—up from $750M three months ago, but down from $1.4B six months ago.
For all intents and purposes we are where we were at closing 2 days ago.
No one jumped into the gap up and few jumped into the sell down. In that only 180 K shares were traded today arguably many people bolstered their positions.
As of yesterday the stock was up nearly 40 percent in two months and appears to be in a clean channel upwards, it's 20 day moving average crossed over the 200 day moving average a few days ago. (and if the stock continues to rise the 50 day crossing the 200 day moving average is in sight- unless things cool off)
I don't see a reason for the gap up nor the perhaps small drop today. Each week into the trial the closer we come to a phase 3 trial and the possibility of proof of best in class perhaps with a few new labels/indications.
ENTA’s fully-diluted share count @12/31/22=26.1M—an increase of 0.9M since 9/30/22 (#msg-170545673).
The 26.1M figure above consists of: 20.88 basic shares on the 12/31/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023002134/enta-20221231.htm#consolidated_balance_sheets ); and 5.25M options and unvested restricted-stock equivalents (whether or not exercisable) (ibid, page 10).
Wow, that was some early price movement today.
ENTA updated corporate slide set (2/7/23):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
The notable differences between the 2/7/23 slide set and the previous version (dated 1/6/23) are:
• Slides 10-11 (new) have additional data on EDP-938.
• Slides 35-36 have updated financials through FY1Q23.
There are a few other trivial changes, such as omitting data pertaining to the (now defunct) Alpha variant of COVID.
ENTA FY1Q23* financials—12/31/22_pro_forma_cash=$270.1M† — a decrease of $37.1M relative to 9/30/22:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-34
FY1Q23 royalty revenue was $22.6M, up from $20.3M in FY4Q22.
FY1Q23 R&D expenses were $40.9M, below the run rate for ENTA’s FY2023 guidance of $210-230M. FY1Q23 SG&A expenses were $12.7M, zzz inline with ENTA’s FY2023 guidance of $46-52M.
†Including a $28.7M tax refund due from IRS.
*ENTA’s fiscal years end on September 30.
ENTA’s officers/directors cumulatively owned 12.7% of shares outstanding*, according to p.6 of the annual-meeting proxy in the post I’m replying to.
12.7% is a high equity stake for officers/directors of a company that has been publicly traded for nearly ten years; this is attributable to ENTA’s not having raised capital since the IPO in Mar 2013.
*As of 12/15/22.
ENTA’s annual-meeting proxy has been filed:
https://www.sec.gov/Archives/edgar/data/1177648/000119312523011979/d398448ddef14a.htm
This just hit the wires, so I haven’t read it yet. Feel free to comment on anything inside.
When I saw slide 22 on the ferret study suggesting that EDP-235 prevented transmission I thought that was a pretty big deal. In that the trajectory was upwards before and there is a high expectation of a Phase 3 trial this year (against the China backdrop and expected continuation of covid) I decided to add a bit more.
And it seems others felt the same way. Per Finviz ENTA is up over 7% in the past week and +21% in the past month.
I am keen also on the fact that they are working on a new additional Covid asset.
ENTA finally back over $50. First time since early October.
CFO, Paul Mellett exercised-and-held ~$135K of stock from options that were about to expire:
https://www.sec.gov/Archives/edgar/data/1177648/000106299323000800/xslF345X03/form4.xml
SRNE encounters some safety questions in phase-1b trial of SARS-CoV-2 protease inhibitor:
https://www.globenewswire.com/news-release/2023/01/09/2585304/0/en/Sorrento-Releases-Positive-Results-from-a-Phase-1b-Study-in-China-in-COVID-19-Patients-and-is-Ready-for-Pivotal-Phase-3-trials-with-OVYDSO-STI-1558-an-Oral-Mpro-Inhibitor-as-a-Stan.html
Addendum—The latest slide set addresses some issues posters have raised on this board about EDP-235’s animal data and in vitro potency assays.
Additions/changes in ENTA’s most recent slide set:
• Slides 17-18 have info on the new program for dual inhibition of hMPV and RSV.
• Slide 21 has new info about EDP-235’s live-virus potency against Omicron and other strains.
• Slide 22 has new preclinical EDP-235 info from a ferret model, including data on viral transmission from animal to animal.
• Slide 25 has a graphic on the design of the (in-progress) phase-2 trial for EDP-235.
• Slide 27 has info on the new program to develop a papain-like protease inhibitor for SARS-CoV-2.
• Slide 35 has a list 2023 catalysts.
What ENTA will be discussing at JPM:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-provide-updates-its-research-and-3
ENTA’s new corporate slide set—(1/6/23):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
Nearly half of passengers from China to Milan have COVID: Italian officials
https://thehill.com/policy/healthcare/3790837-nearly-half-of-passengers-from-china-to-milan-have-covid-italian-officials/?fbclid=IwAR0TtDHh2TmPlQtODvyfI2u0nd9yB6eJNf7DqB7iI2OzV1dD6VHtnjbjiMg
Gosh! Who could have foreseen that?!
In other news J. Luly ENTA CEO, recently characterized the pandemic as moving towards endemic -- but the pandemic part may yet be with us yet a few more years.
No update by ENTA about a second molecule for HepB. I thought ENTA was targeting year end for such a molecule or a combination with a drug from another company.
I wonder when the RSV data for EDP-938 is due for high risk patients and young children. There must have been a large population available for the trial given the RSV surge this year.
As a concern for ENTA shareholders, this is way down on the list. The subject has been discussed several times on ENTA's CCs.
Thanks. How concerning is the possibility of protease mutations that would diminish EDP-235 efficacy?
Impact of SARS-CoV-2 3CL Protease Mutations on Nirmatrelvir Inhibitory Efficiency. Computational Insights into Potential Resistance Mechanisms
ENTA has undoubtedly run the tests you are referring to, but this doesn’t warrant a press release or a new version of the corporate slide set. The additional info should be in the next version of the slide set, which will presumably be released in time for the JPM conference in January.
BQ.1.1 has been around since Sept and the slide deck was posted on Nov 21 and now we're almost into 2023 with no update. Why is it taking so long for ENTA to run a test and update their slide deck or make an announcement?
It shouldn’t be a problem insofar as the main protease (what EDP-235 inhibits) is highly conserved across SARS-CoV-2 variants.
Since Omicron variant BQ.1.1 is resistant to all treatments and is now >57% of all cases in the U.S. and there's no assay listed on slide 19 for BQ.1.1 is that something to be concerned about?
New COVID Subvariant Resistant to All Therapeutic Antibodies
Omicron variant BQ.1.1 found to be resistant to all monoclonal antibody treatments
I am getting whiplash watching ENTA's day to day fluctuations. For some reason the upswings feel a lot better than the downswings. :)
Jay Luly exercised and held $620K of stock today:
https://www.sec.gov/Archives/edgar/data/1177648/000106299322024173/xslF345X03/form4.xml
The options in question did not expire until Dec 2023. Moreover, Luly paid the tax due from the exercised shares in cash rather than in forfeited shares, which makes the exercise-and-hold action mathematically equivalent to an open-market purchase in terms of bullishness.
Note: This exercise-and-hold action was not triggered by Luly’s 10b5-1 plan.
Much of what I am looking at is in the red today.
Further, some Enta (-6.3%) similar small caps are down; AGIO -5.5%. PRDS -13.8%, and ABUS -10.7%. A sea of red.
It seems to me that this December selling is quite common for Enanta. I've also seen large gains also in the New Years period.
FWIW I at one time held MDGL but got impatient and years earlier sold the few shares I had; It was a win in a way cause they were no longer a distraction. The Enanta covid program OTOH has a relatively near time frame readout that very well could distinguish itself from other antivirals.
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