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I don’t believe this is correct. So to register an antiviral for SARS-CoV-2 you don’t have to show reductions in viral load? Just wanted to be clear.
I could find some advil in my medicine cabinet that would also not show inferiority to Paxlovid in today’s world.
If EDP-235 advances to phase-3, ENTA will likely seek to show non-inferiority to Paxlovid, which ought to be an achievable goal.
There is no FDA requirement that a COVID drug has to show any particular result for viral load or IVA to get approval.
You guys- you’re missing the forest for the trees.
It’s not the drug. It’s the patient landscape. They will never, ever, ever, get stat sig antiviral endpoints at this time. This is required for FDA approval.
This is why I believe it was a joke from the start. Safety as a primary for dose ranging in this indication at this time is absurd.
And on stat sig, unvax vs. vax: hope they enrolled in a third world country. There is just no chance. Not to mention seropositivity in the unvax pts!
Safety as a primary for dose ranging in this indication at this time is absurd.
This is why I believe it was a joke from the start. Safety as a primary for dose ranging in this indication at this time is absurd.
And on stat sig, unvax vs. vax: hope they enrolled in a third world country. There is just no chance. Not to mention seropositivity in the unvax pts!
Re: PRDS’ PBI-0451 trial vs ENTA’s EDP-235 trial
Look at prds pbo arm.
EDP-235 will not show clinical or statistical significance.
Edp 235 will not show clinical or statistical significance. Look at prds pbo arm.
PRDS has nothing else in the pipeline. AVIR has a dengue program and a cockamamie attempt to improve on existing HCV regimens.
However, I give PRDS credit for acknowledging failure and terminating the program, unlike what AVIR did after getting a bad phase-2 result in their own COVID program.
Yes, PBI-0450 was not potent, which is why PRDS ran the phase-2 trial at such a high dose.
However, I give PRDS credit for acknowledging failure and terminating the program, unlike what AVIR did after getting a bad phase-2 result in their own COVID program.
PRDS terminates COVID antiviral program—one fewer competitor for ENTA:
The data for the phase 2 trial of EDP-235 is idea a month of 2.
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
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
On March 10, 2023, Enanta Pharmaceuticals, Inc. reported that less than approximately 5% of its cash and marketable securities are held in operating accounts at Silicon Valley Bank. Its investments in marketable securities are held in custody accounts at an independent institution. Accordingly, there is no material impact on its projected cash runway or operations.
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
The so-called Netflix-like subscription model would see the federal government spend a fixed amount on [HCV] drugs, likely in the billions as it costs an average of $24,000 per 12-week course, and then gain access to an unlimited number of pills to treat and cure as many with hepatitis C as possible.
The move — which [NIH Director] Collins said has the support of both Gilead and AbbVie… would also need to come up with a plan to find out who exactly has the virus, as Collins noted that more than 40% of people who have it don’t know that they do.
…Speaking on last night’s panel alongside Collins was another proponent of a major move to cure more hep C cases, ranking member of the Senate health committee, Sen. Bill Cassidy (R-LA), who discussed the Netflix-like subscription model he helped stand up in his home state to increase access to the cures (#msg-142973444).
A ramp-up of usage will go a long way to saving money from liver transplants and other end-of-life care, the panelists noted.
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
A total of 12 subjects reported an AE in the SAD portion of the study, with one AE of elevated blood thyroid-stimulating hormone (TSH) deemed related to STI-1558 in the 2000 mg cohort.
…In the MAD portion of the study in COVID-19 patients, 20 subjects from a total of 46 subjects reported AEs, with only four subjects experiencing STI-1558-related events. These four AEs included two subjects with mild or moderate liver enzyme elevation (ALT/AST) without bilirubin elevation in the 300 BID and 800 BID cohorts, one subject with mild hyperuricemia in the 600 mg BID cohort and one subject with mild rash in the 800 mg BID cohort.
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.
It would be a big deal if EDP-235 was shown to limit transmission of Covid.
IMO, it’s reasonable to surmise that ENTA is unwilling to dedicate much effort to finding a second HBV agent, and is prepared out-license EDP-514 on suitable terms.
• Presents New Preclinical In Vivo Data Demonstrating EDP-235’s Efficacy and Prevention of COVID-19 Transmission
What ENTA will be discussing at JPM:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-provide-updates-its-research-and-3
• Progresses Phase 2 SPRINT Trial of EDP-235, an Oral, 3CL Protease Inhibitor for COVID-19, With Data Expected in 1H 2023
• Presents New Preclinical In Vivo Data Demonstrating EDP-235’s Efficacy and Prevention of COVID-19 Transmission
• Expands Robust COVID-19 Antiviral Portfolio With a New Research Program Developing SARS-CoV-2 Papain-Like Protease Inhibitors—[Note: This is a different target from EDP-235, which impedes the SARS-CoV-2 “main” protease—Dew.]
• Introduces New Research Program Targeting Human Metapneumovirus (hMPV) and Respiratory Syncytial Virus (RSV) with a Single Agent; Clinical Candidate Selection Targeted for 4Q 2023
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.
ENTA FY4Q22 CC transcript:
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.
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