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ENTA’s fully-diluted share count @9/30/22=25.2M—an increase of 0.5M since 6/30/22 (#msg-169621216).
The 25.2M figure above consists of: 20.8M basic shares on the 9/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022025667/enta-20220930.htm#consolidated_balance_sheets ); and 4.4M options and unvested restricted-stock equivalents (whether or not exercisable) (ibid, page F-13).
There will be no phase 3 in high risk pts. Due to the availability of molnupiravir and Paxlovid, it is unethical for a physician to give a placebo to a high risk patient. There is no regulatory framework for this.
Thanks for the reply. There is no phase 3 trial for EDP-235. It is in a standard risk phase 2. This won’t work (again, see real clinical results from the Paxlovid trial) and won’t get to phase 3.
Did I miss anything there?
The Paxlovid standard risk population trial did not meet its endpoint with statistical significance.
Paxlovid does not work in standard risk patients. Check your data. EDP-235 won’t work either.
Deflectors on maximum.
1) you know nothing about making a drug
2) you know nothing about clinical trials
3) long time listener, first time caller
For laughs? Not trying to laugh. Just trying to be objective. And I’m not short anything.
A good example for you is any of the RSV therapeutics- all failed. Great exposures and great potencies - no translation. My point is that just because something is potent and has good PK, that doesn’t mean it will translate into a cure for an acute infection. Remember, this is a phase 2 in standard risk, highly seropositive population with a safety primary endpoint. A very hesitant step, you must agree.
Yes this is a validated MoA. But, they are not showing their full hand. Again- where is the animal efficacy data? They must have it. Everyone else has shown this. If someone was buying, they would have already bought it. Certainly cheap enough here.
What kind of rodent “efficacy” data would you want to see?
This thread is a red herring, IMHO.
Yes, rodent PK has been shown. But why not the efficacy? If I had a dime for every drug that had good absorption and tissue distribution I would be a rich man.
What kind? The same kind Pardes and Shionogi have shown.
Thanks for the thoughtful reply. Indeed HCV had a great outcome. This was realized in a collab with Abbvie, not solo. Completely different game now. Others, including Shionogi and Pardes, have shown rodent efficacy data. Why none from Enanta? Also (as Dew expressed earlier) it is strange that they are running a Phase 2 and not a 2/3 registrational trial. To boot, safety is the primary endpoint! They are setting up for a “positive” P2 result no matter what (standard risk patients), by doing this.
That's trials. : ) Each step you only get a little more clear view of safety, efficacy. If there were animal studies posted you can still correctly assert that it's no proof it will work on people.
Years ago Gilead bought a whole company just to acquire rights to a Hep C drug; a nuke. They hypothesized that another company was having good results in trials using 4 antivirals to treat Hep C. Gilead thought; lets combine the nuke with another competitors drug; an NS5a antiviral - Daclatasvir.
Gilead thought that the nuke and NS5a in combination could work as well as the other HCV pioneering partnership's treatment- Abbott (now Abbvie) and Enanta's. (that was about 2010 or 11)
Gilead paid about 11 billion for the compound and the reaction was similar to yours; it's too much money and it's not proven. I was in that final Phase 3 registration study in 2014 where Gilead was still proving dosing and duration in the middle of the decade. Conventional wisdom was that Gilead had lost it's mind and overpaid........ and was soon proven soundly incorrect.
In the case of Enanta, it was some unknown tiny company, but it did what JNJ, Merck, BMY, Roche, Sherring-Plough, Boehringer Ingelheim, et al couldn't do.
AND Enanta did it twice, in two successful launches of Hep C treatments.
There was a time that conventional wisdom said that a "nuke was necessary" to treat Hep C. And yet this small company in a partnership w/ Abbvie created a pan-genotypic Hep C 2 drug treatment with protease inhibitors they created in each - without the use of a nuke.
How many companies tried to create a Covid antiviral? Who will have the best? That same small company seems to have some of the best data I've seen. Yes, it's still early and things are not yet proven to your satisfaction. We won't have that long to wait for data.
Enanta has demonstrated *proficiency* with protease inhibitors with great success in the past.
ENTA’s updated corporate slide set (11/21/22):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
They have not released any animal efficacy data (as others have). Go ahead and link to the data since you say they have released it. All we have seen is cellular potency.
“Caveat Emptor”
How do you know it removes coronavirus infection in patients? Cellular potency data?
They have an exorbitant spend and no indication that this drug even works. A very tricky clinical development path.
ENTA will presumably seek some up-front cash when they partner EDP-235 following phase-2 (assuming the data are positive).
So with expenses going up $50-75MM and revenue weak, it is possible for $175-200MM (or higher) loss in next 12 months. Sounds like they might need to raise more money sooner than later.
FY3Q22* financials—9/30/22_pro_forma_cash=$307.2M (including $28.7M tax refund due from IRS):
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-33
FY4Q22 royalty revenue was $20.3M, up from $19.5M in FY2Q22 (#msg-169620050). FY2022* (12m) royalty revenue was $86.2M, down from $97.1M in FY2021.
FY2022 (12m) R&D expenses were $164.5M, inline with ENTA’s guidance of $150-170M. FY2022 (12m) SG&A expenses were $45.5M, slightly above ENTA’s guidance of $35-41M.
For FY2023*, ENTA today issued guidance of $210-230M of R&D expenses and $46-52M of SG&A expenses.
*ENTA’s fiscal years end on September 30.
Feature story on EDP-235 in today's Boston Globe:
https://twitter.com/DewDiligence/status/1590639173970538497
ENTA starts phase-2 trial of EDP-235 in non-hospitalized, standard-risk COVID patients:
https://finance.yahoo.com/news/enanta-pharmaceuticals-initiates-sprint-phase-120000085.html
Guessing if P2 turns out great, it doesn't matter it isn't 2/3? eom
I would think so. RVNC is sliding with an approved drug. If everything runs perfectly how long until approval? Like RVNC unless the company is sold the market turns around it will linger
Is ENTA going to keep sliding until they announce their phase 2 or phase 2/3 trial of EDP-235 for Covid, or won’t that even stop it?
“It all has a very COVID-esque feel to it,” said Dr. Meghan Bernier, the medical director of the pediatric intensive care unit at the children’s center. “This is the pediatrician’s COVID. This is our March 2020.”
https://www.yahoo.com/news/march-2020-childrens-hospitals-overwhelmed-183549189.html
RSV is surging, just as Jay Luly predicted:
https://www.npr.org/2022/10/24/1130764314/childrens-hospitals-rsv-surge
ENTA doses the first person in a phase I safety study of their new RSV L-protein inhibitor EDP-323.
https://finance.yahoo.com/news/enanta-pharmaceuticals-doses-first-subject-110000022.html
"Right now, we're in a huge spike of RSV," said Dr. Frank Esper, an infectious diseases expert at the Cleveland Clinic. RSV often affects babies but can also be problematic in adults with underlying lung problems, such as asthma and chronic obstructive pulmonary disease.
Esper said that cases of RSV are usually seen in December and January, but for the past two years, the typical RSV season has come earlier, during summer and early autumn. Rhinoviruses and enteroviruses are also circulating earlier than usual. This is because measures to curb Covid spread didn't allow other viruses to spread as they historically have.
"Flu off to an early start as CDC warns about potentially severe season"
https://www.yahoo.com/news/flu-off-early-start-cdc-235915662.html
==================================
With some luck the trials will be filled with greater ease than during Covid restrictions.
Both the RSV and Covid programs are short treatments and expedited approval processes.
It has been hard to be patient, I must say.
MRK—Lagevrio misses_primary_endpoint_in_large_Oxford_U_trial:
https://ca.finance.yahoo.com/news/merck-ridgeback-biotherapeutics-clinical-non-235000071.html
ENTA starts phase-2b trial_of EDP-938 in high-risk adults:
https://finance.yahoo.com/news/enanta-pharmaceuticals-initiates-phase-2b-110000822.html
PRDS vs ENTA phase-2 dosing:
https://twitter.com/DewDiligence/status/1570156764741632000
Yes, that's an additional opportunity for EDP-235.
EDP-235 as possible treatment for long COVID?
A Key to Long Covid Is Virus Lingering in the Body, Scientists Say
Virus remaining in some people’s bodies for a long time may be causing longer-term complications, recent research suggests
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