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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.
Low volume trading but a big drop in ENTA today on no news. It must be tax loss selling. With the news that China is easing up on their zero Covid policy and that Covid infections are rising dramatically, China would represent a great market opportunity for EDP-235, well if it ever gets approved.
More_on_the_same_story—Paxlovid sales in China:
https://finance.yahoo.com/news/3-china-meheco-distribute-pfizers-180624462.html
Pavlovid sales are ramping up in China:
Pavlovid sales are ramping up in China:
https://finance.yahoo.com/news/1-china-health-app-starts-093451036.html
So they claim it is much more potent than EDP-235 but they don't know if it needs ritonavir.
The Chinese company said that in antiviral cellular assays with infectious SARS-CoV-2, ASC11 showed much higher potency against the virus than other 3CLpro inhibitors including nirmatrelvir, Shionogi's (OTCPK:SGIOF) (OTCPK:SGIOY) oral drug S-217622, Pardes Biosciences' (PRDS) oral therapy PBI-0451, and Enanta Pharmaceuticals' (ENTA) oral medicine EDP-235.
The goal of the phase 1 trial, which is expected to be completed within Q1 2023, is to identify a safe and efficacious dose for the pivotal phase 2/3 in patients with COVID-19.
In addition, the phase 1 study will determine if ASC11 needs to be boosted by ritonavir or not.
Ascletis Pharma (OTCPK:ASCLF) said China's National Medical Products Administration (NMPA) approved its investigational new drug (IND) application to start a trial of oral drug ASC11 for COVID-19.
The goal of the phase 1 trial, which is expected to be completed within Q1 2023, is to identify a safe and efficacious dose for the pivotal phase 2/3 in patients with COVID-19.
In addition, the phase 1 study will determine if ASC11 needs to be boosted by ritonavir or not.
The Chinese company said that in antiviral cellular assays with infectious SARS-CoV-2, ASC11 showed much higher potency against the virus than other 3CLpro inhibitors including nirmatrelvir, Shionogi's (OTCPK:SGIOF) (OTCPK:SGIOY) oral drug S-217622, Pardes Biosciences' (PRDS) oral therapy PBI-0451, and Enanta Pharmaceuticals' (ENTA) oral medicine EDP-235.
Pfizer's (PFE) Paxlovid consists of (nirmatrelvir and ritonavir).
"The IND approvals of ASC11 from both China NMPA and U.S. FDA mark a great recognition to our in-house R&D capabilities," said Ascletis Founder, Chairman and CEO Jinzi Wu.
Ascletis added that ASC11 has potent antiviral activity against several Omicron variants such as BA.1 and BA.5. In the animal model with infectious SARS-CoV-2, ASC11 also showed potent antiviral activity, according to the company.
PFE enlists Clear Creek Bio (private) to develop an oral inhibitor of the SARS-CoV-2 papain-like protease (which is distinct from the SARS-CoV-2 “main” protease that is targeted by Paxlovid):
https://finance.yahoo.com/news/pfizer-clear-creek-bio-collaborate-114500791.html
This collaboration is a tacit admission by PFE that Paxlovid is far from an ideal answer to the question of how endemic COVID should be treated.
Financial terms were not disclosed.
The market is a discounting mechanism, and one where each person makes a bet of one kind or another. Your bet is that something will happen to produce income in the future.
I am not prepared to make that bet yet (though not willing to bet against it either). I prefer bets that MRK, BMY, GILD, and ABBV will continue to produce income longer than the market is saying today (plus they are paying me while I wait).
ENTA's EV at the current share price ($41.58)=~$750M—down sharply from ~$1.4B three months ago.
If there's a better $750M-EV biotech stock out there, I don't know what it is.
Makes sense , thanks Dew. It’s not a trading vehicle for me.
The selloff during the past three months was triggered, in part, by Biden saying (prematurely) that the pandemic was over.
Day-to-day movements in the share price are almost meaningless (unless you're trading them) because the volume is so low.
Agree . Any particular reason it got sold off lately? Healthcare overall doing ok. Really surprised by the reaction. I am a shareholder of ENTA. I mean 7 percent drop on holiday weekend ? For no reason !!
ENTA's EV at the current share price ($41.58)=~$750M—down sharply from ~$1.4B three months ago.
If there's a better $750M-EV biotech stock out there, I don't know what it is.
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.
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.
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.
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.
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.
Paxlovid does not work in standard risk patients.
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
1) you know nothing about making a drug
2) you know nothing about clinical trials
3) long time listener, first time caller
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.
Just trying to be objective. And I’m not short anything.
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.
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.
Possibly inspired by the success of HIV protease inhibitors, of which eleven drugs are FDA approved, multiple SARS-CoV-2 main protease inhibitors are under develop- ment. One protease inhibitor candidate drug with FDA fast track designation, EDP-235 (Enanta Pharmaceuticals), is currently in a phase 2 clinical trial. Unlike Paxlovid and Mol- nupiravir, which require twice-daily doses, EDP-235 is targeted as a once-daily oral drug that does not require co-administration of Ritonavir18. Interestingly, Glecaprevir, a com- ponent of the hepatitis C drug Mavyret (identified jointly by Enanta and AbbVie), is a high affinity macrocyclic inhibitor of SARS-CoV-2 main protease19. As such, is EDP-235 repurposed macrocyclic Glecaprevir that is being developed as an antiviral drug against SARS-CoV-2? This is not unreasonable, since Enanta has two issued compound owner- ship (COM) US patents (8,648,037; and 9,220,748). More likely EDP-235 is a macrocyclic spiropyrrolidine derived structure cited in US patent 11,319,325 and assigned this year to Enanta for treatment of coronavirus infection. A confounding factor regarding little infor- mation about the structure of EDP-235 may be a patent infringement suit concerning Paxlovid, filed by Enanta June 21, 2022 against Pfizer and prompted by Enanta's US patent 11,358,953, issued June 14, 2022.
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.
All we have seen is cellular potency.
– Good oral bioavailability (95% in rats) and long half-life (16 hours)
– Good target tissue distribution (e.g. lung to plasma AUC ratio >4)
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.
All we have seen is cellular potency.
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?
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.
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.
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:......Data are expected in 1H23. I had been hoping for a pivotal phase-2/3 trial. but either ENTA or the FDA evidently didn’t like that idea.
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
The randomized, double-blind, placebo-controlled study will enroll approximately 200 non-hospitalized, symptomatic patients with mild to moderate COVID-19, who are not at increased risk for developing severe disease. Patients will be eligible to participate if they have had symptoms for five days or less and have not received a SARS-CoV-2 vaccine or been infected with SARS-CoV-2 within 90 days of enrollment.
Patients will receive EDP-235 orally at a dose of 200mg or 400mg or placebo once daily for five days. The primary objective of the study includes evaluation of safety and tolerability, and secondary objectives include the evaluation of virologic endpoints, clinical symptoms and outcomes, and pharmacokinetics.
Guessing if P2 turns out great, it doesn't matter it isn't 2/3? eom
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