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"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
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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
https://ir.enanta.com/news-releases/news-release-details/new-preclinical-data-edp-235-enantas-oral-coronavirus-protease
For me this seems one more step validating EDP-325. As J.Luly Enanta CEO addressed some of the potential differences between the Enanta antiviral and it's Pfizer competitor Paxlovid we may soon see some of those differences quantified in a medical conference in about 6 weeks.
willyw,
Thanks for that excellent post.
I've seen a few articles that make it seem that the USA wants to try harder to be ahead of the curve with covid (and or other possible emerging health threats) The CDC has recently spoken to reorganizing, in part based on perceived past failures in covid.
And Fauci really never stopped lamenting our covid response;
https://www.aol.com/fauci-u-covid-response-theres-140731132.html
When I factor in that both Joe and Jill Biden experienced covid/paxlovid viral breakthroughs I have to wonder if EDP-325 might experience a more rapid green lighting of the EDP-325 approval process. Exactly how common is breakthrough? J.Luly Enanta CEO in the recent August earnings report gave a few reasons as to how EDP-325 could be superior to Paxlovid.
EUA? Rolling approval? Some grant or other assistance?
I feel the current climate is that they are not going to make the world wait for a better covid antiviral.
Enanta CEO J.Luly has mentioned that the phase 2 work should be within Enanta's capacity without outside partnership.
The ATM aspect may reassure investors, the government or potential partners that the Phase 2 (or 2/3) IS going forward. This itself could streamline the work of setting up the next stages of trial work.
In gaining a partner to potentially take the trials to phase 3, larger enrollment and world wide to be in a superior bargaining position Enanta may almost need to demonstrate that they don't need a partner. The ATM could ensure Enanta a stronger bargaining position in order to achieve a more lucrative financial agreement with a potential partner.
A final point worth noting is that potentially the patent issue with Pfizer could be decided- either in an legal decision or a settlement.
IF Enanta saw an encouraging legal patent decision the potential EDP-325 collaboration could become even more attractive.
Whether they touch the ATM or not, it seemed responsible to me to make sure that they can move forward in the approval and de-risking process of EDP-325.
I concur. If ENTA inks a partnership deal for EDP-235, the ATM will probably not get used.
ENTA opens $100M ATM with Jefferies:
https://www.sec.gov/Archives/edgar/data/0001177648/000119312522231299/d396056d424b5.htm
ENTA had ~$330M of pro forma cash at 6/30/22 (#msg-169621212), so the ATM looks like a backup contingency in case ENTA decides to conduct the phase-2(/3) EDP-235 trial without a partner.
p.s. ENTA has never raised capital as a public company apart from its 2013 IPO. HCV milestones and royalties from ABBV have been sufficient to fund ENTA's operations.
Reason for today’s ENTA selloff: #msg-169786228.
FDA wants PFE to_test Paxlovid in_relapse_cases:
https://finance.yahoo.com/news/1-fda-asks-pfizer-test-201939904.html
Re: EDP-235 clinical-trial plans
On yesterday’s CC, Jay Luly may have slipped up by inadvertently revealing that ENTA is seeking to conduct a phase-2/3 trial for EDP-235 (rather than separate phase-2 and phase-3 trials). From the CC transcript:
https://www.fool.com/earnings/call-transcripts/2022/08/09/enanta-pharmaceuticals-enta-q3-2022-earnings-call/
ENTA's EV at the current share price ($71.27) is approximately $1.4B, based on the numbers in #msg-169621216 and #msg-169621212.
ENTA’s fully-diluted share count @6/30/22=24.7M—unchanged since 3/31/22 (#msg-168831164).
The 24.7M figure above consists of: 20.7M basic shares on the 6/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022015515/enta-20220630.htm#consolidated_balance_sheets ); and 4.0M options outstanding at 6/30/22 (whether or not exercisable) (ibid, p.12).
ENTA’s pro forma cash @6/30/22=$329.4M—a decrease of $23.9M since 3/31/22 (#msg-168831159).
The $329.4 figure above consists of: $290.0M of net current assets on the 6/30/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017022015515/enta-20220630.htm#consolidated_balance_sheets ); and $39.4M of marketable securities on the 6/30/22 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
Note: Net current assets on the 6/30/22 balance sheet include the $28.7M receivable from the IRS (#msg-169620450).
ENTA is due a $28.7M tax refund from the IRS relating to NOL carrybacks allowed by the 2020 Cares Act.
ENTA hires CMO with Big Pharma credentials:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-appoints-scott-t-rottinghaus-md-senior
ENTA FY3Q22* financials—royalty_revenue=$19.5M—6/30/22_cash=$292.7M (down from $322.5M at 3/31/22):
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-32
FY3Q22 R&D expenses were $39.1M, inline with prior guidance of $150-170M for FY2022; FY2Q22 SG&A expenses were $12.9M, higher than the annualized run rate of the prior guidance of $35-41M for FY2022 (#msg-166871344) due to an increase in headcount.
--
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).
*ENTA’s fiscal year ends on September 30.
Elaborating on #msg-169566734, the MoA of EDP-235 could not be simpler: EDP-235 stops SARS-CoV-2 viral replication. If the next EDP-235 trial (either phase-2 or phase2/3—see #msg-169566784) has a well-chosen endpoint and an appropriate patient pool (e.g. rate of hospitalization, compared to placebo, in high-risk patients), EDP-235 is a big favorite to show meaningful efficacy. To put it another way, ENTA (and a potential partner) would have to screw up royally for EDP-235 to not be successful in the next trial.
p.s. The above may not be entirely clear to investors who are unfamiliar with clinical development of antiviral drugs. This is probably why ENTA’s recent 40% pop occurred over the course of a week rather than in a single day.
Thank you Vin and Willy. - this makes sense “the MOA of Covid protease inhibitors is well defined”
So do we know for certain that the MOA of ENTAs drug identical?
Crazy good call. I actually bought a little more last Thursday at 48. Wish I bought more than I did.
willyw, sorry I didn't see your response before I posted. Nice job.
From Enanta;
"Antiviral treatment for RSV, including EDP-938, has the greatest potential to show optimal efficacy in high-risk populations, as these patients have reduced RSV immunity which manifests in a longer duration of viral shedding and greater disease severity, allowing a bigger window to realize the full potential of EDP-938. Moving forward, our broad clinical development plan will focus on evaluating EDP-938’s potential in populations with the greatest unmet need, namely those who are at high-risk for severe disease, including pediatric patients, immune compromised, and a high-risk adult population."
---------------------------
Think of covid. Where is the business - what population group? The high risk.
Let me reframe "did not meet the primary endpoint in a Phase 2b clinical trial" as
failed to differentiate the treated group (those intentionally infected) to other healthy.
I think that it's because the normal healthy group recovered so quickly that there was little differentiation between the two groups.
The real question is whether the Enanta RSV drug (EDP-938) will create a differentiated response in the higher risk groups with weakened immune response and more attenuated recoveries.
Look at Paxlovid and covid.
What if you attempted to prove Paxlovid worked by comparing it to groups of covid infected "healthies" who were asympotmatic and who recovered quickly? You could easily conclude that Paxlovid didn't work due to the lack of differentiation.
Here is what the trial did show;
"Final data available from all high-risk patients enrolled in EPIC-HR study (n= 2,246) confirmed prior results of interim analysis showing PAXLOVID™ (nirmatrelvir [PF-07321332] tablets and ritonavir tablets) reduced risk of hospitalization or death by 89% (within three days of symptom onset) and 88% (within five days of symptom onset) compared to placebo; no deaths compared to placebo in non-hospitalized, high-risk adults with COVID-19"
That's the way that I interpreted it.
Enanta took data where they could get it, but by no means was it going to be a trial that was going to be where the bulk of their business would be or on a group that would see the most benefit.
That's my quick take on it and there are many here far more sharp than I am.
I could be wrong. But I have to wonder if many on twitter who called the trial results a whiff or a failure are reading it right. Like you, I'm curious myself of other's interpretation of the results.
https://clinicaltrials.gov/ct2/show/NCT03691623?term=EDP-938&cond=RSV&draw=2&rank=2
Was the risk any different for their RSV drug?
respiratory syncytial virus did not meet the primary endpoint in a Phase 2b clinical trial. The therapy did not reduce symptoms when compared to placebo;
Appreciate the input??
How many drugs get thru phase 1 with that type of data and never get approved or take a few years at minimum to get approved. There is still a fairly high degree of risk.
Thanks dew. Seen that info on twitter and didn’t check into much because I’m in Belize diving.
Wishing ENTA well. I will probably miss out on a lot of ENTA gains or maybe never have a chance to get in because I’m waiting for some patient results that show the drug works.
It would be nice to see this drug work. While I’m here I found out my daughter who has trisomy 21, OCD and Autism got Covid. She has been vaccinated and boosted but she is also in the high risk group. Kept her away from Covid for 2 years literally the dayI leave she tested positive. Trying to get Pax for her.
R
I hope you are right. You sure nailed the other call; up $5.50 last Friday and up $4.50 today. 10 bucks in two days and 7 more days to go till earnings.
Biden is still positive for covid.
The rebound may be getting more attention than it would have a month or two earlier.
It may create a sense of urgency in tracking what the ideal dosing period is.
I hate to say.... or I have to say carefully---- It is good that they will have another decent or better antiviral to test against the Paxlovid benchmark. They are bound to learn a lot.
If Luly can provide some color on what the approval process is it would be great.
By no means do they seem to have this pandemic under control.
ENTA is up over $3 today. I figured the rise over the release of the safety data on friday would continue this week. The questions remaining in my mind are how many days in a row will the stock price rise, and will it get to the mid $60s or, dare I say it, get back to $70 before the earnings report is released?
Shionogi’s S-217622 has some issues:
#msg-168536263 teratogenicity
#msg-169462279 efficacy not proven
More info on S-217622 than you probably wanted to know:
https://www.biorxiv.org/content/10.1101/2022.01.26.477782v1.full
Conclusions
• Data presented in Ph1 first-in-human study indicate that S-217622 was well tolerated in healthy individuals, and the pharmacokinetics evaluations highlighted the potential for once-daily administration
• In Ph2a, treatment with 5-day oral administration of S-217622 demonstrated a rapid clearance of SARS-CoV-2 and was well tolerated in patients with mild-to- moderate or asymptomatic infection
• The results support further clinical development of S-217622 through large-scale clinical studies for the treatment of mild-to-moderate or asymptomatic SARS- CoV-2 infection
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2022/ECCMID%20Ph1_2a%20presentation%20final2.1.pdf
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