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That job ad you caught a few weeks ago makes more sense in light of the disclosure on today’s CC that ENTA has initiated discovery work in an undisclosed non-virology area.
On today’s call, there was an admission that there was no regulatory path for the Covid drug. This is pretty disappointing.
Massive cash burn on HMPV. What’s the point?
Combination treatment for RSV remains a possibility, as discussed on today's CC.
I suppose that, theoretically, fusion inhibitors should be better for prophylaxis and N-inhibitors for treatment. However, other properties such as potency, safety, and PK might be more important. It's likely that, as with HIV and HCV, a combination of compounds with different modes of action would have significant synergy."
ENTA FY3Q23* financials—6/30/23_cash=$393M:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-36
FY3Q23 royalty revenue was $18.9M.†
FY3Q23 R&D expenses were $43.0M, consistent with the quarterly run rate of ENTA’s updated FY2023 guidance of $165-175M.
FY3Q23 SG&A expenses were $12.6M, consistent with the quarterly run rate of ENTA’s updated FY2023 guidance of $50-55M.
†ENTA’s partial sale of Mavyret royalties took effect on 7/1/23, so it did not affect the FY3Q23 income statement.
*ENTA’s fiscal years end on September 30.
Fusion inhibitors are not effective once the virus has entered a particular cell. N inhibitors, on the other hand, impede viral replication inside an infected cell.
Is there anyone who knows if N inhibitor is better than Fusion inhibitor in RSV?
The NIH is running trials to assess therapies that might help combat long Covid. I guess Jake should tell the NIH they don't know what they are doing.
Conference Call on August 7 at 4:30 p.m. ET to Discuss its Financial Results for Its Fiscal Third Quarter Ended June 30, 2023:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-host-conference-call-august-7-430-pm-et-1
In 2020 the lowest it went was in the $40s. The only time outside of 2013 and 2023 that ENTA ever neared the $18s was in 2016, and the close that day was $21.72 on 7/28/16.
These low prices today may also reflect broader economic fears, but the lack of faith in Enanta is real.
While I expect Enanta to pursue high risk / high reward opportunities and I believe that their molecule development teams are very skilled I am sometimes troubled by their follow the others forays such as RNA destabilizers and now possibly immunotherapies.
Wow, this is a full round tripper from $18 a few years ago..
Paxlovid sales for the first quarter came in at $4.1 billion, which far exceeded Wall Street's expectation of $2.7 billion. The result also was a $2.8 billion increase from the same period in 2022. Pfizer chalked up the performance to strong demand in China and to new launches in other international markets.
Pfizer’s infringement has damaged and will continue to damage Enanta, which is
entitled to recover damages adequate to compensate for Pfizer’s infringement in an amount to be
determined at trial, and in any event no less than a reasonable royalty for the use made by Pfizer
of Enanta’s invention.
PRAYERS FOR RELIEF
WHEREFORE, Enanta Pharmaceuticals, Inc. respectfully requests that this Court:
a. Enter judgment that Pfizer has infringed the ’953 Patent;
b. Award damages adequate to compensate Enanta for Pfizer’s infringement
together with pre-judgment and post-judgment interest and costs under 35 U.S.C.
§ 284;
c. Award treble damages for Pfizer’s willful infringement;
d. Enter judgment that this case is exceptional and award Enanta its reasonable
attorneys’ fees, costs, and expenses, under 35 U.S.C. § 285; and
e. Award such other and further relief as this Court may deem just and proper.
ENTA reaches new ten year low at 18.79/share. Buy the dip? It looks like this might be going below the IPO price, probably to below $15/share in the near future.
Is there a deal coming? So what’s the Enterprise Value (EV) now?
Caveat Emptor
With the stock at 10 year low's around $20/share, anyone have any thoughts/comments on a buy out potential?
Could be related to the HBV program. A few companies are testing combination regimens in HBV that include an immunotherapy component.
...as Enanta broadens its modalities of focus into the immunology therapeutic area.
I felt it was important that I support my use of the word "immunotherapy" so I am providing the above statement as declared on the job description. Growth or a jump, you choose.
Enanta adding a new direction, immunotherapy (seemingly). Enanta has posted a position for a peptide chemist. I do have some experience in both monoclonal antibody development and immunotherapy, but I do not have comments other than to mention that this is the first insight I have become aware of in regard to Enanta's endeavors in such direction.
Will wonders never cease! ENTA is up for the 3rd day in a row and closed over $22. Still a long, long way to go but it feels nice to see some positive sentiment.
Happy Independence Day!
With ENTA stock continuing to take a beating, I thought I would explain why I remain bullish and a buyer.
The EDP-235 data was quite good. It showed a good safety profile, showed a statistically significant improvement in symptoms and reducing their duration, in a highly vaccinated low risk population that had mostly been previously infected. In stark contrast, Paxlovid failed to do that in an similar low risk population, but one in which most were not yet vaccinated or infected. Despite this effectiveness in improving symptoms, the knock that drove ENTA down was the lack of viral reduction in nasal swabs, even though nasal swabs isn't a metric for approval and Remdesivir didn't do that either yet got FDA approval.
That left the conundrum of why EDP-235 showed robust anti-viral effects with regards to symptoms but not in nasal viral swabs. The anomaly was a rapid decreases nasal swab viral levels in the control group, possibly due to previous infection with Covid generating strong IgM responses. That would explain the rapid clearance in mucosal membranes in controls. ENTA looked closely and saw that if they examined patients who hadn't been previously infected, those without anti-nucleocapsid antibodies, there was indeed a robust viral reduction with EDP-235. Given that the vast majority in the EDP-235 phase 2 trial had been previously infected, that would explain why no difference was seen. The general population doesn't care but prospective partners will be assured. I know I am.
If no funding or co-marketing by $ENTA: $75M+ up-front cash; $250M+ regulatory milestones; $150M+ sales milestones; ~20% royalty on worldwide sales.
I too am hoping for more, although 2B in milestones/yr near term sounds pretty good, still the upfront is lower than I am hoping. I do not have the knowledge base to assess the current market value for this type of asset given the potential sales and potential losses if the drug does not make it to market. I am hoping for a buyout as I feel that ENANTA has demonstrated the creation of small molecule virus inhibitor development machine. Long ago I, and others too (from memory) were hoping for an 8B buyout price, that would be fine by me.
Let me know if my expectations are too high.
I just love it when the market lets me buy stocks I like at a discount. I have already increased my shares of ENTA by 25% since its drop after the successful EDP-235 phase 2 trial. I will buy more
ENTA, new 10 year low today. Deal signed?
ENTA’s PR on phase-1 data for EDP-323, an RSV L-protein inhibitor:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-data-phase-1-0
Enanta posts positive phase one data on EDP-323 initiating Human Challenge Study early Q4 with FDA fast track designation.
What would an Enanta Covid Phase 3 partnership be worth?
I'd think that would that include many factors;
the strength or weakness of the asset, the future market, ease to approval, the current and future competition.
When I think about selling a house I would expect some bartering, which could take some time and much haggling.
Recalling Enanta's Abbvie partnership in HCV I would be inclined to think that they wouldn't want to take the first offer.
The deal might only include EDP-235 or it could include provisions for the follow on (which is not even selected yet).
A partner might gauge it against projections about the covid landscape, or the treatments in pipeline.
It would have to include expectations about trials needed for approval.
Unsure if the PFE lawsuit could impact negations?
What if there is a potential for additional labels for prophylaxis, long covid, etc?
To my way of thinking it would be expensive to run and take some time but there seems like an ample market.
I'm also thinking- doesn't the FDA have to express clearly what might still be EUA, quantify what expediated approval means versus regular approval?
That would be a large factor.
Thanks Dew for sharing. Clearly the data from 235 was impressive enough for other companies to comment and acknowledge. I hope that this helps step up the pace of partnering. I do believe “timing” of a partnership deal is critical in that IF COVID variant(s) currently spreading in China along with other viruses like RSV start to surge later this year, ENTA will be in led with a potential treatment (of course down the road) especially for the immune compromised. Thx again!!
ALGS CEO: “ENTA’s [EDP-235] data were informative and good”:
https://wsw.com/webcast/jeff281/algs/1840410
Listen at the 20:00 mark, right after the comment that PRDS’ COVID drug was too weak.
ALGS has its own SARS-CoV-2 protease inhibitor, but it has not yet started phase-1.
Please see my reply in #msg-172089455.
I listened the talk Jeffries today. It was very uplifting to me. Jay Luly stated that there is sufficient EDP-235 for phase 3 trials, which is reassuring. He also explained a big difference in the Shionogi trial and the EDP-235 trial. For the Shionogi trial the number of nucleocapsid positive patients (i.e. previously Covid infected) was in the single digits whereas it was some 70%-80% in the EDP-235 trial. That would explain why an overall virus decline was seen in the overall population in the Shionogi trial and was also seen in the new analysis from ENTA in nucleocapsid negative population in the EDP-235. Looking at only nucleocapsid negative population in the EDP-235 trial is an apples to apples comparison, and should remove any doubt that EDP-235 has potent anti-viral activity. Well, the statistically significant improvement in symptoms for EDP-235, which Paxlovid failed to show in a standard risk population, should have already made that crystal clear. Still it is nice confirmatory bit of data to see even though the FDA wouldn't base any approval on viral reduction in nasal swabs.
The Jeffries interview was fair but tough and pointed. He made it clear that EDP-235 showed symptom relief and Luly reiterated that Paxlovid failed to do so even with a mostly nucleocapsid low population. They talked about IC90 and Luly pointed out the bar has been raised for new drugs as EDP-235 has reaches a much higher drug level with regards to IC90 than Paxlovid, and that likely explains symptom relief. Yes the Jeffries interviewer/host pressed about timelines not only for EDP-235 but for RSV drugs. There was some ballpark figures about the cost of 2 large phase 3 trials for Covid and it was $100-$200 million. Luly did point out the China was experiencing a major surge in Covid cases. Luly refused to get drawn in and make specific comments. Obviously there are no guarantees, but overall I came away more confident about ENTA and about EDP-235 and ENTA.
Thanks for that confirmation!
Post-hoc analyses cannot be statistically significant in a rigorous sense because the hypotheses being tested were not prespecified. (That’s why ENTA did not show p-values for the new analyses.)
Thanks. Are these new results statistically significant?
ENTA reports additional post-hoc EDP-235 analyses_from_ phase-2_trial—details_in_new_corporate_slide_set:
https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023026739/enta-20230607.htm
Thanks. I appreciate your response.
As a classic layman I often find myself not knowing.
But I also see approval agencies struggling with trial design, trying to determine what to measure.
With COVID we really didn't have the luxury of much time, history, and the virus kept shape shifting.
All this against the backdrop of a far more weaponized political thumb on the scales imposing new dynamics in public health and on drug approvals.
COVID will be one for the textbooks.
Having said that, I think that in the face of so much uncertainty the logical response is to NOT have a strong opinion.
Well..... an opinion is OK, but not opinion that is dressed up as fact.
In that regard, like you I DO appreciate reading the bear view on my stock picks.
It's a great opportunity to learn something I might easily overlook, a flaw in my reasoning, opposing data, a better informed or seasoned investor will know and see things that I don't.
But I've also got to tell you that your feedback has also been very very helpful since I only know what I think and I have no formal background to know if I'm right or wrong.
Hahahah, but I'm not alone there, particularly in the area of COVID.
I replied since you wanted more current data on China covid.
I provided it. It is still into a second wave with an impressive amount of infection.
You have no response to that, when you yourself have at least twice that you expect new variants.
I point out several of your contradictions in your own writings, where you actually lay out your thoughts but you don't or cant explain the error, contradiction or weakness in your argument.
Instead, you change the subject with pure whataboutism.
You write that a phase 3 can't happen cause "seropositivity" as though one word is an answer, yet you warn us that the Pfizer next gen is coming as though - somehow - that molecule won't be subject to the same issues that Enanta's covid candidate faces.
You seem to suggest that it's viral decline that is the bar for approval when all evidence is that it is NOT the metric. You seem able to hold that thought when the Pfizer next gen candidate has not yet provided any such data in their phase 1 trial (have they even dosed participants yet?).
You seem to allege that where it is difficult to contrast viral load declines in dosed versus healthies as undercutting the efficacy of the drug but I suspect that you are aware that if it were in a more impaired group than healthies, or with a nastier variant like Delta or a lesser seropositive cohort the results would be more differentiated.
Rather than answering any of these contradictions you pivot.
If no partnership has been announced you must be right.
We will see what happens- nobody knows until it happens or it doesn't happen.
These things take time- as I suspect that you know.
Is there/has there been a market for Remdesivir? Was that approval based on viral decline?
The same for Paxlovid?
You see, I had thought that approval was based on outcomes.
Are further Phase 3 trials for covid possible? Pfizer and others seem to think so.
Should I believe Pfizer or you?
Your usual pattern is to scare, cast aspersions, create doubt.
Who do you like? Where have you plunked down your money? I don't recall having read that.
Yet many of us have been straightforward in that area with you but you only seem to be able to dish it.
Are you that insecure in your beliefs?
Dew posted to you in Biotech values but you answer with word salad.
"No deal, high seropositivity, Pfizer 2nd gen… going to be a rough road there."
---For a brilliant guy you don't express yourself very well. It's not even a sentence and where you were called for an explanation, here too you pivoted, avoided "The second post I was actually posing the question to you" or answered with more word salad without any clarification; "For the first point, I never commented on viral load reduction but actually antiviral effects".
--that's an explanation?
A guy with more confidence would explain clearly their position and be prepared to defend their thesis.
I don't see that happening in your posts.
It's just mostly about throwing stones.
I probably have the least amount of technical background in biotech compared to many others here.
I'm straight from the trenches; a guy who was infected and cured through his involvement in biotech- cured in a Gilead HVC registration trial.
I suspect that you have a deeper understanding of some of the technical aspects than I do.
So, here's my question.
Why don't you just share your views, explain them clearly and attempt to validate them?
I would find that helpful.
Thanks for the reply. Why do you think everyone has passed on EDP-235?
Thanks for pointing out the NPR link was 5.5 months old. In haste to post I mixed that big initial wave with the current. I am unable to alter the post. Here is a more current article. (from May 26 2023) You will notice that the dates have changed but Covid is still very much present in China. Such as it is with Covid, you have a peak which is then followed by waves.
As in the earlier link it's still serious in China it appears;
"BEIJING — China is bracing for a new wave of Covid infections that could see as many as 65 million cases per week by the time the surge peaks at the end of June."
https://www.nbcnews.com/news/world/china-covid-second-wave-xbb-variant-omicron-rcna86171
As it pertains to the link I posted, the newer link somewhat addresses the results of that wave;
"During China’s first omicron wave in December and January, a different omicron variant was infecting millions of people every day, overwhelming hospitals and crematoriums in cities across the country. Store shelves were emptied of fever medications and schools were shut down.
About 80% of China’s 1.4 billion people were infected during that wave, Wu Zunyou, chief epidemiologist at the Chinese Center for Disease Control and Prevention, said in January. But immunity may have waned in the months since, raising the risk of reinfection."
I appreciate the feedback for the sake of accuracy.
======
I remain skeptical that covid is over.
I remain in the opinion that more covid registration trials can still happen.
The fact that Pfizer is attempting an improved antiviral to replace Paxlovid is ample proof of that- not only that there is a future market, that there is a path forward to getting an improved drug approved, or that a drug can be shown to be non- inferior to Paxlovid.
I've mentioned months before that the bar to approval is very low, which I think you may agree since you seem to have a low opinion of Paxlovid's efficacy.
And in that you seem to feel that the next gen Pfizer drug has great potential I infer you must also agree. What I cannot grasp is how in your mindset that approval is possible for competitors, but also somehow impossible for Enanta's EDP 235.
But as they say, that's what makes a market.
Your NPR article is wildly outdated. You should amend the emphasis.
Yes, I was recently reading on this uptick- interest in how it pertains to ENTA and it's pipeline- and in it's ability to perform trial work.
https://www.forbes.com/sites/brucelee/2023/05/29/human-metapneumovirus-hmpv-has-surged-around-36-higher-in-2023/?sh=f17dc2d71455
Meanwhile in China?
https://www.npr.org/sections/goatsandsoda/2022/12/15/1143002538/china-appears-to-be-facing-what-could-be-the-world-s-largest-coronavirus-outbrea
"COVID spreading faster than ever in China. 800 million could be infected this winter"
I keep hoping that the mechanics of running a Paxlovid non-inferiority study will be rather simple and prescribed. I hope that this translates into action.
hMPV—>“…the most important virus you’ve never heard of”:
https://www.cnn.com/2023/05/29/health/human-metapneumovirus-explainer-wellness
Paxlovid receives full-fledged FDA approval—with boxed warning for DDIs:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-antiviral-treatment-covid-19-adults
Good to see ENTA starting to rebound as it breaks $28/share. Obviously a long way to go but eventually the impulsive moves that cause market over-reactions, like the drop ENTA suffered, are countered by cold hard and rational assessment.
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