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Thank you Vin!
Hoping it doesn’t run away from me. Without that data I don’t think it will go up
much but that’s what I thought about VKTX and that didn’t work out well for me.
I don't have any info on the timeline of the Pavlovid patent suit.
Re ENTA's patent suit against Pfizer.
Is there a timeline of when this will be heard or decided on?
Indeed, yes.
But the primary is safety!
Is the EDP-235 phase 2 designed to show if 235 stops the spread of Covid in 2-4 days after patients start?
The last few days have been a nice move up for ENTA shareholders but it really doesn't matter much. It is finally May and the EDP-235 phase 2 data should be out this month. That will be the real price driver, hopefully it will be what we hope and drive the price much higher that than it has risen the last few days. Fingers crossed.
ENTA updated corporate slide set (4/18/23):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
There are only two differences between the between the 4/18/23 slide set and the previous version (dated 2/7/23):
• Slide 12 has minor changes about competing RSV drug candidates, mainly that the Ark Bio (China) fusion inhibitor, AK-059 is under review by China’s FDA (https://arkbiosciences.com/en_2022n/114 ).
• Slide 22 has an additional bullet point noting that EDP-235 has an FDA Fast Track designation.
Note: ENTA’s partial monetization of the Mavyret royalty stream on 4/25/23 is too recent to be incorporated in the slide set.
It is obvious to anyone with a functioning brain why we need new and perhaps better drugs to fight Covid. Here is a little reminder.
COVID will eventually evade Paxlovid, Deborah Birx says
— Jess (@MeetJess) April 29, 2023
“Right now, we’re just accepting that 270,000 Americans died last year,” she said. “Two-hundred and seventy thousand. We’re going to easily lose over 100,000 this year. That, to me, is not success.” https://t.co/uF1PG8HM7M
The angry dog barks, but the caravan moves on.
Everything used to be about NASH. Tanked. Then it was HBV. Tanked. Then it was RSV. Tanked. History about to repeat itself folks.
Much Lower than average volume on no news has accompanied this drop. I don’t worry myself of such moves. As Warren Buffett said, the stock market is a voting machine in the short run and a weighing in the long run. The only thing that matters right now is the upcoming phase 2 data.
I’d advise against it. Suggest you read between the lines and not lap up every claim they make.
More "the flight you booked is going to crash" posts?
Classic. : )
Such a bloodbath.
We are down 41 cents, 80 minutes to go in the day
and we aren't even at half average daily volume yet.
I bought a little more yesterday.
willyw,
Just to add to your cemmentary, the Pardes drug wasn't very good and pales in comparison to EDP-235. See slide 26 of ENTA's presentation.
Some data comparisons.
Vero cell IC50
EDP235 is 68x more potent than the Pardes drug
Vero cell IC90
EDP235 is 54x more potent than the Pardes drug
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
I'm not following you.
I see different things, of course.
Easily over 12-16 months ago in one of Pardes pitches they showed a graph of viral decline in days; the dosed and the control group. They demonstrated that the viral decline was identical in both groups. If you superimposed the two viral declines over days it would pretty much look like one line.
Here's what Pardes said in the link you provided;
“We continue to believe in the need for new oral antivirals for COVID-19 (my emphasis~W), and the importance of continued investment in next generation therapeutics that will be needed to help prevent the next pandemic. However, these unexpected results have forced us to make the difficult decision to suspend further development of pomotrelvir and pursue alternative strategic opportunities for the company,”
also
"Pomotrelvir did not demonstrate meaningful improvement over placebo in reduction from baseline(my emphasis~W) of SARS-CoV-2 infectious virus titer by IVA or in the reduction from baseline or proportion achieving undetectable viral load (RNA) by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) measured from mid-turbinate swabs".
The short answer is that Pardes created a weak ineffective protease inhibitor that created the same viral decline as placebo.
Pardes seems to think that a better antiviral is possible and needed. I can agree with that.
In a matter of a few weeks we will see the efficacy of Enanta's covid candidate. I have little doubt that it will top Pardes, Pfizer, I believe based on the animal studies it may be more potent than the Shionogi candidate and have a reduced pill burden and will be more safe.
For me a 5 day course of treatment that eliminates the virus could have dramatic differences from those that almost eliminate the virus.
We will soon see.
RE; RSV. They did the challenge study due to the absence of available sick patients. RSV has returned and the trials will provide proof of safety and efficacy or it's lack.
Let's imagine that ENTA RSV compound isn't the final result; the very best iteration of a RSV antiviral.
Well, that may make them like Pfizer's Paxlovid. If it's the first, if it's the only that may be sufficient for an approval with few or no competitors in the antiviral market.
Thanks for the heads up on the acquired Pfizer RSV candidate. I'm not up to speed on that. Frankly I'm focused more on the covid program than RSV at the moment.
An even bigger sidebar is that lack progress in HBV doesn't concern me that much either. They have a potent HBV antiviral (EDP-514) and the competition is also moving very slowly. They could still have a future valuable asset or partnership. I would not characterize it as dead. (see commentary below).
A final thing; these are *trials*. That's stating the obvious. No one knows until the trial is over. We may have hopes or opinions but it's the nature of trials to expose the reality. To know or to attempt to assert that one knows is kind of a fools errand.
That doesn't mean it isn't fun to try to guess outcomes or sift thru data. I find it more interesting than sports, but I never purport to know who is going to win.
Happy to post the data:
https://ir.pardesbio.com/news-releases/news-release-details/pardes-biosciences-announces-top-line-results-phase-2-trial
To simplify for you, look at the “p values”. For the drug to work (in this real world setting that some folks here seem to forget is the only important thing), the p value needs to be below 0.05.
For rsv, please remember that they ran a challenge study which showed stat sig antiviral effects. Want to stress that this is a highly controlled setting. Dosing began right after innoculation, and it was the same for every participant. The lesson with the failure of RSVP contrasted against the challenge study is that it is nearly impossible to catch these people in time, and do so with uniformity, to achieve p less than 0.05.
For babies, elderly, and immunosuppressed, yes, could give better p value. But Enrollment is clearly very slow. Don’t forget, Pfizer acquired Reviral and all of their small molecule RSV assets. It’s another big risk for their RSV program.
Thanks. I am just a layman with an interest and no credentials.
So my opinion, my hope, my whistling past the graveyard posts are no promise I'm right. Many here are way sharper than I.
RE: The Pardes data. I'm not sure I follow, but posting a link to the data would have made it more certain we were on the same page.
I'm no expert but in a trial with placebo I'm unsure you can compare that placebo arm to other trials or would want to. Further unsure what it would prove. Certainly there are more folks with antibodies (both vaccine and natural infection and both) now that when this started but I don't think that precludes being able to run trials that differentiate or show non-inferiority.
Somehow I think there are others or other pharmas that would agree. Unsure I'm following you- probably not.
I agree that it isn't 2021 anymore. That's germane, but it doesn't mean that compounds cannot be evaluated for safety and efficacy and compared to others like Paxlovid.
I think I speak for more than just myself regarding your unhinged thoughts and insights regarding the matters at hand but if you haven’t figured out by now you have close to if not less than zero credibility on this board so unless you’re here looking for genuine discussion and sense based analysis rather than a poorly labeled smear campaign perhaps a board more suited to your attention grabbing needs would be more suitable.
Thanks for the reply, Willy. It’s great discussion.
On the clinical landscape, I would refer you to the Pardes dataset. Review the placebo arm. How will EDP-235 beat the SPRINT placebo arm? It’s not an foregone conclusion, but I do not believe it will. The world population has high seropositivity to Omicron. As far as continued death rate, these people will never be treated with 235 in a clinical trial. If they enroll HR pts during a phase 3, this will take a long time as there is a potential life saving therapy available to most (Pax). Maybe they can enroll HR folks who are on statins? Most docs would pull the patients off the statin. My thesis on 235 is simply born out of the Pardes -real- placebo dataset. Facts there we can’t ignore. It’s just not 2021 anymore.
Now, it’s highly concerning that going into a top line (within 4 weeks!), they announce a “non-dilutive” fundraising event. Remember when they announced a new high risk RSV trial right before announcing a failed result on RSVP? Let’s please not forget this. Smells familiar… I applaud the c suite for this tactful play, but to me it spells uncertainty for them to secure a deal. If they had someone interested, they would already have the deal in place. Selling the royalty stream now does nothing whatsoever to puff their feathers and exert independence to a potential partner. There is no way in hell that results are still blinded if they truly have a May topline. The GC’s recent buy goes counter to this thesis, but I still can’t get a sense of what his total holdings are.
One good point you make is future variants. This is a guaranteed thing for me. Think past Omicron … SARS-3! It will definitely happen and I hope they are around to catch these patients, and differentiate vs pbo.
Thanks, Vin!
I greatly appreciate your response and the value of this board and members.
So I greatly value this board and it's many members.
I've learned a lot- and some of it has nothing to do with investing.
If the Enanta data and FDA response is what I want, I'm sure I will go in deeper.
We've sure waited long enough. I'm hoping for the best.
I have no crystal ball. I have to wait for results.
I do feel I have some cause to see success in efficacy and safety.
Thanks Willy for the leveled response, much appreciated!
Hope you are right but I feel the clinical landscape has changed wrt endpoints.
Also, this ‘mortgage’ today means - no deal is in the works. They will go solo into phase 3. Good luck.
“Very true, but I have been doing the opposite, slowly buying not just ENTA but several stocks including RVNC, ABBV and GILD”.
I like this approach myself. Added to my RVNC position today as well. I have to work 7 more years and have no qualms about adding to my core holdings on days where others decide to exit. Cheers.
I am crossing fingers for you and have considered going back to the well myself.
I can almost see the runway from here.
Landings are always the hardest part. : )
It's always good to get feedback- both constructive positive and negative.
This was a smart and prudent move by ENTA. That should be obvious to anyone with a functional brain, which leaves out our friend Jake. ENTA was going to have to raise cash in a year or so, and with big rise in interest rates over the last year, if they didn't do this they were facing either dilutive financing or a loan on less favorable terms than in a long while. No worries about cash for a while now. All attention shifts to the phase 2 trial data which is due on a few weeks. While ENTA investors hope for, or expect the data to be very good, there is no guarantees. That is why this deal for ~54% of future MAVYRET revenues and placing a cap on revenues sold, were a smart prudent move. By keeping half of the revenues, ENTA will still benefit in MAVYRET revenues rise post-Covid.
Thank you. ; )
I have come to rather enjoy your "the flight you booked is going to crash" type posts.
I've no idea why you are fixated on Enanta; I wager you are just trying to be helpful. : )
For those investing there is always that school of thought that one should jump out of the plane before it crashes. I take a slightly different view; stocks go up and down independent of any apparent reason. For instance, money sometimes rotates in or out of a stock and then (for instance when a drug is de-risked), then money might move back in. Many have gone to cash in this period of uncertainty- that is not a referendum on Enanta's covid program per se.
IMHO people are waiting for results of Enanta's covid drug which could arrive in mere weeks.
Any selling hasn't been at concerning volume (once again my opinion).
Pfizer's sales of Paxlovid reached $18.9 billion in 2022.
Pfizer expects that revenue to drop 58% to $8 billion in 2023.
I expect that in mere weeks Enanta's EDP- 235 covid drug will be shown to be more effective than Paxlovid, be once a day dosing and non-boosted- thus making it safe for large groups without worrisome drug interactions.
IF it is your contention that covid is over, then Enanta's drug could be best in class in a niche where further covid drug development is scuttled.
This is very much like the HCV market today, right?
It may also be that the drug could show promise in long covid or prophylaxis, or save more live in high risk groups. If it is more efficacious it could reduce or eliminate rebounds.
I'm content to wait for results. I could be wrong, but I'm not about to jump out of the plane right before it lands based on your analytical skills.
One thing I am reasonably certain of;
If Enanta's results show that it is more efficacious than Paxlovid, is indeed once a day dosing
you will probably still opine that it can't work, and will fail.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=170538068
I've been wrong before, and I allow I may be this time too. : )
My view is that if you look at drug effects on heathies that presumably will recover regardless you are almost deliberately trying to avoid looking at groups where results will be more highly differentiated. This is true in Covid and I think may also be shown in RSV.
We will see.
Snagged 1,000 shares. Too cheap to pass on.
Running out of $. Need to keep that cash burning fire bright!
ENTA’s partial monetization of the Mavyret royalty stream is a wise move (IMO), although they probably should have done it sooner. I commented on this in #msg-166883690.
Enanta Pharmaceuticals Announces Sale of a Portion of Global Royalties on MAVYRET® (U.S.)/MAVIRET® (ex-U.S.) (Glecaprevir/Pibrentasvir) to OMERS Life Sciences for $200 Million
Non-Dilutive and Strengthens Balance Sheet
Competitive Process Results in the Sale of 54.5% of the MAVYRET®/MAVIRET® Royalty Interest, Subject to a 1.42x Cap
Sale Proceeds to Fund Continuing Clinical Development Across Virology Pipeline
April 25, 2023, 8:01 AM EDT
WATERTOWN, Mass.--(BUSINESS WIRE)--Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today announced the sale to OMERS, one of Canada’s largest defined benefit pension plans, of 54.5% of Enanta’s future royalty payments from AbbVie Inc. on worldwide sales of MAVYRET®/MAVIRET®. The purchase price paid to Enanta was $200 million. OMERS right to receive royalty payments is based on net sales of the product beginning in July 2023 through June 2032, with total payments capped at 1.42 times the purchase price. Enanta retains 45.5% of all royalties until the cap is hit, at which point 100% of all further royalties revert to Enanta.
“We are pleased to partner with OMERS and its Life Sciences team to secure additional non-dilutive funding, which not only provides us with increased financial flexibility and retained economics, but also demonstrates the continued value of MAVYRET®/MAVIRET® and its significance for patients who continue to benefit from this therapy,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “As we execute on our programs, these funds enable us to continue to advance our robust pipeline of treatments for life-threatening viruses.”
“Enanta is a leader in small molecule drug discovery as evidenced by the successful development and commercialization of MAVYRET®/MAVIRET® in collaboration with AbbVie,” said Rob Missere, Managing Director & Head of OMERS Life Sciences. “We are pleased to invest in future sales of MAVYRET®/MAVIRET®, an important cure for chronic hepatitis C virus infection. This deal furthers our mandate to deliver an attractive source of long-term returns for our more than 560,000 members.”
MAVYRET®/MAVIRET® is a fixed-dose combination of glecaprevir, an NS3/4A protease inhibitor, and pibrentasvir, an NS5A inhibitor, indicated for the treatment of chronic hepatitis C virus (HCV) infection. Glecaprevir was discovered by Enanta under a collaboration between AbbVie and Enanta to discover and develop protease inhibitor treatments for chronic HCV infection. MAVYRET®/MAVIRET® was launched globally beginning in 2017.
So if you look at the details of this auto-generated list from Yahoo, you will see they include RSU grants and sell to cover transactions.
But back to the point, the GC’s transaction is interesting. I am still wondering how this one transaction fits into his overall portfolio.. this is the important detail.
Vin, sorry, I was addressing the guy who was criticising your post without giving his reasons for doing so. Apologise for the ambiguity.
Best,
-Fritz
Sure. 400K net shares have not been purchased by insiders in equivalent open market buys.
Please explain your thinking.
Your analysis, vinman, is misleading.
Roy, could you also put this purchase in the broader context of all of his total holdings? Is it a drip or a splash?
Thanks. So he probably saw the low share price and knew he only had to pay 20K tax for the instant gain, and then any future gain could be included as a long term capital gain, assuming hold for 12 mo?
The overall cash outlay was roughly $220K: $200K (6667 x $30) to exercise the options and about $20K for the immediate (federal + state) tax liability.
Agreed. But specifically, how much cash did he just put in? To cover the shares and to cover the tax?
Exercising the options starts the one-year clock for long-term tax treatment of potential capital gains on the exercised shares. The market price on the exercise date becomes the cost basis for the shares resulting from the exercise.
The (unrealized) gain from the difference between the market price on the exercise date and the exercise price of the options is generally taxed immediately as ordinary income. Insiders often pay for this immediate tax liability by forfeiting some shares resulting from the exercise; however, as I noted in this thread Nathaniel Gardiner did not forfeit any shares, so we know he paid the immediate tax liability with cash.
All told, the transaction should be construed as bullish. If the options holder did not confidently expect an increase in the share price, there would be no incentive to exercise the options early and pay the immediate tax liability.
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