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ENTA’s pro forma cash @3/31/23=$454M—an increase of $166.4M* since 12/31/22. The $454M figure consists of:
• $239.0M of net current assets on the 3/31/22 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023019842/enta-20230331.htm#consolidated_balance_sheets );
• $15.0M of marketable securities on the 3/31/23 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year) (ibid); and
• $200M proceeds from partial monetization of the Mavyret royalty stream (#msg-171766236), which was announced on 4/25/23 and hence was not reflected in the 3/31/23 balance sheet.
*Excluding the $200M proceeds from the Mavyret royalty monetization, ENTA pro forma cash at 3/31/23 declined by $33.6M relative to $12/31/22.
ENTA’s fully-diluted share count @3/31/23=26.16M—an increase of 0.03M since 12/30/22.
The 26.16M figure above consists of: 21.05 basic shares on the 3/31/23 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017023019842/enta-20230331.htm#consolidated_balance_sheets ); and 5.11M options and unvested restricted-stock equivalents (whether or not exercisable) (ibid, p.9).
Clearly, the most troubling COVID symptoms are not those in the upper respiratory tract. If there were an easy way to measure viral load in the lung and other organs, the conversation we’re having would likely be very different.
Apropos to ENTA's royalty monetization: #msg-171904228.
I have had the chance to go over the data from the published phase 2 data of Shionogi's anti-Covid drug Ensitrelvir and somethings stand out that just don't make sense, but provides some hope for ENTA's EDP-235. We see that a dose dependence effect for Ensitrelvir doesn't read true and that there isn't a correlation between viral tier in the nose and symptom relief. Keep in mind that Ensitrelvir failed to show a significant relief of Covid-19 symptoms.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10110269/pdf/ciac933.pdf
Figure 2 compares viral changes in placebo and drug (125mg in blue & 250mg in red). In 2B (viral titer decrease log10), the day 4 and day 6 improvement is greater in the 125mg arm than the 250mg arm.
Table 2 shows the same, the lower dose was better.
Table 3 shows patients with treatment related AEs were higher in the 250mg arm (22.1%) than the 125mg arms (13.6%) vs placebo (5.0%). That means the higher dose is doing something, but not doing something beneficial. Still, it provides confidence they didn't mis-label the graphs from Figure 2 or in the supplemental figures following.
Supplementary Figure 1. Mean total symptom changes (A) and change form baseline (B). Keep in mind that Ensitrelvir failed to show a significant relief of Covid-19 symptoms. In looking at the data from B, the 250mg arm looks identical to placebo until 48hrs. The 250mg arm did worse than the 125mg arm until 72hrs then goes back to being worse. None of this is statistically significant but it looks puzzling to me and or shows the weakness of the drug in improving symptoms.
Supplementary Figure 2. Graph of the percentage of patients positive for viral titer in nasal swabs. This is where Ensitrelvir really shines but a disconnect between nasal viral levels and symptom relief becomes clear. By day 4, 54% of patients in the placebo arm are still positive for viral titer. Positive titers are found in only 2% of patients in the 125mg arm and in 6% in the 250mg arm. The difference between the drug arms are likely meaningless but it follows the pattern where dose dependence doesn't follow. However, the major point I am making and that is clear is that a drop in viral titer from nasal swabs does NOT correlate with symptom relief/improvement.
Taking this all to its logical conclusion, if nasal viral titer is NOT a metric for a drug's ability to serve as a anti-covid treatment, then it isn't such a stretch to accept that EDP-235 showed a dose dependent statistical improvement in symptom relief despite not showing a viral reduction in nasal swabs. While not a guarantee, it is food for thought. ENTA will almost certainly present the full data set parsed out in far more detail in a future conference than they did in the press releases. That will be something to look forward to analyzing.
ENTA updated corporate slide set (5/8/23):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
The main difference between the 5/8/23 corporate slide set and the previous version (dated 4/18/23) is three new slides containing data from the EDP-235 phase-2 SPRINT trial. Specific changes in the slide set:
• New Slide 22 has essentially the same info as old Slide 22, but the wording has been shuffled a bit. (The bullet point re 95% bioavailability in rats is gone.)
• Slide 25 is the same as old Slide 26; Slide 26 is the same as old Slide 27; and Slide 30 is the same as old Slide 25.
• Slides 27-29, which contain results from the EDP-235 phase-2 SPRINT trial, replace old Slide 28. (See https://ir.enanta.com/static-files/c9eca2f1-296c-4a0c-9ce4-d668229f1ec5 for the complete slide set for the SPRINT trial.)
• Slides 31-40 are the same as old Slides 29-38 — i.e. subtract “2” from the new slide number to get the corresponding old slide number.
• Slides 37-38, which contain updated financial data, supersede old slides 35-36. Slide 37 has an error of omission insofar as it doesn’t mention the partial monetization of Mavyret royalties starting in 3Q23.
I too was enticed to add 1000 shares @24.00. Never got filled at a < price.
cl
Dewophile made great post on the Biotech values board that fits with my thinking. I will add in that the phase I data for EDP-323 in RSV should be out in a month or so. It is worth the read.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=171872796
The other reason 235 has no chance:
https://clinicaltrials.gov/ct2/show/NCT05580003
Not going to beat them. If a new variant comes along and seropositivity goes for naught, I believe Pfizer will win with this new compound.
Investing in biotech can be risky so you have to have some diversity, and I do and also advise others who ask me to do the same. I made more than >3x as much on IMGN as I lost on ENTA this morning, RVNC has also been doing well and SGEN is getting bought out at a big premiums, so April and May and 2023 have been very good to me.
Back to ENTA, the fact remains that EDP-235 showed a statistically significant reduction in Covid symptoms in a healthy young population, something Paxlovid failed to do in a trial several fold larger that the SPRINT. This was even though the population in the SPRINT trial ENTA just ran.
One question that was asked in the CC was the market for anti-Covid drugs now that Covid is essentially endemic. The market fro such drugs are ~$10 billion in 2023. PFE estimated $8 billion for 2023 but reported $4 billion for Q1. The market is still quite big and will remain so for quite some time.
There is no hiding that is it painful to see an investment drop as much as ENTA did today. I did buy more ENTA this morning at $24.15. I will probably keep buying over the next few days. In a month or two I will likely sell some as I need a tax loss to reduced my capital gains from the SGEN buyout. Still, my goal is to have more shares of ENTA than I did before the SPRINT trial data was released. I am not telling everyone they should do this. That is my plan and you have to weigh what to do yourself.
Good luck to you and other ENTA investors as we move through this challenging time.
Apparently we have a sensitive little fellow on this board who likes to talk smack but can't handle a little himself.
“Vin”, it’s good. Stay optimistic.
If you buy enough shares today, maybe it will go green. You can do it! Rooting for you
The after hours trades means lots of pain tomorrow. However, there is also opportunity possible. I have made some nice cash picking up shares after a drop, as long as you think the drop is unwarranted.
I listened to the CC and the key points, at least to me were.
Enough cash to take ENTA into 2026. This doesn’t model ENTA running their own phase 3 and they aren’t looking to do so. The goal is now and has always been to partner. Looking for partnership for phase 3 as their plan has never been to run their own phase 3. Mentioned phase 2 for long Covid but that will likely be self-funded and run but nothing is set right now.
FDA doesn’t approve Covid drugs aren’t based on viral load changes. It is symptom relief, reduction of hospitalizations and deaths.
Why would symptoms improve with EDP-235 but not really viral load? They speculated that EDP-235 has a higher tissue distribution levels (EC50 & EC90) than Paxlovid but measurements only in the nasal cavity. Effect of EDP-235 on different viral compartments, lung, heat etc could explain systemic symptoms improved with EDP-235 without showing better viral clearance in nasal swabs. It would be difficult to assess these other compartments. Also talked about the much more rapid viral clearance in the nasal swabs in placebo. Nasal swabs only measure viral RNA levels, not active virus that can trigger inflammation.
Question about viral rebound. The analyses haven’t been completed.
Question about EDP-514. looking at other data sets, external assets. No mention of another internal drug.
EDP-323 polymerase inhibitor for RSV. Phase I data safety, tolerability and pharmacokinetics due next month. Challenge study would be next assuming positive data.
Yeah… the market just tanked this thing and you’re still buying. Nice. You’re getting rolled.
Now you are coming around! Great job.
Please don’t buy the “long Covid” bull that they will try to feed you. Viral damage has already been done unfortunately and it’s not coming back from 235.
My agenda is to speak the truth. Anyone here listening yet?
Well, you deny that your bullish thesis was incorrect and grossly overstated. You denied that the placebo arm reality was significant.
Now you deny. Wow. Buying more shares… for what exactly? You’re going to lose all of your money.
Now trading at $24. I suppose your opinion was incorrect “Vin”
“Key secondary endpoints evaluating virologic effect were not met. No difference was observed between patients treated with EDP-235 and placebo in viral RNA decline or infectious viral load, likely due to the rapid viral decline in the placebo arm of this trial’s seropositive, standard risk population. “
Let’s see how long this management team can milk that $450M for.
ENTA FY2Q23* financials—3/31/23_pro_forma_ cash=$454M† :
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-35
FY2Q23 royalty revenue was $18.7M.
FY2Q23 R&D expenses were $43.5M, somewhat below the run rate for ENTA’s FY2023 guidance of $210-230M.
FY2Q23 SG&A expenses were $13.8M, slightly above the run rate for ENTA’s FY2023 guidance of $46-52M.
†Including $200M from partial monetization of Mavyret royalties and a $28.7M tax refund due from IRS.
*ENTA’s fiscal years end on September 30.
ENTA reports phase-2 data for EDP-235:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-positive-topline-results-phase-2
It looks like the 400mg (higher) dose will be the one to be advanced to phase-3, although the PR does not explicitly say this.
EDP-235 did not show a benefit versus placebo in viral load, but this is not surprising insofar as other SARS-Cov-2 inhibitors have been unable to do that.
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.
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