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Jeffries initiates with a $95 price target
WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage
biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today
announced that new preclinical data for EDP-235, its lead oral protease inhibitor specically designed for the
treatment of COVID-19, will be presented at the International Society for Inuenza and Other Respiratory Virus
Diseases (ISIRV)-World Health Organization Virtual Conference (WHO): COVID-19, Inuenza and RSV: SurveillanceInformed Prevention and Treatment. The conference is being held virtually on October 19 – October 21, 2021.
Poster Presentation:
Date: October 19, 2021
Time: 8:00 a.m. CET
Poster #120: “EDP-235, A Potential Oral, Once-Daily Antiviral Treatment and Preventative for COVID-19”
Presenter: Li-Juan Jiang, Ph.D.
ENTA new corporate slide set (updated for NASH discontinuation):
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/10/Enanta-Corporate-Presentation-10.4.21.pdf
ENTA discontinues NASH program:
https://www.businesswire.com/news/home/20211004005192/en
ENTA’s EDP-305 (first-generation FXR) wasn’t going anywhere due to an unacceptably high rate of pruritis, as was previously discussed on iHub (#msg-152426231). The new news in today’s PR is that EDP-297, the follow-on FXR compound, was no better than EDP-305.
The market was ascribing zero value to ENTA’s NASH program, so I don’t expect today’s news to be a market-moving event one way or the other.
Today's jump goes under the heading of "oh what a beautiful morning, oh what a beautiful day".
Today's rise is a mere shadow of what is in store when/if either the NASH data, the Hep-B drug data or he as yet not in trials Covid drug data comes back looking really good.
Similar article from Business Insider:
https://www.businessinsider.com/covid-19-antiviral-pills-results-coming-impacting-the-pandemic-2021-9
$ENTA is the only one of the mentioned companies that is developing a SARS-CoV-2 oral antiviral from the ground up, as far as I know. That's a distinction worth noting.
— Roy Friedman (@DewDiligence) September 30, 2021
ENTA 9/13/21 (latest) corporate slide set:
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/09/Enanta-Corporate-Presentation-9.13.21.pdf
Thank you for the copy and paste. I often read them a few times so this is convenient.
The best insight into the covid program is here in the most recent presentation; from about the 6 minute mark to 14 minute mark.
https://kvgo.com/baird-2021-global-healthcare-conference/enanta-pharmaceuticals-sept
Before that I believe during the recent Q3 earnings call they also announced the covid candidate. In the following Q and A someone asked if they wanted to compare their covid asset EDP-235 to the others which had been in development. Luly passed on talking about the competition, but mentioned that Enanta was pretty aware of the other theraputics/antivirals in development before releasing theirs.
https://seekingalpha.com/article/4446932-enanta-pharmaceuticals-inc-s-enta-ceo-jay-luly-on-q3-2021-results-earnings-call-transcript
I got the impression that they were confident about their asset, and that they were not going to release a sub-par candidate. It may not be the first, but I think it likely superior to a repurposed or rushed compounds further in trials. My hope is that Enanta's expertise and extra time spent in development will mean a seat at the sars-covid table.
Interesting read on Reuters today featuring Enanta and Jay Luly regarding EDP-235 for COVID:
"Reuters
COVID-19 pill developers aim to top Merck, Pfizer efforts
By Deena Beasley
September 28, 2021
(Reuters) - As Merck & Co and Pfizer Inc prepare to report clinical trial results for experimental COVID-19 antiviral pills, rivals are lining up with what they hope will prove to be more potent and convenient oral treatments of their own.
Enanta Pharmaceuticals, Pardes Biosciences, Japan’s Shionogi & Co Ltd and Novartis AG said they have designed antivirals that specifically target the coronavirus while aiming to avoid potential shortcomings such as the need for multiple pills per day or known safety issues.
Infectious disease experts stressed that preventing COVID-19 through wide use of vaccines remains the best way to control the pandemic. But they said the disease is here to stay and more convenient treatments are needed here.
“We need to have oral alternatives for suppression of this virus. We have people who aren’t vaccinated getting sick, people whose vaccine protection is waning, and people who can’t get vaccinated,” said Dr. Robert Schooley, an infectious diseases professor at UC San Diego School of Medicine.
Pfizer and Merck, as well as partners Atea Pharmaceuticals and Roche AG have all said they could seek emergency approval for their COVID-19 antiviral pills this year.
Rivals are at least a year behind. Pardes began an early-stage trial last month, Shionogi plans to start large-scale clinical trials by year-end, Enanta aims to start human trials early next year and Novartis is still testing its pill in animals.
Enanta Chief Executive Jay Luly said re-purposing drugs originally developed for other viral infections is not an unreasonable approach. But it is not known how potent they will be against COVID-19 or how well they can target lung tissue, where the virus takes hold.
The risk is “if it’s not a great effort ...you’ll end up losing time,” Luly said.
Antivirals are complex to develop because they must target the virus after it is already replicating inside human cells without damaging healthy cells. They also need to be given early to be most effective.
Currently, intravenous and injected antibodies are the only approved treatments for non-hospitalized COVID-19 patients.
An effective, convenient COVID-19 treatment could reach annual sales of over $10 billion, according to a recent Jefferies & Co estimate. Merck has a contract with the U.S. government that implies a price of $700 for a course of treatment with its antiviral molnupiravir.
SEARCH FOR AN EASY TREATMENT
Several classes of antiviral drugs are being explored. Polymerase inhibitors such as Atea’s drug - first developed for hepatitis C - aim to disrupt the ability of the coronavirus to make copies of itself. There are also protease inhibitors, like Pfizer’s pill, which are designed to block an enzyme the virus needs in order to multiply earlier in its lifecycle.
We are trying to halt the processes “that allow the virus to set up a replication factory,” said Uri Lopatin, CEO at Pardes, which is also developing a COVID-19 protease inhibitor.
Merck’s molnupiravir, developed with Ridgeback Biotherapeutics, was at one point envisioned as a flu drug and works by introducing errors into the genetic code of the virus.
“The broad spectrum activity of molnupiravir against RNA viruses, including other respiratory viruses, suggests that it should be a durable, useful molecule,” said Jay Grobler, who oversees infectious disease and vaccines at Merck.
Merck said data shows the drug is not capable of inducing genetic changes in human cells, but men in its trials have to abstain from heterosexual intercourse or agree to use contraception.
Until reproductive toxicology study results are available, “we don’t know if there’s any potential effect of drug on sperm,” said Merck research executive Nicholas Kartsonis.
Both molnupiravir and Pfizer’s pill are taken every 12 hours for five days. Pfizer’s drug must be combined with older antiviral ritonavir, which boosts the activity of protease inhibitors but can cause gastrointestinal side effects and interfere with other medications.
“It is a nuisance to add a drug you don’t need to have a drug you want to take be effective,” Schooley said.
Pfizer said a low dose of ritonavir will help its protease inhibitor remain in the body longer and at higher concentrations.
Enanta, which gets most of its revenue from a hepatitis C deal with AbbVie Inc, scanned its library of antiviral compounds early in 2020. It instead chose to design a new protease inhibitor that targets an enzyme vital to the ability of the coronavirus, and its variants, to replicate.
The drug will be tested at once daily dosing with no ritonavir boosting, Luly said.
Lopatin said Pardes is assessing once- and twice-a-day dosing and whether its drug needs to be combined with ritonavir. “We do not anticipate that we will need to use a booster,” he said.
Pardes received funding from Gilead Sciences, which gave up on an inhaled version of its remdesivir, an intravenous polymerase inhibitor approved for hospitalized COVID-19 patients.
Gilead is still working an oral remdesivir, which was also first developed for hepatitis C and is currently the only antiviral approved for treating COVID-19.
This story corrects name to Ridgeback Biotherapeutics."
Indeed sir. I nibbled a little last week. Admittedly surprised how quickly this moved north….
Happy Labor Day weekend to you all!
Some serious under the radar accumulation of ENTA seems to be happening as the stock price has risen from the low $40s to over $58 in about a month.
HBV competitor, ASMB can’t get anything right:
#msg-165734953
Thanks for the well thought out comments. I see a dozen players in the HBV inhibitor space including ENTA and three players in the HBV immunology space. Is ENTA the odds on favorite in the inhibitor space and do you see some possible synergy with T-cell approaches resulting in combos there?
Addendum: ENTA is sufficiently well funded to execute the business plan outlined in #msg-165690818.
Enanta has always been well funded as a research boutique. But to go it alone on some of these products would require a massive investment in personnel in regulatory, manufacturing, commercial, supply chain, etc. and I never had a strong feeling that they were committed to that.
RVNC has made that commitment and suffers somewhat from the massive burn that comes with that strategic direction.
I am just playing a hunch as to why Enanta may be able to change strategic direction more easily with respect to their business as a whole. I could certainly be wrong but still I feel there is a very solid basis for my speculation. Time will tell.
ENTA has always been well-funded on account of its HCV royalties. So, I’m not sure I understand what changed in your view with respect to funding. TIA
You did great!
I'd guess your average cost is less than my recent purchases.
Here's hoping that there's a bit more to run. : )
I'd ultimately like to double, but relatively recently added an additional 2/3rds to my long term position- in a number of buys.
All green at this point- but I confess I was trapped in a position- so I'm not green for some of my longer term position....yet.
Not only do I want to ride the stock price up, but I want to lower my average share price cost.
I feel like with the stock price rising many have looked into the stock to investigate why.
(ENTA up 31%+ this past month)
Like this company a lot. But always thought of them as a research boutique destined to be acquired at some point in the near future. Now I am thinking very differently.
APP. Could be something big going on here. AF acknowledging that vaccines are not working.
Small biotechs had a good week. (XBI +8%.)
Curious if the significant bump the last week is excitement around the HBV or SARS program or both?
If anyone would like to comment or elaborate on #msg-165620670, I’m all ears.
Re: HBV functional-cure market size
Let’s use the HCV market as a comparator, based on the assumption that ENTA (or somebody’s combination regimen) will be is successful in providing a functional cure for HBV.
The number of patients infected with chronic HBV is considerably larger than it ever was for HCV. However, a larger proportion of chronic-HBV patients live in poor countries as compared to HCV, which offsets the larger number of total patients. Thus, as a rough first-order approximation, we could hypothesize that the peak annual size of the addressable market for an HBV-curing regimen will be comparable to what it was for HCV.
The peak-sales year for HCV (2015) saw worldwide sales of approximately $23B, which dropped to about $19B the following year (2016) and has declined steadily since then as more and more patients are cured and the average selling price for a course of treatment has come down.
For HBV, the sales trajectory will not be as parabolic as it was for HCV; due to the greater difficulty diagnosing and treating patients in poorer countries, the initial bolus will be smaller and the rate of decline following the peak will be more gradual. Therefore, as compared to HCV, we should probably model a somewhat lower number for peak annual sales, but perhaps an equal or higher NPV for the total (all years) revenue stream.
For ENTA, specifically, an important question is what proportion of the total HBV functional-cure market will be comprised of all-oral regimens, assuming that an all-oral regimen exists. I would submit that this proportion will likely be at least 50%.
What is your estimate (or range) of successful HBV combo pricing and total addressable market?
This phase 1 work is being run by
Principal Investigator: ED Gane, MD
https://clinicaltrials.gov/ct2/show/NCT04971512?term=Enanta&cond=hbv&draw=2&rank=3
"Dr. Gane is an investigator for many international clinical trials with particular interest in early phase development of new direct acting antiviral therapies against chronic hepatitis C, hepatitis B, NASH and HCC. He has published almost 350 papers in peer-reviewed journals including The Lancet and The New England Journal of Medicine."
(my comment) Enanta seemed pretty confident about EDP-721. The guy they chose to run the phase 1 trial is also top notch, IMHO.
ENTA doses first patient in EDP-721 phase-1:
https://www.businesswire.com/news/home/20210816005078/en
Please see #msg-164540806 for background info.
Yes, that's been a problem for some time.
There is no liquidity. I bought 2K shares and the price jumped 75 cents.
ENTA is a screaming buy, IMO, but it is no longer cash-flow positive because Mavyret sales remain well below pre-pandemic levels.
In 4Q19 (the last full pre-pandemic quarter), Mavyret sales were $632M; in 2Q21, they were $441M. Lower Mavyret sales have caused a more-than-proportional decrease in ENTA’s royalties because the royalty rate is tiered.
it astounds me that this company has not been scooped up by big Pharma. Cash flow positive, solid leadership and promising products in the pipeline.
ENTA files preliminary shelf registration for unspecified amount of capital:
https://www.sec.gov/Archives/edgar/data/1177648/000156459021042633/enta-s3asr.htm
ENTA certainly isn’t planning to raise capital in the near future, so I wouldn’t read anything in particular into this filing.
ENTA’s_enterprise value_at_the_current_share_ price ($45.10) is ~$680M, based on 24.1M fully-diluted shares (#msg-165355921) and pro forma cash of $408.3M (#msg-165355929).
ENTA’s pro forma cash @6/30/21=$408.2M—a decrease of $17.9M since 3/31/21 (#msg-163910195).
The $408.4M figure above consists of: $292.5M of net current assets on the 6/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021042612/enta-10q_20210630.htm#CONSOLIDATED_BALANCE_SHEETS ); and $115.7M of marketable securities on the 6/30/21 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
ENTA’s fully-diluted share count @6/30/21=24.1M—unchanged since 3/31/21 (#msg-163910230).
The 24.1M figure above consists of: 20.2M basic shares on the 6/30/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021042612/enta-10q_20210630.htm#CONSOLIDATED_BALANCE_SHEETS ); and 3.9M options outstanding at 6/30/21 (whether or not exercisable) (ibid, page 13).
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