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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:
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).
Who could have known?!?!
Somebody didn't realize until today that ENTA is a COVID play?
A kind of crazy last few minutes of trading.
At 10 minute till 55.4K shares traded; up +.79 cents
at 5 minutes till 60K shares
at 4 minutes till 91K shares +1.74
at 3 minutes till 120K shares +$3.04
at 2 minutes 138K shares +$3.34
at 1 minute 150K shares +$3.67
at closing 225K shares +3.77 gain
Day's Range $42.18 - $46.52 Gain 8.87%
ENTA FY3Q21* results—royalty_revenue=$21.6M—6/30/21_cash=$372.5M:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Financial-Results-for-Its-Fiscal-Third-Quarter-Ended-June-30-2021-with-Webcast-and-Conference-Call-Today-at-430-p.m.-ET/default.aspx
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).
During calendar 2Q21 (ENTA’s FY3Q21*), ABBV sold $441M of Mavyret. ABBV has issued calendar-2021 guidance for Mavyret sales of $1.9B (#msg-165196250), implying quarterly sales in calendar 2H21 approximately $500M per quarter.
ENTA’s 6/30/21 cash balance of $372.5M was down $27.5M from 3/31/21 (#msg-163650007); the relatively high cash burn was mostly due to R&D spend (see below).
ENTA previously issued FY2021* guidance for gross operating expenses (including non-cash components such as stock-based compensation): $145-165M for R&D; and $27-33M for G&A. The actual FY3Q21 R&D spend of $47.0M was well above that range ($188M annualized), while the actual FY3Q21 G&A spend of was at the top end of the prior guidance.
*ENTA’s fiscal year ends on September 30.
I'm sure they will talk about it in today's CC.
It strikes me that Pfizer is a huge company and has a head start; but not by much.
Enanta has a strong history and record with anti-virals; particularly with protease inhibitors.
I was anxious for ENTA to develop a compound. Did Pfizer's haste to create a PI create a best in class PI? ENTA may have a better solution than the goliath company; they have anti-viral expertise, created the best in class PI for HCV, and may have demonstrated the same in RSV and HBV.
It would seem that covid isn't going away.
There is talk about the virus evading vaccines.
This looks encouraging to me.
Thanks willyw!
Chief scientific officer Mikael Dolsten said that in the phase 1 study, PF-07321332 exceeded the level predicted to inhibit coronavirus viral replication by more than fivefold.
I posted some excerpts from ENTA’s PR in #msg-165291436.
Below an article on the Pfizer competition.
What was intriguing to me was the time line;
this protease inhibitor was in phase 1 this spring
"Pfizer advanced the experimental drug into phase 2/3 testing in July and thinks it could file for EUA in Q4 if all goes well." EUA = Emergency Use Authorization
https://www.fool.com/investing/2021/08/03/this-could-be-pfizers-next-covid-blockbuster-and-i/
Enanta Pharmaceuticals Announces Nomination of Clinical Candidate EDP-235, its Lead Oral Protease Inhibitor Specifically Designed for the Treatment of COVID-19
August 05, 2021
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Announces-Nomination-of-Clinical-Candidate-EDP-235-its-Lead-Oral-Protease-Inhibitor-Specifically-Designed-for-the-Treatment-of-COVID-19/default.aspx
ABBV's 2021 Mavyret guidance of $1.9B (lowered from $2.0B) implies about $500M per quarter in 3Q/4Q21. I thought ABBV might drop the full-year guidance to $1.8B (or less), so I'm ok with the $1.9B figure.
ABBV 2Q21 Mavyret sales=$441M, +6% QoQ:........
New-patient starts are increasing but are not (yet) back to pre-pandemic levels.
ABBV 2Q21 Mavyret sales=$441M, +6% QoQ:
https://news.abbvie.com/news/press-releases/abbvie-reports-second-quarter-2021-financial-results.htm
New-patient starts are increasing but are not (yet) back to pre-pandemic levels.
ABBV’s full-year 2021 Mavyret guidance is $1.9B, down from the prior guidance of $2.0B.
Patience is required, but buying now (when nobody wants it) is a good bet, IMO.
The clinical catalysts for 2021 are pretty modest—see slide #38 at the link in #msg-164535206.
Any catalysts - near term? it's been a dog for 2 years... really disappointing for a company w/ great science... just do not understand the market's ignorance
I added shares today in the institutional account I manage.
More RSV, but in the midwest.
It seems to re-emerging, albeit off season.
Perhaps Enanta can get their trials enrolled soon.
https://www.yahoo.com/news/cold-weather-virus-summer-baffles-141645322.html
RSV reemerging in US South—(contrary to normal seasonality)—as COVID-related social distancing wanes:
https://www.wsj.com/articles/another-respiratory-virus-is-spreading-as-u-s-gets-back-to-pre-covid-19-life-11625140800
I added shares today in the institutional account I manage.
I'm a long time holder but have been adding on the low price.
I was *certain* that based on generally positive data from ENTA in many of their programs that the price would start climbing. : )
- HA!! That was not in the cards today but I still added again today.
I'm a long time holder but have been adding on the low price.
I was *certain* that based on generally positive data from ENTA in many of their programs that the price would start climbing. : )
- HA!! That was not in the cards today but I still added again today.
* Hep B- ENTA has a strong plan and candidates, although they are not the furthest along, they may have a basis for an all oral cure- which in a global scheme would be more desirable than w/ injectable programs.
* RSV has been increasing and if they can just complete their trials they are probably a best in class and first approval- and they have a second compound in the wings.
* Even in NASH where no one is a strong leader ENTA looks somewhat successful, and looks to have an even better 2nd gen compound.
* I have also been adding on the number of near term catalysts and a thinning of competitors in many programs.
* Covid is not going away and continues to mutate. An effective anti-viral oral agent could attract Govt funding and accelerated approval.
* Note that ABBV and ENTA were not first in HCV but in the end were FIRST IN CLASS with the most effective and shortest treatment. Gilead was a close second BUT they didn't create their nuke; they bought it in Phase 3.
A G/P pediatric approval just happened in kids 3 years and older.
HCV acute cases also increased 14% 2018-2019.
* Anyone that has held ENTA has seen periods of volatility; both down and upwards- for me a better time to add than to sell.
Above are a few reasons I added today.
Not sure why the big drop in ENTA today but it may entice me to buy a bit more.
ENTA_presents_preclinical_data_on_EDP-721—an_oral_ HBV_RNA_destabilizer ENTA aims to make the third drug (with EDP-514 and a nuke) in an all-oral function-cure regimen; the data presentation was delivered at the International Liver Conference sponsored by EASL (European Association for Study of the Liver) going on now:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Presents-New-Data-for-EDP-721-an-Oral-Hepatitis-B-Virus-RNA-Destabilizer-at-the-European-Association-for-the-Study-of-the-Liver-EASL-International-Liver-Congress/default.aspx
Enanta Pharmaceuticals…today reported new preclinical data for EDP-721, a novel, oral hepatitis B virus (HBV) RNA destabilizer being developed for use in an all-oral combination regimen for HBV.
The data demonstrate potent, selective and pangenotypic inhibition of HBV surface antigen (HBsAg), with up to a 3-log drop in the AAV-HBV mouse model. The research on EDP-721 was presented in a poster titled Discovery and Characterization of EDP-721, a Novel Hepatitis B Virus RNA Destabilizer, during the EASL International Liver Congress 2021.
“The data presented today strongly support the continued development of EDP-721 for use in an all-oral regimen to provide a functional cure for HBV,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “While existing therapies for chronic HBV are moderately effective at suppressing HBV DNA, high levels of HBsAg present a key barrier to enduring viral clearance. These new preclinical data demonstrate that EDP-721 significantly reduced HBsAg production up to 3 logs and exhibited additive to synergistic activity with antivirals that target different mechanisms.”
[New MoA info]: …EDP-721 was shown to be a selective inhibitor of the non-canonical poly(A) polymerases, PAPD5 and PAPD7, host factors critical to the post-transcriptional stabilization of HBV RNA. Inhibition of PAPD5/7 results in potent and pangenotypic reduction in HBsAg production with minimal effects on the host transcriptome in uninfected primary human hepatocytes. Oral administration of EDP-721 demonstrated HBsAg reductions of up to 3 logs following 14 days of once-daily dosing in the AAV-HBV mouse model. EDP-721 was also shown to exhibit synergistic antiviral activity in vitro when combined with nucleos(t)ide reverse transcriptase inhibitors or the HBV core inhibitor EDP-514.
Enanta expects to initiate a Phase 1 single ascending dose (SAD) and multiple ascending dose (MAD) study to evaluate the safety and tolerability of EDP-721 in healthy volunteers in mid-2021.
Also, slide #24 in ENTA’s new slide set reveals new MoA and other info about EDP-721, the small-molecule HBV RNA destablizer that ENTA hopes will be the third drug in an all-oral functional cure.
A 3 log decrease for a single drug looks quite impressive to me. It makes me excited to see what happens when combination studies happen.
ENTA new_corporate_slide_set—includes EDP-514 data reported today:
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/06/Enanta-Corporate-Presentation-Final-6.22.21.pdf
ENTA reports_positive_phase-1b_data_for EDP-514 in_viremic_HBV patients:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Data-from-Phase-1b-Study-of-EDP-514-a-Hepatitis-B-Virus-HBV-Core-Inhibitor-in-Viremic-Chronic-HBV-Patients/default.aspx
Enanta Pharmaceuticals…today announced positive data from the first two dose cohorts of its Phase 1b study of EDP-514 in viremic chronic HBV patients who were not being treated with a nucleoside reverse transcriptase inhibitor (NUC). The data demonstrated that EDP-514, Enanta’s novel class II oral HBV core inhibitor, was safe and well-tolerated through 28 days of treatment, displayed pharmacokinetics (PK) supportive of once-daily dosing, and resulted in mean HBV DNA reductions of 2.9 and 3.3 logs at 28 days for the 200 mg and 400 mg cohorts, respectively.
“We are extremely pleased with these promising clinical results for EDP-514, which are comparable to the best antiviral effects reported for any core inhibitor to date and also extend the compound’s excellent safety and tolerability profile,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “In particular, we are encouraged by the rapid and robust declines in HBV DNA, which position EDP-514 to be a key component of a combination regimen for HBV. We believe EDP-514, in combination with a NUC and other mechanisms [i.e. EDP-721, ENTA’s small-molecule RNA destabilizer (#msg-164178077)], could provide a foundation for an all-oral treatment approach to achieve functional cures in patients with chronic HBV infection.
Great PR just released on HBV 1B program.
ENTA latest slide set (5/6/21):
https://s22.q4cdn.com/306858242/files/doc_presentations/2021/05/25/Enanta-Corporate-Presentation-5.6.21-updated-v2.pdf
The only differences between the 5/6/21 (latest) slide set and the 3/31/21 (previous version) slide set are the financial info from FY2Q21 and the inclusion of the phase-1b data for EDP-514 in nuke-suppressed HBV patients.
This is exactly what Jay Luly predicted would happen when people ceased wearing masks and socially distancing.. RSV is normally dormant during summer, but these are not normal times!
https://www.yahoo.com/news/another-respiratory-illness-spreading-across-191511447.html
The Centers for Disease Control and Prevention is warning about RSV, a cold-like respiratory illness, amid a spike in cases across the southern U.S."
...."Experts said they’ve seen an uptick in positive infections in at least a dozen states, including Florida, Georgia, Mississippi, Texas, Kentucky, North Carolina and South Carolina."
ENTA will unveil preclinical data on its oral HBV RNA destablizer, EDP-721, at EASL:
https://finance.yahoo.com/news/enanta-pharmaceuticals-present-preclinical-data-110000538.html
Please see #msg-163654846 (bottom) for background info.
ENTA’s_enterprise value_at_the_current_share_ price ($48.59) is ~$740M, based on 24.1M fully-diluted shares (#msg-163910230) and pro forma cash of $426.1M (#msg-163910195).
ENTA’s fully-diluted* share count @3/31/21=24.1M—an increase of 0.2M since 12/31/20 (#msg-161707883).
The 24.1M figure above consists of: 20.2M basic shares on the 3/31/21 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021026025/enta-10q_20210331.htm#CONSOLIDATED_BALANCE_SHEETS ); and 3.9M options outstanding at 3/31/21 (whether or not exercisable) (ibid, page 13).
*Non-treasury method.
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