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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
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.
* 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
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
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.
ENTA’s pro forma cash @3/31/21=$426.1M—a decrease of $15.3M since 12/31/20 (#msg-161707561).
The $426.1.4M figure above consists of: $401.6M of net current assets 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 $24.5M of marketable securities on the 3/31/21 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
Yes, HBV is now the lead program, for all practical purposes. RSV is ready to roll—as soon as the virus makes a re-appearance, which might not be for another six months or so. NASH has been relegated to an afterthought.
Compact, yes.
Each presentation seems to suggest to me the order of importance.
Lately I've been feeling like HBV is getting top billing.
They (and in the last pitch Q and A) have mentioned EDP 514 antiviral and EDP 721 (RNA destabilizer) AND EASL and a submission on 721. They speak of HBV as if it may be on the threshold of becoming curable; at the least a large step towards that.
I become more and more confident about the RSV program.
The last mentioned was the NASH program, and indeed, the covid was mentioned before it.
That was the sequence and that seemed to me also the areas of opportunity ranked, although that was not expressed.
RBC webcast today was compact and informative:
https://event.on24.com/view/presentation/flash/endedNew.html?eventid=3173662&eventuserid=442649498
It will be available for replay in due course.
https://www.journal-of-hepatology.eu/article/S0168-8278(21)00158-6/fulltext (complete text) (partial text available @ natap https://www.natap.org/
Glecaprevir/pibrentasvir + sofosbuvir + ribavirin offers high cure rate for hepatitis C virus retreatment in real-world settings
(My comment- this only has 6 people in it but the implications on re-treating those with DAA resistance AND cirrhosis is of interest. ~Willy)
We read with interest the recent publication by Dietz et al: “Failure on voxilaprevir, velpatasvir, sofosbuvir and efficacy of rescue therapy” and would like to present additional data regarding salvage hepatitis C virus (HCV) treatment in this difficult-to-cure patient population.
Patients who fail to achieve sustained virologic response (SVR) with approved direct-acting antiviral (DAA) regimens have limited options for successful retreatment. Usage of a regimen containing an NS3/4A protease inhibitor, NS5A replication complex inhibitor, and NS5B polymerase inhibitor with weight-based ribavirin is appropriate for patients for whom even triple-DAA rescue therapy with sofosbuvir/velpatasvir/voxilaprevir did not achieve cure.
........
Results
Six patients began 16-24 weeks of HCV retreatment with glecaprevir/pibrentasvir, sofosbuvir, and ribavirin between July 2018 and March 2020. All patients achieved SVR. Baseline resistance was present in most patients (5/5 assessed for NS5A and 3/4 for NS3), and all had cirrhosis. No patients were on dialysis or had HIV or hepatitis B virus. No patients experienced serious adverse events or died during treatment. See Table 1 for additional patient details.
(One final comment- with newer more effective treatments the vast multitude of infected can be cured. That small segment that fails can be "rescued" with various therapies. That small group which fails those still has hope for a cure. Add to this people who are cured and become re-infected but have DAA resistant variants are not without options. ~W)
Are you asking about EDP-514? The phase-1b data, so far, look fine.
Thoughts on the PR and updates ?
ENTA reports HBV data_from_ 200mg_and_400mg_cohorts_of EDP-514 phase-1b:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Data-from-Part-2-of-its-Phase-1b-Study-of-EDP-514-in-Chronic-Hepatitis-B-Virus-Patients-on-Treatment-with-a-Nucleoside-Reverse-Transcriptase-Inhibitor/default.aspx
ENTA FY2Q21 results—royalty_revenue=$20.1M—3/31/21_cash=$400M:
https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Financial-Results-for-its-Fiscal-Second-Quarter-Ended-March-31-2021-with-Webcast-and-Conference-Call-Today-at-430-p.m.-ET/default.aspx
ENTA’s royalty rate 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—the quarter just reported).
During calendar 1Q21 (ENTA’s FY2Q21*), ABBV sold $415M of Mavyret. ABBV has issued calendar-2021 guidance for Mavyret sales of $2.0B (#msg-163517997), expecting Mavyret sales to pick up as the COVID pandemic recedes, which will enable more backlogged HCV patients to seek treatment.
ENTA’s 3/31/21 cash balance of $400M was down $5M from 12/31/20 (#msg-161624309).
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 FY2Q21 numbers ($41.5M for R&D; $8.3M for G&A) were consistent with the prior guidance.
*ENTA’s fiscal year ends on September 30.
ABBV maintained its full-year 2021 Mavyret guidance of $2.0B.
ABBV 1Q21 Mavyret sales=$415M, -14% QoQ:
https://news.abbvie.com/news/press-releases/abbvie-reports-first-quarter-2021-financial-results.htm
The $415M consisted of: $170M US (-23% QoQ); and $245M ex-US (-6%, QoQ).
ABBV’s prior guidance for full-year 2021 Mavyret sales is $2.0B (#msg-161451655). This figure could still be met if patient starts (especially in the US) pick up due to lessening of COVID; however, ABBV may lower the guidance during today’s CC.
ENTA could have a meaningful update on the COVID-19 program in the May-6 earnings release. Unlikely, but possible.
“Today we announced our plans to report our financial results for our fiscal second quarter ended March 31, 2021, at 4:30 p.m. on May 6, 2021. We will also provide an update on the company’s business, including our research and development pipeline. To listen, please register for the webcast here: https://lnkd.in/dpWng-A”
The only difference between the 4/1/21 slide set and the 2/8/21 slide set is that the latter shows the phase-2 pediatric RSV trial (RSVPEDSs) started in March, 2021.
Any ideas why we fell off a cliff this week so far? Ouch.
All-in-one_nasal-swab_Dx_for_ respiratory_viruses_gets_full_FDA_approval—(not_just_an_EUA):
https://www.prnewswire.com/news-releases/fda-permits-marketing-of-first-sars-cov-2-diagnostic-test-using-traditional-premarket-review-process-301249713.html
Bullish for ENTA for the reason mentioned in #msg-156795547.
BioFire Diagnostics LLC, the company selling this test, is private.
Interesting read posted on Seeking Alpha today:
https://seekingalpha.com/article/4412162-bottom-fishing-club-enanta-pharmaceuticals
ENTA’s_enterprise value_at_the_current_share_ price ($54.78) is ~$870M, based on 23.9M fully-diluted shares (#msg-161707883) and pro forma cash of $441.4M (#msg-161707561).
ENTA’s fully-diluted* share count @12/31/20=23.9M—an increase of 0.6M since 9/30/20 (#msg-159770202).
The 23.9M figure above consists of: 20.1M basic shares on the 12/31/20 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021004983/enta-10q_20201231.htm#CONSOLIDATED_BALANCE_SHEETS ); and 3.8M options outstanding (whether or not exercisable) (ibid, page 13).
*Non-treasury method.
ENTA’s pro forma cash @12/31/20=$441.4M—a decrease of $3.9M since 9/30/20 (#msg-159770118).
The $441.4M figure above consists of: $422.9M of net current assets on the 12/31/20 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/1177648/000156459021004983/enta-10q_20201231.htm#CONSOLIDATED_BALANCE_SHEETS ); and $18.5M of marketable securities on the 12/31/20 balance sheet designated as long-term (e.g. bonds with a time to maturity greater than one year).
While RVS program is the closest to being an approved product, I am pleased about developments in the anti-HBV program. I am also pleased to hear that ENTA is getting closer to selecting anti-Covid-19 drugs, and that their approach is to attack the virus polymerase and virus protease rather than using an entry inhibitor. I know some expressed disappointment that the pace of development wasn't faster but ENTA has great expertise in antivirals and i is better to take a bit longer to generate a better drug. Both drugs are being designed to be orally administered and the idea is that someone beginning to show symptoms or testing positive would get a prescription and begin taking tablets that they can take everyday for a specified time frame. Still a long way to go but the approach sounds really smart.
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