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ENTA has had an EHS Manager for the last ten years. The existing manager is moving to a new industry hence the job posting. Part of the reason for the move is the lease expiring in a few years and the building is in “ band aid shape”. The new facility is very close by and new construction.
Wonder if it’s anything related to the ongoing litigation?
Enanta: Multiple Shots On Goal For RSV Makes This A Must Watch
Nov. 30, 2023 3:34 PM ETEnanta Pharmaceuticals, Inc. (ENTA)PFE
Terry Chrisomalis profile picture
Terry Chrisomalis
Investing Group Leader
Summary
Two mid-stage studies RSVHR and RSVPEDs are being advanced using EDP-938 for RSV; data from at least one of these studies expected Q3 of 2024.
Data to be released from phase 2a challenge study, using L-protein inhibitor EDP-323, expected in Q3 of 2024.
It is expected that the global Respiratory Syncytial Virus market is expected to reach $4.20 billion by 2027.
The company has enough cash to fund its operations until fiscal 2027 and has the option to raise additional funds through a mixed shelf offering.
mid-2024
Good to know. Thx.
Confused. With the deal with UAE today why a drop?
Not to my knowledge.
My post did not consider the posted positions, only those let go from existing roles. A total of 21 across almost all areas, mostly science roles , a few G&A.
A reliable source.
ENTA trims ~15% of headcount.
Correct. Only had 9 enrolled over the last 3 years.
ENTA halts enrollment/trial for RSV transplant patients
Agree. I wasn’t meaning it’s a $3 stock this year or next but at some point unless a deal is struck. On the positive side there is also the patent litigation with PFE that could yield positive results as well.
I'M not saying the pipeline doesn't have value, but Wall Street clearly hasn't assigned any value to it therefore if ENTA continues to burn cash and the assigned value is based on the cash, it only makes sense to me that as the on hand cash goes lower, the stock price does as well.
The Street isn't giving much (if any) value to the pipeline. The $15/share price is reflective of only the 393M on hand cash which decreases on a monthly basis with the expected burn rate. With the sale of the royalties, the amount coming in from Abbvie isn't replacing and/or adding to the cash on hand. In summary, with each passing month, the on hand cash decreases and the stock price goes along with it. Correct me if I am wrong....?
Anyone have an educated guess as to the likelihood of a partner for 235 or 938? If low, what in the pipeline would keep this from being a $1-$3 stock?
More like 1.49 Billion in Q2.
With the stock at 10 year low's around $20/share, anyone have any thoughts/comments on a buy out potential?
Enanta posts positive phase one data on EDP-323 initiating Human Challenge Study early Q4 with FDA fast track designation.
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.
Surprised we hover around $40 with news out in May. Any insights as to why? Thought there would be a build to news at least.
Any thoughts or concerns regarding Pfizers Paxlovid guidance for 2023 at $8 billion compared to $22 for 2022 and how that might/will impact EDP-235?
Are we due for a PR today or tomorrow on EDP235?
Thoughts?
Thoughts on this post on “seeking alpha”
“Enanta: Slow Drip
May 17, 2022 6:06 PM ETEnanta Pharmaceuticals, Inc. (ENTA)1 Comment
Out of Ignorance profile picture
Out of Ignorance
6.5K Followers
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Summary
Enanta's pipeline is stuffed with mid-stage RSV therapies and other earlier-stage programs.
Enanta is one of many little biotechs which has a cash cow that can't keep up.
Enanta has a solid balance sheet and a strong albeit recently stressed share price.
Alcohol distillation process in Laos.
Varaporn_Chaisin/iStock via Getty Images
I last checked in on Enanta (NASDAQ:ENTA) in 2016's "Parsing Liver Therapy Perspectives: Gilead And Enanta". At the time I contrasted the two, with Gilead a major player and Enanta a mere small-time character actor.
This article evaluates Enanta on its own with particular attention to its 05/09/2022 fiscal Q2, 2022 earnings call (the "Call").
With the exception of its lead marketed therapy, Enanta's pipeline is a yawn
Enanta's pipeline below is devoid of late-stage molecules likely to bring it near-term cash. As shown by its pipeline slide below it has no phase 3 candidates. It has one molecule, its N-Protein Inhibitor EDP-938, which is in three phase 2 trials in treatment of RSV for differing patient groups:
Enanta Q2, 2022 Earnings Presentation
Enanta Q2, 2022 Earnings Presentation (ir.enanta.com)
During the Call, CEO Luly described its EDP-938 program at considerable length. He characterizes the study molecule as the "most advanced N-protein inhibitor in development". In the phase 2 challenge study, it was safe and well-tolerated. In terms of effect, it reduced viral load and symptoms of infection.
This 179 participant challenge study (NCT03691623) was written up in an 02/2022 article in the New England Journal of Medicine supporting its effects. It concluded, in addition to its favorable safety profile, all four dosing regimens were superior to placebo in terms of their effect as noted and in lowering mucus weight.
During the Call, Luly characterized the RSVP study as:
...a Phase 2b trial in otherwise healthy adults with community-acquired RSV infection... designed to confirm in a community-acquired setting the positive results of our Phase IIa challenge study and to further characterize efficacy by measuring symptom alleviation and viral load decline.
The good news for Enanta shareholders is that enrollment in the study is complete. The plan is to report topline data later this quarter.
Enanta's other two phase 2 studies are expected to see enrollment extending into 2023. They include:
RSVPEDs, a phase 2 study in pediatric patients with RSV (NCT04816721, estimated completion date of 12/2023) and
RSVPTx, a study in adult hematopoietic cell transplant recipients with RSV (NCT04633187, estimated completion date of 12/2022).
The cell transplant study is a larger study of 200 patients. Since enrollment is extending into 2023, its completion date will obviously extend beyond the date listed above from clinicaltrials.gov.
Enanta is going "all in", on its RSV trials. It plans to start yet another phase 2b trial in high-risk adult patients in the fourth quarter of 2022. Its strategy is to focus its RSV treatment on high-risk populations where it believes their suboptimal RSV immunity and greater RSV disease severity and mortality can best showcase EDP-938's full potential.
As an aside, Enanta has some 34 clinical trials listed on clinicaltrials.gov; the overwhelming majority of which (27) are shown as completed. That is a tremendous body of completed trials which have resulted in but two marketed therapies as discussed below.
Enanta's revenues help it with its expenses, but they are slowing
Enanta's main claim to fame is its highly successful research and development collaboration with AbbVie (ABBV) which resulted in two successful HCV therapies. First was its paritaprevir included in AbbVie's Viekira Pak (ombitasvir/paritaprevir/ritonavir tablets; dasabuvir tablets) in treatment of HCV.
Viekira Pak FDA approval generated a $75 million milestone for Enanta. Subsequently, AbbVie discontinued Viekira Pak after it was associated with rare cases of liver toxicity.
More recently Enanta discovered glecaprevir which it developed with AbbVie. Glecaprevir was co-formulated as part of AbbVie's direct-acting antiviral combination treatment for HCV, which is marketed under the tradenames MAVYRET (U.S.) and MAVIRET (ex-U.S.).
The FDA approved MAVYRET in 08/2017. Enanta earns royalties in accordance with the schedule below:
Enanta Q2, 2022 Earnings Presentation
Enanta Q2, 2022 Earnings Presentation (ir.enanta.com)
Since its 2017 approval, Glecaprevir generated royalties totaling $722 million per Enanta's fiscal year ending 09/2021 10-K. As of 03/31/2022, it generated an additional ~$46 million.
The pandemic has negatively impacted sales of MAVYRET, as have declining patient counts as more patients are cured. AbbVie's 10-K shows sequential MAVYRET revenue declines of ~37% from pre-pandemic year 2019 to year 2020. The decline moderated to a decline of ~7% from year 2020 to year 2021. AbbVie has guided to essentially flat MAVYRET revenues for 2022. Enanta's fiscal 2021 MAVYRET revenues were ~$97 million.
Enanta's liquidity is easily sufficient for its near to mid-term needs
Enanta offered no projections for future revenue during the Call. CFO Mellett did offer the following revenue observation:
..for our second fiscal quarter ended March 31, 2022...total revenue was $18.7 million and consisted entirely of royalty revenue earned on AbbVie's global HCV product sales of $380 million. This compares to total revenue of $20.1 million for the same period in 2021. This decrease is due to treated patient volumes continuing to remain suppressed compared to pre-COVID levels.
Additionally, Mellett noted:
Enanta ended the quarter with $322.5 million in cash and marketable securities. Enanta expects that its current cash, cash equivalents and marketable securities as well as its continuing royalty revenue will be sufficient to meet the anticipated cash requirements of its existing business and development programs for at least the next two years.
With so many little biotechs stretched for cash, Enanta situation appears enviable. Its cash flows are in good shape over the near term. Nonetheless as shown by its operating results below from its Q2, 2022 10-Q, it is slowly running through its liquidity:
Enanta Q2, 2022 10-Q excerpt
Enanta Q2, 2022 10-Q excerpt (seekingalpha.com)
Enanta's operations as shown above are leaking solvency; its pristine balance sheet below presents a much brighter picture:
Enanta Q2, 2022 10-Q excerpt, 1st column showing Q2, 2022, 2d column showing previous quarter
Enanta Q2, 2022 10-Q excerpt, 1st column showing Q2, 2022, 2d column showing previous quarter (seekingalpha.com)
Enanta's aggregate liabilities for its latest quarter are easily manageable and show no signs of operational stress.
As for Enanta's share price, it is likewise comforting, although it has popped and dropped over the last year as shown below:
Chart
Data by YCharts
Conclusion
Existing Enanta shareholders are likely kicking themselves for holding during its brief 11/05/2021 run to over $100 for no apparent compelling reason. Been there, done that.
As I write on 05/17/2022, Enanta shares trade at ~$50 with a market cap of ~$1 billion. By my thinking that is a fair price for a company with its finances and prospects as described. In this regard, I am mindful that Seeking Alpha's Quant Ratings and Wall Street Analysts both hold it in higher regard.”
And what were your replies to those comments?
Thoughts on the news from ASCLF today on a possible best in class competitor?
Why the purge today? Yikes.
A new drug shows promise against respiratory virus, study shows
By Brenda Goodman, CNN
Updated 1:39 PM ET, Thu February 17, 2022
A 3-year-old patient in the hospital receives medication via an inhalation mask to treat Respiratory Syncytial Virus (RSV).
A 3-year-old patient in the hospital receives medication via an inhalation mask to treat Respiratory Syncytial Virus (RSV).
(CNN)A new antiviral medication against respiratory syncytial virus, or RSV, appears to be safe and lowered viral levels and symptoms significantly more than a placebo, according to the results of a study published Wednesday in The New England Journal of Medicine.
The study is unusual in that it is based on a two-part human challenge trial, where researchers purposefully infect people with a pathogen to test a new therapy. Challenge studies speed up research because scientists don't have to wait for their study participants to get sick out in the real world. They can also enroll fewer people, knowing that participants will inevitably catch a germ. But they're also risky and only considered ethical when the need for a new treatment or therapy is thought to outweigh the potential risks to study participants.
And the dosing begins with expected read out Q2.
Why the plunge today on a $5 price target drop?
Over reaction today?
Enta terminates edp-721 on safety issues…..
The stock was in the $40’s a few months ago. I’m okay with $80’s…..
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.
“ time will tell”….. time just told. This 15 year scam is over.
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."