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Easy come, easy go as ENTA gives back most of yesterday’s gains.
Given the buildup in anticipation Jay Luly has created for the announcement of ENTA's new therapeutic areas in January, I doubt that MASLD (f/k/a NAFLD) fits the bill since it's an area ENTA has previously worked in.
Infringement lawsuit, more dates from PacerMonitor website 11/21
Judge Denise J. Casper: ELECTRONIC ORDER entered granting133 Motion to Modify Scheduling Order. Fact discovery to be completed by 12/22/23. Expert disclosures by the party with the burden of proof by 2/9/24. Rebuttal expert disclosures by 3/29/24. Expert discovery to be completed by 4/30/24. Summary Judgment and Daubert Motions to be filed by 5/28/24. Opposition to Summary Judgment and Daubert Motions to be filed by 6/18/24. Reply briefs by leave of court. Hearing on Motions for Summary Judgment and Daubert Motions set for 7/31/24 at 2:00PM. If no summary judgment motions are filed, hearing will be converted to an initial pretrial conference. The parties shall confer regarding the topics identified under Local Rule 16.5(d) and shall prepare and submit a joint pretrial memorandum in accordance with Local Rule 16.5(d) no later than five (5) business days prior to the pretrial conference. The pretrial memorandum shall also propose deadlines for the filing of motions in limine, proposed jury instructions, proposed voir dire and a proposed trial date. In light of this new schedule, the status conference set for 12/4/23 is canceled. (Hourihan, Lisa)
MASLD, just my guess. On Oct 27 I cryptically posted "Embracing MASLD" upon stumbling onto a tie to the change in naming convention and an Enanta employee. There are also year 2022 and year 2023 enanta patent applications US and world wide for molecules relating to inhibitors of metabolic diseases. I am not certain the GLP-1 specifically is the target.
Obviously Luly and ENTA know more about running a company than I do. I suggested the possibility of ENTA funding EDP-235 phase 3 Covid trials if a partner wasn't found as a signal of their faith in EDP-235. Instead, Luly and ENTA reduced research expenses to prolong the cash runway until 2027, which propelled the stock price higher today. Being wrong never felt so good. :). Kudos to dewophile for stain he was pleased that cash burn has been reduced.
I was pleased to hear that ENTA referenced their patent infringement lawsuit against PFE. Winning that lawsuit would be major price driver for ENTA.
Oral GLP-1 is a crowded arena (#msg-173206117), but it can't be completely ruled out.
Correction—The references to "calendar 3Q23" for the data readout of ENTA's RSV trials should be "calendar 3Q24." (h/t vinmantoo)
Thanks for catching that typo!
• EDP-938 (RSV N-protein inhibitor): ENTA expects to report data from the phase-2b RSVPEDs (pediatric) and the phase-2b RSVHR (high-risk adults) trials in calendar 3Q23, assuming there is a normal RSV season in the Northern Hemisphere.
• EDP-323 (RSV L-protein inhibitor): ENTA just started a phase-2a “challenge” study; data expected in calendar 3Q23.
Any chance it would be GPL 1?
“The company will announce new therapeutic programs beginning in early 2024.”
ENTA reports FY4Q23* results and pipeline update:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-37
FY4Q23 royalty revenue was $18.9M, unchanged from the prior quarter. 54.5% of ENTA’s Mavyret royalties are payable to OMERS†, and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
9/30/23 cash = $370M, a decrease of $23M relative to 6/30/23.
Today, ENTA issued FY2024* guidance as follows:
• R&D expense of $100-120M, down sharply from $163.5M in FY2023.
• SG&A expense of $45-50M, down modestly from $52M in FY2023.
Based on the reduced operating expenses described above, ENTA says its cash and expected royalty revenue are sufficient to fund operations for the next four years—i.e. through the end of FY2027.
Pipeline
• EDP-938 (RSV N-protein inhibitor): ENTA expects to report data from the phase-2b RSVPEDs (pediatric) and the phase-2b RSVHR (high-risk adults) trials in calendar 3Q23, assuming there is a normal RSV season in the Northern Hemisphere.
• EDP-323 (RSV L-protein inhibitor): ENTA just started a phase-2a “challenge” study; data expected in calendar 3Q23.
• The preclinical program for single-agent dual inhibition of RSV and hMPV has been terminated.
• EDP-235 (COVID protease inhibitor): If a partnership is secured for a phase-3 trial, the population tested will be standard-risk patients with a primary endpoint based on symptom relief.
• Non-virology: “The company will announce new therapeutic programs beginning in early 2024.” An analyst on today’s CC asked if one of these programs was GLP-1, but ENTA declined to answer.
*ENTA’s fiscal years end on September 30
†Ontario Municipal Employees Retirements System (Canada’s largest pension fund)
>> clarity on Covid regulatory pathway
Well, we get some clarify on this... high risk is no go as hospitalization rate is low, standard risk will be the way to go.
Only one question for 285. (and it's the last question) so I guess it means the covid curse will be ending soon.
And market can shift focus on its cash, RSV candidates and royalty steam.
Will be interesting to see what's the new area they are targeting.
That would tell everyone nobody actually wants its covid drug but themselves.
I don’t think the timing is right to monetize the remainder of the royalty. They don’t have enough in NOLs to offset the tax
I don’t think they should fund Covid unless there is some new data showing why they would change course
>> would it be a good move for them to fund the Covid phase 3 trials themself?
Hope not. Not after they committed couple times to only proceed with a partner.
That would tell everyone nobody actually wants its covid drug but themselves.
Monday. The best news we can hope for:
- partnership on either Covid or RSV
- seeking strategy alternatives including sale of the company
- clarity on Covid regulatory pathway
- sold the remaining royalties for around 200mm
- share buyback
Monday. The best news we can hope for:
- partnership on either Covid or RSV
- seeking strategy alternatives including sale of the company
- clarity on Covid regulatory pathway
- sold the remaining royalties for around 200mm
- share buyback
By the way, New 13G filed on this name.
The market jumped so much this morning that even ENTA is up. Will wonders never cease!
Good time to get in...added this morning for $9.10
Irrational, except that the next big lead is "non-virology."
There are investors buying obviously
Just not as many as the irrational sellers
There is lot of value here.
Thanks DC. Agreed. Although DD and others continue to hype- let the truth be seen.
Irrational, except that the next big lead is "non-virology." Without providing any additional information and given the lag in new information on current programs there is nothing irrational about investors not purchasing - so the price goes down.
Dripping down to 60 percent of net cash level
Irrational just irrational
Estimates based on that price (made by dewophile) means about $8 billion in Paxlovid sales in 2024. That should be a positive for ENTA and its negotiations into getting a partner for EDP-235.
https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173052487
Pfizer to more than double price of its COVID antiviral once drug moves to commercial market
https://www.financialjuice.com/News/7707571/-Pfizer-to-more-than-double-price-of-its-COVID-antiviral-once-drug-moves-to-commercial-market.aspx
Pfizer Inc. will charge $1,390 for a five-day course of its Paxlovid COVID-19 antiviral when the drug moves to the commercial market later this year. That’s more than double the amount the company charged the U.S. government during the pandemic.
The government paid about $529 per course when it was making Paxlovid available to patients free of cost. The news of the price increase was first reported by the Wall Street Journal.
What would impress me. European, Canadian, Central and South American governments telling their citizens that if they test positive for RSV, then they must receive treatment with EDP-938 because the burden on the health care system due to RSV is too great. That would impress me, and there is a precedent for it. Touche, Touche, Touche!
DeVincenzo and Wilkinson published together with respect to the viral challenge model so not a huge surprise that he is a panelist. Fergie has served as an advisor/consultant with Enanta for some time so not really additive in terms of broadly recognized support. Maybe, maybe new data will be released, but really, a last minute announcement for this event, come on man!
That's what Jay said! That's what she said too!
Dew, I recall a robust pipeline at Enanta BEFORE Covid. What happened to those programs? Seems like there were 3 or 4…
I've never paid attention to job openings for pharma so no informed opinion here
On the one hand lack of hiring (and indeed cutting costs per some posts) suggests no imminent cash coming in via partnership, but it could suggest interest via a buyout
enta is not exactly cash starved so at a minimum it suggests management realizes that the value if the clinical programs don't pan out is in the cash and remaining royalty, which even accounting for 2-3 quarters of burn is well above present prices
It seems like ENTA is due for some insider buying activity, but since there has been a lull in this activity it makes me think that there is real partnership activity.
"for partnership" Jake, you should have put "for partnership" in quotes.
What DD and other fail to recognize is repeated years of failures in the clinic with HBV and NASH programs. Investors have apparently lost all trust. The attempt to market these dead programs as for partnership is a complete joke!
PFE should just buy ENTA out, remove the patent risk, gain potential better drug for covid and potentially expand their RSV lead
Mouton,
I know it was from a retrospective study not from a trial. It is the best metric we have right now. The death rate was 2.4%-3.4% in the two untreated groups.
As Dew pointed out, EDP-235 would have to show non-inferiority. PFE clearly thinks newer and better drugs than Paxlovid are needed.
…my gut tells me that the trial would have to be very large to show a stat sig difference for 235 v. Paxlovid.
You're citing results from a retrospective observational study based on data that's a year or more old. Not exactly out of date, but we are two boosters beyond that and lots more infections as well. And different strains. So who knows that the current death rate is.
In any event, if you believe the Jama study, what trial is Enanta going to run? 235 v. Paxlovid in high risk 65 and over? In that population, per the article:
Among patients aged 65 years or older, the cumulative incidence of death at 90 days was 0.25% (95% CI, 0.17%-0.37%) for the treated and 2.42% (95% CI, 1.15%-2.67%) for the untreated (eFigure 3A and eTable 4 in Supplement 1).
I think RBCs point is with vaccine, less harmful covid variant and natural immunity, hospitalization rate is lower than before, thus it’s harder than before to show stats significance on the same endpoint. (Reduce hospitalization rate)
So for 235, the regulatory pathway isn’t clear for them. That’s probably one of the reason 235 get discounted by the market even it seems to be superior drug
Hope ENTA can work out the details with FDA and update the market soon
Is it normal for a pharm to have zero opening position? I got that they are in waiting mode for their programs but many companies would still list opening positions just to build up resume database for future positions
I think RBCs point is with vaccine, less harmful covid variant and natural immunity, hospitalization rate is lower than before, thus it’s harder than before to show stats significance on the same endpoint. (Reduce hospitalization rate)
So for 235, the regulatory pathway isn’t clear for them.
That’s probably one of the reason 235 get discounted by the market even it seems to be superior drug
Hope ENTA can work out the details with FDA and update the market soon
From RBC: "the U.S. regulatory path currently emphasizes demonstration of outcomes benefits (hospitalization, mortality, etc.) and this would be difficult to show in the current environment, barring a major mutation."
PFE expects Paxlovid 2023 sales to be around 8b, So I would think 325 is viable and worth more than zero. But the concern seems to be its regulatory pathway?
From RBC: "the U.S. regulatory path currently emphasizes demonstration of outcomes benefits (hospitalization, mortality, etc.) and this would be difficult to show in the current environment, barring a major mutation."
ENTA soared on expectations for the COVID program, but lately investors have (unduly, IMO) downgraded everything related to COVID as though the virus will just disappear.
Meanwhile, ENTA’s RSV program has taken longer than originally anticipated to develop, due to a low incidence of RSV infections during the pandemic, which has slowed patient enrollment in ENTA’s RSV trials.
See #msg-172945060 for related info on valuation.
Trying to understand this stock that I had a position in in 2020. At the time, it had a very promising pipeline.
This was $74 in Nov 21, and now it sits below $10. Can someone please express their opinion on what went wrong? It can’t be just a depression in biotech.
Thanks
Not to my knowledge.
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