Enanta Pharmaceuticals Inc (ENTA)

[vinmantoo]

Looks like c-KIT inhibitors are the way to go for CSU.

Report from Jefferies discusses CSU data from AAAAI24, $CLDX's cKIT looks superior to BTK inhibitors (but both classes look active). Will it be enough to justify monthly injections? I personally think it would. pic.twitter.com/RH48q3Nq4y

— Ohad Hammer (@ohadhammer) February 27, 2024

[DewDiligence]

ENTA’s GC exercised and held $73K of stock:

https://www.sec.gov/Archives/edgar/data/1177648/000106299324004659/xslF345X05/form4.xml

The options in question did not expire until 2033, so this is a bullish signal.

[DC15]

A unique organizational chart? The position search for "Head, Biometrics" includes the primary responsibility of, "Be responsible for final review and sign off with respect to all controlled documents."

I can understand having a biostatistician in the executive crowd, but I do not see marriage of the head of biostatistics and QA authority of all controlled documents being the same individual.

[DewDiligence]

ENTA has_a_brand_new 5% shareholder—Krensavage Asset Management:

https://www.sec.gov/Archives/edgar/data/1177648/000160925124000004/xslSCHEDULE_13G_X01/primary_doc.xml

https://krensavage.com/

Note that this 13G filing is as of 2/22/24 (not 12/31/23).

[vinmantoo]

Looks like Molnupiravir isn't such a good choice for treating Covid. Slow clearance and induction of mutations doesn't seem like something you would want in an anti-Covid drug. It sure seems to me that EDP-235 is a good option to treat Covid. Now if ENTA can just convince another company to think so and partner we will be in business.

The researchers found that molunpiravir initially lowered patients’ viral load more quickly than usual care, with 14% of molnupiravir patients having cleared the virus by day five, compared to only 2% of the usual care group.

However, post-treatment the rate of viral decline in molnupiravir-treated participants significantly slowed. Nine days after treatments, only 48% of molnupiravir-treated patients had cleared the virus, compared to 56% of the patients receiving usual care.

Furthermore, virus from these later samples contained more mutations than those seen in the usual care group. The researchers were able to grow some of these mutated viruses in the lab from samples taken up to nine days post-treatment, which suggests they could potentially be passed from patients who have taken molnupiravir to others.

https://www.ucl.ac.uk/news/2024/feb/covid-19-antiviral-treatment-should-be-taken-longer

Many thanks to Preciouslife1 for the heads up to that link.

https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173930925

[DewDiligence]

ENTA’s pro forma net cash @12/31/23=$176.3M—treating ENTA’s deferred-royalty obligations as debt (as is done under GAAP [#msg-172603887]—but see note at bottom of this post). The $176.3M figure, which is down $24.3M relative to 9/30/23, consists of:

• $327.9M net current assets on the 12/31/22 balance sheet (https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001177648/000095017024012796/enta-20231231.htm#consolidated_balance_sheets );

• ($151.6M) deferred long-term liabilities on the 12/31/23 balance sheet relating to the OMERS royalty agreement. ($36.5M of liabilities relating to the OMERS agreement are booked as current liabilities and hence are included in the $327.9M figure in the first bulleted item.)

Note: Excluding the “debt” associated with the OMERS royalty agreement, ENTA’s pro forma net cash at 12/31/23 was $364.1M ($176.3M + $151.6M + $36.5M).

[DewDiligence]

ENTA’s fully-diluted share count @12/31/23=27.1M—an increase of 1.1M since 9/30/23, due primarily to the issuance of new options following the end of the fiscal year on 9/30/23.

The 27.1M figure above consists of: 21.16 basic shares on the 12/31/23 balance sheet (https://www.sec.gov/ixviewer/ix.html?doc=/Archives/edgar/data/0001177648/000095017024012796/enta-20231231.htm#consolidated_balance_sheets ); and 5.93M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, page 9).

[vinmantoo]

Shares, not persons. Thank you for the correction, but wouldn't it be great if 100,000 individual people suddenly took interest?

The number of people interested in buying shares isn't important. The number of shares being bought over shares being sold. Obviously, trial data and the lawsuit against PFE are the most important.

[DC15]

Shares, not persons. Thank you for the correction, but wouldn't it be great if 100,000 individual people suddenly took interest?

[vinmantoo]

All 100,000 persons.

What??

[DC15]

All 100,000 persons.

[vinmantoo]

ENTA has now gone over $13/share today, a price it hasn't seen in 5 months. The push into immunology along with the statement that ENTA has enough cash to last through the end of 2027 must have made ENTA look like a better risk to people.

[floblu14]

Oppenheimer Keeps Their Hold Rating on Enanta Pharmaceuticals (ENTA)

Feb. 9, 2024, 06:58 AM
Oppenheimer analyst Jay Olson maintained a Hold rating on Enanta Pharmaceuticals (ENTA – Research Report) today and set a price target of $17.00. The company’s shares closed yesterday at $12.36.

Olson covers the Healthcare sector, focusing on stocks such as Biogen, Neurocrine, and Viking Therapeutics. According to TipRanks, Olson has an average return of 13.1% and a 43.99% success rate on recommended stocks.

Currently, the analyst consensus on Enanta Pharmaceuticals is a Moderate Buy with an average price target of $19.67, which is a 59.14% upside from current levels. In a report released on February 7, Leerink Partners also maintained a Hold rating on the stock with a $13.00 price target.

https://markets.businessinsider.com/news/stocks/oppenheimer-keeps-their-hold-rating-on-enanta-pharmaceuticals-enta-1033051923

Baird lowered the firm’s price target on Enanta to $26 from $40 and keeps an Outperform rating on the shares. The firm said results largely met expectations, and we are encouraged that management continues to expect to readout data from the RSVPEDs study of zelicapavir in 3Q24, which Baird continues to view as a key catalyst with potential to drive upside potential on the stock.

https://www.tipranks.com/news/the-fly/enanta-price-target-lowered-to-26-from-40-at-baird?utm_source=markets.businessinsider.com&utm_medium=referral

[vinmantoo]

Why in the world would you think a challenge study would merit breakthrough designation?

[DC15]

Too bad that the challenge study results did not yield and opportunity for breakthrough therapy designation. If so then the peds and HR studies could have been powered for approval.

[vinmantoo]

While the peds RSV population may be considered more naive than the COVID phase 2 population it is striking that the answers from Enanta indicate that in the RSV peds study virology readouts are key vs symptoms.

It make be striking to you, but it makes perfect sense when dealing with a naive population for RSV vs a population which most people had previous infections like for Covid.

[DewDiligence]

With regard to communication and audience interpretation I felt that the answers provide more doubt that there will be an RSV phase III trial…

I did not get any vibes that anything has changed. The RSV programs will progress to phase-3, in the pediatric and/or adult populations, if the phase-2 data warrant advancing the programs. One analyst asked whether weak phase-2 data from the adult trial would preclude advancing the pediatric program, and the answer was no — each program stands on its own merits.

[DewDiligence]

ENTA updated corporate slides (2/7/24):

https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4

The only differences between the latest (2/7/24) slides and the previous version (1/8/24) are:

• Slide 7 includes FY1Q24 royalty revenue.

• Slides 24-26 (new) contain additional info about the CSU program.

[DC15]

People can read for themselves, I know, but as a matter of discussion topics between investors I would like to highlight the following from the QA:

While the peds RSV population may be considered more naive than the COVID phase 2 population it is striking that the answers from Enanta indicate that in the RSV peds study virology readouts are key vs symptoms. In the COVID phase 2 symptom measures were the big deal. I also recognize that perhaps scoring symptoms in a pediatric subject is more complex than in an adult subject, but still there was a reversal of logic.

With regard to communication and audience interpretation I felt that the answers provide more doubt that there will be an RSV phase III trial, the answers did not exude confidence although the introductory statements were quite powerful, but they were also powerful for NASH and COVID.

[DewDiligence]

ENTA FY1Q24 CC transcripts:

https://finance.yahoo.com/news/enanta-pharmaceuticals-inc-nasdaq-enta-140756964.html

https://finance.yahoo.com/news/q1-2024-enanta-pharmaceuticals-inc-120855671.html

[vinmantoo]

Enanta Pharmaceuticals (ENTA) PT Lowered to $26 at Baird - Feb. 8, 2024

$26 would sound pretty good to me.

[floblu14]

Still good?

Enanta Pharmaceuticals (ENTA) PT Lowered to $26 at Baird - Feb. 8, 2024
{Premium - no article}

https://www.streetinsider.com/Analyst+PT+Change/Enanta+Pharmaceuticals+%28ENTA%29+PT+Lowered+to+%2426+at+Baird/22738803.html

[DewDiligence]

ENTA reports FY1Q24* results:

https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-38

• 12/31/23 cash = $337M, a decrease of $33M relative to 9/30/23..

• FY1Q24 royalty revenue was $18.0M, -5% QoQ and –20% YoY. 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).

• FY1Q24 R&D expenses were $36.4M, somewhat above the quarterly run rate of ENTA’s FY2024* guidance of $100-120M.

• FY1Q24 SG&A expenses were $16.5M, somewhat above the quarterly run rate of ENTA’s FY2024* guidance of $45-50M.

• Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.

• ENTA reiterated that its cash and expected royalty revenue are sufficient to fund operations through the end of FY2027.

*ENTA’s fiscal years end on September 30.

[DC15]

I am uncertain, but I think it relates to information that will be considered for the purpose of establishing a monetary value for damages. It does not mean that there will be an award and it does not indicate that the case is near decision, probably still far from a decision. A little more insight into this topic can be gleaned from the information at https://www.finnegan.com/en/insights/articles/d-mass-patent-litigation-update-july-2023.html

It is only a single page, but especially the paragraph which starts with, "Last, the court found..." gives a glimpse of the type of considerations.

I made my post in hopes that a more informed person would extend additional thoughts, or even provide a correction to my implied input.

[DaveAu]

Maybe you could explain what that is for those of us unfamiliar with legal jargon. Thanks.

[DC15]

The part where Pfizer is required to admit that they know how much food the cat has eaten without acknowledging that there is a cat in the bag, below information taken from (https://www.pacermonitor.com/public/case/44980990/Enanta_Pharmaceuticals,_Inc_v_Pfizer_Inc)

Friday, February 02, 2024
163 motion Seal Fri 02/02 4:42 PM
MOTION to Seal Memorandum in Support of Motion to Compel Pfizer to Provide Damages-Related Discovery and Accompanying Exhibits (Unopposed) by Enanta Pharmaceuticals, Inc..(Fiacco, Barbara)

[JK2016]

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.

[DC15]

My comment is both speculative, "I think" and subjective "prolonged period of time."
I do not know that the previous EHS Manager left, nor do I know that Enanta ever had an EHS Manager. I do know what it is like to decommission a lab and to move laboratory operations to a new facility. I recognize that it could be possible to have all new equipment established at the new location prior to ending operations at the present location so that the move does not result in loss of operations, but the information within the job description indicates that readying safety procedures for work at the new facility and gaining IBC approval for the new site as well as getting all of the necessary (local) approvals necessary for the research that Enanta performs is not complete at this time.
As a matter of weighing the potential for extensive interruption of bench R&D activities I offer that this is a consideration to be recognized by the investment community. I also speculate that this move is a positive indication that the company does not intend to dissolve in the near future which is very polar to the vocalization of some that the best move for the company would be to pull the plug later this year.

[DewDiligence]

…this is going to reduce bench R&D activities for a prolonged period of time, sticky tape.

I do not understand what you mean.

[DC15]

ENTA New Lab 2024 (The Move)

I had hoped Enanta's lab move was completed during 2023, but the current job posting for an Environment Health and Safety Manager says the move will occur during 2024. I think this is going to reduce bench R&D activities for a prolonged period of time, sticky tape.

[DewDiligence]

PFE would probably argue for "apportionment" if the case reached the stage of awarding damages, but it seems like a weak counter since ritonavir is not an active agent against COVID and it is only in the mix because of the pharmacokinetic deficiencies of nirmatrelvir.

[DC15]

Patent award apportionment (Ritonavir)

Should the inclusion of Ritonavir be expected to significantly reduce any potential infringement award due to apportionment?

Any thoughts?

[Lishur]

Reversing nicely... Can't wait to see it over $15 in the coming weeks (hopefully)

[Lishur]

SEC reported Today (11JAN2024) that MILLENNIUM MANAGEMENT LLC INCREASED $ENTA shares.

Before: 1,024,676 Shares.
Now: 1,314,949 Shares.
Newly Added: 290,273 Shares.
Increase: 28.33%
Approx Trxn Value :$3.19 M

Own %: 6.20%

#ThinkSabio #StockMarket #SEC #SEC-Update $ENTA: $11.31
Sector: Healthcare

SEC reported Today (11JAN2024) that MILLENNIUM MANAGEMENT LLC INCREASED $ENTA shares.

Before: 1,024,676 Shares.
Now: 1,314,949 Shares.
Newly Added: 290,273 Shares.
Increase: 28.33%
Approx Trxn Value… pic.twitter.com/ETn0mTTiBC

— ThinkSabio.com (@think_sabio) January 11, 2024

[DewDiligence]

ENTA updated corporate slides (1/8/24):

https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4

Differences between the 1/8/24 slides and the previous version (9/12/23) are relatively minor. (In the bullet points below, I’ve omitted mention of slides that were merely re-sequenced with no changes to the content.)

• The pipeline chart on slide 5 includes the newly disclosed preclinical program in chronic spontaneous urticaria (CSU), an autoimmune disease.

• EDP-938, ENTA’s lead RSV compound, is now called Zelicapavir (slides 10-16).

• Old slides 18-20 on the hMPV program are gone; ENTA previously announced the termination of this program for business reasons.

• Slides 21-25 on the EDP-235 program supersede old slides 22-31; the new slides summarize the phase-2 data textually but omit the K-M curves that were previously displayed.

• Slides 27-28 on the HBV program supersede old slides 33-35, condensing this material.

• Slides 30-33 have info on the new CSU program.

• Slide 34 shows 2024 catalysts.

[Lishur]

https://jpmorgan.metameetings.net/events/healthcare24/sessions/49429-enanta-pharmaceuticals-inc/webcast?gpu_only=true&kiosk=true

Link for live webcast

[Lishur]

You mentioned TGTX options...its up over 20 per cent since you did.. If you bought call options..good for you

[Lishur]

Could the Mgt surprise us with partnership news ? Enanta plans to pursue any future COVID-19 efforts in the context of a collaboration, including the development of EDP-235, an oral, once-daily, Phase-3-ready, 3CL protease inhibitor which has been granted Fast Track designation by the FDA.

[Lishur]

Meanwhile.. I just added some FEB 12.50 calls on Friday for 1 dollar each

[DC15]

This is not the first time that Enanta has explored molecules for therapeutic use in immunology:
Cystic Fibrosis - macrolide 2005
Inflammatory bowel disease - macrolide 2008
Name your disease - cyclosporine adnauseam

Hopefully they have learned a lot and the new venture yields more economic rewards that the past ventures.

I thought I would be a long time holder, but getting out sooner is looking better to me all of the time.

[alertmeipp]

Yesterday it takes 752,300 shares to move the price up.. today's early drop was based on mere 30k shares. Somehow is recycling the shares like no tomorrow. Cash + Royalty worth 20 bucks, We get paid 9 dollars for the assets.

[Lishur]

laughing all the way to the bank..scenario..experiencing lol pretty good music to support the statement

[Lishur]

I hope it goes to 20 in the next 2 weeks...then some of my 15 cents call options will become 10 dollars...lol...they're already over 2

[vinmantoo]

ENTA’s new non-virology program is in immunology:

Thanks Dew. Looks like the tax loss selling of ENTA might be finally over as the price has risen over $11, something we haven't seen since September. Higher than normal today based on the announcement the new oral KIT inhibitor drug. I don't if I end up missing my chance to garner some losses for tax purposes. So it looks like betting on a company with great chemists and leadership along with being stubborn just might end up paying off.

Now we just need to read that PFE decided to settle in the patent lawsuit over Paxlovid and grants ENTA a milestone payments and a percentage of future earnings. If that happens, then Ralph Kramden will be describing ENTA's trajectory.

[DewDiligence]

Highly unlikely, IMO.

[DC15]

Is it likely that an agent from this program could be used to counter the itch associated with their MASLD candidates?

[alertmeipp]

Just the net cash + 45% royalty alone translates to $20 per share for ENTA.

Its COVID drug is not dead as PFE's still make billions in sale.

[Lishur]

Good to see ENTA over 11...didn't happen since October 1.... Now...as they say..SKY IS THE LIMIT....we will be having a breakout... and hopefully over 15 in couple of weeks

[Lishur]

Interesting and I hope its good to the ear of the market....

[DewDiligence]

ENTA’s new non-virology program is in immunology:

https://finance.yahoo.com/news/enanta-pharmaceuticals-updates-research-development-120000343.html

Today, Enanta announced its expansion into immunology with its first program in chronic spontaneous urticaria (CSU), a severely debilitating, chronic inflammatory skin disease. CSU is estimated to affect 0.5% to 1% of the global population, and there is a substantial unmet need for an efficacious oral agent. Currently, approximately half of patients are not controlled with antihistamines, and a minority of those patients are treated with one indicated biologic.

Enanta’s approach is to treat CSU by depleting mast cells through KIT inhibition, addressing a primary driver of the disease. The company has developed novel, potent and selective oral inhibitors of KIT, which are now being optimized in preclinical development. Enanta’s prototype inhibitors potently inhibit activity in both binding and cellular function assays and are highly selective for KIT versus other kinases. These inhibitors also demonstrate strong in vitro and in vivo ADME* properties.

More details on ENTA's JPM webcast next week.

*Absorption, distribution, metabolism and excretion.