Enanta Pharmaceuticals Inc (ENTA) News

ENTA’s pro forma net cash @9/30/24=$276.8M—excluding balance-sheet “debt” relating to ENTA’s deferred-royalty obligations, which is a GAAP artifact rather than an actual debt instrument.*

The $276.8M figure, which declined $26.3M since 6/30/24, consists of the net current assets on the 9/30/24 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017024131260/enta-20240930.htm page F-4), after excluding the $34.5M line under Current Liabilities called, “Liability related to the sale of future royalties.” * (There were no non-current marketable securities on the 9/30/24 balance sheet).

*The GAAP treatment for ENTA’s deferred-royalty obligations is described in #msg-172603887.

ENTA’s fully-diluted share count @9/30/24=26.99M—a decrease of 0.05M shares since 6/30/24.

The 26.99M figure consists of: 21.19 basic shares on the 9/30/24 balance sheet (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001177648/000095017024131260/enta-20240930.htm page F-4); and 5.80M options and unvested restricted-stock shares and equivalents (whether or not exercisable) (ibid, F-13).

From Baby FLO to ENANTA's venture capitalists -

Happy Thanksgiving to all!

Thx dd happy thanksgiving

ENTA’s executive officers_received_their_end-of-FY2024 options today priced at $8.83, so now the share price can go up :- )

• Luly (CEO) 250K options:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324019764/xslF345X05/form4.xml

• Or Yat Sun (CSO) 87K options:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324019768/xslF345X05/form4.xml

• Rottinghaus (CMO) 87K options:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324019770/xslF345X05/form4.xml

• Mellett (CFO) 81K options:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324019764/xslF345X05/form4.xml

• Kieffer (Chief Product Strategy Officer) 81K options:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324019772/xslF345X05/form4.xml

• Brendan (Chief Business Officer) 75K options:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324019774/xslF345X05/form4.xml

• Kowalsky (General Counsel) 75K options:
https://www.sec.gov/Archives/edgar/data/1177648/000106299324019776/xslF345X05/form4.xml

All of these options vest pro rata over a 4-year period and expire in 10 years.

ENTA is like a high school Bill Gates hitting on a girl Rarely closes well
But give it enough time will be worth billions

Dont ever jinx it again
Sigh
:)

Yes the company worded guidance as “into fiscal 2027” so technically not an adjustment because that could mean anywhere from calendar year October 2026 through sept 2027 and previous guidance was quarterly through Q3 2027
As to 2025 guidance they said the prior Q 3 fy27 guidance accounted for both a RSV phase 3 amd phase 1 kit inhibitor so they must have had some sense of cost of a phase 3 but yes until they talk to fda can’t narrow it down beyond a rough estimate

The default is “what are they hiding.”With respect to the lack of FY2025 expense guidance in Monday’s PR, I would submit that ENTA didn’t give guidance because they don’t yet know how much they will be spending. Specifically, they have not yet received (and possibly not yet sought) feedback from the FDA on the phase-3 trial design for Zelicapavir.

Yesterday likely had algorithmic bots that sold because the quarterly financials were a "miss," LOL.

❤️ Love the price action today!

A lot of the indications overlap with the kit program. I wonder if there could be additive or synergistic activity with a combination approach. Enta is playing from behind in both areas but is the only company as far as I know with both programs in house. Amd they are not that far behind. So even if no one ahead of them stumbles perhaps they can differentiate w a combo??

and I will repeat myself - We are currently getting paid to own RSV, potential settlement, immunlogy program and now - getting paid for the 45% of the royalty as well!

Of course, cash is going lower, but the bar is low, as long as the ROI on their cash expense is not big time -ve, better days SHOULD be ahead of us.

Re: STAT6 (“oral Dupixent”)

From ChatGPT...

Dupixent Mechanism of Action: Dupixent is a monoclonal antibody that inhibits the signaling of interleukin-4 (IL-4) and interleukin-13 (IL-13), key drivers of type 2 inflammation involved in various allergic and atopic diseases. Administered via subcutaneous injection, with dosing frequency varying based on the specific condition being treated.

Dupixent Development Milestones

March 2017: FDA approval for adults with moderate-to-severe atopic dermatitis.
October 2018: FDA approval as an add-on maintenance treatment for moderate-to-severe asthma in patients aged 12 and older.
June 2019: FDA approval for chronic rhinosinusitis with nasal polyps in adults.
May 2022: FDA approval for eosinophilic esophagitis in individuals aged 12 and older.
September 2022: FDA approval for prurigo nodularis in adults.
September 2024: FDA approval as the first biologic for chronic obstructive pulmonary disease (COPD) in adults with inadequately controlled disease.

Indications:

Atopic dermatitis (eczema)
Asthma
Chronic rhinosinusitis with nasal polyps
Eosinophilic esophagitis
Prurigo nodularis
Chronic obstructive pulmonary disease (COPD)

Dupixent FDA Approval Dates

Atopic Dermatitis: March 2017
Asthma: October 2018
Chronic Rhinosinusitis with Nasal Polyps: June 2019
Eosinophilic Esophagitis: May 2022
Prurigo Nodularis: September 2022
COPD: September 2024

Dupixent Annual Revenues Since Approval

2017: $0.36 billion
2018: $0.92 billion
2019: $2.32 billion
2020: $4.04 billion
2021: $5.25 billion
2022: $8.68 billion
2023: $11.59 billion
2024: $13.0 billion (projected)

[the royalty] are not significant enough to fund all the research to bring any product to market. So finding a partner or buyer is the only hope.

we agree

I would not count on either given my experience as an investor in biotechs.

Given most biotechs fail that is playing the odds. For ENTA specifically:

1. they are in the lead in RSV, which has no antiviral therapies, so good data should make the program very partnerable
2. they have partnered successfully in the past and have a proven track record of inventing drugs that made it to market
3. immunology deals have actually gotten significant partnering deals at very early stages give the massive market opportunity, as evidenced by recludix (private) getting over 100M up front/near term while they were at the discovery stage for their stat6 inhibitor. Interestingly SNY is partnered with KYMR for another program, but probably couldn't get KYMR to agree to partner their stat6 program and still paid major dollars for a competing program that is a year behind.

competitive landscape oral stat6 inhibition:

The leader is KYMR. They have an oral stat6 inhibitor that just entered a phase 1 healthy volunteer study last month:

https://investors.kymeratx.com/static-files/126c7138-25e0-4d8f-b8f4-b2b684dd82ee

"AI insights" of ENTA financials from MSN.

Thank you DewDiligence !

Enanta Pharmaceuticals: Promising RSV Developments and Strong Immunology Pipeline Justify Buy Rating

Roy Buchanan, an analyst from JMP Securities, reiterated the Buy rating on Enanta Pharmaceuticals (ENTA – Research Report). The associated price target was lowered to $21.00.

Roy Buchanan has given his Buy rating due to a combination of factors including Enanta Pharmaceuticals’ ongoing progress in its immunology programs and promising developments in their RSV treatment pipeline. The company is on track to release top-line results next month from a Phase 2 trial of their RSV N-protein inhibitor, zelicapavir, which targets high-risk adult and pediatric populations. The successful completion of this trial could position Enanta as a significant player in the RSV treatment market.

Additionally, Enanta’s strategic advancements in immunology, particularly with their oral KIT inhibitor candidate EPS-1421 and their STAT6-targeted program, illustrate the company’s robust research and development efforts. With a solid cash runway extending into fiscal year 2027 and a commitment to further clinical progress, Buchanan anticipates that Enanta will achieve its development goals, justifying the Buy rating despite the slight reduction in the price target to $21.

https://markets.businessinsider.com/news/stocks/enanta-pharmaceuticals-promising-rsv-developments-and-strong-immunology-pipeline-justify-buy-rating-1034064278

__________________________________________________________

On Tuesday, Baird made an adjustment to the stock price target of Enanta Pharmaceuticals (NASDAQ:ENTA), reducing it to $20 from the previous $26 while maintaining an Outperform rating on the stock. The adjustment follows a recent earnings report and in anticipation of upcoming clinical trial results.

The analyst at Baird noted that the fourth fiscal quarter results for Enanta were as expected, without any significant changes to the earnings outlook. The focus is now on the upcoming readout from the RSVPEDs trial in December, which is expected to be a critical factor in determining the future potential of Enanta's respiratory syncytial virus (RSV) drug candidate, zelicapavir.

The report suggests that the current weakness in Enanta's stock price has created a favorable risk-reward scenario for investors. The Baird analyst believes that the stock's current performance does not fully reflect the potential upside.

Looking ahead, Baird indicated that the initiation of IND-enabling studies for Enanta's lead KIT inhibitor, EPS-1421, is set for 2025. The firm anticipates that progress in inflammation and immunology (I&I) could draw more attention to Enanta's broader development pipeline.

The price target adjustment to $20 is based on an update to Baird's financial model for Enanta. Despite the reduction, the Outperform rating suggests that Baird continues to see long-term value in the stock beyond the immediate challenges and upcoming clinical

https://www.investing.com/news/analyst-ratings/enanta-pharmaceuticals-shares-target-cut-rating-held-ahead-of-clinical-trial-results-93CH-3742324

the partner will share development costs or take it on entirely, enta will retain a stake in the asset, and suddenly you are at 18 cash plus royalty, plus value of the RSV asset

For the record, the shareholder equity is down from ~$10/sh to ~$6/sh over the last 12 months. I know that most here do not agree with the accounting rules that require the sale of the future of royalty be considered debt. But if one adds the remaining future royalty as an asset, it seems to me that you have to subtract the future operating loss as a liability, which is a much larger number. Net/net, it is my view that the cash and royalty have value only in a sale or liquidation situation. Otherwise, they are not significant enough to fund all the research to bring any product to market. So finding a partner or buyer is the only hope. I would not count on either given my experience as an investor in biotechs. JMO.

Yeah seems so logical and rational ; I am betting/investing pretty heavily on this thinking the same, but unfortunately, so far the market is being irrational or we were just wrong.

For me, downside is very limited other than short term panic and misunderstanding (like today) OR company goes alone on RSV even with subpar dataset (unlikely because insiders hold good chunk of shares)

Upside is at least double just because of cash plus royalty. Partnership and settlement would mean a homerun. Seems reasonable case.

Plus - CEO is likely ready for a huge pay day and retirement. The stock is at pretty much all time low, whats not to like lol

Dr. Luly’s statement is from yesterday’s PR. Also same was stated 26 Sep on EDP323 call.

Where did the Dr Lilly statement come from?       Thank You!

Their number one priority now is to get back into investors’ radars again, judging from todays price action, I think most out there didnt realize how undervalued this name is.

Hopefully, the upcoming RSV data will help.

I feel the same way
If they are able to partner RSV then the current valuation makes no sense - the partner will share development costs or take it on entirely, enta will retain a stake in the asset, and suddenly you are at 18 cash plus royalty, plus value of the RSV asset

I keep telling myself to keep my expectations low on RSV as the market is paying me to own it (the market currently assigned negative value to it).

Based on tea leaves reading, the data should be pretty solid or at least partnerable

If the data is pretty good they should be able to partner the program. But it might take the validation that comes from a large pharma partner to move the stock (unless the data is very compelling of course)

Do small biotechs ever have stock buyback programs?Not when they are running at a loss and ramping up expenses. A buyback program, even at the current depressed price, would be reckless.

Do small biotechs ever have stock buyback programs? Sure felt like a bottom today.

I think they mentioned the same in one of the call. But probably market will act as a surprise given how awful the sentiment is now

Yeah amd it’s kind of hard to hit a home Run in a 90 patient trial with 2 distinct subgroups the less than 6 months amd 6mo-3 yrs

They are probably hiding a buyout ;)

What an ugly day, thats after a series of down days all the way from 13 to 8.


Their new presentation deck actually look pumped so much potential, but now selling below net cash

Who would have thought

>> not a home run

It is alright that is not a home run, i think the market is pricing in 1) pretty disastrous result from RSV.
2) SG&A will continue to be evaluated in foreseeable future due to on going patent suit. 3) immunology push will be a burst as well

I think the market is punishing the company for not holding a call when there was significant revision to cash guidance and news on the preclinical pipeline. The default is “what are they hiding”

It suggests to me peds data is positive but not a home run amd there is room for improvement hence having 323 for optionality

All the market is an earning miss ans shorten cash runway and then sell it off.

I agree that the some of the drop is due to he small earnings miss. It is meaningless to me. Some of it could be due to a little disappointment that the RSV data isn't out yet.

(Dr. Luly today) “With results from our RSVPEDs study of zelicapavir, our RSV N-inhibitor, expected in December, we could potentially have two of the leading clinical candidates for the treatment of RSV with different mechanisms of action, providing us with important optionality.“

Does that mean ENTA is going to push EDP-323 into a phase 2 trial, alone and or in combination with zelicapavir?

All the market is an earning miss ans shorten cash runway and then sell it off.

Better days ahead.

i would imagine many people feel the same way hence the share price
not holding a call - esp when there was some news altered cash guidance and new preclinical updates - didn't help. on the other hand the company msut be disillusioned w the market and analysts. even those w buy ratings have price targets in the low 20s which still ascribes very little to the clinical programs. so not holding calls w earnings may jsut be a big F you. it is put up or shut up time anyway nothing has changed the odds of success in the rsv study , or the lawsuit, and the discovery engine remains alive and well especially if they can hit really tough targets like the recently announced program

Previous statements led me to believe that all of the doses of EDP-235 were ready for a phase 3 study once a partner was in place.

History casts shadows upon such beliefs. My belief in the man and his company has been crushed in retrospect.

The revised cash runway is significant, so one can only speculate that one reason is resizing of a peds phase 3.... You are correct!

Here's the proof -
At approximately 11:06+ of the 2024 Cantor Global Healthcare Conference (9.17.2024), Tara Kieffer states ,,,,"we are already planning for success..engaging in some early start-up activities for a Phase 3 study" re:RSVPEDS-EDP-938.

Additionally - Tara states - "we would not wait for the Adult study....if PEDS data is supportive, we'd move quickly....to the Phase 3 study"

https://wsw.com/webcast/cantor22/enta/2074968

>> Would Dr. Luly continue to illuminate the possibility of two leading candidates for RSV, knowing the RSVPEDS trial fell short of expectations? I don’t think so…

(Dr. Luly today) “With results from our RSVPEDs study of zelicapavir, our RSV N-inhibitor, expected in December, we could potentially have two of the leading clinical candidates for the treatment of RSV with different mechanisms of action, providing us with important optionality.“

I’ll take that too!

I am hoping for a buyout next couple quarters ;) no funding issues ever.

I agree w DD on this one. I still think ENTA could get 120-150M if they wanted to monetize the remaining royalty stream today even though sales have been slowing. It would be nicer to get a cash injection from the patent suit and or partnering RSV though

Re: Reason for updated cash-runway guidance I thought it could be realization of decreased MAVYRET sales going forward. The outlook for ENTA’s royalty revenue is a small part of the picture, IMO. ABBV’s quarterly Mavyret sales are rather lumpy due to bolus orders by ex-US governments and US agencies such as state departments of correction. Although Mavyret’s sales are clearly in a downward trajectory, the trend line of the descent is gradual.

A ramp-up in R&D for the reasons posited by ‘dewophile’ is by far the bigger factor in the new guidance, IMO.

ENTA updated corporate slides (11/25/24)

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

The latest version of ENTA’s corporate slide set has new info on ENTA’s dual-pronged immunology program in slides 21-33:

• Slides 21-23 provide an overview of the program and the size of the addressable markets.

• Slides 25-29 describe the KIT program, which now has a lead compound called EPS-1421.

• Slides 30-33 have brand new info on the STAT6 (“oral Dupixent”) program that was announced in today’s press release.

Before reading your post, I thought it could be realization of decreased MAVYRET sales going forward.