Atea Pharmaceuticals Inc (AVIR)

[DewDiligence]

AVIR phase-3 COVID trial fails—stock rises:

https://www.globenewswire.com/news-release/2024/09/13/2945844/0/en/Atea-Pharmaceuticals-Provides-Update-on-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Bemnifosbuvir-for-Treatment-of-COVID-19.html

Atea Pharmaceuticals, Inc. (Nasdaq: AVIR)…today announced the outcome of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, versus placebo for the treatment of COVID-19. The trial did not meet the primary endpoint of a statistically significant reduction in all-cause hospitalization or death through Day 29 in the monotherapy cohort of 2,221 high-risk patients with mild to moderate COVID-19.

This trial was a longshot insofar as Bemnifosbuvir is a repurposed HCV drug rather than something designed specifically for SARS-CoV-2. Moreover, the phase-2 trial for Bemnifosbuvir in COVID was unsuccessful, but AVIR plowed ahead anyhow.

I presume the share price is up slightly today because investors know that AVIR won’t waste more money pursuing COVID. AVIR had about $475M of net current assets as of 6/30/24.

AVIR’s CEO, Jean-Pierre Sommadossi, is continuing to pursue a treatment regimen for HCV, which is a rather extreme case of Zebra’s Law (#msg-172559198).

[Monksdream]

AVIR under $4

[DewDiligence]

AVIR reports 2Q24 results—6/30/24 cash=$502.2M—down_from_$542M_at_3/31/24:

https://finance.yahoo.com/news/atea-pharmaceuticals-reports-second-quarter-200500091.html

CC slides:
https://ir.ateapharma.com/static-files/96ee237a-23d9-4515-8401-69794a5327e0

[DewDiligence]

AVIR 1Q24 results:

https://finance.yahoo.com/news/atea-pharmaceuticals-reports-first-quarter-200500150.html

3/31/24 cash = $542M, down from $578M at 12/31/23.

Final results from the phase-3 SUNRISE COVID trial are expected in 2H24 (no change relative to the prior guidance). There are no interim analyses (#msg-174125019).

[Monksdream]

AVIR under $5

[DewDiligence]

AVIR completes enrollment of phase-3 COVID trial—cancels interim analyses:

https://www.globenewswire.com/news-release/2024/03/27/2853010/0/en/Atea-Pharmaceuticals-Completes-Patient-Enrollment-in-Global-Phase-3-SUNRISE-3-Trial-Evaluating-Oral-Antiviral-Bemnifosbuvir-for-COVID-19-in-High-Risk-Patients.html

Atea Pharmaceuticals…today announced that the company has completed enrollment of the global Phase 3 SUNRISE-3 trial evaluating bemnifosbuvir, an oral nucleotide polymerase inhibitor, or placebo for the treatment of COVID-19. Over 2,200 patients were randomized into the supportive care monotherapy cohort… The primary endpoint of the trial is all-cause hospitalization or death through Day 29 post-treatment in the bemnifosbuvir supportive care monotherapy cohort of high-risk patients.

The two planned interim analyses have been canceled:

“Since full enrollment was achieved ahead of the two planned interim analyses for safety and futility by the Data Safety Monitoring Board (DSMB), the analyses are no longer relevant, and in agreement with the DSMB, we will proceed to the full analysis of the trial. We look forward to reporting SUNRISE-3 results in the second half of 2024…

[DewDiligence]

AVIR phase-3 COVID update:

https://finance.yahoo.com/news/atea-pharmaceuticals-reports-fourth-quarter-210500983.html

The first and second interim analyses in the phase-3 COVID trial will be performed in March and in 2Q24, respectively, and the final results will be available in 2H24. 1,400 patients have been enrolled in the bemnifosbuvir monotherapy cohort (the cohort that the primary endpoint is based on).

AVIR had $578M of cash at 12/31/23, which is why they can afford to blow so much money on a longshot trial.

[DewDiligence]

AVIR rejects Tang buyout offer, as expected:

https://www.globenewswire.com/news-release/2023/05/30/2678205/0/en/Atea-Pharmaceuticals%5B%E2%80%A6%5DTang-Capital-Partners-Affiliate-Concentra-Biosciences.html

The offer was for less than AVIR’s cash value.

[DewDiligence]

It's not a serious offering for the reason mentioned in #msg-171974875.

[mwn]

Why is the sp going so far below the offering?

[DewDiligence]

Yes.

[Paullee]

Did you not notice that a CVR of 80% is included in the package?

[DewDiligence]

In other words, AVIR could do better than $5.75/sh by simply liquidating.

[DewDiligence]

AVIR acknowledges Tang buyout offer—makes_no_recommendation_to_shareholders—(yet):

https://www.globenewswire.com/news-release/2023/05/23/2674788/0/en/Atea-Pharmaceuticals-Confirms-Receipt-of-Unsolicited-Proposal-from-Tang-Capital-Partners-Affiliate-Concentra-Biosciences.html

Even thought Tang’s $5.75/sh offer is a big premium to where AVIR was trading prior to the offer, it’s less than AVIR’s cash value per share. Hence, it’s hard to see how AVIR’s BoD could accept the offer. They could make a counter-proposal, of course.

[DewDiligence]

Tang Capital makes_unsolicited AVIR buyout offer@$5.75/sh +CVR—a_55%_premium_to_Friday’s_close:

https://www.sec.gov/Archives/edgar/data/1593899/000121465923007616/z519230sc13d.htm (scan to bottom)

Why does Tang want to acquire AVIR? Presumably for AVIR’s COVID drug, AT-527, such as it is. AT-527 is a polymerase inhibitor that is similar to an HCV drug BMY dropped several years ago due to toxicity. AVIR is conducting a phase-3 trial in high-risk COVID patients using a daily dose of 1100 mg (550mg BID); the trial listing is at: https://www.clinicaltrials.gov/ct2/show/NCT05629962 .

[Awl416]

Volume

[DewDiligence]

AVIR 1Q23 CC transcript:

https://finance.yahoo.com/news/q1-2023-atea-pharmaceuticals-inc-140930636.html

[DewDiligence]

AVIR 1Q23 results:

https://finance.yahoo.com/news/atea-pharmaceuticals-reports-first-quarter-200500951.html

3/31/23 cash = $621M.

[V63]

So AVIR beat its earnings, and now it might bump up a little tomorrow.

[DewDiligence]

AVIR reports final data from phase-2 COVID trial:

https://www.globenewswire.com/news-release/2023/04/12/2645185/0/en/Atea-Announces-Presentation-of-Bemnifosbuvir-Data-Demonstrating-Reduced-Hospitalizations-for-COVID-19-Patients-at-2023-European-Congress-of-Clinical-Microbiology-Infectious-Disease.html

[DewDiligence]

AVIR 4Q22 CC transcript:

https://finance.yahoo.com/news/atea-pharmaceuticals-inc-nasdaq-avir-022000995.html

[DewDiligence]

AVIR 4Q22 results—12/31/22 cash=$647M:

https://www.globenewswire.com/news-release/2023/02/28/2617674/0/en/Atea-Pharmaceuticals-Reports-Fourth-Quarter-and-Full-Year-2022-Financial-Results-and-Provides-Business-Update.html

AVIR expects the interim analysis of the SUNRISE-3 (COVID) phase-3 trial to occur in 2H23. One possible outcome of the interim analysis is increasing the number of patients to provide more statistical power for the final analysis.

[DewDiligence]

AVIR JPM webcast slides:

https://ir.ateapharma.com/static-files/731c461d-37e4-4364-8a12-eb605580b0aa

[DewDiligence]

AVIR 2023 newsflow:

https://finance.yahoo.com/news/atea-pharmaceuticals-highlights-strategic-priorities-120000077.html

[DewDiligence]

AVIR 3Q22 results—9/30/22 cash=$665M:

https://finance.yahoo.com/news/atea-pharmaceuticals-reports-third-quarter-210500282.html

A phase-3 trial of Bemnifosbuvir (f/k/a AT-527) in 1,500 high-risk, non-hospitalized COVID patients is expected to start by the end of 2022. AVIR is defining “high-risk” as: a) age 80+; b) age 65+ with 1 or more major risk factors; or c) an immunocompromised adult of any age.

The daily dose of Bemnifosbuvir is a whopping 1100mg (550mg BID).

[DewDiligence]

AVIR 2Q22 results—6/30/22_cash=$684.5M (down from $705.5M at 3/31/22):

https://finance.yahoo.com/news/atea-pharmaceuticals-reports-second-quarter-200500782.html

[DewDiligence]

AVIR 3/31/22 cash=$705.5M—burning $58.9M in 1Q22...

1Q22 PR:
https://finance.yahoo.com/news/atea-pharmaceuticals-reports-first-quarter-103000747.html

1Q22 CC slides:
https://ir.ateapharma.com/static-files/8a966559-367b-4a3b-96c0-ff21958c0562

[DewDiligence]

LOL re AVIR’s attempt to be relevant:

https://www.globenewswire.com/news-release/2021/12/14/2352116/0/en/Atea-Pharmaceuticals-Introduces-New-Strategic-Clinical-Development-Program-for-AT-527-in-COVID-19.html

[Jake L]

AVIR - Friday Rundown, Monday Expectations

[Wallst_junkie]

Watching for a uptrend

[dealerschool2006]

GOOD JOB!!! ya, by the time I discovered AVIR it had gone up 50% from the bottom...

[crudeoil24]

Wow! That's why you don't hold these Pharma overnight.

AVIR

[TheFinalCD]

wow went sub $11 and traded the whole float, shit it traded the whole OS 1.5x today https://finviz.com/quote.ashx?t=AVIR

[DewDiligence]

Why AVIR's AT-527 program is no-go: #msg-166425975.

[XWAVXALMIMAN]

David v Goliath

Interesting article - check out RDHL

https://www.yahoo.com/entertainment/david-v-goliath-race-develop-123328764.html

[Chess Master]

What a drop

[ecommceo]

Way over sold here.

[Planopenny]

Out at $16, easy $$$

[Docstemcell2020]

Let's go Brandon! FJB :)

[DewDiligence]

AVIR CC slides (largely BS, IMO):

https://ir.ateapharma.com/static-files/d72bd065-82b3-4eeb-ad3a-40c5518d66d6

[Planopenny]

In at $10

[rosemountbomber]

Well the shit just hit the fan. Didn’t meet primary in study. Stock dow $28

[rosemountbomber]

Thanks DD

[DewDiligence]

The primary endpoint in MRK’s molnupiravir trial was the proportion of patients, relative to placebo, who died or needed hospitalization within 28 days:

https://clinicaltrials.gov/ct2/show/NCT04575597

[rosemountbomber]

So I have to confess to my ignorance when it comes to anti-viral clinical trials. It appears that the primary outcome studied in the AT-527 phase 3 trial is evaluated using a Covid 19 Symptom Diary. It does not sound like it is something very precise when asking a patient to score themselves on these 12 questions (which I have not exactly found yet).

But my question is, did the Merck drug molnupiravir get tested using this same method (symptom diary)? It must have been more than that at least as they also measure deaths, etc. - although that may have been secondary outcomes.

[Whalatane]

AVIR presentation tomorrow Oct 5th

https://newsfilter.io/articles/atea-pharmaceuticals-to-present-at-guggenheim-2nd-annual-vaccines--infectious-day-conference-42a958b2016103f267b2f6525ac4ac0c

Kiwi

[crudeoil24]

You bet! > AVIR up 45% @ 50.05

[Whalatane]

Thx for the updates

Kiwi

[crudeoil24]

AVIR up 45% @ 50.05 > premarket.

[crudeoil24]

AVIR > 53M share trading float.