AVIR rejects Tang buyout offer, as expected:
The offer was for less than AVIR’s cash value.
Did you not notice that a CVR of 80% is included in the package?
In other words, AVIR could do better than $5.75/sh by simply liquidating.
AVIR acknowledges Tang buyout offer—makes_no_recommendation_to_shareholders—(yet):
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.
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 .
AVIR 1Q23 results:
3/31/23 cash = $621M.
AVIR reports final data from phase-2 COVID trial:
AVIR 4Q22 results—12/31/22 cash=$647M:
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.
AVIR 3Q22 results—9/30/22 cash=$665M:
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).
AVIR 2Q22 results—6/30/22_cash=$684.5M (down from $705.5M at 3/31/22):
AVIR 3/31/22 cash=$705.5M—burning $58.9M in 1Q22...
1Q22 CC slides:
Watching for a uptrend
Wow! That's why you don't hold these Pharma overnight.
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
AVIR CC slides (largely BS, IMO):
The primary endpoint in MRK’s molnupiravir trial was the proportion of patients, relative to placebo, who died or needed hospitalization within 28 days:
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.
Thx for the updates
AVIR up 45% @ 50.05 > premarket.
AVIR > 53M share trading float.
Atea Pharmaceuticals to Present at Guggenheim 2nd Annual Vaccines & Infectious Day Conference
7:00 am ET September 29, 2021 (Globe Newswire) Print
Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) ("Atea"), a clinical-stage biopharmaceutical company, today announced that Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea together with other members of the Atea management team, will participate in a fireside chat at the Guggenheim 2nd Annual Vaccines & Infectious Day Conference on Tuesday, October 5, 2021 at 9:30 a.m. ET.
A live webcast of the presentation will be available here and on the Company's website at www.ateapharma.com. A replay of the webcast will be available for 90 days following the presentation.
About Atea Pharmaceuticals
Atea Pharmaceuticals is a clinical stage biopharmaceutical company focused on discovering, developing and commercializing oral therapies to address the unmet medical needs of patients with life-threatening viral diseases. Leveraging the Company's deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleotide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of severe viral diseases. Currently, Atea is focused on the development of orally-available, potent, and selective nucleotide prodrugs for difficult-to-treat, life-threatening viral infections, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For more information, please visit www.ateapharma.com.
SVP, Investor Relations and Corporate Communications
AVIR up 30% @ 45.00 > As Barron's reported in a magazine feature earlier this month , the pills have the potential to play an enormous role as the world adapts to an endemic threat from Covid-19. Even if the antivirals from Merck, Pfizer, the biotech Atea Pharmaceuticals (AVIR), and others, are only moderately effective, they are likely to be in enormous demand globally as patients and governments seek to blunt the human toll of the virus.
The stock is overvalued, IMO.
The mid-cap biotech Atea Pharmaceuticals is a frontrunner in the race to develop a Covid-19 antiviral, and its share price could double if an ongoing trial returns positive data, according to a note out early Thursday from SVB Leerink .
Atea (ticker: AVIR) is one of a number of companies developing Covid-19 antivirals, amid an emerging consensus that the virus that causes Covid-19 will remain a global health challenge for the long-term.
Big pharma giants Merck (MRK) and Pfizer (PFE) both are developing their own Covid-19 antiviral pills, but SVB Leerink analyst Roanna Ruiz writes in her Thursday note that the Covid-19 therapeutic market is "not a zero-sum game."
Atea's pill, known as AT-527, works differently from the Pfizer and Merck antivirals in development. The company is partnering with Roche (RHHBY) on development of the drug, which produced positive data in a Phase 2 trial. It is currently in a Phase 3 trial in non-hospitalized patients.
The trial is expected to produce data in the second half of this year. If those results are positive, Ruiz writes, they would be enough for the company to go to the U.S. Food and Drug Administration for emergency authorization.
If the FDA approves the drug, Ruiz projects that it could hit $2.3 billion in peak annual sales.
Ruiz initiated her coverage of the stock with an Outperform rating on Thursday and a $60 target price. The stock closed Wednesday at $27.70 and was up 0.2% on Thursday. Shares are down 33.6% this year amid a broader pullback among small and midcap biotech names.
In addition to the Phase 3 study of AT-527 in non-hospitalized patients with mild to moderate Covid-19, which will read out in the second half of this year, the company is running other trials of the drug, including one set to start this year that will test the drug as a prophylaxis. Ruiz estimates that the company could submit the drug for FDA authorization in late 2021 or early 2022.
"AT-527 could be one of the first approved oral antiviral therapies against Covid-19 and [key opinion leaders] are desperate for more convenient options," Ruiz wrote.
Amid the intense focus on Covid-19 vaccines, the effort to develop Covid-19 therapeutics has received substantially less attention. While a number of Covid-19 therapeutics do exist, all of the authorized options are either relatively ineffective or relatively inconvenient. The best available treatments, monoclonal antibody therapies from companies like Regeneron Pharmaceuticals (REGN), require patients to go to clinics to receive infusions.
In her note, Ruiz notes that Merck's molnupiravir may be ahead of AT-527 in terms of timing. Still, she writes that the market for a Covid-19 oral antiviral is big enough for more than one drug.
"We believe investors are watching molnupiravir and AT-527 closely, as both are in Phase 3 trials to treat outpatient COVID19; however, we do not think that this is a zero-sum game, and we think both orals would be used broadly in practice," Ruiz writes.
She says that Pfizer's oral antiviral, known as PF-00835231, may be a bit behind molnupiravir and AT-527, but is still a key competitor. "Despite it being slightly behind Merck/Atea, Pfizer's oral protease inhibitor could become a viable outpatient treatment option for COVID-19 if its antiviral efficacy is reiterated in the recently initiated larger Phase 2/3 trial," she writes.
Write to Josh Nathan-Kazis at firstname.lastname@example.org
2 trials estimated to end within a week.
Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19
Actual Study Start Date : February 3, 2021
Estimated Primary Completion Date : June 3, 2021
Estimated Study Completion Date : June 3, 2021
Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19)
Actual Study Start Date : May 26, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : May 2021