Veru phase 3 results of sabizabulin for COVID-19 published in NEJM

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• Phase 3 results of sabizabulin, Veru's (NASDAQ:VERU) anti-viral and anti-inflammatory oral drug candidate, have been published in the New England Journal of Medicine.
• Sabizabulin met its primary endpoint. The drug led to a 55.2% relative reduction in deaths in the intent to treat population at day 60.
• The death rate in the placebo arm at that time point was 45.1%, while it was 20.2% in the treatment group.
• Sabizabulin also met secondary endpoints, including reducing days in the ICU, days on ventilation, and days in hospital.
• Veru (VERU) filed for Emergency Use Authorization for sabizabulin in June.

Comments

[LTView]

A placebo arm with 45 percent death rate is high. The 55.2% relative reduction in deaths is misleading as the placebo was a much smaller group than the medicated group. The conclusion of the NEJM article says: "Sabizabulin treatment resulted in a 24.9% absolute reduction in deaths compared with placebo in hospitalized patients with moderate to severe Covid-19 at high risk for ARDS and death, with a lower incidence of adverse and serious adverse events compared with placebo. (Funded by Veru, Inc.; ClinicalTrials.gov number, NCT04842747.)" Still a drug worth taking, but the 55.2% may be misleading as it is ratio to allow for the fact that the placebo group was only 70 people and the total in the trial was 204 patients". A larger trial is needed to determine the ORR.

[parity]

@LTView You gotta stop repeating the old line and review new info. I can't speak to death rates but that is why it is a double blind study which hypothetically would take care of that. Beyond that, if you read the data, the temporal progression of the % reduction in deaths looked consistent. Also, other factors like days in ICU, vent, hospital (which is harder to skew than deaths) also showed better results which would indicate the drug is doing something. Also, it is very common for the treatment group to be much larger than the placebo group.

[LTView]

I am not repeating some old line - this is just published in the NEJM and is the de facto new information. That is why I copied it word for word. You have to speak to death rates as this is a critical measurement. I feel you can rely on the 24.9%, which is good - at the moment this is the best treatment out there. To determine if the so called 55.2%. is real, a larger study is needed. For sure this drug does something and if I was in the hospital, I would take it. However, the valuation risk is a better performing treatment that could obsolete this treatment. Evaluating the mitigation of this risk requires knowing if the ORR is 24.9% or 55.2%. Time will tell.

[parity]

@LTView Thanks for clarifying. I originally read your message as outright bashing the results. Upon a second read, I see you were pretty moderate with the pros and cons. I think there is a higher likelihood than not that this EUA will go through as there is no drug alternative (for the specific indication) but it is not a slam dunk by any means. My bigger concern is what the revenues would be and I do not believe this will see significant recurring rev from the COVID side. Also I agree with you that other drugs in the pipeline with a cleaner profile may also displace this (for ex. Paxlovid tested for use in later stage) as well as less and less people getting to this sick of a stage over time (more vaccinations, immunity from previous infection, and better therapeutics like Paxlovid).

[Mason A]

These are fantastic results considering how far in the disease course these patients are before receiving treatment.

[Defensive Value]

The average price target of 5 analysts is $34.

[All hail the Beatles]

Jeffries just raise the price target big time -Soaring after hours!

[Defensive Value]

@All hail the Beatles If you or anyone else can provide the Jefferies report then that would be very useful.

[cubz811]

@Defensive Value

www.streetinsider.com/...

Essentially they reiterated near term price target of $55. But their valuation model values it at $98 once approved. Amazingly, that didn’t even include revenue outside of the US. They also said that based on the peer review they now expect approval and for it to come within 30 days.

[Defensive Value]

@cubz811 Thanks

[parity]

I've owned this before EUA. I am not sure if FDA will give EUA as the hurdle is higher now that a lot less people are dying, there is lots of vaccinated people and previous infected people, and there are other very effective therapeutics available (though at earlier stages of disease progression). It all ties into less people dying. It depends on how forward looking (to future unknown variants) the FDA is. From current info, I (not a technical expert on FDA/virology etc) would handicap the chance of EUA at 55-65% based on how the advisory panel and FDA approved the Omicron vaccines recently. I also think the data NOT unreasonable (not fake). The question is how much does a EUA mean for the company. I think the upside from the EUA (vs VERA's other drugs/trials) is a $1bn revenue opportunity that is subject to a rapid revenue drop off after the initial stockpiling of governments. So bottom line IMO (with base assumption of no future substantially severe variants), an EUA is not a stock multiple increase in the valuation of the company. There are scaling benefits of the drug if it gets other trial approvals but I do not see VERU as a 2-3 bagger based on an EUA.

[MakeItRaine]

@parity HA! Save this crap for the Yahoo discussion board. We're over $15 AH and we'll surely surpass $20 upon approval of the EUA, which is about a sure a thing as there can possibly be in biotech.
Once purchase price and POs are announced, $30 is a very realistic near term target. That's not to mention ENTADFI which has been approved and will be available soon. Also late stage trials for cancer indications which are already promising. This is the best thing going in biotech at the moment, in my opinion. Nice try though.

[parity]

@MakeItRaine No value added at all from your reply. Please provide some insight other than the stock price went up.

[Drew Richards]

I been in since November. This has been a fantastic ride and waiting for more. Everything is falling in place. Now waiting on FDA to really run this up.

[All hail the Beatles]

Nothing better then being published in the most prestigious medical journal on the planet. Gives FDA even more confidence to approve the drug. I bet there has been any drugs turned down by the FDA after appearing in the NEJM

[FringDook]

Boom Boom Mancini!

[MakeItRaine]

Rallying hard today! Still over 40% short interest, which is just insane. There was a hit piece put out by a short a few months ago claiming all this fraudulent stuff about the trial data and the team. Today’s publication puts that nonsense to rest once and for all. Time to squeeze.

[moneymanag]

@MakeItRaine Agreed , this is a major step in debunking the short story, which sounded convincing but was all based on innuendo and half truths.

[Defensive Value]

@MakeItRaine They will likely get EUA in the next few weeks after which the sp should go to $17-20. Then they will likely start receiving orders from governments which will likely drive the sp to the $25-30 range. Keep in mind Sabizabulin has potential for application for influenza but that's 1-2 yrs away. You're right, the shorts will get crushed.

[MakeItRaine]

@Defensive Value and the squeeze has begun! Over $15 AH. Just getting started.