CytoDyn’s Data: Approvable Drug Sets Stage For Near-Term Move Upward
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HIV Cure Challenger CytoDyn Takes On Gilead Sciences
Cytodyn's Update Provides A Clear Path Towards Approval With Up-Listing Potential Still In The Cards
CytoDyn Investors Sell Despite Positive Recommendation From DSMB And A More Certain Path To COVID-19 Approval
When CytoDyn (CYDY) announced impressive safety results it was drowned out by the messaging that efficacy data was missing from the study. When CytoDyn announced positive efficacy results in the top line data a week later no one paid attention because STAT News declared it a failure. The only failure however, has been on the part of investors who just haven't been able to connect the dots due to all the background noise from STAT News publishing intentionally misleading headlines. Arguably, many investors have been duped by STAT and have sold out of panic. In my honest opinion, this is a clear sign the risk reward valuation on this stock is clearly wrong . Investors who ended up exiting this stock are going to miss one of the biggest buying opportunities of any stock this year.
The bear raids have been so loud and relentless that phenomenal news has fallen on deaf ears. For example, the company did a $25 million fixed convertible stock offering at a 100% premium. The stock barely moved higher. The only universe where this makes any sense is in Feuerstein’s twittersphere. There are two major catalysts in the next two weeks. The unblinding of the CD12 severe to critical COVID-19 trial by the Data Safety Monitoring Committee (DSMC) and top line efficacy results from the mild to moderate COVID-19 trial. Unlike STAT News’ questionably ethical “early peek” at Gilead Sciences (Nasdaq: GILD) data which was not standard and improper, we hope you are enlightened by the “early peek” at the leronlimab trial data by expert analysis from some leading researchers which is the correct way to deliver such information.
Connecting the Dots Means Efficacy
Dr. Jay Lalezari, MD, interim Chief Medical Officer for CytoDyn, helped investors connect the dots on the July 30th shareholder update. He has been a principal investigator (PI) in over 300 clinical trials with an extensive focus on viruses, primarily HIV.His interpretation of the 64% reduction in SAE’s was extremely positive. He went so far as to herald it, a medically relevant endpoint.
“These are the critical endpoints. They're not endpoints that we're used to seeing, because we're not used to seeing a reduction of SAEs in clinical studies. I've been the P.I. of about 300 studies and I have never seen that before, but SAEs are medically significant events, like deaths and intubation.”
Safety results this positive have hardly ever been seen before in any clinical trials. Even in fighting cancer with chemotherapy or immunotherapy, SAE’s increase along with efficacy. Leronlimab is a paradigm shift in medical treatment. The drug is so targeted that no side effects were exhibited in the study, and some scientists like Dr. Bruce Patterson believe it is the precise mechanism of action needed to defeat COVID-19.
One of the roles of a Data Safety Monitoring Board (DSMB) is to stop the trial early if the primary question has been definitively answered. Dr. Bruce Patterson also helped connect some dots on Dr. Yo’s show with regards to an interim check by the DMSC happening on August 3, 2020. The company can have the DMSC do a safety check at any time, but what prompted the request was the safety data from the CD10 trial for mild to moderate COVID-19 patients.
In clinical trials the mild to moderate patient population has been a graveyard for failures because patients normally respond in 4-7 days regardless of an intervention so it's very difficult to show a statistically relevant clinical outcome. The higher the levels of the cytokine storm the more pronounced the effect is supposed to be. Seeing results of efficacy in this early patient population predicts a positive result in the severe to critical trial patient population so the company was almost obligated to ask for this crucial readout. On Dr Yo’s show on Friday July 31 Dr. Patterson was asked to handicap the DSMC meeting.
“I do think it's a better metric than having a clinical score. There was a lot of confusion when Nader mentioned there were a lot of deaths, but what he was actually trying to say was you need a number of deaths to be able to achieve statistical significance. . . . If you have 60 deaths and you have only 20 deaths in the treated group and 40 deaths in the placebo group you've got the numbers on your side to say that is statistically significant. That's what he was trying to say. Not that you have a lot of deaths. ”
What this means is that in the next couple of days it's possible for the DSMC to compare the number of deaths in the active versus placebo arm and make a recommendation to the FDA that the placebo arm be given the active drug and that CytoDyn should be allowed to conduct an interim readout with the purpose of approving the drug.In the past catalysts like this have been extremely rare, but have led to exponential increases in stock price. In 2014 the DSMB recommended the stoppage of Intercept Pharmaceuticals (Nasdaq: ICPT) mid-stage Flint trial for meeting their endpoint. The stock rocketed 280% and then another 50% a day later on the news.
The anecdotal data from over 60 Emergency IND’s was a real blessing in telling the story of whether or not leronlimab would be a good candidate for COVID-19.In their first 2 critical emergency IND’s their patients came off the ventilator in dramatic fashion that some might even call a miracle. These were critically ill patients with only hours left to live and were brought back from the brink. Dr. Lalezari commented in a KRON4 interview
“From our experience no one is too ill to benefit from Leronlimab,” Dr. Jay Lalezari said. “We have had the sickest of the sick, at deaths door, turnaround.”
In Dr. Patersons first interview with Dr. Yo he was recapping a heartfelt story about how he helped save a patient's life with leronlimab. Paterson said that “Anecdotes don’t come off of life support.”This quote has gained so much traction on social media it was actually turned into a T-shirt and raising money toward breast cancer research
Needless to say, the anecdotal data from over 60 Emergency IND’s was a real blessing.
Final Piece of Puzzle – Funding
For a period of time at the market financing was the primary method of financing CytoDyn’s progress going forward. During this period of consolidation the stock was flat but a huge number of warrants was accumulating and peaked at 175 million. Once excitement started brewing in the field of cancer the stock started its upward trajectory to the strike prices of the warrant. After news that leronlimab might be effective against COVID-19 that stock started to appreciate and some of the warrants started being exercised. The warrants are actually serving as a non-dilutive form of financing for the company. This year the warrants brought in $48 million in financing. As of last count 78 million warrants remain.
Early in the pandemic CytoDyn hinted that BARDA funding was a possibility, but since then there has been no follow through. In Mid June the New York Times broke the news that BARDA was no longer looking for treatments of the disease and was myopically focused on vaccines. There was a disproportionate amount of funding whereby vaccines were raking in an estimated $2.2 billion compared to $359 million for treatments. This dearth of funding from the government is what forced the hand of the CEO to use is personal stock as a means to temporarily fund the manufacturing. A time-critical payment to Samsung biologics ensured that 1.1 million vials would be manufactured this year should the drug be approved. If the drug does get FDA approval the CEO assured investors that funding will definitely be on the table.
The final piece holding CytoDyn back was a big funding tranche that would ensure Nasdaq uplisting and get them to the revenue stage. That milestone was reached last Thursday when the company landed $25 million at $10/share which represented a 100% price premium to the market.
Analyst Rating
On July 6, 2020 HC Wainwright analyst Yi Chen downgraded CytoDyn to neutral citing a “rising valuation” and a “myriad of uncertainties.”This may have been prompted by the lack of clarity regarding their pathway to an uplisting, the timing of their clinical trial readouts, and the refuse to file letter for HIV. In the past month CytoDyn has landed a big financing that is likely to result in a Nasdaq uplisting, they have major clinical milestones expected in the next two weeks, and are working with the FDA to get the data that they need to get their PDUFA date. After the next announcement of efficacy it’s realistic that HC Wainwright will review the rating for an upgrade.
Investment Summary
It is easy to make up potential bad news but it is another thing to prove a drug is effective and doesn’t have an adverse effect. Leronlimab has proved beyond a shadow of a doubt that it doesn’t have an adverse effect on patients and has proven it has a positive effect on patients. That said, I believe the FDA is waiting to determine its need and effectiveness on patients including mild to moderate cases and I believe they would like to have a strong enough case to make this a first line drug for Covid. As stated. the results are very positive towards getting that approval in the near term.
What is needed is patience with the FDA’s procedure and not to be scared out of the process. CytoDyn’s prospects are well worth the risk and the appreciation upon approval should well exceed the $10 a share funding that was approved recently. We can then look at it becoming a major player in such things as cancer and HIV as these trials work their way through the approval process as well.
Disclosure: I currently hold shares of CYDY.
The US needs to start discussions with CYDY if they want to guarantee any of their production upon approval as other countries look to get approval before them. They have taken their sweet time going through the process which helps verify its effectiveness. However, many feel that the cost is people are in ICUs that don't need to be.
Good article.
Here is new information by CYDY
seekingalpha.com/.../...p...oval-of-leronlimab-for
When will your next article on $CYDY be out?
Hi I posted a Cytodyn article on Friday about the meeting if you want to check it out.
I like everyone else is waiting for concrete verification of their drug by the FDA since there is so much questionable stuff being said from everyone. Of course, approval from other countries are welcome as well. Anyways, I don't see any compelling evidence against CYDY and what positive news comes out recently has been dashed. We're also still waiting for up-listing from this exchange which should help with the shorts who have been active.
Anyways, my suggestion especially for companies needing FDA approval is don't over extend yourself, be patient, and wait for the findings. Hopefully, we will be rewarded soon.
finance.yahoo.com/.../...nformation-085100961.html
I didn't expect the stock to move down before so hard before the company released approval, an exchange change, or something else. I do give them credit. They released positive data that would usually moves most biotech stocks. I guess the wait continues.
Your reply makes no sense. You give them credit - for what? They missed the primary endpoint, so why are you trying to spin it as "they released positive data"? The stock has gone down because the street can see through the lies and charades the company peddles. As authors, we should not peddle such untruths here.
Perhaps I should have listened to you and stuck to forex which I know. $CYDY is down quite a bit since I first read this.
Do you even understand phase II trials? The trials passed and their goal of showing safety passed with flying colors. Likewise they also passed to go on to phase III and came near passing phase III goals but its a phase II trial so the sample size isn't large enough to prove this result. This is why they are pretty confident of their phase III trial and they proved a phase III result although it was not primary. This was the same for Remdesivir. They are doing phase III trials right now. That is what we are all waiting for.
I have been in the Pharma industry for 22 years. Am the CEO and Chief Medical Officer of a couple of companies. I know clinical trials much better than you. You should have checked my profile before making that stupid statement. Looks like you just don't understand clinical studies. THEY MISSED THE PRIMARY ENDPOINT. Any study can go to phase III if they don't have safety issues. But phase II endpoints usually reflect what will happen in phase III. AND YOU ARE BEING DECEITFUL. The Phase II study they reported was in mild/moderate. They are doing Phase II/III in severe patients. DONT MIX STUDIES. Hopefully no one listened to you or they would have lost money.
The author may be focusing on the positive aspects, but I don't think he was being deceitful.
In my view, presenting only one, positive, aspect of a company, or cherry picking data, while ignoring the negatives, is tantamount to being deceitful. A balanced article should present both the negatives and the positives.
@[Ketan Desai](user:4649), I think it's rare for authors to cover a stock with a completely unbiased view. Most write about a company because they feel strongly one way or the other.
Personally, I feel it's the reader's obligation to do some due diligence and seek out differing opinions and then make an informed decision on whether to invest. That's one of the reasons I love this site - I can read what different intelligent contributors have to say about the same stock. Unfortunately, there isn't much coverage on $CYDY. I think it would be great if you wrote an article about this stock as well so we could see some differing opinions. If you add up all your comments, the article is practically already written!
I'm sorry to have upset you, however, please review the results between the only other drug to make it this far Remdesivir. Likewise, as you yourself mention yourself phase II endpoints. They did meet a phase II endpoint and no the FDA would not usually let a drug go to phase III without meeting one. It does not necessarily need to be the primary endpoint as I stated Gilead also knew this and got approved with Remdesivir.
If you have a bone to pick, pick it with the FDA or with CytoDYN or Gilead since you apparently don't even accept their findings. I am stating the facts as presented. And yes, you are correct that phase II does reflect what will happen in phase III. However, phase III is trying to get approval for mild and moderate cases as well as critical cases. Phase II dealt with critical cases. You may be applying a standard for trials for a different class or set of FDA trials as you are here.
In the case of remdesivir it was classified as an antiviral the drug and was approved for limited use even though it didn’t reduce the viral load and had limited efficacy even in phase III. Understandably, Covid drug approval is confusing. Perhaps this is because there is a crisis going on and there still needs to be approve-able drugs for Covid. Anyways, facts are facts. Once again, I implore you to read the Trial particulars and findings in both these cases.
I respect you and your qualifications, but please, you are confusing people regarding FDA Covid trials and approvals in this case.
Sigh! You just don't get it. THEY MISSED THE PRIMARY ENDPOINT. Secondary endpoints don't get you approval. Your ignorance of clinical trials is profound. Once again, you can miss all endpoints and still go to phase III so long as there is no safety signal. And don't bring Gilead into this. Wag the dog and distract the issues. AND YOU ARE WRONG - PHASE III IN CRITICAL WILL NOT GET APPROVAL FOR MILD/MODERATE. THAT IS A LIE.
Hopefully no one listens to you or they would have lost money.
What you are missing is that they are going for Emergency Use Authorization and then will file for approval. Gilead did that with remdesvir recently. Now the case you make for a critical approval will not result in a mild to moderate approval is naïve. Calling it a lie doesn’t take away from the fact that the FDA will want to control off label use because the safety profile is so good. An approval in either indication could result in an emergency use authorization.
Likewise, calling me ignorant will accomplish nothing. Missing the primary endpoint in a phase II investigational trial is not a big deal. The trial is labeled investigational because they are investigating what will or won’t work. This wasn’t a PIVOTAL phase 2b/3 trial. Missing the primary endpoint in a pivotal trial is a big deal. That is not the case here.
If you want to claim these facts wrong get proof from the FDA as to your claims. I'd be very interested because in a way you are claiming the FDA is also involved in misleading the public by moving phase III trials forward they shouldn't because they know they will fail. This they do not do although, there is no guarantee either that it will succeed or fail in phase III. If you know it will fail it's your money, do what you think you know for a fact. I won't stop you. I see no reason to continue this conversational line.
Let's see if they get emergency use authorization. If they don't let's see if you have the humility to publicly acknowledge that. i will if they do. And you buttress my point that MM and Severe patient trials are different and cannot replace each other. So you ended up supporting exactly what I've been saying.
Petty bickering aside, what's the likelihood of getting the emergency use authorization? What factors come into play?
Very slim. One has to do ones own due diligence. Saying that since someone lent them 20 million, it must be good is very foolish. And the company CEO is a felon who was convicted of wife beating as well as selling fake Indian artifacts. And they release data (or not release data, to be precise, very selectively). So, yes, they are liars.
Since the trial missed its primary endpoint in phase II, the FDA will ask them to conduct at least one phase III study (with 90%) power. Which means more patients, longer timelines, and more money (which the prodigal (wasteful) company does not have much of (see 10K released last week). If they could not meet endpoints in Mild/Moderate patients, chances of meeting it in the Phase II/III severe patients is even less likely as the patients are much sicker.
We differ on this point. I am waiting for more news. It seems like the shorts think any news is bad and seem to blame and discourage the company from reporting (not like they listen to comment boards).
It's up to each investor to decide. If the FDA, the company, or the company that loaned them millions recently thought there was no chance, I doubt any of them would approve doing phase III. The FDA has better things to do, that's why they don't want to do another hydroxychloroquine trial despite the President's insistence. If the company didn't think it had a chance it would not do it to save money. And if the investor didn't think it would work, they most likely would not have loaned them millions. Unfortunately the other person doesn't agree because he thinks the company is lying. If they were fraudulent, I think they would just not do a trial, not submit to the FDA, not bother doing a lot of interviews, and pocket the money.
Anyways, the stock like any drug trial is a risk and it's up to each investor to determine if its worth the risk and how much to invest. I remain invested and positive although I think they have good chances with Cancer and HIV as well. So that makes me a longer term investor.
I hope this helps.
Looks like shorts were right and you were wrong.
Here's is more info although there is a company event today as well.
www.youtube.com/watch
A recent post on CYDYs recent release.
insiderfinancial.com/.../180253/
Cytodyn's Covid result release is very good. It appears there is disappointment that there isn't immediate approval. There may yet be fast approval, however, irregardless the results disclosed so far meet their endpoints. www.otcmarkets.com/.../CytoDyn-Announces-Clinically-Significant-Top-line-Results-from-its-Phase-2-Trial-in-Mild-to-Moderate-COVID-19-Patients Anyhow, the data is going to the FDA. Despite the market's apparent confusion, this is clinically positive news.
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