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Post by jckrdu on May 10, 2020 15:11:26 GMT
I no longer hold a position in CYDY for the following reasons regarding recent questionable behavior by the CEO: In summary, the CEO recently sold over 75% of his stock, and explained the stock sale as being an altruistic action on his part (via a blog post by someone else named Pat Monarch), as he claims the money was used to pay Samsung (their manufacturing partner) to ramp-up for expected product demand. This claim could be true.The CEO received over $15M from his stock sales, and the company received approximately $3M as part of the transactions. (These are facts supported by SEC filings.) In subsequent statements, the CEO implies (while not clearly and directly stating it) that the $15M he received was then funneled to Samsung to support manufacturing. However, there are no official SEC filings or other documentation that confirms that the $15M we know the CEO received, was forwarded to Samsung... investors in CYDY must take the CEO's word. In addition, the sequence of events leading up to the CEO's stock sale, and events afterwards... raises some major eyebrows, in my opinion. Below is the summary of the chronology:
Company Promotes that a Major Publication will be Released on May 1st - During the week of April 20th and April 27th, the CEO made multiple statements via Proactive videos (self paid promotions) and a company PR, that a major publication would be publishing results on May 1st from their first 11 patients treated under EIND.
Company Promotes "Complete" BLA Submission Prior to May 1 Investors Call - For weeks leading up to the May 1st Investors call when the publication was expected, the CEO also promised the complete submission of the HIV BLA. On April 27th, a PR noting that the company "Submits Completed BLA" was released.
On April 30th and May 1st, the CEO sold over 75% of his Stock - Many of the transactions were done at over $3 which were recent pps highs. On the May 1st Investors Call - After promoting the "May 1st" publication for over a week, no release or mention of the expected major promised publication was made. On May 6th, after the CEO sold over 75% of his shares, the "pre-print" (non-peer reviewed) manuscript of the publication was made public.On May 8th, after the CEO sold over 75% his shares, the status of the BLA filing was clarified via an official PR - The 5/8 PR states that the FDA will not consider the BLA filing "complete" until the company submits additional data, which they expect to do on May 11th. It's important to note that the FDA told Cytodyn in March of 2020 that this data would be required with the BLA filing. Knowing in March that this data was required for the BLA to be considered complete, CytoDyn went ahead and PR'd that they submitted the "completed" BLA on April 27th, which was simply not true. IMO, this opens the company to investigation by the SEC as they are watching for any companies that try to unfairly profit during this pandemic. As expected and as an additional unwanted headache, Adam Feuerstein has jumped all over this... bringing unwanted negative attention to CYDY.
In my opinion: The chronology above is troubling, as both the promoted May 1 publication didn't happen AND the completed BLA didn't happen, right before the CEO sold over 75% of his stock. Some CYDY investors may be willing to give the CEO a pass on this, but all CYDY investors still holding stock should at least consider this has the potential to be a classic pump-and-dump... and may get someone over at the SEC interested to take a look.
Risks from my perspective:
- Stock Gets Halted By SEC Because of CEOs possible pumping and dumping - See chronology above. Maybe this is a low risk, but IMO it's on the table.
- Warrant Holders May Sell - Approximately 100M warrants are out their at an average cost of .65 cents, per a statement made by a company official on 5/1. If these warrants are all executed, it would bring in $65M in cash thus perhaps enabling to company to uplist, but would put downward pressure on the stock.
- Dilution via 46M S-3 Registered Shares - 46M were recently registered via an S-3. The CEO has since sold more than 75% of his shares that became effective via the S-3, but there may be additional selling pressure out there.
- Dilution via Preferred Shares - If you read the SEC filings and search for "preferred", you'll see the company has approximately 5000 preferred shares that can be issued without shareholder approval.
- Data Results - Results of Phase 2 clinical trial Do Not Meet Endpoints
Conclusions: Based on the positive anecdotal results disclosed from their EIND patients, I do think Leronlimab has promise as a Covid treatment given its method of action, the relatively low treatment cost, and the major advantages offered by a treatment that does not require hospitalization. However, I'm not willing to hold a position at this time given the questionable behavior by the CEO, and the current risks listed above. My Plans: I may take a new position if the large lower gap from $1.37 to $1.90 fills, and the CEO adequately explains (via documented evidence) how his $15M gain from his stock sale was subsequently given to Samsung so manufacturing ramp-up could proceed... as he claimed. Note that the CEO can quickly and easily clear this matter up by providing documented evidence of where his $15M went.Note: The above information are facts that can be backed up by SEC filings, company PRs, and company-paid videos.
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Post by jckrdu on May 10, 2020 15:20:13 GMT
I no longer hold a position in CYDY for the following reasons regarding recent questionable behavior by the CEO: In summary, the CEO recently sold over 75% of his stock, and explained the stock sale as being an altruistic action on his part (via a blog post by someone else), as he claims the money was used to pay Samsung (their manufacturing partner) to ramp-up for expected product demand. This claim could be true.The CEO received over $15M from his stock sales, and the company received approximately $3M as part of the transactions. (These are facts supported by SEC filings.) In subsequent statements, the CEO implies (while not clearly and directly stating it) that the $15M he received was then funneled to Samsung to support manufacturing. However, there are no official SEC filings or other documentation that confirms that the $15M we know the CEO received, was forwarded to Samsung... investors in CYDY must take the CEO's word. In addition, the sequence of events leading up to the CEO's stock sale, and events afterwards... raises some major eyebrows, in my opinion. Below is the summary of the chronology:
Company Promotes that a Major Publication will be Released on May 1st - During the week of April 20th and April 27th, the CEO made multiple statements via Proactive videos (self paid promotions) and a company PR, that a major publication would be publishing results on May 1st from their first 11 patients treated under EIND.
Company Promotes "Complete" BLA Submission Prior to May 1 Investors Call - For weeks leading up to the May 1st Investors call when the publication was expected, the CEO also promised the complete submission of the HIV BLA. On April 27th, a PR noting that the company "Submits Completed BLA" was released.
On April 30th and May 1st, the CEO sold over 75% of his Stock - Many of the transactions were done at over $3 which were recent pps highs. On the May 1st Investors Call - After promoting the "May 1st" publication for over a week, no release or mention of the expected major promised publication was made. On May 6th, after the CEO sold over 75% of his shares, the "pre-print" (non-peer reviewed) manuscript of the publication was made public.On May 8th, after the CEO sold over 75% his shares, the status of the BLA filing was clarified via an official PR - The 5/8 PR states that the FDA will not consider the BLA filing "complete" until the company submits additional data, which they expect to do on May 11th. It's important to note that the FDA told Cytodyn in March of 2020 that this data would be required with the BLA filing. Knowing in March that this data was required for the BLA to be considered complete, CytoDyn went ahead and PR'd that they submitted the "completed" BLA on April 27th, which was simply not true. IMO, this opens the company to investigation by the SEC as they are watching for any companies that try to unfairly profit during this pandemic. As expected and as an additional unwanted headache, Adam Feuerstein has jumped all over this... bringing unwanted negative attention to CYDY.
In my opinion: The chronology above is troubling, as both the promoted May 1 publication didn't happen AND the completed BLA didn't happen, right before the CEO sold over 75% of his stock. Some CYDY investors may be willing to give the CEO a pass on this, but all CYDY investors still holding stock should at least consider this has the potential to be a classic pump-and-dump... and may get someone over at the SEC interested to take a look.
Risks from my perspective:
- Stock Gets Halted By SEC Because of CEOs possible pumping and dumping - See chronology above. Maybe this is a low risk, but IMO it's on the table.
- Warrant Holders May Sell - Approximately 100M warrants are out their at an average cost of .65 cents, per a statement made by a company official on 5/1. If these warrants are all executed, it would bring in $65M in cash thus perhaps enabling to company to uplist, but would put downward pressure on the stock.
- Dilution via 46M S-3 Registered Shares - 46M were recently registered via an S-3. The CEO has since sold more than 75% of his shares that became effective via the S-3, but there may be additional selling pressure out there.
- Dilution via Preferred Shares - If you read the SEC filings and search for "preferred", you'll see the company has approximately 5000 preferred shares that can be issued without shareholder approval.
- Data Results - Results of Phase 2 clinical trial Do Not Meet Endpoints
Conclusions: Based on the positive anecdotal results disclosed from their EIND patients, I do think Leronlimab has promise as a Covid treatment given its method of action, the relatively low treatment cost, and the major advantages offered by a treatment that does not require hospitalization. However, I'm not willing to hold a position at this time given the questionable behavior by the CEO, and the current risks listed above. My Plans: I may take a new position if the large lower gap from $1.37 to $1.90 fills, and the CEO adequately explains (via documented evidence) how his $15M gain from his stock sale was subsequently given to Samsung so manufacturing ramp-up could proceed... as he claimed. Note that the CEO can quickly and easily clear this matter up by providing documented evidence of where his $15M went.Note: The above information are facts that can be backed up by SEC filings, company PRs, and company-paid videos. Below is a link to the post by Pat Monarch (no idea who he is) that is meant to explain how the money from the CEO's stock sale went to Samsung to support manufacturing. When asked for comments on his stock sale, the CEO has referred people to this article. I do not believe this explanation, because 1) it was not made by the CEO, and 2) there is not documented evidence to back it up.
Note that the CEO can quickly and easily clear this matter up by providing documented evidence of where his $15M went.
medicalnewsfirst.com/anatomy-of-cytodyns-ceo-financing-selfless-act-to-save-countless-lives/ |
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Post by jckrdu on May 10, 2020 16:24:50 GMT
One additional point: The Pat Monarch article notes that CYDY received $6M after all the warrants and options were exercised. That could be true and is higher than the $3M I noted in my first post above. It could also be true that the $6M was all that was needed to pay Samsung to keep manufacturing on track, and the CEO simply kept the $15M+ that he received.
But, that still doesn't change anything for me, as the argument Pat Monarch makes is that this was a self-less and altruistic transaction by the CEO. Really? The stock was trading at .29 in November/December 2019 and had a ten-fold increase when the CEO sold at an average pps of $3.25... after the questionable pumping chronology outlined in my first post.
Need to hear directly from the CEO on this matter before I'll get comfortable here again.
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Post by selluwud on May 10, 2020 17:56:03 GMT
One additional point: The Pat Monarch article notes that CYDY received $6M after all the warrants and options were exercised. That could be true and is higher than the $3M I noted in my first post above. It could also be true that the $6M was all that was needed to pay Samsung to keep manufacturing on track, and the CEO simply kept the $15M+ that he received. But, that still doesn't change anything for me, as the argument Pat Monarch makes is that this was a self-less and altruistic transaction by the CEO. Really? The stock was trading at .29 in November/December 2019 and had a ten-fold increase when the CEO sold at an average pps of $3.25... after the questionable pumping chronology outlined in my first post. Need to hear directly from the CEO on this matter before I'll get comfortable here again. I know it's not a tangible issue, but the constant news and PRs this company has been publishing is usually a sure sign of some type of pump and dump or irregularity. |
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Post by morangie777 on May 14, 2020 9:17:51 GMT
I have been following this co for a few weeks now and hold a small position.
I generally agree with your statements, jckrdu, and the concerns.
I guess at this point the main reason that is keeping me invested in this, is the speed at which they go about assessing leronlimab for covid-19.
I have not seen anything like it, in any other biotech i have been following, certainly not at all comparable to the pace shown by another favorite of ours, Athersys.
First with eINDs in an number of hospitals, and then in what seems like no time they launched 2 FDA trials for covid-19, a Ph2 75 patient trial for moderate, and a Ph2/3 390 patient trial for severe cases.
The severe one enrolled 1st patient 4/15.
As per yesterdays update, 25 patients have been enrolled. More sites have been added. Interim analysis after 50 patients.
The moderate one enrolled 1st patient 4/6
As per yesterdays update, 45 out of 75 patients have been enrolled. More sites have been added.
They achieved this without being in any spotlight, without any national media attention, government backing or any other big supporter. From this point of view they are in a similar dark spot as Athersys. yet, the pace they are showing is amazing.
It is going to be interesting and not very long before we see data.
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Post by jckrdu on May 14, 2020 12:17:27 GMT
I have been following this co for a few weeks now and hold a small position. I generally agree with your statements, jckrdu, and the concerns. I guess at this point the main reason that is keeping me invested in this, is the speed at which they go about assessing leronlimab for covid-19. I have not seen anything like it, in any other biotech i have been following, certainly not at all comparable to the pace shown by another favorite of ours, Athersys. First with eINDs in an number of hospitals, and then in what seems like no time they launched 2 FDA trials for covid-19, a Ph2 75 patient trial for moderate, and a Ph2/3 390 patient trial for severe cases. The severe one enrolled 1st patient 4/15. As per yesterdays update, 25 patients have been enrolled. More sites have been added. Interim analysis after 50 patients. The moderate one enrolled 1st patient 4/6 As per yesterdays update, 45 out of 75 patients have been enrolled. More sites have been added. They achieved this without being in any spotlight, without any national media attention, government backing or any other big supporter. From this point of view they are in a similar dark spot as Athersys. yet, the pace they are showing is amazing. It is going to be interesting and not very long before we see data. Agree. They are moving fast and the therapy does look promising. Should get results of the Phase 2 in June. I got back in with a small position. Still watching, and holding my nose at all the risks. |
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Post by jckrdu on May 27, 2020 14:16:18 GMT
Out of CYDY for now. Will wait to see terms of financing they secure to enable uplist.
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Post by morangie777 on Jun 23, 2020 15:44:17 GMT
This is a very strong TedX talk by Dr Patterson of IncellDx from last week and listening to it was well worth my time with regards to CYDY and covid in general. www.youtube.com/watch?v=tPMHZiR_htQHis thesis for the MOA of covid is that the CCL5/RANTES protein is the origin for what later develops into the cytokine storm. Which is where Leronlimab comes in. interesting stuff. |
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Post by tatshensini on Jun 25, 2020 17:57:23 GMT
CytoDyn Leronlimab CYDY Long in at $3.20 Bruce Patterson may turn out to win the Nobel Prize if his theory of COVID-19 being a RANTES disease is correct. I really like this guy involved, otherwise, I would not invest a dime. Another You Tube video of DR.'s Patterson, Hansen,Yogendra Leronlimab, RANTES, COVID-19 (Coronavirus) Discussion with Dr. Bruce Patterson of IncellDX 7,063 views•Streamed live on May 17, 2020 www.youtube.com/watch?v=xUboPq8vbUg |
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Post by morangie777 on Jun 26, 2020 9:13:09 GMT
This week, so far Mo-Th, has been phenomenal with the PPS stair stepping up 100% and volume still accelerating.
I took a little bit out, but holding the bigger part. the main catalysts are still pending in July.
Near term catalysts:
1) Uplisting to major exchange expected soon (could be any day, could be weeks out)
2) FDA feedback on BLA review timeline for HIV combo, Jul 10th
3) Interim Readout Serious/Critical Covid. Co stated on Jun 11th that they will have results in 2-3 weeks, i.e. Jul 2nd. That does not necessarily mean though that they are ready for publishing on that day, but likely soon after.
4) Primary endpoint readout Mild/Moderate Covid. Co stated on Jun 11th that they met the enrollment target of 75. Patients are evaluated for 14 days. This would put data to be available this week. However, they also said that they over enrolled, i.e. more patients were screened than planned, so they will exceed the target of 75 patients. This may mean that last patient enrollment was actually later than Jun 11th. So we may be looking at data available beginning of July here too.
#1 is a big enabler but not a must. #3 and #4 are obviously the major near term, possibly binary catalysts.
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Post by morangie777 on Jul 6, 2020 14:41:15 GMT
Worth watching, but lengthy. The Dr Been interview with CEO from Saturday. www.youtube.com/watch?v=WiyjIIpkIJwOn the expected events/catalysts side there are some changes, my interpretations, from memory: 1) Uplisting: this wont happen near term. CEO wants to go to Nasdaq (instead of prev. NYSE) as CYDY now meets Nasdaq share price req. Capital raise would be required for uplist. He does not want to do that at current price level. So ... while no near uplist is a bummer, CEO shows confidence to be able to raise capital at much higher PPS later after results. 2) FDA feedback on BLA review timeline for HIV combo, Jul 10th. No update. Still expected 3) Interim Readout Serious/Critical Covid. prev. guided to happen after 51 patients. new guidance is it will happen together with readout of Mild/Moderate. so the M/M readout drives the timeline. CEO stated current enrollment at about 120 in S/C. 4) Primary endpoint readout Mild/Moderate Covid. Last week all 85 patients finished the primary portion of the trial (2 weeks read out). CEO says they are now waiting for all the hospitals to release the data, then it will be locked and then unblinded. Says, results will be public in July, but did not want to narrow it down more. 5) 4 covid papers are in the making. 1 already known and pre-published by Dr Patterson. CEO announced 3 more papers by 3 different doctors who had treated patients with leronlimab under eIND at different hospitals. But as to when either of these will be peer reviewed and published, we are in the dark. Other developments from last week finance.yahoo.com/news/cytodyn-announces-execution-exclusive-agreement-100010658.htmlDistribution agreement for leronlimab for covid signed with American Regent. |
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Post by jckrdu on Jul 7, 2020 18:07:56 GMT
Worth watching, but lengthy. The Dr Been interview with CEO from Saturday. www.youtube.com/watch?v=WiyjIIpkIJwOn the expected events/catalysts side there are some changes, my interpretations, from memory: 1) Uplisting: this wont happen near term. CEO wants to go to Nasdaq (instead of prev. NYSE) as CYDY now meets Nasdaq share price req. Capital raise would be required for uplist. He does not want to do that at current price level. So ... while no near uplist is a bummer, CEO shows confidence to be able to raise capital at much higher PPS later after results. 2) FDA feedback on BLA review timeline for HIV combo, Jul 10th. No update. Still expected 3) Interim Readout Serious/Critical Covid. prev. guided to happen after 51 patients. new guidance is it will happen together with readout of Mild/Moderate. so the M/M readout drives the timeline. CEO stated current enrollment at about 120 in S/C. 4) Primary endpoint readout Mild/Moderate Covid. Last week all 85 patients finished the primary portion of the trial (2 weeks read out). CEO says they are now waiting for all the hospitals to release the data, then it will be locked and then unblinded. Says, results will be public in July, but did not want to narrow it down more. 5) 4 covid papers are in the making. 1 already known and pre-published by Dr Patterson. CEO announced 3 more papers by 3 different doctors who had treated patients with leronlimab under eIND at different hospitals. But as to when either of these will be peer reviewed and published, we are in the dark. Other developments from last week finance.yahoo.com/news/cytodyn-announces-execution-exclusive-agreement-100010658.htmlDistribution agreement for leronlimab for covid signed with American Regent. Back in CYDY with a small position that I intend to hold thru data. $20+ if data meets endpoints, IMO. Crashes down under $2 if they miss. |
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Post by morangie777 on Jul 15, 2020 14:14:45 GMT
This thing is quite the roller coaster ride.
Just since June from 3 to 10. Back to < 3. Now hovering just below 5.
The communication and expected events are as fluid as the PPS, lol.
But at the very least things are moving and approaching major catalysts shortly.
1) Uplisting: per recent CEO statement, application to NASDAQ has been submitted. No longer mentions the required capital raise. Resolved? By cash inflow from warrant execution perhaps? Unclear. in any case not a near term catalyst. Will take a few weeks to 2 months for the move to happen (if it happens)
2) BLA for HIV combo. FDA requested more data last week. Per CEO will not be an issue to put together this data. But for HIV combo, at the minimum this introduces another unexpected delay. maybe 1 month added?
3) C12 S/C (covid serious/critical trial). CEO no longer talking about interim readout. Instead intends for DSMB to assess the trial this or next week, and then make a recommendation to FDA how to proceed. It is not clear how long this process takes, and when we can expect a PR on this. possible DSMB review outcomes are: Continue as planned / Continue but with modification, e.g. to a certain number of enrollees (more or less than planned) / Stop for safety issues / Stop for futility / Stop for efficacy
4) C10 M/M (covid mild/moderated trial) Per CEO, Data unblinding will happen by end of this week. Then follows analysis. Hinted at communication/PR for next week. I would not be surprised if this slips by a week, but who knows. This is the nearest term catalyst and may cause a buy the rumor effect.
5) Papers status unknown. A lot of noise in the community about possible issues with Pattersons paper or even a rift between Patterson and CYDY. Nothing definitive. All rumors at this point, maybe planted rumors. But for sure the Patterson paper publication is MIA.
CEO has stated in the past that he would like/try to publish results of C10 and interim of C12 at the same time. Seems unlikely, but is a possibility.
Exciting couple weeks ahead. Buckle up.
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